 |
|
 |
EMERITUS NEWS CHANNEL ON LIVESTREAM - Click on video frame for larger display or to control audio- Click here for segment schedule |
|
|
EMERITUS NEWS HEALTH CARE
SUSAN G. KOMEN FOUNDATION REVERSES DECISION / WILL NOT CUT OFF FUNDS FOR BREAST CANCER SCREENINGS AT PLANNED PARENTHOODMore from the Emeritus Newsroom- After two days of blistering public attacks, the Susan G. Komen Foundation reversed its decision to cut funding for breast cancer screenings done by Planned Parenthood. Despite denials that politics were involved with the decision, the Komen Foundation had difficulty explaining the criteria for their decision, which was partially based on Planned Parenthood being investigated by House Republicans over the use of federal funds. Critics accused Komen of having double standards since other providers, such as Penn State University received foundation assistance despite the athletic department's sex scandal investigation. Today, the Komen Foundation said it would NOT cut Planned Parenthood's assistance. Founder and CEO Nancy G. Brinker, said in a statement,"We want to apologize to the American public for recent decisions that cast doubt upon our commitment to our mission of saving women’s lives. The events of this week have been deeply unsettling for our supporters, partners and friends and all of us at Susan G. Komen. We have been distressed at the presumption that the changes made to our funding criteria were done for political reasons or to specifically penalize Planned Parenthood. They were not.
We extend our deepest thanks for the outpouring of support we have received from so many in the past few days and we sincerely hope that these changes will be welcomed by those who have expressed their concern". Planned Parenthood responded to today's developments, with a statement of their own. “The outpouring of support for women in need of lifesaving breast cancer screening this week has been astonishing and is a testament to our nation's compassion and sincerity. “During the last week, millions spontaneously joined a national conversation about lifesaving breast cancer prevention care and reinforced shared values about access to health care for all. This compassionate outcry in support of those most in need rose above political, ideological, and cultural divides, and will surely be recognized as one of our nation's better moments during a contentious political time. Planned Parenthood thanks each and every person who has contributed to elevating the importance of breast cancer prevention for so many women in need. “In recent weeks, the treasured relationship between the Susan G. Komen for the Cure Foundation and Planned Parenthood has been challenged, and we are now heartened that we can continue to work in partnership toward our shared commitment to breast health for the most underserved women. We are enormously grateful that the Komen Foundation has clarified its grant making criteria, and we look forward to continuing our partnership with Komen partners, leaders and volunteers. What these past few days have demonstrated is the deep resolve all Americans share in the fight against cancer, and we honor those who are at the helm of this battle. “Planned Parenthood has been a trusted partner with the Komen Foundation in early cancer detection and prevention services. In particular, Planned Parenthood helps the Komen Foundation reach vulnerable populations — low-income women, African-American women, and Latinas — especially in rural areas and under served communities where Planned Parenthood health centers are their only source of health care. With Komen Foundation grants, over the past five years, Planned Parenthood health centers provided nearly 170,000 clinical breast exams and more than 6,400 mammogram referrals. With the outpouring of support over the past week, even more women in need will receive lifesaving breast cancer care.” Planned Parenthood made no specific mention, what will be done with all the money donated in recent days to make up for the amount the group was expected to lose from Komen's original decision. Other issues involve health care advocates distrust, arising from the earlier decision, which may simmer despite attempts to heal wounds from the public outrage. Full text of Komen Foundation statement, click here. Full text of Planned Parenthood statement, click here. 02/03/2012 SUSAN G. KOMEN FOUNDATION ENDS SUPPORT FOR BREAST EXAMS THROUGH PLANNED PARENTHOOD / POLITICS BLAMED, KOMEN DENIES ITMore from the Emeritus Newsroom- Beyond the businesslike language from both sides, there is bitterness over what some consider an under the table attempt to cut funding for Planned Parenthood. The Susan G. Komen Foundation has announced it is ending subsidization of breast cancer screenings at Planned Parenthood locations. Critics of the decision claim its inner circle anti-abortion politics within the foundation. Komen denies this. In a video below, without mentioning Planned Parenthood by name, Komen's sister and foundation CEO, Nancy Brinker, says it comes down to providing better services for donations received, not political pressure. However, the Foundation cites no specifics as to why they are ending their relationship with Planned Parenthood nor has it made any statement confirming their decision was due to a congressional investigation of the group. Republicans in the House are investigating Planned Parenthood over their use federal funding. So far, there has been no prosecution of any wrongdoing. Critics claim it's a "witch hunt".
In their response to the Komen Foundation decision, Planned Parenthood claims that over the past five years, their health centers, with Komen program funding, have provided nearly 170,000 clinical breast exams out of the more than four million clinical breast exams performed nationwide at Planned Parenthood health centers, as well as more than 6,400 mammogram referrals out of 70,000 mammogram referrals. Anti-choice groups in America have repeatedly threatened the Susan G. Komen for the Cure Foundation for partnering with Planned Parenthood to provide these lifesaving cancer screenings. Nationwide, Planned Parenthood doctors and nurses provide nearly 750,000 breast cancer screenings annually, offering risk assessments, breast exams, breast health information and education, and diagnostic and surgical referrals. Planned Parenthood says s $250,000 gift from the Amy and Lee Fikes’ Foundation has established a Breast Health Emergency Fund to provide immediate funding to ensure that Planned Parenthood health centers can continue to provide breast cancer screenings and care that had previously been supported by Komen. Text of Susan G. Komen statement, click here. Planned Parenthood statement, click here. 02/02/2012 BIRTH CONTROL PACKAGING ERROR FORCES PFIZER RECALLSMore from the Emeritus Newsroom- Pfizer Inc. announced today that it has voluntarily recalled 14 lots of Lo/Ovral®-28 (norgestrel and ethinyl estradiol)Tablets and 14 lots of Norgestrel and Ethinyl Estradiol Tablets (generic)for customers in the U.S. market. An investigation by Pfizer found that some blister packs may contain an inexact count of inert or active ingredient tablets and that the tablets may be out of sequence. The cause was identified and corrected immediately. These products are oral contraceptives indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. These tablets were manufactured and packaged by Pfizer Inc., commercialized by Akrimax Rx Products and labeled under the Akrimax Pharmaceuticals brand. This product is distributed to warehouses, clinics and retail pharmacies nationwide. As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy. These packaging defects do not pose any immediate health risks. However, consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately. Patients who have the affected product (lot numbers are provided below) should notify their physician and return the product to the pharmacy. These products are packaged in blister packs containing 21 tablets of active ingredients and seven tablets of inert ingredients. Correct dosing of this product is important in avoiding the associated risks of an unplanned pregnancy. Correctly Packaged LoOrval Blister Pack Image - www.pfizer.com/img/news/LoOvralCorrectPkg.jpg Pfizer press release, click here. 02/01/2012 FDA APPROVES FIRST DRUG TO TREAT UNDERLYING CAUSE OF CYSTIC FIBROSISMore from the Emeritus Newsroom- Cambridge, Massachusetts based, Vertex Pharmaceuticals announced today it has approval from the Food and Drug Administration to sell a drug used to treat the underlying cause of cystic fibrosis. According to the company, the FDA has approved KALYDECOTM (ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis (CF), a rare, genetic disease. KALYDECO (kuh-LYE-deh-koh) is approved for people with CF ages 6 and older who have at least one copy of the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Approximately 1,200 people in the United States, or 4 percent of those with CF, are believed to have this mutation. KALYDECO was granted approval in approximately three months, making it one of the fastest FDA approvals ever and marking the second approval of a new medicine from Vertex in less than a year. The company has established a financial assistance and patient support program to help get KALYDECO to eligible patients for whom it is prescribed. KALYDECO was discovered as part of a collaboration with Cystic Fibrosis Foundation Therapeutics, Inc., the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation. Vertex states it is ready to support the introduction of KALYDECO and will begin shipping it to pharmacies in the United States this week. "More than 13 years ago we set out to change the lives of people with cystic fibrosis by developing new medicines that address the underlying cause of this rare and devastating disease," said Jeffrey Leiden, M.D., Ph.D., Vertex's incoming President and Chief Executive Officer. "KALYDECO represents a major advance in the treatment of cystic fibrosis for people with a specific type of this disease. But our work isn't done. With the ongoing support of doctors, patients and the Cystic Fibrosis Foundation, we're making progress toward our ultimate goal of developing additional medicines to help many more people with cystic fibrosis." Vertex explains approval of KALYDECO was based on data from two Phase 3 studies of people with CF who have at least one copy of the G551D mutation. Those who were treated with KALYDECO experienced significant and sustained improvements in lung function as well as other disease measures, including weight gain and certain quality of life measurements, compared to those who received placebo. People who took KALYDECO also experienced significantly fewer pulmonary exacerbations, which are periods of worsening in the signs and symptoms of the disease that often require treatment with antibiotics and hospital visits. Fewer people in the KALYDECO treatment groups discontinued treatment due to adverse events than in the placebo groups. The majority of adverse events associated with KALYDECO were mild to moderate. Adverse events commonly observed in those taking KALYDECO included headache, upper respiratory tract infection (common cold), stomach pain and diarrhea. Full text of Vertex press release, click here. 01/31/2012 FDA APPROVES DRUG TO TREAT TYPE 2 DIABETESMore from the Emeritus Newsroom- After years of delays due to potential side effects, Amylin Pharmaceuticals was given approval by the FDA to market a weekly treatment for Type 2 diabetes. A statement from the company claims BYDUREON™ (exenatide extended-release for injectable suspension) is the first once-weekly treatment for type 2 diabetes. the company describes BYDUREON as a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes in multiple clinical settings. BYDUREON will be available in pharmacies nationwide in February. Full text of Amylin announcement, click here - More in this article from the New York Times, click here - 01/27/2012 U-S TEEN PREGNANCY RATE HIGHEST IN DEVELOPED WORLDMore from the Emeritus Newsroom- In its morbidity and mortality report released today, the Centers for Disease Control says approximately 400,000 teens aged 15–19 years give birth every year in the United States , and the teen birth rate remains the highest in the developed world . This, despite recent decreases in the U-S rate. Teen childbearing is a public health concern because teen mothers are more likely to experience negative social outcomes, including school dropout . In addition, infants of teen mothers are more likely to be low birth weight and have lower academic achievement, and daughters of teen mothers are more likely to become teen mothers themselves . To learn why teens wishing to avoid pregnancy become pregnant, CDC analyzed data from the 2004–2008 Pregnancy Risk Assessment Monitoring System (PRAMS). This report describes estimated rates of self-reported pre pregnancy contraceptive use among white, black, and Hispanic teen females aged 15–19 years with unintended pregnancies resulting in live births. Approximately one half (50.1%) of these teens were not using any method of birth control when they got pregnant, and of these, nearly one third (31.4%) believed they could not get pregnant at the time; 21.0% used a highly effective contraceptive method (although less than 1% used one of the most effective methods, such as an intrauterine device [IUD]); 24.2% used the moderately effective method of condoms; and 5.1% used the least effective methods, such as rhythm and withdrawal. Some teens (22.2% of respondents) indicated that they would not mind if they got pregnant. Other reasons included lack of access (13.1% reported having trouble getting birth control) and experiencing side effects from contraception (9.4%). Reasons for nonuse of contraception did not vary substantially by age, race, or ethnicity. However, Hispanic teens were more likely to report that they did not use contraception because they thought they could not get pregnant at the time (42.0%) than both non-Hispanic white (26.7%) and non-Hispanic black (31.9%) teens (p<0.001). Furthermore, Hispanic teens were less likely (4.2%) than non-Hispanic white (9.8%) and non-Hispanic black (12.2%) teens to report avoiding contraceptives because of side effects (p<0.001). Finally, older teens were more likely to report nonuse because of side effects of contraception (10.8%) than younger teens (6.8%) (p<0.01). The CDC recommends more effort to reduce or delay the onset of sexual activity, provide factual information about the conditions under which pregnancy can occur, increase teens' motivation and negotiation skills for pregnancy prevention, improve access to contraceptives, and encourage use of more effective contraceptive methods. Full text of CDC teen pregnancy report, click here. 01/20/2012 NEW RULES ON DRUG COMPANY PAY TO DOCTORS NEAR FINAL APPROVAL / PUBLIC COMMENT PERIOD TILL FEB. 17THMore from the Emeritus Newsroom- Part of the health reform legislation passed by congress and signed by President Obama in 2010, requires disclosure of drug company and medical care suppliers compensation to doctors and other medical providers. A public comment period continues through February 17th before those new rules are effective. According to the Federal Register, Section 6002 of the Affordable Care Act added section 1128G to the Social Security Act (the Act), which requires applicable manufacturers of drugs, devices, biologicals, or medical supplies covered under title XVIII of the Act (Medicare) or a State plan under title XIX (Medicaid) or XXI of the Act (the Children's Health Insurance Program, or CHIP) to report annually to the Secretary certain payments or other transfers of value to physicians and teaching hospitals. Section 1128G of the Act also requires applicable manufacturers and applicable group purchasing organizations (GPOs) to report certain information regarding the ownership or investment interests held by physicians or the immediate family members of physicians in such entities. Specifically, manufacturers of covered drugs, devices, biologicals, and medical supplies (applicable manufacturers) are required to submit on an annual basis the information required in section 1128G(a)(1) of the Act for certain payments or other transfers of value made to physicians and teaching hospitals (collectively called covered recipients) during the course of the preceding calendar year. Similarly, section 1128G(a)(2) of the Act requires applicable manufacturers and applicable GPOs to disclose any ownership or investment interests in such entities held by physicians or their immediate family members, as well as information on any payments or other transfers of value provided to such physicians. Applicable manufacturers must report the required payment and other transfer of value information to CMS in an electronic format by March 31, 2013, and on the 90th day of each calendar year thereafter. Applicable manufacturers and applicable GPOs must report the required information about physician ownership and investment interests, including those held by immediate family members, as well as information on any payments or other transfers of value to such physician owners or investors in the same format, by the same date. Applicable manufacturers and applicable GPOs are subject to civil monetary penalties (CMPs) for failing to comply with the reporting requirements of the statute. We are required by statute to publish the reported data on a public Web site. The data must be downloadable, searchable, and easily aggregated. In addition, we must submit annual reports to the Congress and each State summarizing the data reported. Finally, section 1128G of the Act generally preempts State laws that require disclosure of the same type of information by manufacturers. The rules were passed by congress due to increasing concern over patient care which may be influenced by unreported compensation or other relationships unknown to patients or the general public. Federal Register listing and details of proposed draft rules and comment instructions, click here. 01/17/2012 DRUG MAKER NOVARTIS RECALLS BUFFERIN, EXCEDRIN, GAS-X AND NO DOZ / MISLABELING, BROKEN PILLS AND GEL CAPS TEMPORARILY CLOSE FACTORY IN NEBRASKAMore from the Emeritus Newsroom-Drug maker Novartis has announced the recall of four over-the-counter medications and the temporary closing of the Nebraska facility which produced them. According to a company statement, a voluntarily recall has been ordered on ALL lots of select bottle sizes of Excedrin® and NoDoz® products with expiration dates of December 20, 2014 or earlier as well as Bufferin® and Gas-X® Prevention® products with expiry dates of December 20, 2013 or earlier, in the United States. Novartis says is taking this action as a precautionary measure, because the products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets. As this is a voluntary recall at the consumer level, Novartis Consumer Health advises consumers who have purchased these recalled products to discontinue use and return them to Novartis Consumer Health for a full refund. Consumers that have the product(s) being recalled should contact the Novartis Consumer Relationship Center at 1-888-477-2403 (available Monday-Friday 9 a.m. to 8 p.m. Eastern Time) for information on how to return the affected products and receive reimbursement. Consumers also may click here to obtain a form to obtain a refund. These actions have been communicated to the US Food and Drug Administration (FDA). We are working closely with the FDA and will continue to do so throughout this process. The company also detailed problems that led to the recall.
SHORTAGE OF A-D-H-D DRUGS BLAMED ON PROFIT CENTRIC DRUG COMPANIES AND BATTLE BETWEEN TWO GOVERNMENT AGENCIESMore in this article from Slate, click here - 01/02/2012 DRUG ABUSE THE NUMBER ONE CAUSE OF DEATH IN U-S / PRESCRIPTION DRUG ABUSE RISESMore in YouTube video below from Voice of America- 12/28/2011
BREAST CANCER TREATMENT UPDATE: RED FLAGS FOR FASTER RADIATION THERAPY / LATEST ON OTHER TREATMENT COMPARISONS REVEALED AT SYMPOSIUM THIS WEEKMore from the Emeritus Newsroom- Two major stories involving breast cancer treatment emerged this week during a forum being held in San Antonio, Texas. One involves a finding that an accelerated radiation treatment program, common in breast cancer treatment circles, may actually increase the chance of a mastectomy. Click here for article on the story from the New York Times. Another survey, this one from Britain, released this week by the Early Breast Cancer Trialists Collaborative Group, concludes, a fixed anthracycline-based control regimen (drugs like Daunorubicin, doxorubicin, and epirubicin), extending treatment duration, breast cancer mortality was reduced. In trials with four such extra cycles of taxane, counterbalanced in controls by extra cycles of other cytotoxic drugs, roughly doubling non-taxane dosage, there was no significant difference. However, the study also suggests that anthracycline-based regimens with substantially higher cumulative dosage than standard were superior to standard dosage. Trials, versus no chemotherapy, also suggested greater mortality reductions. Translated, the study suggests more advanced dosages of chemotherapy, were more effective than those that included radiation therapy. See collaborative group study, click here (Not light reading, but highly informative). Other articles worth reading from online publication, Medscape (available to registered readers only, sign up for FREE): More reasons why regular mammograms reduce deaths due to breast cancer by nearly half, click here- Also see, Risks for Reoccurrence of Breast Cancer, from AACR, click here- Schedule and web page for San Antonio Breast Cancer Symposium, click here. American Association for Cancer Research home page, click here. 12/07/2011 FDA ORDERS DRUG "AVASTIN" CAN'T BE USED FOR BREAST CANCER TREATMENTMore from the Emeritus Newsroom- FDA Commissioner Margaret A. Hamburg, M.D., said today she is revoking the agency’s approval of the breast cancer indication for Avastin (bevacizumab) after concluding that the drug has not been shown to be safe and effective for that use.Avastin will still remain on the market as an approved treatment for certain types of colon, lung, kidney and brain cancer (glioblastoma multiforme).“This was a difficult decision. FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments. But patients must have confidence that the drugs they take are both safe and effective for their intended use,” Dr. Hamburg said. “After reviewing the available studies it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks. Nor is there evidence that use of Avastin will either help them live longer or improve their quality of life.” Avastin’s risks include severe high blood pressure; bleeding and hemorrhaging; heart attack or heart failure; and the development of perforations in different parts of the body such as the nose, stomach, and intestines. Today’s decision, outlined in Dr Hamburg’s 69-page opinion, involves Avastin used in combination with the cancer drug paclitaxel for those patients who have not been treated with chemotherapy for their form of metastatic breast cancer known as HER2 negative. This indication must now be removed from Avastin’s product labeling.Dr. Hamburg’s decision is based on an extensive record, which includes thousands of pages submitted to a public docket, data from several clinical trials and the record from a two-day hearing held in June, 2011. Full text of FDA announcement, click here- 11/18/2011 FDA DRUG AND DEVICE APPROVAL NEAR RECORD HIGHMore from the Emeritus Newsroom- The Food and Drug Adminsitration announced today it has reached near record number approvals for drugs and medical devices and has also prepared new initiatives to ease drug shortages, with the help of an order from President Obama. The FDA says that over the past 12 months, it has approved 35 new medicines. This is among the highest number of approvals in the past decade, surpassed only by 2009 (37). Many of the drugs are important advances for patients, including: two new treatments for hepatitis C; a drug for late-stage prostate cancer; the first new drug for Hodgkin’s lymphoma in 30 years; and the first new drug for lupus in 50 years. In a report released today, FY 2011 Innovative Drug Approvals, the FDA provided details of how it used expedited approval authorities, flexibility in clinical trial requirements and resources collected under the Prescription Drug User Fee Act (PDUFA) to boost the number of innovative drug approvals to 35 for the fiscal year (FY) ending Sept. 30, 2011. The approvals come while drug safety standards have been maintained. “Thirty-five major drug approvals in one year represents a very strong performance, both by industry and by the FDA, and we continue to use every resource possible to get new treatments to patients,” said Margaret Hamburg, M.D., Commissioner of Food and Drugs. “We are committed to working with industry to promote the science and innovation it takes to produce breakthrough treatments and to ensure that our nation is fully equipped to address the public health challenges of the 21st century.” Among the new drugs approved in FY 2011, a number are notable for their advances in patient care and for the efficiency with which they were approved: • Two of the drugs – one for melanoma and one for lung cancer – are breakthroughs in personalized medicine. Each was approved with a diagnostic test that helps identify patients for whom the drug is most likely to bring benefits; • Seven of the new medicines provide major advances in cancer treatment; • Almost half of the drugs were judged to be significant therapeutic advances over existing therapies for heart attack, stroke and kidney transplant rejection; • Ten are for rare or “orphan” diseases, which frequently lack any therapy because of the small number of patients with the condition, such as a treatment for hereditary angioedema; • Almost half (16) were approved under “priority review,” in which the FDA has a six month goal to complete its review for safety and effectiveness; • Two-thirds of the new approvals were completed in a single review cycle, meaning sufficient evidence was provided by the manufacturer so that the FDA could move the application through the review process without requesting major new information; • Three were approved using “accelerated approval,” a program under which the FDA approves safe and effective medically important new drugs quickly, and relies on subsequent post-market studies to confirm clinical benefit. For example, Corifact, the first treatment approved for a rare blood clotting disorder, was approved under this program; and • Thirty-four of 35 were approved on or before the review time targets agreed to with industry under PDUFA, including three cancer drugs that FDA approved in less than six months. The Prescription Drug User Fee Act was established by Congress in 1992 to ensure that the FDA had the necessary resources for the safe and timely review of new drugs and for increased drug safety efforts. The current legislative authority for PDUFA expires on Sept. 30, 2012. “Before the PDUFA program, American patients waited for new drugs long after they were available elsewhere,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “As a result of the user fee program, new drugs are rapidly available to patients in the United States while maintaining our high standards for safety and efficacy.” In October 2011, the FDA released a new plan, Driving Biomedical Innovation: Initiatives to Improve Products for Patients, to assist companies engaged in new product development, particularly smaller, entrepreneurial companies. In a separate action, the agency also released a report this week on drug shortages, expanded its current actions to address the problem, and, at the direction of the President, will broaden early notification of drug shortages and work with the Department of Justice to prevent price gouging. Full text of FDA announcement and direct links to specific reports, click here. 11/04/2011 GLAXO TO PAY $3 BILLION FOR DOCTORING RESULTS IN RESEARCH ON DRUG "AVANDIA"More from the Emeritus Newsroom- GlaxoSmithKline announced today that it has agreed to pay $3 billion to settle several investigations into marketing claims of it's diabetes drug, "Avandia". The company says the final settlement, which is expected to address civil and criminal liabilities, remains subject to negotiation of specific terms and is expected to be finalized in 2012. The settlement of $3 billion is covered by existing provisions and GSK expects to make payments under the final agreement in 2012. These payments will be funded through existing cash resources. The GSK Board and management team have been focused on resolving these long-standing legal matters and reducing financial uncertainty for the Group and believe this agreement in principle to be in the best long-term interests of shareholders. Commenting on the agreement, GlaxoSmithKline CEO Andrew Witty said: “This is a significant step toward resolving difficult, long-standing matters which do not reflect the company that we are today. In recent years, we have fundamentally changed our procedures for compliance, marketing and selling in the US to ensure that we operate with high standards of integrity and that we conduct our business openly and transparently. We reiterate our full commitment to ensuring appropriate promotion of our medicines to healthcare professionals and to the standards rightly expected by the US Government.” Federal investigators claimed the GSK's illegal marketing cost the Medicare and Medicaid program billions of dollars and was suspected for increasing risks of heart attacks and strokes. GSK press release, click here. 11/03/2011 RESEARCHER SAYS ADHD DRUGS NOT RESPONSIBLE FOR CARDIAC EVENTS IN KIDS AND YOUNG ADULTSMore from the Emeritus Newsroom- Using data from 1,200,438 children and young adults between the ages of 2 and 24 years and 2,579,104 person-years of follow-up, including 373,667 person-years of current use of ADHD drugs, researchers say there is no link between ADHD drugs and the cause of cardiac events. The panel identified serious cardiovascular events (sudden cardiac death, acute myocardial infarction, and stroke) from health-plan data and vital records, with end points validated by medical-record review. We estimated the relative risk of end points among current users, as compared with nonusers, with hazard ratios from Cox regression models, used for analysis of the data. The data used, originated from four U-S health plans, Tennessee Medicaid, Washington State Medicaid, Kaiser Permanente California, and OptumInsight Epidemiology. Researchers concluded current users of ADHD drugs were not at increased risk for serious cardiovascular events . Risk was not increased for any of the individual end points, or for current users as compared with former users. Alternative analyses addressing several study assumptions also showed no significant association between the use of an ADHD drug and the risk of of a cardiac event. Even with a margin of error added to the statistics, the panel concludes the absolute effect of the drugs causing cardiac events would be low. Full text of study summary and links to expanded report in the New England Journal of Medicine, click here. 11/01/2011 OBAMA SIGNS ORDER TO EASE DRUG SHORTAGESMore from the Emeritus Newsroom- Playing to his newly adopted theme, "We can't wait", President Obama today signed an executive order, directing the FDA to step up work to reduce the drug shortages and protect consumers. The President said, "We'll still be calling on Congress to pass a bipartisan bill that will provide additional tools to the FDA and others that can make a difference. But until they act, we will go ahead and move".Obama, frustrated with the lack of action in congress since February over the issue, promised, "We're going to require that drug companies let us know earlier about the potential for drug shortages so that we can respond successfully. We're going to make sure that if we find out that prices are being driven up because shortages are being made worse by manipulations of companies or distributors, that we are making sure that we stop those practices. We're going to further empower the FDA and the Department of Justice to investigate any kinds of abuses that would lead to drug shortages".Some of the most notable shortages, include drugs used in cancer chemotherapy treatments and those used to treat ADHD patients. Click on YouTube video below for President's explanation of the order and signing. Click here for You Tube testimony of cancer patient affected by the drug shortage. 10/31/2011
COMMONWEALTH FUND REPORT SHOWS U-S HEALTH CARE PERFORMANCE SCORING ONLY 64%More from the Emeritus Newsroom- The Commonwealth Fund's latest report on the U-S health care system shows it is continuing to erode. The report, entitled, "National Scorecard on U.S. Health System Performance, 2011", claims the U.S. health system performance continues to fall far short of what is attainable, especially given the enormity of public and private resources devoted nationally to health. Across 42 performance indicators, the U.S. achieves a total score of 64 out of a possible 100, when comparing national rates with domestic and international benchmarks. Overall, the U.S. failed to improve relative to these benchmarks, which in many cases rose. Costs were up sharply, access to care deteriorated, health system efficiency remained low, disparities persisted, and health outcomes failed to keep pace with benchmarks. The Affordable Care Act targets many of the gaps identified by the Scorecard. Commonwealth Fund REport, click here. 10/18/2011 PANEL CHALLENGES EFFECTIVENESS OF PROSTATE CANCER SCREENINGSMore from Associated Press, click here- Also, see this must read article about a study on underdiagnosis of prostatte cancer from the Prostate Cancer Foundation, click here. Below, NBC Nightly News segment, MUST SEE. 10/07/2011 Visit msnbc.com for breaking news, world news, and news about the economy BREAST AND CERVICAL CANCER RATES UP WORLDWIDEMore below in this video from Voice of America- 09/29/2011
SUICIDES AMONG BABY BOOMERS HIGHEST SINCE 1998More from this article in the Atlanta Journal-Constitution, click here- 09/21/2011 MORE EVIDENCE LINKS DIABETES AND ALZHEIMERSMore from the Emeritus Newsroom- A new study detailed in the publication, "Neurology", has found age and sex adjusted incidence of all-cause dementia, Alzheimer disease (AD), and vascular dementia (VaD) were significantly higher in subjects with diabetes than in those with normal glucose tolerance. These associations remained robust even after adjustment for confounding factors for all-cause dementia and AD. In its conclusion, the study states, "Our findings suggest that diabetes is a significant risk factor for all-cause dementia, AD, and probably VaD. Moreover, 2-hour plasma glucose (PG) levels, but not fasting plasma glucose (FPG) levels, are closely associated with increased risk of all-cause dementia, AD, and VaD". Full text of Neurology summary, click here. 09/20/2011 HHS ANNOUNCES NEW RULES FOR PATIENT ACCESS TO THEIR OWN MEDICAL RECORDSMore from the Emeritus Newsroom- HHS Secretary Kathleen Sebelius today proposed new rules that would expand the rights of patients to access their health information through the use of health information technology (IT). Specifically, the new rules would empower patients and allow them to gain access to test results reports directly from labs. They would ensure that labs covered by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) provide such information, upon request, directly to patients or their personal representatives. The announcement came at the kick-off of the first-ever HHS Consumer Health IT Summit, which brought consumers, providers, and the public and private sectors together to discuss how best to empower consumers to be partners in their health and care through health IT. “When it comes to health care, information is power. When patients have their lab results, they are more likely to ask the right questions, make better decisions and receive better care,” said Secretary Sebelius.“This Summit offers a unique opportunity for the public and private sectors alike to share strategies to improve consumer access to their health information, while safeguarding the privacy and security of their data.” Secretary Sebelius also announced the appointment of Leon Rodriguez as the new Director of the Office for Civil Rights. Rodriguez brings his Department of Justice experience to HHS and will be dedicated to ensuring consumers’ health information is kept private and secure. “Consumers need to know that private and secure access to their health information is a given,” stated OCR Director Rodriguez. “The privacy and security of health data will be a top priority for OCR during my tenure.” Secretary Sebelius also unveiled today an innovative voluntary Personal Health Record (PHR) Model Privacy Notice, which creates an easy-to-read, standardized template allowing consumers to compare and make informed decisions based on their privacy and security policies and data practices about PHR products. The new template is similar to the Nutrition Facts Labels in that it presents certain complex information in a simple way to improve transparency and consumer understanding about data practices. By making this Model Privacy Notice available, PHR companies can help build greater trust in PHRs. Today’s Summit included more than 25 health care stakeholder organizations, representing consumers, large and small practice providers as well as insurers and health IT industry leaders, that have pledged to empower consumers by making it easier for them to get secure access to their health information to engage more fully in their health. “As technology improves more aspects of our daily lives, it makes sense to marry cutting-edge technology with our medical and personal health records so that we can improve both the quality and efficiency of the care that people receive,” said National The Summit highlighted vital benefits of electronic health records and health IT, including:
“We are at a critical moment in time when we can either choose to innovate, or lag behind in care,” said Dr. Mostashari. “A commitment by health care stakeholders to support health IT and provide greater consumer access to their health information is the first step toward a healthier future.” In the coming year, ONC will work with health care stakeholders to further consumer access to information and empower consumers to become active participants in their health. The new website, www.HealthIT.gov creates dedicated consumer-oriented information that describes the benefits of health IT, provides consumer health education materials and will be a valuable resource for learning about new advances in health IT. For more information about the proposed amendments to the CLIA and HIPAA Privacy regulations, please visit https://www.cms.gov/apps/media/fact_sheets.asp. 09/12/2011 MAXIM HEALTHCARE SERVICES TO PAY $150 MILLION TO SETTLE HOME HEALTH CARE BILLING FRAUD CASEMore from the Emeritus Newsroom- The FBi announced today that Maxim Healthcare Services Inc., one of the nation’s leading providers of home health care services, has entered into a settlement to resolve criminal and civil charges relating to a nationwide scheme to defraud Medicaid programs and the Veterans Affairs program of more than $61 million. According to Federal prosecutors,The agreement will allow Maxim to avoid a health care fraud conviction on the charges if it complies with the DPA’s requirements. As required by the DPA, which will expire in 24 months if the company meets all of its reform and compliance requirements, Maxim has agreed to pay a criminal penalty of $20 million and to pay approximately $130 million in civil settlements in the matter, including to federal False Claims Act claims. To date, nine individuals—eight former Maxim employees, including three senior managers and the parent of a former Maxim patient—have pleaded guilty to felony charges arising out of the submission of fraudulent billings to government health care programs, the creation of fraudulent documentation associated with government program billings, or false statements to government health care program officials regarding Maxim’s activities. The criminal complaint accuses Maxim, a privately-held company based in Columbia, Md., with hundreds of offices throughout the United States, of submitting more than $61 million in fraudulent billings to government health care programs for services not rendered or otherwise not reimbursable. The investigation revealed that the submission of false bills to government health care programs was a common practice at Maxim from 2003 through 2009. During that time period, Maxim received more than $2 billion in reimbursements from government health care programs in 43 states based on billings submitted by Maxim. FBI press release on Maxim case, click here. 09/12/2011 MORE RESEARCH FINDS NO LINK BETWEEN AUTISM AND VACCINESMore from the Emeritus Newsroom- A committee of The National Institute of Medicine produced more research backing conclusions that vaccines are not a cause of autism. The committee finds that evidence convincingly supports a causal relationship between some vaccines and some adverse events—such as Measles, Mumps and Rubella, or (MMR), varicella zoster, influenza, hepatitis B, meningococcal, and tetanus-containing vaccines linked to anaphylaxis. Additionally, evidence favors rejection of five vaccine-adverse event relationships, including MMR vaccine and autism and inactivated influenza vaccine and asthma episodes. However, for the majority of cases (135 vaccine-adverse event pairs), the evidence was inadequate to accept or reject a causal relationship. Overall, the committee concludes that few health problems are caused by or clearly associated with vaccines. The Health Resources and Services Administration asked the IOM to review a list of adverse events associated with eight vaccines—varicella zoster, influenza (except 2009 H1N1), hepatitis B, HPV, MMR, hepatitis A, meningococcal, and those that contain tetanus—and evaluate the scientific evidence about the event–vaccine relationship. The IOM committee appointed to this task was not asked to assess the benefits or effectiveness of vaccines but only the risk of specific adverse events. The full report will be issued next month. Advance summary of report, click here. 08/25/2011 SENIORS MAY IMPROVE LEARNING THROUGH "TRIAL AND ERROR" METHODMore from online publication, Natural Health Care, click here- 08/25/201 THE TOTAL COST OF WAR / PRICE FOR TREATING WAR VETS HAS NOT YET REACHED PEAKMore in this article from the New York Times, click here- 07/28/2011 RECORD NUMBER OF HIGH PRICED DRUGS TO TURN GENERICMore in this article from the Chicago Tribune, click here - 07/25/2011 AMERICAN COLLEGE OF OBSTETRICIANS AND GYNECOLOGISTS URGES ANNUAL MAMMOGRAMS FOR WOMEN 40 AND OLDERMore from the Emeritus Newsroom- In a recommendation, clearly taking aim at the confusion over timing of mammograms, the American College of Obstetricians and Gynecologists today endorsed annual exams. The ACOG issued new breast cancer screening guidelines that recommend mammography screening be offered annually to women beginning at age 40. Previous College guidelines recommended mammograms every one to two years starting at age 40 and annually beginning at age 50. The recommendations take issue with those two years ago from another advisory group. The U.S. Preventive Services Task Force recommended in 2009 that women in their 40s should not get routine mammograms. The group, which was made up of 16 health care experts, none of whom were oncologists, suggested that before having a mammogram, women ages 40 to 49 talk to their doctors about the risks and benefits of the test, and then decide whether to be screened. the ACOG took issue with those findings but had not yet finished research of their own. According to Jennifer Griffin, MD, MPH, who co-authored The College guidelines, the change in mammography screening for women beginning at age 40 is based on three factors: the incidence of breast cancer, the sojourn time for breast cancer growth, and the potential to reduce the number of deaths from it. The time period between when a breast cancer may be detected by a mammogram while it is very small and before it grows big enough to become symptomatic is known as the sojourn time. Although the sojourn time of individual cancers can vary, the greatest predictor is age. Women ages 40-49 have the shortest average sojourn time (2-2.4 years), while women ages 70-74 have the longest average sojourn time (4-4.1 years). "Although women in their 40s have a lower overall incidence of breast cancer compared with older women, the window to detect tumors before they become symptomatic is shorter, on average," said Dr. Griffin. The five-year survival rate is 98% for women whose breast cancer tumors are discovered at their earliest stage, before they are palpable and when they are small and confined to the breast. "If women in their 40s have annual mammograms, there is a better chance of detecting and treating the cancer before it has time to spread than if they wait two years between mammograms." The College continues to recommend annual clinical breast exams (CBE) for women ages 40 and older, and every one to three years for women ages 20-39. Additionally, The College encourages "breast self-awareness" for women ages 20 and older. Enhanced breast cancer screening, such as more frequent CBEs, annual MRI (magnetic resonance imaging), or mammograms before age 40, may be recommended for women at high risk of breast cancer. Breast MRI is not recommended for women at average risk of developing breast cancer. Full text of ACOG statement, click here. 07/21/2011NEW WALTER REED HOSPITAL REPLACES 102 YEAR OLD FACILITY / PATIENTS BEING TRANSFERED IN D-C AREA REALIGNMENT THIS SUMMERBy Elizabeth M. Collins WASHINGTON, July 20, 2011 - The transfer of Walter Reed Army Medical Center's functions to Bethesda, Md., and the construction of a new hospital on Fort Belvoir, Va., are expected to be completed on schedule, according to top military health care leaders. Navy Vice Adm. John M. Mateczun, commander of Joint Task Force National Capital Region Medical, told Pentagon reporters that the mission to consolidate and integrate military health care functions in the National Capital Region is well under way, with 9,400 medical personnel and patients expected to finish moving by the end of August. Under the Base Realignment and Closure Act of 2005, the Defense Department was required to combine four inpatient hospitals in the national capital region -- Walter Reed, the National Naval Medical Center in Bethesda, DeWitt Army Community Hospital at Fort Belvoir, Va., and Malcolm Grow Medical Center at Joint Base Andrews, Md. -- into two, while maintaining the same patient care capacity. "This is the largest medical restructuring ever undertaken in the military health system," Mateczun said, adding that military medical officials are concentrating on three areas of priority throughout the process. "One is quality of care -- all of the patient care that we're providing," Mateczun said. Focus also is being placed on the wounded, ill and injured service members presently under medical care, he added. The third area of priority, he said, is "the capacity to take care of the wounded, ill and injured who are returning now from Iraq and Afghanistan as we do these moves." The new facility at Bethesda will include 345 medical-surgical beds, 50 intensive care unit beds and 20 operating rooms, while the expanded DeWitt hospital will hold 120, 10 and 10, respectively, Mateczun said. The two facilities should have more than enough capacity to care for all combat casualties, as well as family members and veterans, Mateczun said, especially because military medical facilities nationwide and civilian TRICARE medical plan partners can take additional cases if the need should arise. Of the 445 wounded, ill and injured soldiers currently assigned to the Warrior Transition Brigade at Walter Reed, about a third will transition to DeWitt, while the other two-thirds will move to the Bethesda facility, said Lt. Col. Larry Gunther, the brigade's executive officer. Both Bethesda and Belvoir have added and renovated barracks and lodging facilities for these service members and their families. Patients moving to DeWitt are more ambulatory and need less specialized and intensive care, Mateczun explained. They also may have post-traumatic stress, mild-to-moderate traumatic brain injuries or substance-abuse problems, as the Fort Belvoir hospital is adding additional inpatient behavioral health and substance-abuse programs. Service members evacuated from the combat theater and patients who need very specialized care for catastrophic injuries, such as complex orthopedic trauma and open traumatic brain injuries, will go to the new Walter Reed National Military Medical Center in Bethesda, along with the specialized doctors and other medical professionals who care for them. Complex surgeries such as organ transplants also will be performed at the Bethesda facility. Walter Reed Army Medical Center, which has served the nation for 102 years, will close its doors Sept. 15, and a ceremony to case the colors of all Walter Reed activities will take place July 27. 07/20/2011 LATEST UPDATE ON HEALTH CARE TREATMENT STANDARDS RELEASED BY FEDERAL AGENCYMore from the Emeritus Newsroom- As part of a national campaign to help medical patients in the U-S to make more informed treatment choices, the Agency for Healthcare Research and Quality (AHRQ) (http://www.ahrq.gov), which is part of the U.S. Department of Health and Human Services, is undertaking a major promotional effort, complete with a summary of treatment options research. AHRQ says its mission is to improve the quality, safety, efficiency and effectiveness of health care for all Americans. Translated, that means it's an attempt to make patients aware of accepted treatment standards, so patients have information to compare to what medical professions are suggesting they do, to treat their specific ailments. It makes patients more aware of what may be unaccepted treatment options, suggested to them, which carry risks, physically, emotionally and financially, that medical professionals may not explain to them. First, the agency announced, "Explore Your Treatment Options," a new multimedia ad campaign. AHRQ says the goal of this campaign is television, radio, print, web and outdoor ads that encourage consumers to visit AHRQ's Effective Health Care Program web site to find plain-language guides that summarize the scientific evidence on treatments for numerous medical conditions, including diabetes, osteoarthritis, high blood pressure, high cholesterol and more. "We see the best outcomes when doctors and patients work together to come up with a treatment plan that takes into account the patient's quality-of-life concerns," said AHRQ Director Carolyn M. Clancy, M.D. "Information is power in health care, and this campaign will provide patients with the information they need to become partners with their doctors in their health and health care." Since 2005, AHRQ's Effective Health Care Program has compared the outcomes and effectiveness of different treatments and communicated findings to providers and consumers to help them make informed decisions about health care. For example, Treating High Cholesterol: A Guide for Adults, provides easy-to-understand information about different kinds of cholesterol medicines, including how they work and their side effects. The guide also includes a list of questions that patients can ask their doctors to help them choose their best treatment option. As part of the campaign, AHRQ's Effective Health Care Program Web site features personal stories from patients with chronic conditions who achieved better health results by exploring their treatment options. In addition, a new Health Priorities Snapshot tool features questions about common daily activities and allows users to rate the importance of quality-of-life concerns. Patients can print out a list of their own health priorities and share it with their clinicians during medical appointments. These features are available at http://www.effectivehealthcare.ahrq.gov/options. Created pro bono for the Ad Council by Grey New York, the new television, radio, print, outdoor and web ads highlight the fact that consumers have options when buying clothing, dining out, watching a movie or buying a car and should expect options when it comes to their health care. "This new campaign is a wonderful extension of our ongoing efforts with AHRQ to encourage Americans to take a more active role in their health care," said Peggy Conlon, president and CEO of the Ad Council. "These ads speak to a compelling insight—we look for options in nearly every aspect of our lives, but we're not always exploring all treatment options available when it comes to our health care. It's a very important message, as these decisions can affect the length and quality of our lives." Full text of AHRQ ad campaign statement, click here. Effective health program treatment special webpage, click here. 07/19/2011 DRAMATIC RISE REPORTED IN NUMBER OF STATES WITH OBESE RESIDENTSMore from the Emeritus Newsroom- America is losing its battle with obesity. Despite more publicity over healthier diets and weight, Americans are becoming obese at an alarming rate. The problem is brought home through statistics in a new report from the Trust for America's Health. The group released their report today, showing adult obesity rates increased in 16 states in the past year and did not decline in any state, according to F as in Fat: How Obesity Threatens America's Future 2011, a report from the Trust for America's Health (TFAH) and the Robert Wood Johnson Foundation (RWJF). Twelve states now have obesity rates above 30 percent. Four years ago, only one state was above 30 percent. TFAH says the obesity epidemic continues to be most dramatic in the South, which includes nine of the 10 states with the highest adult obesity rates. States in the Northeast and West tend to have lower rates. Mississippi maintained the highest adult obesity rate for the seventh year in a row, and Colorado has the lowest obesity rate and is the only state with a rate under 20 percent. This year, for the first time, the report examined how the obesity epidemic has grown over the past two decades. Twenty years ago, no state had an obesity rate above 15 percent. Today, more than two out of three states, 38 total, have obesity rates over 25 percent, and just one has a rate lower than 20 percent. Since 1995, when data was available for every state, obesity rates have doubled in seven states and increased by at least 90 percent in 10 others. Obesity rates have grown fastest in Oklahoma, Alabama, and Tennessee, and slowest in Washington, D.C., Colorado, and Connecticut. “Today, the state with the lowest obesity rate would have had the highest rate in 1995,” said Jeff Levi, Ph.D., executive director of TFAH. “There was a clear tipping point in our national weight gain over the last twenty years, and we can't afford to ignore the impact obesity has on our health and corresponding health care spending.” Obesity has long been associated with other severe health problems, including diabetes and high blood pressure. New data in the report show how rates of both also have risen dramatically over the last two decades. Since 1995, diabetes rates have doubled in eight states. Then, only four states had diabetes rates above 6 percent. Now, 43 states have diabetes rates over 7 percent, and 32 have rates above 8 percent. Twenty years ago, 37 states had hypertension rates over 20 percent. Now, every state is over 20 percent, with nine over 30 percent. Racial and ethnic minority adults, and those with less education or who make less money, continue to have the highest overall obesity rates. Full text of TFAH press release on report, click here. 07/07/2011 LATEST AUTISM STUDY GIVES BOOST TO ENVIRONMENTAL FACTORSMore from the Emeritus Newsroom - A study revealed in the Archives of General Psychiatry concludes environmental factors may be equal to those of genetics when determining the cause of autism in children. the study from a team of researchers examines statistical results among twins. According to the findings, autism is a complex neurodevelopmental disorder that interferes with the normal course of social, communicative, and cognitive development. The diagnosis of autism is made in early childhood, with symptoms manifesting within the first 3 years of life. Over the last 3 decades, a substantial increase in the prevalence of autism has been reported, from 4 to 5 per 10 000 in the 1960s to around 40 per 10 000 children today. For autism spectrum disorders (ASDs), prevalence rates have been estimated to be about 1%. This 10-fold increase in prevalence has received considerable attention, with concomitant increases in research funding. The results showed, both genetic and shared environmental components were significant. The best-fitting research models for both strict autism and ASD suggest that a large proportion of the variance in liability is due to shared environmental factors in addition to genetic heritability. For strict autism, we could conclude that heritabilities in males and females were equal and that the shared environmental components in males and females were also equal. The best-fitting model had a genetic heritability of 37% and a shared environmental variance component of 55%. For the broader ASD phenotype, again we could conclude that heritabilities and shared twin environmental components were equal in males and females. Heritability was estimated to be 38%and the shared environmental component, to be 58%.. The shared environment component was estimated to be larger than the genetic heritability component. Full text of study summary, click here. 07/05/2011 INSURANCE COMPANIES STEP UP ATTEMPTS TO BUY DOCTORS GROUPSMore in this article from the Washington Post, click here- 07/03/2011 U-S LIFE EXPECTANCY FALLING BEHIND MOST INDUSTRIALIZED NATIONSMore from the Emeritus Newsroom - Between 2000 and 2007, life expectancies in more than 80% of United States counties fell in standing against the average of the 10 nations with the best life expectancies in the world, according to new research by The Institute of Health Metrics and and Evaluation, in collaboration with researchers from Imperial College London. The study, Falling behind: life expectancy in US counties from 2000 to 2007 in an international context , shows that compared to countries like Japan and Canada, where life expectancies significantly increase every year, most counties within the US are falling behind. Researchers found that across US counties, life expectancy in 2007 ranged from 65.9 to 81.1 years for men and 73.5 to 86 years for women. Geographically, the counties with the lowest life expectancies for both sexes were in counties in Appalachia and the Deep South, extending across northern Texas. Counties with the highest life expectancies tended to be in the northern Plains and along the Pacific coast and the Eastern Seaboard. One way of analyzing county-level life expectancies is to compare them to a life expectancy time series of the 10 nations with the lowest mortality, known as the “international frontier.” Compared to this international frontier, US counties range from being 16 calendar years ahead to more than 50 calendar years behind for women and from 15 calendar years ahead to more than 50 calendar years behind for men. Nationwide, women fare more poorly than men. The researchers found that women in 1,373 counties – about 40% of US counties – fell more than five years behind the nations with the best life expectancies. Men in about half as many counties – 661 total – fell that far. Life expectancy for black women ranges from 69.6 to 82.6 years, and for black men, from 59.4 to 77.2 years. In both cases, no counties are ahead of the international frontier, and some are more than 50 years behind. The researchers note that the poor relative performance of the US compared to the international frontier is not simply due to racial disparities, as the pattern of life expectancy performance for white Americans is similar to that of all races combined. MUST SEE MAPS OF COUNTY BY COUNTY LIFE EXPECTANCY FOR BOTH MALE AND FEMALE- CLICK HERE Full text of IHME summary of study, click here. See Voice of America video story below. 06/15/2011
UNION WORKERS HEALTH BENEFITS LARGER PERCENTAGE OF TOTAL COMPENSATIONMore from the Emeritus Newsroom- The Bureau of Labor Statistics today released their comparison survey of total compensation costs for employees in various sectors of the economy. According to the BLS, Employer costs for employee compensation averaged $30.07 per hour worked in March 2011. Wages and salaries averaged $20.91 per hour worked and accounted for 69.6 percent of these costs, while benefits averaged $9.15 and accounted for the remaining 30.4 percent. Total employer compensation costs for private industry workers averaged $28.10 per hour worked in March 2011. Total employer compensation costs for State and local government workers averaged $40.54 per hour worked in March 2011. Among occupational groups, employer costs for health insurance benefits ranged from 91 cents per hour worked and 6.5 percent of total compensation for service workers, to $3.17 and 6.3 percent of total compensation for management, professional, and related occupations. Among other occupational categories, employer costs for health benefits averaged $1.90 (8.6 percent) for sales and office occupations, lower than $2.47 (8.0 percent) for natural resources, construction, and maintenance occupations, and $2.39 (10.1 percent) for production, transportation, and material moving occupations .Employer costs for health insurance benefits were significantly higher for union workers, averaging$4.63 per hour (12.3 percent), than for nonunion workers, averaging $1.85 (6.8 percent In goods-producing industries, health insurance benefit costs were higher, at $2.94 per hour (8.9 percent of total compensation), than in service-providing industries, at $1.95 per hour (7.2 percent of total compensation). Among the four regions, costs for health insurance benefits ranged from $1.79 per hour in the South to$2.49 in the Northeast. Health insurance costs were $2.28 in the Midwest and $2.13 in the West .Within census divisions, hourly health benefit costs ranged from $1.72 in the West South Central division to $2.50 in the Middle Atlantic division. Health insurance benefit costs increased, both in average hourly dollar amount and as a proportion of total compensation, with establishment size. Establishments with fewer than 50 workers averaged $1.34per hour worked (6.0 percent of total compensation); those with 50-99 workers averaged $1.83 (7.1percent); those with 100-499 employees averaged $2.40 (8.4 percent); and those with 500 or more employees averaged $3.54 (8.7 percent). 06/08/2011 STUDY SHOWS PROMISE FOR CUTTING BREAST CANCER RISKMore in this article from the Boston Globe, click here - 06/05/2011 FEDERAL APPEALS COURT BLASTS V-A FOR POOR MENTAL HEALTH SERVICES / ORDERS OVERHAULMore from the Emeritus Newsroom- The U-S Ninth Circuit Court of Appeals in San Francisco has delivered a stern assessment of mental health care from Veterans Affairs medical facilities. The court has ordered the agency to change the way it delivers mental health care. The order came in a stinging 2-1 decision, which said the V-A's treatment of vets with Post Traumatic Stress Disorder, violated the vets constitutional rights. The case was filed by two veterans rights groups, Veterans for Common Sense and Veterans United for Truth. the court recognized that an average 18 vets a day commit suicide from combat related mental illnesses and that the V-A to often delays or denies mental health care to veterans who need it. Chief Judge Alex Kozinski dissented, believing the court should not be telling the V-A what to do. Kozinski stated concerns the ruling may prompt more lawsuits, putting the agency farther behind delivering mental health services. The supervision for overhauling the mental health services was dealt back to the federal district court in San Francisco, where the lawsuit originated four years ago. Full PDF text of the actual court decision, click here. 05/11/2011 W-H-O SAYS LIFESTYLES COULD BREAK HEALTH CARE IN SOME NATIONSMore from the Emeritus Newsroom- In what is becoming an increasing epidemic from economic gains throughout the world, diseases due to lifestyle choices will soon force some countries health care systems to the breaking point. the United Nations sponsored World Health Organizations status report, released today, shows Non communicable diseases (NCDs) are the leading global causes of death, causing more deaths than
all others causes combined, and they strike hardest at the world’s low- and middle-income populations.
These diseases have reached epidemic proportions, yet they could be significantly reduced, with
millions of lives saved and untold suffering avoided, through reduction of their risk factors, early
detection and timely treatments. The Global Status Report on Non communicable Diseases is the first
worldwide report on the state of NCDs and ways to map the epidemic, reduce its major risk factors and DRUG COMPANIES TO PAY $44.3 MILLION FOR BRIBES TO BOOST PRESCRIPTIONSMore from the Emeritus Newsroom- Adding to the debate over physician prescription records, now before the U-S Supreme Court, more drug companies have settled a case involving bribe to medical professionals to encourage use of their products in prescriptions. According to the Justice Department, Pharmaceutical manufacturers Serono Laboratories Inc., EMD Serono Inc., Merck Serono S.A, and Ares Trading S.A. have agreed to pay $44.3 million to resolve False Claims Act allegations in connection with the marketing of the drug Rebif, the Justice Department announced. The settlement resolves allegations that Serono paid health care providers from the launch of Rebif in about January 2002 through December 2009, to induce them to promote or prescribe Rebif, a recombinant interferon injectable that is used to treat relapsing forms of multiple sclerosis. Serono is alleged to have made payments to providers for hundreds of speaker training meetings and programs, as well as payments for attending consultant, marketing and advisory board meetings, all at upscale resorts and other locations. Serono’s actions allegedly resulted in the submission of false claims to federal health care programs including Medicare and Medicaid for the payment of Rebif, i.e., claims that were tainted by kickbacks. “It’s imperative that medical determinations are guided by a patient's needs, not tainted by illegal incentives or fraud,” said Tony West, Assistant Attorney General of the Civil Division. “We are committed to ensuring that the chronically ill and other vulnerable members in our communities who rely on Medicare and Medicaid programs receive the best possible care.” “Health care decisions must be based solely upon what is best for the individual patient and not on which pharmaceutical company is paying the doctor the biggest kickback,” said Rod J. Rosenstein, U.S. Attorney for the District of Maryland. “All consumers have the right to know that their health care provider’s judgment about medications they should take has not been undermined by kickbacks from pharmaceutical manufacturers.” “In settling this second case with Serono, the Office of the Inspector General extended Serono’s existing corporate integrity agreement by three years, and required enhanced provisions such as specifically requiring that company directors and senior executives take responsibility for ensuring and monitoring compliance with federal law,” said Daniel R. Levinson, Inspector General of the Department of Health and Human Services (HHS-OIG). “If we can alter the cost-benefit calculus of some directors and executives, OIG can influence corporate behavior without putting access to government health care benefits at risk.” Full text of Justice Department Press release, click here. 05/04/2011 BIG NAME DRUGS ABOUT TO GO GENERICMore in this article from the Chicago Tribune- 05/04/2011 CURRENT DRUG SHORTAGES SPREADING / PHARMACISTS PROPOSE LEGISLATIONMore from the Emeritus Newsroom- April has been a scarey month for those in need of certain medications which made the latest "short supply" lists from the Food and Drug Administration. Today alone, four more were added. They are , Duragesic Transdermal System, Methylphenidate HCl, Norepinephrine Bitartrate Injection and Sodium Phosphate injections. The problem has intensified over the last year. There have been 22 drug shortage announcements and updates, in April alone, (See FDA RSS feeds below). Pharmacists, represented by the American Society of Health System Pharmacists claims the shortages affect cancer and heart patients among others. The group claims the issues include safety and pricing, which make it more difficult for pharmacists to serve their customers. Accordng to the group, a consequence of some drug shortages is that product becomes available from secondary sources at
sometimes drastically different price levels. Some price variation is expected when purchasing outside The bill would require manufacturers to notify the FDA of any discontinuance, interruption or adjustment in the manufacture of a drug that may result in a shortage. If the manufacture plans on discontinuing the drug, notification must be made to FDA at least 6 months in advance. The bill would additionally require FDA to publish information relating to manufacturing problems and drugs experiencing an actual shortage on its web site. The bill would require FDA to implement evidence-based criteria for identifying drugs vulnerable to a shortage. This would be based upon factors such as: number of manufacturers, sources of raw material or active pharmaceutical ingredients, supply chain characteristics, and the availability of therapeutic alternatives. The bill would require FDA to revise the definition of medically necessary to include the prevalence of use of a drug as a factor in determining whether the drug is medically necessary. ."Drug Shortage", RSS feeds from FDA, click here. ASHSP drug shortage resource page, click here. PDF Summary of S. 296, click here. 05/02/2011 APPEALS COURT REMOVES BAN FROM FEDERAL STEM CELL FUNDINGMore from the Emeritus Newsroom- President Obama is applauding an appeals court decision, which has reversed a federal district court order, banning federal funding of stem cell research. A statement released Friday by the Whitehouse, outlined the President's position on the issue and how the ruling will help medical research. The statement reads, Today, millions of Americans suffer from conditions like Alzheimer’s Parkinson’s and heart disease. And while we don’t know exactly what stem cell research will yield, scientists tell us that this research has the potential to help treat or cure these and many other diseases and conditions.That’s why President Obama supports responsible stem cell research and it’s why we’re pleased with a court decision that paves the way for stem cell research to continue. Earlier today, a court ruled that a lawsuit challenging the federal government’s ability to support stem cell research was unlikely to succeed and allowed federally supported stem cell research to continue.The ruling was a victory for scientists and the patients who will benefit from their work. And the ruling will help ensure our nation remains at the forefront of scientific and medical research and innovation. As President Obama said tonight to the students of Miami Dade College at their commencement , “America will only be as strong as our pursuit of scientific research and our leadership in technology and innovation”. Stem cell research has the potential to cure diseases that have touched virtually every American family. We’re committed to realizing this potential and supporting responsible research that could develop new treatments, improve public health and deliver relief to patients in America and around the world. The 2-1 decision (No. 10-5287 DR. JAMES L. SHERLEY, ET AL.,APPELLEES v. KATHLEEN SEBELIUS, IN HER OFFICIAL CAPACITY AS SECRETARY OF THE DEPARTMENT OF HEALTH AND HUMANSERVICES, ET AL., APPELLANT), by the U-S Court of Appeals in Washington DC, reverses a decision last August by Washington DC U.S. District Judge Royce Lamberth, who ruled the research likely violates a 1996 law banning federal funding of embryo destruction during stem cell research. Full HTML text of Appeals Court decision, click here. 04/30/2011 RATED A MUST READ: VETERANS DISABILITY APPEALS STILL DRAG ON FOR YEARSMore on this article from the Washington Post, click here- 04/23/2011 U-S HEALTH CARE SYSTEM LOSING FAVOR WITH PATIENTSMore from the Emeritus Newsroom- A national public opinion study shows the quality of U.S. health care is considered average, at best. That's according to researchers at Harvard University's School of Public Health—sober news for the nation’s health care leaders. More than half of American adults surveyed (55%) barely give the quality of American health care a passing grade—a C or D on a standard report card scale. More than one in 10 (11%) give the quality of care an F. In addition, nearly half (47%) of Americans give the quality of hospital care in the country a rating of C, D or F. The poll was commissioned by the Robert Wood Johnson Foundation and presented today at last week's American Hospital Association’s annual membership meeting in Washington, D.C. “The poll is a wake-up call for payers and the health care industry, both of which have been working steadily to improve the quality of care, but need to kick their efforts into overdrive toward accountability,” said Risa Lavizzo-Mourey, M.D., M.B.A., president and CEO of the Robert Wood Johnson Foundation. “American health care faces a crisis in quality. There is a dangerous divide between the potential for the high level of quality care that our health system promises, and the uneven quality that it actually delivers. Clearly, consumers are aware of it. There are too many errors, too much misuse of medical treatments and, too often, poorly coordinated care among a patient’s different health care providers.” According to the study, the results show that while many consumers think quality of care is low, they think more highly of their own care than they do about the health care system in general. Across the board, respondents rank the quality of the health care and hospital care they receive as markedly better than what they think the country as a whole receives. Despite significantly more data comparing the quality of local health care providers becoming available to consumers in recent years, the poll shows that people still turn to the doctors and hospitals with which they are most familiar, not necessarily where evidence suggests care is best coordinated and delivered. When asked to choose between different hospitals—one where a person has been treated for years and another that rates much higher in quality—most respondents (57%) say they would choose the familiar, over those (38%) who would opt for a hospital that scores better in quality. Although many studies have pointed to racial and ethnic disparities in health care, the poll shows that a majority of Americans do not perceive this to be the case when it comes to the quality of hospital care. A majority of the public thinks that African Americans get the same (60%) or better quality of care (2%) as Whites do when they are hospitalized. Similarly, a majority believe that Hispanics get the same (56%) or better quality of care (3%) as Whites. The poll shows a sharp difference by income when it comes to Americans’ perception of the quality of health care they receive. More than four in 10 Americans (43%) with household incomes of less than $50,000 give a grade of C, D or F to the quality of health care they receive. Only about one in five Americans (21%) with household incomes of $50,000 or more rate the quality of their health care with grades of C, D or F.The complete survey results can be found at www.rwjf.org or http://www.hsph.harvard.edu/news/press-releases/files/quality-healthcare-topline.pdf. 04/20/2011 MORE ABUSE OF PRESCRIPTION DRUGS THAN THOSE OFF THE STREET / INVOLVES AT LEAST 5 MILLION PEOPLEMore from the Emeritus Newsroom- A plan to take on the county's burgeoning problem of prescription drug abuse, was revealed today by the Obama Administration.The White House Office of Drug Control Policy conducted a Facebook town hall style introduction and discussion today. The problem is the focusw of a 2009 report which cites prescription drug abuse as one that has exceeded the illicit drug trade, such as cocaine. According to the 2009 survey, nearly one-third of people aged 12 and over who used drugs for the first time in 2009 began by using a prescription drug non-medically. Some individuals who misuse prescription drugs, particularly teens, believe these substances are safer than illicit drugs because they are prescribed by a healthcare professional and dispensed by a pharmacist. Obama administration officials say addressing the prescription drug epidemic is not only a top priority for public health, it will also help build stronger communities and allow those with substance abuse disorders lead healthier, more productive lives. The White House 2011 Prescription Drug Abuse Prevention Plan advocates;
Read the full Prescription Drug Abuse Prevention Plan.Watch a replay of the Prescription Drug Abuse Event hosted at the National Press Club. Full text of White House Prevention Plan, click here. You Tube video report from Voice of America, click here. 04/19/2011 GAO SAYS FDA MUST DO MORE TO KEEP UNSAFE MEDICAL DEVICES OFF MARKETMore from the Emeritus Newsroom- Noting improvements the Food and Drug Administration has made, the Governmental Accountability Office says the agency has to do more to keep unsafe devices from presenting risks to the public. In its report on oversight of the medical device market, the GAO says, in 2009, it recommended that FDA expeditiously take steps to issue regulations for the device types classified as high risk that are currently allowed to enter the market via the 510(k) process. Since then, FDA has set strategic goals to address these device types, but has issued a final rule regarding the classification of only one device type. As of April 1, 2011, FDA's action on the 26 remaining types of high-risk devices was incomplete. Thus, these types of devices--such as automated external defibrillators and implantable hip joints--can still enter the U.S. market through the less stringent 510(k) process. GAO found that, since its report was issued in January 2009, FDA has cleared at least 67 510(k) submissions that fall within these high-risk device types. FDA has taken some additional steps to enhance pre market device safety since GAO's 2009 report was issued--for example, it commissioned the Institute of Medicine to conduct an independent review of the pre market review process--but it is too early to tell whether any forthcoming changes will enhance public health. GAO's preliminary analysis shows that, from 2005 through 2009, firms initiated 3,510 voluntary medical device recalls, an average of just over 700 per year. Although FDA maintains extensive information on each recall, it has not been routinely analyzing recall data that would allow it to explain trends in recalls over time, thus missing an opportunity to proactively identify and address the risks presented by unsafe devices. GAO's preliminary work also identified several gaps in the medical device recall process that limited recalling firms' and FDA's abilities to ensure that the highest-risk recalls were being implemented in an effective and timely manner. GAO found that firms frequently were unable to correct or remove all devices subject to the highest-risk recalls. GAO's preliminary findings indicate that FDA lacks clear guidance for overseeing recalls which has led to inconsistencies in FDA's assessments of whether individual recalls were implemented effectively. Consequently, FDA officials examining similar situations sometimes reached opposite conclusions regarding whether recalls were effective. In addition, FDA had not established thresholds for assessing whether firms effectively completed recalls by correcting or removing a sufficient number of recalled devices. Further, GAO determined that FDA's decisions to terminate completed recalls--that is assess whether firms had taken sufficient actions to prevent a reoccurrence of the problems that led to the recalls--were frequently not made within its prescribed time frames. Finally, GAO found that FDA did not document its justification for terminating recalls. Taken together, GAO's preliminary work suggests that the combined effect of these gaps may increase the risk that unsafe medical devices could remain on the market. Full text GAO summary of report on medical device supervision by FDA, click here. 04/14/2011 HUNDREDS OF U-S VETERANS, ILL FROM AGENT ORANGE ON AMERICAN BASES IN JAPAN, MAY FINALLY GET JUSTICEMore from the Emeritus Newsroom- Veterans, exposed to Agent Orange, a toxic and hazardous defoliation chemical, have won a huge round in the battle for disability and treatment benefits from the Department of Veterans Affairs. The chemical was used extensively in Vietnam for to clear jungle areas of dense vegetation. See this article in English, from the Japan Times, about a U-S veteran with prostate cancer, who worked the docks of an American military base, handling barrels of Agent Orange. 04/12/2011 PROGRESS MADE WITH NEW TREATMENTS FOR AUTISM BEHAVIORS / SIDE EFFECTS REMAIN A PROBLEMMore from the Emeritus Newsroom- The journal, Pediatrics, reports progress in new treatments for autism behaviors, with side effects still a major drawback. According to a review of the study by the Agency for Healthcare Research and Quality, the comparative effectiveness report found that two commonly used medications—risperidone and aripiprazole—show benefit in reducing some behaviors, including emotional distress, aggression, hyperactivity and self-injury. However, these medicines are associated with significant side effects, such as rapid weight gain and drowsiness. The review found that no medications used for ASDs improved social behaviors or communication skills. The report also found that several medications show promise and should be studied further, but that secretin, which has been studied extensively, has shown no effectiveness. Children with ASDs have difficulty in social interaction, behavior, and communication. Some children with ASDs may also have impaired cognitive skills and sensory perception. Based on limited evidence, behavioral interventions also showed promise for improving some symptoms and behaviors, but their effects varied. For example, early intensive behavioral and developmental interventions seemed to improve cognitive performance, language skills, and adaptive behavior in some groups of children, the report found. Other interventions, which focused on parent training and cognitive behavioral therapy, may be useful for children with ASDs to improve social communication, language use and potentially symptom severity, researchers said. "Autism spectrum disorders are frustrating and challenging for patients, their families and caregivers," said AHRQ Director Carolyn M. Clancy, M.D. "This report will help parents and clinicians understand their options and design a course of treatment that is consistent with their goals and values." Researchers at the Vanderbilt Evidence-based Practice Center in Nashville, TN, who prepared the report for AHRQ, noted that further research is needed to identify which children are likely to benefit from particular interventions. The authors also were critical of the fact that current studies contain few comparisons of medical interventions with behavioral interventions as well as combinations of the two, despite the fact that most children undergo multiple treatments at the same time. Because of these limitations in the available evidence, researchers were not able to compare treatments and interventions to each other. In addition, they noted that every case of ASD is different and did not conclude that one type of treatment is superior. ASDs—which include autistic disorder, Asperger syndrome, and pervasive developmental disorder-not otherwise specified—affect an estimated 1 in every 110 children in the United States. Treatment goals for ASDs often focus on improving social communication and addressing certain behaviors. Other treatments also target anxiety, attention difficulties, and sensory difficulties. Goals for treatment often vary by child. The report, Comparative Effectiveness of Therapies for Children with Autism Spectrum Disorders, is the latest comparative effectiveness review from AHRQ's Effective Health Care program is available at http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct"productid=656. The Effective Health Care program sponsors the development of evidence reports and technology assessments to assist public- and private-sector organizations in their efforts to improve the quality of health care in the United States. The program, authorized by the Medicare Prescription Drug, Improvement and Modernization Act, represents an important Federal effort to compare alternative treatments for health conditions and make the findings public. The program is intended to help patients, doctors, nurses, pharmacists and others choose the most effective treatments. Information can be found at http://www.effectivehealthcare.ahrq.gov. 04/04/2011 STUDY SAYS RADIATION FROM AIRPORT SCANNERS "TRIVIAL" / RESEARCH INCLUDES FREQUENT FLYERSMore from the Emeritus Newsroom- The Archives of Internal Medicine released a study today showing, even repeated scans for frequent flyers, did not pose a health threat to the masses. In it's conclusion, the study states, "Based on what is known about the scanners, passengers should not fear going through the scans for health reasons, as the risks are truly trivial. If individuals feel vulnerable and are worried about the radiation emitted by the scans, they might reconsider flying altogether since most of the small, but real, radiation risk they will receive will come from the flight and not from the exceedingly small exposures from the scans. Discomfort with the backscatter scanners exists in part because of health and privacy concerns and in part because the TSA does not permit independent assessment of the machines, raising concerns that if the machines do not function as provided, or if the settings are changed by employees after the machines are installed, or if they undergo software or mechanical errors or malfunctions, unknown effects could result.The TSA asserts that the machines have been adequately tested by various organizations, but, as pointed out by J. Sedat, PhD, 1 of 4 professors at the University of California, San Francisco, who wrote John P. Holdren, advisor to President Barack Obama for Science and Technology, more independent testing is necessary, and he noted that "it is premature to put a whole population through this with out more due diligence and independent testing." It would seem prudent for the TSA to permit additional testing to verify the safety of the devices". In reviewing the background, the study recounts how, the past year, the Transportation Security Administration has deployed full-body scanners in airports across the United States in response to heightened security needs. Several groups have opposed the scans, citing privacy concerns and fear of the radiation emitted by the backscatter x-ray scanners, 1 of the 2 types of machines in use. The radiation doses emitted by the scans are extremely small; the scans deliver an amount of radiation equivalent to 3 to 9 minutes of the radiation received through normal daily living. Furthermore, since flying itself increases exposure to ionizing radiation, the scan will contribute less than 1% of the dose a flyer will receive from exposure to cosmic rays at elevated altitudes. The estimation of cancer risks associated with these scans is difficult, but using the only available models, the risk would be extremely small, even among frequent flyers. We conclude that there is no significant threat of radiation from the scans. In response to a passenger smuggling plastic explosives hidden in his underwear onto a Detroit-bound airliner on Christmas Day, 2009, the Transportation Security Administration (TSA), a department of the US Department of Homeland Security, began pushing forward with its plan to place full-body scanners in all American airports. Thus far, the TSA has deployed 486 scanners in 78 airports in the United States, with an estimated 1000 scanners to be deployed by the end of 2011. Full text of study summary from Archives of Internal Medicine, click here. 03/31/2011 FDA TARGETS KV PHARMACEUTICALS FOR MISINFORMATION SENT TO PHARMACIESMore from the Emeritus Newsroom- In what is shaping up as a broadening public relations disaster, KV Pharmaceuticals was chastised again today, this time by the Food and Drug Administration. Also today, the company promised to revise its pricing structure in the wake of a firestorm over their more than 1,000% price increase for the high risk pregnancy drug, "Makena". See previous story below for more specifics on the drug. In a statement released by the FDA today, the agency took KV to task for attempting to stop pharmacies from producing, in house, compounded versions of Makena. The agency claims, that For many years, a version of the active ingredient of Makena, which is a synthetic protesting, has been available to patients whose physicians requested the drug from a pharmacist who compounded the drug. Generally, FDA says it has exercised enforcement discretion with respect to most products made through traditional pharmacy compounding. This has included products made from the active ingredient in Makena, hydroxyprogesterone caproate. Because Makena is a sterile injectable, where there is a risk of contamination, greater assurance of safety is provided by an approved product. However, the FDA says, under certain conditions, a licensed pharmacist may compound a drug product using ingredients that are components of FDA approved drugs if the compounding is for an identified individual patient based on a valid prescription for a compounded product that is necessary for that patient. The agency's statement explains, "FDA prioritizes enforcement actions related to compounded drugs using a risk-based approach, giving the highest enforcement priority to pharmacies that compound products that are causing harm or that amount to health fraud.FDA understands that the manufacturer of Makena, KV Pharmaceuticals, has sent letters to pharmacists indicating that FDA will no longer exercise enforcement discretion with regard to compounded versions of Makena. This is not correct. In order to support access to this important drug, at this time and under this unique situation, FDA does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products. As always, FDA may at any time revisit a decision to exercise enforcement discretion". KV has justified the price increase, saying it invested heavily in development of the drug. That claim is contested by researchers who say the overwhelming majority of development costs were research dollars from the federal government, not KV. Today the company responded, defending it's decision to raise the price of Makena, but offering to restructure its pricing by the end of the week. their statement reads, in part, "Ther-Rx has invested or committed over a quarter of a billion dollars to-date to bring Makena to market, including more than $50 million in research and clinical trial costs, including those associated with conducting major, multi-year follow-on health studies of Makena involving 1,700 mothers and more than 500 infants. To remove financial barriers to access, Ther-Rx established and has activated a patient financial assistance program (PAP) that not only reduces the total out-of-pocket costs for qualified patients, but eliminates out-of-pocket costs entirely for patients whose financial need is greatest. The level of assistance already exceeds many federal program guidelines for healthcare subsidies. Based on the feedback the company has received, we are currently exploring additional ways to help provide affordable access for all patients who are prescribed Makena. This includes the expansion of the existing patient assistance program. Specialty injectable products like Makena are not typically carried by retail pharmacies. To make the process of prescribing and obtaining Makena as easy as possible for healthcare providers and patients, Ther-Rx established the Makena Care Connection™, a comprehensive program for patients and healthcare providers that provides administrative, financial, and treatment support for Makena patients in one single point of contact. The Makena Care Connection is actively processing prescriptions for Makena, and is already facilitating access to the financial assistance program for patients in financial need. It is our commitment that every woman who is prescribed Makena will have affordable access to this FDA-approved and FDA-monitored therapy". For more information about Makena, please visit www.makena.com. Full text of FDA press release, click here. Full text of KV Pharmaceutical statement, click here. 03/30/2011 NEW HOPE FOR HEPATITUS "C" PATIENTS / ADDITION OF NEW DRUG CAN DOUBLE CHANCES FOR EFFECTIVE TREATMENTMore in this article from US News, click here - 03/30/2011 K-V PHARMACEUTICALS BLASTED OVER 1000% PRICE BOOST FOR HIGH RISK PREGNANCY DRUG / COMPANY ANNOUNCES AID PROGRAMMore from the Emeritus Newsroom- In a letter to K-V Pharmaceuticals, The Society for Maternal-Fetal Medicine (SMFM) says recent price increases on the drug, “Makena', were not justified and constitute hardships for low income mothers to be. SMFM says it represents more than 2,000 physicians who have specialized training in maternal-fetal medicine and work with high-risk pregnancies where drugs such as Makena are often prescribed. SMFM claims the drug, designed to prevent pre term pregnancies is being sold at $1,500 per dose. "Makena", which has been produced as compound 17-hydroxyprogesterone by compounding pharmacies for several years, has typically cost $10 to $20 per dose. "The research for this drug was funded by taxpayer dollars,” stated George Saade, M.D. president of SMFM. Tax dollars funded the initial clinical trial in 2003 under the auspices of the National Institute of Child Health and Human Development (NICHD) at the National Institutes of Health. Additional trials were funded by NICHD through its multi center network of medical institutions over several years. “The studies found that pregnant women who had previously delivered a preterm baby, if treated with weekly injections of hydroxyprogesterone caproate, had fewer pre term babies, and the babies had fewer complications of pre maturity,” added Saade. The drug was also found to be effective in both African American and Non-African American women. An economic analysis authored by Dr. Balit of Case Western Reserve University showed that weekly injections of compounds similar to Makena, given to at risk women, would dramatically reduce the incidence of premature births—and more over it could save the health care system at least $2 billion per year. KV says it has begun a patient assistance program for those who cannot afford the drug, or are uninsured. the company also responded to congressional complaints about the price increase. The KV website response states, Ther-Rx Corporation takes very seriously the concerns raised about the list price of Makena™ (hydroxyprogesterone caproate injection) by Members of Congress and other stakeholders. Ther-Rx has received a letter from Members of the Committee on Energy and Commerce and will respond to the letter. Ther-Rx is committed to ensuring that this significant, FDA-approved medication is covered at an affordable cost and available to all women who are prescribed Makena, and looks forward to cooperating with the Members of Congress on these issues. KV says those eligible for assistance program include;
Full text of KV Makena Assistance Program rules, click here. 03/29/2011 PAYOFFS TO DELAY GENERIC DRUGS, TARGETED IN NEW SENATE BILLMore from the Emeritus Newsroom- Senator Herb Kohl (D) WI and Charles Grassley (R) IA, lost a bid last year to enact a similar bill and are trying, once again. Called, The Preserve Access to Affordable Generics Act (S 27 ), another version of the proposal has been introduced in this session. Grassley and Kohl object to pharmaceutical companies paying off makers of generic drugs to delay their introduction to the market. The lawmakers claim it would save consumers more than $35 billion dollars a year. In the most recent case, involving such practices, the U-S Supreme Court ruled earlier this month, that it would not enter the fray over drug company payoffs to delay generic drugs entrance into the market. The case involved a 1997 settlement in which Bayer AG paid Barr Pharmaceuticals Inc. $398 million to drop an early bid to market a generic version of Cipro, an antibiotic drug. The pattern of such settlements, the generic drug producer is paid in exchange for dropping court challenges to the brand drug's patents. Justice Department and FTC officials have claimed the practice amounts to violation of anti-trust laws, which increase drug prices to consumers. In the most recent case, drug retailers CVS Caremark and Rite Aid requested the Supreme Court hear the case. But, the justices refused. While Grassley and Kohl pursue their bill in the Senate, the Obama administration is proposing regulatory powers be granted the Federal Trade Commission to stop such agreements. Congress passed the Hatch-Waxman Act back in 1984 to encourage generic manufacturers to challenge patents that either are invalid or narrow enough to be designed around. The legislation has worked. Studies have shown that generic manufacturers have prevailed in the majority of patent challenges. The resulting generic entry, which often occurs well before patent expiration, leads to significantly lower prices and huge savings for patients and the health care system. Grassley-Kohl bill (S27) from Thomas, click here. 03/14/2011 PHYSICAL VIDEO GAMES HELP KIDS
PRESCRIPTIONS: THE BATTLE OVER MAIL ORDER VS. PHARMACIESMore in this article from the New York Times, click here- 03/04/2011 KIDS RAISED ON FARMS HAVE FEWER ALLERGY/ASTHMA PROBLEMSMore from the Emeritus Newsroom- A study published this week in the New England Journal of Medicine shows kids raised on farms are 30-50 percent less likely to develop allergies and asthma related health issues. The reason centers around their exposure to more allergens, germs and other microbes, which have boosted immune systems. It was also found that good germ populations, most prevalent on farms, also help fight off the bad, though the extent of that dynamic was not established. The researchers compared children living on farms with those in a reference group with respect to the prevalence of asthma and atopy (various allergy sensitivities) and to the diversity of microbial exposure. In one study — PARSIFAL (Prevention of Allergy — Risk Factors for Sensitization in Children Related to Farming and Anthroposophic Lifestyle) — samples of mattress dust were screened for bacterial DNA with the use of single-strand conformation polymorphism (SSCP) analyses to detect environmental bacteria that cannot be measured by means of culture techniques. In the other study — GABRIELA (Multidisciplinary Study to Identify the Genetic and Environmental Causes of Asthma in the European Community [GABRIEL] Advanced Study) — samples of settled dust from children's rooms were evaluated for bacterial and fungal content with the use of culture techniques. Full text of New England Journal of Medicine summary article, click here. 02/24/2011 FEDS MASSIVE BUST NETS 100+ SUSPECTS IN $225 MILLION MEDICARE & MEDICAID BILLING SCANDALMore from the Emeritus Newsroom- The multi agency Medicare fraud strike force has announced it has arrested at least 111 suspects in a fraud scandal that allegedly netted more than $225 million in federally paid claims. During a news conference yesterday, Attorney General Eric Holder said, “With this takedown, we have identified and shut down large-scale fraud schemes operating throughout the country. We have safeguarded precious taxpayer dollars. And we have helped to protect our nation’s most essential health care programs, Medicare and Medicaid,” said Holder, adding, “As today’s arrests prove, we are waging an aggressive fight against health care fraud.” According to court documents, the defendants charged today participated in schemes to submit claims to Medicare for treatments that were medically unnecessary and oftentimes, never provided. In many cases, indictments and complaints allege that patient recruiters, Medicare beneficiaries and other co-conspirators were paid cash kickbacks in return for supplying beneficiary information to providers, so that the providers could submit fraudulent billing to Medicare for services that were medically unnecessary or never provided. Collectively, the doctors, nurses, health care company owners, executives and others charged in the indictments and complaints are accused of conspiring to submit a total of more than $225 million in fraudulent billing. Full text of press release from HHS, click here. 02/18/2011 STROKES SPREAD AMONG TEENS AND OTHER YOUNG AMERICANSMore from the Voice of America- The number of young people in the United States hospitalized due to stroke has jumped by 50 percent since the mid-1990s, even as the number of older Americans suffering from stroke has declined. Each year, nearly 800,000 Americans suffer a stroke. While three-quarters of these individuals are elderly, the disease can and does occur in younger adults, and even children. Among the two oldest age groups, men and women aged 45 to 64 and those over the age of 65, there was a marked decrease in the number of hospitalizations due to ischemic stroke.
LYMPH NODE REMOVAL UNNECESSARY FOR SOME FORMS OF BREAST CANCERMore in this article from Reuters, click here- 02/08/2011 BEDBUG ERADICATION SUMMIT HEARS, "IF WE ARE NOT CAREFULL, THE BEDBUGS WILL WIN"More from the Voice of America-Bedbug infestations have been reported in towns and cities in every American state in the last few years, according to experts at the federal government’s second annual bedbug summit, held in early February in Washington, D.C. The insectile invasion of American homes and public places is expected to worsen. Experts say that increased resistance to pesticides means the tiny insects, which feed on warm-blooded animals, are here to stay, especially in densely-populated cities. It's not funny to Christine Drabicki. The Michigan woman is a plaintiff in one of several lawsuits which have been filed against New York’s luxury Waldorf-Astoria hotel, where world leaders often stay. She alleges she was bitten on her arms and chest, causing allergic welts, when she stayed at the hotel in May 2010. Drabicki also claims that she unknowingly took bugs home to her two daughters, who were also bitten. “Some medical people feel it's not a direct health issue because it's an insect that doesn't transmit or vector a disease,” says Lou Sorkin, an entomologist at the American Museum of Natural History in New York. “But on the other hand, it affects people. People have to go see dermatologists if it affects them physically, they have very bad itching, secondary infections because of scratching." Now, people are waking up again with itchy bites. Pesticides have become increasingly less lethal as bedbugs have evolved strong resistance. Only high heat or freezing are currently effective against the bugs, which can live up to a year without feeding, hiding in mattresses, walls or furniture.
STUDY: STROKE CENTERS IMPROVE CHANCES FOR VICTIMSMore from Voice of America- Hospital stroke centers are saving lives, according to the latest findings.
CDC REPORT PROBES RACIAL DISPARITIES IN HEALTH CAREMore from the Emeritus Newsroom- Disparity in health care can be traced to gender, color, race and socio economic status, according to a report from the Centers for Disease Control. Highlights of the findings include:
HHS & EPA LOWER LIMITS ON FLOURIDATED WATER SUPPLIES / DUE TO SIDE EFFECTS FROM OVEREXPOSUREMore from the Emeritus Newsroom- Federal health officials say Americans have more exposure than ever to fluoride, the chemical in public water supplies that prevents tooth decay. Because it is also found in toothpastes, mouth rinses and other products, some people have been getting spots on their teeth from overexposure to the chemical. Though the problem may only be noticed by dentists, researchers say it's indicative of a larger problem. Today, both Health and Human Services, and the Environmental Protection Agency issued revised guidelines for lowering recommended fluoride levels. According to a press release from HHS, the proposed recommendation of 0.7 milligrams of fluoride per liter of water replaces the current recommended range of 0.7 to 1.2 milligrams. This updated recommendation is based on recent EPA and HHS scientific assessments to balance the benefits of preventing tooth decay while limiting any unwanted health effects. These scientific assessments will also guide EPA in making a determination of whether to lower the maximum amount of fluoride allowed in drinking water, which is set to prevent adverse health effects. The EPA claims assessments of fluoride were undertaken in response to findings of the National Academies of Science (NAS). At EPA’s request, in 2006 NAS reviewed new data on fluoride and issued a report recommending that EPA update its health and exposure assessments to take into account bone and dental effects and to consider all sources of fluoride. In addition to EPA’s new assessments and the NAS report, HHS also considered current levels of tooth decay and dental fluorosis and fluid consumption across the United States. Full text of HHS press release, click here. 01/07/2011 BRITISH MEDICAL JOURNAL DECLARES 1998 VACCINE-AUTISM LINK STUDY A FRAUDMore in this article from USA Today, click here- 01/06/2011 NEW BLOOD TEST MAY CHANGE CANCER TREATMENTSMore from the Emeritus Newsroom-A new blood test formulated at Massachusetts General Hospital in Boston is being used a four cancer treatment centers, which can help isolate types of cancer cells and improve treatment. The breakthrough tests can cut the time it takes to identify specific cancer cells and therefore improve outcome. Full text of story from Voice of America, click here. 01/05/2011
OBAMA SIGNS HEALTH CARE BILL FOR 9/11 WORKERSMore from the Emeritus Newsroom- After being delayed in the closing days of the lame duck session of congress, President Obama Sunday signed into law, the "James Zadroga 9/11 Health and Compensation Act," which extends and expands eligibility for compensation under the September 11th Victim Compensation Fund of 2001. According to the the World Trade Center Medical Working Group appointed by New York City Mayor Michael Bloomberg, the act will provide long-term federal funding for: WTC Centers of ExcellenceThe WTC Centers of Excellence provide monitoring and treatment (including medication) in the New York City area for 9/11-related illnesses with no out-of-pocket costs to patients.
WTC National Responder Health ProgramThousands of rescue and recovery workers rushed to New York City’s aid in the days and weeks after 9/11. They came from every state and nearly every Congressional district in the country. The federal government offers monitoring and treatment services to 9/11 rescue and recovery workers through the WTC National Responder Health Program. World Trade Center Health RegistryEstablished by New York City and the federal government in 2002, the WTC Health Registry monitors the health of more than 71,000 people directly exposed to the WTC disaster. The Registry will periodically survey enrollees over the next 20 years to track changes in their physical and mental health. Enrollees are from every state and 15 other countries.
Full text of act from the NYC 9/11 special web page. 01/03/2011 CDC SAYS U-S BIRTH RATE DECLINES AGAIN / TEENAGE PREGNACY LOWEST IN 70 YEARSMore from the Emeritus Newsroom- The Centers for Disease Control comparison of 2008 birth data to that from 2009 reveals another surprising drop in U-S birth rates, most notably, among teens. According to the CDC, the 2009 preliminary number of US births declined 3 percent from 2008, to 4,131,019; the 2009 general fertility rate (66.7 per 1,000 women) and the total fertility rate (2,007.5 births per 1,000) declined (3-4 percent). The number of births and rates declined for all race and Hispanic origin groups in 2009. the economy is believed a major factor in the dropping stats. • The birth rate for US teenagers 15-19 fell 6 percent to 39.1 per 1,000, a record low for the Nation. CDC birth rate report, click here. 12/29/2010 RESEARCH GROUP SAYS MAJOR CITIES DRINKING WATER HAS CARCINOGEN, CHROMIUM-6 / HAS ALSO CONTAMINATED WATER IN RURAL AREASMore from the Emeritus Newsroom- According to the Environmental Working Group, most of the top 30 major cities in the U-S have higher than normal levels of the carcinogen, Chormium-6. The chemical is known to cause intestinal tumors among other adverse effects. According to the group, Tap water from 31 of 35 U.S. cities tested contains hexavalent chromium (or chromium-6), the carcinogenic “Erin Brockovich chemical,” according to laboratory tests commissioned by Environmental Working Group (EWG). The highest levels were detected in Norman, Okla.; Honolulu, Hawaii; and Riverside, Calif. The chemical has long been associated with waste water from metal plating, pulp mills and other industrial sites.The group claims that despite the contaminant’s toxic effects, including a U.S. Environmental Protection Agency (EPA) draft toxicological review that classifies it as “likely to be carcinogenic to humans” when consumed in drinking water, the agency has not set a legal limit for chromium-6 in tap water and does not require water utilities to test for it. Hexavalent chromium is commonly discharged from steel and pulp mills as well as metal-plating and leather-tanning facilities. It can also pollute water through erosion of soil and rock. The National Toxicology Program has found that hexavalent chromium in drinking water shows clear evidence of carcinogenic activity in laboratory animals, increasing the risk of otherwise rare gastrointestinal tumors (NTP 2007, 2008). In response to this study and others, California officials last year proposed setting a public health goal for chromium-6 in drinking water of 0.06 parts per billion (ppb). This is the first step toward establishing a statewide enforceable limit (OEHHA 2009). Levels of the carcinogen in 25 cities tested by EWG were higher than California’s proposed public health goal. Tap water from Norman, Okla. (population 90,000) contained more than 200 times California’s proposed safe limit. Full text of study from the Environomental Working Group, click here. 12/20/2010SURGEON GENERAL RELEASES MOST DAMAGING EVIDENCE YET ON SMOKINGMore from the Emeritus Newsroom- Surgeon General Regina Benjamin says even very limited exposure to second hand smoke can prove deadly. It was one of a number of new findings backing up already deadly conclusions about smoking from decades of research. According to Benjamin, tobacco smoke contains a deadly mixture of more than 7,000 chemicals and compounds, of which hundreds are toxic and at least 70 cause cancer. Every exposure to these cancer-causing chemicals could damage DNA in a way that leads to cancer. Exposure to smoke also decreases the benefits of chemotherapy and other cancer treatments. Smoking causes more than 85% of lung cancers and can cause cancer almost anywhere in the body. One in three cancer deaths in the U.S. is tobacco-related. The report describes how the delicate lining of the lungs becomes inflamed as soon as it is exposed to the chemical mixture in cigarette smoke. Over time, the smoke can cause chronic obstructive pulmonary disease including emphysema and chronic bronchitis. Even brief exposure to secondhand smoke can cause cardiovascular disease and could trigger acute cardiac events, such as heart attack. The report describes how chemicals from tobacco smoke quickly damage blood vessels and make blood more likely to clot. The evidence in this report shows how smoking causes cardiovascular disease and increases risks for heart attack, stroke, and aortic aneurysm. Smoking causes many other harmful effects throughout the body, including making it harder for diabetics to control their blood sugar. Smoking makes it harder for women to get pregnant and can cause a miscarriage, preterm delivery, low birth weight, as well as damage to fetal lungs and brain tissue. Babies who are exposed to secondhand smoke are more likely to die from sudden infant death syndrome, the report finds. “This report makes it clear – quitting at any time gives your body a chance to heal the damage caused by smoking,” the Surgeon General said. “It’s never too late to quit, but the sooner you do it, the better.” Surgeon General press release, click here. 12/10/2010 LIFE EXPECTANCY DIPS IN THE U-SMore from the Emeritus Newsroom- The the first time in fifty years, respiratory diseases and disorders were the third place leading cause of death supplanting strokes. Asthma, Chronic Bronchitis, and Emphysema and related deaths were up 7.8% from 2007-2008 according to the report from the Centers for Disease Control. Life expectancy for Americans in general declined by a little more than one month, from 77.9 to 77.8 years. For women, the average life expectancy dropped by a tenth of one year, to 80.3 years; for men it also dropped by the same amount, to 75.3 years. According to a press release from the CDC, some of the decline may be due to a modification made by the World Health Organization in the way deaths from chronic lower respiratory diseases are classified and coded. The National Center for Health Statistics will conduct a thorough analysis on this change and its effect on the chronic lower respiratory disease category before the final 2008 deaths data are released. "Deaths: Preliminary Data for 2008," also finds that life expectancy at birth dropped slightly to 77.8 years from 77.9 years in 2007. Life expectancy was down by one-tenth of a year (a little over a month) for both men and women. However, black males had a record high life expectancy in 2008 of 70.2 years – up from 70 years in 2007. The life expectancy gap between the white and black populations was 4.6 years in 2008, a decrease of two-tenths of a year from 2007. The data are based on 99 percent of death certificates reported to NCHS through the National Vital Statistics System from all 50 states, the District of Columbia and U.S. territories. CDC press release on life expectancy, click here. 12/10/2010 WOMENS' WELLBEING IN U-S TAKES STEP BACKWARDMore from the Emeritus Newsroom- There was good news, but the bad news tipped the balance of overall well being for women in the U-S, in a survey co-sponsored by the National Women's Law Center. The 2010 edition of Making the Grade on Women’s Health: A National and State-by-State Report Card shows that the nation and the states continue to fall short in meeting women’s health needs. Despite some progress on individual health status indicators, overall the nation is still so far from meeting key women’s health objectives that it receives a grade of “Unsatisfactory” in this fifth and last report for this decade. Additionally, the Report Card shows that while states continue to adopt policies to advance women’s health, progress has slowed—and in some cases stagnated—at a time when they still have a long way to go. Fortunately, a new health policy landscape is forming as a result of the federal health care law (the Patient Protection and Affordable Care Act or ACA) that was enacted in March 2010. Many of the policy goals examined in the Report Card will be realized as the ACA is implemented. With the law’s emphasis on access to health care—including the critical preventive services that women need to stay healthy—the new law can, over time, lead to major improvements in the health status of women.
Summary of key findings, direct links to full report and state by state reports, click here. 12/10/2010 FDA APPROVES LATE STAGE BREAST CANCER TREATMENT DERIVED FROM SEA SPONGESMore from the Emeritus Newsroom- Halaven (eribulin mesylate) has been approved by the Food and Drug Administration as a late stage treatment for breast cancer. Tests involved women with metastatic breast cancer who received at least two prior chemotherapy regimens for late-stage disease. Breast cancer is the second leading cause of cancer related death among women, according to the National Cancer Institute. This year, an estimated 207,090 women will be diagnosed with breast cancer, while 39,840 women will die from the disease. Halaven is a synthetic form of a chemotherapeutically active compound derived from the sea sponge Halichondria okadai. This injectable therapy is a microtubule inhibitor, believed to work by inhibiting cancer cell growth. Before receiving Halaven, patients should have received prior anthracycline- and taxane-based chemotherapy for early or late-stage breast cancer. Halaven’s safety and effectiveness were established in a single study in 762 women with metastatic breast cancer who had received at least two prior chemotherapy regimens for late-stage disease. Patients were randomly assigned to receive treatment with either Halaven or a different single agent therapy chosen by their oncologist. Full text of FDA press release, click here. 11/17/2010 BEST CITIES FOR WELL BEING SURVEY / D-C #1More from the Emeritus Newsroom- The survey is called "Measure of America" and explains the reasons why Washington DC is at the top of the nation's top ten cities for well being. The survey, conducted for the non profit, the American Human Development Project, is part of a larger picture of global well being, as to the lackluster performance of the U-S compared with other countries. The survey based its decisions, in part, on life expectancy, education and income. Among the more interesting features of the survey; higher life expectancy among whites, compared with minorities, except Asian Americans who rank the highest of any group. Also, despite women having higher overall levels of educational attainment than men, their median earnings average $11,000 less per year. The top ten cities were, in order, Washington DC, Boston, New York, Philadelphia, Chicago, Los Angeles , Atlanta, Miami, Dallas-Fort Worth and Houston. Topping the 2010-2011 index for states, congressional districts, racial and ethnic groups, and The report presents strong evidence that the capabilities a person has going into a crisis— As for solutions the survey points to Health Education Income Full text of press release for "Measuring America", click here. Full report only available for purchase. See special page on American Human Development Project website, click here. 11/10/2010 WILL MEDICARE & MEDICAID PAY FOR $93,000 PROSTATE CANCER DRUG TREATMENT PROGRAM?More in this story from the Washington Post, click here - 11/08/2010 ANNUAL C-T SCANS RECOMMENDED TO CUT LUNG CANCER DEATHSMore from the Emeritus Newsroom- Results of research released today by the National Cancer Institute shows annual C-T scans reduce the risk of dying from lung cancer by 20%. According to the NCI press release, The National Lung Screening Trial (NLST), a randomized national trial involving more than 53,000 current and former heavy smokers ages 55 to 74, compared the effects of two screening procedures for lung cancer -- low-dose helical computed tomography (CT) and standard chest X-ray -- on lung cancer mortality and found 20 percent fewer lung cancer deaths among trial participants screened with low-dose helical CT. The NLST was sponsored by NCI, a part of the National Institutes of Health, and conducted by the American College of Radiology Imaging Network (ACRIN) and the Lung Screening Study group. A paper describing the design and protocol of the NLST, “The National Lung Screening Trial: Overview and Study Design” by the NLST research team, was published yesterday by the journal Radiology and is openly available at http://radiology.rsna.org/cgi/content/abstract/radiol.10091808. Even with today's medical advancements, the mortality rate for lung cancer after diagnosis is 85%. More than 160,000 people die from lung cancer every year. Among the reasons for the trial was to to determine the effectiveness of low radiation C-T scans versus conventional X-rays, and potential negative effects from additional radiation on patient care and outcomes. Low radiation dose C-T scans were given three times in two years to patients who chose C-T scans over conventional X-rays. Researchers claim that if the C-T scans were used with the trial patients over a ten year period perhaps as many as 80% of the lung cancer deaths could have been prevented. NCI press release, click here. 11/04/2010 VETERANS AFFAIRS MEDICAL BUDGET FACES LONGTERM SHORTFALL / PARTLY DUE TO RISING TOLL FROM TWO WARSMore from the Emeritus Newsroom- Veterans Affairs budgets may face shortfalls in the coming years due to to three main factors. In their October 2010 report, the Congressional Budget Office says, "First, as is true for all U.S. health care, VA’s medical expenditures per enrollee have grown more rapidly than has the overall price level. Second, the ongoing deployments to combat operations in Iraq and Afghanistan have increased the number of veterans seeking care from VA. Third, VA has been easing restrictions on enrolling higher-income veterans (those in P8), in part because of concerns expressed by policymakers and others who believe that restrictions on enrollment have caused some veterans to be denied benefits that they deserve". One of the projections covered in the CBO report finds total enrollment would grow from 8.0 million in 2009 to more than 8.8 million by 2016—an increase of about 10 percent—but would edge down to 8.7 million in 2020. The resources required to treat all enrolled veterans would be about $69 billion in 2020, nearly 45 percent higher than the $48 billion that has been provided for 2010. Full text of CBO projections, click here. 11/03/2010 G-A-O REPORT SAYS FDA INSPECTION OF IMPORTED DRUGS REMAINS WEAKMore from the Emeritus Newsroom- The Glaxo Smith Kline settlement was more ammunition for advocates of better inspections by the Food and Drug Administration. It added more evidence to the concerns over offshore pharmaceutical production facilities, in GSM's case, involving a subsidiary in Puerto Rico. Though PR is an American territory, critics of FDA inspections say it might as well be in Asia, for the effectiveness of the inspection process. A report issued last month by the Governmental Accounting Office pointed out FDA increased the number of foreign drug inspections it conducted from fiscal year 2007 to 2009, but still conducts relatively fewer foreign drug inspections each year than it conducts domestically. In fiscal year 2009, FDA conducted 424 foreign inspections, compared to 333 and 324 inspections conducted in fiscal years 2007 and 2008, respectively. Using a list FDA developed to prioritize foreign establishments for inspection, GAO estimated that FDA inspected 11 percent of foreign establishments on this list in fiscal year 2009. At this rate, GAO estimated it would take FDA about 9 years to inspect all establishments on this list once. In contrast, in that same year, FDA conducted 1,015 domestic inspections, inspecting approximately 40 percent of domestic establishments. GAO estimated that at this rate FDA inspects domestic establishments approximately once every 2.5 years. Further, FDA's approach in selecting establishments for inspection is inconsistent with GAO's 2008 recommendation that FDA inspect, at a comparable frequency, those establishments that are identified as having the greatest public health risk potential if they experience a manufacturing defect, regardless of whether they are a foreign or domestic establishment. Instead, its foreign inspections continue to be driven by the establishments listed on an application for a new drug, instead of those already producing drugs for the U.S. market. GAO INSISTS it is urgent that FDA implement GAO's prior recommendations to better protect public health. HHS reviewed a draft of this report and agreed that more progress is needed in order to meet the challenge of safeguarding the nation's drug supply in today's global marketplace. Summary and full text of GAO report on FDA drug inspections, click here. 10/26/2010 GLAXO-SMITH-KLINE AGREES TO $750 MILLION SETTLEMENT FOR MISLABELING AND ADULTERATING DRUGSMore from the Emeritus Newsroom- The US Attorney in Boston has reached agreement with Glaxo-Smith-Kline to pay more than $750 million to settle a case involving botched drugs and shipments made by a subsidiary at a plant in Puerto Rico. According to US Attorney Carmen Ortiz, SB Pharmco Puerto Rico, Inc., a subsidiary of GlaxoSmithKline, PLC (“GSK”), has agreed to plead guilty to charges relating to the manufacturing and distribution of certain adulterated drugs made at GSK’s now-closed Cidra, Puerto Rico, manufacturing facility. The resolution includes a criminal fine and forfeiture totaling $150 million and a civil settlement under the False Claims Act and related state claims for $600 million. The drugs, manufactured at the plant between 2001 and 2005, are Kytril, Bactroban, Paxil CR, and Avandamet. Kytril is a sterile anti-nausea medication. Bactroban is a topical anti-infection ointment commonly used to treat skin infections. Paxil CR is the controlled release formulation of the popular anti-depressant drug, Paxil, and Avandamet is a combination Type II diabetes drug. According to the information, Avandamet tablets manufactured by SB Pharmco did not always have the FDA-approved mix of active ingredients, and, as a result, potentially contained too much or too little of the ingredient with the therapeutic effect. Finally, it is alleged in the criminal information that SB Pharmco’s Cidra facility suffered from longstanding problems of product mix-ups, which caused tablets of one drug type and strength to be commingled with tablets of another drug type and/or strength in the same bottle. Under the plea agreement, the company will pay a criminal fine of $150 million including forfeiting assets of $10 million. A date for the plea hearing has not been set. Under the civil settlement, GSK has agreed to pay an additional $600 million to the federal government and the states to resolve claims that it caused false claims to be submitted to government health care programs for certain quantities of adulterated Kytril, Bactroban, Paxil CR and Avandamet. The government contends that GSK knowingly caused false and/or fraudulent claims to be submitted to, or caused purchases by, the Medicaid Program and the other federal health care programs, by selling drugs that did not meet the quality specified in the drugs’ NDAs. The federal share of the civil settlement amount is $436,440,000 and GSK will pay up to $163,560,000 to states that opt to participate in the agreement. US Attorney press release, click here. Actual court filing for settlement agreement, click here. Actual court filing charging GSK with violations in pharmaceutical manufacturing, click here. 10/26/2010 REPORT SAYS HORMONE THERAPY FOR WOMEN MAY CAUSE CANCERMore from the Emeritus Newsroom- This week's edition of the Journal of the American Medical Association (JAMA) details a study on hormone therapy, adding to concerns that certain types leave patients more vulnerable to cancer. According to the study, the therapy regimen of estrogen plus progestin was associated with greater breast cancer incidence, and the cancers are more commonly node-positive. Breast cancer mortality also appears to be increased with combined use of estrogen plus progestin. There were more deaths directly attributed to breast cancer (25 deaths [0.03% per year] vs 12 deaths [0.01% per year as well as more deaths from all causes occurring after a breast cancer diagnosis (51 deaths [0.05% per year] vs 31 deaths [0.03% per year]; among women who received estrogen plus progestin compared with women in the placebo group. Summary and link to full text of JAMA article, click here. More in this article from RedOrbit, click here. 10/20/2010 CHANGES TO C-P-R / CHEST PRESSES FIRSTMore in this article from Associated Press, click here. American Heart Association and American Red Cross joint announcement Regarding CPR changes, click here. Below, video from the American Red Cross.
10/18/2010 FDA RECINDS APPROVAL OF MENAFLEX KNEE CUSHION PATCHES / ALSO TAKES ACTION AGAINST OVER THE COUNTER CHELATION THERAPIESMore from the Emeritus Newsroom- Political pressure is being blamed for the premature approval by the FDA of a knee cushion patch. Today, the FDA announced it was recinding its approval due to a lack of documentation as to the safety of the patch. According to the agency, the Menaflex Collagen Scaffold, was cleared for marketing by the FDA in December 2008 for the repair and reinforcement of the meniscal tissue in the knee. The meniscus is a C-shaped disk of fibrocartilage in the knee that acts as a cushion between the ends of bones in the joint and helps lubricate the joint. A September 2009 report recommended a scientific re-evaluation of the device because the administrative record did not supply a basis for the FDA’s December 2008 decision to clear that was adequate to dispel questions about the role of outside pressures on the review process. This re-evaluation, initiated in the fall of 2009, included a team of scientists at the agency who were not involved in previous reviews of the device. Another advisory committee meeting was also held in March 2010. It is unlikely that explanting the device will generally be appropriate or necessary because the device is resorbed and replaced with new tissue. However, patients who have had the Menaflex device implanted should talk with their surgeon or other health care professional about what, if any, steps should be taken. A rescission is an FDA action to revoke a marketing clearance later determined to be erroneous. After implementing a rescission, the FDA prohibits the manufacturer from further U.S. marketing until the agency approves or clears a new marketing application, or grants a classification petition. After the FDA issues a rescission notice, a manufacturer has the option of requesting a regulatory hearing with the FDA or can choose to voluntarily withdraw their marketing clearance. The device will remain on the market until the agency rescinds its clearance. The circumstances surrounding the Menaflex device are unique, and FDA’s decision in this case does not affect the status of other devices on the market. ALSO TODAY, THE FDA ANNOUNCED IT WAS TAKING ACTION AGAINST EIGHT COMPANIES MARKETING OVER THE COUNTER CHELATION THERAPIES. The FDA ordered products are unapproved drugs and devices and that it is a violation of federal law to make unproven claims about these products. There are no FDA-approved OTC chelation products.The companies that received the warning letters claim that their products treat a range of diseases by removing toxic metals from the body. Some also claim to treat autism spectrum disorder, cardiovascular diseases, Parkinson’s disease, Alzheimer’s disease, macular degeneration, and other serious conditions. Some companies that received the warning letters also claim their products will detect the presence of heavy metals to justify the need for chelation therapy.The drug products involved have not been evaluated by the FDA for treatment of these diseases, and violate the Federal Food, Drug, and Cosmetic Act (FFDCA). Despite the claims of the companies that received warning letters, the effectiveness in treating any of the diseases listed is unsubstantiated. Depending on the condition, when relying on unproven OTC chelation products to treat serious conditions, patients may delay seeking effective medical care. In addition, there are serious safety issues associated with chelation products, which can alter the levels of certain substances in the blood. Even when used under medical supervision, these products can cause serious harm, including dehydration, kidney failure, and death. “These products are dangerously misleading because they are targeted to patients with serious conditions and limited treatment options,” said Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA must take a firm stand against companies who prey on the vulnerability of patients seeking hope and relief.” The agency advises consumers to avoid non-prescription products offered for chelation or detoxification. See specific products and companies in FDA press release link below. Full text of FDA statement on Menaflex, click here. Full text of FDA statement on chelation therapy, click here. 10/15/2010 CVS DRUG CHAIN AGREES TO $75 MILLION FINE FOR FAILURE TO MONITOR SALES OF DRUGS TO METH PRODUCERS / STEMS FROM SALE OF COLD MEDSMore from the Emeritus Newsroom- In what has been termed as the largest paid settlement for a violation of the Controlled Substances Act, CVS has agreed to pay a $75 million fine. The case was originally filed in California where government investigators claimed the company did little or nothing to stop bulk sales of cold meds with pseudoephedrine, used for the production of meth. Other states joined the lawsuit. The Central California District Attorney's Office reports that it and CVS agreed to the settlement that levies $75 million in civil penalties and another $2.6 million in profits the company earned as a result of the illegal conduct. Federal investigators claim the company failed to ensure compliance with laws limiting sales of pseudoephedrine, which allowed criminals to obtain a key ingredient used in the manufacture of methamphetamine from CVS stores located primarily in Los Angeles County; Orange County, California; and Clark County, Nevada. Between September 2007 and November 2008, CVS supplied large amounts of pseudoephedrine to methamphetamine traffickers in Southern California, and the company’s illegal sales led directly to an increase in methamphetamine production in California. CVS eventually changed its sales practices to prevent these illegal sales, but it did so only after it became aware of the government’s investigation. The federal investigation also uncovered thousands of violations of the Combat Methamphetamine Epidemic Act of 2005, which, among other things, limits the amount of pseudoephedrine that a customer can purchase in one day. In 2007, CVS implemented an automated electronic logbook system to record individual pseudoephedrine sales, but the system did not prevent multiple purchases by an individual customer on the same day. The government learned that violations occurred not only in California and Nevada, but likely also in 23 other states where CVS failed to implement appropriate safeguards. The settlement therefore addresses CVS’s liability in a total of 25 states. CVS admitted the case represented a breakdown in oversight and vowed not to repeat the offense. "We are announcing today that we have resolved this issue, which unfortunately resulted from a breakdown in CVS/pharmacy's normally high management and oversight standards," said Thomas M. Ryan, Chairman and CEO, CVS Caremark. "While this lapse occurred in 2007 and 2008 and has been addressed, it was an unacceptable breach of the company's policies and was totally inconsistent with our values. CVS/pharmacy is unwavering in its support of the measures taken by the federal government and the states to prevent drug abuse. "To make certain this kind of lapse never takes place again," Ryan continued, "we have strengthened our internal controls and compliance measures and made substantial investments to improve our handling and monitoring of PSE by implementing enhanced technology and making other improvements in our stores and distribution centers." Ryan concluded, "CVS/pharmacy will continue to cooperate fully with the DEA and other law enforcement agencies in their efforts to keep PSE out of the wrong hands". District Attorney press release on CVS settlement, click here. CVS statement on settlement, click here. 10/15/2010 EARLY RETIREMENT COULD BRING EARLY MEMORY LOSSMore from the Emeritus Newsroom- More evidence to support the "Use it or lose it" theory behind memory loss. A study showcased in the Journal of Economic Perspectives claims that those who take early retirement are more likely to suffer from early memory loss. The study, from authors, Susann Rohwedder and Robert J. Willis, concludes: "Early retirement appears to have a signififi cant negative impact on the cognitive "During the past decade, older Americans seem to have reversed a century-long Full text of study, click here. 10/12/2010 DRUG MAKERS NOT COMPLYING WITH FEDERAL LAWS ON PRICE REPORTING / HAMPERS REBATES TO STATES FOR DRUG PURCHASES / ALSO FINDS $8.2 MILLION PAYMENTS FOR MEDICAL SERVICES CLAIMED AFTER PATIENT DEATHSMore from the Emeritus Newsroom- A probe by the Inspector General of Health and Human Services finds that drug companies are not complying with price reporting requirements as part of state medicaid programs. This delays or prevents rebates to states for their drug purchases, according to the report. Another report found that in just a sample of claims, the Centers for Medicare and Medicaid Services had paid at least $8.2 million in payments for medical services on patients who were dead at the time the services were claimed. The report, issued by Inspector General Daniel Levinson claims: In 2008, more than half of manufacturers did not fully comply with quarterly submission requirements for AMP data. Of the 592 manufacturers that were required to submit quarterly AMP data during 2008, 313 (53 percent) failed to provide pricing data by the statutorily defined due date. In 2008, more than three-fourths of manufacturers did not fully comply with monthly submission requirements for AMP data. Of the 579 manufacturers that were required to submit monthly AMP data during 2008, 453 (78 percent) failed to provide pricing data by the statutorily defined due date. According to the Inspector General report, all 50 States and the District of Columbia (hereinafter referred to as States) offer prescription drug coverage under Medicaid. Medicaid beneficiaries typically obtain covered drugs from pharmacies, which bill and are reimbursed by State Medicaid agencies using NDCs. In 2008, Medicaid payments for prescription drugs totaled approximately $24 billion. However, billions of dollars in rebates and fines are paid late, due to late price reporting, adding to budget problems for states. As of this posting, no response from the leading pharmaceutical lobbying group, The Pharmaceutical Research and Manufacturers of America (PhRMA). Full text of Inspector General report, click here. The report on $8.2 million in mistaken or bogus charges for medical services on dead patients found mistakes in all of the 150 cases it sampled. The Inspector General called for CMS to improve its oversight and collection system to recoup any overpayments. Full text of Inspector General report on medical services claims for dead patients, click here. 09/30/2010 HHS ANNOUNCES $320 MILLION IN GRANTS TO BOOST PRIMARY HEALTH CARE WORK FORCE / MONEY COMES FROM HEALTH REFORM LAWMore from the Emeritus Newsroom- With more federal support coming from the "Affordable Care Act", the Department of Health and Human Services today announced $320 million to strengthen the primary health care workforce in the U-S. According to HHS Secretary Kathleen Sebelius, $253 million will go to improve and expand the primary care workforce under the Prevention and Public Health Fund of the Affordable Care Act. Another $67 million in Health Profession Opportunity Grants will provide low-income individuals with education, training and supportive services that will help them prepare to enter and advance in careers in the healthcare sector. “Chronic diseases, most of which are preventable, are one of the main reasons health care costs have soared over the past several decades,” said Secretary Sebelius. “Investing in our primary care workforce will strengthen the role that wellness and prevention play in our health care system. With these grants, Americans from all backgrounds will have new opportunities to enter the health care workforce.” HHS press release, click here. 09/28/2010 STUDY CLAIMS FLU SHOTS LOWER HEART ATTACK RISKMore from the Voice of America, click here- 09/24/2010 NEW RESTRICTIONS ON THE DRUG"AVANDIA"More from the Emeritus Newsroom- The U.S. Food and Drug Administration today announced that it will significantly restrict the use of the diabetes drug Avandia (rosiglitazone) to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.“The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks,” said FDA Commissioner Margaret A. Hamburg, M.D. “We are seeking to strike the right balance to support clinical care". Rosiglitazone also is available in combination with other diabetes medications, metformin under the brand name Avandamet or glimepiride under the brand name Avandaryl. Avandia, manufactured by GlaxoSmithKline (GSK), is in a class of drugs known as thiazolidinediones, or TZDs. It is intended to be used in conjunction with diet and exercise to improve glucose (blood sugar) control in patients with Type 2 diabetes mellitus.The FDA will require that GSK develop a restricted access program for Avandia under a risk evaluation and mitigation strategy, or REMS. Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class. Current users of Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do so. Doctors will have to attest to and document their patients' eligibility; patients will have to review statements describing the cardiovascular safety concerns associated with this drug and acknowledge they understand the risks. The agency anticipates that the REMS will limit use of Avandia significantly. Full text of FDA press release, click here. 09/23/201 HHS TO SPEND $130 MILLION ON GRANTS TO SERVE THE UNDERSERVED AND DIVERSITY IN THE WORKFORCEMore from the Emeritus Newsroom- HHS Secretary Kathleen Sebelius today announced $130.8 million in grants to strengthen and expand the health professions workforce. Six areas are targeted: primary care workforce training, oral health workforce training, equipment to enhance training across the health professions, loan repayments for health professionals, health careers opportunity programs for disadvantaged students, and Patient Navigator outreach and chronic disease prevention in health disparity populations. The grants include $88.7 million in funding from the American Recovery and Reinvestment Act. “An adequate health care workforce is the linchpin for reforming our health care system to ensure greater access, improve the quality of health care and cut overall costs in the long term,” said Secretary Sebelius. “Today’s awards not only will provide more training opportunities for people interested in a health professions career, but also will support equipment purchases and faculty development to expand and enhance the quality of training.” “With an aging and increasingly diverse population, we need to prepare our health professionals to meet the challenges of providing health care in the twenty-first century,” noted Mary K. Wakefield, Ph.D., R.N., administrator of HHS’ Health Resources and Services Administration (HRSA), which oversees the programs. “This includes ensuring diversity in the workforce, and that well-trained professionals practice in areas of severe need.” Full text of HHS press release, click here. 09/20/2010 INDEPENDENT GOVERNMENT PANEL SAYS HEALTH COSTS DUE TO REFORM WILL INCREASE BY ONLY .3 OF GDP THROUGH 2019More from the Emeritus Newsroom- In what is being seen as a victory of health reform advocates, a special independent government panel confirms health reform will not take as much of the country's gross domestic product as opponents had claimed. The panel's report, which was not widely circulated to news media, finds that increased medical costs will consume 19.6% of the county's GDP by 2019, however, of that increase, the panel says only .3% (three tenths percent) of that increase will be due to the health reform laws. The panel says that reform will have a "moderate" effect on holding down cost increases of medical services. Some other points of the report includes: Average annual growth in NHE for 2009 through 2019 is expected to be 6.3 percent, 0.2 percentage point faster than pre-reform estimates. Projected growth in NHE for 2010 is higher than previously estimated by 1.2 percentage points at 5.1 percent. Conversely, growth in NHE for 2011 is projected to be 4.2 percent, or 1.0 percentage point slower than the previous estimate. These differences are largely attributable to legislative changes to the Sustainable Growth Rate system which removed physician-administered drugs from the formula in late 2009, postponed a 21.3-percent rate reduction in January 2010, and currently calls for a 23-percent payment rate reduction in December 2010. Also contributing to the revised rates of projected growth are changes in law related to the Consolidated Omnibus Reconciliation Act (COBRA) subsidies, which were amended to extend eligibility to more people, as well as lengthen the timeframe for which enrollees could receive the subsidy. In 2014, Private Health Insurance (PHI) expenditure growth is projected to reach 12.8 percent, 6.1 percentage points higher than the pre-Affordable Care Act estimate, as a projected 16 million people sign up for coverage through the State-level Health Insurance Exchange plans. For 2015 through 2019, PHI spending is expected to average 6.6 percent, or 0.3 percentage point faster than was projected before health reform was enacted, in part due to the continued transition of many into the Exchange plans who were previously uninsured. In 2014, out-of-pocket (OOP) spending is projected to decline by 1.1 percent as the major provisions of the Affordable Care Act are implemented and millions of people, many of whom were previously uninsured, attain health coverage through Medicaid or the Health Insurance Exchanges. Prior to passage of the Affordable Care Act, OOP spending growth was expected to be 6.4 percent. While available over the internet, the report is virtually buried in the actuarial reports sections of the Centers for Medicare and Medicaid Services web site. Full PDF text of "National Health Expenditure Projections 2009-2019 (September 2010)", click here. 09/10/2010 INDEPENDENT GOVERNMENT PANEL SAYS MEDICAL COSTS WILL BE 20% OF ECONOMY BY 2019 / PANEL SAYS REFORM LAW WILL HELPMore from the Emeritus Newsroom- A review by an independent panel for the Centers for Medicare and Medicaid Services finds the new health care reform law will have a moderate impact restricting medical costs. Still, the panel expects medical spending to consume 19.6% of the American economy by the year 2019, with an average annual growth rate of 6.3%, outpacing the projected yearly rates of inflation. The report also projects that 93% of Americans will be covered by health insurance by the end of the decade, compared to the current 84%. The panel found that, while it will cost more to cover the uninsured, the cost increase amounts to only .3 (three tenths) of a percent, through the year 2019. The report was not widely distributed to news media, but was available on the Centers for Medicare and Medicaid Services national health expenditure data. Full pdf text of report, click here. 09/09/2010 JOHNSON AND JOHNSON ORDERS RECALL OF HIP REPLACEMENTSMore from the Emeritus Newsroom- A recall of hip replacement systems may mean corrective surgery. Johnson and Johnson announced today that those with ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing Systems used in hip replacement surgery may require a second hip replacement procedure, called a revision surgery. A subsidiary, DePuy Orthopaedics, made the decision after reviewing cases involving those patients with the implants, who later required corrective surgery. The ASR device is part of a class of large diameter, monoblock hip resurfacing and replacement devices often selected by surgeons for younger patients who may benefit from a more stable device that can reduce the chances of dislocation after surgery. The DePuy ASR™ Hip Resurfacing System was introduced in 2003 and is only approved for use outside the U.S. The ASR™ XL Acetabular System was first launched in 2004 and has been available worldwide. “We regret that this recall will be concerning for patients, their family members and surgeons,” said David Floyd, president, DePuy Orthopaedics. “We are committed to assisting patients and health care providers by providing information through multiple channels and paying for the cost of doctor visits, tests and procedures associated with the recall.” Full text of Johnson and Johnson press release on hip replacement recall, click here. 08/26/2010 SECRET MEDICAL SERVICES COSTS KEEP PRICES HIGHMore in this article from Bloomberg News, click here- 08/20/2010 WORLD HEALTH ORGANIZATION DECLARES END TO H1N1 SWINE FLU PANDEMICMore from the Emeritus Newsroom- With evidence that flu is transitioning to seasonal strains, the WHO says the H1N1 strain of flu has been reduced or controlled in most countries. However, in a press released from U-S Health and Human Services: "Members of the Emergency Committee further noted that the 2009 H1N1 viruses will likely continue to circulate for some years to come, taking on the behavior of a seasonal influenza virus. This does not mean that the H1N1 virus has disappeared. Rather, it means current influenza outbreaks including those primarily caused by the 2009 H1N1 virus, show an intensity similar to that seen during seasonal epidemics. Pandemics, like the viruses that cause them, are unpredictable. WHO noted that continued vigilance is extremely important, and it is likely that the virus will continue to cause serious disease in younger age groups and pregnant women, at least in the immediate post-pandemic period" U-S Health and Human Services claims the only impact on the United States resulting from the WHO declaration will be a cessation in weekly reporting under the International Health Regulations (IHR) to the Pan American Health Organization and the World Health Organization. CDC has reported weekly to IHR since early in the pandemic. There are no changes for the United States in terms of CDC’s recommendations for the upcoming influenza season and the United States is already proceeding with the understanding that the 2009 H1N1 virus is now part of seasonal influenza virus circulation. As is customary, beginning in October, 2010, CDC will provide weekly reports of influenza surveillance information throughout the season with the publication of FluView available at www.cdc.gov/flu/weekly . WHO press release from HHS, click here. 08/11/2010 MORE PROOF SPINAL FLUID IS PREDICTOR FOR ALZHEIMER'S / DIRECT LINK TO STUDY SUMMARYMore from the Emeritus Newsroom- Over the last 20 years, spinal fluid has been the focus of promising research for predicting Alzheimer's disease. A study just released in the Archives of Neurology suggests there is more evidence to solidify that conclusion. It was based on data from more than 300 patients in various stages of Alzheimer's and suspected Alzheimer's cases as well as those presenting no symptoms for the disease. A large team of physicians and researchers worked on the study examining data and patients from the Alzheimer's Disease Neuroimaging Initiative, The Collaborative Aging and Memory Project patients from Amish communities in Ohio and Indiana, John-Hopkins University, and other genome research groups. In less technical terms, the group found spinal fluid proteins, normally associated as potential predictors or indicators of Alzheimer's, amyloid beta, associated with plaque, and tau, which is responsible for keeping dying or dead nerve cells in the brain, consistently present in every stage of the disease. Some patients presenting no memory impairment had spinal fluids with evidence of the suspected proteins and are expected to eventually develop the disease. Those with mild memory impairment, with suspected proteins in their spinal fluid, eventually did develop cases of Alzheimer's. Nearly all those with established Alzheimer's cases were found to have the suspected proteins. In technical terms the study concludes, Consistent with conclusions from previous studies showing interaction of APOE with PSEN1,36 PSEN2,37 and APP,37-38 our results suggest that the APOE and PICALM gene products participate in a common pathogenic pathway leading to AD. Since PSEN1, PSEN2, and APP are all involved in β-amyloid production, PICALM may also participate in this process, though a more indirect involvement cannot be ruled out and the biology of these interactions remains to be determined. We did not detect an interaction of APOE with CR1 or CLU, though this could be because of sample size, which was not large enough to detect very weak interactions. Also, since the APOE effect on AD risk is much stronger in young case populations,35 the age structure of our study and of others may not be optimal for detecting these interactions. Our study and those from other consortia6-7 (E. M. Wijsman, PhD, Y. Choi, MS, J. H. Rothstein, MS, et al, unpublished data, June 2010) show that AD susceptibility loci can be identified by GWAS. Initial AD GWAS had samples sizes that, in comparison with those from the large consortia, were modest and inadequately powered to detect the small effect loci replicated herein.18, 46-51 As sample sizes increase, as in other complex disorders, we expect additional loci to be identified. The researchers say more work is needed to establish procedure for testing in doctors offices. However, there is consensus among the researchers such testing should be done by those specializing in spinal taps, less likely to be available in general and family medical practices. The study was funded by grants from various agencies of the U-S government, major pharmaceutical companies, medical research hospitals and medical schools. Full text of study release, click here. 08/09/2010 STUDY CONCLUDES FOREIGN EDUCATED DOCTORS OFFER EQUAL CARE / LOWER DEATH RATESMore from the Emeritus Newsroom- A study, published August 4th, in Health Affairs magazine, claims there is no difference in the quality of care offered by doctors educated in foreign countries and their American counterparts. The study was supported by the Educational Commission for Foreign Medical Graduates. the study finding also claimed that patients of doctors who went to medical school outside the United States and weren't American citizens had a 9 percent lower death rate on average than those whose doctors trained at home. This story has been the subject of conflicting reports the past week, based on various interpretations of the results. An article from b-net points out: Economics may help explain the gap in patient outcomes, said John Norcini, co-author of the study. Internal medicine and primary care have failed to attract the best students in the United States because of lower pay, relative to other specialties, he said. "Primary care may not be getting the best and the brightest from U.S. medical schools," said Norcini, chief executive officer of the Foundation for Advancement of International Medical Education and Research, a Philadelphia-based nonprofit. "Foreign students see primary care as a gap that they can fill and a way to practice medicine here." Primary-care doctors, including internists and family practice physicians, earn on average from $175,000 to $200,000 annually, while orthopedic surgeons make $519,000; radiologists, $417,000; and anesthesiologists $331,000, according to a survey released in June by the national physician search firm Merritt Hawkins, based in Irving, Texas. Medical schools don't produce enough graduates to fill all the postgraduate training slots available, and the void has been filled by graduates from institutions in other countries, Norcini said. These international-schooled doctors make up a quarter of practicing physicians in the country and are especially important in the area of primary care, he said. The findings were based on more than 244,000 heart related hospitalizations in Michigan and Pennsylvania. MedPage Today article on the study, click here. b-net article, click here. Direct link to Health Affairs website. 08/08/2010 OBAMA: U-S HAS MORAL OBLIGATION TO DISABLED VETS / WILL OBSERVE AUGUST GOAL FOR WITHDRAWING TROOPS FROM IRAQMore from the Emeritus Newsroom- Disabled vets have served as both a focus and a support base for President Obama in his campaign to improve health care access for all Americans. Today, he brought his message before the annual convention of Disabled American Veterans in Atlanta. The DAV has, for decades, pushed for many of the changes Obama signed into law. The President reminded the group of the battles which have been won, from advanced appropriations of the Department of Veterans Affairs to changes in treatment for Post Traumatic Stress Disorder and other illnesses. According to Obama, "That includes the largest percentage increases to the VA budget in the past 30 years; help for about about 200,000 Vietnam vets who may have been exposed to Agent Orange, as well as help for Gulf War vets with specific infectious diseases; eliminating co-pays for catastrophically disabled veterans; increased funding for veterans' health care across the board; eliminating delays both in the funding for medical care and the claims process; pooling the wisdom of VA employees to help cut through red tape; and an ongoing fight to end homelessness amongst veterans, which has already seen significant progress. His success so far eliminating the claims backlog, and his promise to stop it from returning with new claims processors and streamlined technology, was met with a "Hallelujah!" "Finally, we’re keeping faith with our newest veterans returning from Afghanistan and Iraq. We’re offering more of the support and counseling they need to transition back to civilian life. That includes funding the post-9/11 GI Bill, which is already helping more than 300,000 veterans and family members pursue their dream of a college education".
The President also used the DAV convention to restate his goal to get US troops out of Iraq by the end of August. "As a candidate for President, I pledged to bring the war in Iraq to a responsible end. (Applause.) Shortly after taking office, I announced our new strategy for Iraq and for a transition to full Iraqi responsibility. And I made it clear that by August 31st, 2010, America’s combat mission in Iraq would end. (Applause.) And that is exactly what we are doing -- as promised and on schedule. (Applause.) Already, we have closed or turned over to Iraq hundreds of bases. We’re moving out millions of pieces of equipment in one of the largest logistics operations that we’ve seen in decades. By the end of this month, we’ll have brought more than 90,000 of our troops home from Iraq since I took office -- more than 90,000 have come home". Reviewing changes at the VA ordered by the President,
Text of President's speech, click here. MP4 Video of President's speech before the DAV, click here. 08/02/2010 WHITE HOUSE ORDERS INSURERS TO COVER PREVENTIVE TESTS WITH NO CO PAYSMore from the Emeritus Newsroom-In an effort to boost preventive care by providing free yearly check up services, the White House has released rules under the new health reform law, mandating free health services in all private health insurance plans effective September 23d . According to the website www.healthcare.gov , here's a summary of the timeline for changes that have already taken place along with those still to some. On March 23, 2010, President Obama signed the Affordable Care Act. The law puts in place comprehensive health insurance reforms that will roll out over four years and beyond, with most changes taking place by 2014. Others have already begun. Use this timeline to learn about what’s changing and when. Changes to note: Effective Jan. 1, 2010 Up to 4 million small businesses are eligible for tax credits to help them provide insurance benefits to their workers. The first phase of this provision provides a credit worth up to 35% of the employer’s contribution to the employees’ health insurance. Small non-profit organizations may receive up to a 25% credit. Learn more Effective April 1, 2010 States will be able to receive federal matching funds for covering some additional low-income individuals and families under Medicaid for whom federal funds were not previously available. This will make it easier for states that choose to do so to cover more of their residents. First checks mailed in June, 2010, and will continue monthly throughout 2010 as seniors hit the coverage gap An estimated 4 million seniors will reach the gap in Medicare prescription drug coverage known as the “donut hole” this year. Each such senior will receive a $250 rebate. Applications for employers to participate in the program available June 1, 2010. Learn more about the Early Retiree Reinsurance Program. Too often, Americans who retire without employer-sponsored insurance and before they are eligible for Medicare see their life savings disappear because of high rates in the individual market. To preserve employer coverage for early retirees until more affordable coverage is available through the new Exchanges by 2014, the new law creates a $5 billion program to provide needed financial help for employment-based plans to continue to provide valuable coverage to people who retire between the ages of 55 and 65, as well as their spouses and dependents. National program established July 1, 2010 A Pre-Existing Condition Insurance Plan will provide new coverage options to individuals who have been uninsured for at least six months because of a pre-existing condition. States have the option of running this new program in their state. If a state chooses not to do so, a plan will be established by the Department of Health and Human Services in that state. This program serves as a bridge to 2014, when all discrimination against pre-existing conditions will be prohibited. Learn more about the Pre-Existing Condition Insurance Plan. Effective July 1, 2010 The law provides for an easy-to-use website where consumers can compare health insurance coverage options and pick the coverage that works for them. Effective for health plan years beginning on or after September 23, 2010 Under the new law, young adults will be allowed to stay on their parent’s plan until they turn 26 years old. (In the case of existing group health plans, this right does not apply if the young adult is offered insurance at work.) Some insurers began implementing this practice early. Check with your insurance company or employer to see if you qualify. Learn more about the young adults insurance policy. Effective for health plan years beginning on or after September 23, 2010 Under the new law, young adults will be allowed to stay on their parent’s plan until they turn 26 years old. (In the case of existing group health plans, this right does not apply if the young adult is offered insurance at work.) Some insurers began implementing this practice early. Check with your insurance company or employer to see if you qualify. Learn more about the young adults insurance policy. Effective for health plan years beginning on or after September 23, 2010 In the past, insurance companies could search for an error, or other technical mistake, on a customer’s application and use this error to deny payment for services when he or she got sick. The new law makes this illegal. After media reports cited incidents of breast cancer patients losing coverage, insurance companies agreed to end this practice immediately. Effective for new plans beginning on or after September 23, 2010 The law provides consumers with a way to appeal coverage determinations or claims to their insurance company, and establishes an external review process. Effective for health plan years beginning on or after September 23, 2010 Under the new law, insurance companies will be prohibited from imposing lifetime dollar limits on essential benefits, like hospital stays. Effective for health plan years beginning on or after September 23, 2010 Under the new law, insurance companies’ use of annual dollar limits on the amount of insurance coverage a patient may receive will be restricted for new plans in the individual market and all group plans. In 2014, the use of annual dollar limits on essential benefits like hospital stays will be banned for new plans in the individual market and all group plans. Effective for health plan years beginning on or after September 23, 2010 for new plans and existing group plans The new law includes new rules to prevent insurance companies from denying coverage to children under the age of 19 due to a pre-existing condition. Grants will be awarded beginning in 2010 The law allows states that have, or plan to implement, measures that require insurance companies to justify their premium increases to be eligible for $250 million in new grants. Insurance companies with excessive or unjustified premium increases may not be able to participate in the new health insurance Exchanges in 2014. Turn pages on summary of HealthCare.gov summary of changes, click here. 07/15/2010 OBAMA SIGNS BILL TO HELP CARETAKERS OF INJURED VETERANSMore from the Emeritus Newsroom - According to supporters of the new law, signed by President Obama this week, S. 1963, called the Caregivers and Veterans Omnibus Health Services Act, establishes an unprecedented permanent program to support the caregivers of wounded warriors, improve health care for veterans in rural areas, help VA adapt to the needs of women veterans, and expand supportive services for homeless veterans. The new act, according to Senate Veterans Affairs Committee Chairman Daniel Akaka (D) HI: • Fulfills VA’s obligation to care for the nation’s wounded veterans by providing their caregivers with training, counseling, supportive services, and a living stipend The bill will also provide numerous other improvements for veterans, by: • Expanding health care services for women veterans Full text of the legislation, click here. Thomas summary of act, click here. 05/07/2010 JOHNSON & JOHNSON SUBSIDIARIES PAY MORE THAN $81 MILLION TO SETTLE ILLEGAL MARKETING OF DRUG "TOPAMAX"More from the Emeritus Newsroom- For the second time this week, federal officials have announced a settlement for illegal drug marketing. This time with Johnson & Johnson subsidiaries, charged with marketing the epilepsy drug "Topamax" for psychiatric conditions which has not been approved by federal regulators. The government alleged that Ortho-McNeil Pharmaceutical promoted the sale of Topamax for off-label psychiatric uses through a practice known as the "Doctor-for-a-Day" program. Using this program, Ortho-McNeil hired outside physicians to join sales representatives in their visits to the offices of health care providers and to speak at meetings and dinners about prescribing Topamax for unapproved uses and doses . Full text of Justice Department press release, click here. 04/29/2010 FEDS SETTLE DRUG MARKETING FRAUD CASE AGAINST ASTRA ZENECA FOR $520 MILLION / FEDS CLAIMED COMPANY PROMOTED IMPROPER USE OF THE DRUG "SEROQUEL"More from the Emeritus Newsroom - The Department of Health and Human Services and the U-S Department of Justice today announced an out of court settlement in the drug marketing fraud case against drug maker, AstraZeneca. The company will pay $520 million to avoid prosecution that it fraudulently marketed the drug "Seroquel". The drug is used as an anti-psychotic drug treatment for for schizophrenia and specific types of bipolar mania. AstraZeneca was charged with promoting Seroquel to physicians for use "off-label" in children and the elderly. Doctors are allowed to prescribe drugs for unapproved uses but FDA rules state that drug manufacturers may only promote their products for approved conditions and age groups. Full text of Attorney General Holder statement, click here. Video of news conference from C-SPAN, click here. 04/27/2010 FDA ISSUES ADVISORY ON INFUSION PUMP SAFETY ISSUES / PROMPTED BY MORE THAN 500 DEATHSMore from the Emeritus Newsroom- Failures of infusion pumkps have forced the Food and Drug Administration to issue a "guidance" warning of potential problems of the pumps and what manufacturers should be doing to fix the problems. The FDA says that many of the reported problems appear to be related to deficiencies in device design and engineering. As part of its initiative, the FDA published draft guidance today recommending that infusion pump manufacturers begin to provide additional design and engineering information to the agency during premarket review of the devices. Full text of FDA press release, click here. 04/23/2010 CDC SAYS DOCTORS' IN-OFFICE TESTS NOT RECOMMENDED FOR COLORECTAL CANCER SCREENING / HOME SCREENING RESULTS SEEN AS MORE ACCURATEMore from the Emeritus Newsroom - The CDC says it has found that 75% of primary care doctors are using an in-office test colorectal test, rather than relying on the home-based test, even though the home-based test is more accurate. The CDC says national guidelines recommend that FOBT testing be done with stool samples collected at home. Previous studies have shown that the in-office FOBT, in which a single stool sample is collected by a physician during a digital rectal examination, is ineffective. CDC press release, click here. Full PDF of actual report, click here . 04 /15/2010 SWINE FLU AT ALL TIME LOW SINCE OUTBREAK / OFFICIALS WARN SEASON NOT OVERMore from the Emeritus Newsroom- The spread of H1N1Swine flu remains low in the us, both in the number of doctor visits, confirmed hospitalizations and deaths. According to the Centers for Disease Control, no states are reporting widespread flu activity, with only isolated regional outbreaks reported in five states, Alabama, Georgia, Maine, Mississippi and South Carolina. The agency also reported today that the majority of the influenza viruses identified so far continue to be 2009 H1N1 influenza A viruses. These viruses remain similar to the virus chosen for the 2009 H1N1 vaccine, and remain susceptible to the antiviral drugs oseltamivir and zanamivir with rare exception. Some influenza B viruses are circulating at low levels, and these viruses remain similar to the influenza B virus component of the 2009-10 seasonal flu vaccine. Officials warn the season may still bring a rebound of the virus and that personal hygiene and vaccinations remain the best defense. Full text of CDC press release, click here. 03/12/2010 ALZHEIMER'S REPORT ESTABLISHES NUMBERS TO HIGHER CASES AMONG MINORITIESMore from the Emeritus Newsroom- higher cases among minorities has been clearly established for year. What had not been clearly established, until today, was a quantification to the extent released today by the Alzheimer's Association. According to the Alzheimer’s Association’s® 2010 Alzheimer’s Disease Facts and Figures, African-Americans are about two times more likely and Hispanics are about one and one-half times more likely than their white counterparts to have Alzheimer’s and other dementias. Although whites make up the great majority of the more than five million people with Alzheimer’s and other dementias, African-Americans and Hispanics are at higher risk for developing the disease. WORLD HEALTH ORGANIZATION SAYS SWINE FLU HAS NOT PEAKED / NEW OUTBREAKS REPORTED IN AFRICA / EXPECTATIONS FOR INCREASE IN SOUTHERN HEMISPHEREMore from the Emeritus Newsroom- An emergency committee of the World Health Organization today warned the H1N1 Swine Flu was on the rise in Western Africa with another increase expected with the onset of winter in the Southern Hemisphere. The virus has declined in the US and in Europe, however the increases in Africa and potential elsewhere has forced W-H-O officials to project that the virus has not yet peaked and could make a huge rebound. WHO press release, click here. 02/24/2010 REPORT: DIABETES DRUG AVANDIA SHOULD BE PULLED FROM MARKET / LINKED TO HEART ATTACKS AND HEART FAILURE / INTERNAL REPORT LEAKS TO NEW YORK TIMES / SENATE QUESTIONS FDA ACTIONSMore from the Emeritus Newsroom- Senators Max Baucus (D) MT and Charles Grassley (R) IA have released a Senate committee report which questions how much information GlaxoSmithKline had about cardiac effects of their drug AVANDIA. They also question what the Food and Drug Administration knew about the problem and whether the agency acted appropriately. “There’s a real problem when FDA’s office that reviews drugs that are on the market is The News York Times is reporting today it obtained an internal memo that calls for the drug, "Avandia" to be taken off the market . The report points to the drug being a factor in 500 heart attacks and 300 heart failure cases each month. Avandia is commonly prescribed for treatment of adult onset or Type 2 diabetes. A must read! Full text of the New York Times article, click here. 02/20/2010 LATEST SURVEY: 20% OF NURSING HOMES SUB STANDARDMore from the Emeritus Newsroom - The latest survey of the nations nursing homes, published today in the national publication USA Today, reflects an extension of what has already been reported by The Centers for Medicare and Medicaid Services Five Star Rating Program. The survey by the newspaper found that among that among 15,700 nursing homes nationally, about 20% receive low marks for overall quality, and those with the lowest ratings – one or two stars - were owned by for-profit companies. There are an estimated 1.4 million Americans in nursing homes. About a quarter-million live in the low-ranked nursing homes. Full articles and direct links to specific nursing home listings, click here. 01/28/2010 OBAMA ADMINISTRATION PROPOSES $8.8 BILLION FOR ASSISTANCE TO SUPPORT MILITARY FAMILIESMore from the Emeritus Newsroom - As part of the proposed 2010-2011 budget, President Obama wants $8.8 billion for additional support of military families. The President's proposed budget is expected to be submitted February 1st. ?the list includes everything from improved mental health services and relocation assistance, to building projects for schools. The proposal was outlined today by First Lady Michelle Obama, speaking to a wives club at Bolling Air Force Base near Washington DC. The Obama proposal will include a 1.4 percent basic pay raise officials say is designed to keep military pay increases in line with those in the private sector. The request also will include an average housing allowance increase of 4.2 percent, as well as a variety of enlistment and re-enlistment bonuses and monthly payments for specialty skills. istration have worked to do right by our armed forces and their families," she said, "to be there for you like you have been there for us, to lighten your load as all of you>TEXT of ACOG announcement, copy click here. 11/20/2009
WHAT TO DO WHEN YOU NEED MENTAL HEALTH CARE AND HAVE NO INSURANCEMore in this article from the New York Times, click here- 11/20/2009 HHS SECRETARY SEBELIUS SAYS SAYS NEW MAMMOGRAPHY GUIDLINES WON'T BRING ANY GOVERNMENT CHANGESMore from the Emeritus Newsroom- This week's controversy over the U.S. Preventive Services Task Force recommendations on breast cancer screenings, HHS Secretary Kathleen Sebeleius says there will be no government policy changes. The Task Force recommended that women should not have routine mammography as breast cancer screening before age 50. A change from earlier recommendations for routine screenings beginning at age 40. In a statement released today, Sebelius said, “There has been debate in this country for years about the age at which routine screening mammograms should begin, and how often they should be given. The Task Force has presented some new evidence for consideration but our policies remain unchanged. Indeed, I would be very surprised if any private insurance company changed its mammography coverage decisions as a result of this action". “What is clear is that there is a great need for more evidence, more research and more scientific innovation to help women prevent, detect, and fight breast cancer, the second leading cause of cancer deaths among women". “My message to women is simple. Mammograms have always been an important life-saving tool in the fight against breast cancer and they still are today. Keep doing what you have been doing for years -- talk to your doctor about your individual history, ask questions, and make the decision that is right for you”. Full text of press release, copy click here. 11/18/2009 AMERICAN CANCER SOCIETY TAKES ISSUE WITH GUIDELINES OPPOSING ROUTINE MAMMOGRAM USE IN WOMEN UNDER AGE 50More from the Emeritus Newsroom - Routine annual mammograms for women ages 40-49 is no longer suggested by The United States Preventive Services Task Force (USPSTF) . The group is usually seen as the nation's top authority for establishing medical treatment standards in the US. The group's own words, according to their report, "The USPSTF recommends against routinely providing the service. There may be considerations that support providing the service for an individual patient. There is at least moderate certainty that the net benefit is small. Offer or provide this service only if other considerations support the offering or providing the service in an individual patient. The USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits. Discourage the use of this service". "Standards which may ultimately lead to what is covered by insurance companies. In a broadcast tonight, CNN Chief Medical Correspondent Dr. Sanjay Gupta told Anchor Anderson Cooper that the insurance lobbying group, America's Health Insurance Plans, are saying their members will continue to offer plans which pay for mammograms. However, they did not rule out the possibility of restricting payment for mammographies in women under age 50 unless recommended by a doctor. Otis W. Brawley, M.D., Chief Medical Officer, American Cancer Society responded to the USPSTF study, saying, “The American Cancer Society continues to recommend annual screening using mammography and clinical breast examination for all women beginning at age 40. Our experts make this recommendation having reviewed virtually all the same data reviewed by the USPSTF, but also additional data that the USPSTF did not consider. When recommendations are based on judgments about the balance of risks and benefits, reasonable experts can look at the same data and reach different conclusions". “In 2003, an expert panel convened by the American Cancer Society conducted an extensive review of the data available at the time, which was not substantially different from the data included in the current USPSTF review. Like the USPSTF, the Society’s panel found convincing evidence that screening with mammography reduces breast cancer mortality in women ages 40-74, with age-specific benefits varying depending on the results of individual trials and which trials were combined in meta-analyses". USPSTF report and other direct links, copy click here. American Cancer Society response, copy click here. 11/16/2009 VETERANS DAY 2009 / RECOGNITION OF THE TOLL WAR TAKES ON AND OFF THE BATTLEFIELD / ADVOCATES REFLECT ON GAINS IN V-A BENEFITS OVER PAST YEARMore from the Emeritus Newsroom- President Obama spent part of his day at Arlington National Cemetery, in observances for the nation's war dead. The President also visited the section of the cemetery where war dead from Iraq and Afghanistan have been given their final resting place. He talked with families and others who had gathered for the day's memorial services. Later in the day, the White House announced that the President had ruled out all the options currently being considered by his "war council" for a surge of US forces in Afghanistan. Said to be the most considered of the alternatives, sending an additional 30,000 American troops to the country until Afghans are able to increase and stabilize their national security forces. A number of advisors including, former Secretary of State Colin Powell say they have told the President to take his time because this decision will have consequences for years to come. One of the latest polls, the CNN/Opinion Research Poll, shows 57% of Americans are opposed to escalating the war in Afghanistan. The President has been at the forefront of numerous changes in V-A benefits since taking office. Among them, advance budgeting for Veterans Affairs Medical Centers including additional aid for mental health, rural outreach, and homelessness among veterans. Most recently the President signed the Veterans Health Care Budget Reform and Transparency Act, copy click here. Statement from House Committee on Veterans Affairs Chairman Rep. Bob Filner (D) CA, copy click here. Daisabled American Veterans Washington Headquarters Executive Director David W. Gorman also praised Congress for including $48.1 billion for the veterans medical care budget for fiscal year 2011 as part of the 2010 budget and appropriations process. NEW STUDY SHOWS CONTINUING HIGH U-S INFANT MORTALITY RATEMore from the Emeritus Newsroom-The United States compares favorably with Europe in the survival of infants born pre term. Infant mortality rates for pre term infants are lower in the United States than in most European countries. That's the good news. T he bad news in the latest study on infant mortality released today by the Centers for Disease Control shows infant mortality rates for infants born at 37 weeks of gestation or more are generally higher in the United States than in European countries. The study also concludes that the primary reason for the United States’ higher infant mortality rate when compared with Europe is the United States’ much higher percentage of pre term births. In 2004, 1 in 8 infants born in the United States were born pre term, compared with 1 in 18 in Ireland and Finland. Pre term infants have much higher rates of death or disability than infants born at 37 weeks of gestation or more (2–4, 6), so the United States’ higher percentage of pre term births has a large effect on infant mortality rates. If the United States had the same gestational age distribution of births as Sweden, the U.S. infant mortality rate (excluding births at less than 22 weeks of gestation) would go from 5.8 to 3.9 infant deaths per 1,000 live births, a 33% decline. These data suggest that pre term birth prevention is crucial to lowering the U.S. infant mortality rate. Study text as released by the CDC, copy click here. 11/03/2009 U-S DEPARTMENT OF JUSTICE TO ALLOW MEDICAL MARIJUANA USE IN STATES THAT APPROVE ITMore from the Emeritus Newsroom-Federal prosecutors will not charge those using medical marijuana in states where it is legal. The directive from Holder came today in orders to federal prosecutors in states that have enacted laws authorizing the use of marijuana for medical purposes. The guidelines make clear that the focus of federal resources should not be on individuals whose actions are in compliance with existing state laws, while underscoring that the Department will continue to prosecute people whose claims of compliance with state and local law conceal operations inconsistent with the terms, conditions, or purposes of those laws. "It will not be a priority to use federal resources to prosecute patients with serious illnesses or their caregivers who are complying with state laws on medical marijuana, but we will not tolerate drug traffickers who hide behind claims of compliance with state law to mask activities that are clearly illegal," Holder said. "This balanced policy formalizes a sensible approach that the Department has been following since January: effectively focus our resources on serious drug traffickers while taking into account state and local laws."Text of AG Holder press release, copy click here. 10/19/2009 GOVERNMENT ACCOUNTABILITY OFFICE SAYS F-D-A INSPECTION ON IMPORTED FOOD IS WEAK / POTENTIAL RISK FOR CONSUMERSMore from the Emeritus Newsroom- Poor communication and regulations favorable to the food industry are cited as reasons why consumer are at increased risk for imported food shipments. The GAO says gaps in enforcement and collaboration undermine food safety monitoring and enforcement. First, the computer system at Customs and Border Protection does not currently notify FDA or FSIS when imported food shipments arrive at U.S. ports, although efforts are underway to provide this information to FDA for air and truck shipments. This lack of communication, according to the GAO, may potentially increase the risk that unsafe food could enter U.S. commerce without FDA review, particularly at truck ports. Second, FDA has limited authority to ensure importers' compliance with its regulations. Third, CBP and FDA do not identify importers with a unique number; as a result, FDA cannot always target food shipments originating from high risk importers. GAO report on imported food safety enforcement, copy click here. 10/14/2009 OBAMA: RECOVERY ACT HELPING CANCER RESEARCHMore from the Emeritus Newsroom- President Obama today outlined his administrations efforts to boost medical research, which has been accelerated with funds from the Recovery Act. The President says additional research at the National Institutes of Health is expanding the Cancer Genome Atlas, collecting more than 20,000 tissue samples to sequence the DNA of more than 20 types of cancer. Obama said, "...This has extraordinary potential to help us better understand and treat this disease. Cancer has touched the lives of all Americans, including my own family's; 1.5 million people will be diagnosed in the next year. Half a million people will lose their lives. We all know the terrible toll on families and the promise of treatments that will allow a mother to be there for her children as they grow up; that will make it possible for a child to reach adulthood; that will allow countless people to survive a disease that's claimed far too many lives". Obama's speech followed his tour of the National Institutes of Health campus in Bethesda, Maryland.Text of Obama's Speech, copy click here. Full text of Armed Forces Press Service Report, click here. More in this article from Associated Press, copy click here. 01/26/2010 JOHNSON & JOHNSON SUED FOR PAYING KICKBACKS IN NURSING HOME DRUG SCHEMEMore from the Emeritus Newsroom- In what has become symbolic of the way drug companies do business, the Government has filed a civil False Claims Act complaint against drug manufacturer Johnson & Johnson (J&J), of New Brunswick, New Jersey, and two of its subsidiaries, Ortho-McNeil-Janssen Pharmaceuticals, Inc., and Johnson & Johnson Health Care Systems, Inc., for paying millions of dollars in kickbacks to Omnicare, Inc. (“Omnicare”), the nation’s largest pharmacy that specializes in dispensing drugs to nursing home patients. In November 2009, the United States, numerous states, and Omnicare entered into a $98 million settlement agreement that, among other things, resolved Omnicare’s civil liability under the False Claims Act for taking kickbacks from J&J. Massachusetts U.S. Attorney Carmen Ortiz said, “Kickbacks in the nursing home pharmacy context are particularly nefarious because they can result in excessive prescribing of strong drugs to patients who have little or no control over the medical care they are receiving. Nursing home doctors should be able to rely on the integrity of the recommendations they receive from pharmacists, and those recommendations should not be a product of money that a drug company is paying to the pharmacy.” The problem also involves the drug involved, Risperdal, which is used to treat schizophrenia, but has also been used as a controversial alteernative in treating Alzheimer's Disease, for which it is not approved by the FDA. In fact, the FDA mandated that the label for Risperdal carry a“black box” warning that “Elderly Patients with dementia-related psychosis treated with atypical antipsychotic drugs [including Risperdal] are at an increased risk of death compared to placebo.”. Full text of U-S Attorney press release, copy click here.01/16/2010 CENTERS FOR MEDICARE AND MEDICAID SERVICES SAYS HEALTH CARE SPENDING INCREASES SLOWINGMore from the Emeritus Newsroom- With increasing concerns that health care spending is soaking up more the of the U-S economy, the Centers for Medicare and Medicaid Services reports that the rate of increase has slowed. According to a CMS report, nominal health spending in the United States grew 4.4 percent in 2008, to $2.3 trillion or $7,681 per person. This was the slowest rate of growth since the Centers for Medicare & Medicaid Services started officially tracking expenditures in 1960. Despite slower growth, however, health care spending continued to outpace overall nominal economic growth, which grew by 2.6 percent in 2008 as measured by the Gross Domestic Product (GDP). The findings are included in a report by CMS’ Office of the Actuary, released in the health policy journal Health Affairs. “This report contains some welcome news and yet another warning sign,” said Jonathan Blum, director of CMS’ Center for Medicare Management. “Health care spending as a percentage of GDP is rising at an unsustainable rate. It is clear that we need health insurance reform now.”The 4.4 percent growth in 2008 was down from 6.0 percent in 2007, as spending slowed for nearly all health care goods and services, particularly for hospitals. Full text of CMS press release, copy click here. 01/08/2009 HHS ANNOUNCES $27 MILLION DOLLAR PROGRAM TO HELP ELDERLY WITH CHRONIC DISEASESMore from the Emeritus Newsroom - In what has been described as a "competitive initiative", the Department of Health and Human Services today announced a $27 million grant program providing every state Aging and Health Department and U.S. territory the opportunity, if they win approval, to implement rigorously tested Chronic Disease Self-Management Programs (CDSMP), one of the most prominent being the Stanford University model. The CDSMP is a six-week peer-led training program that covers topics such as healthy eating, exercise, managing fatigue and depression, and communicating effectively with health care professionals. While further research is underway, rigorous evaluations have suggested that the program improves participants’ overall health and energy levels and result in savings to Medicare through fewer hospital stays. CDSMP are specifically designed to be delivered by non-health professionals in community settings, such as senior centers, congregate meal programs, faith-based organizations and senior housing projects. Full text of the HHS press release, copy click here. 12/16/2009 $61 MILLION MEDICARE FRAUD CASE NETS 30 ARRESTSMore from the Emeritus Newsroom - A special fraud task force has arrested and charged thirty people in three cities for their alleged roles in schemes to submit more than $61 million in false Medicare claims. According to a statement from the U-S Department of Health and Human Services, the Departments of Justice (DOJ) and HHS announced the expansion of Strike Force operations to Brooklyn, Tampa and Baton Rouge in the fifth, sixth and seventh phases of a targeted criminal, civil and administrative effort against individuals and health care companies that fraudulently bill the Medicare program. Five indictments were unsealed today in Miami, Detroit and Brooklyn, following the arrests of 25 individuals in Miami, four individuals in Detroit and one in Brooklyn. In addition, Strike Force agents executed four search warrants at businesses and homes in Coconut Creek, Fla.; Miami and Brooklyn. The joint DOJ-HHS Medicare Fraud Strike Force is a multi-agency team of federal, state and local investigators designed to combat Medicare fraud through the use of Medicare data analysis techniques and an increased focus on community policing. Strike Force teams are operating in seven cities in the United States: Miami, Los Angeles, Detroit, Houston, Brooklyn, Tampa and Baton Rouge. According to charging documents, the defendants participated in schemes to submit claims to Medicare for products and services that were in fact medically unnecessary and oftentimes, never provided. In the Detroit cases, defendants are alleged to have participated in a scheme whereby they paid kickbacks to patients who received instructions from the clinic owners and patient recruiters to feign symptoms to justify expensive testing, including nerve conduction studies. In Brooklyn, the two defendants are alleged to have billed Medicare for durable medical equipment, including expensive shoe inserts reserved for diabetes patients, when in fact much cheaper and over-the-counter shoe inserts were provided to beneficiaries who often did not need them. In Miami, 15 individuals, including doctors and nurses, are charged in connection with fraudulent claims to Medicare for home health services. In another case in Miami, individuals are charged for their various roles in running a medical clinic that purported to provide injection and infusion treatments to HIV/AIDS patients and submitted fraudulent claims Medicare for such services, which were often medically unnecessary and/or never provided. Collectively, the physicians, business owners, executives and others charged in the indictments are accused of conspiring to submit approximately $61 million in false claims to the Medicare program. .Full text of HHS press release, copy click here. 12/15/2009 PRESIDENT SIGNS NEW FUNDING FOR COMMUNITY HEALTH CENTERS / ADVANCES SERVICES FOR POOR AND UNINSUREDMore from the Emeritus Newsroom- Community health centers across the country are getting the biggest boost in years for staffing, renovations and construction. So far the federal government has forked over $1.4 billion. Now President Obama has signed a bill that provides more than $500 billion for medical care costs at those faculties. Before signing the bill, the President said, "Studies show that people living near a health center are less likely to go to the emergency room and less likely to have unmet critical medical needs. CHCs are proven to reduce ethnic and racial disparities in care. And the medical expenses of regular CHC patients are nearly 25 percent lower than those folks who get their care elsewhere -- 25 percent lower. So you can see why, in a speech marking the first anniversary of the first community health centers in America, Senator Ted Kennedy declared, "You have not only assured the best in health care for your families and neighbors, but you've also begun a minor revolution in American medicine.Now, unfortunately, today, nearly 45 years later, that care has yet to reach many of the folks in this country who need it most. So starting today, we're making $88 million in funding available for centers to adopt new health information technology systems to manage their administrative and financial matters and transfer old paper files to electronic medical records. (Applause.) These investments won't just increase efficiency and lower costs, they'll improve the quality of care as well –- preventing countless medical errors, and allowing providers to spend less time with paperwork and more time with patients. That's the purpose of the final initiative I'm announcing today as well -– a demonstration project to evaluate the benefits of the "medical home" model of care that many of our health centers aspire to. The idea here is very simple: that in order for care to be effective, it needs to be coordinated. It's a model where the center that serves as your medical home might help you keep track of your prescriptions, or get the referrals you need, or work with you to develop a plan of care that ensures your providers are working together to keep you healthy". "So taken together, these three initiatives –- funding for construction, technology, and a medical home demonstration –- they won't just save money over the long term and create more jobs, they're also going to give more people the peace of mind of knowing that health care will be there for them and their families when they need it". Full text of the President's speech at bill signing, click here. 12/10/2009 WOMENS HEALTH SERVICE PROPOSAL PASSED IN SENATEMore from the Emeritus Newsroom- An Amendment from Maryland Senator Barbara Mikulski (D) has passed the Senate on a 59-41 vote. The amendment forces insurance companies to pay for mammograms and expands previously proposed preventive services for women as part of the overall package proposed in the Senate to reform health insurance. The amendment breaks a stalemate over moving the Senate version of the health insurance reform proposal to the Senate floor. Sen. Mikulski's amendment proposal, as printed in the Congressional Record. 12/03/2009 NATIONAL INSTITUTES OF HEALTH MAKES EMBRYONIC STEM CELLS AVAILABLE FOR RESEARCH/ PART OF OBAMA'S FEDERAL FUNDING FOR RESEARCHMore from the Emeritus Newsroom- A total of 13 new "lines" of stem cells are now available for research purposes, the result of President Obama's Executive Order, signed in March to provide federal funds. In an announcement released today by the National Institutes of Health, the NIH says Children's Hospital Boston developed 11 of the approved lines and Rockefeller University in New York City developed two of the approved lines. The NIH also says an additional 96 lines have been submitted to NIH for either internal administrative review or consideration by the external Working Group for Human Embryonic Stem Cell Eligibility Review and the NIH Advisory Committee to the Director (ACD), including more than 20 that will be considered by the ACD on December 4, 2009. The working group provides findings to the ACD, which makes recommendations to the NIH Director, who decides whether the hESCs may be used in NIH-funded research and lists those deemed eligible on the NIH Human Embryonic Stem Cell Registry. Text of NIH announcement, copy click here. 12/02/2009 INSTITUTE OF MEDICINE CLAIMS WASTE IN U-S MEDICAL CARE SYSTEM EXCEEDS $800 MILLIONMore from the Emeritus Newsroom- Office of Management and Budget Director Peter Orszag says the latest survey by the Institute of Medicine is more proof of the huge level of waste in America's health care system. Orszag points out the wasted $800 billion a year does not make us healthier. The result is higher premiums for us all and higher costs for the government — but it also means you may receive tests and procedures that you do not need, putting your health at risk. According to the study, excess costs arise from a variety of sources. Excessively high administrative costs for insurers, physician and hospitals come to about $200 billion. Unnecessary services, such as using more expensive brand name drugs when generics are just as good and overusing tests and treatments compared to professional guidelines, account for another $200 billion or so. Errors and avoidable complications add $75 billion, and fraud adds another $75 billion. Preventive measures — both in terms of keeping healthy people healthy and keeping people with chronic illness such as diabetes out of the hospital — tack on another $55 billion. And the list goes on. Orszag statement press release, copy click here. Institute of Medicine summary of study, copy click here. 10/05/ 2009
NEW GUIDELINES ANNOUNCED FOR CERVICAL CANCER PAP SCREENINGSMore from the Emeritus Newsroom -An announcement today from The American College of Obstetricians and Gynecologists suggested changes for routine pap screenings.
ACOG's announcement points out cervical cancer rates have fallen more than 50% in the past 30 years in the U-S due to the widespread use of the Pap test. The incidence of cervical cancer fell from 14.8 per 100,000 women in 1975 to 6.5 per 100,000 women in 2006. The American Cancer Society estimates that there will be 11,270 new cases of cervical cancer and 4,070 deaths from it in the US in 2009. The majority of deaths from cervical cancer in the US are among women who are screened infrequently or not at all. Cervical cancer is a slow growing cancer caused by certain strains of the human papillomavirus (HPV), an extremely common sexually transmitted disease among women and men. HPV also causes genital and anal warts, as well as oral and anal cancer. Video of Obama's Speech, click here. 09/30/2009 GAO SAYS MONITORING PROGRAM SHOULD BE EXPANDED FOR 580 POOR PERFORMING NURSING HOMESMore from the Emeritus Newsroom - In a review of the Special Focus Facility Program for poorly performing nursing homes, the Governmental Accountability Office says the number of homes in the program should be expanded from the current 136 to 580. The program is currently handled by the Centers for Medicare and Medicaid Services. In their report, the GAO claims: "Almost 4 percent—or 580—of the nation’s roughly 16,000 nursing homes could be considered the most poorly performing. These 580 homes overlap somewhat with the 755 SFF Program candidates and the 136 nursing homes actually selected as SFFs.30 For example, our estimate of 580 most poorly performing nursing homes includes (1) 302, or 40 percent, of the 755 SFF Program candidates as of December 2008 (see fig. 2) and (2) 65 nursing homes that 31 states selected as SFFs from among the SFF Program candidates, or about half of the active SFFs as of February 2009.31 In addition, our estimate resulted in some states having fewer or more poorly performing homes than CMS currently allocates to states under the SFF Program. For example, 10 states each had over 20 of the most poorly performing nursing homes. Indiana had the greatest number, with 52 such nursing homes, or almost 9 percent of the total of 580 homes. Eight states had no such nursing homes." Senate Special Committee on Aging Chairman Herb Kohl (D)WI and Ranking Member Sen. Charles Grassley (R) IA, offered their comments on the report. “If far more than 136 nursing homes are found to have the bleakest conditions, then perhaps we should consider expanding the Special Focus Facility program,” said Kohl. “Regardless, we should use the tools we have to let American consumers know which homes the federal government considers the very worst, whether or not they receive additional scrutiny through the program.”
“Policymakers and those directing federal-state inspection efforts need to pay attention to reports like this because they delineate how we're still failing to identify poorly performing nursing homes. The information in this report should be used to better direct efforts to improve quality and protect nursing home residents,” said Grassley.
GAO Report, copy click here. Letter from Kohl and Grassley, copy click here. 09/28/2009 FDA ADMITS IT APPROVED UNSAFE KNEE PATCH DEVICE / POLITICAL PRESSURE FOR QUICK APPROVAL BLAMEDMore from the Emeritus Newsroom- Medical device manufacturer ReGen today offered no comment on a preliminary FDA internal report that it used political contributions to push approval for its faulty knee patch device. Meanwhile, the FDA announced it was reviewing its approval of Menaflex knee patches, due to the number of reported failures, which forced patients to undergo additional surgery. The internal FDA report cities ReGen's complaint that it was being treated unfairly during the FDA review of Menaflex, but the report states, "We think the incidents reflected poor communication and mistakes rather than unfair treatment, and did not substantially prejudice ReGen in any event; the changing grounds and any departures from applicable legal standards more likely reflected differences of opinion and confusion within the Center than unfair treatment of the Company". During a panel review of the product, the FDA report claims that, MEDICAID PATIENTS GET LESS PREVENTIVE CARE ACCORDING TO G-A-OMore from the Emeritus Newsroom- Boosting payment for Medicaid preventive care services and clearly establishing what preventive services will be paid, are among the solutions proposed in a Government Accountability Office report. As an example, the report detailed observations from one expert on Medicaid managed care contracts, state Medicaid programs run the risk that managed care organizations may not cover certain services the program intends to cover if Medicaid managed care contracts lack specific and comprehensive contract language related to covered services. Three of the contracts did not specifically refer to any of the preventive services that state Medicaid programs reported were required to be covered by managed care organizations in those states. By contrast, two contracts specifically referred to all of the preventive services that the state reported covering. Most state Medicaid programs reported that they choose to cover some HHS UNDERSCORES NEED TO UNDERSTAND SEASONAL FLU SHOT WON'T PROTECT AGAINST SWINE FLU / ADDITIONAL SWINE FLU SHOTS NEEDEDMore from the Emeritus Newsroom - The Department of Health and Human Services today released information from the Food and Drug Administration which details reasons why people need both regular seasonal flu inoculations, available now, and those for the swine flu, which are scheduled to be available next year. The FDA says: The newly approved influenza vaccine is directed against strains of influenza that were expected to be circulating during the 2009-2010 influenza season, based on information available in February, when a decision regarding the composition of the vaccine was made. The seasonal flu vaccine will not protect people against the 2009 (pandemic) H1N1 influenza virus, which emerged later in the year and resulted in the declaration of a pandemic by the WHO in June 2009. FDA is working with manufacturers, international partners, and other government agencies to facilitate the availability of a safe and effective vaccine against the 2009 (pandemic) H1N1 influenza virus. Although no vaccine is 100 percent effective in preventing disease, vaccination is the key to flu prevention. FDA statement on inoculations, copy click here. 09/04/2009 OBAMA SAYS ADMINISTRATION READY AND WORKING FOR FALL SWINE FLU OUTBREAKMore from the Emeritus Newsroom- Members of President Obama's cabinet met this morning at the White House to give the President an update on preparations for the upcoming flu season and the spread of the H1N1 virus. After the meeting the President held a news conference in the Rose Garden. Obama, in a short statement, repeated some of the advice already given by HHS and the CDC to contain the spread of flu, but the President also said that every American has a role to play in responding to this virus. We need state and local governments on the front lines to make antiviral medications and vaccines available, and be ready to take whatever steps are necessary to support the health care system. We need hospitals and health care providers to continue preparing for an increased patient load, and to take steps to protect health care workers. We need families and businesses to ensure that they have plans in place if a family member, a child, or a co-worker contracts the flu and needs to stay home. And most importantly we need everyone to get informed about individual risk factors, and we need everyone to take the common-sense steps that we know can make a difference. Stay home if you're sick. Wash your hands frequently. Cover your sneezes with your sleeve, not your hands. And take all the necessary precautions to stay healthy. I know it sounds simple, but it's important and it works. The Department of Health and Human Services also unveiled a new public service announcement campaign with the help of Sesame Street celebrities. PSA's video click here. Text of President Obama's news conference on flu season preparations, copy click here. 09/01/2009 PRESIDENT OF ECONOMIC POLICY INSTITUTE TELLS OBAMA TO STICK WITH PUBLIC OPTIONMore from the Emeritus Newsroom- The President of the Economic Policy Institute is calling on President Obama to stay the course on a public option to help curb medical insurance costs. Lawrence Mishel released a copy of a letter to the president stating: "Without the competitive check provided by a robust public plan, however, many Americans will find themselves with no meaningful health insurance choices even after reform. Further, while reform without a public plan can expand coverage in the short-run, these gains will be fleeting unless the central long-run challenge of health reform, “bending the curve” of long-run cost growth, is addressed. A substantial body of evidence suggests that a large public role in financing health insurance is associated with better cost-control. We know that your administration is committed to evidence-based policy decisions. We urge you to honor this commitment by insisting firmly that fundamental health reform needs a public option". Text of Mishel letter, copy click here. 09/01/2009 REPUBLICAN NATIONAL COMMITTEE MAILER SUGGESTS DEMOCRATIC HEALTH REFORM PROPOSALS WOULD DENY CARE TO REPUBLICANSMore from the New York Times, copy click here- 08/28/2009 A MUST READ: HOW OTHER COUNTRIES DO HEALTH CARE AT NOWHERE NEAR THE COST IN THE U-SMore from the Washington Post, copy click here- 08/27/2009 GOVERNMENT PROJECTION: HALF THE U-S POPULATION COULD GET SWINE FLUMore from the Emeritus Newsroom- The President's Council of Advisors on Science and Technology today predicted that as much as half the country's population will contract swine flu. As for projections as statistics, the council claims that could mean up to 120 million people with more than 1.8 million needing hospital treatment, 300,000 of them for intensive care. In an average year, seasonal flu deaths range from 30,000-40,000. But, the Swine Flu outbreak could bring the toll to more than double that, perhaps, 90,000. The report concludes that the 2009-H1N1 flu is unlikely to resemble the deadly flu pandemic of 1918-19. But in contrast to the benign version of swine flu that emerged in 1976, the report says the current strain "poses a serious health threat" to the nation. The issue is not that the virus is more deadly than other flu strains, but rather that it is likely to infect more people than usual because it is a new strain against which few people have immunity. This could mean that doctors’ offices and hospitals may get filled to capacity. PCAST press release, copy click here. 08/24/2009 OBAMA ADMINISTRATION PUMPS MILLIONS INTO ACCELERATED ELECTRONIC MEDICAL RECORDS / NEW LAW BEGINS REQUIRING NOTIFICATION OF PATIENTS IF RECORDS CONFIDENTIALITY IS BREACHEDMore from the Emeritus Newsroom- Delivering on its pledge to stop up electronic medical record conversions, the Obama administration has ordered $1.2 billion spent for that effort. Yesterday, HHS Secretary Kathleen Sebelius announced here department will spend $25.7 million in grants to increase and improve health and support services at the nation's health centers.
Colorectal cancer is the second leading cause of cancer deaths in the United States, after lung cancer. In 2006, more than 139,000 new cases of colorectal cancer were diagnosed and more than 53,000 people died from this disease. Full text of CDC colorectal press release, click here. 04/19/2010 FORECLOSURES THREATEN ELDER CARE HOMES / RESIDENTS OFTEN LEFT NO ALTERNATIVES WHEN EVICTION TAKES PLACEMore from the New York Times, click here - 04/19/2010 EXECUTIVES OF UNITED HEALTH REAP TENS OF MILLIONS IN STOCK OPTIONSMore in this article from the Washington Post, click here- 04/16/2010 THOUSANDS OF VETS ELIGIBLE FOR RECONSIDERATION ON DENIED DISABILITY CLAIMS HAVE NOT FILEDMore in this article from AP, click here- 04/02/2010 PFIZER PAYS $35.3 MILLION TO DOCTORS, CONSULTANTS, MEDICAL CENTERS AND RESEARCH GROUPS WHO USE OR STUDY THEIR DRUGSMore from the Emeritus Newsroom - Pfizer today released totals it has paid outside medical professionals based on data collected from July through December 2009 about work done with approximately 4,500 healthcare professionals resulting in total payments of $35 million for their time and expertise to gain and share real-world experience about the safe and appropriate use of medicines and the development of medical innovations. Pfizer is reporting data for healthcare professionals who received payments, meals or non-monetary educational items worth $25 or more and totaling $500 or more during the six-month reporting period. Pfizer also makes the point that almost 44 percent of the total payments disclosed for the reporting period are associated with Pfizer's collaborations with approximately 250 research organizations to study how medicines work and to discover new medicines to treat and prevent life-threatening and debilitating illnesses. In total, Pfizer reported payments of approximately $15.3 million to these institutions for all new clinical trials initiated after July 1, 2009 as well as clinical trial payments made between July 1 and December 31, 2009 to academic medical centers for ongoing or new research. These payments cover a variety of critical activities including participant recruitment, coordinating and conducting the clinical trials and completing compliance activities to ensure regulatory requirements are met. The drugmaker also explains the need to compensate professionals in other settings.
Pfizer promises in their press release that In accordance with the August 2009 Corporate Integrity Agreement with the Office of the Inspector General of the U.S. Department of Health and Human Services (HHS), effective with the report for 2010, the company will expand its reporting to include the value of all financial interactions including non-monetary items such as meals and educational items, regardless of value. Pfizer says such expenses will be posted quarterly beginning in June 2011. Full text of Pfizer press release, click here. 04/01/2010 INSPECTOR GENERAL FINDS PHARMACEUTICAL COMPANIES CUTTING REBATES BY REBRANDING DRUGS UNDER OTHER NAMESMore from the Emeritus Newsroom- The Inspector General at Health and Human Services has found a stunning rebate branding and accounting practice that could have saved various governmental entities billions of dollars. The full extent remains unknown. The Inspector General report claims that, Our review found that of the top 150 brand-name drugs for calendar year 2007 ranked by Medicaid reimbursement, 114 had more than one version. For 65 of the 114, the prices of the earliest versions of the drugs exceeded their inflation-adjusted prices when the new versions entered the market. We calculated that for calendar years 1993 through 2007, States could have collected approximately $2.5 billion in additional rebates for the 65 brand-name drugs if the baseline average manufacturer prices (AMP) of the new versions had been adjusted (i.e., reduced) to reflect price increases in excess of inflation for the earliest versions. For a manufacturer’s covered outpatient drug to be eligible for Federal Medicaid funding, the manufacturer must enter into a rebate agreement that is administered by CMS and pay quarterly rebates to the States. Federal law requires manufacturers to pay an additional rebate when the AMP for a brand-name drug increases more than inflation. We did not evaluate the drug manufacturers’ bases for developing the new versions of existing drugs identified in our review. Because the Medicaid drug rebate program calculates rebates separately for each version of a drug, manufacturers could develop new versions of existing brand-name drugs solely to avoid paying additional rebates when they substantially increase prices. Without some modification to the rebate law, the risk of manufacturers taking advantage of this potential loophole may increase over time. Full text of press release and direct link to full report , click here. 03/31/2010 |
|
