Emeritus News MobileHEALTH CARE PAGETOP HEALTH CARE STORIES BELOW SPECIAL INFORMATION LINKS / CLICK HERE TO RETURN TO HOME PAGE AND DIRECTORYREVIEW OF CHANGES / OPTIONS WITH MEDICARE PART "D"More in this article from the Chicago Tribune, click here- 10/18/2010 NEW HEALTH CARE LAW FACT CHECKMore in this article from the Washington Post, click here TOP HEALTH CARE STORIESFDA ORDERS CANCER DRUGS FROM OVERSEAS SOURCES TO EASE CRITICAL SHORTAGESMore from the Emeritus Newsroom- The U.S. Food and Drug Administration today announced a series of steps to increase the supply of critically needed cancer drugs and build on President Obama’s Executive Order to help prevent future drug shortages. “A drug shortage can be a frightening prospect for patients and President Obama made it clear that preventing these shortages from happening is a top priority of his administration,” said FDA Commissioner Margaret A. Hamburg, M.D. “Through the collaborative work of FDA, industry, and other stakeholders, patients and families waiting for these products or anxious about their availability should now be able to get the medication they need.” In response to the critical shortage of the cancer drug Doxil (doxorubicin hydrochloride liposome injection) and rapidly declining supplies of methotrexate, the FDA took proactive steps needed to increase available supply for patients in the U.S. For Doxil, there will be temporary importation of a replacement drug, Lipodox (doxorubicin hydrochloride liposome injection), which is expected to end the shortage and fully meet patient needs in the coming weeks. For methotrexate, in addition to already announced actions, the Agency has approved a new manufacturer of preservative-free formulation of methotrexate that is expected to further bolster supply and help avert a shortage of this lifesaving medicine. FDA expedited review of the application to help address this potential shortage. In addition, in response to President Obama’s Executive Order on prescription drug shortages, FDA today issued draft guidance to industry on detailed requirements for both mandatory and voluntary notifications to the agency of issues that could result in a drug shortage or supply disruption. Increased awareness of the importance of early notification due to President Obama’s Oct. 31, 2011, Executive Order and FDA’s letter to manufacturers on the same day has resulted in a sixfold increase in voluntary notifications by industry of potential shortages. In 2011, there were a total of 195 drug shortages prevented. Since the Executive Order, FDA has prevented 114 drug shortages. Under FDA’s exercise of enforcement discretion the chemotherapeutic drug Lipodox will be imported as an alternative to Doxil. Doxil is used in multiple treatment regimens, including treatment of ovarian cancer after failure of platinum-based chemotherapy. The drug is also indicated for use in AIDS-related Kaposi’s sarcoma and multiple myeloma. FDA anticipates that the incoming supply of Lipodox will be able to fully meet patient needs. FDA’s exercise of enforcement discretion for Lipodox is a temporary, limited arrangement specific to Sun Pharma Global FZE and its authorized distributor, Caraco Pharmaceutical Laboratories Ltd. Temporary importation of unapproved foreign drugs is considered in rare cases when there is a shortage of an approved drug that is critical to patients and the shortage cannot be resolved in a timely fashion with FDA-approved drugs. When a company is identified that is willing and able to import the needed drug product, FDA evaluates the foreign-approved drug to ensure that it is of adequate quality and that the drug does not pose significant risks for US patients. Only after successful evaluation of these factors does FDA exercise its enforcement discretion for the temporary importation of an overseas drug into the U.S. market. With regard to methotrexate, a drug that is needed for the treatment of many forms of cancer and other serious diseases, FDA has successfully engaged many firms to assist in maintaining supplies to meet all patient needs. Preservative-free methotrexate is needed for the intrathecal (injection into the fluid surrounding the brain and spinal cord) treatment of children with acute lymphocytic leukemia (ALL) and for the high-dose therapy of osteosarcoma. First, FDA has prioritized review of and approved a preservative-free methotrexate generic drug manufactured by APP Pharmaceuticals and expects that product to become available in March and continue indefinitely. Second, Hospira expedited release of additional supplies, resulting in 31,000 vials of new product – enough for more than one month’s worth of demand – being shipped to hundreds of U.S. hospitals and treatment centers today. FDA is actively working with other manufacturers of methotrexate who have also stepped up to increase production in order to meet patient needs, including Mylan and Sandoz Pharmaceuticals. APP’s application for preservative-free methotrexate is a supplement to its already approved generic drug application that the firm had previously discontinued. When FDA became aware of potential problems with the supply of the drug (due to the largest manufacturer, Bedford/Ben Venue voluntarily closing its plant), the Agency reached out to other firms to see how FDA could assist to meet the shortfall. Prior to approval of APP’s application and subsequent to Ben Venue’s voluntary shutdown, FDA worked with Ben Venue on release of already manufactured preservative-free methotrexate, following confirmation of its safety. This supply is available already and will provide emergency supplies as the other firms also work to increase production of methotrexate in response to requests by FDA and the public. J. Leonard Lichtenfeld, MD, deputy chief medical officer of the American Cancer Society, who attended the FDA’s announcement, said, "“The actions announced today will help to boost the supply of some of the most badly needed cancer drugs by patients across the country. It is critical that the FDA ensure that the added supply of these drugs is safe and made easily available to the patients who urgently need them”. Full text of FDA statement, click here. 02/21/2012 GRAPE INFANTS TYLENOL SUSPENSION FORMULA RECALLEDMore from the Emeritus Newsroom- McNeil Consumer Healthcare, has announced it is voluntarily recalling, at the wholesale and retail levels, seven lots, approximately 574,000 bottles, of Infants’ TYLENOL® Oral Suspension, 1 oz. Grape distributed nationwide in the United States (see full product list below). Infants’ TYLENOL® is an over-the-counter (OTC) product indicated as a pain reliever/fever reducer.
Adverse events that may be related to the use of this product may be reported to U.S. Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:
Full text of Tylenol recall press release, click here - 02/18/2012 ONE SUGARY SODA = 50 MINUTES OF JOGGING / STUDY REVEALS PEOPLE MAY CHOSE WATER WHEN PRESENTED FACTSMore from the Emeritus Newsroom- In an effort to get more people to consider what that sugary soda means to their bodies, the National Institutes of Health is pushing signs in stores that may change your mind. How much exercise do you need to burn off the calories in a typical soda? Researchers at Johns Hopkins Bloomberg School of Public Health wanted to see what inner-city teenagers would do when they found the answer to that question. The researchers had posters put in convenience stores, which told teens the amount of jogging they would have to do. The study found teens then bought fewer sugar-sweetened sodas, and more water. Researcher Sara Bleich says it’s better to avoid calories than to lose them: "It may take you 5 minutes to drink a bottle of soda. But if you are a typical adolescent weighing 110 pounds, it would take you 50 minutes of jogging to burn off that bottle of soda." (8 seconds) The study in the American Journal of Public Health was supported by the National Institutes of Health. Abstract of American Public Health article, click here - 02/17/20112 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 Obma 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 story from the New York Times, click here - More in this story from Reuters, click here 01/02/2012 DRUG ABUSE THE NUMBER ONE CAUSE OF DEATH IN U-S / PRESCRIPTION DRUG ABUSE RISESMore in this YouTube video from Voice of America, click here - 12/28/2011 BREAST CANCER TREATMENT UPDATE: RED FLAGS FOR FASTER REDIATION 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", Presideent 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 here for YouTube testimony of cancer patient affected by the drug shortage. Click here for YouTube playback of President singing and explaining order- 10/31/2011 UPDATE: STATE LIMITING WHAT PATIENTS GET FROM MEDICAIDMore from Kaiser Health News, click here- 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. 10/07/2011 BREAST AND CERVICAL CANCER RATES UP WORLDWIDEMore in this video from Voice of America, click here- 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 patients 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 annolunced 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 |
