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| FDA Pharma Reps Diddle As Glaxo's Avandia Drug Causes Multiple Deaths | ||
A Catalyst for Public Debate: Promoting Openness, Full Disclosure, and Accountability http://www.ahrp.org  Avandia, a Deadly Case of Déjà vu all over againFYI Once again, a front page report in The New York Times (below) lays bare unseemly facts about the pharmaceutical industry’s deadly norm and practice of concealing fatal risks of drugs that millions of patients consume as a result of aggressive marketing campaigns. Once again, the FDA is shown to be complicit in turning a blind eye when a drug manufacturer, in this case, GlaxoSmithKline, concealed documented risks of heart attacks linked to its adjuctive diabetes drug, Avandia (rosiglitazone), putting of patients in harm’s way. Gardiner Harris reports that a fierce debate that has been brewing for years within the FDA about “what to do about Avandia:” inasmuch as the preponderance of evidence shows patients taking the drug suffer cardiac harm. Once again, a detailed Senate Finance Committee investigation reveals the true magnitude of the potentially deadly cardiac risks involving Avandia, an aggressively marketed diabetes drug whose sales reached $3.2 billion in 2006, but whose deadly risks the manufacturer, GlaxoSmithKline, concealed from patients and physicians for YEARS.” See Senate Finance Committee Press Release packet. The report, overseen by Senator Max Baucus, a Democrat, and Senator Charles E. Grassley, a Republican, examined 250,000 internal GSK documents, concluded that instead of issuing a warning—as is a drug manufacturer’s duty--“G.S.K. executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk.” See Senate Finance Committee letter to FDA Commissioner (below). The Committee packet posted on its website includes a comprehensive benefit-risk assessment report (2008. 75 pp.) by FDA safety officers, Dr. David Graham and Dr. Kate Gelperin. They report that the preponderance of evidence showed that "there was no evidence that rosiglitazone [Avandia] confers any unique health benefit over pioglitzone [Actos] while there was strong evidence that [Avandia] confers an increased risk of AMI [acute myocardial infarction] and heart failure compared to [Actos]. The evidence led these expert FDA safety officers to concluded that the drug “should be removed from the market” inasmuch as an estimated 500 heart attacks and 300 cases of heart failure would be averted EVERY MONTH, if patients took another diabetes drug.” See Finance Committee packet Attachment B. Avandia’s cardiac risk was in evidence as early as November 2003, when GSK completed a study in which “diabetics given Avandia had far more heart problems than those given placebos.” European regulators ordered GSK to conduct a study to examine Avandia’s heart risks, but when the study showed harm (2004), GSK conducted a meta-analysis which it submitted to the FDA in 2005, and updated in 2006. The analysis showed that “Avandia increased the risks of serious heart problems by nearly a third.” However, despite the totality of evidence, from company studies, adverse event reports filed with FDA’s Medwatch, and FDA safety evaluations corroborating Avandia’s deadly cardiac risks, the agency continued to drag its feet, “negotiating” with GSK, rather than pulling the drug off the market or, at the very least, issuing public warnings. Even worse, in 2007, after the New England Journal of Medicine published a report warning of the cardiovascular risk for patients taking Avandia; and after warnings were issued in several countries--including Canada, the European Union, and Australia--that Avandia was CONTRAINDICATED in patients with acute coronary syndrome; FDA officials, in collusion and collaboration with GSK, approved an unethical and exploitative clinical trial—TIDE, which is on-going. See HERE. The trial does not meet the ethical principle of equipoise—requiring that so far as is known, benefit-risk of each comparator were equal. The accumulated evidence showed that Avandia posed higher risks than Actors. Furthermore, the FDA-approved trial allows the enrollment of very high risk patients with ischemic heart disease—for whom Avandia is contraindicated in several countries See Attachment C The Informed Consent form given to patients is deceptive by commingling the risks of Avandia with the comparator drug, Actos (pioglitzone), which does not pose the cardiac risk that Avandia does. See Finance Committee Attachment D. Corporate tactics of intimidation are, once more, in evidence: The Senate Finance Committee report states that “GSK executives intimidated independent physicians” who suggested in public that Avandia might have serious risks. It’s difficult to tell whether GSK took a leaf from Merck’s tactics of intimidation—such as, Merck’s physician “hit list” of doctors who publicly raised concerns about Vioxx cardiac risks—or whether intimidation of honest physicians is but “the norm and practice” within the pharmaceutical industry. FDA’s consistent failure to act in the public interest continues unabated under the Obama administration, much as it did under the Bush Administration. Avandia--and an untold number of other drugs that damage the heart--continue to be aggressively marketed, killing thousands of consumers: FDA officials continue to diddle. Contact: Vera Hassner Sharav 212-595-8974 veracare@ahrp.org ~~~~~~~~~~~~~~~~~ United States Senate Committee on Finance Via Electronic Transmission The Honorable Margaret A. Hamburg, MD Commissioner U.S. Food and Drug Administration White Oak Building 1 10903 New Hampshire Avenue Silver Spring, MD 20993 Dear Commissioner Hamburg: As senior members of the United States Senate and Chairman and Ranking Member of the Committee on Finance (Committee), we have a duty under the Constitution to conduct oversight into the actions of executive branch agencies, including the Food and Drug Administration (FDA). In this capacity, we must ensure that FDA properly fulfill their mission to advance the public’s welfare, safeguard the nation’s drug supply, and protect patients participating in clinical trials. We recently released a report raising concerns about Avandia, a diabetes drug made by GlaxoSmithKline (GSK). We began this inquiry after the New England Journal of Medicine published a study in May 2007 warning of the possible cardiovascular risk of Avandia. Our report was based on a review of hundreds of thousands of pages of internal GSK documents and concluded: The totality of evidence suggests that GSK was aware of the possible cardiac risks associated with Avandia years before such evidence became public.… Based on this knowledge, GSK had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner. Instead, GSK executives intimidated independent physicians, focused on strategies to minimize findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that the rival drug ACTOS (pioglitazone) might reduce cardiovascular risk. In 2007, the FDA asked GSK to perform a cardiovascular safety trial, called TIDE (Thiazolidinedione Intervention With Vitamin D Evaluation), to compare Avandia to other diabetes treatments such as ACTOS (piolglitazone). According to clinicaltrials.gov, the TIDE trial is currently recruiting patients. [ATTACHMENT A] In response to several document requests made to the FDA, we received and reviewed an analysis conducted by two FDA safety officials. It is our understanding that this analysis, conducted in October 2008, reviewed all available studies comparing rosiglitazone (Avandia) to pioglitazone (ACTOS). The analysis by these FDA officials raise some alarms. For instance, they wrote: [T]here is no evidence that rosiglitazone confers any unique health benefits over pioglitazone while there is strong evidence that rosiglitazone confers an increased risk of [heart attacks] and heart failure compared to pioglitazone. [ATTACHMENT B] Even more alarming, they concluded that “any proposed head-to-head trial of rosiglitazone vs. pioglitazone would be unethical and exploitative.” Two days after releasing this analysis, one of these same safety officers reviewed the protocol for the TIDE trial. This safety officer wrote that because of cardiovascular concerns with Avandia “the safety of the study itself cannot be assured, and mis not acceptable.” [Attachment C] After reading these documents, we would like to know what steps the FDA has taken to protect patients in the TIDE trial, and why this trial is allowed to continue. We would also like to know if the Office for Human Research Protection (OHRP) was notified about the safety concerns of the TIDE trial identified by the FDA. Further, we were alarmed to learn that the warnings from these safety officers do not appear to be addressed in the consent form that was handed out to patients that were enrolled in the study. [Attachment D] We look forward to hearing from you by no later than March 4, 2010. All documents responsive to this request should be sent electronically in PDF format to Brian_Downey@finance-rep.senate.gov. If you have any questions, please do not hesitate to contact Chris Law (Senator Baucus) or Paul Thacker (Senator Grassley) at (202) 224-4515. Sincerely, Max Baucus Charles E. Grassley Chairman Ranking Member THE NEW YORK TIMES February 20, 2010 Controversial Diabetes Drug Harms Heart, U.S. Concludes By GARDINER HARRIS |
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