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Government Report Links Avandia to Heart Attack and Heart Failure, Says GSK Knew of Dangers

By Paul Napoli

February 20, 2010

'Hundreds of people taking Avandia, a controversial diabetes medicine, needlessly suffer heart attacks and heart failure each month, according to confidential government reports that recommend the drug be removed from the market,' said an article published in The New York Times yesterday, exposing the findings of confidential government reports the newspaper had obtained.

Avandia (rosiglitazone) is a prescription medication manufactured by GlaxoSmithKline (GSK) and approved by the U.S. Food and Drug Administration (FDA) in 1999 to control high blood sugar in patients diagnosed with type 2 diabetes. Resulting from of a study published in the New England Journal of Medicine that showed that after a review of 42 studies of over 14,000 people, Avandia users had 43 percent more heart attacks than those taking placebos, the FDA decided in 2007 that a black box warning be added to Avandia packaging warning of cardiac dangers.

'The reports, obtained by The New York Times, say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month because Avandia can hurt the heart,' said the New York Times article.

The article stated that Avandia is linked to 304 deaths during the third quarter of 2009. Read the article in its entirety here: http://www.nytimes.com/2010/02/20/health/policy/20avandia.html?hp

One report cited in The New York Times article is the result of a 2-year inquiry into Avandia by the U.S. Senate's Committee on Finance, who oversees the FDA, prompted by the May 2007 study in the New England Journal of Medicine. Senator Max Baucus, Chairman of the Committee on Finance, and Senator Chuck Grassley, Ranking Member, released the report today.

'Americans have a right to know there are serious health risks associated with Avandia and GlaxoSmithKline had a responsibility to tell them. Patients trust drug companies with their health and their lives and GlaxoSmithKline abused that trust,' Baucus said in a release today.

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). In a letter to Margaret A. Hamburg, MD, Commissioner of the U.S. Food and Drug Administration, Senators Baucus and Grassley ask the FDA to outline the steps the agency has taken to protect patients in this ongoing Avandia clinical trial. The letter states they were 'alarmed' to find cardiovascular concerns of safety officers not addressed in the consent form given to patients enrolled in the study. They what to know why the study is even allowed to continue, given that the FDA itself estimated that the drug caused approximately 83,000 excess heart attacks between 1999 and 2007. In 2008, FDA officials called the clinical trial, as then-designed, 'unethical and exploitative' of patients.

The Senators demanded that the FDA respond to the letter no later than March 4, 2010.

'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,' the letter to Hamburg said.

GlaxoSmithKline responded to The New York Times article today, saying in a press release that the company rejected the conclusions newspaper's story.

'Contrary to the assertions in the story, and consistent with the FDA-approved labeling, the scientific evidence simply does not establish that Avandia increases ischemic cardiovascular risk or causes myocardial ischemic events,' GSK said in the press release.

If you or someone in your family has used or still uses Avandia and suffered heart problems as a result, you may be entitled to compensation for your injury. Please contact Napoli Bern Ripka, LLP at 888-529-4669 to discuss your options for filing a claim and recovering compensation for your medical expenses, lost wages, pain and suffering or the wrongful death of a loved one.

Originally posted at InjuryBoard by Paul Napoli

Full post as published by New York City Personal Injury Lawyer on February 21, 2010 (boomark / email).