Maryland Injury and Disability Law : Washington DC Metro Injury & Disability Lawyer & Attorney : Greenberg & Bederman : Accidents, Falls, Medical Malpractice : Maryland, DC, Virginia

Avandia works by making the cells more sensitive and responsive to insulin, which reduces the body’s need for the stringent blood sugar monitoring that diabetic patients require. If it works like it is supposed to, it allows diabetes patients to live their lives without going through the constant testing and monitoring that takes up so much of their time. But you have to think that if people had to choose between less blood testing and a massive heart attack, they would be willing to accept the inconvenience of the testing.

As important as the FDA’s actions are, they didn’t exactly come as a surprise to anyone. A 2007 study in the New England Journal of Medicine had already suggested that users of Avandia had an increased risk (by as much as 43%) of heart failure as opposed to diabetics who were treating their condition with regular insulin. And the FDA has further issued a so-called “black box warning label” for the medication, which is a way for the FDA to let the general public know that there are some real concerns about the medication that patients are about to take.

GlaxoSmithKline, who designed, manufacture and market the drug, went into full damage control mode, which meant an onslaught of press releases, as well as “rejecting the conclusions” of the New England Journal of Medicine, the FDA, and anyone with any teeth who had anything negative to say about their type 2 diabetes drug. To give you an idea of GSK’s overall game plan (as well as give you an idea as to how nervous this drug was making people, all you have to do is look at the titles of the numerous press releases that they put out in the wake of all of these negative studies:

o    24 Feb 2010: GlaxoSmithKline responds to US Senate Committee on Finance report on Avandia

o    20 Feb 2010 - GSK rejects conclusions of Senate Committee on Finance Staff Report on Avandia

o    20 Feb 2010 - GSK rejects conclusions reported in The New York Times story on Avandia

o    6 February 2008 - GlaxoSmithKline responds to findings in ACCORD study

o    3 December 2007 - GSK response to Nature Medicine article on rosiglitazone and bone in mice

o    11 September 2007 - GlaxoSmithKline responds to JAMA articles

o    27 July 2007 - GlaxoSmithKline statement in diabetes care study thiazolidinediones and heart failure: a teleo-analysis

o    5 June 2007 - GSK response to New England Journal of Medicine editorials

o    21 May 2007 - GSK response to NEJM article

o    21 May 2007 - GSK response to US Senate Committee on Finance

In case you aren’t keeping count, that’s ten solid denials of studies and warnings by the official digest of the American Medical Association, The New England Journal of Medicine, The New York Times, and the Senate Finance Committee.

One thing that GSK seems particularly adept at is refuting any studies that portray Avandia in a negative light and creating a more positive outlook on the side effects of Avandia. As personal injury attorneys who represent product liability injuries, this is certainly something familiar with. Quite often, when we present one expert witness, the attorneys for the defendant will provide two or three expert witnesses claiming the opposite.

Over two hundred studies were sent to the FDA by GSK. These all contradicted any negative reports of Avandia, whether it was articles in medical journals, independent studies, or even editorials in newspapers. Rather than just accept that both the NEJM and the FDA had been buried in an avalanche of contradictory news, the British Medical Journal not only took a look at the data in these positive studies, but also at who was responsible for writing and researching them.

What the BMJ found out was that of these, a full 45% of these studies were done by people who had authors with serious financial conflicts of interest. This means that they were essentially on the payroll of either GSK or other competing pharmaceutical companies, either through research grants or consulting fees. There was more:

“Moreover, in an era of “seemingly ubiquitous” requirements for disclosure of financial interests in medical journals, only 53% of the articles reviewed included a competing interest statement, noted the authors from the Mayo Clinical in Rochester, US.”

“…Of these 90 articles, only 69 (77%) included a statement disclosing the conflict of interest in the article itself, while three of the 21 articles that did not disclose the relationship published a statement declaring no conflicts of interest.”

This is hardly unbiased research. If your next grant or paycheck depends on positive reviews, what are the odds that your reports will be, if not skewed in favor, at least carefully neutral?

This isn’t the first time such conflicts have been brought to light. In the wake of the Vioxx scandal, the New York Times discovered that the FDA’s independent advisory committee (which essentially makes or breaks controversial drugs) was populated with scientists and researchers who had similar conflicts of interest. This is profoundly interesting to us, especially if you take a look at the following press release from GSK:

July 30, 2007 — Philadelphia, PA

GlaxoSmithKline [NYSE: GSK] today welcomed the nearly unanimous recommendation of a US Food and Drug Administration’s (FDA) advisory committee to support Avandia’s (rosiglitazone maleate) continued availability to patients in the US. The company said it will continue to provide information to the FDA to assist in the Agency’s final decision-making.

Greenberg and Bederman is currently offering free legal consultations to people in the Washington, D.C. area who have been injured and/or hospitalized due to heart complications from taking Avandia.  For a free legal review of your Avandia bad drug injury, please fill out a free legal Avandia form, or call Andrew Bederman at (301) 589-2200 for a free legal consultation.