Avandia's heart attack risk often 'silenced'

When a congressional hearing into the Food and Drug Administration (FDA) and its approval process for Avandia opened on June 6, 2007, one of the recurring themes was how Avandia manufacturer GlaxoSmithKline (formerly Smith Kline Beecham) and the FDA seemingly conspired to “silence” critics of the drug. Dr. John Buse, incoming president of the American Diabetes Association and one of the first people to question the safety of Avandia, testified before the hearing that he was pressured to stop talking about it.

The congressional hearings were called by Senator and House Oversight Chairman Henry Waxman after the New England Journal of Medicine (NEJM) released a new study showing that Avandia could cause as much as a 43% increase in heart attack risk.

Since that publication, there have been a number of debates from both sides of the argument. On June 5, one day before the hearings were to begin, the NEJM published some early analysis of Glaxo’s own study that, according to the drug manufacturer, showed Avandia did not increase heart attack risk. However other scientists looking at the same data claimed that although inconclusive, the study raised concerns about the safety of Avandia.

Arguing over the validity of data is one thing, but pressuring scientists to stop voicing their opinions – especially those regarding the safety profile of drugs – is something else altogether. As shocking as it is to hear that Dr. Buse was threatened with a lawsuit for trying to speak the truth, it is not the first instance of big business pharmaceutical coercing a cover-up. There are well-documented examples of doctors and researchers threatened or bribed to stop them from talking about the downside of any particular drug. In many cases, such asVioxx, the concerns of these medical professionals turned out to be correct.

Dr. David Graham, famous as the “Vioxx Whistleblower” as well as a critic of other drugs, was pressured by the FDA itself to be quiet about his findings. He was told to “soften” his view about the safety of Vioxx by senior FDA officials. In fact, 1 in 5 FDA scientists told of similar circumstances in which they were pressured to change their views and stop voicing their concerns to help a drug get to market, and get it there faster.

'Black Box' warning denied

As it turns out, this also occurred in the latest Avandia scandal. Dr. Rosemary Johann-Liang describes how she was demoted after she recommended that Avandia receive a “Black Box” warning – the strongest FDA warning possible – because of its connection to heart attack risk. This was in March 2006, fifteen months before the world learned the truth about Avandia.

Even in the wake of the panic where prescriptions of Avandia dropped by 40%, both GlaxoSmithKline and the FDA are apparently still colluding, cautioning that doctors wait until the final results about its safety profile are complete before deciding whether or not to stop prescribing it. The average person would think that you might want to confirm the safety of a drug before using it, not before stopping its use. And the average person might think that eight years is long enough to wait for the safety profile in the first place.

If you or a loved one has been injured by Avandia, contact an Avandia lawyer with Jim S. Adler & Associates for a free case assessment. Your heart attack may be directly due to the negligence of Avandia’s manufacturer, and therefore you could be eligible for compensation to cover your added medical bills, lost wages, and pain and suffering. Don’t settle for less. Call Jim S. Adler & Associates directly right now or fill out the form on this page with the details of your Avandia injury to start your free case review.