Type II diabetes is a major problem in this country. Type II diabetes is caused from years of eating poorly and can lead to serious health problems such as heart attack, heart failure and even death. In the US 23.6 million people have diabetes. The pharmaceutical industry knows this and makes a host of drugs to treat this disease, when it is most easily treated with diet and exercise. One of these drugs is Avandia and new research shows it is very dangerous.
Avandia is an oral diabetes medication that works by making the body’s cells more sensitive to insulin. A low carbohydrate diet and exercise also have the same effect, but without the risk of death. Now, the FDA is recommending that Avandia be removed from the market. GlaxoSmithKline, the drug’s maker, disagrees of course and from the outset has sought to cover up the potential problems with the drug. 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. What if those people had been on an intensive diet and exercise program instead? Avandia also caused 304 deaths in the third quarter of 2009.
GlaxoSmithKline has attempted to cover up the information and it has been shown they did not warn the public of the dangers despite knowing more than 10 years ago that it was dangerous. The reason? It was a huge seller. Avandia was once one of the biggest-selling drugs in the world. Driven in part by a multimillion-dollar advertising campaign, sales were $3.2 billion in 2006. An upcoming bipartisan multiyear senate investigation sharply criticized GlaxoSmithKline for not waring of the potentially deadly side effects.
‘Instead, 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,’ concludes the report, which was overseen by Senator Max Baucus, a Montana Democrat, and Senator Charles E. Grassley, an Iowa Republican.
Mr. Baucus said of the report, ‘Patients trust drug companies with their health and their lives, and GlaxoSmithKline abused that trust.’ (From The NY Times)
The first mistake is that you should never trust a pharmaceutical company. They are the most deceitful companies in existence and are only interested in big profits, even if it destroys lives. They seek to cover up unfavorable information and when confronted with the proof they attempted a cover up, simply deny or “disagree” with the findings.
Unfortunately, there is an internal battle within the FDA. Some are adamant that this drug should be removed. This comes from the public safety arm of the FDA. Other are not so sure. The FDA has requested that GlaxoSmithKline undertake a study to prove whether this drug actually does cause heart problems. First of all, this is a dangerous undertaking because the drug has already been shown to cause these problems, hence the reason the FDA is recommending it be removed from the market. Secondly, asking the drug’s maker to conduct the study is like asking the family dog to watch your food for you while you go to the bathroom. Nothing good can come of it.
Senator Grassley said the internal agency battle showed that the agency needed to be restructured to give more power to safety officials like Dr. David Graham and Dr. Kate Gelperin (who are part of the FDA and have recommended it be removed) over their counterparts who approve medicines and deal more directly with drug makers.
‘It doesn’t make any sense to have these experts who study drugs after they have been on the market for several years under the thumb of the officials who approved the drug in the first place and have a natural interest in defending that decision,’ Mr. Grassley said. ‘The Avandia case may be the most alarming example of the problem with this setup.’
Below is an exerpt from the NY Times article about the process through with Avandia has gone and shows that it has been known for years that this is dangerous.
The Senate investigation — the result of years of digging through more than 250,000 internal company documents — concludes that GlaxoSmithKline and by extension the F.D.A. delayed far too long in this process.
In November 2003, for instance, the company completed a study in which diabetics given Avandia had far more heart problems than those given placebos. Two months later, the World Health Organization sent the company an alert linking Avandia to heart ailments. In a June 2004 meeting, the company’s Global Safety Board said a hard look should be taken at all Avandia clinical trials for more signs of heart problems, documents show.
European regulators had earlier ordered GlaxoSmithKline to conduct a study — called the Record trial — to examine Avandia’s heart risks because hints of these problems appeared in the company’s earliest trials.. But the Senate report shows that by at least 2004, company executives were aware that the Record trial was going so poorly that it would never answer the heart question with any kind of certainty.
So company executives gathered dozens of Avandia studies and sifted their combined data. Called a meta-analysis, this combined look found first in 2005 and in an updated look in 2006 that Avandia increased the risks of serious heart problems by nearly a third, the Senate investigation shows. Because two-thirds of diabetics die of heart problems, this was hugely worrying.
In 2005, executives revealed the results of their meta-analysis to the F.D.A., and in 2006 they provided the agency with the underlying data.
Two large company-sponsored trials — called Dream and Adopt — were published near the end of 2006, and each provided more hints that Avandia hurts the heart, the documents show. In a March 2007 meeting of the company’s Diabetes Franchise Cardiology Advisory Board, advisers called the safety worries found in these many studies “disquieting.” Negotiations with agency officials about how and whether to alert the public continued.
All while this is going on, GlaxoSmithKline continued to market the drug aggresively, all the while knowing it was dangerous. The senate inquiry shows that as far back at 1999 there were attempts to silence doctors who spoke out publicly about Avandia.
Dr. John Buse, a professor of medicine at the University of North Carolina, gave presentations at scientific meetings suggesting that Avandia had heart risks. GlaxoSmithKline executives complained to his supervisor and hinted of legal action against him, according to the Senate inquiry. Dr. Buse eventually signed a document provided by GlaxoSmithKline agreeing not to discuss his worries about Avandia publicly. The report cites a separate episode of intimidation of investigators at the University of Pennsylvania. GlaxoSmithKline said that it “does not condone any effort to silence” scientific debate, and that it disagrees with allegations that it tried to silence Dr. Buse. Still, it said the situation “could have been handled differently.”
Again, there is a plethora of proof that:A) GlaxoSmithKline knew this was dagerous for years and did nothing about it. B) They actively engaged in covering up the data. C) Tried to suppress and intimidate doctors who spoke out publicly about the drug.
GlaxoSmithKline will probably get a slap on the wrist for this, but they should be fined billions. Avandia is only one example of how crooked the pharmaceutical industry is. Until we get the lobbying money out of politics things will continue as is and people will continue to get hurt by corporate giants that have no regard for peoples’ health and safety.