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As we have stressed before, Avandia (rosiglitazone) is a dangerous diabetes drug that the FDA should have pulled it from the market a decade ago. A recent report from the Senate Finance Committee has revealed that Avandia has been responsible for more than 83,000 heart attacks and thousands of personal injuries and wrongful deaths, and the carnage continues.Avandia, which had sales of $3.4 billion in 2006, carries the absolutely worthless “FDA approved” label, and Avandia victims in the United States now suffer an estimated 500 heart attacks and 300 cases of heart failure every month. That record of death and destruction is clear evidence that the only reason why diabetes patients still have access to the drug is that GlaxoSmithKilne (GSK), the manufacturer, has good friends at the FDA.

The story of Avandia shows everything that’s wrong with the process of testing, approving, and evaluating drugs after they go to market. It shows how the combination of unethical drug companies and the corrupt FDA puts Americans in early graves.

The evidence of Avandia’s risks has been piling up for more than a decade, and the drug has no clear record of success. Because of its lack of proven benefits, the FDA package inserts for Avandia advise that: “There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with any oral antidiabetic drug.”

The FDA gives a medicine its approval if researchers decide that the benefits are greater than the risks. The FDA has the authority to pull a drug from the market at any time, but sometimes, even when the researchers say No to a drug or recommend withdrawal, the decision makers give their approval or allow a drug to stay on the market.

That happened in 2007 when the FDA brought together a panel of 23 supposedly independent experts to assess Avandia. Twenty of the experts concluded that Avandia does pose a significantly increased risk of heart attack and heart failure, but the panel voted 22 – 1 to allow Avandia to remain on the market and to continue to pile up the wrongful deaths.

Since 2005, Avandia has carried Public Citizen’s Do Not Use rating, and many drugs that have earned that rating have been withdrawn from the American market. Vioxx and Bextra are two visible examples, and Avandia should be another. However, the FDA has said that it will take no action on Avandia before July. Here is the FDA’s statement from February 22, 2010:

“Once FDA completes its review of the data from the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) study, the agency will present the totality of new and existing cardiovascular safety data on rosiglitazone at a joint public meeting of the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees in July 2010. At that meeting, the Advisory Committee will provide an updated assessment of the risks and benefits of rosiglitazone in the treatment of type 2 diabetes.”

The only thing about Avandia that will change between February 22 and July 10 is the body count: more personal injuries and more wrongful deaths.  Two of the FDA’s own researchers, Dr. David Graham and Dr. Kate Gelperin, have called for the immediate withdrawal of Avandia from the market, but the agency continues to follow its philosophy of putting the financial interests of drug companies ahead of the health and safety of American consumers, which is what the agency has done with Avandia since 1999.

In 1999, Dr. John Buse, a professor of medicine at the University of North Carolina, gave presentations that showed Avandia’s heart risks. GSK executives responded by making suggestions that they might bring legal action against him, and the evidence suggests that GSK just might have used its position as a major donor to UNC to influence Dr. Buse’s behavior.

GSK has its headquarters in London, but it has a huge operation in the Research Triangle in North Carolina. The Research Triangle is close to Chapel Hill, the location of UNC, and UNC has been the recipient of millions of dollars in donations from GSK. GSK’s intimidation tactics apparently worked because Dr. Buse agreed not go public with his insights into Avandia.

That’s just one of many examples of GSK’s tactics cited in the Senate Finance Committee’s report. In her response to the report, Connecticut Congresswoman Rosa DeLauro, who is chairwoman of the U.S. Agriculture-FDA Appropriations Subcommittee, examined the evidence against Avandia and GSK and said, “I strongly urge the FDA to remove Avandia from the market until a truly independent, science-based advisory panel can evaluate the safety and effectiveness of the drug. The safety and efficacy of a prescription drug should be based on independent, science-based evidence, and not a drug company’s interpretation of what constitutes science-based evidence. The Avandia case provides further evidence that patients should not trust drug companies with their health.”

This new report has exposed documents from GSK that leave absolutely no doubt that the company has knowingly sold a dangerous drug for more than a decade. One document showed that Moncef Slaoui, Glaxo’s research head, admitted to the FDA that Glaxo researchers and Dr. Steven Nissen of the Cleveland Clinic both reached the conclusion that Avandia substantially raised the likelihood of heart attacks and wrongful deaths. “FDA, Nissen and GSK all come to comparable conclusions regarding increased risk for ischemic events, ranging from 30 percent to 43 percent!” he wrote.

On February 25, GSK issued a 30-page rebuttal to the evidence contained in the Senate report. In its White Paper, GSK predictably said that it had done nothing wrong and that Avandia is a wonderful medicine that would never hurt anyone.

GSK’s rebuttal is a hollow attempt to protect its profits, and the case against Avandia is clear. Thousands of Avandia victims have suffered personal injuries and wrongful deaths. GSK has known about the dangers of its highly profitable drug for more than a decade, and the company has done everything it can to keep the profits flowing.

The FDA, meanwhile, has been GSK’s enabler. The FDA has been completely aware of the dangers of Avandia for more than a decade, but the agency has failed to do its job of protecting American consumers.

Despite the lack of action from the FDA, GSK is responsible for all the damage that this highly dangerous drug has done. We are prosecuting injury claims for patients injured by this drug and we welcome the first Avandia lawsuit filed by a government body against the pharmaceutical giant.  Santa Clara County spent more than $2 million on Avandia for indigent diabetes patients from 1999 to 2007, and when the drug caused heart attacks and other personal injuries, the county also had to pay to treat those problems.

If you or a loved one is an Avandia victim, contact us to learn if legal action can compensate you for your suffering.

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Richard Alexander