What did they know and when did they know it

What did they know and when did they know it

Back when the original story on Avandia was leaked to the media, many including Diabetic Investor, assumed GlaxoSmithKline (NYSE:GSK) was blinded-sided and had no idea of the study results done by Dr. Nissen. At the time Diabetic Investor commented that the respected New England Journal of Medicine acted irresponsibly. The uproar over Avandia lead to Congressional hearings and was ultimately responsible for the destruction of what was once a $3 billion drug franchise.

Yesterday we learned that seventeen days before the article was published in May 2007, Steven Haffner, a professor of internal medicine at the University of Texas Health Science Center at San Antonio, faxed a copy of the article to a GlaxoSmithKline employee he knew from working on an earlier clinical trial of the drug. According to an article in today’s Wall Street Journal; “Dr. Haffner had financial ties to Glaxo, including getting paid for giving speeches for the company, Glaxo said. Sen. Grassley, citing FDA documents, said Glaxo has paid Dr. Haffner about $75,000 in consulting fees and speaking honorariums since 1999.”

This news creates more questions than answers and calls into question the actions taken by GSK. According to the WSJ article Glaxo spokeswoman Nancy Pekarek confirmed the company was already discussing Avandia’s possible risk with the FDA BEFORE the article was published. Why then did the company go to such lengths to discredit Dr. Nissen and claim that Avandia usage was safe. The reason is obvious, the company put profits ahead of patients.

This information also calls into question the lack of action by the FDA. Realizing that GSK would not act responsibly and inform physicians of a potential issue with the drug, the FDA should have demanded that GSK inform both patients and physicians. Instead the FDA did nothing and contributed to the panic that set in after the story broke.

Once again the FDA failed to protect the public. The most devastating consequence of the FDA failure is the long term effect it has had on patients with diabetes. Diabetic Investor has interviewed several physicians who have reported that because of the controversy many of their patients have stopped taking their medications, even medications that were prescribed as replacement for Avandia. The fact is patients have lost all faith in the FDA and believe drug companies are skewing the data.

Although Diabetic Investor does not agree with how GSK has handled the situation, the fact is they are a publicly traded company who did what they did to mitigate the damage. Diabetic Investor is also sure that GSK and their legal team were looking ahead to potential legal action if they pulled the drug from the market. This is the reason the FDA exists to protect the public, to step in when a company fails to act. The fact that the Avandia franchise was generating $3 billion in sales or that GSK’s stock would suffer if they issued a stern warning or pulled the drug from the market should not factor into what the FDA does. This is especially true here because patients and their physicians had alternatives, Avandia was not the only drug a patient could take. The FDA’s lack of action would be understandable if there weren’t alternatives but this isn’t the case.

Today we have another drug controversy with Vytorin and once again the actions of the FDA and drug companies are being questioned. Back when the Avandia controversy was front page news Diabetic Investor wondered if this would be the event that finally made Congress wake up and actually attempt to fix the FDA. Action that should have been taken when Rezulin was pulled from the market and reinforced with the Vioxx situation. With millions of patients taking Avandia and the uproar created by the controversy one would think Congress would step in and demand changes be made at the agency.

Instead what we got was more of the same thing from the people we elect, lots of hot air and no action. Diabetic Investor is not surprised by this lack of action as we have all become accustomed to politicians talking big only to do nothing. Politicians are interested in getting re-elected and assigning blame. They can then go back to their constituents and say they stood up to the big bad drug companies. Companies that are spending millions on lobbyists and lining the pockets of politicians with campaign contributions.

In a few days millions of Americans will head to polls and vote. What these voters say will go along ways towards determining who our next President will be. According to polling data healthcare is a major issue for voters. Each candidate has come up with a healthcare plan with an emphasis on providing coverage. Providing coverage is just fine but this does nothing to solve the problems at the FDA. How many patients need to die or suffer needlessly before action is taken? How much evidence is needed before the politicians do something? The public, patients and physicians, have lost confidence in the system and do not trust the agency that is supposed to protect the public.

All we get is more of the same; hot air from politicians, drug companies who are more concerned with lawsuits and their stock price and the FDA who is only interested in covering their collective keysters. It should also be noted that throwing more money at the agency won’t solve what are fundamental problems. True reform is needed.

As Ralph Waldo Emerson wrote; “In a virtuous community men of sense and principle will always be placed at the head of affairs. In a declining state of public morals men will be so blinded to their true interests as to put the incapable and unworthy at the helm. It is therefore vain to complain of the follies or crimes of a government. We must lay our hands on our hearts and say, Here is the sin that makes the public sin.”

David Kliff
Diabetic Investor
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