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Commentary: Toxic combination: Profit motive and regulatory failure

On Feb. 21, 2010, The New York Times published an article by Gardiner Harris titled "Diabetes Drug Harms Heart, U.S. Concludes."  Rosiglitazone, a product of GlaxoSmithKline (GSK), is sold under the brand name Avandia. Studies have indicated it could be responsible for about 500 heart attacks and 300 cases of heart failure a month.

Avandia is used in the treatment of type 2 diabetes mellitus, a disease for which there are multiple safe and effective alternative therapies including its cousin, pioglitazone (brand name Actos). A debate has been underway regarding the removal of the drug from the market. An informed public would have no trouble reaching its own conclusions and making its own decisions.

There have been at least three parties to the debate. The first is GSK.

The company has known of this increased risk since 1999. That year, a professor of medicine at the University of North Carolina presented a paper at a scientific meeting suggesting such risks. GSK executives complained to his superiors and threatened legal action. (The company denies this.) The World Health Organization alerted GSK to the risk in 2004. GSK did a meta-analysis in 2005, which it updated in 2006 confirming an increased risk of adverse cardiac events by one-third.

So what did the company do?

In 2006 and 2007, GSK's Diabetes Franchise Cardiology Advisory Board characterized these scientific reports merely as "disquieting." On July 13, Harris reported again saying the latest GSK documents show the company knew of the problem from its own research as long ago as 1999 but made a concerted effort over the years to keep it from the public. Now, with the information coming to light, the company continues to assert that the risk of these adverse events has not been "scientifically established."

The second party in the debate has been the U.S. Senate. GSK's actions regarding Avandia have been the subject of a bi-partisan, multi-year investigation by the Senate Finance Committee. Sens Max Baucus, D-Mont., chairman of the committee, and Charles Grassley, R-Iowa, the ranking Republican, have been critical of GSK for its failure to warn patients years earlier about these potentially deadly risks. The Times quotes Baucus as saying, "Patients trust drug companies with their health and their lives and GlaxoSmithKline abused that trust."

Sadly, I think anyone having such trust in a pharmaceutical company -- patient, physician, or legislator -- is somewhat naive. All the more reason we need to have confidence in our regulatory agencies.

That brings us to the third party in the debate, the Food and Drug Administration. According to Harris, the FDA has been "... torn over pulling Avandia."

In 2007, there was enough evidence of these risks that the FDA issued a warning, and sales of the drug plummeted. But in 2009, Dr. Janet Woodcock, director of the FDA's drug center, wrote an internal memorandum saying "...here are multiple conflicting opinions" within the agency. She ordered the formation of a second advisory committee to take a look at the drug. That committee has now issued its recommendations.

As reported by Harris on July 15, the panel's vote was split: 12 voted to withdraw the drug; 10 voted to restrict its use and enhance the warnings; 7 voted to enhance the warnings; 3 voted to permit continued sales without additional restrictions or warnings. No one voted to weaken the warnings. In the meantime Dr. Margaret Hamburg, an FDA commissioner, stated she was "... reviewing the inquiry made by Senators Baucus and Grassley ..."

In 2006, due at least in part to a multi-million dollar advertising campaign, Avandia was one of the world's best selling drugs with sales of $3.2 billion. Is it any wonder that GSK executives are trying to preserve their revenue stream?

Sen. Grassley has observed astutely that it is the FDA that approves drugs to be released into the market. To later have to withdraw the drug means the agency must admit to the possibility of having made a mistake. That is a difficult thing to do.

Here are some key considerations.

First, we should expect that pharmaceutical companies will act -- as we all do most of the time -- in their own best interests, even when it places patients at risk. GSK exhibited similar behavior in 1994 when it settled a case regarding its anti-depressant drug, Paxil. It hid data showing Paxil led children and teenagers to more suicidal behaviors and thoughts. We saw comparable behavior on the part of Merck with respect to its arthritis drug, Vioxx.

Second, we should take steps to assure that patients and their doctors make decisions about treatment based on science, not advertising and sales promotion. Indeed, we should eliminate advertising of prescription drugs directly to patients. (The only countries in the world that permit it are the U.S. and New Zealand.)

Third, the same body that approves a drug should not be responsible for decisions about withdrawing it. Independent parties should make those decisions.

Finally, we should worry about the effectiveness of the FDA when it finds itself relying on investigations by legislative bodies to make its decisions. We need to take steps to assure that this agency's only concern is to protect the public and that it has the resources and leadership to do so.

We have seen what greed and failure of oversight can do in our housing and financial markets and, most recently, in deep-water drilling for oil. That same toxic combination can also be harmful to our health.

Terry D. Weiss is a retired physician, who had a medical office practice and did clinical research. He is on the Provider Services Advisory Board of the Regional Health Commission.

This article originally appeared in the St. Louis Beacon.

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