Look Before You Leap

by Theresa Spranger, Bioethics Program Alumna (MSBioethics 2012)

Last week a US Food and Drug Administration (FDA) Advisory Committee recommended that restrictions on the diabetes drug, Avandia, be lessened.  The restrictions were originally placed in 2010 because of concerns that the drug caused an increased risk of heart failure.  The increased risk of heart failure was originally suggested by a researcher at the University of Cincinnati, he performed a study compiling data from several old Avandia trials.  His work suggested a 43% increased risk of heart attack in diabetic patients taking Avandia.  GlaxoSmithKline, the developer of Avandia, insisted that they had a study being performed that showed no increased risk of heart failure and had a superior design to the data analysis study.

At the time of the 2010 decision, Avandia was the most popular diabetes drug on the market, its popularity instantly dropped and the pharmaceutical company was accosted with lawsuits.  Settling these lawsuits and dealing with other issues from the FDA’s decision cost the company a small fortune.

The re-review we saw at the FDA last week is extremely rare.  The committee was called because of an analysis performed by Duke University.  Duke re-analyzed the data from the original study by GlaxoSmithKline.  This is a study that was specifically designed to show cardiac risk and that the company had stated showed no increased risk of cardiac event in patient’s taking the medication.

Duke’s analysis matched that of GlaxoSmithKline and because of this the board reversed their initial decision and recommended that restrictions be lessened. They have also asked that additional studies be performed to confirm this result.  It is important to note that the advisory board decision is only a recommendation to the FDA, so no formal lessening of restrictions has been made at this point.

If this reversal is formally made by the FDA it won’t erase the damage done.  Millions of Americans were using Avandia and were forced to change drugs because of these restrictions; they were told that the drug was dangerous to their health, which may not have been true.  Avandia’s stock plummeted, the company lost millions on penalties and legal cases, and the drug’s reputation is forever tarnished.

GlaxoSmithKline is certainly not a hapless victim. They had a history of data integrity issues with other drugs that led to a mistrust of the Avandia data.  However, when making decisions like this it’s a fine line between being cautious for reasons of patient safety and jumping to unfair conclusions about the risks of an experimental drug or treatment.

Pharmaceutical companies are often placed in a bad light by our society.  We view them as power hungry, money grabbing machines that have little or no regard for the people they claim to help.  This is a gross misinterpretation.  Certainly, they are companies and therefore concerned with profit margins, but our American market system is based on a big risk/big reward theory.

These companies risk billions of dollars on drugs that have a limited chance of ever getting to market. Clinical trials are hugely expensive and placed under heavy scrutiny along the way.  This is not to say that data cannot be manipulated.  However, even the most cynical among us should admit that a pharmaceutical company would be concerned about the safety of their drug, if for no other reason than that being repeatedly sued is an expensive endeavor.

It is important in a situation like this, with so much at stake, to have all of the facts before making a decision.  It’s nice that the advisory committee has corrected their mistake, but it would have been nicer to have avoided the error in the first place.

[This blog entry was originally posted in a slightly edited form on Ms. Spranger’s blog on June 14, 2013. Its contents are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]



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