Risk to Benefit Ratio: when is a drug too risky to stay on the market?

August 24, 2010
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Pundits have said it takes at least 100 deaths for the FDA to act regarding pulling a prescription drug from the marketplace. The playing field is far from level for risky medications versus the risks of supplements including herbs. It is of little comfort to consumers that the FDA has no written guidelines for deciding such action (that is, pulling a drug from the market). In fact, Dr. Joshua Sharfstein, the FDA’s principal deputy commissioner, states “each drug has its own complex story”. Click here to read further http://www.usatoday.com/news/health/2010-07-03-unsafe-drugs_N.htm.

The drug approved in 1999 to control high blood sugar, Avandia, now has faced a review of its heart attack and death risk. A 700-page review has been posted by the FDA in advance of the meeting that considered action on Avandia which is used by hundreds of thousands of diabetics in the U.S.

One of the multiple considerations that faced the FDA included “Is there a safer alternative?” Not included on the FDA’s review are the following questions:

• Does targeting the blood test result number (in this case, blood sugar) change the outcome of the disease for the patient?
• What is the drug induced nutrient depletion of the medication?

The FDA considers the seriousness of the illness being treated, the harm, and the frequency of the risks versus the benefits from the medication.

The FDA seems oblivious to the current literature which has stated repeatedly that targeting a blood sugar number often worsens the outcome for type II diabetes. Click here to read current studies on the topic: http://www.sciencedaily.com/releases/2010/06/100629122946.htm

Why did more people in the intensive blood sugar treatment group die?

It seems incomprehensible that the FDA would fail to consider that using a medication with significant risks to target blood sugar readings when there is a profound debate that achieving this target has any benefit at all. Of course, in the famed words of John Abramson, MD author of “Overdosed America”, the medical system currently is “designed to medicalize symptoms in order to market medications.” The FDA has now ruled that Avandia will remain on the market with stronger warnings placed on the drug. Click here to read in further detail http://pubs.acs.org/cen/news/88/i29/8829news3.html. However, given the previous study that indicates “healthcare providers are often not knowledgeable about the origin, meaning, and implications of these “black box” warnings,” that is of little comfort given the information that it appears Avandia risks were hidden from the FDA and consumers. Click here to read in further detail http://www.jacionline.org/article/S0091-6749(05)02325-0/abstract.

It seems less than prudent to allow Avandia to remain on the market with the knowledge the manufacturer, Glaxo SmithKline (GSK), has hidden communication dating back to 2001 acknowledging the risks associated with Avandia. The Senate Finance Committee including its ranking member Charles Grassley (R-IA) has released a fraction of the 14 million pages of documents that relate to consumers’ suits against GSK for Avandia product liability. Why would the FDA trust GSK to monitor the ongoing risks of Avandia and potential harm to consumers?

This situation also highlights the inconsistency of the FDA regarding allowing supplements it considers to be risky on the market. The most famous of these cases involve the contaminated batch of tryptophan let into the U.S. by the FDA which banned l, tryptophan from the consumer market and ephedra both of which had enviable safety track records when used appropriately.  Click here to read in further detail about the FDA’s action on the herb ephedra http://www.ephedra.nu/en/news.htm.

It seems incredible that consumers retain the right to access Avandia and make an informed decision about the risks versus the benefits with their healthcare provider yet the same is not true of an herb like ephedra with thousands of years of safe usage or an amino acid like tryptophan found normally in the human body. Consumers’ right to choose to use products educating themselves about the risks vs. the benefits in a discussion with a healthcare provider is a fundamental freedom of healthcare choice. This type of action by the FDA remains one of the fundamental reasons many groups and consumers continue to call for FDA reform.

Deborah Ray, MT (ASCP)

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