Friday, May 25, 2007

Avandia and Promoting Consumer Fear

Source: DTC Perspectives
Issue 262 May 25, 2007

Avandia and Promoting Consumer Fear

" Here is another useful drug accused of being dangerous."
-Bob Ehrlich

A New England Journal of Medicine story released this week, that said diabetes drug Avandia causes significantly more heart attacks than other oral diabetes treatments, is leading to the usual hysteria among patients. Stock analysts predict dire consequences for sales of Avandia and a negative effect on ratings for Glaxo stock. The media, in its desire for catchy story lead-ins, says a drug taken by millions is dangerous.

Congress is demanding investigations of how this drug was approved and monitored. Physicians are wondering what to tell patients who demand to be taken off Avandia. The public is wondering how such a drug can be on the market.

In my view, here is another useful drug accused of being dangerous in the unrealistic desire for risk free medications. Glaxo says the study is not accurate because it did not include all information submitted to FDA. I read the article published in the New England Journal. Let's assume for sake of discussion the study is accurate in reflecting risk. Of the 15,324 patients tested in clinical trials 39 people died versus 22 in the smaller control group. That is 17 additional deaths among 15,324 people. Certainly that is tragic for those 17 but is about 1 in a thousand odds among a very ill population. If you hear the story reported in the media you hear it as a 64% increase in heart attack risk with no other context.

If the media reported it as a 1 in a 1000 chance of death versus a 1 in 1600 chance of death it would not have the punch as making it appear so much more deadly. How many patients will pull themselves off Avandia or be afraid to take any diabetes drug because of this story? That reaction will be more harmful than continuing the drug. The media does a great disservice by not telling the real odds of a problem. Most diabetics taking Avandia are pretty sick. They need better control of blood sugar and most have tried other oral drugs. So if told they have a 1 in a 1000 chance of a fatal heart attack from Avandia; would that scare them? I doubt it because most are over 50 and have numerous other health problems, and if Avandia works well then they would probably accept that risk.

Americans expect and deserve real odds of risks and side effects when considering a drug. Drug makers have an obligation to honestly give them such facts in an understandable format. The media has a public duty to report side effects in an understandable way as well. They must provide context to medical journal articles. Instead most try to hype the issue to get viewers to watch or read the story. Many good drugs get this treatment and patients get scared beyond their wits. These are people who have enough problems without adding fear of medication to their misery.

It is possible Avandia users have safer alternatives and those should be explored. For some a switch to other available drugs may reduce risk with similar efficacy. For others Avandia is doing a great job controlling blood sugar and no alternative is better. Americans must expect risk when they take any drug. Side effects are a tragedy for those that get them, but getting them is not always the fault of the drug company. Properly warned, patients and their physicians need to weigh the risk and benefits of any drug. In some of those carefully considered cases, patients will still die because of a reaction to a drug intended to make them better. That has and always will be the case. Those deaths pale in comparison to lives saved. That part of the story gets lost because "greedy uncaring drug company" makes better copy. A shame indeed.

Bob Ehrlich, Chairman
DTC Perspectives, Inc.

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