The latest from DTC Perspectives

Looking For Bad Guys

The search for drug company evil continues as Glaxo’s Avandia is the latest drug in the crosshairs of regulators, the media and lawyers. This diabetes drug is highly effective at regulating blood sugar and is used by millions of type 2 diabetics. It may have a higher risk of causing heart attacks than some alternate therapies and placebo according to some studies

The issue as with all drugs is benefit/risk ratio. Avandia may cause a heart attack just as aspirin may cause a stroke or intestinal bleeding. The issue is how many heart attacks we should accept versus the serious risks from poorly controlled diabetes.

The harsh reality of drugs is that they have side effects and risks. There are no completely safe drugs. There may be real issues with Avandia's benefit/risk ratio and I am not downplaying the issues raised by critics. The feeding frenzy from lawyers and drug critics seeking a new scapegoat for drug company evil is what bothers me. Since Avandia was a DTC drug we can also expect new calls for bans based on claims that consumers were led to take "dangerous" Avandia by DTC ads.

I have been a critic of how risk is regulated by FDA. People need to know the real odds of a serious side effect, not vague terms describing every potential risk. If a diabetes sufferer well-controlled on Avandia is given the odds of them suffering a heart attack, they can make the decision with their doctor. My guess is that the real odds of increased risk are quite small. The media will report figures like a 50% increased risk of heart attack which sounds horrible to consumers. In reality that may mean 1.5 in a thousand get a heart attack versus 1 in a thousand not on the drug.

I sympathize with Glaxo's plight because I was on the Rezulin team in the late 1990's when we faced the same issue. Rezulin, in the same class of drug as Avandia, was associated with fatality. As I recall the level of fatality was one in thousands, but since alternative drugs existed, it was pulled. The lawyers had a feeding frenzy and a good drug was no longer available for the many patients it helped.

To the person getting a rare side effect the consequences are devastating. We cannot, however, have life saving drugs if we will not accept that some people may actually die taking those life saving drugs. The question is always how many die versus how many saved? Much of the latest criticism of Avandia has been hyped to the point that it will scare diabetics from treating their disease. If Avandia has a negative risk benefit profile it should be withdrawn but not because of lawyers and knee-jerk critics but because of hard facts. I now see commercials from lawyers seeking "harmed" Avandia patients. Glaxo may face billions in potential liabilities as lawsuits grow exponentially. These lawsuits raise the cost of our medicines as eventually all of us pay for liability settlements in higher prices.

We can also expect new Congressional hearings on drug safety so our legislators can get face time bashing executives on what they knew and when did they know it. The Avandia commercials will be shown as examples of demand creation for a dangerous drug. Waxman will call for a moratorium on drug ads. Sidney Wolfe will cry cover up of key clinical information. No critic will be dealing with facts just hyperbole du jour. That is a sad reality in the world of drug makers.