Warning: The FDA May Be Hazardous to Your Health

By: Brooks A. Mick

I’ve noticed something a bit odd about the warnings that the FDA is putting out about various drugs. Two which struck me most strongly were the warnings about Advair, an inhaler that combines a corticosteroid to fight inflammation and a direct long-acting bronchodilator to expand the breathing passages, and Avandia, a medication used to treat diabetes mellitus.

The odd thing is that the original studies done on the Advair prompted the FDA to conclude that the benefits far outweighed any problems that the medication might cause. And then, just recently, without any new data at all, the FDA added a warning that the use of a long-acting bronchodilator might result in dangerous consequences. Note, without any new data at all, the FDA changed its opinion. I’ll return to that later.

And with Avanda, there was a meta-analysis a few years ago which suggested that there might be a slight increased risk of heart attacks with Avandia compared to other diabetic medications. Subsequent to that study, there have been other large, long-term studies which showed no increased risk of death from any cause and no increased risk of heart attacks in people taking Avandia. The latest was an analysis of the BARI-2D study. And yet the FDA, after finding no clearcut reason to regulate the use of Avandia based upon the original meta-analysis, now decides to issue warnings even though newer, better studies show no risk.

A brief word about meta-analysis. This is a statistical technique wherein patients from different research studies are lumped together and various fudge factors applied to the data to correct, theoretically, for differences in study techniques and patient populations. While such techniques may produce important findings, the results are always somewhat less statistically reliable than those of single-population, well-designed studies done under standardized techniques.

Now back to the recent FDA warnings. I was discussing these seemingly arbitrary decisions with a medical school professor recently, and I proposed that perhaps Obama had gone to the FDA, much as when he went to NASA and told them to engage in Muslim esteem-building, and told the FDA to create new opportunities for trial lawyers, perhaps to pay them back for their campaign contributions. The professor said that she and her colleagues had a different conspiracy theory: Obama has asked the FDA to begin pre-rationing expensive medications by scaring patients and doctors into avoiding the use of such medicines, even though no statistical data indicated danger. She pointed out that, regarding Advair, no study had ever demonstrated any increased risk of using this combination of corticosteroid and long-acting bronchodilator, and that the entire FDA rationale was based on an old study using the long-acting bronchodilator alone. In other words, the warning is without basis and seems designed only to decrease the use of the Advair inhaler, a device that is very beneficial in the treatment of asthma.

I have been telling patients and writing pieces for websites for quite some time about Avandia and how the warnings appear to be baseless. The professor agreed with my conclusion about Avandia, also, that it was a fine and useful drug and had no more risk of heart attacks than any other diabetic drug. We both noted that, in patients wtih pre-existing heart failure, it should be used with caution if at all because it can cause some fluid retention, which is undesirable in such a condition.

I agreed that her and her colleagues’ conspiracy theory was probably more likely than mine, but that it was a two-fer as far as the Democrats were concerned, both driving down the use of expensive–though very beneficial–medications, and also giving a boon to the trial lawyers. We both noted the TV commercials by ambulance-chasers that imply that Avandia is a “bad drug.”

I conclude that the FDA is dangerous to your health. It is inhibiting the use of very beneficial drugs by issuing scare notices based on no statistical data whatsoever, or based on old data which has subsequently been demonstrated to be in error. I would watch for further examples of their attempting to frighten you about medications, and I would be very cautious about stopping a medication based upon FDA scare tactics.

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