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Reflections, by Victor Niederhoffer

The hearings on pain killers at FDA will be held during the next three days. And it will be good to study the kinds of statistical errors that are made in weighing the results of one study with a percentage of heart attacks that varies about 1% a year from expectation with the base figures as this will enable one to see better the kind of randomness that fools the mystics in our field. Of course, with us, itís just money.

Every now and then a number of forces come together that crystallize the million wrong things that emanate from the idea that a human does not have the right to his own life. Such is the case with the tests, propaganda and hearings associated with the well publicized side effects of the pain killers. The main thing that's wrong with such hearings is that every patient should have the right to decide for himself whether he should be taking the drug after assessing the benefits and costs. The related main problem is that there is a total emphasis in the controversy about whether there is an increased risk of heart attacks and strokes without regard to the benefits involved in pain reduction and cancer prevention.

It turns out that the risk of heart attack in the most frequently cited studies by the "take it off the market group" goes up from 1% or 2% a year to 2% or 3% a year for people in the 50 year old bracket. That's what they're referring to when they talk about the doubling of rates. But compare that to the approximately 100% reduction in pain the drugs cause and the approximately 50% reduction in polyps that the drugs cause, with many estimates of about an 80-90% conversion of polyps to cancer.

But that's just the first of the problems. The whole subject is junk science at its worst. The drugs themselves have been used for hundreds of millions of patient-years. And they have been tested for efficacy and safety in double blind studies in hundreds of studies. They have numerous spillover benefits in all sorts of off-label uses. And indeed at the time they were pulled hundreds of studies were going on as to their efficacy for such things as prostate, breast and colon cancer, and stroke. Of course, one of these studies with a hundred patients or a thousand patients is going to show a increased rate of disease of 1% a year. That's guaranteed to happen with randomness. As a benchmark, consider that the variability of a proportion is of the order of 2% with a study of 100 patients.

Regrettably the problem runs into the tort system. Lawyers using junk science have an industry in suing companies whose products have side effects. In a typical such study, the patients get 100 bucks each and the lawyers get 50 million. But politicians benefit because the tort lawyers are one of their biggest contributors. While the litany of abuses runs deeper and deeper, all stemming from the idea that people are incompetent to make choice, the drug companies, or big pharma as they're known in the industry, should not be absolved. The outcome of all such hearings is to preclude competition, reduce their permitted level of expenses, and make it harder for other companies to bring out competitive drugs. Think of the tobacco settlement as an example here, with restriction on entry into the industry by companies that didnít participate in the settlement. Multiply such witch hunts by 1000 fold, and think of all the molecules that donít get invented, and all the patients that donít get treated, and the delays and restrictions in the drugs that do go through the pipeline, and you can readily estimate that the average life span of all of us would be increased enormously, say five years, within five years of the abolition of the organization that likes to think of itself as a proper noun, with benevolent influence, FDA.