But then, and the late 1950's and early 60's, something horrible happened, both to the citizen and to the State. In Europe, a drug called thalidomide was marketed as a tranquilizer. In America, the FDA official in charge of the American "new drug application" for thalidomide (Nov., 1960) was a woman physician (Francis Kelsey, M.D.) whose physician/pharmacist husband did not like the way routine pharmacologic tests had been done on thalidomide. Dr. Kelsey was also concerned about some medical reports in late 1960 that thalidomide might cause neuropathy in some of its users. Neither of these concerns was fatal for the thalidomide application, but together they were enough to hold up the FDA's approval of thalidomide for a year. Since neither problem had anything to do with birth defects, it was only by the sheerest chance that the red-tape in these matters caused introduction of thalidomide to be delayed in the U.S. until it began to be suggested in late 1961 that thalidomide was a dangerous drug for pregnant women. In the end, the association between thalidomide and birth defects was discovered in Europe, not America -- and certainly was not discovered by the FDA. Despite this, on August 7, 1962 a grateful President John F. Kennedy awarded the Distinguished Federal Civil Service Award to Dr. Kelsey, who by this time was beginning to make (in retrospect) statements about how she had been concerned with the reproductive safety of thalidomide all along.
However much we all like heroic tales and medals, there is actually very little in the record to bear out the official heroic version of the thalidomide story. Upon careful examination it appears that no reproductive tests were done at all on thalidomide before 1961, nor indeed did the FDA ask for any. In fact, it appears that even had any pre-marketing reproductive tests of thalidomide in rats been done, they would have *still* have shown negative results, for thalidomide (as it turned out later) does not cause birth defects in rats. We now know that it would have taken a much more exhaustive set of animal tests to catch thalidomide than was routinely used anywhere in 1961. An honest reading of the facts thus forces the conclusion that (questions of luck aside) Dr. Kelsey's medal was awarded basically for being a delay-causing bureaucrat and thereby allowing Europeans to serve as first-class "guinea pigs" for Americans, in a case where (quite literally) guinea pigs themselves would not have done an adequate job. Dr. Kelsey's medal was soon to become an excuse for much self-congratulation regarding FDA policy, without much thought being given to what the consequences of a de-facto U.S. marketing delay policy might be, if applied to all new drugs across-the-board.
And there was other fallout. In 1962 the thalidomide disaster gave unexpected new life to several stalled bills on capitol hill which proposed to give the FDA power over not only safety, but also the _efficacy_ of new drugs. There was a some irony in this, since the thalidomide disaster itself was of course an issue of safety, and had nothing at all to do with efficacy (the bills were themselves introduced before anyone had heard of thalidomide). Unfortunately, however, the fine distinction was lost on congress, which only knew that the FDA seemed to be a good thing and should therefore be made bigger. In 1962 the so-called "Kefauver Amendments" to the Food, Drug and Cosmetic Act were passed into law, giving the FDA new broad powers, and thus the bloated and mutated regulatory agency that we know today was born. Thalidomide, as it turned out, proved to be a monster--producing drug in more ways than one.
Today, thirty years later, the cost of developing and marketing a new drug in the United States has risen to an average of about a quarter of a billion dollars PER DRUG. To make a long story short, a large part of this money is regulatory cost. Not surprisingly, the huge sums spent in drug development are reflected in the price which the consumer pays when he/she picks up any prescription for a newer drug. The reader who wishes to directly assess the regulatory cost of the FDA is invited to shop for pharmaceuticals in Mexico, where (except for packaging) the identical pharmaceutical product made by the identical company can sometimes be had for as little as 1/5th the U.S. price.
The FDA is responsible for high regulatory costs in money; the regulatory cost in lives is more difficult to assess, but is probably significant. The high cost of drugs has led not a few impoverished patients to stop taking what the doctor ordered, sometimes with expensive or even tragic results. Even worse, the newest drugs now, as a rule, are available in Europe for years before being available in the U.S., and in the interim many U.S. patients almost certainly die for lack of treatment. One estimate, for instance, puts the number of people who died of cardiac arrhythmias, as the direct result of the historical FDA's multi-year lag-time in evaluating beta-blocker drugs, in the hundreds of thousands-- a number which, if correct, makes up for thalidomide many times over.
It is important to understand that this situation arises via one of the significant shortcomings of democracy. Politically, the FDA comes under severe pressure for passing a drug which is later shown to be unsafe, but (in an unbalanced way) comes in for much less political pressure as regards the equally dangerous failure to swiftly pass a drug which proves to be efficacious. This lack of balance results from the fact that patients who die as the result of a drug-reaction are seen to die because of the drug, but patients who die as the result of lack of a drug (especially one which the local docs are not familiar with) are seen to die of the *disease*. Even if the local doctor understands the FDA's role in preventing the patient from being properly treated, "Stenosis of the Government" is not a medical diagnosis, and cannot be written on a Death Certificate.
It is also important to understand that this situation arises because of a certain laziness of the citizenry in understanding that the decision of whether to take a specific drug for a specific purpose, is only partly a scientific one. The reason for this is that, even in the rare case where the probabilistic risks and the benefits of "taking the drug vs. not taking it" have been fully defined by science, the *balancing* of these risks and benefits is still an ethical and moral decision, and one which varies wildly from person to person, due to circumstance and personal preference.
To put it succinctly, the decision to try a new and possibly dangerous treatment may well and properly be influenced by how much pain the prospective treatment-taker is in, and even upon how soon he or she can expect to die if nothing is done. Unfortunately, however, these factors do not directly enter into decisions made in Washington, basically because Washington is not in pain, and Washington is not dying. If you are the patient with a serious problem, therefore, you may expect that having a decision about your treatment made for you in Washington is less likely to be satisfactory, if for no other reason simply due to the fact that they do not know you or your problems in Washington, and even if they did know you, still could not care about your problems nearly so much as you and your family do. Empathy is a function of proximity; all physicians know this. It is an elementary principle of medicine that nearly any displacement of medical decision-making away from patient and physician in the direction of a place thousands of miles away, is bound to result in needless suffering. Thus, the FDA as it functions today is basically engaged in an evil enterprise. To be sure, the people who run the FDA may not be evil people (though perhaps some are) but unfortunately, this does not change the facts about the FDA's generally negative impact upon the world.
The FDA, it must be remembered, is in the game for the political power, not for the benefit of the citizenry. This is a fact which comes across in many issues, large and small: