Publish or perish, Education, Surveys, Brownlashers, Cons
Welcome to the new world of "one rat experiments". So glad you came, as you shall soon see, you are the subject of this missive.
In the years of old, before computers, much of research was drudge work that involved long hours before the lab bench trying and trying to find the philosopher's stone that would yield new riches for the pharmaceutical houses. In those days, once embarked on a project, care was taken to dot all the "i"s and cross the "t"s, to be sure that false steps were not taken. Experiments were carefully designed, ensuring that adequate numbers of data were obtained so that the product emerging from the lab was safe, effective, and of low-cost. Government intervention was essentially non-existent, and self-interest groups had not as yet emerged on the scene.
Now contrast that to the present. There are more activist than there are causes so they joust for the funds (both public and private) and make quite a nuisance of themselves. The scientist must be aware that "Peter Rabbit" has rights too, and it is wrong to put dreadful chemicals in his/her eye. The poor little hairless mouse (nude if you like) enjoys air-conditioned splendor and a quality diet not available to perhaps half our "people" population. And the spare dog, "Rover", can't be used in experiments. No, it is much better that he be euthanized; discreetly of course. And to be sure that this is so, the Government issues literally tons of documents to be read, followed, reported on, and of course filed. Inspectors and regulators make up a much larger population than the scientist themselves.
So at the bench what is the company and its scientist to do? Why shift the burden of proof of the effectiveness of new products to the only unregulated, unprotected, dumb animal that still exist. That's you! Welcome to the world of the "one rat experiment". Now when a new product is on the horizon, or perhaps it's just some half-baked idea that has a corporate sponsor, the best and safest (for the company that is) approach is to rush to "phase one" testing. That is; let's try it on someone and see what happens!
Phase one - Just a few brave soles, or perhaps some poor college student, prison inmate or a janitor who needs a few bucks or maybe just does it for kicks, is enlisted. The "product", let's not call it a drug at this time, is tested by administering a dose of unknown potentency to see if the "test animal" curls up and dies or maybe just takes the couple of bucks and heads for the local bar (prisons excepted). Hot-damn, we have passed phase one, now on to phase two!
Phase two - Maybe, says the pharmaceutical house, we are on to something big so let's see if this stuff causes any problems. If only we can find a target population that is willing. Back to the schools again, this time to the Universities. Most "campus" newspapers carry ads seeking "volunteers" to test new drugs. If you meet the criterion, (able to walk in, sign your name and lie if there is something in your background that would prevent your being included in this "population"), you can be a guinea pig too. So you take the "unknown" which is either a sugar coated pill (placebo) or the real McCoy and the "scientist" stand around waiting for you to expire (of course not, they have already decided that you will be OK). If the drug has an effect that is beyond the observation period, too bad, they may try to find you but chances are that they will not. Congratulations! No one turned up their toes or was rushed to the emergency room so now on to phase three. Phase three - Having spent all this money, it's about time to see it this stuff really works. Guess we will have to find some individuals with the malady that this drug is designed to treat. Nothing could be easier. With a nation of hypochondriacs afoot, you just have to approach most any doctor who with the proper encouragement, dollars work very well, will offer up a number of his selected patients. The reasoning goes, since these folks are sick and dying, why not help them on their way. Maybe, just maybe, our screening of this population of "test animals" will reveal some benefit from our magic elixir. If so, EUREKA, we have hit the jackpot. Now the most difficult part of our quest is before us. We must pass regulatory muster in the vortex called FDA.
Regulatory vortex - Having just spent many dollars and perhaps a few lives on this next palliative for mankind, we must be prepared to now offer up to the Gods in Washington, some very convincing evidence that our product is not only effective, but that without it mankind is doomed to death or discomfort, at only a small cost to the unwary or those that seem to have an "adverse reaction" (use small print and lots of words that only a Merlin can understand). Fortunately, as has been discovered by some in the industry, the wheels of justice within the FDA can be greased by judicious placement of political funds into just the right coffer. Alas, others are not quite so luck and they may be destined to circle endlessly within the Agency, trying without success to win favorable action. Maybe they just didn't get the right "consultant" (spelled: retired or ex-agency employee), or maybe they are on the most-favored list of some activist list, who knows. Assuming that the money has been well spent it is now time for the "real experiment", placing the product in the hands of doctors who will give it to their most unsuspecting patients.
Free samples - Having jumped over the messy business of manufacture, packaging, distribution, advertising and the like, our product is now ready for "testing" in the brave new world. How do we do this you may ask? Simple, I respond. Our jobbers, detailmen, golf buddies, &c;., whatever you choose to call them, drop off free samples with the receptionist, the nurse or the Doctor if he can be found and then we anxiously await the results. What results - adverse reactions of course. With good luck, Matilda or John will just recover from what ails them regardless of the laying on of the hands of the Doctor, and of course this means our product is GOOD. Well what happens if M_ or J_ (names deleted to protect their families and the Doctor as well as ourselves), just don't play fair and insist in turning up their toes? We can't just rush to the FDA and say, bad M_ or J_. Nor do we withdraw our product. We have to carefully examine the history of the patient, who knows, perhaps they drank a case of beer each day and smoked three packs of cigarettes as well as indulging in some other unwholesome acts (you can fill in the blanks), and perhaps there is a mitigating effect of superimposition of these dastardly pleasures. So now we study the result of all our "one rat experiments" to see if perhaps we have actually exposed the populace to another diethylstilbestrol, thalidomide, &c;.
Alas, we must remove our product from the market. Our wonder drug is no wonder at all but simply just another failed market venture. Never mind, our investors will reward us for being on the cutting edge of technology. Our Doctor friends love us for our free samples, little prizes we drop off at the door, from time to time and the nice all-expenses paid trip (spelled vacations) to some remote tropical island to hear all about our next miracle drug. The Regulators love us, for without our being, they would have no work and in a generation or so, the public might wise up to their presence at the trough of tax monies. And best of all, the public, bless their little pea-picking-brains, just adore the way we have some new medicine for what-ails-you, as evidenced by the number that belly up to the bar for their daily dose of pills.
My-my, the headline in today's paper, "Controversial Diet Drugs Removed from Market", could this be so?
So who's complaining? Me.
(Those "rats" that fell by the wayside have no voice.)
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ABOUT Joe Wortham