One of the drawbacks of living well is that one becomes increasingly vulnerable to ulcers, and not long ago this happened to me too. I had to cut right back on my intake of Bourbon.
Actually, it happened twice. The first time, I was vacationing abroad, and woke up in Sweden one morning feeling very nauseous and weak - but did not throw up. Having never had such symptoms before, I took them to the doctor, who happened to be an English-speaking Dane. He swiftly diagnosed the stomach ulcer, and prescribed tablets called Lusak. And, he did say to lay off the Aquavit.
It worked very well. Next day I felt much better and within a week all trace of the problem was history.
Then about a year later and back in the U S of A, I hit the same problem over again, but this time the physician prescribed Zantac. Now, I have nothing against Zantac, it may work well for others in the same position, but for me it was a very poor substitute. It gradually improved the symptoms (or was that the diet she also put me on?) and three months later I could take an occasional sip of wine and a year later I could risk a small Bourbon again.
So the question is, why could I not be treated here with Lusak?
Enter the F.D.A.
My physician would willingly have prescribed it, but she was not allowed to do so, by law. Lusak had not been through the 10-year testing cycle of the Food and Drug Administration (FDA) and so nobody may use it. Nanny says No.
Now, Sweden is hardly a model of laissez-faire capitalism, though it's fast improving, but even in that Socialist utopia, they don't nanny people as badly as the FDA does. They approve new drugs far quicker. Does that lead to a bigger risk? - probably! Nobody said that life is safe. But somebody there must have done the simple calculation that ensuring a new drug is 99.999% safe instead of 99.99%, is going to result in a net loss of life by delaying the treatment.
That elementary line of reasoning doesn't hold much sway at the FDA. They will never admit it, but what they mostly mean by "making sure the drug is safe" is that they, the pen-pushers of the Administration, will be safe; safe from any accusation that they let the drug go on the market too soon.
Trouble is, they can and do easily measure how many die from a drug released too early; but nobody even counts how many die because it came too late. Well, you can guess how much I care about the job security of some nerd in the FDA, and so can understand how it was I became a drug smuggler. We're not allowed to buy Lusak at home? - then I'll go abroad and buy it there. Easy. Illegal, perhaps; but it was not I who trivialized the Law, making it an ass.
My condition was minor compared with those who suffer, for example, from AIDS. As far as I know nobody has yet found a cure, but all over the world researchers are researching, and the same problem arises if a promising drug is found: the FDA's procedures will keep it off the US market until exhaustively tested to make sure it's "safe". The dying AIDS patient is literally told that he's not allowed to use it in case it has any side effects. As if he cared!
The outcry has been so vigorous in that particular case that the FDA has been made to relax some of its rules. Yet the demand from the great bulk of AIDS activists is not that this taxpayer-funded albatross be abolished, but that taxpayers be forced to finance more research! - as if government-run research has ever been the fastest route to any discovery on the planet!
One can understand their desperation, but just as abolition of the FDA would be the fastest way to bring them immediate relief (so that the patient can try any drug from anywhere, at his own risk) abolition of all other government-run and -controlled medical research would be the fastest way to bring them the ultimate cure; for private, for-profit enterprise always produces better results faster than those run on tax money by government.
Hit in the Pocket
Inferior medication is not the only cost of keeping the FDA in existence.
It also costs us a pile of money. I don't mean just the cost of paying its employees - that may be a drop in the $1.5T Federal bucket - rather, I mean the prices of drugs it approves, and which you and I pay - either directly to the pharmacist, or indirectly to our insurance company. Here's how it works.
The ABC Drug Co invests in research and discovers a promising new treatment. Cost so far, say, $3.4 million. They are ready to go to market, and will obtain a 17-year patent and will price it so as to bring a nice profit while recovering that $3.4M at the rate of $200,000 a year. If they reckon to sell 2 million of their new pills a year, the price must include only 10 cents each to recover the necessary cost of research and development.
Now cometh the FDA, and maketh it jump through an incredible number of extra hoops to prove conclusively that a multi-megadose of the new drug will never harm a whisker of any laboratory mouse; and to take 10 years doing it. Costs rocket up to $14 million, and only seven years of patent protection remain when at last it emerges; 14/7 leaves $2M a year to be recovered. So the net effect of the FDA intervention is to multiply by ten the development cost component of the price - from 10 cents a tablet to $1 per tablet.
Now you know why a prescription may cost $70 instead of $10 or so. And the FDA will go on doing this until you elect someone who swears to abolish them.
|© Copyright Jim Davies 1999|
Jim Davies lives in New Hampshire,
and enjoys contemplating which way is up.
The above is Edition # 53
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