"Cuiusvis hominis est errare; nullius nisi insipientis in errore perseveare"
Any man can make a mistake; only a fool keeps making the same one.
Cicero (Status Vivitatis)
The FDA in all its glory causes more deaths in America than all gun related and all car related deaths combined every year. This diabolical agency feeds on life, for the sole purpose of enhancing its bureaucracy by staffing it with more fools. Media however, daily informs that any curtailment of this agency would result in jeopardizing life on this planet. They in fact speak of healthcare rationing, epidemics and horrendous loss of life.
To understand the problems relating to this agency it is necessary to view the revolving door between the agency and large pharmaceuticals. Management service in the FDA knows that they can easily retire after 20 years with full pensions, at which point they can seek employment in the large multinational pharmaceutical industry as a lobbyist to the FDA, that is of course, if they played their cards right during their employment there. The most egregious failure of this agency is its ever-expanding sphere of regulatory power over new issues continuously. The aforementioned revolving door induces FDA employees to require expansive testing for not only drugs but for everything that the agency regulates.
It is a well-known fact that smaller companies not only in the pharmaceutical industry but also in medical instruments, and other related matters produce the largest amount of new procedures and medicines for public consumption. Large corporations, in all venues dislike competition especially from small up-starts and thus induce the FDA to force financially devastation regimens of testing even for products that are benign in human interaction. To gain understanding of this, be advised that the average cost for FDA approval of a drug, or instrument, costs that produce about $ 14 million. So, per example a company produces a benign test for breast cancer which is consumer friendly, and locates any developing tumor, it can be used by any woman and is superficial on the exterior of the body, it’s cost is minimal and can be sold by any drugstore. It will however greatly reduce the use of X-ray equipment for breast cancer screening and is thus opposed by large instrument companies as well as the X-ray service industry, and those who manufacture FDA approved X-ray equipment. In the aforementioned case it took the manufacturer of the new technology two years to get FDA approval. Breast cancer can easily be cured if it is found early, the delay in obtaining FDA approval that is totally unnecessary for such technology was responsible for thousands of deaths for no reason.
We live in an ever-smaller world and if government does not interfere in the markets we all benefit from new technology produced in foreign nations. This is not so in the pharmaceutical industry, because instruments and drugs produced in even highly industrialized nations like Germany, Switzerland, France, Japan, Italy and Spain, even if they have proven safe in those nations for decades, are bared from the American markets because they do not have FDA approval. This is even the case for huge pharmaceuticals like Novatis, which have production plants worldwide including in America. In 2011 your author was in Switzerland when a bone became abscessed in my jaw, the dentist gave me a anti-biotic produced in France that is not allowed in America that targets tooth and jaw abbesses, two pills per day for four days. I was cured in three days. In America I would have been forced to pay at least $50, for a ten-day course of anti-biotic that attacks the entire body, destroying the entire beneficial flora in the body.
The most pronounced effect of the FDA is related to the cost of instruments as well as drugs, and in fact everything regulated by the FDA, making medications the most expensive in the entire world. Their regimen of over-regulation they cause the price of all medical relates issue to be between 30% and 80% more expensive than any other place in the world. The appalling fact is that a sampling of ten drugs that have an average cost of $74.30 in America costs $ 40.00 in Canadian and $35.25 in Western Europe or $ 30.00 in Switzerland. Unfortunately that’s only half the story. The diabolical profit margins of American pharmaceuticals, places that industry in an entirely different light to any other industry. Average profit margins in per example the machine tool industry, whose R&D costs are higher than pharmaceuticals, is between 3% and 4%. The claim by the drug industry that their development costs are higher than in all other business is pure fiction. Thus we see margins in drugs as follows:
Selling price Cost of ingredients Profit margin
Celebrex $139.27 $0,60 22x105
Novarex $188.29 $0.14 134x105
Prozac $247.47 $0.11 255x105
Xanax $136.79 $0.0024 570x105
Zoloft $206.87 $1.75 12x105
From the “New American Newspeak Dictionary”
We repeat to make it absolutely clear there is no other industry located anyplace on this planet that has that sort of profit margins, we do not consider Hedge funds or banking an industry, banksters and Ponzigonifs produce nothing, and are consequently in a league of their own.
It has come to our attention that the FDA is now actively engaged in an attempt to get congress to do a number of things: Firstly they want to again expand their staffing by 8% in the 2008-2012 five year plan. They also want a budgetary increase of $ 2.88 billion in those five years, and they presently employ 11,516 bureaucrats. In regulatory powers they want to regulate homeopathic medicine, which has been unregulated since time immemorial, they want to regulate vitamins and mineral supplements that are not yet under their control. And lastly they want total control over all medical devices produced and sold. The fact that there are no recorded deaths due to the use of homeopathic medicine, vitamin supplements or of mineral supplements does not deter the planned expansion. They in fact want to regulate to increase their fiefdom. Government is the last place in America that has yet to realize that in a depression you don’t increase expenditures, you cut costs.
The result of any such expansion would again as it has done in every previous case of increase of FDA authority and size, expand death rates, reduced life spans (Now 14th worldwide due to the FDA), and drive medical cost through the roof. America’s principal medical problem is over regulation by the FDA, something that the entire (over 2,000-page Obamacare bill) does not even address. A3P is animate in policy relating to the FDA, the agency must be reduced and all regulatory function must be overhauled, using common sense something that no manger of FDA has done since its foundation.
Dr. Krieg is a member of the board of directors of A3P and a widely published author of books and essays.