Wednesday, March 02, 2011

The Bizarre Antics of the FDA

Dr. A. H. Krieg

In the annals of government there is no possibility of an agency as bizarre as the American Food and Drug Administration, with the possible exception of the Obama White House budget office that is projecting a 61% increase in tax revenues for 2011. As of February 2011 the national debt exceeds the entire national annual economy. FDA employs a total of 13,586 regulators and an anticipated increase for 2011 of 1,251 more in an a-typical move by the Obama administration at cost cutting and reducing the size of government. After all the new budget by the President is only $ 1.6 trillion larger than last year, making me speculate if Obama has immediate plans to outdo King Louis the XVI with possibly the same outcome? The FDA is part of HHS deriving its power from Sec. 361 of the Public Health Service Act. The FDA is an outgrowth of the Bureau of Chemistry [1901-1927 USA Established in 1862] The projected budget for the FDA for 2011 is $4.03 billions, reflecting a 6.0% increase over 2010. In 1990, the budget for FDA was a mere $601 million. Some new budgeted items include massive expansion into new regions of regulating, including small family farm stands, individual holistic medicine, vitamin supplements, medical instrument expansion, and regulation of products that have safely been on the market for over 100 years. The verified by this author fact, that there are 18 federal agencies that has overlapping food safety programs totaling over $62.5 billions has not been considerd in budgetary discussions. HHS, FDA, and the Dep. of Agriculture, as well as many food safety groups, among other agencies prosecute food safety.
In general terms, to understand the Obama’s Nanny State plans we see that it began in 1932 with FDR, scaled down to 1940 due to the war and came into its own in the mid 50’s. From 1954 to 2009 the per capita fixed dollar expenditure on state welfare spending is 18.6 times what it was in 1954. It is doubling about every 18 years. This does not include HHS or the FDA it is only direct pay out programs to citizens or on behalf of citizens. It is of course the primary reason for the dramatic increase in medicine, and medical procedures naturally along with Obamacare, another cause for alarm.

America has become the ultimate Nanny State, the land of special interests, the nation of group rights, and the home of double standards. So if the FDA lies to us, it simply an error, but if we lie to the FDA, it’s a crime. If we’re Caucasian males we are automatically racists, but if we’re Black, Jews or Hispanics we are incapable of violating white rights.

Public opinion on the FDA is uniform in that over 80% of the people believe that the pharmaceutical industry has undue influence on FDA policy relating to drugs, food, as well as testing (1). This is certainly borne up by facts as outlined later in this essay. 60% of Americans think that doctors and scientists who have investments in pharmaceutical companies should not be allowed on “FDA advisory boards” which they do paying out hundreds of thousands of dollars to such people. (2) There is overwhelming opposition, almost unanimous, to FDA incursion into regulating vitamins, food supplements, and farm stands. There are scores of regulatory foul-ups; we will only list some of the most egregious.

All cases as reported here see their prices at unconscionable costs from between 500%to many thousands percent higher than Europe and Canada, where the FDA has no access. Our society is being driven to bankruptcy due to the cozy relationship between the pharmaceutical industries and the FDA.

Some examples of this are:
Drug Quant. Potency USA EU Can.
Augmentin 12 500 mg 55.50 8.70 12.00
Coumadin * 100 5 mg 64.80 15.00 24.00
Pravachol 28 10 mg 85.60 20.00 40.00
Prozac 20 20 mg 91.80 18.00 20.00
Zocor 28 10 mg 123.00 28.00 45.00
All prices converted to US Dollars * rat poison

Profit margins by percent:
Drug Profit Margin
Celebrex 22% X 10 5th power
Norvasc 134% X 10 5th power
Prozac 255% X 10 5th power
Xanax 570% X 10 5th power

Genital Herpes is a virus suffered by 20% of the women 14 to 49 years of age in America; there is an assumption that 80% of the cases remain unreported. It is not unrealistic to call it an epidemic. The primary treatment for this malady is Valacyolovir ® (Valtrex ®) it previously sold for $ 3.00 per tablet. It is now $ 7.40per tablet and the generic product is almost the same price. Since it must be administered daily the annual cost is about $ 2,400.00. The actual cost of making Valtrex ® for a thirty day supply is 0,60 cents. Total production cost may be assumed to be about $2.10 for 30 tablets of 500-mg. producing an obscene profit margin of 9,523%. All this came about because the FDA grated certain specific rights to the produces of Valtrex after the patents ran out. (3)

Gouty arthritis is a common illness. It has been treated with Colchicine since the 19th century its origin as a treatment goes back 3,000 years. Never mind all that, the FDA had to get a rake off, so they instituted a totally unnecessary three-year study relating the efficiency and safety of it. This would be about akin to testing salt. The study by NIH gave the testing companies certain special rights to produce the drug. The net outcome was a 50-fold price increase and an additional burdens to the taxpayers in the form of an increase to Medicare and Medicaid of $49 million a mere 5,000%.

The FDA is an out of control arm of government that must be reigned in. Healthcare costs even without Obamacare are totally out of control. The reason is the FDA. Healthcare costs are rising at exponential rates that exceed the rate of inflation at over 400%. This agency through it inordinate regulatory powers is causing all medical costs to skyrocket. If you have employer based healthcare coverage his costs have risen by 100% in the last ten years (4) Healthcare costs are crushing Small Business according to the Wall Street Journal. In the public sector states that guaranteed workers 100% healthcare coverage are going bankrupt. Worse yet is the fact that the pharmaceutical industry has seen fit to increase prices by 9.1% for pharmaceuticals and 11.5% for biotech products in a downturn economy not based on costs, just greed. What the FDA in fact is, is an insulator and protector of pharmaceutical manufacturers, guaranteeing their unheard of profit margins for the rerun favor of political contributions, kick back schemes to advertise the benefits of Obamacare, and the continued expansion of their power and growth.

(1) Natural News
(2) Consumer Report
(3) Life Extension Foundation
(4) Commonwealth fund

Dr. Krieg’s books are available from Northern Voice.


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