Vol. 30 October 1 ,2010 Fake Pharma and Terror Pharma

October 1, 2010

If, by chance, you are one of those people who ordered some excellently priced prescription drugs from a slick, clean, multi-colored Canadian website (without having to submit a prescription, of course), and then received, a number of days later, a plain brown package postmarked from India, you MAY have received counterfeit drugs.
You may never know.
Neither may the FDA.

The FDA did discover in June of 2010 that some Tamiflu (an anti-flu drug in great demand at the time) postmarked from India was really cloxacillin (an anti-staph drug unrelated to influenza).

  • Estimate of the world market for all types of counterfeit drugs: $75 Billion annually

The yearly appropriation to the FDA is $2.5 billion, or $8 per person per year. That is what the FDA has to safeguard us from harmful or ineffectual prescription drugs. Congress never actually authorizes (“allows the checks to be written”) that much money and a shortfall of about $600 million each year is made up by collecting “user fees” from pharmaceutical companies making new applications for drug approval. Before you jump to the conclusion that this is too cozy a situation, “the hens are paying the fox”, you should know that Big Pharma complains that “sponsors of new applications have had to triple the time taken to respond to FDA inquiries.”

Counterfeit hypertension drugs might make themselves known eventually as your blood pressure climbs, assuming that someone is checking it regularly. Counterfeit diabetes control drugs might declare themselves sooner than that. A kilogram of Viagra can be bought in China for about $60 which when converted into 25 mg. tablets of Viagra is worth $200,000 in the U.S. Counterfeit Viagra, Levitra, Cialis, and the like would probably be the quickest to be unmasked as fake. Maybe they should add an additional warning to the drug ads,

. “If your erection lasts more than four hours, call your physician.
. If it lasts less than four minutes, call the FDA.”

Of course, that may not be true since the literature is now full of papers about the powerful effects of placebo. “If you think you took Viagra, you may be able to act like you did.” That would be a fun study for T. Kaptchuk to do; “Placebo Effect on Penile Erection Compared to Viagra and Fake Viagra; a survey of 100 middle-aged Boston academics”.

There are six pharmacies that are approved by the National Association of Boards of Pharmacy to provide drugs on the internet. One way to make sure you are getting what you have asked for on the Web is to use one of those.

Botox is an apparent favorite for counterfeit drug sellers. In 2006 a “naturopathic” doctor in Colorado pleaded guilty and was sentenced to 9 years in prison for selling $1.5 million of “fake Botox” to doctors across the U.S. There are no less than 20 companies from China selling “botox” on the web. Russia and India are the two next largest suppliers.

Botox is made from botulinum toxin , a powerful neurotoxic agent that was actually developed as an “orphan drug” in 1959. “Orphan drugs” are agents developed for patients with rare or unusual conditions and are subsidized by incentives from the U.S. government. It was approved for a small number of patients suffering from neck and facial muscle diseases in 1989. Its use soon extended to helping control spastic muscles in patients with cerebral palsy.

When its effect of erasing facial wrinkles by paralyzing the underlying muscles was discovered in 1992, its use literally exploded, first by plastic and ENT surgeons for “non-surgical” facelifts, and now, by just about anyone who wants to throw a living room”botox party”. In 2007 use of injectable botox was the most common cosmetic procedure (4.2 million/yr.) according to the American Society of Plastic Surgeons.

As a potent muscle paralytic in very small doses , and a lethal agent in larger doses, Botox is a potentially effective terrorist weapon due to its relatively easy manufacturing and availability through the internet.

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Vol. 22 June 1, 2010 Drugs, Tobacco, and Insurance

June 1, 2010

Tobacco is a drug.

Date that the Family Smoking Prevention and Tobacco Control Act gave the FDA extensive authority to regulate tobacco products: June 22, 2009

Date that the FDA regulated use of “modified-risk” words like “light”and “low tar” in cigarette advertising and banned candy- or fruit-flavored (but not menthol-flavored) cigarettes: June 22, 2010 (1)

Value of stocks in tobacco companies held by 7 health and life insurance companies: $ 4.5 Billion  (2)

Amount the drug company making Flomax (for prostate symptoms) spent in 2008 on direct advertising to consumers: $116 Million (3)

Per cent increase in price for Flomax in 2009 “anticipating health care reform”: 20% (4)

Year that the FDA was given authority to approve generic drugs (Waxman-Hatch Act): 1984

Per cent of prescriptions dispensed in U.S. in 2009 that are generic and per cent of total dollars spent on generic medications: 70% / 20% (5)

Number of years of patent protection and market exclusivity for new drugs under the 1984 Act:  5 and 5 years

Number of years of market exclusivity for biologics (like Herceptin, Epogen, Humira) under Health Care Reform Bill of 2010: 12

Number of registered drug-company lobbyists in Washington, D.C. for every member of Congress: 2 (6)

Per cent of U.S. military stockpiled drugs found in a FDA study to be perfectly safe and effective after their expired date: 90% (7)

Per cent of 17,000 retirees with a new diagnosis of hypertension and a higher co-pay ($15-20) that failed to fill their antihypertensive prescriptions: 55%

Per cent of the same group with a lower co-pay ($5) that failed to fill their prescription: 40% (8)

Per cent of patients in health plans that had NO co-pay for medications that did not adhere to their lipid-lowering prescription instructions: 40% (9)

Per cent increase in “abandoned prescriptions” (prescriptions submitted but never picked up) from 2006 to 2008: +34% (10)

References:

1. NEJM 362:19, May 13, 2010, p.1753
2. NEJM 360:23, p.2483
3. Consumer Reports, Dec. 2009 (from Nielson Media Research)
4. AARP Bulletin, Jan-Feb 2010, Patricia Berry
5 .NEJM 361;20, p.1917
6. Harper’s Index, November 2009, (from Open Secrets. com)
7.Wired, December 2009, p. 46
8. Arch Int Med 169:740, Apr 27, 2009
9. Circulation 2009;119:390-7
10. Wolters Kluwer Health 2009 survey in Philadelphia, AARP Bulletin, Oct 2009, p.10


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