FDA and pharma investors

[Turbineguy]

My friend invests heavily in bio-pharma companies. He has done fairly well at it and passes along a hot tip from time to time.

But for me, watching the republican controlled government I have to wonder. Is there any evidence that politics and insider profits are dictating FDA drug approvals (or dis-approvals)? Stock prices skyrocket or tank on these things.

Supposedly people who work in these agencies cannot have conflicts. But "Conflict of Interest" is the Bush Administration's middle name.

[HysteryDiagnosis]

1. Seen this.... it's good to know about.... no conflicts here I hope....

http://www.worstpills.org/public/page.cfm?op_id=5
#
At least 16,000 injuries from auto crashes each year involving older drivers are attributable to the use of psychoactive drugs, specifically benzodiazepines and tricyclic antidepressants.4 Psychoactive drugs are those that affect the mind or behavior. (See list of drugs that can cause automobile accidents.)
#
Each year 32,000 older adults suffer from hip fractures—contributing to more than 1,500 deaths—attributable to drug-induced falls.5, 6 In one study, the main categories of drugs responsible for the falls leading to hip fractures were sleeping pills and minor tranquilizers (30%), antipsychotic drugs (52%), and antidepressants (17%). All of these categories of drugs are often prescribed unnecessarily, especially in older adults. (See section on sleeping pills and tranquilizers, antipsychotic drugs, and antidepressants.) The in-hospital death rate for hip fractures in older adults is 4.9%.7 Multiplying this times the 32,000 hip fractures a year in older adults attributable to drug-induced falls, 1,568 older adults die each year from adverse drug reactions that cause hip fractures. (See list of drugs that can cause hip fractures because of drug-induced falls)
# Approximately 163,000 older Americans suffer from serious mental impairment (memory loss, dementia) either caused or worsened by drugs.8, 9 In a study in the state of Washington, in 46% of the patients with drug-induced mental impairment, the problem was caused by minor tranquilizers or sleeping pills; in 14%, by high blood pressure drugs; and in 11%, by antipsychotic drugs. (See list of drugs that can cause or worsen dementia.)

[Celebration]

2. this is just a guess

Most large pharmaceutical companies are now marketing rather than research companies. They way they get new products are to buy smaller biotech firms with promising products. In this endeavor they are aided by the FDA who put way more obstacles in the way of drug approval for smaller companies than for larger companies. When the small companies run out of money, and need investors, the price is kept low by the delaying tactics of the FDA.

It might be hard to prove actual complicity with various products, but do some reading about David Graham of the FDA, and his whistle blowing about Vioxx.

http://www.forbes.com/sciencesandmedicine/2004/12/13/cx_mh_1213faceoftheyear.html

The FDA, he said, had ignored warnings that the pain pill Vioxx was killing people by causing heart attacks and strokes--and he said the agency was incapable of defending the public against another drug disaster. "I could have given a very mealy-mouthed statement," says David Graham, the scientist. "But then I would have been part of the problem."

For his steadfast advocacy of drug safety and his willingness to blow the whistle on his bosses, we're naming David Graham our Face of the Year.

Without Graham, the Vioxx debacle might have been seen as an isolated event. But because he was willing to step into the spotlight, the withdrawal of Vioxx from the market looks like part of a systemic failure to properly weigh the risks and benefits of drugs. To hear Graham tell it, this is part of a systemic failure to address drug safety on the part of the FDA, a story that reaches back over the entirety of his 20-year career at the agency. That could kick-start a broad debate over what risks we're willing to take every time we swallow pills. In the long run, change would be good for regulators and drug companies.

[HysteryDiagnosis]

3. A priceless book for those who have no idea

http://www.lef.org/magazine/mag2000/july2000_review.html



LE Magazine July 2000


REVIEW
image

by Ross Pelton, R. Ph., PhD., CCN
James B. Lavalle, R. Ph.
Ernest B. Hawkins, R. Ph.
Daniel L. Krinsky, R. Ph.
Lexi-Comp, Inc. 1999
Soft Cover, 485 pages

Drugs That Deplete-
Nutrients That Heal
A review of Drug-Induced Nutrient Depletion Handbook, 1999-2000

by Ivy Greenwell

Ross Pelton and three other pharmacists with a holistic orientation have given us a valuable gift: a reference guide that lists not only the common side effects of various widely used drugs, but also the nutrients that these drugs deplete, whether by interfering with absorption, or by inhibiting transport or metabolism.

The knowledge that long-term use of many drugs leads to nutritional deficiencies of specific nutrients is not new; it has been documented by a large number of studies done over the last three decades. And yet this information is not generally communicated to the patients taking these drugs. In the case of the elderly, who are already likely to suffer from nutritional deficiencies, the ravages of the multiple drugs typically prescribed for aging-related diseases could lead to serious consequences. In addition, the elderly are more likely to use non-prescription drugs such as non-steroidal anti-inflammatories or antacids. Generally, they are completely unaware that these might make them deficient in calcium, phosphorus, folic acid and iron.