FOR IMMEDIATE RELEASE
Orthomolecular Medicine News Service, November 5, 2008

Rigged Trials: Drug Studies Favor The Manufacturer

by Andrew W. Saul

(OMNS, November 5, 2008) If you have often suspected that drug studies are rigged by the pharmaceutical manufacturer, you are right. "Drug studies skewed toward study sponsors," reported The Washington Post. (1) "Industry-funded research often favors patent-holders, study finds." Specifically, the American Journal of Psychiatry study authors said, "In 90% of the studies, the reported overall outcome was in favor of the sponsor's drug. . . On the basis of these contrasting findings in head-to-head trials, it appears that whichever company sponsors the trial produces the better antipsychotic drug." (2)

Marcia Angell, MD, former editor-in-chief of the New England Journal of Medicine, agrees. "Is there some way (drug) companies can rig clinical trials to make their drugs look better than they are? Unfortunately, the answer is yes. Trials can be rigged in a dozen ways, and it happens all the time." One "way to load the dice," she writes, "is to enroll only young subjects in trials, even if the drugs being tested are meant to be used mainly in older people. Because young people generally experience fewer side effects, drugs will look safer." Another of the "common ways to bias trials is to present only part of the data - the part that makes the product look good - and ignore the rest." She adds, "The most dramatic form of bias is out-and-out suppression of negative results." (3)

You will rarely hear academia complain. Why? Because they are aboard the gravy train. Dr. Angell: "Columbia University, which patented the technology used in the manufacture of Epogen and Cerezyme, collected nearly $300 million in royalties" in 17 years. "The patent was based on NIH-funded research." That means you, the taxpayer, footed the bill. Harvard is in just as deep. In its own Faustian dealings with the drug companies, "a Harvard hospital has a deal that gives Novartis rights to discoveries that lead to new cancer drugs. . . Merck is building a twelve-story research facility next door to Harvard Medical School . . . In Harvard Medical School 's Dean's Report for 2003-4, the list of benefactors included about a dozen of the largest drug companies."

Clearly drug companies are more concerned with profits than with patients. The psychiatric drug market is a very big business. American doctors prescribe $10 billion worth of antipsychotic drugs every single year. The pharmaceutical industry, says Angell, is "primarily a marketing machine to sell drugs of dubious benefit." Big pharma is "taking us for a ride." And it is no mere jaunt around the park. Total drug industry worldwide sales are in excess of $500 billion per year, half of which are in North America. Profit margins are typically 20 per cent, so high that "the combined profits for the ten drug companies in the Fortune 500 were more than the profits for all the other 490 businesses put together."

But more cash does not buy more cures. In fact, said the Washington Post: "When the federal government recently compared a broader range of drugs in typical schizophrenia patients in a lengthy trial, the two medications that stood out were cheaper drugs not under patent." (1) It gets even more interesting when we broaden our list of treatment options to include nutrition. With the therapeutic use of vitamin supplements, the cost goes down much further, and the success rate goes way up. Orthomolecular (nutritional) therapy, says psychiatrist Abram Hoffer, MD, PhD, is many times more effective than drug therapy. He says that niacin (vitamin B-3) in sufficiently high doses is the most effective, least expensive, and safest treatment for schizophrenia and a number of other very serious mental illnesses. Hoffer and colleagues demonstrated this decades ago when, in the early 1950s, they successfully conducted the very first double-blind, placebo-controlled nutritional studies in the history of psychiatry. (4)

Niacin is a clinically proven therapy for serious mental illness, and yet the medical profession has delayed endorsing it for over fifty years. Instead, drug treatments dominate. But drugs are not doing the job. A double-blind study of schizophrenics showed that three-quarters of them stopped taking pharmaceutical medication either because of intolerability or inefficacy. That means that either the drug side effects were unbearable, or the drug just plain did not work. (5)

Perhaps drugs are not the answer because mental illness is not caused by drug deficiency. But much illness, especially mental illness, may indeed be caused by nutrient deficiency or nutrient dependency. Only nutrients can correct this problem. This not only makes sense, it has stood up to clinical trial again and again. (6) Vitamins like niacin are cheap, safe and effective. Modern "wonder drugs" are none of those. But they do make money. Especially when the drug makers control the research, the advertising, and the doctors. No wonder which approach you've heard more about.

We've all been carefully taught that drugs cure illness, not vitamins. The system is remarkably well-entrenched. 2.3 million Americans per year serve as human subjects for pharmaceutical company drug testing. Pharmaceutical companies set up patient support or advocacy groups to attract specific subjects for their clinical trials. Doctors are paid an average of $7,000 per patient for every patient they enroll in a drug study. Drug companies pay nearly two-thirds of the costs of continuing medical education. While the pharmaceutical industry's reach into education is bad enough, its grip on research is scandalous. For example: Drug company "publications strategies" have them "sponsor minimal research, prepare journal articles based on it, and pay academic researchers to put their names on those articles." So bad is it that Dr. Angell wrote an editorial in NEJM (7) entitled "Is Academic Medicine for Sale?" A reader wryly responded, "No. The current owner is very happy with it."

The result? "Bias is now rampant in drug trials. . . (Pharmaceutical) industry-sponsored research was nearly four times as likely to be favorable to the company's product as NIH-sponsored research." (3) Remember, "NIH-sponsored" means "taxpayer-funded." And then, when they need to use a drug, those same taxpayers pay again, and way too much, for the drug they already paid out grant money to develop, in a rigged trial, for a high-profit company.

What a sweet system for the pharmaceutical industry.

References:

(1) Drug studies skewed toward study sponsors. Industry-funded research often favors patent-holders, study finds. Vedantam S. The Washington Post, April 11, 2006. http://www.msnbc.msn.com/id/12275329/from/RS.5/

(2) Heres S, Davis J , Maino K, et al. Why Olanzapine Beats Risperidone, Risperidone Beats Quetiapine, and Quetiapine Beats Olanzapine: An Exploratory Analysis of Head-to-Head Comparison Studies of Second-Generation Antipsychotics. Am J Psychiatry 163:185-194, February 2006. http://ajp.psychiatryonline.org/cgi/content/full/163/2/185

(3) Angell M. The Truth about the Drug Companies. NY: Random House, 2004.

(4) Hoffer A. Healing Schizophrenia. Complementary Vitamin & Drug Treatments. Ontario: CCNM Press (2004). ISBN-10: 1897025084; ISBN-13: 978-1897025086. Also: Vitamin B-3 and Schizophrenia: Discovery, Recovery, Controversy, by Abram Hoffer, MD. Quarry Press, Kingston, Ontario Canada (1998) ISBN 1-55082-079-6. Reviewed at http://www.doctoryourself.com/review_hoffer_B3.html

List of publications by Abram Hoffer: http://www.doctoryourself.com/biblio_hoffer.html

(5) Stroup TS, Lieberman JA, McEvoy JP et al. Effectiveness of olanzapine, quetiapine, risperidone, and ziprasidone in patients with chronic schizophrenia following discontinuation of a previous atypical antipsychotic. Am J Psychiatry. 2006 Apr;163(4):611-22. See also: Stroup TS, McEvoy JP, Swartz MS et al. The National Institute of Mental Health Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) project: schizophrenia trial design and protocol development. Schizophr Bull. 2003;29(1):15-31.

(6) For free access to peer-reviewed nutrition therapy journal articles: http://orthomolecular.org/library/jom

(7) Angell M. Is academic medicine for sale? N Engl J Med. 2000 May 18;342(20):1516-8.

Nutritional Medicine is Orthomolecular Medicine

Orthomolecular medicine uses safe, effective nutritional therapy to fight illness. For more information: http://www.orthomolecular.org

The peer-reviewed Orthomolecular Medicine News Service is a non-profit and non-commercial informational resource.

Editorial Review Board:

Damien Downing, M.D.
Steve Hickey, Ph.D.
Abram Hoffer, M.D., Ph.D.
James A. Jackson, PhD
Bo H. Jonsson, MD, Ph.D
Thomas Levy, M.D., J.D.
Erik Paterson, M.D.
Gert E. Shuitemaker, Ph.D.

Andrew W. Saul, Ph.D., Editor and contact person. Email: omns@orthomolecular.org