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ISBN: 091638604X

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The Controlled Clinical Trial: An Analysis

by Harris L. Coulter, Ph.D.

In THE CONTROLLED CLINICAL TRIAL: AN ANALYSIS, Harris Coulter, author of DIVIDED LEGACY: A HISTORY OF THE SCHISM IN MEDICAL THOUGHT and DPT: A SHOT IN THE DARK, critically examines the usefulness of randomised clinical trials. His thorough research, based almost exclusively on medical literature, reveals why the "controlled clinical trial" (CCT) cannot guarantee drug safety and efficacy.

Coulter argues that while allopaths talk pompously about this so-called "gold standard" of medicine, no controlled clinical trial matching the textbook definition has ever been performed. "Because the theoretical requirements are unrealistic and unscientific. How can you test a drug on 12 or 100 or 1,000 identical or 'homogenous' people all with the same thing wrong with them? Allopaths can't even find five homogenous patients. You'll always find things that are different between people, because we are all chemically, physically, structurally, and emotionally unique. The CCT can never tell a doctor how a given patient will react to a given drug at any given time. The findings from the so-called controlled clinical trial are useless in one-on-one doctor patient interactions."



THE CONTROLLED CLINICAL TRIAL not only investigates the science behind the CCT, but also delves into its history and politics. According to Coulter, the CCT has become popular primarily for political reasons. "It's used as a stick to beat alternative medicine with for failing to perform these trials. Since these trials are very expensive it costs about $200 million today to get a new drug on the market the controlled clinical trial is really an instrument for limiting competition in medicine, and for raising the costs of medicines to the public."

He asserts that monopolistic objectives are not the only built-in fraud feature of the CCT. Fraud in safety testing of drugs is a strong likelihood. The clinical investigator is paid enormous sums of money by the very manufacturer of the drug, and financial temptation to perform dishonest trials is strong. It's a very lucrative business - many of them receive more than $1 million annually from their testing programs. Coulter dedicates a chapter of the book to demonstrate the extent of fraudulent drug testing. "Frightful examples of dishonesty, fraud, negligence, and other kinds of wrongdoing in clinical trials have been staple fare for readers of the [US] daily press since the 1970s, when Congressional committees and subcommittees renewed their interest in the topic." One typical example cited is that in the United States in 1976 the General Accounting Office found that trials of a drug designed to prevent rejection of kidney transplants had led to 85 deaths in the 650 patients participating, and not one of these deaths was reported to the Food and Drug Administration.

Senator Edward Kennedy, conducting a Hearing of the Senate Health Subcommittee, noted that if only 10% of the data from ongoing clinical trials is defective, the problem is enormous. "When you consider the potential cumulative effect of faulty animal data coupled with faulty human data, you have the elements of a regulatory nightmare."

While Coulter doesn't dismiss the CCT outright - saying that if it's properly conducted it may have some role - he offers an alternative that helps overcome the problem of biological and physiological differences among patients.


A solid book for the researchers, March 16, 2001
Reviewer: "carminepl" (Barquisimeto, Venezuela) - See all my reviews

As his author himself has stated, this book is now out ofprint. As a researcher, I think this book is very useful, particularly to those who are just beginning their path in clinical trials; the book contains abundant information, as well as practical examples that make it easy to comprehend the basis of this kind of study; I think the chapter on sample size ism an especially interesting reading. In my opinion, this book deserves (and needs) a second edition, one in which some of the innovations could be included and some gaps could be filled; maybe a chapter about meta-analyses might be added.