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Fiction and Fantasy in Medical Research

The Large-Scale Randomised Trial

by
James Penston
2003

Reviewed by Mira de Vries

Small books can have great messages. This one exposes in its few pages the pharmaceutical fraud governing our bodies and minds.

Large-scale randomized trials fool professionals with their façade of scientific respectability, the author explains. They fail to satisfy the fundamental principles of science, namely that the objects under study are precisely definable, the variables identifiable, the results directly observable and consistent, the research replicable, and the predictions emanating from it reliable. These principles were already established by Francis Bacon four centuries ago. Bacon also warned us of bias, which causes researchers to focus on results that seem to confirm their proposed hypothesis while ignoring contradictory evidence. And Bacon surely hadn’t dreamed of the mega-profits that would be biasing pharmaceutical research in the 21st century!

Penston is no enemy of upfront pharmacology. Anesthetics for surgery, insulin, and antibiotics are examples of medicines that have an impressive record in helping to save lives. There is no need for large-scale randomized trials to investigate the benefits of these drugs, as their benefits are immediately apparent. However, many diseases and discomforts have proved resistant to medical researchers’ best efforts. There have, in fact, been few important pharmaceutical breakthroughs in the last half century.

Most of the conditions treated by drugs in over-developed societies are not acute life-threatening illnesses but vague complaints, the natural consequences of ageing, or even the test results of perfectly healthy people. In acute illness the patient either rapidly improves or dies. Both outcomes terminate the need for treatment. It is in the chronic categories mentioned above that the potential for the most humongous profits lie for the pharmaceutical industry. But how do you persuade doctors to prescribe medicines for such nebulous conditions, particularly when no benefit to the patient is discernable?

Whether or not originally designed for this purpose, large-scale randomized trials fit the bill. Because of their size, which includes thousands of words of text along with an array of tables and figures, they are highly susceptible to mystical statistical tricks, epitomized by the meaningless term “relative risk reduction.” The fallibility of the background theory is illustrated by one such mega-trial, which wound up recommending the drug under study for a different condition than it set out to. Furthermore, because of their dimensions, the trials cannot be controlled or replicated, and they easily conceal fraud. Rules set up for them by professional organizations or government watchdogs, which are always directly or indirectly funded by the pharmaceutical industry, only serve to further obscure the fuzziness of the research and protect it against criticism. Busy peer reviewers may base a recommendation for publication on the abstract, which often suggests conclusions not justifiable by the body of the paper. The only valid generalization that can be derived from these trials is that the test drug has no beneficial effect on 98% or more of the study population. Yet randomized trials remain stubbornly sacrosanct. Finding fault with them is taboo, unless the treatment under investigation is not a bonanza drug but less lucrative, such as prayer.

This book is understandable to even the less sophisticated lay reader, so it should also be understandable to physicians, who are widely credited with superior intelligence. I wonder how they have received it? Have they embraced it (we should be so lucky)? Have they marginalized and defamed its author as they do Szasz and Duesberg? Or do they ignore him and hope nobody will notice, like they do Mary Boyle?

As regarding most of the books I review, no matter how enthusiastically I endorse the author’s argument, the conclusions I draw from it are different from his. Penston is a physician. He fleetingly mentions that patients are misled, but his focus is not, as is MeTZelf’s, on the individual’s freedom and empowerment. Unsurprisingly, he is concerned with the ramifications for physicians. Guidelines based on these trials usurp the medical profession's power and dislodge physicians as the sole arbiters of their patients’ treatment, Penston laments. He is worried about the trend that other medical professionals increasingly perform services formerly reserved for qualified physicians, and fears the specter of litigation on the grounds that a doctor failed to comply with guidelines produced by panels of experts with ties to the pharmaceutical industry. He admits that medicine is the business of managing patients, and suggests that only the clinical experience of physicians justifies that role. But clinical experience is also fuzzy and unreplicable.

The author does not question the state’s licensing of drugs, nor its investing in physicians the power to forbid, advise, and even compel an individual to take them, on the premise that most of us are too stupid or ignorant to regulate our own drug use. Surely the non-existent science illuminating the decisions of those supposedly wiser than ourselves, as the author argues so well, exposes the folly of the state's interfering with private decisions? Drug regulation resembles the obedience once demanded of us by priests and kings on the authority invested in them as appointees of The Mighty Creator Himself. At a certain point in history, most of humanity revolted against kings and abandoned allegiance to priests. However, as illustrated by a survey that Penston cites, people today continue to regard doctors as the most trustworthy of all professionals. As long as we live in parliamentary democracies (or some variation of them as in the US) rather than in free states, belief in Dr. Santa Claus will continue to erode our liberty and bring us closer to complete pharmacracy*.

*This term was coined by Thomas Szasz. He was referring to the union of health care and state, rather than to rule by the pharmaceutical industry.

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