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Fiction And Fantasy In Medical Research: The large scale randomised trial [Paperback]

James Penston
4.0 out of 5 stars  See all reviews (2 customer reviews)
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Book Description

27 Jun 2003 0954463617 978-0954463618
Fiction and Fantasy in Medical Research: The Large-Scale Randomised Trial Every day, millions of patients around the world take medication based on the results of large-scale randomised trials. This method of testing the efficacy of new drugs is widely accepted as the gold standard of medical research. But is this accolade deserved? Fiction and Fantasy in Medical Research subjects the large-scale randomised trial to scrutiny and finds it to be seriously flawed. The best that may be said for these studies is that they merely demonstrate a trivial benefit to patients. But, given the lack of any sound foundation for the methodology, even such modest claims have to be questioned. On the basis of the results of these studies, more than 95% of patients receiving long-term treatment with lipid lowering drugs obtain no benefit whatsoever; of every ?1 million pounds spent on these drugs, more than ?950,000 is wasted. If, as is argued, the methodology is flawed, then these estimates exaggerate the possible benefits of treatment. Yet, the drugs continue to be widely prescribed, exposing patients over long periods of time to the risk of side-effects. This critical appraisal of the large-scale randomised trial raises fundamental issues. How is it that a flawed methodology is so readily embraced by all involved in the delivery of health care? To what extent are those with a vested interest able to influence the outcome of these studies? And what are the ethical implications of treating patients on the basis of such dubious data? The answers to these and many other questions make uncomfortable reading for the advocates of the large-scale randomised trial currently involved in clinical research.

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Product details

  • Paperback: 144 pages
  • Publisher: The London Press (27 Jun 2003)
  • Language: English
  • ISBN-10: 0954463617
  • ISBN-13: 978-0954463618
  • Product Dimensions: 24 x 16 x 1 cm
  • Average Customer Review: 4.0 out of 5 stars  See all reviews (2 customer reviews)
  • Amazon Bestsellers Rank: 1,235,880 in Books (See Top 100 in Books)

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6 of 6 people found the following review helpful
4.0 out of 5 stars One side of the argument clearly stated. 22 Feb 2011
Format:Paperback|Verified Purchase
The author's synopsis is a very fair account of his book. As he says in his introduction, most medical scientists and statisticians consider the Randomised Controlled Trial to be the "gold standard" when comparing the effectiveness of treatments. All of the textbooks on the subject make it very clear that the results are only valid when all of the necessary safeguards are observed, and experience with young medics has shown that those conditions are often ignored.

Penston's book sets out very clearly all of the possible failure points in clinical trials, but instead of following the conventional line that they should be conducted more carefully, he argues that in large trials it is almost impossible to fulfil all of the conditions, and so small apparent treatment improvements may not be genuine. He also argues that mass medication which benefits only 5% of those taking is wasting money and risking side-effects in the other 95%. Researchers should try to identify the 5% who might benefit, so that only they would take the medicine.

His book is very clearly written. After extensive experience with the conventional methods I first read it as a bit of a rave, but after reading it again after plenty of time to think, I see it as a critique which every researcher in the field should read - even if they don't end up agreeing with Penston. Although Penston rejects the argument that there are no alternatives to conventional trials, he does not offer any convincing ones.

Anyone who has read the conventional books about clinical trials should read it - BUT, if you are only going to read one book on the subject, don't choose this one! It would be a mistake for a jury after hearing a devastating speech for the prosecution to immediately conclude guilt without first hearing the defence, which might be even more convincing.
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3 of 3 people found the following review helpful
Format:Paperback
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 facade 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 aging, 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.
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Amazon.com: 4.0 out of 5 stars  4 reviews
5 of 5 people found the following review helpful
4.0 out of 5 stars Randomized trials aren't what they're cracked up to be 11 July 2011
By Mira de Vries - Published on Amazon.com
Format:Paperback
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 facade 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 aging, 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.

Copyright MeTZelf
4 of 5 people found the following review helpful
4.0 out of 5 stars A Useful Introduction 4 April 2006
By J. Treasure - Published on Amazon.com
Format:Paperback
This little text is an excellent introduction to the problematic "metaphysical" assumptions underlying large scale randomized clinical trials.(RCT's) The author nicely summarizes David Hume's philosophy of causality and includes some trenchant methodological criticisms of RCTs. Despite its apparent "philosophical" tone, this text is a very practical resource for patients challenged with decisions about treatment options ostensibly governed by available and conflicting clinical trial data.
2 of 3 people found the following review helpful
5.0 out of 5 stars Easy to underestimate - a very good book 10 April 2010
By Bruce_in_LA - Published on Amazon.com
Format:Paperback|Verified Purchase
This is a very smoothly written, fairly short book, that deserves broader recognition. The author describes major problems with "mega" RCTs. I recently wrote a publication on evidence based medicine, and I wish I had found this book a few weeks earlier, as I would have cited it. Those who like this book may enjoy medical pubicatios by Worrall, Cartright, and others.
The short form of Penston's arguments is found in a medical journal at: Med Hypotheses. 2005;64(3):651-7.
"The London Press" is essentially a self-published book, hence it did not find its way into many bookstores or reviews. But it deserves attention and I very glad it is in print. Since sales are probably very low, perhaps the author ought to *both* leave it in its current, self-published form at sites like Amazon, but also offer it as a pdf ebook somewhere. Those with a passing curiousity could see the ebook and be impressed, while those who really want to add to their library would still buy it just the same for reference on the shelf.
1 of 9 people found the following review helpful
3.0 out of 5 stars A reasonably good read 16 Sep 2003
By Mark Lewis - Published on Amazon.com
Format:Paperback
This book is a reasonably good read, it covers the mani aspects and I did enjoy certain parts of it. I felt it could have gone into more details at other points.
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