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  “Testing Treatments: Better Research for Better healthcare” Imogen Evans, Hazel Thornton & Iain Chalmers
  By Michael Baum | Published Wednesday 30 January 2008


Michael Baum


View all articles by Michael Baum 
Book Review


In 1969, nearly 40 years ago, I helped design, recruit and launch the first multi-centre randomized controlled trial of Breast Cancer treatment in the UK. This was known as the Kings/Cambridge or Cancer Research Campaign 1 for the treatment of breast cancer. In this simple pragmatic trial, we compared mastectomy with or without radiotherapy for early breast cancer. It was also the first trial that I know about that seriously considered statistical power up front, leading to the recruitment of over 3,000 patients, a record that stood for over a decade. From this study we learnt as the data matured, that radiotherapy controlled local relapse and to a small extent impacted on breast cancer specific mortality but at the cost of excess cardiac mortality from ischaemic heart disease. These were unexpected findings that illustrate the beauty of the RCT to teach you something you might not have predicted.

However on looking back we were a bunch of amateurs. There was no proper infrastructure, records were lost and randomization was compromised because the brown envelopes used for achieving random allocation were subverted by clinicians who had elected to make “personal choices” on behalf of their patients. Furthermore the ideas about informed consent were not yet fully developed and this trial would never have passed the scrutiny of today’s ethics committees. In fact there were no ethics committees (IRB) in those days that I can recall.

The next trial of importance that I was involved in was the NATO trial that stated recruiting in 1977. This was the first trial to demonstrate the survival advantage of adjuvant tamoxifen. This trial was nearly scuppered along with my personal career, by a mischievous journalist and a “patient” advocate who accused me of human experimentation. I was even likened to a Nazi war criminal on a televised debate with a self-styled medical ethicist.

The third important study I want to mention is the CRC breast conservation trial. This was launched in 1981 shortly after I established the first professionally run clinical trials centre at Kings College School of Medicine and Dentistry. We also had the first lay member on a trial steering committee and a full formal description of the trial and its ethical underpinning was published in the BMJ. At last all the pieces were in place but that trial was a complete flop and had to be abandoned after three years when only 150 patients had been accrued. Yet ironically during that three year period thousands of women were being treated either by a mastectomy that we now know is over-treatment or by breast conserving techniques that were of unproven safety.

Well we’ve come a long way since then. In the last 25 years we’ve witnessed a revolution in the affairs of testing treatments. RCTs are all now run out of clinical trial centres with professional input from coordinators and statisticians. Several thousand in a trial are the norm rather than the exception. The National Cancer Research Networks in the UK are funded and committed to increasing recruitment into RCTs. RCTs are now seen as the best way of providing treatment whenever possible and specialist units are audited on their contribution. Finally lay activists are in the front line promoting RCTs in the name of their enlightened self-interest. How and why this all came about is the topic of the slim and attractive book, “Testing treatments”.

I couldn’t have hand picked a better triad of authors for a book of this nature if I had tried. Imogen Evans worked with the Lancet from 1984 until 1996 and then with the Medical Research Council until 2005 and has represented the UK government on the Council of Europe Biomedical Ethics Committee. My old friend Hazel Thornton, is a lay advocate of RCTs, a survivor of screen detected DCIS with a CV of publications on the ethics and conduct of RCTs that would be the envy of any senior academic. Sir Iain Chalmers, the third author, almost needs no introduction. He originally achieved distinction as director of the National Perinatal Epidemiology Unit and then went on to direct the UK Cochrane centre.

The book is extremely accessible and entertaining. The informative text is broken up with amusing anecdotes, historical vignettes and aphorisms in boxed inserts and each chapter concludes with a list of key points as an aide memoire. In other words a subject that might at first glance appear rather stuffy and scholarly is presented almost as an entertainment. I hope like me future readers will enjoy a sense of righteous indignation about the false beliefs and fallacies of the not so distant past that often ruined the lives as a result of unexpected and unrecognized toxicities. The second chapter has a very topical side-swipe against untested screening interventions just at the time our prime minister has launched an evidence-free new initiative on screening and prevention of disease. However for the serious student of the subject most of the book is an elegantly simple description on the how and the why of RCTs and an aid to their interpretation. Testing treatments in real life is everybody’s business and the understanding of what represents evidence should be taught in schools. Failing that the lay public will not be able to differentiate the siren appeal of alternative medicine from the ever-expanding field of evidence based medicine (EBM) that has depended on recent generations selflessly volunteering for RCTs. To ignore EBM is both foolish and ungrateful. Sadly at the time I’m writing this I’ve also been tasked with reading and reviewing another book, “Suckers” by Rose Shapiro, which traces the relentless rise of quackery over the very same period of time that EBM has flowered. It breaks my heart that according to some of our political leaders, some of our Royal household, many celebrities and many young doctors, alternative medicine should enjoy equal status in the NHS as scientific medicine that is based on proper testing. I hope this book becomes a standard undergraduate text. That may to some extent stop the rot. It would also be a good idea to send free copies to some of those high profile personages who are trying to subvert the practice of rational health care by promoting neo-Galenism, ancient Eastern mysticism and witchcraft in its place.

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