Chasing Medical Miracles: The Promise and Perils of Clinical Trials

by Alex O'Meara

Journalist Alex O'Meara is one of the more than twenty million Americans enrolled in a clinical trial―three times as many people as a decade ago. Indeed, clinical trials have become a $24 billion industry that is reshaping every aspect of health-care development and delivery in the United States and around the world. As O'Meara chronicles, twentieth-century medical trials have led to epic advances in health care, from asthma inhalers and insulin pumps to heart valves and pacemakers. And yet, although regulations safeguard against grossly unethical tests, significant problems are still associated with how clinical trials are carried out and reported. For example, despite eight clinical trials for Vioxx before the FDA approved it in 1998 for use as a painkiller, Merck took it off the market in 2004, too late for the eighty-eight thousand Americans who suffered heart attacks while taking Vioxx and the thirty-eight thousand who died. Chasing Medical Miracles is the first book to give readers a behind-the-scenes look at the complicated world of clinical trials, revealing how a multibillion-dollar industry of private companies conducting them with little oversight has taken root and quietly become a major part of the American medical establishment. Whether you are participating in a clinical trial, considering that option, or interested in our medical system, Alex O'Meara's ground-breaking book is essential reading.

Genres: Science, Nonfiction

272 pages, Hardcover

First published July 1, 2009

Reviews

[David · Rating 4 out of 5]

very good, balanced overview of clinical trials (medical ones anyway -- doesn't discuss psychotherapy trials). Author does not focus much on the scientific aspects and did not apparently talk to many investigators, but the experience of subjects (including professional guinea pigs who make it a point to sign up for as many trials as possible to earn money)is highlighted.

Also describes very well recent trends and the issues they provoke, such as tendency to shop around for third world countries with less well-developed protections for subjects in order to conduct riskier trials more cheaply, the shift in location of the bulk of trials from universities to freestanding clinical research organizations, the distortions caused by selective publication of favorable results, etc.

Poignant final chapter on the author's own experience serving as a subject in a trial regarding islet cell transplanation [he has type 1 diabetes:]. It works only temporarily to free him from insulin dependence, and during the grueling regimen of testing, extra drugs he has to take, etc. his wife leaves him. Remarkably, he still sees the value [mostly to future advances in diabetes care:] of his participation.

[Joan · Rating 3 out of 5]

This book was written by a freelance journalist who was also a longtime diabetic and who participated in a clinical trial investigated the potential of islet cell transplantation in the treatment of diabetes. It provides a comprehensive review of many aspects of clinical trials, including ethical issues, financial issues, studies in Africa as well as his own experience as a subject. Although there are some details that are not completely in context, and some language may have a pejorative slant, the book is relatively balanced and makes very clear an important understanding - clinical trials are not the same as medical treatment.

I would encourage people who work in clinical research to read the book. It isn't a long book, and some of the details will be dismissed as ignorance of an 'outsider', but it may help us to do a better job in designing clinical trials and getting the details as far as the subjects right.

A couple amusing notes. Explaining the toxicology requirements for testing drugs in people, the authors states that tests must be done in 'two animals'. I'm sure it was an editorial change to remove the important word 'species'. Describing the experiences of a volunteer who had participated in several clinical trials, she had 'had a chunk of her right high removed for testing (?a chunk? or a skin biopsy?) and had more blood drawn than she can remember (compared to regular blood donors?)'.

The tedium of long (28 day) studies was well described as was the feeling of being a 'lab rat' on the part of volunteers participating in multiple assessments. It would have been a bit more balanced if the author had acknowledged that the assessments should be validated testing and not simply arbitrary testing and that interest or involvement of the researcher as a subject completes the assessments may bias the result itself. There is an excellent discussion on the differences of philosophy of placebo vs active control.

Although the author does quote review articles from medical literature, primarily the NEJM, he doesn't seem to read clinical trials themselves to examine the frequency of adherence to good clinical practice - which would have made his arguments stronger. The author also doesn't make clear that 'dispensing drugs after a clinical trial' in the US and EU is frequently within the context of yet another trial - but a safety trial rather than the original intervention.

[James · Rating 4 out of 5]

The author describes his participation in a cutting edge clinical trial.
Insulin producing cells from a dead person are infused into his liver and for several months work well.
Eventually they die off & he has to go back on insulin.

Lots of other info about clinical trials including some internet sites,
which may or may not still be active.

guineapigsgetpaid.net
guineapigzero.com
and clinicaltrials.gov

[Anita · Rating 2 out of 5]

This is interesting when he discusses his own experience in a medical trial on a cure for diabetes. It bogs down when he reports on medical trials in general. It did make me rethink joining them as I am currently on a shingles vaccine study. Elise, I think you might find this one interesting.

[Emily Tegen · Rating 2 out of 5]

This book I felt could have been better. I think I set my standards to high in starting this read, I was hoping the Medical Miracles were going to be crazy, life changing, "out of the box" clinical trials; like, the cure for cancer, AIDS and Alzheimers/Dementia. Oh well, someday.

[Patrick Henry]

not in the FCPL catalag

[Jill · Rating 3 out of 5]

Got a little insight into the industry I work in.