Ben Goldacre has done it again. In his previous book, “Bad Science,’’ Goldacre, a British physician and epidemiologist, made hash of much of the pseudoscience that attempts to pass itself off as a credible alternative to modern biomedicine. This time, in “Bad Pharma,’’ Goldacre turns his attention to an issue that has undermined the empirical scientific basis of biomedicine itself: the collusion of pharmaceutical companies, physicians, medical journals, governmental regulatory agencies, and medical schools in hiding and manipulating data about drug development and marketing.
Both have resulted in rendering much of what we think we know about what works and what doesn’t work in medicine not fully accurate, to put it mildly. It is heartbreaking to look at the professionals, organizations, and institutions who have been involved in this and to realize that these are precisely the ones you would have expected to rise above the opportunity to enrich themselves and to make all efforts to ensure that patients are treated with safe and effective medications.
“The book’’ Goldacre begins, “follows a simple trajectory,’’ starting with the notion that industry-sponsored studies tend to “flatter’’ the sponsor’s drug and then proceeds to look at how the positive trials are created, at the drug-discovery process, regulation, the “tricks’’ in “bad trials,’’ the marketing of drugs, and finally what can be done.
Goldacre identifies the overarching problem, first and foremost, as being one of missing data. Data from clinical trials that were never published but demonstrated that many of the medications being promoted as tomorrow’s blockbusters were no more effective — and often less so — than those already available. Data from post-marketing studies that revealed unexpected side effects from new drugs that had sickened and killed patients, but which companies delayed releasing for as long as they could. Data on the web of financial ties between industry, physicians, medical schools, and the very regulatory agencies who were supposed to be keeping the pharma-medical complex honest.
“[E]vidence in medicine is not an abstract academic preoccupation. Evidence is used to make real-world decisions, and when we are fed bad data, we make the wrong decision, inflicting unnecessary pain and suffering, and death, on people just like us,” writes Goldacre. And indeed, it is hard to read his exceedingly well-written and extensively researched account of how a lethal combination of greed and ambition, coupled with an absence of scruples, drove so many to conspire to manipulate the science from which biomedical practice derives, without sharing his outrage.
One of Goldacre’s most troubling conclusions is that repairing the damage would take much more than simply changing these unethical behaviors and standards of conduct from today onward. “[W]e need full disclosure, and I don’t say this out of some waffly notion of truth and reconciliation,” Gold-acre writes, and goes on to explain that the current practice of medicine is based, in part, upon some studies whose data were fudged, manipulated, and then presented in papers that appeared in some of the world’s most prestigious medical journals over decades. Undoing all this will require a huge review of current biomedical practice to figure out which ones need to be corrected because the data they are based upon are simply unreliable.
Goldacre is an exceptionally gifted writer: funny, sarcastic, occasionally caustic, and very thorough in his research. This is a very broad topic, which makes it difficult to condense into one volume, and yet he has succeeded in doing so in a persuasive and engaging manner. This is a morbidly fascinating and dispiriting account, yet one which deserves (and needs) to be read and acted upon without delay, if we are to be able not only to receive effective treatment when we need it, but also to believe that those who provide us that treatment actually know what they are doing.
Dennis Rosen, M.D., a pediatric lung and sleep specialist who practices in Boston, can be reached at dennis.rosen@child