Saturday, May 18, 2013

Catching Up: Dr. Ben Goldacre's Bad Pharma

I recently noticed that I had only mentioned Dr. Ben Goldacre's book Bad Pharma in one previous post:

In that post I was perhaps unduly dismissive. Since I only recently got around to reading his book, I wanted to update the record with a few observations.

The book, Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients, was published last year in the UK by Fourth Estate and in the US this year by Faber & Faber. Dr. Oldacre trained as a psychiatrist and is presently a research fellow in epidemiology. He is author of a popular "Bad Science" column in The Guardian, and Bad Science was the title of his earlier book.

My initial assessment of his book, that it would provide little that is new to any regular reader of this blog, is more or less correct. I also admit to being miffed that (as far as I can see) it fails to cite HOOKED, which naturally raises questions about how thorough a literature search the author did. But there are definitely some unique strengths to the book that deserve notice.

  • Dr. Goldacre's main thrust is the quality of the medical data, as befits a researcher in epidemiology. He's as concerned about the data he uses to make his case as well as about the data that medicine has at its disposal to make decisions about patient care. In general he does a very good job of presenting an evidence-based assessment; where his evidence is weak, he says so. That means that whenever he addresses a topic, such as for instance the impact of drug ads in medical journals on physicians' prescribing, he seeks out the most recent systematic review of the literature as his ideal source. That means that this book is a good compendium of those reviews. (It also indicates why he might not cite HOOKED, as he's more interested in the original data and in systematic reviews than in commentaries by other authors.)
  • Dr. Goldacre obviously practices in Britain and so his view is a British perspective. This adds punch to a number of things he says, since, for instance, when drug companies mislead doctors, they waste British taxpayers' money. He has harsh criticisms for the way the UK and Europe regulate the drug industry, especially their penchant for keeping all their activities secret; and it's a tiny bit reassuring that he sees some US practices (like the Sunshine Law) as ahead of Europe.
  • Being worried about missing data hidden by drug firms and the way this has systematically distorted the medical literature means that Dr. Goldacre has some recommendations that are stronger than those we often hear. For example, most critics of industry practices of burying unfavorable trial results and of sponsoring ghostwritten articles would be quite happy if Pharma agreed that as of now, they would stop doing these things, and then somehow demonstrated to us they had kept their promise.  Goldacre would not be satisfied, though, until we had fixed the problem retroactively--publishing all previous trial data now hidden, wherever the data are currently stashed away, and accounting for all past ghostwritten papers and revealing their true authors. Only in that way could future systematic reviews of the literature be reasonably sure of getting the right answer, he says reasonably.
  • Dr. Goldacre makes one recommendation that simply seems impractical, calling for a pledge that any clinical trial results will be published within one year of completion of the trial. In principle this sounds fine. I am author of many papers that have not been published as of one year after the completion of the project, and none of those are complex clinical trials that require a lot of work to sift through all the data and decide how to present them meaningfully. The way the medical journal business works means that no author can be held responsible if any paper, let alone a trial, is not published after a set time has passed. Maybe what Goldacre really has in mind is that medical journals should no longer publish trial data, and all of these should be freely available on an open access website. If that's what he has in mind he should say so.
  • The title would suggest that Dr. Goldacre is following in the footsteps of the US's Dr. Marcia Angell in her The Truth about the Drug Companies (2004), blaming the big bad drug industry for all wrongdoing and absolving physicians as innocent victims. Never fear; he's as critical of physician and professional society misbehavior as he is of industry's.
One thing Dr. Goldacre said raised my ethicist hackles. He describes a promising project in the UK where GP practices are fully computerized and some geeks have figured out a way to run comparative effectiveness trials as a smooth, routine part of everyday office practice. A physician, instead of prescribing a drug, could be presented with a pop-up box on the computer screen saying that right now we don't know which of two drugs is better for this problem, so if she just clicks on one button, the patient will automatically be enrolled in a controlled trial and assigned one or the other drug randomly. He's quite enraged at the research ethics review boards who won't let his group do this without a detailed informed consent process.

What Dr. Goldacre proposes has a lot of advantages, and if he goes to the British public, and they endorse his scheme, and change the rules in the UK to permit this type of research, and individual patients are notified and can opt out if they wish, I'd be all in favor. But in the absence of public dialogue and democratically voted approval, I can't agree that the convenience and ease of doing trials this way simply trumps patients' rights. Goldacre focuses on the physical harm of taking a medicine in a trial setting and notes that there can be no increased harm if the two medicines being compared are both in common use by GPs. But that's not the issue. The issue that once your physician stops treating you and starts doing research on you, then the relationship fundamentally changes, and patients need to be made fully aware if what that means. As clunky as the informed consent process is (and I agree that 20-page forms are much less useful than a 1-page form would be), it's the way we now try to signal to patients that this basic change in relationship has occurred.

Bottom line: Dr. Ben Goldacre's Bad Pharma has a number of positive features to recommend it.


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