Tuesday, October 02, 2012

How good is the information provided on pharmaceuticals?

In its review of Bad Pharma by Ben Goldacre, The Economist criticizes the information published on pharmaceuticals produced by the pharmaceutical industry.

Dr Goldacre describes the routine corruption of what is supposed to be an objective scientific process designed to assess whether new drugs work, whether they are better than drugs already on the market and whether their side effects are a price worth paying for any benefits they might convey. The result is that doctors, and the patients they treat, are hobbled by needless ignorance. 
So, for instance, pharmaceutical companies bury clinical trials which show bad results for a drug and publish only those that show a benefit. The trials are often run on small numbers of unrepresentative patients, and the statistical analyses are massaged to give as rosy a picture as possible. Entire clinical trials are run not as trials at all, but as under-the-counter advertising campaigns designed to persuade doctors to prescribe a company’s drug.
I have never personally observed an FDA drug review, but I know that it is a peer review process, and I have observed many medical research peer review meetings in the United States and have worked with people from FDA. I would be very surprised if the FDA licensing process for new drugs is as flawed as Dr. Goldacre seems to suggest. Since he is British, perhaps his criticism applies to drug approval processes in other countries -- I wouldn't know nor be able to comment on those processes.

On the other hand, with the application of the computerized patient record systems that are coming into operation across the United States, it should be possible to provide much better information on patient response to pharmaceuticals, including both efficacy and adverse reactions. With increasing availability and use of genetic information, it should be possible to provide much more detailed information on which drugs are likely to prove effective against which conditions in which patients.

The article also states:
Many published studies are not written by the academics whose names they bear, but by commercial ghostwriters paid by drug firms.
I don't know how pharmaceutical companies use technical writers in helping researchers get their results into print, but I have worked with technical writers when I was a research engineer and when I was running research grants programs. In both cases they were really helpful in getting what I wanted to say into better shape to be understood by the reader, and did so without ever trying to compromise the accuracy of what I was writing. Indeed, They always deferred to my understanding of the substance of the articles. I also subjected some of the articles I wrote seeking to popularize our scientific results to an association of professional science writers, and benefited from their insightful critiques of the articles.

I suspect that the average professional carrying out drug tests can write pretty well -- you don't get that kind of job without having succeeded through a number of levels of education (although technical writers have told me that some of the stuff that they have to edit is pretty bad). Even a good writer can benefit from an outside view of their prose provided by a good professional. That is why publishers provide fiction writers with editors.

On the other hand, I am not sure how good the communication is to doctors and I am pretty sure it is not too good to patients. The problems may not be in the quality of the information provided, but in the quality of its reception. Of course, the instructions provided with prescription meds is almost unreadable, perhaps because it is written to satisfy bureaucratic regulations and legal advice on how to limit product liability, and not to maximize understanding by the patient.

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