Six not-so-simple steps toward protecting people from dangerous drugs

Over the past two years there has been a steady diet of books and media reports about the disturbing influence the pharmaceutical industry has on medical research and doctors' prescribing patterns. Not a week goes by without a new report on the marketing muscle of the industry and the pervasive ties between the industry and the doctors upon whom we rely for supposedly objective medical advice.

A recent addition to this growing body of literature is The Risks of Prescription Drugs, which explains why the number of Americans taking prescription drugs has soared 72 percent in the last decade, with the result that an estimated 46 million Americans suffer from adverse side effects and 2.2 million are hospitalized every year. The book is co-written by five health policy experts and for the most part coalesces what has been written about in other places, including Marcia Angell's The Truth about Drug Companies, Jerome Kassirer's On the Take, Howard Brody's Hooked, Melody Petersen's Our Daily Meds, Peter Conrad's The Medicalization of Society and Side Effects, along with many newspaper reports.

However, The Risks of Prescription Drugs, published by Columbia University Press, does two things particularly well. First, it explains in a clear concise fashion why, despite the fact most new drugs offer little or additional benefit over existing meds, so many doctors prescribe these new drugs, exposing patients to serious side effects and adding billions in wasted costs to an already overburdened health care system.

Second, in the final chapter, the book offers comprehensive solutions to the problem, such as:

* Prohibit direct to consumer advertising by drug companies (because advertising to patients conveys inherently commercialized, biased information). Read more about this here.
* Create a stronger more independent Food and Drug Administration by more fully funding this federal agency so that it is no longer reliant on drug company user fees. (As reported in Side Effects, drug company money now accounts more than half of the FDA's entire drug-review budget.
* Change FDA policy so that new drugs are tested against existing drugs rather than against a placebo or sugar pill. (Right now, most drugs only need to show they are more effective than a placebo to win FDA approval).
* Reduce the commercial influence on doctors. While some medical schools such as Harvard have enacted strict policies prohibiting doctors from accepting free gifts, lunches and lucrative consulting and speaking deals from drug companies, too many others continue to allow such conflicts, all of which have been shown to bias doctors' judgment as researchers and clinicians).
* Get Big Pharma out of medical education. The Carlat Psychiatry blog makes a persuasive, ongoing case for why drug companies should not be allowed to fund continuing medical education.
* Limit the prescribing of unapproved uses of drugs, since such off-label uses are responsible for many of the adverse side effects seen in patients. See more about this here and here.
* Create and fund a new federal institute of medical science that can run clinical trials of new medications free of the drug industry's commercial interests. This institute could also be charged with doing objective research that compares the effectiveness of new products with existing drugs. As reported here, in the economic stimulus bill passed last year, President Obama included $1.1 billion for just this kind of comparative effectiveness research, but that should only be the beginning of a much larger, more comprehensive effort).

While all of these solutions are crucial if we want to improve our health care system and protect the public from dangerous and unnecessary drugs, the reality is that they will require the kind of political will that is in short supply on Capital Hill these days. That doesn't mean, however, that we should stop working toward such reforms. If anything, books like The Risk of Prescription Drugs are more important than ever -- in getting the truth out.

Mount Holyoke journalism class gains real-world experience

At the risk of tooting my own horn, I thought I'd post this video that was produced by Mount Holyoke College about the multimedia journalism class I teach there and our collaboration with the local newspaper, The Daily Hampshire Gazette. The video talks about how Mount Holyoke students are gaining real world journalism experience and helping a local newspaper gain a bigger footprint in its own community.

Government oversight agency calls on NIH to ban ghost-writing

Much has been written about the insidious practice of ghost-writing in medical research in this and other blogs and news articles. Even Dr. Francis Collins, the director of the National Institutes of Health (NIH), expressed dismay over the problem in a C-SPAN interview last year, calling it a threat to the "integrity of science." So far, however, not much has been done to curb such abuses.

In an open letter to the NIH yesterday, the Project on Government Oversight dialed up the pressure on Collins and the NIH by calling attention to several particularly egregious examples of ghost-writing. In the first, two psychiatrists, Dr. Charles Nemeroff and Dr. Alan Schatzberg, (whose ties to the pharmaceutical industry and conflicts of interest have been well-publicized) signed their names to a psychiatric textbook for primary care physicians that was in fact ghost-written by a contractor for SmithKline Beecham, now known as GlaxoSmithKline. As Duff Wilson reports in The New York Times, not only did SmithKline pay for the contractor to develop the outline and text for the two named authors but in emails obtained by PGO and the Times, the contractor also said it planned to show drafts and page proofs of the book to the drug company for sign off and final approval. Yet such company control was never disclosed in the textbook, which doesn't come as any particular surprise, since Nemeroff and Schatzberg have a history of failing to fully disclose their ties to the drug industry; see here.

Another ghostwriting example that the Program on Government Oversight highlights in its letter to NIH is one that I exposed in Side Effects: that a study of Paxil, spearheaded by Dr. Martin Keller, then chief of psychiatry at Brown University, was in fact ghost-written by the same contractor that ghost-wrote the psychiatric textbook mentioned above. According to documents that I obtained and posted here, this particular clinical trial, known as study 329, was skewed to downplay the suicidal risks of Paxil in adolescents and to make the drug seem more effective than it really was. According to email correspondence obtained by a law firm suing Glaxo, the contractor also sent this study to the drug company for final approval before it was published. In Side Effects, I quote an employee of Brown's department of psychiatry saying, “Everybody knew we had to keep [SmithKline] happy and give them the results they wanted."

While Keller has stepped down as chair of psychiatry at Brown, he remains a full professor there and is still receiving lucrative NIH grants. As the PGO letter notes, "Currently, [Keller] is the primary investigator on two NIH grants, with funding in 2010 of $1,341,493. Over the last five years, the NIH has given Dr. Keller $7 million in grants."

This is unacceptable. Keller has been accused of manipulating scientific data not only in my book but in scientific journals as well; see here and here. It's high time that the NIH stepped up to the plate and did as the Project on Government Oversight asked: "implement new policies that will require institutions to ban ghostwriting and make NIH funding contingent upon periodic certification from institutions that ghostwriting is strictly prohibited..."