Feb/Mar 2013

The Pill Pushers

Chris Wilson


Most of us would like to believe that our doctors spend every free moment buried in medical journals, impervious to the long tentacles of drug companies—no matter what their inexhaustible supplies of AstraZeneca pens and Eli Lilly clipboards may suggest to the contrary. But physician and journalist Ben Goldacre takes firm and decisive aim at that comforting myth in Bad Pharma, a sequel of sorts to his 2009 title, Bad Science.

Thanks to the moral ineptitude of oil and tobacco companies, we’re all familiar with tales of soulless corporations skewing data, buying off critics, and silencing dissidents. Pharmaceutical companies are especially practiced in these dark arts because the regulatory process is long, bureaucratic, and deeply entangled with many different stakeholders—ensuring, in other words, that the drugmakers have ample room to induce all sorts of players into making new markets for them. Most accounts of how the industry games the regulatory process concern themselves with the new breed of shady marketing and advertising come-ons that sends patients flocking to their doctors demanding worthless, expensive medications. Goldacre covers this ground thoroughly, but he is more concerned with the phony ways that companies get their drugs past the phalanx of would-be regulators to begin with. It is surely the most comprehensive account of the subject to date.

Documents exposed by litigation and the diligent work of various watchdog concerns have provided an extensive public record of just how drug manufacturers can manipulate each stage of a drug’s lifetime. Occasionally, some of these practices, such as false advertising and the suppression of harmful side effects, result in lawsuits like the one that GlaxoSmithKline settled last summer for $3 billion. Most of the time, though, the abuses take place in the expansive gray area where industry and academia intersect. Goldacre contends that every person and entity responsible for policing this relationship has failed us: companies themselves, regulators, researchers, journal editors, and doctors. The result is a glut of ineffective medications with poorly understood side effects that often continue to be prescribed years after they’re shown to be useless.

But do not bother checking the book’s index for mentions of every drug you’ve ever taken, just to see what monkey business took place during its approval and subsequent testing. For one thing, that information is probably still locked from public scrutiny, if not lost entirely, given the secrecy that typically surrounds research on commercial drugs. And more to the point, Goldacre’s core argument is that drug regulators need to institute clear, enforceable guidelines ensuring that the results of all clinical trials are made public in a timely fashion. So his principal focus here is on bias in academic studies, and the related practice of withholding research in other studies. With such data-heavy material driving the argument, Bad Pharma can be dry and hastily written in places, but one sympathizes with Goldacre’s inclination to go overboard with citations: If you’re going to target an industry for cherry-picking research, you’d better make sure your own endnotes are in order.

Bad Pharma is arranged loosely around the stages of how a pill becomes a law, from the first tests in petri dishes to the publication—or, in many cases, the burying—of the results of clinical trials on humans. Again and again, we see that drug companies are more likely to report favorable outcomes while withholding negative ones—and that trial subjects are handpicked for the best possible outcome, then quietly dropped from a study when something bad happens to them.

In addition to constituting poor, even fraudulent, research behavior, this is arguably a breach of the moral compact that drug researchers strike with trial subjects: Though compensated as “paid volunteers,” study participants are ostensibly driven by a sense of altruism akin to the spirit of generosity that prompts people to give blood. The idea that data resulting from the risk you or I took in participating in a trial is being scuttled because it’s unfavorable to a multibillion-dollar corporation is offensive. It is also, as Goldacre reminds us, dangerous: Trials desperately need subjects from all walks of life, but those who do not need the money are unlikely to volunteer if there is no guarantee that the results will be used to benefit anyone.

Still, Bad Pharma is short on practical prescriptions for reform. It is not until the last ten pages that Goldacre acknowledges that, unlike the corporations marketing cigarettes or oil, drug companies are manufacturing products that save lives and alleviate pain for billions of people. “Medicines are made by commercial organisations, that is the reality, and they often produce good medicines,” he concedes. The first step in diminishing big pharma’s distortions of research, we are told, is to clearly identify all the relationships that exist between the researchers and the manufacturers, a policy that is already enforced in some parts of academia and the academic press (though usually in a spotty, inconsistent way).

We are also told that a majority of research is sponsored by drug companies, and that studies have found that doctors are more distrustful of data from studies in which these conflicts of interest are clearly disclosed. Goldacre never teases out the implications of this finding, nor does he address the thorny conflict between the need for well-funded research and the attendant difficulties it presents—let alone any plan to develop alternative sources of R&D and funding for new drugs. Goldacre acknowledges, toward the end of the book, that there is a difference between the appearance of a conflict of priorities and a demonstrable pattern of undue influence in research—though there is plenty of both to go around in contemporary medicine. It is not always helpful, however, to assume that everything the pharmaceutical industry touches is toxic. Goldacre’s ideas for how to promote transparency and counter the actual influence of industry are very good ones—but the stubborn appearance of a conflict of interest seems unavoidable, barring a complete overhaul of the drug business. In the meantime, though, we can at least take one step in the right direction: Doctors should buy their own pens.

Chris Wilson is a Yahoo! News columnist.

Sign alltrials.net

February 24, 2013
11:21 pm

The earlier portions of this review are on point. However, the review goes off the rails once it says:

“Still, Bad Pharma is short on practical prescriptions for reform.” As well as in practically the entire last paragraph of the review, especially “In the meantime, though, we can at least take one step in the right direction: Doctors should buy their own pens.“

No, people can take at least two steps in the right direction, and it does not involve stationery products:

1. Buy and read Goldacre’s book.
2. Go over to alltrials.net and join the eminently practical campaign for reform that Goldacre is spearheading.

Goldacre is NOT suggesting that research and development from drug companies is not of central and continued importance. He is suggesting that this R&D does not need to be linked to the right to withhold with impunity from the medical community at large the methodology and findings of a huge number of clinical trials. A key part of that sentence being “the medical community at large.”

Missing data is at the heart of the book. You represent that fairly.

Addressing the problem of missing data, addressing missing data regardless of funding source and NOT just looking at conflicts of interest, is what Goldacre is campaigning for, and it is that focus that really sets this book apart. That, I do not feel you represented sufficiently.

PUBLICIZE all your pharmaceutical funding proudly. PUBLICIZE all your pharma swag.
Just do the same with all your data.

That's a bit of an oversimplification/exaggeration, but not by much.

I would hope you would revise the end of your review or consider adding an addendum making reference to alltrials.net

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