Big pharma, at home and outsourced

When I was in college, a friend told me something that sounded too good to be true: I could get paid forty dollars for a blood test. And if I didn’t have a history of a certain symptom, they would pay me forty dollars every month for the next two years in exchange for more blood tests. They were in the last year of signing up subjects for a clinical trial (something I’d read about in my biochemistry classes) on a common, as-of-yet uncured disease for which a bigger pharmaceutical company had developed a vaccine. There were no abnormal reactions worse than those of a flu shot, and I might get the placebo, making the whole thing even more of a walk in the park. The first nurse I talked to assured me that during the trial, anyone contracting the disease would receive immediate and free treatment for as long as it was required, even if they had been on the placebo.

If the above sounds like your dream job, you can be a guinea pig, joining the ranks of many familiar faces from Western popular culture. Medical test subject was the entry-level occupation in the first version of The Sims, and is featured a few times on the Simpsons. When Bart gets expelled, he imagines a future testing dangerous food additives; the “2-4-dexoxypropaniramine” in Nature’s Goodness, a new diet soft drink, mutates him into a hulking beast (whereupon the lead scientist remarks “pleasing taste, slight monsterism”). In a different episode, Homer signs up to be a guinea pig at the “Screaming Monkey Research Lab” where he goes blind from a diet pill.

Unfortunately, clinical trial participants overseas face a situation much closer to Homer Simpsons’ than to that of the North American undergrad. Far from the gaze of the undermanned and budget-strained F.D.A, pharmaceutical companies are running more and more drug trials in increasingly remote locations; trials accused of being unethical, unsound, and unsafe. Deadly Medicine, an article from the January 2011 issue of Vanity Fair, exposed the current state of the global pharmaceutical industry, where thousands of clinical trials take place “in countries with large concentrations of poor, often illiterate people, who in some cases sign consent forms with a thumbprint, or scratch an ‘X.’” Donald L. Barlett and James B. Steele, the article’s authors, lamented that “the only people who seem to care about the surge of clinical trials in foreign countries are the medical ethicists—not historically a powerhouse when it comes to battling the drug companies.” While drug companies have argued that their clinical trial participants receive a higher standard of care than they do at any other time in their lives, critics point to massive conflicts of interest (many doctors in these countries receive ten times their salary for each new patient enrolled), lack of regulations, and an uncertainty about whether such results are even relevant to the North American eventual consumers of such medication.

Cash-strapped North American undergrads – or anyone tempted by the “Are you a non-smoker between 18 and 35?” bus ads, aren’t likely to face a situation as dire as that of the overseas clinical trial participant.  It’s unclear to me, however, that the former aren’t another vulnerable group being taken advantage of. Despite assurances of safety and tighter regulations, there’s still a dotted line to sign that absolves the company of liability should something go catastrophically wrong. And things sometimes do go wrong, as in the 2006 clinical trial of TGN1412 which left all non-placebo participants in the intensive care unit; comments by family members suggest to me that some participants did not understand the risks of signing up for the trial. So be careful with renting your body to drug companies, no matter how much of a damage deposit they can afford.

4 Comments

  • W. Dean Reply

    I was going to read Barlett and Steele’s article, in spite of the fact that it appears in Vanity Fair, but I couldn’t get past the teaser:

    “Prescription drugs kill some 200,000 Americans every year. Will that number go up, now that most clinical trials are conducted overseas—on sick Russians, homeless Poles, and slum-dwelling Chinese—in places where regulation is virtually nonexistent, the F.D.A. doesn’t reach, and “mistakes” can end up in pauper’s graves? The authors investigate the globalization of the pharmaceutical industry, and the U.S. Government’s failure to rein in a lethal profit machine.”

    Ah yes, true and accurate stuff this: “Prescription drugs kill some 200,000 Americans every year.” All the same, I have to wonder why those who trade in misinformation are not willing to simply bring expression in line with intention and say, “Big Pharma kills some 200,000 Americans every year.” After all, could there be a legal defense of the first, but not the second, when both nakedly imply that all these deaths were caused by willful negligence on the part of pharmaceutical companies?

    Notice the logical error in the second sentence. It’s like a Freudian slip that’s particular to wild-eyed partisans: the number of American deaths is conjectured to rise even though Big Pharma’s killing machine is moving overseas to Russia, Poland and China. If anything, American deaths should decrease. But maybe he means to suggest that Big Pharma’s foreign victims should be counted (through some unstated metaphysical calculus of cosmic justice) as Americans when they’re tossed in those pauper’s graves by Big Pharma.

    As for “lethal profit machine,” well, that’s not pejorative at all. It’s just speaking truth to power. After all, wouldn’t it be more dishonest to use neutral language when the facts are staring you in the face?! EH?!! EH?!!!

    • Eleanor Louson
      Ellie Louson Reply

      I agree that the teaser borders on sensational, for sure, but it belies the quality of the overall article. Their argument makes a little more sense than you give it credit for, though: I think they’re saying that if unregulated clinical trials are being used in place of regulated ones, and the results of those trials put unsafe drugs on the market, then the eventual consumers of those pharmaceuticals are at a higher risk of side effects and deaths above the currently estimated 200 000 deaths in the United States from F.D.A.-approved prescription medications. They support their claim with some pretty chilling examples: diabetes-causing Seroquel, contaminated heparin, heart-attack-causing Avandia and more.

      I don’t see any error in the teaser. If trials are moved overseas (leading to overseas deaths) then medications become more unsafe (leading to more deaths in the United States). The authors aren’t conflating the two categories of deaths, even though they are both related to the pharmaceutical industry’s products and practices.

      If you read the article, and the leaked memos from pharmaceutical companies that applaud keeping unsuccessful clinical trials secret in order to ensure profitability, “lethal profit machine” is less of a stretch.

      • W. Dean Reply

        Ellie,

        I suggest that your analysis is flawed, first, because you’re comparing deaths from side-effects to no deaths from side-effects, when you should be comparing death from side-effects to the total mortality that would ensue without side-effect causing drugs. All drugs have side-effects; the question for the patient is the trade-off. If someone has a 1 in 4 chance of suffering a stroke without medication and a 1 in 10,000 chance of suffering a heart-attack if he does, then the best option is to take the drug.

        No doubt this patient and Vanity Fair would be upset to find out that the drug’s producer suppressed evidence that the chances of suffering a heart-attack were actually 1 in 1,000; but would the patient’s choice have been any different? Come to that, would Vanity Fair be justified in telling its readers not to take the drug out of a sense of betrayal? I think not. But it certainly could, because it won’t face liability for pandering to conspiratorial thinking, which brings me around to my second point.

        While it’s true that the profit motive gives pharmaceutical companies an incentive to sell their wares, they not only lose customers with bad products, but they are liable for harms caused by their products. So regulation is not the only incentive to produce safe products. Moreover, to ignore the incentive provided by the profit motive, while at the same time invoking it as the reason for the creation of unsafe drugs is to look to have it both ways. The question really comes down to cost-benefit: will the cost of liability and non-returning dead customers outweigh the profit to be made off unsafe products?

        The answer to this is closer than you think. Not only is the illicit drug market completely unregulated, but it is liability-free (try suing your dealer); yet deaths from contamination or adulteration are a rarity. To my knowledge there’s no definitive study on this, but anecdotal evidence suggests it’s rare that producers and dealers sell wholly counterfeit products.

        I’ve also heard of this memo and it doesn’t impress me. Journalists, crusaders, politicians and ambulance-chasers all have an incentive of their own when it comes to exploiting the public’s ignorance of medicine. Yet when someone dies because he ceased taking a medication that kept him alive after reading the latest ill-informed “gotcha” story, these groups cannot be held liable for their part in it. So it doesn’t surprise me that Big Pharma would gloat over suppressing evidence that might have exposed them to a massive and perhaps unjustified recall that would have grown out of the inevitable hysteria whipped up by the aforementioned groups.

        On a technical note, the fallacy arises from the ambiguity of the cause(s) of the deaths mentioned in the first sentence. The unspoken partisan premise is that these people died as a result of negligent clinical trials. But if you read the first sentence without presuming that drug companies caused the deaths (instead assuming the deaths were the result of complications or “mistakes”), then it links up with “mistakes” in the second sentence. It’s only when you import the suppressed accusation into the first sentence (i.e., that the deaths were caused by negligent clinical trials) that the prediction in the second sentence makes sense.

        • Eleanor Louson
          Ellie Louson Reply

          I’m certainly no expert on the pharmaceutical industry and you have made some excellent points; this article merely brought to light some practices that to an outsider seemed quite alarming. I do think there’s a difference between someone with a serious disease choosing a more risky course of medication, (as long as they have been properly informed of those risks) leading to a death that might have occurred otherwise, and someone taking medication for diabetes or alzheimer’s or depression and dying of a heart attack, especially if the risks of such side-effects were known in advance and the results of those trials covered up. I am glad I don’t have to rely on pharmaceutical executives themselves to let me know how they applaud the “smoke-and-mirrors job” accomplished by their physicians who suppress data; without journalists publicizing such memos, we’d never hear about them.

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