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Scientific Fraud Hits Home

Last week the story broke that Scott Reuben, an anesthesiologist and clinical researcher at Baystate Medical Center in Springfield, MA, had falsified data in at least 21 publications over a period of at least 12 years—making it one of the most enduring examples of scientific fraud in memory. Almost all of Reuben’s papers had reported innovative methods for providing post-operative pain relief (analgesia); many of them involved ‘multimodal’ regimens for painful orthopedic procedures such as spinal fusions and total knee replacements. Recent papers reported regimens that included celecoxib (Celebrex) and pregabalin (Lyrica), both made by Pfizer. Much of Reuben’s research had been funded by Pfizer, and Reuben has been a member of the Pfizer speaker’s bureau (that information is included because the reader would otherwise wonder, but there is no indication that Pfizer has been intentionally involved in Reuben’s fraud).

I will not discuss this case in detail; look for a more comprehensive piece on SBM next week. Rather, I present it now to offer a local example of how such a breach of trust affects those who rely on clinical research to inform their care of patients.

The case hit home in a couple of ways. Although SBM readers may think of me as one of the 10 or so most knowledgeable skeptics of pseudomedicine in the entire world, in my day job I am a practicing anesthesiologist in Massachusetts. A big problem in anesthesia and surgery is how to provide adequate pain relief for patients after especially painful operations, without having to use such high doses of narcotics that many, particularly the elderly, will become somnolent and have depressed respiratory drives. The issue thus involves both comfort and safety. Multimodal regimens such as those reported by Reuben seemed to offer one solution, and have become increasingly popular over the past couple of years. Reuben gave a talk on the subject to my anesthesia department about a year ago. I’m sorry to say that I wasn’t there, but my colleagues remember him as having seemed utterly normal. No surprise, in a way; that’s what it takes to fly under the radar for so long.

My wife, a nurse practitioner, is one of the voices of pain management at our hospital. She’s given many talks and made many recommendations about multimodal analgesia—based predominantly, as it turns out, on Reuben’s ‘work’. The hospital pharmacy agreed to put the expensive Lyrica on its formulary after a formal plea from my wife and a couple of my anesthesia colleagues. Upheaval now reigns, and my wife feels deceived and embarrassed. The timing couldn’t be worse: money’s tighter than it’s ever been. It’s Madoff writ small.

All of which, further, leads to this irony: there’s enough plausibility, and a bit of corroborating clinical research, to suggest that Reuben’s fraud notwithstanding, the multimodal regimen might be useful. The collective clinical impression at our hospital, where we do 20-30 total joint replacements and 10-15 spinal fusions every week, is that it has made a big difference. Have we merely been fooling ourselves in the same way that sCAMsters do, or does the stuff really work? This is important enough that at least some Reubenesque studies need to be repeated, minus the data fabrication. And who will pay for them? Yup, you guessed it. What else is new, my friend?

So now we’re talking about doing a study. If we do we’ll almost certainly ask Pfizer to fund it, even though that would be far from ideal. Pfizer has the money, the motivation, and the still-valid protocols from previous, misreported studies. It is also an obvious source of sham facsimiles of its own drugs (placebos). The alternative—starting from scratch and applying for a grant from the NIH, for example—would be prohibitively cumbersome for busy clinicians, and not at all guaranteed. Maybe the NIH itself will do a study, but don’t hold your breath. Man, I just don’t understand what’s goin’ on.

Posted in: Clinical Trials, Health Fraud, Pharmaceuticals, Science and Medicine

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7 thoughts on “Scientific Fraud Hits Home

  1. qetzal says:

    Nice post. I just wanted to highlight this sentence:

    Have we merely been fooling ourselves in the same way that sCAMsters do, or does the stuff really work?

    There’s the difference between science and woo: the willingness to ask that question, seek an objective answer, and proceed accordingly.

  2. Dr Benway says:

    It’s okay for James Randi to test psychics and it’s okay for pharmaceutical manufacturers to fund drug trials. Both have obvious biases regarding the outcomes. But if the science is done properly and the process is sufficiently transparent, that shouldn’t matter.

    People who imagine bias = money are thinking too simplistically about human nature. They’re in danger of grading someone “unbiased” inappropriately.

  3. Delphi Ote says:

    If I was making a list of top unethical things a person could do, faking clinical data about analgesia should be somewhere in the top 50. What could be more selfish than knowingly putting others at risk of suffering greatly just so you can cut a few corners? On top of that, he greatly undermined people’s trust in the medical community.

    This man should be shamed out of his career for life. He should consider himself lucky if he’s trusted enough to flip burgers.

  4. Prometheus says:

    Having worked in pain research a number of years back, I can attest that “multimodal” analgesia is a “hot” topic and has been for many years. The idea of combining a NSAID and a drug (like gabapentin or pregabalin) that is used to treat neuropathic pain has been around for over ten years.

    Fortunately, Dr. Reuben was not the only person doing this sort of research. While the other studies are not as “clear” as Dr. Reuben’s, they suggest that there is some validity to using these two classes of drgus together.

    We may never know why Dr. Reuben falsified his data – his lawyer’s statement seems to imply that Dr. Reuben is claiming that he didn’t falsify the data (although there seems little doubt that he forged a colleague’s signature on a paper and may have lied to the IRB).

    If Dr. Reuben did falsify data, I suspect that the reason was the usual reason: the data didn’t clearly show what he knew was true.

    This is the challenge that all scientists face at least once in their career – after a long and difficult study (and all human research is long and difficult), the data are ambiguous or – worse – contradict what you know is true.

    What distinguishes the “lapsed” or “failed” scientist from the “fraud” is when they decided that they would falsify data to “support” their hypothesis. The “lapsed” scientist makes that decision when faced with data that doesn’t support their hypothesis – the “fraud” has decided to falsify data (if necessary) before the experiment starts.

    Both have passed “the point of no return”.

    Dr. Reuben will pay for his lapse in judgment with his career. Maybe he can get a job at “Thoughtful House” with Dr. Wakefield.

    Prometheus

  5. wertys says:

    As another of the followers of Reuben, I and my colleagues in our anaesthetic department were appalled and disgusted by what looks like a fairly clear decision on his part to use drug company funding to pump up his own research career. There doesn’t appear so far to be any collusion from Pfizer, but you don’t have be too skeptical to imagine that they would be keen to fund his work if it involved the possible large-scale use of Pfizer products.

    The strength of the scientific method is that it demands reproducibility, and here things get interesting. Even if, as it appears, Reuben just made shit up to fit his hypotheses, there are other lines of data to support some of the principles of multi-modal analgesia. The irony may be that Reuben didn’t need to fabricate data after all, and that by doing so he has slowed and tarnished progress towards more effective perioperative analgesia, instead of helping it.

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