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 by Kimball Atwood