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A Medical Madoff
March 12, 2009 10:10 PM   Subscribe

A Medical Madoff: Anesthesiologist Faked Data in 21 Studies. "A pioneering anesthesiologist has been implicated in a massive research fraud that has altered the way millions of patients are treated for pain during and after orthopedic surgeries."
posted by homunculus (46 comments total) 6 users marked this as a favorite

 
She added that "with the [investigating] committee's guidance, he is taking steps to ensure this never happens again."

An overdose of the fucking drugs he profited by promoting would be my choice.
posted by maxwelton at 10:17 PM on March 12, 2009


That was a fascinating article. Putting as co-authour the guy who was questioning your work? Ballsy, and kind of a dick move.

On the other hand, I would like to register my official disapproval of using 'Madoff' to mean 'fraud'. Not to you, homunculus, I know that it's the article.
posted by Lemurrhea at 10:22 PM on March 12, 2009 [1 favorite]


Medical Madoff?

I'd say the Stephen Glass of general anesthesia.
posted by collywobbles at 10:23 PM on March 12, 2009 [1 favorite]


The abuse of intelligence rings and echos.
posted by Mblue at 10:26 PM on March 12, 2009


Yeah, Madoff was a Ponzi artist; what this guy did is entirely different. Also, as someone whose treatment regimen has included at least two of the drugs dude faked data on, I'd like to medically administer him a steel-toed kick to the dingus.
posted by jtron at 10:28 PM on March 12, 2009 [1 favorite]


If only science possess such attributes as peer review, or double-blind trials.
posted by turgid dahlia at 10:31 PM on March 12, 2009 [4 favorites]


Possessed, even.
posted by turgid dahlia at 10:31 PM on March 12, 2009


Ick. Ick. What a dirtbag. Hopefully, he saved enough from his huge bags of Pfizer money to hire good attorneys.
posted by EatTheWeak at 10:44 PM on March 12, 2009


turgid dahlia, it sounds like you're coming dangerously close to thinking over there.

We'll send a car around.
posted by baphomet at 10:45 PM on March 12, 2009


Also, as someone whose treatment regimen has included at least two of the drugs dude faked data on, I'd like to medically administer him a steel-toed kick to the dingus.

"Motherfuckers perpetrate a massive research fraud that has altered the way millions of patients are treated for pain during and after orthopedic surgeries, I'ma punch 'em in the dick."
posted by DecemberBoy at 11:30 PM on March 12, 2009 [12 favorites]


Peer review doesn't protect science against people falsifying data in a credible way, and the studies he wrote about, he reported to be double-blind. The trouble is that in order to determine faked research, you need to do independent retesting of the research. According to the article, the studies were done by others, who didn't get nearly as strong results for the drugs in question as Dr. Reuben did.

The remarkable thing is that he got away with it for so long. Did he gather all the data himself? I know it is common for some co-authors to only be tangentially involved in the actual data collection for these types of studies, but I bet more than a few had a feeling that something dishonest was going on.
posted by demiurge at 11:36 PM on March 12, 2009 [2 favorites]


Reuben, 50, has been stripped of his research and educational duties and has been on medical leave since May.

Medical Leave? Did someone break his legs?

Now that would be ironic, AMIRITE!?
posted by delmoi at 11:55 PM on March 12, 2009


Oh, for the love of all that's holy, please don't let "Madoff" become the new "Gate."
posted by Cyrano at 11:58 PM on March 12, 2009 [7 favorites]


turgid dahlia, it sounds like you're coming dangerously close to thinking over there.

You're right. What I actually meant to say was "does this smell like chlorophorm to you? lol!"

It's just fascinating to me whenever I hear about stuff like this. The whole structure of science is based on self-correcting mechanisms like the aforementioned double-blind trials, and peer review of material. You run your experiment, then give the data to another scientist to run the experiment again in the hopes that they will duplicate the results, or otherwise find out ways to improve either the outcome or the primary hypothesis.

But then you hear about the usual suspects like Pfizer and Merck, heavy-hitters with a strong influence in every strata of medicaldom and you just know, without reading further, that shady shit without any vestige of accountability has been going on. This then places the onus of responsibility on the FDA, but fuck if I know what they've ever done.
posted by turgid dahlia at 12:08 AM on March 13, 2009 [1 favorite]


And what I actually meant to say in the middle there was that this is actually a great way of doing things, in fact the only way, and it's so disheartening that men and women of science get so protective of their theories that they will fudge data, or even just make it up on the spot. It's the only field of human endeavour outside politics where an opinion can actually seriously fuck something up.
posted by turgid dahlia at 12:12 AM on March 13, 2009


and it's so disheartening that men and women of science get so protective of their theories that they will fudge data, or even just make it up on the spot.

True dat. In all my college lab courses pretty much everyone fudged their data so that it would fit. They were just menial lab courses with no consequences but it sets up a pattern for how to conduct research. Some of these people are out doing real research now and I'm sure most of them have enough integrity to be honest about their work but I wouldn't be surprised if this kind of thing happens a lot.
posted by BrnP84 at 12:39 AM on March 13, 2009


It's the only field of human endeavour outside politics where an opinion can actually seriously fuck something up.

World economic clusterfuck, anyone?
posted by Wolof at 12:50 AM on March 13, 2009


Good point, but I'd call that a mixture of politics and soft science, maybe? Stop looking for evidence to falsify my hypothesis it isn't fair this idea is rock-solid!
posted by turgid dahlia at 1:01 AM on March 13, 2009 [2 favorites]


I'd say the Madoff tag is appropriate, since this is also possibly a billion-dollar fraud with millions of victims.

In all my college lab courses pretty much everyone fudged their data so that it would fit.

Ssshhh, in my alma mater we called that "result optimisation".
posted by Skeptic at 2:41 AM on March 13, 2009 [1 favorite]


Some of these people are out doing real research now and I'm sure most of them have enough integrity to be honest about their work but I wouldn't be surprised if this kind of thing happens a lot.

Heh. When my grand-grandfather started his doctorate in physics, he was handed as a research subject the then-popular N-rays. When, after several years of research, he had a grand total of...zero results, he ended up dumping physics and got a PhD in chemistry instead.

When I heard the story I couldn't but admire his integrity: there weren't that many researchers who were that forthright at the time, and I'm afraid there would be even fewer now.
posted by Skeptic at 2:49 AM on March 13, 2009 [1 favorite]


So wait...no one ever tried to replicate his results?
posted by DU at 4:31 AM on March 13, 2009


Heh: Scientific American misspelled "anesthesiologist" in the URL for the article. Now I don't feel so bad about all my typoes.

I saw this a few days ago in Anesthesiology News, which is where Scientific American got the story. That was a little surprising to me, since Anesthesiology News is a throwaway journal and its articles can be interesting but not particularly newsworthy. They have a list of the 21 suspect articles on their website, which requires free registration. I have checked the websites for Anesthesiology and Anesthesia and Analgesia, the two main anesthesiology journals and ones that published much of his work and they have nothing on this but I am sure they will.

So wait...no one ever tried to replicate his results?

According to one article I read some researchers were suspcious early because they were unable to get results as impressive as his. But from one of the Anesthesiology News articles:

Early April is an exciting time at Baystate Medical Center. That’s when the Springfield, Mass., institution prepares for its annual research week highlighting the latest studies by its 270 faculty members and other scientists.

But 2008 was different. In the run-up to the event, Hal Jenson, MD, Baystate’s chief academic officer, made an alarming discovery. During a routine audit of the summaries, Dr. Jenson found that two abstracts submitted by one of the hospital’s prominent anesthesiologists, Scott S. Reuben, MD, had a potentially critical flaw: neither of the studies appeared to have the approval of Baystate’s institutional review board. That wasn’t necessarily a breach of ethics; after all, multicenter trials often have IRB approval only from sites where patients are enrolled. But it was enough of a red flag that Dr. Jenson asked one of his colleagues to speak with Dr. Reuben about the missing information.

What ensued was the unraveling of what medical ethicists are calling one of the largest instances of research fraud ever reported, a massive scandal that has led to the withdrawal of as many as 21 journal articles (see list).

Virtual Patients

Investigators for the hospital reached a shocking conclusion. “It turned out there was not IRB approval because the data were partially or completely fabricated,” Dr. Jenson told Anesthesiology News. Simply put, Dr. Reuben had concocted the data—and in many cases the patients themselves—out of vapor.


The same article goes on to say that Anesthesia and Analgesia will publish a series of editorials on the case in its May issue. Also, there are not one but two co-authors who claim he put their names on papers without their knowledge. I cannot see how he expected to get away with that sort of thing.
posted by TedW at 5:24 AM on March 13, 2009 [1 favorite]


Forging someone's name on a paper submission is not the work of a balanced mind. You can't really be thinking ahead and imagining that will go unnoticed. Which puts me in mind of a post I think we had here recently about anesthe...whatevers who get hooked on their own drugs. Any possibility of that with this guy, in a research rather than therapy position?
posted by DU at 5:53 AM on March 13, 2009


Any possibility of that with this guy, in a research rather than therapy position?

He was doing clinical research which means he was in the OR taking care of patients so he definitely had access to drugs. I have seen no speculation that that is the case here, but it is a reasonable question to ask.
posted by TedW at 6:01 AM on March 13, 2009


Also, there are not one but two co-authors who claim he put their names on papers without their knowledge.

Why did he not get investigated at this point? That would seem to be a huge red flag.
posted by shothotbot at 6:58 AM on March 13, 2009


His lawyer, Ingrid Martin of Dwyer & Collora, LLP, in Boston, told ScientificAmerican.com that Reuben has cooperated with the investigation and that he "deeply regrets that all of this happened." She added that "with the [investigating] committee's guidance, he is taking steps to ensure this never happens again.

"I'm sorry and it will never happen again."
"Right. That's all I wanted to hear. Off you go then, and don't let me catch you falsifying test results again or next time you will be in big trouble, mister."
posted by Secret Life of Gravy at 7:23 AM on March 13, 2009


That's all I wanted to hear. Off you go then, and don't let me catch you falsifying test results again or next time you will be in big trouble, mister.

There have been cases of research fraud that resulted in prison terms.
posted by TedW at 7:28 AM on March 13, 2009


I think you could make a plausible case for reckless endangerment at the very least. Or have I been watching too much Law & Order?
posted by GrammarMoses at 8:28 AM on March 13, 2009


BUT at least we can all say that this doctor received PLENTY of golf games, dinners, hotel rooms, trips to faraway places and possibly even hookers from all the marketers/sales people of the Pharma companies he was getting paid by.

SEE...there is a positive to this!

Is it just me, or does anyone else think this counts as conspiracy to murder?
posted by hal_c_on at 8:40 AM on March 13, 2009


You run your experiment, then give the data to another scientist to run the experiment again in the hopes that they will duplicate the results, or otherwise find out ways to improve either the outcome or the primary hypothesis.

You don't just give the data to other scientists. I mean, you publish what you found out, but if you publish some wack ass made up data that looks credible, there's a good chance no one is going to audit you. Replication is definitely a critical part of the scientific process, but it's damn hard to get funded for or publish an experiment that is nothing more than an exact replication.

The medical/academic-political implications of insinuating that a prominent researcher is not on the level are huge, and while this dude was wildly shady, it can take a while before what goes around comes around.
posted by solipsophistocracy at 9:02 AM on March 13, 2009


Wow. Maddoff is a fucker for destroying a lot of people's lives, but at least he can say that he didn't directly profit off of their pain.

How screwed up do you have to be to think it would be ok to make money by faking the results on the very thing that eases people's suffering? Repeatedly.
posted by quin at 9:30 AM on March 13, 2009


I cannot see how he expected to get away with that sort of thing.

Forging someone's name on a paper submission is not the work of a balanced mind.

I'm glad you're in this thread, TedW, because I was anxious to hear your opinion of this and because I want you to tell me I'm full of it if that's what you think (though I'm fully cognizant that my desires obligate you not to the slightest degree).

I think you're right DU, this is not the work of a balanced mind.

But it doesn't surprise me that he's an anesthesiologist, either. The very first operation I ever witnessed in person (while awake), a complicated brain surgery where the surgeon drilled a series of holes in the skull of the relatively young woman patient, then connected the dots with a power saw and lifted away a substantial piece of the skull still connected by a skin flap so that it would be able to heal back in place later, at one point half an hour in, the anesthesiologist snuck up behind the surgeon and stuck a great big wad of shaving cream on the back of his neck!

The surgeon jumped a foot and everyone on the surgical team just broke out laughing. The old doc who'd invited me to the operating theater turned to his little group with a smile and said "typical anesthesiologist."

I think a career of peripheral exposures to anesthetics of the sort a working anesthesiologist experiences can lead to, shall we say, a permanently partly disinhibited state of mind.

My guess is that this is not due to brain damage, but to persistent anesthetic residues hanging out in the cell membranes of neurons in the brain.

From anecdotal accounts of high irritability on the part of people who work for long periods of time in helium-oxygen atmospheres under pressure, I imagine these residues could be flushed out by sessions in hyperbaric chambers with heliox atmospheres. (I think the irritability workers report from these conditions is probably due to flushing out the natural anesthetics of dissolved argon and nitrogen all of us might be carrying in our cell membranes.)
posted by jamjam at 9:42 AM on March 13, 2009 [2 favorites]


Reuben, 50, has been stripped of his research and educational duties and has been on medical leave since May.

Medical Leave? Did someone break his legs?


I heard someone kicked him in the dingus.

I wonder what kind of pain meds he'd take for that.
posted by homunculus at 12:04 PM on March 13, 2009 [1 favorite]


Having had a few orthopedic surgeries in the last 10 years, I'm really grateful that my doctor was "old school" and prescribed hydrocodone and tylenol. We talked about some of these studies, and my doctor said that he wasn't convinced that the new proprietary meds were any better than the ones with a zillion years of research behind them.

I've sort of started a policy where I'm just not willing to use any drug that doesn't have a long, long time on the market. Long enough to go generic in many cases. There have just been too many cases in the last decade where pharmaceuticals have been rushed to market, only to be proven incredibly dangerous, or completely worthless.

Our whole medical system is so screwed by the "every one needs to get rich" mentality, that we're willing to sacrifice humans for profit and that's just wrong.
posted by dejah420 at 12:31 PM on March 13, 2009


More than tangentially related (due to his "work" on Celebrex and cox-2 inhibitors): those who find this angle interesting should check out Poison Pills. Despite the slightly sensationalist title, it is a well-written, well-researched read on the pharmaceutical industry and how things like this happen.

It was so scary I could only read a few pages a night, though, so have something happy to read afterward.
posted by fiercecupcake at 1:30 PM on March 13, 2009


(One example: Researchers in the Vioxx studies tried to claim that naproxen must have some sort of heretofore undiscovered and amazing cardioprotective effect, and that's why it made Vioxx look so bad in the trials. Yeah, nice try, guys.)
posted by fiercecupcake at 1:32 PM on March 13, 2009


I've sort of started a policy where I'm just not willing to use any drug that doesn't have a long, long time on the market.

This seems to be going around. I'm pretty stubborn on this one, a good friend is the same, and we both have a doctor who seems to agree.... The drug companies are kinda pissing in their own soup, here, and destroying consumers' (patients') trust.
posted by dilettante at 5:31 PM on March 13, 2009


I've sort of started a policy where I'm just not willing to use any drug that doesn't have a long, long time on the market.

This seems to be going around.


Yes this is something my mom (a nurse) and I talk about. For one thing the old, established medicines are usually a fraction of the cost. It is astonishing how often a new medication will come out that will be less effective yet cost 10 times as much-- it is almost as though the pharmaceutical companies think we are a captive audience with little say in our own treatment.
posted by Secret Life of Gravy at 8:18 PM on March 13, 2009 [1 favorite]


BrnP84 - Some of these people are out doing real research now and I'm sure most of them have enough integrity to be honest about their work but I wouldn't be surprised if this kind of thing happens a lot.

I'd be surprised it they managed to get a MSc or a PhD.

If they're out doing research for a pharmaceutical company, they're going to be unemployed and unemployable now, if not soon. Unless they're doing it under supervision of someone high up who has politicians/reviewers in their pocket.

You can cheat in undergrad classes if you know what the answer is supposed to be. When you're doing research, if you're asking the right questions, you don't know what the answer is. You shoulnd't know the answer, but there's one that you expect or suspect or hope for, until you test the question.

If you make some shit up, people are going to call you on it. Then you never work in science again unless you're charismatic and can promise people that you can clone their beloved deceased pets. But that's not science, just charlatanism.
posted by porpoise at 8:42 PM on March 13, 2009


You bring up a number of points, jamjam, which are worth addressing.

But it doesn't surprise me that he's an anesthesiologist, either.

It sounds like you are basing your opinion of anesthesiologists on a single incident. A lot more tomfoolery goes on in the OR than most people realize, and I have seen incidents similar to what you describe involving pretty much every member of the OR team, not just anesthesiologists and surgeons. I personally would not do something like that, but one of our scrub techs once filled a heart surgeon's gloves with KY jelly before he got gowned and gloved for a case. Everyone, including the surgeon got a good laugh out of it. Lest anyone think it is all fun and games, I have also been with the same team in difficult cases where everyone was dead silent and the room was filled with tension every bit as thick as any TV drama. Also, the researcher in the fraud case I linked earlier was a psychiatrist, so it happens in other fields as well. I would say that anesthesiologists, like any other group, have their share of people who don't follow the rules for whatever reason.

...persistent anesthetic residues hanging out in the cell membranes of neurons in the brain...

This idea is interesting; a few researchers have put forth the idea that anesthesiologists are predisposed to addiction because they are exposed to minute amounts of drugs like fentanyl in the OR air, but that idea is far from universally accepted. As far as other substances present in the air of the OR, our gasses are actively scavenged to avoid contaminating the OR atmosphere and only very small amounts are present; they would be unlikely to displace normal atmospheric gasses in the body to any measurable degree. I actually looked into the anesthetic properties of atmospheric gasses while preparing a lecture on Xenon recently and they affect consciousness only at very extreme pressures, if at all, and so the small, perhaps even undetectable, alterations in their partial pressure in the body are unlikely to alter anyone's behaviour. (As an aside, that same project led me to this paper, which has the best title of any scientific paper I have seen.)
posted by TedW at 5:28 AM on March 14, 2009 [1 favorite]


One example: Researchers in the Vioxx studies tried to claim that naproxen must have some sort of heretofore undiscovered and amazing cardioprotective effect, and that's why it made Vioxx look so bad in the trials.

That's actually not unreasonable, fiercecupcake. Naplroxen is an anti-inflammatory drug and inflammation plays a big role in heart disease. Your larger point is a good one, however. Another book along the lines of Poison Pills (which I haven't read) is Overdosed America, which was critical of these drugs long before their shortcomings were well known. This incident is part of a larger problem: scientific research is being privatized just like many other things previously funded by the government. This limits the type of research being done to that which is likely to find something profitable (which means no studies on novel uses for older drugs that are long off patent and very inexpensive). It also introduces a funding source with deep pockets and a strong financial interest in the results of the study. There have been instances of pharmaceutical companies suing researchers who published negative results. The medical community is aware of this problem, but until public funding for research outpaces corporate funding, it is likely to continue.

I've sort of started a policy where I'm just not willing to use any drug that doesn't have a long, long time on the market.

While there are certainly times when newer drugs are appropriate, I encourage my friends and family to take a similar approach. I myself tend to use older, more established drugs on my patients unless I have a good understanding of how and why a newer drug is better. Even so I can get burned; I used to routinely use aprotinin in my patients until serious questions about its safety were raised. In my defense, I will say that the patients I was using it in (pediatric cardiac surgery) are very different than the adult cardiac patients that had problems with it and many people still think it is useful in pediatric heart surgery.
posted by TedW at 5:57 AM on March 14, 2009 [2 favorites]


Thank you very much, TedW, I really appreciate your thoughtful responses.

I actually looked into the anesthetic properties of atmospheric gasses while preparing a lecture on Xenon recently and they affect consciousness only at very extreme pressures, if at all, and so the small, perhaps even undetectable, alterations in their partial pressure in the body are unlikely to alter anyone's behaviour.

This surprises me, and I'm not sure how to square it with the current state of understanding of Nitrogen narcosis:

Narcosis while diving, commonly called nitrogen narcosis, inert gas narcosis or rapture of the deep, is a reversible alteration in consciousness in scuba divers at depth. It produces a state similar to alcohol intoxication or nitrous oxide inhalation. It occurs to some small extent at any depth, but in most cases does not become noticeable until greater depths, usually from 30 to 40 meters (100 to 130 feet).[2]

Apart from helium, all gases that can be breathed have a narcotic effect, which is greater as the lipid solubility of the gas increases.


130 ft. is only about four atm. beyond ordinary atmospheric pressure at sea level, and even at sea level a considerable amount of nitrogen is dissolved in our tissues, as witness the sound a person can make cracking their knuckles, which is thought to be due to nitrogen coming out of solution to make a bubble in response to the sudden but quite small drop in pressure in the fluid sac surrounding the joint pulling on the finger produces.

If a nitrogen partial pressure of ~4 atm. (130ft) produces a marked narcotic effect, as is apparently the case, then it seems extremely unlikely to me that a nitrogen PP of .8 (ordinary atmospheric pressure) produces no significant narcotic effect when compared to a baseline of zero nitrogen PP (heliox atmospheres).

We don't notice it, perhaps, because we are all drunk in common, though I'm not prepared to rule out a lowering of nitrogen PP as a factor in the intensification of consciousness and the exhilarating feeling of being more fully awake some people report from being in the mountains.
posted by jamjam at 10:50 AM on March 14, 2009


Slightly different, I suppose, but in regards to the whole academic honesty in clinical trials business there was a fascinating paper in Science last week about plagiarism. The paper itself is registration-only but the supporting material is free and contains a slew of responses from the authors of the papers who were called out. Fascinating and depressing stuff.
posted by you're a kitty! at 10:51 AM on March 14, 2009


Just found this article about Pfizer's manipulation of research on Neurontin. Doesn't look like this anesthesiologist is that much of an outlier.
posted by dilettante at 1:15 PM on March 14, 2009


In the same vein, this Rolling Stone article talks about how Zyprexa wound up being used on misbehaving kids. How the pharmaceutical industry turned a flawed and dangerous drug into a $16 billion bonanza
posted by dejah420 at 11:15 AM on March 16, 2009


JAMA editors pressure antidepressant whistle blower
posted by homunculus at 10:33 PM on March 16, 2009


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