Showing posts with label Scientific Fraud. Show all posts
Showing posts with label Scientific Fraud. Show all posts

Tuesday, December 23, 2014

Dr. Scott Reuben: A Slap on the Wrist, Another Lie on the Lips

This piece was originally published on 1 August 2010. I only reread it due to its sudden surge in popularity among visitors to this blog, surpassing even those obsessed with that physician turd, Ochoa. Then I realized that Scott Reuben must be celebrating, not just one of the season's holidays, but his release from court-ordered supervision. May his patients be protected, his research unfunded, and any attempt at publication, refused.





In the course of preparing the recent posts on CRPS-related clinical trials, thoughts popped up of Dr. Scott Reuben.  I was reading the background for a trial about the anti-hyperalgesic effects of Coxibs, and Reuben's name and face came to the forefront of my consciousness when I read that there was "no valid information available" on the topic.

Yes, a quick review of the original 21 fudged and fabricated articles shows the long arm of Dr. Reuben, hard at work, and featured in a peer-reviewed journal:

Update on the role of nonsteroidal anti-inflammatory drugs and coxibs in the management of acute pain.  Reuben SS.  Curr Opin Anaesthesiol. 2007 Oct;20(5):440-50. Review.
PMID: 17873597

In fact, Reuben was prolific on the subject of coxibs (COX2 inhibitors), almost as if he had a personal stake in their reception and use:

[One journal editor] estimates that Reuben's studies led to the sale of billions of dollars worth of the potentially dangerous drugs known as COX2 inhibitors, Pfizer's Celebrex (celecoxib) and Merck's Vioxx (rofecoxib), for applications whose therapeutic benefits are now in question. Reuben was a member of Pfizer's speaker's bureau and received five independent research grants from the company.
On June 24, 2010, Dr. Reuben was sentenced to 6 months in prison, after pleading guilty to a single count of fraud.  Oh, but that's not all. No, he also has to pay a $5,000 fine and $361,932 in restitution.  Lord only knows how much money was made in collusion with pharmaceutical companies and [I am convinced] silent partners (also known as "co-authors").

The legal system's wink at his wrongdoing and its impact is almost as insulting and frightening as the crimes themselves.

In my first post about Reuben, I asked:  "How to accurately quantify the amount of pain this man has caused? How many 'adverse reactions,' how much permanent impairment, how many deaths?"

The title of that first post was "Follow the money." By presuming him to be a common criminal, I seem to have hit upon the truth pretty easily.

Harrumph!

What trumps my harrumph is the load of total crap that has been delivered as his "defense," and which constitutes the ultimate insult to anyone dealing with pain management based on his fraudulent research.

The poor man fudged all those research studies while MANIC... My eye!  Mon oeil!

He surely is impugning the character of people with bipolar disorder by naming the psychiatric disorder as the cause of this fraud perpetrated on his field of study, his co-workers and larger colleagues, his patients, and science, in general. 

What an ass, what a jerk, what a con.

There is a growing literature on bipolar illness and criminality, most of it written by and for a medical audience.  In strictly legal terms, however, the liaison is more tenuous, in that a mood disorder does not affect cognition.

Comorbidity of psychiatric disease with twisted conduct, in the case of Scott Reuben?  Unless the claim is that depression and mania ought to be linked with some kind of periodic antisocial disorder... Oh, please.  It's such good news that he's feeling much better now.

If the mania of bipolar disorder mitigates his guilt in committing these frauds, what explanation is there for his failure to rectify his wrongs once he had cycled on to some other affective phase, once he had begun treatment? Unless, of course, he did not think that imposing his opinions constituted a crime because of his innate superiority, because of the presumed stupidity of his colleagues (the peer-review process didn't exactly have him shaking in his boots!) and patients (he never thought they would actually consult, and weigh the value of, his purported research).

Or, it could have been all about the money.

I fear that the delusions of mania being claimed as defense and explanation by Reuben are borne of the same deluded self-image that we encourage in our physicians and researchers, though we're much more comfortable with the narcissism of a trauma surgeon than we are of the pain manager/anesthesiologist.

Looking back, it's scary to see the evidence of our willingness, as patients, to subvert what we know to be right due to our own delusions, our worship of Dr. God.  Witness this comment left after one of the first discussions of Reuben's falsifications:


Keep in mind he isn't a person off the street he's a DOCTOR and has many years of service and experience...

And this, from one of his patients, still boggles the mind:
I do know that new drugs are not passed by FDA without a certain amount of research on so many people. I do know him and he was my Dr. for many years. Those people that know him and had him as Dr. can all say the same thing, you can't find a more gentle, caring, concerned Dr. as Scott Reuben. If all he did was altar names on charts then that's not so bad. Keep in mind the HIPA law.
If this doctor (married to a psychiatrist, by the way) lacked the massive insight required to know right from wrong in an instance such as inventing test subjects for a fictive drug trial, I might wonder if his problem was not so much a persistent megalomania but more a high-functioning psychosis.

Oh, but have no fear of future wrongdoing to complement his decades of past criminality, because Dr. Reuben will undergo THREE whole years of supervision upon his release.  How it is that he retains his medical license is beyond my powers of comprehension.  And clearly wrong, given the severity of his psychiatric impairment.

When Reuben entered his guilty plea, his attorneys claimed that he had been suffering from an undiagnosed bipolar disorder during the period when he committed the fraud, the apparent result of a manic phase. Reuben was unusually prolific with “research” projects during a 2000-2001 sabbatical, having published 8 papers. Dr. Reuben’s wife, Susan Romm Reuben, MD, is a psychiatrist. Dr. Reuben attempted suicide twice in 2002, his lawyers said. His claim of mental illness has been called under question however.

Glenn J. Treisman, MD, PhD, professor of psychiatry, behavioral science and internal medicine at the Johns Hopkins University School of Medicine in Baltimore, said that although some criminals have bipolar disorder, the condition does not necessarily foster antisocial behavior. “Lots and lots of people have bipolar disorder who don’t commit fraud,” Dr. Treisman said. Equally strange is when “that person was better and knew that he did wrong but didn’t come forward.” Dr. Treisman said it was “unlikely” that Dr. Reuben’s disease would have gone undiagnosed for so long, given that he was a physician married to a psychiatrist. “By the time someone’s tried suicide twice, their psychiatrist wife would have known something was going on,” he said.

Reuben’s bogus research was published in various prominent journals including Anesthesia & Analgesia, Anesthesiology, Journal of Clinical Anesthesia, Journal of Arthroplasty and other titles, which have since retracted the papers. The journals stressed that Dr. Reuben’s co-authors on those papers have not been accused of wrongdoing. He has been accused by at least two of his co-authors of putting their names on his papers without their consent. Anesthesiology News uncovered fraudulent inclusion of one co-author by contacting the alleged research partner he claimed.

Dr. Reuben’s research helped lay the foundation for an emerging area of perioperative care known as“multimodal analgesia”. The scope of the fraud has left “a large hole in our understanding of this field,” said Steven L. Shafer, MD, editor of Anesthesia and Analgesia, “It will take a while for science and practice to sort this out.”Anesthesia and Analgesia published more of the tainted papers than any other journal and quickly announced changes to its guidelines to avoid similar incidents. Allegations of rampant fraud involving Dr. Reuben’s research and the retraction of papers were first reported by Anesthesiology News (March 2009) after Baystate Medical Center officials uncovered evidence of wrongdoing following a routine audit. Falsified reports involved at least 21 articles dating back to 1996. The “research” was funded by grants from Pfizer, Merck & Co. and Wyeth/Rays of Hope for the drugs Celebrex, Vioxx and others.

For what it is worth, I cannot fathom how the pharmaceutical companies with which he colluded (there *had* to be collusion -- you know it, I know it) are walking away unscathed from the revelations of bad and evil science;  Nor do I understand how "co-authors" claim to be unaware of their publishing histories!  Academic publishing is highly insular... Who publishes, when, and where, is common knowledge, fodder for everyday gossip and little things like job retention and the granting of tenure. 

Maybe these hapless co-authors don't read some of the foundational journals in their field?  Is that their explanation?  Or -- maybe -- they were all so lost inside of a huge cloud of clinical depression that they just couldn't find the energy to care? 

More likely?  The Mysteriously Published were too busy meeting the needs of nymphomania, screwing their colleagues, right and left...

The Powers That Be may have blinked, and winked -- but not everyone has lost the capacity to unscramble the plots of this tragicomedy:


Pfizer: The Drug Giant That Makes Bank from Drugs That Can Kill You
 
To say Pfizer’s been accused of wrongdoing is like saying BP had an oil spill. Other drug companies have a portfolio of products, Pfizer has a portfolio of scandals including, but not limited to, Chantix, Lipitor, Viagra, Geodon, Trovan, Bextra, Celebrex, Lyrica, Zoloft, Halcion and drugs for osteoarthritis, Parkinson’s disease, kidney transplants and leukemia.

During one week in June Pfizer 1) agreed to pull its 10-year-old leukemia drug Mylotarg from the market because it caused more, not less patient deaths 2) Suspended pediatric trials of Geodon two months after the FDA said children were being overdosed 3) Suspended trials of tanezumab, an osteoarthritis pain drug, because patients got worse not better, some needing joint replacements (pattern, anyone?) 4) Was investigated by the House for off-label marketing of kidney transplant drug Rapamune and targeting African-Americans 5) Saw a researcher who helped established its Bextra, Celebrex and Lyrica as effective pain meds, Scott S Reuben, MD, trotted off to prison for research fraud 6) was sued by Blue Cross Blue Shield to recoup money it overpaid for Bextra and other drugs 7) received a letter from Sen. Charles Grassley (R-Iowa) requesting its whistleblower policy and 8 ) had its appeal to end lawsuits by Nigerian families who accuse it of illegal trials of the antibiotic Trovan in which 11 children died, rejected by the Supreme Court. And how was your week?
To read all posts about Scott Reuben on elle est belle la seine, click HERE.
Graphic credit: Clinical Guidelines for the Use of Coxibs in Osteoarthritis (OA) and Rhematoid Arthritis (RA)

Monday, January 7, 2013

Have you seen Scott Reuben?


Another bit of housekeeping, this related to a promise to keep half-an-eye on ex-con physician Scott Reuben.  To read my previous posts on "doctor" Reuben, click HERE.  While we wait for him to make [up] the news again, here's the obvious question on many peoples' minds:



Big Pharma's Ghostwriters
Why Are These Fraudulent Papers Unretracted?
by MARTHA ROSENBERG

According to Science Times, the Tuesday science section in the New York Times, scientific retractions are on the rise because of a “dysfunctional scientific climate” that has created a “winner-take-all game with perverse incentives that lead scientists to cut corners and, in some cases, commit acts of misconduct.”

But elsewhere, audacious, falsified research stands unretracted–including the work of authors who actually went to prison for fraud!

Richard Borison, MD, former psychiatry chief at the Augusta Veterans Affairs medical center and Medical College of Georgia, was sentenced to 15 years in prison for a $10 million clinical trial fraud[2] but his 1996 US Seroquel® Study Group research is unretracted.[3] In fact, it is cited in 173 works and medical textbooks, misleading future medical professionals.[4]


Scott Reuben, MD, the “Bernie Madoff” of medicine who published research on clinical trials that never existed, was sentenced to six months in prison in 2010.[5] But his "research" on popular pain killers like Celebrex and Lyrica is unretracted.[6] If going to prison for research fraud is not enough reason for retraction, what is? [Please read the rest of the article HERE.]



[1] http://www.nytimes.com/2012/04/17/science/rise-in-scientific-journal-retractions-prompts-calls-for-reform.html?_r=1&pagewanted=all

[2]  Steve Stecklow and Laura Johannes, “Test Case: Drug Makers Relied on Two Researchers Who Now Await Trial,” Wall Street Journal, August 8, 1997

[3] Richard Borison et al., “ICI 204,636, an Atypical Antipsychotic: Efficacy and Safety in a Multicenter, Placebo-Controlled Trial in Patients with Schizophrenia,” Journal of Clinical Psychopharmacology 16, no. 2 (April 1996): 158–69

[4] Alan F. Schatzberg and Charles B. Nemeroff, Textbook of Psychopharmacology (New York: American Psychiatric Publishing, 2009) p. 609

[5] http://www.scientificamerican.com/article.cfm?id=a-medical-madoff-anesthestesiologist-faked-data

[6] Scott Reuben et al., “The Analgesic Efficacy of Celecoxib, Pregabalin, and Their Combination for Spinal Fusion Surgery,” Anesthesia & Analgesia 103, no. 5 (November 2006): 1271–77.

Thursday, March 22, 2012

Additional Sanctions Against Scott Reuben


Scott S. Reuben: Debarment Order




SUMMARY

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act permanently debarring Scott S. Reuben, M.D. from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Reuben was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the Federal Food, Drug, and Cosmetic Act. Dr. Reuben was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Reuben failed to respond. Dr. Reuben's failure to respond constitutes a waiver of his right to a hearing concerning this action.Show citation box

Friday, January 15, 2010

Scott Reuben, Come on down! Let's Make a Deal!


Newsflash -- courtesy of WSJ Health Blog:

It looks like Scott Reuben, the Massachusetts anesthesiologist said to have used phony research data in 21 published papers, has reached a plea deal with
the feds.


Federal prosecutors accused Reuben of health-care fraud for allegedly
faking data that suggested after-surgery benefits from painkillers including
Merck’s Vioxx and Pfizer’s Bextra and Celebrex, the Justice Department said yesterday. The Justice announcement said he faces as much as a 10-year sentence and a $250,000 fine.

But the Associated Press said Reuben, the former chief of acute pain at Baystate Medical Center in Springfield, has agreed to plead guilty in exchange for prosecutors recommending a more lenient sentence. The sentence
would also reportedly include forfeiting assets of at least $50,000 that Reuben
received for the allegedly phony research. The Republican, a Springfield newspaper, said Reuben has signed a plea agreement under which he must pay $420,000 in restitution to pharmaceutical companies.

Reuben is accused with taking pharma money for doing research, then fabricating results and getting studies published in anesthesiology journals.The tale began to unravel last year as Baystate said it found Reuben had faked data and the Boston U.S. attorney began looking into the case. (For refreshers, see our posts here and here.)

Reuben’s attorney has said in the past his client cooperated with the hospital review and expressed regret. The lawyer didn’t immediately return a call for comment after Thursday’s federal complaint, the AP said.

Monday, September 14, 2009

Trinity


There are three topics that I hope to keep alive on this blog until such time as it is no longer necessary: the missing child Lindsey J. Baum, updates on CRPS clinical trials, and the infamous case of Dr. Scott Reuben.

The hopes, of course, are that Lindsey will be found, the clinical trials will end up being unnecessary, and Dr. Reuben will be in jail.

Then, too, I continue to find interesting related information in the process, like this article on the frequency of scientific fraud that popped up when I updated my googling of Scott Reuben this morning. I found it at an odd site for archived group mail -- the group in this instance being one about Sustainable Fuels! It was originally published at Natural News but it is worth taking a look at it where I first found it -- just for the supporting articles added at the end.

So -- one in seven "scientists" say that their colleagues falsify the data in their research. If that's the ratio among those willing to admit such a thing -- the actual numbers are awful to contemplate.


One in seven scientists report that they have known colleagues to falsify or
slant the findings of their research, according to a study conducted by
researchers from the University of Edinburgh, Scotland, and published in the
journal PLoS One.

A number of scientific data falsification scandals have emerged in recent years, such as the case of a South Korean researcher who invented data on stem cell research. At the same time, increasing controversy over close industry ties to medical research has called into question whether researchers who take money from drug companies might be induced to falsify their data.

"Increasing evidence suggests that known frauds are just the tip of the iceberg and that many cases are never discovered," said researcher Daniele Fanelli.

The researchers reviewed the results of 21 different scientific misconduct surveys that had been performed between 1985 and 2005. All respondents were asked whether they or anyone they knew of had taken part in either fabrication (outright invention of data) or "questionable practices."

Questionable practices were any improper procedure short of fabrication, including failing to publish results contradicting one's prior research, modifying data based on a "gut feeling," changing conclusions after pressure from a funder or selectively choosing which data to include in an analysis.

One in seven scientists said that they were aware of colleagues who had engaged in fabrication, while nearly half -- 46 percent -- admitted to knowing of colleagues who had used questionable practices. Only two percent, however, admitted to fabricating results themselves.

While two percent is higher than previous estimates of the prevalence of data fabrication, researchers believe that the number is still too low. In all likelihood, it reflects both a reluctance by researchers to admit to serious misconduct and a tendency to interpret one's behavior as favorably as possible -- questionable instead of fabrication, or acceptable rather than questionable.

Researchers in the medical and pharmacalogical fields were the most likely to admit to misconduct than researchers in other fields.



Well, thank goodness that medical and pharmacological fields lead the pack in fraud! Jeez... And to round out my failing opinions of those industries:

Six prominent medical journals "published a significant number of articles in 2008 that were written by ghostwriters financed by drug companies," according to a New York Times story. The story cites a study by JAMA editors presented at an international meeting of journal editors.

Overall, 7.8% of the authors who responded anonymously to an online questionnaire "acknowledged contributions to their articles by people whose work should have qualified them to be named as authors on the papers but who were not listed," according to the Times.

Here is the "ghostwriting" rate by journal:

New England Journal
of Medicine – 10.9%;
JAMA – 7.9%;
Lancet – 7.6%;
PLoS Medicine – 7.6%;
Annals of Internal Medicine – 4.9%;
Nature Medicine – 2%.

The editors of the NEJM objected that the study "used an improperly broad definition of ghostwriting," according to the Times, an objection that one of the study's authors dismissed.



*Oh, and there was no updated news on either Lindsey Baum or Scott Reuben. But an updated list of clinical trials can always be found here.



photo credit: US Dept. of Energy, The Manhattan Project, The Trinity Test