the letter and spirit of the law: a time for a new precedent…

Posted on Sunday 7 October 2012


Fraud in the Scientific Literature
New York Times
Editorial
October 5, 2012

A surprising upsurge in the number of scientific papers that have had to be retracted because they were wrong or even fraudulent has journal editors and ethicists wringing their hands. The retracted papers are a small fraction of the vast flood of research published each year, but they offer a revealing glimpse of the pressures driving many scientists to improper conduct. Last year, Nature, a leading scientific journal, calculated that published retractions had increased tenfold over the past decade — to more than 300 a year — even though the number of papers published rose only 44 percent. It attributed half of the retractions to embarrassing mistakes and half to “scientific misconduct” such as plagiarism, faked data and altered images.

Now a new study, published in the Proceedings of the National Academy of Sciences, has concluded that the degree of misconduct was even worse than previously thought. The authors analyzed more than 2,000 retracted papers in the biomedical and life sciences and found that misconduct was the reason for three-quarters of the retractions for which they could determine the cause. The problem is global. Retracted papers were written in more than 50 countries, with most of the fraud or suspected fraud occurring in the United States, Germany, Japan and China. The problem may even be greater than the new estimates suggest, the authors say, because many journals don’t explain why an article was retracted — a failure that calls out for uniform guidelines.

There are many theories for why retractions and fraud have increased. A benign view suggests that because journals are now published online and more accessible to a wider audience, it’s easier for experts to spot erroneous or fraudulent papers. A darker view suggests that publish-or-perish pressures in the race to be first with a finding and to place it in a prestigious journal has driven scientists to make sloppy mistakes or even falsify data. The solutions are not obvious, but clearly greater vigilance by reviewers and editors is needed.

From the PNAS study [see what he said…]:


[reformatted for clarity]

In the law, there are layers of justice. Did the defendant break the law beyond any shadow of doubt? Was the procedure that convicted the defendant proper, following the letter of the law? We even have a word for that:
    le·gal·is·tic  [lg-lstk]
    adjective
      of, relating to, or exhibiting strict adherence to the law, especially to the letter of the law rather than its spirit.
The the accused gets all the breaks, whereas the authorities must follow their rigid procedures or the criminal walks. Two systems, one for the criminal and another for the policeman. This dichotomy is the subject of endless television series and movies – bad cops; good cops who bend the law in the service of Truth, Justice, and the American way; the other kind of bad cops. And while we all know the historical reasons for insisting on such pristine behavior from our criminal justice system, we still cheer weekly as Brenda Lee [the Closer] bends the rules to get the bad guys.

In certain areas, we hold people to a higher standard: elected and legal officials, airline pilots, doctors, scientists, even our lawyers. When accused, we come closer to a standard of "guilty until declared innocent" than the opposite from our criminal system – a standard of "above suspicion."

The point here is that the predictable reaction to that editorial or the graphs from the PNAS article is to be horrified that the scientists are sinners, and that scientific sin is on the rise. We don’t expect that. From my perspective as someone who has spent a lot of time looking at the scientific literature produced over the last twenty years in psychiatry, my reaction is different. I see that graph as the tip of an iceberg, and the result of allowing scientists the latitude afforded criminals instead of applying a time honored higher standard. In the case of the article often discussed here [Paxil Study 329], no one questions that it is not just wrong, but it is wrong on purpose. It was shepherded into the literature by an unethical pharmaceutical company using a talented ghost-writer and endorsed by scientists who were hardly moral giants. They didn’t change the data – instead they mis-used the tools of science to twist it beyond recognition to reach a conclusion that was the opposed to its true meaning [on purpose]. And we know that’s true because we have all the details, including a $3 B confession by the pharmaceutical cartel that masterminded the dirty deed.

So why hasn’t Paxil Study 329 been retracted? A medley of le·gal·is·tic [lg-lstk] arguments [see The Rules of Retraction]:

  • they didn’t fabricate or falsify the data
  • "no evidence of scientific errors"
  • "nor any justification for retraction according to current editorial standards and scientific publication guidelines"
  • "It generated all sorts of useful discussion which is the purpose of a scholarly journal"
  • "There are very many papers where, if you looked at the data, you could argue that the conclusions are not justified"
  • "Many highly expert child and adolescent psychiatrists were participants in that study, and others that were similar, and others equally expert contributed to the review process"
Melanie Newman’s 2010 article in the British Medical Journal [The Rules of Retraction] tells the story prior to the recent GSK $3 B settlement in which they admit all allegations, including the dark story of Paxil Study 329. So now that legal settlement is in the mix. The Spirit of the Law in this case is not in question. All scientists know how it should be. None would argue that using the tools of science to misrepresent scientific data is fair game. It’s the Letter of the Law that’s on the line.
Le·gal·is·tic [lg-lstk] arguments rely on precedents [and sometimes on hypotheticals] and in this case, there really aren’t any solid precedents because these things don’t directly end up in courtrooms, at least not yet. There are just some guidelines scattered around with nothing like "case law." But the ramifications do end up in court – like this recent settlement with GSK or the numerous Civil suits won in part on the evidence of the misbehavior in this particular article. And Study 329 is not alone in the psychiatric literature – only a well-known example of the conscious, willful, and deceitful use of scientific methodology by a commercial enterprise in concert with academic physicians to defraud help-seeking patients by giving their physicians false information without fabricating or falsifying the data.

So we need a precedent. We need for someone to step up to the plate and do the obviously right thing, retracting the article, ignoring the le·gal·is·tic arguments as inappropriate for a respected scientific community. The only reason that Medicine is respected is that it is believed to operate on a higher ethic than the courts of crimes and misdemeanors. And who should move for retraction? The American Academy of Child and Adolescent Psychiatry. Paxil Study 329 was published by their official journal, and the vulnerable population they treat and represent were the inured party. It’s their precedent to set.

The way to get that graph to look better is to stop overlooking this kind of fraud and assert the ethic that we hold so precious. The only way to get that graph to go down is to push it up to where it belongs…
  1.  
    Joel Hassman, MD
    October 7, 2012 | 6:24 PM
     

    I think you might want to spend some time and energy addressing an alleged statement and plan by the DSM 5 task force to be preparing a version for primary care providers, as it was said by Dr Kupfer in the Clinical Psychiatry News this past month.

    That will be much more damaging, what with these new ridiculous diagnoses like Suicidal Behavior Disorder, to be diagnosed and put on patient records by PCPs/NPs and other non psychiatrists. Now there is a retraction to be chasing!

  2.  
    Bernard Carroll
    October 7, 2012 | 10:05 PM
     

    This tension between legalism and ethics shows up also in the wider behavior of corrupted academic physicians. It’s not just an issue that concerns publications. Some time back I looked at several egregious KOLs and at how they bias the discussion in favor of legalism at the expense of ethics. See here: http://tinyurl.com/9zg66ge

    My main point here was that it is more important to get rid of the bums than to prosecute them. And that’s the job of the professional societies, which are not known for their spine – if at all possible they want to shift the responsibility onto the legal system.

    This line of thinking dovetails with Dr. Nardo’s call on AACAP to initiate retraction of the Study 329 report. Let the authors say it is a no fault retraction but get it done. All eyes now are on AACAP.

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