Showing posts with label Philip Felig. Show all posts
Showing posts with label Philip Felig. Show all posts

Monday, November 05, 2007

Memory Hole (1 November): The case of Philip Felig

Scientific Misconduct Blog Memory Hole: Events of November 1st

whitewashing the spots

29 years ago today: Philip Felig - an important misconduct case begins

Around 1 November 1978 Helena Wachslicht-Rodbard submitted a publication to the The New England Journal of Medicine. The article concerned insulin receptors in patients with Anorexia. What followed became a case study in research misconduct, its definition and the typical reality of its handling.

The following is an abstracted summary of a compelling article on the affair from the New York Times of 1 Nov 1981 ("A fraud that shook the world of science").

NEJM sent the article out for peer review. Two reviewers recommend acceptance subject to revision, and one recommended rejection. Wachslicht-Rodbard began the process of revision. While revising the manuscript, Wachslicht-Rodbard received a rather similar paper from The American Journal of Medicine to review. That paper was written by Vijay Soman and his very famous superior, Philip Felig, of Yale. On reviewing the manuscript she found that it looked like her own. Some paragraphs were identical to those in her article and an equation she had devised to calculate receptor numbers was identical. Moreover it appeared that the authors of that paper had been the very reviewers who had recommend rejection of her own unpublished manuscript.

Felig admitted that he had received the manuscript for review, and had passed the paper onto his junior Soman. He did not regard this as inappropriate, and in terms of his rejection of the competing Wachslicht-Rodbard manuscript felt this was "touch and go who got priority" and that "the issue of conflict of interest needed consideration."

Wachslicht-Rodbard wrote to Relman at the NEJM accusing Soman and Felig of plagiarism.

Wachslicht-Rodbard became increasingly incandescent as it appeared that nothing of substance would be done and that the respective institutions were attempting a quiet cover-up. She noted that her own superior had tried to shut her up, and that she was ordered to stop using N.I.H. stationery and time to pursue her grievance. She stated that she was threatened with dismissal.

Soman admitted that he had kept the Wachslicht-Rodbard paper and had copied some of it, including the equation. Felig stated that "I severely reprimanded him for this".

Time went on. Wachslicht-Rodbard became increasingly angry and wrote to Dean Berliner of the Yale School of Medicine expressing doubts about the whole Soman-Felig paper, asking whether the study had been done at all. Felig himself however looked no further and simply stated that there was no problem. Berliner simply accepted this reassurance, and wrote to Wachslicht-Rodbard: "There is no question that the studies of Soman and Felig were done as described in their manuscript" and that he hoped she would consider the matter closed.

She refused. She stated that she would publicly denounce Soman and Felig at a scheduled scientific meeting. It was then agreed that the Soman+Felig paper would be "audited". In the meantime Wachslicht-Rodbard, totally disillusioned, resigned from the NIH, and left research.

Felig selected an "independent" auditor himself. Weeks passed, and nothing happened. However, Felig was then appointed Samuel Bard Professor and chairman of the Department of Medicine at Columbia, a key position. The Wachslicht-Rodbard charges were still confidential and those awarding the post had not been told anything. Felig felt the storm had passed, took Soman along to his new post, and recommended that Soman be appointed assistant professor.

The challenged Soman-Felig paper then appeared in the American Journal of Medicine that very month despite all questions remaining unanswered. Wachslicht-Rodbard was furious and suggested that a new "auditor" be found. New and strange problems were found with the paper (though the conclusions were identical to who own). For one thing, neither the psychotherapists nor the hospital where the studies had been done were named. A graph appeared to have been invented, with data falling neatly on a curve in an impossible manner.

Vijay SomanAn investigator (Flier) was appointed. Soman then claimed to have thrown away his raw data from the just-published manuscript. The investigator became suspicious. What raw data was available bore no relation to the paper. Soman then admitted to having invented most of the data. At least one of the six participants did not exist. Soman agreed to resign. The Soman-Felig paper would have to be retracted. All of his previous papers would have to be examined - but not to examine them would be far more scandalous.

Felig wrote apologetic letters. However, he did not inform his new prospective employers apart from vaguely mentioning the issue "in the course of discussing other things".

None of Soman's papers could be reconstructed from underlying data. Of 14 papers by Soman and others most appeared to have been fraudulent. Felig was a co-author, along with others, of most of these papers. Felig could no longer constrain the discussion and stories were circulating. Letters of retraction were sent to journals for 12 papers emanating from Yale Medical School, eight co-signed by Felig were retracted.

Felig met with his new employers but told them only of Soman's falsifications. He told nothing about the plagiarism, his rejection of the competing manuscript, or his failure to "discover in the course of a year what [the investigator] had been able to find out in three hours". He had not bothered to show any integrity. He simply moved to New York and started his new post. The rumors reached his new employers and everything Felig had not revealed was made available. A committee was established to review Felig's actions. It was concluded that Felig had failed to communicate incriminating information about himself.

"The Committee must conclude that the events disclosed by the correspondence, and Felig's attitude when asked about these events, reflect ethical insensitivity and the application of unacceptable standards to scientific research." The committee concluded "with the deepest regret" that Felig should not retain his professorship and posts at Columbia.

Felig was fired. But having not been himself guilty of fraud, he returned to Yale and even got some grants.

Helena Wachslicht-Rodbard decided never to return to research.

This all begs the question - what is scientific fraud? What of pretend naivete over the usual norms of scientific behavior? Felig in retrospect felt it was a "mistake" not to investigate his junior colleague's work. "I can't make sense of it. I consider the actions of the people at Columbia so outrageous that I have never been able to explain them in my own mind".

What of actions that are not fraud (as narrowly defined), but are otherwise grossly inappropriate and incompatible with the business of being a scientist? What of the whistleblower who was silenced and ignored? What of the deliberate failure to examine simple questions when it would seem mandatory to do so? What of the collusion with colleagues to "smooth" things over. If actions are not defined as fraud then they are clearly OK.

Source: Abstracted Summary of "A fraud that shook the world of science" - New York Times Nov 1 1981
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Wednesday, October 10, 2007

Memory Hole (10 October): A society of sheep

Scientific Misconduct Blog Memory Hole: Events of October the 10th

Quote of the day

A society of sheep must in time beget a government of wolves.
Juvenal

Pairs of Gypsy twins Auschwitz experiments

63 years ago today: 800 Gypsy children gassed at Auschwitz

On 10 October 1944 800 Gypsy children were gassed to death at Auschwitz. Many children were subjected to medical experiments before they were exterminated. Some Gypsies used in experiments by Mengele at Auschwitz were twins (two pairs of twins at right). Approximately 300,000 Gypsies were murdered in all. Almost all German and Austrian Gypsies (about 30,000) were murdered. The rationale for murder was based in part on the academic "research" of racial scientists Dr. Robert Ritter (a psychiatrist), Dr. Adolf Wurth and Dr. Sophie Ehrhardt (anthropologists) and Eva Justin (a nurse). At the end of the research projects most of their subjects were killed.
Sources: The Nazi Doctors, O Porrajmos - the Gypsy Holocaust, Sinti and Roma Victims of the Nazi era

Windscale 50 years50 years ago today: Coverup of a UK Nuclear disaster at Windscale

On 10 October 1957 Britain suffered its worst nuclear accident. On that night, a fire began to spread throughout the core of the Windscale nuclear reactor (now Sellafield), sending radioactive dust across Britain."

"Radioactive leaks were found and the core of the reactor began dangerously overheating. Some scientists warned that radioactive materials inside could catch fire. But the leaks were hushed up and the warnings ignored. Instead, Windscale was ordered to achieve even greater increases in output to meet a political deadline to explode Britain's first H-bomb. The result was potential disaster - the core of the reactor caught fire and radioactive dust began spreading over the country. Windscale workers faced a terrible dilemma - if they tried to put the fire out with water they risked turning the reactor into a gigantic nuclear bomb, and if they let the fire burn, it could contaminate people across a huge area. Risking death from explosion and radioactive poisoning, the Windscale men averted a major tragedy. The inquiry revealed that the warnings about the risks had been hushed up or ignored. But the government kept its findings secret, and instead blamed the fire on an "error of judgement" by the very workers who had first warned of the potential problems and then battled so heroically to prevent tragedy." A new BBC broadcast discusses the disaster and the coverup: (Read more). See also here and here.

28 years ago today: Pac-Man is born

On 10 October 1979 Pac-Man was released in Japan. It involved ghosts and all sorts.
Proportion of Procter and Gamble data that resembles Pac-Man
Source: Pac-Man

27 years ago today: Philip Felig's loss of the Chair of Medicine at Columbia

On 10 October 1980 the journal Science reported on the ongoing saga of Philip Felig, his rogue co-author Vijay Soman, and the problem at Yale. It is an interesting story and involves the responsibility of coauthors, the reluctance of institutions to investigate themselves, and a lot more. The New York Times has a good summary.

Source: "Imbroglio at Yale (II): A Top Job Lost," Science 210 (10 October 1980), pp. 171-173.

18 years ago today: Dispute over David Baltimore presidency of Rockefeller University

On 10 October 1989 the New York Times reported on the dispute over the invitation to David Baltimore to presidency of Rockefeller University. The New York Times had a "conversation . . . with 15 of the university's 42 full professors . . . All said they opposed the Baltimore candidacy, for various reasons and in varying degrees, and they added that informal polls indicate that perhaps half the full professors oppose him too."

For more on the Baltimore affair see:
Serge Lang QUESTIONS OF SCIENTIFIC RESPONSIBILITY: THE BALTIMORE CASE, Ethics and Behavior Vol. 3 No. 1 (1993) pp. 3-72

Source: New York Times 10 October 1989 (p. 1): "Dispute on New President Shatters Tranquil Study at Rockefeller U."

GSK Study 329

5 years ago today: Dr. Alastair Benbow of GlaxoSmithKline asserts safety of Seroxat/Paxil

On 10 October 2002 Dr. Alastair Benbow, Head of European Psychiatry for GlaxoSmithKline made the following statement:

The overwhelming view of independent medical experts and regulatory bodies around the world who have seen the data, is that Seroxat has a well established safety profile and is an effective treatment with experience in tens of millions of patients worldwide since launch in the UK over ten years ago.
Dr. Alastair Benbow, Head of European Psychiatry for GlaxoSmithKline, 10/10/2002

He later stated:

"I utterly refute any allegations we are sitting on data, that [we] have withheld data or anything like that. We have provided all the data both relating to safety and efficacy in the pediatric population to the regulatory authorities around the world and have hidden nothing."
Dr. Alastair Benbow, Head of European Psychiatry for GlaxoSmithKline, 6/15/2003

It is not clear that these statements were true, but that is perhaps a matter involving the redefinition of words. It is also not clear what data "independent medical experts" have seen, the independence of those experts, or the definition of "all the data". Perusal of some of the evidence makes very worrying reading. Everything is not OK.

It is said that when your taxi driver starts talking about the stock market, it's time to think again about your finances. The same might apply to medicine. Patients are asking the scientific and ethical questions we should be asking.

For some patient writings see:
Seroxat Secrets
Furious Seasons
It's Quite an Experience
Bob Fiddaman Blog

3 years ago today: Anthrax documents show pentagon lied

On 10 October 2004 US "Government officials have acknowledged that the Department of Defense secretly tested squalene on human beings in Thailand. [Col. Felix] Grieder believes they did the same in Dover."

"A former Dover Air Force Base commander says military officials used his troops as guinea pigs in illegal medical experiments under the government's controversial anthrax vaccination program."

"The Delaware News Journal has uncovered documents and videos that reveal that Pentagon officials lied; that US troops were given an experimental concoction of anthrax vaccine laced with squalene. Many soldiers have suffered permanent harm as a result."

"The military's anthrax Web site claims the vaccine is safe, because "The Food and Drug Administration individually approves each lot before release." But FDA documents obtained under the Freedom of Information Act show that the FDA no longer tests the lots for squalene." "The FDA gave limited approval for the Defense Department to test vaccines boosted with squalene during the 1990s. The results of those tests are confidential."

There seems to be a dispute about the science, but how can science function when there is government sanctioned lying? And why should the results of such research ever be confidential?

Source: "Ex-DAFB commander says troops used as guinea pigs" Delaware News Journal, 10 Oct 2004

2 years ago today: Safety of long-term PPI acid-suppressing drugs

On 10 October 1947 questions over the safety of long-term use of proton-pump inhibitors (PPIs) hit the Wall Street Journal.

The long-term safety of PPIs is not completely known. PPIs include Nexium, Protonix and Prevacid. They account for $13 billion in sales each year, making PPIs the second most popular drug after statins. Stomach acid clearly serves a function. Given widespread use we need to know a bit about long term effects. The reports suggested that preliminary research links PPIs to a rising incidence of esophageal cancer. Concerns are also expressed about "overgrowth of bacteria in the digestive tract" and possible rare cases of life threatening Clostridium difficile colitis. All these things are disputed. PPIs seem to be a risk factor for osteoporosis and fractures.

The fact remains that we really know rather little about the long-term balance of risks and benefits for the most widely used drugs. We may be asking the wrong questions and designing the wrong studies. Watch this space.

Source: "The hidden dangers of heartburn" Oct 10 2005, Wall Street Journal

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