Posts Tagged ‘Scientific Fraud’

Pfizer writes off $725 million – were they a victim of scientific fraud?

January 20, 2014

Whether it is just error or bad judgement or fraud we will never know. Perhaps all three.

NewsObserver: In 2008, Pfizer paid $725 million for the rights to a Russian cold medicine called Dimebon. The pharmaceutical giant thought the drug could help ameliorate the symptoms of Alzheimer’s. Several clinical trials showed the medicine had no more impact than a placebo. Pfizer has largely abandoned the project.

Earlier this week came the news that Pfizer have now written off the entire $725 million.

The last flickering hope that Medivation’s Dimebon could help Alzheimer’s disease patients has just been extinguished. The biotech announced this morning that a 12-month study of the drug failed to register significant improvements for patients, mirroring two shorter Phase III studies in which Dimebon failed to outperform a sugar pill. Pfizer took the opportunity to bow out of its partnership, writing off its $225 million upfront and $500 million milestone program for what proved to be another embarrassing pipeline failure.

In 2008, Dimebon looked like an odds-on success, with positive data from a Russian study and 10 years of sales experience to underscore its safety. But Medivation was shaken to the core when its first late-stage study ended in failure, with an additional pratfall for Huntington’s disease to cap the disaster.

In the end, Dimebon’s failure helped tarnish the reputation of Russian drug studies while raising severe doubts about Medivation.

It is not only Pfizer which has been forced to make costly write-offs. Not long ago  GlaxoSmithKline was forced to shut down Sirtris Pharmaceuticals which it had acquired in 2008 for $720 million:

Xconomy:

Glaxo paid $720 million to acquire Sirtris in April 2008, to get ahold of technology that generated lots of breathless media coverage as a modern-day fountain of youth. The company sought to make drugs that act on sirtuins, a class of proteins that scientists believe play a role in aging, programmed cell death, and other key cell processes.

Even though the company is closing the Sirtris site, Stubbee says Glaxo remains confident in the drug candidates it got from that acquisition. ….

…. Sirtuins are known to be active when the body is in a calorie-restricted state, which scientists have shown contributes to longer lifespan. The idea at Sirtris was to make small-molecule chemical compounds that activated sirtuins as a way of fighting diseases that develop as people age—including Type 2 diabetes and cancer. ….. The research into the biological role of sirtuins, from Sirtris co-founder David Sinclair, has attracted its share of skeptics. Just last week, Sinclair, a researcher at Harvard Medical School, sought to buttress his early work with a new article in Science that says resveratrol and related compounds can activate sirtuins. One critic, quoted by the Boston Globe last week, said the role of one sirtuin called SIRT1 in aging, “is still as clear as mud.”

GSK is putting a brave face on all of this.

But for many medical and biotech researchers, the path to fame and fortune is by starting a start-up with some new compound or technique and by “leveraging the promise”. For pharma and biotechnology start-ups the objective is to be bought up by one of the majors for as exorbitant an amount as can be managed. And it seems that one way to inflate the value is by making preliminary data and trials show very optimistic results. Negative results never see the light of day and the positive aspects are exaggerated and at worst manipulated.

The ten-fold growth of retractions in medicine related fields since 1975 is mainly due to misconduct according to this report in Nature where “fraud or suspected fraud was responsible for 43% of the retractions”.

For Big Pharma this is simply a consequence of having “outsourced” part of their research. They can afford a few failures it could be thought. Of course the final cost is eventually borne by the consumers but some start-ups make a killing along the way.

Advertisements

Good news today: “Green groups walk out of UN climate talks”

November 21, 2013

The UN Climate conferences must count as the most useless, misguided and profligate international cooperation ever.Therefore one hopes that this report in the Guardian is true. The best thing that could happen would be if everybody walked out of these orgies of decadence and the world could forget the last two decades of waste.

I doubt it will happen, since these UN jamborees provide a wonderful and regular forum for the do-gooders and the catastrophe mongers to gather and wallow in their delusions. Mostly financed by taxes. The IPCC is at best a disgrace to both science and to international cooperation. I suspect the green groups think they will get valuable publicity with their walk-out stunt but will all return tomorrow.

They are on to too good a thing and I doubt that they will walk out never to return. But I can always hope:

The Guardian: 

Environment and development groups together with young people, trade unions and social movements walked out of the UN climate talks on Thursday in protest at what they say is the slow speed and lack of ambition of the negotiations in Warsaw. 

Wearing T-shirts reading “Volverermos” (We will return), around 800 people from organisations including Greenpeace, WWF, Oxfam, 350.org, Friends of the Earth, the Confederation and ActionAid, handed back their registration badges to the UN and left Poland’s national stadium, where the talks are being held. 

“Movements representing people from every corner of the Earth have decided that the best use of our time is to voluntarily withdraw from the Warsaw climate talks. This will be the first time ever that there has been a mass withdrawal from a COP,” said a WWF spokesman. 

“Warsaw, which should have been an important step in the just transition to a sustainable future, is on track to deliver virtually nothing. We feel that governments have given up on the process,” he said.

One more scientist of Indian origin found to have faked data in the US

October 18, 2013

Nitin Aggarwal – a researcher in cardiology – apparently falsified and invented data. Once again a scientist of Indian origin caught faking data. Perhaps it’s the peer pressure – but it does make for depressing reading.

This is scientific fraud and  – once again – I wonder why scientists and scientific bodies should not be held liable and accountable for their “product” which is whatever they publish.

Maybe it is time to sell my shares in BMS.

Retraction Watch reports:

Nitin Aggarwal, formerly of the Medical College of Wisconsin, faked data in his PhD thesis, grant applications to the NIH and American Heart Association, and in two papers, according to new findings by the Office of Research Integrity.

(The case would have apparently first been published in the Federal Register on October 2, except for the government shutdown.)

Here were their findings:

…the Respondent engaged in research misconduct by falsifying and/or fabricating PHS-supported data in six (6) figures that were included in the following two (2) publications, one (1) grant application to the American Heart Association (AHA), one (1) grant application to NIH, and the Respondent’s Ph.D. thesis:

  • Aggarwal, N.T., Principal Investigator (P.I.), National Scientist Development grant application to the American Heart Association No. 11SDG7650072, “Sulfonylurea rReceptor-2 splice variant and mitochondrial mechanisms for cardioprotection and arrhythmia” (hereafter the “AHA grant application”).
  • K99 HL113518-01, “Mitochondrial ATP-sensitive K-channels and pharmacological approaches for cardioprotection,” Aggarwal, Nitin, Ph.D., P.I.
  • Aggarwal, N.T. “Endothelial 15-lipoxygenase regulates vasorelaxation and blood pressure in rabbits in normal and pathological condictions.” A Dissertation Submitted to the Faculty of the Graduate School of Biomedical Science of the Medical College of Wisconsin in Partial Fulfillment of the Requirements for the Degree of Doctor of Philosophy, Milwaukee, Wisconsin, 2008 (hereafter the “thesis”).

…………

Aggarwal won a $1,000 award for his dissertation in 2009. According to his LinkedIn profile and a recent speaker announcement, he’s now working at Bristol Myers-Squibb. We’ve tried to reach BMS for comment, along with the Medical College of Wisconsin, and will update with anything we learn.

Update, 6 p.m. Eastern, 10/17/13: The Medical College of Wisconsin tells us they have no comment on the ORI’s findings.

Dutch social psychologist sacked for faking data over a “prolonged period”

September 12, 2011

On September 7th, Tilburg University officially suspended Diederik Stapel, who heads the Tilburg Institute for Behavioral Economics Research. University Rector Philip Eijlander said that Stapel had admitted to using faked data and said that he would not be allowed to return.

Diederik Stapel

Stapel’s homepage on the Tilburg University website has been removed “by the administrator”.

Mark van Vugt is a Netherlands evolutionary psychologist who currently holds a professorship in psychology at the VU University (Vrije Universiteit) Amsterdam, the Netherlands, and has affiliate positions at the Institute for Cognitive and Evolutionary Anthropology at University of Oxford, UK, and the University of Kent, UK. Mark van Vugt writes about his colleague Diederik Stapel in Psychology Today:

After the high profile case of Marc Hauser, the Harvard psychologist found guilty of serious scientific misconduct there is the recent case of my colleague, Diederik Stapel, a social psychology professor in the Netherlands who has been suspended by his university after admitting to have fabricated experimental data over a prolonged period.

The extent of his fraud is yet unclear but it has produced shock waves among the international social psychology community.

Stapel was the poster boy of Dutch social psychology, having published in the major psychology journals, and receiving various grants and prestigious awards for his research on social cognition and stereotyping. In a recent article published in Science, he and his colleagues showed that in a messy environment (a dirty railway station) White participants were more prejudiced against a Black person. The authenticity of these results is now being investigated…

The Science article that is being investigated is Coping with Chaos: How Disordered Contexts Promote Stereotyping and Discrimination by Diederik A. Stapel and Siegwart Lindenberg, Science 8 April 2011: Vol. 332 no. 6026 pp. 251-253 DOI: 10.1126/science.1201068

But this is not the only article being investigated and there may be a rash of retractions to come.

Science Insider writes:

A Dutch social psychologist whose eye-catching studies about human behavior were fodder for columnists and policy makers has lost his job after his university concluded that some of the data in those studies were fabricated.

Tilburg University today officially suspended Diederik Stapel, who heads the Tilburg Institute for Behavioral Economics Research. But in a TV interview today, university Rector Philip Eijlander said that Stapel had admitted to using faked data and said that he would not be allowed to return.

Stapel has worked at the university, located in southern Netherlands, since 2006. He is known as a prolific researcher and a successful fundraiser. His studies appeared to offer new insights into the workings of the human mind; for instance, a Science paper published in April showed that people are more likely to stereotype or discriminate in messy environments.

In the TV interview, Eijlander says he was first contacted on 27 August by “junior researchers” in Stapel’s lab who alleged that his conduct was fraudulent. Stapel immediately admitted that there was “something strange” in his papers, Eijlander says, and “yesterday, he told me that there are faked data.” The university has asked Willem Levelt, a psycholinguist and former president of the Royal Netherlands Academy of Arts and Sciences, to lead a panel investigating the extent of the alleged fraud. Eijlander says that all “tainted papers” will be retracted.

As to the whistleblowers, Eijlander told the television interviewer that “I have a lot of respect for them, because they found it very difficult.”

Just last week, Stapel made headlines with a press release claiming that thinking of eating meat makes people “more boorish” and less social. The announcement, which said that “meat brings out the worst in people,” raised eyebrows because the study hadn’t yet been written up, let alone published.

Roos Vonk, a psychologist at Radboud University Nijmegen and a collaborator on the study, wrote on her blog today that she believes the latest study is likely among those based on fabricated data. She writes that her conclusion is based on the fact that, although the results had been collected by Stapel’s group, “when we discussed [them], I thought it was odd that Diederik didn’t mention the name of his assistant.” But at the time, she writes, the possibility of fraud didn’t occur to her.

Roos Vonk writes further as she apologises on her blog

I regret very much that this has happened and I will do everything what I can so that trust in the scientific work within social psychology will recover. It is conceivable that this extensive lapse of a few colleagues effects the reputation of our entire profession. I understand that this way can work, but I want to stress that this is a single exception  probably much more shocking and shameful for me and my colleagues than for outsiders, because we all in our education are imbued with the importance of integrity.

An interesting UPDATE from Retraction Watch:

An alert Retraction Watch reader has pointed us to a 1999 paper by Stapel with the impossibly ironic title: Framed and misfortuned: identity salience and the whiff of scandal.”

In the article, which appeared in the European Journal of Social Psychology, Stapel and two colleagues reported the results of survey they’d conducted of Dutch psychologists in the wake of a major plagiarism scandal involving an unidentified Dutch clinical psychologist (“we decided to use neither the name of the person who was accused of plagiarism nor the university to which he was affiliated,” they wrote).

Put briefly, the researchers claimed to have found (rather unsurprisingly) that hows psychologists identified themselves professionally dictated how strongly they were affected personally by the scandal. Money quote:

Whether social psychologists view an article about a plagiarist clinical psychologist as relevant or irrelevant to the self may thus be determined by whether their social identity is narrowly defined (‘social  psychologists’), so as to exclude the plagiarist, or broadly define (‘psychologists’) to include the plagiarist.

Stapel’s group also showed that psychologists from the accused’s own university felt the shame of his alleged misdeeds more than those from other institutions.

And from what Roos Vonk has written it would seem that his collaborators indeed feel a stronger sense of shame than others.

It would seem that much of the research by Diederik Stapel will now be investigated and a number of his papers are likely to be retracted. In addition to the Science paper which is already under investigation some of his other earlier publications are:

I wonder whether cognitive psychology is particularly subject to the faking of data – possibly because faking is relatively easy when the data are so often subjective and so little of it is required to be reproducible or quantitative.

Medical ghostwriters and scientists guilty of misconduct should be liable

August 3, 2011

I have long thought that scientific publications (and scientific endeavour in general) cannot be exempt from liability for scientific misconduct – at least a civil liability even if  any criminal liability would depend upon the extent of any fraud involved in a publication or in the performance of scientific activity. The liability would obviously start with the scientists/authors but the entire publishing chain including reviewers, editors and publishers and those who commission the science or the ghost writing must carry their share of responsibility and cannot be exempt.

In a scientific context I think ghostwriting – of itself – is tantamount to fraud.

Why cannot a concept of tort or “product liability”apply to scientists?  

It seems to me that the concept of tort or “product liability” should be applicable to the work of scientists and researchers where their work is the result of faking data, fraud or other misconduct since it would be work that “had not been done in good faith”. Tort would apply because the ramifications of their misconduct would extend far beyond their employment contracts with their employers.

Ghostwriting and guest authoring in industry-controlled research raise “serious ethical and legal concerns, bearing on integrity of medical research and scientific evidence used in legal disputes,”  say two University of Toronto law professors:

Legal Remedies for Medical Ghostwriting: Imposing Fraud Liability on Guest Authors of Ghostwritten Articles

by Simon Stern, Trudo Lemmens PLoS Med 8(8): e1001070. doi:10.1371/journal.pmed.1001070

Summary Points

  • Ghostwriting of medical journal articles raises serious ethical and legal concerns, bearing on the integrity of medical research and scientific evidence used in legal disputes.
  • Medical journals, academic institutions, and professional disciplinary bodies have thus far failed to enforce effective sanctions.
  • The practice of ghostwriting could be deterred more effectively through the imposition of legal liability on the “guest authors” who lend their names to ghostwritten articles.
  • We argue that a guest author’s claim for credit of an article written by someone else constitutes legal fraud, and may give rise to claims that could be pursued in a class action based on the Racketeer Influenced and Corrupt Organizations Act (RICO).
  • The same fraud could support claims of “fraud on the court” against a pharmaceutical company that has used ghostwritten articles in litigation. This claim also appropriately reflects the negative impact of ghostwriting on the legal system.

CTV News says:

Academics who lend their names to medical and scientific articles that they didn’t actually write are doing little more than prostituting themselves, according to two law professors at the University of Toronto. …. 

Academic ghostwriting is a little-known practice that finally came to the public’s attention after some popular drugs like the now-discontinued painkiller Vioxx started showing serious problems.

Lawsuits revealed that studies that suggested the drugs were safe and effective were often not written by the scientists listed as the authors. Instead, they were ghostwritten by writers working for the drug companies that make the medications. The scientists listed as authors were offered payment in return for attaching their names.

The problem of course is that doctors rely on information in the medical literature to make treatment decisions. That’s when “ghostwritten” articles can have devastating effects: by swaying doctors to give patients improper and even harmful treatment. ….

Bengü Sezen – A “Master of Fraud” at Columbia University

August 2, 2011

The case of fraud by Bengü Sezen a chemist at Columbia University goes back many years and was a scandal in 2007 and briefly reported back in December 2010 by Retraction Watch.

Bengu Sezen

Further details have now emerged from the Office of Research Integrity and are put together by Chemical and Engineering News which  “show a massive and sustained effort by Sezen over the course of more than a decade to dope experiments, manipulate and falsify NMR and elemental analysis research data, and create fictitious people and organizations to vouch for the reproducibility of her results.”

A Master of Fraud (MFr) and it strikes me that she could probably have achieved great things if she had spent half as much creativity in real research as she did in duping her peers. Fraud by correction fluid in the age of photo-shopping seems particularly ingenious!!

Dalibor Sames: image njacs.org

No doubt there are extenuating circumstances but for this deception to have continued for a decade does not do any credit to her supervisor Prof. Dalibor Sames. Whether Sames has been subjected to any sanctions by the University is not clear. His role has been the subject of many posts and one “inside story” is available here.

The total number of papers retracted by Sames seems to be eight with Sezen involved in 6 of them.

C & EN carries the story:

Bizarre new details of the Bengü Sezen/Columbia University chemistry research fraud case are revealed in two lengthy reports obtained by C&EN this week from the Department of Health & Human Services. The documents—an investigative report from Columbia and HHS’s subsequent oversight findings—show a massive and sustained effort by Sezen over the course of more than a decade to dope experiments, manipulate and falsify NMR and elemental analysis research data, and create fictitious people and organizations to vouch for the reproducibility of her results. Sezen was found guilty of 21 counts of research misconduct by the federal Office of Research Integrity (ORI), which is housed at HHS, in late 2010 (C&EN, Dec. 6, 2010, page 10). A notice in the Nov. 29, 2010, Federal Register states that Sezen falsified, fabricated, and plagiarized research data in three papers and in her doctoral thesis. Some six papers that Sezen had coauthored with Columbia chemistry professor Dalibor Sames have been withdrawn by Sames because Sezen’s results could not be replicated. The ORI findings back Columbia’s own investigation.

The Sezen case began in 2000 when the young graduate student arrived in the Columbia chemistry department. “By 2002, concerns about the reproducibility of Respondent’s [Sezen’s] research were raised both by members of the [redacted] and by scientists outside” Columbia, according to the documents, obtained by C&EN through a Freedom of Information Act request. The redacted portions of the documents are meant to protect the identities of people who spoke to the misconduct investigators.

By the time Sezen received a Ph.D. degree in chemistry in 2005, under the supervision of Sames, her fraudulent activity had reached a crescendo, according to the reports. Specifically, the reports detail how Sezen logged into NMR spectrometry equipment under the name of at least one former Sames group member, then merged NMR data and used correction fluid to create fake spectra showing her desired reaction products.

The documents paint a picture of Sezen as a master of deception, a woman very much at ease with manipulating colleagues and supervisors alike to hide her fraudulent activity; a practiced liar who would defend the integrity of her research results in the face of all evidence to the contrary. Columbia has moved to revoke her Ph.D. …… 

…… After leaving Columbia, Sezen went on to receive another Ph.D. in molecular biology at Germany’s Heidelberg University. At some point during the Columbia investigation, however, Sezen vanished, though some reports place her at Turkey’s Yeditepe University. Her legacy of betrayal, observers say, remains one of the worst cases of scientific fraud ever to happen in the chemistry community.

See also

Julia Wang’s – The Sames and Sezen case, 2007

Chemical Villain of 2006: Dalibor Sames 

The Sezen Files – Part II: Unraveling the Fabrication


%d bloggers like this: