Clinical Trial Fraud

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June 28, 2021 | 13 Comments

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  1. Medics credited with work of firms’ employees
     US court documents reveal ‘author’ culture

    Sarah Boseley, health editor

    https://www.theguardian.com/science/2009/sep/18/doctors-ghost-writing-pharmaceutical-research

    Ginny Barbour, editor in chief of PloS Medicine, said she was taken aback by the systematic approach of the agency. “I found these documents quite shocking,” she said. “They lay out in a very methodical and detailed way how publication was planned.”Other documents released through US court action show that GlaxoSmithKline employed a ghostwriting programme named Caspper in which doctors could take credit for medical journal articles written by the company’s consultants.

    The project was aimed at boosting the US sales of an antidepressant called paroxetine, which goes by the brand name Paxil in the US and Seroxat in the UK.

    Caspper stood for Case Study Publication for Peer Review. It enabled doctors with positive experiences of Paxil to get into medical journals. A busy doctor could sit back and let a medical writing agency paid by GSK do all their work, from the first draft to getting it accepted for publication by a journal.

    The medical writing agency would prepare drafts using whatever material the doctor sent them and create figures and tables. These would go to the doctor for approval. “The author ensures accuracy of material, updates references, supplies missing information, etc,” says the leaflet. Eventually the doctor would complete a sign-off form and the agency would send the paper for publication.

    Caspper came to light when internal GlaxoSmithKline documents were released in court action in the US brought by the legal firm Baum Hedlund on behalf of patients who claim they were harmed by Paxil. GSK says the programme was discontinued some years ago and that the names of medical writers were included on any published papers.

    But Caspper shows there was no dividing line at the time between science and marketing – the leaflet states its purpose is to “strengthen the product positioning and overcome competitive issues”. Doctors and medical journals became part of a promotional campaign, aimed at selling more drugs.
    CASPPER, GlaxoSmithKline’s Friendly Ghostwriting Program

    https://www.wsj.com/articles/BL-HEB-21375

    Drug makers have been taking heat for a while now over ghostwritten articles in medical journals. Basically, there have been instances where drug companies went out and found doctors willing to put their names on articles that the company paid someone else to write or make significant contributions to.

    So it isn’t surprising to learn from the Associated Press that GlaxoSmithKline used this sort of program several years back to generate articles favorable to its antidepressant Paxil. But the company gave the program a name too clever for us to pass up: CASPPER. Think of it as your own friendly ghostwriter.

    A GSK spokeswoman told the AP that published articles disclosed any assistance the main author received. And, she said, the program was discontinued several years ago.

    Wyeth was in the news last month for ghostwritten articles on hormone therapy, and Merck agreed last year as part of a Vioxx-related deal to stop engaging in ghostwriting.

    Indeed, the drug industry may be moving away from the practice. New industry guidelines set to take effect later this year say that anyone who makes significant contributions to an article should be listed as an author, and anyone who does not shouldn’t be.

    Three Amigos …

    https://davidhealy.org/study-329-response-from-the-authors/

    This picture comes from Carl Eliot based on Johanna Ryan’s noting a curious phrase in the conflict of interest statement from Gabrielle Carlsson below.

  2. “UP TO 90% OF THE PUBLISHED MEDICAL INFORMATION IS FLAWED” – PSYCHOLOGY TODAY

    by Silviu “Silview” Costinescu

    This article is as old as 2010, but no one has ever heard of any actual progress on these issues since, so it’s as good as fresh off the press. It originally appeared with a different title, as seen below.

    Christopher Lane Ph.D.

    GHOSTWRITING AND MEDICAL FRAUD

    CAN ANY MEDICAL RESEARCH STUDIES BE TRUSTED?
    https://silview.media/2020/09/23/psychology-today-up-to-90-of-the-published-medical-information-is-flawed/

    Project on Government Oversight (POGO) 

    Psychiatry Texbook Penned by Two Academic Leaders –GSK Ghosted

    November 30, 2010

    https://ahrp.org/psychiatry-texbook-penned-by-two-academic-leaders-gsk-ghosted/

    Duff Wilson of The New York Times reports (below) that previously sealed GlaxoSmithKline documents  show that a psychiatry textbook, whose listed authors are psychiatrists,  Charles Nemeroff, MD and Alan Schatzberg, MD, was actually ghostwritten by Sally Laden of STI. GSK paid the ghostwriter and the “authors” who penned their names to the book.

     The sheer audacity prompted former FDA commissioner, Dr. David Kessler to exclaim: “To ghostwrite an entire textbook is a new level of chutzpah. “I’ve never heard of that  before. It takes your breath away.”  Surely that is a dubious distinction in academic medicine! 

    Below, we post a copy of the POGO letter to the director of NIH–in which a handful of researchers who used ghostwriters for scientific publications are identified.

    These prominent academic psychiatrists received $66.8 million in NIH grants over the last five years.   

    Shouldn’t anyone who engages in professional misconduct such as fraud, which corrupts the integrity and practice of medicine, be disqualified from having academic standing?

  3. Its a grubby industry filled with rogues, infiltrating their greedy desires into the bottomless pit of a dark corrupt system.
    Sadly, money comes before ethics.
    Are we becoming cash cows for all the wrong reasons?
    When I read about research clinics, I get goosebumps running up my spine. How can we allow ourselves to become guinea pigs and not know the consequences of doing so?
    How did we allow medicine to become the way it is today?
    The doctors will never be held responsible if they give a dodgy medicine to a patient?
    However, if clinicians are found to misprescribe and overprescribe, I am sure that they would be put under the microscope for doing unethical business. (For the layperson, obtaining that proof and evidence is like finding a pin in the haystack. It’s not what you know, it’s what you can prove.
    If most of the information is flawed, how can one possibly give informed consent to information that is unreliable?
    Medicine to me seems more like a wacky lab experiment than a permanent safe cure. With ghostwriters included in the mix, it makes Casper the ghost ever so alluring. The ghostwriters like Casper, can come and go as they pleases and if harm is inflicted they can mysteriously disappear and say it never happened!

  4. One field where ghostwriting is becoming an increasing problem is psychiatry.

    Dr David Healy, of the University of Wales, was doing research on the possible dangers of anti-depressants, when a drug manufacturer’s representative emailed him with an offer of help.

    The email, seen by The Observer, said: ‘In order to reduce your workload to a minimum, we have had our ghostwriter produce a first draft based on your published work. I attach it here.’

    The article was a 12-page review paper ready to be presented at an forthcoming conference. Healy’s name appeared as the sole author, even though he had never seen a single word of it before. But he was unhappy with the glowing review of the drug in question, so he suggested some changes.

    The company replied, saying he had missed some ‘commercially important’ points. In the end, the ghostwritten paper appeared at the conference and in a psychiatric journal in its original form – under another doctor’s name.

    Healy says such deception is becoming more frequent. ‘I believe 50 per cent of articles on drugs in the major medical journals are not written in a way that the average person would expect them to be… the evidence I have seen would suggest there are grounds to think a significant proportion of the articles in journals such as the New England Journal of Medicine, the British Medical Journal and the Lancet may be written with help from medical writing agencies,’ he said. ‘They are no more than infomercials paid for by drug firms.’

    In the United States a legal case brought against drug firm Pfizer turned up internal company documents showing that it employed a New York medical writing agency. One document analyses articles about the anti-depressant Zoloft. Some of the articles lacked only one thing: a doctor’s name. In the margin the agency had put the initials TBD, which Healy assumes means ‘to be determined’.

    Dr Richard Smith, editor of the British Journal of Medicine, admitted ghostwriting was a ‘very big problem’ .

    ‘We are being hoodwinked by the drug companies. The articles come in with doctors’ names on them and we often find some of them have little or no idea about what they have written,’ he said.

    ‘When we find out, we reject the paper, but it is very difficult. In a sense, we have brought it on ourselves by insisting that any involvement by a drug company should be made explicit. They have just found ways to get round this and go undercover.’
    Revealed: how drug firms ‘hoodwink’ medical journals

    Pharmaceutical giants hire ghostwriters to produce articles – then put doctors’ names on them
    Antony Barnett, public affairs editor
    7 Dec 2003

    https://www.theguardian.com/society/2003/dec/07/health.businessofresearch

    Researchers Expose Pharmaceutical Industry Misconduct and Corruption
    Corruption of pharmaceutical industry sponsored clinical trials identified as a “major obstacle” facing evidence-based medicine

     Zenobia Morrill
    January 29, 2018

    https://www.madinamerica.com/2018/01/researchers-expose-pharmaceutical-industry-misconduct-corruption/

    Researchers Jay Amsterdam, MD, Leemon McHenry, PhD, and Jon Jureidini, MD recently published a paper aimed at exposing how the pharmaceutical industry corrupts clinical trials through the manipulation of scientific data. They discuss ghostwriting in medical journals, the use of key opinion leaders as co-conspirators, and the failure of top medical journals to uphold standards of science and peer review.

    “When the probability of having a ghostwritten, fraudulent, industry-sponsored clinical trial accepted for publication in a high-impact medical journal is substantially higher than the probability of having a critical, deconstruction of the same trial accepted there can be no confidence in the medical literature.”

    “Ghostwriting in the hands of the pharmaceutical industry has become a major factor in the ‘crisis of credibility’ in academic medicine,” the authors write, “The integrity of science depends on the trust placed in individual clinicians and researchers and in the peer-review system which is the foundation of a reliable body of knowledge. When, however, academic physicians allow their names to appear on ghostwritten articles, they betray this basic ethical responsibility and are guilty of academic misconduct.”

    “Ghostwriting is not limited to drafting a manuscript; rather it is an academic façade for research that has been designed, conducted and analyzed by industry and it is the main vehicle through which the misrepresentation of the data in favor of the study drug is achieved,” explain the researchers.

  5. Deadly Medicines and Organised CrimeHow big pharma has corrupted healthcarePETER C GØTZSCHE
    with
    Forewords byRichard Smith former editor-in-chief, BMJ (Ironic or what – re study 329

  6. “But, you can only hide the truth for so long. Too many people have been harmed by these drugs, too many lives have been shattered.” –

    https://ahrp.org/spitzers-lawsuit-will-shake-up-the-drug-industry-full-disclosure-is-the-goal/

    The New York Attorney General’s lawsuit will afford the medical community and the public at large an opportunity to learn about the nature and scope of the concealed data, and about the intricate drug marketing schemes in which a prominent cadre of psychiatrists participated. The media’s failure to identify psychiatrists who are paid consultants to drug manufacturers, lent credibility to their, often false, claims about the drugs. They proclaimed the drugs “safe and effective” in medical journals, at professional meetings, and in the media. They did so in the knowledge that negative data contradicting those claims was kept hidden.

    In a press release, Spitzer stated: “Doctors should have access to all scientifically sound information so that they can prescribe appropriate medication for their patients. By concealing critically important scientific studies on Paxil, GSK impaired doctors’ ability to make the appropriate prescribing decision for their patients and may have jeopardized their health and safety.”

    CBS News

    Inside GSK’s CASSPER Ghostwriting Program

    https://www.cbsnews.com/news/inside-gsks-cassper-ghostwriting-program/

    BNET noted yesterday that GSK (formerly SmithKline Beecham in the U.K.) maintained the program to create ghostwritten medical journal articles about its antidepressant, Paxil.

    A look inside the program brochure reveals that Paxil Product Management at GSK expected its drug sales reps to manage doctors as they engaged with CASSPER, even those physicians who are clearly unfamiliar with existing published data on the drug.

    CASSPER ghostwriting brochure 

    http://i.bnet.com/blogs/par000570546-59-caspper-case-study-pub-for-peer-review.pdf

    A look inside…

  7. Opioids: first jury trial opens in US as Johnson & Johnson pays $230m to settle out of court
    BMJ 2021; 374 doi: https://doi.org/10.1136/bmj.n1678 (Published 01 July 2021)

    Owen Dyer
    The State of New York’s lawsuit against US opioid makers and distributors opened on 29 June without several expected defendants, as five companies including Johnson & Johnson removed themselves at the last minute by agreeing to pay out-of-court settlements.

    J and J is one of the companies manufacturing vaccines….hmmm

  8. This is the crux of the problem that all honest doctor and patients have been dealing with for way too long. I couldn’t have said it better myself.

    “Honest doctors can no longer practice honest medicine. We have a healthcare system failure an an epidemic of misinformed doctors and misinformed and harmed patients.” Dr Aseen Malhotra

    When are those in positions of power, Big Pharma, lecturers in academic institutions, doctors and research institutions, pharmaceutical scientists, epidemiologists etc; ever going to make the positive changes we have all been longing for………………..
    Too many lives matter however, what are we doing about it?

  9. “that calls the practice dishonest, unacceptable, and sanctionable. But it seems that these tactics are simply not enough to prevent ghostwriting, and are being sidestepped by those involved.”

    Beware the ghost(writer)s of medical research

    As long as pharmaceutical companies hold the purse strings of medical research, medical knowledge will serve to market drugs, not to promote health. And as long as universities grovel for more partnerships with these companies, the door will remain wide open to proceed with the corruption of scientific research.

    http://www.laleva.org/eng/2011/06/beware_the_ghostwriters_of_medical_research.html

    THE GHOSTMANAGEMENT OF MEDICAL RESEARCH:
    The emergence of corporate science
    Presentation for Carleton University, Ottawa

    By Marc-André Gagnon*, PhD

    http://sellingsickness.com/wp-content/uploads/2012/05/Marc-Andre-Gagnon.pdf

    -UofT: Nancy Olivieri (Apotex), David Healy (Prozac) (Schaffer 2004).

    Ghostwriting: The Dirty Little Secret of Medical Publishing That Just Got Bigger

    https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1000156

    If you are an editor, author, reviewer, or reader of medical journals, or if you depend on your doctor or health care provider getting unbiased information from medical journals, then the 1,500 documents now hosted on the PLoS Medicine Web site [1] should make you very concerned and angry. Because, quite simply, the story told in these documents amounts to one of the most compelling expositions ever seen of the systematic manipulation and abuse of scholarly publishing by the pharmaceutical industry and its commercial partners in their attempt to influence the health care decisions of physicians and the general public.

    This is not the place to review everything written on this topic. Others have written about ghostwriting campaigns concerning single drugs that have led to catastrophic health effects [7], and how even research papers and clinical trials are affected by ghost authors [7],[8]. What’s clear is that ghostwriting can no longer be considered one of the “dirty little secrets” of medical publishing that nothing can be done about.
    While editors, medical schools, and universities have turned a blind eye to, or at the least failed to tackle head-on the pervasive presence of ghostwriting, drug companies and medical education and communication companies have built a vast and profitable ghostwriting industry. Recruitment of academic “authors” appears, within some academic circles, to have come to be considered acceptable, and marketing campaigns are no longer orchestrated around paid display advertisements but instead center on “evidence” provided by seemingly respectable academic review articles, original research articles, and even reports of clinical trials. What, a cynical reader might ask, can I truly trust as being unbiased? The answer is that, sadly, for some or even many journal articles, we just don’t know.

    So what can be done? 

    Primarily, it would mean a sea change in the thinking and behavior of editors, who should create—and be prepared to enforce—journal policies clarifying that involvement with ghostwriting is a serious and punishable breach of publication ethics. 

    It’s time to get serious about tackling ghostwriting.

    5 – “To put it simply: if a cook isn’t cooking, what is a cook then doing?”

  10. Hello Annie,

    Thank you for the inside information. I cannot believe the following:

    These prominent academic psychiatrists received $66.8 million in NIH grants over the last five years. This is indeed, dirty business!

    Shouldn’t anyone who engages in professional misconduct such as fraud, which corrupts the integrity and practice of medicine, be disqualified from having academic standing?

    There is certainly:
    No Ethics, Integrity or Moral Conscience. Anyone, who participates in professional misconduct should have their names shamed and should not be practicing their chosen profession. Catch them out for who they are!
    I would be horrified to discover how many practice unscrupulously and allow this shemozzle to fester?
    What a disgrace!

  11. When it comes to the issue of how the whole ghostwriting business works, Scott nails it in one purple passage, when Griffin says:

    “… the pathway to market for everything you find at the pharmacy begins in medical journals, as scientists publish their findings on the experiments that broaden our understanding of human health….. So, I learned a great deal about how much these papers are the work of hired guns…. science written by marketing professionals posing as clinical researchers. It’s troubling. This process of creating evidence for the FDA seems to have become a pantomime of science…. What I mean by pantomime of science … is that we want to make sure these articles are written by scientists, not salesmen. And it turns out that they are almost entirely written by salesmen.… It’s not against the law or even the ethical codes that govern practice in the various specialties. Think of it as a loophole big enough to drive through with a bus wrapped in vinyl humping Bioferex.” (237)

    https://www.madinamerica.com/2020/09/malcharist-psychiatry-kols-ghostwriters/

    PSYCHIATRIST WHO TOOK $1.2M FROM DRUG COMPANIES

    Professor’s invitation to give prestigious lecture in London causes outrage among peers

    https://www.independent.co.uk/life-style/health-and-families/health-news/honoured-britain-us-psychiatrist-who-took-1-2m-drug-companies-8654535.html

    Britain’s premier institute for the study of mental illness has become embroiled in a damaging row over its decision to invite a disgraced US academic to give the inaugural lecture for a new research centre.

    The decision by the Institute of Psychiatry at Kings College, in central London, Europe’s largest psychiatric research organisation, to invite Professor Charles Nemeroff, an expert in the treatment of depression, has split the psychiatric profession and been attacked by members of the institute itself. Professor Nemeroff, a leading authority on the biological causes of mental illness, is one of the highest profile doctors to have been exposed for concealing large payments from pharmaceutical companies.

    He was forced to resign his post at Emory University, Atlanta, in 2008 after an investigation revealed that he had failed to report more than $1.2m of payments from GlaxoSmithKline, despite having signed an undertaking to limit payments to $10,000 a year.

    He received the payments whilst undertaking a study on behalf of the National Institutes of Health into drugs made by GSK.

    In 2009, Professor Nemeroff was appointed chair of psychiatry at the University of Miami and was subsequently awarded a research grant of $400,000 a year for the next five years by the National Institutes of Health. In 2012 it emerged that US Senator Charles Grassley, whose 2008 investigation triggered Professor Nemeroff’s downfall, had written to the National Institutes of Health to ask why they had given him a grant when he was still under federal investigation.

    Now a group of UK psychiatrists have written to the Institute of Psychiatry protesting against its decision to invite Professor Nemeroff to give the “inaugural annual lecture for the new Centre for Affective Disorders”, which is due to take place at the institute next Monday.

    The group representing the radical Critical Psychiatry Network claims the Nemeroff case is frequently cited as “one of the starkest examples of the financial corruption of medicine” through its “overly cosy relationship with the pharmaceutical industry”.

    “Many medical institutions have recognised this relationship is unhealthy and is bringing the profession into disrepute. We find it surprising therefore that the Institute of Psychiatry has seen fit to invite Nemeroff to deliver this important lecture,” they wrote.

    Separately, Derek Summerfield, honorary senior lecturer at the Institute, wrote in the BMJ, formerly called the British Medical Journal, last week that the Institute of Psychiatry’s lauding of Professor Nemeroff as “one of the world’s leading experts” showed how psychiatric academe “sails blithely on as if such revelations beg no broader questions about its associations and supposed scientific independence.”

    In a response, the Institute said it was “aware of the concerns” and took the issue of declaring financial conflicts of interest “extremely seriously”.

    “We have been informed by Professor Nemeroff that he will not be presenting any research that was funded by commercial companies or affected by commercial implications. Obviously, he will be declaring any relevant conflicts of interest prior to his lecture.”

    Professor Nemeroff could not be contacted for comment. He has previously said that his payments from GSK were for talks about GSK drugs now on the market, while his research funded by NIH involved basic laboratory studies of GSK chemical compounds that were years away from market.

  12. Another case of rotten apples in the Inst of Psychs barrel Some years ago I discovered they were getting funds from BAC British American Tobacco The Inst lead put into writing that the funds were considered acceptable as enabling research ‘for the greater good ‘ of people with mental illness.

  13. Suzanne,
    What a heap of baloney!
    ‘For the greater good ‘ of people with mental illness or to feather their own nests!
    For the love of money, just look at what greedy people do?
    How many people have genuinely benefitted by all this corruption?
    Very sickening, indeed!
    If I was to speak up on corrupt issues my voice would indeed, tremble!

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