Cass A
Frequent Contributor (1K+ posts)
Member # 11134
posted
Dear Friends,
I have recently written critically about published medical studies. Here is some recent information about this situation.
Best,
Cass A
ALLIANCE FOR HUMAN RESEARCH PROTECTION A Catalyst for Public Debate: Promoting Openness, Full Disclosure, and Accountability http://www.ahrp.org
FYI Pharmaceutical companies are in business to sell their drugs at prices that will yield the highest profit.
Companies that have failed to develop breakthrough treatments or even improved, clinically significant treatments, have embarked on aggressive marketing campaigns aimed at overcoming unfavorable evidence that would impede market demand for their drugs.
Pharmaceutical companies are employing fraudulent tactics whose purpose is to substitute scientific evidence with promotional hype. They hire "communication firms"--such as GYMR, Emron, DesignWrite, et al--to craft ghostwritten articles that simulate scientific reports favoring their clients' drugs.
Ghosted reports are crafted to create demand for highest priced, often inferior medical products.
Prominent physicians at prestigious academic institutions are paid to pen their name as fake "authors" in order to gain a semblance of credibility and acceptance for publication in influential medical journals.
Ghostwritten journal reports masquerading as scientifically validated reports are a menace to public health.
Many physicians' prescribing practices are guided by fraudulent, industry-sponsored, marketing reports whose very authorship is falsified by academics who relinquish their professional integrity for cash. As a result, patients are harmed by tainted drugs and tainted medical devices.
As stated in PLoS Medicine's motion to obtain the release of 1500 Wyeth documents detailing how articles written by ghostwriters working for DesignWrite, a communication firm hired by Wyeth, were crafted in order to highlight specific marketing messages: ghostwritten reports penned by academic physicians "give corporate research a veneer of independence and credibility;" "substantially distorting the scientific record"; and "threatening the validity and credibility of medical knowledge."
Dr. Daniel Carlat notes that Emron (not Enron) not only produces ghosted promotional reports, but also accredited continuing medical education (CME) programs. http://carlatpsychiatry.blogspot.com/
The firm advertises itself as follows:
"When you're looking to compete on quality, set your sights on Emron for top-flight healthcare marketing communications and brand management. We drive sales, access and reimbursement in competitive markets: our clients achieve sustained competitive advantage by creating product demand and reducing price-sensitivity."
Emron's CME programs help their clients "achieve sustained competitive advantage." http://www.emron.com/emron_flash.htm In other words, Enron helps drug companies create demand and maintain sky-high prices.
The Wyeth documents uncovered during the discovery process in litigation involving the company's hormone replacement therapy, identify dozens of academics who violated their professional and moral integrity, serving as promoters. The Wyeth documents are posted on the PLoS website at: http://www.plos.org/ghostwriting/.
"DesignWrite, a medical writing company hired by Wyeth to prepare an estimated 60 articles favorable to its hormone drugs.
In one publication plan, for example, DesignWrite wrote that the goal of the Wyeth articles was to de-emphasize the risk of breast cancer associated with hormone drugs, promote the drugs as beneficial and blunt competing drugs.
The articles were published in medical journals between 1998 and 2005 - continuing even though a big federal study was suspended in 2002 after researchers found that menopausal women who took certain hormones had an increased risk of invasive breast cancer and heart disease." http://www.nytimes.com/2009/08/05/health/research/05ghost.html
Academics who sell their credibility to facilitate publication of promotional articles in authoritative medical journals, bear responsibility for undercutting the integrity of the medical literature.
Yet, few have been censured for their professional misconduct--indeed, their career, their influence, and their consulting fees have been enhanced.
The Montreal Gazette was first to report about Dr. Sherwin's misconduct: "McGILL Prof Caught in Ghostwriting Scandal?" Court documents indicate thatDesignWrite penned Sherwin's article and faxed it to her 18 months prior to its publication, asking her to "review the enclosed outline."
Prof. Sherwin has been a leading Canadian researcher for more than 20 years. Shortly after the article was published, she received a prestigious James McGill Professor award, which recognizes "a senior scholar's status as outstanding and original researcher of world-class caliber."
What does that say about what constitutes outstanding scholarship in medicine?
Professor Margaret Soltan, an outspoken critic of academic corruption, who doesn't mince words on her blog, UniversityDiaries, skewered the culture that bestows awards on those who corrupt the integrity of science: "It's rare, outside of plays like Tartuffe, that you get hypocrisy so pure. One hundred percent hypocrisy."
University World News reports (below) that Dr. Sherwin has issued an apology, saying she regretted not disclosing the fact that Wyeth had paid a PR firm, DesignWrite, to work on an article published in the Journal of the American Geriatrics Society (2000) to which she penned her name as the author.
The article claimed that estrogen could help treat memory loss in older patients.
Another physician on the PLoS Index of Ghostwriting is Dr. Rogerio Lobo, the former chair of Obstetrics and Gynecology at Columbia's College of Physicians and Surgeons, whose article in the Journal of Reproductive Medicine (2002) was discredited as utter rubbish. Nevertheless, he continues to be a member of the Columbia faculty in good standing. See: http://www.margaretsoltan.com/?s=rogerio+lobo
The Columbia University OBGYN department has the dubious distinction of having at least three members identified as having penned their name to ghostwritten Wyeth reports who are under investigation by Senator CharlesGrassley. Dr. Michelle Warren, Dr. Lori MOsca, and Dr. Rogerio Lobo.
Professor Margaret Soltan (UniversityDiaries) is right when she lays responsibility on academia for turning a blind eye to the corruption of medicine: "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."
How did we get to the point that falsifying the medical literature is acceptable?
The answer lies in the public's misplaced trust in doctors in the absence of a system of independent validation.
The medical profession failed to adhere to the scientific method of independent verification, which requires access to all the raw data from ALL clinical trials.
Instead, the profession caved-in to industry's confidentiality agreements which inevitably give rise to corrupt practices. They caved-in because the financial rewards were so high.
Jim Szaller, a Cleveland lawyer who uncovered the evidence of ghostwriting in his work representing 8,400 women who are suing the drug company Wyeth for misrepresenting the benefits of hormone drugs, said, "ghostwriting is now rampant....This particular practice has to be stopped. It can't continue, because patients are going to suffer."
The reason ghostwriting is "rampant" is the proliferation of ethically challenged academics who find it very easy to become partners in fraud.
Doctors have an inordinate sense of entitlement: they see nothing wrong with getting paid to append their name to work done by others. They see nothing wrong with taking full credit by inserting the ghostwritten articles into their curriculum vita--thereby enhancing their consultancy fees--all without doing the work.
What's more, even when their professional misconduct is uncovered, their academic standing among their academic peers hardly ever suffers.
To whit: Shortly after the ghostwritten article was published, Dr. Sherwin received a prestigious James McGill Professor award, which recognizes 'a senior scholar's status as outstanding and original researcher of world-class caliber."
And in 2007, she was appointed Canada Research Chair in Hormones, Brain and Cognition, which garnered McGill federal funding of $200,000 annually for seven years.
Last year she was granted $70,089 by the federally funded Canadian Institutes of Health Research for a four-year study on "estrogen and cognitive aging in women."
What does this reveal about the standards of scholarship for academics who are awarded endowed chairs in medicine?
Read UniversityDiaries, a blog maintained by Professor Margaret Soltan (George Washington University). Her blistering posts about "ghost-ridden professors" are illuminating. http://www.margaretsoltan.com/?paged=3
In psychiatry, ghosted journal articles are the norm not the exception: most of psychiatry's leading figures have penned their names to articles perpetuating unsubstantiated, false claims about clinically dubious, mostly toxic treatments.
They have done so even after they knew the evidence showed that the drugs hazardous effects were shortening lives.
For example, 20 leading US child psychiatrists penned their name to a (now discredited) ghostwritten report published in the Journal of the American Academy of Child and Adolescent Psychiatry (2001). The claimed positive findings had been falsified by GlaxoSmithKline.
A ghostwritten review praising a dubious invasive treatment, was published in Biological Psychiatry, the official journal of the American College of Neuropsychopharmacology.
The ostensible authors included the chairman of psychiatry at Emory University who was the editor-in-chief of that journal.
Another example of hypocrisy and the awards bestowed on stealth marketers: Psychiatrist Dr. Frederic Goodwin, the former director of the National Institute of Mental Health, who is a Research Professor of Psychiatry at The George Washington University and Director of the University's Psychopharmacology Research Center, was the host of an influential, National Public Broadcasting program, The Infinite Mind, an hour long, national weekly public radio program "dedicated to issues relating to the mind, the brain, and mental illness."
Dr. Goodwin postured as an independent, objective, authoritative scientist, while concealing his extensive financial pharmaceutical ties. Between 2000 and 2007, it was revealed that he earned at least $1.3 million giving marketing lectures for drugmakers, income not mentioned on the program.
Indeed, he used his considerable influence and publicly funded forum to issue seemingly authoritative statements designed to increase use of psychoactive drugs.
His biography posted on his website (2002) states: The Infinite Mind is an award winning program "now carried in more than 170 markets. It's estimated 500,000 + listeners make it the most popular health show in public radio." http://www.drgoodwin.com/bio.html
"In a program broadcast on Sept. 20, 2005, he warned that children with bipolar disorder who were left untreated could suffer brain damage."
This is an unsupportable, controversial view.
Indeed, the bipolar diagnosis in children is not even recognized outside of the US--it has been promoted by US psychiatrists--most aggressively by influential child psychiatrists on the faculty of Harvard University-Massachusetts General Hospital whose multi-million dollar financial ties to drug manufacturers were uncovered by a Congressional investigation.
The toxic drugs financially compromised US psychiatrists recommend for use in children as young as 3 years of age, have caused children to die.
In 2006, USA Today reported that at least 45 child deaths were linked to antipsychotics..... See:http://www.redorbit.com/news/health/488438/new_antipsychotic_drugs_carry_ris ks_for_children/
In 2008, an article in Slate, followed by The New York Times revealed how Dr. Goodwin misinformed his audience, misrepresenting the hazards of antidepressants: "As you will hear today, there is no credible scientific evidence linking antidepressants to violence or to suicide."
He made that assertion even as the increased risk of suicide was by then acknowledged by manufacturers in FDA-mandated Black Box label warnings.
That same week, it was revealed that, "Dr. Goodwin earned around $20,000 from Glaxo, which for years suppressed studies showing that its antidepressant, Paxil, increased suicidal behaviors."
Senator Charles Grassley's public censure of academics is having greater impact than public disclosure of ethical / professional misconduct is not.
That's because his power of persuasion is the authority to withhold public funding from academics who fail to disclose their commercial financial interests, and engage in stealth marketing, and from the academic institutions that harbor them.
Academic institutions--which have themselves become accustomed to getting kick-backs from pharmaceutical companies--will be roused into taking action to prevent faculty members from participating in corporate fraud, only if legislation is enacted--The Physician's Payment Sunshine Act--with meaningful penalties specified.
The practice of ghostwriting, where pharmaceuticals companies convince university professors to put their names on articles written by someone else, was brought further into the light after a Canadian professor admitted she wrote only a portion of a published paper, despite being listed as sole author.
McGill University psychology professor Barbara Sherwin issued an apology, saying she regretted not disclosing the fact that pharmaceutical giant, Wyeth, had paid a firm to work on an article published in the Journal of the American Geriatrics Society.
The article ran in 2000 and reported that oestrogen could help treat memory loss in older patients.
The apology was sparked by a recent unveiling of court documents by the New York Times and the medical journal PLoS Medicine.
The documents showed that 26 articles published between 1998 and 2005, which had emphasised the benefits of taking hormones to protect against various conditions, had been partially or fully written by a writing firm paid by Wyeth.
The drugs company's oestrogen medications, Premarin and Prempro, had annual sales of nearly US$2 billion in 2001.
Sherwin, who holds a Canada Research chair in hormones, brain and cognition, said in her apology that she backed the findings and that they represented "sound and thorough scholarship".
But she regretted not disclosing the writing firm had been involved.
"I made an error in agreeing to have my name attached to that article without having it made clear that others contributed to it," she said.
McGill said it was investigating the matter but would not comment, while the journal appears to have removed the article from its archive.
Sherwin seems to be the first professor to apologise for a situation that others, who have been confronted about ghostwritten material, have dismissed.
Mina Dulcan editor of the Journal of American Academy of Child and Adolescent Psychiatry which published a study on paroxetine and children, told the BBC investigative show Panorama two years ago that she was not bothered by the fact the published article was at odds with the data and appeared to have been ghostwritten.
"I don't have any regrets about publishing at all. It generated all sorts of useful discussion which is the purpose of a scholarly journal," Dulcan said.
An article in the Journal of Reproductive Medicine listing Gloria Bachmann, a professor of obstetrics and gynaecology at the Robert Wood Johnson Medical School in New Jersey, as its lead author was near verbatim to a draft written by the company DesignWrite, the same firm involved in the Sherwin article.
Bachmann told the New York Times:"This is my work, this is what I believe, this is reflective of my view."
Pharmaceutical critic David Healy, a psychiatry professor at Bangor University in the UK, has been warning of ghost-written articles for years.
Healy said the practice was so pervasive he estimated almost all articles linked to an on-patent pharmaceutical were likely to be ghost-written and he has warned journal editors of certain articles that have passed his desk.
"Despite being told the article is ghost-written, the journal published and didn't ask the company to make the data available," Healy said, alluding to his call for raw data to be made available from trials which would help ghostwriters more accurately portray the drug.
Healy has criticised the heavy use by the pharmaceuticals of paid university-based consultants and the burying of negative data.
He said the practice of using ghost-writers was starting to emerge as an issue that threatened the reputations of universities.
"The issue has crept up on people so universities may get their act together in due course.
"They have been prepared to accept some hits to their credibility in return for the money and influence, but if it becomes clear their credibility is suffering too badly this will change.
"Up until now it's been win-win. It will be interesting to see if things change."
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