For years, the Alliance for Human Research Protection has been disseminating news reports documenting the corrosive impact the intermingling of academic medicine and the pharmaceutical industry has had on the integrity of medical research and clinical practice. In 2002, I made a presentation about conflicts of interest at a symposium sponsored by the U.S. Army Medical Department, in which I included my "dirty dozen" corrupt research review practices that undermine both the safety of human subjects and the integrity of the research findings.
When we observed that not only the pharmaceutical industry, but physician-scientists, academic institutions, and medical journals are all invested in "keeping up appearances" rather than preserving the integrity of science, and honest medicine, we were ridiculed or dismissed as being "anti-science."
We are no longer "blowin’ in the wind." A growing number of prominent physician-scientists, including several former journal editors, and New York Times columnists, have written sobering critiques about the corrupting impact pharmaceutical industry influence has had on medicine. That influence has debased the integrity of medical research, clinical practice and medicine’s institutions.
"The Truth About Drug Companies" (2004) an influential book by Marcia Angell, MD, who had been the editor of The New England Journal for two decades, laid bare the ubiquitous influence industry has on medicine.
Doctors "on the take" [to borrow the title of a book (2005) by another former editor of the NEJM, Jerome Kassirer, MD] are encouraged to promote and widely prescribe clinically worthless drugs for untested uses, without regard for the serious harm caused patients.
Although industry’s cash inducements have corrupted both individual doctors, universities, professional associations, and industry front groups that masquerade as "patient advocates," those most responsible for the corruption of medicine are medicine’s academic leaders, prestigious medical institutions, journal editors, experts charged with formulating practice guidelines, and federal oversight agencies–in particular, the FDA, the National Institutes of Health, and the Center for Disease Control.
When academia and government agencies became stakeholders in the business of medicine, promoting the commercial interests of manufacturers, rather than the public interest, they betrayed the public trust and their professional integrity.
Richard Smith, MD, the former editor of the BMJ (for 25 years) has been an outspoken critic focusing in particular on the role journal editors have played in the corruption of medicine. His book, The Trouble With Medical Journals, 2004, describes journal editors’ unacknowledged significant conflicts of interest.
Readers of the New York Times got a dose of reality in 2006, when Lawrence Altman, MD, the paper’s senior medical reporter, wrote a scathing appraisal of science journal editors’ poor performance in maintaining scientific integrity. Altman lifted the veil of illusion to reveal that the scientific fraternity has vested financial and political interests in maintaining an illusion that "passing peer review is the scientific equivalent of the Good Housekeeping seal of approval." Journal editors recoil at suggestions that the reviewing process for scientific reports itself be tested in accordance with scientific methods. They reject conducting random audits “like those used to monitor quality control in medicine,” citing costs and “the potential for creating distrust.”
Yet, Altman wrote: "even the system’s most ardent supporters acknowledge that peer review does not eliminate mediocre and inferior papers and has never passed the very test for which it is used… If peer review were a drug, it would never be marketed, say critics, including journal editors." See, "For Science’s Gatekeepers, a Credibility Gap."
In 2005, Paul Krugman, a professor at Princeton and a New York Times columnist, wrote, Drugs, Devices and Doctor s the Vioxx crisis at Merck, and the Cleveland Clinic’s firing of Dr. Eric Topol, who, in sworn testimony, accused Merck of scientific misconduct. Krugman pointed out that the real story behind the Merck-Cleveland Clinic scandal "is bigger than either the company or the clinic. It’s the story of how growing conflicts of interest may be distorting both medical research and health care in general."
"The economic logic of the medical-industrial complex is straightforward. Prescription drugs and high-technology medical devices account for a growing share of medical spending. Both are products that are expensive to develop but relatively cheap to make. So the profit from each additional unit sold is large, giving their makers a strong incentive to do whatever it takes to persuade doctors and hospitals to choose their products."
Surely, healthcare reform in the absence of any measures aimed at stemming the corruption will not improve anyone’s health.
A recent article in PLoS Medicine "Conflicts of Interest at Medical Journals: The Influence of Industry-Supported Randomised Trials on Journal Impact Factors and Revenue – Cohort Study" (abstract below) confirms that industry’s influence injects bias into medical journals.
The PLoS study examined industry influence in 6 major medical journals–Annals of Internal Medicine, Archives of Internal Medicine, BMJ, JAMA, The Lancet, and New England Journal of Medicine [NEJM]). For each journal, they identified randomized trials published in 1996–1997 and 2005–2006, categorized by the type of financial support.
They found that the proportion of trials with sole industry support varied between journals: from 7% in BMJ to 32% in NEJM in 2005–2006. Industry-supported clinical trials are far more frequently cited than trials with other types of support. Furthermore, a journal’s impact factor–not to mention, its profit-margin–is greatly enhanced from publication of industry-sponsored clinical trial reports.
The authors’ conclusion and recommendation: "Publication of industry-supported trials was associated with an increase in journal impact factors. Sales of reprints may provide a substantial income. We suggest that journals disclose financial information in the same way that they require them from their authors, so that readers can assess the potential effect of different types of papers on journals’ revenue and impact."
In his BMJ blog, Richard Smith, MD sheds light on the magnitude of undisclosed financial stakes for journal editors with one convincing example. Conflicts of interest arise when considering an article about a large clinical trial funded by a drug company. He informs us that a third of the trials in the NEJM are funded by industry with almost another half having mixed funding that includes a drug company.
"Editors know well that they may be able to sell a million dollars worth of reprints of such an article, with a profit margin of perhaps 70%. In other words publishing that one paper will lead to $700 000 on the bottom line. Very few actions in business provide such a substantial profit from so little."
Industry’s financial influence stacks the deck overwhelmingly in its favor: cash payments buy high impact value. Wide dissemination of commercially-driven reports published in prestigious journals ensure that they will be highly influential–i.e., have high impact–drowning out any independent analyses contradicting industry’s sponsored reports that were designed to promote marketing goals. This symbiotic relationship between industry and journals has polluted the medical literature and debased the practice of therapeutic medicine.
"It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine."
Vera Hassner Sharav
Conflicts of Interest at Medical Journals: The Influence of Industry-Supported Randomised Trials on Journal Impact Factors and Revenue – Cohort Study by Andreas Lundh, Marija Barbateskovic, Asbjørn Hróbjartsson, Peter C. Gøtzsche, members of the prestigious Cochrane Center.
Transparency in reporting of conflict of interest is an increasingly important aspect of publication in medical journals. Publication of large industry-supported trials may generate many citations and journal income through reprint sales and thereby be a source of conflicts of interest for journals. We investigated industry-supported trials’ influence on journal impact factors and revenue.
Methods and Findings
We sampled six major medical journals (Annals of Internal Medicine, Archives of Internal Medicine, BMJ, JAMA, The Lancet, and New England Journal of Medicine [NEJM]). For each journal, we identified randomised trials published in 1996–1997 and 2005–2006 using PubMed, and categorized the type of financial support. Using Web of Science, we investigated citations of industry-supported trials and the influence on journal impact factors over a ten-year period. We contacted journal editors and retrieved tax information on income from industry sources. The proportion of trials with sole industry support varied between journals, from 7% in BMJ to 32% in NEJM in 2005–2006. Industry-supported trials were more frequently cited than trials with other types of support, and omitting them from the impact factor calculation decreased journal impact factors. The decrease varied considerably between journals, with 1% for BMJ to 15% for NEJM in 2007. For the two journals disclosing data, income from the sales of reprints contributed to 3% and 41% of the total income for BMJ and The Lancet in 2005–2006.
Publication of industry-supported trials was associated with an increase in journal impact factors. Sales of reprints may provide a substantial income. We suggest that journals disclose financial information in the same way that they require them from their authors, so that readers can assess the potential effect of different types of papers on journals’ revenue and impact.
Please see later in the article for the Editors’ Summary
Complete article at: http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000354#
Richard Smith on editors’ conflicts of interest
2 Nov, 10 | by BMJ Group
We are all more interested in the conflicts of interests of others than we are in our own, and editors are no exception. Having preached to authors and reviewers on conflict of interest, editors have largely neglected their own, but an important and fascinating paper in PloS Medicine shows how editors can be exposed to dramatic conflicts of interest.
The paper is suitably po faced, as is the accompanying editorial, but, as a blogger and ex-editor, I can spell out one of the conflicts of editors in stark terms. It arises when considering a large clinical trial funded by a drug company, and, for example, a third of the trials in the New England Journal of Medicine are funded by industry with almost another half having mixed funding that includes a drug company. Editors know well that they may be able to sell a million dollars worth of reprints of such an article, with a profit margin of perhaps 70%. In other words publishing that one paper will lead to $700 000 on the bottom line. Very few actions in business provide such a substantial profit from so little.
Deciding whether to publish such a paper provides a stark conflict of interest because editors have to think a lot about money. As income from advertising falls, as it is for many journals just as with newspapers, some journals slip into the red. The minute that a journal loses rather than makes money the owners begin to wonder if they need it. Then even if the journal makes a great deal of money, as do several of the bigger journals, the owners would always like it to make more—or at least maintain the profits because they may well be dependent on them.
So how else might editors put $700 000 onto the bottom line? They have to sell about 10 000 extra subscriptions—because subscriptions have a much lower profit margin. To sell so many subscriptions is virtually impossible—and remember that this is to replace the profit from publishing one drug company sponsored trial. As the paper in PloS Medicine shows, the New England Journal of Medicine in 2005-6 published 66 trials supported solely by industry and another 95 with some industry funding.
Another option would be to cut costs, which probably means staff. The editor would have to fire at least five staff (and probably many more) to add $700 000 to the journal’s profits, and clearly such a strategy could not be followed more than a couple of times.
It’s thus very tempting to publish that drug company sponsored trial, and the temptation is increased further by such trials boosting impact factors, as the PloS Medicine paper shows. Such trials are well cited partly because they are important and partly because drug companies have considerable resources to promote the papers, not least by distributing hundreds of thousands of reprints. The PloS Medicine authors calculate that the impact factor of the New England Journal of Medicine would be reduced by about 15% if it declined to publish drug company sponsored trials.
And editors care very much about impact factors. A high score means not only prestige but also more important papers, more subscriptions, and so more money. Publishing a drug company sponsored trial rather than, say, a study of changing the built environment to increase physical activity will bring both profit and an increased impact factor. How tempting.
The PloS Medicine authors show, as have others, that the proportion of trials funded solely by industry ranges from 7% in the BMJ through 26% for JAMA to 32% for the New England Journal of Medicine. The authors asked the owners of the six journals they studied to give them data on sources of income, but only the BMJ and the Lancet agreed. In 2005-6 the BMJ made 16% of its income from display advertising and 3% from the sale of reprints, while the Lancet made 1% from display advertising and 41% from reprints. The Lancet sold 11,5 million reprints, and the BMJ 968 000.
The authors tried to work out the income of the American journals from their tax returns, but it wasn’t easy because their owners publish more than one journal. They asked the owners to confirm their calculations but were unable to elicit any response from the editors of JAMA and the New England Journal of Medicine.
The conclusion of the authors is that journals should disclose financial conflicts of interest in the way that they require authors and reviewers to do. They will, I suspect, have a long wait.
I must confess that nothing surprised me in the paper, but I do think that it’s am important step to begin to provide some data, albeit tentative and incomplete, on the financial conflicts of interest of editors and journals.
But what did surprise me was the quote from Marcia Angell with which Harvey Marcovitch ended his editorial in PloS Medicine. Angell was an editor on the New England Journal of Medicine for some 20 years, and I knew her a little. She is brilliant and feisty, has been voted one of the most influential women in the US, and fought battles with the Massachusetts Medical Society, the owners of the New England Journal of Medicine. She wrote a very readable and influential book on medicine and the drug industry, and she writes excellent pieces in the New York Review of Books.
I’ve read several of her articles, but I hadn’t read the one that Marcovitch quoted in which she wrote: “it is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of the New England Journal of Medicine.”
Sadly I followed the same path and spelt out my disillusionment in my “j’accuse” book The Trouble with Medical Journals. I wrote it in 2004, and since then my pessimism has deepened.
Competing interest: RS was editor of the BMJ and chief executive of the BMJ Publishing Group from 1991 to 2004. He is also a member of the board of the Public Library of Science.