In December 2004, the Journal of the American Medical Association(JAMA) published an article that found that medical journals consistently emphasize the positive results of clinical research studies on therapeutic pharmaceutical drugs, without fully disclosing possible negative effects of drugs. The JAMA article stated in the results that: "[Of] One hundred two trials with 122 published journal articles and 3736 outcomes were identified. Overall, 50% of efficacy and 65% of harm outcomes per trial were incompletely reported."
"...In comparing published articles with protocols, 62% of trials had at least 1 primary outcome that was changed, introduced, or omitted. [86%] percent of survey responders (42/49) denied the existence of unreported outcomes despite clear evidence to the contrary."
Today, a Wall Street Journal front page story, "Worrisome Ailment in Medicine Misleading Journal Articles" (May 10, 2005) focuses on the problem. The article presents the responses of various journal editors to the problem of journalistic integrity, before concluding that journals are addressing the problem and striving to present more balanced studies. Is this false reassurance?
Publishing has multiple points of responsibility. To put it simply, scientists in the lab from techs to post-docs and residents report up to the principal investigator, who oversees and sets the direction of the lab research and assumes responsibility as the primary author on the paper. Publishing authors must be forthright about their results, and journal editors and publishers must select articles that compel readers and sponsors to support the magazine while maintaining journalistic integrity.
The issue at stake is that the journals are increasingly dependent on advertising from pharmaceutical companies, and are therefore increasingly beholden to their influence. Editors of sponsored drug efficacy studies assume integrity, but a pharmaceutical company has every incentive to report positive results. Journals receive advertising support from these authors.
What is most clear from the WSJ article is that at every juncture all parties both recognize the problem and shrug off their own responsibility in the solution. There are two problem areas, according to this account:
- 1) The editorial challenge of verifying submitted research.
- 2) The tension between the pharmas and journals about which results and conclusions are valid.
Pharmaceutical companies feel they are being unfairly scrutinized. All parties disagree about who has greater responsibility. WSJ quotes Jama's editor in chief, who says: "The single thing we change the most often is the conclusion....It comes in as: 'This product is the greatest thing' and we say, 'Under these circumstances, in this population, this medications seems to control a,b and c.'"
JAMA's deputy editor adds: "Science depends on trust...[b]ut if you have trust, you're going to be fooled. You can't have a policeman in every lab." He suggests that the problems stem from dishonest research, which is out of the hands of editors.
The editor of Arthritis and Rheumatism is willing to let others to sort out the fray:
"People have to be realistic about what a journal can do." He said that the job of verifying the drug data was the job of the FDA.
An associate vice president of PHARMA (The Pharmaceutical Research and Manufacturers of America) complained: "Why are our submitted articles different from all other submitted articles?"
But when the FDA criticized article authored by Merck-Johnson & Johnson on the pros of selling a drug over the counter, a Merck official was very critical: "[The FDA] went very, very strictly by the label."
The Wall Street Journal article is interesting, but focuses undue attention on the "tension" between the pharmas, pharma researchers and the journals and therefore fails to uncover the full story. Undeniably, university researchers AND journal publishers in the past 50 years are more reliant on pharma funding and partnerships. Consequently the integrity of study results (and not just those from pharmaceutical companies) should be brought into question, shouldundergo greater scrutiny.
Journal editors may indeed be increasingly challenged to adequately check the veracity of the research studies that are submitted. Without trivializing these issues however, there is another side to the story, which is not the tension between the researchers or journals and pharmaceuticals, but the symbiotic and increasingly intertwined relationship between the journals and the pharmaceutical companies. Beyond the as-if-on-cue responses quoted above is the story that the WSJ chose to omit. It is not a new story.
In a 2003 journal article by Alexader Tsai in the International Journal of Health Services titled "Conflicts Between Commercial and Scientific Interests in Pharmaceutical Advertising for Medical Journals", available as a link from here the author articulately and interestingly details some history between the increasingly symbiotic relationship between the pharmaceutical industry and medical journals.
More than a decade ago, in 1992, Michael S. Wilkes coauthored a paper on the increasing prevalence of distortions of drug advertising in medical journals. Wilke's paper was published in the Annals of Internal Medicine after being rejected by JAMA and NEJM (New England Journal of Medicine). The article spurred outrage from the pharmaceutical industry and *discomfort* for the editors, publishers, and readers of the International Journal of Health Services. According to the New York Times coverage of the debate: (August 1999-- "A Doctor's World; Inside Medical Journals, A Rising Quest for Profits") "drug companies stopped advertising, costing the journal $1 million to $1.5 million, Dr. [Susanne] Fletcher [editor of the Annals at the time] said".
The ensuing turmoil highlighted the increasingly co-dependent relationship between medical journals and pharmas and underscored the diverging goals of editors and publishers. The NYT article elaborated on the rising conflicts of interest between successful - meaning profitable - medical publishing, where the pharmaceuticals were the source of most advertising dollars, and content integrity.
"These societies were kind of frumpy and esoteric, and they are no longer that way," Dr. Fletcher said. "They are big businesses, and editors who traditionally worked with small staffs and had time to read a lot now go to meetings about new ventures."
While the mission of medical journals to disseminate current, useful information to doctors may not have changed, from decades ago, the advertising revenues have grown from tens of thousands of dollars annually to tens of millions of dollars. According to the New York Times report:
"...the journals have increasingly become cash cows for the medical societies and companies that own them, with annual profits in the tens of millions of dollars, largely from drug company advertisements....The New England Journal of Medicine [reported it's earnings in] 1979, when its earnings were less than $400,000 a year. Now [it's] earnings are estimated to be at least $20 million a year..."
The Times went on to quote Dr. Suzanne W. Fletcher, who until 1994 was the co-editor of The Annals of Internal Medicine, owned by the American College of Physicians (she is currently a Harvard professor):
"The journals' success has created an enormous new market force that is beginning to dominate the way medical societies are run," Dr. Fletcher said. In some not-for-profit societies, the business staff is gaining influence over editors, creating frictions between the two traditionally separate sides....."
So the question is, if medical journals are dependent of pharmaceuticals for advertising dollars, can they afford not to be biased? It's not a question of keeping abreast of the data, it's a question of playing CEO, and with that job comes onerous public relations obligations, to readers, doctors, and advertising sponsors, in an order that meets revenue expectations, therefore preserving the entity.
