The New England Journal of Medicine last month published studies warning that aggressive efforts to treat anemia in kidney-disease patients with the drug erythropoietin, or EPO, as recommended by the National Kidney Foundation, appear to increase the risk of heart failure and the need for dialysis. [See related posts here and here.] But the medical journal spiked an opinion piece commissioned from one of its senior writers that was critical of the foundation's reliance on multimillion-dollar donations from the companies that make such drugs.
Meanwhile, the author of the spiked editorial, Dr. Robert Steinbrook, submitted it to one of the journal's chief rivals, the British medical journal Lancet, which ran a version on its Web site on Nov. 17, a day after the New England Journal published its reports on the matter. [Steinbrook R. Haemoglobin concentrations in chronic kidney disease. Lancet 2006; 368: 2191-3.]
Dr. Steinbrook's article said that the foundation's guidelines have been questioned because of the group's close relationship with the drug industry. The article also noted that in fiscal 2005, the foundation received more than half of its support from 'corporate and organizational partners,' and, in the calendar-year 2005, it received $4.1 million from Amgen Inc. and $3.6 million from Johnson and Johnson's Ortho Biotech, the current marketers of EPO in the U.S.
The kidney foundation, which issued its recommendations earlier this year, credits Amgen as the 'founding and principal sponsor' of the guidelines. Such sponsorship is unusual -- the American Diabetes Association, for instance, says it doesn't 'receive or allow for any corporate contributions for our clinical practice recommendations.'
Ellie Schlam, a foundation spokeswoman, says Amgen's sponsorship money paid for guideline-development staffers, a $3,000 grant to each member for travel to meetings and other expenses, plus phone, faxing, copying and other administrative expenses. A disclosure on the foundation's Web site noted that most members of the guideline group have a financial relationship with either Amgen or dialysis providers, who resell EPO and stand to profit from its increased use. Still, the foundation says sponsors aren't informed or involved in any aspect of guideline development.
A spokesman for Amgen said the company is 'not involved in the creation and design of the guidelines we sponsor.'
The New England Journal declined to discuss Dr. Steinbrook's article, saying 'we discuss only content that we have published.' Dr. Steinbrook, a former deputy editor of the New England Journal, has been a national correspondent since 2002. According to a person familiar with the matter, he was told his manuscript lacked balance because it suggested that the commercial support of the guidelines influenced the medical recommendations made by that group. New England Journal editors also criticized the piece for failing to credit the guideline writers for striving to find the right balance when it comes to anemia guidelines.
Meanwhile, Richard Horton, editor of the Lancet, said 'I was surprised Robert came to us because I have admired his work for the New England Journal of Medicine.' Dr. Horton said of the article: 'We thought it extremely important -- because of the significant clinical implications and because of the questions it raised about the propriety of the arrangements over funding and guideline development.'
Then there was the more innocuous in-house editorial,
The journal did run a less-critical editorial on the studies co-authored by Julie Ingelfinger, a nephrologist and deputy editor at the journal who is the immediate past president of the Massachusetts-based chapter of the National Kidney Foundation and a member of the state group's medical advisory board. The editorial that ran made no mention of the foundation's industry funding, and Dr. Ingelfinger's relationship with the foundation wasn't disclosed.
Asked why Dr. Ingelfinger's roles at the Massachusetts Kidney Foundation weren't listed along with the article she co-authored, a spokeswoman for the New England Journal said, 'We publish financial associations that are relevant to the content of the article. We tend to be inclusive, rather than exclusive.'
Frank Davidoff, the editor emeritus of the Annals of Internal Medicine, says Dr. Ingelfinger's association with the kidney foundation should have been made known to readers. 'She should have disclosed that, even if she is the best person to write the editorial,' he said. Dr. Davidoff said medical journals historically have paid less attention to the potential conflicts of editorial writers than they have to researchers publishing original studies.
And the somewhat under-stated conclusion,
The handling of the two articles has reignited debate about the journal's standards and whether it is tough enough on issues involving industry funding of research and treatment guidelines.
Again, as we have stated before, people with conflicts of interest may not be consciously aware of the binds in which they find themselves. However, common sense, economics, and cognitive psychhology suggest people respond to incentives, including financial incentives (see post here). If a person or organization is paid by company x, how likely is he, she, or it to criticize company x's products? How likely is he, she, or it to give company x the benefit of the doubt?
Thus, at a minimum, we urge that all potential conflicts of interest affecting health care decision makers, and those who seek to influence them, ought to be fully and thoroughly disclosed. And we need to consider whether some such conflicts ought to be banned outright.
But people with conflicts, who are now prevalent in academic medicine, and various other health care organizations, are likely to find such discussions very uncomfortable. But that is just why we need to have them.