NEJM- Caught Covering Up for National Kidney Foundation--an industry front group
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Promoting Openness, Full Disclosure, and Accountability
http://www.ahrp.org
FYI
Readers of the New England Journal of Medicine should be forewarned:
The information in the pages of the NEJM is tainted by industry influence,
its professional and scientific integrity are tainted.
The latest example of corruption at the NEJM was reported by The Wall Street
Journal (below). The NEJM is clearly in the business of promoting industry
tainted treatment recommendations that call for aggressive drug
interventions by suppressing scientific information about lethal effects,
misleading physicians, the media, and the public about the safety of drugs
that in reality pose life threatening risks of harm.
The Wall Street Journal reports that the NEJM suppressed a critical
editorial by its own medical writer, Dr. Robert Steinbrook, because he
disclosed the truth about the drug erythropoietin, or EPO, as recommended by
the National Kidney Foundation.
Dr. Steinbrook informed readers about the Foundation's extensive ties to
industry, noting 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 & Johnson's Ortho Biotech, the current marketers of EPO
in the U.S. Of the 18 members of the group that formulated the guidelines,
two-thirds disclosed financial associations with Amgen or other EPO
manufacturers or marketers, he noted."
Dr. Steinbrook "then 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."
However, he noted that "given the billions of dollars at stake for the drug
and dialysis, such guidance is likely to receive the broadest acceptance if
developed without industry support and by experts without relevant financial
associations." That means lives will be sacrificed on the altar of profits.
The NEJM replaced Dr. Steinbrooks' editorial with one by Dr. Julie
Ingelfinger but neglected to tell readers that she is listed on the Web site
of the Massachusetts chapter of the National Kidney Foundation "as president
and chairman of its medical board at the time her editorial was published
last month."
Earlier this year, the journal was faulted for not being more aggressive in
rooting out problems with a 2000 study it published on Merck & Co.'s
painkiller Vioxx, which was removed from the market in 2004 because of
safety concerns.
It is clear that under the present leadership the NEJM has repeatedly
betrayed its professional and public responsibiltiy and shown bad faith
toward its readership. Industry's version of "evidence-based" medicine has
supplanted scientific integrity.
Contact: Vera Hassner Sharav
212-595-8974
veracare@ahrp.org
http://online.wsj.com/article/SB116709354076459273.html
THE WALL STREET JOURNAL
Medical Journal Spikes Article On Industry Ties
Of Kidney Group
By DAVID ARMSTRONG
December 26, 2006; Page B1
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. 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.
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.
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.
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 & Johnson's Ortho Biotech, the current marketers of EPO
in the U.S. Of the 18 members of the group that formulated the guidelines,
two-thirds disclosed financial associations with Amgen or other EPO
manufacturers or marketers, he noted.
Dr. Steinbrook commented that "given the billions of dollars at stake for
the drug and dialysis, such guidance is likely to receive the broadest
acceptance if developed without industry support and by experts without
relevant financial associations."
The editorial that was published in the New England Journal also expressed
doubt about the kidney foundation guidelines -- saying "these
recommendations are not based on persuasive randomized, controlled trials"
-- but made no mention of the industry funding of the kidney foundation.
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. Considered the most
influential medical journal in the world, the publication is closely watched
for what it says, or doesn't say, about industry influence on medicine.
Earlier this year, the journal was faulted for not being more aggressive in
rooting out problems with a 2000 study it published on Merck & Co.'s
painkiller Vioxx, which was removed from the market in 2004 because of
safety concerns.
The journal in 2002 relaxed its conflict-of-interest policy for editorial
writers. Complaining that it was difficult to find qualified editorial
writers who didn't have a conflict of interest, it loosened its policy to
forbid only writers who have a "significant" stake in the research they
opine on.
By contrast, earlier this year, the rival Journal of the American Medical
Association toughened its disclosure rules, telling study authors it wanted
more information about their relationships with drug and medical-device
companies. This followed a series of gaffes in which authors of studies
published in the medical journal failed to reveal their financial ties with
pharmaceutical companies.
The incident also highlighted the uncertainty over how aggressively to treat
anemia, a shortfall in the body's hemoglobin or oxygen-carrying red blood
cells, in patients with kidney disease. The EPO drugs, such as Amgen's
Epogen, have become best-sellers for their ability to relieve anemia-related
fatigue and allow kidney patients to forestall regular blood transfusions.
The foundation has issued guidelines encouraging doctors to keep hemoglobin
levels in such patients even higher than the level approved by the Food and
Drug Administration. But two clinical trials published in the New England
Journal found that such aggressive efforts to treat anemia appeared to
increase the risk of heart failure in one study, and to accelerate the need
for dialysis in the other.
In one of the studies -- led by Ajay Singh, clinical director of the renal
division of Brigham and Women's Hospital in Boston, and sponsored by J&J's
Ortho unit -- one set of patients received EPO treatments designed to raise
hemoglobin to the near-normal level of 13.5 grams per deciliter. Doctors
targeted a lower hemoglobin level of 11.3 grams per deciliter for the
remaining patients, within the FDA's approved target range of 10 to 12 grams
per deciliter. The kidney foundation's guidelines encompass a hemoglobin
range of 11 to 13 grams per deciliter. The researchers found that patients
in the high-hemoglobin group were nearly 50% more likely to experience heart
problems than patients in the low-hemoglobin group.
The second study, sponsored by Roche and led by Tilman Drueke, a
nephrologist with Necker Hospital in Paris, assigned kidney patients either
to aggressive anemia treatment with a target hemoglobin range of 13 to 15
grams per deciliter or to a more traditional range of 10.5 to 11.5 grams per
deciliter. The team found no significant difference in heart problems
between the groups, although the high-hemoglobin patients reported better
general health and vitality. However, more of the intensively treated
patients had to start dialysis treatment than their counterparts, and tended
to do so more quickly.
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." He said the company promotes the
anemia levels approved by the FDA and not the higher levels suggested by the
guideline committee. Ortho didn't provide financial support for the
development of guidelines, a spokesman says, adding that money it donated
has been used to fund patient screening and medical education programs.
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."
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."
The article did disclose that Dr. Ingelfinger's co-author, Giuseppe Remuzzi,
had received lecture fees from Abbott Laboratories, Sanofi-Aventis, and
AstraZeneca PLC, none of which make EPO. Dr. Remuzzi was unavailable for
comment.
The Web site of the Massachusetts chapter listed Dr. Ingelfinger as
president and chairman of its medical board at the time her editorial was
published last month. But the New England Journal spokeswoman said Dr.
Ingelfinger wasn't in a leadership role there at the time she wrote the
editorial and that her positions have been unpaid.
Calls to Dr. Ingelfinger were returned by public relations staff at the
medical journal, who declined to say whether Dr. Ingelfinger was involved in
vetting Dr. Steinbrook's piece or if her superiors were aware of her roles
at the kidney foundation.
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.
Write to David Armstrong at david.armstrong@wsj.com1
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