From the archives of The Memory Hole |
The Los Angeles Times reports that the New England Journal of Medicine has acknowledged apparently in direct response to charges in an earlier L.A. Times piece that there may have been a few bad eggs spoiling their otherwise spotless image. Needless to say, the acknowledgement fell well short of admitting just how far the underlying pathology extends. That would've meant tarnishing not just their own image but that of the entire high-stakes medical/pharmaceutical complex. Of particular note in this context is the individual briefly mentioned at the bottom of this article.
Medical journal admits, apologizes for
ethical lapses: Doctors wrote reviews of drugs despite ties to the manufacturers
From the Los Angeles Times via the Baltimore Sun (24 February
2000)
One of the world's most influential medical journal has admitted to an extraordinary
betrayal of its own ethics, saying that nearly half the drug reviews published
since 1997 were written by researchers with undisclosed financial support
from companies marketing the drugs.
The New England Journal of Medicine, in an unusual internal inquiry
published in today's edition, found that 19 of about 40 drug therapy reviews
violated its tough conflict-of-interest policy. The policy bars researchers
with ties to pharmaceutical companies from writing reviews or editorials
about company products.
Journal editors conducted the audit in response to reports last fall
in the Los Angeles Times identifying eight drug therapy articles
that broke the journal's conflict-of-interest rules. In a terse letter,
the journal confirmed those findings and noted 11 additional articles that
violated the policy.
The authors of the 19 offending articles had disclosed their support from
drug companies to journal editors, who disregarded the guidelines.
"We regret our failure to apply our policy correctly," says the
letter. It was signed by editor in chief Dr. Marcia Angell, deputy editor
Dr. Robert Utiger, and the editor of the drug therapy reviews, Dr. Alastair
J. J. Wood.
"We were careless," Angell said in an interview. The editorial
staff has "heightened vigilance" to the problem and has implemented
new disclosure policies to guard against it, she said.
The 188-year-old weekly has positioned itself as a leading voice in medical
ethics and goaded other publications to adopt standards as high as its own.
"They set up an admirable policy, and it's a pity they didn't follow
up on it," said Dr. Drummond Rennie, an editor at the Journal of
the American Medical Association who has written on ethical dilemmas
in publishing.
For a premier journal to err on a basic matter of editorial integrity raises
questions about the quality of medical data in lesser publications. In fact,
most medical journals would not consider the violations identified by the
New England Journal to be a problem.
The ethical breach shows the deep inroads that commercial sponsorship has
made into academic research and publishing.
"It's symptomatic of where the money comes from nowadays to do research
in medicine," said Mildred Cho, a research scholar at the Stanford
University Center for Biomedical Ethics.
That poses a challenge to readers and editors because authors with a drug
company's financial support are more inclined to write favorably about its
products than are authors lacking such support, studies have shown.
As do most medical publications, the New England Journal prints original
studies by researchers with company support and discloses the link to readers.
But it allows no such links with authors of editorials and review articles,
because those encourage authors to interpret data and express opinions,
the guidelines explain.
Angell said the journal does not plan to change its policy, but will tighten
the monitoring of it.
"It's a difficult policy to maintain because the connections between
academic researchers and the private sector are so close and so manifold,"
Angell said. "Nevertheless, we believe the rationale for the policy
is a good one. So, we're going to soldier on."
She blamed the recent violations on misunderstandings between Wood, who
is a pharmacology professor at Vanderbilt University in Nashville, Tenn.,
and the journal's main editorial office in Boston.
Yesterday's letter consists of three paragraphs and a list of the 18 articles
with one or more authors who received commercial support. The journal had
identified another article in a letter in November.
All the articles should have been disqualified because of major research
support from drug companies, the journal concedes, and three articles had
authors who served as company advisers.
The letter offers few details of the journal's internal audit. No explanation
is offered of why the audit reached back only to January 1997, the starting
date the Times chose for its analysis. The journal implemented its
basic conflict of interest policy in 1990, and Wood -- whom Angell singled
out as a source of the confusion -- has edited the drug therapy review series
for a decade.
The interactions between prospective authors and editors may have entailed
as much coercion as carelessness. In some cases, Angell acknowledged, one
or more editors may have told prospective authors that it was all right
to provide a misleading answer on the journal's mandatory financial disclosure
statement.
That appears to have been the case with Dr. Vera Price, a University of
California, San Francisco dermatology professor, whose favorable review
of hair-loss treatments appeared in the September issue despite her drug
company ties.
About the time the journal asked her to write the article, she was given
the standard disclaimer statement. It says: "I/we have no current,
recent past, or planned future financial associations (such as equity interest,
consultancies or major research support) with a company that stands to gain
from the use of a product (or its competitor) discussed in the editorial
or review article."
Price signed the disclaimer, even though her laboratory would receive more
than $1.7 million in research funding from 1994 to last year from Merck
& Co. and Pharmacia Upjohn, the makers of hair-loss treatments Propecia
and Rogaine, according to records obtained under the California Records
Act.
According to Angell, Wood signaled to Price and probably other prospective
authors that it was all right to sign the disclaimer. "Dr. Wood's assurances
took precedence over [the form]. If they do want to do the article, they're
inclined to hear what they want to hear or to place emphasis on that,"
she said.
Angell disputed that the articles were deficient but acknowledged that readers
were justified in wondering. "These articles all passed painstaking
peer review," she said. "If any bias had been detected, we wouldn't
have published them. But that doesn't mean there isn't a bias. That's why
we have the policy in the first place."
Another article was a review of protease inhibitors, a class of AIDS-fighting
drugs, written by Dr. Charles Flexner, a pharmacologist with the Johns Hopkins
School of Medicine. The journal noted that Flexner had received grants from
Abbott Laboratories and Agouron Pharmaceuticals, two producers of protease
inhibitors.
Flexner could not be reached for comment.
Sun staff writer Jonathan Bor contributed to this article.
Originally published on Feb 24 2000