Top medical journal eases ethics policy- this is sad

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Top medical journal eases ethics policy

By Gorner

Tribune science reporter

Published June 13, 2002

In what some view as another concession to the power of money in medical

research, the New England Journal of Medicine is relaxing its

conflict-of-interest rules for authors of its most comprehensive articles

because it cannot find qualified experts with no financial ties to drug

companies.

Medical journal editors estimate that 95 percent of academic researchers

looking at which drugs and treatments work and are safe have financial

relationships with pharmaceutical companies. Critics argue that these

relationships can sway research, influence what is being studied and what is

not, and create a loss of trust by the public that makes everyone suffer.

Since 1991 the prestigious journal's rule was that no author of a review

article covering state-of-the-art treatments for diseases could have any

financial interest in a company that made a product discussed in the

article--or in any competing product.

" But new treatments are brought out by investigators whose research is in

part supported by industry. They're the ones who know about the new stuff, "

said Dr. Drazen, the journal's editor in chief.

" And if you're a doc, they're the experts you want telling you what works

and what doesn't. "

Drazen was an arthritis researcher at Harvard University whose own ethics

were challenged when one of his review articles had to be withdrawn by the

publication he now heads.

He said that in the two years he has run the Boston-based weekly compendium

of medical studies he has been able to commission and publish only one

review article about a new drug. He called that a disservice to journal

readers as well as to contributors.

Both the New England Journal and the rival Journal of the American Medical

Association have spearheaded attempts to expose ethical problems in

medicine, and the changes at the journal come at a time when the credibility

of such publications is under fire.

Only last week, JAMA published studies criticizing itself and its rival

publications--as well as the media--for presenting some material to the

public that isn't true or is stained by conflicts of interest.

The man behind the New England Journal's tough old policy bade it farewell

with a shrug.

`A sad commentary'

" I'm dismayed, " said Harvard's Dr. Arnold Relman, who edited the publication

from 1977 to 1991. " I think it's a sad commentary on the state of academic

medicine that you can't find top-flight experts who aren't connected to

industry.

" Too much money is changing hands, and I blame the academic leadership, not

the drug companies. They should be pushing for more public funding and less

industry funding.

" The public is better served if academic researchers are looking at hard

evidence and doing objective science. That becomes increasingly difficult

when they're taking money from the drug industry. "

In a related issue Tuesday, a public watchdog group alleged that many

bioethicists have financial ties to the companies they evaluate.

The Center for Science in the Public Interest (CSPI) urged more than 125

bioethics organizations and journals to address the problem by disclosing

consulting, advisory and funding arrangements with biotechnology,

pharmaceutical, chemical and other companies.

Biomedical companies have given at least $2 million to bioethics centers and

offered lucrative contracts to academic researchers, according to published

reports.

" This is a classic case of the fox guarding the henhouse, " said CSPI

Director F. son. " I fear that professional ethicists may lose

sight of right and wrong as they try to make their opinions more palatable

to corporate sponsors. "

According to CSPI, of 89 bioethics organizations surveyed, only the

University of Pennsylvania's center has on its Web site a policy on external

funding and conflicts of interest. Of 53 bioethics journals, only two have

published requirements for disclosing conflicts to the journal and its

readers.

" The problem with ethics consultants is that they look like watchdogs and

can be used like show dogs, " said Carl Elliott, a bioethicist at the

University of Minnesota.

If the New England Journal of Medicine had stuck with its old policy, the

cost would have been high, researchers said.

Since 1812, doctors have been reading the journal. Each week, more than

250,000 copies of the austere white and purposely somber magazine are sent

to homes and doctors' offices in the U.S. and 176 foreign lands.

In 2000, after a series of articles in the Los Angeles Times, the journal

was forced to acknowledge it had violated its own conflict-of-interest

policy 19 times over the previous three years when choosing doctors to

review new drug treatments.

No effect on original studies

The policy change does not affect original studies in the publication--3,500

to 3,800 are submitted each year, of which only 5 to 7 percent are selected.

Those will still contain disclosures of who sponsored the research being

presented and any financial stakes the authors might have.

Review articles, however, are major opinion pieces by authors who are chosen

for their expertise. They are evidence-based, but not data-based, and the

reasoning behind the opinions hinges on authors' integrity.

From now on, the journal will forbid only a " significant " financial stake,

as defined by the National Institutes of Health and the Association of

American Medical Colleges: Payments of up to $10,000 a year are not

considered significant.

Under the new guidelines, the ownership of stock, stock options or patents

is still considered significant because their value can rise and their

potential profitability is unlimited.

Also, authors of review articles cannot have received major support or a

major part of their funding from relevant companies within two years of the

article's publication.

The policy change brings the New England Journal in line with other medical

journals, including JAMA.

" I really think this is much ado about nothing, " said Dr.

DeAngelis, editor of JAMA. " The New England Journal joined the rest of us by

adding the word, `significant.' That's all that's new.

" Who do you want writing editorials but the best people in the business? And

they have the right to be compensated when they take time away from their

patients or their research to consult or serve as visiting professors for a

company.

" What matters is the quality of their opinions. Is the article balanced? Is

it fair? Is it true? Bias has a distinct odor, and it's up to us to smell it

before publication. "