Jeffrey Drazen editor NEJM Turns Activist on Drug Trials

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[sSRI-Research] Jeffrey Drazen editor NEJM Turns Activist on

Drug Trials

 

 

 

Jeffrey Drazen editor NEJM Turns Activist on Drug Trials

 

http://www.ahrp.org/infomail/05/05/26a.php

 

Thu, 26 May 2005

 

Journal editors, one by one are trying to retrieve the integrity of

their publications, at last recognizing that the pharamaceutical

industry is a corrupting factor in medical research and the

information disseminated about medicine.

 

Jeffrey Drazen who replaced Marcia Angell as editor of the NEJM, had

extensive financial ties to the drug industry. Initially he scoffed

at those who recognized its corrosive effects on medicine.

 

Drazen said: " This isn't about poking a stick in the eyes of the drug

companies, " he said, adding that his only mission is to " help

physicians do their jobs better and help patients get better

information. " He adds that one of the things that got the editors of

the major medical journals together to try to establish guidelines is

that " we've all had these experiences " in which drug

researchers " weren't giving us the straight story. "

 

No, Dr. Drazen, they haven't given a straight story since they took

over American medicine from the University, the FDA, and the National

Institutes of Medicine.

 

Hopefully, journal editors will step out of their ivy towers and read

investigative news reports that document the corrosive effect the

collapse of needed checks and balances has had on the quality and

integtrity of American medicine.

 

Contact: Vera Hassner Sharav

212-595-8974

 

 

Wall Street Journal

Medical Editor Turns Activist On Drug Trials

Rachel Zimmerman and Robert Tomsho.

May 26, 2005. p. B.1

Full Text (1126 words)

 

JEFFREY DRAZEN, editor of the prestigious New England Journal of

Medicine, has prescribed a strong dose of disclosure for the

pharmaceutical industry he was once accused of embracing too closely.

 

This week, Dr. Drazen accused three big pharmaceutical companies

of " making a mockery " of a government database designed to provide

accessible information about drug trials. He also joined a dozen

other medical-journal editors in again warning that they might refuse

to publish studies that don't adhere to their disclosure demands. Dr.

Drazen has also recently written, and his journal has published,

pieces critical of companies suppressing negative information about

drug trials.

 

And the journal today plans to publish a study suggesting that drug

companies may be exerting more influence over the supposedly

independent academic investigators that they hire to conduct drug

trials than had previously been known. The study, a survey of 107

medical-school research centers, shows that half would allow sponsors

of their research to draft manuscripts reporting the results while

limiting the role of the investigator to suggesting revisions.

 

In the past, taking on drug makers directly, or being seen as

overzealous in trying to uphold the integrity of journals against

commercial interests, has been a perilous path for medical-journal

editors. The journals rely on the companies for advertising and

subscriptions and want to be first to publish new findings that might

come from their trials.

 

The New England Journal says there is no sign that drug companies are

striking back by decreasing advertising. The publication doesn't

release its own advertising figures. But the disclosure campaign

comes at a time when medical journals overall are seeing a decline in

their share of advertising dollars from pharmaceutical concerns, amid

a rapid growth of direct-to-consumer ads. According to IMS Health

Inc., a pharmaceutical information and consulting concern based in

Fairfield, Conn., drug makers spent $448 million, or about 5% of

their promotional budgets on advertising in medical journals in 2003;

in 1996, they spent $459 million, or about 11%.

 

Dr. Drazen's newfound activism is especially striking since he came

under fire for his own financial ties to the pharmaceutical industry

when he took his current job at the New England Journal five years

ago.

 

" He's been converted, " said Marcia Angell, senior lecturer at Harvard

Medical School and Dr. Drazen's predecessor as editor-in-

chief. " Through painful experience, Jeff is learning what these

companies are about. He sees the ugly side that he hadn't seen

before -- the bias that company-sponsored research contains, the

suppression of results that they don't like, the spin of unfavorable

results. "

 

Ken Johnson, a spokesman for the Pharmaceutical Research and

Manufacturers of America, the industry trade group, said Dr. Drazen's

comments were " an unfair criticism. "

 

" Our member companies are committed to making certain that all

patients and their doctors get the information they need to make

informed decisions about medicines, " he said. " They're committed to

making data available from all ongoing controlled clinical trials and

they have until Sept. 13 to post this information. "

 

The trade group has been critical of comments made by Dr. Angell in

the past. But one person familiar with the group said they are trying

to establish a better working relationship with the medical journals.

 

Dr. Drazen, a bow-tie wearing pulmonologist and Harvard Medical

School graduate who still sees patients at the Brigham & Women's

Hospital, said he is no firebrand. But he said he has a new

perspective since becoming editor and witnessing more of the inner

workings of research publishing.

 

" This isn't about poking a stick in the eyes of the drug companies, "

he said, adding that his only mission is to " help physicians do their

jobs better and help patients get better information. " He adds that

one of the things that got the editors of the major medical journals

together to try to establish guidelines is that " we've all had these

experiences " in which drug researchers " weren't giving us the

straight story. "

 

In September, Merck & Co. pulled painkiller Vioxx from the market

after years of efforts by the company to keep safety concerns from

destroying the drug's commercial prospects. In October, regulators

forced several drug companies to add strong warnings about a link

between antidepressants and suicidal tendencies among young people to

medication labels. After regulators started probing the links,

researchers familiar with the data wrote that some unflattering

findings about the antidepressants hadn't been published, potentially

creating an overly positive portrait of some of the drugs.

 

Also in September, Dr. Drazen and editors for several other

international medical journals jointly said that they would no longer

consider publishing studies that weren't registered with a publicly-

available database before the first patient was enrolled. The group

said the policy applied to trials that start after July 1, 2005 and

set a Sept. 13, 2005 registration deadline. The editors indicated

www.clinicaltrials.gov, an online registry operated by the National

Institutes of Health, was the only one meeting its requirements.

 

This week, Dr. Drazen said Merck, Pfizer Inc., and GlaxoSmithKline

PLC were making it extremely difficult to search the NIH database for

information because they had not provided the names of many drugs

under study. He said his criticism was based on a review of the NIH

database by its director, Deborah Zarin. In an interview, Dr. Zarin

said drug names were missing in 90% of the 132 Merck trials she

reviewed; there were also no drugs named in 53% of the 55 Glaxo

trials and 36% of the 75 Pfizer studies.

 

The three drug companies said their filings in the NIH database are

in compliance with federal law and that they are working to expand

the amount of data available there and on their own Web sites. A

Merck spokeswoman said some drugs are not named until late in their

development. A Pfizer spokeswoman said her company's filings omitted

some early-stage trials for competitive reasons. A Glaxo spokesman

said his company provides additional study details to editors,

physicians and patients who inquire.

 

An asthma specialist, Dr. Drazen had financial ties to more than 20

drug companies when he first became editor. He also came under

scrutiny after heaping praise on an asthma drug marketed by a drug

company where he was working as a paid consultant. His statements

were used in company promotions that were found to be misleading by

the Food and Drug Administration. Dr. Drazen said he has severed all

his drug company ties.

 

In 2002, Dr. Drazen was criticized for adopting a new policy whereby

doctors writing reviews or editorials for the journal could accept up

to $10,000 a year from drug companies in consulting and speaking

fees. Previously, they couldn't accept anything. Dr. Drazen argued at

the time that maintaining an absolute ban would have made it too

difficult to find writers.

 

Copyright © 2005, Dow Jones & Company Inc. Reproduced with

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