Drug Trials - Are They A Farce?

It's no wonder that people are dieing at the hands of these drug companies!  The pharmaceutical companies rig their own studies and suppress negative findings!  Do you still trust the pills that your doctor prescribes to make you well?  It is more likely that those same pills will make you feel worse, if they don't kill you!  ~EV

The Wall Street Journal
May 26, 2005

Medical Editor Turns Activist On Drug Trials

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.

http://online.wsj.com/article/0,,SB111707527980343804,00.html?mod=yahoo_hs&ru=yahoo