Excerpt:  "There is a view that these drugs are effective all the
time," he said. "I would say they only work 40% to 50% of the time,
and they would say, 'What are you talking about? I have never seen a
negative study.'" Dr. Turner, from his time reviewing studies at the
FDA, said he knew there were negative studies that hadn't been
published.

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Study Says Patients, Doctors Get
Distorted View of Antidepressants
Researchers Say Unpublished Reports Have Found
Many Drugs Have Little or No Effect on Patients

http://online.wsj.com/article/SB120051950205895415.html?mod=hpp_us_whats_news
By DAVID ARMSTRONG
January 16, 2008 5:23 p.m.

Numerous unpublished studies submitted to the Food and Drug
Administration by pharmaceutical companies have found that many
popular antidepressants have little or no effect on patients,
according to a new review of the previously hidden findings.

As a result, researchers asserted in this week's New England Journal
of Medicine, doctors and patients are getting a distorted view of the
effectiveness of blockbuster anti-depressants like Wyeth's Effexor and
Zoloft, made by Pfizer Inc.

Since the overwhelming amount of published data on the drugs show they
are effective, doctors unaware of the unpublished data are making
inappropriate prescribing decisions that are not in the best interest
of their patients, according to researchers led by Erick Turner, a
psychiatrist at Oregon Health and Science University. Sales of
antidepressants total about $21 billion a year, according to IMS
Health.

Pharmaceutical companies are under no obligation to publish the
studies they sponsor and submit to the FDA, nor are the researchers
they hire to do the work. The researchers publishing in the New
England journal were able to identify unpublished studies by obtaining
and comparing documents filed by the companies with the FDA against
databases of medical publications.

Pfizer and Wyeth declined to comment on the study results. Both
companies said they had committed to disclose all study results,
although not necessarily in medical journals.

An FDA spokesperson said, "There is no effort on the part of the FDA
to withhold or to not post drug review documents." For newer drugs,
information is posted online "as soon as possible," the spokesperson
said. The agency said older documents are not always available online
and efforts to add those files to the Web are slowed by "a lack of
resources." As for the delay in fulfilling Dr. Turner's records
requests, the agency said it doesn't comment on individual requests.
It did acknowledge there is a backlog in complying with records
requests.

A total of 74 studies involving a dozen anti-depressants and 12,564
patients were registered with the FDA from 1987 through 2004. The FDA
deemed 38 of the studies to be positive. All but one of those studies
was published, the researchers said.

The other 36 were found to have negative or questionable results by
the FDA. Most of those studies -- 22 out of 36 -- were not published.
Of the 14 that were published, the researchers said at least 11 of
those studies mischaracterized the results and presented a negative
study as positive.

One way of turning the study results upside down is to ignore a
negative finding for the primary outcome being measured and highlight
a positive secondary outcome. In nine of the negative studies that
were published, the authors simply omitted any mention of the primary
outcome.

The resulting publication bias threatens to skew the medical
professional's understanding of how effective a drug is for a
particular condition, the researchers say. The growing movement of
evidence-based medicine depends on analysis of published studies to
make treatment decisions.

Dr. Turner, who once worked at the FDA reviewing data on psychotropic
drugs, said the idea for the study was triggered in part by colleagues
who questioned the need for further clinical drug trials looking at
the effectiveness of antidepressants.

"There is a view that these drugs are effective all the time," he
said. "I would say they only work 40% to 50% of the time, and they
would say, 'What are you talking about? I have never seen a negative
study.'" Dr. Turner, from his time reviewing studies at the FDA, said
he knew there were negative studies that hadn't been published.

In 2004, the New York state attorney general sued GlaxoSmithKline PLC
for alleged fraud, saying it suppressed studies showing that the
antidepressant Paxil was no better than placebo in treating depression
in children. Glaxo denied the charge and eventually settled with the
attorney general. The company later posted on its Web site the full
reports of all of the studies of Paxil in children.

In this week's study, the researchers found that failing to publish
negative findings inflated the reported effectiveness of all of the
anti-depressant drugs. The researchers used a measurement called
effect size. The larger the effect size, the greater the impact of a
treatment.

The effect size of the antidepressant Zoloft was increased 64% by the
failure to publish negative or questionable data on the drug, the
researchers found. Looking at it another way, the researchers found
the drug was closer to having a "small" effect for people taking it
when all of the data is considered. When primarily positive results
are all that is published, the drug was shown to have an increased
effect closer to "medium."