See Douglas Kennedy/Fox News piece here:
_http://youtube.
_ (http://youtube.
Douglas Kennedy for being the only
TV network speaking out on behalf of consumers instead of vested interests
here: bigstory@foxnews.
Fox News’ Douglas Kennedy has really outdone himself this time! This is
clearly one of the best pieces he has ever done on these drugs!
The article below from the Wall Street Journal spells it all out.
After eighteen long years of trying to educate the world about the dangers
of antidepressants, the only thing left for me to say any longer as each of
these new pieces of evidence come out is “I told you long ago!” and if the world
had listened 18 years ago there would be a lot more people still on the
planet, lots fewer divorces, definitely fewer diagnoses for Bipolar Disorder,
lots less diabetes, far less need for CPAP machines, far less people imprisoned
for things they did only in someone’s delusional mind, etc.,etc, etc.
This whole situation is clearly an international tragedy of astronomical
proportions and as was clear all along (at least to me), it was based on half
truths and lies!
Dr. Ann Blake Tracy, Executive Director,
International Coalition for Drug Awareness,
_www.drugawareness.
_www.ssristories.
author of Prozac: Panacea or Pandora – Our Serotonin
Nightmare & Help! I Can’t Get Off My Antidepressant! (800-280-0730)
_http://online.
pj_
(http://online.
Antidepressants
Under Scrutiny
Over Efficacy
Sweeping Overview Suggests
Suppression of Negative Data
Has Distorted View of Drugs
By DAVID ARMSTRONG and KEITH J. WINSTEIN
January 17, 2008; Page D1
The effectiveness of a dozen popular antidepressants has been exaggerated by
selective publication of favorable results, according to a review of
unpublished data submitted to the Food and Drug Administration.
ACCENTUATE THE POSITIVE
A review of research submitted to the FDA:
• Of 74 studies reviewed, 38 were judged to be positive by the FDA. All but
one were published, researchers said.
• Most of the studies found to have negative or questionable results were
not published, researchers found.
Source: The New England Journal of Medicine
As a result, doctors and patients are getting a distorted view of how well
blockbuster antidepressants like Wyeth’s Effexor and Pfizer Inc.’s Zoloft
really work, researchers asserted in this week’s New England Journal of Medicine.
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effective, doctors unaware of the unpublished data are making inappropriate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 aren’t in the best interest of their patients,
according to researchers led by Erick Turner, a psychiatrist at Oregon Health &
Science University. Sales of antidepressants total about $21 billion a year,
according to IMS Health
Wyeth and Pfizer declined to comment on the study results. Both companies
said they had committed to disclose all study results, although not necessarily
in medical journals. GlaxoSmithKline PLC, maker of Wellbutrin and Paxil,
said it has posted the results of more than 3,000 trials involving 82
medications on its Web site, and also has filed information on 1,060 continuing trials
at a federal government Web site.
Schering-Plough Corp., whose Organon Corp. unit markets Remeron, and Eli
Lilly & Co., which makes Prozac, said their study results were indeed published
— not individually, but as part of larger medical articles that combined
data from more than one study at a time. The New England Journal study counted a
clinical trial as published only if it was the sole subject of an article.
“Lilly has a policy that we disclose and publish all the results from our
clinical trials, regardless of the outcomes from them,” a Lilly spokeswoman
said.
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.
“There is no effort on the part of the FDA to withhold or to not post drug
review documents,” an FDA representative said. For newer drugs, information is
posted online “as soon as possible.” Older documents aren’t always available
online and efforts to add those files to the Web are slowed by “a lack of
resources,” the agency said, acknowledging that there is a backlog in complying
with records requests.
A total of 74 studies involving a dozen antidepressants and 12,564 patients
were registered with the FDA from 1987 through 2004. The FDA considered 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 — weren’t published, the researchers
found. 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.
Five Trials
For example, Pfizer submitted five trials on its drug Zoloft to the FDA, the
study says. The drug seemed to work better than the placebo in two of them.
In three other trials, the placebo did just as well at reducing indications
of depression. Only the two favorable trials were published, researchers
found, and Pfizer discusses only the positive results in Zoloft’s literature for
doctors.
One way of turning the study results upside down is to ignore a negative
finding for the “primary outcome” — the main question the study was designed to
answer — 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 researchers said.
The resulting publication bias threatens to skew the medical professional’
understanding of how effective a drug is for a particular condition, the
researchers say. This is particularly significant as the growing movement toward
“evidence-based medicine” depends on analysis of published studies to make
treatment decisions.
Colleagues’ Questions
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,” based on his reviews of the
research at the FDA, “and they would say, ‘What are you talking about? I have
never seen a negative study.'” Dr. Turner, said he knew from his time with
the agency that there were negative studies that hadn’t been published.
The suppression of negative studies isn’t a new concern. The tobacco
industry was accused of sitting on research that showed nicotine was addictive, for
instance.
The issue has come up before notably with antidepressants: In 2004,
the New York state attorney general sued GlaxoSmithKline for alleged fraud,
saying it suppressed studies showing that the antidepressant Paxil was no
better than a 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.
But publication of negative studies is an issue that cuts across all medical
specialties. And it has engendered some strong reactions in the
medical-research world: To make it harder to conceal negative study findings, an
association of medical journal editors began requiring in 2005 that clinical trials
be publicly disclosed at the outset to be considered for publication later.
The system isn’t foolproof, since manufacturers often run exploratory studies
without registering them and can selectively disclose favorable results. The
rule only applies to studies intended for publication in a medical journal.
Some studies that don’t eventually get published are registered with online
trial registries, including the federal government’s www.clinicaltrials.
Nonetheless, many studies still aren’t being registered or reported, says Kay
Dickersin, the director of the Center for Clinical Trials at the Johns
Hopkins Bloomberg School of Public Health. “We need something more meaningful,”
she said. “The average person has no idea that www.clinicaltrials.
comprehensive.
The New England Journal study also points to the need for the FDA to
disclose more information about the studies it receives, says Robert Hedaya, a
professor of clinical psychiatry at Georgetown University Hospital. He said it was
“disturbing” that the information on the negative studies wasn’t made widely
available by the FDA.
The FDA does post information, including unpublished studies, for some drugs
on its Web site, says Dr. Turner. But information that hasn’t yet made it
online is hard to come by. Dr. Turner said he made public records requests for
information not on the Web site more than a year ago, but the requests have
gone largely unfulfilled. He said he was able to get some of the FDA’s
information on unpublished studies from other researchers who acquired it from the
agency through their own record requests.
The ‘Effect Size’
In this week’s study, the researchers found that failing to publish negative
findings inflated the reported effectiveness of all 12 of the
antidepressants studied, which were approved between 1987 and 2004. The researchers used a measurement called effect size. The larger the effect size, the greater the
impact of a treatment. The average effect size of the antidepressant Zoloft rose 64% by the failure to publish negative or questionable data on the drug, the researchers found.
Write to David Armstrong at _david.armstrong@