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Vienna, Virginia http://www.909shot.com
"Protecting the health and informed consent rights of children since
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From Michael Belkin:
"For whatever reason, they seem to think that safety is not as
important,"
http://my.webmd.com/content/article/1728.70552
Drug Trials Underreport Side Effects, Emphasize Benefits
By Ori Twersky
WebMD Washington Correspondent
Reviewed by Dr. Dominique S. Walton
Jan. 23, 2001 (Washington) -- How effective is a drug if it's not
completely safe? While all drugs come with the risk of side effects, doctors
can't treat patients effectively unless they have all the information they need
to pick the best drug. Yet, a report in the Jan. 24 issue of the Journal
of the American Medical Association shows clinical investigators
and medical journals often neglect to publish the severity and
frequency of side effects discovered during the testing of drugs.
According to the analysis, the clinical investigators published the frequency
and severity of side effects less than 40% of the time. Moreover, of
those that did publish side-effect information, less than one-third also
outlined the side effects documented during earlier
laboratory tests, the researchers found.
The analysis focused on the published accounts of 192 randomized
trials for seven different drug classes, ranging from antibiotics to
HIV treatments. In total, the trials involved more than 130,000 patients.
The primary reason for this oversight, speculates co-author Joseph Lau, MD, is
because medical journals generally place more emphasis on publishing the
clinical benefits rather than side effects.
"For whatever reason, they seem to think that safety is not as
important," he tells WebMD.
But side-effect data is both necessary and significant, argues the professor of
medicine at the New England Medical Center in Boston.
Consider the fate of several popular drugs that were pulled in recent years --
all because of severe side effects:
The irritable bowel syndrome drug Lotronex was pulled Nov. 28, 2000, because of
links to several cases of a potentially life-threatening intestinal condition
and five deaths. On March 21, 2000, the diabetes drug Rezulin was taken off the
market because the drug was reported to cause liver failure. Propulsid,
approved for heartburn, was found to cause
heart-rhythm disorders and completely removed from the market last July. Links
to heart valve damage led to the removal of the antiobesity drug Redux in
September 1997.
"We clinicians now have several alternatives available to treat different
conditions, and we need the safety information to make sound choices," Lau
says.
Safety data usually is reported to government regulators and is published
following the clinical trials conducted to support the approval of a new
treatment. However, Lau says, the lack of emphasis on also reporting the side
effects in subsequent journal articles may have dire consequences.
For instance, initial trials of a drug may not establish the true safety
profile of the drug, Lau explains. And physicians also may neglect or be unable
to reference the historical safety data when evaluating the latest article on a
specific drug's clinical benefits, Lau notes.
To address this oversight, Lau recommends that journals require an addendum to
each article summarizing the side effects. In essence, he tells WebMD, these
supplements will then "let the readers be the judge" of the drug's
true costs vs. benefits.
These article supplements could report the number of patients who withdrew from
the trial and the reasons why, Lau points out. The supplements also could
outline the type and frequency of the side effects seen in each study arm, as
well as offer a detailed description of each unusual side effect, he says.
But in some cases, those clinical investigators may not have had any unusual or
pertinent information to report, suggests another study released in JAMA.
That study, led by Salim Yusuf, MBBS, Dphil, FRCPC of Ontario's McMaster
University, found a wide disparity between the side effects found during phase
2 clinical trials vs. phase 3 trials.
The investigators found that phase 2 trials often missed side effects
documented during the larger phase 3 studies.
The most reasonable explanation is that phase 2 studies frequently enroll a
narrow spectrum of patients, who may be at a lower risk of suffering side
effects, the authors said. Also, phase 2 trials frequently employ a variety of
dosing regimens, some of which may have less propensity to cause side effects,
the authors said.
Still, although the pooled analysis of the 192 trials included a number of
phase 2 studies, this is not a good reason for journals to avoid publishing
even that limited safety data, Lau tells WebMD.
Overall, the amount of space presently reserved for the reporting of side
effects in journal articles is similar to the amount of space devoted to
listing the contributor’s names and affiliations, he points out. The percentage
of space reserved for reporting side effects also is frequently less than
one-tenth of the amount of space reserved for reporting the clinical benefits,
he observes.
The journals may have a limited amount of space, and people in general do
prefer to read good vs. bad news, Lau says, but even these facts do not excuse
the glaring lack of safety information, especially since it could be outlined
in about one-third of a page, he tells WebMD.
"The issue here is that journal editors are not doing their jobs,"
Lau says. "What is reported and
what isn't reported is just not consistent."
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Breaking News Archives - each day's breaking news from December 1, 2003 (check here for breaking news you might have missed and breaking news that didn't ever hit the "front page")
More News - all the news most recently posted on this website
All the News - a running tab of everything posted on this website since October 29, 2003
Top Stories Archives - daily breaking and other important news stories
Daily News Archives - all the news posted on this website each day (from April 2001)
Hot Topics - selected stories, by category
Return to Vaccination News Home Page (for best results, right click to "open in new window")
DISCLAIMER: All information, data, and material contained, presented, or provided here is for general information purposes only and is not to be construed as reflecting the knowledge or opinions of the publisher, and is not to be construed or intended as providing medical or legal advice. The decision whether or not to vaccinate is an important and complex issue and should be made by you, and you alone, in consultation with your health care provider.