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 Fuzzy Math In Drug Studies?

 By Eric Sabo

 Jan. 23 2001(CBSHealthWatch)--How safe are
 those medications you're taking?
 Researchers who test these drugs in
 clinical trials are the first to find
 any troubles, but two new reports charge
 that many investigators do a poor
 job of divulging all the risks.

 The bad reactions from an experimental
 treatment, which doctors ultimately
 rely on to prescribe new medications, are
 sometimes downplayed if not
 skimmed over, possibly making the drug
 seem safer than it really is. In
 fact, researchers who publish their
 results in medical journals often devote
 more ink to their academic affiliations
 than they do to explaining the
 nature and severity of a drug's side
 effects, claims a new study in the
 Journal of American Medical Association.
 "Important information is not adequately
 reported," says study author Joseph
 Lau, MD, of the New England Medical
 Center. "In real clinical practice, side
 effects are far more common than what
 appears in these studies."
 Lau and John Ioannidis of Tufts University
 reviewed close to 200 trials of
 drugs used to treat various diseases,
 including AIDS, arthritis and
 hypertension. The severity of the side
 effects, according to their analysis,
 was poorly explained in more the 60% of
 the studies.
 Moreover, less than half of the published
 findings listed how frequent these
 problems were in patients who stopped
 taking the drugs. Reporting just the
 basic drawbacks allows for more discussion
 of other important issues in the
 study, but Lau says that drug side effects
 deserve greater attention.
 "When a drug may be of a small benefit,
 and you begin to take into
 consideration the side effects, then the
 overall benefit may no longer be in
 your favor," he says. "You need to have a
 good understanding of both the
 benefits and side effects to make a good
 And skipping over the bad news may start
 even before study results are
 published, claims one expert. Based on
 records made available through the
 Freedom of Information Act, Adil Shamoo,
 MD, of the University of Maryland
 contends in a soon to be released study
 for Accountability in Research that
 investigators are not always up front with
 government regulators. Over the
 last 10 years, Shamoo found that the
 National Institutes of Health (NIH)
 received less than 900 reports of serious
 adverse events, including just 8
 "There's only eight reported deaths in ten
 years? It doesn't make any
 sense," he says. Out of the 70 million or
 so subjects who were involved in
 clinical trials, Shamoo estimates that
 about 51,000 are likely to die in a
 one-month period. The only explanation, he
 argues, is that researchers are
 not reporting all the problems they

 "Thousands of patients have died in
 research settings and no one has said
 anything," Shamoo says.
 These allegations come at time when the
 Food and Drug Administration (FDA)
 is calling for greater scrutiny of studies
 involving high-tech treatments
 like gene therapy and xenotransplantion.
 Just last week, the FDA proposed
 new rules that would make once
 confidential safety information from these
 trials open to the public. Industry groups
 are deeply opposed.
 "Disclosing data on all adverse events in
 clinical trials without first
 investigating the causes could
 unnecessarily frighten patient sand the
 public," said Carl Feldbaum of the
 Biotechnology Industry Organization, in a
 statement. "The vast majority of adverse
 events in clinical trials are
 related to the patients' underlying
 diseases, not the experimental

[Fred A. Baughman Jr., MD:
In clinical trials of psychiatric drugs 100% of
medical/physical complications, including death, are due to the
medication for the simple reason that no psychiatric disorder—not a
single one—is a bona fide disease having a confirming, demonstrable
(diagnostic) physical/chemical abnormality. And, today, the NIMH is
poised to begin drugging NORMAL children 2 years old and up, claiming
they have ADHD, claiming they can diagnose it at these ages, claiming
that this research is legitimate. It is criminal and it must be

 But for long-time government watchdogs
 like Shamoo, the FDA should go
 further. "It's positive step," he says.
 "But just because these trials have
 more publicity doesn't mean all others
 don't need it."

 Indeed, Shamoo says that the
 scandal-tainted research has brought other
 potential dangers to light. Before Jesse
 Gelsinger died in a gene therapy
 trial nearly two years ago, there were
 fewer than 50 adverse events reported
 with similar type drugs in an 8-year
 period. During the next 4 months after
 his death, Shamoo says that more than 900
 serious events popped up.
 Lau points to many reasons for why drug
 side effects might get less press:
 Journal articles need to cut for space,
 researchers tend to care more about
 treatment benefits rather than how a
 patient handles the medication, and
 drug companies like to see their products
 in the best possible light.
 "I think everyone is at fault," Lau says.

[Fred A. Baughman Jr., MD:
Clearly journal editors
and article reviewers are also at fault. All within the ranks of
medical academia are on the take from, and are beholden to the
pharmaceutical industry. This includes the FDA, DEA, NIH—every
Institute, CDC, Surgeon General]

 Shamoo places the blame on money. "It's
 the conflict of interests," he says.
 "If I have a small company, and the stock
 goes up or down based the news of
 the data, than it's human tendency not
 report these problems."
 © 2001 by Medscape Inc. All rights

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