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 decision." 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 deaths. "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 should. "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 medicines."
[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 disordernot a
single oneis 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
stopped]
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, NIHevery
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