• Buried mistakes Buried mistakes From the St. Louis Post-Dispatch – June 22, 2003 What your doctor doesn’t know about drugs can hurt you. Unfortunately, there’s a great deal they don’t – and can’t – know about commonly prescribed drugs.
• Buried mistakes
Buried mistakes
From the St. Louis Post-Dispatch – June 22, 2003
What your doctor doesn’t know about drugs can hurt you. Unfortunately, there’s a great deal they don’t – and can’t – know about commonly prescribed drugs.
Most drug studies are paid for by drug companies, which gives them the ability to suppress research they don’t like. Consequently, research articles in medical journals may not give a true picture of a drug’s risks and benefits.
Antidepressants prescribed for children are a case in point. Last year, British authorities began looking into the safety of a relatively new class of drugs to treat depression. Most initially were marketed for adults, but they’re now frequently prescribed for children. Published reports suggested the drugs could help depressed teens, but there were anecdotal reports of suicides. It wasn’t clear whether the cause of the suicides was depression or the drugs.
It still isn’t clear. American officials say the evidence is inconclusive but recommend closely watching young people given those drugs. British officials, however, banned the new antidepressants (except Prozac) for kids. During their investigation, British medical authorities reviewed published and unpublished research and found a disturbing pattern: Studies questioning the benefits of the drugs went unpublished, while studies showing the drugs were safe were submitted to medical journals.
This month, New York Attorney General Eliot Spitzer sued drug maker Glaxo-SmithKline, charging it with fraud for withholding negative information about its drugs. An internal company memo discussed the need to “effectively manage the dissemination of these data in order to minimize any potential negative commercial impact.”
Regulators, including the U.S. Food and Drug Administration, often treat drug studies as proprietary information. They release summaries of studies after a drug is approved but often don’t make all the data public. That lack of transparency is dangerous and must stop.
Last week, an organization of top medical journals said it’s considering a plan that would require all clinical drug trials to be registered at the start in a public database. Studies not registered in advance wouldn’t be considered for publication in the journals. The American Medical Association endorsed such a proposal.
It’s a start, but more must be done. Doctors should be able to get reliable, complete information about the risks and benefits of drugs, including benefits compared to existing drugs. The federal government easily could develop such a database, and Congress has already provided some money for it.
Federal regulators understand the importance of protecting proprietary information developed at great cost by drug makers. But the regulators’ most important job is to protect patients. If drug companies are allowed to withhold or suppress information that threatens profits, they will also end up burying some of their customers.
