Troubling Drug Study

Taken from USA Today - July 11, 2002
By Quin Tian, USA Today

Troubling drug study
raises questions that go unanswered.

Our View:
Women taking hormone therapy deserve better guidance.

For 16,000 women enrolled in a federal study of hormone replacement therapy, the advice this week was clear. After new research showed that the popular drug therapy does more harm than good, federal investigators sent study participants letters that told them to stop taking their pills.

Too bad 6 million other US. women taking similar combinations of progestins and estrogen can't get such clear guidance. For them, the answer to the urgent question, "Should I quit, too?" is nonexistent, garbled or suspect. Clarity isn't likely anytime soon.

The confusion follows an announcement Tuesday that the popular medical therapy prescribed to treat conditions ranging from menopausal symptoms to osteoporosis increases the risk for invasive breast cancer, heart attacks, strokes, and blood clots.

The study isn't the first to cast doubt on a drug treatment that has long been sold as a fountain of youth for middle-aged women. Earlier research questioned whether hormone therapy made women feel more vibrant, prevented fractures caused by osteoporosis or staved off heart disease.

But the latest study is the largest to suggest that a drug therapy taken by about 15% of all post-menopausal women causes serious health problems, including some it was once thought to prevent.

The findings jolted the National Heart, Lung, and Blood Institute into calling an early halt to it's study of the therapy, slated to last until 2005. In explaining this unusual action, government officials said the evidence showed "overall health risks exceed any benefits."

Yet other women looking for sound advice on how to proceed found little help.

Delayed protections.

The Food and Drug Administration (FDA) has the authority to demand new warnings on drugs and restrictions on advertising. So far, it is only studying the issue, a bad sign in view of the agency's history. The last time the FDA sought label changes on hormone replacement therapy, two years passed before some companies complied.

Mixed Messages.

The medical groups to whom women rightly look for advice putting out conflicting or patronizing messages. The American College of Obstetricians and Gynecologists, for example, announced a special task force to study the issue. Meanwhile, women were advised to consult their doctors and "not panic".

Suspect advice.

Drug makers such as Wyeth, which produces the most popular hormone-replacement-therapy drugs, have the loudest voice, given their aggressive marketing campaigns. Not surprisingly, they were quick to downplay the news that might cut sales totaling more than $2 billion last year. Wyeth also spends millions promoting hormone replacement as an indispensable youth and beauty aid. And the company quietly influences doctors by underwriting teaching programs and receptions at medical conventions.

The promotions pay off. More than 63 million prescriptions for two popular versions of hormone drugs were filled in the 12 months through March. Health insurers spend some $1.8 billion on the drugs in 2001.

Now women who filled these prescriptions need to know what to do. Until the government and doctors provide more help, only the fortunate few in one study are getting the advices all women deserve.

 

 

 


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