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Why one size doesn’t fit all in medicine (MS)

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By Phyllis Greenberger February 23, 2009

Many prescription drugs, including antihistamines, antidepressants, and heart medications, work much differently on men and women. Women are also more vulnerable to certain diseases. Eighty percent of those with osteoporosis are women. Heart disease kills over 50,000 more women than men each year. And women are more than twice as likely to suffer from depression.

The difference between the sexes is worth keeping in mind as the Obama administration implements its plan for a Federal Coordinating Council for Comparative Effectiveness Research. Created as part of the economic stimulus package that was signed last week, the council stands a good chance of improving the quality of healthcare delivery nationwide by codifying best practices and developing world-class clinical guidelines for medical treatments.

Witness the success of Premier Inc., a national alliance of thousands of hospitals and healthcare sites.

By collecting data from its members, Premier is able to analyze which treatments, practices, and techniques yield the best results. This information is stored in a database accessible to participating physicians, administrators, and other healthcare personnel, helping them make more informed decisions.

By harnessing the extraordinary resources of the federal government, the newly created council could similarly improve the delivery of care.

There is a risk, though. Elsewhere in the world, comparative effectiveness research has been used to ration treatments. Such research has also gained a reputation for a one-size-fits-all approach to medicine.

In Britain, the National Institute for Health and Clinical Excellence has been issuing appraisals of medical treatments for close to a decade. The institute considers both cost effectiveness, which measures the benefits of a treatment against the expense to provide it, and clinical effectiveness, which measures how much better a newer treatment is for patients than an older one. The agency then makes recommendations to Britain’s National Health Service about which treatments are worth covering.

Sometimes, though, the agency’s findings prevent people from getting the best care possible. Last year, for instance, the institute recommended that the National Health Service not cover the life-extending lung cancer drug Tarceva because of its price tag. Even though the institute’s decision was eventually overturned, some British cancer patients were denied their last hope for staying alive.

As the American comparative effectiveness agency is assembled in the coming months, administrators must take into account the personal needs of individual patients. If the council were to primarily focus on cost effectiveness, it would likely only consider the "average" patient. But in medicine, every patient is unique.

Just consider all the differences between men and women. At every level of the human body – the system, organ, tissue, cellular, and sub-cellular – there are a host of differences between sexes. Only recently have we started to understand how these differences impact the prevention, diagnosis, and treatment of disease. This underscores why physicians must have the freedom to prescribe the treatments best suited to the particular patient for whom they’re caring.

The law does ensure that "subpopulations are considered when research is conducted," but this is hardly a guarantee that comparative effectiveness research won’t one day be abused at the expense of patients in the United States.

Lawmakers had the right idea when they created the council. It’s now up to the Obama administration and the Department of Health and Human Services to make sure that this new body is used properly.

Otherwise, doctors could find themselves unable to provide individual patients with the personalized treatments they need. That would leave all of us – men and women alike – worse off.

Phyllis Greenberger is president and CEO of the Society for Women’s Health Research.