Fw: Health Care Jeopardy article by Zuckerman

[Guest guest]

Sent: Wednesday, July 17, 2002 11:07 PM

Subject: Health Care Jeopardy article by Zuckerman

I thought this might interest you.

Best wishes,

Zuckerman

Detroit Free Press

Public needs FDA to improve watchdog policies on drugs

July 17, 2002

BY DIANA ZUCKERMAN

If there were a game show with health care questions, nobody would win.

What is hormone replacement therapy? The fountain of youth -- or a pill that will give you breast cancer? What is mammography? A procedure that saves lives -- or a painful waste of your time and money?

The correct answers are hard to guess, even though our health is in real jeopardy if we can't. And there have been lots of other recent unanswerable health questions just like these: Should we take the latest drugs and be thankful for the opportunity, or should we avoid newly approved ones -- as recommended recently in a prestigious medical journal -- and let others be the guinea pigs?

It's easy to blame the headlines and sound bites, but in these cases, even "the experts" can't agree. Some so-called experts add to the confusion by relying too heavily on their own experiences. Those experiences are valuable, but we still need well-designed studies on thousands of patients to draw solid conclusions.

For example, doctors prescribed hormone replacement therapy like candy for women over 50, before it had ever been carefully evaluated. It's been widely advertised and touted by "experts" as a fountain of youth that would prevent the depression and ills associated with aging. But when research was finally conducted in well-designed studies, we learned that hormone therapy increases the risk of breast cancer, heart attacks and blood clots, and does not prevent depression. Even so, some physicians continue to encourage their patients by reminding them that their individual risk is not that high.

In the case of many new drugs, consumers have a right to be confused. Pharmaceutical companies spend billions of dollars on ads aimed at convincing consumers and doctors that these drugs are great. But new drugs almost always cost more, and many physicians question how well they work.

How did we get to this point?

The Food and Drug Administration approves the use of drugs and medical devices based on studies of people who use the products for a few days or weeks or at most a few months. Unfortunately, the FDA doesn't require manufacturers to prove that the products are safe for many months or years of use.

We need longer-term safety information, especially as baby boomers age and depend more and more on spare parts such as hip replacements and heart valves, and even breast implants, as well as drugs for chronic diseases like high blood pressure.

Currently, the FDA encourages manufacturers to do those studies after products are approved for use, but it doesn't usually check to see if the studies are done.

Finally, a new law has passed that will increase funding for the FDA to review the long-term safety of new prescription drugs. Starting in October, there will be stronger safeguards for drugs that have just been put on the market to evaluate their long-term safety in the real world.

The new law will not include additional funds for safety programs for drugs already on the market or for implanted medical devices, unfortunately.

It's time for Congress to pass similar legislation to ensure the long-term safety of heart valves, hip replacements and other implants. Until that happens, controversies will continue to rage about breast implants and many other products, and patients will be justifiably confused about what to believe.

Meanwhile, what can we do to provide better medical information to those of us who need it? Physicians, patients and the media should be more skeptical about the hype and the advertisements, just as they are for ads for any other product that seems too good to be true.

Perhaps most important, the FDA, which regulates medical products, needs to be a better watchdog. For starters, the agency should make sure that ads for medical products are accurate and include clear information about risks in words that consumers can understand.

This is no game show. When our health is at stake, there's no consolation prize if we guess wrong.

DIANA ZUCKERMAN is president of the National Center for Policy Research for Women & Families. Write to her at National Center for Policy Research for Women & Families, 1901 Pennsylvania Ave. NW, Suite 901, Washington, D.C. 20006, or via e-mail at dz@....

Zuckerman, Ph.D.PresidentNational Center for Policy Research (CPR) for Women & Families1901 Pennsylvania Avenue, NWSuite 901Washington, DC 20006202 223-4000www.center4policy.org