Fw: Dangerous Laxity on Medical Implant Safety

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----- Original Message -----

From: " Kathi " <pureheart@...>

Sent: Thursday, October 17, 2002 5:27 AM

Subject: Dangerous Laxity on Medical Implant Safety

> Dear Friends,

>

> I wrote this article for the Los Angeles Times to let people know that

> the medical device bill that is likely to pass Congress has serious

> flaws.

>

> This legislation has a good provision that would urge (but not require)

> the NIH to conduct studies of the health risk of breast implants. Of

> course, it would have been better to strongly require it. And,

> unfortunately, the bill would also speed FDA approvals of potentially

> risky implants and would allow corporations to hire someone (Arthur

> Andersen?) to conduct inspections of their facility instead of the FDA.

>

> Our goal is to improve the bill. If you are concerned, please contact

> your U.S. senators by phone or email this week! The bill is called the

> " Medical Device User Fee and Modernization Act. " Feel free to send this

> article or quote from it.

>

> Senators (and their staff) that need special attention include: Sen.

> Kennedy (Att: Nexon) Sen Clinton (Att: Ho), Sen Harkin

> (Iowa -- Att: Adam Gluck)), Sen Durbin (Illinois -- Att: Anne Marie

> ), Sen. Dodd (Connecticut -- ATT: Deb Barrett), Sen. Patty Murray

> (Washington state), and Sen Bingaman (New Mexico -- ATT: Young)

> -- but ALL senators deserve to hear from their constitutuents, and Sen

> Kennedy may need to hear from other women too since he chairs the

> committee.

>

> The article is below.

>

> Best wishes,

>

> Zuckerman, Ph.D.

> President

> National Center for Policy Research (CPR) for Women & Families

> 1901 Pennsylvania Avenue, NW

> Suite 901

> Washington, DC 20006

> 202 223-4000

> www.center4policy.org

>

> Remember CPR when you give to United Way or CFC, by designating #9884!

>

>

>

> Los Angeles Times

>

http://www.latimes.com/news/opinion/commentary/la-oe-zuckerman14oct14,0,3702

543.story?coll=la%2Dnews%2Dcomment%2Dopinions

>

> COMMENTARY

> Dangerous Laxity on Medical Implant Safety

> By Zuckerman

>

> October 14 2002

>

> The news about the checkup on Vice President Dick Cheney's heart and

> pacemaker came just as key congressional negotiators were meeting behind

> closed doors to craft a law on all medical devices -- including Cheney's

> implant. It would be nice if a new law gave all patients a free one-year

> checkup for their implants, like Cheney's. Instead, the proposed law

> would make it easier for dangerous implants to stay on the market.

>

> In the year of Enron and WorldCom, the Food and Drug Administration is

> urging Congress to give a free pass to medical device manufacturers that

> are too busy to conduct long-term safety research on the implants they

> sell. Apparently, medical device manufacturers are so honest that they

> don't need independent oversight. Instead, the proposed law would speed

> up the approval of implants and other lifesaving medical devices without

> any new protections to make sure the heart valves and other implants

> were safe for long-term use.

>

> Why worry? Although concerns about prescription drug prices, a possible

> war with Iraq and other issues have dominated headlines, the last few

> months have brought mind-boggling news stories questioning the safety of

> implants and other medical devices.

>

> Here are a few examples:

>

> * U.S. News & World Report published a story saying gastric lap bands,

> bladder slings, jaw joints and other implants had caused deaths and

> irrevocable damage to thousands, many of whom wanted to lose weight or

> had relatively minor health problems before surgery.

>

> * In July, the FDA quietly held a meeting to discuss data collected over

> five years on saline breast implants, which indicated that, on average,

> patients suffered from several serious complications and many required

> at least two additional surgeries during the first five years.

>

> * In August, the Newark (N.J.) Star-Ledger reported that device

> manufacturers had covered up patient deaths and severe adverse reactions

> instead of reporting them to the FDA as required by law. And when

> companies finally reported them, the FDA did nothing to penalize the

> companies for wrongdoing.

>

> With so much attention on the cost of prescription drugs, few Americans

> have been concerned about medical implants. Meanwhile, we are rapidly

> becoming a nation of people with implanted parts. Who among us doesn't

> have a friend or relative with an implant of some sort? My baby-boomer

> brother has a hip replacement, my mother-in-law has new knees, a

> cousin's baby is relying on a shunt and several friends have

> complications from the breast implants they chose after mastectomies. I

> wonder how many of them have annual checkups for their replacement parts

> the way our vice president does.

>

> Many implants have been on the market since before 1976, when the FDA

> first was given authority to regulate medical devices. Although they had

> been on the market for years, heart valves, shunts, breast implants, jaw

> implants and many other devices were approved by the FDA after only

> short-term studies following patients for, in some cases, just a few

> weeks or months.

>

> Even though patients will need these implants for the rest of their

> lives, the FDA rarely requires studies to find out what happens five or

> 10 or 20 years later. Even worse, newly designed implants are sometimes

> approved based on scanty data if the company convinces the FDA that the

> implants are " substantially equivalent " to other previously approved

> implants.

>

> It's not too late for Congress to listen to its own rhetoric about the

> need for independent oversight of the business world and apply it to

> medical device companies. If that doesn't happen, then patients and

> other buyers will just have to beware. Perhaps instead of birthday and

> anniversary cards, we should start sending friends and relatives annual

> reminders to get checkups on their implants. If patients don't take

> matters into their own hands, we may never find out whether these

> implants are safe until it is too late.

>

> *

>

> Zuckerman is president of the National Center for Policy Research

> for Women & Families, a nonprofit research-based organization in

> Washington, D.C., that analyzes health policies. E-mail:

> dz@....

> If you want other stories on this topic, search the Archives at

> latimes.com/archives. For information about reprinting this article, go

> to www.lats.com/rights.

>

>