SAFE ENOUGH? BRAVO BRAVO: Dr. Zuckerman responds to Milloy in Washington Ti

[Guest guest]

(In response to last Sunday's:

http://washingtontimes.com/commentary/20050820-102457-9502r.htm )

The Washington Times

http://washingtontimes.com/commentary/20050827-1120047678r.htm

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Safe enough?

By Zuckerman

Published August 28, 2005

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How safe need an implant be before the Food and Drug Administration

decides it is " safe enough " for a surgeon to put it in your body?

The answer may surprise you.

Congressional leaders from both parties continue their scathing

criticism of FDA for failing to protect consumers from unsafe

medical products. Vioxx is the most obvious example but far from the

only one.

The problem is not just prescription drugs. In just the last few

weeks, the FDA announced the potentially fatal risks of heart valves

and defibrillators. And, the FDA now seems poised to make another

blooper, recently announcing their intention to approve silicone gel

breast implants for the first time.

Pundits have had a field day, castigating women's organizations

for expressing concerns about a product that implant makers and

plastic surgeons assure us is perfectly safe. They trot out flawed

research and old reports to back up their claim, conveniently

ignoring evidence that conflicts with their conclusions.

A cardinal rule of medical research is some products that seem

safe at first may be found harmful years later. When the National

Academy of Sciences first published a report on Agent Orange in

1974, for example, it concluded there was no clear evidence Agent

Orange harmed Vietnam veterans. Years later, scientists concluded it

causes birth defects and several types of cancer. Similarly, the

first Institute of Medicine (IOM) reports of " Gulf War Syndrome "

concluded war exposures had not caused health problems. Scientists

now agree Gulf war veterans are at increased risk of ALS (Lou

Gehrig's disease), and possibly other fatal diseases.

In 1999, the IOM concluded there was no evidence implants caused

diseases. Instead, they were concerned implants could break or

interfere with mammograms, cause pain, or require additional

surgery. They reviewed all the studies published, but many were of

animals or cells. There were very few clinical trials or

epidemiological studies of women with implants, and almost all were

funded by Dow Corning, the company that makes silicone and

commissioned the studies to avoid losing billions of dollars in

legal settlements with implant patients who became ill.

As an epidemiologist, I realized the Dow studies were

scientifically flawed. Since most cancers or autoimmune diseases

take many years to develop and be diagnosed, the studies should have

focused only on women who had implants for at least seven to 10

years. Instead, they included many women who had implants for only a

few months or years. The studies also included small numbers of

women who had implants for 25 years or more -- but those " silly

putty " breast implants were much thicker and more durable than the

implants sold after 1980. It would not have mattered who paid for

the research if it was well designed -- but it wasn't. That is why

scientists wonder if the studies were designed to prove implants

safe, rather than determine if they were safe.

In contrast, in studies funded by the National Cancer Institute

or the FDA rather than implant makers, findings were dramatically

different. By studying women who had breast implants for at least

seven years, they included many women whose implants were possibly

leaking. The results showed statistically significant increases in

several cancers and autoimmune diseases. They also found a doubling

of deaths from brain cancer and a tripling of deaths from lung

cancer when women with implants were compared to other plastic

surgery patients, even though the two groups are very similar in

access to health care, smoking and other health habits that could

influence disease.

When symptoms are studied instead of diseases, even short-term

research reveals implant problems. In 2003 and 2005, the FDA

scrutinized two breast implant makers' research. A surprising number

of patients were found to have pain, broken implants or other

problems that required surgical removal of their implants within the

first three years. Even more surprising, women were more likely to

report autoimmune symptoms, such as joint pain and fatigue after

having these implants for two years, compared to how they felt just

before getting implants. Statisticians note these differences were

not caused by aging.

In a recent rant in this newspaper, Steve Milloy accused me of

frightening people about the risks of breast implants, and accused

other women's organizations of ignoring scientific evidence of the

safety of implants. I would be happy to sit down with him and

together examine every single study. Unfortunately, accurately

describing research results sometimes frightens people. But what

really frightens people is learning too late they can't trust FDA-

approved medical products, whether painkillers or implants.

Why are so many Americans harmed by FDA-approved products? It

has been suggested companies sold products they knew were unsafe. In

some cases, the FDA has been accused of ignoring the allegations or

even actively helping to conceal them. For example, when the FDA

closed its criminal investigation of Mentor, an implant maker, the

agency compliance officer resigned in disgust and complained to the

FDA commissioner. A congressional investigation continues into the

matter, but FDA officials seem ready to approve breast implants

before the ongoing congressional investigations are completed.

Are silicone breast implants safe enough for breast cancer

patients? Are they safe enough for people you care about? Implant

makers have flooded medical journals with articles claiming they

are. The few government studies raise important, never-answered

questions about long-term safety. The key question here is what does

the FDA mean by " safe enough? "

Zuckerman is president of the National Research Center for

Women & Families. She was formerly a congressional investigator,

Yale faculty member and Harvard University researcher.

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www.BreastImplantInfo.org (Dr. Zuckerman's website)

For more on this ongoing controversy:

www.BreastImplantAwareness.org