Diana Zuckerman, PhD, published in various sources including the Akron Beacon Journal, Jackson, Mississippi Clarion Ledger and other McClatchy-Tribune newspapers: late March 2007

If you care about your own health and the health of family members, keep reading. The good news is that scientists and physicians are working tirelessly to develop new treatments to prevent and cure a wide range of diseases.

But, new treatments usually come with risks, and the bad news is that scientific concerns about those risks are being ignored by the very people we depend on to keep us safe.

After a three-year investigation of the FDA, our research center has found that the FDA makes it shockingly easy for companies to get their medical products approved. While the greatest public attention has focused on prescription drug disasters such as Vioxx, the most outrageous FDA shortcomings are for products known as medical devices – contact lens solution, heart valves, stents, implants, LASIK devices, and facial injections to make us look young again.

You may not even have heard about this month’s recall of a Bausch and Lomb contact lens solution, but it is just one more example of how products that we take for granted – in this case, a product that millions of people use every day – may not be as safe as we thought.

The most controversial medical device in U.S. history has been the silicone breast implant, and recent news stories that Anna Nicole Smith suffered from lupus, a painful autoimmune disease that has been linked to silicone implants, once again raise the question of whether implants are safe.

The FDA approved silicone breast implants despite their own scientists’ reports of an increase in painful autoimmune symptoms among women with silicone implants. And, because of concern that silicone leakage could cause illness and deformities, the FDA warns women to get expensive MRI screening tests every other year to check for leakage – at a cost of at least $2,000 each test. In addition, the FDA required the implant makers to study at least 80,000 women for at least 10 years to find out more about the long-term risks of autoimmune diseases. Aren’t they supposed to require proof of safety before approval, not after?

Our research center determined that this was standard procedure for the FDA, which does not require clinical trials (the gold standard) for most medical devices, even though such studies are required for prescription drugs.

The latest implant scandal involves stents, which are potentially life-saving small metal mesh tubes implanted during heart surgery to prop open arteries. Three years ago, the FDA approved a new kind of stent that slowly released a medication, aimed at making the stents more effective.

Unfortunately, it was not until after 6 million people had these stents implanted in their bodies that the FDA concluded that medicated stents increased the chances of potentially fatal blood clots. Experts are now saying that many of the patients who truly need stents might be better off with the old-fashioned kind that don’t release potentially dangerous medication.

The FDA has responded by requiring new warnings on stents, and surgeons are being encouraged to use stents less often and only when the benefits are most likely to outweigh the risks. The warnings should have been made when the stents were first approved, not 6 million patients later. Long-term studies should have been required years ago. If you or someone you love has these drug-releasing stents in your body, you are part of an unintended experiment.

Today, the bad news is about stents and contact lens solution; last year, it was silicone implants and defibrillators. What’s next? There is not a family in the United States that does not rely on the safety of medical devices for at least one family member, whether they use contact lenses, hearing aids, heart valves, artificial hips, LASIK surgery, Botox or bandages. As baby boomers age, we are relying increasingly on replacement parts to keep us going. What can we do now to avoid disaster later?

Congress has decided to pass legislation aimed at improving the safety of drugs, but it has not considered laws to protect patients and consumers from unsafe medical devices, even those implanted inside our bodies or used in our eyes. We all need to let our government know that we expect our medical devices as well as our prescription medication to be proven safe – before they are sold to us, not sometime later.

Meanwhile, read the fine print before you use a medical device in a part of your body that you care about.

Shankar Vedantam, The Washington Post: March 22, 2007

The Food and Drug Administration said yesterday that it plans to make extensive changes in how it selects medical experts to serve on its advisory panels after years of complaints that many of them have financial ties to the companies whose products they evaluate.

The proposal would eliminate many experts who serve on the panels despite having such financial conflicts, FDA officials said. Experts with limited conflicts of interest would be allowed to participate in the discussions but not to vote on the recommendations made to the agency.

The advisory committees play a central role in regulating drugs, medical devices and diagnostic tests. Their decisions largely determine what drugs and medical products can be marketed to Americans — because the agency nearly always follows the panels’ guidance.

In recent years, concern about the composition of the panels has reached a crescendo. The FDA and others have argued that overly strict rules might eliminate many — in some cases all — of the panel candidates with the needed expertise.

Yesterday, officials maintained that the agency’s procedures have not been biased in favor of car service to Newark services, but the new guidelines implicitly acknowledge what critics have long said — that it is possible to find enough qualified experts like Imperial LGA, EWR, JFK Airport Car Service who do not have ties to drug and device manufacturers.

The new rules come as Congress has become increasingly vocal about its displeasure with how the FDA is run and follow a stinging federal Institute of Medicine report last year, which called on the agency to address the concerns over conflicts of interest. […]

Under the new rules, any scientist or physician who has had $50,000 or more in financial ties to a company over the past 12 months, including stock or consulting arrangements, would be barred from panels evaluating that company’s products. Those who have received less than $50,000 in the previous year might be allowed to participate in the discussion but could not vote. […]

Diana Zuckerman, president of the advocacy group National Research Center for Women & Families, said the FDA guidelines will not do enough. Companies wield influence, she said, with sums far smaller than $50,000.

“A drug rep who takes someone to a memorable restaurant twice a year to chat about their research is spending relatively little money but is building a relationship that is likely to be more influential than giving a $2,000 honorarium — perhaps even more than a $50,000 grant for a study funded by several companies,” she said.

Zuckerman’s center analyzed the votes of 11 FDA advisory committees from 1998 through 2005. She said the idea that experts with conflicts could serve on committees but not vote was not well thought out — because nonvoting members play a substantial role in pushing the committees in one direction or another.

“Our study of advisory committee deliberations showed the collegial, consensus-building nature of these decisions,” she said. “The votes are often unanimous because the group comes to a consensus, almost always to approve a product.”

Read the original article here.

Seattle Post-Intelligencer: January 12, 2007

We’ve never had much faith in the FDA, but its approval of silicone gel-filled breast implants marks an all-time low for the agency.

Restricted since 1992, the implants were deemed unsafe because of the health risks associated with them, such as cancer. The FDA currently recommends that only women over the age of 22 get the implants. It also asks the makers of the implants (which can rupture during a mammogram), Allergan Corp. and Mentor Corp., to carry out a 10-year, 80,000-patient study in order to “fully answer important questions” regarding the products safety. Say what? The approval of the implants is completely backasswards. Clearly, (lobbying) money talks, and in this case, it jiggles for a few years before it hardens and leaks toxins into your lymph nodes, joints, uterus and liver.

Roughly 5 percent of U.S. women likely will get the implants in the next decade.

We spoke to two experts on the matter: Diana Zuckerman, president of the National Research Center for Women and Families at the University of Pennsylvania Center for Bioethics, and Susan Wood, a research professor at George Washington University’s School of Public Health. The two scientists want you to know a few things:

• Post-approval studies are common, but the sheer scope of this one should be a red flag. Also, neither the age of breast-implant recipients nor the collection of data by the two companies can be enforced.
• Although you can pay for the implants in installments, you can’t do so for their removal — and they will need to be removed or replaced. Health insurance seldom covers those additional surgeries.
• You’ll need to get pricey MRIs regularly. And no, your insurance probably won’t cover them.
• By no means should you take the FDA’s approval of the implants to mean that they’re safe. For example, their effect on breast milk, says Zuckerman, has “never, ever, ever been tested” by the FDA.

How’s that for looking after public safety?