Georgina Coolidge, Reuters: July 28, 2008

WASHINGTON – A partial ban on controversial plastic-softening chemicals called phthalates has been agreed on as part of a bill to revamp consumer product safety, lawmakers involved in the negotiations said Monday.

The legislation also would sharply cut the amount of lead allowed in toys and other products while increasing funding for the Consumer Product Safety Commission (CPSC), an agency much criticized after millions of toys, mostly made in China, were recalled last year.

The ban on phthalates, which some believe can cause abnormal reproductive development in children, was one of the most hotly debated items considered by members of the House and Senate who hammered out the final version of the legislation.

Three types of phthalates would be permanently banned in children’s toys and child care items, except for minute amounts, while three others would be temporarily banned pending further study.

“The compromise on phthalates is a significant victory for families, because the ban goes into effect before the research review is completed,” said Diana Zuckerman, president of the National Research Center for Women and Families, a consumer group. “Congress put children’s safety first.”

But the American Chemistry Council criticized the phthalate restrictions. “There is no scientific basis for Congress to restrict phthalates from toys and children’s products,” the industry group said.

The bill, which still needs to be voted on, also would mandate national safety standards for all-terrain vehicles, linked to hundreds of deaths each year, as well as set standards for toys.

It would authorize an increase in the CPSC’s annual budget from its current $80 million to $118 million starting in fiscal 2010 and growing to $136 million over five years.

“The Consumer Product Safety Commission has been a neglected agency for too many years, but this legislation puts an end to that neglect,” said a statement by Sen. Daniel Inouye, an Hawaii Democrat and chairman of the Senate Commerce Committee.

The legislation also includes whistle-blower protections, third-party testing requirements for certain children’s products, and gives CPSC the authority to inspect manufacturers’ proprietary labs.

In addition, the bill would increase maximum criminal penalties for violations.

“This reauthorization gives the CPSC more teeth and a deeper bite, and makes it dramatically more certain that toys aren’t tested for safety by kids on the living room floor before they’re tested in a lab by experts,” said Rep. Joe Barton, a Texas Republican and ranking minority member of the House Energy and Commerce Committee.

Senate and House members have been meeting in conference for several weeks to resolve differences between two bills that aimed to overhaul the CPSC. House members passed their legislation in December, and the Senate passed its bill in March, that included a ban on phthalates.

The conferees agreed the legislation should not preempt state regulations and requirements.

Mattel Inc, RC2 Corp, and other companies were forced to pull millions of their toys from shelves last year, mainly due to excessive lead content in paint.

The trend continued into 2008, with total recalls up 22 percent so far this year compared to that same period in 2007, according to an analysis of CPSC data by a group of consumer advocate organizations including Consumers Union and the Consumer Federation of America.

“We applaud the conference committee for reconciling their differences and coming up with an extremely strong and consumer protective bill,” said Rachel Weintraub, director of product safety and senior counsel for the CFA.

Diana Zuckerman, PhD, McClatchy and AP news services: June 2007

This article was published in numerous newspapers including the Anchorage Daily News, The Bellingham Herald, Beaufort Gazette, Billings Gazette, Sacramento Bee, South Carolina Herald, The News & Observer, The New York Sun, Press of Atlantic City, The Southern Illinoisan, Times Herald-Record, Tri-City Herald, and Winona Daily News

If you think an apple is just like an orange, you should work for the Food and Drug Administration.

You probably thought that the FDA required all prescription drugs and medical devices to be proven safe and effective before being sold. You’d be wrong. Since 1976, the FDA has approved thousands of medical products every year without requiring clinical trials, if the FDA agrees they are “substantially equivalent” to other products on the market. In recent years, the FDA has been defining “substantial” and “equivalent” in ways you never dreamed of.

Apples and oranges are both fruit. They are both round. They have different nutritional benefits and taste different, and only one prevents scurvy, but they are much more similar than thousands of the medical products that the FDA has allowed to be sold under this amazing loophole in the law.

Two weeks ago, a company took their Complete MoisturePlus contact lens solution off the market because it caused horrible eye infections that could result in blindness. The lens solution had been approved as “substantially equivalent” to an older and safer contact lens solution that is made with different chemicals. No safety studies were required.

The problem seems to be that, unlike other contact lens cleaning solutions, the Complete MoisturePlus solution does not kill a particular parasite that can cause eye infections. To me, this makes the product definitely not “substantially equivalent.”

Don’t confuse this with last year’s recall of ReNu with MoistureLoc, a different contact lens solution that was found to cause an entirely different eye infection that also caused blindness. ReNu with MoistureLoc had also been approved on the basis of its similarity with an older, safer product. I doubt that is reassuring to the men and women whose eye infections caused them to need cornea transplants to restore their eyesight.

There are many other horror stories, but I’ll just mention two. There were jaw implants made with Teflon, which were approved as similar to a sheet of silicone material. The FDA didn’t require any safety studies so they didn’t know that the Teflon would flake off and cause a biological reaction that caused bones of the jaw and skull to disintegrate. There were ProteGen bladder slings for women with stress incontinence, which were supposed to be very similar to slings made with a completely different material. Since safety studies weren’t required, they didn’t know that ProteGen’s new material caused infections and vaginal erosion.

Although you may not have heard about these problems before, you have certainly heard of the FDA fiascos about prescription drugs. For the 16 million American families of diabetics, the recent news that the popular diabetes drug Avandia increases the risk of heart disease has been frightening and confusing.

At the same time that the FDA was telling the public that they weren’t sure whether or not Avandia is safe and that patients should “ask your doctor,” they were asking the drug company to warn patients that the product can increase heart disease. In most of the world, the FDA’s failure to admit their concerns to the public would be called lying.

Why didn’t FDA warn us last month? Why didn’t they warn us last year?

FDA scientists raised questions about the safety of Avandia, Vioxx and numerous other drugs years before patients or doctors were informed. Congress is aware of these problems. They are considering changes in the law that would help protect patients, by requiring that all implants in the body are proven safe before they can be sold, and requiring that companies make all their research findings available to the public.

Independent researchers could then evaluate how safe and effective those products really are. Lives would be saved.

So, if you think apples are different than oranges, instead of asking our doctors what to do, we need to ask our members of Congress for help. Legislation is about to be passed that could help make medical products safer — or riskier. Unfortunately, companies have been paying millions of dollars to congressional campaigns to speed up the FDA approval process instead of making sure it is safe as well as speedy.

In the House of Representatives, four congressmen have key roles in deciding what to do about the FDA: Rep. John Dingell from Michigan, Rep. Frank Pallone from New Jersey, Rep. Nathan Deal from Georgia, and Rep. Joe Barton from Texas.

Several Members of Congress have championed safe medical products, but there are now several drug and medical device company lobbyists for every member of Congress. Some are even former members of Congress. That’s why every congressman and congresswoman needs to hear from their constituents to let them know we are watching and we care about the safety of every medical product. And that we know the difference between apples and oranges — and expect the same from our congressional representatives.

We can’t let drug and device companies convince Congress that we care more about having new medicines than having medical products that are safe. We deserve both. If we care about our own health and those of our loved ones, now is the time to do something about it.

Judy Norsigian and Diana Zuckerman, Boston Globe: April 17, 2007

Senator Edward M. Kennedy is leading efforts in Congress to pass legislation to overhaul the Food and Drug Administration. Such reform is needed, because the FDA has repeatedly failed to protect the public from drugs and medical devices that prove dangerous to patients. Unfortunately, the proposed legislation is so weak that it is unlikely to save any lives.

We hoped for more. Last year, Mike Enzi, a conservative Republican from Wyoming, was in charge of health legislation in the Senate, and Kennedy was in the minority party. The two senators introduced a drug safety bill that pleased the pharmaceutical industry considerably more than consumer advocates. This, supposedly, was the best these advocates could get from a Republican Congress.

The bill was delayed, luckily, and much has happened since then. Kennedy is now in charge of health legislation in the Senate. Nevertheless, he and Enzi introduced the same bill this year.

When drugs are allowed into the market before their side effects are fully evident, the potentially deadly results are all too familiar: think of drugs like Vioxx, Trasylol, and Ketek, and devices such as drug-eluting stents and defibrillators.

Preventing unnecessary deaths will take more congressional muscle. For example, when new drugs are widely advertised to consumers before the risks are known, thousands of those who take them may be harmed. Most could have been treated by older, safer, cheaper drugs. That’s why the American Medical Association, most physicians, and the Institute of Medicine — a respected nonprofit that offers advice on biomedical issues — recommend a two-year moratorium on direct-to-consumer advertising of all new drugs.

That sounds like a great idea, but the Senate bill rejects it. Instead, it would allow (but not require) the FDA commissioner to impose a moratorium only when there is clear evidence that advertising to consumers would harm patients. This is hard to prove because new drugs lack data on widespread use. Even worse, Kennedy’s bill doesn’t even require the FDA to review new drug ads for accuracy.

The Institute of Medicine also calls for reducing conflicts of interest among FDA advisory panel members. A few weeks ago, the FDA adopted some of those suggestions. It proposed to exclude from advisory panels all doctors and scientists with financial ties of more than $50,000 in the previous 12 months to the products under review; those with a lesser financial interest could still serve on the committees, but only as nonvoting members.

Having any advisers with a financial interest is like having referees who bet on their own games — an obvious conflict of interest. Yet the Senate bill allows paid consultants, scientists with stock in the companies, and other financially conflicted experts to vote on FDA advisory committees — as long as their financial ties are made public and the FDA grants a waiver. And, the bill would also create a new foundation, also funded by drug companies, to do the kind of drug safety research that the FDA should be doing.

This month, Kennedy is expected to attach provisions of his drug safety bill to another measure that, among other provisions, expands the user fees that are charged to pharmaceutical companies to pay for drug reviews. Meantime, the FDA itself proposed several changes that Congress should build on — but hasn’t. For example, the FDA proposed that $29 million of the almost $400 million dollars in user fees paid by drug companies should be spent to “ensure the safety of medications after they are on the market.” But the Institute of Medicine has said $100 million is needed for this purpose.

Much more — almost $370 million in user fees — would be spent to speed up the review process, so companies can get their drugs to market more quickly. Although new medications can potentially save lives, most “new drugs” approved by the FDA in recent years are merely newer, more expensive versions of equally effective drugs. Speeding up their approval translates to millions of dollars for pharmaceutical companies, but usually no lives saved.

It’s a sad day when the public good is completely overshadowed by pharmaceutical companies’ lobbying. A strong reform bill would protect the health of all Americans. We hope Senator Kennedy will fix this bill before it’s too late.

Judy Norsigian is executive director of Our Bodies Ourselves, a women’s health advocacy organization. Diana Zuckerman is president of the National Research Center for Women & Families.

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?