Liz Szabo, USA TODAY: September 16, 2008

ROCKVILLE, Md. – A hormone-like chemical should be taken out of food packaging, especially baby bottles, infant formula cans and other products used by children and pregnant women, university researchers and consumer advocates told a Food and Drug Administration subcommittee Tuesday.

The FDA has said that the chemical, bisphenol A, or BPA, doesn’t pose a risk at the levels to which people are commonly exposed. BPA has been detected in the bodies of virtually all Americans tested.

But critics questioned why the FDA based that ruling on three studies funded by the chemical industry, all of which found BPA to be safe at current exposure levels. Hundreds of independent studies in animals and cells suggest the estrogen-like chemical poses serious risks.

The newest research – the first large study in humans – links BPA to both heart disease and diabetes in adults. Adults with the highest BPA levels in their urine were more than twice as likely to have heart disease or diabetes than those with the lowest levels, according to the study of 1,455 people, published online Tuesday in The Journal of the American Medical Association. The total number of people with these conditions was small: 79 had heart disease and 136 had diabetes.

In a letter sent to the FDA Tuesday, Sen. Charles Grassley, R-Iowa, Tuesday became the latest lawmaker to ask the agency FDA why it gave preference to industry-funded studies. Grassley – who noted that much of the research rejected by the FDA was paid for by the National Institutes of Health – asked the FDA to provide copies of all communication with the American Chemistry Council, which funded one of the pivotal studies cited by the FDA.

FDA scientist Laura Tarantino said the agency relied on industry studies because they were very large and included raw data, which allows the FDA to independently verify the findings. But Frederick vom Saal, a University of Missouri professor, says the industry studies’ flaws make them useless in deciding on a safe exposure level for BPA. “The FDA is ignoring all of this research,” vom Saal says. “While it has been doing that, Americans have been at risk.”

The FDA’s report puts it at odds with the National Toxicology Program, which this month expressed “some concern” that BPA alters the brain, behavior and prostate in fetuses and children. That study included many studies that were not weighed in the FDA safety standard. Babies are mainly exposed to BPA through liquid infant formula, which is usually sold in metal cans lined with the chemical, as well as bottles made of polycarbonate plastic, according to the FDA report. Powdered formula probably is much less contaminated with BPA. John Bucher, the toxicology program’s associate director, says this put formula-fed infants most at risk.

D. Gail McCarver, a pediatrician at the Medical College of Wisconsin, says the FDA report underestimates how much BPA children are exposed to. She notes that the report’s safety ruling is based on “average” exposures for formula-fed infants – even though some babies may consume much more than average. “I do not believe we should be protecting our children at an average level,” McCarver says.

Consumer activists have warned about the dangers of BPA for a decade. Now that research also finds disease in humans, activists say the FDA needs to revise its ruling that the chemical is safe in everyday use.

At the very least, the FDA should require a prominent warning on products made with BPA, says Diana Zuckerman, president of the National Research Center for Women & Families. Products made with BPA today are rarely labeled, making it difficult for consumers to avoid them.

The FDA received about 200 public comments on its draft report. About 20 people – most opposed to the use of BPA – spoke at the hearing. Sonya Lunder of the Environmental Working Group says it’s especially important to protect fetuses and infants from BPA, because they are the most vulnerable to hormonal influences. Yet she says babies are exposed to more than 12 times as much BPA per pound of body weight as adults.

McCarver says there’s a critical need to measure BPA exposure in babies, especially premature infants, who are exposed to many plastic medical devices and tubes while in the hospital.

But McCarver says she doesn’t support completely banning BPA, which is used to make life-saving bicycle helmets. If manufacturers replace it with another chemical, she says, there should be thorough tests to make sure the replacement is safe.

Jared A. Favole, CNNMoney.com: September 8, 2008

ROCKVILLE, Md. – (Dow Jones) – A panel of medical experts on Monday said Pfizer Inc.’s (PFE) proposed osteoporosis drug has benefits for postmenopausal women, but suggested the drug be restricted to women at high-risk of fracture or those who fail other treatments.

Pfizer is seeking U.S. Food and Drug Administration approval for the drug to treat osteoporosis, which generally leads to bone fractures, in postmenopausal women. Nine panel members said the benefits of Fablyn outweigh the risks, three said it didn’t and one member abstained.

Panel members, overall, said the drug would give women an alternative to other osteoporosis treatments, some of which have multiple side effects, and would most benefit postmenopausal women at “high risk” of fractures, said Chairwoman Sandra Carson, a professor of gynecology at Brown University.

Scott Monroe, director of the FDA’s urologic and reproductive product division, said the panel’s thoughts didn’t represent a clear rejection of the drug, “nor a clear endorsement.”

It’s unclear whether the FDA will approve the drug, and if it will suggest restricting it to a certain population of women. The FDA will consider the panel’s advice in its decision. The FDA has until sometime in October to make a decision. A rejection of Fablyn would be a setback for Pfizer as analysts estimate the drug could bring in peak sales of $1 billion.

For its part, Pfizer believes Fablyn offers “unique benefits” for postmenopausal women at high risk for fractures, spokesman Jack Cox said in a statement.

Fablyn belongs to a group of medicines that work like the hormone estrogen in some parts of the body and not in other parts. These drugs, called selective estrogen receptor modulators, may exert beneficial effects in some tissues without the side effects associated with estrogen. Eli Lilly & Co.’s (LLY) Evista osteoporosis drug is in that category.

FDA officials has raised concerns in pre-meeting documents that Fablyn puts patients at a higher risk of death than a placebo, but a majority of panel members said there wasn’t enough information for them to substantiate that claim.

“I’m really dismayed that we don’t have a head-to-head trial” of Fablyn with other FDA-approved drugs, said panel member Clifford Rosen. Rosen, a senior scientist at the Maine Center for Osteoporosis, added, “Without head-to-head trials, we really can’t make absolute definitions about what drugs work and don’t work.”

Pfizer said the increased number of deaths appears to be due to an unusually low mortality rate for the placebo group during the study period.

Groups representing women made presentations during the public portion of the meeting, and came down against Fablyn.

“Clearly the benefits of this drug are really small,” said Diana Zuckerman, president of the Washington-based nonprofit National Research Center for Women & Families.

Cindy Pearson, executive director of the National Women’s Health Network, a consumer advocacy group, said there isn’t enough information presently for women to make decisions on whether this drug is good for them.

Pfizer has brought this drug before the FDA two other times. In 2005, the FDA rejected Pfizer’s application of the drug – then called Oporia – for prevention of osteoporosis and in 2006 rejected it for a second indication of vaginal atrophy, both times because of concerns about increased risk of endometrial cancer. Pfizer resubmitted the drug with all-new data last December as Fablyn for treatment of osteoporosis.

Meghan McCarthy, CQ Healthbeat News: September 4, 2008

A new report from the Advanced Medical Technology Association, or AdvaMed, aims to stress the safety and efficacy of the current Food and Drug Administration (FDA) process for approving medical devices to counter criticism of the process that could appear in an upcoming Government Accountability Office (GAO) report.

GAO reports released in January and May of this year have been highly critical of the FDA’s medical device approval processes. The reports found that the agency has not met requirements to inspect domestic plants manufacturing medical devices every two years, and that FDA also faces major challenges inspecting foreign establishments. The new GAO report is expected to be released in September.

The approval process — also known as a 510(k) — is used for products that the FDA determines to be a low or moderate risk to consumers and are similar to devices already approved. A 510(k) is significantly faster — usually around 90 days — than the pre-market approval process used for higher risk devices, which can take more than 180 days. Additionally, 510(k) approval is less expensive, as companies are not required to conduct clinical trials on the products.

The industry has argued that the 510(k) process draws unfair criticism because it is frequently misunderstood despite its ubiquitous use by the FDA. AdvaMed estimates the 510(k) process is used to approve 90 percent of medical devices on the market.

“This process is misunderstood because people look at legislation and look at regulations, and they don’t always remember that some of these things need to be quite broad in order to apply to a whole range of medical devices. People who are not intimately involved with the process, who don’t have to put together the submissions can easily come to that conclusion,” said Susan Alpert, senior vice president at Medtronic and a former director of the FDA’s Office of Device Evaluation.

But many believe that the 510(k) process is neither safe nor effective. Last year, the process came under congressional scrutiny by the House Energy and Commerce Health Subcommittee, which reviewed the safety and efficacy of the expedited approval process in the lead-up to legislation (HR 3580 – PL 110-85) that extends the user-fee programs for medical devices and mandates the GAO report on 510(k) approval.

In the report, AdvaMed said patient injuries that occur as a result of devices that have been approved through 510(k) are not evidence of a faulty approval system; instead, report authors highlight faulty manufacturing processes as the cause of device failure, and also emphasize the impossibility of knowing all risks associated with a device in the pre-market phase.

“Further, the long-term effects of devices will never be fully identified and problems eliminated by clinical evaluation in the pre-market period, whether the FDA review is through the PMA or 510(k) processes. In essence, the experience cited by the program’s critics is independent of the pathway to market.”

The report references the deterioration of a jaw implant made by Vitek Inc. as a case that critics use to highlight the pitfalls of 510(k) approval. The report said that injuries occurred due to manufacturing problems, not the 510(k) process.

“Based on this unfortunate experience, it has been inferred that had the device been regulated through the more rigorous PMA program, the failures would not have occurred. This line of thinking is simply flawed.”

In congressional testimony last year, National Research Center for Women and Families President Diana Zuckerman called attention to Boston Scientific’s ProteGen bladder sling, which was approved through the 510(k) process despite being made with a synthetic material different from its predecessor. After implementation, some ProteGen devices began to break down in patients’ bodies, causing major infections and significant harm.

A Boston Scientific spokesman said the company could not comment on the ProteGen device. “Due to pending litigation, it is not appropriate for us to comment at this time,” he said.

AdvaMed members emphasized the historical precedence set by Congress in permitting the FDA to interpret what makes devices similar. In 1990, Congress codified the FDA’s definition of “substantial equivalency” as a device that maintained a similar intended use to its predecessor, and it could include technological developments if the safety of the product was not brought into question.

“Intended use is a pretty broad term, and it really gave the FDA a fair amount of discretion in determining what was and was not a new intended use. The agency typically made that determination based on risk,” said Pat Shrader, senior vice president of corporate, regulatory and external affairs at BD. “Congress did not see a need to go back and make a fundamental change, they merely adopted what FDA was already doing.”

In an interview Zuckerman said, “The problem is that the definition of what is an ‘substantially equivalent’ device has become such a loose definition that it no longer has a scientific or logical meaning. The original definition was pretty good . . . it did not mean you could change what the thing is made out of, and it doesn’t mean you can use a different mechanism of action.”

Alpert said the development of the 510(k) process along with technological advances in the medical device industry has allowed the FDA to keep up with industry and consumer needs.

“When the program first started most products were tool-type products. This industry has evolved significantly in 30-plus years and the program has evolved right along side that . . . it gives the FDA the authority and capacity to state and design specific controls for different technologies to uniquely regulate the different types of products while building off knowledge that has been gained in these many years,” Alpert said.

Zuckerman said improvements to the 510(k) process start with a redefinition of what low- to moderate-risk products are. “A lot of these devices are not of lower risk to patients. An implanted device is never lower risk — it may not be life-saving, but it could become life threatening — once you put something into someone’s body it can do some harm. Anything implanted should go through the pre-market approval process.

“The requirement that GAO do a report was just the first step in dealing with this problem, which I believe has gotten worse over time and is worse today than when I testified a year ago,” Zuckerman said.

Christopher Lee, Washington Post: August 16, 2008

A controversial chemical commonly found in can linings, baby bottles and other household products does not pose a health hazard when used in food containers, according to a draft assessment released by the Food and Drug Administration yesterday.

The report stands in contrast to more than 100 studies performed by government scientists and university laboratories that have found health concerns associated with bisphenol A (BPA). Some studies have linked the chemical to prostate and breast cancers, diabetes, behavioral disorders such as hyperactivity and reproductive problems in laboratory animals.

Exposure to the small amounts of BPA that migrate from the containers into the food they hold are not dangerous to infants or adults, the draft said.

“FDA has concluded that an adequate margin of safety exists for BPA at current levels of exposure from food contact uses,” regulators wrote in the draft report, which will be reviewed Sept. 16 at a meeting of members of an FDA advisory committee studying the safety of the chemical.

The chemical industry and the agencies that regulate the use of BPA, the FDA and the Environmental Protection Agency, have deemed the chemical safe, largely on the strength of two industry-funded studies that found no problems. The American Chemistry Council welcomed the findings of the new report.

“FDA is the premier agency responsible for the safety of our food,” Steven G. Hentges, an executive of the group, said in a statement. “FDA’s thorough analysis confirms that food contact materials containing BPA can continue to be used safely.”

FDA critic Diana Zuckerman, president of the National Research Center for Women and Families, said the agency lacks sufficient data to declare the chemical safe.

“Clearly, their effort was to minimize people being concerned about this,” Zuckerman said. “It just seems that whenever there is an opportunity to look at a new, important issue, they just seem to be siding with industry’s point of view.”

BPA, in commercial use since the 1950s, is found in many everyday items, including compact discs and automobiles. One federal study estimated the chemical is present in the urine of 93 percent of the population.

Concerns about the safety of BPA have kept the chemical industry on the defensive in recent months.

Canadian regulators recently decided to ban the controversial compound in baby products. Wal-Mart, the nation’s largest retailer, and Toys R Us, the largest toy seller, have said that by January their shelves will be free of children’s products containing BPA.

Democrats in Congress have introduced one bill that would ban the chemical in products intended for use by children younger than 8, and another that would restrict its use in food containers. Neither bill has advanced beyond the committee stage.

“Ask any mother of a child if there is an adequate margin of safety for the things that she puts her child in contact with,” said Liz Hitchcock, public health advocate for U.S. PIRG, a consumer advocacy group. “When you’re talking about the stuff that’s going to carry your child’s food into their body, you want the safest thing possible.”

Kevin Freking, AP news services: August 4, 2008

WASHINGTON –Outside experts may not participate in federal advisory committee meetings on drugs and medical devices if they have more than a $50,000 financial interest in the companies governed by their decisions, according to new guidelines released Monday.

The Food and Drug Administration’s guidance formalizes draft policy issued in March 2007. If an adviser’s financial interest falls below $50,000, the FDA may grant them a waiver that allows them to participate, but will do so only if they find there is an essential need for the adviser’s particular expertise.

“It’s imperative that we seek advice from independent experts, and that we do so in a way that is public, open and transparent,” Randall Lutter, a deputy FDA commissioner said Monday.

Advisory committee members often represent the world’s leading authorities on a particular disease or condition. Drug and device makers often pay them lucrative consulting and speaking fees, but such financial arrangements also can lead to the appearance of a conflict of interest.

Last year, the FDA convened 48 meetings of advisory committees on topics ranging from the safety of diabetes medications to the evaluation of a new anticancer drugs for use in children.

Jill Hartzler Warner, a senior policy adviser at the FDA, said excluding people from committees who have some financial interest in the drug and device industry would make it extremely hard to find qualified advisers. “The industry relies on recognized experts. So do we,” she said.

In 2006, researchers reviewed 221 meetings by 16 boards. They found that disclosure of conflicts of interest at advisory committee hearings was commonplace and rarely results in someone being barred from participating. The researchers, writing in the Journal of the American Medical Association found a “weak relationship” between the financial conflicts and voting behavior. However, excluding committee members from the vote would not have altered the outcome at any of the meetings studied.

Dr. Sidney Wolfe, one of the authors of that study, said the agency weakened proposed restrictions for those with a financial interest of less than $50,000. Previously, the FDA proposed allowing participation in meetings, but not a vote. Now, it will consider waivers that could allow them to vote. Still, he described the guidance as a step in the right direction.

“Over time, the percentage of people who have these (conflicts) will diminish,” said Wolfe, director of Public Citizen’s Health Research Group. “A lot of it will have to do with how much energy the FDA is willing to expend to find people who don’t have a conflict of interest.”

Diana Zuckerman, president of the National Research Center for Women & Families, said the $50,000 threshold was too high. She said she was concerned that too many advisers below the threshold would get waivers that allow them to vote.

“The FDA has consistently used a very low standard for granting waivers, and there is no evidence that this will change,” she said.

Hartzler Warner said the new guidance is much stricter than past policy. She said the agency will limit the number of waivers it grants and it will insist that an adviser show the waiver is necessary to provide the committee with essential expertise.

Rep. Maurice Hinchey, D-N.Y., said the FDA’s waiver policies had led to a broken system in which advisory panels were filled by experts with direct financial interests in the drugs and devices being reviewed.

“By making the standard for waivers more stringent and improving the voting system, the FDA is moving closer toward ensuring the only interest taken into account during these advisory panels is that of the American people,” Hinchey said.

The $50,000 cap was one of several policy changes announced Monday. The agency also recommended that advisory board members vote all at one time, rather than one at a time.

“Simultaneous voting avoids voting momentum, in which some voters may be influenced, even subconsciously, by the votes of those who precede them,” the agency said in a press release.

The agency also recommended that all votes be announced immediately at the meeting, and it said that all votes will be detailed on the FDA’s Web site.

——

On the Net:

http://www.fda.gov

Fox News: August 3, 2008

When someone well-known such as Christina Applegate is diagnosed with breast cancer, many adult women become concerned as to what the future holds for them.

While it’s true that 1 out of 8 American women will be diagnosed with breast cancer at some point in her lifetime, there are also a lot of misconceptions about the disease floating around.

Although Applegate is just 36 years old, the fact remains that breast cancer is more likely to strike women over the age of 50.

Still, many women under the age of 40 may now be tempted to run out and demand mammograms.

But mammograms are ineffective for most young women, Dr. Diana Zuckerman, president of the National Research Center for Women & Families, told FOXNews.com in October.

“Young women’s breasts are dense and if they get mammograms, their breasts show up very white on mammograms and cancer shows up as white,” she said. “But, as women get older, their breasts are less dense and show up gray on a mammogram, which makes it easy to identify the white cancer. If there is a family history, and women are worried, they can start earlier and in this case a digital mammography may work better than a traditional mammography.”

Here are five myths about breast cancer:

— There’s no history of breast cancer in my family so I won’t get it.

“That’s not true,” Dr. Marisa Weiss, an oncologist and the president of breastcancer.org, said previously. Although women with a family history are at a higher risk for the disease, environmental factors, drinking, smoking, medication and diet can all influence a woman’s chances of getting breast cancer.

Knowing the history of breast cancer on both sides of your family is also important. Just because a woman doesn’t have a history of breast cancer on her mother’s side, doesn’t mean she’s at a decreased risk. A paternal family history of breast cancer also increases a woman’s chances of getting it.

— I have breast cancer, so I have to get a mastectomy if I want to stop the spread and prevent the cancer from coming back.

Very few women diagnosed with breast cancer actually need a mastectomy, said Zuckerman. “In fact, most of the women who get mastectomies don’t need them,” she said. “And for women to lose their breasts, in addition to the normal emotional turmoil that they go through having breast cancer, is harmful emotionally and physically.”

Specifically, Zuckerman said that about 75 percent of the women who get breast cancer each year will not need mastectomies. Many women with stages 0, 1 or 2 breast cancer respond well to treatment that includes a lumpectomy with radiation and chemotherapy, she added.

“Women with early stage breast cancer usually do not need a mastectomy and will benefit from chemotherapy almost always,” said Zuckerman. “Women who get a lumpectomy will need radiation and that’s the difference. Women who get a mastectomy will not need radiation, but with a lumpectomy you always need radiation.”

— Young women are just as likely to get breast cancer as older women.

Both Weiss and Zuckerman agree that this also is not true. Women older than 50 are most at risk for this disease, explained Zuckerman.

“Breast cancer in women younger than 30 is so rare, and this is one of the things that concerns me,” she said. “I think the media focuses on young women, because it’s so shocking when someone in their 20s gets cancer. But what you end up with are women in their 20s and 30s who are terrified that they’re going to get cancer and women in their 50s who think they don’t need to worry about it, when the opposite is true.”

Of the nearly 200,000 women who will get breast cancer next year, half will be over the age of 61, said Weiss. About 25,000 women will be under the age of 40.

“It’s still a significant number, but when you compare it to the overall number of women who get breast cancer, it’s a small percentage,” she said.

— Breast cancer is fatal.

“Breast cancer is not fatal in and of itself,” said Zuckerman. “What makes it fatal is if it goes into other parts of the body and gets into the lymph nodes, lungs and other organs,” she said.

“Also if it gets into the blood or the bones, it can kill a person. That’s the risk of metastasized cancer. That means it has spread and once it hits the lymph nodes, it can become out of control.”

Zuckerman said early detection is the best way to prevent cancer from spreading.

— Men don’t get breast cancer.

“This is certainly not true,” said Weiss. “Men do get it.”

The American Cancer Society estimates that about 2,030 new cases of invasive breast cancer will be diagnosed in men this year, and about 450 men will die after getting the disease.

Still, breast cancer is about 100 times more common in women, and women whose fathers are diagnosed with breast cancer are at an increased risk for the disease just as they would be if their mothers are diagnosed with it, added Weiss.

Lyndsey Layton,Washington Post: August 2, 2008

Samantha Rosenberg eyed the toy plastic cellphone that her 9-month-old daughter has chewed so much, the color is fading. She wondered if the shiny plaything, and others that fill her home, are endangering Addison’s health.

Congress this week approved a ban on a family of chemicals widely used in soft plastic toys and other baby products. Health advocates say the compounds, known as phthalates, have been linked to kidney and liver cancer and to reproductive disorders in fetuses and infants, especially boys.

Toymakers and the chemical industry ran an expensive lobbying campaign trying to block the legislation, arguing that phthalates have been used commercially since the 1950s, that they are safe and that the ban is an overreaction.

Rosenberg and other consumers are not sure what to think.

“Am I being neurotic, or is it really not safe?” Rosenberg, a 30-year-old District resident, said about the toy cellphone. “It just gets compounded, because everything is plastic and made in China. You end up worrying about lead paint, plastics, all these things our parents never worried about.”

Her questions are echoed by millions of parents who feel overwhelmed by conflicting information and are struggling to strike the right balance. For those discussing toy safety at neighborhood playgrounds, in Internet chat rooms and in the toy aisles of big-box stores, every plastic geegaw has grown suspect.

“In the past six months, I started freaking out about the BPA stuff and plastic toys,” said Sherri Bohinc, a 32-year-old mother of two young children who lives in Bethesda, referring to health concerns raised about bisphenol A, another additive used in plastic. “In Target, I’ll ask other moms shopping in the same aisles what they think about a toy. I’ve run into some really paranoid moms, and then I run into people who are like, ‘Eh, don’t pay attention.’ ”

Kara Dillon, 29, a mother of two in Surprise, Ariz., threw out baby bottles that contained BPA and replaced them with BPA-free bottles. Now the phthalates ban leaves her wondering whether to toss her children’s soft plastic toys, too.

“It’s really hard as a mom to know what to do,” Dillon said. “As consumers, we’re buying what’s out there, and you just trust the companies — especially when it comes to things designed especially for babies — that they’re safe.”

The United States is one of the last industrialized nations to outlaw phthalates in children’s products. The European Union has banned them since 1999. California was the first state to approve a ban; it takes effect in January. Lawmakers in Washington state and Vermont have followed suit.

The federal ban will take effect six months after President Bush signs it, which he is expected to do in the next several weeks. That means it would not be in place until after the holiday season. Wal-Mart, the nation’s largest retailer, and Toys R Us, the largest toy seller, have said that by January their shelves will be free of children’s products containing BPA and phthalates.

Chemical companies, including ExxonMobil, which manufactures the phthalate most often found in toys, have argued that banning the compounds could force toymakers to use substitutes that pose greater risks. But several alternative chemicals used to make toys for the European market have been found to be safer than phthalates, said Janet Nudelman of the Breast Cancer Fund, which pushed for the U.S. ban. Chemical makers say the alternatives are not as cheap or versatile as phthalates.

It is nearly impossible for consumers to tell whether a children’s product contains phthalates because chemical ingredients are not listed. Some toy manufacturers do not even know what is in the plastic they buy from suppliers.

Diana Zuckerman, president of the National Research Center for Women and Families, which lobbied in favor of the phthalates ban, suggested that parents get rid of soft, squeezable plastic teethers, rattles and other toys and wait until the ban takes effect before buying replacements.

“Don’t keep them around your house for visiting friends with children, or to gather dust in your child’s room,” she said. “And don’t give them as hand-me-downs to relatives or charities.”

Zuckerman stressed that she was referring to soft plastic toys, such as plastic books, rubber ducks and teething toys.

She also cautioned that many shampoos and lotions for babies and children contain phthalates. Personal care products are not covered by the ban because the legislation applies to the Consumer Product Safety Commission, which does not have jurisdiction over cosmetics, shampoos and lotions. Zuckerman said the next goal for health advocates is to bar phthalates from cosmetics, perfumes and products that children and adults slather on their skin, which readily absorbs the chemicals.

“Everybody in Congress is now well aware that phthalates are ubiquitous and exposure is coming from many different products,” Zuckerman said. “And children’s toys are probably not the main culprit. Clearly, the next step is personal care products.” […]

Read the original article here.

View all comments that have been posted about this article.

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.