All posts by CPTFeditor

Testimony of Dr. Diana Zuckerman before DC Health Committee, on HPV

April 9, 2009Testimony & BriefingsCPTFeditor

Diana Zuckerman, PhD, Cancer Prevention and Treatment Fund, April 9, 2009

I am pleased to have the opportunity to testify as president of the National Research Center for Women & Families.

Our Center is dedicated to improving the health and safety of adults and children, and we do that by scrutinizing medical and scientific research to determine what is known and not known about specific treatments and prevention strategies, and to compare their safety and effectiveness.

I was trained in epidemiology at Yale Medical School. I have worked on federal health policy issues in Congress, the White House, the Institute of Medicine, and for nonprofit organizations for 25 years. In addition, I am a fellow at the University of Pennsylvania Center for Bioethics.

Like all of you, I am interested in the health and safety of D.C.’s citizens, and like many of you I was, until recently, strongly in favor of mandating the HPV vaccine for girls. Who among us wouldn’t gladly immunize our daughters to protect them from cervical cancer?

I am here today to share with you some research information that I have only recently uncovered and draw attention to a number of unanswered questions regarding Gardasil, the only HPV vaccine currently available in the U.S. This research information is available on the FDA web site but most of it is not published yet.

As most of you know, Gardasil protects against two types of Humanpapilloma Viruses (HPV) that cause genital warts and two types of HPV that cause cervical cancer. Almost all HPV viruses go away by themselves – just like a cold virus goes away by itself. The goal of the vaccine is to protect the less than 10% of girls and women for whom HPV does not go away by itself.

In clinical trials, Gardasil has been shown to be 100% effective against those 4 HPVs – but not for very long. The FDA approved Gardasil based on about 2-3 years of data! Even Merck, the vaccine’s manufacturer admits that, “the duration of protection of Gardasil has not been established.” All that we know now is that it stimulates short-term protection against various strains of HPV and certain kinds of lesions known to be precursors of cervical cancer.

There is new evidence that if Gardasil is given to 12 year old girls, they will not be well protected when they are 16 or 17:

1. Just three years after being vaccinated with Gardasil, one-third of the girls had lost all their antibodies to one of the two strains of HPV that can lead to cervical cancer-HPV 18. Girls with antibodies to HPV are protected against HPV. Those without probably aren’t.

2. Older teenagers who were already exposed to HPV but didn’t have active infections when vaccinated benefited as much as 12 year olds

3. Teenage girls and young women who were exposed to HPV through sexual contact had as many or more antibodies against HPV as those who were vaccinated. Since not all girls are exposed to HPV and about 90% of HPV infections go away by themselves without any risk of cancer, the vaccine is providing protection to less than 10% of all vaccinated girls.

4. In their studies, Merck gave a booster shot to all the girls and young women 5 years after they were vaccinated with Gardasil. Then they measured their antibodies and reported how high they were after 5 years – but they don’t sell anything called booster shots for HPV and they have never advertised or publicly discussed the need for a booster shot.

5. Gardasil is the most expensive vaccine in the world, consisting of 3 shots that cost between $400 and $1,000. The booster shot in the Merck study was a repeat of the first Gardasil shot and costs at least $150.

When the Centers for Disease Control and Prevention recommended Gardasil for young girls, they didn’t have all this research information. They assumed the vaccine would last forever, not for just a few years. They believed Merck – as we all did – that it was important to vaccinate young girls before they were sexually active. But that doesn’t seem to be true.

Instead, if we vaccinate 12 year old girls, we will probably have to vaccinate them with a booster shot when they are 16 or 17. In fact, they might need another booster shot every 5 years for the rest of their lives.

Most women in Washington are unlikely to be able to afford those expensive HPV booster shots every 5 years. If they don’t get them, however, they will no longer be protected from cervical cancer at an age when they are most likely to get it.

What can we do about this? The good news is that there is another HPV vaccine that has been shown to last longer – more than 6 years. It is already approved in 66 other countries. However, it is still being analyzed by the FDA so we don’t yet know if it is really that effective.

The other good news is that if the DC government decides to delay any kind of HPV vaccine program for a year, that will not harm our girls. The reason it won’t harm them is that Gardasil seems to work even better if it is given to older girls and young women, instead of 12-year olds.

So, as a budget matter, I strongly urge you to delay implementing an HPV vaccine program for another year, until data are available to tell you which HPV vaccine is more effective and more cost effective.

Patient and Consumer Coalition letter to Congressional leaders, March 18, 2009

March 15, 2009LegislationCPTFeditor

March 18, 2009

The Honorable Henry Waxman
Chairman
Energy and Commerce Committee
United States House of Representatives
Washington, DC 20515

Dear Chairman Waxman:

The above members of the Patient and Consumer Coalition strongly support H.R. 1523, the “Ban Poisonous Additives Act of 2009,” which will remove Bisphenol A (BPA) from food and beverage containers. The Centers for Disease Control and Prevention (CDC) found BPA in more than 90 percent of Americans tested for the chemical, and BPA is linked to numerous adverse health effects.

We are particularly concerned about BPA’s effects on pregnant women. Scientists have reported that BPA adversely affects the health of fetuses (along with infants and children) at currently exposed levels. Six major baby bottle manufacturers have recently announced that they will stop using BPA in bottles, but other manufacturers will continue to sell baby bottles with BPA. In addition, if a pregnant woman drinks or eats food stored in a container lined with BPA, her fetus would also be exposed to the chemical. H.R. 1523 addresses this issue by banning BPA in all food and beverage containers.

We are also gravely concerned about BPA’s effect on chemotherapy patients, especially those with breast cancer. A 2008 University of Cincinnati study concluded that “BPA at environmentally relevant doses” makes “chemotherapy significantly less effective.” This is particularly disturbing since studies have shown BPA can cause breast cancer in laboratory animals, and now a study shows that it interferes with chemotherapy-an important tool in treating breast cancer.

Numerous other scientific studies raise red flags about BPA. A recent study published in JAMA indicates that adults with higher levels of BPA in their bodies were more likely to be diagnosed with diabetes or heart disease, even when obesity was statistically controlled. Studies have also linked BPA to miscarriages, insulin resistance (a risk factor for Type II diabetes), and increased formation and growth of fat cells (which can lead to obesity). A 2008 Yale study linked BPA to brain and mood disorders in monkeys, which has implications for depression and learning in humans. Other studies state that BPA can affect the prostate and mammary glands and lead to early puberty in girls.4

Alternatives to BPA are available and several manufacturers and retailers have pledged to remove it from their products. BPA maker Sunoco recently announced that it will refuse to sell BPA to companies for use in food and beverage containers for children younger than 3.

However, a comprehensive ban, such as the “Ban Poisonous Additives Act of 2009” is needed to make sure that all manufacturers stop using BPA. It is not enough to ban BPA in products that directly affect infants and small children. The only way to protect pregnant women, all children and chemotherapy patients, is to ban BPA from products used by adults as well. We strongly support H.R. 1523, the Ban Poisonous Additives (BPA) Act, introduced by Rep. Ed Markey.

Sincerely,
Breast Cancer Action
Breast Cancer Fund
Community Access National Network (CANN)
Consumer Federation of America
Consumers Union
Government Accountability Project (GAP)
National Research Center for Women & Families/Cancer Prevention and Treatment Fund
Our Bodies Ourselves
U.S. PIRG
Woodymatters
For additional information, contact Paul Brown at the National Research Center for Women & Families at (202) 223-4000 or at pb@center4research.org

Statement of Diana Zuckerman at the FDA Science Board Meeting on the Use of Bisphenol A in Food Containers

February 24, 2009Testimony & BriefingsCPTFeditor

Diana Zuckerman, PhD, Cancer Prevention and Treatment Fund, February 24, 2009

Thank you for the opportunity to testify on behalf of the National Research Center for Women & Families. I have no conflicts of interest.

In addition, I am a fellow at the University of Pennsylvania Center for Bioethics, and a board member for two nonprofit organizations that work to improve resources for the FDA: the Alliance for a Stronger FDA, and the Reagan Udall Foundation.

I was trained in epidemiology at Yale Medical School; was on the faculty at Yale and Vassar; and directed a longitudinal research project at Harvard. I have worked on health policy issues in Congress, the White House, and for nonprofit organizations for 25 years.

Science Board Subcommittee Report on Bisphenol A (BPA)

We were very pleased with the Science Board’s criticisms of the FDA Draft report on BPA and were disappointed that the FDA has not acknowledged the bottom line criticism: that the FDA drew conclusions about the safety of BPA that were not based on sound science, and that no conclusions can be made about safety until the FDA pays attention to the best studies conducted by federally funded scientists and designs appropriate follow-up research.

The FDA’s response to the Science Board criticisms also ignored several issues that were raised at your meeting in October:

1. Prenatal Exposures
The FDA says they agree with the Science Board that they should focus on the health effects of BPA on infants and young children. However, in our testimony in October and in the Science Board’s response, it was pointed out that prenatal exposures are probably even more important.

Unfortunately, pregnant women don’t have a special diet of canned foods and beverages-they eat the same food as everyone else. That means the FDA needs to be concerned about BPA exposure from all containers for foods and beverages commonly consumed by adults.

2. Chemotherapy Patients
A study published online in Environmental Health Perspectives in October and in the print edition this month found that the effectiveness of chemotherapy could be undermined by exposure to BPA among women with breast cancer. At the Science Board meeting in October, the need to study the impact of BPA on chemotherapy was also mentioned. Again, this means that BPA levels in all foods and beverages consumed by adults will need to be examined.

3. Sprague-Dawley Rats
The FDA is proposing new research using Sprague-Dawley rats. The use of Sprague-Dawley rats was criticized at the Science Board subcommittee meeting because those rats are inappropriate for use in BPA research: they are less sensitive to estrogens than other types of rats. If the FDA’s goal is to do objective research, these are not the right rats to use.

What Else is Needed?

We are pleased that the FDA plans to do a new study of BPA levels in cans of infant formula. This decision responds to criticisms we made in September, echoed by the Science Board subcommittee on BPA, that the safety levels for infant formula were based on an inadequate sample-a sample of infant formula that was outdated, too small, and not generalizable to a national sample.

The next question is: Will the FDA move quickly to answer these crucial safety questions, or will they follow the time-honored Washington tradition of study and stall.

New studies will be enlightening, but the FDA has thus far ignored many very well-designed studies which indicate that there are real risks to BPA exposure. While the FDA studies and stalls, new research is emerging almost every month. These studies need to be scientifically summarized by the FDA to determine BPA’s likely risks to human health.

Risks vs. Benefits

We’d like to believe that BPA in food containers is safe, but wishing doesn’t make it so. There is a growing body of research evidence that suggests that current BPA levels are likely to be harmful for at least some of our children, and perhaps many adults and children.

The FDA has continued to reassure consumers that BPA is safe at current levels when the FDA does not even know what current levels are and doesn’t have well-designed research to conclude that they are safe.

The FDA should not draw conclusions that are biased and premature.

While the FDA is deciding what to do about BPA in food containers, they should at the very least empower consumers by requiring that food and beverage containers list whether or not they contain BPA.

But ultimately, it is not fair to consumers to give them information (this container has BPA!) without explaining the implications. For that reason, the FDA should ban the use of BPA or at the very least require reduced levels of BPA until more conclusive studies can be performed to assure the American public that the chemical is safe. I think we can all agree that there is no clear evidence that the products are safe. It is still unclear how unsafe they are, and for whom.

Alternatives to BPA Are Available

Alternatives include oleoresinous, vinyl, or PET film lamination to line cans, and glass bottles, polypropylene bottles and bottles with polymeric liners for baby bottles.

Other Countries and Companies Are Reducing BPA Exposure-But Not The FDA

Japan has taken measures to reduce BPA in consumer products, such as canned beverages and plastic tableware. They are using different linings for beverage cans, which either contain no BPA or leach only a small amount of BPA, and plastic tableware that had BPA has been replaced with tableware that does not.¹ Canada has designated BPA as the highest priority chemical in need of regulation and has banned its use in infant products. A number of cities and states across the U.S. have weighed the scientific evidence and are seeking to implement bans.

Responsible retailers are not waiting for the FDA to act. Wal-Mart and Toys-R-Us have pledged to remove products containing BPA from their shelves.² Bottle manufacturers such as Playtex and Nalgene are using non-BPA materials for their products.

Keeping Consumers Safe

It is the FDA’s job to make sure that food and beverage containers don’t increase the risks of food and beverages. The bottom line is we just don’t know if the amount of BPA in infant formula cans and other food containers is safe.

More than 100 studies have raised doubts about the safety of BPA, and alternatives to BPA are available. The FDA’s job is to protect consumers. For that reason, the FDA should ban BPA in baby bottles, as Canada has done. And the FDA should go further, by eliminating BPA in food and beverage containers used by pregnant women, infants, and children.

We urge the Science Board to carefully monitor the FDA’s efforts on BPA and to make sure that well-designed studies-free of industry bias-are conducted immediately. Well-designed, independently conducted studies in the scientific literature should be reviewed and summarized within the next few months. The Science Board should also ensure that FDA’s reports and regulatory actions on BPA are completed as quickly as possible and are consistent with the scientific evidence and the public health needs of all our families. We depend on the FDA to protect our families, but the agency has let us down in their failure to acknowledge the need for caution regarding BPA.

References:

1. Advanced Industrial Science and Technology. 2007. Risk Assessment Document: Bisphenol A.
2. Parker-Pope, T., (2008, April 22). A Hard Plastic is Raising Hard Questions, The New York Times.

Statement of Diana Zuckerman Regarding Food Safety Before the USDA Dietary Guidelines Advisory Committee

January 29, 2009Testimony & BriefingsCPTFeditor

Diana Zuckerman, PhD, Cancer Prevention and Treatment Fund, January 29, 2009

I am Dr. Diana Zuckerman, president of the National Research Center for Women & Families. I have no conflicts of interest.

In addition, I am a fellow at the University of Pennsylvania Center for Bioethics. I was trained in epidemiology at Yale Medical School; was on the faculty at Yale and Vassar; and directed a multi-site research project at Harvard. I have worked on health policy issues in Congress, the White House, and for nonprofit organizations for 25 years.

I want to thank this Advisory Committee for its excellent work. There are many important issues for you to consider, but I am going to focus on two less-frequently discussed food safety issues that deserve your careful attention.

Methylmercury in Fish

In 2005, this Advisory Committee’s Dietary Guidelines Report included information about the risks of methylmercury in fish consumed by pregnant and nursing women and young children. This was consistent with a 2004 joint advisory from FDA and EPA. However, the FDA recently issued a draft report that focuses on the benefits of fish and downplays the risks of methylmercury. They implicitly justify this change by focusing on average levels of mercury, rather than the range of mercury levels in specific species of fish. Mercury is a neurotoxin, so children can be seriously harmed if pregnant or nursing moms consume canned tuna or other fish with dangerously high mercury levels. This draft report has been strongly criticized and should not influence this Advisory Committee.

The problem is that tuna is fish that is most often consumed in the U.S., and albacore canned tuna and all fresh and frozen tuna are quite high in methylmercury – sometimes extremely high. Although mercury levels are higher in swordfish, shark, tilefish, and king mackerel, those fish are not on the weekly menu for most families. In 2005, your report quoted the FDA and EPA advisory limiting pregnant and nursing women and young children to no more than 12 oz of fish each week. I urge you to emphasize that these vulnerable groups can safely eat more than 12 oz. of fish and seafood if they only eat fish that are very low on mercury, such as tilapia, haddock, and cod. Unfortunately, these vulnerable populations can be harmed if they eat even 6 oz. of albacore tuna every week.

Food containers

Bisphenol A (BPA) is used in the lining of canned foods and beverages, and in the lining of metal tops for bottled food and beverages, such as juices and sauces. Last September, the National Toxicology Program final report stated that “Bisphenol A can migrate into food from food and beverage containers with internal epoxy resin coatings…”¹ and that “Bisphenol A in food and beverages accounts for the majority of daily human exposure.”

In summary: this estrongenic chemical is in the food and beverages we consume. Any chemical that affects hormones can affect puberty and increase the risk of certain cancers. There is also evidence that BPA can affect cognitive functioning and mood. BPA in packaged food and beverages is therefore an important safety issue for this Advisory Committee.

The National Toxicology Program report concludes that there is reason for “some concern” about the effects of BPA on “brain, behavior, and prostate gland” at current levels of exposure. “Some concern” doesn’t sound serious, but for the National Toxicology Program, it means a substantial level of concern. The report also concluded that there was “negligible concern” about the effects on early puberty – which means that there is possible reason for concern, but not much evidence. The report expressed less concern about BPA’s effects on fetal or neonatal mortality, birth defects, or birth weight.

However, after the NTP report was completed in September, more research was published indicating even more evidence that BPA may be dangerous at current levels. Based on their analysis of existing studies last fall, the FDA Science Board concluded that more research was needed to determine if the current levels of BPA are safe in infant formula containers and other food container exposures for young children. The FDA’s Science Board criticized last year’s FDA report on BPA, saying that the FDA had not considered all the appropriate scientific evidence. The Science Board also pointed out the need to determine if BPA levels are safe for pregnant women and people undergoing chemotherapy. Meanwhile, research published in the Journal of the American Medical Association in September, based on data from the highly respected NHANES survey, indicates that even when obesity is statistically controlled, adults with more BPA in their bodies are at higher risk of diabetes and heart disease.²

A final point: there is new research suggesting that corn syrup may have high levels of mercury. We don’t know enough to draw conclusions about this new research, but the implications are very important for the public health so we urge you to keep appraised of any new findings regarding corn syrup as you do your work.

References:

1. National Toxicology Program, NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A, http://cerhr.niehs.nih.gov/chemicals/bisphenol/bisphenol.pdf
2. Lang IA, Galloway TS, Scarlett A et al, Association of Urinary Bispehnol A Concentration With Medical Disorders and Laboratory Abnormalities in Adults, JAMA, September 17, 2008, 300 (11), 1303-1310.

In FDA Files, Claims of Rush to Approve Devices

January 13, 2009News Stories & EditorialsCPTFeditor

Gardiner Harris, New York Times: January 13, 2009

An official at the Food and Drug Administration overruled front-line agency scientists and approved the sale of an imaging device for breast cancer after receiving a phone call from a Connecticut congressman, according to internal agency documents.

The legislator’s call and its effect on what is supposed to be a science-based approval process is only one of many of accusations in a trove of documents regarding disputes within the agency’s office of device evaluation.

Nine agency scientists complained in May to Andrew C. von Eschenbach, the F.D.A. commissioner, and the agency began an internal review. Dissatisfied with the pace and results of that review, the scientists wrote a letter to Congress in October pleading for an investigation, and the House Committee on Energy and Commerce announced in November that it would begin one. Last week, the scientists wrote a similar letter to President-elect Barack Obama’s transition team.

Agency documents that are part of the internal investigation, including e-mail messages, were provided to The New York Times. Details of the investigations have not previously been made public.

The documents show that front-line agency scientists, like many outside critics of the agency, believe that F.D.A. managers have become too lenient with the industry. In medical reviews and e-mail messages, the scientists criticize the process by which many medical devices gain approval without extensive testing. And in e-mail correspondence, they contend that an agency supervisor improperly forced them to alter reviews of the breast imaging device and others.

William McConagha, the agency’s assistant commissioner for integrity and accountability, said he was continuing to investigate the scientists’ claims. Mr. McConagha said that Dr. von Eschenbach had offered to meet with the nine scientists before Friday, his last day in office.

“We in the Office of Commissioner are extremely concerned about allegations like this,” Mr. McConagha said.

In the documents, Representative Christopher Shays, a Connecticut Republican who lost re-election in November, is described as having called an agency supervisor a year ago to express concern about the fate of a computer device that is supposed to help radiologists detect breast tumors.

The device, the iCAD SecondLook Digital Computer-Aided Detection System for Mammography, is used with screening equipment made by Fujifilm Medical Systems.

Fujifilm Medical is based in Stamford, Conn., the heart of Mr. Shays’s former district. In the documents, Mr. Shays is referred to as “Congressman Fuji.”

“I am the Fuji congressman because I represented that district,” Mr. Shays said in an interview Friday.

Mr. Shays said he had called the agency supervisor only to demand that the agency make a final decision, not that it approve the product.

He scoffed at suggestions in the documents that his call led the supervisor to overrule scientists and approve the device. “That would be idiotic for someone to approve something they don’t think should be approved,” he said.

A spokeswoman for Fujifilm Medical, Courtney A. Kraemer, said the company had called its “local Congressional offices to ask them to help us get clarification on the F.D.A. process.”

The dissenting scientists protested, according to the internal documents, that “iCAD never tested the device by the intended users (i.e. radiologists) under the intended conditions of use. This is the most basic and fundamental requirement of all F.D.A. submissions.”

An internal review said the risks of the iCAD device include missed cancers, “unnecessary biopsy or even surgery (by placing false positive marks) and unnecessary additional radiation.”

Ken Ferry, iCAD’s chief executive, said, “We have done all the appropriate testing to get the product approved.”

Mr. Ferry said that F.D.A. scientists were increasingly asking for more rigorous testing of devices, and that his company complied with those demands.

Diana Zuckerman, president of the National Research Center for Women and Families, said the Bush administration had “finally made the device approval process so meaningless that it’s intolerable to the scientists who work there.” Ms. Zuckerman, a longtime critic of the agency’s device approval process, particularly as it relates to breast implants, added, “Virtually everything gets approved, no matter what.”

The F.D.A. has a three-tiered approval process for medical devices that, depending on their newness or complexity, requires varying amounts of proof.

A growing chorus of critics contends that the agency requires few devices to complete the most rigorous of these reviews and instead allows most devices to be cleared with minimal oversight. In 2007, 41 devices went through the most rigorous process, compared with 3,052 that had abbreviated reviews. […]

Read the original article here.

The Price of Beauty: Some Hidden Choices in Breast Reconstruction

December 23, 2008News Stories & EditorialsCPTFeditor

Natasha Singer, New York Times: December 23, 2008

For many cancer patients undergoing mastectomies, reconstructive breast surgery can seem like a first step to reclaiming their bodies.

But even as promising new operations are gaining traction at academic medical centers, plastic surgeons often fail to tell patients about them. One reason is that not all surgeons have trained to perform the latest procedures. Another reason is money: some complex surgeries are less profitable for doctors and hospitals, so they have less of an incentive to offer them, doctors say.

“It is clear that many reconstruction patients are not being given the full picture of their options,” said Diana Zuckerman, the president of the National Research Center for Women and Families, a nonprofit group in Washington.

One patient, Felicia Hodges, a 41-year-old magazine publisher in Newburgh, N.Y., chose a double mastectomy after she was found to have cancer of the right breast in 2004. She consulted a plastic surgeon, who offered her only reconstruction with breast implants, she said.

Ms. Hodges chose implants filled with saline, a procedure for which more than a third of reconstruction patients underwent a follow-up operation, studies show.

Ms. Hodges developed wound-healing problems that required her surgeon to remove her right implant, and she was left with a concave chest with a quarter-size hole in it, she said; she described the experience as “worse than the mastectomy.”

Then Ms. Hodges discovered a chat room on the patient-information Web site breastcancer.org, where women share detailed information about breast reconstruction beyond what they may have heard from their doctors.

Ms. Hodges learned of newer, more complex procedures that involve transplanting a wedge of fat and blood vessels from the abdomen or buttocks, which would be refashioned to form new breasts.

“It’s unfortunate that a lot of general surgeons, breast surgeons and plastic surgeons don’t mention it,” said Ms. Hodges, who underwent one of the surgeries, known as a GAP flap, last year. A lifelong athlete and a karate enthusiast, she is now back at her dojo.

To raise awareness of breast reconstruction and to market it to patients, the American Society of Plastic Surgeons has adopted the vocabulary of the movement to support a woman’s freedom to choose an abortion, adjusting it for women with breast cancer. Although women “don’t choose their diagnosis, they can choose to go ahead with reconstruction or not, and with the aid of a knowledgeable plastic surgeon they can choose what their options might be,” Dr. Linda G. Phillips, a plastic surgeon in Galveston, Tex., said in a telephone news conference organized by the plastic surgery society to mark Breast Cancer Awareness Month in October. “Then they have that much more power over their lives if they have that power to choose.”

But for many patients, the options may be limited because their doctors are not proficient in the latest procedures. Dr. Michael F. McGuire, the president-elect of the American Society of Plastic Surgeons, said it is not unusual for surgeons to omit telling patients about operations they do not perform. He compared the rise of more complex breast reconstruction to the advent in the late 1980s of minimally invasive laparoscopic surgery of the gallbladder.

“At the time, only a small percentage of surgeons were doing them and doing them well,” said Dr. McGuire, who is chief of plastic surgery at St. Johns Hospital in Santa Monica, Calif. “If you were not familiar with laparoscopic gallbladder surgery, you were still doing it the traditional way with an open great big scar across the abdomen.”

Uneven information about reconstructive options is a subset of a larger problem, said Dr. Amy K. Alderman, an assistant professor of plastic surgery at the University of Michigan Medical School in Ann Arbor. Only one third of women undergoing operations for breast cancer said their general surgeons had discussed reconstruction at all, according to a study by Dr. Alderman of 1,844 women in Los Angeles and Detroit that was published in February in the journal Cancer.

“In the big picture, it would be great if we could just get doctors to tell people they have an option of reconstruction,” Dr. Alderman said.

Once patients are so informed, she added, plastic surgeons should tell them of options beyond implants. “The next hurdle would be letting them know that using their own tissue is an option, because my guess is that they are not even getting that far in the discussion,” Dr. Alderman said.

About 66,000 women in the United States had mastectomies in 2006, the latest figures available, according to the federal government. And about 57,000 women had reconstructive breast surgery last year, according to estimates from the plastic surgery society.

For many of these women, the operations were more about feeling whole again than about restoring their appearance.

Implant surgery is the most popular reconstruction method in the United States. Often performed immediately after a mastectomy, it initially involves the least surgery usually a short procedure to insert a temporary balloonlike device called an expander and the shortest recovery time.

But implants come with the likelihood of future operations. Within four years of implant reconstruction, more than one third of reconstruction patients in clinical studies had undergone a second operation, primarily to fix problems like ruptures and infections, and a few for cosmetic reasons, according to studies submitted by implant makers to the Food and Drug Administration. (Reconstructive patients are more likely to develop complications after implant surgery than cosmetic patients with healthy breast tissue.)

Complication rates for newer flap procedures like the one Ms. Hodges had have not been well studied, though many surgeons say they are less likely to require follow-up operations. […]

Read the original article here.

Statement of Diana Zuckerman at the FDA Science Board Meeting on the FDA Draft Assessment of Bisphenol A for Use in Food Contact Applications

October 31, 2008Testimony & BriefingsCPTFeditor

Diana Zuckerman, PhD, Cancer Prevention and Treatment Fund, October 31, 2008

Thank you for the opportunity to testify as president of the National Research Center for Women & Families. I have no conflicts of interest.

Science Board Subcommittee Report on Bisphenol A (BPA)

We generally agree with the Science Board Subcommittee criticisms of the FDA Draft report.

I was especially pleased that the report included criticisms I made in September that the safety levels for infant formula were based on an inadequately small sample. I want to emphasize that it isn’t just the small sample size that is a problem – the sample of infant formula cans were from about 15 years ago, and the sample was only from Washington, D.C. area stores. The FDA needs to conduct new studies of a much larger and more representative sample of infant formula containers. And, we agree that the FDA should not focus on the average BPA level but rather the range of BPA levels, in determining safety.

We also agree that the 5 mg/kg level is too high and that for these and other reasons, the margins of safety are inadequate.

We applaud the Science Board report for taking on the more complicated issue of whether the FDA should be analyzing safety as if food containers are the only source of BPA exposure. We agree that the FDA is not doing its job if they are ignoring the fact that all of us are exposed to BPA from many sources, and that BPA from food containers is adding to our levels, it is not the only source of exposure. That raises broader issues of how to safeguard the health of the American people, especially our children.

And of course, exposure of pregnant women to BPA is crucially important and needs to be considered. For that reason, the FDA needs to analyze the implication of BPA levels from products other than infant formula, baby bottles, and other products used by infants and children.

Why was the FDA Draft Report so Flawed?

It’s great that the Science Board subcommittee did a good job, but here’s a crucial question: why did the FDA do such a bad job in their draft report? Why did they make the fundamentally flawed decision to base their conclusions on two industry-funded studies, ignoring so many other excellent peer-reviewed studies? Why did the FDA rush to judgment, concluding that there was evidence of safety when it was so obvious that there were many unanswered questions about BPA? And why, after the Science Board subcommittee criticized the FDA’s draft report on BPA, did the FDA come out with a misleading statement that was obviously intended to reiterate their claim that there was every reason to think that BPA levels in food containers are safe. A closer look shows how disingenuous that statement is. The FDA carefully parsed their words so that they could justify their report as being consistent with other countries’ regulatory inaction. They did not want to point out that Canada had just taken action to eliminate BPA from baby bottles, for example.

Risks vs. Benefits

We’d like to believe that BPA in food containers is safe, but wishing doesn’t make it so. There is a growing body of research evidence that suggest that current BPA levels are likely to be harmful for at least some of our children, and perhaps many of our children.

The most disturbing aspect of the FDA report is the conclusion that BPA is safe at current levels when the FDA does not know what current levels are and doesn’t have well-designed research to conclude that they are safe.

For example, the FDA’s draft assessment states: “FDA does not have a specific list of BPA-containing end products as provided to consumers.” Why not? Without it, we don’t really know what the exposure is, and consumers can’t avoid BPA-tainted products.

The FDA should not draw conclusions that are biased and premature.

While the FDA is deciding what to do about BPA in food containers, they should at the very least empower consumers by requiring that food and beverage containers list whether or not they contain BPA.

Alternatives to BPA Are Available

Alternatives include oleoresinous, vinyl, or PET film lamination to line cans, and glass bottles, polypropylene bottles and bottles with polymeric liners for baby bottles.

Other Countries and Companies Are Reducing BPA Exposure-But Not The FDA

Responsible retailers are not waiting for the FDA to act. Wal-Mart and Toys-R-Us have pledged to remove products containing BPA from their shelves at the end of 2008.² Bottle manufacturers such as Playtex and Nalgene are using non-BPA materials for their products.

Keeping Consumers Safe

It is your job and the job of the FDA to make sure that food and beverage containers don’t increase the risks of food and beverages. The bottom line is we just don’t know if the amount of BPA in infant formula cans and other food containers is safe.

I urge the Science Board to endorse the subcommittee’s report, and to carefully monitor the FDA’s efforts on BPA and to make sure that well-designed studies – free of industry bias — are conducted as soon as possible. The Science Board should also ensure that any resulting reports and regulatory actions on BPA are consistent with the scientific evidence and the public health needs of all our families. We depend on the FDA to protect our families, but the agency has let us down in their failure to acknowledge the need for caution regarding BPA.

References:

1. Advanced Industrial Science and Technology. 2007. Risk Assessment Document: Bisphenol A.
2. Parker-Pope, T., (2008, April 22). A Hard Plastic is Raising Hard Questions, The New York Times.

Quickly Vetted, Treatment Is Offered to Patients

October 26, 2008News Stories & EditorialsCPTFeditor

Reed Abelson, New York Times: October 26, 2008

After a surgeon removed a cancerous lump from Karen Medlock’s breast in November, he recommended radiation, a routine next step meant to keep cancer from recurring.

But he did not send her for the kind of radiation most women have received for decades.

Instead, the surgeon referred her to a center in Oakland, Calif., specializing in a newer form of treatment where radioactive “seeds” are inserted in the tumor site. It could be completed in only five days instead of the six weeks typically required for conventional treatment, which irradiates the entire breast using external beams.

To Ms. Medlock, it seemed an obvious choice. The newer treatment given through a system called MammoSite has been performed on about 45,000 breast cancer patients in this country since the Food and Drug Administration cleared it for use in 2002.

Only when Ms. Medlock, 49, sought a second opinion did she learn a startling truth: MammoSite is still highly experimental.

The MammoSite system is among the thousands of devices the F.D.A. lets onto the market each year after only cursory review and with no clear evidence that they help patients. Doctors are free to use those products as they see fit, without telling patients that the devices are not proved. And because the doctors are frequently paid more by Medicare as a way to compensate them for the extra time and expense of adopting new procedures, these unproven products can become widely adopted.

F.D.A. officials defend the quick-review process as a way to promote innovation. Because most new products are simply an improvement on an existing device, they say, there is rarely need for a full review.

Demanding lengthy study of such devices would be “very, very inappropriate and a waste of resources,” said Dr. Daniel G. Schultz, the director of the F.D.A.’s Center for Devices and Radiological Health.

The agency let MammoSite on the market on the basis of a study involving only 25 women that did not answer the fundamental question of how effective it is against breast cancer. Six years later, many cancer specialists say there is still no conclusive proof that it works as well as conventional radiation. The F.D.A. says it did require a label warning that the system had not been shown to be a substitute for conventional radiation.

Dr. Valery Uhl, the radiation oncologist who provided Ms. Medlock’s second opinion, outlined the evidence behind the available treatments. Ms. Medlock chose conventional external-beam radiation because of its well-documented record of success in preventing the return of cancer. To use an unproven therapy like MammoSite, Dr. Uhl said, “makes me really nervous.”

Critics say the F.D.A.’s process for reviewing medical technology, under which medical devices have become a $75 billion-a-year industry in this country, is often too lax. More devices, they say, should get the same scrutiny applied to new drugs. While that process is not perfect, a new drug is typically studied in hundreds or even thousands of patients before the F.D.A. will approve it as safe and effective.

But under the fast-track review for most devices, a product’s effectiveness is never directly established. Regulators simply determine if the device does what its maker says it does in MammoSite’s case, that it delivers radiation and whether it poses any undue safety risks.

“Nobody is looking to see whether they help patients,” said Diane C. Robertson, an executive with the ECRI Institute, a nonprofit group in Plymouth Meeting, Pa., that evaluates new devices for insurers and hospitals. “We’re never going to wisely allocate resources in health care unless we start to focus on what’s best for patients.”

In response to a Congressional request to study the effectiveness of the F.D.A.’s device-review process, the nonpartisan Government Accountability Office is expected to release a report next month.

Critics say that when the F.D.A. clears a device, the public may wrongly assume that the government has proof it is medically effective. F.D.A. approval has been “widely misinterpreted,” said Dr. Jay R. Harris, the chairman of radiation oncology at the Dana-Farber Cancer Institute and Brigham and Women’s Hospital in Boston.

Differing Opinions

Dr. Dennis R. Hill, the doctor who originally saw Ms. Medlock, scoffs at the notion that MammoSite is in any way experimental. “It is a proven method,” he said. He said the oncologist who told Ms. Medlock it was experimental was skeptical because she provides only traditional radiation.

But the oncologist in question, Dr. Uhl, says she has performed many radioactive-seed treatments but wants to make sure patients are fully informed about the range of options.

Of the 250,000 women in this country who are found to have breast cancer each year, around 200,000 are candidates for radiation treatment if they choose to undergo a lumpectomy or partial removal of a breast. Most still get conventional radiation.

MammoSite proponents say that is because most doctors simply recommend the treatments they know best. “There is a natural bias for radiation oncologists to do what they have been doing,” said David Harding, an executive at Hologic Inc., the company in Bedford, Mass., that markets MammoSite.

Many prominent specialists, though, say the gold standard remains conventional radiation, for which breast cancer local recurrence rates are 3 percent or less at five years. Success in preventing cancer recurrence is measured in long intervals of 5 or 10 years or more, and there has been little long-term study of MammoSite.

Even a radiation oncologist who is a leading proponent of the MammoSite treatment, Dr. Frank A. Vicini, wants to know how it compares with traditional radiation. He is directing a national study of MammoSite’s effectiveness, but he cautions that it could take decades to conclude whether it should be used in lieu of conventional radiation.

“We have to make sure patients know we don’t have 30-year data,” said Dr. Vicini, the chief of oncological services for Beaumont Hospitals in Royal Oak, Mich. “We simply don’t.”

A System From the Past

The nation’s system for regulating medical devices was set up more than three decades ago, when devices played a much smaller role in medicine. A growing chorus of doctors, consumer advocates and health insurance executives say it is overdue for an overhaul.

The process has become “a barrier to evidence development,” said Dr. Winifred S. Hayes, whose firm, Hayes Inc., evaluates new health care technologies.

Although federal drug regulation dates back more than 100 years, medical devices did not come under the government’s purview until 1976, after Congress responded to deaths linked to the Dalkon Shield, an intrauterine contraceptive device.

Because the new law would not apply to devices on the market before 1976, Congress did not want makers of newer products to be at a competitive disadvantage. So lawmakers provided the quick review process for any new product deemed “substantially equivalent” to something already on the market. That expedited process became known as a 510(k) review under the relevant section of the law.

But critics say that what Congress intended as a way to let simple devices quickly enter the market has expanded so much that even critical therapies are cleared without enough research.

“It is supposed to be for the Band-aids of the world,” said Diana Zuckerman, president of the National Research Center for Women and Families, a Washington advocacy group. “The 510(k) process should have been used less and less. It’s being used more.”

But defenders of the F.D.A. process, including the officials in charge of it, argue that tighter gatekeeping could deprive patients of promising alternatives. And they contend that most new medical devices introduced each year involve minor modifications to mundane items like thermometers.

To be sure, sophisticated devices like a new artificial hip or a novel heart stent do go through the same evidence-based scrutiny given to new drugs. Of the 41 medical devices that went through that full review last year and in which the F.D.A. reached a decision, 27 received approval.

But during those same 12 months, the F.D.A. reviewed 3,052 devices under the more cursory 510(k) process and cleared 2,640 of them. […]

Read the original article here.

Statement of Diana Zuckerman to the FDA Science Board on the FDA Draft Assessment of Bisphenol A (BPA) in Food Containers

September 16, 2008Testimony & BriefingsCPTFeditor

Diana Zuckerman, PhD, Cancer Prevention and Treatment Fund, September 16, 2008

I am pleased to have the opportunity to testify as president of the National Research Center for Women & Families. Our nonprofit research and education center does not accept contributions from companies that make medical products that we evaluate, or competing companies, and so I have no conflicts of interest.

I was trained in epidemiology at Yale Medical School; I have worked on federal health policy issues in Congress, the White House, the Institute of Medicine, and for nonprofit organizations for 25 years; and I have reviewed FDA safety issues for almost 20 years.

Bisphenol A (BPA)

BPA is used in a variety of products including reusable water bottles, baby bottles, and plastic tableware. Epoxy resins made with BPA are used to coat the insides of canned foods and beverages.

There is no debate that BPA leaches out of plastic into liquids and foods. The Centers for Disease Control and Prevention (CDC) found measurable amounts of BPA in the bodies of more than 90 percent of the U.S. population studied.¹

FDA Draft Assessment Conclusion

The FDA Draft Assessment concluded “that an adequate margin of safety exists for BPA at current levels of exposure from food contact uses.”

The FDA’s conclusions are primarily drawn from two-industry funded studies, one of which was sponsored by the American Plastics Council and the other by the Society of Plastics Industry.²

In contrast to the industry-funded studies, more than 150 government-funded BPA experiments on lab animals and tissues reported adverse effects, while only 14 did not. These statistics were compiled by the journal published by the American Chemical Society, the professional association for chemists.

However, 13 out of 13 industry-funded studies found no adverse effects.³ It seems that “He who pays the piper calls the tune.”

In addition, the FDA’s estimates of exposure are based on questionable data. On page 7, the FDA draft report explains that the studies by FDA laboratories were done in the early 1990’s-more than 12 years ago. The study was based on only 14 samples of infant formula representing 5 brands purchased in Washington, DC supermarkets. Is that representative of all infant formula cans in the early 1990s or today? No. In an update from this past June, an FDA official pointed out that studies of more recent samples of infant formula have found a more dramatic range of BPA levels. The FDA has stuck with their old estimate of 6.6 ppb as the maximum level, but it is not the maximum level, as the FDA well knows. In fact, 6.6 ppb is lower than the level found in several other studies.⁴

What Does “Some Concern” Mean?

The FDA Draft Assessment focuses on cancer and reproductive and developmental toxicity of BPA. They quote the National Toxicology Program’s report, which concluded that “some concern” exists for developmental toxicity, and less concern for other risks.

Unfortunately, the terminology used is misleading. The National Toxicology Program is judging their “concerns” on the basis of how conclusive the research evidence is. The research on rats and mice and tissue can’t be considered conclusive regarding human health. But, this does not mean there is conclusive evidence that there is no need for concern. The lack of conclusive evidence is not the same thing as the evidence of safety.

On the contrary, the weight of the evidence, especially the unbiased evidence of government-funded research, is that we should be concerned.

The FDA relies on industry for research everyday, but in this case there is an abundance of well-designed studies that are being discounted for inappropriate reasons, such as the lack of good laboratory practices (GLP). GLP are industry standards – they have nothing to do with whether the study is well designed or not. A poorly designed study using GLP will not provide accurate safety information, and that is exactly the problem we have with the industry studies FDA relied on. In academia, science is built on replication by different scientists in different labs.

Most Independent Studies Show Risks of BPA

Well-respected scientists from across the country have found that BPA is potentially dangerous for humans. Many of these scientists worked together on the Chapel Hill Consensus Statement on BPA, which expressed strong concerns about the impact of BPA on human health.

The Statement also noted increases in neurobehavioral problems, such as attention deficit hyperactivity disorder and autism, increases in childhood and adult obesity and Type II diabetes, decrease in sperm count, and increases in hormonally mediated cancers, such as prostate cancer.⁵

Several newly published studies support the concerns of the Chapel Hill Consensus Statement. Several of these studies were not published in time to be considered by the National Toxiciology Program or the FDA.

Researchers at Yale just published the first study of the effect of BPA on primates, which demonstrated “an adverse effect of BPA on the brain…and further amplifies concerns about the widespread use of BPA…in food preparation and storage.”⁶

A study that is published online in Environmental Health Perspectives and will soon be in print concluded that low doses of BPA could inhibit the release of a key hormone (adiponectin) that protects humans from the metabolic syndrome, thereby linking BPA to an increase in heart attacks and Type II diabetes.

In addition, a study in this month’s issue of Endocrinology found that young female mice exposed to BPA showed brain and behavior traits more typical of male mice.

A study in the June issue of Cancer Research showed a correlation between rats that had early BPA exposure and those that developed prostate cancer in later life. The study was done by Shuk-mei Ho, head of environmental health at the University of Cincinnati, and Gail Prins, physiology professor at the University of Illinois in Chicago.

Risks vs. Benefits

Companies that make plastics and plastic food and beverage containers have said that BPA has been used for years and therefore it is safe. We’d like to believe it, but wishing doesn’t make it so. There are several disturbing disease trends that coincide with the increased use of BPA, such as Type II diabetes, learning disabilities, and breast cancer. And, of course, the lag time between exposure to a carcinogen and developing cancer is usually 15-20 years or more. If it weren’t so long, we’d have a lot of Americans dying of lung cancer in their 20’s and 30s.

What Should The FDA Do?

The most disturbing aspect of the FDA report is the conclusion that BPA at current levels is safe when the FDA does not know what current levels are and doesn’t have well-designed research to conclude that they are safe.

The FDA estimates of BPA are based on studies of 14 samples sold more than 12 years ago, in supermarkets in Washington, D.C. We need more recent measurements in a larger number of products sampled from stores across the country.

The draft assessment states: “FDA does not have a specific list of BPA-containing end products as provided to consumers.” Why not? Without it, we don’t really know what the exposure is, and consumers can’t avoid BPA-tainted products.

The FDA should not draw conclusions that are biased and premature.

While the FDA is deciding what to do about BPA in food containers, they should at the very least empower consumers by requiring that food and beverage containers list whether or not they contain BPA.

Alternatives to BPA Available

Alternatives include oleoresinous, vinyl, or PET film lamination to line cans, and glass bottles, polypropylene bottles and bottles with polymeric liners for baby bottles.

Other Countries Are Reducing BPA Exposure-But Not The U.S.

In the United States, the NTP points out that “exposure to bisphenol A may be increasing” and the median levels of BPA in human urine doubled from 1988 to 2004.⁸

Responsible retailers are not waiting for the FDA to act. Wal-Mart and Toys-R-Us have pledged to remove products containing BPA from their shelves at the end of 2008.⁹ Bottle manufacturers such as Playtex and Nalgene are using non-BPA materials for their products.

Keeping Consumers Safe?

It is your job and the job of the FDA to make sure that food and beverage containers don’t increase the risks of food and beverages. The bottom line is we just don’t know if BPA in infant formula cans and other food containers is safe.

More than 100 studies have raised doubts about the safety of BPA, and alternatives to BPA are available. If the FDA is to err, it should be on the side of consumer safety, not corporate profits, by banning BPA in baby bottles, plastic tableware, foods and beverages, and other products.

References:

Hileman, B., (2007, April). Bisphenol A on Trial, Chemical & Engineering News Government & Policy, Vol. 85, Number 16. http://pubs.acs.org/cen/government/85/8516gov2.html
Ibid.
Hileman B., (2007, April). Ibid.
Bailey, A, June 2, 2008 Update on Cumulative Exposure to BPA, Memorandum to the File, Division of Food Contacts Notification, http://www.fda.gov/ohrms/dockets/AC/08/briefing/2008-0038b1_01_07_FDA%20Reference%20Material-FDA%20Memo%20Cumulative.pdf
vom Saal, F., (2007). Chapel Hill Bisphenol A Expert Panel Consensus Statement: Integration of Mechanism, Effects in Animals and Potential to Impact Human Health at Current Levels of Exposure, Reproductive Toxicology.
Leranth, C., et.al., (2008). Bisphenol A prevents the synaptogenic response to estradiol in hippocampus and prefrontal cortex of ovariectomized nonhuman primates, Yale University School of Medicine, The National Academy of Sciences. http://www.pnas.org/content/early/2008/09/02/0806139105.abstract?sid=a6820950-175f-4d84-86b1-035e4b42213b
Advanced Industrial Science and Technology. 2007. Risk Assessment Document: Bisphenol A.
National Toxicology Program, U.S. Department of Health and Human Services, Center for the Evaluation of Risks to Human Reproduction, (September 2008). NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A. NIH Publication No. 08-5994.
Parker-Pope, T., (2008, April 22). A Hard Plastic is Raising Hard Questions, The New York Times.

Scientists, FDA face off over safety of BPA in consumer plastics

September 16, 2008News Stories & EditorialsCPTFeditor

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.