June 12, 2007

Diana Zuckerman, PhD, Cancer Prevention and Treatment Fund, November 12, 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. We do not accept contributions from companies that make medical products.

In addition, I am a fellow at the University of Pennsylvania Center for Bioethics. I was previously on the faculty at Yale and Vassar, conducted research at Harvard, and I have worked on federal health policy issues in Congress, the White House, the Institute of Medicine, and for nonprofit organizations for the last 25 years.

I want to start by saying that I think it is unfortunate that the timing and structure of this week’s meeting made it impossible for many nonprofit organizations to participate. Those of us who are here know that our concerns are shared by many other public health, patient, and consumer organizations. However, most do not have the staff or resources to set aside two days of unscheduled time for a meeting, especially non-reimbursed time, and especially in the middle of the health care reform negotiations. They would have been here if they could have. I’d like to make a few points, and then spend a few minutes talking about Wikipedia as a popular source of information on medical products.

1. Direct to consumer advertising is persuasion, not information. Every year, millions of Americans are persuaded that they need medications they have seen advertised – and many of those Americans have limited understanding of the likely benefits or possible risks of those medications. DTC regulations need to be improved and enforced, and those regulations should be the minimum requirement for ads on the Internet and other media.
2. In TV, radio, and magazine ads, every piece of information costs a lot of money to include. That isn’t true for the Internet, smart phones, or other digital hardware. FDA should demand much better information about risks in all media, but especially the Internet and other new media. Risk information and other caveats about safety or effectiveness should be as prominent and persuasive as the information about benefits. It should be as accessible – not hidden behind or below the more positive promotional information—and should not require clicking other links. One click away is one click too many. If the information about benefits doesn’t require a click, the information about risks shouldn’t require a click either.
3. Companies should be held responsible for the accuracy and balance of all information about their product that appears to be promotional, regardless of the ostensible source of that information. That is necessary because so much information in blogs, patient Web sites, and other “third party” sources is bought and paid for, directly or indirectly, by the companies whose products are being praised. Latisse is a good example of a product that is widely promoted on the Web, in articles where it is unclear whether the author is or isn’t associated with the company that makes the product. Latisse is a medical device that treats the tragedy of thin eye lashes, but it has risks, including changing one or both of a person’s blue eyes to brown. Many of us would like longer, thicker eye lashes, but we don’t want our eye color to change, and we especially don’t want the color of just one eye to change. That risk information should be clearly stated on any Web site, but it isn’t. If a company says it is not responsible for the content of a blog or Web site that praises its product in a biased or inaccurate way, the company should be required to request corrections and, if unsuccessful, prove to the FDA that it is not responsible for the content. Penalties should be substantial for companies that pay for any promotional materials that are biased or inaccurate.
4. Some have suggested an electronic FDA logo or other type of FDA seal of approval for Web content that is consistent with FDA approved labels or other FDA content. There are at least two problems with that idea:

#1. Content can be identical but incomplete. For example, a Web site can include exact wording about benefits but incomplete information about risks.

#2. Content can be identical to FDA’s approved information today but can be inaccurate tomorrow or next week, if the label changes.

For example, if you look up Vytorin on drugs.com, it has accurate information about risks and benefits, but fails to mention a caveat that the FDA has required on the company’s Web site: a statement that says:

VYTORIN contains two cholesterol medicines, Zetia (ezetimibe) and Zocor (simvastatin), in a single tablet. VYTORIN has not been shown to reduce heart attacks or strokes more than Zocor alone.

If you type “Vytorin” in google, Drugs.com is the first Web address that comes up, so it is a very widely used source of information. I don’t know why drugs.com doesn’t include that crucial caveat, but it isn’t because they don’t know about it. In fact, I sent an email to drugs.com a few days ago to ask about it. They have not responded to me, nor have they added the statement on their Web article. I don’t want to pick on drugs.com. I don’t know who pays them or who makes decisions about what is on their Web site. And, this is a problem on other web sites, not just drugs.com. But the fact that Vytorin is not more effective than a drug with half the ingredients and half the risks is important and should be included on all Web sites.

• 5. In contrast to the FDA seal of approval idea, we like the idea of requiring a direct link to FDA’s online content on a medical product for any Web site that is owned by or supported with funds from the manufacturer. The link should be in a very noticeable location, and would NOT take the place of balanced, accurate information.
• 6. Limitations are needed to restrict ads on email, text messaging, and social networking sites. We agree with Consumers Union, which is testifying tomorrow, that drug or device companies should not be permitted to promote their products via email, text messaging to consumers, chat rooms, or social networking bulletin boards.

I’d now like to say a few words about Wikipedia. Our Center has quite a bit of experience with Wikipedia, some very good, some very bad. Anybody can create an article on Wikipedia, and anyone can edit an article on Wikipedia. It’s a very egalitarian system in terms of the rules: a middle school student can edit the Wikipedia contributions of a Harvard professor and vice versa. If there are disagreements, they are usually resolved by volunteers called “administrators,” who often have little knowledge of the specific information involved.

It is against the Wikipedia rules for companies to promote themselves, and in fact even the most altruistic nonprofit organization is not supposed to promote itself – but the reality is very different. While Wikipedia does not discriminate against people on the basis of age or education level, it does discriminate on the basis of how much time you spend on Wikipedia. If someone were to go on Wikipedia to write one article praising one product, a Wikipedia monitor or administrator would likely notice it and assume that person was from the company that makes the product, and might delete the article. However, if someone were to spend a few hours a week editing a lot of articles, and wasn’t only adding information praising one company’s product, this person would probably get away with just about anything he wanted to say about specific products, even if he were from the company that made the product, or were paid by that company. Wikipedia editors would be unlikely to notice.

As a result, Wikipedia articles about prescription drugs and medical devices vary greatly in balance and quality. I noticed this week that articles on many anti-psychotic medications, for example, are very balanced – more so than articles on drugs.com and other popular Web sites. However, Wikipedia articles on some FDA-regulated medical products read like promotional literature. For example, the Wikipedia article on NeuroStar, a device used for the treatment of depression, is definitely written by someone who loves the product, and probably by someone tied to the company that makes the product. The Wikipedia article on breast implants is similarly promotional in nature, and when researchers attempted to add warning information from published peer-reviewed articles or the FDA Web site, it was immediately deleted by a man who said on a Wikipedia discussion page that he was a plastic surgeon and knew more than the FDA or others who disagreed with him. I don’t know if the man really was a plastic surgeon, I don’t know if he was paid by an implant company, but I can tell you that he spent hours each day fixing that Wikipedia article by deleting risk information and adding promotional information. That would be a very unusual activity for a physician. Regardless, the result is that an article about a medical device is providing very biased information and Wikipedia administrators who were involved in the debate made the decision to support the promotional bias of the article.

Wikipedia is a major source of information for millions of people around the globe. Wikipedia articles on medical products rank high on google and other search engines. It would be extremely time-consuming for FDA to monitor all relevant Wikipedia articles, but I strongly suggest that the agency reach out to Wikipedia officials to develop a process that can maximize the accuracy of articles about FDA-regulated medical products.

To do that, and to ensure the balance and accuracy of ads on the Internet and “new media” will require substantially more resources for the FDA. Realistically, that money will need to come from new industry user fees. We will join Consumers Union and other consumer groups to advocate for that as part of the PDUFA 5 negotiations next year.

Thanks for the opportunity to comment on these very important issues.

Diana Zuckerman, PhD, Cancer Prevention and Treatment Fund, June 24, 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 programs, and to compare their safety and effectiveness.

In addition to my work at the National Research Center for Women & Families, I am a fellow at the University of Pennsylvania Center for Bioethics.

My doctorate is in clinical psychology and my post-doctoral training at Yale was in epidemiology and public health. Prior to my current position, I was on the faculty at Yale and Vassar, directed a multi-site longitudinal research project at Harvard, and worked in the U.S. Congress, the White House, and the Public Health Service. I have worked on FDA issues for 19 years. I am speaking from a public health perspective as a researcher and policy expert.

I was very glad to hear the FDA Commissioner and Deputy Commissioner talk about the need to refocus the FDA on its public health mission. This initiative on transparency is a great place to start.

I have scrutinized FDA policies, processes, and decisions as a Congressional investigator and in my current position. There is no doubt that I know more about the FDA than at least 99% of Americans and probably more than at least 95% of health policy experts. However, as an outsider who does not work at the FDA, I am still amazingly limited in terms of the information that I have access to. That’s why this conversation about transparency is so important.

I know how to go to the FDA web site to find industry data and FDA analyses for medical products that have been reviewed at public FDA Advisory Committee meetings since 1998, when that information was put online. I know how to use the FDA web site to find other information about those same medical products, such as approval decisions and recalls.

However, if I want to see data about other medical products—the vast majority of medical products that were not subject to public FDA Advisory Committee meetings—I am not able to get that information. The information available is the tip of the iceberg in terms of FDA’s data and decisions about prescription drugs and vaccines, and not even the tip of the iceberg for the thousands of medical devices cleared for market by the FDA every year.

In recent years, I have written testimony and articles about the safety and effectiveness of certain medical products reviewed at FDA meetings, based on FDA statistical analysis. In some cases, such as Neurostar, a medical device for the treatment of depression, the data presented at the public meeting clearly indicated that the product was not effective—in that case, Neurostar was shown to be equally effective whether it was turned on or off. In other words, it was no more effective than sham treatment. As one of the Advisory Committee members so eloquently summarized the situation: you can’t determine the risk-to-benefit ratio when the benefit is 0. And yet, about a year later the FDA quietly announced that they had cleared Neurostar for market, and that the data indicated it was effective. What happened to magically transform data indicating no effectiveness to data indicating it was effective? I don’t know. Those data are not available. However, published data suggest that post-hoc manipulation of the outcome measures produced the results the company needed for approval.

Similarly, data presented at FDA meetings on silicone gel breast implants indicated that women who got breast implants had lower self-esteem and lower quality of life two years after getting breast implants than they had before surgery. Those data were made available on the FDA web site. Since the manufacturers and the plastic surgeons claimed that increased self-esteem was a major benefit of breast implants, these scientific results should have been devastating for the application. However, despite the lowered self-esteem and quality of life, silicone breast implants were approved by the FDA, apparently over the objections of FDA scientists. As a condition of approval, FDA required that doctors provide free booklets to their patients prior to breast implant surgery, showing the risks and benefits as analyzed by the FDA, but the data in the patient booklets are substantially different from the data presented at the FDA meetings. Complication rates are lower, and data indicating lower self-esteem and quality of life have magically disappeared. How did those data change to make the products look more effective? We don’t know and there is no way to find out.

These are just two examples, but there are many more. For example, when medical devices are approved under the condition of continued longitudinal research, those future longitudinal data are almost never made public. They are not on the FDA web site and they are usually not published either. Are they not published because the product is found to be less safe or less effective than expected? Or are so many patients lost to follow-up that the studies are not publishable? We don’t know because we can’t see the data. In some cases, I know that key Members of Congress have requested the data from FDA regarding required long-term studies and have not received them.

These are examples of lack of transparency regarding medical devices, but the same is true for drugs and biologics. The data are rarely available, the data made available at Advisory Committee meetings sometimes mysteriously change behind closed doors, and the public has no way to know if those changes are a result of new data or of non-scientific decisions resulting from negotiation between a company and the FDA, or some other reason. We don’t have access to the data or to a clear explanation of how FDA made a decision—even when the decision seems suspicious.

The American public deserves better. Most people will not go on the FDA web site looking for data, but any scientist, journalist, or other interested person who wants to see the data on products that the FDA has approved or not, should be able to access that information, whether the studies were the basis of approval (or non-approval) or whether those studies were required in the post-market period.

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.

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.

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 health and safety issues.

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.

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.

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 health and safety issues.

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.

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.

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 health and safety issues.

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 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.

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, the only question is whether they are unsafe.

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

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.

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.

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.