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.

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.

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.

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; 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.

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 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.

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.⁷

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:

1. 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
2. Ibid.
3. Hileman B., (2007, April). Ibid.
4. 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
5. 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.
6. 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
7. Advanced Industrial Science and Technology. 2007. Risk Assessment Document: Bisphenol A.
8. 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.
9. 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, September 8, 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.

Our Center is dedicated to improving the health and safety and 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.

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; 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 testified at FDA advisory committee meetings on numerous safety issues for almost 20 years.

Osteoporosis is a serious disease. Fortunately, there are numerous treatments available, and those options should help the FDA determine whether the risks of this drug, Fablyn, outweigh the benefits.

I have examined the data that were made available to you, I have reviewed the FDA’s summary of the data, and I have listened to the presentation today. The data from The PEARL Study indicate that Fablyn at .5 mg significantly decreases the risk of new or worsening radiographic vertebral fractures by about 50% — but that is only from 2% to 1% during the first year and from 4.6% to 2.2% during the first two years. Over three years, the risk reduction is somewhat lower, from about 6.4% to 3.8%.

However, most of those fractures were asymptomatic. The results were not significant and were much less impressive for clinical vertebral fracture – from only 1.7% to 1.2% through the third year.

Since Fablyn’s reduction of vertebral fracture seems to decrease over time for radiographic fractures and is not significant for symptomatic fractures, it is very unfortunate that no 5-year data were made available for FDA analysis. Preliminary data are not adequate to judge this product.

The safety data from the same study are apparently available through the 5th year, and the risks are significant. Women taking this osteoporosis drug were significantly more likely to die during the 5 years of the study. Surprisingly, it seems that at 3 years the death rate was similar for either the .5 mg dose or the .25 mg dose, but at 5 years the death rate was higher for women taking the lower dosage (.25 mg) than the .50 mg. Even so, the death rate was higher for women taking Fablyn than for the placebo group, and these findings are obviously worrisome. The increased risk of death was primarily from cancer, stroke, and other non-coronary vascular causes – which is consistent with mortality data from women taking other SERMS.

In addition, the number of serious adverse reactions also is higher among women taking Fablyn, especially for those classified as “treatment-related.” These include pulmonary emboli, uterine polyps, and deep vein thrombosis.

What Does This Mean for Women?

Clearly, the benefits of this drug are quite small – primarily in preventing new vertebral fractures that can be diagnosed with x-rays but have no symptoms of pain or discomfort. In contrast, women taking this drug were more likely to die, and slightly more likely to have serious adverse reactions, such as pulmonary emboli and gynecological symptoms requiring invasive procedures.

As you consider what this would mean for women in the U.S., not in a research study, keep in mind that there were very rigorous exclusion criteria for the major study of Fablyn. If you look on page 18 of the FDA memo, there is a long list of exclusions, such as atrial fibrillation, history of breast cancer or DCIS, history of various types of hip or vertebral fractures, or stroke or MI within the last 6 months. In addition, only women with specific bone mineral density levels – not too high and not too low – were included in the study. It is not likely that the women excluded from the study would be excluded from taking Fablyn if it were sold in the U.S., and we don’t know what impact that would have on safety or efficacy, or the likely risks vs. benefits.

Osteoporosis can be a serious and debilitating disease, but there are other treatments available.

In the ideal world, we could tell patients what the risks and benefits seem to be for each medication, and let them decide. In the real world, however, that doesn’t work well for several reasons.

#1: In our experience, many doctors don’t know all the details of research findings and are not at all likely to recall all the exclusion criteria that were used in this study.

#2: Even those doctors who know the details of research findings don’t do a good job of explaining them to patients.

#3: Just under 1% of the women in the study are black. The 18% who are Asian women are primarily living in India, not the U.S. So, we don’t know if the risks or benefits would be different for African American women or other Asian women. And, although 5 % of the women are Hispanic, they were apparently from Argentina and other countries, not the U.S. Since most of the women in the study are not from the U.S., and many from countries such as Croatia and India where diet and exercise might be quite different than the U.S., and that would affect osteoporosis, we don’t really know what the impact of Fablyn would be on the mortality of women living in the U.S.

#4: The data from these studies are short-term. We don’t know the long-term risks or benefits. For cancer, for example, one would not expect risks to show up within 3-5 years, and certainly they would not be statistically significant. In the U.S., women live an average of 80 years, and women who have already lived to be post-menopausal live even longer. So, it is not enough to know the 3-5 year risks and benefits for women who could live another 20-30 years after they start taking an osteoporosis drug.

In conclusion, the data on Fablyn are incomplete to draw the conclusion that the benefits outweigh the risks, and the data thus far suggest that the risks probably outweigh the benefits.

It is the job of the FDA, with your help, to determine if this drug is safe and effective, and if the benefits outweigh the risks. Those decisions should be based on science, not wishful thinking. It is not enough to say “this drug will probably decrease breast cancer” or “this drug will probably continue to reduce fractures over time.” For example, we know that other SERMS, such as tamoxifen, are only effective for 5 years, and not after that. We need more data to determine if this drug does more good than harm for women suffering from osteoporosis.

Diana Zuckerman, PhD, Cancer Prevention and Treatment Fund: June 8, 2006

I am Dr. Diana Zuckerman, President of the National Research Center for Women & Families. Our independent, nonprofit organization is a think tank that gathers and explains research information and uses it to improve the health and safety of women, children, and families.

I am speaking from the perspective of someone trained in psychology and epidemiology, who was a university faculty member and researcher at Harvard and Yale and taught courses in research methods before moving to Washington, DC to work on health issues in the U.S. Congress, U.S. Department of Health and Human Services, White House, and for nonprofit organizations.

I have read every published epidemiological study on breast implants and will briefly discuss what is known and not known, based on those studies. I will also tell you about a criminal investigation of one of the implant manufacturers, Mentor, and the many calls and emails we have received from women in Canada who are finding it impossible to have their leaking silicone gel breast implants removed in a timely manner.

Who Conducts Research on Breast Implants?

Clinical trials are a major source of information on the short-term risks of silicone breast implants. In clinical trials, the goal is to follow women prospectively to determine what complications and health problems occur, and to compare that to a control group. Although silicone implants have been on the market for 40 years, the only well-designed clinical trials have data for only 2-3 years and they do not include a control group. The clinical trials have been conducted by the implant companies as part of their effort to obtain approval to market the implants in Canada and the post construction cleaning services carmel.

Epidemiological studies are the major source of information about what actually happens to women who have breast implants for at least five years. Almost every published epidemiological study on breast implants has been paid for by companies that sell or sold breast implants. In fact, one company in the U.S. has received many millions of dollars from Dow Corning to conduct most of these studies, almost all of them in Europe, and every one of those studies has concluded that implants are safe. However, careful scrutiny of the results in the peer-reviewed articles indicates serious health problems among women with those implants. For example, one recent study reported that women with breast implants were significantly more likely to report breast pain and take anti-depressants, but still concluded that breast implants were safe.

More importantly, a small number of studies have been conducted by independent researchers, not using implant company funds or funds from plastic surgeons. These include government-funded researchers in Canada and the U.S. Their findings almost always indicate problems with implants that are in direct contradiction to the findings of the studies funded by implant companies. I will focus on their findings today.

What do we Know about the Health Effects of Ruptured Silicone Gel Implants?

The FDA funded, designed, and conducted the best study on the health of women with ruptured silicone implants. FDA scientists concluded that most women with implants for 11 years or more have at least one ruptured implant, even if they don’t realize it. They also found that 21% of women with implants for at least 7 years have at least one implant that is leaking silicone outside the scar tissue, and that women with leaking implants were more likely to report fibromyalgia or several other painful and debilitating autoimmune diseases. The FDA study is superior to other studies because it focused on women who were basically happy with their implants, and who had implants for at least 7 years. That length of time is key. Other studies have included women who had implants for an average of 7 years — but not at least 7 years.

Most women who have had problems with rupture had implants for a long time — usually much longer than seven years.

Cosmetic Problems

More independently funded research is needed on the risks of ruptured silicone gel implants. Meanwhile, let’s look at some of the cosmetic results of silicone gel implant problems.

Here is a 29-year old woman who had her implants removed after 7 years. Her capsular contracture was so painful that she apparently preferred getting her implants out to keeping them in. This photograph is from the FDA’s website.

That is obviously not a good outcome, but here is a woman who wasn’t so lucky — Sharyn Noakes. Her ruptured implant had leaked into her healthy breasts. When the silicone was removed, this is all that was left of her breasts.

And this is Kathy Nye, a breast cancer survivor who suffered from necrosis and her implant extruded through her skin. Inamed reported a 6% necrosis rate among reconstruction patients in their Core study.

Signs and Symptoms

Now that you have seen some of the cosmetic problems, let’s take a look at the women’s symptoms. In data presented to the FDA, Inamed and Mentor both found that women with implants for only two years had a significant increase in auto-immune symptoms such as joint pain and nervous system symptoms. FDA asked a statistician to determine if this was due to aging. It wasn’t. And, these findings are consistent with what we have heard from thousands of women with silicone breast implants. Most were happy with their implants for years and never suspected that their increasing problems with fatigue or aches and pains might be related to their implants. The women’s personal experiences are not conclusive evidence, but they indicate a pattern that needs to be considered — especially since they are consistent with Inamed and Mentor’s own data showing an increase in autoimmune symptoms over a period of only two years on a cohort of young augmentation patients.

What do we Know about the Health Risks of Silicone Gel Implants More Generally?

Aleina Tweed, an epidemiologist at the British Columbia Centre of Excellence for Research on Women, conducted a study of breast augmentation patients in Canada, most of whom had implants for 10 years or longer. She found that the women with implants visited doctors and specialists more often, and were four times as likely to be hospitalized, compared to other women the same age from the same communities.

Why has that important Canadian study received so little attention? Probably because no one was paid to do PR on the study. In contrast, studies funded by Dow Corning, the maker of silicone, have received enormous publicity. You may have heard that hundreds of studies, including studies at Harvard and the Mayo Clinic and a report of the U.S. Institute of Medicine, provide clear proof that breast implants are safe. However, the Institute of Medicine report is outdated – completed in 1999 and based on studies conducted before that. And, it was based on the other studies that are so often quoted, such as the Mayo Clinic study and the Harvard study – studies that were all funded by Dow Corning and other implant makers.

Almost all the studies included in the Institute of Medicine report suffered from the same shortcomings: they were too small, and they lacked statistical power because they included women who had implants for too short a period of time. For example, the Mayo Clinic study included only 749 women with breast implants, only 125 of whom were reconstruction patients. To be in the study, women had to have implants for at least one month. The average length of time was about 7.5 years, which means that only about 375 women had implants for more than 8 years. Since diseases like lupus, scleroderma, and rheumatoid arthritis are not very common among women in their 20’s and 30’s, this study doesn’t have the power to detect most of the diseases it measured. The authors themselves acknowledged that major shortcoming.

So, while I agree with the Institute of Medicine that there is not sufficient evidence to conclude that implants cause autoimmune disease, the report can’t be considered conclusive proof that implants don’t cause autoimmune disease.

The U.S. government has also funded some important studies of breast implants, and like the Canadian study, they tend to report serious health problems for women who have implants for a long period of time. The National Cancer Institute study found a doubling of brain cancer, lung cancer, and suicide. It is an exceptionally well-designed study, because all the women in the study had breast implants for at least 12 years. Another major strength of the study is that it compared women with silicone implants to women who underwent other kinds of plastic surgery, such as liposuction. This is important because all plastic surgery patients tend to be above average in health and income, but also tend to smoke more than other women.

How do the many implant studies funded by Dow Corning compare to the government funded studies in Canada and the U.S.? Many of the Dow Corning studies focused on women with implants for a short period of time, and at least one on women with ruptures for a short period of time. Many measured illness in terms of hospitalization rather than diagnosis. Remember that most women getting breast augmentation are in their 20’s or 30s, with many in their teens. Think of how unlikely it is that a 30-year old woman will be hospitalized for rheumatoid arthritis.

Inamed and Mentor Research Quality and Integrity

Inamed and Mentor both started clinical trials to analyze the safety of silicone gel breast implants in 1990. Both companies lost track of almost all of their patients to follow-up within 5 years. If only they had done a good job on those studies, we would have great long-term data today. But they didn’t, and so we don’t.

The companies both were given the opportunity to test their silicone gel implants on thousands of patients in the Adjunct Studies that they conducted. They enrolled thousands of patients and then failed to follow-up on most of them, making those studies useless.

Last year, shortly after Inamed and Mentor silicone implants were considered by advisory committees in Canada and the U.S., I heard from several Mentor employees who expressed concerns about the accuracy of the data that Mentor provided to the FDA, and also informed me that the patch used on Mentor implants leaks silicone and should be fixed. I contacted the FDA and arranged for the Mentor employees to speak to FDA officials. As a result, the FDA started a criminal investigation, interviewing me and several former Mentor employees. I was told several weeks ago that the investigation is still underway. I would be glad to put those former Mentor employees in touch with officials at Health Canada as well.

What Does Approval Matter?

Although there are restrictions on silicone gel breast implants in Canada and the U.S., tens of thousands of women have continued to get them. Many of those women were not breast cancer patients.

Even so, approval matters. If Health Canada approves silicone gel breast implants, it will send a clear message that it believes that the implants are safe, and more teenage girls and women will certainly choose silicone implants as a result.

The study by Aleina Tweed shows that in Canada, women with breast implants have more health problems and their efforts to get well are costly to the Canadian system. Most of the women had at least one surgery to fix an implant problem, and 17% had four or more additional surgeries. Tweed’s findings are especially striking to us because our Center hears from many Canadian women with breast implants who tell us that they can’t get help from most Canadian plastic surgeons. Many have discovered — often after years of symptoms – that their implants are leaking. They need a plastic surgeon to remove them, and often can’t afford to pay for the surgery. But the waiting list is very long. We know a patient who contacted Dr. Mitchell Brown’s office this spring, because she heard he is an excellent surgeon who knows how to remove leaking silicone implants. She was told she would need to wait until December 2006 just to see him for a consultation. She was told that if she needed surgery, that would have to wait until December 2007. My staff found that hard to believe, so we also contacted Dr. Brown’s office more than a week later and we were told the exact same thing. My staff asked if there was a shorter wait if she could pay for the surgery, and we were told that the wait was much shorter.

We know several patients who tried to arrange surgery with other Canadian plastic surgeons. They were told that silicone would likely leak during the surgery and that they could be left looking deformed, They were discouraged from removing their implants, and told that at least they should replace them with new implants.

If Health Canada approves silicone gel breast implants, the number of teenagers and women needing to have leaking silicone implants removed will increase dramatically. To allow that to happen in a country where few plastic surgeons know how to remove leaking silicone gel breast implants, and those that do have very long waiting lists is not ethical or appropriate. And, according to Aleina Tweed’s research, it will cost the Canadian healthcare system dearly.