Diana Zuckerman, PhD, National Center for Health Research,April 11, 2018

The National Center for Health Research is a nonprofit research center staffed by scientists, medical professionals, and health experts who analyze and review research on a range of health issues. We conduct studies, we scrutinize research done by others, and we try to make sense of conflicting research findings.  Our goal is to explain that information so it can be used to improve policies, programs, services, and products.  Thank you for the opportunity to share our views concerning the Consumer Product Safety Commission’s (CPSC) priorities for fiscal year 2019 and 2020. We respect the essential role of the CPSC, as well as the challenges you face in selecting the most important priorities.

I’m trained as an epidemiologist at Yale Medical School, and I was on the faculty at Yale and Vassar and a researcher at Harvard before moving to Washington, D.C. as a Congressional Fellow in the program sponsored by the American Association of the Advancement of Science (AAAS).  While our Center’s mission overlaps with much of the work of the CPSC, today I will talk as a scientist about safety risks that you don’t hear as much about – the ones that we can’t see.

We are surrounded by chemicals in the air we breathe, the table in front of me, and the dust in the room.  Today I will focus on three issues involving chemicals in products that affect our health and our children’s health. These issues are clearly consistent with the CPSC priorities. We are very concerned about flame retardants and phthalates, both of which migrate out of products and into the dust we breathe and touch. We’re also very concerned about artificial turf fields and playgrounds, which contain a range of endocrine-disrupting chemicals and other toxic materials that can harm children’s development and possibly increase risk for cancer as these children grow up.

Organohalogen Flame Retardants

Thank you for voting to initiate rulemaking on non-polymeric organohalogen flame retardants (OFRs) and to provide guidance for manufacturers, distributors, and retailers to avoid OFRs.¹ We urge you to convene a Chronic Hazard Advisory Panel (CHAP) as soon as possible and develop regulations to address OFRs in children’s products, upholstered residential furniture, mattresses/mattress pads, and the plastic casing of electronic devices. In addition, it is essential to consider current flammability standards to determine if there are changes that would improve their safety from both chemical exposures and potential fire.

Since OFRs are not bound to products, they migrate out of products and into dust, and thus get onto our skin and food as well as into the air we breathe. Because so many products are made with these chemicals and because they are so long-lasting, consumers are repeatedly exposed day after day.^2,3 In addition, many OFRs bioaccumulate in our food supply.^4,5,6,7 As a result, nearly all people in the U.S. have OFRs in their bodies. ⁸

OFRs have been associated with various health problems, including disrupting hormones, altering brain development, and harming reproductive health, such as reduced ability to get and stay pregnant and the timing of puberty.^5,9,10,11 While not all OFRs have been sufficiently studied to determine whether all are unsafe, those that have been sufficiently studied have proved to be harmful to health.

While we recognize that the Commission must be concerned about fire hazards as well, it seems that these flame retardants may not be effective at preventing deaths in real world situations.^12,13 When the chemicals burn during a fire, the inhaled smoke is more toxic to humans, and exposures could result in serious harms, including death.

Artificial Turf and Playground Surfaces

We appreciate the CPSC’s ongoing efforts to investigate the safety of crumb rubber on playgrounds and playing fields. This requires your immediate attention, because artificial turf fields are becoming increasingly popular surfaces for fields and playgrounds where children are exposed day after day, year after year. And yet, the materials used are often treated as “trade secrets” making it impossible to know exactly what they are, which ones are safer, and which ones are more dangerous. We encourage you to closely evaluate the research that has been done, focusing on independently funded research rather than industry claims. We also urge you to carefully examine the EPA/CDCs studies when they are completed, and to develop rules that will protect our children from harm. We urge you to convene a Chronic Hazard Advisory Panel (CHAP) to examine the short-term and long-term risks of different types of artificial turf used in playing fields and children’s playgrounds.

Crumb rubber contains chemicals with known health concerns, which are released into the air and onto skin and clothing and even into children’s ears and noses. This is inevitable for a product that is outdoors and in constant use. The chemicals include endocrine disruptors such as phthalates, heavy metals such as lead and zinc, as well as other carcinogens and skin irritants such as some polycyclic aromatic hydrocarbons (PAHs) and volatile organic compounds (VOCs).^{14,15,16,17,18,19} While one time or sporadic exposures are unlikely to cause long-term harm, children’s repeated exposures over the years, especially during critical developmental periods, raise the likelihood of serious harm.

These fields can also cause short-term harms. Artificial turf generates dust which may exacerbate children’s asthma.^20,21 Fields heat up to temperatures far higher than ambient temperature, reaching temperatures that are more than 70 degrees warmer than nearby grass; for example, 180 degrees when the temperature is in the high 90’s and 150-170 degrees on a sunny day when the air temperature is only in the 70’s. ^22,23,24 This can cause heat stress and burns.

Fields made of crumb rubber have been marketed as reducing injuries compared to grass. However, research has shown that this is not the case. We have spoken to students harmed by turf burn, and some studies have indicated increased risk for joint injuries and brain injury.^25,26

We need to know more about the risks of “virgin rubber” compared to “recycled tires.” However, we already know that “virgin” rubber is made from many of the same chemicals that have these health concerns.^27,28

Phthalates in Children’s and Household Products

CPSC has helped millions of American children by finalizing the phthalate rule to ban five additional phthalates (DINP, DPENP DHEXP, DCHP, DIBP) in children’s toys and care products.

The next priority should be for CPSC to expand its work on phthalates to include other household products. Children are exposed to many products with the same phthalates as those that are banned in toys and products specifically for children. Restricting the use of phthalates in common household products would reduce exposure for young children and also older children, pregnant women and other adults. Phthalates in household dust can be harmful regardless of what products it comes from and prenatal exposure is of particular concern.

Phthalate exposure has been associated with an increased risk for early puberty and reproductive problems.^29,30,31 In utero exposure or exposure through breast milk puts the developing fetus, neonate, or infant at serious risk of abnormal neurological and reproductive development.³²

In conclusion, endocrine disruptors and chemicals in common consumer products that do not stay bound to those products get into the air and dust and thus into our bodies. These chemicals tend to pose greater risks to fetuses and children. There are large gaps in our knowledge about the chemicals in the products on the market. Ideally, all of these chemicals would be evaluated in the final product for health concerns before it was sold. Since that is not happening, we must constantly play catch-up as health concerns are identified. Too often this leads to cases of false claims regarding the safety of new products that we later learn are as harmful or even more harmful that the ones they are replacing. While research is lacking regarding the exact extent of the dangers of many of these products, there is already sufficient evidence to cause concern. We need CPSC to address those as soon as possible.

References:

1. Consumer Product Safety Commission. (2017) Guidance document on hazardous additive, non-polymeric organohalogen flame retardants in certain consumer products. https://www.federalregister.gov/documents/2017/09/28/2017-20733/guidance-document-on-hazardous-additive-non-polymeric-organohalogen-flame-retardants-in-certain
2. Gramatica P, Cassani S, Sangion A. (2016) Are some “safer alternatives” hazardous as PBTs? The case study of new flame retardants. J Hazard Mater. 306:237-246.
3. Allgood JM, Vahid KS, Jeeva K, Tang IW, Ogunseitan OA. (2017) Spatiotemporal analysis of human exposure to halogenated flame retardant chemicals. Sci Total Environ. 609:272-276.
4. Lupton SJ, Hakk H. (2017) Polybrominated diphenyl ethers (PBDEs) in US meat and poultry: 2012-13 levels, trends and estimated consumer exposures. Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 34(9):1584-1595.
5. Lyche JL, Rosseland C, Berge G, Polder A. (2014) Human health risk associated with brominated flame-retardants (BFRs). Environ Int. 74:170-180.
6. Schecter A, Colacino J, Patel K, Kannan K, Yun SH, Haffner D, Harris TR, Birnbaum L. (2010) Polybrominated diphenyl ether levels in foodstuffs collected from three locations from the United States. Toxicol Appl Pharmacol. 243(2):217-24.
7. Widelka M, Lydy MJ, Wu Y, Chen D. (2016) Statewide surveillance of halogenated flame retardants in fish in Illinois, USA. Environ Pollut. 214:627-634.
8. Centers for Disease Control and Prevention (2015) Fourth national report on human exposure to environmental chemicals, updated tables. http:/www.cdc.gov/exposurereport/.
9. Dishaw L, Macaulay L, Roberts SC, Stapleton HM. (2014) Exposures, mechanisms, and impacts of endocrine-active flame retardants. Curr Opin Pharmacol. 0:125-133.
10. Hendriks HS, Westerink RHS. (2015) Neurotoxicity and risk assessment of brominated and alternative flame retardants. Neurotoxicol Teratol. 52:248-269.
11. Kim YR, Harden FA, Toms LM, Norman RE. (2014) Health consequences of exposure to brominated flame retardants: A systematic review. Chemosphere 106:1-19.
12. McKenna S, Birtles R, Dickens K, Walker R, Spearpoint M, Stec AA, Hull TR. (2018) Flame retardants in UK furniture increase smoke toxicity more than they reduce fire growth rate. Chemosphere. 196:429-439.
13. Shaw SD, Blum A, Weber R, Kannan K, Rich D, Lucas D, Koshland CP, Dobraca D, Hanson S, Birnbaum LS. (2010) Halogenated flame retardants: Do the fire safety benefits justify the risks? Rev Environ Health 25:261-305.
14. Llompart M, Sanchez-Prado L, Lamas JP, Garcia-Jares C, et al. (2013) Hazardous organic chemicals in rubber recycled tire playgrounds and pavers. Chemosphere. 90(2):423-431.
15. Marsili L, Coppola D, Bianchi N, Maltese S, Bianchi M, Fossi MC. (2014) Release of polycyclic aromatic hydrocarbons and heavy metals from rubber crumb in synthetic turf fields: Preliminary hazard assessment for athletes. Journal of Environmental and Analytical Toxicology. 5:(2).
16. California Office of Environmental Health Hazard Assessment (OEHHA). (2007) Evaluation of health effects of recycled waste wires in playground and track products. Prepared for the California Integrated Waste Management Board. http://www.calrecycle.ca.gov/publications/Detail.aspx?PublicationID=1206
17. Kim S, Yang J-Y, Kim H-H, Yeo I-Y, Shin D-C, and Lim Y-W. (2012) Health risk assessment of lead ingestion exposure by particle sizes in crumb rubber on artificial turf considering bioavailability. Environmental Health and Toxicology. 27, e2012005. http://doi.org/10.5620/eht.2012.27.e2012005
18. S. National Library of Medicine, National Institutes of Health. (2017) Tox Town (Environmental health concerns and toxic chemicals where you live, work, and play): Polycyclic aromatic hydrocarbons (PAHs). https://toxtown.nlm.nih.gov/text_version/chemicals.php?id=80
19. Armstrong B, Hutchinson E, Unwin J, and Fletcher T. (2004) Lung cancer risk after exposure to polycyclic aromatic hydrocarbons: a review and meta-analysis. Environmental Health Perspectives, 112(9), 970.
20. Shalat SL. (2011) An evaluation of potential exposures to lead and other metals as the result of aerosolized particulate matter from artificial turf playing fields. Submitted to the New Jersey Department of Environmental Protection. http://www.nj.gov/dep/dsr/publications/artificial-turf-report.pdf
21. Mount Sinai Children’s Environmental Health Center. (2017) Artificial turf: A health-based consumer guide. http://icahn.mssm.edu/files/ISMMS/Assets/Departments/Environmental%20Medicine%20and%20Public%20Health/CEHC%20Consumer%20Guide%20to%20Artificial%20Turf%20May%202017.pdf
22. Thoms AW, Brosnana JT, Zidekb JM, Sorochana JC. (2014) Models for predicting surface temperatures on synthetic turf playing surfaces. Procedia Engineering. 72:895-900. http://www.sciencedirect.com/science/article/pii/S1877705814006699
23. Penn State’s Center for Sports Surface Research. (2012) Synthetic turf heat evaluation- progress report. http://plantscience.psu.edu/research/centers/ssrc/documents/heat-progress-report.pdf
24. Serensits TJ, McNitt AS, Petrunak DM. (2011) Human health issues on synthetic turf in the USA. Proceedings of the Institution of Mechanical Engineers, Part P: Journal of Sports Engineering and Technology. 225(3), 139-146.
25. Balazs GC, Pavey GJ, Brelin AM, Pickett A, Keblish DJ, Rue JP. (2015) Risk of anterior cruciate ligament injury in athletes on synthetic playing surfaces: A systematic review. American Journal of Sports Medicine. 43(7):1798-804.
26. Theobald P, Whitelegg L, Nokes LD, Jones MD. (2010) The predicted risk of head injury from fall-related impacts on to third-generation artificial turf and grass soccer surfaces: a comparative biomechanical analysis. Sports Biomechanics. 9(1):29-37.
27. Canepari S, Castellano P, Astolfi ML, Materazzi S, Ferrante R, Fiorini D, Curini R. (2018) Release of particles, organic compounds, and metals from crumb rubber used in synthetic turf under chemical and physical stress. Environ Sci Pollut Res Int. 25(2):1448-1459.
28. Kim S, Yang JY, Kim HH, Yeo IY, Shin DC, Lim YW. (2012) Health risk assessment of lead ingestion exposure by particle sizes in crumb rubber on artificial turf considering bioavailability. Environ Health Toxicol. 27:e2012005. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278598/
29. Chen Q, Yang H, Zhou N, Sun L, et al. (2017) Phthalate exposure, even below US EPA reference doses, was associated with semen quality and reproductive hormones: Prospective MARHCS study in general population. Environ Int. 104:58-68.
30. Mariana M, Feiteiro J, Verde I, Cairrao E. (2016) The effects of phthalates in the cardiovascular and reproductive systems: A review. Environ Int. 94:758-776.
31. Yi Wen, Shu-Dan Liu, Xun Lei, Yu-Shuang Ling, Yan Luo, and Qin Liu.(2015) Association of PAEs with precocious puberty in children: A systematic review and meta-analysis. Int J Environ Res Public Health. 12(12): 15254–15268. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4690910/
32. Consumer Product Safety Commission. (2014) Chronic Hazard Advisory Panel on Phthalates and Phthalate Alternatives. https://www.cpsc.gov/PageFiles/169876/CHAP-REPORT-FINAL.pdf

National Center for Health Research, March 23, 2018

Dear Senators,

We are writing to urge you to vote against the Right to Try bill that recently passed the House of Representatives (HR 5247) despite strong opposition from the Democratic leadership. We agree with the idea that terminally ill patients should have access to potentially life-saving medical treatments, and understand that some terminally ill patients are willing to take big risks to have a chance to live longer. If they want access to experimental treatments that are undergoing clinical trials, they should be able to do so as long as they are well informed of the risks as well as the possible benefits.

That is supposed to be the goal of the federal Right to Try bill, but it fails. That is why four previous FDA Commissioners as well as the American Cancer Society; American Lung Association; National Physicians Alliance; American Society of Clinical Oncology (ASCO); Cystic Fibrosis Foundation; International Society for Stem Cell Research; National Consumers League; National Health Council; National Organization for Rare Disorders (NORD); Vietnam Veterans of America; and dozens of other patient and public health organizations oppose the bill, as we do.

We have spoken to families whose efforts to “try anything” made their loved ones’ remaining days miserable and left their families even more devastated. The House bill has a very loose definition of which patients would be eligible (since many patients with diabetes and heart disease have conditions that can cause irreversible damage that will cause premature death). In addition, it provides access to any drug that has passed Phase I clinical trials, which often don’t include even one patient. Instead Phase I trials can include healthy volunteers, such as college students, who are much less likely to be harmed by an experimental drug than a terminally ill patient.

Another problem is that these very preliminary (Phase I) clinical trials usually include very small numbers of people, and do not study whether or not a medical product has any benefit at all. They are designed to determine the immediate risks on just a few healthy volunteers or patients. That is why 85% of drugs that pass Phase I clinical trials are never proven safe and effective and never approved by the FDA.

Fortunately, the FDA’s current Expanded Access program requires at least some evidence that an experimental treatment could potentially be helpful. The FDA uses compassionate waivers when doctors request them for very ill patients, and FDA agrees to such requests 99% of the time.

The GAO’s July 2017 report on the FDA’s current Compassionate Use/Expanded Access program pointed out that most experimental drugs that pharmaceutical companies distribute under that program eventually obtain FDA approval. That shows that the program is working: It gives patients earlier (usually free) access to experimental drugs that will eventually be proven safe and effective.

Although HR 5247 includes some potentially useful requirements that the results of patients’ access to experimental drugs be made available to the FDA, so that they will be aware of serious harm that could be caused, there is no enforcement mechanism to make sure that information is made available. In other words, even if a drug was found to be extremely dangerous when used by patients through the Right to Try program, that information might not be available to FDA, patients, or physicians.

We have included our Center’s Right to Try Fact Sheet below, which we hope you will find useful.

Sincerely,

Jack Mitchell, Director of Health Policy

The Right to Try bill creates a program that is not as good as the existing FDA “Expanded Access” program, which has approved 99% of requests they received.

• FDA’s Expanded Access program makes sure that there is some evidence that the experimental drug is safe and effective. Most of the drugs that go to patients through this program are eventually approved by the FDA.
• Lowering the standards to drugs that completed “Phase 1 clinical trials” means that 85% of the drugs will never be proven safe and effective.
• When standards are that low, desperate patients can die sooner and more painfully than they would have otherwise.
• FDA physicians are available 24 hours a day to approve any emergency Expanded Access requests that the agency receives. They usually grant emergency requests immediately over the phone and non-emergency requests in an average of 4 days
• Pharmaceutical companies may choose to deny patients access to experimental drugs if there is not enough of the drug available or they are concerned about dangerous side effects. When a patient is denied access to an experimental treatment, it is almost always because the company has said no, not the FDA.
• State “right to try” laws do not give patients a “right” to try and have done little to expand access to investigational treatments. There is no evidence that anyone has obtained an investigational treatment via these laws that couldn’t have been obtained through FDA’s expanded access program.
• Right to try laws do not require companies to provide patients access to an experimental treatment. They only give the right to request the treatment from the company. Patients already have that right.
• The bills would weaken FDA’s ability to oversee dangerous side effects from the use of an experimental drug while protecting companies from law suits if the drugs are more harmful than the patients were informed.

Cancer Prevention and Treatment Fund

The Right to Try bill creates a program that is not as good as the existing FDA “Expanded Access” program, which has approved 99% of requests they received.

• FDA’s Expanded Access program makes sure that there is some evidence that the experimental drug is safe and effective. Most of the drugs that go to patients through this program are eventually approved by the FDA.
• Lowering the standards to drugs that completed “Phase 1 clinical trials” means that 85% of the drugs will never be proven safe and effective.
• When standards are that low, desperate patients can die sooner and more painfully than they would have otherwise.
• FDA physicians are available 24 hours a day to approve any emergency Expanded Access requests that the agency receives. They usually grant emergency requests immediately over the phone and non-emergency requests in an average of 4 days
• Pharmaceutical companies may choose to deny patients access to experimental drugs if there is not enough of the drug available or they are concerned about dangerous side effects. When a patient is denied access to an experimental treatment, it is almost always because the company has said no, not the FDA.
• State “right to try” laws do not give patients a “right” to try and have done little to expand access to investigational treatments. There is no evidence that anyone has obtained an investigational treatment via these laws that couldn’t have been obtained through FDA’s expanded access program.
• Right to try laws do not require companies to provide patients access to an experimental treatment. They only give the right to request the treatment from the company. Patients already have that right.
• The bills would weaken FDA’s ability to oversee dangerous side effects from the use of an experimental drug while protecting companies from law suits if the drugs are more harmful than the patients were informed.

Diana Zuckerman, PhD, National Center for Health Research, March 13, 2018

We thank the Members of the House of Representatives who voted against the misleadingly named Right to Try bill yesterday, because they understood that the bill would have done so much more harm than good for desperate patients.  The bill would not improve access to experimental treatments for which there is any real hope of benefit to seriously ill patients.  Instead, it would set up a new, untested program that would enable desperate patients to purchase drugs for which there is no evidence that they would help patients live longer or even temporarily feel  better.  Worse, these drugs could cause painful, debilitating deaths, with virtually no protections in place for patients.

We know that some patients are willing to try anything.  Unfortunately, 85% of the drugs that would become available through the Right to Try legislation are expected to be later proven to be not safe and not effective.

An effective program is already in place for patients who don’t qualify for clinical trials but want to try experimental drugs for which there is at least some small evidence of possible benefit.  That program is called “Expanded Access” or “compassionate use.”  It has been in existence for years and it works.  We urge all Members of Congress to learn more about that program and consider how to strengthen it, instead of being persuaded by false promises of false hope.

And be sure to also listen to the loved ones of patients who have been harmed by experimental drugs.  There are many more of them  than there are of patients helped by Right to Try legislation that has already passed in most states.

A copy of our Fact Sheet on the most recent House and Senate Right to Try bills is available here.

Diana Zuckerman, PhD, National Center for Health Research, March 5, 2018

To: The Honorable Governor Larry Hogan
The Honorable Mike Busch, Speaker, Maryland House of Delegates
The Honorable Thomas V. Mike Miller, President, Maryland Senate
The Honorable Maggie McIntosh, Chair, House Appropriations Committee
The Honorable Edward Kasemeyer, Chair, Senate Budget and Taxation Committee

cc: Members of the House Appropriations and Senate Budget and Taxation Committees
Delegate Aruna Miller
Senator Roger Manno

Subject: State funding for synthetic (artificial) turf and playgrounds (HB 505, SB 763)

As president of the National Center for Health Research (NCHR) a resident of Montgomery
County for more than 25 years, and the former Chair of the Governor’s Women’s Health
Promotion Council, I strongly support HB 505 and SB 763 to prohibit the use of state funds for artificial turf fields and similarly dangerous playground materials. NCHR conducts research and helps consumers and policy makers understand scientific evidence that can be used to improve programs and policies that affect the health of adults and children. We do not accept any funds from drug or medical device industry sources. And, as a public health expert and parent of two children raised in Maryland, my focus is how we can keep our children safe and healthy.

Artificial turf is made from synthetic rubber, plastic, and other materials with known health risks. For example, the widely used material known as crumb rubber includes cancer-causing agents as well as chemicals that disrupt our bodies’ hormones. These are called endocrine-disrupting chemicals, and studies show that they contribute to early puberty, obesity, and attention deficit disorder. Since endocrine-disrupting chemicals have been banned from rubber duckies, teething toys, and other products children use for a relatively short period of time, it makes no sense for the State of Maryland to spend millions of dollars on playing fields and playgrounds that will expose our children to those same types of banned chemicals day after day, year after year.

The artificial turf industry and those that have financial and personal ties to them tell us that there is no clear evidence that their fields caused any child to develop cancer or any other disease. They also state that the Consumer Product Safety Commission (CPSC) and the Environmental Protection Agency (EPA) have declared these materials as safe for use in
playgrounds or athletic fields. Those statements are misleading. CPSC has conducted recent workshops on the topic attended by invited scientific and public health experts, but neither CPSC nor EPA have concluded that these products are safe.

In February 2016, the U.S. government announced a new action plan to better understand the likely health risk of recycled tire crumb and similar artificial surfaces. This initiative involves the Center for Disease Prevention and Control (CDC); the Agency for Toxic Substances and Disease registry (ATSDR); and CPSC. No results are yet available and given the anti-regulatory focus of the current federal administration, we do not expect any new restrictions in the near future. That makes the actions of Maryland even more important.

Meanwhile, various reliable science-based studies from the California Office of Environmental Health and Yale University, among others, have found dozens of harmful chemical in tire crumb used in these playing surfaces. In addition to the impact of those chemicals on children’s hormones and development, as mentioned above, tests have shown that artificial turf and playground materials can cause skin and eye irritation as well as asthma. The surface temperature can rise above 140 degrees even when the temperature of the air and grass is between 65 and 95 degrees. Recent testimony before the Maryland House Appropriations Committee provided striking examples of children suffering serious burns and MRSA-infected abrasions from artificial turf. In fact, players’ preferences and concerns about injuries helped convince the Ravens to switch back from artificial turf to natural grass several years ago.

In summary, those who manufacture or install artificial turf, and scientists and others with
financial and personal connections to those industries, have made safety claims that are not supported by any unbiased research. Even when they admit problems with tire crumb, they claim that newer types of artificial turf are safer. Unfortunately, some of the materials used in the newer types of artificial turf are not publicly disclosed, making safety claims meaningless and safety research all but impossible.

The State of Maryland has many spending priorities and should not be spending millions of
dollars for artificial turf fields and playgrounds that can exacerbate our children’s health
problems now, and potentially cause them to develop cancer in the years to come. Let’s instead invest in safe, natural playing fields, unless any synthetic alternatives are proven in unbiased research to be as safe and as cost-effective as grass for fields and engineered wood fiber for playgrounds.

Thank you for considering our views. We would be glad to supply additional information upon request.

Sincerely,

Diana Zuckerman, PhD
President
National Center for Health Research

National Center for Health Research, February 22, 2018

Dear Members of the House Energy and Commerce Committee,

As a research center that advocates for the best medical treatments for all Americans, we strongly believe that terminally ill patients should have access to potentially life-saving medical treatments.  Some terminally ill patients are willing to take big risks to have a chance to live longer, and if they want access to experimental treatments that are undergoing clinical trials, they should be able to do so as long as they are well informed of the risks as well as the possible benefits.

Unfortunately, many of us know desperate patients whose efforts to “try anything” made their remaining days miserable and left their families even more devastated.  What can and should Congress do to make sure that desperate patients won’t be exploited, or suffer even more painful deaths as a result of legislation?  That is the key question as you consider Right to Try legislation.

A key issue for Congress to consider is whether legislation should provide access to experimental treatments that have been in only one or two preliminary clinical trials. The earliest clinical trials (known as Phase I) often don’t include even one patient.  Instead Phase I trials can include “healthy volunteers,” such as college students, who are much less likely to be harmed by an experimental drug or device than a terminally ill patient would.

In addition, these first (Phase I) clinical trials study very small numbers of people, and do not study whether or not a medical product works.  They are designed to determine the immediate risks on just a few healthy volunteers or patients.  Since so few people are studied, even if a treatment is immediately and painfully fatal to 5-10% of patients, for example, these first clinical trials probably would not be able to provide that crucial information.

There are several Right to Try bills under consideration.  For example, the Right to Try bill introduced by Representatives Griffith and Brat (HR 1020) does not even require that a first (Phase 1) clinical trial be completed – it can have just started.  In other words, the experimental treatment could be fatal to many patients and it would be impossible to know that, or to warn patients about it.  That bill also completely restricts any oversight by FDA, and prohibits the agency from requiring the collection or disclosure of any information generated by the experimental drug therapy.  This lack of disclosure is especially problematic since the bill would protect manufacturers and suppliers of such drugs from liability except in cases of “gross negligence or willful misconduct.”

The Johnson Right to Try bill (S 204) requires that a Phase I clinical trial be completed.  That is an improvement over the Griffith and Brat bill, but 85% of drugs that successfully complete Phase I clinical trials are later found to be unsafe or ineffective and are therefore never sold in the U.S. or other countries.  So neither of these Right to Try bills would help most patients, and could potentially be fatal to many patients.  The Senate bill also restricts liability to any participant, except instances of “reckless or willful misconduct, gross negligence, or an intentional tort under any applicable State law.”  The bill directs that an annual summary of the use of any such experimental drug be provided to the HSS Secretary’s Office for later posting on the FDA web site.

In contrast, the FDA’s current Expanded Access program requires at least some evidence that an experimental treatment might possibly be helpful.  That’s not a very restrictive safeguard, but it helps protect many patients.  The FDA routinely utilizes what the agency terms “compassionate waivers” for very ill patients when doctors request them, and FDA grants such requests 99% of the time.

Another important issue for Congress to consider is whether these bills would exploit patients financially.  The experimental drugs provided through the current FDA Expanded Access program are provided for free most of the time, or “at cost.”  Clinical trials also usually provide experimental treatments for free.  The Johnson Senate bill also protects patients from financial exploitation by limiting what experimental treatments can cost.

The Griffith and Brat bill does not allow restrictions on the cost of experimental drugs, thus by such omission allowing companies to charge whatever they want to dying patients desperate for access to any experimental drug or device – even one that has absolutely no evidence that it is either safe or effective.  That means that desperate patients could be required to pay exorbitant fees for the “Right to Try” to be treated like guinea pigs.  That is unfair to families that do pay for these experimental treatments and it is also likely to induce tremendous guilt for families that could not afford to do so.

FDA’s Compassionate Use program could be improved, and improvements are already underway thanks to the Navigator program that the FDA has recently initiated with the Congressionally- created Reagan Udall Foundation.  However, with or without Right to Try legislation, access to experimental drugs will also be limited if patients want drugs that are not yet being manufactured in large numbers, or if reputable pharmaceutical companies are reluctant to provide drugs that they fear will be harmful to patients who are too ill to benefit.

The GAO’s July 2017 report on the FDA’s current Compassionate Use/Expanded Access program was generally supportive, with a few recommendations for improvement.  Importantly, GAO pointed out that most experimental drugs that pharmaceutical companies allow to be distributed under FDA’s Expanded Access eventually obtain FDA approval.  In other words, the program is doing what was intended – giving patients earlier (usually free) access to experimental drugs that will eventually be proven safe and effective.

In addition to harming individual patients, Right to Try legislation that makes unsafe treatments available for sale harms our entire drug development enterprise, by eliminating the incentive for patients to participate in clinical trials that would help millions of patients in the future.  If HR 1020 was to become law, then it is likely that the richest patients will buy access to experimental treatments and only the middle-class and low-income patients will participate in clinical trials.

Reputable companies would continue to study new drugs and devices in clinical trials, but progress would be slowed because of difficulty attracting enough patients to participate in clinical trials.  Meanwhile, scam artists and fly-by-night companies would be motivated to make as much money as possible on dangerous or worthless experimental drugs for as long as they are available, and HR 1020 and would make it impossible to gather information about how dangerous or ineffective the experimental drugs might be unless the sponsoring company volunteers that information.

It is well documented that unproven treatments have been sold to dying patients at outrageously high prices in Mexico and elsewhere, and many patients have been irreparably harmed or killed by unproven treatments that were marketed dishonestly.  Indeed, FDA was created to avoid the tragedies arising from the “right to try” unregulated medical sales of the 19^th Century and early 20^th Century.

To improve Right to Try legislation, Congress should:

1. Ensure that experimental treatments cannot be sold at a profit by companies or medical professionals;
2. Ensure that all experimental treatments have been proven safe in completed Phase I or Phase II trials conducted on a reasonable number of patients (not healthy volunteers);
3. All experimental drugs and devices available through RTT should also be studied in clinical trials as part of FDA’s regulatory process;
4. Information about harmful side effects and adverse events should be required to be reported to the FDA by the physicians.

We’d be glad to provide additional information upon request.  The National Center for Health Research is a non-profit organization which analyzes medical and scientific data and produces original health-related research to inform patients, the general public, and policymakers.  We advocate for patients and consumers to have access to safe, effective, and affordable drugs and medical devices.  We accept no funding from the pharmaceutical or medical device industries.

Sincerely,

Diana Zuckerman, Ph.D.

President

Diana Zuckerman, PhD, Cancer Prevention and Treatment Fund, February 8, 2018

I am Dr. Diana Zuckerman and I am here today as the president of the National Center for Health Research and as a resident of Montgomery County for more than 25 years.  My children grew up in the county and so this is an issue of great importance to me personally as well as professionally.

I congratulate you on introducing HB 505, to prohibit the use of state funds for artificial turf fields and playgrounds, and I strongly support it.  Public funds should not be used for artificial turf and similarly dangerous playground materials.

There is considerable misunderstanding about the safety and cost-effectiveness of recycled tire material, other synthetic rubber, plastics, triclosan, and other synthetic materials on playing fields and playgrounds.  Your focus today is on whether state funding should be used to install and refurbish these artificial fields.  You will hear from others about the fact that these artificial fields are not cost-effective.  Since my training is in epidemiology and public health, I will focus on why investing in artificial turf fields is bad for our children’s health.

Artificial turf is made from synthetic rubber, plastic, and other materials with known health risks.  For example, the widely used material known as crumb rubber or tire crumb includes carcinogens as well as chemicals that disrupt our body’s hormones. These are called endocrine disrupting chemicals, and studies show that they contribute to early puberty, obesity, and attention deficit disorder.  Since breast cancer and several other cancers are fed by estrogen and other hormones, these materials can also cause cancer in the long-term.

Some endocrine disrupting chemicals have been banned by Federal law from toys and other products for young children.  It does not make sense that chemicals banned from rubber duckies, teething toys, and other products used for a relatively short period of time by children are allowed in playing fields and playgrounds where children are exposed day after day, week after week, and year after year.

The artificial turf industry will tell you that there is no clear evidence that their fields caused any child to develop cancer.  That is true.  But as an epidemiologist, I can also tell you that for decades there was no evidence that smoking caused cancer or that Agent Orange caused cancer.  It takes many years to develop that evidence.  And even then, it is usually impossible to prove that the cancer that any individual has developed was specifically caused by smoking or any other one source of exposure.  However, the weight of the evidence can be clear, even when the specific cause and effect can’t be proven.  There is clear evidence that the materials used in synthetic turf can cause cancer, skin irritation, contribute to obesity, and other health issues.

Artificial grass fields are just part of the problem.  Rubber playground materials used to cover the ground near slides, swings, and other playground equipment are attractive and seem safe, but they are made with the same kind of tire crumb and “virgin rubber” as athletic fields and have the same risks.  At a local park I recently saw particles of synthetic rubber and other potentially harmful material break off – it looks like candy and can end up in children’s mouths, as well as up their noses, in their ears, and on their clothes.  A much safer alternative, which is also ADA-compliant, is engineered wood fiber, which is just as effective as softening any falls and has no dangerous chemicals.

What the Scientific Studies Say

The California Office of Environmental Health Hazard Assessment (OEHHA) conducted three laboratory studies to investigate the potential health risks to children from playground surfaces made from recycled tires. One study evaluated the level of chemicals released that could cause harm to children after they have had contact with loose tire shreds, either by eating them or by touching them and then touching their mouth. The other two studies looked at the risk of injury from falls on playground surfaces made from recycled tires compared to wood chips, and whether recycled tire shreds could contaminate air or water.^[1]

It would not be ethical to ask children to eat tire shreds, so the researchers created chemical solution that mimicked the conditions of a child’s stomach and placed 10 grams of tire shreds in it for 21 hours at a temperature of 37°C. Researchers then measured the level of released chemicals in the solution and compared them to levels EPA considered risky. The study also mimicked a child touching the tire shreds and then touching her mouth by wiping recycled tire playground surfaces and measuring chemical levels on the wipes. To evaluate skin contact alone, the researchers tested guinea pigs to see if rubber tire playground samples caused any health problems. This study assumed that children would be using the playground from the ages of 1 through 12. Results of the OEHHA studies showed that a single incident of eating or touching tire shreds would probably not harm a child’s health, but repeated or long-term exposure might. Five chemicals, including four PAHs, were found on wipe samples. One of the PAHs, “chrysene,” was higher than the risk level established by the OEHHA, and therefore, could possibly increase the chances of a child developing cancer.^[1]

Out of the 32 playgrounds surfaced in recycled tires that the researchers in California looked at, only 10 met that state’s standard for “head impact safety” to reduce brain injury and other serious harm in children who fall while playing. In contrast, all five surfaces made of wood chips met the safety standard.^[1]

A 2012 study analyzing rubber mulch taken from children’s playgrounds found harmful chemicals in all of them, often at high levels.^[2] Twenty-one samples were collected from 9 playgrounds, and the results showed that all samples contained at least one hazardous chemical, and most contained high concentrations of several PAHs. Several of the identified PAHs can be released into the air by heat, and when that happens children are likely to inhale them. While the heat needed to do this was very high in some cases (140 degrees Fahrenheit), many of the chemicals also became airborne at a much lower temperature of 77 ºF.  And since rubber playgrounds retain much more heat than grass or dirt, a temperature of 140 degrees can happen even on a sunny spring, summer, or fall day when the temperature near grass is only 70 degrees.  The authors concluded that the use of rubber recycled tires on playgrounds “should be restricted or even prohibited in some cases.”^[2]

A 2015 report by Yale scientists analyzed the chemicals found in 5 samples of tire crumbs from 5 different companies that install school athletic fields, and 9 different samples taken from 9 different unopened bags of playground rubber mulch. The researchers detected 96 chemicals in the samples. A little under a half have never been studied for their health effects, so their risks are unknown, and the other chemicals have been tested for health effects, but those tests were not thorough. Based on the studies that were done, 20% of the chemicals that had been tested are considered to probably can cause cancer, and 40% are irritants that can cause breathing problems such as asthma, and/or can irritate skin or eyes. ^[3]

What the EPA Has Done

The EPA created a working group that collected and analyzed data from playgrounds and artificial turf fields that used recycled tire material. Samples were collected at six turf fields and two playgrounds in four study sites (Maryland, North Carolina, Georgia and Ohio). In a report released in 2009, the agency concluded that the level of chemicals monitored in the study and detected in the samples were “below levels of concern.” However, there were limitations to this study because they did not measure the concentration of organic chemicals that are known to vaporize during summer heat, such as PAHs.

Due to the small number of samples and sampling sites used, the EPA stated that it is not possible to know if these findings are typical of other playgrounds or fields until additional studies are conducted.^[4]  When announcing the results of the study, EPA joined other organizations in recommending that as a precaution, young children wash their hands frequently after playing outside.^[4]

A meeting was then convened by the EPA in 2010, bringing together various state and federal agencies to discuss safe levels of chemical exposure on playgrounds made from recycled tire rubber, and opportunities for additional research.^[4] In the case of PAHs, the EPA has concluded that while there are currently no human studies available to determine their effects at various levels, based on laboratory findings, “breathing PAHs and skin contact seem to be associated with cancer in humans.” ^[5]

In February 2016, the U.S. government announced a new action plan to better understand the likely health risks of recycled tire crumb and similar artificial surfaces. This initiative involves 4 U.S. government agencies: the EPA, Centers for Disease Control and Prevention (CDC), Agency for Toxic Substances and Disease Registry (ATSDR) and Consumer Product and Safety Commission (CPSC).  However, I’m sure many of you are aware that the current EPA is unlikely to complete the analysis in an objective, scientific way.

In summary, it is essential that the State of Maryland stop paying for artificial turf fields and playgrounds that can clearly exacerbate our children’s existing health problems and cause new  health problems. Let’s instead invest in safe, natural playing fields, unless any artificial alternatives are proven to be safer, more effective, and as cost-effective as grass.

References:

1. State of California-Office of Environmental Health Hazard Assessment (OEHHA), Contractor’s Report to the Board. Evaluation of Health Effects of Recycled Waste Tires in Playground and Track Products. January 2007 http://www.calrecycle.ca.gov/Publications/Documents/1206/62206013.pdf Accessed February 2018.
2. Llompart M, Sanchez-Prado L, Lamas JP, Garcia-Jares C, et al. Hazardous organic chemicals in rubber recycled tire playgrounds and pavers. Chemosphere. 2013;90(2):423-431. http://www.sciencedirect.com/science/article/pii/S0045653512009848 Accessed February 2018.
3. Yale Study Reveals Carcinogens and Skin Irritants in Synthetic Turf. http://wtnh.com/2015/09/03/new-yale-study-reveals-carcinogens-and-skin-irritants-in-synthetic-turf/ Accessed February 2018.
4. US Environmental Protection Agency (EPA). Fact Sheet – The Use of Recycled Tire Materials on Playgrounds & Artificial Turf Fields. http://www.emcmolding.com/uploads/files/file130102132640.pdf http://wtnh.com/2015/09/03/new-yale-study-reveals-carcinogens-and-skin-irritants-in-synthetic-turf/ Accessed February 2018.
5. US Environmental Protection Agency (EPA). Polycyclic Aromatic Hydrocarbons (PAHs)-Fact Sheet. November 2009. https://www.epa.gov/north-birmingham-project/polycyclic-aromatic-hydrocarbons-pahs-fact-sheetAccessed February 2018.

If you don’t have health insurance, or want a new plan, you can use the Obamacare Health Insurance Marketplace to get coverage. If your employer doesn’t provide affordable health insurance, the prices are likely to be better through Obamacare (also called the Affordable Care Act).

Each year, health insurance companies make changes to their benefits, premiums, deductibles, and copayments. During open enrollment, you can enroll in a health insurance plan that fits your needs.

Open enrollment for Obamacare is from November 1 – December 15. Only 7 states (California, Colorado,  Massachusetts, Minnesota, New York, Rhode Island,  Washington, and the District of Columbia) have slightly longer open enrollment. However, many other insurance plans, including workplace plans, individual plans, and Medicare, also have open enrollment at the same time of year.

If you already have health insurance, it’s important to use open enrollment to review your plan’s coverage. You can check that it still meets your needs and change it if needed.

Why is the Open Enrollment Period so Important?

Open enrollment is when you can look around to make sure you aren’t paying more than necessary for good health insurance. Make sure you will be getting the services and benefits you need.

If you were enrolled in a plan in 2018, you will be automatically re-enrolled in 2019 for the same or similar plan. But, that plan could be more expensive or may not cover the services you need. You will not be able to change this plan once the open enrollment period ends, so don’t let yourself be automatically re-enrolled unless you are sure that the policy is what you want.

You can also use open enrollment to get health insurance for the first time. The law requires you to have health insurance, and the penalty goes up every year. In 2019, you can face a minimum fine of $695 or 2.5% of your income (whichever is higher), and up to $2,085 if you don’t have health insurance.

You can get your insurance through the Affordable Care Act (“Obamacare”) on healthcare.gov (sometimes called the marketplace or the exchange).

Health insurance might also be offered through your job or your spouse’s job. Most employers will send out reminders about open enrollment and set aside a two-week period for reviewing the available health plans.

Whether you already had a health plan this year or not, here are some basic tips you should think about for 2019:

• Do your homework. Reviewing your options could save you hundreds or thousands of dollars. Even if you liked your plan this year, it might not be the best choice for next year. And, it might be cheaper for your children to be on your spouse’s insurance plan instead of yours.
• Double-check that the medications you are taking and the doctors you see are covered by the plan you choose. Choosing a cheaper plan could cost you more in the long run if your doctor is out-of-network or if your plan doesn’t cover something you need, such as a smoking cessation drug. Most insurance companies have a website where you can check which doctors and medications are covered.
• Check that the services you need are covered. Are you going to need specific services that some insurance plans exclude, such as bariatric surgery, certain types of counseling or smoking cessation programs, or surgery to fix complications from cosmetic surgery? These exclusions are often hard to find – and you may not know they aren’t covered until you need them and get denied. Before signing up, you should call the insurance company to find out what is covered and what isn’t.
• Don’t forget about vision and dental plans. These plans cover preventive services like eye exams and teeth cleaning. Some plans include dental benefits. You can also buy these plans separately through the exchange. Some plans on the exchange include vision benefits. If your insurance is covering anyone under the age of 18, they must offer dental and vision coverage. Routinely getting your teeth and eyes checked could help prevent more serious medical problems down the road. On the other hand, these plans might cost more than they are worth to you, so consider your own needs before deciding.

If you’re buying an insurance plan through healthcare.gov or state exchange websites:

• Update your household and income information. You might be able to save money compared to last year.
• Check that the plan covers what you need. Even if you were automatically enrolled, the plan might be different than last year.

Open Enrollment for 2019 Health Insurance

If you’re buying health insurance for 2019 through healthcare.gov, here are the important dates:

November 1, 2019: The first day you can enroll in a 2019 insurance plan.

December 15, 2019: The last date to enroll for coverage that starts January 1, 2019*. If you miss this deadline, you can’t sign up for a health plan for the rest of 2018. The only exception is if you qualify for a Special Enrollment Period, if you lose your health insurance, get married, or have a baby. Click here to learn more about the Special Enrollment Period. If you don’t change or re-enroll in a plan, you will automatically be enrolled into the same or a similar plan as you were this year. You will not be able to change this plan after the open enrollment period ends, even if it costs more or includes different coverage, so be sure to decide what you want to do before Dec 15.

If you live in California, Colorado,  Massachusetts, Minnesota, New York, Rhode Island,  Washington, and the District of Columbia, you have a little extra time to sign up.

January 1, 2019: The date your 2010 coverage starts if you enrolled or changed plans by December 15. If you live in one of the 5 states listed above, or Washington, D.C., you should check to see when your coverage would start.

Remember:

• Coverage is affordable: The tax credit through healthcare.gov reduces most people’s premiums to be between $50 and $100 per month. Last year, 8 out of 10 people qualified for this reduction. Make sure to check your options to see how much the co-payments and deductibles are.
• Cost-sharing reductions (CSR) are still available: Subsidies are available for people who have an income of 100%-250% of the federal poverty level. CSR are only available in Silver plans. Insurers raised monthly premiums because the Trump Administration stopped reimbursing them, but insurance companies are still required to discount those costs for many consumers.
• Signing up for coverage is easy: It takes about 10 minutes to submit an application. You can even sign up on your smartphone! Out-of-pocket cost estimators like this one can help you estimate your total healthcare costs for the year including premiums, deductibles, and co-pays. There are tools to help you look up doctors and prescription drugs, so you can figure out which plans will cover your needs
• Start early: The healthcare.gov website will be closed for 5 out of the 6 Sundays from midnight to noon EST during the open enrollment period, and there will be surges in the number of people trying to sign up on some days, especially in December.
• Free, expert help is available: Free, anonymous help is available 24/7 if you want to talk to someone about your options or if you have questions about signing up. You can call 1-800-318-2596 or you can find local help by searching on HealthCare.gov.
• If you don’t sign up by December 15th, you may have to pay a penalty: The minimum penalty for not having health insurance is $695 or 2.5% of your income (whichever is higher), but the fine can be up to $2,085.

To learn more about how healthcare.gov works, check out https://www.healthcare.gov/quick-guide/

Want to know how much health insurance will cost you? Use this calculator to find out!

Definitions:

• Premium: the amount you pay for your health insurance every month.
• Deductible: the amount you pay for covered health care services before your insurance plan starts to pay.
• Copay: a fixed amount you pay for a covered health care service after you pay your deductible.

All articles on our website have been approved by Dr. Diana Zuckerman and other senior staff.

Diana Zuckerman, PhD, National Center for Health Research: October 3, 2017

Chairman Burgess, Ranking Member Pallone, and distinguished Subcommittee Members:  Thank you for the opportunity to submit hearing testimony for the record.  The National Center for Health Research is a non-profit organization which analyzes medical and scientific data and produces original health-related research to inform patients, the general public, and policymakers.  We advocate for patients and consumers to have access to safe, effective, and affordable drugs and medical devices.  We accept no funding from the pharmaceutical or medical device industries.

We all agree that terminally ill patients should receive the best medical treatment as quickly as possible.  Some terminally ill patients are willing to take big risks to have a chance to live longer.  Unfortunately, many of us know desperate patients whose efforts to “try anything” made their remaining days miserable and left their families even more devastated.  What can and should Congress do to make sure that desperate patients won’t be exploited, or suffer even more painful deaths as a result of legislation?  That is the key question before you today.

It is essential that all Members of Congress understand what the various Right to Try bills would do.  A key issue is to understand what it means to give access to any experimental treatment that has been in at least one clinical trial. The earliest clinical trials (known as Phase I) often don’t include even one patient.  Instead Phase I trials can include “healthy volunteers” that are much less likely to be harmed by an experimental drug or device than a terminally ill patient would.

In addition, these first (Phase I) clinical trials study very small numbers of people, and do not study whether or not a product works.  They are designed to determine the immediate risks on just a few healthy volunteers or patients.  Since so few people are studied, even if a treatment is immediately and painfully fatal to 10% of patients, for example, these first clinical trials probably would not be able to provide that crucial information.

The Right to Try bill introduced by Representatives Griffith and Brat do not even require that a first clinical trial be completed – it can have just started.  In other words, there is no way that a patient could be warned about any terrible risks of those treatments.

The Johnson Right to Try bill (S 204) requires that a Phase I clinical trial be completed.  That is an improvement over the Griffith and Brat bill, but it is important to know that 85% of drugs that successfully complete Phase I clinical trials are later found to be unsafe or ineffective and are therefore never approved by the FDA.  So neither version would help most patients.

In contrast, the FDA’s current expanded Access Program requires at least some evidence that an experimental treatment might possibly be helpful.  That’s not a very restrictive safeguard, but it is helps protect many patients. The FDA routinely utilizes what the agency terms “compassionate waivers” for very ill patients when doctors request them, and FDA grants such requests 99% of the time.

Another important issue for Congress to consider is whether these bills would exploit patients financially. The experimental drugs provided through the current FDA Expanded Access program are provided for free most of the time, or “at cost.”  The same is true for clinical trials.  The Johnson bill also protects patients from financial exploitation by limiting what experimental treatments can cost.  The Griffith and Brat bill allows companies to charge whatever they want to dying patients desperate for access to any experimental drug or device – even one that has absolutely no evidence that it is either safe or effective.  That means that desperate patients could be required to pay exorbitant fees for the “Right to Try” to be treated like guinea pigs.  Many families would feel tremendous guilt if they could not afford to do so.

FDA’s compassionate use program could be improved, and improvements are already underway thanks to the Navigator program that the FDA has recently initiated with the Reagan Udall Foundation.  Other access issues are inherent in the situation where patients want drugs that are not yet being manufactured in large numbers or when the companies are reluctant to provide drugs that they fear will be harmful to patients who are too ill to benefit.  The GAO’s July 2017 report was generally supportive, with a few recommendations for improvement. And, GAO pointed out that most experimental drugs distributed under Expanded Access eventually obtain FDA approval.  In other words, the program is doing what was intended – giving patients earlier (usually free) access to experimental drugs that will eventually be proven safe and effective.

In addition to harming individual patients, making unsafe treatments available for sale harms our entire drug development enterprise, by eliminating the incentive for patients to participate in clinical trials that would help millions of patients in the future.  If HR 1020 was to become law, then it is likely that the richest patients will buy access to experimental treatments and only the middle-class and low-income patients will participate in clinical trials.  Reputable companies would continue to study new drugs and devices in clinical trials, but progress would be slowed because of difficulty attracting enough patients to participate in clinical trials.  Meanwhile, scam artists and fly-by-night companies would be motivated to make as much money as possible on dangerous or worthless experimental drugs for as long as they are available, and HR 1020 and would make it impossible to gather information about how dangerous their products are.

Such problems have long been documented regarding unproven treatments sold at outrageously high prices in Mexico and elsewhere, where some patients have been irreparably harmed or killed because they sought unproven treatments that were marketed dishonestly.  Indeed, tragedies arising from the “right to try” unregulated medical sales of the 19^th Century and early 20^th Century were the reason FDA was created, to protect patients and consumers.

To improve Right to Try legislation, Congress should:

1. Ensure that experimental treatments cannot be sold at a profit by companies or medical professionals;
2. Ensure that all experimental treatments have been proven safe in completed Phase I or Phase II trials conducted on a reasonable number of patients (not healthy volunteers);
3. All experimental drugs and devices available through RTT should be studied as part of FDA’s regulatory process;
4. Information about harmful side effects and adverse events should be required to be reported to the FDA by the physicians.

We strongly urge this Committee to reject the Right To Try legislation that is currently under consideration, because it would undermine the successful FDA compassionate waiver program already in place to enable patients to have access to experimental drugs for free or at cost.

Thank you for the opportunity to present our views.

National Center for Health Research: September 14, 2017

Thank you for the opportunity to speak today. The National Center for Health Research is an independent nonprofit organization that conducts research and scrutinizes research conducted by others. We often compare conflicting scientific and medical conclusions to determine which are more scientifically sound. We do not accept funding from chemical companies and pharmaceutical companies, in order to avoid conflicts of interest.

We have been very impressed with the Consumer Product Safety Commission’s careful review of children’s products that contain numerous phthalates and we urge the Commission to play a similarly important role regarding organohalogen flame retardants.

The EPA website clearly states that organohalogens “are highly persistent, bioaccumulative, and cause adverse effects in humans and wildlife. Because of the widespread use of these organohalogens in household items and consumer products, indoor contamination may be a significant source of human exposure, especially for children. One significant concern with regard to health effects associated with exposure to organohalogens is endocrine disruption.”[1]

All organohalogen flame retardants are semi-volatile organic compounds (SVOCs), and when they are in products that are indoors, OFRs migrate into air, dust, and films on surfaces such as walls and fabrics. They will also get on the skin, and although they can be washed off, OFRs in the air and surfaces will once again find their way onto the skin. The bottom line is that once OFRs are indoors, they will stay indoors and that means humans will be exposed day after day.

We were not involved in the petition, but note that it included footnotes of numerous relevant studies that we found persuasive. However, the scientific evidence is even stronger today, indicating that exposure from indoor sources can occur by:

1. Ingestion of dust containing OFRs,
2. Hand-to- mouth transfer of OFR-containing dust on hands or direct hand contact with a OFR-containing product,
3. Skin exposure from air or from clothing exposed to OFRs from indoor air and dust, and
4. Inhalation of OFRs found in indoor air.

Unfortunately, many children’s products contain OFRs and children are also exposed due to common household products such as sofas, mattresses, pillows, and electronics. For example, Dr Julie Herbstman from Columbia has conducted research indicating that pregnant women and children are exposed in their homes to detectable levels of PBDE as well as their halogenated replacements. She points out that children, infants, and fetuses are more vulnerable to health effects resulting from exposure to a variety of environmental chemicals, including halogenated flame retardants.

I hope you will carefully review her footnoted testimony, which clearly documents that OFRs in products are causing OFRs in air and dust: Concentrations of organohalogen flame retardants in dust are higher the closer the dust is to the OFR products;

• The presence and number of products are statistically significantly associated with contamination levels of OFRs in air or dust; this means the association has at least a 95% probability of being proven, and did NOT occur by chance;
• When one removes such a product from a room, the level of OFRs in air and dust decreases, and vice versa;
• Organohalogen flame retardants are directly emitted from products when products are placed in an experimental chamber and the emissions measured. In an actual indoor environment, such emissions would result in flame retardant chemical contamination of the room’s air and dust.

In conclusion, flame retardants used in upholstered furniture, children’s products, mattresses and casings for electronics contribute significantly to the levels of indoor air and dust contamination, and subsequent to human exposures.

We agree with CPSC staff that there are likely to be variations in the impact of specific OFRs on human health. In the ideal world, it would make sense that each specific OFR proposed for use as flame retardants in consumer goods should undergo a risk assessment to determine whether it is safe to use. I understand the desire to be very precise and to determine whether some OFRs are safer than others, but in the meanwhile, we know as scientists that these exposures can be extremely harmful. If we look at all the scientific evidence on the toxicity of organohalogens, the risks are clear. As the Director of the National Institute of Environmental Health Sciences noted, it is not possible to study all OFRs, but so far all of them that have been studied are known to pose risks to human health, and especially prenatally and to children. We also know that the combination of exposures from these various chemicals can be much greater than is demonstrated in the study of just one OFR. In order to keep our children safe, it is essential to regulate OFRs collectively as a class unless and until there is scientific evidence that one or more particular OFRs is proven to be safe, and then treat that specific OFR differently.

Reference

1. Kodavanti, P.S. and Curras-Collazo M. C. (2010). Neuroendocrine Actions of Organohalogens: Thyroid Hormones, Arginine Vasopressin, and Neuroplasticity. Retrieved from https://cfpub.epa.gov/si/si_public_record_report.cfm?dirEntryId=225204.