Category Archives: Policy

NCHR Statement by Dr. Diana Zuckerman at FDA Covid Vaccine Advisory Committee

October 22, 2020

I’m Dr. Diana Zuckerman, president of the National Center for Health Research. Our center scrutinizes the safety and effectiveness of medical products, and we don’t accept funding from companies that make those products, although I’ve personally inherited stock in Johnson & Johnson. My expertise is based on post-doc training in epidemiology and as a faculty member and researcher at Vassar, Yale, at Harvard. I’ve also worked at HHS, the U.S. Congress and White House.

We’ve heard today that the agencies are doing many things right, but the vaccine trials have serious design flaws. The standards set in FDA guidances and the study protocols make it likely that vaccines that will be authorized or approved won’t achieve what the public and policy makers expect. Instead, these vaccines will only be proven to reduce the risk of mild infections but not proven to reduce the risk of hospitalization, ICU use, or deaths.

The major flaws are as follows:

  • The FDA’s proposed primary endpoint is defined as symptomatic Covid-19 that can include only 1 very mild symptom, such as a mild cough or sore throat – as long as the person has tested positive.
  • FDA’s requirement of at least 2 months median follow-up after vaccination or placebo is too short to study efficacy.  Even if a person is exposed during that time, we don’t know the correlates of protection and so we need a longer follow-up to know how long an effective vaccine remains effective.  We can’t rely on post-market studies for that information, because once a vaccine is on the market, many people in the placebo control group will switch to a vaccine.
  • We don’t know whether diversity of study participants will be achieved in terms of age, race, or co-morbidities, especially for people who are exposed to the virus.
  • The requirement of at least 5 serious Covid-19 cases in the placebo group is completely inadequate for 2 reasons:
    • Serious Covid-19 cases are too loosely defined, and could include a case of mild Covid-19 if the patient has a blood oxygen saturation under 93%. But thousands of otherwise healthy Americans have levels below that.
  • Even if the definition were more stringent, such as requiring hospitalization or death, and even if there were no such cases among the vaccinated patients, the absolute difference in disease between 0 and 5 serious cases would not be clinically meaningful to individuals and could easily have occurred by chance.

The American public has been told for months that life can go back to normal when we have a vaccine.  It isn’t FDA’s job to achieve that overly optimistic goal for any vaccine, but it is FDA’s job to make sure that a vaccine has meaningful benefits for the health and lives of most Americans, and especially those most at risk.

Testimony of Dr. Diana Zuckerman of NCHR before the FDA Advisory Committee on Pfizer COVID Vaccine

December 10, 2020

I’m Dr. Diana Zuckerman, president of the National Center for Health Research.  Thank you for the opportunity to speak today.

Our center scrutinizes the safety and effectiveness of medical products, and we don’t accept funding from companies that make those products. My expertise is based on post-doc training in epidemiology and as a previous faculty member and researcher at Vassar, Yale, and Harvard, and a fellow in bioethics at University of Pennsylvania.  I’ve also worked at HHS, the U.S. Congress and the White House.  

Today I will focus on 2 major concerns and how to improve the data:

#1:  The 2 month median follow-up is too short, so it’s essential that the randomized controlled trial be continued, to learn about long-term safety and efficacy.

#2:  There’s a lack of diversity in COVID cases:  There were 0 Black cases in the vaccine group, and only 7 Black cases in the placebo group.  

There were 0 cases who are ages 75+ in the vaccine group, 5 in placebo group  

We need more cases in these groups in order to understand the efficacy.  I’m concerned that conclusions will be inappropriately drawn, as when an article in the Wall Street Journal article included a chart saying the vaccine was 100% effective in Blacks.

THERE are also too few severe cases to draw conclusions:

There were only 4 severe cases after the 2nd dose:  3 of which were in the placebo group.  Not all these cases required hospitalization.  In summary, there are too few severe cases to draw conclusions about whether the vaccine prevents severe COVID.

Long-term care patients were not included in the study.  About 800 people ages 75 and older were in the study but only 5 were cases (all of them placebo).

We want to save their lives, but how can we ensure informed consent to nursing home patients with no data?  How many frail elderly or their family members can make an informed decision based on so little information?

We need longer-term data to fully understand if benefits outweigh the risks for frail patients and all races/ethnicities, and for everyone else as well.  That’s why it is essential that FDA ensure the continuation of the randomized controlled trial.

In conclusion, EUA is not approval and it should have more restrictions than approval would have:

  • FDA should require continuation of the RCT while targeting EUA to priority populations, especially healthcare workers.  Study participants in the placebo group should not “jump the queue.”  Continuing the RCT for at least a few more months will make an important difference in knowledge.
  • EUA should not allow off-label use, and celebrities and others should not be allowed to jump the queue.  Off label use could occur when urgently needed under FDA’s Expanded Access program.
  • FDA should delay access to vaccines by placebo group unless they are in priority populations.  I am concerned about the blinded crossover proposal, because if the vaccine is effective very long-term, such as 9 months or a year, we would lose that information if placebo participants were crossed over after just 3-9 months.   Blinded crossover would only provide useful information if the efficacy doesn’t last long.  Let’s hope that isn’t true. 

Dr. Diana Zuckerman’s Testimony on Moderna’s COVID Vaccine Before the FDA Advisory Committee

December 17, 2020.

I’m Dr. Diana Zuckerman, president of the National Center for Health Research.  Thank you for the opportunity to speak today.

Our center scrutinizes the safety and effectiveness of medical products, and we don’t accept funding from companies that make those products. My expertise is based on post-doc training in epidemiology and as a previous faculty member and researcher at Vassar, Yale, and Harvard, and a fellow in bioethics at University of Pennsylvania.  I’ve also worked at HHS, the U.S. Congress and the White House.

Today I will focus on 3 major concerns:

#1:  The 2 month median follow-up is too short, so Moderna’s proposal to immediately unblind and offer to vaccinate the entire placebo group should be rejected.

#2:  Moderna made a good effort to include a diverse group of participants, but only 4 COVID cases were in Black patients, and there were even fewer in other racial groups.  We can’t assume that the vaccine was highly effective in demographic groups with so few cases because just 1 Covid case in the vaccinated group would have greatly reduced the efficacy rate.

The data on cases for participants with co-morbidities was slightly more substantial, with 24 placebo cases and only 1 vaccinated case

#3  I’m glad to see that unlike Pfizer, Moderna provided info on the total number of  participants who reported 1 or more adverse events.  That’s important.  Unfortunately, the total of severe systemic adverse events after the 2nd dose was over 17% for vaccinated group compared to 2% for the placebo group.

There are also too few severe cases to draw conclusions:

There were 30 severe cases after the 2nd dose, and none were in the vaccine group.  This is a strong finding.  However, only 9 of the severe cases required hospitalization; 12 involved the questionable criteria of at least slightly low blood oxygen saturation.

Long-term care patients were not included in the study.  About 1300 people ages 75 and older were in the study, almost half of them vaccinated, but only 3 were cases (all of them placebo).  Only 15 cases were in patients over 65.

We want to save their lives, but with no data it’s not possible to provide useful informed consent to nursing home patients.  That puts a tremendous burden on those patients and their family members to decide whether or not to be vaccinated.

We need longer-term data to fully understand the benefits and risks for different types of patients.  The vaccine is clearly effective, but does that last 2 months, 4 months, or a year?  We need to know that, and that’s why it is essential that the blinded randomized controlled trial is continued.

In conclusion, EUA is not approval, and it should have more restrictions than approval would have.  The EUA should be targeted to priority populations, because if the EUA applies to all adults, celebrities and others who are well-connected will cut in line.  We’ve already seen that this week.

Other people could apply for the vaccine under FDA’s Expanded Access program.

We need at least 1 year of blinded, randomized, controlled data.  We agree with Dr. Goodman’s proposal that FDA should delay access to vaccines by members of the placebo group unless they are in priority populations.  Blinded crossover has limitations because it can’t control changes in the community spread of the virus, but it is better than not continuing a blinded controlled study, if continuing the current study is not possible.

Public Comments Regarding ACIP Meeting on December 1, 2020

Diana Zuckerman, Ph.D., on behalf of the National Center for Health Research

Thank you for the opportunity to express my views on behalf of the National Center for Health Research regarding the priorities for allocation of initial supplies of the COVID-19 vaccines. Our center is a nonprofit think tank that scrutinizes the safety and effectiveness of medical products, and we do not accept funding from companies that make those products. My expertise is based on post-doctoral training in epidemiology and public health and more than 30 years of health policy expertise, including my previous employment at the U.S. Department of Health and Human Services, the U.S. Congress, and the White House.

If a COVID-19 vaccine is authorized through an EUA or approved by the FDA, we support prioritizing allocation to healthcare workers, paid and unpaid, and especially those in contact with patients. We agree that people working at long-term care facilities should be included with other healthcare workers. We also support the sub-prioritization considerations for healthcare workers that were specified by Dr. Sara Oliver at the December 1 meeting.

We support prioritizing healthcare workers because they are at clear risk of infection and also have the knowledge to make an informed decision about whether to be vaccinated. Protecting them against infection also protects their patients. We emphasize that healthcare workers should have the choice of whether or not to get the vaccine; it should not be required for a vaccine that is authorized rather than approved by the FDA.

Although we agree that people living in long-term care facilities are clearly at the greatest risk of severe reactions to COVID-19, including death, we are concerned about the lack of data on those types of patients, or any patients over 65 years of age. According to the Reactogenicity chart presented by Dr. Oliver, data are available for only 10 community-dwelling patients in that age group in the Moderna study and only 12 patients in the Pfizer study. It is not clear whether these are the total number of individuals who were vaccinated in those age groups, or the total number in studies published so far. Either way, that is not enough information for older adults living in long-term care facilities to make an informed decision about whether or not to get the vaccine, or for family members or physicians to help make that decision. It is essential that more patients over 65, and preferably more frail elderly patients, be carefully studied in the randomized clinical trials prior to a massive vaccination distribution to tens of thousands of patients. Such data should not take more than a few months to add to existing studies.

Patients in these facilities should not be pressured to be vaccinated.  They should make an informed decision influenced by their personal preference and specific risk of infection.  We are especially concerned that the vaccine might be less effective for older patients and that the pain and fatigue that was reported in the reactogenicity data for younger and older patients could be especially debilitating to long-term care patients, many of whom would not be at high risk of exposure if the employees at their facility have been vaccinated.  

Joint Letter Opposing Efforts to Weaken FDA’s Authority over Tobacco Products

July 7, 2020

The Honorable Nita Lowey
Committee on Appropriations
United States House of Representatives
Washington, D.C. 20515

The Honorable Kay Granger
Ranking Member
Committee on Appropriations
United States House of Representatives
Washington, DC 20515

Dear Chairwoman Lowey and Ranking Member Granger:
As your committee proceeds to mark up the Fiscal Year 2021 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill, we urge you to oppose any efforts to weaken FDA’s authority over cigars or any other tobacco products.

Tobacco use is the leading cause of preventable death and disease in the United States. More than 480,000 Americans die from tobacco use each year, and more than 16 million Americans are currently living with a tobacco-caused disease. With the enactment of the Family Smoking Prevention and Tobacco Control Act in 2009, Congress recognized that all tobacco products should be overseen by an agency with expertise in assessing health risks and experience promulgating science-based regulation.

Over the years, manufacturers and sellers of tobacco products have sought to exclude certain products from FDA’s authority or weaken FDA oversight of them, including through the appropriations process. Fortunately, Congress has not restricted FDA’s statutory authority. All  tobacco products pose risks to health and should adhere to science-based public health protections. As our nation confronts the COVID-19 pandemic – a pandemic that impacts the lungs and has taken the lives of more than 100,000 Americans – surely now is not the time to weaken FDA oversight of tobacco products.

Manufacturers and sellers of certain types of cigars have argued that their products should not be overseen by FDA despite the agency’s determination that there is no appropriate public health justification for exempting them. While cigar smoking is often perceived as an activity of older adults, cigars are popular among youth, particularly high school boys. Cigars are marketed in a wide array of flavors and are often inexpensive, making them especially appealing to youth. Despite industry claims to the contrary, cigar use has serious negative health risks and can lead to lung and heart diseases and numerous types of cancer. FDA has determined that all cigars are potentially addictive and that cigar use leads to approximately 9,000 premature deaths each year.

We urge you to oppose any amendments to weaken FDA’s authority over cigars including an amendment that would add language that was adopted during the Energy and Commerce Committee’s consideration of H.R. 2339, the Reversing the Youth Tobacco Epidemic Act, that would have exempted certain cigars from having to undergo a public health review by FDA. Our organizations opposed this amendment when it was added to H.R. 2339 because it would restrict an important tool FDA now has to protect public health. Despite our opposition to this amendment, we continued to support the bill because other parts of the legislation – including a prohibition on all flavored tobacco products – would substantially reduce youth tobacco use and greatly benefit public health. That would not be the case if a similar amendment were adopted by this Committee.

In passing the Tobacco Control Act, Congress wisely recognized the addictive and deadly nature of tobacco products and the critical need for manufacturers to demonstrate that new products are “appropriate for the protection of public health.” Given their risks to health, no tobacco product should be exempt from FDA product review.

We thank you for not adopting any provisions during consideration of the FY 2020 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill that would weaken FDA oversight of tobacco products, and we urge you to once again oppose any efforts to exempt cigars or any other tobacco products from FDA oversight during consideration of the FY 2021 bill.


Action on Smoking & Health
African American Tobacco Control Leadership Council
Allergy & Asthma Network
American Academy of Nursing
American Academy of Oral and Maxillofacial Pathology
American Academy of Oral and Maxillofacial Radiology
American Academy of Otolaryngology- Head and Neck Surgery
American Academy of Pediatrics
American Association for Cancer Research
American Association for Dental Research
American Association for Respiratory Care
American Cancer Society Cancer Action Network
American College of Cardiology
American College of Chest Physicians (CHEST)
American College of Physicians
American College of Preventive Medicine
American Heart Association
American Lung Association
American Psychological Association
American Public Health Association
American Society of Addiction Medicine
American Thoracic Society
Americans for Nonsmokers’ Rights
Asian Pacific Partners for Empowerment, Advocacy and Leadership (APPEAL)
Association for Clinical Oncology
Association of Black Cardiologists
Association of Schools and Programs of Public Health
Association of State and Territorial Health Officials (ASTHO)
Campaign for Tobacco-Free Kids
Cancer Prevention and Treatment Fund
Catholic Health Association of the United States
ClearWay Minnesota
Community Anti-Drug Coalitions is America (CADCA)
COPD Foundation
Eta Sigma Gamma – National Health Education Honorary
LUNGevity Foundation
National African American Tobacco Prevention Network
National Association of County and City Health Officials (NACCHO)
National Association of Pediatric Nurse Practitioners
National Association of School Nurses
National Association of Social Workers
National Black Nurses Association
National Education Association
National Network of Public Health Institutes
Oncology Nursing Society
Parents Against Vaping E-Cigarettes (PAVe)
Society for Cardiovascular Angiography and Interventions
Students Against Destructive Decisions (SADD)
The Society of State Leaders of Health and Physical Education
The Society of Thoracic Surgeons
CC: United States House of Representatives Committee on Appropriations Members

NCHR Comments on Public Access to Federally Funded Research

National Center for Health Research, May 6, 2020

National Center for Health Research Public Comments on
OSTP’s Request for Information: Public Access to Peer-Reviewed Scholarly
Publications, Data and Code Resulting From Federally Funded Research

The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work.

Our research center has long advocated for making federally funded research publicly available. As a think tank focused on research and data related to human health, we have supported data sharing and other efforts to make research results more freely available, particularly for research that was funded by federal agencies or submitted to federal agencies as part of application materials to the FDA and other federal agencies. Research data and results that are partially or fully funded by or conducted by the federal government should be freely available to the public.

In this comment, we will focus on two issues: 1) Access to peer-reviewed scholarly publications and 2) Access to data for analysis.

Despite efforts to make articles in scholarly publications freely available to the public, most are not. All journal articles based on research funded by the federal government should be freely available to the public, and that should not require the authors to pay thousands of dollars for each article to be available through open access. We understand the financial needs of scholarly publications, but U.S. taxpayers should not be required to pay to read an article based on research that they also paid for. Since journals depend on high quality data to succeed, the government should require that journals have an open access policy for federally funded research results; authors either should not be required to pay anything, or should be offered a greatly discounted rate that the federal government requires the researcher to pay using the research funding that supported the work.

Unfortunately, has not fulfilled its goal of making research results publicly available in a transparent and timely fashion. Despite Congressional pressure, too often study results are not reported on the website or are greatly delayed, and neither FDA nor NIH has enforced the requirements or penalized those who failed to comply. In addition, results reported on are often subjective summaries rather than objective charts and graphs that present the aggregate data. The information most often provided is insufficient for other researchers or medical providers to scrutinize.

In addition, research conducted partially or entirely with federal funds is not always published in a timely manner, or at all. In some cases, the authors have submitted manuscripts that have been rejected by journals; in some cases, there are competing pressures that make it difficult for the researchers to finish writing and submitting manuscripts, and in other cases, the only journals willing to publish a specific article charge thousands of dollars for publication that the authors can’t afford. We strongly urge that PIs of federally funded studies be required to make the raw data available to other U.S. researchers if it hasn’t been published within 3 years of completion of the initial study. Such data sharing between researchers is essential for ensuring that federal agencies have not wasted taxpayers’ money on research that never becomes available to potentially benefit the public.

Even when federally funded research results are published, the results may be biased or inaccurate. Sharing of raw data after publication is an invaluable tool for confirming the accuracy of reported research findings and enabling other researchers to replicate results and understand any conflicting findings.

U.S. taxpayers deserve to have the government maximize the usefulness of the funds they’ve invested in research by making that research publically available. Efforts to improve public access to federally funded research will benefit the scientific community, the medical community, public health, and the public.

National Center for Health Research can be reached at or at (202) 223-4000.

NCHR’s Public Comments on FDA’s Proposed Inclusion of Older Adults in Cancer Clinical Trials

May 4, 2020

National Center for Health Research’s Public Comments on FDA’s Proposed Inclusion of Older Adults in Cancer Clinical Trials Guidance for Industry


We are writing to express our views on the FDA Draft Guidance on Older Adults in Cancer Clinical Trials. The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work.

We have long urged the FDA to require older adults in clinical trials of drugs for the treatment of cancer and other diseases that are likely to be used by people over 65. When our Center’s president served on CMS’ Medicare Evidence Development & Coverage Advisory Committee (MEDCAC), she pointed out at every meeting that there were few if any patients over 65 who had been tested in clinical trials for the drugs and devices that were seeking to be covered by Medicare. As a result, it was impossible for the MEDCAC members to determine if the likely benefits outweighed the risks of any of those products, including cancer diagnostic tests and treatments.

We strongly support FDA’s efforts to improve the diversity of clinical trials and analyses of demographic subgroups, but have been disappointed that these efforts have not been enforced in a meaningful way. Subgroup analyses of safety and efficacy are essential for new drugs and devices so that patients and clinicians can make informed treatment decisions. New medical products should only be approved for populations for which there has been sufficient testing to determine that the benefits outweigh the risks. This is of particular importance for older adults in cancer trials. Moreover, if the FDA refused to approve cancer drugs for patients over 65 or over 70 when those age groups were not adequately studied, it would provide a substantial incentive for sponsors to be more vigilant about recruiting and studying patients in older age groups.

As stated in the guidance, it is not sufficient to only study the safety and efficacy of treatments among younger adults and assume that the results would be the same for older adults as well. We also strongly support the recommendation to evaluate smaller, discrete age groups (such as ages 65-74 and 75 and up), as well as the recommendation to collect additional safety measures for older adults, such as cognitive functioning. However, there are additional aspects of subgroup analysis that must be taken into consideration.

Subgroup analysis must determine the unique benefit to risk ratio for each subgroup, rather than determine whether the benefits of a treatment differ between younger and older patients. Older adults are more likely to have comorbidities that can affect how drugs are absorbed, metabolized, or eliminated, which may impact the safety and efficacy of a particular treatment. Therefore, there must be an assessment of the unique risks and benefits for older adults. It is not important to know that a medical product is more or less safe or effective for older patients compared to younger patients; what matters to older patients is whether the benefits outweigh the risks for patients in their age group.

In addition, it is not necessary that the proportion of older patients studied is consistent with the proportion of older patients with the particular type of cancer. What matters is that there be sufficient numbers of older adults so that subgroup analyses can be conducted to assess the benefits and risks of treatment for patients in several older age groups. Subgroup analyses are not meaningful if the numbers of older patients in the trials are small.

Since older adults are likely to be more frail and to have other serious comorbidities, it is imperative to determine the adverse effects and the efficacy of new drugs for older adults prior to FDA approval. All too frequently, post-market research, even if required, is delayed, follow-up is inadequate, or for other reasons the results are not as informative as had been expected.

The National Center for Health Research can be reached at or at (202) 223-4000.


NCHR Comments on CPSC Priorities for FY2021/2022

National Center for Health Research, April 2020

Diana Zuckerman, Ph.D., President of the National Center for Health Research

Comments on the U.S. Consumer Product Safety Commission
Agenda and Priorities for FY2021/2022

April 2020

The National Center for Health Research is a nonprofit research center staffed by scientists, medical professionals, and public health experts who analyze and review research on a range of health issues. Thank you for the opportunity to share our views concerning the Consumer Product Safety Commission’s (CPSC) priorities for fiscal years 2021 and 2022. We greatly respect the essential role of the CPSC, as well as the challenges you face in selecting the most important priorities.

We want to start by emphasizing two issues involving chemicals in products that affect our and our children’s health, (1) artificial turf and playground surfaces and equipment, and (2) organohalogen flame retardants. We will also briefly discuss sport and recreational helmets, sleep-related products for infants, furniture stability, home elevators, and liquid nicotine packaging. All these issues should be CPSC priorities.

Artificial Turf and Playgrounds: Risky Chemicals and Lead

We expressed our concerns about artificial turf and playgrounds last year. Our concerns are even greater this year because of increasing evidence of lead exposure from these products, as well as from playground equipment.

Requiring testing for artificial turf, playground surfaces, and the paint used for playground equipment needs to be a priority, because children are exposed to these synthetic rubber and plastic fields and playground surfaces as well as playground equipment – and the lead and harmful chemicals they contain – day after day, year after year.

A new issue that arose in the last year is research indicating that the paint used on outdoor playground equipment contains lead. Professor Alexander Wooten from Morgan State conducted studies in Maryland that indicate that paint with lead is widely used on playground equipment, such as climbing structures, in some cases at very dangerous levels.1 We have learned that there are no federal restrictions on lead used in outdoor paint, even for products used exclusively by young children. CPSC should investigate this issue immediately.

The rubber and plastic that make up turf and playground surfaces contain chemicals with known health risks, which are released into the air and get onto skin and clothing. Crumb rubber – whether from recycled tires or “virgin rubber”– includes 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).2,3,4,5,6 Other plastic or rubber surfaces used in playgrounds also contain many of these chemicals.7 Moreover, the plastic grass in artificial turf also has dangerous levels of lead, PFAS, and other toxic chemicals as well. PFAS are of particular concern because they are “forever chemicals” that get into the human body and are not metabolized, accumulating over the years. Replacing tire waste with silica, zeolite, and other materials also has substantial risks.

Tire crumb is widely used as infill for artificial turf fields and also used for colorful rubber playground surfaces. In addition to the chemicals noted above, these playground surfaces contain lead and create lead dust on the surface that is invisible to the eye but that children are breathing in when they play.8

The CPSC is well aware that no level of lead exposure is safe for children, because lead can cause cognitive damage even at low levels. Some children are even more vulnerable than others, and this vulnerability can be difficult or even impossible to predict. Since lead has been found in tire crumb as well as new synthetic rubber, it is not surprising that numerous artificial turf fields and playgrounds made with either tire crumb or “virgin” rubber have been found to contain lead. However, the Centers for Disease Control and Prevention (CDC) also warns that the “plastic grass” made with nylon or other materials also contain lead. Whether from infill or from plastic grass, the lead doesn’t just stay on the surface – it can get into clothes, on the skin, or into the air that children breathe.

While one-time or sporadic exposures are unlikely to cause long-term harm, children’s repeated exposures, especially during critical developmental periods, raise the likelihood of serious harm. There are few activities that children engage in for as many hours in their early years as those on playgrounds and playing fields.

We appreciate the CPSC’s ongoing efforts to investigate the safety of crumb rubber on playgrounds and playing fields. As your study using focus groups to examine children’s use of playgrounds and exposure to playground surfaces has shown, children who use playgrounds with artificial surfaces could be exposed to the chemicals in these surfaces.9 It is unfortunate that the EPA report on artificial turf (which did not include playground surfaces or playground materials) did not provide the scientific evidence needed to support their assumptions that the likely levels of exposure to dangerous chemicals was low enough that it was not likely to harm children. The EPA did not study the actual impact of the exposure to endocrine disrupting chemicals on children and did not study lead exposure from synthetic playground surfaces, leaded paint used on playground equipment, or artificial turf.10

Meanwhile, we have repeatedly heard the companies that make these products and those that install them make erroneous claims at the state and local government levels, falsely stating that CPSC and other federal agencies have concluded that these materials are proven safe. As we all know, that is not correct.

We encourage you to closely evaluate the research that has been done, focusing on independently funded research of short-term and long-term safety issues. We need information that can protect our children from harm. In addition, we strongly 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, including surfaces and lead paint used on climbing equipment and other materials.

In addition to the risks of lead and the long-term risks of cancer and other health problems caused by hormone disruption, these fields can cause short-term harms. Artificial turf generates dust which may exacerbate children’s asthma.11,12 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.13,14 We have measured the temperatures ourselves and been shocked by the results. These temperatures 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 terribly harmed by turf burn, and studies have indicated increased risk for some types of injuries, including joint, foot, and brain injuries.15,16,17 That is the reason that only two Major League Baseball parks use artificial turf and why the men’s soccer World Cup is now always played on grass.  In response to the demands of women soccer players, the Women’s World Cup will require grass in 2023.

Organohalogen Flame Retardants

The National Academies of Sciences, Engineering, and Medicine issued their scoping plan to assess the hazards of organohalogen flame retardants (OFRs) last year.18 The report concluded that OFRs can be divided into subclasses on the basis of chemical structure, physicochemical properties, and predicted biologic activity. As noted in their summary of the report:

The committee identified 14 subclasses that can be used to conduct a class-based hazard assessment and concluded that the best approach is to define subclasses as broadly as is feasible for the analysis; defining subclasses too narrowly could defeat the purpose of a class approach to hazard assessment.

We encourage you to convene a CHAP to use this scoping plan to evaluate OFRs and to 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 chemical exposures as well as exposures during a fire.

OFRs are not bound to products to which they are added, so they migrate out of products and into dust. This allows them to get onto our skin and food and into the air. Because of their widespread use and the long-lasting nature of OFRs, consumers are continuously exposed to OFRs19 and many bioaccumulate in our food supply.20,21 As a result, OFRs are present in nearly all people in the U.S.22,23 For these reasons, CPSC should focus on the potential for hormone disruption, altered brain development, reduced ability to get and stay pregnant, and the timing of puberty.24,25 While not all OFRs have been adequately studied to determine whether all are unsafe, those that have been sufficiently studied have proved to be harmful to health.

We share the Commission’s concerns about fire hazards as well, but there is evidence that these flame retardants may not be effective at preventing deaths in real world situations.26,27 When the chemicals burn during a fire, the inhaled smoke is more toxic to humans, and exposures could result in serious harms, including death.

Helmets for Sport and Recreational Activities

There are up to 3.8 million concussions reported each year related to sport or recreational activities, with most reported for children and adolescents.28 This number is likely an underestimate.29 We urge the CPSC to focus greater attention on the need to ensure the effectiveness of helmets intended to protect against brain injuries during athletic activities. Currently, CPSC only provides guidelines for bicycle helmets, even though many organized sports and recreational activities use helmets to reduce the risk for severe head injuries, including baseball, football, snow sports, skiing/snowboarding, and climbing. Unfortunately, these helmets are not necessarily designed to prevent mild concussions.30 We encourage CPSC to consider how design changes could improve the ability of helmets to prevent severe head injuries as well as mild concussions, and to develop guidelines for helmets that reduce these risks without interfering with vision or hearing or other safety concerns.

Baby Products and Products Posing Risks to Young Children

The CPSC is the major safeguard to protect infants and young children from unsafe products that are widely sold and inadequately studied. Crib bumpers and infant sleepers are two examples that have received CPSC attention but CPSC has not adequately protected families from the tragedies of infant deaths caused by these products.

There is nothing more tragic than when an infant or young child dies due to a product in the home that families or loved ones purchased because they erroneously assumed they were tested and found to be safe. The standard for these products should not be based on the number of deaths per year, but rather the 1) risk to benefit ratio of the product and 2) whether regulations or restrictions would make the product safer. In the case of crib bumpers, they have no benefit. In the case of inclined infant sleepers, products were sold that were promoted as superior to other available products but in fact had no comparative benefits and were less safe.

Furniture that tips over and home elevators are two other examples of products that have resulted in deaths of young children. In both cases, CPSC should do more to prevent the sale of products that can be redesigned or modified to make them safe.

Liquid Nicotine Packaging

We agree with other public health and consumer organizations that have urged CPSC to immediately remove from the market dangerous liquid nicotine products lacking the child-resistant packaging and flow restrictors required under the Child Nicotine Poisoning Prevention Act of 2015. The law requires the CPSC to enforce a mandatory child-resistant packaging standard for liquid nicotine containers, including the use of flow restrictors.

Liquid nicotine is a highly toxic product that can seriously harm or kill children. Since liquid nicotine can be quickly absorbed through the skin, flow restrictors are an essential safeguard to reduce the risk of nicotine poisoning in children.

Effective CPSC enforcement measures to remove noncompliant products from the market are long overdue, and that enforcement should be an immediate priority.

Final Thoughts

CPSC is the only federal agency whose mission is to protect children and adults from harmful products used in their daily life. Flame retardants and lead and many different chemicals in artificial turf and playground surfaces and equipment get into the air and dust and thus into our bodies. These chemicals tend to have greater risks for fetuses and children. There are large gaps in our knowledge about the chemicals in the products on the market, because the companies do not provide that information to the public. Ideally, the potential health impact of all of these chemicals would be evaluated in the final product before it was sold. If that doesn’t happen, CPSC must do more to identify the health risks as soon as possible after children and adults have been exposed.

Too often, the lack of independently funded and publicly available research has been used to mislead the public. Claims that “there is no evidence of harm” are misunderstood to mean “there is no harm.”

While reducing exposures to dangerous products is key, there will always be some potential for harm. Whether those harms are from the intended use of a consumer product or an unintended but foreseeable use, CPSC has a very important role to play in reducing harm. Improving the timeliness and targeting of information campaigns to warn parents and children about harmful products is also a key task of the CPSC.


  1. Wooten, Alexander, Lead and Playgrounds, Presentation at the Takoma community forum in Washington, DC, July 29, 2019.
  2. California Office of Environmental Health Hazard Assessment (OEHHA). Evaluation of Health Effects of Recycled Waste Wires in Playground and Track Products. Prepared for the California Integrated Waste Management Board. 2007.
  3. Llompart M, Sanchez-Prado L, Lamas JP, et al. Hazardous organic chemicals in rubber recycled tire playgrounds and pavers. Chemosphere. 2013;90(2):423-431.
  4. Marsili L, Coppola D, Bianchi N, et al. 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. 2014;5(2):1133-1149.
  5. Benoit G, Demars S. Evaluation of organic and inorganic compounds extractable by multiple methods from commercially available crumb rubber mulch. Water, Air, & Soil Pollution. 2018;229:64.
  6. Perkins AN, Inayat-Hussain SH, Deziel NC, et al. Evaluation of potential carcinogenicity of organic chemicals in synthetic turf crumb rubber. Environmental Research. 2018;169:163–172.
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  8. Baca, N. Parents demand answers on playground lead in DC. October 2, 2019.
  9. Consumer Product Safety Commission. Summary of Playground Surfacing Focus Groups. 2018.
  10. National Center for Health Research. Children and Athletes at Play on Toxic Turf and Playgrounds.
  11. Shalat, SL. 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. 2011.
  12. Mount Sinai Children’s Environmental Health Center. Artificial Turf: A Health-Based Consumer Guide. 2017.
  13. Serensits TJ, McNitt AS, Petrunak DM. Human health issues on synthetic turf in the USA. Proceedings of the Institution of Mechanical Engineers, Part P: Journal of Sports Engineering and Technology. 2011;225(3):139-146.
  14. Penn State’s Center for Sports Surface Research. Synthetic Turf Heat Evaluation- Progress Report. 2012.
  15. Theobald P, Whitelegg L, Nokes LD, et al. 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. 2010;9(1):29-37.
  16. Balazs GC, Pavey GJ, Brelin AM, et al. Risk of anterior cruciate ligament injury in athletes on synthetic playing surfaces: A systematic review. American Journal of Sports Medicine. 2015;43(7):1798-804.
  17. Mack CD, Hershman EB, Anderson RB, et al. Higher rates of lower extremity injury on synthetic turf compared with natural turf among national football league athletes: Epidemiologic confirmation of a biomechanical hypothesis. American Journal of Sports Medicine. 2019;47(1):189-196.
  18. National Academies of Sciences, Engineering, and Medicine; Division on Earth and Life Studies; Board on Environmental Studies and Toxicology; Committee to Develop a Scoping Plan to Assess the Hazards of Organohalogen Flame Retardants. A Class Approach to Hazard Assessment of Organohalogen Flame Retardants. Washington (DC): National Academies Press (US). 2019.
  19. Allgood JM, Vahid KS, Jeeva K, et al. Spatiotemporal analysis of human exposure to halogenated flame retardant chemicals. Science of the Total Environment. 2017;609:272-276.
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  22. Centers for Disease Control and Prevention. Fourth National Report on Human Exposure to Environmental Chemicals, Updated Tables. 2019.
  23. Ospina M, Jayatilaka N, Wong LY, et al. Exposure to organophosphate flame retardant chemicals in the U.S. general population: Data from the 2013-2014 National Health and Nutrition Examination Survey. Environment International. 2017;110:32–41.
  24. Dishaw L, Macaulay L, Roberts SC, et al. Exposures, mechanisms, and impacts of endocrine-active flame retardants. Current Opinion in Pharmacology. 2014;19:125-133.
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  29. Baldwin GT, Breiding MJ, Dawn Comstock R. Epidemiology of sports concussion in the United States. Handbook of Clinical Neurology. 2018;158:163-74.
  30. Consumer Product Safety Commission. Which helmet for which activity?
  31. Perry, C. Why Inclined Baby Sleepers Are So Dangerous. November 8, 2019.

CPTF Statement Supporting Maryland House Bill to Ban State Funds for Artificial Turf and Playgrounds

Diana Zuckerman, PhD, National Center for Health Research, March 5, 2020

CPTF Statement Supporting Maryland House Bill 1098
To Ban State Funds for Artificial Turf and Playgrounds
March 5, 2020

Diana Zuckerman, PhD, President

Thank you for the opportunity to express our strong support for of HB 1098, to restrict the funding of additional artificial turf fields and playground surfaces in Maryland.

As a long-time resident of Montgomery County and president of the National Center for Health Research (NCHR), I am hoping that this bill will finally get the support it deserves.  NCHR is a non-profit public health organization which analyzes and explains scientific and medical information that can be used to improve policies, programs, services, and products.

Our organization has been testifying and writing about the dangers of synthetic turf and playground surfaces for several years, and we’ve testified before state, local and federal legislative bodies and regulatory agencies.  Our scientific staff has reviewed all publicly available scientific studies pertaining to the health impact of the lead and toxic chemicals that are in artificial turf and playground surfaces, compared to natural surfaces such as grass and engineered wood fiber.

In the last year, scientists have reported finding potentially dangerous levels of lead in artificial turf fields and playground surfaces.  In addition, plastic and synthetic rubber are made with different types of hormone-disrupting chemicals, some of which are known to be particularly harmful to growing children.  Scientists at the National Institute of Environmental Health Sciences, which is an institute of NIH, have concluded that these chemicals can be threats to health even at low levels.  According to research at Yale University, 20% of the 96 chemicals they found in samples at five different synthetic turf companies were classified as probable carcinogens.[1]

Manufacturers and advocates for synthetic turf often state that artificial turf has been declared safe by federal authorities.  That is completely untrue.  It is essential to understand that there are no federal requirements for safety testing of these synthetic turf products before they are sold.   Although the EPA and the federal Consumer Product Safety Commission are jointly studying the chemicals used in these products, they have not released any data on studies of children exposed to these fields and playgrounds day after day and week after week.

We commend you for considering how to reverse the dangerous trend of replacing natural fields and playground surfaces with materials that are dangerous to our children’s health, potentially dangerous to adult fertility and health, and bad for our environment.  In the last year, we’ve learned new information about lead and PFAS in artificial turf, as well as the risks of some of the newer infill materials that turf companies are using to replace tire crumb.

Tire crumb, used as infill for artificial turf fields and also used for colorful rubber playground surfaces, has well-known risks, containing lead as well as chemicals that have the potential to increase obesity; contribute to early puberty; cause attention problems such as ADHD; exacerbate asthma; and eventually cause cancer.  However, the plastic grass itself has dangerous levels of lead, PFAS, and other toxic chemicals as well.  PFAS are of particular concern because they are “forever chemicals” that get into the human body and are not metabolized, accumulating over the years. Replacing tire waste with silica, zeolite, and other materials also has substantial risks.

Federal agencies such as the EPA and the U.S. Consumer Product Safety Commission have been investigating the safety of these products.  Despite claims to the contrary, none have demonstrated that artificial turf is safe.  Although the Trump Administration’s EPA stated that there was no conclusive evidence that the levels of chemicals in artificial turf was harmful to children, they made it clear that their research was based on assumptions rather than scientific research on children.


The American Academy of Pediatrics states that no level of lead exposure is safe for children, because lead can cause cognitive damage even at low levels.  Some children are even more vulnerable than others, and that can be difficult or even impossible to predict.  Since lead has been found in tire crumb as well as new synthetic rubber, it is not surprising that numerous artificial turf fields and playgrounds made with either tire crumb or “virgin” rubber have been found to contain lead.  However, the Centers for Disease Control and Prevention (CDC) also warns that the “plastic grass” made with nylon or some other materials also contain lead.  Whether from infill or from plastic grass, the lead doesn’t just stay on the surface.  With wear, the turf materials turn to dust that is invisible to the eye but that children are breathing in when they play.

Why are chemicals that are banned from children’s toys allowed in artificial turf and rubber playground surfaces?

Synthetic rubber and plastic are made with different types of endocrine (hormone) disrupting chemicals (also called EDCs) and other toxins.  There is very good evidence regarding these chemicals in tire crumb, based on studies done at Yale and by the California Office of Environmental Health Hazard Assessment (OEHHA).

The California OEHHA conducted three laboratory studies to investigate the potential health risks to children from playground surfaces made from tire waste.1 The researchers created a 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.  One study 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.  Results of the OEHHA studies showed that 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.

A 2018 report by Yale scientists detected 92 chemicals in samples from 6 different artificial turf companies, including unused bags of tire crumb. Unfortunately, the health risks of most of these chemicals had never been studied.  However, 20% of the chemicals that had been tested are classified as probable carcinogens and 40% are irritants that can cause asthma or other breathing problems, or can irritate skin or eyes.[2]

There are numerous studies indicating that endocrine-disrupting chemicals found in rubber and plastic cause serious health problems. Scientists at the National Institute of Environmental Health Sciences (which is part of NIH) have concluded that unlike most other chemicals, hormone-disrupting chemicals can be dangerous at very low levels, and the exposures can also be dangerous when they combine with other exposures in our environment.

That is why the Consumer Product Safety Commission has banned numerous endocrine-disrupting chemicals from toys and products used by children. The products involved, such as pacifiers and teething toys, are banned even though they would result in very short-term exposures compared to artificial turf or playground surfaces.

A report warning about possible harm to people who are exposed to rubber and other hormone disrupting chemicals at work explains that these chemicals “can mimic or block hormones and disrupt the body’s normal function, resulting in the potential for numerous health effects… Similar to hormones, EDC can function at very low doses in a tissue-specific manner and may exert non-traditional dose–response because of the complicated dynamics of hormone receptor occupancy and saturation.”[3]

Studies are beginning to demonstrate the contribution of skin exposure to the development of respiratory sensitization and altered pulmonary function. Not only does skin exposure have the potential to contribute to total body burden of a chemical, but also the skin is a highly biologically active organ capable of chemical metabolism and the initiation of a cascade of immunological events, potentially leading to adverse outcomes in other organ systems.

Scientific Evidence of Cancer and Other Serious Harm

It is essential to distinguish between evidence of harm and evidence of safety. Like the Trump Administration’s EPA, companies that sell and install artificial turf often claim there is “no evidence children are harmed” or “no evidence that the fields cause cancer.” This is often misunderstood as meaning the products are safe or are proven to not cause harm. Neither is true.

It is true that there no clear evidence that an artificial turf field has caused specific children to develop cancer. However, the statement is misleading because it is virtually impossible to prove any chemical exposure causes one specific individual to develop cancer.

As an epidemiologist, I can also tell you that for decades there was no evidence that smoking or Agent Orange caused cancer.  It took many years to develop that evidence, and the same will be true for artificial turf.

I have testified about the risks of these materials at the U.S. Consumer Product Safety Commission, as well as previous Maryland hearings.  I am sorry to say that I have repeatedly seen and heard scientists paid by the turf industry and other turf industry lobbyists say things that are absolutely false.  They claim that these products are proven safe (not true) and that federal agencies have stated there are no health risks (also not true).

However, we know that the materials being used in artificial turf and rubber playground surfaces contain carcinogens, and when children are exposed to those carcinogens day after day, week after week, and year after year, they increase the chances of our children developing cancer, either in the next few years or later as adults.  That should be adequate reason not to install them in your community.  That’s why I have spoken out about the risks of artificial turf in my community and on a national level.  The question must be asked: if they had all the facts, would Maryland families choose to spend millions of taxpayer dollars on fields that are unhealthy and unsafe rather than well-designed natural grass fields?

Dangerously Hot and Hard Fields

Summers in Maryland can get hot.  Even when the temperature is a pleasant 80 degrees Fahrenheit, artificial turf and playground surfaces can reach 150 degrees or higher.  Obviously, turf and playground surfaces are likely to be even hotter than 150 degrees on a sunny 90 degree day.  That can cause “heat poisoning” as well as burns.

Artificial turf fields get hard as well.  Turf companies recommend annual tests at 10 locations on each turf field, using something called a Gmax scores.  A Gmax score over 200 is considered extremely dangerous and is considered by industry to pose a death risk.  However, the synthetic turf industry and ASTM (American Society for Testing and Materials), suggest scores should be even lower — below 165 to ensure safety comparable to a grass field.  Are Maryland communities paying to have these tests conducted on all public artificial turf fields?

The hardness of natural grass fields is substantially influenced by maintenance, rain and other weather; if the field gets hard, aeration water will make it safe again.  In contrast, once an artificial turf field has a Gmax score above 165, it needs to be replaced because while the scores can vary somewhat due to weather, the scores will inevitably get higher because the turf will get harder.  Gmax testing involves testing 10 different areas of a playing fields, to make sure all are considered safe.  Some officials average those 10 scores to determine safety; however, experts explain that is not appropriate.  If a child (or adult) falls, it can be at the hardest part of the field, which is why safety is determined based on each area tested.

Environmental Issues

In addition to the health risks to school children and athletes, approximately three tons of infill materials migrate off of each synthetic turf field into the greater environment each year.  About 2-5 metric tons of infill must be replaced every year for each field, meaning that tons of the infill have migrated off the field into grass, water, and our homes.  The fields also continuously shed microplastics as the plastic blades break down.[4,5] These materials may contain additives such as PAHs, flame retardants, UV inhibitors, etc., which can be toxic to marine and aquatic life; and microplastics are known to migrate into the oceans, food chain, and drinking water and can absorb and concentrate other toxins from the environment.[6,7,8]

Synthetic surfaces also create heat islands.[9,10]  In contrast, organically managed natural grass saves energy by dissipating heat, cooling the air, and reducing energy to cool nearby buildings.  Natural grass and soil protect groundwater quality, biodegrade polluting chemicals and bacteria, reduce surface water runoff, and abate noise and reduce glare.[11]

Envirofill and Alternative Infills

Envirofill artificial turf fields are advertised as “cooler” and “safer,” but our research indicates that these fields are still at least 30-50 degrees hotter than natural grass. Envirofill is composed of materials resembling plastic polymer pellets (similar in appearance to tic tacs) with silica inside. Silica is classified as a hazardous material according to OSHA regulations, and the American Academy of Pediatrics specifically recommends avoiding it on playgrounds. The manufacturers and vendors of these products claim that the silica stays inside the plastic coating.  However, sunlight and the grinding force from playing on the field breaks down the plastic coating. For that reason, even the product warranty admits that only 70% of the silica will remain encapsulated. The other 30% can be very harmful as children are exposed to it in the air.

In addition, the Envirofill pellets have been coated with an antibacterial called triclosan.  Triclosan is registered as a pesticide with the EPA and the FDA has banned triclosan from soaps because manufacturers were not able to prove that it is safe for long-term use.  Research shows a link to liver and inhalation toxicity and hormone disruption.  The manufacturer of Envirofill says that the company no longer uses triclosan, but they provide no scientific evidence that the antibacterial they are now using is any safer than triclosan.  Microscopic particles of this synthetic turf infill will be inhaled by children, and visible and invisible particles come off of the field, ending up in shoes, socks, pockets, and hair.

In response to the concerns of educated parents and government officials, other new materials are now being used instead of tire crumb and other very controversial materials.  However, all the materials being used (such as volcanic ash, corn husks, and Corkonut) have raised concerns and none are proven to be as safe or effective as well-designed grass fields.


There have never been any safety tests required prior to sale that prove that any artificial turf products are safe for children who play on them regularly.  In many cases, the materials used are not publicly disclosed, making independent research difficult to conduct.  None of these products are proven to be as safe as natural grass in well-constructed fields.

I have cited several relevant scientific articles on artificial turf in this letter, and there are numerous studies and growing evidence of the harm caused by these synthetic materials.  I would be happy to provide additional information upon request (

I am not paid to write this statement.  I am one of the many parents and scientists who are very concerned about the impact of artificial fields on our children.  Your decisions about artificial turf and playground materials will directly and indirectly help educate parents throughout the state, making it even more important that your decision is based on scientific evidence, not on sales pitches by individuals with conflicts of interest.

Officials in communities all over the country have been misled by artificial turf salespeople. They were erroneously told that these products are safe.  But on the contrary, there is clear scientific evidence that these materials are harmful.  The only question is how much exposure is likely to be harmful to which children?  We should not be willing to take such a risk.  Our children deserve better.

Please pass HB 1098 and thank you for addressing this critical public health issue.



  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.
  2. Benoit G, Demars S. Evaluation of organic and inorganic compounds extractable by multiple methods from commercially available crumb rubber mulch. Water, Air, & Soil Pollution. 2018;229:64.
  3. Anderson SE and Meade BJ. Potential Health Effects Associated with Dermal Exposure to Occupational Chemicals. Environmental Health Insights. 2014; 8(Suppl 1):51–62.
  4. Magnusson K, Eliasson K, Fråne A, et al. Swedish sources and pathways for microplastics to the marine environment, a review of existing data. Stockholm: IVL- Swedish Environmental Research Institute. 2016.
  5. Kole PJ, Löhr AJ, Van Belleghem FGAJ, Ragas AMJ. Wear and tear of tyres: A stealthy source of microplastics in the environment. International Journal of Environmental Research Public Health. 2017;14(10):pii: E1265.
  6. Kosuth M, Mason SA, Wattenberg EV. Anthropogenic contamination of tap water, beer, and sea salt. PLoS One. 2018,13(4): e0194970.
  7. Oehlmann J, Schulte-Oehlmann U, Kloas W et al.  A critical analysis of the biological impacts of plasticizers on wildlife. Philosophical Transactions of the Royal Society B. 2009;364:2047–2062.
  8. Thompson RC, Moore CJ, vom Saal FS, Swan SH. Plastics, the environment and human health: Current consensus and future trends. Philosophical Transactions of the Royal Society B. 2009;364:2153–2166.
  9. Thoms AW, Brosnana JT, Zidekb JM, Sorochana JC. Models for predicting surface temperatures on synthetic turf playing surfaces. Procedia Engineering. 2014;72:895-900.
  10. Penn State’s Center for Sports Surface Research. Synthetic turf heat evaluation- progress report. 012.
  11. Stier JC, Steinke K, Ervin EH, Higginson FR, McMaugh PE. Turfgrass benefits and issues. Turfgrass: Biology, Use, and Management, Agronomy Monograph 56. American Society of Agronomy, Crop Science Society of America, Soil Science Society of America. 2013;105–145.

NCHR’s Testimony to FDA on TOOKAD to Treat Low-Risk Prostate Cancer

Diana Zuckerman, National Center for Health Research, February 26, 2020

Thank you for the opportunity to speak today.  I am Dr. Diana Zuckerman, president of the National Center for Health Research. Our center analyzes scientific and medical data to provide objective health information to patients, health professionals, and policy makers. We do not accept funding from drug or medical device companies, so I have no conflicts of interest.

Although active surveillance is recommended for many patients with low-risk prostate cancer, some patients prefer treatment and that can be a reasonable choice as long as the treatment has a meaningful benefit and does not increase patients’ harms. However, the clinical data for TOOKAD that we are discussing today do not clearly demonstrate that its benefits outweigh its risks – efficacy is uncertain, particularly for U.S. patients, and the drug has the well-known very negative side effects typical of prostate cancer treatments.  

There are 5 major problems with the data, and the FDA did an excellent job of expressing their concerns:

#1.  There was only 1 clinical trial. Replication is the key to science, and effective treatments are available for prostate cancer, so the FDA should not approve a new treatment based on just one study.

#2.  This one trial took place in Europe, and 99.8% of participants were white.  Five patients – not 5% but only 5 men — were not white. Given the higher percentage of African American men who die of prostate cancer, this lack of diversity should not be considered acceptable, unless the FDA is considering approving this product for white men only.

#3. The accuracy of detecting cancer is one major problem. The data showed a high false negative rate. 13.5% of those in the active surveillance arm had a negative biopsy after 2 years. Since it is unlikely that the cancer would spontaneously disappear, this probably reflects false positives in the original diagnosis or false negatives in the post-test. This high false negative rate raises major concerns about the accuracy of biopsies in the treatment arm and at baseline. 

#4. Further, there was a large amount of missing data regarding biopsies at 24 months. Unfortunately, 18.4% of the patients in the treatment arm and 41.5% of those in the active surveillance arm were missing these crucial pieces of information regarding efficacy.  That makes it impossible to draw conclusions based on this one study. 

 #5. The trial was open-label, meaning patients as well as those collecting the data knew whether a particular patient was receiving the treatment or active surveillance. The decision to pursue definitive therapy  — such as surgery — was a subjective decision. Wouldn’t active surveillance patients be more likely to choose treatments later. Also, when biopsy results were uncertain, pathologists may have been biased by their knowledge of whether or not a patient was assigned to the treatment group. 

The FDA held a workshop in September 2018 to discuss issues related to clinical trials of novel treatments for localized prostate cancer.  They concluded that treatment endpoints might be clinically meaningful only if 1) the patients using the new therapy were less likely to undergo subsequent treatment (such as surgery), 2) there was an overall reduction in adverse events, and 3) there was no reduction in long-term cancer control.  However, in this trial, these criteria were not met. 95% of those treated with TOOKAD had adverse event in the weeks after treatment compared to 55% of the men on active surveillance. For many men these problems continued 2 years after treatment, when 34% continued to have urinary problems compared to 16% with active surveillance. Two years after treatment, 38% of patients treated with TOOKAD had erectile dysfunction, compared with 12% of those assigned to active surveillance. In other words, erectile dysfunction was 3x as prevalent among those treated with TOOKAD.

The long-term complications of the treatment that are unclear.  In addition to the urinary problems and ED that might be worse for those who are subsequently treated with surgery, it may be more difficult to obtain accurate biopsies. 

The American Urological Association recommends active surveillance as the best available treatment for low-risk prostate cancer patients, and the data clearly support that recommendation.  We understand that the fear of cancer can persuade men to seek treatment, but if so they should not be bamboozled by ads to choose a product that may have no benefits for them but that does have clear risks of erectile dysfunction and urinary problems. If the FDA thinks this product might have a useful benefit, they should require at least one double-blind study – preferably two – since the treatment does not involved surgery and is therefore easier to blind.  The studies should also include a patient population that represents the diversity of men with prostate cancer. There is no need to rush to approve this particular treatment based on a single, open label trial with endpoints of questionable clinical relevance and problems with inaccurate diagnoses. Better research needs to be completed before approval because the sponsor did not comply with FDA’s recommendations for the study and was even less likely to do so after the product is approved.   

The Oncologic Drugs Advisory Committee voted 13 to 2 against approval of TOOKAD to treat low-risk prostate cancer.