Category Archives: Policy

NCHR Written Statement for North Salem Central School District Board of Education

May 12, 2021


Dear Dr. Freeston and the North Salem Central School District Board of Education:

As president of the National Center for Health Research, I want to share the information we have provided to Members of Congress, state and federal agencies, state and local legislators, parents, and others who want to ensure that our children are not exposed to dangerous chemicals or other substances when they play on artificial turf or playgrounds. Our nonprofit think tank is located in Washington, D.C. Our scientists, physicians, and health experts conduct studies and scrutinize research conducted by other experts in the field. Our goal is to explain scientific and medical information that can be used to improve public health.

Our organization has been testifying and writing about the dangers of synthetic turf and playground surfaces for several years.  Our scientific staff has reviewed all publicly available scientific studies pertaining to the health impact of the lead and 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 grass 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.

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. The EPA and the federal Consumer Product Safety Commission are jointly studying the chemicals used in these products, but they have not yet released any data on studies of children exposed to these fields and playgrounds day after day and week after week.

There is a 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.

The “plastic grass” itself has dangerous levels of lead, PFAS, and other toxic chemicals.  PFAS are of particular concern because they are “forever chemicals” that get into the human body and are not metabolized, accumulating over the years. As I mentioned in an NPR interview this week1, new research published in the prestigious Journal of the National Cancer Institute found that people with greater exposure to PFAS are significantly more likely to be diagnosed with kidney cancer.2  Previous research suggests that testicular cancer is also associated with PFAS.

Lead

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. You may have been told that lead is only a problem for artificial turf made with tire crumb infill, but that’s not correct. The Centers for Disease Control and Prevention (CDC) warns that the “plastic grass” made with nylon or some other materials also contain lead.  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 inhaling when they play.

Why are Chemicals that are Banned from Children’s Toys Allowed in Artificial Turf and Rubber Playground Surfaces?

There are numerous studies indicating that endocrine-disrupting chemicals found in plastic cause serious health problems. As noted above, scientists at the National Institute of Environmental Health Sciences have concluded that unlike most other chemicals, these 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 U.S. Consumer Product Safety Commission has banned numerous endocrine-disrupting chemicals from toys and products used by children. The products involved, such as pacifiers and rubber duckies, 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 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 [endocrine disrupting chemicals] 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.

Envirofill and Other Alternative Infills

Replacing tire waste with silica, zeolite, and other materials also has substantial risks because the dust from these materials can be inhaled.

Summers in New York 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.

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.

Despite claims to the contrary, no independent studies 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 about likely exposures rather than scientific research on children.

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 is no clear evidence that an artificial turf field has caused specific children to develop cancer. However, that 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 hearings of the U.S. Consumer Product Safety Commission and state and local agencies.  At these 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, most recently at a hearing in a Connecticut community. They claim that these products are proven safe (not true) and that federal agencies have stated there are no health risks (also not true).

On the contrary, we know that the materials being used in artificial turf 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 families choose to spend millions of taxpayer dollars on fields that are unhealthy and unsafe rather than well-designed natural grass fields?

Dangerously Hard Fields and Injuries From Turf

Artificial turf fields get hard over time, and this can cause brain injuries and other injuries.  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.  Do you want to pay to have those tests conducted annually on artificial turf fields, and replace a relatively new field that fails the test?

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.

Any child who plays on artificial turf knows about “turf burns” that can be very painful and can get infected, but other injuries are even more serious. A study of more than 2,000 young female soccer players from 109 teams over the course of a season found that ankle sprains were almost twice as likely on turf compared to natural grass.4 Knee injuries are also much more likely on artificial turf.  A 10-year study of 5 different types of knee injuries on grass compared to artificial turf was conducted across all 3 divisions of NCAA football. They found that posterior cruciate ligament (PCL) tears occurred almost 3 times as often on turf than on grass.5 Athletes playing at lower levels experienced anterior cruciate ligament (ACL) tears 1.6 times more often on turf than they did on the grass.  This issue persists at the professional level as well, which is why the National Football League’s Player Association demanded artificial turf fields be replaced with natural grass, citing the league’s official report regarding increases in injuries on artificial turf surfaces. The report showed non-contact knee injuries happened 32% more often on turf.6

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 community 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.7,8 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.9,10,11

Synthetic surfaces also create heat islands.12,13  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.14

Conclusions

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 (dz@center4research.org).

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.  I’m sure you agree that it is important that decisions are 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.

 

Sincerely,

Diana Zuckerman, Ph.D.

President

 

References

  1. Vega, T., & Zuckerman, D. (May 10, 2021). The Role of Environmental Regulations in the Fight Against Cancer. The Takeaway. New York City, New York; WNYC.
  2. Shearer, JJ et al, Serum Concentrations of Per- and Polyfluoroalkyl Substances and Risk of Renal Cell Carcinoma. 2021; JNCI: Journal of the National Cancer Institute, Volume 113, Issue 5, , Pages 580-587, https://doi.org/10.1093/jnci/djaa143
  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. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4270264/
  4. Steffen, K., Andersen, T. E., & Bahr, R. Risk of injury on artificial turf and natural grass in young female football players. British Journal of Sports Medicine. 2007; 41 Suppl 1(Suppl 1), i33–i37. https://doi.org/10.1136/bjsm.2007.036665
  5. Loughran, G. J., Vulpis, C. T., Murphy, J. P., Weiner, D. A., Svoboda, S. J., Hinton, R. Y., & Milzman, D. P. Incidence of Knee Injuries on Artificial Turf Versus Natural Grass in National Collegiate Athletic Association American Football: 2004-2005 Through 2013-2014 Seasons. The American journal of sports medicine.2019;47(6), 1294–1301. https://doi.org/10.1177/0363546519833925
  6. Dulik, Brian. NFLPA asking teams to change all fields to natural grass. AP News. September 20, 2020. https://apnews.com/article/nfl-football-archive-9b34d4402f2f82ae60708605f65aa560
  7. 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. https://www.naturvardsverket.se/upload/miljoarbete-i-samhallet/miljoarbete-i-sverige/regeringsuppdrag/utslapp-mikroplaster-havet/RU-mikroplaster-english-5-april-2017.pdf
  8. 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. https://www.ncbi.nlm.nih.gov/pubmed/29053641/
  9. Kosuth M, Mason SA, Wattenberg EV. Anthropogenic contamination of tap water, beer, and sea salt. PLoS One. 2018,13(4): e0194970. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5895013/
  10. 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. http://rstb.royalsocietypublishing.org/content/364/1526/2047
  11. 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. https://royalsocietypublishing.org/doi/full/10.1098/rstb.2009.0053
  12. Thoms AW, Brosnana JT, Zidekb JM, Sorochana JC. Models for predicting surface temperatures on synthetic turf playing surfaces. Procedia Engineering. 2014;72:895-900. http://www.sciencedirect.com/science/article/pii/S1877705814006699
  13. Penn State’s Center for Sports Surface Research. Synthetic turf heat evaluation- progress report. 012. http://plantscience.psu.edu/research/centers/ssrc/documents/heat-progress-report.pdf
  14. 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. https://dl.sciencesocieties.org/publications/books/tocs/agronomymonogra/turfgrassbiolog

NCHR Statement at FDA Advisory Committee Meeting on Keytruda and Tecentriq for Advanced Urothelial Carcinoma

April 28, 2021


I’m Dr. Diana Zuckerman, president of the National Center for Health Research. Our center is a nonprofit think tank that scrutinizes the safety and effectiveness of medical products, and we don’t accept funding from companies that make those products.  I am trained in statistics, clinical trial design, epidemiology, and public health and was a faculty member and researcher at Yale and Harvard and a Fellow in Bioethics at Penn.  I’ve also worked at HHS. 

The details differ but in both cases our statistical and research analyses support the FDA findings that the data do not confirm the indication.

That’s especially important because both Tecentriq and Keytruda cause substantial adverse events and an alternative treatment has shown clear benefit!

FDA grants accelerated approval with requirements for post-market RCTs to evaluate overall survival to ensure clinically meaningful benefit.  But the randomized clinical trials conducted did NOT show benefit. How could FDA continue to offer accelerated approval for any drugs in the future if post-market RCTs results are ignored?

Most of you are clinicians and you’re used to trying different types of treatment in hopes that something will work. But the rules for FDA approval are different.  Shouldn’t cancer patients be eligible for free treatments in clinical trials instead of paying for treatment that isn’t proven to work – and that has risks?

Can other studies be used to confirm the indication?  FDA explained the problems very clearly.

Not appropriate to use studies with data based on patients that aren’t for the same indication: #1) PD-L1 high and #2) not eligible for cisplatin or other options.

Merck is not a start-up company – they should conduct well-designed studies. If less appropriate studies are accepted as alternatives, does this create disincentives for all companies to do the well-designed studies they agreed to do?

Our analysis agrees with FDA that neither progression-free survival not overall survival were clinically meaningful or statistically significant. What is the justification for keeping the indication for years while awaiting data that might or might not support approval?

FDA also points out that Real World data must meet scientific standards to confirm meaningful benefit.

Patients deserve treatments that provide meaningful benefits that outweigh meaningful risks and they need to be able to trust that FDA approval confirms that.

As a cancer survivor myself, I know that patients want hope.

What are the ethics of your decision today?  FDA approval has always meant rigorous evidence – it isn’t supposed to be based on wishful thinking or speculation about cross-over data or post hoc manipulation of data.  I respectfully urge you to listen to what the FDA scientists told us repeatedly in their memo — the evidence DOES NOT support continued approval and using other studies can’t provide the data needed. 

In conclusion, patients have suffered from taking cancer drugs that aren’t proven to work.  Other treatment options are proven to work.  Physicians can still choose whatever treatments are on the market, but treatment decisions shouldn’t be based on the mistaken belief that these drugs are proven effective for advanced urothelial carcinoma.

NCHR Statement Regarding Cancer Drugs that Failed to Confirm Efficacy after Accelerated Approval

April 29, 2021


I’m Dr. Diana Zuckerman, president of the National Center for Health Research.  Our center is a nonprofit think tank that scrutinizes the safety and effectiveness of medical products, and we don’t accept funding from companies that make those products.  Today I’m speaking from my perspective as a scientist who left Harvard more than 30 years ago to come to Washington D.C. to work in the House of Representatives. I worked as a Congressional investigator for the Subcommittee that conducted oversight over all of HHS, and that’s when I first learned about the laws and regulations governing the FDA.  I was responsible for several oversight hearings that attracted enormous media attention, because we found that patients had been harmed when the FDA was not following the law pertaining to FDA approval.

The law is very clear:  Drugs and biologics must be proven safe and effective, and that’s defined as having benefits that outweigh the risks for most patients.  FDA’s memoranda that were provided to this Committee for this meeting and for each of these indications over these last 3 days have made it clear that the data do not support that.  This Advisory Committee has looked at the data, seen reasons for optimism when looking at nonsignificant trends, and recommended that the FDA keep drugs on the market that don’t meet the standard specified by law.  That’s your right to do that, since you are advising the FDA based on your perspectives, experiences, and interpretations of the data.

I want to thank the FDA scientists who carefully analyzed the data and presented their findings.  You did a great job.  I’m here to urge the FDA to follow in your footsteps and follow the law and rescind approval for these indications until the companies complete randomized clinical trials that prove that the benefits outweigh the risks. I especially want to thank Dr. Pazdur for explaining how the FDA’s Expanded Access program can fill in the gaps for patients who need access to these drugs.  The companies agreed to complete confirmatory trials as part of the accelerated approval of their drugs, and I strongly urge the FDA to hold them to it.

All of these companies are leaders in their field and absolutely capable of conducting the research needed to prove whether or not their drugs have benefits that outweigh the risks for the exact specific indications they were previously approved for.  The companies also have the ability to make expanded access quick and easy.  Let’s face it, if they don’t have the expertise and resources to do the studies and help with expanded access, who does?  If the data don’t confirm the initial accelerated approval, the companies should work with the FDA to design trials to narrow the indication to figure out which are the patients most likely to be helped and which are the ones most likely to be harmed.

Written Statement Regarding Artificial Turf to Woodbridge Ordinance Committee

March 16, 2021


Dear Members of the Ordinance Committee:

I am writing to share scientific information about artificial turf and playground surfaces, which I am confident will help you determine the best decisions to make for the children and adults in your community.

As President of the National Center for Health Research, I am writing at the request of many of your constituents to share the information we have provided to Members of Congress, state and federal agencies, state and local legislators, parents, and others who want to ensure that our children are not exposed to dangerous chemicals or metals when they play on artificial turf or playgrounds. Our nonprofit think tank is located in Washington, D.C. Our scientists, physicians, and health experts conduct studies and scrutinize research. Our goal is to explain scientific and medical information that can be used to improve policies, programs, services, and products.

We commend you for considering the possible risks of replacing grass fields and natural playgrounds with artificial turf. In the last two years, 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 has well-known risks, containing 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 enter the body and the environment as “forever chemicals,” which means that they are not metabolized and do not deteriorate, 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 concluded 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.

Lead

As you probably know, the American Academy of Pediatrics states that no level of lead exposure should be considered safe for children, because lead can cause cognitive damage even at low levels. Some children are 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 in new synthetic rubber, it is not surprising that numerous artificial turf fields and playground surfaces 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 contains lead. Whether from infill, plastic grass, or rubber playground surfaces, the lead doesn’t just stay on the surface. With wear, the materials turn to dust containing lead and other chemicals that is invisible to the eye and is inhaled by children 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). 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).1

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 (also called hormone-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, endocrine-disrupting chemicals 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 Systemic Harm

It is essential to distinguish between evidence of harm and evidence of safety. 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 state legislatures and city councils. 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 Woodbridge or any other community choose to spend millions of dollars on fields that are less safe than well-designed natural grass fields?

Dangerously Hot and Hard Fields

I lived in Connecticut for several years while on the faculty at Yale and Vassar, and I know the climate well. When the weather is warm and/or sunny, it is usually quite pleasant to be outside – as long as you aren’t on artificial turf or an outdoor rubber surface. Even when the temperature above the grass is 80 degrees Fahrenheit, artificial turf can reach 150 degrees or higher. Obviously, a 90 degree day is likely to be even hotter than 150 degrees on turf. 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 score. A Gmax score over 200 is considered extremely dangerous, and it is considered by industry to pose a death risk. However, the synthetic turf industry and American Society for Testing and Materials (ASTM), suggest scores should be even lower — below 165 to ensure safety comparable to a grass field. Will Woodbridge pay to have these tests conducted annually on all your public artificial turf fields?

The hardness of natural grass fields is substantially influenced by rain and other weather; if the field gets hard, rain or watering 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 supposed to be determined by the score of the hardest part of the field.

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.4 The fields also continuously shed microplastics as the plastic blades break down.5,6 These materials may contain additives such as PAHs, flame retardants, and UV inhibitors, which can be toxic to marine and aquatic life. Microplastics are known to migrate into the oceans, the food chain, and drinking water, and they can absorb and concentrate other toxins from the environment.7,8,9

Synthetic surfaces also create heat islands.10,11 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; abate noise; and reduce glare.12

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.

Conclusions

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 (dz@center4research.org).

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 decision about artificial turf and playground surfaces can save lives and improve the health of children in your community.  You owe it to your community to make sure that you know the risks of artificial turf and do all you can to protect your children from both the known risks and the suspected risks. Your decisions about artificial turf will be cited by other communities, 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. 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.

Sincerely,

Diana Zuckerman, Ph.D.

President

 

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/Tires%5C62206013.pdf
  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. https://doi.org/10.1007/s11270-018-3711-7
  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. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4270264/
  4. York T. Greener grass awaits: Environmental & fiscal responsibility team up in synthetic turf. Recreation Management. February 2012. http://recmanagement.com/feature_print.php?fid=201202fe02
  5. 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. https://www.naturvardsverket.se/upload/miljoarbete-i-samhallet/miljoarbete-i-sverige/regeringsuppdrag/utslapp-mikroplaster-havet/RU-mikroplaster-english-5-april-2017.pdf
  6. 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. https://www.ncbi.nlm.nih.gov/pubmed/29053641/
  7. Kosuth M, Mason SA, Wattenberg EV. Anthropogenic contamination of tap water, beer, and sea salt. PLoS One. 2018,13(4): e0194970. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5895013/
  8. 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. http://rstb.royalsocietypublishing.org/content/364/1526/2047
  9. 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. https://royalsocietypublishing.org/doi/full/10.1098/rstb.2009.0053
  10. Thoms AW, Brosnana JT, Zidekb JM, Sorochana JC. Models for predicting surface temperatures on synthetic turf playing surfaces. Procedia Engineering. 2014;72:895-900. http://www.sciencedirect.com/science/article/pii/S1877705814006699
  11. Penn State’s Center for Sports Surface Research. Synthetic turf heat evaluation- progress report. 012. http://plantscience.psu.edu/research/centers/ssrc/documents/heat-progress-report.pdf
  12. 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. https://dl.sciencesocieties.org/publications/books/tocs/agronomymonogra/turfgrassbiolog

Statement on Keytruda for Early Stage Triple Negative Breast Cancer

February 9, 2021


The National Center for Health Research is a nonprofit think tank that scrutinizes the safety and effectiveness of medical products.  We don’t accept funding from companies that make those products, so we have no conflicts of interest.  We welcome the opportunity to provide our views on Merck’s application for approval of Keytruda for the indication of high-risk early stage triple negative breast cancer.

Triple negative breast cancer has a lower survival rate than other breast cancers.  However, chemotherapy clearly improves 5-year survival.  Patients need additional treatment options but the bottom line for patients is that FDA should not approve an indication that is not proven to have clinically meaningful benefits, especially when the treatment has clear risks.   

The first issue to address is whether there is evidence that immune checkpoint inhibitors (ICIs) are effective for TNBC.  We agree with FDA scientists that “there is still uncertainty regarding ICIs for TNBC” based on the results from several clinical trials.

  • KEYNOTE-119 failed to meet its primary OS endpoint. 
  • KEYNOTE-355 has not met its OS endpoint. 
  • IMpassion130: clinical benefits need to be confirmed
  • IMpassion131 interim OS results favored control group

The second major issue pertains to pCR data in the study.  The results indicate only 7.5% improvement in pCRs at IA3 (the most recent interim analysis), which the FDA scientists point out may not be clinically meaningful even if statistically significant.  We agree.  The problem is that it is impossible to determine how this slight improvement would affect overall survival, and even if it does, how much neoadjuvant and adjuvant use each contribute to any benefit. 

FDA scientists were clear to the sponsor that there were concerns with their study design and that the application for approval was premature since the study was not yet completed.  The agency made it clear that that the event free survival (EFS) study results were not statistically significant, not clinically meaningful, and did not show a “stable trend.” 

FDA reviewers are clear that data on overall survival “are too immature to provide a conclusive interpretation regarding the difference in OS between treatment arms.” 

What about safety?

At IA3 (the most recent interim analysis), there were 96 deaths, which FDA points out “accounts for only 32% of the events needed for the final analysis. Therefore, the OS estimate may be unreliable, and the treatment effect size reported is subject to uncertainty.”

It is notable that the study included patient-reported outcomes (PROs), but unfortunately, KEYNOTE-522 was not designed to compare differences in PROs (symptoms, side effects, health-related quality of life), nor were these patient-reported endpoints prospectively identified and statistically tested. 

PRO assessments should have been more frequent, both for neoadjuvant and adjuvant treatments

Since many high-risk, early-stage TNBC patients will be cured with standard therapy, the key issue is whether this drug has benefits that outweigh the risks.  The benefits are unclear.  Therefore, the evidence of the drug’s “added toxicity” is worrisome.  FDA scientists concluded that “Some of these toxicities may be irreversible or require lifelong medication in patients cured of their breast cancer.

Although the sponsor counted 2 deaths due to immune-mediated adverse events, the FDA counted 4.  Either way, these deaths must be considered worrisome given the lack of clear evidence of a meaningful benefit.  And, there are many other serious adverse events in addition to the small number of deaths.   All-grade and grade ≥3 immune-mediated AEs and infusion reactions occurred more frequently in Keytruda patients compared to placebo:    43% vs. 22% for all grade AEs, and 15% vs. 2% for high grade AEs.  In fact, 10% of Keytruda patients had immune-mediated AEs and infusion reactions leading to hospitalization compared to 1% of placebo.  These included the following relatively high number of adverse events:

  • Infusion reactions (18%), 
  • Hypothyroidism (15%), 
  • Severe skin reactions (6%)
  • Hyperthyroidism (5%), adrenal insufficiency (3%), pneumonitis (2%), and thyroiditis (2%).

It is important to note that these adverse events were not resolved at the last assessment in the study for 19% of Keytruda patients.   It is also important to note that 16% of the Keytruda patients initiated thyroid hormone replacement during the study.

In summary, we agree with FDA scientists that the deaths are “particularly concerning in this curative disease setting.”

  • “All grade and grade ≥3 immune-mediated AEs were increased in [Keytruda] patients.’
  • Some “may be severe or lifelong.” 
  • The adjuvant treatment has fewer adverse events but “has not demonstrated a significant effect on any efficacy endpoint, and may be adding risk without benefit.”

Based on our analysis, we agree with the overall conclusions made by FDA scientists: 

  1. Neoadjuvant Keytruda “confers only a small absolute improvement in pCR rate of questionable clinical meaningfulness.
  2. Event-free survival and overall survival are “immature and unreliable.”
  3.  “The design and results of KEYNOTE-522 do not currently support a role for adjuvant [Keytruda].”
  4. Supportive data of clinical benefit … are lacking.” 
  5. Adding Keytruda “is associated with increased toxicity … which may be severe, irreversible, and/or require life-long medication in potentially curable and otherwise healthy patients.” 

In conclusion, the FDA and the medical community do patients no favors to approve a treatment that is not proven to benefit them and at the same time is proven to cause harm for a substantial percentage of patients.  The studies should be continued to determine whether the benefit of adding Keytruda to other treatments outweigh the risks.

 

This written statement was submitted to the FDA on February 8, 2021 and an oral version with PowerPoint slides was presented at the FDA Advisory Committee meeting on February 9, 2021.

We are pleased that the FDA Advisory Committee agreed with our views and voted 10-0 on February 9 in favor of deferring an FDA regulatory decision until the study is completed.

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
Chairwoman
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.

Sincerely,

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