Category Archives: Legislation

The Breast Implant Working Group’s Breast Implant Black Box Warning and Patient Checklist

The Breast Implant Working Group’s Breast Implant Black Box Warning

This black box warning was developed by the Breast Implant Working Group, which consists of Dr. Diana Zuckerman (National Center for Health Research), Dr. Scot Glasberg  American Society of Plastic Surgeons), Dr, Alan Matarasso (also ASPS), Jamee Cook (Breast Implant Victim Advocacy), Raylene Hollrah (Just Call me Ray), and Karuna Jaggar (Breast Cancer Action).   As individuals, we are urging the FDA to include a black box warning about the risks of cancer and other serious health problems for women considering breast implants.

BLACK BOX WARNING: Breast implants can cause a type of cancer of the immune system called BIA-ALCL (Breast Implant Associated Anaplastic Large Cell Lymphoma).  People with silicone or saline breast implants have developed this rare disease, which can be deadly if not treated early. Almost all women who have developed BIA-ALCL have had textured breast implants or expanders at some point.

Several studies also suggest that women with breast implants have a small but significant increase in their chances of developing certain autoimmune or connective tissue diseases. Women with silicone gel or saline breast implants have reported symptoms that are sometimes serious, such as joint or muscle pain, fibromyalgia, mental confusion, and painful skin conditions.  Many of these symptoms improve partially or completely when their breast implants are removed and not replaced.

The Breast Implant Working Group’s Patient Informed Consent Checklist

This checklist was developed by the Breast Implant Working Group, which consists of Dr. Diana Zuckerman (National Center for Health Research), Dr. Scot Glasberg (American Society of Plastic Surgeons), Dr, Alan Matarasso (also ASPS), Jamee Cook (Breast Implant Victim Advocacy), Raylene Hollrah (Just Call me Ray), and Karuna Jaggar (Breast Cancer Action).  The checklist has been endorsed by their organizations, as a requirement to be read and signed by all potential breast implant patients.

See the checklist here or below:

BREAST IMPLANT PATIENT/DOCTOR CHECKLIST 

The purpose of this checklist is to provide information for patients considering breast implants for augmentation or reconstruction, so that they can carefully weigh the risks and benefits of breast implants and make the decision that is right for them. The risks in this checklist are in addition to common surgical risks such as infection, necrosis (skin death), or problems with anesthesia.

After reviewing the Patient Information Booklet, please read and discuss the items in this checklist with your surgeon. You should not initial or sign the document, and should not undergo the procedure, if you do not understand each of the issues listed below.

How long do breast implants last? I understand that breast implants are not expected to last for the rest of my life.  Implants may rupture or leak at any time, and that is more likely the longer you have them.  In addition, it is likely that I will need other surgeries related to my breast implants over the course of my life.  If I am a cosmetic surgery patient, my health insurance policy may refuse to cover these surgeries. These additional surgeries and procedures can include implant removal with or without replacement, muscle and tissue repair, scar revisions, MRI diagnostic exams, or other procedures. I understand that undergoing multiple surgeries may increase my chances of permanent breast deformity.

Patient Initials____________

Who shouldn’t get breast implants?  I understand that the safety of breast implants was never studied for people who have autoimmune symptoms or diseases, or a family history of those diseases. Breast implants may be more likely to cause serious health problems and symptoms for these people.  In addition, breast implants may not be safe for anyone with a weakened immune system or certain genetic risk factors that have not yet been identified.

Patient Initials____________

Chemicals and Metals in Breast Implants:  I understand that all breast implants contain chemicals and small amounts of heavy metals that may cause health problems. I understand that most of these chemicals are confined to the shell of the implant or stay inside the shell.  However, small quantities have been found to diffuse (bleed) from or through the implant shell, even if the implant is intact and not ruptured.

Patient Initials____________

Rupture and Leakage:  I understand that the longer my breast implants are in place, the more likely they are to rupture, especially after the first few years. When a saline implant ruptures, it usually deflates quickly. When a silicone gel implant ruptures, I may not notice any changes and the rupture may not be detected by my doctor or by mammogram, MRI, or sonogram. I understand that an MRI is recommended for silicone gel breast implants 3 years following surgery and every 2 years after that to check for silent rupture, and that these MRIs often are not covered by health insurance. I understand that silicone may migrate from the implant into nearby tissues such as the chest wall, lymph nodes, upper abdominal wall, and into organs such as the liver or lungs where it cannot be removed. Since migrated silicone can cause health problems, it is currently recommended that any ruptured silicone implant should be removed as soon as possible. I understand that, if needed, treatment of these conditions may be at my own expense and not covered by insurance or a manufacturer warranty.

Patient Initials____________

BIA-ALCL (Breast Implant Associated Anaplastic Large Cell Lymphoma):  I understand that there is a small risk for me to develop BIA-ALCL, a cancer of the immune system. BIA-ALCL is a type of lymphoma that develops on or around the scar capsule that surrounds the breast implant. I understand that the symptoms of BIA-ALCL include breast swelling, lumps, pain, and asymmetry that develop after surgical incisions are completely healed, usually years after implant surgery.

Treatment for BIA-ALCL includes removal of the implant and scar capsule, and, if not treated early, may include chemotherapy and radiation. This diagnosis and treatment may be at my own expense and is not always covered by insurance.

Patient Initials________________

Symptoms of “Breast Implant Illness:” I understand that because of the lack of long-term safety data, we are still learning about the health problems that result from breast implants.  To date, thousands of women have reported to the FDA or to researchers that they have experienced serious health problems that several studies have linked to their breast implants. This may occur either immediately after getting implants or years later. These often include symptoms such as: joint and muscle pain or weakness, memory and concentration problems, chronic pain, depression, fatigue, chronic flu-like symptoms, migraines, or rashes and skin problems.

Several studies of women with breast implants have shown that they are significantly more likely to be diagnosed with one or more of the following diseases compared to other women: • Chronic Fatigue Syndrome • Multiple Sclerosis (MS) • Rheumatoid Arthritis (RA) • Sjögren’s syndrome  • Systemic Sclerosis/Scleroderma

Although women who develop these symptoms or diseases can’t be certain that they were caused by breast implants, several studies indicate that most symptoms improve partially or completely after having their implants and capsules removed.

Patient Initials____________

Capsular Contracture:  I understand that one of the most common complications of breast implants is when the scar tissue capsule that forms around the implant hardens. In some cases, this can be quite painful, distort the shape of the breast, and can make mammography more painful and less accurate. Removing the implant and capsule without replacing the implant is the only recommended way to guarantee that this problem is corrected.

Patient Initials____________

Breast Cancer:  I understand that all breast implants can interfere with mammography and breast exams, possibly delaying the diagnosis of breast cancer. I understand that if I get breast implants, I should inform the mammography technologist about the implants and ask for additional views to improve the accuracy. I understand that mammography can also cause the breast implant to rupture or leak.

Patient Initials____________

Interference with Breastfeeding:  I understand that breast implants and breast surgery may interfere with my ability to successfully breastfeed.  No long-term research has been conducted to determine the possible transmission of chemicals and heavy metals in the breast milk of women with implants.

Patient Initials____________

Loss of Sensation to Breast or Nipple(s): I understand that breast implants and breast surgery may cause the nipple or breast to be painful, or to have decreased sensation. These changes may be temporary or permanent, and may affect sexual response or the ability to nurse a baby.

Patient Initials____________

Cosmetic Complications:  Asymmetry, Implant Displacement, Ptosis I understand that if my breasts had slightly different shapes before surgery, they may remain slightly different after surgery. I understand that the implants may cause the breasts to look slightly different in size or shape. I understand that the implant may move from the original placement location and that may result in asymmetry or other cosmetic problems. Breast implants can cause the breasts to sag over time due to the weight of the implants. I understand that if I am not happy with the results, I may need future surgeries to improve the appearance of my breasts.

Patient Initials____________

CONFIRMATION OF DISCUSSION OF RISKS 

Patient: I acknowledge that I have received and read the Breast Implant Patient Information Booklet and this checklist. I have had time to discuss the information in both with my doctor, and understand the benefits and risks of the implants and surgery.

______________________________________________Patient Signature & Date

Physician: I acknowledge that I have discussed the benefits and risks of breast implants as described in the Breast Implant Patient Information Booklet and this checklist. I have encouraged the patient to ask questions, and answered all questions accurately.

____________________________________________Physician Signature & Date

NCHR Letter to Senators Regarding the Impact of the Government Shutdown on Patient Safety

A similar version of this letter was sent to Senators Alexander and Murray of the Senate Health, Education, Labor, and Pensions (HELP) Committee, majority leader McConnell, minority leader Schumer, and members of both the Appropriations and HELP Committees.

 

January 11, 2019

Chairman Richard Shelby and Vice Chairman Patrick Leahy

Appropriations Committee

U.S. Senate

Washington, DC 20510

Dear Mr. Chairman and Mr. Vice Chairman:

I am writing to you on behalf of the National Center for Health Research to alert you to the dangerous situation facing all Americans as a result of the lack of FDA funding for post-market surveillance and safety evaluations during the current government shutdown.

As you know, during the shutdown the FDA is funded through user fees and the only staff that are allowed to work are focused on the review of new products in compliance with the performance goals (timely review) required by user fees.  The medical device user fees are not used for post-market surveillance activities.  The drug user fees are almost entirely used for premarket review, and there has been no public announcement of whether any post-market activities for prescription drugs or biologics are underway for the last three weeks.  The situation will remain dangerous throughout the shutdown.  When the Congress eventually passes legislation to provide appropriations for the FDA for FY 2019, it is inevitable that there will be an enormous backlog that will also undermine patient safety.  The longer the shutdown, the more dangerous the situation will be during the shutdown and the more challenging the backlog will be.

Post-market surveillance is especially important for medical devices because the pre-market standards for approval or clearance are so much lower than they are for prescription drugs.  While all prescription drug approvals are based on at least one pivotal clinical trials, less than 5% of medical devices are required to have submitted clinical trial data to get on the market. Even the highest risk (PMA) devices do not always submit clinical trials of their own devices when seeking approval. Of those approximately 5% that submit clinical trials, the vast majority of those trials are not randomized double-blind clinical trials, even though that is the gold standard for clinical trials.  In fact, many of the PMA device trials have no active control groups to compare with the patients with the new device, and therefore provide very limited information about either safety or effectiveness.  As a result, very little is known about the safety or effectiveness of new medical devices except through post-market information, which may include:

  • Adverse event reports (mandatory and voluntary)
  • Required post-market clinical trials, such as the study FDA has required for Essure
  • FDA Advisory Panel meetings to review devices already on the market (such as the meeting that the Commissioner announced would be held early this year to review breast implants)
  • Registries of patients with implanted devices (such as knee and hip joints)
  • Formal or informal studies conducted by concerned physicians, investigative reporters, and other non-industry researchers that are reported in the media or submitted to the FDA as part of citizens’ petitions.  Although the studies themselves are not part of the FDA surveillance activities, these studies are additional safeguards if FDA reviews them and responds by considering issuing a warning to physicians or patients or a device recall.

The impact of the shutdown on drug or device safety surveillance by the FDA has not been mentioned in the media or, to our knowledge, by Members of Congress.  As you know, food safety efforts are greatly limited during the shutdown. Fortunately, the Center for Tobacco is entirely funded by user fees so that their work has not been affected.

The National Center for Health Research (NCHR) is a non-profit organization that analyzes scientific and medical data and provides objective health information to patients, providers, and policymakers. We do not accept funding from the drug or medical device industry and have no conflicts of interest on these matters.   We have published several groundbreaking studies pertaining to FDA recalls of medical devices, and lack of safety data, including problems with cybersecurity and recalls of faulty medical software.  Delays in high-risk recalls will clearly put patients’ lives at risk during the shutdown and while FDA attempts to deal with the backlog when appropriations become available.

The Senate will be part of the solution by immediately passing legislation to fund the FDA.

Please contact me with any questions at (202) 223-4000 or dz@center4research.org .

Thank you for your commitment to patient safety.

Sincerely,

Diana Zuckerman, Ph.D.

President

Comments on Tobacco Control Efforts in the U.S.-United Kingdom Trade Agreement

January 15, 2019

Re: Docket No. USTR-2018-0036
Mr. Edward Gresser
Chair of the Trade Policy Staff Committee
Office of the United States Trade Representative
600 17th Street N.W.
Washington, D.C. 20508

Dear Mr. Gresser:

We are pleased to submit these comments in the above-designated docket. Our organizations are public health and medical organizations which are actively engaged in efforts to eliminate the disease and death caused by the use of tobacco products in the United States and throughout the world.

As you prepare to negotiate a trade and investment agreement with the United Kingdom, we urge that you ensure that the agreement provides the protections necessary to enable both countries to adopt public health measures to protect their citizens from the death and disease caused by tobacco products without facing the risk of litigation by the tobacco companies. It is essential that any agreement recognize the unique harms tobacco products cause, and includes provisions to ensure that the United States and the United Kingdom do not face the threat of investor litigation from the tobacco industry.

Tobacco products are the only consumer products that kill when used exactly as intended. Each year more than 480,000 Americans die from tobacco use. Globally, tobacco kills more than 7 million people annually, and without effective tobacco control policies to reduce consumption, one billion people will die from using tobacco products this century. For these reasons, tobacco products are the only consumer product subject to a treaty specifically designed to prevent and reduce their use — the Framework Convention on Tobacco Control.

Countries around the globe are implementing tobacco control policies from graphic health warning labels to plain packaging. The tobacco industry has aggressively responded by using investor-state dispute settlement (ISDS) provisions in trade and investment agreements to both threaten and file legal challenges against countries’ tobacco policies. Despite not prevailing on its investment claims, the tobacco industry has long used legal threats and challenges to intimidate governments from moving forward with policies to prevent or reduce tobacco consumption. The tobacco industry’s behavior is a real and direct threat to public health.

The United States-Mexico-Canada Agreement (USMCA) significantly limits the tobacco industry’s ability to initiate disputes challenging tobacco control measures by eliminating ISDS between the U.S. and Canada and limiting ISDS claims between the U.S. and Mexico for the majority of industries, including the tobacco industry, to direct expropriation and discrimination claims brought under the grounds of National Treatment or Most-Favored Nation Treatment.

Any ISDS provision included in a U.S. – U.K. trade agreement should prohibit challenges from private tobacco companies to tobacco control measures to reduce tobacco use. Given the experience of the tobacco companies using the investor-state provisions in other agreements to challenge tobacco control measures, this protection is critical. It is also particularly important because the U.S. is moving forward with adopting graphic warning labels to accompany textual warnings that together will cover 50% of the front and back of a cigarette pack. Also note that the United States has previously defended a tobacco-related NAFTA claim in Grand River v. United States, which, despite the United States’ prevailing on the seven-year long claim, cost the taxpayers millions of dollars to litigate. Protecting the right of the United States and the United Kingdom to implement tobacco control policies free from the threat of tobacco industry ISDS challenges is critical for both nations to protect the health of their citizens.

As you develop your negotiating objectives for a U.S. – U.K. trade and investment agreement, we respectfully request that you recognize that the agreement must set the example for a 21st century agreement by, at a minimum, recognizing the unique harms caused by tobacco products and preventing the tobacco industry from using the agreement to challenge U.S. or U.K. actions to reduce the use of tobacco products.

Sincerely,

Action on Smoking & Health
Allergy & Asthma Network
American Academy of Family Physicians
American Academy of Otolaryngology—Head and Neck Surgery
American Academy of Pediatrics
American Association for Dental Research
American Cancer Society Cancer Action Network
American College of Physicians
American Heart Association
American Lung Association
American Medical Association
American Psychological Association
American Public Health Association
American Society of Addiction Medicine
Association of Schools and Programs of Public Health
Association of Women’s Health, Obstetric and Neonatal Nurses
Campaign for Tobacco-Free Kids
Cancer Prevention and Treatment Fund
Community Anti-Drug Coalitions of America
Eta Sigma Gamma – National Health Education Honorary
March of Dimes
National African American Tobacco Prevention Network
National Association of County & City Health Officials
National Association of School Nurses
National Network of Public Health Institutes
Oncology Nursing Society
Society for Cardiovascular Angiography and Interventions
Society for Public Health Education
The Society of State Leaders of Health and Physical Education

Letter from Nonprofits to DC Mayor and Other Officials About Dangers of Artificial Turf and Playgrounds


Identical letters were sent to members of the DC City Council, the DC superintendent of schools, and other DC officials.

July 10, 2018

Dear Mayor Bowser:

We, the undersigned organizations and businesses, are writing to strongly urge that the District government stop installing synthetic turf and poured in place (PIP) playgrounds in Washington, D.C.  There is a growing body of evidence that these synthetic surfaces endanger children’s health, are harmful to our environment, and are very expensive to install and maintain compared to natural grass.1,2,3,4

  • In the District, children have been endangered by surface temperatures that have been measured in excess of 160 degrees Fahrenheit.5,6,7,8
  • For years, children in the District have been endangered by playing fields that are excessively hard, far out of compliance with any safety standards.  Until last year, the District did not correctly monitor Gmax testing of field hardness (called impact attenuation) to ensure even a minimum safety standard to prevent injuries when children fall.  A score of 165 or higher is considered too dangerous for children by the Synthetic Turf Council.  Dozens of DCPS playing fields exceeding that 165 score remain in service with no remediation at all.8,9,10,11

When products with known risks of injuries from infection, high temperature and hardness are installed, the District has an obligation to provide monitoring and safety standards.  That hasn’t been done in a timely manner,12 and students have been harmed.13,14,15

We oppose the District’s plans to install more synthetic turf of any type on playing fields or playgrounds. These plastic carpet systems and infills are exposing our children and environment to harmful toxicants, as documented by independent researchers at Yale,1  Mount Sinai Children’s Environmental Health Center,16,17 and the National Center for Health Research.18  

Synthetic rubber playground materials (often called PIP) that are used under slides, swings, and other children’s play areas contain similarly harmful toxicants.19

  • Claims from vendors or industry-funded scientists that the materials are proven safe are inaccurate.  Misleading claims that there is “no evidence” of harm does not mean that the synthetic systems are proven to be safe.  On the contrary, concerns about safety have been documented by independent scientists noted above, and were examined during the Obama Administration by the Consumer Product Safety Commission (CPSC) and the Environmental Protection Agency (EPA).20  The CPSC and EPA reviews were not completed as expected in 2016 or 2017, and it is not clear whether those reviews are held to the scientific standards that had previously been established.
  • 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, such as tire crumb, 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,21 and the fields also continuously shed microplastics as the plastic blades break down.22,23 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 adsorb and concentrate other toxins from the environment.24,25,26
  • Synthetic surfaces also create heat islands.27,28  In contrast, organically managed natural grass saves energy in urban areas 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.29

We urge your support for the installation of organically managed natural grass fields and Engineered Wood Fiber (EWF) playgrounds that are properly engineered, installed, and maintained for ADA compliance.  It is incumbent upon the District of Columbia to:

  1. Halt all installation of synthetic playgrounds and playing fields.
  2. Remove synthetic playgrounds and playing fields instead of renovating them or replacing with new synthetic materials.
  3. Prioritize proper installation and maintenance of ADA compliant natural surfaces.
  4. Solicit public ideas for increasing the inventory of playing fields and recreation opportunities.

We endorse the January 2018 policy recommendations made by DC Safe Healthy Playing Fields, which provide a measured and reasonable approach to phasing out of synthetic fields and playgrounds in DC and replacement with natural surfaces.

As noted above, there is well-documented evidence on the environmental and health dangers of synthetic fields and playground surfaces.  The scientists and consultants denying these risks to the DC Government have financial and other ties to the companies that manufacture and install synthetic turf or to the recycled rubber industry.

Tax dollars should not be spent on products that endanger children’s health and harm our environment.

Sincerely,

DC Safe Healthy Playing Fields

Alliance of Nurses for Healthy Environments

American Academy of Environmental Medicine

Audubon Naturalist Society

Beyond Pesticides  (October 2017 Testimony to DC City Council)

Cedar Lane Unitarian Universalist Church Environmental Justice Ministry

Center for Environmental Health

Children’s Environmental Health Network (October 2017 Testimony to DC City Council)

Kids in Danger

MOM’s Organic Market

Maryland Public Interest Research Group

Maryland Environmental Health Network

Moms Clean Air Force

National Center for Health Research

Neighbors of the Northwest Branch of the Anacostia River

New Hampshire Safe Water Alliance

Non Toxic Communities

Public Employees for Environmental Responsibility (Statement on EPA Study)  

Safe Grow Montgomery

Safe Healthy Playing Fields Coalition

Sierra Club DC

Trash Free Maryland

Toxics Action Center Campaigns

Women’s Alliance for Democracy & Justice

 

CC:

City Administrator Rashad Young

Department of Energy & the Environment Director Tommy Wells

Deputy Mayor of Education Ahnna Smith

Deputy Mayor for Health and Human Services HyeSook Chung

Department of Parks and Recreation Director Keith Anderson

Department of General Services Director Greer Gillis

DCPS Chancellor Amanda Alexander

Interagency Synthetic Turf Task Force

Evan Lambert, Fox5

Mike Ozanian, Forbes

Rachel Sadon, DCist

 

PDF Copy: July 10 Safe Healthy Playing Fields to Mayor Bowser et al

References:

  1. Benoit G, Demars S. Evaluation of organic and inorganic compounds extractable by multiple methods from commercially available crumb rubber mulch. Water Air Soil Pollut 2018. 229(3): 64. https://doi.org/10.1007/s11270-018-3711-7
  2. Llompart M, Sanchez-Prado L, Pablo Lama J, Carcia-Jares C, Roca E, Dagnac T. Hazardous organic chemicals in rubber recycled tire playgrounds and pavers. Chemosphere. 2013. 90: 423-431. http://www.elcorreodelsol.com/sites/default/files/chemosphere_maria_llompart.pdf
  3. Massachusetts Toxics Use Reduction Institute. Sports turf alternatives assessment: Preliminary results: Cost analysis. September 2016. http://www.turi.org/Our_Work/Home_Community/Artificial_Turf/Cost_Analysis
  4. Ozanian M. How taxpayers get fooled on the cost of an artificial turf field. Forbes. September 28, 2014. https://www.forbes.com/sites/mikeozanian/2014/09/28/how-taxpayers-get-fooled-on-the-cost-of-an-artificial-turf-field/#ea43caf5db28
  5. Images of the high temperatures recorded at Janney Elementary on June 12, 2017. On a day when the ambient air temperature was 96°F, poured-in-place surfaces were 164°F and 165°F, artificial turf field was 162°F, while mulch and concrete were 122°F and 127°F, respectively.
  6. Image of the high temperature of an Envirofill field at Janney Elementary on October 1, 2017. The field was 136°F when the ambient air was 64°F.
  7. As temperatures increase, surface hardness also increases: Vidair C, Haas R, Schlag R. Testing impact attenuation on California playground surfaces made of recycled tires. Int J Inj Contr Saf Promot. 2007. 14(4): 225-30. https://www.ncbi.nlm.nih.gov/pubmed/18075871
  8. National Center for Health Research. Letter to the DC City Council on Artificial Turf. October 26, 2017. http://www.center4research.org/nchr-letter-dc-city-council-artificial-turf/
  9. Evaluation of D.C. testing results found that dozens of DCPS playing fields exceeded a g-max score of 165: Zuckerman D. Risks of head injuries on artificial turf fields in Washington, D.C. National Center for Health Research. 2017. http://www.center4research.org/risks-head-injuries-artificial-turf-fields-washington-d-c/ 
  10. Sadon R. Hardness test results reveal wider scope of artificial turf failures. DCist. October 12, 2017. http://dcist.com/2017/10/even_more_artificial_turf_fields_fa.php 
  11. Synthetic Turf Council. Guidelines for synthetic turf performance. 2011. https://cdn.ymaws.com/www.syntheticturfcouncil.org/resource/resmgr/guidelines/STC_Guidelines_for_Synthetic.pdf
  12. D.C. Department of General Services. Artificial athletic turf fields: Frequently asked questions. September 21, 2017. https://dgs.dc.gov/sites/default/files/dc/sites/dgs/service_content/attachments/UPDATED%20-%20FAQ%20Artificial%20Athletic%20Turf%20Fields%20-%209-21-17.pdf 
  13. McCray Q. Safety checks at D.C. playgrounds under question after boy injured on crumb rubber floor. WJLA. October 27, 2017. http://wjla.com/news/local/safety-checks-at-dc-playgrounds-under-question-after-boy-injured-on-crumb-rubber-floor
  14. Infections are the result of increased incidence of abrasions on artificial turf, see Williams S, Trewartha G, Kemp SP, Michell R, Stokes KA. The influence of an artificial playing surface on injury risk and perceptions of muscle soreness in elite rugby union. Scand J Med Sci Sports. 2016. 26(1): 101-108. https://www.ncbi.nlm.nih.gov/pubmed/25644277.  Kazakova SV, Hageman JC, Matava M, et al. A clone of methicillin-resistant staphylococcus aureus among professional football players. N Engl J Med. 2005. 352(5): 468-475. https://www.nejm.org/doi/full/10.1056/NEJMoa042859.  Van den Eijnde W, Masen M, Lamers E, van de Kerkhof P, Peppelman M, Van Erp P. The load tolerance of skin during impact on artificial turf using ex-vivo skin as the readout system. Science and Medicine in Football. 2018. 2(1): 39-46. https://www.tandfonline.com/doi/full/10.1080/24733938.2017.1390593
  15. Graphic one-minute video of student with serious infection from synthetic turf in DC
  16. The Children’s Environmental Health Center of the Icahn School of Medicine at Mount Sinai. Letter to DC City Council concerning state of fields and playgrounds maintained by the District Public Oversight Roundtable. October 12, 2017.
  17. The Children’s Environmental Health Center of the Icahn School of Medicine at Mount Sinai.  Artificial turf: A health-based consumer guide. May 2017. http://icahn.mssm.edu/files/ISMMS/Assets/Departments/Environmental Medicine and Public Health/CEHC Position Statement on Recycled Rubber Turf Surfaces May 10 2017.pdf
  18. Booker N, Fox-Rawlings S. Children and athletes at play on toxic turf and playgrounds. National Center for Health Research. 2018. http://www.center4research.org/children-athletes-play-toxic-turf-playgrounds/
  19. Canepari S, Castellano P, Astolfi ML, Materazzi S, Ferrante R, Fiorini D, Curini R. (2018) Release of particles, organic compounds, and metals from crumb rubber used in synthetic turf under chemical and physical stress. Environ Sci Pollut Res Int. 25(2): 1448-1459. https://link.springer.com/article/10.1007%2Fs11356-017-0377-4
  20. EPA. Federal research on recycled tire crumb used on playing fields. 2018 https://www.epa.gov/chemical-research/federal-research-recycled-tire-crumb-used-playing-fields
  21. 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.
  22. 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
  23. Kole PJ, Löhr AJ, Van Belleghem FGAJ, Ragas AMJ. Wear and tear of tyres: A stealthy source of microplastics in the environment. Int J Environ Res Public Health. 2017 14(10). pii: E1265. https://www.ncbi.nlm.nih.gov/pubmed/29053641/
  24. 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/
  25. Oehlmann J, Schulte-Oehlmann U, Kloas W et al.  A critical analysis of the biological impacts of plasticizers on wildlife. Phil Trans R Soc B. 2009. 364: 2047–2062. http://rstb.royalsocietypublishing.org/content/364/1526/2047
  26. Thompson RC, Moore CJ, vom Saal FS, Swan SH. Plastics, the environment and human health: Current consensus and future trends. Philos Trans R Soc Lond B. 2009. 364: 2153–2166. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2873021/
  27. 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
  28. Penn State’s Center for Sports Surface Research. Synthetic turf heat evaluation- progress report. 2012. http://plantscience.psu.edu/research/centers/ssrc/documents/heat-progress-report.pdf
  29. 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

Letter to Board of Education of Montgomery County on Artificial Turf Fields and Playgrounds

Diana Zuckerman, PhD, National Center for Health Research, April 23, 2018

April 23, 2018

Dear Board of Education members,

As a long-time resident of Montgomery County and as president of the National Center for Health Research, I am shocked by the misinformation I have seen circulating about all types of artificial turf and rubber playgrounds in Montgomery County.

The recent plan to use Zeolite indicates a dangerous lack of understanding of the need for safety testing before using materials that our children will be exposed to day after day.  Zeolite is a mined volcanic mineral.  Its use in artificial turf has not been tested for human health,  but there is every reason to be concerned that inhaling the dust from Zeolite could cause lung damage, similar to the damage from asbestos.

In addition, it is my understanding that synthetic rubber play surfaces are now being proposed for MCPS outdoor play spaces.  These “poured in place” and other types of rubber playground surfaces have many of the same risks as tire crumb and other rubber infill that the County Council realized were too dangerous to use in 2015.  These rubber playgrounds look very attractive and feel good when they are new, but you can’t see the chemicals that are in them.  As a result, these synthetic rubber playgrounds (like artificial turf playing fields) are often over 140-160 degrees Fahrenheit 50-60 degrees on a sunny day – even on days when the air temperature is only 60 degrees!.  In addition, the rubber (which is made from petroleum and other products) release toxins that can cause cancer and also contribute to early puberty, obesity, attention deficit disorder, asthma, and rashes.  The playground surfaces also start to tear, and very small pieces of colorful materials are very tempting for young children to eat because they look like candy.

Please stop these dangerous installations from going forward.

As president of the National Center for Health Research, I testified about the risks of these materials at the U.S. Consumer Product Safety Commission this past week, and have previously testified before the Maryland House of Delegates Appropriations Committee  and the D.C. City Council.  I am sorry to say that I have repeatedly seen and heard scientists from 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).  They also give misleading assurances such as “there is no evidence of a child getting cancer from these products.” The problem with that type of statement is that it is virtually impossible to prove that a chemical exposure causes one specific individual to develop cancer.  What we do know is that many of the materials being used 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 now or as they get older.  That should be adequate reason to not install them in Montgomery County.  Add to that the short-term risk of asthma, obesity, attention problems, and early puberty, and it is time  for the County to educate its opinion leaders and stop spending millions of dollars on fields and playgrounds and insurance for trip that are less safe and more expensive than well designed natural grass fields and ADA-compliant engineered wood fiber.

For more information, please read our user-friendly footnoted summary at http://www.center4research.org/children-athletes-play-toxic-turf-playgrounds/

Sincerely,

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

Comments by Diana Zuckerman, Ph.D. on the U.S. Consumer Product Safety Commission Agenda and Priorities for FY2019/2020

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

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

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

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

Organohalogen Flame Retardants

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

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

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

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

Artificial Turf and Playground Surfaces

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

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

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

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

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

Phthalates in Children’s and Household Products

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

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

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

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

References:

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

NCHR Letter to the Senate on Right To Try

National Center for Health Research, March 23, 2018

Dear Senators,

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

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

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

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

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

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

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

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

Sincerely,

Jack Mitchell, Director of Health Policy

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

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

Right To Try Fact Sheet

Cancer Prevention and Treatment Fund

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

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

Statement on Failure of “Right to Try” Bill

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

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

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

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

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

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

NCHR Letter to Maryland on State Funding for Artificial Turf and Playgrounds

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

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

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

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

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

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

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

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

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

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

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

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

Sincerely,

Diana Zuckerman, PhD
President
National Center for Health Research