Cancer Prevention and Treatment Fund

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Sincerely,

Diana Zuckerman, PhD
President
National Center for Health Research

National Center for Health Research, February 22, 2018

Dear Members of the House Energy and Commerce Committee,

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

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

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

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

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

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

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

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

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

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

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

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

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

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

To improve Right to Try legislation, Congress should:

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

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

Sincerely,

Diana Zuckerman, Ph.D.

President

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

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

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

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

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

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

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

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

What the Scientific Studies Say

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

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

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

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

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

What the EPA Has Done

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

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

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

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

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

References:

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