National Center for Health Research: November 6, 2017

Thank you for the opportunity to express our views about the USPSTF’s evidence review and draft recommendation statement on behavioral counseling interventions for skin cancer prevention. The National Center for Health Research is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work.

Skin cancer prevention is a very important public health issue, and the public needs better information. The USPSTF previously cited evidence linking UV radiation exposure to an increased risk for melanoma later in life for children, and to a lesser extent, adults. Encouraging healthy sun-related behaviors that prevent UV exposure, and ultimately skin cancer, would save lives.

We support the efforts of the U.S. Preventive Services Task Force (USPSTF) to re-evaluate its recommendations in light of new research regarding behavioral counseling interventions to prevent skin cancer. We have a few comments regarding the draft recommendations:

#1: Based on new studies of children younger than 10 years old, we agree that there is sufficient evidence for USPSTF to expand their “B” grade recommendation for fair-skinned individuals from 10-24 years to 6 months-24 years.

#2: We agree with a “C” grade recommendation for fair-skinned adults older than 24 instead of an “I” grade. This means that discussion about behavioral counseling will be left to doctors and patients to decide based on doctors’ professional judgment and patients’ preferences. Some studies indicated that adults benefited from behavioral counseling interventions, particularly for interventions that were longer and more involved (e.g. sun protection-focused text messages over 12 months vs. single behavioral counseling session).

#3: We concur with maintaining an “I” grade for skin self-examination as the review team did not find any eligible studies to evaluate.

#4: Available data present challenges to making recommendations. For example, studies were not sufficiently long-term to study the incidence of skin cancer outcomes. Two adult studies followed patients for 24 months, but most studies only followed patients for 3-13 months. We agree that, ideally, additional studies are needed to assess skin cancer outcomes over a much longer period of time. We also recognize that it is not feasible to study the impact of these interventions long-term and agree with the USPSTF’s focus on reviewing behavioral counseling interventions aimed at promoting sun-protective behaviors that prevent individuals’ exposure to UV radiation in the short-term.

#5: Future reviews and recommendations should expand the recommendations to include people who do not have fair skin and light-colored hair and eyes. Although white people have the highest risk of melanoma and were overwhelmingly represented in this review, researchers noted that it is unknown whether these findings also apply to people of color, who die at higher rates from skin cancer. In addition, it would be beneficial to know if the benefits and risks were similar between men and women and for those who have family members who developed skin cancer.

#6: Studies are needed to determine which, if any, primary care-related interventions are effective for which demographic subgroups. Researchers concluded that successful behavioral counseling interventions were typically multi-component, including varying combinations of intervention components such as in-person counseling, print media, and sun protection aids like sunscreen.

In conclusion, we support USPSTF’s draft recommendations for behavioral counseling interventions to prevent skin cancer as well as their broader efforts to improve the health of all Americans by making evidence-based recommendations about clinical preventive services. As more information becomes available, we encourage the provision of additional recommendations about more specific behavioral interventions to prevent skin cancer for individuals in various subgroups.

For questions or more information, please contact Megan Polanin, PhD, at mp@center4research.org.

National Center for Health Research: October 26, 2017

Dear Council Members,

I am writing to respond to the request for additional information from Councilwoman Cheh as follow-up to my statement and the written materials I provided at the October 13 roundtable on artificial turf.

As the president of the National Center for Health Research, I expressed my strong concerns about the safety of the synthetic turf that the city has used and is continuing to use.  As a scientist who has worked on health policy issues for more than 30 years, I don’t shock easily.  However, the fact that school athletic fields and playgrounds are exposing D.C. children on a daily basis to chemicals and materials that are known to increase obesity; contribute to early puberty; cause attention problems such as ADD; harbor deadly bacteria; and exacerbate asthma is very disturbing.  Surely these are exactly the types of health problems that the D.C. government should be doing its best to reduce, not increase.

Federal agencies were investigating the safety of these products during the Obama Administration and were close to completion when the Trump Administration took over the two federal agencies involved, the Environmental Protection Agency and the Consumer Product Safety Commission.  Despite claims to the contrary at the October roundtable, neither agency has concluded that artificial turf is safe.  However, it is clear that we can’t depend on the Trump Administration to scrutinize the science regarding these products in a way that will be credible, and that means more work for the rest of us who care about children’s safety.

Envirofill and Other Hot Artificial Turf

As noted at the roundtable, all types of turf have risks and benefits, including natural grass.  However, some materials are well known to have substantial risks.  For example, DCPS is installed synthetic turf with Envirofill at Janney Elementary.  Although it is advertised as “cooler” and safer than older types of artificial turf, on a recent 64 degree afternoon, the temperature at the new Janney Envirofill field was 136 degrees, compared to 89 degrees on the grass.  And Envirofill is composed of materials resembling plastic polymer pellets (similar in appearance to tic tacs) with silica inside.  Silica is classified as a hazardous material according to OSHA regulations, and the American Academy of Pediatrics specifically recommends avoiding it on playgrounds. The manufacturers and vendors of these products claim that the silica is contained inside the plastic coating.  However, sunlight and the grinding force from playing on the field breaks down the plastic coating.   For that reason, even the product warranty admits that only 70% of the silica will remain encapsulated.  The other 30% can be very harmful as children are exposed to it in the air; here’s a screen grab from a November 2016 Patriots vs. Seahawks game, which shows how the silica sand infill is kicked up when players dive on a synthetic surface with silica sand infill.

In addition, the Envirofill pellets are coated with an antibacterial called Microban, which is a trade name for triclosan.  Triclosan is registered as a pesticide with the EPA and last year the FDA banned triclosan from soaps because manufacturers were not able to prove that it is safe for long-term use, since research shows a link to liver and inhalation toxicity and hormone disruption.  Microscopic particles of this synthetic turf infill will be inhaled by children, and visible and invisible particles come off of the field, ending up in shoes, socks, pockets, and hair.

I recently gave a guest lecture at a local college and when I asked if anyone had experience with artificial turf, two young women had stories to share.  They described playing on an artificial turf field on a sunny day, where they could actually see the heat waves rising off the field that had a strong chemical odor.

Councilwoman Cheh asked me to provide scientific evidence to back up my statements.  In addition to the links provided above regarding triclosan and silica, I want to describe the data regarding carcinogens and hormone disrupting chemicals that can cause obesity, early puberty, and attention deficits.

Scientific Evidence of Cancer and Other Systemic Harm

First, it is important to distinguish between evidence of harm and evidence of safety.  Companies that sell and install artificial turf often claim that there is “no evidence that children are harmed” or “no evidence that the fields cause cancer.”  That is often misunderstood as meaning that the products are safe or are proven to not cause harm. Neither is true.

It took decades to prove that smoking can cause cancer, a fact that everyone now agrees is true.  As each type of artificial turf is replaced by a new type of artificial turf, it will be equally difficult to prove that these different types of fields cause specific children to develop cancer, obesity, early puberty, or ADD.  For that reason, we need to focus on what is known about the materials the fields are made of and what the implications are for children’s health.

Synthetic rubber and plastic are made with different types of endocrine (hormone) disrupting chemicals as well as carcinogens.  There is very good evidence regarding these chemicals in tire crumb, based on studies done at Yale and by the California Office of Environmental Health Hazard Assessment (OEHHA).  The latter 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 and the other two studies looked at the risk of injury from falls.

The OEHHA studies showed that the children would be exposed to five chemicals, including four PAHs, one of which, chrysene,” was high enough to possibly increase the chances of a child developing cancer.^[1]

Out of the 32 playgrounds studied, 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. All five surfaces made of wood chips met the safety standard.^[1]

A 2015 report by Yale scientists detected 96 chemicals in samples from 5 different artificial turf companies, including unused bags of tire crumb. Unfortunately, the health risks of most of these chemicals had never been studied.  However, 20% of the chemicals that had been tested are classified as probable carcinogens and 40% are irritants that can cause asthma or other breathing problems, or can irritate skin or eyes. ^[2]

Less is known about the materials that are used in PIP and other rubber products; some are recycled tire materials and some are “virgin rubber” but all are made from synthetic rubber, which is a petroleum based product.  This week I visited a playground at Chevy Chase Recreation Center.  Although the playground seems to be a relatively new solid rubber surface, there are several areas that are already broken, with dark crumb rubber and other very small colorful particles clearly showing. Some of the particles look like they could be from plants, but you can’t crush or tear them as you can with plant material.  Children can pick up those particles intentionally or unintentionally; little children are likely to eat it or get it in their mouths, shoes, or clothes, and children of any age will certainly get it on their skin.  As noted above, the evidence is clear that these rubber particles are dangerous.

Rather than provide a lengthy description of all the studies showing the impact of hormone-disrupting chemicals (also called endocrine disrupting chemicals or EDCs), I will assume you know that the evidence is clear about those chemicals being in rubber and plastic and causing health problems.  Scientists at the NIH environmental institute, which is called the National Institute of Environmental Health Sciences, have concluded that unlike most other chemicals,  hormone-disrupting chemicals can be dangerous at very low levels as well as at higher levels, and the exposures can be even more dangerous when they combine with other exposures in our environment.  That is why the Consumer Product Safety Commission has banned numerous endocrine disrupting chemicals from toys and products used by children ages 3 and younger.  Like playgrounds and artificial turf fields, these products were sold in the U.S. for many years prior to the ban, because the companies were not required to prove that the products were safe.

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

That article lists numerous EDCs found in rubber products and warns that “studies are beginning to demonstrate the contribution of skin exposure to the development of respiratory sensitization and altered pulmonary function. Not only does skin exposure have the potential to contribute to total body burden of a chemical but also the skin is a highly biologically active organ capable of chemical metabolism and the initiation of a cascade of immunological events, potentially leading to adverse outcomes in other organ systems.”

Dangers of Hard Fields and Playgrounds

I want to briefly mention safety issues pertaining to Gmax scores.  As you know, a Gmax score over 200 is considered extremely dangerous and is considered by industry to pose a death risk.  The synthetic turf industry and ASTM suggest that scores should be below 165 to ensure safety comparable to a grass field.  At the roundtable it was mentioned that grass fields can also get extremely hard, which is true.  However, the hardness of natural grass fields is substantially  influenced by rain and other weather; if the field gets hard, rain or watering will make it safe again.  In contrast, once an artificial turf field has a Gmax score above 165, it needs to be replaced because while the scores can vary somewhat due to weather, the scores will inevitably get higher because the turf will get harder.  Moreover, averaging Gmax scores for a field is an inappropriate way to determine safety.  If a child (or adult) falls, it can be at the hardest part of the field, which is why that is the way safety is determined.

Conclusions

I have appreciated the opportunity to meet with several Councilmembers’ staff and I commend the Council for banning crumb rubber during FY 2018.  Unfortunately, however, Envirofill, “poured in place” rubber (PIP), EPDM, and all the other synthetic materials currently on the market all have petroleum based materials and therefore share some of the same health risks.  While the companies that sell these products claim they are safe and meet federal safety standards, there are currently no federal safety tests required to prove that these products are safe.  In many cases, the materials used are not public, making independent research difficult to conduct. None of these products are proven to be as safe as natural grass in well-constructed fields such as the Maryland Soccerplex. Although a well-respected grass expert offered a free consultation on how to install well-engineered grass designed to withstand rain and play, DGS did not respond to his offer.

I have also attached an annotated bibliography of numerous relevant scientific articles on artificial turf that will help you see that there is growing evidence of the harm of these synthetic materials on fields and playgrounds.  This is just a sample of studies, and there are many more, so let me know if you’d like additional information.

I am one of many parents and scientists in D.C. that are very concerned about the impact of these artificial fields and playgrounds on our children.  It is clear that city officials have assumed these products are safe because the salespeople told them they were safe.  Unfortunately, there is clear scientific evidence that these materials are potentially harmful, and the only question is how harmful are they and how much exposure is likely to be harmful?  Our children deserve better.

Sincerely,

Diana Zuckerman, PhD

President

1. State of California-Office of Environmental Health Hazard Assessment (OEHHA), Contractor’s Report to the Board. Evaluation of Health Effects of Recycled Waste Tires in Playground and Track Products. January 2007. http://www.calrecycle.ca.gov/publications/Documents/Tires%5C62206013.pdf 
2. 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/
3. Anderson SE and Meade BJ, Potential Health Effects Associated with Dermal Exposure to Occupational Chemicals, Environ Health Insights. 2014; 8(Suppl 1): pgs 51–62. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4270264/

National Center for Health Research: October 9, 2017

Thank you for the opportunity to express our views on the U.S. Preventive Services Task Force (USPSTF) draft recommendation statement, evidence review, and modeling report for cervical cancer screening. The National Center for Health Research is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work.

We agree that this is the right time for the U.S. Preventive Services Task Force to re-evaluate its cervical cancer screening recommendations, due to new research studies and decision modeling analysis. In 2012, the USPSTF recommended starting screening at age 21 and stopping at age 65. Women could get a Pap every 3 years, or starting at age 30, women could get both a Pap and HPV test (co-test) every 5 years. Based on the USPSTF’s review, we agree with maintaining most of the 2012 recommendations, but have significant concerns about changes USPSTF has proposed.

We are very concerned about the proposed grade “A” recommendation to exclusively screen women with the HPV test every 5 years starting at age 30. As the Task Force recognized, clinical trial evidence to support primary HPV screening as a preferred screening strategy is inadequate. There is also a lack of well-designed and implemented clinical trials comparing co-testing and primary HPV screening. The pivotal ATHENA trial, the U.S. prospective study supporting the efficacy of primary HPV screening, had significant shortcomings and does not provide clear and substantial evidence that primary HPV testing reduces cancer incidence or mortality. The Task Force appropriately classified this study as “poor quality” and excluded it from the draft evidence review. However, some medical societies are still quoting it.

Due to lack of available evidence, the Task Force relied heavily on mathematical models to arrive at the grade “A” recommendation. While mathematical models that incorporate real world data help to support available evidence, they are hypothetical, and conclusions must still be weighed against evidence from clinical trials and observational studies. This definitely is well below the standard of an “A” recommendation; in fact, we believe screening based exclusively on HPV tests should not be recommended.

Based on the USPSTF’s decision modeling analysis, primary HPV testing potentially confers a slightly higher mortality benefit (approximately 10 life-years per 1000 women) compared to cytology alone, but it requires significantly more colposcopies to be done for each possible cancer averted (766 vs. 39). Moreover, the models demonstrate that primary HPV testing and co-testing prevent approximately the same amount of deaths, but co-testing would require more total tests (19,806 vs. 12,151). However, models are necessarily based on assumptions that are not necessarily accurate.  The conclusions from these models are not based on research conducted on actual patients.

In addition, while the USPSTF depended on the draft modeling report to conclude that primary HPV screening may provide more benefits than harms, other recent modeling analyses by Felix et al., concluded that screening by co-testing may be superior to screening by HPV test alone. Therefore, the totality of the evidence does not support eliminating co-testing as an acceptable strategy.

We therefore conclude that the Task Force’s grade “A” recommendation assigned to primary HPV screening is inappropriate, because it is primarily based on modeling analysis and not clinical trials or real-world data. This grade “A” would certainly mislead physicians and women to believe that there is incontrovertible evidence to support an HPV testing-only screening strategy rather than co-testing or Pap smear only testing. Since the recommendation is that women can select a Pap smear every 3 years or the HPV test every 5 years, many women will likely choose the less frequent screening option, not realizing that they will be at increased risk of needing additional, more invasive testing with the HPV test only screening.

The seven cited randomized clinical trials are difficult to interpret. First, the studies cannot be assumed to be representative of women in the U.S. since they were conducted primarily in European countries with national screening programs and more standardized triage strategies. Second, the studies were extremely heterogeneous in terms of test technology, screening intervals, and follow-up protocols. Third, the study results were mixed. For instance, the NTCC phase II trial found that hrHPV test alone had a higher CIN3 detection rate only in the first screening round, and actually had a lower rate of detection in the second round. The Task Force’s review contends that the “cumulative rate was still double.” However, it is possible  that detection rates of CIN3 declined in the second screening round because the lesions regressed due to HPV clearance.  Thus, perhaps the colposcopies triggered by HPV positivity in the first screening round were unnecessary. Bottom line: these data are inconclusive. Last, the studies included surrogate endpoints for cancer incidence and mortality, such as CIN2 or CIN3 detection. These endpoints are likely not the most meaningful outcomes for women, since CIN2/3 lesions do not always progress to cervical cancer and sometimes regress instead.  There are several other determinants of disease trajectory that may differ among women in different countries.

While we understand why the USPSTF advises women to “discuss with their provider which testing strategy is best for them” it is obvious that this advice will not necessarily provide excellent guidance for the average patient.  Many providers will not realize that population-based studies and well-conducted clinical trials do not substantially support primary HPV as a preferred testing strategy. Instead, providers are likely to depend on the USPSTF recommendation or those of medical societies, rather than careful scrutiny of the data.  Furthermore, the triage strategy for a positive HPV test is not standardized; it varies from cytology test, HPV genotype test, or direct colposcopy. Such a decision would depend on organized follow-up and would necessitate an informed discussion, which may not be possible in a single office visit. As suggested in the ARTISTIC subsample, a positive HPV test is likely to cause anxiety, and many patients will undergo colposcopy they would not have been needed had they been screened with a Pap smear instead.

In conclusion, we agree with maintaining much of the 2012 recommendations, but we strongly disagree with the proposed “A” rating for HPV testing alone, and urge that the USPSTF reconsider the shortcomings of the evidence and revise their recommendation to give preference to co-testing and Pap smears alone, rather than stand-alone HPV testing.

Thank you for the opportunity to comment on this most important issue which will have an impact on the lives of many adult women on a national level.

For questions or more information, please contact Danielle Shapiro, MD, MPH at ds@center4research.org.

References:

Felix, JC., et. al. The Clinical and Economic Benefits of Co-Testing Versus Primary HPV Testing for Cervical Cancer Screening: A Modeling Analysis. J Women’s Health. 2016; 25(6):606-16

Draft Recommendation Statement: Cervical Cancer: Screening. U.S. Preventive Services Task Force. October 2017. https://www.uspreventiveservicestaskforce.org/Page/Document/draft-recommendation-statement/cervical-cancer-screening2

Megan Polanin, PhD, National Center for Health Research: September 13, 2017

Thank you for the opportunity to speak today. My name is Dr. Megan Polanin. I am a Senior Fellow at the National Center for Health Research. Our research center analyzes scientific and medical data and provides objective health information to patients, providers, and policymakers. We do not accept funding from industry, so I have no conflicts of interest.

An effective shingles vaccine is important for public health. As patients get older, they are more likely to develop long-term pain, or post-herpetic neuralgia (PHN), as a complication of shingles. This pain can be severe and chronic. There is no cure, and treatments do not reliably relieve pain for all patients. The only way to reduce the risk of developing shingles and PHN is to get vaccinated.

Like any public health strategy, a vaccine’s benefits must outweigh its risks. Based on available research, Shingrix has displayed significant benefits compared with the current shingles vaccine on the market, Zostavax:

1) Shingrix showed much higher levels of vaccine efficacy (e.g. 97% for 50+ and 90% in 70+) ​ than the current shingles vaccine. Zostavax only reduces the occurrence of shingles by about half for patients 60 and older, and its effectiveness declines as patients age.  For patients 80 and older, Zostavax is only 18% effective.

2) Shingrix has displayed efficacy in preventing ​PHN​ in patients 50 years and older by preventing shingles. Zostavax is less effective in preventing PHN because it is less effective at preventing shingles. For people who were vaccinated and still developed shingles, Zostavax helped to reduce the duration of PHN, but not the severity of pain.

3) Shingrix can potentially be administered to vulnerable patients with ​weakened​ immune systems. Zostavax is a live attenuated vaccine, and therefore is not safe for people with weakened immune systems, such as patients who have had radiation or chemotherapy and those with HIV.

Shingrix requires two doses while Zostavax is a one-time injection. However, that is a small price to pay for a much more effective vaccine.

Post-licensure studies are critical as we need long-term data to evaluate Shingrix’s long-term efficacy for patients 50 years and older. This is especially relevant since Zostavax may no longer be effective 8 to 11 years after vaccination. The company’s proposed long-term follow-up studies will help to determine whether Shingrix is able to protect older adults from contracting shingles as they age. It is essential that those studies be completed in a timely matter and that the company provide adequate incentives to patients to stay in the study.

We do have some concerns about risks. Patients treated with Shingrix had a higher rate of common adverse reactions (e.g. 74% vs. 9% for placebo group), such as pain, swelling, and fatigue. In addition, one serious adverse event, supraventricular tachycardia, was reported more frequently for patients vaccinated with Shingrix compared with patients who had not during the 30-day post-vaccination period. We are also concerned about optic ischemic neuropathy, which was reported within 30 days by 2 patients, within 2 months by another patient, and not reported at all in the placebo group. These issues warrant further attention.

For that reason, we agree with the company and FDA reviewers that continued pharmacovigilance is critical to evaluate adverse events for patients vaccinated with Shingrix compared to those vaccinated with Zostavax and those with placebo. This should include uncommon adverse events observed soon after vaccination and any other adverse events that may arise with larger sample sizes in longer-term studies.

We concur with the FDA’s requests that the company specifically address risks of inflammation from the vaccine, which can lead to the some of the adverse events reported during pre-licensure studies (e.g. optic ischemic neuropathy, gout).

We urge this Advisory Committee to recommend that the FDA require critical post-approval long-term studies to further evaluate the efficacy and safety of Shingrix. We also strongly recommend that the company conduct subgroup analyses to ensure that the vaccine is safe and effective for both women and men and also people of color.

Thank you for the opportunity to share our perspective.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 11-0, that the available data are adequate to support the efficacy and safety of Shingrix when administered to adults 50 years of age and older.