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Opinion: Are Turf Fields a Safe Place for Kids to Play in Westfield?

Dr. Diana Zuckerman, PH.D, Tap into Westfield: September 12, 2022


As a mother, I used to think that artificial turf and rubber playground surfaces were a clever and attractive alternative to grass fields. As a scientist, however, I learned that my children were being exposed to unsafe chemicals without my knowledge or consent.  I recently wrote to the mayor, superintendent of schools and members of the Westfield Town Council and Board of Education to share scientific information about artificial turf and playground surfaces. I want to provide the same information to you, so you can determine what is best for Westfield.

As president of the National Center for Health Research, I have testified about these products to local, state and federal agencies and legislators; parents; and others who want to ensure that our children are not exposed to dangerous chemicals that can harm them now or as they grow up. Our nonprofit think tank includes scientists, physicians and health experts who conduct studies and scrutinize research conducted by others. We explain scientific and medical information that can be used to improve policies, programs, services and products.

Toxic Chemicals in Artificial Turf and Infill Materials

In recent years, scientists have learned about lead and PFAS in artificial turf, as well as the risks of some of the newer infill materials that are available to replace tire crumb and that are used in rubber playground surfaces. Tire crumb and rubber have well-known risks, containing chemicals that increase obesity; contribute to early puberty; cause attention problems such as ADHD; exacerbate asthma; and eventually cause cancer. However, the plastic grass itself has dangerous levels of lead, PFAS, and other toxic chemicals as well.

PFAS are of particular concern because they enter the body and the environment as “forever chemicals.” They are not metabolized and do not deteriorate, accumulating over the years. PFAS can cause liver damage and other serious health problems.  PFAS from artificial turf can get into groundwater, streams, etc. and from there into drinking water. New Jersey has one of the most stringent standards for PFAS in drinking water.

Replacing tire waste with silica, zeolite and other infill materials also has substantial risks.  For example, it is well known that “particulate matter” can cause lung problems and eventually cause lung cancer.

Evidence of Harm vs. Evidence of Safety

Scientists at the National Institute of Environmental Health Sciences (which is part of NIH) have concluded that unlike most other chemicals, hormone-disrupting chemicals (found in artificial turf and plastic) can be dangerous at very low levels, and also when they combine with other exposures in our environment.  That is why the U.S. Consumer Product Safety Commission has banned these chemicals from toys, pacifiers, teething toys and other products used by young children.

Companies that sell and install artificial turf often claim there is “no evidence children are harmed” or “no evidence that the fields cause cancer.” This is often misunderstood as meaning the products are safe or are proven to not cause harm. Neither is true.

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

As an epidemiologist, I can tell you that for decades there was no evidence that smoking or 9/11 exposures caused cancer. It took many years to develop that evidence, and the same will be true for artificial turf.

We know that the materials used in artificial turf and rubber playground surfaces contain carcinogens.  When children are exposed to those carcinogens day after day, week after week, and year after year, it increases the chances of our children developing cancer, either in the next few years or later as adults. That should be adequate reason not to install them in your community.

I grew up in New Jersey and know that when the weather is warm and/or sunny, it is usually quite pleasant to be outside. But when the temperature above the grass is 80 degrees Fahrenheit, artificial turf and rubber playground surfaces can reach 150 degrees or higher. A sunny 90-degree day could exceed 160 degrees on these surfaces. These temperatures can cause “heat poisoning” as well as burns.

Bottom Line

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

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

I am not paid to write to you or to speak at meetings on this topic. I do so because I care about the health of my children and yours.

To read the entire op-ed on the Tap on Westfield website, click here.

Letter to the Editor: Asphalt playgrounds are bad for kids. So is artificial grass

Los Angeles Times and Yahoo News, September 7, 2022


To the editor: It’s frightening that L.A. schoolchildren are playing on sizzling asphalt, but the commentary and reporting on it miss an important part of the story.

Years of research show that the school playground surfaces that are even hotter than pavement are made from artificial turf or colorful rubber. On a warm, sunny day, when grass fields are about 90 degrees, artificial turf fields are often 150 degrees or hotter; my organization has measured temperatures up to 180 degrees. Rubber playground surfaces are similarly hot.

Artificial turf is sometimes installed in an effort to save water, but unfortunately, artificial turf must be watered to prevent it from getting so hard that it can cause injuries when children fall.

Scientists have clearly documented the dangers of artificial turf, including heat and PFAS and other chemical exposures, but their concerns are regularly ignored by school boards and other community decision makers. The Times can contribute to the health and safety of children across the country by examining what these dangers are and why they are being ignored.

Diana Zuckerman, Washington

The writer is president of the National Center for Health Research.

This letter originally appeared in Los Angeles Times.

Trump Covid Report Stirs Calls for FDA to Rebuild Public Trust

Celine Castronuovo and Jeannie Baumann, Bloomberg Law, August, 26, 2022


A House report detailing coordinated attempts by Trump White House officials to influence the FDA’s pandemic response underscores the need for more transparency at an agency that’s facing historically low public trust, health policy analysts say.

The House Select Subcommittee on the Coronavirus Crisis said this week that advisers to former President Donald Trump sought to build support for hydroxychloroquine as a Covid-19 treatment, despite limited evidence on its efficacy. The report serves as a reminder of how allegations of behind-the-scenes political pressure can influence the public’s perception of federal health agencies’ independence.

“When things are happening behind closed doors, it’s easier for people to try to mess with the FDA,” said Joshua M. Sharfstein, who served as the FDA’s second-in-command during the first two years of the Obama administration.

“The more transparent FDA is, the harder it is for someone to come in and try to interfere with decisions,” he added.

The report comes as positive ratings of the US public health system dropped by nearly 10 percentage points over the past decade, according to a May 2021 joint study by the Robert Wood Johnson Foundation and the Harvard T.H. Chan School of Public Health.

Former federal officials and policy watchers say the FDA must maintain transparency in decision making to prevent external influence, especially as the agency oversees several ongoing health priorities—including authorization requests for omicron-specific Covid-19 vaccines and responses to the growing monkeypox outbreak.

The latest findings have garnered mixed reactions, with some policy watchers saying it shows the FDA defended scientific evidence in the face of efforts to politicize health policy. Others say any reports of attempted political interference is damaging to public trust in the FDA and other agencies.

FDA Commissioner Robert M. Califf has said he will make combating health misinformation a priority of his tenure. And “throughout the pandemic, the FDA career staff has worked around-the-clock to make the best, science-based decisions on behalf of the American people in a rapidly evolving and unprecedented public health emergency,” agency spokesman Michael Felberbaum said in an emailed statement.

Building Resiliency

The subcommittee’s document, which also alleges efforts to promote convalescent plasma as a Covid-19 treatment ahead of the 2020 Republican National Convention, marks the second in a series unveiling findings from an investigation into Trump administration interference with federal health agency pandemic responses.

Many of the Trump administration’s alleged attempts to interfere happened behind closed doors, though the report found the FDA stood up to pressure to keep hydroxychloriquine around after data showed it lacked efficacy as a Covid-19 treatment. The FDA authorized the drug in March 2020 as a treatment for certain hospitalized Covid-19 patients. It revoked the emergency use authorization in June 2020.

Meanwhile, the FDA muscled guidance past the White House that made clear the agency wouldn’t let politics tamper with its decisions, all while facing pressure to authorize vaccines before the 2020 election.

Former FDA Commissioner Stephen Hahn said in an interview with the subcommittee that chief of staff Mark Meadows and other White House officials had “objections” to vaccine guidance language requiring that manufacturers submit at least two months of follow-up safety data for late-stage clinical trials. Hahn said he resisted attempts to change the guidance because “any changes would be obviously reported and would further reduce vaccine confidence.”

[….]

Fighting Misinformation

Califf’s efforts to highlight the dangers of the pandemic’s rise in health misinformation is one way to rebuild public trust in the FDA, although the overall effort will be a challenge, policy analysts say.

“There are some people for whom I think it will be difficult, if not impossible, to regain their trust,” Diana Zuckerman, president of the National Center for Health Research and a former senior policy adviser to the Clinton White House, said. “It’s not really that much the fault of anything that the FDA did; it’s the fault of the misinformation they’re getting from news sources or social media.”

Califf wrote in an Aug. 22 article in the Journal of the American Medical Association that “the global information environment has been contaminated by misinformation and disinformation.”

“The FDA must be more proactive in preempting and countering misinformation,” he said, adding that there’s also a need for “collaboration across sectors to create an information environment in which decisions” by “consumers, patients, and clinicians are more likely to be informed by reliable information based on high-quality evidence from trustworthy sources.”

Zuckerman argued that “Commissioner Califf has made it clear that he will not let the FDA’s reputation be undermined by misinformation.”

“He’s not going to have a political hack telling him what to do or say, and he’s shown a commitment to focusing on the science and protecting the reputation of the FDA,” she said.

To read the entire article, click here.

Diana Zuckerman Statement on the Role of FDA in Health Inequities Meeting of the National Academy of Medicine

July 26, 2022

Thank you for the opportunity to speak today on how current FDA policies contribute to health inequities.

The National Center for Health Research is a nonprofit think tank founded in 1999 that conducts research and scrutinizes research conducted by others to evaluate medical products, procedures, and policies. We do not accept funding from companies whose products we evaluate.

There are many reasons for health inequities in the U.S., but today I will focus on one that usually gets no attention: Federal laws regarding diversity in clinical trials.

The U.S. Department of Health and Human Services requires research studies to include people representing diverse racial and ethnic backgrounds. This is not always enforced, but the requirement is in the law and NIH, CDC, SAMHSA and other agencies make an effort to abide by this law.

The one exception among federal public health agencies is the FDA, which encourages but does not require diversity in clinical trials. They justify this because the agency doesn’t pay for the studies – the companies that make the products pay for the studies. However, taxpayers do pay for FDA staff that regulate these products, and taxpayers also pay for the products themselves.

Our NCHR Study of Racial Diversity

To see the impact of the lack of a requirement for FDA, we examined 22 of the highest risk medical devices reviewed by the FDA Advisory Panels for 4 recent years. We found:

  • The number of nonwhite patients in key trials ranged from 4 (3%) to 6,788 (17%).
  • Of 19 treatment devices, only 7 had analyses for racial groups for effectiveness and only 3 for safety.
  • 69% to 99% of the patients in the studies were White. The number of nonwhites was as low as 4; 1 for Hispanics.
  • There were too few patients in most racial or ethnic groups to draw meaningful conclusions.
  • Even when subgroup analyses were conducted, their conclusions were often discredited by the FDA, blamed on chance differences due to small sample size. If there was a lack of diversity or even when racial or ethnic differences were significant, that information was were often not included on the label, which is the main source of information for physicians and patients.

    Recent Examples from the FDA

    When the FDA reviewed the data on Aduhelm for Alzheimer’s Disease, they focused on 2 studies comparing placebo to high and low dosage:

    Study 301: 8 Black patients (half of 1%) and 37 Hispanic patients (2%)
    Study 302: 11 Black patients (less than 1%) and 67 Hispanic patients (4%)

    When the FDA reviewed data on the Reducer circulatory system device for angina, they found that there were no Black or Hispanic patients, and more than 80% of the patients were White or male, or both. And yet, most patients with angina are not White males.

    Why is Diversity Important in Clinical Trials?

    Response to treatment can vary due to genetics, health habits, metabolism, body part size/shape and other factors. If you exclude certain groups, you don’t know what works best for them. Keep in mind that you need enough patients to study safety and effectiveness for patients in each group.

    Example – Lutonix drug-coated balloon catheter to open blocked arteries

    You can see on this graph that the device seemed effective compared to the control group when men and women were combined. However, you can also see that the device was only effective for men, not for women. In fact, women did better with placebo. This is an example of how evaluating safety and effectiveness for a specific demographic group can provide information that is completely different from an analysis of a diverse group as a whole.

    Shortcomings of Very Small Samples

    When the racial or ethnic group is very small, the results may not be generalizable to the larger population that those patients represent. A few outliers can have an outsized effect on the outcomes – resulting in significant differences where they do not exist. Or, real differences may be apparent but not be statistically significant because the sample lacks statistical power.

    If an analysis is conducted on a small number of patients of a particular ethnic group, any differences could easily be due to chance. For example, the graphic below shows that the new drug seems to be more effective than an older drug (40% effective compared to 30% effective) , but that difference is not statistically significant. However, if the same difference was based on a much larger sample, it would be statistically significant.

    In conclusion, when the FDA approves a medical product that has not been evaluated on a relatively large number of patients in a specific racial or ethnic group, it is not possible to conclude whether the product is safe or effective for members of that group. If the FDA does not require adequate diversity in clinical trials used as the basis for FDA approval, then the agency should only approve those products for the types of individuals studied. That precision in approval decisions would create the incentive needed for companies to improve diversity in their trials and conduct appropriate subgroup analyses.

    Reference
    1. Fox-Rawlings SR, Gottschalk LB, Doamekpor LA & Zuckerman DM. (2018) Diversity in Medical Device Clinical Trials: Do We Know What Works for Which Patients? Milbank Quarterly, Vol 96 (3) 499-529.

    Dr. Diana Zuckerman Statement to CDC Advisory Committee On Breast Cancer in Young Women

    August 23, 2022

    I’m pleased to have the opportunity to provide this statement on behalf of the National Center for Health Research. We are a nonprofit research center, and our largest program is focused on cancer prevention and treatment. I previously worked at the White House office of Science and Technology Policy, the U.S. Department of Health and Human Services, the U.S. House and Senate, Harvard, and Yale. I am also a breast cancer survivor.

    Today I want to mention an issue that hasn’t been talked about: fear. Research shows that many young women are disproportionately afraid of breast cancer and that young breast cancer survivors are more afraid of recurrence than older survivors. I encourage you to think of what we can do together to help reduce that fear so that young women don’t let their fear overwhelm them as they become aware of and educated about their risks as well as their prevention and treatment options.

    Despite their fear, few women of any age know that diet and exercise help prevent breast cancer. You’ve heard today that alcohol increases the risk of breast cancer, but did you know that drinking more than 3 alcoholic beverages per week can raise the risk of breast cancer? We all know young women who drink much more than that. We should also educate young women about the link between cancer and ultra-processed foods – I’m not just talking about the usual culprits, I’m talking about sauces and many other prepared foods that we assume are healthy when we buy them at the supermarket. In addition, being overweight or obese also increases the risk of breast cancer and of recurrence, because fat cells make more estrogen. We should be educating young women about these strategies for reducing their risks, since these are changes they can control.

    Research shows that more women undergo mastectomies and bilateral mastectomies in the U.S. than most comparable countries. And yet, research shows that early-stage breast cancer patients who undergo lumpectomy (BCT) and radiation live longer with better quality of life than early-stage mastectomy patients, and a study of more than 23,000 young women with early-stage breast cancer found that the 10-year survival rate was at least as good for BCT plus radiation as for mastectomy. Research is needed to see how outcomes vary among women with specific demographic traits and risk factors, but the research available thus far is reassuring. On a personal note, as a professional in the field, I was shocked when my breast surgeon repeatedly urged me to consider a bilateral mastectomy for Stage 1 breast cancer. I had heard from many other women who had similar experiences. I am sure women who aren’t experts in the field, and especially young women, are being influenced by that kind of pressure.

    In addition to all the other important issues raised by this committee today, I want to add that we should make sure that young women understand the difference between lifetime risk of breast cancer and their annual risk of developing breast cancer. And the difference between DCIS and invasive breast cancer. Educating young women can help reduce their fear and help enable them to take the time they need to advocate for themselves based on the information needed to make the treatment decisions that are best for them.

    One last suggestion: We’ve heard many great ideas today about the information that primary care physicians, OB/GYNs, and the public need to know about young women and breast cancer, as well as prevention and treatment strategies. Wouldn’t it be great if CDC put together an education campaign on some of these key issues, to be shown on TV so it reaches a large audience?

    Draft Senate Contact Letter for Patients Supporting User Fee legislation With Policy Riders

    [Date]

    Dear [Name of Senator],

    I am writing on behalf of myself as a cancer [patient/advocate] and constituent of the state of [add State] to convey my strong opposition to efforts to strip user fee legislation of important public health protections in favor of a “clean” user fee bill. I urge that as you work to reconcile these bills, you address urgent public health challenges by maintaining critical protections in the FDA Safety and Landmark Advancements Act (FDASLA), S. 4348.

    This legislation must include provisions that will help ensure the safety and efficacy of cancer drugs, as well as accuracy and reliability for cancer-related diagnostic tests. Accelerated approval reform is necessary to protect patients such as [myself/ my relative/other] from harmful and possibly ineffective treatments. Reform to diagnostic tests will provide the FDA with the authority and resources necessary to ensure that the highest-risk diagnostic tests are valid and reliable. Increasing numbers of patients make life-altering decisions based on diagnostic tests, which can be used to predict cancer or fetal abnormalities.

    We urge you not to forgo this key opportunity to advance long-awaited solutions for the American public. While some provisions could be strengthened still further from the Senate version, we express our continued support for the meaningful reforms contained in the bill, and hope that Congressional and committee leadership remain committed to negotiating these protections as you advance this important legislation.

    Thank you,

    [Name]

    [Affiliation if applicable]

    NCHR Comments on Recommended Diversity Plan to Improve Enrollment of Racial and Ethnic Minorities in Clinical Trials

    June 13, 2022.

    National Center for Health Research’s Comments on Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials [FDA-2021-D-0789]

    We are writing to express our views on the Food and Drug Administration’s (FDA) draft guidance to provide recommendations to sponsors developing medical products on the approach for developing a plan to enroll representative numbers of participants from underrepresented racial and ethnic populations.

    The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

    We strongly support the proposed recommendations which provide specific, actionable guidance for sponsors to develop a meaningful Race and Ethnicity Diversity Plan. In particular, we appreciate the proposed recommendation for sponsors to clearly define and justify enrollment goals for underrepresented racial and ethnic minority populations. Most important, representation in a trial must be adequate to conduct appropriate subgroup analyses on efficacy and safety. For example, if a minority group is 20% of the patient population but there are only 100 patients in the entire study, 20 patients would be 20% but would not be sufficient to determine safety or efficacy for that group.

    It is thus encouraging that the draft proposal recommends that sponsors provide any available evidence describing disparities in health outcomes related to the drug or therapy, but acknowledges that the lack of this evidence should not be grounds to ignore the importance of diversity.  For too long, many clinically meaningful disparities in the efficacy of drugs or therapies in minority populations have been hidden by a lack of data. Thus, it is crucial to ensure that sponsors describe existing research on similarities and differences in how the disease or condition under study is experienced by racial and ethnic minorities, and identify potential gaps in existing data.

    The goal is for the inclusion of these recommendations to improve the accountability of sponsors to make real and sustainable improvements in the representation of minorities in trials. However, to truly hold sponsors accountable, this draft proposal should go further by providing meaningful incentives for sponsors to follow the recommendations outlined. The most meaningful incentive within current law would be that FDA make it clear that the agency will not approve medical products for all populations if the product was not adequately tested for safety and efficacy on sufficient numbers of patients representing major demographic subgroups.

    National Center for Health Research can be reached at info@center4research.org or at (202) 223-4000.

    FDA official bolting to Big Tobacco shines a light on the agency’s revolving-door problem

    Dan Vergano, Grid News, August 3, 2022


    The departure of the head of the Food and Drug Administration’s tobacco science office for a job in the tobacco industry shines a new spotlight on a long-running problem: the “revolving door” between government regulators and the industries they police.

    Matt Holman, whose work at the FDA influenced decisions around the safety of products such as e-cigarettes, left the agency Tuesday for a job with Philip Morris International, whose products — sold overseas — include Marlboro cigarettes and the electronic tobacco-delivery system IQOS.

    Agency watchdogs say where there is smoke, there’s an ethics fire. They’ve warned of revolving-door concerns — only well-documented for high-level positions and for the Defense Department — for decades. But there is little hard data on just how big the problem is. A Grid analysis of LinkedIn profile data suggests that at least 2,700 ex-FDA employees now work for the pharmaceutical industry. Another 1,100 current FDA employees have moved the other way, from industry to the agency, according to the profile information.

    Former FDA employees are found throughout many other industries regulated by the agency as well: Around 1,200 now work in the biotechnology industry, and more than 600 work in the medical devices industry. Some of the most high-profile examples include Trump FDA chief Scott Gottlieb, on the board of directors of Pfizer weeks after he left the job, as well as the current commissioner, Robert Califf, who went from heading FDA during the Obama administration to Alphabet Inc.’s health subsidiaries, and then back to heading the agency this year. Califf pledged not to work for a pharmaceutical or medical device firm for four years after leaving his current post to win the Senate votes he needed for his confirmation.

    In a July 26 memo announcing Holman’s departure, newly installed FDA Center for Tobacco Products Director Brian King said that Holman had recused himself from tobacco-related regulatory decision-making and been on leave before July. “I’m grateful to Matt for his contributions to the Center and unwavering commitment to you all over the years,” said King.

    The numbers are both interesting and not surprising, said Michael Carome of Public Citizen, a public health watchdog group based in Washington, D.C. The count likely underestimates the number of agency employees who have jumped to the industries they once regulated, he added, and obviously doesn’t include industry figures who have moved to the agency, where they briefly stay before returning to their home industry, another area of concern for ethics experts.

    “Unfortunately, when you see somebody go from a regulating agency to the regulated industry, the public is naturally going to react like it’s a betrayal, because it does call into question your commitment to the mission of protecting the public,” said government ethics expert Walter Shaub of the Project on Government Oversight. While regulated companies may honestly want the expertise of the people charged with regulating them, said Shaub, “the other thing is that they want to know the inside workings of the FDA.”

    “They want to, or one might suspect they want to, create an atmosphere in which employees at FDA know that there’s a lucrative job waiting for them, potentially, as long as they don’t really upset the regulated industry, right? I just think that’s human nature,” he added.

    [….]

    Regarding Holman, Philip Morris International said the former FDA official “is committed to helping existing adult smokers access scientifically substantiated smoke-free alternatives while protecting youth,” in a statement sent to Grid.

    Holman is barred from communicating with the FDA about Philip Morris for a year, under ethics rules, and about any matter he was personally involved with at the agency for life. In comments to the New York Times, Holman defended his move, noting that he consulted with agency ethics lawyers and viewed Philip Morris International as moving away from cigarettes to less harmful tobacco products, saying he could have jumped to the industry much earlier after 20 years at the FDA if that had been his goal. (He has not yet responded to a request for comment from Grid.)

    However, numerous regulatory affairs or drug development employees at FDA-regulated pharmaceutical companies, including Merck, Abbott and Johnson & Johnson, worked at the FDA for more than a decade prior to moving to the industry, according to the LinkedIn data. “The idea that they recuse themselves is really BS, because they are telling the companies how to manipulate the system behind the scenes,” said Diana Zuckerman, president of the National Center for Health Research, herself a former Department of Health and Human Services employee.

    Holman’s departure comes as the Biden administration has turned up the heat on the tobacco industry, planning to require slashing nicotine in cigarettes to minimally addictive levels, and moving to prohibit menthol cigarettes. A 2016 law has led to a crackdown on e-cigarettes, threatening small vaping shops and leading to a lawsuit with Juul after the agency last month ordered the e-cigarette maker to halt sales, despite allowing tobacco giant RJR to sell its own e-cigarettes. The agency’s tobacco and food safety programs are now under external review after the recent infant formula shortage and a surge in teens vaping nicotine since 2017.

    “There have been a lot of strange decisions coming out of that office,” said Stanton Glantz, founding director of the UCSF Center for Tobacco Control Research and Education, a longtime tobacco industry critic, referring to the Center for Tobacco Products.

    [….]

    To read the entire article, click here.

    National Center for Health Research’s Public Comment on AHRQ Draft Review on Partial Breast Irradiation and Whole Breast Irradiation for Breast Cancer

    July 29, 2022

    We are writing to express our views on the AHRQ Draft Comparative Effectiveness Review comparing Partial Breast Irradiation (PBI) to Whole Breast Irradiation (WBI) as a treatment for early-stage breast cancer.

    The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

    We agree with the AHRQ review that clinical trials provide sufficient evidence that PBI is a valuable treatment option for select patients with early-stage breast cancer. Patient outcomes for several types of PBI did not differ significantly from WBI patients in terms of ipsilateral breast recurrence (IBR), overall survival, and cancer-free survival at 5 and 10 years. However, IORT PBI patients did have higher levels of recurrence (IBR) than WBI patients, despite no difference in overall survival or cancer-free survival.  Overall, PBI patients have fewer acute adverse effects, lower transportation costs and days away from work, and fewer financial strains, making it a more convenient therapy option compared to WBI.  

    However, there are numerous types of PBI, and the data are not adequate on the effectiveness of each one of them compared to WBI.  In addition, we agree with the AHRQ review that there is currently insufficient data to draw conclusions about the risks and benefits of different types of PBI compared to each other or to WBI for women who are diverse in terms of patient, tumor, and treatment characteristics. Outcomes at 15 and 20 years are also important to evaluate. For these reasons, more research is necessary to provide the most useful information to patients considering breast irradiation.

     

    For more information, please contact Dr. Diana Zuckerman at dz@center4research.org. 

    Toxic chemicals lurk at playgrounds

    Ariel Wittenberg, E&E News: July 8, 2022


    When Diana Zuckerman was growing up, there was dirt underneath the slides. Her children played on playgrounds placed atop sand and mulch. But, today, when she drives around her Bethesda, Md., neighborhood, Zuckerman sees [many] rubber playgrounds.

    The sight concerns Zuckerman, because as president for the National Center for Health Research she has testified in front of multiple municipal and even state governments about the toxic chemicals that can lurk in rubber playground surfaces.

    The chemicals can include neurotoxins like lead and other heavy metals, as well as carcinogenic chemicals like polyaromatic hydrocarbons, endocrine-disrupting chemicals like phthalates, and chemicals linked to other organ damage like volatile organic compounds and PFAS, or per- and polyfluoroalkyl substances.

    “All these rubber surfaces, they can be very pretty, and when you know nothing, you think it’s great because if my child fell on it, it is so spongy and pretty and safe,” she said. “But we actually don’t believe that it’s safe from the chemical exposure perspective.”

    Concerns about modern playground surfaces were first raised decades ago, when recycled tire crumb rubber became a popular playground surface. The recycled tires often contained lead and other heavy metals, and public health experts were especially concerned that using the bite-sized material on playgrounds could unnecessarily expose small children, particularly toddlers, who are prone to putting objects in their mouths.

    Nowadays, many municipalities searching for new playground surfaces know enough to stay away from tire crumb rubber.

    But many continue to install what’s called “pour in place” rubber, flat, spongy rubber surfaces that can contain other chemicals of concern, like polyaromatic hydrocarbons, phthalates, and volatile organic compounds. Those more solid rubber surfaces can also contain additives and binders that could harm the health of children, though the exact chemicals vary by manufacturer.

    Artificial turf, long-popular on athletic fields, has also been marketed as a playground surface. Some PFAS are used to manufacture the plastic grass blades (Greenwire, Dec. 8, 2021).

    Sarah Evans, an assistant professor of environmental medicine and public health at Mount Sinai Hospital in New York City, says those poured in place rubber playgrounds still pose exposure risks to kids. Children could pick up chemicals on their hands as they play and then accidentally ingest them when they eat meals or snacks at the playground.

    “We are very concerned about that,” she said. “And we don’t have a good handle of what is in those products.”

    Indeed, the exact risks rubberized playgrounds pose to children are unknown, in part because the federal government’s efforts to investigate the issue have been stalled by both the Trump administration and the coronavirus pandemic.

    In 2016 EPA completed a report looking specifically at tire crumb rubber playgrounds meant only to explain the best ways to test such surfaces for chemicals. A second report meant to characterize potential human exposure to tire crumb rubber has never been released.

    [….]

    In the absence of federal action, industry has continued to say that all playground surfacing options are safe.

    [….]

    Evans, at Mount Sinai, said she also hears from parents who are concerned that their cities and towns have already installed rubber playgrounds.

    Playing outside, even on a rubber playground, can be very important for kids’ development. So, rather than eschew the playground altogether, Evans recommends that parents be extra vigilant if their children play on rubberized surfaces and make sure hands are washed before children eat or as soon as they get home. Kids who play on crumb rubber should shake out their clothes and change when they come home.

     To read the entire article, click here.