All posts by CPTFadmin

Medical Professors are Supposed to Share Their Outside Income With the University of California. But Many Don’t.

For nearly two decades, Dr. Neal Hermanowicz has led the movement disorders program at the University of California’s Irvine campus, where he earns more than $380,000 a year in salary and bonuses. The widely respected expert on Parkinson’s and Huntington’s diseases adds to his income by consulting for drug companies.

[…]

In recent years, internal audits at the university’s Irvine and San Francisco campuses have both found that, of a sample of health science faculty, about one-quarter weren’t disclosing all of their outside income. ProPublica’s investigation and the audits show that campus administrators fail to monitor or enforce the rules adequately, and that they rarely penalize violators — a testament, critics say, both to the power of tenured faculty and the university’s desire to accommodate pharmaceutical companies that fund academic research. The underreporting at the UC campuses contrasts with the increase in researchers’ disclosures of potential conflicts in academic journals.

[…]

After Nuplazid hit the market, reports of deaths associated with the drug surged. “It’s a very high number” of deaths, said Diana Zuckerman, president of the National Center for Health Research. While it’s difficult to determine why there are so many fatalities, she said, the drug’s benefit isn’t worth the risk. In hundreds of cases, patients’ hallucinations, which are supposed to subside with the drug, were instead aggravated.

[…]

Some faculty members do take pains to comply with the university’s policy on outside income. Dr. Anjay Rastogi, a professor and clinical chief of nephrology at UCLA medical school, meticulously tracks all payments he receives from industry in a centralized spreadsheet — and remits the required portion, which he said funds academic enrichment, teaching or research.

“We need to disclose everything, I disclose more rather than less,” he said. “In my opinion, it’s fair that we help the university, and they help us as well.”

Read original story here.

Not Just Blowing Water — Vaping Presentation Will Sort Myth and Reality

“We keep calling it vaping, and calling it vapor,” Amy Osterman said. “But it’s an aerosol. It’s more like hairspray.”

That’s an image Osterman, youth marijuana and tobacco prevention coordinator for Walla Walla County’s Department of Community Health, likes to share with parents and teens.

Osterman is one of a trio of specialists presenting a vaping prevention and education night for parents and young adults on Monday.

[…]

Vaping is not safe for teens, kids and young adults, the federal agency has decreed.

School districts nationwide have been caught flat-footed and struggle to banish vaping on campuses, said Diana Zuckerman, author and president of the National Center for Health Research.

[…]

Read original story here.

How Minnesota Schools are Doubling Down on Anti-vaping Efforts

As teen vaping rates continue to rise, Minnesota educators are monitoring their classrooms and hallways for well-disguised vaping devices.

Some are shaped like USB flash drives that students can charge by plugging them in to their laptop. Others double as pens and highlighters. Some are even less conspicuous: shaped like a smart watch, an ID badge attachment and even a replacement hoodie string.

[…]

‘We’re trying to rewrite the script’

In the Forest Lake Area Schools district, J.P. Jacobson, a middle-school principal, says the anti-vaping push has continued to focus on arming students with “good information, so they can make a good choice when there’s not an adult right there.”

That means talking about the health implications with students during advisory periods, reaching students in health classes and putting up anti-vaping posters.

[…]

Building out recovery resources

Working with students in the Wayzata Public Schools district, Ali Wobschall, director of Partners in Prevention, says the addictive qualities of vaping make it particularly concerning.

“I think that’s one of the most difficult aspects of this,” she says. “Because the vape is so highly concentrated with nicotine, addiction is happening faster than with other substances our coalition works to address.”

So while last year’s anti-vaping campaign focused on getting information to students, educators and parents at the secondary level, she says, the focus this year has been on getting students into recovery.

[…]

A less punitive approach

Likewise, in the Rosemount-Apple Valley-Eagan district, health staff are looking at ways to build out a more holistic approach to dealing with vaping in schools — a less punitive approach that’s better fit to address any related mental health issues.

[…]

Health officials have linked recent vaping-related lung injuries to THC and vitamin E oil, mostly found in illegal vaping products. But even legal ingredients — like nicotine and formaldehyde — are “potential carcinogens and very toxic” says Zuckerman. And manufacturers aren’t required to list all of the ingredients, since they’re considered trade secrets.

[…]

Read the original article here.

Report Claims More Women than Men Injured by Medical Devices

Steps had to be taken to identify the gender of those within the database as although the FDA gathers information on the sex of patients, this data is not made publicly available. Therefore, in order to overcome this obstacle, the ICIJ realised that the sex of patients was sometimes disclosed through pronouns and adjectives within the incident reports submitted to the FDA.

[…]

Talking about the findings, the ICIJ stated: “The trend we noticed is consistent with studies that have shown that women experience higher rates of hip-implant failure than men and have stronger immunological reactions to metal-containing devices.”

Other experts within the industry were keen to voice their opinion over the importance of looking at the effects of medical devices on different genders. Diana Zuckerman, president of the National Center for Health Research commented: “Having information about sex is very important because some products differ in safety between men and women.”

[…]

Read original story here.

Should You Get a Sentinel Lymph Node Biopsy (SLNB) for Stage Zero Breast Cancer (DCIS)?

Nina Zeldes, National Center for Health Research


Thanks to widespread use of screening mammography, there has been a dramatic increase in women diagnosed with ductal carcinoma in situ (DCIS), the most frequently diagnosed type of Stage Zero breast cancer. It accounts for 20-25% of new breast cancer cases diagnosed each year. DCIS is referred to as “stage zero breast cancer” or a “pre-cancer” because it is not invasive. It is almost always diagnosed on a mammogram, where it looks like white specks. DCIS rarely forms a lump, which is why it isn’t diagnosed by a breast exam. In DCIS, some of the cells lining the ducts (the parts of the breast that secrete milk) have developed abnormally, but since it is not invasive, it does not spread unless the DCIS changes into stage 1 breast cancer.

DCIS is not painful or dangerous and most women with DCIS will never develop invasive cancer whether they are treated or not. But DCIS can change into stage 1 breast cancer, and it is impossible to predict which women with DCIS will develop cancer and which ones won’t. That’s why treatment is recommended. Fortunately, only 3% of women treated for DCIS die of breast cancer within 20 years.

What are Your DCIS Treatment Options?

DCIS usually grows slowly. A patient can spend a few weeks after her diagnosis to talk with her doctors, learn the facts about her treatment choices, and think about what is important to her before she chooses which kind of treatment to have.

Treatment choices for DCIS are similar to those for invasive breast cancer. Most patients can choose fewer treatments with fewer side effects, but surgery to remove the DCIS is almost always recommended.

Most DCIS patients can choose a lumpectomy (which removes the DCIS but does not remove the entire breast). Radiation therapy and/or hormonal therapy are often recommended to reduce the chances of recurrence, although neither increases the already very good chances of survival.

Sentinel Lymph Node Biopsies for DCIS – Beneficial or Overtreatment?

Some DCIS patients that choose lumpectomy are encouraged to undergo a sentinel lymph node biopsy, which removes a few lymph nodes from under the arm to check if cancer has spread there. However, since DCIS does not spread, experts generally do not recommend this procedure for patients diagnosed with DCIS.

Despite this, approximately one in four women diagnosed with DCIS currently undergo sentinel lymph node biopsies. Is this a good way to “be cautious” to prevent breast cancer in the future, or is it overtreatment?

To find out if there are any long-term benefits for women, Dr. Shiyi Wang and his colleagues at Yale University published a study in 2019[1] that looked at 5,957 women who were diagnosed with DCIS and had undergone a lumpectomy, and compared the women who had also undergone sentinel lymph node biopsies with those who had not.

They found that over the next 5.75 years, the biopsy did not:

  • decrease DCIS patients’ chances of undergoing mastectomy (removal of the breast)
  • decrease DCIS patients’ chances of developing invasive breast cancer
  • reduce the likelihood of a DCIS patient dying from breast cancer

At the same time, the study found that having the biopsy increased the risk for several serious side effects, such as pain, wound infection, and lymphedema. Lymphedema is a painful, chronic condition that can restrict a woman’s arm movements.

The researchers therefore concluded that there are no long-term benefits for undergoing sentinel lymph node biopsies for DCIS patients, and that the risks of complications should convince most DCIS patients and their physicians not to undergo the procedure.

The study was limited to older women (67-94) and did not control for risk factors such as obesity or using hormonal therapy such as Tamoxifen or aromatase inhibitors. For that reason, the results might not be relevant to younger women or women with a high-risk type of DCIS, which can be diagnosed prior to surgery. The possible impact of hormonal therapy or weight is unknown. However, the study has important implications for tens of thousands of women with the most common type of stage zero breast cancer (DCIS).

Bottom Line: Most women who receive a lumpectomy for DCIS (stage zero breast cancer) are being overtreated if they undergo a sentinel lymph node biopsy. The most recent research shows that this procedure has no long-term benefits for most DCIS patients and can cause long-lasting pain and other problems.

Read more information about this study here. You can access the study by clicking on the following link: Long-Term Outcomes of Sentinel Lymph Node Biopsy for Ductal Carcinoma in Situ.

For more information about surgery options for DCIS, see our free DCIS patient booklet. Find out if women with pre-cancers are getting mastectomies they don’t need here. You can also find some more general information about DCIS here. If you want to find out more about radiation therapy for DCIS click here. For more information about hormone therapy, such as Tamoxifen, for DCIS, click here.

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff. 

  1. Hung, Peiyin, et al. “Long-Term Outcomes of Sentinel Lymph Node Biopsy for Ductal Carcinoma in Situ.” JNCI Cancer Spectrum 3.4 (2019): pkz052.

NCHR’s Comments on the Safer Technologies Program (STeP) for Medical Devices

National Center for Health Research, November 18, 2019


National Center for Health Research’s Public Comments on 
Safer Technologies Program for Medical Devices; Draft Guidance for
Industry and Food and Drug Administration Staff; Availability
[FDA-2019-D-4048]

Thank you for the opportunity to express our views on the proposed Safer Technologies Program (STeP) for medical devices.

The National Center for Health Research (NCHR) is a non-profit 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, so we have no conflicts of interest.

We appreciate FDA’s efforts to get medical devices with an improved safety profile to consumers and patients more quickly. However, the mission of the FDA is to protect patients and consumers from medical products that are not proven safe or not proven effective. FDA guidance must be very clear how this program would protect patients from unsafe or ineffective medical devices. The proposed guidance is so vaguely worded that it is not possible to have confidence that patients’ needs will be protected.

We agree that increased interactions with FDA throughout the development process and more timely interactions could 1) speed development and review, and 2) improve the quality of the data available for review by providing more consideration into needed data, study design, and early detection of concerns. Unfortunately, most medical devices are cleared through review pathways that require little or no clinical data to demonstrate safety or effectiveness, and while premarket approval applications (PMA) require clinical trial data, those studies are often small, poorly designed, and lacking in appropriate control groups. Thus, while the proposed Safer Technologies Program may get medical devices to patients sooner, the program will be harmful to patients unless it also strengthens the premarket requirements for scientific evidence of safety and effectiveness.

Textured breast implants, Essure, POP mesh, and metal-on-metal hip replacements are just a few of the many examples of devices that were implanted in tens of thousands of patients and consumers prior to being removed from the market due to serious, unexpected complications. It is disturbing that the proposed guidance includes no explicit instructions aimed at reducing the harm caused when patients unwittingly serve as guinea pigs for implants and other devices that were not adequately tested prior to going on the market. It is not fair to patients or their physicians to rely primarily on post-market studies and surveillance, because too many patients will be harmed before those studies are completed, and too many of those studies will never be completed. We therefore respectfully urge the FDA to revise the proposed guidance in ways that ensure that all medical devices undergo more rigorous testing prior to being approved or cleared.

For questions or more information, please contact the National Center for Health Research at info@center4research.org or at (202) 223-4000.

NCHR Testimony on Research Needed on Immunological Responses to Metal in Implants

Diana Zuckerman, PhD, National Center for Health Research, November 13, 2019


Thank you for the opportunity to speak at this Advisory Committee meeting today regarding immunological responses to metal in implants.

The National Center for Health Research is a nonprofit research center that focuses on the quality of medical products and procedures and does not accept funding from medical device companies or pharmaceutical companies. I’m here today to share my perspective as a scientist as well as a patient.  I am trained in epidemiology and served on the faculty at Vassar and Yale and as a researcher at Harvard.  I’ve also worked in the U.S.  Congress on FDA issues and as president of the National Center for Health Research I have  a great deal of experience with FDA regulatory issues.

In addition, I got a hip implant 10 years ago, and I’m glad to say my experience has been a very good one.  But at the time I was deciding on the surgery, neither the surgeons I interviewed nor the research literature provided the kind of information I needed to make an informed choice.  In fact, one surgeon recommended a metal-on-metal hip for me because I was relatively young and active.  Fortunately, I was already aware of metal debris issues so I did not make that choice.  But the lack of information then and now was very clear to me as a patient.  I was not able to obtain scientific data from the surgeons or online, including PubMed.

I want to say that this has been one of the most interesting and informative FDA meetings I’ve attended, and the speakers have provided a great deal of important information.

What Research is Needed?

I’m here to talk about the big picture.  We’ve heard this morning about a great deal of research findings and the need for more and better research.  I want to emphasize that we need much better pre-market studies, not just post-market studies.  Pre-market clinical trials are often lacking because of the 510(k) process, but even when premarket clinical trials are conducted, they are often inadequate to provide the information patients deserve.

We need clinical trials and other well-designed studies of large number of patients, and as one of the speakers said this morning, we need to compare information about patients who have good experiences with their implants with those who do poorly with their implants.  These studies need to include a patient population with sufficient diversity in terms of age, sex, race, BMI, activity levels, allergies, and metal sensitivity, to determine how safe and effective the products are for these subgroups.

We need clinical trials and big data analyses that follow patients for years in order to evaluate the effects of wear and changes in immune responses over time.

We heard this morning that patch testing is inadequate to identify which patients will have a negative reaction to an implant, and that other diagnostic testing also has limitations.

I also want to express our concern with the tendency to extrapolate results from an implant used in one part of the body to implants made of the same materials that are intended to be used in another part of the body.   We know from listening to patients that this can result in terrible problems.

We are also concerned about extrapolating results from an earlier version of an implant to a newer implant, when the newer implant differs in ways that could affect safety and effectiveness.  Those differences might be different metals, changes in size or shape, differences in manufacturing, or numerous other changes typically made in an effort to improve implanted devices.

We encourage the FDA to require that studies specifically look for adverse events that are related to immune reaction or wear.  These adverse events might be local or might be systemic, and some of these events would not necessarily be included in studies asking about all adverse events.

Perhaps most important, we need comparative effectiveness studies that compare clinical effectiveness and patient-centered outcomes.  I know that the FDA rarely requires comparative effectiveness studies, but those are the types of studies that are most likely to provide useful information for patients and their physicians.

If certain implants seem to be causing certain reactions with certain kinds of patients, wouldn’t it be very important to know how that compares to other alternatives of the same kind of implants? We can’t treat all hip implants that are polyethylene and metal as if they’re all the same.  We can’t treat all metal-on-metal implants as if they’re the same. We need to compare different models, different implants made in different ways with different materials by different companies and get the kind of real data that patients and physicians can use to make informed decisions. Until then, it won’t be possible to figure out to what extent negative responses and implant failures are due to patient vulnerabilities or sensitivities and how much is due to the difference between various devices.

For more information about this public meeting, read these articles here or here.

FDA Challenged Over Metal Implants ‘Public Health Travesty’

Sasha Chavkin, International Consortium of Investigative Journalists: November 14, 2019


Patients who suffered debilitating immune reactions after being implanted with metal-containing devices have joined doctors, scientists and industry representatives to testify before a United States government advisory panel probing the risks of immunological responses to metals placed inside the body.

The hearing represented the most systematic look by the U.S. Food and Drug Administration at the issue of adverse reactions to metals, a problem that affects a minority of implant patients but one that can cause severe pain, neurological damage and cognitive impairments.

“I’m in a great deal of pain, so please bear with me,” testified Sue Francis, a hip implant patient who has experienced severe health effects stemming from her reaction to metal. “We need to recognize that these metals from day one are interacting with our bodies.”

Metals are a major component of common devices such as artificial hips, spinal fusion implants and the contraceptive coil Essure, but there is limited scientific research on auto-immune and allergic responses to them.

The International Consortium of Investigative Journalists reported extensively on hip implants and Essure as part of its global Implant Files investigation, which revealed massive gaps in medical device oversight that left patients vulnerable to flawed and poorly tested products.

Patients and their advocates urged the FDA to order more detailed disclosure of the metals used in devices, to require device labels to disclose the risks associated with metals, and to send a letter to doctors across the country alerting them to the threat of adverse metal reactions.

[…]

Unlike hearings earlier this year on breast implants and vaginal mesh that focused on specific products and regulatory steps, yesterday’s hearing focused on trying to understand and improve the state of scientific knowledge on metal reactions.

As such, it is unlikely to result in the short term in dramatic steps such as banning products from the market.

Experts urged the FDA to make the hearing the beginning of a sustained effort to gather data on the problem of metal reactions, including their differential effects among patients of different gender, age and socioeconomic status.

For example, the substantial majority of adverse responses to metal devices occur among women, who are generally more vulnerable to auto-immune, rheumatic and thyroid disorders.

“There’s a need for more and better pre-market research,” said Diana Zuckerman, the president of the National Center for Health Research. “We need to really have better data on diversity of patients.”

Read the original article here.

NCHR Letter to Mayor Cohn and Members of the Rye City Council Concerning the Health Risks of Artificial Turf and Playgrounds

National Center for Health Research, November 18, 2019


Download the letter here.

Dear Mayor Cohn and Members of the City Council:

Residents of Rye reached out to me to obtain my expertise in assessing the validity of the articles and letters provided by Stantec Design Services, regarding the health risks of installing artificial turf at what is now Nursery Field.   I am providing this information pro bono because our nonprofit research center is very concerned about the misleading information that has been presented to Rye officials regarding artificial turf.

The purpose of this letter is to focus on the research literature summarized and presented in Stantec’s review, including those in their Appendix.  It will not be focused on the logistical issues, but rather the health issues of importance to children using the field, and those who would be exposed to the chemicals in artificial turf because of its location near homes, wetlands, and a main tributary to Long Island Sound.

I will focus first on the claims that artificial turf does not cause cancer.  Dr. Archie Bleyer, quoted by Stantec, has impressive credentials, but his conclusions are based on his expertise regarding decades-old research while ignoring many of the most recent published studies.  Most important, as city officials, it is essential to distinguish between the lack of conclusive research linking artificial turf to cancer, and the often-made claim by the turf industry that artificial turf does not cause cancer.  The lack of conclusive proof of danger is not equal to proof of safety.  It is widely known that artificial turf contains chemicals that are probable and known carcinogens.   However, it takes years for cancer to develop after exposure to carcinogens.  For example, most smokers start smoking as teenagers but they don’t develop lung cancer for at least 3-4 decades. The reports of cancer clusters, such as the one among soccer players in Washington state, are the first hint that exposure to the chemicals contained in artificial turf increase the risk of cancer, but this too takes years to conclusively determine whether the cancer risk is higher due to the exposure.  That is one of the reasons why cancer clusters, such as the one reported in Washington State, can rarely determine causality.  It reminds me of cancer clusters among Vietnam veterans exposed to Agent Orange that were considered just a fluke until years later, when researchers concluded that Agent Orange caused certain types of cancer.  While we wait for this research, we cannot accurately conclude that there is no risk. Instead, we can only state that we do not know the level of risk.

Equally important, cancer is not the only health risk associated with the use of artificial turf.  The rubber pieces break down into very small pieces called particulate matter, which are kicked up into the air when the field is used where they can be inhaled.  The particulate matter can aggravate asthma, and can contain irritants and heavy metals.  The research cited by Stantec ignores that serious issue.

In addition, as the field gets hot, which can be 50-80 degrees hotter than the air or natural grass, the heat can cause heat stroke and even cause burns.  The highest temperature we have tested on a summer day in the 90’s was over 180 degrees.  In addition, heat from the fields makes it more likely that the chemicals are released into the air.  These can include polycyclic aromatic hydrocarbons (PAHs), and endocrine disruptors such as phthalates. These exposures can contribute to obesity, early puberty, ADHD, and eventually cancer.  Children are more vulnerable to these exposures than adults.

The Massachusetts HHS letter from 2015 and the letter from the State of Connecticut from 2015 both attempt to summarize information that focuses on cancer data but is broader than the cancer risk of artificial turf.  However, the studies quoted in the letter are small and so their generalizability to other fields is limited.  Importantly, it excluded several studies that raised concerns about the risks posed by artificial turf and pre-dates several more recent studies that have raised serious health concerns.

This year, testing in several communities found dangerous levels of lead in artificial turf as well as playgrounds made from synthetic rubber.  For example, testing of playgrounds and artificial turf fields in affluent and lower-income communities in Washington, D.C. resulted in more than 2 dozen that were closed due to health risks (see signs below).

Sign on artificial turf field stating that the field failed an "impact attenuation" or "hardness" test, which means that there is an increased risk of injury in the event of a fall.Sign - Warning: Do not eat infill mix in artificial turf as it may be harmful to your health

In the below left photo, children are playing on an artificial turf field near their school; tire crumb infill that had been hidden in the plastic grass came to the surface due to rain and wind.

Children playing in tire crumb infill from field

Used artificial turf with trash in the dumpster

The environmental implications of artificial turf are also important.  In the above right photo, you can see old turf has been dumped in a dumpster with trash. Much of the infill has already spread to the nearby playground, grass, and stream.

I will now focus on just a few of the studies that were not discussed in the letters submitted by Stantec, all of which demonstrate the very serious, evidence-based concerns about health risks, in chronological order:

Shalat 2011 (for the New Jersey Department of Environmental Protection) – They analyzed lead and other metals in particulate matter (dust) that is kicked up into the air by activity on the field, and thus, able to be inhaled, on 5 artificial turf fields.  The study found that there was more inhalable particulate matter in the air around a moving object (either a robot or a child soccer player) than a stationary collection system on the side of the field.  This suggests that studies using stationary collection systems underestimate exposures.  It also suggests that even low levels of activity on the field can cause inhalable particulate matter to get into the air where it can be harmful.  The study also found that the oldest field studied (8 years old) had more inhalable particulate matter than younger fields in this study (1–3 years old).  This is especially worrisome because the dust contains lead.  The authors state, “While it is not possible to draw broad conclusions from this limited sample of fields, the results suggest that there is a potential for inhalable lead to be present on turf fields that have significant amounts of lead present as detectable by surface wipes.  It also would appear likely from this sample that if the lead is present to any appreciable extent in the wipes it will likely be present in the breathing zone of players who are active on these fields, and that furthermore, these levels potentially exceed ambient EPA standards.”  Since no level of lead exposure is considered safe for children, “only a comprehensive mandated testing of fields can provide assurance that no health hazard on these fields exists from lead or other metals used in their construction and maintenance.”[1]

Llompart et al 2013 (Universidad de Santiago de Compostela) – This study examined samples from 9 playgrounds and 7 newly purchased rubber floor tiles that were made from recycled tire rubber in Spain.  It found all samples released hazardous chemicals into the air, where they can be inhaled, some of which were at high or very high levels. PAHs were found in all samples, including the carcinogenic B[a]P.  Other chemicals of concern include the phthalates DEP, DIBP, DBP, DEHP, and BHT.  The authors conclude, “The present study highlights the presence of a high number of harmful compounds, frequently at high or extremely high levels, in these recycled rubber materials.  Therefore, they should be carefully controlled, and their final use should be restricted or even prohibited in some cases.”[2]

Marsili et al 2014 (Siena University) – This study evaluated the recycled rubber infill (4 samples were not yet installed and 4 from fields that were 1-8 years old) and 1 new sample from virgin rubber in Italy. It found that levels of cadmium and zinc exceeded regulatory requirements for some or all samples, respectively. It also found very high levels of PAHs released into the air from some samples. After calculating a risk assessment for PAH inhalation from synthetic fields, the authors stated that “the quantity of toxic substances it releases when heated does not make it safe for public health.”[3]

Canepari et al 2016 (Sapienza University of Rome) – This study examined particulate matter and extractable chemicals from 1 sample of recycled tire rubber, 2 new and a single 7-year-old sample of natural rubber, and 1 sample of last-generation thermoplastic elastomer crumb (TPE).  The recycled tire rubber had a larger concentration of toxic elements, such as heavy metals.  TPE released the lowest amount of elements with high concentrations of only magnesium and calcium.  Natural rubber was more sensitive to aging and more easily broke down into small pieces that could be inhaled.  The authors concluded, “The use of natural rubber and of not-recycled thermoplastic materials, which are progressively replacing recycled tire scraps as synthetic turf fillers, does not seem to be adequately safe for human health, particularly when considering that children are the most exposed bracket of population.  Exposure risks arising from the use of these materials deserve to be further deepened.”[4]

Celeiro et al 2018 (Universidad de Santiago de Compostela) – This study evaluated the amount of chemicals released into the air from samples of recycled tire rubber infill from 15 soccer fields in Spain.  Analysis found high levels of PAHs, including the highly toxic B[a]P.  The levels of PAHs exceeded REACH Regulations for consumer products.  The study also found heavy metals such as cadmium, chromium and lead, as well as phthalates, adipates, vulcanizing agents and antioxidants could leach into runoff. “The environmental and health risks derived from the use of these surfaces have to be considered and some regulations should be adopted.”[5]

Benoit and Demars 2018 (Yale University) – This study analyzed 9 bags of recycled tire mulch from chain stores and 6 samples of recycled tire infill for athletic fields.  It focused on the chemicals which people using the fields would be expected to be exposed to, and found 92 chemical compounds.  Only about half of these compounds have been tested for effects on human health, of which 9 are carcinogens and 20 are irritants.  They concluded, “But what is known is that people routinely ingest, inhale, handle, and have abrasions which contact ground tire material.  That being so, it is prudent to assume that any chemicals in the tires or released by them can be transferred to exposed individuals.  This study shows that a large number of compounds, many of them carcinogenic or irritants, are released from shredded recycled tires through several potential routes.  Caution would argue against use of these materials where human exposure is likely, and this is especially true for playgrounds and athletic playing fields where young people may be affected.”[6]

Perkins et al 2019 (Yale University) – Based on previously published research, the researchers identified 306 chemicals found in crumb rubber. Fifty-two of these chemicals were classified as carcinogens by the U.S. EPA and/or the European ECHA. Then the researchers used the known characteristics of each chemical, such as the structure, to predict whether or not it was likely to be a carcinogen. Using this process, 197 were predicted to be carcinogens. They concluded, “Our study highlights a vacuum in our knowledge about the carcinogenic properties of many chemicals in crumb rubber infill.”  “The crumb rubber infill of artificial turf fields contains or emits chemicals that can affect human physiology.”[7]

The bottom line:  There is a growing body of evidence of the risks of the chemicals and lead in artificial turf and rubber surface playgrounds.  It would not be ethical to intentionally expose children to these play areas, and no independent researchers or government researchers have conducted long-term studies to determine if children with greater exposures are more likely to develop the health problems that are expected, such as obesity, asthma, cognitive damage, early puberty, and eventually cancer.

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

Sincerely,

Diana Zuckerman, Ph.D.
President

References

  1. Shalat SL. An Evaluation of Potential Exposures to Lead and Other Metals as the Result of Aerosolized Particulate Matter from Artificial Turf Playing Fields. 2011. New Jersey Department of Environmental Protection. http://www.nj.gov/dep/dsr/publications/artificial-turf-report.pdf
  2. Llompart M, Sanchez-Prado L, Pablo Lamas J, et al. Hazardous Organic Chemicals in Rubber Recycled Tire Playgrounds and Pavers. Chemosphere. 2013;90(2):423-431. https://doi.org/10.1016/j.chemosphere.2012.07.053
  3. Marsili L, Coppola D, Bianchi N, et al. Release of Polycyclic Aromatic Hydrocarbons and Heavy Metals from Rubber Crumb in Synthetic Turf Fields: Preliminary Hazard Assessment for Athletes. Journal of Environmental & Analytical Toxicology. 2014;5(2):265 http://dx.doi.org/10.4172/2161-0525.1000265
  4. Canepari S, Castellano P, Astolfi ML, et al. Release of Particles, Organic Compounds, and Metals from Crumb Rubber Used in Synthetic Turf under Chemical and Physical Stress. Environmental Science and Pollution Research International. 2018;25(2):1448-1459. https://doi.org/10.1007/s11356-017-0377-4
  5. Celeiro M, Dagnac T, Llompart M. Determination of Priority and other Hazardous Substances in Football Fields of Synthetic Turf by Gas Chromatography-Mass Spectrometry: A Health and Environmental Concern. Chemosphere. 2018;195:201-211. https://doi.org/10.1016/j.chemosphere.2017.12.063
  6. Benoit G, Demars S. Evaluation of Organic and Inorganic Compounds Extractable by Multiple Methods from Commercially Available Crumb Rubber Mulch. Water, Air, & Soil Pollution. 2018;229:64. https://doi.org/10.1007/s11270-018-3711-7
  7. Perkins AN, Inayat-Hussain SH, Deziel NC, et al. Evaluation of Potential Carcinogenicity of Organic Chemicals in Synthetic Turf Crumb Rubber. Environmental Research. 2019;169:163-172. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6396308/

FDA Advisers Hear About Problems, Research Needs With Metal Implants

Mary Jo M. Dales, MedPage Today: November 14. 2019


Reports of adverse events related to metal-containing implants are on the rise. While still rare on a proportional basis, the numbers are increasing as the sheer volume of surgical implants has expanded, an FDA advisory committee was told Wednesday.

At the first day of a two-day meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee, members heard from experts that it isn’t easy to tease out which patients are likely to have an adverse event. While patients with a known metal allergy might be an obvious risk group, the ability to screen for these allergies is limited.

And while these devices each have a unique identifier, the metallic components within individual devices are seldom detailed in this labelling further limiting the patient’s ability to avoid a known metal allergy, based on public testimony given during the meeting. Over 50 registered speakers were granted speaking time at the two-day meeting.

In a discussion of an array of histologic, imaging, and serologic studies that might be useful for selected out patients at risk for metal-related adverse events, experts pointed out that these measures alone fell short. Abnormal test results do not reliably predict adverse events. Further, the combinations of tests that might be indicative would be prohibitively expensive to perform on a large population of patients to determine a small sub-population at risk.

As device implantation has grown in recent years, so have problems tied to them. In 2012, for instance, the FDA held a two-day advisory committee meeting to address failure rates and adverse effects from metal-on-metal hip implants. That led the agency a few months later to put restrictions on these products. Still, issues remain around management of patients who received them. And that’s just one type of metallic implant, of which there are hundreds if not thousands.

Earlier in 2019, the FDA announced efforts to further evaluate the safety of specific materials used in medical devices and how to better identify patients who might be at increased risk of experiencing a hypersensitivity response. The agency is accepting public comment on the issue until December 16.

[…]

In public testimony Wednesday, Karin Pacheco, MD, MSPH, an allergist at National Jewish Health and the University of Colorado in Denver, presented data on 1,500 patients with unexplained joint failure referred by their orthopedic surgeons who have ruled out infections and mechanical issues. The findings indicate that half of these patients are sensitized to something in the joint — about a quarter of them to the relevant metal in their implant, about 20% to bone cement, and a smaller proportion to both components.

Further, people with allergies and revised to another implant with different components do “extremely well,” she said. The implications are that sensitization to implant components is a cause of joint failure. “We think that nickel, cobalt and chromium, and maybe titanium, are the culprits, but we need more research.”

“If you have a history of skin reactivity [to device components], then you probably need to be tested” before receiving an implant, she said. Pacheco emphasized that over a million joint replacements are done each year in the U.S. and more of them are going to people ages 45-64.

Diana Zuckerman, PhD, president of the nonprofit National Center for Health Research, urged comparative effectiveness research.

“If certain implants seem to be causing certain reactions with certain kinds of patients, wouldn’t it be very important to know how that compares to other alternatives of the same kind of implants? We can’t treat all hip implants that are polyethylene and metal as if they’re all the same,” she said.

“We can’t treat all metal-on-metal implants as if they’re the same. We need to compare different models, different implants made in different ways with different materials by different companies and get some kind of real data” that patients and physicians can use to make informed decisions, Zuckerman added. Until then, figuring out how much is due to patient vulnerabilities and how much is the difference between various devices will remain challenging.

Several speakers detailed their personal experiences of adverse events, including neurologic and rheumatologic events that followed their receiving an implant. Linda Radach said she received a metal-on-metal hip implant requiring two subsequent revision surgeries, concluding, “The bottom line between all the harm is the materials. Go after that. Set rigid standards for biocompatibility testing.”

[…]

The Immunology Devices Panel will hear additional comments on Thursday, especially in regard to dental amalgam, and will respond to a series of questions posed by FDA staff.

Read the original story here.