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

In the News, We're In the News, ,

Sheila Hager, Walla Walla Union-Bulletin: December 3, 2019

“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, for anyone who has somehow missed all the talk, is equated with the electronic cigarette trend. According to the Centers for Disease Control and Prevention, a host of names are affiliated with the subject, including vape pens, vapes, tank systems and e-hookahs.

At their core, e-cigs produce an aerosol by heating a liquid that usually contains nicotine — the addictive drug in traditional cigarettes, cigars and other tobacco products — plus flavorings and other chemicals that help to make the aerosol.

Users inhale this aerosol into their lungs, but bystanders can also breathe in this aerosol when the user exhales into the air, according to the CDC.

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.

The devices used can be as small as a USB drive or a pen. Since there is no smoke, vaping at school can be virtually undetectable, Osterman said.

“That’s one of the challenges.”

Data is showing 31% of the teens who vape have transitioned to smoking regular cigarettes within six months, Zuckerman recently said in a session for education journalists.

CDC officials have been on the front lines of a sweeping, multi-state outbreak of lung injury associated with vaping.

As of Nov. 20, nearly 3,000 cases of e-cigarette, or vaping-associated lung injuries have been reported to CDC from 49 states (Alaska has not reported any cases), Washington, D.C., Puerto Rico and the U.S. Virgin Islands.

Forty-seven deaths have been confirmed, two of those in Oregon, and more are being investigated.

According to the CDC, analysis of fluid samples collected from the lungs of patients with e-cigarette or vaping-associated lung injury identified vitamin E acetate, an additive in some THC-containing vaping fluid.

Recent CDC laboratory test results of lung fluid samples from 29 patients from 10 states found vitamin E acetate in all of the samples, THC in 82% of the samples and nicotine in 62% of the samples.

Officials have said these findings are the first time they have detected a chemical of concern in biological samples from patients with these lung injuries, and that the latest national and state findings suggest THC-containing vaping products — particularly from informal sources like friends, family or dealers online or in-person — are linked to most of the cases and play a major role in the outbreak.

Those being hospitalized are often normally healthy kids, Zuckerman said, including the high school athletes “who will never be able to play their sport again.”

Even with awareness rising, 66% of teens believe vape fluid is simply flavoring, she said.

“We know (traditional) smoking is dangerous, but that’s 20, 30, 40 years down the road. But vaping is hospitalizing kids. It’s an unprecedented epidemic.”

Osterman agrees, noting Washington’s number of kids using vape products lines up with national rates. On the most recent Healthy Youth Survey taken by Washington’s Department of Health, 21% of 10th-graders and 30% of 12th-graders reporting vaping in the 30 days prior to the survey.

“Youth of all kinds are vaping. It’s not the troubled kids, but the kids on the honor roll at Wa-Hi,” she said.

Her department works with schools across the county, and none are immune to this issue.

[…]

Read original story here.

How Minnesota Schools are Doubling Down on Anti-vaping Efforts

In the News, We're In the News, ,

Erin Hinrichs, MinnPost: December 2, 2019

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.

What started out as a fad marketed to youth as a safer, healthier alternative to smoking cigarettes has ballooned into a health epidemic that public health officials and politicians are scrambling to rein in. As of Nov. 20, the Centers for Disease Control and Prevention (CDC) says 2,290 injuries and 47 deaths have been reported as a result of using e-cigarette or vaping products. Teens and young adults make up the bulk of those vaping-related hospitalizations resulting from serious lung damage, says Diana Zuckerman, president of the National Center for Health Research.

“I just want to emphasize how serious this is,” she told education reporters during a recent webinar hosted by the Education Writers Association. “When we think about smoking, we know it’s dangerous 20, 30, 40 years down the road. The fact that we already have so many kids hospitalized from vaping is just an unprecedented kind of epidemic.”

Armed with this new health information, administrators and educators at many metro area schools are doubling down on their anti-vaping efforts. While the bulk of their focus remains on getting information to students and parents, many are expanding the scope of their educational outreach and shifting from a punitive disciplinary approach to one that takes a more holistic approach.

[…]

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.

Deb Mehr, the district’s health services coordinator, says the district recently received a grant from the county that will be used to accomplish two key things: add vaping information to the curriculum and support diversion efforts that keeps kids in school and connect them with resources to make healthier decisions.

Addressing misperceptions about the health risks associated with vaping, she says, are paramount. And it’s hard to have engaging conversations with youth when they’re too fearful of disciplinary action to seek information or help.

Her sense of urgency around addressing vaping is spurred by two recent seizure episodes at two different school sites — once this year and once last year. In other instances, she’s found students who’ve been vaping experience very high blood pressure and pulse rates.

“I think part of the problem is kids don’t know what they’re vaping,” she said.

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.

Along these lines, teaching students to be more critical consumers is key to keeping them safe, says Leslie Stunkard, a licensed drug and alcohol counselor in the Minneapolis Public Schools district.

With more than 70 schools districtwide, she says the push from her team has really been to teach students, especially the older ones, to be “skeptical about the advertising they hear.” She likes to point out how these companies are trying to market themselves as a good thing — by offering scholarships and even selling vitamins.

Offering another example of how educators in her district are getting students to think more critically about vaping, she says a science teacher at Washburn High School has created a lesson on vaping that explains the how even the name “vaping” is deceiving.

“I think one of the things that slowed us down a bit is the staff are learning — just as we and the students are learning — just how dangerous it is,” she said.

Read the original article here. 

Report Claims More Women than Men Injured by Medical Devices

Uncategorized, We're In the News,

The ICIJ used the Food and Drug Administration’s (FDA’s) Manufacturer and User Facility Device Experience (MAUDE) database to conduct the research. This data is publicly available and contains eight million reports which have been filed by doctors, patients and manufacturers when a medical device is suspected of putting someone at risk, causing injury or resulting in death.

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.

The ICIJ group followed four steps to identify the gender of those in the FDA MAUDE database:

1. Generate a set of labels

This stage involved classifying patient sex in 1,000 incident reports from the MAUDE database. Patient sex was classified as female, male or unknown.

2. Assign rules to the computer

The group used rules to train the computer to conduct automatic sex classification on the data.

3. Validate the results from the computer

Humans looked at the results from the computer and implemented additional rules to improve the quality of the results.

4. Run the code against all of the data in the FDA Maude database

Using 1997-2017 (the same time frame as the Implant Files investigation), the computer assigned a gender to 23% of patients with 96% accuracy.

The ICIJ claim that the algorithm created using the above steps was able to positively identify the sex of the patient in more than 340,000 injury and death cases. These findings reported 67% of these people were women and 33% were men.

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.”

Madris Tomes, founder and CEO of Device Events and a former FDA manager described the ICIJ’s work as critical. Tomes said: “It has long been unclear why the FDA’s device division redacts data elements that are so vital to scientific study…age, sex, and even the outcome of the adverse event are redacted by the device division but not the drug division.”

“But, if we are to look at allergy and autoimmune issues (presented in the FDA Immunology panel’s meeting on Metals in Implants) resulting from the metals and polymers in the hips, this could provide a second reason why the revision rates for women is higher than it is for men. It is an area where more research is necessary, and it shows the need for the FDA to un-redact fields which are so important for patients, physicians and hospitals to evaluate the safety of devices”, she added.

This report is part of the well-known Implant Files, which began from a report on medtech adverse events last year.

Read original story here.

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

Breast Cancer

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 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, 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

Testimony & Briefings, ,

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

Policy, Testimony & Briefings, Uncategorized

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’

In the News, News Stories & Editorials, We're In the News,

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

Environmental Exposures, Testimony & Briefings, , , , ,

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

In the News, News Stories & Editorials, We're In the News, , ,

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.

FDA’s Special Treatment Of Big Tech Faces Mounting Scrutiny

We're In the News

Kevin Stawicki, Law360, November 12, 2019.

The U.S. Food and Drug Administration is taking heat from prominent lawmakers over a special approval pathway for health software products sold by Apple, Samsung and other major tech companies, opening the door to a congressional showdown over whether the agency has the right to start such a program.

The FDA has spent two years working with nine tech giants and health companies to test a new approval route for rapidly evolving health software such as artificial intelligence applications to make treatment plans, calculate heart rates and track insulin levels. In addition to Apple Inc. and Samsung Electronics Co. Ltd., participating companies include Fitbit Inc., Johnson & Johnson and Roche Diagnostics Corp.

But lawmakers and legal experts have increasingly complained that the pilot program is shrouded in secrecy. In an Oct. 30 letter, several Democratic senators — including presidential contender Elizabeth Warren of Massachusetts and Assistant Democratic Leader Patty Murray of Washington — asked the FDA whether streamlined approvals are turning Americans into guinea pigs.

[…]

The pilot program is called Digital Health Software Precertification, or simply Pre-Cert. It covers digital health products, such as mobile medical apps, that generally fall outside the agency’s traditional approval pathways.

A key component of the pilot program is known as an “excellence appraisal.” If a company undergoes the appraisal and is deemed a reliable producer of safe, high-quality software, it becomes eligible for streamlined approvals.

But what the appraisal process looks like in practice is an open question. The agency lists product safety, proactive culture, clinical and cybersecurity responsibility as the model’s main categories and insists that there should be “flexibility in the specific mechanisms by which excellence can be demonstrated.”

In a 2018 letter, the senators were among the first to ask the FDA what that flexibility entails. The agency in June replied with a 19-page letter, but the senators apparently weren’t satisfied, responding with 10 pages of additional questions and requests in their Oct. 30 follow-up.

“The agency stated that it is ‘exploring what types of data are appropriate to demonstrate excellence,'” the senators said, adding that the agency made no attempt to “provide any additional detail on the data or evidence it used to determine companies’ adherence to the excellence principles.”

The senators aren’t alone in demanding more details.

“When it comes to medical devices, anything that’s subjective results in very low standards,” Diana Zuckerman, president of the National Center for Health Research, told Law360.

“You have this idea of precertifying companies on the basis of somebody deciding they have confidence about the company’s standards,” Zuckerman said. “But we know from experience that many times prestigious companies have covered up information about risks of their products.”

Some big-name companies that aren’t participating in the pilot program have said the metrics need work.

Lisa Bollinger, a vice president at biotech Amgen Inc., told the FDA in a letter last year, “It is not clear how an organization can demonstrate consistent, adequate evidence generation for clinical effectiveness based on the proposed appraisal elements for pre-certification.”

[…]

Read full article here.