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Cancer Prevention and Treatment Funds’ Comments On USPSTF Draft Recommendation Statement for Breast Cancer: Medication Use to Reduce Risk

February 11, 2019.


We are pleased to have the opportunity to express our strong concerns about the draft recommendations for the use of prophylactic hormonal treatments for women at increased risk for breast cancer.  The Cancer Prevention and Treatment Fund is a nonprofit program that conducts, analyzes, and reviews research, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers.  We do not accept funding from pharmaceutical companies and have no financial ties to this issue.

We have several concerns about the draft proposal and strongly urge USPSTF to reconsider the recommendation guidelines proposed for the following reasons:

  1. Most importantly, the evidence does not include information on absolute risk, which is much more meaningful to patients than relative risk.  The overall lifetime risk of breast cancer attributed to Tamoxifen would be reduced from 12% to 8%[i],[ii] if tamoxifen is taken over 5 years.  At the same time however, it would increase the lifetime risk of endometrial cancer from 3% to 6.5%[iii],[ii] and the lifetime risk of thromboembolism from 20% to 39%.[iv] Similarly, raloxifene reduces the lifetime risk of breast cancer from 12% to 5%[i],[iii] but increases the risk of thromboembolism from 20% to 31%.[iv]  Aromatase inhibitors lower the absolute risk of breast cancer from 12% to 5%,[i],[ii] while the lifetime risk of venous thromboembolism increased from 20% to 25%4 and the average lifetime risk of stroke from 20% to 23% as well.[v]  The risk of fractures increases with AI and decreases with tamoxifen and raloxifene, but those comparisons are primarily based on x-rays and bone mineral density, rather than health outcomes of importance to patients, such as pain, other quality of life issues, or abilities regarding activities of daily living.[ii]  In summary, the increases in absolute risk for several serious outcomes are considerably higher than the decrease in absolute risk of breast cancer.
  2. The importance of shared decision-makingthat was included in 2013 is missing in 2019.  The 2013 USPSTF recommendations included “shared informed decision-making” but the 2019 draft recommends that doctors “offer to prescribe.”  Research shows that informative discussions have a significant impact on patients’ decisions; those who are better informed of their associated risks are less likely to take these hormonal drugs.[vi],[vii]  As noted above, this discussion should focus on absolute risks, not relative risks.  The 2019 draft guidelines recommend physicians “offer to prescribe” these drugs to women who are at high risk of breast cancer but at low risk for adverse events; the ambivalence over risk-benefit ratio that was included in the evidence review draft is not reflected in this wording.[ii]
  3. Another major concern is the definition of women at high risk of breast cancer.  Since the risk of breast cancer increases with age, most women over 65 with one or two other risk factors would be categorized by the NCI risk model as “high risk” because their risk would be above 1.7% in the following 5 years.[viii] In addition, the NCI risk model is based on certain characteristics, but not mitigating variables.  The USPSTF definition of high risk would expose many women who have a moderate to low increased risk of breast cancer to the many unpleasant and serious side effects of these drugs.  In 2013, the USPSTF referred to high risk of breast cancer as at least 3% over the next 5 years, and that is a much more appropriate definition.[ix]
  4. Impact of side effects on quality of life is not adequately considered. Studies have shown that women on tamoxifen have significanly increased rates of hot flashes, arthralgia, vaginal dryness, and sexual dysfunction.  For these reasons, high-risk women on tamoxifen were more likely to discontinue these drugs within 5 years due to adverse events when compared to women in the placebo group.[x]

In addition to the specific issues above, we strongly urge the USPSTF to consider its recommendations regarding hormonal treatments in the context of other factors that can decrease the risk of breast cancer.  Healthy habits such as a healthy weight, a diet low in red meat and alcohol, as well as regular exercise have been known to reduce the overall risk of breast cancer.  For example, a major prospective study looking at health outcomes in postmenopausal women found that women with the healthiest diets and the most exercise will decrease their lifetime risk of breast cancer from 12% to 9%.[xi]

As noted above, the risks of these drugs are likely to outweigh the benefits for most women.  The USPSTF key questions focus too heavily on benefits of these drugs and do not give sufficient consideration to risks.  They should be revised to better assess cancer risk, potential benefit, and potential harm.  Only the women at very high risk of breast cancer and low risk of endometrial cancer and vascular disease should consider them.  We strongly urge USPSTF to substantially change the recommendations in light of the absolute risks involved, and that doctors engage in shared decision-making discussions, considering these drugs only for their highest-risk patients, focused on those absolute risks, in order to ensure informed decisions.

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

References:

  1. NCHR calculated the absolute risk based on the statistics provided by the National Cancer Institute; National Cancer Institute. (2012). Breast Cancer Risk in American Women. https://www.cancer.gov/types/breast/risk-fact-sheet
  2. NCHR calculated the absolute risk based on the statistics provided by the United States Preventative Services Task Force Draft Recommendation Statement. (2019). Breast Cancer: Medication Use to Reduce Risk.
    https://www.uspreventiveservicestaskforce.org/Page/Document/draft-recommendation-statement/breast-cancer-medications-for-risk-reduction
  3. NCHR calculated the absolute risk based on the statistics provided by the National Cancer Institute. (2013). Uterine Cancer – Cancer Stat Facts. https://seer.cancer.gov/statfacts/html/corp.html
  4. NCHR calculated the absolute risk based on the statistics provided by Bell EJ, Lutsey PL, et al. (2015). Lifetime Risk of Venous Thromboembolism in Two Cohort Studies. American Journal of Medicine.
  5. NCHR calculated the absolute risk based on the statistics provided by Seshadri S., & Wolf, P.A. (2007). Lifetime risk of stroke and dementia: current concepts, and estimates from the Framingham Study. The Lancet Neurology.
  6. Fagerlin A, Zikmund-Fisher BJ, et al. (2010). Women’s decisions regarding tamoxifen for breast cancer prevention: responses to a tailored decision aid. Breast Cancer Res. Treatment.
  7. Melnikow J, Paterniti D, et al. (2005). Preferences of Women Evaluating Risks of Tamoxifen (POWER) study of preferences for tamoxifen for breast cancer risk reduction. Cancer.
  8. National Cancer Institute. The Breast Cancer Risk Assessment tool. https://bcrisktool.cancer.gov/
  1. United States Preventative Services Task Force. (2013). Breast Cancer: Medications for Risk Reduction. https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/breast-cancer-medications-for-risk-reduction
  1. Day, R. (2001). Quality of Life and Tamoxifen in a Breast Cancer Prevention Trial. Annals of the New York Academy of Sciences.
  2. Thomson, CA et al. (2014). Nutrition and Physical Activity Cancer Prevention Guidelines, Cancer Risk, and Mortality in the Women’s Health Initiative. Cancer Prevention Research.

Policing Big Pharma’s Influence Over Doctors’ Treatment Guidelines

Ronnie Cohen, Undark: February 4, 2019.


Dr. Samir Grover was taken aback when, early in his gastroenterology career, he saw one physician speak two times and present contradictory conclusions about the same medication. Each time, the speaker presented identical data on a drug used to treat inflammatory bowel disease. First, he recommended the pharmaceutical. A week later, he deemed it ineffective. “How could this exact same data be spun in two very different ways?” asked Grover, a professor at the University of Toronto. One fact did change — the drug manufacturer that sponsored and paid for the lecture.

It’s no secret that drug makers pay doctors to hype their products to other doctors. But few outside the halls of hospitals witness physicians bending a single set of facts in opposing ways. After watching similar acts of statistical wizardry throughout his nine years of medical practice, Grover set out to investigate a more sweeping question about conflicts of interest. Do they infect clinical practice guidelines? Professional societies produce thousands of these documents every year. They steer the decisions of health care professionals and insurance companies about how to prevent and treat an ever-widening range of conditions — from diabetes, hypertension, and heart disease to arthritis, hepatitis, cancer, and depression.

Grover and his colleagues’ paper and a companion study recently published in JAMA Internal Medicine suggest that simply following clinical practice guidelines could lead doctors — even those who shun all industry gifts — to unwittingly dispense financially tainted medicine. More than half of the authors of guidelines examined in the two studies had financial conflicts of interest. In many cases, the doctors who wrote the guidelines were paid by the same companies that produced the drugs they recommended. In addition, a significant portion of the doctors who took pharmaceutical money failed to disclose the payments, many of which amounted to $10,000 or more.

The consequences of financial entanglements can be profound, warned Dr. John P.A. Ioannidis, a professor at the Stanford University School of Medicine. “Writing guidelines is like prescribing something to millions of people,” he said. For their part, medical societies acknowledge the need for impartiality in the guideline-development process. Yet many view the task of disentangling industry from clinical practice guidelines as challenging, maybe impossible. Grover believes that panels can do better, particularly when it comes to disclosing conflicts. Still, he said, “it would be very hard to find experts, particularly for high-grossing medicines, to be completely devoid of conflict.”

Grover’s study examined financial conflicts of interest for the authors of 18 clinical practice guidelines that provided recommendations for the 10 highest grossing medications of 2016. The blockbuster drugs included treatments for hepatitis C, rheumatoid arthritis, and Crohn’s disease. Nearly one third of the authors declared receiving payments from companies marketing one or more of the top-revenue medications. A separate study underscored Grover’s findings. It examined industry payments received by the authors of 15 gastroenterology guidelines published from 2014 to 2016. More than half of the gastroenterology guideline authors received money from industry. In both studies, the payments could be funds for clinical trials, or they could be for travel, honoraria, or speaking fees.

The payments could bias guideline authors’ votes on prescription recommendations, and they could also prompt guideline authors to try to sway the votes of other committee members, said Matt Vassar, the study’s senior author and a professor at Oklahoma State University Center for Health Sciences in Tulsa. Prior research suggests that doctors who receive pharmaceutical money and gifts have different prescribing patterns than their peers who don’t. A 2016 study of nearly 280,000 doctors showed that those who attended a single industry-sponsored meal, with an average value of less than $20, were more likely to prescribe a brand-name medication promoted at the event than alternatives within its class.

“Doctors who take money from companies tend to prescribe drugs from these companies more — quite a bit more,” said Diana Zuckerman, president of the National Center for Health Research, a Washington, D.C. think tank. “We have to assume the same for doctors on guidelines teams.”

Especially worrisome to Vassar was his finding that the vast majority of the gastroenterology guideline authors failed to disclose industry payments that were reported in a federal database. Grover, too, discovered a lack of disclosure among guideline authors in his study — more than a quarter with conflicts failed to report payments they took from companies marketing one of the top 10 drugs. The undisclosed payments ranged from $1,638 to $102,309. For Grover, “the issue is not the conflict,” he said. “The issue is the transparency and adequately and appropriately noting conflicts.”

For Dr. Daniel Brauner, a professor of medicine at the University of Chicago, simply disclosing conflicts isn’t a cure-all. A geriatrician, he regularly sees patients suffering from what he believes are the consequences of specialists with conflicts writing clinical practice guidelines. “It’s over-prescription and a lack of really looking out for patients,” he said. When doctors adhere to multiple clinical practice guidelines, “older patients end up being on ridiculous numbers of drugs that will interact with each other and cause harm.” Yet doctors feel compelled to follow the guidelines, Zuckerman said. If they don’t, and their patients fare poorly, they can be sued for malpractice.

Ioannidis argues for a barrier blocking industry’s participation in clinical practice. “It’s fine to do research with industry funds,” he said. But then someone else should write the clinical guidelines. How can you be objective, he asks, “when every sentence you write may affect your own revenue, your own success, your own reputation?”[…]

See the original story here.

NCHR Letter to Senators Regarding the Impact of the Government Shutdown on Patient Safety

A similar version of this letter was sent to Senators Alexander and Murray of the Senate Health, Education, Labor, and Pensions (HELP) Committee, majority leader McConnell, minority leader Schumer, and members of both the Appropriations and HELP Committees.

 

January 11, 2019

Chairman Richard Shelby and Vice Chairman Patrick Leahy

Appropriations Committee

U.S. Senate

Washington, DC 20510

Dear Mr. Chairman and Mr. Vice Chairman:

I am writing to you on behalf of the National Center for Health Research to alert you to the dangerous situation facing all Americans as a result of the lack of FDA funding for post-market surveillance and safety evaluations during the current government shutdown.

As you know, during the shutdown the FDA is funded through user fees and the only staff that are allowed to work are focused on the review of new products in compliance with the performance goals (timely review) required by user fees.  The medical device user fees are not used for post-market surveillance activities.  The drug user fees are almost entirely used for premarket review, and there has been no public announcement of whether any post-market activities for prescription drugs or biologics are underway for the last three weeks.  The situation will remain dangerous throughout the shutdown.  When the Congress eventually passes legislation to provide appropriations for the FDA for FY 2019, it is inevitable that there will be an enormous backlog that will also undermine patient safety.  The longer the shutdown, the more dangerous the situation will be during the shutdown and the more challenging the backlog will be.

Post-market surveillance is especially important for medical devices because the pre-market standards for approval or clearance are so much lower than they are for prescription drugs.  While all prescription drug approvals are based on at least one pivotal clinical trials, less than 5% of medical devices are required to have submitted clinical trial data to get on the market. Even the highest risk (PMA) devices do not always submit clinical trials of their own devices when seeking approval. Of those approximately 5% that submit clinical trials, the vast majority of those trials are not randomized double-blind clinical trials, even though that is the gold standard for clinical trials.  In fact, many of the PMA device trials have no active control groups to compare with the patients with the new device, and therefore provide very limited information about either safety or effectiveness.  As a result, very little is known about the safety or effectiveness of new medical devices except through post-market information, which may include:

  • Adverse event reports (mandatory and voluntary)
  • Required post-market clinical trials, such as the study FDA has required for Essure
  • FDA Advisory Panel meetings to review devices already on the market (such as the meeting that the Commissioner announced would be held early this year to review breast implants)
  • Registries of patients with implanted devices (such as knee and hip joints)
  • Formal or informal studies conducted by concerned physicians, investigative reporters, and other non-industry researchers that are reported in the media or submitted to the FDA as part of citizens’ petitions.  Although the studies themselves are not part of the FDA surveillance activities, these studies are additional safeguards if FDA reviews them and responds by considering issuing a warning to physicians or patients or a device recall.

The impact of the shutdown on drug or device safety surveillance by the FDA has not been mentioned in the media or, to our knowledge, by Members of Congress.  As you know, food safety efforts are greatly limited during the shutdown. Fortunately, the Center for Tobacco is entirely funded by user fees so that their work has not been affected.

The National Center for Health Research (NCHR) is a non-profit organization that analyzes scientific and medical data and provides objective health information to patients, providers, and policymakers. We do not accept funding from the drug or medical device industry and have no conflicts of interest on these matters.   We have published several groundbreaking studies pertaining to FDA recalls of medical devices, and lack of safety data, including problems with cybersecurity and recalls of faulty medical software.  Delays in high-risk recalls will clearly put patients’ lives at risk during the shutdown and while FDA attempts to deal with the backlog when appropriations become available.

The Senate will be part of the solution by immediately passing legislation to fund the FDA.

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

Thank you for your commitment to patient safety.

Sincerely,

Diana Zuckerman, Ph.D.

President

Prepared Statement to the Greenwich Board of Estimate and Taxation Regarding Dangers of Artificial Turf, January 24, 2019

Diana Zuckerman, PhD, National Center for Health Research: January 24, 2019.


January 24, 2019

 

Dear Madam Chairwoman and Members of the Greenwich Board of Estimate and Taxation:

 

I am Dr. Diana Zuckerman, President of the National Center for Health Research.  Our nonprofit think tank is located in Washington, D.C. Our scientists, physicians, and health experts conduct studies and scrutinize research. Our goal is to explain scientific and medical information that can be used to improve policies, programs, services, and products. 

As a scientist who has worked on health policy issues for more than 30 years, I don’t shock easily.  However, it is shocking and disturbing that artificial turf athletic fields and playgrounds are exposing children on a daily basis to chemicals and materials that are known to have the potential to increase obesity; contribute to early puberty; cause attention problems such as ADHD; harbor deadly bacteria; and exacerbate asthma.  

Federal agencies such as the EPA and the U.S. Consumer Product Safety Commission have been investigating the safety of these products. Despite claims to the contrary, none have concluded that artificial turf is safe.

Scientific Evidence of Cancer and Other Systemic Harm

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

The artificial turf industry will tell you there is no clear evidence that their fields caused any child to develop cancer.  That is true, but the statement is misleading because it is virtually impossible to prove any chemical exposure causes one specific individual to develop cancer.

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

I have testified about the risks of these materials at the U.S. Consumer Product Safety Commission as well as state legislatures and city councils. I am sorry to say that I have repeatedly seen and heard scientists paid by the turf industry and other turf industry lobbyists say things that are absolutely false. They claim that these products are proven safe (not true) and that federal agencies have stated there are no health risks (also not true). 

What we do know is that the materials being used contain carcinogens, and when children are exposed to those carcinogens day after day, week after week, and year after year, they increase the chances of our children developing cancer, either in the next few years or later as adults. That should be adequate reason not to install them in your community. That’s why I have spoken out about the risks of artificial turf in my community and on a national level. The question must be asked: if they had all the facts, would Greenwich or any other community choose to spend millions of dollars on fields that are less safe than well-designed natural grass fields?

Synthetic rubber and plastic are made with different types of endocrine (hormone) disrupting chemicals as well as carcinogens.  There is very good evidence regarding these chemicals in tire crumb, based on studies done at Yale and by the California Office of Environmental Health Hazard Assessment (OEHHA). [1]

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

There are numerous studies on the impact of hormone-disrupting chemicals (also called endocrine disrupting chemicals or EDCs), and the evidence is clear that these chemicals found in rubber and plastic cause serious health problems.  Scientists at   the National Institute of Environmental Health Sciences have concluded that unlike most other chemicals, hormone-disrupting chemicals can be dangerous at very low levels, and the exposures can also be dangerous when they combine with other exposures in our environment. 

That is why the Consumer Product Safety Commission has banned numerous endocrine-disrupting chemicals from toys and products used by children. The products involved, such as pacifiers and teething toys, are banned even though they would result in very short-term exposures compared to artificial turf.

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

Studies are beginning to demonstrate the contribution of skin exposure to the development of respiratory sensitization and altered pulmonary function. Not only does skin exposure have the potential to contribute to total body burden of a chemical, but also the skin is a highly biologically active organ capable of chemical metabolism and the initiation of a cascade of immunological events, potentially leading to adverse outcomes in other organ systems.

Envirofill and Alternative Infills

Envirofill artificial turf fields is advertised as “cooler” and safer, but our research indicates that these fields are still at least 30-50 degrees hotter than natural grass.  Envirofill is composed of materials resembling plastic polymer pellets (similar in appearance to tic tacs) with silica inside.  Silica is classified as a hazardous material according to OSHA regulations, and the American Academy of Pediatrics specifically recommends avoiding it on playgrounds. The manufacturers and vendors of these products claim that the silica stays inside the plastic coating.  However, sunlight and the grinding force from playing on the field breaks down the plastic coating.   For that reason, even the product warranty admits that only 70% of the silica will remain encapsulated.  The other 30% can be very harmful as children are exposed to it in the air.  

In addition, the Envirofill pellets have been coated with an antibacterial called triclosan.  Triclosan is registered as a pesticide with the EPA and the FDA has banned triclosan from soaps because manufacturers were not able to prove that it is safe for long-term use.  Research shows a link to liver and inhalation toxicity and hormone disruption.  The manufacturer of Envirofill says that the company no longer uses triclosan, but they provide no scientific evidence that the antibacterial they are now using is any safer than triclosan.  Microscopic particles of this synthetic turf infill will be inhaled by children, and visible and invisible particles come off of the field, ending up in shoes, socks, pockets, and hair.

In response to the concerns of educated parents and government officials, other new materials are now being used instead of tire crumb and other very controversial materials.  However, all the materials being used (such as volcanic rock, corn husks, and Corkonut) have raised concerns and none are proven to be as safe or effective as well-designed grass fields.

Dangerously Hard Fields

I want to briefly mention safety issues pertaining to Gmax scores.  A Gmax score over 200 is considered extremely dangerous and is considered by industry to pose a death risk.  However, the synthetic turf industry and ASTM (American Society for Testing and Materials)suggest scores should be even lower — below 165 to ensure safety comparable to a grass field. 

The hardness of natural grass fields is substantially influenced by rain and other weather; if the field gets hard, rain or watering will make it safe again.  In contrast, once an artificial turf field has a Gmax score above 165, it needs to be replaced because while the scores can vary somewhat due to weather, the scores will inevitably get higher because the turf will get harder.  Gmax testing involves testing 10 different areas of a playing fields, and some officials average those 10 scores to determine safety.  However, experts explain that is not appropriate.  If a child (or adult) falls, it can be at the hardest part of the field, which is why that is the way safety is determined.

In addition to the health risks to school children and athletes, approximately three tons of infill materials migrate off of each synthetic turf field into the greater environment each year.  About 2-5 metric tons of infill must be replaced every year for each field, meaning that tons of the infill have migrated off the field into grass, water, and our homes.4 The fields also continuously shed microplastics as the plastic blades break down.5,6 These materials may contain additives such as PAHs, flame retardants, UV inhibitors, etc., which can be toxic to marine and aquatic life; and microplastics are known to migrate into the oceans, food chain, and drinking water and can absorb and concentrate other toxins from the environment.7,8,9

Synthetic surfaces also create heat islands.10,11 In contrast, organically managed natural grass saves energy by dissipating heat, cooling the air, and reducing energy to cool nearby buildings.  Natural grass and soil protect groundwater quality, biodegrade polluting chemicals and bacteria, reduce surface water runoff, and abate noise and reduce glare.1

Conclusions

There are currently no safety tests required prior to sale that prove that any artificial turf products are safe.  In many cases, the materials used are not made public, making independent research difficult to conduct. None of these products are proven to be as safe as natural grass in well-constructed fields. 

I have cited several relevant scientific articles on artificial turf in this letter, and I can attest to the fact there are numerous studies and growing evidence of the harm caused by these synthetic materials. I would be happy to provide additional information upon request (dz@center4research.org).

I am not paid to write this statement. I am one of the many parents and scientists who are very concerned about the impact of artificial fields on our children.  Your decision about artificial turf can save lives and improve the health of children in Greenwich.  And, because of Greenwich’s reputation as a well-educated and affluent community, the decisions made by you about artificial turf in Greenwich will serve as a model to other communities.

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

Sincerely,

Diana Zuckerman, Ph.D.

President

 

 

Footnotes

  1. State of California-Office of Environmental Health Hazard Assessment (OEHHA), Contractor’s Report to the Board. Evaluation of Health Effects of Recycled Waste Tires in Playground and Track Products. January 2007. http://www.calrecycle.ca.gov/publications/Documents/Tires%5C62206013.pdf 
  2. Yale Study Reveals Carcinogens and Skin Irritants in Synthetic Turf. http://wtnh.com/2015/09/03/new-yale-study-reveals-carcinogens-and-skin-irritants-in-synthetic-turf/
  3. Anderson SE and Meade BJ, Potential Health Effects Associated with Dermal Exposure to Occupational Chemicals, Environ Health Insights. 2014; 8(Suppl 1): pgs 51–62. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4270264/
  4. York T. Greener grass awaits: Environmental & fiscal responsibility team up in synthetic turf. Recreation Management. February 2012. http://recmanagement.com/feature_print.php?fid=201202fe02.
  5. Magnusson K, Eliasson K, Fråne A, et al. Swedish sources and pathways for microplastics to the marine environment, a review of existing data. Stockholm: IVL- Swedish Environmental Research Institute. 2016. https://www.naturvardsverket.se/upload/miljoarbete-i-samhallet/miljoarbete-i-sverige/regeringsuppdrag/utslapp-mikroplaster-havet/RU-mikroplaster-english-5-april-2017.pdf
  6. Kole PJ, Löhr AJ, Van Belleghem FGAJ, Ragas AMJ. Wear and tear of tyres: A stealthy source of microplastics in the environment. Int J Environ Res Public Health. 2017 14(10). pii: E1265. https://www.ncbi.nlm.nih.gov/pubmed/29053641/
  7. Kosuth M, Mason SA, Wattenberg EV. Anthropogenic contamination of tap water, beer, and sea salt. PLoS One. 2018. 13(4): e0194970. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5895013/
  8. Oehlmann J, Schulte-Oehlmann U, Kloas W et al.  A critical analysis of the biological impacts of plasticizers on wildlife. Phil Trans R Soc B. 2009. 364: 2047–2062. http://rstb.royalsocietypublishing.org/content/364/1526/2047
  9. Thompson RC, Moore CJ, vom Saal FS, Swan SH. Plastics, the environment and human health: Current consensus and future trends. Philos Trans R Soc Lond B. 2009. 364: 2153–2166. 
  10. Thoms AW, Brosnana JT, Zidekb JM, Sorochana JC. Models for predicting surface temperatures on synthetic turf playing surfaces. Procedia Engineering. 2014. 72: 895-900. http://www.sciencedirect.com/science/article/pii/S1877705814006699
  11. Penn State’s Center for Sports Surface Research. Synthetic turf heat evaluation- progress report. 012. http://plantscience.psu.edu/research/centers/ssrc/documents/heat-progress-report.pdf
  12. Stier JC, Steinke K, Ervin EH, Higginson FR, McMaugh PE. Turfgrass benefits and issues. Turfgrass: Biology, Use, and Management, Agronomy Monograph 56. American Society of Agronomy, Crop Science Society of America, Soil Science Society of America. 2013. 105 – 145. https://dl.sciencesocieties.org/publications/books/tocs/agronomymonogra/turfgrassbiolog

Municipal and Schools Budgets Proposed for FY ’19-20, Public Comments Focus on Turf, Ice Rink

Greenwich Free Press: January 25, 2019.


On Thursday night Greenwich First Selectman Peter Tesei presented his recommended budget for the fiscal year starting July 1, 2019 and ending on June 30, 2020 to the BET.

After his presentation and that of the Schools Superintendent Mayo, there were about 90 minutes of public testimony which primarily focused on opposition to artificial turf. Several residents said they favor investing in grass fields with better drainage. There was also vocal support for a new Dorothy Hamill Ice Rink.

Diana Zuckerman, a 30 year health policy scientist and president of the National Center for Health Research, traveled from Washington DC to testify about artificial turf.

“Artificial turf companies say there is no evidence that the fields can cause cancer,” she said. “This is often misunderstood to mean turf is safe. It takes many years to conclude that long-term exposure is safe, and there’s no such evidence for artificial turf. The materials contain carcinogens. Day after day, year after year, this increases the chances of cancer in children and later on as adults. Why spend millions on turf that is less safe than well designed grass fields?” she asked.

Rick Loh from the Parks & Rec Advisory Board said of the Hamill Rink project,” It has taken many years to see these numbers in the budget. Hopefully you’ll keep them where they are. There has been a number of people working on this for a number years. RFPs have come back and we’re ready to take it to the next step.”

[…]

During the public hearing, Susan Rudolph said she had studied the artificial turf industry, which she described as large, rich and powerful.

“Plastic grass looks pretty but is made of petroleum,” said Ms. Zuckerman, president of National Center for Health Research. “Turf companies hide what is in it. There are no safety tests to prove artificial turf is safe for long term use. Meanwhile they advise parents how to reduce exposure. I’ve seen firsthand that officials in school systems have been erroneously assured that artificial turf is safe. Greenwich can set an important example by protecting children from artificial turf.”

Dr. David R Brown, public health toxicologist, who spent part of his career at the CDC, cited a March 2018 study of 200 soccer players with cancer. He said most of them were goalies and they suffered from Lymphomas, Sarcomas, Testicular cancer, Thyroid cancer, Brain cancer, and Lung cancer.

Dr. Patricia Taylor said that at Guilford High School, an artificial turf failed after it was installed. She said Malone and MacBroom received $87,000 for design, inspection and contract management. The field cost $1.15 million to install.

“They chose Envirofill and in 2016 the field was installed. It was used starting in 2017. Defects were noticed in 2018,” she said. “The field was literally coming apart at the seams. It cost $40,000 for consultant to look at it. And it was not in use as of May 2018.”

Taylor said that field was determined to have failed due to extreme temperatures and a drainage issue, and that there was disagreement about who was liable. Ultimately, she said the case was settled confidentially.

“The field will be rebuilt, but will not be ready for spring 2019,” she said. “Companies like Malone and MacBroom make assurances about safety, but human health risk studies have not been done.”

Taylor warned the BET that if the Town uses artificial turf to cover contaminated soil at Greenwich High School, the Town may have liability. “Plastic and rubber absorb hitchhikers – chemicals in the environment around them.”

“Synthetic turf fields are also flammable,” she added. “So they’re fenced and keep neighbors off, access is restricted and the it becomes a source of revenue.

Mary Jones with the Toxins Action Center in Boston said injuries such as burns and abrasions are more common than with real grass. “Grass turf is growing in popularity across the country.  The residents of Greenwich are not alone in their preference for grass for their playing fields. Greenwich can continue to be a leader in sustainability in Connecticut.”[…]

See the full article here.

Comments on Tobacco Control Efforts in the U.S.-United Kingdom Trade Agreement

January 15, 2019

Re: Docket No. USTR-2018-0036
Mr. Edward Gresser
Chair of the Trade Policy Staff Committee
Office of the United States Trade Representative
600 17th Street N.W.
Washington, D.C. 20508

Dear Mr. Gresser:

We are pleased to submit these comments in the above-designated docket. Our organizations are public health and medical organizations which are actively engaged in efforts to eliminate the disease and death caused by the use of tobacco products in the United States and throughout the world.

As you prepare to negotiate a trade and investment agreement with the United Kingdom, we urge that you ensure that the agreement provides the protections necessary to enable both countries to adopt public health measures to protect their citizens from the death and disease caused by tobacco products without facing the risk of litigation by the tobacco companies. It is essential that any agreement recognize the unique harms tobacco products cause, and includes provisions to ensure that the United States and the United Kingdom do not face the threat of investor litigation from the tobacco industry.

Tobacco products are the only consumer products that kill when used exactly as intended. Each year more than 480,000 Americans die from tobacco use. Globally, tobacco kills more than 7 million people annually, and without effective tobacco control policies to reduce consumption, one billion people will die from using tobacco products this century. For these reasons, tobacco products are the only consumer product subject to a treaty specifically designed to prevent and reduce their use — the Framework Convention on Tobacco Control.

Countries around the globe are implementing tobacco control policies from graphic health warning labels to plain packaging. The tobacco industry has aggressively responded by using investor-state dispute settlement (ISDS) provisions in trade and investment agreements to both threaten and file legal challenges against countries’ tobacco policies. Despite not prevailing on its investment claims, the tobacco industry has long used legal threats and challenges to intimidate governments from moving forward with policies to prevent or reduce tobacco consumption. The tobacco industry’s behavior is a real and direct threat to public health.

The United States-Mexico-Canada Agreement (USMCA) significantly limits the tobacco industry’s ability to initiate disputes challenging tobacco control measures by eliminating ISDS between the U.S. and Canada and limiting ISDS claims between the U.S. and Mexico for the majority of industries, including the tobacco industry, to direct expropriation and discrimination claims brought under the grounds of National Treatment or Most-Favored Nation Treatment.

Any ISDS provision included in a U.S. – U.K. trade agreement should prohibit challenges from private tobacco companies to tobacco control measures to reduce tobacco use. Given the experience of the tobacco companies using the investor-state provisions in other agreements to challenge tobacco control measures, this protection is critical. It is also particularly important because the U.S. is moving forward with adopting graphic warning labels to accompany textual warnings that together will cover 50% of the front and back of a cigarette pack. Also note that the United States has previously defended a tobacco-related NAFTA claim in Grand River v. United States, which, despite the United States’ prevailing on the seven-year long claim, cost the taxpayers millions of dollars to litigate. Protecting the right of the United States and the United Kingdom to implement tobacco control policies free from the threat of tobacco industry ISDS challenges is critical for both nations to protect the health of their citizens.

As you develop your negotiating objectives for a U.S. – U.K. trade and investment agreement, we respectfully request that you recognize that the agreement must set the example for a 21st century agreement by, at a minimum, recognizing the unique harms caused by tobacco products and preventing the tobacco industry from using the agreement to challenge U.S. or U.K. actions to reduce the use of tobacco products.

Sincerely,

Action on Smoking & Health
Allergy & Asthma Network
American Academy of Family Physicians
American Academy of Otolaryngology—Head and Neck Surgery
American Academy of Pediatrics
American Association for Dental Research
American Cancer Society Cancer Action Network
American College of Physicians
American Heart Association
American Lung Association
American Medical Association
American Psychological Association
American Public Health Association
American Society of Addiction Medicine
Association of Schools and Programs of Public Health
Association of Women’s Health, Obstetric and Neonatal Nurses
Campaign for Tobacco-Free Kids
Cancer Prevention and Treatment Fund
Community Anti-Drug Coalitions of America
Eta Sigma Gamma – National Health Education Honorary
March of Dimes
National African American Tobacco Prevention Network
National Association of County & City Health Officials
National Association of School Nurses
National Network of Public Health Institutes
Oncology Nursing Society
Society for Cardiovascular Angiography and Interventions
Society for Public Health Education
The Society of State Leaders of Health and Physical Education

Health Care Industry Spends $30 Billion a Year on Marketing

Liz Szabo, Kaiser Health News: January 8, 2019.


Spending on health care marketing nearly doubled from 1997 to 2016, soaring to at least $30 billion a year, according to a study published Tuesday in JAMA.

The FDA is Still Letting Doctors Implant Untested Devices into Our Bodies

Jeanne Lenzer and Shannon Brownlee, Washington Post: January 4, 2019.


Ten years ago, Kathleen Yaremchuk raced to the bedside of a patient inexplicably gasping for breath. Chair of the department of otorhinolaryngology (ear, nose and throat) at Henry Ford Hospital in Detroit, Yaremchuk performed an emergency tracheotomy on the woman, cutting a hole in her windpipe, inserting a breathing tube and saving her life. When Yaremchuk began getting more calls over the following months for mysterious cases of respiratory distress, she launched a study to figure out what was going on.

All these patients, it turned out, had a small device implanted in the top of their spines to relieve pain. The object, used to hold a protein that stimulates bone growth, was cleared for sale by the Food and Drug Administration in 2003 without clinical testing in humans. When Yaremchuk and her colleagues reviewed the records of all 260 patients implanted with the device at Henry Ford Hospital between 2004 and 2009, they found that a significant number developed airway obstruction, trouble swallowing and respiratory failure, in some cases leading to death.

The neck implant is just one of the products associated over the past decade with 1.7 million injuries and more than 80,000 deaths. A searing global investigation last year by the International Consortium of Investigative Journalists places much of the blame on significant failings in the FDA’s oversight. The agency’s laissez faire attitude has resulted in artificial hips that cause cobalt poisoning (which can damage the heart and brain); surgical mesh that cuts through flesh and organs, causing infections and hemorrhage; and defibrillators that repeatedly shock patients beyond human endurance. Safety problems have led to recalls of devices implanted in hundreds of thousands of people. And the devices can be difficult or impossible to remove if they go bad. No wonder many patient advocates cheered when the FDA announced in November that it planned to make “transformative” changes in the way more than 80 percent of medical devices are cleared for sale in the United States. Some 32 million Americans walk around with such products in their bodies.

But the promised transformation is mere window dressing. Two key loopholes still exist, allowing most products to be approved for sale without clinical trials in humans. Although the FDA insists that high-risk devices undergo “stringent” testing to win approval, few actually do. A recent study, for example, found that only 5 percent of the highest-risk implantable cardiac devices were subjected to clinical trials on par with the testing required for drug approval.

In 1976, when medical devices first came under the regulatory control of the FDA, the agency simply grandfathered in all devices that were already on the market. Under this provision, known as the 510(k) pathway, new artificial joints, cataract lens implants and thousands of other devices developed after 1976 can win approval for sale (or “clearance” in FDA parlance) if the product is shown to have “substantial equivalence” to a previously cleared “predicate” device.” Four out of five devices are cleared for sale this way. Of those, at least 95 percent were cleared without clinical studies, according to research by Diana Zuckerman and her colleagues at the National Center for Health Research.

For some devices, that makes sense. You don’t need a clinical trial to test a new tongue depressor or hospital stretcher. But the agency also lets higher-risk devices through based on predicate devices, some of which have been recalled for safety problems. A recent study by researchers at the University of Oxford discovered that 16 percent of surgical meshes cleared for sale in the United States between 2013 and 2015 were based on products previously removed from the market because of serious complications. When one of us asked the FDA how this could happen, officials answered that the agency doesn’t evaluate the performance of the predicate when clearing devices for sale, just that there is (or was) a predicate.

According to the FDA, the “most impactful” change it is considering is recommending (not mandating) that companies cite predicate devices no older than 10 years. Yet device-makers could still cite predicates that were themselves based on earlier devices that may date back well past 10 years, something the FDA acknowledged in an email to us, stating that “devices cleared under a 510(k), regardless of how long the predicate has been on the market, have met the 510(k) regulatory review standard.”

The second loophole is the supplement pathway, which applies to new versions of the highest-risk devices, such as artificial hips, deep brain stimulators and spine implants. This process allows manufacturers to inform the FDA that they want to market an updated version of a device with minor changes — once again, allowing them to circumvent clinical trials. Researchers at Harvard found that 99 percent (5,829 of 5,906) of implanted cardiac devices, such as pacemakers and defibrillators, were approved through the supplement pathway from 1979 to 2012.

The supplement pathway has led to a number of disasters, such as one involving Medtronic’s Sprint Fidelis defibrillators, which are implanted in the chest to shock the heart if it goes into a deadly rhythm known as ventricular fibrillation. The company told the FDA in 2003 that it had updated the device to use thinner electrical leads into the heart. But the new wires were prone to fracture, hitting some patients repeatedly with shocks when their hearts were fine, and not delivering shocks to others who needed them. Doctors put the Sprint Fidelis into Bridget Robb, a patient from Pennsylvania in her early 30s. It shocked her 31 times in a span of minutes in 2007. She said in congressional testimony that it felt like being shot in the chest by a cannon at close range.

By the time Medtronic recalled the defibrillator in 2007, about a quarter-million were in circulation worldwide. Individuals implanted with it live under a sword of Damocles: They risk electrocution and possible death if they leave the Sprint Fidelis alone — and they risk death if their heart stops and the product fails. If they choose to have it removed, they face a 12 to 16 percent rate of serious complications or death from the surgery, according to a study published in 2010 in the journal Circulation.

Cases like these have received widespread coverage in the press but have had virtually no effect on FDA policy. Even a damning 2011 report by the Institute of Medicine (requested by the FDA), which deemed the agency’s 501(k) pathway so flawed it should be thrown out, fell on deaf ears.

Part of the problem lies in whom the agency believes it serves. At a recent meeting in Utah, the FDA’s device director repeatedly referred to manufacturers as the agency’s “customers” and showed a slide proclaiming “90 percent customer satisfaction.” Another slide documented the agency’s shorter and shorter approval times over the past eight years. These might not be the priorities of patients and taxpayers if they knew how often devices go on to harm people.

The FDA has become a captive agency. In 2007, Congress passed the Medical Device User Fee Amendments (MDUFA), which requires manufacturers to pay for device approvals. (Similar legislation, the Prescription Drug User Fee Act, directs money from drug companies to the FDA.) By 2018, 35 percent of the FDA’s budget for regulating devices came directly from the companies that make them. Zuckerman says that to continue collecting user fees under the MDUFA, the agency has to meet “performance goals” for faster approvals — leaving less time to evaluate products before they go on the market. It’s an inherent conflict of interest exacerbated by the revolving door of directors and commissioners who come from industry to the FDA and then go back. Before being appointed by President Trump to head the agency, Scott Gottlieb was paid millions of dollars for consultancies, directorships and other ties with some 20 health-care companies. He is a vocal supporter of Trump’s deregulation drive, arguing in 2013 that “the FDA’s caution is hazardous to our health.”

This is not a new problem. Before Gottlieb, President Barack Obama appointed Margaret Hamburg, who was then a director of Henry Schein, a leading medical-device distributor, to head the FDA. And in 2005, President George W. Bush named Lester Crawford, who abruptly resigned after just two months and came under criminal investigation for making false statements to Congress concealing his ties to companies the FDA regulates.

The relationship between the agency and the device industry is so cozy that in 2015, Rob Califf, then the FDA commissioner, met secretly with the Advanced Medical Technology Association (AdvaMed), the industry trade organization, to help craft the 21st Century Cures Act, which lowered the bar of evidence needed to approve devices even further.

Last fall, the FDA and AdvaMed were aware of the planned release of the Implant Files, the report by the investigative journalists’ consortium. AdvaMed executives were so concerned that they held a meeting to discuss strategies for dealing with the anticipated stories, which made headlines around the world in November. The executives promised their member companies that they would “hit back and hit back hard.” One day after the first reports were published, the FDA issued its “transformative” changes to the 510(k) pathway.

If Americans want devices that are safe and effective, they’ll need a new kind of regulation. First, the FDA should recategorize any implanted device as a high-risk or Class III product, which would subject it to rigorous clinical trials. Data from these studies should be made publicly available, or the manufacturer would forfeit the right to sell its product. And implanted devices should be entered into registries that track outcomes; patients should be given access to a website where they can immediately report problems and receive updates.

Lawmakers should also revive the congressional Office of Technology Assessment, which the House of Representatives killed in 1995, during a fit of anti-regulation insanity inspired by Newt Gingrich’s Contract With America. The office provided an invaluable service by independently assessing evidence for a wide range of technologies.

Finally, the FDA commissioner should be a civil servant without financial conflicts, not a political appointee (a practice started under Richard Nixon).

To do all of this, the FDA needs to overcome the constant threat of losing funding if it goes against the wishes of the industry it is supposed to regulate. Congress should repeal the MDUFA (and the prescription-drug equivalent) and fully fund the agency. Until the FDA requires clinical testing of implanted devices, as it does for drug approval, we simply won’t have the evidence to prove that a device is safe or effective.

See the original article here.

29-Year-Old Fitness Model Gets Breast Implants Removed after She Says the Silicone Gave Her Seven Years of ‘Brain Fog, Bald Spots and Rashes’

Mary Kekatos, Daily Mail: December 19, 2018.


A fitness blogger said she had her breast implants removed because the silicone was ‘poisoning’ her.

Sia Cooper, the 29-year-old behind the blog Diary of a Fit Mommy, revealed she got implants in October 2011 to boost her self-confidence after weight loss left her with small breasts.

However, over the next seven years, the Florida mother-of-two struggled with extreme fatigue, facial rashes, chest pain, brain fog and even hair loss.

post-explant, 2 weeks

After undergoing multiple blood tests, diagnostic tests and X-rays that came back negative, Cooper was convinced her symptoms were related to what described as  ‘breast implant illness’.

 

Patient Satisfaction After Breast Reconstruction with Implants Compared to Flap Procedures

 

For many women, breast reconstruction can be an important step in recovering physically and mentally after a mastectomy.  However, research shows less than half of mastectomy patients received the information and counseling necessary to make an informed decision regarding their reconstruction choice.

A 2018 study by Katherine Santosa and her colleagues found that patients who undergo autologous breast reconstruction (also called “flap” procedures), are generally more satisfied in the long-term than women who choose reconstruction with breast implants.  The study included 2,013 patients, 74% of whom got breast implants and 26% of whom had autologous reconstruction. Autologous tissue transfer refers to any procedure in which the body’s own tissue is used to reconstruct breasts. Surgeons take fat and other tissue from another part of a woman’s body, usually the abdomen, and move it to create breasts.

The researchers surveyed women on their quality of life 90 days before their mastectomy, and at 1, 2, 3, and 4 years after reconstruction. The survey included questions on four topics: Patients’ satisfaction with their breasts, emotional and social well-being, sexual well-being, and physical well-being. In the satisfaction with breasts category, women were asked questions about their breasts appearance, their satisfaction with breasts and how bras fit, and how the breasts feel to the touch. To understand women’s emotional and social well-being, researchers asked questions about body image and a woman’s confidence in social settings. Women were also asked about their sexual well-being, including questions about feelings of sexual attractiveness, sexual confidence, and comfort level during sex. Lastly, researchers asked women about their physical well-being, including information about pain, tightness, and any physical difficulty with performing daily activities.

Patients who chose autologous reconstruction reported higher satisfaction with their breasts than those who got breast implants. The women who had autologous reconstruction also reported greater emotional and social well-being and sexual well-being compared to before reconstruction. In contrast, patients who got breast implants reported worsened sexual well-being compared to before reconstruction.

The information from this study can provide useful information to patients and their doctors about patients’ likely quality of life following breast reconstruction with autologous or “flap” procedures compared to breast implants.

You can read a summary of the original article here.

Reference:

  1. Santosa, Katherine B et al. Long-term Patient-Reported Outcomes in Postmastectomy Breast Reconstruction. JAMA Surgery. 2018; 153(10): 891 – 899.