Category Archives: Policy

NCHR Testimony on the Opioid Buprenorphine/Samidorphan for Depression

Policy, Testimony & Briefings

Stephanie Fox-Rawlings, PhD, National Center for Health Research: November 1, 2018

Thank you for the chance to speak today on behalf of the National Center for Health Research. I am Dr. Stephanie Fox-Rawlings. Our Center analyzes scientific and medical data to provide objective health information to patients, health professionals, and policy makers. We do not accept funding from drug and medical device companies, so I have no conflicts of interest.

As we’ve heard today, depression is a serious health issue. However, FDA approval requires proof that new drugs are safe and effective. New drugs have to work to help patients.

I’ll focus on efficacy first. The evidence presented for buprenorphine/samidorphan (BUP/SAM) does not provide adequate evidence that it reduces depression more than placebo.

Two of the three trials designed to provide evidence of efficacy did not find any statistical benefit of the drug compared to placebo. The third trial, study 207, had a statistically significant reduction in depression on the MADRS for the 2mg/2mg dose. However, this trial also has major shortcomings. For example, it used the MADRS-6, which lacks important aspects of depression and therefore can’t prove efficacy.

Using the full MADRS, the only time the drug is more effective than placebo is for just a few weeks in the middle of a short trial. By the end of the trial, the placebo group was doing as well as the treatment group. This does not demonstrate a meaningful benefit for patients. And though statistically significant for that short time, treated patients improved less than 2 points more than placebo on a 60 point scale. This difference seems too small to be clinically meaningful for patients.

MADRS has clear standards for improvement. “Responders” are defined as those whose symptoms improve by at least 50%. Remission is defined by those scores are 10 or below on MADRS. Patients taking the drug were not more likely to be a responder or go into remission than patients taking placebo for any of the efficacy trials. This again raises questions about whether the benefit in study 207 is clinically meaningful compared to studies of other antidepressants. These trials may just be too short, but there needs to be confirmatory evidence that the statistically significant result is real.

Study 202 was designed as a proof of concept study and FDA points out that it can’t prove efficacy because it lacks the statistical controls to make sure that the difference did not occur by chance. Also, the relatively high dropout rate for patients in the drug arms could have a large effect on the results. We agree with the FDA reviewers that the lack of a dose response also raises red flags. If the drug is effective, the high dose (8mg/8mg) should at least show a statistical trend toward significance. It doesn’t.

As we all know, in studies of depression the placebo groups often do quite well. Placebo controls are essential because they help control for the natural ebb and flow of depression episodes. Instead, the sponsor tries to eliminate evidence of the placebo effect. Without the trial-long comparison of the placebo to drug arms, it is not possible to determine whether natural fluctuations in depression or the treatment are affecting the results.

There are concerns about safety.

The clinical trials included very few older patients. Older patients metabolize drugs more slowly and are more likely to have adverse reactions. They are also likely to be taking many other drugs that could interact with this drug.

Like all opioids, even ones with abuse-deterrent properties, this drug has the potential for misuse and abuse. This is a major concern because depressed patients are more likely to have substance abuse disorders and are at increased risk for opioid overdose.

In summary, the clinical trial data do not provide adequate evidence that BUP/SAM reduces the symptoms of depression. There are concerns about it potential for long-term harms to patients and others who might misuse or abuse it. BUP/SAM needs to provide strong evidence of efficacy before approval.

Although refractory depression is a serious condition, prescribing a treatment with unproven benefits and unknown risks is very dangerous. And, as you know, new drugs for depression tend to be more widely prescribed than the narrow indications that FDA approves. Approving this drug even for refractory depression could easily contribute greatly to our current opioid epidemic.

 

The joint Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted against approval (21 against and 2 for).

NCHR Testimony on the Opioid Sufentanil

Policy, Testimony & Briefings

Varuna Srinivasan MBBS MPH, National Center for Health Research: October 12, 2018

Thank you for the opportunity to speak today. My name is Dr. Varuna Srinivasan. I am a physician with a Master of Public Health from Johns Hopkins University. I am a Senior Fellow at the National Center for Health Research, which analyzes scientific and medical data to provide objective health information to patients, health professionals, and policy makers. We do not accept funding from drug and medical device companies, so I have no conflicts of interest.

We have strong concerns about the safety of the drug in question today: Sufentanil.

First, we are concerned that the level of pain relief provided by sufentanil is not clinically meaningful. Patients taking the drug had statistically lower levels of pain than patients taking placebo based on their SPID score, but this difference was so small I would not consider it helpful to my patients. Just as important, there was no difference in how long it took for patients to experience “meaningful pain relief” between placebo and this drug that is supposedly five times more potent than fentanyl! If it was really more effective than placebo, surely it would work more quickly to relieve pain.

The weak results are even more problematic because there was only one pivotal phase 3 clinical trial. We have an opioid epidemic and it is crucial that the FDA not approve opioids that are not proven to work.

There is limited diversity in the clinical trials. Most of the study patients were white and younger. We would assume that a wide variety of patients visit the ER or undergo surgery, but that diversity of demographic background is not reflected in the study population. In fact, the FDA memorandum provides is no information on any racial and ethnic subgroups. They combined trials where they gave 15mcg and 30 mcg to different patients. These have different profiles but they controlled by the study sites and FDA finds it to be relevant. While there are no older patients in the trial with 30mcg, they are extrapolating the safety data as a whole and the mean age for the trial with 15 mcg is 58 so keeping this in mind, how do I phrase this sentence – The sponsor also failed to look at older patients, even though we know that pain tends to increase with age..

In summary, this drug is not proven to have a meaningful impact on reducing pain in post-operative settings. I respectfully urge you to let the FDA know that the agency should require better evidence of the efficacy of this drug. The sponsor should submit more conclusive data to this advisory committee before it can consider recommending approval for sufentanil.

On October 12th, the advisory committee voted 10-3 in favor of approving Sufentanil

 

NCHR Testimony of TIRF REMS

Policy, Testimony & Briefings

Stephanie Fox-Rawlings, National Center for Health Research: August 3, 2018

Thank you for the opportunity to speak today on behalf of the National Center for Health Research. I am Dr. Stephanie Fox-Rawlings. Our Center analyzes scientific and medical data to provide objective health information to patients, health professionals, and policy makers. We do not accept funding from drug and medical device companies, so I have no conflicts of interest.

Our Center worked with Congress to create the REMS [risk evaluation and mitigation strategy] program in legislation that became law quite a few years ago.  The goal always was to enable FDA to approve effective drugs even if they had worrisome risks. The REMS were intended to lower those risks as much as possible, so that patients taking the drug were most likely to be helped and least likely to be harmed.

A major shortcoming of these risk mitigation strategies has always been ensuring that they are effective in lowering risks.  It is difficult to evaluate the effects of the REMS on prescribers, pharmacists, patients, and others who accidentally or intentionally misuse the drugs.

The data before you today that evaluated these REMS are limited.  However, we commend the efforts of TRIG [TIRF REMS Industry Group] and the FDA to assess these REMS and to improve the data as well as the effectiveness of these REMS. We strongly urge that TRIG implements the FDA recommendations in a timely and complete manner to more fully understand to what extent the REMS are or are not working, so that they can increase the benefit to risk ratio of their products.

The data are especially limited regarding the proportion of prescriptions for cancer pain or other indications.  That is a big problem since this product is only approved for cancer pain.

And, also like the FDA reviewers, we are very concerned about the increased rate of adverse events after implementing REMS.  Even though the reports are voluntary and therefore could be biased, the increase after REMS is very disturbing. The quality of the REMS data are also low because only a subset of potential events are evaluated.  This makes the data very difficult to interpret. However, other sources of data also suggest that there are concerning numbers of therapeutic errors, misuse and exposures with severe consequences.

Congress supported REMS because they were intended to reduce the risk of serious harms, while continuing to make the product available to those who need it. The data indicate that these REMS need improvements. For example:

  • 42% of new users were not opioid-tolerant. That is not the indication, so that means at least 42% are prescribed off label.  This increases the risk for central nervous system and breathing problems.
  • Relatively high proportion of survey respondents did not know the correct indication or that TIRFs need to be stopped if around-the-clock opioid medication is stopped.  They learned this in the training, but could not remember it when surveyed later.

Changes to the REMS should be designed to make them more effective at protecting patients. Changes in REMS should not be aimed primarily at increasing the number of prescriptions.  An increase in prescriptions without ensuring appropriate prescribing, dispensing, use, and disposal increases the risk that more patients will be harmed, and that the drugs will be used accidentally or misused by individuals who were not prescribed the drug.

Bottom line: TIRFs [transmucosal immediate-release fentanyl] provide important options for cancer patients dealing with pain. However, we all know that they carry very serious risks and that’s why we need REMS that protect patients’ these risks.  These REMS are not working as well as the should to protect patients and need to be improved.

 

Letter from Nonprofits to DC Mayor and Other Officials About Dangers of Artificial Turf and Playgrounds

Legislation, Policy

Identical letters were sent to members of the DC City Council, the DC superintendent of schools, and other DC officials.

July 10, 2018

Dear Mayor Bowser:

We, the undersigned organizations and businesses, are writing to strongly urge that the District government stop installing synthetic turf and poured in place (PIP) playgrounds in Washington, D.C.  There is a growing body of evidence that these synthetic surfaces endanger children’s health, are harmful to our environment, and are very expensive to install and maintain compared to natural grass.1,2,3,4

  • In the District, children have been endangered by surface temperatures that have been measured in excess of 160 degrees Fahrenheit.5,6,7,8
  • For years, children in the District have been endangered by playing fields that are excessively hard, far out of compliance with any safety standards.  Until last year, the District did not correctly monitor Gmax testing of field hardness (called impact attenuation) to ensure even a minimum safety standard to prevent injuries when children fall.  A score of 165 or higher is considered too dangerous for children by the Synthetic Turf Council.  Dozens of DCPS playing fields exceeding that 165 score remain in service with no remediation at all.8,9,10,11

When products with known risks of injuries from infection, high temperature and hardness are installed, the District has an obligation to provide monitoring and safety standards.  That hasn’t been done in a timely manner,12 and students have been harmed.13,14,15

We oppose the District’s plans to install more synthetic turf of any type on playing fields or playgrounds. These plastic carpet systems and infills are exposing our children and environment to harmful toxicants, as documented by independent researchers at Yale,1  Mount Sinai Children’s Environmental Health Center,16,17 and the National Center for Health Research.18  

Synthetic rubber playground materials (often called PIP) that are used under slides, swings, and other children’s play areas contain similarly harmful toxicants.19

  • Claims from vendors or industry-funded scientists that the materials are proven safe are inaccurate.  Misleading claims that there is “no evidence” of harm does not mean that the synthetic systems are proven to be safe.  On the contrary, concerns about safety have been documented by independent scientists noted above, and were examined during the Obama Administration by the Consumer Product Safety Commission (CPSC) and the Environmental Protection Agency (EPA).20  The CPSC and EPA reviews were not completed as expected in 2016 or 2017, and it is not clear whether those reviews are held to the scientific standards that had previously been established.
  • 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, such as tire crumb, 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,21 and the fields also continuously shed microplastics as the plastic blades break down.22,23 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 adsorb and concentrate other toxins from the environment.24,25,26
  • Synthetic surfaces also create heat islands.27,28  In contrast, organically managed natural grass saves energy in urban areas 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.29

We urge your support for the installation of organically managed natural grass fields and Engineered Wood Fiber (EWF) playgrounds that are properly engineered, installed, and maintained for ADA compliance.  It is incumbent upon the District of Columbia to:

  1. Halt all installation of synthetic playgrounds and playing fields.
  2. Remove synthetic playgrounds and playing fields instead of renovating them or replacing with new synthetic materials.
  3. Prioritize proper installation and maintenance of ADA compliant natural surfaces.
  4. Solicit public ideas for increasing the inventory of playing fields and recreation opportunities.

We endorse the January 2018 policy recommendations made by DC Safe Healthy Playing Fields, which provide a measured and reasonable approach to phasing out of synthetic fields and playgrounds in DC and replacement with natural surfaces.

As noted above, there is well-documented evidence on the environmental and health dangers of synthetic fields and playground surfaces.  The scientists and consultants denying these risks to the DC Government have financial and other ties to the companies that manufacture and install synthetic turf or to the recycled rubber industry.

Tax dollars should not be spent on products that endanger children’s health and harm our environment.

Sincerely,

DC Safe Healthy Playing Fields

Alliance of Nurses for Healthy Environments

American Academy of Environmental Medicine

Audubon Naturalist Society

Beyond Pesticides  (October 2017 Testimony to DC City Council)

Cedar Lane Unitarian Universalist Church Environmental Justice Ministry

Center for Environmental Health

Children’s Environmental Health Network (October 2017 Testimony to DC City Council)

Kids in Danger

MOM’s Organic Market

Maryland Public Interest Research Group

Maryland Environmental Health Network

Moms Clean Air Force

National Center for Health Research

Neighbors of the Northwest Branch of the Anacostia River

New Hampshire Safe Water Alliance

Non Toxic Communities

Public Employees for Environmental Responsibility (Statement on EPA Study)  

Safe Grow Montgomery

Safe Healthy Playing Fields Coalition

Sierra Club DC

Trash Free Maryland

Toxics Action Center Campaigns

Women’s Alliance for Democracy & Justice

 

CC:

City Administrator Rashad Young

Department of Energy & the Environment Director Tommy Wells

Deputy Mayor of Education Ahnna Smith

Deputy Mayor for Health and Human Services HyeSook Chung

Department of Parks and Recreation Director Keith Anderson

Department of General Services Director Greer Gillis

DCPS Chancellor Amanda Alexander

Interagency Synthetic Turf Task Force

Evan Lambert, Fox5

Mike Ozanian, Forbes

Rachel Sadon, DCist

 

PDF Copy: July 10 Safe Healthy Playing Fields to Mayor Bowser et al

References:

  1. Benoit G, Demars S. Evaluation of organic and inorganic compounds extractable by multiple methods from commercially available crumb rubber mulch. Water Air Soil Pollut 2018. 229(3): 64. https://doi.org/10.1007/s11270-018-3711-7
  2. Llompart M, Sanchez-Prado L, Pablo Lama J, Carcia-Jares C, Roca E, Dagnac T. Hazardous organic chemicals in rubber recycled tire playgrounds and pavers. Chemosphere. 2013. 90: 423-431. http://www.elcorreodelsol.com/sites/default/files/chemosphere_maria_llompart.pdf
  3. Massachusetts Toxics Use Reduction Institute. Sports turf alternatives assessment: Preliminary results: Cost analysis. September 2016. http://www.turi.org/Our_Work/Home_Community/Artificial_Turf/Cost_Analysis
  4. Ozanian M. How taxpayers get fooled on the cost of an artificial turf field. Forbes. September 28, 2014. https://www.forbes.com/sites/mikeozanian/2014/09/28/how-taxpayers-get-fooled-on-the-cost-of-an-artificial-turf-field/#ea43caf5db28
  5. Images of the high temperatures recorded at Janney Elementary on June 12, 2017. On a day when the ambient air temperature was 96°F, poured-in-place surfaces were 164°F and 165°F, artificial turf field was 162°F, while mulch and concrete were 122°F and 127°F, respectively.
  6. Image of the high temperature of an Envirofill field at Janney Elementary on October 1, 2017. The field was 136°F when the ambient air was 64°F.
  7. As temperatures increase, surface hardness also increases: Vidair C, Haas R, Schlag R. Testing impact attenuation on California playground surfaces made of recycled tires. Int J Inj Contr Saf Promot. 2007. 14(4): 225-30. https://www.ncbi.nlm.nih.gov/pubmed/18075871
  8. National Center for Health Research. Letter to the DC City Council on Artificial Turf. October 26, 2017. http://www.center4research.org/nchr-letter-dc-city-council-artificial-turf/
  9. Evaluation of D.C. testing results found that dozens of DCPS playing fields exceeded a g-max score of 165: Zuckerman D. Risks of head injuries on artificial turf fields in Washington, D.C. National Center for Health Research. 2017. http://www.center4research.org/risks-head-injuries-artificial-turf-fields-washington-d-c/ 
  10. Sadon R. Hardness test results reveal wider scope of artificial turf failures. DCist. October 12, 2017. http://dcist.com/2017/10/even_more_artificial_turf_fields_fa.php 
  11. Synthetic Turf Council. Guidelines for synthetic turf performance. 2011. https://cdn.ymaws.com/www.syntheticturfcouncil.org/resource/resmgr/guidelines/STC_Guidelines_for_Synthetic.pdf
  12. D.C. Department of General Services. Artificial athletic turf fields: Frequently asked questions. September 21, 2017. https://dgs.dc.gov/sites/default/files/dc/sites/dgs/service_content/attachments/UPDATED%20-%20FAQ%20Artificial%20Athletic%20Turf%20Fields%20-%209-21-17.pdf 
  13. McCray Q. Safety checks at D.C. playgrounds under question after boy injured on crumb rubber floor. WJLA. October 27, 2017. http://wjla.com/news/local/safety-checks-at-dc-playgrounds-under-question-after-boy-injured-on-crumb-rubber-floor
  14. Infections are the result of increased incidence of abrasions on artificial turf, see Williams S, Trewartha G, Kemp SP, Michell R, Stokes KA. The influence of an artificial playing surface on injury risk and perceptions of muscle soreness in elite rugby union. Scand J Med Sci Sports. 2016. 26(1): 101-108. https://www.ncbi.nlm.nih.gov/pubmed/25644277.  Kazakova SV, Hageman JC, Matava M, et al. A clone of methicillin-resistant staphylococcus aureus among professional football players. N Engl J Med. 2005. 352(5): 468-475. https://www.nejm.org/doi/full/10.1056/NEJMoa042859.  Van den Eijnde W, Masen M, Lamers E, van de Kerkhof P, Peppelman M, Van Erp P. The load tolerance of skin during impact on artificial turf using ex-vivo skin as the readout system. Science and Medicine in Football. 2018. 2(1): 39-46. https://www.tandfonline.com/doi/full/10.1080/24733938.2017.1390593
  15. Graphic one-minute video of student with serious infection from synthetic turf in DC
  16. The Children’s Environmental Health Center of the Icahn School of Medicine at Mount Sinai. Letter to DC City Council concerning state of fields and playgrounds maintained by the District Public Oversight Roundtable. October 12, 2017.
  17. The Children’s Environmental Health Center of the Icahn School of Medicine at Mount Sinai.  Artificial turf: A health-based consumer guide. May 2017. http://icahn.mssm.edu/files/ISMMS/Assets/Departments/Environmental Medicine and Public Health/CEHC Position Statement on Recycled Rubber Turf Surfaces May 10 2017.pdf
  18. Booker N, Fox-Rawlings S. Children and athletes at play on toxic turf and playgrounds. National Center for Health Research. 2018. http://www.center4research.org/children-athletes-play-toxic-turf-playgrounds/
  19. Canepari S, Castellano P, Astolfi ML, Materazzi S, Ferrante R, Fiorini D, Curini R. (2018) Release of particles, organic compounds, and metals from crumb rubber used in synthetic turf under chemical and physical stress. Environ Sci Pollut Res Int. 25(2): 1448-1459. https://link.springer.com/article/10.1007%2Fs11356-017-0377-4
  20. EPA. Federal research on recycled tire crumb used on playing fields. 2018 https://www.epa.gov/chemical-research/federal-research-recycled-tire-crumb-used-playing-fields
  21. 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.
  22. 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
  23. 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/
  24. 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/
  25. 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
  26. 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. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2873021/
  27. 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
  28. Penn State’s Center for Sports Surface Research. Synthetic turf heat evaluation- progress report. 2012. http://plantscience.psu.edu/research/centers/ssrc/documents/heat-progress-report.pdf
  29. 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

NCHR Letter to CDC Director Supporting Review of Biopsy Before Hysterectomy or Myomectomy

Policy

May 9, 2018

Robert R. Redfield, MD
Director, Centers for Disease Control and Prevention
1600 Clifton Road
Atlanta, GA 30329-4027

Dear Dr. Redfield:

I am writing to you on behalf of the National Center for Health Research to strongly urge the Centers for Disease Control and Prevention (CDC) to conduct a review to determine the potential benefits of requiring pre-surgical biopsies for women scheduled for hysterectomy or myomectomy (removal of fibroids).

The review is urgent because a recent article that was published in the medical journal Obstetrics & Gynecology reports that the rate of unsuspected cancer is dangerously high in women undergoing these procedures.  When women with undetected cancer undergo those surgeries, especially but not only when the surgery involves a medical device called a power morcellator, the cancer can spread inside the woman’s abdomen, resulting in an early-stage cancer being upstaged to a much more dangerous stage 4 cancer.  Until recently, experts assumed that the risk of these patients having an undetected cancer was less than 1 in 1,000, which was later revised to 1 in 352.  However, the new study indicates that the risks are much higher, and the risk of an undiagnosed uterine cancer is close to 10% for women ages 55 and older.

Researchers from Yale Medical School and the Columbia University College of Physicians and Surgeons studied more than 26,000 women who underwent hysterectomy or fibroid removal. Their finding that undetected cancers were much higher than previously estimated demonstrates that thousands of women are at risk every year.  A review by the CDC would provide important information that could be used to develop new guidelines.  It seems likely that including a biopsy as the standard of care for women undergoing these gynecological procedures could save thousands of women’s lives.

We thank you for your interest and attention to this matter. We strongly urge you to move forward with a review as soon as possible with the goal of developing guidelines pertaining to tissue biopsy methods that will identify women with gynecological cancer before undergoing a surgical procedure to remove the uterus or fibroid.

The National Center for Health Research is a nonprofit research center that conducts and scrutinizes research that can be used to improve public health through better healthcare services, programs, and policies.  We have no financial ties to the products or procedures that we evaluate.

Sincerely,

Diana Zuckerman, Ph.D.
President

 

See our related statement here.

Letter to Board of Education of Montgomery County on Artificial Turf Fields and Playgrounds

Legislation, Policy
Diana Zuckerman, PhD, National Center for Health Research, April 23, 2018

April 23, 2018

Dear Board of Education members,

As a long-time resident of Montgomery County and as president of the National Center for Health Research, I am shocked by the misinformation I have seen circulating about all types of artificial turf and rubber playgrounds in Montgomery County.

The recent plan to use Zeolite indicates a dangerous lack of understanding of the need for safety testing before using materials that our children will be exposed to day after day.  Zeolite is a mined volcanic mineral.  Its use in artificial turf has not been tested for human health,  but there is every reason to be concerned that inhaling the dust from Zeolite could cause lung damage, similar to the damage from asbestos.

In addition, it is my understanding that synthetic rubber play surfaces are now being proposed for MCPS outdoor play spaces.  These “poured in place” and other types of rubber playground surfaces have many of the same risks as tire crumb and other rubber infill that the County Council realized were too dangerous to use in 2015.  These rubber playgrounds look very attractive and feel good when they are new, but you can’t see the chemicals that are in them.  As a result, these synthetic rubber playgrounds (like artificial turf playing fields) are often over 140-160 degrees Fahrenheit 50-60 degrees on a sunny day – even on days when the air temperature is only 60 degrees!.  In addition, the rubber (which is made from petroleum and other products) release toxins that can cause cancer and also contribute to early puberty, obesity, attention deficit disorder, asthma, and rashes.  The playground surfaces also start to tear, and very small pieces of colorful materials are very tempting for young children to eat because they look like candy.

Please stop these dangerous installations from going forward.

As president of the National Center for Health Research, I testified about the risks of these materials at the U.S. Consumer Product Safety Commission this past week, and have previously testified before the Maryland House of Delegates Appropriations Committee  and the D.C. City Council.  I am sorry to say that I have repeatedly seen and heard scientists from 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).  They also give misleading assurances such as “there is no evidence of a child getting cancer from these products.” The problem with that type of statement is that it is virtually impossible to prove that a chemical exposure causes one specific individual to develop cancer.  What we do know is that many of 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 now or as they get older.  That should be adequate reason to not install them in Montgomery County.  Add to that the short-term risk of asthma, obesity, attention problems, and early puberty, and it is time  for the County to educate its opinion leaders and stop spending millions of dollars on fields and playgrounds and insurance for trip that are less safe and more expensive than well designed natural grass fields and ADA-compliant engineered wood fiber.

For more information, please read our user-friendly footnoted summary at http://www.center4research.org/children-athletes-play-toxic-turf-playgrounds/

Sincerely,

Diana Zuckerman, Ph.D.
President
National Center for Health Research

Comments by Diana Zuckerman, Ph.D. on the U.S. Consumer Product Safety Commission Agenda and Priorities for FY2019/2020

Legislation, Policy
Diana Zuckerman, PhD, National Center for Health Research,April 11, 2018

The National Center for Health Research is a nonprofit research center staffed by scientists, medical professionals, and health experts who analyze and review research on a range of health issues. We conduct studies, we scrutinize research done by others, and we try to make sense of conflicting research findings.  Our goal is to explain that information so it can be used to improve policies, programs, services, and products.  Thank you for the opportunity to share our views concerning the Consumer Product Safety Commission’s (CPSC) priorities for fiscal year 2019 and 2020. We respect the essential role of the CPSC, as well as the challenges you face in selecting the most important priorities.

I’m trained as an epidemiologist at Yale Medical School, and I was on the faculty at Yale and Vassar and a researcher at Harvard before moving to Washington, D.C. as a Congressional Fellow in the program sponsored by the American Association of the Advancement of Science (AAAS).  While our Center’s mission overlaps with much of the work of the CPSC, today I will talk as a scientist about safety risks that you don’t hear as much about – the ones that we can’t see.

We are surrounded by chemicals in the air we breathe, the table in front of me, and the dust in the room.  Today I will focus on three issues involving chemicals in products that affect our health and our children’s health. These issues are clearly consistent with the CPSC priorities. We are very concerned about flame retardants and phthalates, both of which migrate out of products and into the dust we breathe and touch. We’re also very concerned about artificial turf fields and playgrounds, which contain a range of endocrine-disrupting chemicals and other toxic materials that can harm children’s development and possibly increase risk for cancer as these children grow up.

Organohalogen Flame Retardants

Thank you for voting to initiate rulemaking on non-polymeric organohalogen flame retardants (OFRs) and to provide guidance for manufacturers, distributors, and retailers to avoid OFRs.1 We urge you to convene a Chronic Hazard Advisory Panel (CHAP) as soon as possible and develop regulations to address OFRs in children’s products, upholstered residential furniture, mattresses/mattress pads, and the plastic casing of electronic devices. In addition, it is essential to consider current flammability standards to determine if there are changes that would improve their safety from both chemical exposures and potential fire.

Since OFRs are not bound to products, they migrate out of products and into dust, and thus get onto our skin and food as well as into the air we breathe. Because so many products are made with these chemicals and because they are so long-lasting, consumers are repeatedly exposed day after day.2,3 In addition, many OFRs bioaccumulate in our food supply.4,5,6,7 As a result, nearly all people in the U.S. have OFRs in their bodies. 8

OFRs have been associated with various health problems, including disrupting hormones, altering brain development, and harming reproductive health, such as reduced ability to get and stay pregnant and the timing of puberty.5,9,10,11 While not all OFRs have been sufficiently studied to determine whether all are unsafe, those that have been sufficiently studied have proved to be harmful to health.

While we recognize that the Commission must be concerned about fire hazards as well, it seems that these flame retardants may not be effective at preventing deaths in real world situations.12,13 When the chemicals burn during a fire, the inhaled smoke is more toxic to humans, and exposures could result in serious harms, including death.

Artificial Turf and Playground Surfaces

We appreciate the CPSC’s ongoing efforts to investigate the safety of crumb rubber on playgrounds and playing fields. This requires your immediate attention, because artificial turf fields are becoming increasingly popular surfaces for fields and playgrounds where children are exposed day after day, year after year. And yet, the materials used are often treated as “trade secrets” making it impossible to know exactly what they are, which ones are safer, and which ones are more dangerous. We encourage you to closely evaluate the research that has been done, focusing on independently funded research rather than industry claims. We also urge you to carefully examine the EPA/CDCs studies when they are completed, and to develop rules that will protect our children from harm. We urge you to convene a Chronic Hazard Advisory Panel (CHAP) to examine the short-term and long-term risks of different types of artificial turf used in playing fields and children’s playgrounds.

Crumb rubber contains chemicals with known health concerns, which are released into the air and onto skin and clothing and even into children’s ears and noses. This is inevitable for a product that is outdoors and in constant use. The chemicals include endocrine disruptors such as phthalates, heavy metals such as lead and zinc, as well as other carcinogens and skin irritants such as some polycyclic aromatic hydrocarbons (PAHs) and volatile organic compounds (VOCs).14,15,16,17,18,19 While one time or sporadic exposures are unlikely to cause long-term harm, children’s repeated exposures over the years, especially during critical developmental periods, raise the likelihood of serious harm.

These fields can also cause short-term harms. Artificial turf generates dust which may exacerbate children’s asthma.20,21 Fields heat up to temperatures far higher than ambient temperature, reaching temperatures that are more than 70 degrees warmer than nearby grass; for example, 180 degrees when the temperature is in the high 90’s and 150-170 degrees on a sunny day when the air temperature is only in the 70’s. 22,23,24 This can cause heat stress and burns.

Fields made of crumb rubber have been marketed as reducing injuries compared to grass. However, research has shown that this is not the case. We have spoken to students harmed by turf burn, and some studies have indicated increased risk for joint injuries and brain injury.25,26

We need to know more about the risks of “virgin rubber” compared to “recycled tires.” However, we already know that “virgin” rubber is made from many of the same chemicals that have these health concerns.27,28

Phthalates in Children’s and Household Products

CPSC has helped millions of American children by finalizing the phthalate rule to ban five additional phthalates (DINP, DPENP DHEXP, DCHP, DIBP) in children’s toys and care products.

The next priority should be for CPSC to expand its work on phthalates to include other household products. Children are exposed to many products with the same phthalates as those that are banned in toys and products specifically for children. Restricting the use of phthalates in common household products would reduce exposure for young children and also older children, pregnant women and other adults. Phthalates in household dust can be harmful regardless of what products it comes from and prenatal exposure is of particular concern.

Phthalate exposure has been associated with an increased risk for early puberty and reproductive problems.29,30,31 In utero exposure or exposure through breast milk puts the developing fetus, neonate, or infant at serious risk of abnormal neurological and reproductive development.32

In conclusion, endocrine disruptors and chemicals in common consumer products that do not stay bound to those products get into the air and dust and thus into our bodies. These chemicals tend to pose greater risks to fetuses and children. There are large gaps in our knowledge about the chemicals in the products on the market. Ideally, all of these chemicals would be evaluated in the final product for health concerns before it was sold. Since that is not happening, we must constantly play catch-up as health concerns are identified. Too often this leads to cases of false claims regarding the safety of new products that we later learn are as harmful or even more harmful that the ones they are replacing. While research is lacking regarding the exact extent of the dangers of many of these products, there is already sufficient evidence to cause concern. We need CPSC to address those as soon as possible.

References:

  1. Consumer Product Safety Commission. (2017) Guidance document on hazardous additive, non-polymeric organohalogen flame retardants in certain consumer products. https://www.federalregister.gov/documents/2017/09/28/2017-20733/guidance-document-on-hazardous-additive-non-polymeric-organohalogen-flame-retardants-in-certain
  2. Gramatica P, Cassani S, Sangion A. (2016) Are some “safer alternatives” hazardous as PBTs? The case study of new flame retardants. J Hazard Mater. 306:237-246.
  3. Allgood JM, Vahid KS, Jeeva K, Tang IW, Ogunseitan OA. (2017) Spatiotemporal analysis of human exposure to halogenated flame retardant chemicals. Sci Total Environ. 609:272-276.
  4. Lupton SJ, Hakk H. (2017) Polybrominated diphenyl ethers (PBDEs) in US meat and poultry: 2012-13 levels, trends and estimated consumer exposures. Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 34(9):1584-1595.
  5. Lyche JL, Rosseland C, Berge G, Polder A. (2014) Human health risk associated with brominated flame-retardants (BFRs). Environ Int. 74:170-180.
  6. Schecter A, Colacino J, Patel K, Kannan K, Yun SH, Haffner D, Harris TR, Birnbaum L. (2010) Polybrominated diphenyl ether levels in foodstuffs collected from three locations from the United States. Toxicol Appl Pharmacol. 243(2):217-24.
  7. Widelka M, Lydy MJ, Wu Y, Chen D. (2016) Statewide surveillance of halogenated flame retardants in fish in Illinois, USA. Environ Pollut. 214:627-634.
  8. Centers for Disease Control and Prevention (2015) Fourth national report on human exposure to environmental chemicals, updated tables. http:/www.cdc.gov/exposurereport/.
  9. Dishaw L, Macaulay L, Roberts SC, Stapleton HM. (2014) Exposures, mechanisms, and impacts of endocrine-active flame retardants. Curr Opin Pharmacol. 0:125-133.
  10. Hendriks HS, Westerink RHS. (2015) Neurotoxicity and risk assessment of brominated and alternative flame retardants. Neurotoxicol Teratol. 52:248-269.
  11. Kim YR, Harden FA, Toms LM, Norman RE. (2014) Health consequences of exposure to brominated flame retardants: A systematic review. Chemosphere 106:1-19.
  12. McKenna S, Birtles R, Dickens K, Walker R, Spearpoint M, Stec AA, Hull TR. (2018) Flame retardants in UK furniture increase smoke toxicity more than they reduce fire growth rate. Chemosphere. 196:429-439.
  13. Shaw SD, Blum A, Weber R, Kannan K, Rich D, Lucas D, Koshland CP, Dobraca D, Hanson S, Birnbaum LS. (2010) Halogenated flame retardants: Do the fire safety benefits justify the risks? Rev Environ Health 25:261-305.
  14. Llompart M, Sanchez-Prado L, Lamas JP, Garcia-Jares C, et al. (2013) Hazardous organic chemicals in rubber recycled tire playgrounds and pavers. Chemosphere. 90(2):423-431.
  15. Marsili L, Coppola D, Bianchi N, Maltese S, Bianchi M, Fossi MC. (2014) Release of polycyclic aromatic hydrocarbons and heavy metals from rubber crumb in synthetic turf fields: Preliminary hazard assessment for athletes. Journal of Environmental and Analytical Toxicology. 5:(2).
  16. California Office of Environmental Health Hazard Assessment (OEHHA). (2007) Evaluation of health effects of recycled waste wires in playground and track products. Prepared for the California Integrated Waste Management Board. http://www.calrecycle.ca.gov/publications/Detail.aspx?PublicationID=1206
  17. Kim S, Yang J-Y, Kim H-H, Yeo I-Y, Shin D-C, and Lim Y-W. (2012) Health risk assessment of lead ingestion exposure by particle sizes in crumb rubber on artificial turf considering bioavailability. Environmental Health and Toxicology. 27, e2012005. http://doi.org/10.5620/eht.2012.27.e2012005
  18. S. National Library of Medicine, National Institutes of Health. (2017) Tox Town (Environmental health concerns and toxic chemicals where you live, work, and play): Polycyclic aromatic hydrocarbons (PAHs). https://toxtown.nlm.nih.gov/text_version/chemicals.php?id=80
  19. Armstrong B, Hutchinson E, Unwin J, and Fletcher T. (2004) Lung cancer risk after exposure to polycyclic aromatic hydrocarbons: a review and meta-analysis. Environmental Health Perspectives, 112(9), 970.
  20. Shalat SL. (2011) An evaluation of potential exposures to lead and other metals as the result of aerosolized particulate matter from artificial turf playing fields. Submitted to the New Jersey Department of Environmental Protection. http://www.nj.gov/dep/dsr/publications/artificial-turf-report.pdf
  21. Mount Sinai Children’s Environmental Health Center. (2017) Artificial turf: A health-based consumer guide. http://icahn.mssm.edu/files/ISMMS/Assets/Departments/Environmental%20Medicine%20and%20Public%20Health/CEHC%20Consumer%20Guide%20to%20Artificial%20Turf%20May%202017.pdf
  22. Thoms AW, Brosnana JT, Zidekb JM, Sorochana JC. (2014) Models for predicting surface temperatures on synthetic turf playing surfaces. Procedia Engineering. 72:895-900. http://www.sciencedirect.com/science/article/pii/S1877705814006699
  23. Penn State’s Center for Sports Surface Research. (2012) Synthetic turf heat evaluation- progress report. http://plantscience.psu.edu/research/centers/ssrc/documents/heat-progress-report.pdf
  24. Serensits TJ, McNitt AS, Petrunak DM. (2011) Human health issues on synthetic turf in the USA. Proceedings of the Institution of Mechanical Engineers, Part P: Journal of Sports Engineering and Technology. 225(3), 139-146.
  25. Balazs GC, Pavey GJ, Brelin AM, Pickett A, Keblish DJ, Rue JP. (2015) Risk of anterior cruciate ligament injury in athletes on synthetic playing surfaces: A systematic review. American Journal of Sports Medicine. 43(7):1798-804.
  26. Theobald P, Whitelegg L, Nokes LD, Jones MD. (2010) The predicted risk of head injury from fall-related impacts on to third-generation artificial turf and grass soccer surfaces: a comparative biomechanical analysis. Sports Biomechanics. 9(1):29-37.
  27. Canepari S, Castellano P, Astolfi ML, Materazzi S, Ferrante R, Fiorini D, Curini R. (2018) Release of particles, organic compounds, and metals from crumb rubber used in synthetic turf under chemical and physical stress. Environ Sci Pollut Res Int. 25(2):1448-1459.
  28. Kim S, Yang JY, Kim HH, Yeo IY, Shin DC, Lim YW. (2012) Health risk assessment of lead ingestion exposure by particle sizes in crumb rubber on artificial turf considering bioavailability. Environ Health Toxicol. 27:e2012005. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278598/
  29. Chen Q, Yang H, Zhou N, Sun L, et al. (2017) Phthalate exposure, even below US EPA reference doses, was associated with semen quality and reproductive hormones: Prospective MARHCS study in general population. Environ Int. 104:58-68.
  30. Mariana M, Feiteiro J, Verde I, Cairrao E. (2016) The effects of phthalates in the cardiovascular and reproductive systems: A review. Environ Int. 94:758-776.
  31. Yi Wen, Shu-Dan Liu, Xun Lei, Yu-Shuang Ling, Yan Luo, and Qin Liu.(2015) Association of PAEs with precocious puberty in children: A systematic review and meta-analysis. Int J Environ Res Public Health. 12(12): 15254–15268. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4690910/
  32. Consumer Product Safety Commission. (2014) Chronic Hazard Advisory Panel on Phthalates and Phthalate Alternatives. https://www.cpsc.gov/PageFiles/169876/CHAP-REPORT-FINAL.pdf

NCHR Letter to the Senate on Right To Try

Legislation, Policy
National Center for Health Research, March 23, 2018

Dear Senators,

We are writing to urge you to vote against the Right to Try bill that recently passed the House of Representatives (HR 5247) despite strong opposition from the Democratic leadership. We agree with the idea that terminally ill patients should have access to potentially life-saving medical treatments, and understand that some terminally ill patients are willing to take big risks to have a chance to live longer. If they want access to experimental treatments that are undergoing clinical trials, they should be able to do so as long as they are well informed of the risks as well as the possible benefits.

That is supposed to be the goal of the federal Right to Try bill, but it fails. That is why four previous FDA Commissioners as well as the American Cancer Society; American Lung Association; National Physicians Alliance; American Society of Clinical Oncology (ASCO); Cystic Fibrosis Foundation; International Society for Stem Cell Research; National Consumers League; National Health Council; National Organization for Rare Disorders (NORD); Vietnam Veterans of America; and dozens of other patient and public health organizations oppose the bill, as we do.

We have spoken to families whose efforts to “try anything” made their loved ones’ remaining days miserable and left their families even more devastated. The House bill has a very loose definition of which patients would be eligible (since many patients with diabetes and heart disease have conditions that can cause irreversible damage that will cause premature death). In addition, it provides access to any drug that has passed Phase I clinical trials, which often don’t include even one patient. Instead Phase I trials can include healthy volunteers, such as college students, who are much less likely to be harmed by an experimental drug than a terminally ill patient.

Another problem is that these very preliminary (Phase I) clinical trials usually include very small numbers of people, and do not study whether or not a medical product has any benefit at all. They are designed to determine the immediate risks on just a few healthy volunteers or patients. That is why 85% of drugs that pass Phase I clinical trials are never proven safe and effective and never approved by the FDA.

Fortunately, the FDA’s current Expanded Access program requires at least some evidence that an experimental treatment could potentially be helpful. The FDA uses compassionate waivers when doctors request them for very ill patients, and FDA agrees to such requests 99% of the time.

The GAO’s July 2017 report on the FDA’s current Compassionate Use/Expanded Access program pointed out that most experimental drugs that pharmaceutical companies distribute under that program eventually obtain FDA approval. That shows that the program is working: It gives patients earlier (usually free) access to experimental drugs that will eventually be proven safe and effective.

Although HR 5247 includes some potentially useful requirements that the results of patients’ access to experimental drugs be made available to the FDA, so that they will be aware of serious harm that could be caused, there is no enforcement mechanism to make sure that information is made available. In other words, even if a drug was found to be extremely dangerous when used by patients through the Right to Try program, that information might not be available to FDA, patients, or physicians.

We have included our Center’s Right to Try Fact Sheet below, which we hope you will find useful.

Sincerely,

Jack Mitchell, Director of Health Policy

The Right to Try bill creates a program that is not as good as the existing FDA “Expanded Access” program, which has approved 99% of requests they received.

  • FDA’s Expanded Access program makes sure that there is some evidence that the experimental drug is safe and effective. Most of the drugs that go to patients through this program are eventually approved by the FDA.
  • Lowering the standards to drugs that completed “Phase 1 clinical trials” means that 85% of the drugs will never be proven safe and effective.
  • When standards are that low, desperate patients can die sooner and more painfully than they would have otherwise.
  • FDA physicians are available 24 hours a day to approve any emergency Expanded Access requests that the agency receives. They usually grant emergency requests immediately over the phone and non-emergency requests in an average of 4 days
  • Pharmaceutical companies may choose to deny patients access to experimental drugs if there is not enough of the drug available or they are concerned about dangerous side effects. When a patient is denied access to an experimental treatment, it is almost always because the company has said no, not the FDA.
  • State “right to try” laws do not give patients a “right” to try and have done little to expand access to investigational treatments. There is no evidence that anyone has obtained an investigational treatment via these laws that couldn’t have been obtained through FDA’s expanded access program.
  • Right to try laws do not require companies to provide patients access to an experimental treatment. They only give the right to request the treatment from the company. Patients already have that right.
  • The bills would weaken FDA’s ability to oversee dangerous side effects from the use of an experimental drug while protecting companies from law suits if the drugs are more harmful than the patients were informed.

Right To Try Fact Sheet

Legislation, Policy
Cancer Prevention and Treatment Fund

The Right to Try bill creates a program that is not as good as the existing FDA “Expanded Access” program, which has approved 99% of requests they received.

  • FDA’s Expanded Access program makes sure that there is some evidence that the experimental drug is safe and effective. Most of the drugs that go to patients through this program are eventually approved by the FDA.
  • Lowering the standards to drugs that completed “Phase 1 clinical trials” means that 85% of the drugs will never be proven safe and effective.
  • When standards are that low, desperate patients can die sooner and more painfully than they would have otherwise.
  • FDA physicians are available 24 hours a day to approve any emergency Expanded Access requests that the agency receives. They usually grant emergency requests immediately over the phone and non-emergency requests in an average of 4 days
  • Pharmaceutical companies may choose to deny patients access to experimental drugs if there is not enough of the drug available or they are concerned about dangerous side effects. When a patient is denied access to an experimental treatment, it is almost always because the company has said no, not the FDA.
  • State “right to try” laws do not give patients a “right” to try and have done little to expand access to investigational treatments. There is no evidence that anyone has obtained an investigational treatment via these laws that couldn’t have been obtained through FDA’s expanded access program.
  • Right to try laws do not require companies to provide patients access to an experimental treatment. They only give the right to request the treatment from the company. Patients already have that right.
  • The bills would weaken FDA’s ability to oversee dangerous side effects from the use of an experimental drug while protecting companies from law suits if the drugs are more harmful than the patients were informed.

NCHR, NWHN, and OBOS Comments to USPSTF on Behavioral Weight Loss Interventions

Policy, Testimony & Briefings
National Center for Health Research: March 19, 2018

Public Comment of National Center for Health Research, National Women’s Health Network, and Our Bodies Ourselves for
USPSTF Draft Recommendation Statement: Weight Loss to Prevent Obesity-Related Morbidity and Mortality in Adults: Behavioral Interventions

Thank you for the opportunity to share our views regarding the U.S. Preventive Services Task Force (USPSTF) draft recommendation statement concerning behavioral interventions for weight loss in adults.

The National Center for Health Research, National Women’s Health Network, and Our Bodies Ourselves are all nonprofit organizations that strongly support the role of USPSTF in reviewing and assessing scientific evidence about the harms and benefits of specific preventive care services to provide science-based recommendations for the public. In 2012, USPSTF made the same recommendation for behavior-based weight loss interventions with a “B” grade.[1] Since then, researchers have published additional studies on this topic, and changes in science or medical practice could alter the benefit risk ratio. Thus, we support the USPSTF’s current efforts to re-evaluate their 2012 based on updated evidence.

Based on the draft evidence review, we concur with the Task Force that there is sufficient evidence that behavior-based weight-loss interventions for adults with obesity (BMI ≥ 30) can help patients reduce weight and decrease incidence of type 2 diabetes and elevated plasma glucose levels.[2]

Prevention of obesity-related morbidity and mortality is an important public health issue, and providers need the most current information to help their patients. More than 35% of men and 40% of women living in the United States are obese.3 Obesity is associated with increased risk of numerous health issues, including: heart disease, type 2 diabetes, cancer, stroke, renal disease, dementia, sleep apnea, osteoarthritis, and premature death.

Primary care screenings identify many patients with obesity who could benefit from behavioral weight loss interventions. As discussed in the review prepared for USPSTF, research indicates that intensive behavior-based weight loss and maintenance interventions can be effective in helping individuals lose weight and prevent weight regain.[3] Although weight reduction was moderate, interventions were associated with meaningful health improvements, such as reduced incidence of type 2 diabetes. Importantly, the review did not identify any long-term or serious harms, so that even moderate benefits outweigh the risks.

Given the differences in BMI cutoffs and disparities between racial/ethnic subgroups and older adults, we strongly agree with the USPSTF that future research on important subpopulations should be a high priority.[2] This information could provide insight into how different populations will benefit from behavior-based weight loss interventions.

In conclusion, we support the USPSTF draft recommendation for behavior-based interventions for weight loss to prevent obesity-related health problems and death. We further support USPSTF’s efforts to improve the health of all Americans by making evidence-based recommendations about clinical preventive services. As more information becomes available, we encourage the re-evaluation and potential development of additional recommendation to improve the health of individuals with weight-related health concerns.

If you have questions about these comments please contact NCHR through Stephanie Fox-Rawlings at sfr@center4research.org.

Respectfully,

National Center for Health Research
National Women’s Health Network
Our Bodies Ourselves

References:

  1. Moyer VA, U.S. Preventive Services Task Force. Screening for and Management of Obesity in Adults: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med. 2012;157:373–378. doi: 10.7326/0003-4819-157-5-201209040-00475. http://annals.org/aim/fullarticle/1355696/screening-management-obesity-adults-u-s-preventive-services-task-force
  2. Draft Recommendation Statement: Weight Loss to Prevent Obesity-Related Morbidity and Mortality in Adults: Behavioral Interventions. U.S. Preventive Services Task Force. February 2018. https://www.uspreventiveservicestaskforce.org/Page/Document/draft-recommendation-statement/obesity-in-adults-interventions1
  3. Draft Evidence Review: Weight Loss to Prevent Obesity-Related Morbidity and Mortality in Adults: Behavioral Interventions. U.S. Preventive Services Task Force. February 2018. https://www.uspreventiveservicestaskforce.org/Page/Document/draft-evidence-review/obesity-in-adults-interventions1