Category Archives: Testimony & Briefings

NCHR Comments on the USPSTF’s Evidence Review and Draft Recommendation Statement for Behavioral Counseling for Skin Cancer Prevention

National Center for Health Research: November 6, 2017

Thank you for the opportunity to express our views about the USPSTF’s evidence review and draft recommendation statement on behavioral counseling interventions for skin cancer prevention. The National Center for Health Research is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work.

Skin cancer prevention is a very important public health issue, and the public needs better information. The USPSTF previously cited evidence linking UV radiation exposure to an increased risk for melanoma later in life for children, and to a lesser extent, adults. Encouraging healthy sun-related behaviors that prevent UV exposure, and ultimately skin cancer, would save lives.

We support the efforts of the U.S. Preventive Services Task Force (USPSTF) to re-evaluate its recommendations in light of new research regarding behavioral counseling interventions to prevent skin cancer. We have a few comments regarding the draft recommendations:

#1: Based on new studies of children younger than 10 years old, we agree that there is sufficient evidence for USPSTF to expand their “B” grade recommendation for fair-skinned individuals from 10-24 years to 6 months-24 years.

#2: We agree with a “C” grade recommendation for fair-skinned adults older than 24 instead of an “I” grade. This means that discussion about behavioral counseling will be left to doctors and patients to decide based on doctors’ professional judgment and patients’ preferences. Some studies indicated that adults benefited from behavioral counseling interventions, particularly for interventions that were longer and more involved (e.g. sun protection-focused text messages over 12 months vs. single behavioral counseling session).

#3: We concur with maintaining an “I” grade for skin self-examination as the review team did not find any eligible studies to evaluate.

#4: Available data present challenges to making recommendations. For example, studies were not sufficiently long-term to study the incidence of skin cancer outcomes. Two adult studies followed patients for 24 months, but most studies only followed patients for 3-13 months. We agree that, ideally, additional studies are needed to assess skin cancer outcomes over a much longer period of time. We also recognize that it is not feasible to study the impact of these interventions long-term and agree with the USPSTF’s focus on reviewing behavioral counseling interventions aimed at promoting sun-protective behaviors that prevent individuals’ exposure to UV radiation in the short-term.

#5: Future reviews and recommendations should expand the recommendations to include people who do not have fair skin and light-colored hair and eyes. Although white people have the highest risk of melanoma and were overwhelmingly represented in this review, researchers noted that it is unknown whether these findings also apply to people of color, who die at higher rates from skin cancer. In addition, it would be beneficial to know if the benefits and risks were similar between men and women and for those who have family members who developed skin cancer.

#6: Studies are needed to determine which, if any, primary care-related interventions are effective for which demographic subgroups. Researchers concluded that successful behavioral counseling interventions were typically multi-component, including varying combinations of intervention components such as in-person counseling, print media, and sun protection aids like sunscreen.

In conclusion, we support USPSTF’s draft recommendations for behavioral counseling interventions to prevent skin cancer as well as their broader 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 provision of additional recommendations about more specific behavioral interventions to prevent skin cancer for individuals in various subgroups.

For questions or more information, please contact Megan Polanin, PhD, at mp@center4research.org.

NCHR Letter to the DC City Council on Artificial Turf

National Center for Health Research: October 26, 2017

Dear Council Members,

I am writing to respond to the request for additional information from Councilwoman Cheh as follow-up to my statement and the written materials I provided at the October 13 roundtable on artificial turf.

As the president of the National Center for Health Research, I expressed my strong concerns about the safety of the synthetic turf that the city has used and is continuing to use.  As a scientist who has worked on health policy issues for more than 30 years, I don’t shock easily.  However, the fact that school athletic fields and playgrounds are exposing D.C. children on a daily basis to chemicals and materials that are known to increase obesity; contribute to early puberty; cause attention problems such as ADD; harbor deadly bacteria; and exacerbate asthma is very disturbing.  Surely these are exactly the types of health problems that the D.C. government should be doing its best to reduce, not increase.

Federal agencies were investigating the safety of these products during the Obama Administration and were close to completion when the Trump Administration took over the two federal agencies involved, the Environmental Protection Agency and the Consumer Product Safety Commission.  Despite claims to the contrary at the October roundtable, neither agency has concluded that artificial turf is safe.  However, it is clear that we can’t depend on the Trump Administration to scrutinize the science regarding these products in a way that will be credible, and that means more work for the rest of us who care about children’s safety.

Envirofill and Other Hot Artificial Turf

As noted at the roundtable, all types of turf have risks and benefits, including natural grass.  However, some materials are well known to have substantial risks.  For example, DCPS is installed synthetic turf with Envirofill at Janney Elementary.  Although it is advertised as “cooler” and safer than older types of artificial turf, on a recent 64 degree afternoon, the temperature at the new Janney Envirofill field was 136 degrees, compared to 89 degrees on the grass.  And 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 is contained 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; here’s a screen grab from a November 2016 Patriots vs. Seahawks game, which shows how the silica sand infill is kicked up when players dive on a synthetic surface with silica sand infill.

In addition, the Envirofill pellets are coated with an antibacterial called Microban, which is a trade name for triclosan.  Triclosan is registered as a pesticide with the EPA and last year the FDA banned triclosan from soaps because manufacturers were not able to prove that it is safe for long-term use, since research shows a link to liver and inhalation toxicity and hormone disruption.  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.

I recently gave a guest lecture at a local college and when I asked if anyone had experience with artificial turf, two young women had stories to share.  They described playing on an artificial turf field on a sunny day, where they could actually see the heat waves rising off the field that had a strong chemical odor.

Councilwoman Cheh asked me to provide scientific evidence to back up my statements.  In addition to the links provided above regarding triclosan and silica, I want to describe the data regarding carcinogens and hormone disrupting chemicals that can cause obesity, early puberty, and attention deficits.

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 that there is “no evidence that children are harmed” or “no evidence that the fields cause cancer.”  That is often misunderstood as meaning that the products are safe or are proven to not cause harm. Neither is true.

It took decades to prove that smoking can cause cancer, a fact that everyone now agrees is true.  As each type of artificial turf is replaced by a new type of artificial turf, it will be equally difficult to prove that these different types of fields cause specific children to develop cancer, obesity, early puberty, or ADD.  For that reason, we need to focus on what is known about the materials the fields are made of and what the implications are for children’s health.

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).  The latter conducted three laboratory studies to investigate the potential health risks to children from playground surfaces made from recycled tires. One study evaluated the level of chemicals released and the other two studies looked at the risk of injury from falls.

The OEHHA studies showed that the children would be exposed to five chemicals, including four PAHs, one of which, chrysene,” was high enough to possibly increase the chances of a child developing cancer.[1]

Out of the 32 playgrounds studied, only 10 met that state’s standard for “head impact safety” to reduce brain injury and other serious harm in children who fall while playing. All five surfaces made of wood chips met the safety standard.[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]

Less is known about the materials that are used in PIP and other rubber products; some are recycled tire materials and some are “virgin rubber” but all are made from synthetic rubber, which is a petroleum based product.  This week I visited a playground at Chevy Chase Recreation Center.  Although the playground seems to be a relatively new solid rubber surface, there are several areas that are already broken, with dark crumb rubber and other very small colorful particles clearly showing. Some of the particles look like they could be from plants, but you can’t crush or tear them as you can with plant material.  Children can pick up those particles intentionally or unintentionally; little children are likely to eat it or get it in their mouths, shoes, or clothes, and children of any age will certainly get it on their skin.  As noted above, the evidence is clear that these rubber particles are dangerous.

Rather than provide a lengthy description of all the studies showing the impact of hormone-disrupting chemicals (also called endocrine disrupting chemicals or EDCs), I will assume you know that the evidence is clear about those chemicals being in rubber and plastic and causing health problems.  Scientists at the NIH environmental institute, which is called the National Institute of Environmental Health Sciences, have concluded that unlike most other chemicals,  hormone-disrupting chemicals can be dangerous at very low levels as well as at higher levels, and the exposures can be even more 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 ages 3 and younger.  Like playgrounds and artificial turf fields, these products were sold in the U.S. for many years prior to the ban, because the companies were not required to prove that the products were safe.

Instead of focusing on those studies, here is just one recent scientific study on the health risks of synthetic rubber.  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]

That article lists numerous EDCs found in rubber products and warns that “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.”

Dangers of Hard Fields and Playgrounds

I want to briefly mention safety issues pertaining to Gmax scores.  As you know, a Gmax score over 200 is considered extremely dangerous and is considered by industry to pose a death risk.  The synthetic turf industry and ASTM suggest that scores should be below 165 to ensure safety comparable to a grass field.  At the roundtable it was mentioned that grass fields can also get extremely hard, which is true.  However, 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.  Moreover, averaging Gmax scores for a field is an inappropriate way to determine safety.  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.

Conclusions

I have appreciated the opportunity to meet with several Councilmembers’ staff and I commend the Council for banning crumb rubber during FY 2018.  Unfortunately, however, Envirofill, “poured in place” rubber (PIP), EPDM, and all the other synthetic materials currently on the market all have petroleum based materials and therefore share some of the same health risks.  While the companies that sell these products claim they are safe and meet federal safety standards, there are currently no federal safety tests required to prove that these products are safe.  In many cases, the materials used are not public, making independent research difficult to conduct. None of these products are proven to be as safe as natural grass in well-constructed fields such as the Maryland Soccerplex. Although a well-respected grass expert offered a free consultation on how to install well-engineered grass designed to withstand rain and play, DGS did not respond to his offer.

I have also attached an annotated bibliography of numerous relevant scientific articles on artificial turf that will help you see that there is growing evidence of the harm of these synthetic materials on fields and playgrounds.  This is just a sample of studies, and there are many more, so let me know if you’d like additional information.

I am one of many parents and scientists in D.C. that are very concerned about the impact of these artificial fields and playgrounds on our children.  It is clear that city officials have assumed these products are safe because the salespeople told them they were safe.  Unfortunately, there is clear scientific evidence that these materials are potentially harmful, and the only question is how harmful are they and how much exposure is likely to be harmful?  Our children deserve better.

Sincerely,

Diana Zuckerman, PhD

President

  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/

NCHR Comments on the USPSTF’s Draft Recommendation Statement, Evidence Review, and Modeling Report on Cervical Cancer Screening

National Center for Health Research: October 9, 2017

Thank you for the opportunity to express our views on the U.S. Preventive Services Task Force (USPSTF) draft recommendation statement, evidence review, and modeling report for cervical cancer screening. The National Center for Health Research is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work.

We agree that this is the right time for the U.S. Preventive Services Task Force to re-evaluate its cervical cancer screening recommendations, due to new research studies and decision modeling analysis. In 2012, the USPSTF recommended starting screening at age 21 and stopping at age 65. Women could get a Pap every 3 years, or starting at age 30, women could get both a Pap and HPV test (co-test) every 5 years. Based on the USPSTF’s review, we agree with maintaining most of the 2012 recommendations, but have significant concerns about changes USPSTF has proposed.

We are very concerned about the proposed grade “A” recommendation to exclusively screen women with the HPV test every 5 years starting at age 30. As the Task Force recognized, clinical trial evidence to support primary HPV screening as a preferred screening strategy is inadequate. There is also a lack of well-designed and implemented clinical trials comparing co-testing and primary HPV screening. The pivotal ATHENA trial, the U.S. prospective study supporting the efficacy of primary HPV screening, had significant shortcomings and does not provide clear and substantial evidence that primary HPV testing reduces cancer incidence or mortality. The Task Force appropriately classified this study as “poor quality” and excluded it from the draft evidence review. However, some medical societies are still quoting it.

Due to lack of available evidence, the Task Force relied heavily on mathematical models to arrive at the grade “A” recommendation. While mathematical models that incorporate real world data help to support available evidence, they are hypothetical, and conclusions must still be weighed against evidence from clinical trials and observational studies. This definitely is well below the standard of an “A” recommendation; in fact, we believe screening based exclusively on HPV tests should not be recommended.

Based on the USPSTF’s decision modeling analysis, primary HPV testing potentially confers a slightly higher mortality benefit (approximately 10 life-years per 1000 women) compared to cytology alone, but it requires significantly more colposcopies to be done for each possible cancer averted (766 vs. 39). Moreover, the models demonstrate that primary HPV testing and co-testing prevent approximately the same amount of deaths, but co-testing would require more total tests (19,806 vs. 12,151). However, models are necessarily based on assumptions that are not necessarily accurate.  The conclusions from these models are not based on research conducted on actual patients.

In addition, while the USPSTF depended on the draft modeling report to conclude that primary HPV screening may provide more benefits than harms, other recent modeling analyses by Felix et al., concluded that screening by co-testing may be superior to screening by HPV test alone. Therefore, the totality of the evidence does not support eliminating co-testing as an acceptable strategy.

We therefore conclude that the Task Force’s grade “A” recommendation assigned to primary HPV screening is inappropriate, because it is primarily based on modeling analysis and not clinical trials or real-world data. This grade “A” would certainly mislead physicians and women to believe that there is incontrovertible evidence to support an HPV testing-only screening strategy rather than co-testing or Pap smear only testing. Since the recommendation is that women can select a Pap smear every 3 years or the HPV test every 5 years, many women will likely choose the less frequent screening option, not realizing that they will be at increased risk of needing additional, more invasive testing with the HPV test only screening.

The seven cited randomized clinical trials are difficult to interpret. First, the studies cannot be assumed to be representative of women in the U.S. since they were conducted primarily in European countries with national screening programs and more standardized triage strategies. Second, the studies were extremely heterogeneous in terms of test technology, screening intervals, and follow-up protocols. Third, the study results were mixed. For instance, the NTCC phase II trial found that hrHPV test alone had a higher CIN3 detection rate only in the first screening round, and actually had a lower rate of detection in the second round. The Task Force’s review contends that the “cumulative rate was still double.” However, it is possible  that detection rates of CIN3 declined in the second screening round because the lesions regressed due to HPV clearance.  Thus, perhaps the colposcopies triggered by HPV positivity in the first screening round were unnecessary. Bottom line: these data are inconclusive. Last, the studies included surrogate endpoints for cancer incidence and mortality, such as CIN2 or CIN3 detection. These endpoints are likely not the most meaningful outcomes for women, since CIN2/3 lesions do not always progress to cervical cancer and sometimes regress instead.  There are several other determinants of disease trajectory that may differ among women in different countries.

While we understand why the USPSTF advises women to “discuss with their provider which testing strategy is best for them” it is obvious that this advice will not necessarily provide excellent guidance for the average patient.  Many providers will not realize that population-based studies and well-conducted clinical trials do not substantially support primary HPV as a preferred testing strategy. Instead, providers are likely to depend on the USPSTF recommendation or those of medical societies, rather than careful scrutiny of the data.  Furthermore, the triage strategy for a positive HPV test is not standardized; it varies from cytology test, HPV genotype test, or direct colposcopy. Such a decision would depend on organized follow-up and would necessitate an informed discussion, which may not be possible in a single office visit. As suggested in the ARTISTIC subsample, a positive HPV test is likely to cause anxiety, and many patients will undergo colposcopy they would not have been needed had they been screened with a Pap smear instead.

In conclusion, we agree with maintaining much of the 2012 recommendations, but we strongly disagree with the proposed “A” rating for HPV testing alone, and urge that the USPSTF reconsider the shortcomings of the evidence and revise their recommendation to give preference to co-testing and Pap smears alone, rather than stand-alone HPV testing.

Thank you for the opportunity to comment on this most important issue which will have an impact on the lives of many adult women on a national level.

For questions or more information, please contact Danielle Shapiro, MD, MPH at ds@center4research.org.

References:

Felix, JC., et. al. The Clinical and Economic Benefits of Co-Testing Versus Primary HPV Testing for Cervical Cancer Screening: A Modeling Analysis. J Women’s Health. 2016; 25(6):606-16

Draft Recommendation Statement: Cervical Cancer: Screening. U.S. Preventive Services Task Force. October 2017. https://www.uspreventiveservicestaskforce.org/Page/Document/draft-recommendation-statement/cervical-cancer-screening2

NCHR Testimony at the FDA on Shingles Vaccine, Shingrix

Megan Polanin, PhD, National Center for Health Research: September 13, 2017

Thank you for the opportunity to speak today. My name is Dr. Megan Polanin. I am a Senior Fellow at the National Center for Health Research. Our research center analyzes scientific and medical data and provides objective health information to patients, providers, and policymakers. We do not accept funding from industry, so I have no conflicts of interest.

An effective shingles vaccine is important for public health. As patients get older, they are more likely to develop long-term pain, or post-herpetic neuralgia (PHN), as a complication of shingles. This pain can be severe and chronic. There is no cure, and treatments do not reliably relieve pain for all patients. The only way to reduce the risk of developing shingles and PHN is to get vaccinated.

Like any public health strategy, a vaccine’s benefits must outweigh its risks. Based on available research, Shingrix has displayed significant benefits compared with the current shingles vaccine on the market, Zostavax:

1) Shingrix showed much higher levels of vaccine efficacy (e.g. 97% for 50+ and 90% in 70+) ​ than the current shingles vaccine. Zostavax only reduces the occurrence of shingles by about half for patients 60 and older, and its effectiveness declines as patients age.  For patients 80 and older, Zostavax is only 18% effective.

2) Shingrix has displayed efficacy in preventing ​PHN​ in patients 50 years and older by preventing shingles. Zostavax is less effective in preventing PHN because it is less effective at preventing shingles. For people who were vaccinated and still developed shingles, Zostavax helped to reduce the duration of PHN, but not the severity of pain.

3) Shingrix can potentially be administered to vulnerable patients with ​weakened​ immune systems. Zostavax is a live attenuated vaccine, and therefore is not safe for people with weakened immune systems, such as patients who have had radiation or chemotherapy and those with HIV.

Shingrix requires two doses while Zostavax is a one-time injection. However, that is a small price to pay for a much more effective vaccine.

Post-licensure studies are critical as we need long-term data to evaluate Shingrix’s long-term efficacy for patients 50 years and older. This is especially relevant since Zostavax may no longer be effective 8 to 11 years after vaccination. The company’s proposed long-term follow-up studies will help to determine whether Shingrix is able to protect older adults from contracting shingles as they age. It is essential that those studies be completed in a timely matter and that the company provide adequate incentives to patients to stay in the study.

We do have some concerns about risks. Patients treated with Shingrix had a higher rate of common adverse reactions (e.g. 74% vs. 9% for placebo group), such as pain, swelling, and fatigue. In addition, one serious adverse event, supraventricular tachycardia, was reported more frequently for patients vaccinated with Shingrix compared with patients who had not during the 30-day post-vaccination period. We are also concerned about optic ischemic neuropathy, which was reported within 30 days by 2 patients, within 2 months by another patient, and not reported at all in the placebo group. These issues warrant further attention.

For that reason, we agree with the company and FDA reviewers that continued pharmacovigilance is critical to evaluate adverse events for patients vaccinated with Shingrix compared to those vaccinated with Zostavax and those with placebo. This should include uncommon adverse events observed soon after vaccination and any other adverse events that may arise with larger sample sizes in longer-term studies.

We concur with the FDA’s requests that the company specifically address risks of inflammation from the vaccine, which can lead to the some of the adverse events reported during pre-licensure studies (e.g. optic ischemic neuropathy, gout).

We urge this Advisory Committee to recommend that the FDA require critical post-approval long-term studies to further evaluate the efficacy and safety of Shingrix. We also strongly recommend that the company conduct subgroup analyses to ensure that the vaccine is safe and effective for both women and men and also people of color.

Thank you for the opportunity to share our perspective.


The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 11-0, that the available data are adequate to support the efficacy and safety of Shingrix when administered to adults 50 years of age and older. 

NCHR Comments on CPSC Agenda and Priorities for FY2018-2019

Diana Zuckerman, PhD, National Center for Health Research: July 26, 2017

 

Diana Zuckerman, PhD, President of National Center for Health Research 
Comments on the U.S. Consumer Product Safety Commission 
Agenda and Priorities for FY2018/2019

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. Thank you for the opportunity to share our views concerning the Consumer Product Safety Commission’s (CPSC) priorities for fiscal year 2018 and 2019. We respect the essential role of the CPSC, as well as the challenges you face in selecting the most important priorities.

Two priorities that are clearly consistent with CPSC priorities are the safety of children’s products. We are very concerned about exposures to phthalates in children’s toys and other products as well as endocrine-disrupting chemicals and other safety concerns related to recycled tire crumb rubber and other artificial turf (including “poured in place” surfaces).

The CPSC has been a champion for children with its careful analysis of phthalates in toys and products for children under 3 years of age. As you know, products specifically for children under 3 are not the only ones that pose risks: we need to also be concerned about phthalates in many products used by pregnant women and children. Through dust and other means, phthalates migrate from many products into our environment and bodies. Phthalate metabolites are detectable in nearly all people in this room and in the U.S.[1] Many phthalates are endocrine disruptors that can have long-term effects on our health and children’s development, including their ability to learn.

Our Center was instrumental in shaping the law resulting in permanent and temporary bans on six phthalates in children’s toys and child care articles.[2] However, these bans need to be expanded. Over 2 years ago, CPSC proposed the rule “Prohibition of Children’s Toys and Child Care Articles Containing Specified Phthalates” following the Chronic Hazard Advisory Panel (CHAP).[3][4] This rule is absolutely essential in providing additional protections for children.

We support the permanent bans on four additional phthalates (DIBP, DPENP, DHEXP, and DCHP) and making permanent the interim ban on DINP.[3] However, the CHAP report also recommended an interim ban on DIOP, which should also be included in the rule. We strongly disagree with the proposal to lift the interim bans on DNOP and DIDP. While they may not affect male hormones, they are associated with organ toxicity and altered development.

The CHAP report also recommended additional studies on three other phthalates (DMP, DPHP, and DEP) and six phthalate alternatives.[4] The final rule should include a timeline for the completion of these studies that reflects the potential damage these phthalates can cause.

It is also important for CPSC to expand its work on phthalates to include products that can cause prenatal exposures as well as those that can harm older children and other vulnerable adults. Phthalate exposure has been found to increase risk for early puberty and problems with reproduction.[5][6][7] This is especially important because a new meta-analysis of 185 studies shows that male sperm counts are less than half what they were just a generation ago.[8]  Phthalate exposure also affects pregnant and breastfeeding women and thus their children, which can affect brain and reproductive system.[4][9] Phthalates in household dust can be extremely harmful regardless of what products it comes from.

Artificial turf made with recycled tire crumb rubber and other products raises similar issues because it is widely used and can release chemicals that affect the health of children of all ages, pregnant women, and other adults. Artificial turf is currently used on more than 12,000 athletic fields and numerous playgrounds in the U.S. and most parents are unaware of the risks it poses.[10]

Scientific evidence suggests that crumb rubber, “poured in place” (PIP) rubber and other artificial turf pose potential safety hazards when used on playground and playing field surfaces. Rubber from recycled tires and even from “virgin tires” and “virgin rubber products” is not comprised only of rubber from a rubber plant.  Instead it includes phthalates, polycyclic aromatic hydrocarbons (PAHs), volatile organic compounds (VOCs), heavy metals, and other chemicals known or suspected to harm human health.[11][12][13][14] In addition to disrupting hormones, some PAHs may increase a person’s chance of developing cancer.[15][16] While one time or sporadic exposures are unlikely to cause long-term harm, repeated exposures over years, especially during critical developmental periods clearly raise the likelihood of harm.

Artificial turf made with crumb rubber and poured rubber products can also cause short-term harms. For example, crumb rubber generates dust which may exacerbate asthma for children.[17][18] These products heat up much more than ambient temperature, which can cause heat stress and burns.[19][20][21]
In addition, some studies have indicated increased risk for joint injuries and mild traumatic brain injury.[22][23] In other words, we can conclude that grass is a relatively safe alternative. We can’t say that of artificial turf, whether crumb rubber or other products.

As is often the case when researchers are paid by those with conflicts of interest, some studies suggest that the risk is minimal. However, the studies that are more reassuring do not comprehensively evaluate health risks from exposure to recycled tire crumb material. In addition, many studies of air quality pertaining to crumb rubber and similar products use stationary measures, while particulate matter becomes airborne during activity, so these measurements may not accurately reflect exposures during play activities.[24] Our conclusion from the research is that definitive studies of the harm caused by crumb rubber and other rubber products are difficult to conduct, but there are clear reasons to be concerned about children being harmed by them.

We are encouraged that the CPSC is working with other federal agencies to investigate the safety of crumb rubber on playgrounds and playing fields.[8][25][26]

However, we strongly urge you to broaden your investigation to include other synthetic rubber products and to provide warnings to families and athletes as soon as possible. The public has limited access to information about the chemicals that make up these products, which can affect our health and that of our children. All Americans rely on the CPSC to protect us and our children from unsafe products.

In summary, we strongly urge the CPSC to consider our views as it finalizes the proposed rule on phthalates in children’s toys and child care articles, and consider how these rules could be expanded to cover other products that expose children and adults to harmful substances.

References

  1. National Health and Nutrition Examination Survey (NHANES). (2016) Phthalates and Plasticizers Metabolites – Urine (PHTHTE_H); years of content 2013-2014. https://wwwn.cdc.gov/Nchs/Nhanes/2013-2014/PHTHTE_H.htm
  2. Federal Register. (2014) Consumer Product Safety Commission. Prohibition of Children’s Toys and Child Care Articles Containing Specified Phthalates. Docket No. CPSC-2014-0033. http://www.gpo.gov/fdsys/pkg/FR-2014-12-30/pdf/2014-29967.pdf
  3. Federal Register. (2014) Consumer Product Safety Commission. Prohibition of Children’s Toys and Child Care Articles Containing Specified Phthalates. Docket No. CPSC-2014-0033. http://www.gpo.gov/fdsys/pkg/FR-2014-12-30/pdf/2014-29967.pdf
  4. Consumer Product Safety Commission. (2014) Chronic Hazard Advisory Panel On Phthalates and Phthalate Alternatives.https://www.cpsc.gov/PageFiles/169876/CHAP-REPORT-FINAL.pdf
  5. Bourguignon JP, Juul A, Franssen D, Fudvoye J, Pinson A, Parent AS. (2016) Contribution of the Endocrine Perspective in the Evaluation of Endocrine Disrupting Chemical Effects: The Case Study of Pubertal Timing. Hormone Research in Paediatrics. 86(4):221-232.
  6. Wang YX, Zeng Q, Sun Y, Yang P, Wang P, Li J, Huang Z, You L, Huang YH, Wang C, Li YF, Lu WQ. (2016) Semen phthalate metabolites, semen quality parameters and serum reproductive hormones: A cross-sectional study in China. Environmental Pollution. 211:173-82.
  7. Hannon PR, Flaws JA. (2015) The effects of phthalates on the ovary. Frontiers in Endocrinology. 6:8.
  8. Levine H, Jøgensen N, Martino-Andrade A, Mediola J, Weksler-Derri D, Mindlis I, Pinotti R, Swan SH. (2017) Temporal trends in sperm count: a systematic review and meta-regression analysis. Human Reproduction Update. 1-14.
  9. Ejar Ejaredar M, Nyanza EC, Ten Eycke K, Dewey D. (2015) Phthalate exposure and childrens neurodevelopment: A systematic review. Environmental Research. 142:51-60.
  10. Synthetic Turf Council. About synthetic turf. https://syntheticturfcouncil.site-ym.com/page/About_Synthetic_Turf
  11. Llompart M, Sanchez-Prado L, Lamas JP, Garcia-Jares C, Roca E, Dagnac T. (2013) Hazardous organic chemicals in rubber recycled tire playgrounds and pavers. Chemosphere. 90(2):423-431.
  12. 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).
  13. 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
  14. Kim S, Yang J-Y, Kim H-H, Yeo I-Y, Shin D-C, 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
  15. U.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
  16. Armstrong B, Hutchinson E, Unwin J, Fletcher T. (2004) Lung cancer risk after exposure to polycyclic aromatic hydrocarbons: a review and meta-analysis. Environmental Health Perspectives, 112(9), 970.
  17. 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
  18. 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
  19. Thoms AW, Brosnana JT, Zidekb JM, Sorochana JC. (2014) Models for predicting surface temperatures on synthetic turf playing surfaces. Procedia Engineering. 72:895-900.
  20. 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
  21. 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.
  22. 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.
  23. 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.
  24. U.S. Environmental Protection Agency. (2017) Federal research on recycled tire crumb used on playing fields. https://www.epa.gov/chemical-research/federal-research-recycled-tire-crumb-used-playing-fields
  25. U.S. Consumer Product Safety Commission. Crumb rubber information center.https://www.cpsc.gov/Safety-Education/Safety-Education-Centers/Crumb-Rubber-Safety-Information-Center
  26. U.S. Centers for Disease Control and Prevention/Agency for Toxic Substances and Disease Registry (ATSDR). (2016) Federal research action plan on recycled tire crumb used on playing fields and playgrounds. https://www.atsdr.cdc.gov/frap/index.html

NCHR Comment on the USPSTF’s Draft Recommendations for Ovarian Cancer Screening

National Center for Health Research: August 10, 2017

Comments on the USPSTF’s Draft Recommendations for Ovarian Cancer Screening

Thank you for the opportunity to express our views on the draft recommendations for ovarian cancer screening. The Cancer Prevention and Treatment Fund is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

We support the efforts of the U.S. Preventive Services Task Force (USPSTF) to re-evaluate its 2012 grade “D” recommendation in light of new results from a large study, the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). This study confirmed that screening for ovarian cancer does not decrease deaths from ovarian cancer in asymptomatic women who are not known to be at high risk for ovarian cancer. Based on the USTSPF’s robust review of the literature, we agree that there is insufficient evidence to support screening for asymptomatic women.

Effective screening is urgently needed to reduce the number of deaths from ovarian cancer, which is estimated to exceed 14,000 in the United States this year. When ovarian cancer is treated before the cancer has spread outside the ovaries and fallopian tubes, the 5-year relative survival rate is 93%. However, the FDA warns that studies in the medical literature do not provide evidence that currently available ovarian cancer screening tests are accurate and reliable, particularly for asymptomatic women.

We agree with the USPSTF that none of the studies indicated that screening significantly reduced ovarian cancer mortality. Additionally, researchers found that the risks of screening for women are significant, including a high number of false-positive results, which can lead to unnecessary surgery and other medical complications. We agree that these significant potential risks outweigh the benefits of early detection for women with no symptoms of ovarian cancer.

In conclusion, we strongly support the USPSTF’s draft recommendation to maintain the “D” grade for ovarian cancer screening, as well as their broader efforts to improve the health of all Americans by making evidence-based recommendations about clinical preventive services. We also appreciate the attention to quality of life as an outcome of interest, as this is an important factor. As more high-quality research becomes available, we encourage the provision of additional recommendations about the benefits and harms of using new screening strategies in asymptomatic women who are not known to be at increased risk for ovarian cancer.


For questions or more information, please contact Megan Polanin, PhD at mp@center4research.org or at (202) 223-4000. 

References

Food and Drug Administration (2016, September 7). The FDA recommends against using screening tests for ovarian cancer screening: FDA Safety Communication. Retrieved from https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm519413.htm

National Cancer Institute: Surveillance, Epidemiology, and End Results Program. Cancer of the Ovary: 5-Year Relative Survival by Stage at Diagnosis (2007-2013). Retrieved from https://seer.cancer.gov/csr/1975_2014/browse_csr.php?sectionSEL=21&pageSEL=sect_21_table.08.html#table5

U.S. Preventive Services Task Force (2017, July). Draft Recommendation Statement. Ovarian Cancer: Screening. Retrieved from https://www.uspreventiveservicestaskforce.org/Page/Document/draft-recommendation-statement174/ovarian-cancer-screening1

NCHR Comment on the USPSTF’s Draft Recommendations for Hepatitis B Virus Infection Screening in Pregnant Women

National Center for Health Research: August 9, 2017

Comment on the USPSTF’s Draft Recommendations for Hepatitis B Virus Infection Screening in Pregnant Women

Thank you for the opportunity to express our views on the draft research plan regarding screening for the Hepatitis B virus infection in pregnant women. The National Center for Health Research is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

Hepatitis B is a virus infection that is best prevented through vaccination. The risk of infection is especially high for newborns; 90% of infected infants become chronically infected. Chronic Hepatitis B can lead to serious health issues, such as cirrhosis or liver cancer, and in the United States, results in an estimated 1,800 deaths per year. Detecting Hepatitis B infection in pregnant women and preventing transmission to their children would benefit our society greatly by decreasing its disease burden.

Women who are pregnant are at a unique moment in their health care journey, during which they have multiple visits with a provider. Ideally, strong and trusting relationships will develop between women and their doctors. Thus, the capacity for women to acquire knowledge and respond to information regarding screening and potential immunization is greater during pregnancy than at other times and with other providers. This can lead to positive public health outcomes.

The U.S. Preventive Services Task Force (USPSTF) last reviewed the literature in 2009 and reaffirmed their “A” grade for HBV screening for women at their first prenatal visit. We support the efforts of the USPSTF to carefully draft a research plan to guide the systematic review of available evidence for universal screening and case management programs to prevent vertical transmission of the infection as well as reduced rates of morbidity and mortality. We also endorse the efforts of the USPSTF to obtain updated information on the harms and benefits of universal screenings and case management programs for women with Hepatitis B.

We have two recommendations regarding key and contextual questions:

1) While the proposed research questions may intend to refer to both the mother and child, they do not explicitly state the benefits and harms of maternal screening and subsequent immunization or administration of HBIG for children. We believe that explicitly including harms and benefits to children in utero within your proposed questions will improve your research plan.

2) We commend the USPSTF’s inclusion of proposed contextual question #1 to address subgroup analyses. We particularly recommend subgroup analyses by race/ethnicity, mothers’ age, and mothers’ health. Some subgroups of pregnant women may experience different levels of benefits/harms, and this information is critical in making a recommendation for all women. In addition to benefits, we recommend including any harms of repeat screening in the third trimester based on the presence of specific risk factors for different groups of pregnant women.

Universal screening and prevention programs for pregnant women with Hepatitis B can help to identify pregnant women who are at risk for passing the virus to their children. Preventing vertical transmission protects children from a potentially serious disease and other diseases that may develop as a result, such as cancer; protects others who may be infected; and allows children to participate in school and play activities important to their healthy development. Therefore, screening is highly beneficial for these children.

In conclusion, we support the USPSTF’s draft recommendation for Hepatitis B screening in pregnant women as well as their broader efforts to improve the health of all Americans by making evidence-based recommendations about clinical preventive services.

For questions or more information, please contact Megan Polanin, PhD at mp@center4research.org or at (202) 223-4000.

References

Centers for Disease Control and Prevention (2015, May 31). Viral Hepatitis. Retrieved from https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm#overview

U.S. Preventive Services Task Force (2017, July). Draft Research Plan for Hepatitis B Virus Infection in Pregnant Women. Retrieved from https://www.uspreventiveservicestaskforce.org/Page/Document/draft-research-plan/hepatitis-b-virus-infection-in-pregnant-women-screening

Testimony at FDA Advisory Committee Oncology Meeting on Mylotarg (“GO”)

Jack Mitchell, National Center for Health Research, July 12, 2017

Thank you for the opportunity to speak today.  I’m Jack Mitchell, Director of Health Policy at the National Center for Health Research (NCHR).  Our research center analyzes medical and scientific data to provide objective health information to patients, providers and policy makers.  We do not accept funding from pharmaceutical or medical device companies, and so I have no conflicts of interest to report.

I’m not a scientist or clinician, but I previously worked in a senior position in FDA’s Office of the Commissioner and we have a number of science and public health PhDs on our staff.  I’m presenting the organization’s views on behalf of the many patients and consumers whom we represent.

While we strongly support the need for more and better treatments for AML (Acute Myeloid Leukemia) patients, we are very concerned about the data used to support the application for GO.  Problems with the trial design raise questions about its validity.

First of all, the only pivotal trial was open label, which increases the risk for bias.  The purpose of blinding in a clinical trial is to control for the placebo effect, since the knowledge that one is taking the newest experimental drug tends to encourage patients and clinicians to have a greater belief in a perceived effectiveness.

Second, all lower grade safety events and some important severe safety events were collected retrospectively, which increases the risk for inaccuracies.  And, which as FDA presenters have noted, limits the analysis of the safety profile.

Third, the trial took place only in France.  This is of note because there are numerous examples of medical products that do not work as well in American patients as they do in patients in other countries.  French patients can have different health habits and health care.  These issues would raise concerns, even if the data supporting approval was strong, which we believe they are not.  Instead, it is not clear that the data support the efficacy or safety of GO.

As I noted previously, the application is based on a single pivotal trial along with a review of the literature.  The pivotal trial does not provide evidence for overall survival, and the previous clinical trial included in the literature review found an inconsistent effect of GO in overall survival.  It is important to remember that this drug was approved based on a single trial and later removed from the market, in part, because the post-market study did not demonstrate effectiveness.

The pivotal trial and literature review do demonstrate improvement in event-free survival.  The trial also shows an improvement in relapse-free survival.  However, the important metric is overall survival, which is not clearly demonstrated.  FDA reviewers and the sponsor’s scientists showed that event-free survival does not correlate well with overall survival.  This especially is a problem in an open label study where the placebo effect can’t be controlled.

Our research center recently published an article in an AMA journal revealing that many cancer drugs have been approved based on surrogate endpoints, such as event-free survival.  But later studies have found that those drugs did not improve overall survival or quality of life.  We found that patients and their insurers were spending $100,000 or more and suffering serious adverse events for treatments that often had no measurable benefit for their health or survival.

The change in dosing does appear to reduce adverse events compared to the earlier version of this medication.  Nevertheless, there were still serious adverse events that can result in death.  The drug was associated with increased bleeding events, including four fatal hemorrhages, and liver disorders, including three fatal cases of VOD (veno occlusive disease).  There were no fatal hemorrhage or VOD events that occurred without exposure to the drug.   However, we acknowledge the sponsor’s efforts to address the ongoing VOD issue and risk profile.

It’s noteworthy that these results were in a clinical trial where patients are carefully monitored.  Patients in the real world are typically monitored less carefully than patients in clinical trials.  As a result, it is possible that more patients could continue on a drug causing serious adverse events because they hope the drug will improve their condition, putting themselves at increased risk.  Well-intentioned doctors who are unaware of the history of the drug may also decide to increase the dose of patients who are not improving, putting patients at greater risk for adverse events without improving the chance for survival.

In summary, surrogate endpoints, such as event-free survival, often do not predict overall survival or other measures of improved health or quality of life.  Given the research design, only one pivotal study, the lack of U.S. patients, and a less than convincing literature review, the data do not support sufficient support for approval.  The studies, in our view, do not provide strong evidence that GO is effective and there are still continuing safety concerns.

We believe that the evidence does not indicate that the benefits outweigh the risks, which is the most single important consideration before you today.  Thank you for providing this opportunity to present our views.

Testimony at the FDA Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting

Megan Polanin, National Center for Health Research: June 21, 2017

Thank you for the opportunity to speak today. My name is Dr. Megan Polanin. I am a Senior Fellow at the National Center for Health Research, and I previously trained at Johns Hopkins University School of Medicine. Our research center analyzes scientific and medical data and provides objective health information to patients, providers, and policymakers. We do not accept funding from pharmaceutical companies, and therefore I have no conflicts of interest.

We realize that the goal of all five of the drugs discussed during this meeting are for treating rare pediatric cancers and that these patients desperately need new treatments. In some recent approval decisions, the FDA has been criticized for approving treatments for rare diseases based on inadequate data and wishful thinking. As a result, most insurance companies were not willing to pay for those approved drugs. Instead of getting free drugs in clinical trials, those patients are left with no affordable options. So, it is essential that the studies conducted are designed to be able to prove whether or not any of these 5 drugs have benefits that outweigh the risks.

We strongly support FDA Advisory Committee meetings like this one to garner input from experts on how best to design and conduct clinical trials for pediatric patients. This committee has been and will continue to be thorough in asking specific questions of the drug sponsors on their trial design while also offering helpful critiques and suggestions when needed.

Despite the challenge of studying these drugs for extraordinarily rare populations of patients, it is critical to uphold the scientific integrity of the proposed trials. For example, when possible, researchers should use randomized or well-matched control group/comparison samples for new drugs because it is the most methodologically sound design in order to demonstrate whether a drug is safe and effective. When a proper control group is not available, researchers should observe a robust single agent response rate in order to support a drug’s efficacy.

By law, FDA decisions are NOT based on cost, but you know that the cost of these drugs can be a huge issue for children and their families. In the last year, two drugs used to manage — not to cure — rare diseases were priced at $300,000 and $750,000 per patient, per year. As I noted, insurance companies are making sure these drugs are proven to work before they are willing to pay for them. You can help the FDA make sure that the evidence is clear.

When analyzing the proposed clinical trials, we urge this committee to keep in mind the possible pitfalls associated with using biomarkers and surrogate endpoints in lieu of outcomes that are most meaningful for patients such as overall survival and quality of life. A study published in JAMA found that only 14% of cancer drugs approved using surrogate endpoints were later determined to improve patients’ overall survival. Our Center found that only one of these drugs was proven to improve quality of life, and yet all were still on the market — costing an average of almost $100,000 per year. Let’s make sure that cancer drugs for children are proven to provide meaningful improvement in patients’ health or quality of life, if not both.

Additionally, there are clearly subpopulations of patients who respond better to treatment than others. We encourage the sponsors to further characterize the positive responders in order to target the population of patients who are most likely to benefit and least likely to be harmed by adverse events from their treatment.

Drug efficacy is a complex issue for children with chronic and/or rare diseases like the cancers discussed here. We commend the FDA and this committee for providing an open discussion focused on the best ways to test these five new drugs in pediatric populations. This marks a positive effort to help ensure that drugs are safe and effective for everyone for whom they are prescribed, particularly when the cost of these drugs can be so high.

Thank you for the opportunity to express our views.

Public Comments at the FDA’s Safe Use Symposium: A Focus on Outpatient Preventable Adverse Drug Effects

Megan Polanin, PhD, National Center for Health Research: June 15, 2017

Thank you to the FDA and the Safe Use Team for hosting this meeting and for the opportunity to share our perspective. I’m Dr. Megan Polanin, and I am a Senior Fellow at the National Center for Health Research.

Our focus is patient-centered comparative effectiveness research. With support from PCORI (the Patient-Centered Outcomes Research Institute), we’ve trained about 120 patient advocates to understand the value as well as the limitations of clinical trials.

Some of the patients we’ve trained are desperate for new cures, and others have been harmed by medical products and believe that the FDA needs to require better evidence of safety before approving new drugs or devices.

But the one thing they all agree on is that patients aren’t really getting informed consent about the drugs they are taking. Most doctors aren’t talking to most patients about potential side effects, or even about how good the evidence is that the treatment will work. Most patients blindly fill prescriptions because they assume that the drugs are proven safe and effective for patients just like them.

A big problem is that doctors rarely tell patients if their prescriptions are off-label. Most patients who are prescribed a drug off-label don’t realize that the drug they are prescribed has not been approved for the particular indication they need. Research shows that off-label uses are often ineffective and have more adverse side effects than on label use. Patients deserve to know if a doctor recommends a use that hasn’t been proven to have benefits that outweigh the risks.

Reducing the chances of adverse drug events requires a discussion between the doctor and patient about any evidence that the drug really will do more harm than good.  Unfortunately, doctors often have limited information – most of which they got from drug reps, not from the FDA. Drug labels have gotten so long that most doctors and patients don’t read them. I ask you: Why include the chemical composition of the drug on those labels? Why not focus on the risks and benefits in simple language instead?

And, as we all know, many doctors don’t have a lot of time to discuss these kinds of issues with their patients, and many doctors are not skilled in having these kinds of conversations.

In addition, FDA rarely provides information to patients or doctors about adverse events for specific major demographic groups, such as women, men, people of color, or for older patients. Having that information clearly on the label would help reduce adverse drug effects.

Doctors and patients should be clearly told when a drug is approved on the basis of biomarkers, and whether there are other drugs for the same indication that are proven to improve survival or clinically meaningful health measures, such as fewer heart attacks or better quality of life.

Bottom line: An important way for the FDA to help prevent adverse drug events is to make sure that patients know in advance what kind of choices they have for prescription drugs, and which ones are likely to be safer for them as women, people of color, patients over 65, and people with a particular illness. Patients deserve to know this information before filling their prescription.