Category Archives: Testimony & Briefings

NCHR Letter Concerning Lead in DC Public School Playground

National Center for Health Research: May 2, 2019


Paul Kihn
Acting Deputy Mayor for Education, Washington, DC
1350 Pennsylvania Avenue, NW, Suite 307
Washington, DC 20004
dme@dc.gov

Dr. Lewis Ferebee
Chancellor
District of Columbia Public Schools
1200 First Street, NE,
Washington, DC 20002
lewis.ferebee@dc.gov

 

Dear Mr. Kihn and Dr. Ferebee:

I am writing on behalf of the National Center for Health Research (NCHR) to express strong concerns about the report released today that demonstrates high levels of lead in the rubber shred from the playground at Janney Elementary School in Northwest.

NCHR 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.

The new report, which used independent professional laboratories to evaluate the components that are visible in breaks in the playground at Janney, found that 8 of the 34 samples (24%) had levels of lead that were over 1,951 ppm. The highest level of lead found was over 59,000 ppm. We can compare this to EPA’s standard for lead in soil in a playground, which is 400 ppm and the Consumer Product Safety Commission’s standard for lead in consumer products intended for children is 100 ppm in all accessible parts.

At Janney, the average lead for all samples, including the samples with low levels of lead, was 2,417 ppm, which is more than 7 to 19 times the EPA and CPSC standards, respectively.

These very high levels are of great concern because children are being exposed in 3 ways:

  1. When they play on the playground, breathing in the lead dust;
  2. When their skin or clothes come in contact with the rubber shred that is now on the surface rather than below the “poured in place” surface; and
  3. When they put pieces of shred, some of which are pretty colors, in their mouths.   Studies have shown that swallowed rubber shred that can apparently be digested and thereby expose the child to the lead.

These results were so frightening, that I included them in my testimony before the U.S. Consumer Product Safety Commission at their annual meeting yesterday.

Experts agree that there is no safe level of lead exposure. Children exposed to even low levels of lead can be harmed, including attention-related behavior problems and poorer cognitive abilities. It can also delay puberty, reduce growth, and may affect kidney function. Exposure as a child can lead to lifelong health effects.

We understand that the school system and government of the District of Columbia have many urgent issues, but since the dangers of lead are so well understood, surely lead in the playground requires your immediate attention.

 

Sincerely,

Diana Zuckerman, PhD
President

References

  1. Ecology Center. Report on lead in PIP playground at Janney School. May 2, 2019. https://drive.google.com/file/d/1UfMzsVQ0EZKquGlnUKBgkspohIod9D-H/view
  2. Environmental Protection Agency. Hazard standards for lead in paint, dust and soil (TSCA Section 403). Updated 2018. https://www.epa.gov/lead/hazard-standards-lead-paint-dust-and-soil-tsca-section-403
  3. Consumer Product Safety Commission. Total lead content business guidance & small entity compliance guide. https://www.cpsc.gov/Business–Manufacturing/Business-Education/Lead/Total-Lead-Content-Business-Guidance-and-Small-Entity-Compliance-Guide

 

NCHR Public Comment to FDA on breast implant safety

National Center for Health Research, April 26, 2019


National Center for Health Research Public Comment on General and Plastic Surgery
Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting [FDA-2019-N-0426].

Thank you for the opportunity to provide comments on FDA’s General and Plastic Surgery
Devices Panel of the Medical Devices Advisory Committee meeting on breast implants. The
National Center for Health Research is a nonprofit research center staffed by scientists, medical professionals, and health experts focused on research, programs, services, and policies that affect public health. Our Center analyzes scientific and medical data and provides objective health information to patients, providers, and policymakers. We do not accept funding from companies that make medical products, so we have no conflicts of interest.

Our Program to Help Women Seeking Insurance Coverage for Implant Removal

Since its founding in 1999, our Center has heard from thousands of women who told us that their breast implants have caused serious health problems. In 2015, we began to offer a program that helps women navigate their health insurance policies so that they can get coverage when the removal of breast implants is medically necessary. In the past 3 years, more than 6,000 women have contacted us, and the number continues to grow dramatically. Some weeks we are contacted by more than 200 new women seeking our help to get their breast implants removed because of serious medical problems. Their reasons for needing their implants removed include leaking and ruptured breast implants, chronic pain from capsular contracture or from implants that are too large, autoimmune or connective tissue symptoms or diseases (referred to as “breast implant illness”), and ALCL. Some women contact us after recently developing symptoms from their breast implants, while others have been living with chronic health issues for years but either did not know they might be related to their breast implants or did not have the financial resources to have their implants removed. Prior to passage of the Affordable Care Act, breast implants were considered a “pre-existing condition” and explant surgery was almost never covered by health insurance.

Most women tell us that had they known that breast implants might cause these serious health problems, they never would have gotten them. We hear every day how women trusted their doctors when they were told that breast implants were safe and that complications were rare.

Recent research on 123,255 Israeli women by Watad et al. concluded that breast implants
significantly increase the chances of a woman being diagnosed with several autoimmune
diseases, such as rheumatoid arthritis and Sjogren’s Syndrome. However, because the FDA has repeatedly denied a link between autoimmune or connective tissue symptoms and breast implants, insurance companies will rarely pay for the removal of implants for women with symptoms of breast implant illness, such as joint or muscle pain, chronic fatigue, mental confusion, rashes, hair loss, and persistent flu-like symptoms. Of the thousands of women who seek assistance from our organization, only about 20% are able to get their implants removed. Even fewer get insurance coverage for their medically necessary explant surgery. The rest have to empty their savings, rely on credit cards or loans, or borrow money from friends and family. Unfortunately, most women who are unable to get insurance coverage for their breast implant removal are also unable to afford to pay out-of-pocket for explant surgery, which is why so many live with debilitating symptoms and escalating health problems for years. What might start as gradual increases in symptoms become so debilitating that many of the women lose their jobs (and with it, often their insurance), their ability to care for themselves or their families, and sometimes their spouses.

Implications for the Registries

The PROFILE Registry is intended to gather information about patients with BIA-ALCL, but not other health problems. The National Breast Implant Registry is designed to include as many Board-Certified plastic surgeons and their patients as possible, and therefore focuses only on re-operations – information that is relatively easy for physicians to document. It does not include information about the range of life-changing symptoms that thousands of women have reported, and also fails to include the thousands of women who need to have their implants removed, but are financially unable to do so. As we have found in our program assisting women who desperately seek insurance coverage for explant surgery, the number of women who have their implants removed and not replaced is only a small percentage of the number of women who want explant surgery because of medical problems. The registry needs to be substantially improved by including information about the autoimmune and connective tissue disease diagnoses as well as the moderate to severe symptoms that women refer to as breast implant illness. In addition, registries need to include information from primary care physicians and non-surgical specialists who are often conducting medical tests in an effort to determine the cause of the women’s symptoms. Most women who experience autoimmune or other symptoms from their breast implants are making appointments with primary care physicians, rheumatologists, neurologists, and other specialists; they rarely return to their plastic surgeons because those symptoms aren’t clearly related to their implants. Moreover, they tell us that when they go to a plastic surgeon because they have heard from other patients that the symptoms may be related to their implants, most surgeons tell them they are mistaken.

Another major shortcoming of the current Registry is that the data from the Registry is not
available to researchers or the public unless the ASPS Foundation chooses to make it public. Since the FDA considers registries an important aspect of post-market surveillance, it is essential that the data be available to anyone who wants to analyze it.

If Implants Can Cause Serious Symptoms, Will Removal Improve Health?

Our Center recently conducted a study of 449 women who had sought our help and succeeded in having their implants removed in 2016, 2017, or 2018. Fifty-seven percent of the women filled out our online questionnaire, all between November 2018 and January 2019. All of the women who we contacted had provided medical information to us when we had previously tried to help them obtain insurance coverage for explant surgery. Fifty-nine percent of the women in the study had symptoms for more than 5 years before they had their breast implants removed and 25% reported having symptoms for more than 10 years before explant surgery. These findings are consistent with patients’ testimony at the FDA meeting and with what thousands of patients have told us over the years: Many women have had debilitating symptoms for years, but did not know they were linked to their breast implants. So, instead of removing their implants when they first noticed health problems, they waited years, and sometimes decades, to seek explant surgery without replacement. Whether because of lack of money or lack of information that their symptoms were caused by their implants, our findings suggest that a short, easy-to-understand booklet and informed consent checklist could help warn women with limited financial resources about the risks of breast implants and also help women recognize their symptoms and consider explant surgery as an option before their health deteriorates.

We asked about family and personal health history and found that 69% of the women in our study reported a family history of autoimmune disease, 3% reported a personal history of autoimmune symptoms prior to getting implants, and 51% of the women reported that they were newly diagnosed with an autoimmune disease after getting breast implants.

Using a Likert scale with responses ranging from “much worse” to “much better,’ 61% of the women reported that their symptoms were much better since getting their implants removed and an additional 29% reported that their symptoms were somewhat better after having their breast implants removed. After performing a logistic regression to determine the factors that independently predicted health improvement after explant surgery, having explant surgery that removed as much capsule as possible predicted improvement after explant, as did not having a family history of autoimmune disease.

Implications for Informed Consent

Although all implant companies have patient booklets, in our experience most women report never seeing those booklets. In addition, the booklets are much too long and technical; they range in length from 55 to 180 pages, and include a great deal of information that is difficult to understand or promotional rather than informational. Nevertheless, the patient booklets include important information, such as the warning that breast implants were not studied on women with a history of autoimmune disease and therefore the safety of implants is not established for those women. However, there is so much information in these lengthy booklets that these types of important warnings are unlikely to be noticed by either doctors or patients that read them.

Although all patients sign an “informed consent” document, many are too technical for the
average patient to understand and include information that may be vague or confusing. They are often signed without having been carefully read. Informed consent is supposed to be a process, not just a piece of paper. Patients tell us that regardless of what the informed consent forms stated, their plastic surgeons were very reassuring about how safe implants are, rather than being candid about the risks. At the FDA Advisory Committee meeting on March 25-26, many plastic surgeons spoke about how carefully they provide informed consent to their patients, but those claims were undermined by the fact that many of those same surgeons stated that their patients are very happy with their implants, that ALCL is very rare and ‘not a big deal’ if caught early, and that the symptoms of breast implant illness are the same symptoms that all women tend to have. It is obvious that these physicians are unable to provide objective, informed consent about risks if they think the risks are minimal or non-existent.

Improving Informed Consent

Women need better informed consent in terms of written material and in terms of what their physicians tell them. Patient booklets specific to each company and implant model should be no longer than 20 pages and written at an 8th grade reading level, which is the reading level recommended by health educators. They should include easy-to-understand information about complications and risks, including information about BIA-ALCL and symptoms of breast implant illness. They should also include information from studies indicating that many women with breast implant illness experience significant improvement when their implants and scar capsules are removed. The writing of these booklets should require consensus among a group of experts that includes patients harmed by implants and their physicians, Board-certified plastic surgeons who put in breast implants and Board-certified plastic surgeons who primarily explant, the relevant implant manufacturer, and health educators.

In addition, there should be a required checklist, no longer than 3-4 pages, that is similar to the one that the FDA required for Essure, that provides information about the potential risks of all breast implants including BIA-ALCL and breast implant illness. These should be read and signed by patients and their doctors prior to any nonrefundable deposits for surgery. The checklist should include a black box warning regarding BIA-ALCL and breast implant illness, and information about the potential improvement in health for women who have their implants removed and not replaced.

In conclusion, we urge the FDA to require an informed consent checklist that specifically and succinctly warns of the symptoms and disease development risks that the patients at this meeting have reported. We ask that the FDA require manufacturers to complete the large, long-term studies that evaluate systemic symptoms. And finally, we urge the FDA to develop a national registry that includes symptoms as well as re-operations.

Thank you for the opportunity to comment on this important issue.

For more information, please contact Diana Zuckerman, PhD, at dz@center4research.org.

Cancer Prevention and Treatment Funds’ Comments On USPSTF Draft Recommendation Statement for BRCA-Related Cancer: Risk Assessment, Genetic Counseling, and Genetic Testing

March 18th, 2019


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

We have concerns about the familial risk prediction methods and the baseline mutation probability threshold being used to refer large numbers of women for genetic counselling and potentially genetic testing.

According to the CDC[1], 1 in 40 Ashkenazi Jewish women have the BRCA mutation. Based on most of these models, most 30-year-old Jewish women with any first- or second-degree family history of breast cancer would likely be referred for genetic counseling, and yet 90% will not have a BRCA mutation.  This will clearly raise anxiety levels and we question whether the benefits outweigh those concerns.

Studies have shown that applying a seemingly universal mutation probability threshold of 10% for almost all risk prediction models will lead to a phenomenon called ‘over-dispersion.’  This means that those who are most likely to be carriers will have a very high probability prediction and those who are least likely to be carriers will have very low probability estimation.[2] Statistically, this often provides misleading and conflicting results to physicians.

Additionally, further research on the validation of risk prediction models has shown that the decision threshold should be derived from “diagnostic accuracy measures rather than defined directly by any breast cancer risk.”[3] Science has shown that tests in clinical settings with a high sensitivity are more likely to detect a higher number of carriers ultimately reducing the burden of unnecessary medical expense.3

Therefore, we urge the USPSTF to reconsider its assessment of the risk prediction models by employing a universal standardized sensitivity threshold instead of a universal standard mutation probability threshold. A universal sensitivity for all predication models will yield varying but statistically relevant mutation thresholds for different models. This will more accurately identify mutation carriers in need of genetic counselling and reduce the overall number of non-carriers who are sent for genetic counselling.

For questions or more information, please contact Dr.Varuna Srinivasan, MBBS, MPH at vs@center4research.org.

[1] Center for Disease Control and Prevention,  Jewish Women and BRCA Gene Mutations, www.cdc.org, https://www.cdc.gov/cancer/breast/young_women/bringyourbrave/hereditary_breast_cancer/jewish_women_brca.htm, November 5th 2018

[2] Lindor, N. M., Lindor, R. A., Apicella, C., Dowty, J. G., Ashley, A., Hunt, K., Mincey, B. A., Wilson, M., Smith, M. C., … Hopper, J. L. (2007). Predicting BRCA1 and BRCA2 gene mutation carriers: comparison of LAMBDA, BRCAPRO, Myriad II, and modified Couch models. Familial cancer, 6(4), 473-82.

[3] Schneegans, S. M., Rosenberger, A., Engel, U., Sander, M., Emons, G., & Shoukier, M. (2011). Validation of three BRCA1/2 mutation-carrier probability models Myriad, BRCAPRO and BOADICEA in a population-based series of 183 German families. Familial cancer, 11(2), 181-8.

NCHR Comment on Management of Cybersecurity in Medical Devices

National Center for Health Research, March 18, 2019


National Center for Health Research Public Common on
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
[FDA-2018-D-3443]

Thank you for the opportunity to provide our views on the draft guidance “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.”

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 support FDA’s efforts to update their approach to address growing concerns about cybersecurity risks in medical devices through the premarket submission process.  Software and medical devices have become increasingly interconnected and vulnerable to network-related cybersecurity breaches, which puts patients at risk.  We have several concerns and recommendations to improve the updated guidance.

Justify the intended users, purpose, and value of the Cybersecurity Bill of Materials (CBOM).  The CBOM is defined as “including but not limited to a list of commercial, open source, and off-the-shelf software and hardware components to enable device users (including patients, providers, and healthcare delivery organizations)…to effectively manage their assets, to understand the potential impact of identified vulnerabilities to the device (and the connected system), and to deploy countermeasures to maintain the device’s essential performance.”  We agree that a CBOM that lists device hardware and software that could be vulnerable to cybersecurity breaches will be valuable going forward.  However, the guidance should also more clearly justify the CBOM intended users, purpose, and value:

  • How will the CBOM be helpful to the aforementioned users (particularly patients and providers) who may not have the required technical expertise to leverage this information to better manage their cybersecurity risks?
  • What are potential uses (and users) of the machine-readable format of the CBOM (described in Section B.1.g)? If this includes integration into FDA’s existing medical device databases or with ongoing (or planned) post-market surveillance initiatives, those should be mentioned.

 Explain how digital health cybersecurity that impacts medical devices will be addressed.  In the current document, one of the key criteria that places a medical device in the “higher cybersecurity risk” tier is its ability to connect with “another medical or non-medical product, or to a network, or to the Internet.”  However, many digital health technologies (e.g. clinical decision support, mobile apps, and electronic health records) are already capable of connecting and interacting with networks, as well as with other medical devices.  While recent legislation removed some digital health products from FDA regulatory oversight, cybersecurity attacks make no distinction between these different technologies, all of which play a potential role in patient care or clinical decision-making.1  As a result, guidance should explain how to handle cybersecurity attacks that target medical devices directly as well as indirectly through digital health technologies that could connect to these devices.  If the FDA plans to address digital health cybersecurity through the FDA Software Precertification program or other related initiatives, this should also be included in the guidance document.

Reinforce medical device cybersecurity without sacrificing usability.  The previous (2014) version of the draft guidance stated that “manufacturers should also carefully consider the balance between cybersecurity safeguards and the usability of the device in its intended environment of use,” yet the current draft completely removes the discussion of usability.  Cybersecurity and usability in medical devices are not mutually exclusive.  Indeed, poor product usability is a key problem in healthcare technology today, a source of frustration for healthcare providers, and also has important patient safety implications.2  We therefore strongly recommend reintroducing the usability discussion into the guidance document.

 

References

1         Ronquillo JG, Zuckerman DM.  Software-related recalls of health information technology and other medical devices: Implications for FDA regulation of digital health. Milbank Quarterly. 2017. 95:535–53. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5594275/

2         Ratwani R, Benda N, Hettinger A, et al. Electronic health record vendor adherence to usability certification requirements and testing standards. JAMA. 2015. 314:1070–1. https://jamanetwork.com/journals/jama/fullarticle/2434673

 

 

NCHR Testimony on the Evaluation for High-Risk HPV Detection Devices

Dr. Varuna Srinivasan, MBBS, MPH, National Center for Health Research, March 8th 2019


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 policymakers.

We do not accept funding from drug and medical device companies, so I have no conflicts of interest.

  1. We would like to start by saying that we agree with the FDA’s evaluation that a clinical endpoint of CIN3+ for a HrHPV test is more meaningful in assessing pre-cancerous lesions. We agree that although the prevalence of these lesions is seen in fewer numbers in the population, recruiting more women for evaluation studies to detect CIN3+ will help maximize resources and prevent overtreatment in the future.  For these reasons, the National Center for Health Research encourages the panel to consider the presence of CIN3+ alone as a positive result and not the combination of CIN2+/CIN3+.
  2. We disagree with the proposed indications for use. As the FDA pointed out, 90% of all HPV clears on its own.  On average, women over 30 tend to have fewer sexual partners and more monogamous relationships than women under 30, and women over 65 have even fewer. That is why the USPSTF recommends co-testing or Pap smears every 5 years for women under 30 years of age.  The FDA proposal to screen all women from 25-60 with the HrHPV test exposes a large population of women to this test unnecessarily.  For that reason, we believe that HR HPV testing should be recommended only for women over the age of 30.1

It is important to keep in mind that Pap smears directly determine the presence of cancerous or precancerous cells in your body. Co-testing can provide the added benefit of identifying high-risk HPV infection and allow for more vigilant follow-up if HPV-16 or HPV-18 is diagnosed.

We respectfully urge the panel today to consider these suggestions while providing their final recommendations.

Thank you.

1 Varuna Srinivasan, MBBS, MPH, Jared Hirschfield, National Center for Health Research. Cervical Cancer Screening Options: What Is Best For You? www.center4research.org. http://www.center4research.org/cervical-cancer-screening-options/


The advisory committee panel deliberated and provided input on specific questions prepared by the FDA to discuss new approaches to the development and evaluation of HR HPV devices. The FDA 24 Hour summary provides information on the topics and questions discussed during this meeting and can be found here

NCHR Statement to the Maryland State House Environmental Committee, Artificial Turf

National Center for Health Research, March 1, 2019.


Good afternoon. Thank you for the opportunity to speak today in support of this legislation to restrict the disposal of synthetic turf and turf infill.

I’m Jack Mitchell, director of health policy for the National Center for Health Research. NCHR is a non-profit public health organization which analyzes medical and scientific information to better inform policymakers and the public. We also monitor health-related legislation and explain the implications for patients and consumers. We do not accept funding from any company that makes products we evaluate, so I have no conflicts of interest.

Our organization has been testifying and writing about the dangers of synthetic turf for several years, and we’ve testified before state and local legislative bodies and federal agencies. Our staff has reviewed all publicly available scientific studies pertaining to the health impact of the toxic chemicals which are used in the manufacture of synthetic turf. We’re very concerned about it, and that’s why I’m here today.

Plastic and synthetic rubber are made with different types of hormone-disrupting chemicals, some of which are known to be particularly harmful to growing children. Scientists at NIH have concluded that these chemicals can be threats to health even at low levels. And 20% of the 96 chemicals taken from samples at five different synthetic turf companies were classified as probable carcinogens, according to a 2015 study by Yale University.

Contrary to what is often stated by industry supporters and manufacturers, synthetic turf has not been declared safe by federal authorities. In fact, the EPA and the federal Consumer Product Safety Commission are jointly studying the chemicals used in these products and have not yet finished their analyses. Unfortunately, there are no federal requirements for safety testing of these synthetic turf products before they are sold.

Since independent scientists are convinced that synthetic turf in playgrounds and parks is less safe than grass, the bill before you is especially important. Dumping these used synthetic turf products in unregulated locations, or worse, incinerating them, increases the dangers to all of us, and especially those living near such locations. Requiring a “chain of custody” of those who seek to dispose of these products, as this legislation outlines, is an excellent, common sense public health proposal and should be adopted.

Use of synthetic turf has exploded in recent years, and industry has stated there may be as
many as 12,000 of these fields and parks throughout the country. They each account for
hundreds of tons of construction-like and demolition debris, synthetic rubber and plastic waste, containing an array of toxic chemicals. Additional toxic materials are added every year to these fields, as rain washes some of it into our streams and lawns. These toxic materials belong in controlled waste facilities, not in undisclosed, unregulated dump sites where they can contaminate our air, water and soil.

Please pass this legislation and thank you for addressing this critical public health issue.

Please contact Jack Mitchell, jm@center4research.org, with any questions.

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

February 11, 2019.


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

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

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

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

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

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

References:

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

NCHR Comments on USPSTF’s Draft Research Plan for Colorectal Cancer: Screening

National Center for Health Research: January 30, 2019

National Center for Health Research’s Public Comments on
the USPSTF’s Draft Research Plan for Colorectal Cancer: Screening

Thank you for the opportunity to share our views regarding U.S. Preventive Services Task Force (USPSTF)’s draft research plan regarding screening for colorectal cancer. The National Center for Health Research is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

The USPSTF last reviewed the literature in 2016 and provided an “A” grade for colorectal cancer screenings in adults aged 50 to 75 at average risk.1 It did not provide recommendations for particular stool-based, direct visualization, or serum screening tests, leaving the choice to be based on the balance of benefits, risks and preferences of the clinician and patient. However, recent studies based on the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program indicates that the rates of colorectal cancer are increasing among adults in their 40s.2  In response to that research, in 2018 the American Cancer Society released new guidelines recommending that adults at average risk for colorectal cancer begin screening at 45 years of age.3 In addition, the U.S Multi-Society Task Force on Colorectal Cancer supports screening African Americans for colorectal cancer beginning at age 45.4

We support the efforts of the USPSTF to carefully draft a research plan to guide the systematic review of available evidence for colorectal cancer screenings to reduce rates of colorectal cancer mortality. We also strongly support the efforts of the USPSTF to review the evidence regarding the harms and benefits of specific types of colorectal cancer screenings, and how they vary by age, sex, and race/ethnicity.

The draft research plan is specifically for average-risk adults, with adults at higher risk intentionally excluded. It is essential that the USPSTF always clearly specify whether recommendations are aimed only at individuals at average-risk.

We commend inclusion of the proposed contextual questions to determine what tools exist to assess the risk of colorectal cancer in the average-risk population. However, we strongly urge that these tools also be explicit regarding the impact of race/ethnicity, sex, and age, because those traits can affect the development of colorectal cancer as well as mortality.

While we understand that screening recommendations for high-risk individuals might differ from those for average-risk individuals, it is not clear why the draft research plan excludes all studies based on high-risk individuals.  Such studies could have important implications for the effectiveness or safety of screening methods for average-risk individuals.  This decision should be clarified or reconsidered.

We disagree with the plan to exclude the analysis of minor harms that affect screening behaviors and compliance with screening guidelines, such as physical discomfort and convenience.  Preparation for colonoscopy is the subject of considerable criticism and even derision.  As a result, it is essential to consider avoidance behaviors that result from minor harms.

We also urge that the analyses include studies of the potential harms of false positives that result in unnecessary colonoscopies or polypectomy.

We commend the inclusion of demographic subgroup analyses for screening program effectiveness, screening test accuracy, and harms.  We urge that these be analyzed in terms of whether the screening tests have benefits that outweigh the risks for each subgroup, rather than compare which subgroup has the best outcomes compared to other subgroups.  What matters to patients is whether the screening test is safe and effective for patients like them, not whether there are other types of patients for whom some tests are better.

In conclusion, we strongly support the USPSTF’s efforts to update recommendations for different types of colorectal cancer screening for different demographic subgroups, as well as their broader efforts to improve the health of all Americans by making evidence-based recommendations about clinical preventive services.

Thank you for the opportunity to comment on this issue.

The National Center for Health Research can be reached through Stephanie Fox-Rawlings, PhD at sfr@center4research.org.

References

  1. Final Recommendation Statement: Colorectal Cancer: Screening. U.S. Preventive Services Task Force. June 2017. https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/colorectal-cancer-screening2
  2. Siegel RL, Fedewa SA, Anderson WF, et al. Colorectal cancer incidence patterns in the United States, 1974–2013. JNCI: Journal of the National Cancer Institute. 2017. 109(8). https://doi.org/10.1093/jnci/djw322
  3. Smith RA, Andrews KS, Brooks D, et al. Cancer screening in the United States, 2018: A review of current American Cancer Society guidelines and current issues in cancer screening. CA: A Cancer Journal for Clinicians. 68(4):297-316. https://onlinelibrary.wiley.com/doi/full/10.3322/caac.21446
  4. Rex DK, Boland CR, Dominitz JA, et al. Colorectal cancer screening: Recommendations for physicians and patients from the US Multi-Society Task Force on Colorectal Cancer. The American Journal of Gastroenterology. 112(7):1016-1030. https://www.nature.com/articles/ajg2017174

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

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


January 24, 2019

 

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

 

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

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

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

Scientific Evidence of Cancer and Other Systemic Harm

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

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

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

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

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

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

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

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

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

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

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

Envirofill and Alternative Infills

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

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

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

Dangerously Hard Fields

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

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

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

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

Conclusions

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

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

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

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

Sincerely,

Diana Zuckerman, Ph.D.

President

 

 

Footnotes

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

NCHR Comment on FDA’s 510(k) Third Party Review Program Draft Guidance

National Center for Health Research: December 13, 2018


Comment of the National Center for Health Research Regarding the
510(k) Third Party Review Program:
Draft Guidance for Industry, FDA Staff, and Third Party Review Organizations.
OMB Control Number 0910-0375

The National Center for Health Research (NCHR) is a non-profit organization which conducts original research to better inform policy makers, health professionals, and patients.   NCHR accepts no funding from any entity which manufactures or distributes medical products.

We appreciate the opportunity to comment on this draft guidance.  We note that this draft guidance applies to low-to-medium risk medical devices, which concerns us because many Class II devices are permanent implants that have the potential to cause permanent harm to patients.  In fact, our research indicates that even Class I devices have been subjected to high-risk recalls by the FDA due to the potential for causing death or permanent harm.1 2 3

We have several serious concerns about the draft guidance.  First, Original Equipment Manufacturers (OEM) are accountable for the efficacy and safety of their medical devices.  FDA standards require that devices manufactured by OEM’s comply with relevant regulatory standards.  OEMs are required to track, monitor, and report product issues to FDA.  Overseeing the OEMs and their reporting are FDA’s responsibility to ensure patient safety.

Second, in the past FDA has had the opportunity to review the work of any third party reviewer, and reject it if deemed inadequate or shoddy.  In fact, the agency has often found problems with the third party reviews.  The proposed guidance would sharply reduce the agency’s oversight of third party reviews, which will clearly compromise safety.  Even if certified as qualified, third party review companies have an inherent conflict of interest: If their standards are too high, no device company will hire them and they will go out of business.  The system is similar to the EU regulation of medical devices, which has resulted in very harmful decisions, such as the clearance of the PIP breast implants that were found to use non-medical grade silicone.4  In addition, investigative reporters recently obtained CE clearance for a “surgical” mesh that was made out of a plastic mesh bag used for oranges.

Transparency is also a crucial factor.  Currently, third party review companies are not required to clearly label an OEM device indicating that a critical repair has been completed by someone other than the OEM.  Once that repair is made, the device is no longer the same device that was approved or cleared by FDA.  It is important that this chain of accountability is not broken or interrupted.

While we understand the desire of FDA officials to reduce medical device review times and reduce the burden on FDA staff and industry, the 510(k) program already is a quick way to get devices to market and the device industry has clearly benefitted from it.  The 510(k) pathway has been widely criticized by the Institute of Medicine, physicians, patients, and the media for its lack of clinical trials and lack of scientific evidence.5  Despite its weaknesses, the 510(k) pathway is considered superior to the EU regulatory system, however.  By reducing the “burden” for FDA staff and industry, the proposed guidance increases the burden on patients and doctors to figure out which devices are safe and which are not.  This would clearly put U.S. patients at greater risk.

FDA has not demonstrated that its proposed changes to the third party review pathway of Class I and Class II devices will benefit patients.  By definition, 510(k) devices only rarely are substantially superior to recent predicates.  Speeding up the process of clearance is not demonstrated to benefit patients.  Moreover, with registries, NEST, and other planned efforts to improve post-market surveillance still far from effectively implemented, any loosening of 510(k) regulations is very premature.

Finally, we note that Commissioner Gottlieb responded to recent media criticism of CDRH regulations by promising improvements to the 510(k) pathway to ensure patient safety.  The third party review program clearly moves in the opposite direction, reducing patient safety, rather than protecting patients from potentially harmful devices.   We strongly oppose it for that reason.

 

References

  1. Zuckerman, D.M., Brown, P, and Nissen, S.E.  (2011) Medical Device Recalls and the FDA Approval Process, Archives of Internal Medicine, 117, 1006-11.
  2. Zuckerman D.M., Brown P., Nissen S.E. (2011). In Reply, Archives of Internal Medicine, 171(11), 1045.
  3. Zuckerman D.M., Brown P., Nissen S.E. (2011). In Reply, Archives of Internal Medicine, 171(21), 1963.
  4. Zuckerman, D., Booker, N, and Nagda, S. (2012) Public Health Implications of Difference in US and European Union Regulatory Policies for Breast Implants, Reproductive Health Matters, 20 (40),102-111.
  5. Zuckerman D.M., Brown P. & Das A. (2014) Lack of Publicly Available Scientific Evidence on the Safety and Effectiveness of Implanted Medical Devices,  JAMA Internal Medicine, 174(11): 1781-1787.