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NCHR Comment on Management of Cybersecurity in Medical Devices

Policy, Testimony & Briefings

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Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability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Thank you for the opportunity to provide our views on the draft guidance “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.”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

Policy, Testimony & Briefings

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. 

What Does Gottlieb’s Resignation Mean for Medtech?

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

David Lim, Medtech: March 6, 2019.

Under Gottlieb’s tenure FDA rolled out a number of medical device initiatives, some mandated by the landmark 21st Century Cures Act, such as guidances on breakthrough devices, CLIA waiver improvements and least burdensome device review.

Other policies, such as the agency’s proposal to examine limiting manufacturer reliance on 510(k) predicate devices older than 10 years came in the midst of criticism the agency is too lax in its regulatory oversight.

But Gottlieb often left device decision making to Shuren, a sign he trusted the career staffer to run the show.

“At CDRH, really what he was doing was letting Jeff Shuren do his thing. It was Jeff driving it and Gottlieb giving him permission to do so,” Brad Thompson, a digital software attorney at Epstein Becker & Green, told MedTech Dive.  “I don’t mean to minimize that. There are some commissioners who would have said no, just saying yes to Shuren was significant.”

But Gottlieb was not hands off either. He regularly jointly announced medtech initiatives with Shuren including efforts to stand up a Pre-Cert Program for software as a medical device, which “at least created the impression that Dr. Gottlieb was very involved and proactive” in the device space, according to Jeffrey Shapiro, a device attorney at Hyman, Phelps & McNamara.

“I didn’t see an initiative from the device center that it hadn’t been working on to some extent in the last few years,” Shapiro said. “I don’t see a big change unless the new commissioner somehow has a different set of priorities or ideas about device regulation.”

President of the National Center for Health Research Diana Zuckerman agreed, telling MedTech Dive the true impact of Gottlieb’s exit on the device center will depend on if his replacement “will continue to let Jeff Shuren run the show or want to make changes.”

It’s unclear who will take Gottlieb’s place, but some in industry fear a less conventional, more typical Trump administration candidate. During the last FDA chief search, the rumored nomination of Peter Thiel associate Jim O’Neill, who advocated against mandating companies prove the effectiveness of new products, spooked some.

Bakul Patel, FDA associate center director for digital health, is another CDRH leader who shepherded the Pre-Cert Program from conception to its current proposal. His presence will maintain additional normalcy at CDRH, according to Thompson.

The agency is in the process of collecting feedback on the latest working model for the Pre-Cert Program, which has drawn fire from Democrats and some in industry for potentially overstepping FDA’s statutory authority.

Gottlieb and Shuren also worked together to stand up the National Evaluation System for health Technology (NEST), a real world evidence collection initiative tied to a postmarket surveillance push denoted in the Medical Device Safety Action Plan.

Transparency via social media may also take a hit with exit of Gottlieb, widely considered an effective communicator for FDA with his robust presence on Twitter. ​Twitter-less Shuren has kept a relatively low public profile compared to the commissioner.

“The most immediate change at FDA will no doubt be a radical slow-down in the news flow. Gottlieb is a genius at offering a constant stream of newsy updates, packaging almost any FDA guidance or workshop into a larger more gripping narrative,” Cowen Washington Research Group’s Rick Weissenstein said in a note. “In the absence of the constant, agency-directed messaging, those outside groups could start to reshape the narrative.”

Shuren, who has served as director of CDRH since 2010, has been the source of many of the center’s novel ideas over the past decade. For example, ​he recently co-authored a JAMA Viewpoint article advocating continuing to leverage RWE.

“We anticipate that decentralized network models, such as PCORnet and NEST, although still in their infancy, will emerge as appropriate models to harness the breadth of electronic data generated in health systems,” Shuren jointly wrote.

Abernethy, if appointed, will likely be supportive of the effort, according to Thompson.

Another potential downside for FDA will be a lack of a cheerleader to Congress. Senate HELP Committee Chairman Lamar Alexander, R-Tenn., praised Gottlieb’s time at the agency, noting he has worked closely with Congress and implemented Cures provisions aimed at bringing more medical devices to market faster. Rebecca Wood, who served as FDA chief counsel under Gottlieb, echoed the sentiment to MedTech Dive.

Gottlieb secured a nearly $50 million boost in appropriations for a spate of device and radiological health programs FDA recently received in the February package.

“He was one of the most politically astute commissioners. He knew how to get Congress on his side much more successfully than most FDA commissioners are able to do,” Zuckerman added. “It’s really actually unlikely that his successor will be as good at that.”

 

See the original story here.

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

Policy, Testimony & Briefings

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.

Double-Booked Surgeons: Study Raises Safety Questions For High-Risk Patients

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

Rebecca Ellis, NPR: February 26, 2019.

Surgeons are known for their busy schedules — so busy that they don’t just book surgeries back to back. Sometimes they’ll double-book, so one operation overlaps the next. A lead surgeon will perform the key elements, then move to the next room — leaving other, often junior surgeons, to open the procedure and finish it up.

A large study published Tuesday in JAMA suggests that this practice of overlapping surgeries is safe for most patients, with those undergoing overlapping surgeries fairing the same as those who are the sole object of their surgeon’s attention.

But the study also identified a subset of vulnerable patients who might be bad candidates; the practice of double-booking the lead surgeon’s time seemed to put these patients at significantly higher risk of post-op complications, such as infections, pneumonia, heart attack or death.

Researchers say Tuesday’s study by a multidisciplinary research team from several universities is the most comprehensive analysis of the practice to date, delving into the outcomes of more than 60,000 knee, hip, spine, brain or heart surgeries among patients ages 18 to 90 at eight medical centers. The study compared the outcomes of procedures done in isolation with those that were scheduled to overlap by an hour or more.

Dr. Anupam Jena, a physician and health economist on the faculty of Harvard Medical School and senior author of the study, says his research team found overlapping surgeries to be “generally safe.” Overlapping surgeries were not significantly associated with difference in rates of death or post-op complications.

These findings, says Jena, are in line with all but one of several such studies conducted since 2015, when an investigative team at the Boston Globe first turned searing attention on Harvard’s Massachusetts General Hospital. There, at one of the nation’s premier teaching hospitals, reporters highlighted a practice that at that point was little-studied and not widely discussed outside hospitals. In extreme cases, the surgeries were essentially concurrent, with the multi-tasking lead surgeon moving back and forth between ORs.

Within a year, the Senate Finance Committee jumped in with a report detailing lawmakers’ safety concerns about little-studied practice. And the American College of Surgeons updated its guidelines, adding that juggling “critical” parts of a surgery was “inappropriate.”

However, the less extreme practice of letting the beginning and end of surgeries overlap is still viewed by hospitals as an efficient means of deploying the skillful hands of their top surgeons. Mass General, which has continued the practice, is in the company of teaching hospitals nationwide. Overlapping surgeries in this way “offers greater and more timely access to certain surgical specialties,” Mass General says in an FAQ on the topic, “many of them high-demand, high-volume elective procedures.”

Jena says this is the first study to show that certain types of patients might particularly be at risk.

“This is the only [study] that breaks out and finds in certain high-risk groups, we might have worse outcomes”— namely, in older patients, those with pre-existing medical conditions, and those undergoing coronary artery bypass graft surgery, where blood flow is restored to the heart.

When the researchers homed in on these high-risk patients, they found slightly higher mortality rates among the patients who had undergone overlapping surgeries and were older or had underlying medical conditions — 5.8 percent compared with 4.7 percent for patients who had the lead surgeon’s full attention.

The scientists found a similar discrepancy in complication rates — 29.2 percent of high-risk patients experienced post-surgical complications when subject to overlapping surgery, compared to 27 percent of patients whose procedure was done in isolation. (The “complications” recorded in the study ranged from minor infections at the surgical site to heart attack or stroke.)

This discrepancy, says Jena, “could occur because a surgeon is separating their mental effort between two cases or [from] literally being [in] two places at once. Those kinds of problems would have a measurable effect on high-risk patients.”

The study also found that surgeries booked to overlap lasted a half-hour longer, on average, than those done in isolation.

Dr. Robert Harbaugh, former president of the American Association of Neurological Surgeons and current chair of the department of neurosurgery at Penn State’s Milton S. Hershey Medical Center, was not involved in the study, but says he was not surprised to see the findings show a “modest but real” risk posed to high-risk patients.

“In my practice, if I know someone is a very high-risk patient, you’re much less likely to (schedule) that patient for an overlapping surgery,” says Harbaugh. Surgical patients who have multiple underlying conditions, such as diabetes or hypertension, he says, require his full attention.

This study, he says, supports his sense that there is “a specific group of patients that probably has to be moderated more closely.”

However, Harbaugh says, overlapping surgeries are crucial “to make the operating room run more efficiently.” Surgeons are fully booked two or three months in advance in his department at Penn State, he says. Allowing four surgeries a day lets patients be treated that much sooner — as well as providing “the next generation of surgeons” much-needed training time.

The leading surgeon is always scrubbed-in for the “dangerous part of the surgery,” Harbaugh notes, and only leaves the patient with residents who are “competent to open or close a case.”

“If you’re finishing an operation and you tell your resident, ‘you can you go ahead and close the incision,’ they’re more than competent enough to do that,” he says. “Then you leave, go to another room where a [surgical] fellow has started a case. That’s an efficient use of time.” Harbaugh estimates 15 percent of the surgeries done by doctors in his department overlap.

Harbaugh also notes that his surgical department at Penn State requires surgeons to explain to patients when they sign the consent form that that they will be stepping out for parts of the surgery. But he doubts that policy of transparency is universal, he says.

Jena says there is “little information about what patients know” when it comes to the practice of overlapping surgeries. A 2017 study found few people had ever heard of the practice.

He says he and the study’s lead author, Dr. Eric Sun, an anesthesiologist and assistant professor at Stanford University, “both would agree that doctors should be telling patients about this practice.” Jena recommends patients ask, ahead of the operation, if their surgeon will be dividing their time.

If they don’t like the answer, Jena says, “At any point, the patient could say, “I don’t want care provided to me.”

Diana Zuckerman, a policy analyst and president of the National Center for Health Research, is doubtful many such conversations are likely to occur. “Most patients wouldn’t know to ask,” she says.

“The good news is, for an an individual patient, they shouldn’t worry,” Zuckerman says, pointing to the fact that the study found no significant increase in post-op problems or deaths overall.

However, she says, questions linger over whether patients should be informed about a surgeon’s other commitments, even if the risks of complications are low.

“I think it’s safe to say if patients were told, nobody would like it,” Zuckerman says. “Nobody wants to feel like the doctor is going in and out their surgery.”

 

See full article here.

Is FDA Doing Enough to Make Sure Sunscreens are Safe?

Policy, Press Releases

Is FDA Doing Enough to Make Sure Sunscreens are Safe?
National Center for Health Research Statement in Response to FDA Proposed Regulations
February 22, 2019

 The National Center for Health Research (NCHR) supports the FDA’s proposed new regulations for over-the-counter (OTC) sunscreens. The proposed updates on how products are labeled should make it easier for consumers to identify key product and ingredient information.  Expanding the requirements for broad spectrum protection is an important safeguard, because it provides better protection against damaging UVA radiation.

FDA has found two ingredients commonly used in sunscreens, zinc oxide and titanium dioxide, to be GRASE (Generally Recognized as Safe and Effective) and found two others, . PABA and trolamine salicylate to be not GRASE. The latter two were previously removed from sunscreens so that decision has no impact.  We are disappointed that the FDA has not recognized a widely used sunscreen ingredient, oxybenzone, as unsafe.  Oxybenzone has been found to disrupt hormones, and could increase the risk of endometriosis in women, and alters sperm in animals.  For those reasons, NCHR recommended in 2016 that this ingredient be banned from sunscreen products.

FDA’s proposed rule admits that “there is potential for toxicity associated with the transdermal absorption and systemic availability of oxybenzone.”  However, the proposed regulation states that “This new information about absorption and potential safety risks is inadequate, by itself, to support an affirmative conclusion that products containing the active ingredients at issue are not safe”.  NCHR strongly encourages FDA to require research as soon as possible if the companies plan to continue using it.

Sunscreens are proven to prevent sunburn and since sunburn increases the risk of skin cancer, sunscreens are assumed to also reduce the risk of skin cancer.  Since that link isn’t proven, the role of FDA in ensuring these products are safe is absolutely essential.  As we did in 2016, NCHR strongly urges that FDA expedite the adoption of the proposed rule’s safety and efficacy measures for sunscreens, and immediately require research on other sunscreen ingredients for which the agency has insufficient information.

If you have any questions, please contact Jack Mitchell at jm@center4research.org.

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

Policy, Testimony & Briefings

February 11, 2019.

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

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

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

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

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

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

References:

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

Policing Big Pharma’s Influence Over Doctors’ Treatment Guidelines

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

Ronnie Cohen, Undark: February 4, 2019.

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

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

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

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

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

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

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

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

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

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

See the original story here.

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

Legislation, Policy

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

 

January 11, 2019

Chairman Richard Shelby and Vice Chairman Patrick Leahy

Appropriations Committee

U.S. Senate

Washington, DC 20510

Dear Mr. Chairman and Mr. Vice Chairman:

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

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

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

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

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

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

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

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

Thank you for your commitment to patient safety.

Sincerely,

Diana Zuckerman, Ph.D.

President

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

Policy, Testimony & Briefings

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