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Trump’s diversity purge freezes hundreds of millions in medical research at universities across the country

 

By Sarah Owermohle, May 8, 2025

Universities across the country are scrambling to comply with President Donald Trump’s anti-diversity push in an effort to hold on to hundreds of millions of dollars in federal grants that fund critical medical research in areas such as cancer and maternal health.

Last month, the Trump administration threatened to cancel medical research funds and to pull the accreditation for universities that have diversity and inclusion programs and that boycott Israeli companies.

The latest moves broaden the anti-DEI mandate that Trump signed just hours into his second term, declaring diversity, equity and inclusion efforts discriminatory.

The administration is locked in a legal battle with Harvard University that on Monday saw officials cut off future funding, escalating a total freeze on $2.2 billion in federal grants directed to Harvard. The university has sued to unlock those funds, a fight that will likely be expensive, and take months to resolve.

Most universities, particularly public and smaller institutions, lack the resources to take up the fight the way Harvard has. Dozens of schools across the country have publicly ended DEI programs and quietly taken down or rerouted websites referencing diversity and equity. Some have more openly acquiesced to the administration’s demands, banning the use of certain words and phrases such as “equality,” “gender” and “White supremacy,” and laying off dozens of university staff.

But those efforts haven’t spared them from mass funding cuts.

At Columbia University, some $250 million in health research grants remain in limbo even after the university made significant policy changes in late March to placate the administration. Leaders at Ohio State University, Vice President JD Vance’s alma mater, acted early to end DEI programs and eliminate 16 staff positions in February, citing Trump’s mandate and a state bill.

But in March, the administration still canceled 10 grants to Ohio State, clawing back $2.4 million in planned spending on HPV and Covid-19 vaccine uptake and separate studies on substance use, suicide risk and PrEP access among different LGBTQ populations.

Starting in February, the US National Institutes of Health terminated roughly 780 research grants that referenced equity, racial disparities, minority health, LGBTQ populations and Covid-19. The canceled grants spanned the country: Roughly 40% were to organizations in states Trump won in November, according to a KFF analysis.

Those have included cuts to research seemingly squarely in line with the stated goals of the Trump administration and US Health and Human Services Secretary Robert F. Kennedy Jr., such as studies on autism diagnoses, chronic disease improvements and environmental exposures’ intersection with health.

Besides the immediate impact of frozen research and staff layoffs, scientists and public health experts worry about a chilling effect for health care studies overall. The NIH is the world’s largest public funder of biomedical research, issuing roughly 60,000 grants a year to nearly 3,000 universities and hospitals. That accounts for more than 80% of the agency’s current $48 billion annual budget, although the administration aims to slash that spending by a third next year.

“People are frightened,” said Diana Zuckerman, president of the National Center for Health Research, a nonprofit group aimed at improving health care research. “One of the things that I’ve said to people is, you know, ‘how much can you do what you’ve been doing but just call it something else?’”

That can be a tricky prospect for research on health care issues that disproportionately affect certain populations.

Medical researcher: We should be sharing vaccines with developing world

For instance, the US reports persistently high rates of maternal and infant deaths compared with other high-income countries. There are stark disparities within those figures: Black women are three times more likely to die of pregnancy-related causes than White women.

Researchers and state medical boards attribute those statistics to a range of factors including racial bias, health care access, underlying health conditions and socioeconomic status.

That makes it extraordinary difficult to strip equity, race and risks for certain populations from questions about maternal health care and other research, experts say. Whether it’s new mothers’ postpartum survival, HIV prevention in LGBTQ populations or higher risk of aggressive breast cancer in Black women, many studies necessitate a focus on the people most affected, those experts say. The NIH cut research in all those areas.

“There’s real issues here that could be better understood and responded to, and lives could be saved, but only if you study them – and only if you understand what you’re studying,” Zuckerman said.

Beyond hundreds of grants citing words such as equity, disparities, gender, minority, LGBTQ populations or race, the NIH also canceled spending on Covid-19 outreach, vaccination and messaging.

“HHS grants will only go to the most qualified applicants and will not adhere to ideological requirements or discriminatory quotas,” an HHS spokesperson said in response to questions about the canceled grants.

The mass culling of NIH grants has even stoked concern among Republican leaders who argue that the US could slide in medical innovation and world leadership with the combined funding cuts, mass layoffs and agency shakeups.

“We must not lose sight at what is truly at stake here,” Sen. Susan Collins, a Maine Republican, said during a Senate Appropriations hearing last week. “If clinical trials are halted, research is stopped and laboratories are closed, effective treatments and cures for diseases like Alzheimer’s, type 1 diabetes, childhood cancers and Duchenne muscular dystrophy will be delayed or not discovered at all.”

Maternal health and the DEI battle

In 2023, the NIH launched a $168 million initiative across 10 universities to improve maternal health care.

In March, the agency canceled funding to two of them.

Columbia University, one of the 10 maternal health centers in the mass NIH project, was one of the first schools ensnared in grant freezes and a public battle with the Trump administration.

But the broad grant cancellations also caught the Morehouse School of Medicine, part of a historically Black university in Atlanta, Georgia, a state with some of the worst maternal mortality rates in the country.

Along with Georgia’s Emory University, Morehouse stood up a program focused on improving pregnancy and postpartum care for Black women. There was $1.6 million remaining in the $2.9 million grant when the NIH cut funding. Morehouse School of Medicine President Valerie Montgomery Rice stood fast against anti-DEI efforts in February, telling local radio station WABE that “diversity, equity and inclusion, as it relates to health, is not a political term.”

[….]

“The reason that we knew that we were having disparities in our maternal outcomes is because we started disaggregating the data. We started looking at the outcomes for Black women and White women and Hispanic women,” said one OB/GYN researcher focused on maternal mortality. “If we’re not measuring it, we won’t do anything to improve, because we won’t know. It’s almost like sticking our heads in the sand.”

The researcher asked that their name not be used because they are affiliated with one of the still-funded maternal health programs and are fearful that research could be cut next. Although many of the remaining universities in the program have publicly ended their DEI programs, none feel safe, the person said.

[….]

 

MAHA priorities amid NIH cuts

Dozens of the cancellations seemingly clash with Kennedy’s vision for a healthier America with fewer chronic illnesses, researchers said. Those include at least two research projects aimed at autism, two focused on diabetes and others on cancer research in rural and underserved areas, and disparities in long-term chronic disease outcomes. In most cases, the grants explicitly mentioned a minority population, equity or disparities in care.

Many of those researchers were years, and thousands to millions of dollars, into their projects: Some were ending soon anyway, and had just a fraction of their grants left to spend.

[….]

Ohio State’s 10 canceled grants include one focused on substance use and associated chronic illnesses across sexual minorities in urban and rural areas. Of the nearly $173,000 grant, just $538.11 was left to be disbursed, according to federal data. The grant was cancelled on March 21; it was scheduled to end 10 days later.

[….]

At the Tulane School of Medicine, the $16 million grant for the maternal health center was untouched in March funding cuts. However, the administration did axe the remaining funding, roughly $279,000, for a $4.2 million grant to study lupus progression in Black Americans. Tulane also lost funding for research on Covid-19 treatment in cancer patients.

The medical school has since quietly removed and rerouted diversity pages on its website. The psychiatry department’s page on equity, diversity and inclusion now says that the content is unavailable: “Some content is currently under review to ensure compliance with the latest federal guidelines and executive orders.”

The president of Tulane University announced in a message to students and faculty on March 13 that it would transition its DEI program into a new “Office of Academic Excellence and Opportunity” to comply with federal law. Diversity pages now reroute to that site.

[….]

Read original article here.

Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER 

By Sarah Karlin-Smith, May 7, 2025


The US Food and Drug Administration’s announcement of Vinayak “Vinay” Prasad as the new director of the Center for Biologics Evaluation and Research may signal a major philosophical shift in the data required to approve medical products, particularly cell and gene therapies. 

FDA Commissioner Martin Makary announced the pick of Prasad, a hematologist and oncologist, in a 6 May email to staff obtained by Pink Sheet. Prasad most recently worked at the University of California, San Francisco, as a professor of epidemiology and biostatistics. 

Prasad will replace Peter Marks who resigned from FDA rather than be fired in late March

[….] 

Will Prasad Nix Makary’s ‘Provisional’ Pathway? 

Prasad also has a long track record of criticizing the agency for making it too easy to get drugs on the market, raising concerns about the accelerated approval pathway and recent gene therapy approvals, such as Sarepta’s Elevidys (delandistrogene moxeparvovec-rokl). 

He has supported randomized controlled studies with hard clinical outcomes even as the FDA, including Marks, embraced more flexible approaches, particularly for rare diseases. 

Whether Prasad’s views can align with Makary’s recent proposal for a new ‘plausible mechanism’ pathway for rare disease drugs is unclear. 

Prasad’s history, which includes criticism of the FDA and pharma’s close working relationship, worries industry. 

His appointment “seems counter,” to Makary’s discussions in recent weeks about reforming the drug approval process, particularly for rare diseases, said Nicole Paulk, CEO and Founder of Siren Biotechnology, which is developing gene therapies for cancer. 

“Based on [Prasad’s] books that he’s written and the tweets that he has shared, and podcast that he has been on and all of these various public forums, it would seem to be that his position, kind of broadly regardless of modality is pretty anti-FDA, fairly anti-innovation, fairly anti-accelerated anything,” Paulk told Pink Sheet. 

Investor Misunderstanding About CDER, CDER Product Oversight 

The news of Prasad’s appointment sent biotech stocks plummeting. 

A 6 May analyst note from William Blair suggested investors may be confused about the products regulated by CBER and the Center for Drug Evaluation and Research. The analysts said they do not believe there is a risk to the existing development path for most oncology drugs, which are overseen by CDER. 

For cell and gene therapies, “there are clearly outstanding questions and increased uncertainty now as we wait to see whether Dr. Makary or Dr. Prasad will have more impact on the guidelines and regulatory development requirements for these novel therapies, particularly in rare diseases,” the analysts wrote. “Dr. Makary has been vocal since being confirmed as commissioner for more accelerated approval opportunities in the cases of ultrarare diseases or therapies with overwhelming efficacy.” 

Prasad’s appointment also likely will add to the negative sentiment in the vaccine space, they added. 

A Triumph For Evidence Over Hope? 

Many critics of the FDA’s approval standards hope Prasad’s appointment will lead to tougher approval standards. 

“Like us, Vinay has led several impactful research projects raising concerns around surrogate markers and their lack of association with meaningful clinical outcomes, particularly in oncology,” said Reshma Ramachandran, co-director of the Yale Collaboration for Regulatory Rigor, Integrity and Transparency. “He also similarly expressed concerns around the previous CBER Director’s decision to override multiple scientific and technical review teams to approve Elevidys despite lack of evidence of its efficacy. Hopefully, this is a sign that in his new role, he will listen to his scientific review staff in making regulatory decisions.” 

“I think very highly of him,” said Diana Zuckerman, president of the National Center for Health Research. She suggested that Prasad’s track record suggests someone who would not allow products on the market simply because patients lack any treatment, unlike Marks. 

“I understand the desire to be responsive to patients’ needs and desire to have hope for a new treatment, but I think it does patients no favor to give them false hope by approving treatments that end up being extremely expensive and not only ineffective, but they don’t follow through with the required post-marketing testing,” Zuckerman said. “So for years they end up on the market with companies that make a lot of money off of them and patients who don’t benefit at all or are harmed financially, physically or both.” 

Ethan Perlstein, CEO Of Perlara, a biotech public benefit corporation developing treatments for rare genetic diseases, said the negative reaction to Prasad comes from “traditional bio” because they dislike a person as outspoken as Prasad who “can’t be controlled in some way or is not beholden to them or to anybody.” 

Perlstein said he understands why many in the industry see Prasad as a “chaos agent,” but added that he appreciates Prasad demonstrating that he is “not beholden to anybody except his principles,” and seems willing to evolve. 

Has Prasad Changed? 

Other medical experts who raised concerns about Prasad’s views on COVID-19 and other vaccine issues in recent years acknowledged that before 2020 they liked many of his stances, such as requiring more rigorous follow up on oncology drugs after accelerated approval. 

But they were not confident that Prasad still existed. 

[….]

“He started out criticizing the COVID vaccines and I think a lot of it is audience capture,” said David Gorski, a professor of surgery and oncology at Wayne State University and editor of the blog Science Based Medicine. “As he drifted into more contrarian positions, he got more likes, clicks praise, as a brave truth teller.” 

[….] 

Gorski suggested Prasad is a victim of what he calls “evidence-based medicine fundamentalism,” which is “if it isn’t a randomized placebo-controlled, double-blind clinical trial, it’s crap,” Gorski said. 

[….]

To read the entire article, click here

CPTF Public Comment Regarding the FDA’s Draft Guidance for the Study of Sex Differences in the Clinical Evaluation of Medical Products

April 7, 2025

[Docket No. FDA-2024-D-4245]


Thank you for the opportunity to comment on the FDA’s Draft Guidance for the Study of Sex Differences in the Clinical Evaluation of Medical Products. The National Center for Health Research has conducted research on this issue for decades and our comments today build on the findings of that research.

We strongly support most of the FDA’s proposed guidance, but we note that the agency has attempted to improve the representation of women, older Americans, and racial and ethnic minorities for many years but has fallen short. We have scrutinized this proposed guidance and are providing several suggestions that we respectfully encourage the FDA to implement.

Meaningful Representation of Males and Females and Major Demographic Subgroups

First and foremost, the agency should not focus entirely on increasing females but rather focus on ensuring males and females be substantially represented in all studies of medical products that will be used by males and females. Just as women have historically been underrepresented in studies of treatments for heart disease and several other illnesses, males have been underrepresented in studies of weight loss products and implants that are used by both males and females, for example. We therefore agree with the statement that “For diseases or conditions that can occur in both females and males but rarely occur in one of the sexes in actuality, avoid arbitrary exclusion criteria that prohibit participation based on sex.” It is not sufficient that males and females in the studies be represented in proportion to their likely use of the product; instead, meaningful representation requires that sufficient numbers of patients of the underrepresented sex (or demographic group) be included so that they can be statistically analyzed separately, and the statisticians can draw conclusions about safety and effectiveness for members of each sex.

We agree that sex differences should be the focus, rather than gender differences. We also agree with the importance of enrolling females and males of different ages, races, ethnicities, co-morbidities, and hormonal statuses. For example, when males or females are taking any form of sex hormones for whatever reason (birth control, menopausal symptoms, low testosterone, or due to gender preference), it may be necessary to analyze those groups separately to see if the hormonal treatments affect sex differences. If there are too few to analyze these subgroups separately, the indication on the product label should make it clear that the data may not apply to patients in those subgroups.

We agree with the proposed guidance that companies should analyze and interpret sex-specific data to hormonal and other changes with age, for products used by adults of all ages. Ideally, researchers should first analyze the data separately by sex to see if there are age differences in safety or effectiveness.

Encouraging Rather Than Requiring Meaningful Representation

Unlike other U.S. public health agencies, the FDA merely “encourages representation of females (or other demographic groups) in clinical trials submitted to the FDA” rather than requiring representation. As a result, major demographic groups have often been under-represented in clinical trials submitted to the FDA (Fox-Rawlings et al., 2018). The FDA has justified this lower standard by stating that the studies submitted to the FDA are paid for industry, rather than the U.S taxpayer. However, the U.S. taxpayer pays for the treatments that the FDA approves, even when those treatments are not studied on patients that meaningfully represent the U.S. population. Therefore, encouraging rather than requiring representation is potentially misleading and unsafe for the patients who are not meaningfully represented. At the very least, the FDA should improve the incentives for companies to comply with the recommendations by ensuring that labeling indicates which types of patients were not reliably studied, and limiting the indication to the sex (and age groups, etc.) for whom safety and effectiveness data are reliably provided. 

We support the FDA Draft Guidance statement that sponsors “must submit a diversity action plan with goals for study enrollment, disaggregated by sex, among other demographic characteristics.” Unfortunately, diversity action plans do not always result in achieving the goals intended. We agree with the FDA’s list of ways “to improve the recruitment, enrollment, and retention of females in clinical trials” but believe they are also suitable for improving recruitment of men of all ages as well.

Trial Design

We agree with the initial statement of the draft guidance regarding trial design: “For most drugs and devices, males and females should be included in clinical trials in numbers adequate to allow for reliable benefit-risk assessments and to understand any potential sex related differences in medical product response.” 

However, we strongly disagree with the Draft Guidance’s strong focus on determining if a product is safer or more effective for one sex than the other, because that does not matter to patients. What matters to patients is whether the product is statistically significantly safe and effective compared to placebo or other treatments. In other words, there is no reason why a woman would care if a product is more effective for men that for women as long as it is beneficial in a clinically meaningful way for females. Similarly, why would any man care if a product is safer for women than men, if its benefits outweigh the risks for both? Rather than analyze men and women together and separately and then determine if it is safe and effective for both, as the guidance suggests, it would introduce less bias to start with the smaller number of study participants in each sex and if each has statistically significant benefits that outweigh the risks, then it is not necessary to combine males and females. If those benefits are not statistically significant compared to placebo but suggest meaningful benefits, then the men and women can be combined to see if together the results are statistically significant or not. 

We disagree with the draft suggestion that only where sex differences “are anticipated, there should be sufficient numbers to inform reliable benefit-risk assessments in males and females.” Since, it is often unanticipated or unknown whether there will be sex differences, there should always be sufficient numbers of males and females to provide meaningful data. 

Statistical Concepts

We agree that “Analyzing sex differences in medical product performance is an important component of assessing product safety and effectiveness and can inform what goes in the product labeling to improve patient care.” We also agree that “Sex is [only] one of many potential demographic characteristics typically evaluated in subgroup analyses of a clinical trial or non-interventional study.’ We agree that when many subgroup analyses are performed, some will be statistically significant by chance, and that different effects between males and females may be due to other factors associated with sex, such as age and weight. These must be taken into consideration when multiple statistical analyses are performed.

Reporting Results of Analyses 

We support the requirement that sponsors “must include in their annual reports for drug and biological products conducted under an IND, the number of participants entered into the study to date tabulated by age group, sex, and race, and sponsors must present safety and effectiveness data in the clinical data section of an NDA by sex, age, and racial subgroups. Because the enrollment demographics of the clinical study may impact the generalizability of the conclusions, for clinical studies of devices, the FDA recommends that sponsors report the number and proportion of study participants by sex.” We also agree that “Any potential difference by sex should be investigated, explained, and discussed with the Agency.” 

We agree that the labeling should specify the safety and effectiveness of any product separately for males and females of different demographic subgroups when available, and we add that the labeling should specify when those subgroup analyses are not available.

Other General Considerations 

We reiterate that if a product is not proven safe and/or effective compared to placebo or a different treatment, that information should influence the indication. The Draft Guidance suggests that such differences “may potentially be further explored in a study after approval” and that the FDA can require a postmarketing study when applicable criteria are met.” We strongly disagree with this laissez-faire approach, because it can result in years of inappropriate or ineffective treatment for males or females when other treatments might be more beneficial. Therefore, when there is evidence that a product is not safe or not effective for females, or for males, additional research should be conducted before approval.

For example, in our study of high-risk medical devices, we examined publicly available documents for all 22 medical devices that the FDA designated “highest risk” or “novel,” that were reviewed through the premarket approval (PMA) pathway, and were scrutinized at the FDA public meetings from 2014 to 2017 (Fox-Rawlings et al., 2018).1 We evaluated patient demographics and subgroup analyses for all pivotal trials. Although 20 were intended for men and women, the number of patients in the minority gender was only 1 in one study and half the studies included less than 35% of the minority gender. Only 6 (33%) of the devices included subgroup analysis by sex for safety and 13 (72%) included subgroup analysis by sex for effectiveness. One of the devices, the Lutonix drug-coated balloon catheter used to reduce blockage in the leg, was effective for the total patient sample, but that was because it was effective for men. Women assigned to the Lutonix study arm had slightly worse outcomes than women in the control arm of the study; the artery remained sufficiently dilated a year after the procedure for just over half the women. Nevertheless, the FDA approved this high-risk device for women as well as men. The FDA required a post-market randomized study, but the sponsor said it was unable to enroll a sufficient number of patients. Subsequent data continued to indicate female Lutonix patients did not do as well as male patients, but no publicly available studies indicate if non-drug eluting catheters are superior to Lutonix using real life data. Lutonix continues to be approved for female as well as male patients.

Our study indicated that the frequent lack of subgroup analyses makes it impossible to inform patients or physicians as to whether many newly approved medical devices are safe and effective for specific demographic subgroups defined by gender, race, and age. However, even when the analyses indicated that the women did not benefit from a high-risk device, it was approved by the FDA for women and men anyway.

References

1 Fox-Rawlings, S. R., Gottschalk, L. B., Doamekpor, L. A., & Zuckerman, D. M. (2018). Diversity in Medical Device Clinical Trials: Do We Know What Works for Which Patients?. The Milbank quarterly96(3), 499–529. https://doi.org/10.1111/1468-0009.12344

2 U.S. Food and Drug Administration. (n.d.). PAS 1 (Extended Follow-up Study) [Post-Approval Studies Database]. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma_pas.cfm?c_id=&t_id=524729

3 Becton, Dickinson and Company. (n.d.). Lutonix™ Drug Coated Balloon PTA Catheters: Clinical Data. BD. Retrieved April 7, 2025, from https://www.bd.com/en-us/products-and-solutions/products/product-families/lutonix-drug-coated-balloon-pta-catheters#clinicaldata

National Center for Health Research Comment on USPSTF Draft Recommendations on Cervical Cancer Screening

 1. Based on the evidence presented in this draft Recommendation Statement, do you believe that the USPSTF came to the right conclusions?

  • Yes; I believe the USPSTF came to the right conclusions.
  • Somewhat; I believe the USPSTF came to the right conclusions in some ways but not in others.
  • No; I do not believe the USPSTF came to the right conclusions.
  • Unsure; I am not sure if the USPSTF came to the right conclusions.

Somewhat; I believe the USPSTF came to the right conclusions in some ways but not in others.

2. Please provide additional evidence or viewpoints that you think should have been considered.

Our main disagreement is that our review determined that the data are insufficient to conclude that HPV is superior to cytology for women ages 30-65, taking into consideration all patient outcomes, including diagnosis, overtreatment, survival, psychosocial impact, and costs.

We agree with the USPSTF statements about the high sensitivity of HPV testing, but the USPSTF statement underemphasizes the anxiety and overtreatment for women with a positive HPV test result from a transient infection. The major disadvantage of HPV testing is that a positive HPV result for women from 30-65 years is likely to result in a colposcopy. We therefore question whether HPV testing should be considered preferable to Pap cytology, since the two have comparable effectiveness for many women and Pap cytology avoids diagnosing transient HPV infections. Moreover, while HPV testing can identify more precancerous lesions earlier, its impact on reducing invasive cancer and improving survival is unclear and may depend heavily on follow-up care and screening adherence.

The ARTISTIC trial (Kitchener et al., 2009) found that HPV testing was more sensitive than cytology for detecting CIN3+ lesions in the initial round of screening. However, it did not demonstrate a significant reduction in invasive cervical cancer rates by the second round. Castle et al. (2018) demonstrates that while HPV testing detects more high-grade lesions earlier, it does not significantly reduce invasive cervical cancer rates or improve survival outcomes. Similarly, McCredie et al. (2008) demonstrated that while many high-grade lesions progress to invasive cancer if left untreated, a significant proportion regress spontaneously. These studies suggest that while HPV testing can identify more precancerous lesions earlier, its impact on reducing invasive cancer and improving survival may depend heavily on follow-up care and screening adherence.

In contrast, a pooled analysis looking at the results of 4 studies with a total of more than 170,000 patients, Ronco et al. (2014) found that HPV-based screening significantly reduced the incidence of invasive cervical cancer compared to cytology alone over a 6.5-year period.  The fact that patients enrolled in these 4 studies lived in Europe and Scandinavia could explain why these findings seem to contradict the Kitchener, Castle, and McCredie trials cited in our previous paragraph. It is possible that HPV testing may be more effective than cytology in countries where health care is free and very widely available. Overall, the results suggest that the incremental benefit of HPV testing over cytology is unclear but may be strongest in countries where access to care is not limited. These results do not justify considering it the preferred option for women between the ages of 30 and 65 in the U.S., given the increased costs, uncertain access to follow-up care, psychological stress, and patients’ desire to avoid the cost of potentially unnecessary procedures.

The importance of follow-up care is evident in studies like Dillner et al. (2008), which emphasized the critical need for systems to manage HPV-positive results effectively in order to avoid unnecessary interventions without compromising cancer prevention. Since colposcopies are invasive and more expensive and anxiety-producing than a cytology test, we strongly urge the USPSTF to specify that if HPV is used as the primary test, a positive HPV result should be followed by cytology as the next step before proceeding to colposcopy. This approach is supported by international guidelines such as those in the Netherlands and Australia. Specifically, the Dutch program incorporates cytology as a triage step following a positive HPV test to reduce unnecessary colposcopies, while maintaining sensitivity for clinically significant lesions (Rijkaart et al., 2012). Similarly, Australia’s National Cervical Screening Program transitioned to primary HPV screening with reflex cytology for non-HPV16/18-positive cases to improve cost-effectiveness and patient outcomes (Lew et al., 2017). Similarly, in the four countries studied by Ronco et al, for women whose initial screening was an HPV test, if the results were positive that was followed by cytology rather than colposcopy. If the cytology test was negative despite the positive HPV test, the women underwent a follow-up HPV test approximately one year later. These strategies show that cytology offers a balanced approach to triage, reducing unnecessary referrals after a positive HPV test, while maintaining detection rates.

In addition, the USPSTF draft does not sufficiently address the impact of self-collected HPV samples in real-world settings. Studies like Arbyn et al. (2014) and Polman et al. (2019) highlight logistical barriers, accuracy concerns, and the importance of robust follow-up systems.

References

Arbyn M, Verdoodt F, Snijders PJ, et al. Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis. Lancet Oncol. 2014;15(2):172-183. doi:10.1016/S1470-2045(13)70570-9

Castle PE, Kinney WK, Xue X, et al. Effect of Several Negative Rounds of Human Papillomavirus and Cytology Co-testing on Safety Against Cervical Cancer: An Observational Cohort Study. Ann Intern Med. 2018;168(1):20-29. doi:10.7326/M17-1609

Dillner J, Rebolj M, Birembaut P, et al. Long term predictive values of cytology and human papillomavirus testing in cervical cancer screening: joint European cohort study. BMJ. 2008;337:a1754. Published 2008 Oct 13. doi:10.1136/bmj.a1754

Kitchener HC, Almonte M, Gilham C, et al. ARTISTIC: a randomised trial of human papillomavirus (HPV) testing in primary cervical screening. Health Technol Assess. 2009;13(51):1-iv. doi:10.3310/hta13510

Lew JB, Simms KT, Smith MA, et al. Primary HPV testing versus cytology-based cervical screening in women in Australia vaccinated for HPV and unvaccinated: effectiveness and economic assessment for the National Cervical Screening Program. Lancet Public Health. 2017;2(2):e96-e107. doi:10.1016/S2468-2667(17)30007-5

McCredie MR, Sharples KJ, Paul C, et al. Natural history of cervical neoplasia and risk of invasive cancer in women with cervical intraepithelial neoplasia 3: a retrospective cohort study. Lancet Oncol. 2008;9(5):425-434. doi:10.1016/S1470-2045(08)70103-7

Polman NJ, Ebisch RMF, Heideman DAM, et al. Performance of human papillomavirus testing on self-collected versus clinician-collected samples for the detection of cervical intraepithelial neoplasia of grade 2 or worse: a randomised, paired screen-positive, non-inferiority trial. Lancet Oncol. 2019;20(2):229-238. doi:10.1016/S1470-2045(18)30763-0

Rijkaart DC, Berkhof J, Rozendaal L, et al. Human papillomavirus testing for the detection of high-grade cervical intraepithelial neoplasia and cancer: final results of the POBASCAM randomised controlled trial. Lancet Oncol.2012;13(1):78-88. doi:10.1016/S1470-2045(11)70296-0

Ronco G, Dillner J, Elfström KM, et al. Efficacy of HPV-based screening for prevention of invasive cervical cancer: follow-up of four European randomised controlled trials [published correction appears in Lancet. 2015 Oct 10;386(10002):1446. doi: 10.1016/S0140-6736(15)00411-0]. Lancet. 2014;383(9916):524-532. doi:10.1016/S0140-6736(13)62218-7

3. How could the USPSTF make this draft Recommendation Statement clearer?

  • USPSTF’s statement should acknowledge and take into account the psychosocial and economic impacts of unnecessary colposcopies, particularly for low-income and underserved populations.
  • UPSTF should review and include well-designed studies on invasive cancer and survival outcomes tied to HPV testing versus cytology, or clearly state that such data are unavailable or inconclusive. Detection alone is not a meaningful endpoint without demonstrated survival benefits.
  • USPSTF should provide clearer guidance on triage pathways, emphasizing cytology as the next step after a positive HPV result instead of immediate colposcopy.

4. What information, if any, did you expect to find in this draft Recommendation Statement that was not included?

  • A more comprehensive review of comparative data on invasive cancer and survival for HPV testing and cytology as primary screening strategies.
  • More nuanced recommendations for women over 65, which consider individual risk factors such as new sexual partners or immunosuppressive conditions.
  • Greater detail on the feasibility and cost-effectiveness of implementing self-collected HPV testing in the U.S. in the real world, not just in research or clinical settings, including follow-up protocols to prevent gaps in care.

5. What resources or tools could the USPSTF provide that would make this Recommendation Statement more useful to you in its final form?

The USPSTF could enhance the utility of this Recommendation Statement by providing:

  1. Decision-making algorithms or flowcharts for clinicians and patients that clearly outline the steps following various screening outcomes (e.g., HPV-positive, cytology-positive, or combined). This would be particularly helpful in reinforcing the role of cytology as a triage step before colposcopy.
  2. Cost-effectiveness analysis summaries comparing different screening strategies (e.g., HPV testing alone, Pap cytology alone, and co-testing) in terms of cancer detection, survival outcomes, and healthcare utilization.
  3. Guidance on self-collection implementation, including best practices for ensuring accuracy and follow-up care, particularly for underserved populations.
  4. Risk calculators or interactive tools to help patients better understand their individualized risk and the potential benefits or harms of different screening intervals or modalities.

6. The USPSTF is committed to understanding the needs and perspectives of the public it serves. Please share any experiences that you think could further inform the USPSTF on this draft Recommendation Statement.

From a clinical perspective, patients often express significant anxiety about abnormal HPV results, particularly when the next step involves immediate colposcopy. This underscores the need for clear communication about the low risk of invasive cancer in many HPV-positive cases and the rationale for using cytology as an intermediate triage tool. Additionally, underserved populations face barriers such as lack of follow-up after abnormal results or inadequate access to colposcopy services. Unfortunately, when patients are concerned about cost or access associated with a positive HPV test, they may delay follow-up until their condition is much worse. In such cases, the absence of robust systems for patient navigation exacerbates disparities in cervical cancer outcomes.

Based on our experiences with patients, it is especially essential to integrate follow-up protocols into any recommendations involving self-collection or HPV primary screening.

7. Do you have other comments on this draft Recommendation Statement?

Yes, there are additional points to consider:

  1. The Recommendation Statement could benefit from a stronger focus on survival outcomes rather than cancer detection alone. Current evidence does not consistently demonstrate that HPV testing translates into better survival outcomes compared to cytology. For example, the ARTISTIC trial found no significant reduction in invasive cancer rates despite increased lesion detection with HPV testing (Kitchener et al., 2009).
  2. The USPSTF should provide greater emphasis on individualized screening decisions, especially for women over 65, where risk factors like recent sexual activity or changes in immune status may necessitate continued screening despite adequate prior testing.
  3. To ensure equitable care, the Statement should explicitly address the logistical challenges of access to colposcopy and to implementing self-collected HPV testing in real-world settings, including the importance of integrating results into electronic health records (EHRs) and ensuring timely follow-up.
  4. Lastly, the draft should clarify the USPSTF’s position on triage pathways for HPV-positive results. Cytology following HPV-positive results should usually serve as an intermediate step before colposcopy, and should be described as the preferred strategy after a positive HPV because it is  more cost-effective and patient-centered.

NCHR Public Comment on Communications From Firms to Healthcare Providers Regarding Scientific Information on Unapproved Uses of Approved Medical Products

We appreciate the opportunity to comment on the FDA’s guidance: “Communications From Firms to Healthcare Providers Regarding Scientific Information on Unapproved Uses of Approved Medical Products, Questions and Answers.”

The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. Our largest program is the Cancer Prevention and Treatment Fund. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

Research indicates that off-label use of medications is common, that physicians prescribing unapproved uses often are unaware that they are doing so, that evidence of safety and efficacy are usually lacking, and that patients are often harmed by off label uses, financially and in terms of their health. That is why it is essential that the FDA provide unambiguous guidance to industry about how to provide information to healthcare providers about unapproved uses of approved medical products.

NCHR agrees with the FDA that any communication between drug firms and healthcare providers regarding scientific information on the unapproved uses of an otherwise approved medical product should be factual and unbiased. However, even when communication is based on high-quality scientific evidence, including randomized, double-blinded controlled superiority trials, the interpretation of the research results can be biased and misleading. That is why all such communication should be subject to regulatory review, as well as clear explanations by the firms to the providers that the product is not approved by the FDA for that purpose, either because the company has not provided evidence to support the off-label use, or because FDA considered any evidence that the company provided to the agency to be insufficient to warrant that off-label indication.

We agree that the FDA should reject the use of scientific communication based on case reports, early-stage development reports, or studies that lack an adequate comparison or control group, even when these limitations are disclosed. Data gathered from these types of studies are insufficient to permit a thorough clinical evaluation for the unintended use of a medical product. Moreover, since not all physicians have expertise in study design and data interpretation, providing such information could easily be misleading or misunderstood.

We strongly support FDA’s proposal to limit the use of presentations to communicate scientific information on the unapproved uses of approved medical products. Because there is rarely enough time to carefully examine the evidence in PowerPoint or other oral presentations, they are unlikely to present information in the full context needed for healthcare providers to interpret the strengths and weakness of the data provided. Presentations may also unintentionally misrepresent or manipulate results, by using figures and graphs that do not fully represent the data. Moreover, the FDA should oppose any communication that uses marketing techniques, since such techniques often unduly influence and bias the audience’s understanding of the risks and benefits of the medical product being considered. All communication should focus on the scientific facts, so that the information will be accurate and understood based on the objective evidence, and healthcare professionals can then accurately share that information with patients. That will enable patients and their providers to make well-informed decisions.

We agree with the FDA that firms should be required to provide a statement identifying that the off-label use of the medical product has not been approved by the FDA and the safety and effectiveness has not been established. A statement acknowledging any serious or life-threatening risks that may be associated with the medical product should also be included, whether the risks have been associated with the approved or unapproved uses. Additionally, a declarations and disclosures statement should be included in these communications that acknowledges investigators who contributed to the design and publication of the study and also had financial ties to the company, whether as employees, consultants, stockholders, researchers, guest speakers, or who received compensation from the firm for any reason. Declarations and disclosures will provide transparency about a financial conflict of interest or the appearance of a conflict of interest that may have affected the design, conduct, or reporting of the research. This will facilitate a healthcare provider’s accurate evaluation of the scientific information provided and awareness of any apparent conflicts of interest or bias.

Lastly, the communication standards specified in this guidance should be consistently and strongly reinforced by the FDA. We recommend that the FDA provides clear instructions encouraging clinicians to report firms that fail to comply with scientific communication standards provided in this guidance. Reporting mechanisms should be made easily accessible and user-friendly for providers and any firms in violation should be publicly reported on the FDA website. This will help ensure that firms incorporate the communication recommendations provided by the FDA and help ensure that clinicians have the information they need to make evidence-based decisions that get past the hype of promotional materials that erroneously purport to be scientific evidence. The bottom line is that transparency in the process and regarding firms that do not comply with the requirements for accuracy and transparency will help safeguard patients from ineffective and unsafe uses of medical products. Given that the FDA frequency distributes press releases to announce the approval of new medical products, it is only right that the FDA be as willing to distribute press releases when companies inappropriately promote unapproved uses or when specific unapproved uses are found to be harmful.

F.D.A. names a new chief of medical devices

Christina Jewett, The New York Times, Oct. 22, 2024


The Food and Drug Administration on Tuesday announced that Dr. Michelle Tarver, an agency veteran, will be the new director of the medical device division.

Dr. Tarver will face a slate of pressing tasks, that include addressing calls to strengthen standards to protect the public from issues like racial bias in artificial intelligence software and hastily authorized and faulty cardiac devices, like external defibrillators.

She will also confront the challenge of restoring credibility to a division clouded by ethical lapses of Dr. Jeffrey Shuren, her predecessor, and of navigating her way in an agency with close ties to the industry.

In addition, Dr. Tarver is assuming the position at a time of stunning technological advancement, overseeing research and potential approvals of devices meant to tap into brain signals to restore speech and movement.

The division reviews thousands of medical products that are central to medical diagnosis and surgery, like DNA tests and surgical staplers. Other devices are implanted in the body for decades, including pacemakers and hip prostheses. The division has a budget of about $790 million and a staff of about 2,500.

A 15-year veteran of the agency, Dr. Tarver is viewed by those inside the F.D.A. as a candidate who would sharpen the division’s focus on safety and quality. She is an ophthalmologist who continues to treat patients on the weekends, and she is also trained as an epidemiologist and has developed ways to measure patient preference in medical care.

“Dr. Tarver demonstrates a true passion about data, science, medicine and the evidence, all of which are critical to supporting and driving the F.D.A.’s decisions,” Dr. Robert Califf said in an announcement to agency staff Tuesday. “She works to build collaboration and transparency in achieving the strategic priorities for the center and the agency.”

Dr. Tarver said in a statement that she was honored to lead the division and planned to “remain committed in our service to public health and ensuring all patients in the U.S. have access to high-quality, safe and effective medical devices.”

Dr. Shuren headed the division for 15 years and has been credited with speeding the pace of approvals and solidifying the United States as a destination for medical device study and innovation. He has also been divisive, facing pressure from the start of his tenure to strengthen lax device-approval standards. Those calls have continued unabated over the years. The American Medical Association, a major doctors group, voted in 2023 on a resolution urging the agency to raise the bar on product authorizations and to more carefully monitor the safety of approved products.

 

Dr. Shuren announced his retirement in July, and the agency has said he will leave by the end of the year.

An investigation by The New York Times found that his official work had overlapped for years with that of his wife, Allison Shuren, a lawyer for major medical device companies. The F.D.A. acknowledged ethics violations, saying that Dr. Shuren should have sought authorization or stepped aside in some matters, but asserted that the lapses had not affected regulatory decisions.

In recent weeks, two lawmakers called on the inspector general of the Health and Human Services Department to investigate whether those matters were “simply an appearance of impropriety or actual inappropriate and unethical conduct.”

Before joining the agency in 2009, Dr. Tarver had been an assistant professor at the Johns Hopkins School of Medicine.

At the F.D.A., she became a medical officer in the ophthalmology unit, and then took on other roles, including working with the division’s patient engagement advisory committee.

Dr. Tarver later moved on to an F.D.A. office focused on emergency preparedness and response as well as digital health.

Maria Gmitro, president of the Breast Implant Safety Alliance, said she had been impressed with Dr. Tarver’s warmth and willingness to listen. Ms. Gmitro said she had raised concerns about whether women were aware that they received recalled breast implants that were associated with rare cases of blood cancer.

Ms. Gmitro said Dr. Tarver helped her group in a practical manner, working to open access to data on age and gender for an analyst examining reports of harm related to breast implants.

“So we are very optimistic with Dr. Tarver being in this position,” Ms. Gmitro said. “I’m hopeful about the progress that can happen.”

Diana Zuckerman, president of the National Center for Health Research, a nonprofit that tracks F.D.A. device policy, said she had found Dr. Tarver to be concerned about patient safety and “in making sure that patients understand the risks and benefits” of devices.

Scott Whitaker, president of AdvaMed, the largest device industry trade association, said the group was pleased with Dr. Tarver’s appointment.

[….]

Dr. Tarver will face skepticism from advocates for people who have had unwanted symptoms after LASIK surgery, such as distorted vision and eye pain.

Dr. Tarver was a leader in the agency’s ophthalmology division for years and played a role in F.D.A.-backed research on the procedure. Yet after more than 15 years of advocacy and an agency proposal in 2022 to strengthen warnings to prospective patients, no change has come about, said Paula Cofer, who suffered harm from LASIK and served as a patient representative on a 2008 panel on the matter.

The F.D.A. has said it is still reviewing comments submitted on the 2022 proposal. Among its opponents are clients of Dr. Shuren’s wife, which include a group of prolific laser surgeons and a company that makes LASIK lasers.

“She’s been involved in LASIK device policy at the agency for what, 15 years, and during this time, the agency has failed to act on evidence of high rates of harm to the public due to LASIK devices,” Ms. Cofer said. “This is just not passing the smell test.”

To read the entire New York Times article, click here.

High Levels of Toxic Flame Retardants Found in Toys, Kitchen Utensils Made From Black Plastic

Researchers found flame retardants, linked to carcinogenicity, endocrine disruption, neurotoxicity, and reproductive harm, in toys, take-out containers and kitchen utensils made from black-colored plastic.

Michael Nevradakis Ph.D., The Defender, October 2, 2024

This article was originally published by The Defender — Children’s Health Defense’s News & Views Website.


Some common household products made from black-colored plastic — including toys, take-out food containers and kitchen utensils — contain high levels of toxic flame retardants, according to a study published Tuesday in the journal Chemosphere.

The contamination stems from the improper recycling of electronic products like televisions, whose casings are made from black plastic. When plastic casings containing flame retardants are mixed with other plastics during recycling, the contaminants make their way into the end product.

Toxic-Free Future and the Amsterdam Institute for Life and Environment conducted the study.

Megan Liu, science and policy manager for Toxic-Free Future, told The Defender:

“These flame retardants are hazardous because they are associated with a range of negative health effects, including carcinogenicity, endocrine disruption, neurotoxicity, and reproductive harm.

“The findings of flame retardants in children’s toys are of particular concern, because flame retardants have been found to leach from toys into children’s saliva.”

The researchers examined 203 products manufactured from black-colored plastics. They screened the products for bromine, a man-made chemical used in flame retardants.

Products containing 50 parts per million of bromine were further analyzed for the presence of brominated flame retardants, organophosphate flame retardants and plastic polymers.

The results showed that toxic flame retardants were present in 85% of the products analyzed, with concentrations reaching 22,800 milligrams per kilogram The contaminants detected included decabromodiphenyl ether, or decaBDE, a compound commonly used in the casings of electronics before the U.S. Environmental Protection Agency (EPA) banned it in 2021.

 

One compound, decabromodiphenyl ether, or BDE-209, was commonly found in black-colored plastic kitchen utensils at an average level of 34,700 nanograms per day, “exceeding estimates for intake from dust and diet.”

A 2014 study published in the journal Frontiers in Genetics found that BDE-209 has highly carcinogenic effects on humans.

Other contaminants detected include compound 2,4,6-tribromophenol, which has been detected in human breast milk, according to a 2023 study published in the journal Environmental Pollution.

According to a study published by JAMA Network Open in April, people with high concentrations of polybrominated diphenyl ethers or PBDE, a common flame retardant, are approximately 300% more likely to die from cancer compared to people with the lowest levels. DecaBDE belongs to this category of flame retardants.

Dr. Leonardo Trasande, a professor of pediatrics and population health at NYU Langone Health, told CNN that brominated flame retardants are of particular concern due to high levels of toxic contaminants that can remain in the human body for years.

“I’m not aware of any safe level of brominated flame retardants,” Trasande said. Earlier this year, Trasande co-authored a study, published in the Journal of the Endocrine Society, finding that such contaminants cost the U.S. healthcare system up to $249 billion in 2018 alone.

‘Mistakes in the recycling of electronic waste’ are behind widespread contamination

According to the Toxic-Free Future study, the presence of toxic flame retardants in a wide range of household and commercial products “indicates that recycling, without the necessary transparency and restrictions to ensure safety, is resulting in unexpected exposure to toxic flame retardants in household items.”

“Flame retardants are a highly hazardous class of chemicals, but they are still allowed for use in products like electronics, and as a result of dirty electronic-waste recycling, we’re seeing flame retardants appear in unexpected products, like our kitchen utensils, food service ware, and hair accessories,” Liu said.

Diana Zuckerman, Ph.D., president of the National Center for Health Research, told The Defender that the findings of this study are “worrying” and reflect the need for better regulation of plastic recycling and toxins in plastics.

Zuckerman said:

“It’s become increasingly obvious that the public has been misled about the effectiveness and safety of recycling plastics and it is no longer possible to trust the information that we’ve been given, most of which comes from industry.

“For that reason, the FDA [U.S. Food and Drug Administration] and EPA need to scrutinize the safety of all plastic products used with foods, instead of the vague reassurances the agencies have been offering.”

According to Liu, the study focused on black-colored plastic “because we hypothesized that the black plastic used for television casings and electronic enclosures, which flame retardants are intentionally added to, were being recycled into non-electronic, household products.”

 

The study noted that the styrene-based plastics typically used in the casings of electronics contained “significantly higher levels” of toxic flame retardants, compared to plastics like polypropylene and nylon, which are less frequently used for such casings.

“It appears the plastics used to make the consumer products were contaminated with flame retardants due to mistakes in the recycling of electronic waste,” Liu told CNN.

The study focused on items such as kitchen utensils and toys “because of high-risk exposure concerns” and frequent use by children, Liu said:

“Kitchen utensils are things we use on a regular, maybe even daily basis, and studies have shown that flame retardants can leach out of kitchen utensils into our food.

“Children also play with toys for extended periods of time, so it’s important to think about the compounded exposures we might be getting from these products, as well as other products that may contain flame retardants, when thinking about how this is affecting people, especially vulnerable populations like children.”

Liu separately told CNN that studies specifically testing food contact materials, such as black plastic kitchen utensils or take-out containers, hadn’t previously been conducted.

According to the study, lax regulation in the U.S. has helped contribute to the widespread contamination:

“A lack of transparency related to chemicals in products and limited restrictions on use of FRs [flame retardants] in electronics have led to widespread use and dissemination of harmful FRs.

“Despite the lack of transparency and restrictions, plastics from electronics are often recycled and can be incorporated in household items that do not require flame retardancy, resulting in potentially high and unnecessary exposure.”

For instance, Liu told CNN that decaBDE was found in 70% of the samples tested in the study, at levels up to 1,200 times higher than the European Union’s limit of 10 parts per million. The contamination persists despite the EPA’s ban on decaBDE in 2021.

According to CNN, decaBDE is linked to “cancer, endocrine and thyroid issues, fetal and child development and neurobehavioral function and reproductive and immune system toxicity.”

High levels of toxic flame retardants found in toys, sushi trays

Aside from their use in casings for electronics, flame retardants are also commonly used in furniture, car upholstery, infant car seats, carpet padding, foam-padded yoga mats and padded baby items, according to the National Institute of Environmental Health Sciences.

These flame retardants can “leach from products into the air and then attach to dust, food, and water, which can be ingested,” the institute noted.

But according to the study, toxic flame retardants can be found in many more items commonly found in homes — including children’s toys.

Liu told CNN, “A product with one of the highest levels of flame retardants were black plastic pirate coin beads that kids wear.” This product had up to 22,800 parts per million of total flame retardants, which Liu said was “almost 3% by weight.”

Another product identified as highly contaminated were black plastic sushi trays. Liu told CNN such items contain 11,900 parts per million of decaBDE.

 

Calls for stronger regulations against toxic contaminants in plastics

Liu told The Defender the latest findings demonstrate the need for stronger regulations on hazardous chemicals and materials entering the recycling stream. She said she is unaware of any such regulations in the U.S.

“What we need is our state and federal government, along with retailers, to ban these harmful chemicals and materials,” Liu said. “We need policy and market change to increase the transparency of what’s being used in the supply chain, including for recycled materials, as well as require the use of safer solutions.”

“Taking these steps and turning off the tap on toxic chemicals and plastics will help protect the health of women and children,” Liu said.

She noted that the study’s results were published “at a critical time when leaders around the world are negotiating a Global Plastics Treaty.”

The proposed treaty has a stated goal of ending “plastic pollution by 2040 through a circular economy where all plastics are responsibly managed during production, use, and end-of-life, enabling a climate-neutral plastics industry.”

The ongoing negotiations for this treaty come two years after the United Nations Environment Assembly passed a resolution, endorsed by 175 nation states, to end plastic pollution. The resolution calls for the completion of a legally binding international treaty by the end of 2024.

Such a treaty “will chart a course for how quickly and effectively the plastics crisis is addressed,” Liu said.

In the meantime, Liu suggested people “reduce any uses of plastics,” including replacing plastic kitchen utensils “with safer options, like wood or stainless steel.” Plastic containers should be replaced with glass containers.

“When possible, choosing plastic-free when purchasing any item can help reduce your overall exposure to harmful additives in plastic,” Liu said.

Regular cleaning and ventilating will also help “clear out any flame retardants accumulating in dust or air,” as will “frequent handwashing, regular wet-dusting and mopping, and vacuuming,” Liu added.

Zuckerman advised the public not to “microwave food in any kind of plastic,” adding that “we’ve been advising that for well more than a decade.”

“But the onus shouldn’t fall onto consumers,” Liu said. “We can’t shop our way out of this problem. We need policies that restrict the use of the most hazardous chemicals and plastics at the corporate and government level.”

Zuckerman said it’s “unrealistic to offer advice to individual consumers because the information we need is not currently available.”

“What we all need is independent research, scrutiny and oversight to take unsafe products off the market.”

This article was originally published by The Defender — Children’s Health Defense’s News & Views Website under Creative Commons license CC BY-NC-ND 4.0. 

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CPTF Testimony in Support of HB1147 for the Maryland House of Delegates Environment and Transportation Committee

February 28, 2024

Dear Chair Korman, Vice Chair Boyce and Committee Members:

Thank you for this opportunity to express the views of the National Center for Health Research (NCHR) in strong support of HB1147.

I have lived in Montgomery County for over 30 years and been president of NCHR for 25 years.  I am a scientist trained in epidemiology and public health, and NCHR is a nonprofit think tank 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.

I am writing to share scientific information about the risks posed by certain playground surfaces that I have provided to Members of Congress, federal agencies, state and local legislators, parents, and others who want to ensure that our children are not exposed to dangerous chemicals when they play on playgrounds.

We understand that these issues are hotly debated, but some information is more accurate than others. For example, although PIP (poured in place) playground surfaces are attractive and seem safe if children fall, they are made with recycled tire crumb. After a few years, the top layer of rubber will wear off (especially in places where children are most active, such as the bottom of a slide or swing).  The material underneath the top layer is typically granular and will seem quite interesting to small children, who will play with it and put it in their mouths and pockets – sometimes even up their noses.

In the last few years, scientists have learned more about lead, other heavy metals, and PFAS in various playground surfaces. Playground surfaces of loose tire crumb is especially dangerous, but the tire crumb beneath the top PIP rubber layer as well as the synthetic rubber surface has well-known risks, containing chemicals that have the potential to increase obesity; contribute to early puberty; cause attention problems such as ADHD; exacerbate asthma; and eventually cause cancer. When PFAS is in playground surfaces that is of particular concern because they enter the body and the environment as “forever chemicals,” which means that they are not metabolized and do not deteriorate, instead building up in a child’s body over the years. Recent research indicates that PFAS can cause liver damage and other serious health problems. PFAS from playground surfaces can also get into ground water, streams, etc. and from there into drinking water.

Federal agencies such as the Environmental Protection Agency (EPA) and the U.S. Consumer Product Safety Commission have been investigating the safety of these products, and I was recently a featured speaker at a national meeting of the Centers for Disease Control and Prevention (CDC) in Atlanta (https://www.center4research.org/zuckerman-speech-cdc-clppp-2023-meeting/ ) talking about the lead and other chemicals in tire crumb and PIP.

Lead

Lead can cause cognitive damage even at low levels. I’m sure you know that the American Academy of Pediatrics warns that no level of lead is safe, and the lead in tire crumb and lead dust on playgrounds is especially unsafe because it will get on children’s hands and clothing, and they will breathe it in their mouth and lungs when they play.  Some children are more vulnerable than others, and that can be difficult or even impossible to predict. Since lead has been found in recycled SBR rubber, it is not surprising that numerous playground surfaces made with either tire crumb or PIP have been found to contain lead. However, the lead doesn’t just stay on the surface. With wear, the materials turn to dust containing lead and other chemicals that is invisible to the eye and is inhaled by children when they play.

Hormone-Disrupting Chemicals

Why are chemicals that are banned from children’s toys allowed in areas used by children such as artificial turf and rubber playground surfaces?  Synthetic rubber and plastic are made with different types of endocrine (hormone) disrupting chemicals (also called EDCs). There is very good evidence regarding these chemicals in tire crumb used in PIP and artificial turf, based on studies done at Yale and by the California Office of Environmental Health Hazard Assessment.[1] Rubber playground surfaces like EPDM contain many of the same dangerous chemicals as tire crumb, since they are very similar materials, all made from petroleum.

A 2018 report by Yale scientists detected 92 chemicals in recycled tire crumb samples from 6 different companies. 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 indicating that endocrine-disrupting chemicals (also called hormone-disrupting chemicals) found in rubber cause serious health problems. Scientists at the National Institute of Environmental Health Sciences (which is part of NIH) 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 playground surfaces.

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, endocrine-disrupting chemicals 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 starting 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.

Scientific Evidence of Cancer and Other Systemic Harm

It is essential to distinguish between evidence of harm and evidence of safety. Companies that sell and install PIP 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.

It is true that there is no clear evidence that a PIP playground has caused specific children to develop cancer. However, the industry’s 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 publicly available evidence that cigarettes or Agent Orange caused cancer. It took many years to develop that evidence, and the same will be true for playground surfaces.

We know that the materials being used in rubber playground surfaces contain carcinogens, and when children are exposed to those carcinogens day after day, week after week, and year after yearthey 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 Maryland. That’s why I have spoken out about these risks in my community and on the state and national level. The question must be asked: if they had all the facts, would Maryland communities choose to spend millions of dollars on playgrounds that are less safe than those made with engineered wood fiber?

I have testified about the risks of playground surface materials at the U.S. Consumer Product Safety Commission, the CDC, and EPA as well as state legislatures and city councils. I am sorry to say that I have repeatedly seen and heard scientists and lobbyists paid by the recycled rubber industry say things that are absolutely false. They claim that these products are proven safe (not true) and that federal agencies have stated there are no health risks (also not true). They also claim that the products do not contain PFAS or lead, but independent researchers find those claims are also false.

Dangerously Hot

Children enjoy playing in warm and sunny weather –but even when the temperature above the grass is 80 degrees Fahrenheit, we have found that rubber playground surfaces in Maryland can reach 150 degrees or higher. A sunny 90-degree day is likely to be even hotter than 160 degrees on these surfaces. These temperatures can cause “heat poisoning” as well as burns.

Alternative Playground Surfaces

Engineered wood fiber products are a safe material for playground surfaces and are ADA compliant. Don’t be fooled by other wood products, such as BrockFILL, which has been scientifically tested and found to contain PFAS, the “forever chemicals.” In addition, the Brock shock pad also tested positive to PFAS.

Conclusions

There have never been any safety tests required prior to sale that prove that synthetic playground surfaces are safe for children who play on them regularly. In many cases, the materials used are not publicly disclosed, making independent research difficult to conduct. None of these products are proven to be as safe as engineered wood fiber.

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 on our children of chemicals and heavy metals in currently used playground surfaces.

Your support for this legislation can save lives and improve the health of children in communities throughout Maryland.

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

That is why we urge this committee to give HB1147 a favorable report.  Thank you for considering our views.

Sincerely,

Diana Zuckerman, Ph.D.

President

References

  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. Benoit G, Demars S. Evaluation of organic and inorganic compounds extractable by multiple methods from commercially available crumb rubber mulch. Water, Air, & Soil Pollution. 2018;229:64.https://doi.org/10.1007/s11270-018-3711-7
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Deep flaws in FDA oversight of medical devices — and patient harm — exposed in lawsuits and records

Fred Schulte & Holly K. Hacker, KFF HEALTH NEWS, ON CBSNEWS.COM, December 20, 2023


Living with diabetes, Carlton “PeeWee” Gautney Jr. relied on a digital device about the size of a deck of playing cards to pump insulin into his bloodstream.

The pump, manufactured by device maker Medtronic, connected plastic tubing to an insulin reservoir, which Gautney set to release doses of the vital hormone over the course of the day. Gautney, a motorcycle enthusiast, worked as a dispatcher with the police department in Opp, Alabama.

The 59-year-old died suddenly on May 17, 2020, because — his family believes — the pump malfunctioned and delivered a fatal overdose of insulin.

“There’s a big hole left where he was,” said Gautney’s daughter, Carla Wiggins, who is suing the manufacturer. “A big part of me is missing.”

The wrongful-death lawsuit alleges the pump was “defective and unreasonably dangerous.” Medtronic has denied the pump caused Gautney’s death and filed a court motion for summary judgment, which is pending.

The pump Gautney depended on was among more than 400,000 Medtronic devices recalled, starting in November 2019, after the company said in a recall notice that damage to a retainer ring on the pump could “lead to an over or under delivery of insulin,” which could “be life-threatening or may result in death.”

As the recall played out, federal regulators discovered that Medtronic had delayed acting — and warning patients of possible hazards with the pumps — despite amassing tens of thousands of complaints about the rings, government records show.

Over the past year, KFF Health News has investigated medical device malfunctions including:

  • Artificial knees manufactured by a Gainesville, Florida, company that remained on the market for more than 15 years despite packaging issues that the company said could have caused more than 140,000 of the implants to wear out prematurely.
  • Metal hip implants that snapped in two inside patients who said in lawsuits that they required urgent surgery.
  • Last-resort heart pumps that FDA records state may have caused or contributed to thousands of patient deaths.
  • And even a dental device, used on patients without FDA review, that lawsuits alleged has caused catastrophic harm to teeth and jawbones. CBS News co-reported and aired TV stories about the hip and dental devices.

The investigation has found that most medical devices, including many implants, are now cleared for sale by the FDA without tests for safety or effectiveness. Instead, manufacturers must simply show they have “substantial equivalence” to a product already in the marketplace — an approval process some experts view as vastly overused and fraught with risks.

“Patients believe they are getting an implant that’s been proven safe,” said Joshua Sharlin, a former FDA official who now is a consultant and expert witness in drug and medical device regulation. “No, it hasn’t,” Sharlin said.

And once those devices reach the marketplace, the FDA struggles to track malfunctions, including deaths and injuries — while injured patients face legal barriers trying to hold manufacturers accountable for product defects.

In a statement to KFF Health News, the FDA said it “has a scientifically rigorous process to evaluate the safety and effectiveness of medical devices.”

“Too little, too late”

The FDA approved the MiniMed 670G insulin pump on Sept. 28, 2016, after its most stringent safety review, a little-used process known as premarket approval.

In a news release that day, Jeffrey Shuren, who directs the FDA’s Center for Devices and Radiological Health, lauded the device as a “first-of-its-kind technology” that would give patients “greater freedom to live their lives” and to monitor and dispense insulin as needed. The pump was tested on 123 patients in a clinical trial over several months with “no serious adverse events,” the release said. Shuren declined to be interviewed.

The FDA’s enthusiasm didn’t last. In November 2019, Medtronic, citing the ring problem, launched an “urgent medical device recall” of the pumps, which it expanded in late 2021.

During an inspection at Medtronic’s plant in Northridge, California, FDA officials learned the company had logged more than 74,000 ring complaints between 2016 and the November 2019 recall. More than 800 complaints weren’t investigated at all, according to the FDA, which sharply criticized the company in a December 2021 warning letter.

Medtronic is facing more than 60 lawsuits filed by injured patients and their families and the company believes it may be hit with claims for damages from thousands more patients, the company disclosed in an August Securities and Exchange Commission filing.

Medtronic pumps that allegedly dispensed too much, or too little, insulin have been blamed for contributing to at least a dozen patient deaths, according to lawsuits filed since 2019. Some cases have been settled under confidential terms, while others are pending or have been dismissed. Medtronic has denied any responsibility in response to the lawsuits.

In one pending case, a Las Vegas man using the pump allegedly fell into an “insulin-induced coma” that led to his death in 2020. In another 2020 case, a 67-year-old New Jersey resident collapsed at her home, dying later the same day at a local hospital.

The recall notice Medtronic sent to a 43-year-old Missouri man’s home arrived a few days after police found him dead on his bedroom floor, his family alleged in a lawsuit filed in August. “Simply too little, too late,” the suit reads. The case is pending, and Medtronic has yet to file an answer in court.

Medtronic declined to answer written questions from KFF Health News about the pumps and court cases. In an emailed statement, the company said it replaced pump rings with new ones “redesigned to reduce the risk of damage” and “fulfilled all pump replacement requests at no cost to customers.”

In April, Medtronic announced that the FDA had lifted the warning letter a few days after it approved a new version of the MiniMed pump system.

Shortcut to market

The 1976 federal law that mandated safety testing for high-risk medical devices also created a far easier — and less costly — pathway to the marketplace. This process, known as a 510(k) clearance, requires manufacturers to show a new device they plan to sell has “substantial equivalence” to one already on the market, even if the prior product has been recalled.

Critics have worried for years that the 510(k)-approval scenario is too industry-friendly to protect patients from harm.

In July 2011, an Institute of Medicine report concluded that 510(k) was “not intended to evaluate the safety and effectiveness of medical devices” and said “a move away from the 510(k) clearance process should occur as soon as reasonably possible.”

More than a decade later, that hasn’t happened, even amid mounting controversy over the clearance of hundreds of devices that employ artificial intelligence.

The FDA now clears about 3,000 low- to moderate-risk devices every year through 510(k) review, which costs the device maker a standard FDA fee of about $22,000. That compares with about 30 approvals a year through the stricter premarketing requirements, which cost nearly $500,000 per device, according to FDA data. Diana Zuckerman, president of the National Center for Health Research, said even many doctors don’t realize devices cleared for sale typically have not undergone clinical trials to establish their safety.

“Doctors are shocked to learn this,” she said. “Patients aren’t going to know it when their doctors don’t.”

In response to written questions from KFF Health News, the FDA said it “continues to believe in the merits of the 510(k) program and will continue to work to identify program improvements that strengthen the safety and effectiveness of 510(k) cleared devices.” The FDA keeps a tight lid on data showing which devices manufacturers choose to demonstrate substantial equivalence — what the agency refers to as “predicate” devices.

“We can’t get detailed data,” said Sandra Rothenberg, a researcher at the Rochester Institute of Technology. “It’s very hard for researchers to determine the basis on which substantial equivalence is being made and to analyze if there are problems.”

Rothenberg cited the history of “metal-on-metal” artificial hip implants, which under 510(k) spawned many new brands — along with a disastrous toll of patient injuries. The implants could release metal particles that damaged bone and led to premature removal and replacement, a painful operation. Just four of these hip devices have been the target of more than 25,000 lawsuits seeking damages, court records show. In early 2016, the FDA issued an order requiring safety testing before approving new metal-on-metal hip devices.

Alarm bells

Two former Medtronic sales executives in California argue in a whistleblower lawsuit that the 510(k) process can be abused.

According to the whistleblowers, the FDA approved the Puritan Bennett 980, or PB 980, ventilator in 2014 based on the assertion it was substantially equivalent to the PB 840, an earlier mechanical ventilator long viewed as the workhorse of the industry.

Medtronic’s subsidiary company Covidien made its claim even though the device has completely different “guts” and operates using software and other “substantially different” mechanisms, according to the whistleblowers’ suit.

In response, Medtronic said it “believes the allegations are without merit and has moved to dismiss the case.” The case is pending.

The whistleblowers argue the PB 980 ventilator was plagued by dangerous malfunctions for years before its recall in late 2021.

One ventilator billowed smoke in an intensive care unit while the whistleblowers were told by one hospital that “the wheels for the ventilator cart may actually fall off the ventilator during transport,” according to the suit.

Batteries could die without warning, kicking off a scramble to keep patients alive; monitor screens froze up repeatedly or otherwise went on the blink; and, in several cases, alarm bells warning of a patient emergency rang continuously and could be quieted only by unplugging the unit from the wall socket and pulling out its batteries, according to the suit.

The December 2021 recall of the PB 980 cited a “manufacturing assembly error” that the company said may cause the ventilator to become “inoperable.”

Medtronic said in an email that the ventilator “has helped thousands of patients around the world,” including playing a “critical role in the global response to the COVID-19 pandemic.”

Late warnings

The FDA operates a massive database, called MAUDE, to alert regulators and the public to emerging device dangers. The FDA requires manufacturers to advise the agency when they learn their device may have caused or contributed to a death or serious injury, or malfunctioned in a way that might recur and cause harm. These reports must be submitted within 30 days unless a special exemption is granted.

But FDA officials acknowledge that many serious adverse events go unreported — just how many is anybody’s guess.

Since 2010, the FDA has cited companies more than 5,000 times for not handling, reviewing, or investigating complaints properly, or for not reporting adverse events on time. For instance, the FDA cited an Ohio company that made electric beds and other devices more than 15 times for failing to properly scrutinize complaints or report adverse events, including the death of a patient who allegedly became trapped between a bedrail and mattress, agency records show.

In about 10% of reports, more than a year or two elapsed from when a death or serious injury occurred and when the FDA received the reports, a KFF Health News analysis found. That works out to nearly 60,000 delayed reports a year.

Experts and lawmakers say the FDA needs to find a way to detect safety problems quicker.

Sens. Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) have tried for years to persuade the agency to add unique device identifiers to Medicare payment claim forms to help track products that fail. In an email statement to KFF Health News, Grassley called that a “commonsense step we can take up front to mitigate risk, improve certainty and save money later.”

The FDA said it is working to “strike the right balance between assuring safety and fostering device innovation and patient access.” Yet it noted: “Additional resources are required to establish a fully functioning active surveillance system for medical devices.” For now, injured patients suing device companies often cite the volume of adverse event reports to MAUDE, or FDA citations for failing to report them, to bolster claims that the company knew about product malfunctions but failed to correct them.

In one case, a New York man is suing manufacturer Boston Scientific, claiming injuries from a device called the AMS 800 that is used to treat stress urinary incontinence.

Though Boston Scientific says on its website that 200,000 men have been treated successfully, the lawsuit argues complaints piled up in MAUDE year after year and no action was taken — by the company or by regulators.

The number of complaints filed soared from six in 2016 to 2,753 in 2019, according to the suit. By far, the largest category involved incontinence, the condition the device was supposed to fix, according to the suit. Boston Scientific did not respond to a request for comment. The company has filed a motion to dismiss the case, which is pending.

By the FDA’s own count, more than 57,000 of some 74,000 complaints Medtronic received about the MiniMed insulin pump’s retainer rings were reported to the agency. The FDA said the complaints “were part of the information that led to the compliance actions.” The agency said it “approved design and manufacturing changes to the retainer ring to correct this issue” and “has reviewed information confirming the effectiveness of the modification.”

“What is the threshold for the FDA to step in and do something?” said Mara Schwartz, who is a nurse, diabetes educator, and pump user. “How many deaths or adverse events does there have to be?”

In 2020, she sued Medtronic, alleging she suffered seizures when the pump mistakenly delivered an overdose of insulin. Medtronic denied her claims, and the case has since been settled under confidential terms.

Private eyes

Some countries don’t trust the device industry to play such a key role in oversight.

Australia and about a dozen other nations maintain registries that measure the performance of medical devices against competitors, with an eye toward not paying for care for a substandard device.

That’s not likely to happen in the United States, where no device or drug manufacturer must demonstrate its new product is better than what’s already for sale.

Product liability lawsuits in the U.S. often cite troubling findings from overseas. For instance, registries in Australia and other countries pinpointed durability problems with the Optetrak knee implants manufactured by Florida device company Exactech years before a major recall. Exactech has declined comment.

The Australian surveillance network also detected deficiencies with the Medtronic PB 980 ventilator, prompting the country’s health authority to suspend its use for six months until Medtronic completed training for health care workers and took other steps to improve it, court records show. Medtronic told KFF Health News that it had “worked closely” with the Australian group to resolve the problems. “We take patient safety very seriously and have processes to identify quality issues and determine appropriate actions,” Medtronic said.

Registries have gained some traction in America. But so far, they typically have been controlled, and sometimes funded, by industry and medical specialty groups that share their findings only with doctors.

One private registry managed by the Society of Thoracic Surgeons, called Intermacs, tracks death and injury rates at 180 hospitals in the United States certified to implant a mechanical heart pump known as an LVAD. Some patients might find that information helpful, but it’s not available to them.

“Exciting features”

While the FDA clears thousands of devices for use based on the “substantial equivalence” premise, manufacturers often tout “new and exciting features” in their advertising and other marketing, said Alexander Everhart, a researcher at the Washington University School of Medicine in St. Louis.

These marketing campaigns have long been controversial, especially when they rely partly on wining and dining surgeons and other medical professionals to gain new business, or when surgeons have financial ties to manufacturers whose products they use. Orthopedic device makers have funneled billions of dollars to surgeons, including fees for consulting, doing medical research, or royalties for their role in fine-tuning surgical tools and techniques, even promoting the products to their peers.

Marketing campaigns directed at prospective patients may receive little scrutiny. The FDA has “limited resources to actively monitor the volume of direct-to-consumer advertising,” according to a Government Accountability Office report issued in September. From 2018 to 2022, the FDA took 255 enforcement actions involving advertising claims made for devices, according to the GAO report.

Legal barriers

While manufacturers can advertise devices directly to patients, courts may not hold them accountable for communicating possible risks to patients.

Consider the case of Richard Greisberg, a retired electronics business owner in New Jersey. He sued Boston Scientific in 2019, years after having a Greenfield vena cava filter implanted. The device is intended to prevent blood clots that develop in the lower body from traveling into the lungs, which can be deadly.

Greisberg argued that the device had migrated in his body, causing pain and other symptoms and damage that took years to identify. Representing himself in court, he tried to argue that nobody had told him that could happen and that if they had done so he wouldn’t have agreed to the procedure.

He lost when the judge cited a legal doctrine called “learned intermediary.” The doctrine, which is recognized in many states, holds that manufacturers must warn only physicians, who are presumed to have the knowledge to understand a medical device’s risks and relay them to patients.

The court ruled that a 27-page manual the manufacturer sent to the physician who implanted it, which included details about possible risks, was adequate and tossed the case.

Greisberg, 81, felt sucker-punched. “They never gave me any warning about what could happen down the road,” he said in an interview. “I never had a chance to have my day in court.”

The family of PeeWee Gautney also faces challenges pursuing the insulin pump lawsuit.

Gautney died in a motel room in Destin, Florida, a day after riding his Harley-Davidson to the Panhandle beach town on a weekend jaunt. The MiniMed pump was still strapped to his body, according to a police report.

Medtronic had sent Gautney a form letter in late March 2020, less than two months before he died, advising him to make sure the ring was locking in place correctly. A week later, he wrote back, telling the company: “It’s fine right now,” court records show.

Wiggins, 33, his daughter, who is also a neonatal respiratory therapist, said she believes a crack in the retainer ring caused it to release too much insulin, which her dad may not have recognized.

“It should never be put on the patient to determine if there is a problem,” Wiggins said.

Medtronic has denied the pump failed and caused Gautney’s death. The FDA approved the device knowing patients faced the risk of it administering wrong doses, but believed the benefits outweighed these risks, Medtronic argued in a motion for summary judgment in September. The motion is pending.

Medtronic also cited a legal doctrine holding that Congress granted the FDA sole oversight authority over devices receiving premarket approval, which preempts any product defect claims brought under state laws. Manufacturers have drawn on the preemption defense to sidestep liability for patient injuries, and often win dismissal, though federal courts are split in applying the doctrine.

Wiggins hopes to beat those odds, arguing that the December 2021 FDA warning letter reveals that Medtronic violated safety and manufacturing standards.

Her lawyer, Scott Murphy, said that insulin pumps are “really wonderful” devices for people with diabetes when they work right. He argues that the FDA records confirm that Medtronic significantly downplayed its pump’s hazards.

“The risks get minimized and the benefits exaggerated,” he said.

To read the original article with photos, click here.