Peer-Reviewed Publications
The list on this page includes selected first-author and senior-author publications. A more comprehensive list of publications is available at this NCBI PubMed profile and this Google Scholar profile.
Biomedical Technologies: Drugs, Devices, AI, and Cybersecurity
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Abstract
Large language models (LLMs) show considerable promise for clinical decision support (CDS) but none is currently authorized by the Food and Drug Administration (FDA) as a CDS device. We evaluated whether two popular LLMs could be induced to provide device-like CDS output. We found that LLM output readily produced device-like decision support across a range of scenarios, suggesting a need for regulation if LLMs are formally deployed for clinical use.
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On February 21, 2024, Change Healthcare, a data processing firm owned by UnitedHealth Group, was the target of a cyberattack by the ransomware group ALPHV Black Cat. An active ransomware operation, ALPHV Black Cat is thought to also be behind a 2021 attack on Colonial Pipeline that disrupted the nationwide fuel supply chain. In the wake of the attack on Change Healthcare, hundreds of thousands of physician practices, hospitals, and pharmacies were unable to submit claims or receive payments. With the weeks-long paralysis and ponderous shift to alternative protocols, many facilities found themselves unable to deliver care and facing financial collapse.
So, what exactly does Change Healthcare do within the health care ecosystem? How did a cyberattack on one segment of a single company incapacitate large parts of the US health care system? And what can we learn from this disruption about the vulnerabilities of the health care system?
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Importance Integration of pharmacies with physician practices, also known as medically integrated dispensing, is increasing in oncology. However, little is known about how this integration affects drug use, expenditures, medication adherence, or time to treatment initiation.
Objective To examine the association of physician-pharmacy integration with oral oncology drug expenditures, use, and patient-centered measures.
Design, Setting, and Participants This cohort study used claims data from a large commercial insurer in the US to analyze changes in outcome measures among patients treated by pharmacy-integrating vs nonintegrating community oncologists in 14 states between January 1, 2011, and December 31, 2019. Commercially insured patients were aged 18 to 64 years with 1 of the following advanced-stage diagnoses: breast cancer, colorectal cancer, kidney cancer, lung cancer, melanoma, or prostate cancer. Data analysis was conducted from May 2023 to March 2024.
Exposure Treatment by a pharmacy-integrating oncologist, ascertained by the presence of an on-site pharmacy or nonpharmacy dispensing site.
Main Outcomes and Measures Oral, intravenous (IV), total, and out-of-pocket drug expenditures for a 6-month episode of care; share of patients prescribed oral drugs; days’ supply of oral drugs; medication adherence measured by proportion of days covered; and time to treatment initiation. The association between an oncologist’s pharmacy integration and each outcome of interest was estimated using the difference-in-differences estimator.
Results Between 2012 and 2019, 3159 oncologists (745 females [27.1%], 2002 males [72.9%]) treated 23 968 patients (66.4% female; 53.4% aged 55-64 years). Of the 3159 oncologists, 578 (18.3%) worked in practices that integrated with pharmacies (with a low rate in 2011 of 0% and a high rate in 2019 of 31.5%). In the full sample (including all cancer sites), after physician-pharmacy integration, no significant changes were found in oral drug expenditures, IV drug expenditures, or total drug expenditures. There was, however, an increase in days’ supply of oral drugs (5.96 days; 95% CI, 0.64-11.28 days; P = .001). There were no significant changes in out-of-pocket expenditures, medication adherence, or time to treatment initiation of oral drugs. In the breast cancer sample, there was an increase in oral drug expenditures ($244; 95% CI, $41-$446; P = .02) and a decrease in IV drug expenditures (–$4187; 95% CI, –$8293 to –$80; P = .05).
Conclusions and Relevance Results of this cohort study indicated that the integration of oncology practices with pharmacies was not associated with significant changes in expenditures or clear patient-centered benefits. description
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With the debut of ChatGPT, clinicians and health systems are embracing a brainy, fluent colleague eager to assist with some of the most thankless tasks in medicine….
All technological advancements, however, come with uncertainty and risk, especially if they are medical technologies handling protected health information (PHI). And although there are many risks associated with the deployment of AI in medicine, the risk to patient privacy posed by AI chatbots presents unique challenges…
Although the ease of pasting medical information into a chat interface is tempting, clinicians and health systems could unintentionally violate HIPAA and incur substantial fines and penalties with chatbot queries.
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ABSTRACT
PURPOSE:
The integration of pharmacies with oncology practices—known as medically integrated dispensing or in-office dispensing—could improve care coordination but may incentivize overprescribing or inappropriate prescribing. Because little is known about this emerging phenomenon, we analyzed historical trends in medically integrated dispensing.
METHODS:
Annual IQVIA data on oncologists were linked to 2010-2019 National Council for Prescription Drug Programs pharmacy data; data on commercially insured patients diagnosed with any of six common cancer types; and summary data on providers' Medicare billing. We calculated the national prevalence of medically integrated dispensing among community and hospital-based oncologists. We also analyzed the characteristics of the oncologists and patients affected by this care model.
RESULTS:
Between 2010 and 2019, the percentage of oncologists in practices with medically integrated dispensing increased from 12.8% to 32.1%. The share of community oncologists in dispensing practices increased from 7.6% to 28.3%, whereas the share of hospital-based oncologists in dispensing practices increased from 18.3% to 33.4%. Rates of medically integrated dispensing varied considerably across states. Oncologists who dispensed had higher patient volumes (P < .001) and a smaller share of Medicare beneficiaries (P < .001) than physicians who did not dispense. Patients treated by dispensing oncologists had higher risk and comorbidity scores (P < .001) and lived in areas with a higher % Black population (P < .001) than patients treated by nondispensing oncologists.
CONCLUSION:
Medically integrated dispensing has increased significantly among oncology practices over the past 10 years. The reach, clinical impact, and economic implications of medically integrated dispensing should be evaluated on an ongoing basis.
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ABSTRACT
The coronavirus disease 2019 (COVID-19) pandemic has highlighted the importance of intensive care unit (ICU) beds in preventing death from the severe respiratory illness associated with COVID-19. However, the availability of ICU beds is highly variable across the US, and health care resources are generally more plentiful in wealthier communities. We examined disparities in community ICU beds by US communities’ median household income. We found a large gap in access by income: 49 percent of the lowest-income communities had no ICU beds in their communities, whereas only 3 percent of the highest-income communities had no ICU beds. Income disparities in the availability of community ICU beds were more acute in rural areas than in urban areas. Policies that facilitate hospital coordination are urgently needed to address shortages in ICU hospital bed supply to mitigate the effects of the COVID-19 pandemic on mortality rates in low-income communities.
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ABSTRACT
Background:
For decades, the prevailing assumption regarding the diffusion of high-cost medical technologies has been that competitive markets favor more aggressive adoption of new treatments by health care providers (ie, the “Medical Arms Race”). However, novel regulations governing the adoption of transcatheter aortic valve replacement (TAVR) may have disrupted this paradigm when TAVR was introduced.
Objective:
The objective of this study was to assess the relationship between the market concentration of physician group practices and the adoption of TAVR in its first years of use.
Research Design:
This was a retrospective cohort study.
Subjects:
Physician group practices (n=5116) providing interventional cardiology services in the United States from May 1, 2012, to December 31, 2014.
Measures:
The first use of TAVR as indicated by a fee-for-service Medicare claim. Covariates including characteristics of the physician groups (ie, case volume, hospital affiliation, mean patient risk) as well as county-level and market-level characteristics.
Results:
By the close of 2014, 9.3% of practices had adopted TAVR. Cox proportional hazards models revealed a hazard ratio of 1.26 (95% confidence interval: 1.16–1.37, P<0.001) per 1000 point increase in the physician group practice Herfindahl-Hirschman Index, indicating each 1000 point increase in group practice Herfindahl-Hirschman Index was associated with a 26% relative increase in the rate of TAVR adoption.
Conclusions:
Adoption of TAVR by physician groups in concentrated markets was potentially a consequence of the unique regulations governing TAVR reimbursement, which favored the adoption of TAVR by physician groups with greater market power. These findings have important implications for how future regulations may shape patterns of technology adoption.
Conflicts of Interest in Health Care
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We examined the revolving door—inflows from and exits to industry—of government appointees to HHS between 2004 and 2020. We found that 15 percent of appointees had been employed in private industry immediately before their appointment. At end of their tenure, 32 percent of appointees exited to industry. HHS offices with the highest rates of net exits to industry (that is, exits minus entries) included the Centers for Disease Control and Prevention (CDC), the Office of the Deputy Secretary, the
Centers for Medicare and Medicaid Services (CMS), and the Food and Drug Administration (FDA). At the CDC, although only 8 percent of appointees came from industry, 54 percent exited to industry positions, resulting in a net exit rate of 46 percentage points. More than half of the appointees at the CDC, CMS, and the Office of the Deputy Secretary exited to industry employment. [link] [PDF]
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[Link] [Response to Tringale and Hattangadi-Gluth Commentary]
ABSTRACT
Importance Transparency of industry payments to physicians could engender greater public trust in physicians but might also lead to greater mistrust of physicians and the medical profession, adversely affecting the patient-physician relationship.
Objective To examine the association between nationwide public disclosure of industry payments and Americans’ trust in their physicians and trust in the medical profession.
Design, Setting, and Participants Survey study using difference-in-difference analyses of a national longitudinal survey comparing changes in states where industry payments were newly disclosed by Open Payments with changes in states where payments information was already available because of state sunshine laws. The US population-based surveys were conducted in September 2014—shortly before the initial public disclosure of industry payments—and again in September 2016. Final analyses were conducted September through December 2018. Participants were adults 18 years and older (n = 1388).
Exposures National public disclosure through Open Payments of payments made by pharmaceutical and medical device firms to physicians.
Main Outcomes and Measures Wake Forest measure of trust in one’s own physician and Wake Forest measure of trust in the medical profession.
Results Of the 3542 original survey respondents, 2180 (61.5%) completed the second survey 2 years later, and 1388 named the same most frequently seen physician in both surveys. The mean age of respondents at the time of the first survey was 53 years, and 749 (54.0%) were women. Race/ethnicity was white in 76.6% (1063 of 1388) and non-Hispanic black in 8.0% (111 of 1388). Public disclosure of payments was associated with lower trust in one’s own physician regardless of whether respondents knew their physicians had received payments (decrease in Wake Forest measure of trust in one’s own physician of 0.56 point; 95% CI, −0.79 to −0.32 point; P < .001). Open Payments was also associated with lower trust in the medical profession (decrease in Wake Forest measure of trust in the medical profession of 0.35 point; 95% CI, −0.58 to −0.12 point; P = .004).
Conclusions and Relevance Nationwide public disclosure of industry payments may be associated with decreased trust in physicians and in the medical profession. More judicious presentation of payments information may counteract unintended negative trust and spillover consequences of public disclosure.
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ABSTRACT
Objective To determine the effect of the public disclosure of industry payments to physicians on patients’ awareness of industry payments and knowledge about whether their physicians had accepted industry payments.
Design Interrupted time series with comparison group (difference-in-difference analyses of longitudinal survey).
Setting Nationally representative US population-based surveys. Surveys were conducted in September 2014, shortly prior to the public release of Open Payments information, and again in September 2016.
Participants Adults aged 18 and older (n=2180).
Main outcome measures Awareness of industry payments as an issue; awareness that industry payments information was publicly available; knowledge of whether own physician had received industry payments.
Results Public disclosure of industry payments information through Open Payments did not significantly increase the proportion of respondents who knew whether their physician had received industry payments (p=0.918). It also did not change the proportion of respondents who became aware of the issue of industry payments (p=0.470) but did increase the proportion who knew that payments information was publicly available (9.6% points, p=0.011).
Conclusions Two years after the public disclosure of industry payments information, Open Payments does not appear to have achieved its goal of increasing patient knowledge of whether their physicians have received money from pharmaceutical and medical device firms. Additional efforts will be required to improve the use and effectiveness of Open Payments for consumers.
This is an open access article distributed in accordance with the
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ABSTRACT
Background
The Physician Payments Sunshine Act, part of the Affordable Care Act, requires pharmaceutical and medical device firms to report payments they make to physicians and, through its Open Payments program, makes this information publicly available.
Objective
To establish estimates of the exposure of the American patient population to physicians who accept industry payments, to compare these population-based estimates to physician-based estimates of industry contact, and to investigate Americans’ awareness of industry payments.
Design
Cross-sectional survey conducted in late September and early October 2014, with data linkage of respondents’ physicians to Open Payments data.
Participants
A total of 3542 adults drawn from a large, nationally representative household panel.
Main Measures
Respondents’ contact with physicians reported in Open Payments to have received industry payments; respondents’ awareness that physicians receive payments from industry and that payment information is publicly available; respondents’ knowledge of whether their own physician received industry payments.
Key Results
Among the 1987 respondents who could be matched to a specific physician, 65% saw a physician who had received an industry payment during the previous 12 months. This population-based estimate of exposure to industry contact is much higher than physician-based estimates from the same period, which indicate that 41% of physicians received an industry payment. Across the six most frequently visited specialties, patient contact with physicians who had received an industry payment ranged from 60 to 85%; the percentage of physicians with industry contact in these specialties was much lower (35–56%). Only 12% of survey respondents knew that payment information was publicly available, and only 5% knew whether their own doctor had received payments.
Conclusions
Patients’ contact with physicians who receive industry payments is more prevalent than physician-based measures of industry contact would suggest. Very few Americans know whether their own doctor has received industry payments or are aware that payment information is publicly available.
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Introduction
In 2008 pharmaceutical companies spent over $12 billion on product promotion and detailing aimed at U.S. health care practitioners. Drug and device manufacturers rely on a workforce of detailers and physician speakers to reach health care practitioners and nudge their prescribing habits. To prevent undue influence and protect the public fisc, a number of states began regulating these marketing practices, requiring companies to disclose all gifts to practitioners, prohibiting the commercialized sale of prescription data, and prohibiting certain gifts altogether. The 2010 enactment of the Physician Payment Sunshine Act (PPSA) marks the first Congressional involvement in the regulation of disclosure related to pharmaceutical marketing. Overall, the Act improves transparency in pharmaceutical marketing to physicians and expands the regulation of disclosure of pharmaceutical marketing activities in important substantive ways.
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FDA Advisory Committees
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Does the US Food and Drug Administration (FDA) follow the counsel of its advisory committees? In this issue of JAMA Health Forum, Daval et al report their analysis of FDA actions and committee recommendations over the 2010 to 2021 period. The authors found high agency alignment with committee advice when the committee recommended approval: 97% of drug applications were approved when the committee advised approval. However, they also found that when the committee did not recommend approval, the FDA was only in agreement 67% of the time. Put differently, the FDA almost always agreed with its advisory committee when the committee said “go” and disagreed one-third of the time when the committee said “stop.”
The asymmetry in the FDA’s response to approval vs nonapproval recommendations says something very important about the agency’s view of advisory committees. On its face, the chief question that the FDA poses to advisory committees appears to be, “Should we approve this drug?” What these findings tell us is that the FDA is not really asking that. Instead, the agency is asking, “What is preventing this drug from being approved right now?” or perhaps, “What are different ways we can get this drug approved?”
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ABSTRACT
Background
The US Food and Drug Administration (FDA) plays a critical role in bolstering public confidence in vaccines and the vaccine review process. An important tool for enhancing transparency and public trust is the FDA's Vaccine and Biological Related Products Advisory Committee (VRBPAC), a group of external experts that advises on scientific issues related to the licensure of vaccines.
Objective
To analyze key features of VRBPAC meetings convened over 20 years; estimate the probability of advisory committee review of newly approved vaccines, focusing on vaccines targeting emerging diseases; and examine the speed of and variance in approval times as a function of VRBPAC review.
Methods
Cross-sectional study of VRBPAC meetings convened and new vaccine licensure applications approved between January 1, 2000, and December 31, 2019. We analyzed the frequency of VRBPAC meetings and sessions; the percentage of newly licensed vaccines reviewed by VRBPAC; and the number of days between the submission of the licensure application and the date of FDA approval.
Results
Between 2000 and 2019, VRBPAC convened for a mean of 4.1 sessions per year. One-quarter of sessions was devoted to the review of specific vaccine products. During the same period, 44 new vaccine licensures were approved, 20% of which were for vaccines targeting emerging diseases. Almost half (48%) of successful new vaccine applications were reviewed by VRBPAC (n=21), a rate lower than for therapeutic applications. Among new applications targeting emerging diseases, 29% of non-influenza vaccines were reviewed by VRBPAC. There was no difference in the median time to approval as a function of VRBPAC review (364 days with VRBAC review vs. 365 days with no review, p=0.870).
Conclusion
The FDA has convened VRBPAC for reviews of about half of its vaccine products, less frequently for vaccines against non-influenza emerging diseases. There is considerable scope for the FDA to increase VRBPAC engagement in the vaccine review process.
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ABSTRACT
Context: The Food and Drug Administration (FDA) Safety and Innovation Act has recently relaxed conflict-of-interest rules for FDA advisory committee members, but concerns remain about the influence of members’ financial relationships on the FDA’s drug approval process. Using a large newly available data set, this study carefully examined the relationship between the financial interests of FDA Center for Drug Evaluation and Research (CDER) advisory committee members and whether members voted in a way favorable to these interests.
Methods: The study used a data set of voting behavior and reported financial interests of 1,379 FDA advisory committee members who voted in CDER committee meetings that were convened during the 15-year period of 1997–2011. Data on 1,168 questions and 15,739 question-votes from 379 meetings were used in the analyses. Multivariable logit models were used to estimate the relationship between committee members’ financial interests and their voting behavior.
Findings: Individuals with financial interests solely in the sponsoring firm were more likely to vote in favor of the sponsor than members with no financial ties (OR = 1.49, p = 0.03). Members with interests in both the sponsoring firm and its competitors were no more likely to vote in favor of the sponsor than those with no financial ties to any potentially affected firm (OR = 1.16, p = 0.48). Members who served on advisory boards solely for the sponsor were significantly more likely to vote in favor of the sponsor (OR = 4.97, p = 0.005).
Conclusions: There appears to be a pro-sponsor voting bias among advisory committee members who have exclusive financial relationships with the sponsoring firm but not among members who have nonexclusive financial relationships (ie, those with ties to both the sponsor and its competitors). These findings point to important heterogeneities in financial ties and suggest that policymakers will need to be nuanced in their management of financial relationships of FDA advisory committee members.
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[Link to Book or email for a copy of the chapter]
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[Link]