Over the past two decades, research investment in gastroenterological
diseases such as inflammatory bowel disease has been growing. Together
with research funding from the public sector,1research collaborations between gastroenterologists and the healthcare
industry increasingly represent an important source of research funding
for gastroenterologists leading to current advances in the treatment of
gastroenterological diseases.2,3
However, one previous study by Ying et al. found that the healthcare
industry spent only 6% of all payments to gastroenterologists,
equivalent to only $27.5 million, for research and grant funding in the
United States between 2014 and 2020.4 This study could
significantly underestimate the magnitude and prevalence of
gastroenterologists receiving research funding from the healthcare
industry, as the author previously showed that majority of the
healthcare companies provided their research funding to physicians via
teaching hospitals and research institutions.5-8 For
example, the healthcare industry spent more than $799,9 million, 76.0%
of all payments to pulmonologists, for research purposes between 2014
and 2021.5 One possible reason for the underestimation
of industry-sponsored research funding for gastroenterologists is that
the previous study only included research funds provided directly to
individual gastroenterologists. Additionally, given that
industry-sponsored clinical trials conducted by physicians are required
to introduce new treatments to the market and patients, the evaluation
of all industry-sponsored research funding to gastroenterologists is of
particular importance in the United States.
This longitudinal cross-sectional study examined the magnitude and
extent of
industry-sponsored research payments to pediatric and adult
gastroenterologists, using the Open Payments Database from 2014 to 2021.
All physicians whose primary specialty is classified as either
gastroenterology, hepatology, transplant hepatology, pediatric
gastroenterology, or pediatric transplant hepatology were extracted from
the National Plan and Provider Enumeration System (NPPES) database, as
previously noted.5-7 All grant and research payments
directly provided to individual gastroenterologists (direct research
payments) and research payments whose principal investigator is a
gastroenterologist (associated research payments) were extracted from
the Open Payments Database from 2014 to 2021. Most research payments
came indirectly to physician researchers via teaching hospitals,
universities, and other third parties.5-10 Grant and
direct research payments were incorporated into one payment category, as
both payments were directly provided to individual gastroenterologists.
The extracted payment data were
descriptively analyzed. Per-physician payments were calculated among
physicians who received payments, as most gastroenterologists did not
receive research payments from the healthcare industry. The payments
were analyzed by the content of research and companies making the largest
payments. Payments with preclinical indicators were considered payments related to preclinical trials. Additionally, the study assessed
yearly trends in the number of gastroenterologists receiving payments
and per-physician payments using a population-averaged generalized
estimating equation (GEE) model at the individual physician level, as
noted previously.5-7,11 Inflation in US dollars was
adjusted to the 2021 Consumer Price Index using the US Bureau of Labor
Statistics inflation calculator. The detailed data analysis method was
described in Supplemental Material 1.
After adjusting for inflation, a sum of $1,527,127,494 was provided to
gastroenterologists for research and grant payments by 284 companies
between 2014 and 2021. Of 20,986 gastroenterologists included in this
study, 3,338 (15.9%) received at least one grant, direct research,
and/or associated research payments from the companies over the eight
years. Among them, 89.6% (2,757 gastroenterologists) were listed as PIs
for 97.6% of overall industry-sponsored research payments worth
$1,491.1 million (Table 1). Only 1.8% and 0.6% of the total research
payments worth $27.4 million and $8.6 million were directly paid to
individual gastroenterologists in direct research and grant payments,
respectively. There were large gaps between median and average
per-physician payments. The median per-physician eight-year combined
payments were $85,080 (interquartile range: $19,899–$382,206), while
the average was $540,848 (standard deviation: $2,309,907) in
associated research payments, indicating that only the small number of
gastroenterologists received large amounts of research payments.
Of all gastroenterologists, 1.2%-2.2% and 5.8%-7.2% received direct
and associated research payments each year, respectively. The total
amounts of associated research payments decreased by $2.8 million (95%
confidence interval [95% CI]: -$2,852,498
to -$2,838,517, p<0.001), equal to a 1.6% decrease in relative
average percentage change, each year between 2014 and 2021. There were
no continuing trends in per-physician amounts of direct research and
grant payments and associated research payments between 2014 and 2021.
Meanwhile, the number of gastroenterologists receiving associated
research payments increased from 1251 in 2014 to 1357 in 2021 with a
peak of 1505 in 2019. The relative annual average percentage change in
the number of gastroenterologists receiving associated research payments
was 2.1% (95% CI: 1.3%–2.9%, p<0.001) between 2014 and
2021 (Table 1).
Only 2.2% ($33.2 million) of associated research payments were made
for preclinical research. Meanwhile, 24.5% of associated research
payments were provided for registered clinical trials (Supplemental
Material 2). There was an increasing trend in the proportion of research
payments to registered clinical trials from 14.0% in 2014 to 45.6% in
2021. The payment amounts to registered clinical trials increased by
165.7% from 2014 to 2021 ($26.1 million to $69.3 million). The top 20
registered clinical trials with the largest total associated research
payments included 16 randomized controlled trials, 14 double-blind
trials, and 12 trials for ulcerative colitis and/or Crohn’s disease. The
number of trial participants ranged from 177 to 10,078.
Of 284 companies making at least one research payment to
gastroenterologists, Gilead Sciences provided the largest amount, worth
$253.6 million, followed by AbbVie ($224.2 million) and Pfizer
($117.9 million). Payments from the top 10 and 20 companies accounted
for 68.0% and 83.2% of all research and grant payments, respectively
(Supplemental Material 3).
This cross-sectional analysis of the Open Payments Database demonstrated
that more than $1.5 billion were directly or indirectly provided by the
small number of pharmaceutical companies for research where
gastroenterologists served as principal investigators between 2014 and
2021. Additionally, the number of gastroenterologists receiving
associated research payments significantly increased over the study
period. Research payments for registered clinical trials increased by
more than double from 2014 to 2021. These registered clinical trials
that received research funding were generally rigorously designed in
large numbers of patients aiming for new approvals or new indications.
In contrast, the healthcare industry spent only a small amount of
research payments on preclinical trials.
Compared to a previous study by Ying et al., the amount of research
payments to gastroenterologists was 55.5 times larger than those
previously reported.4 We found that the research
payments provided to research via teaching hospitals and research
institutions where gastroenterologists served as principal investigators
were 41.4 times larger than research payments directly distributed to
individual gastroenterologists. Such large industry research investments
and industry-sponsored clinical trials have undoubtedly contributed to
developing novel drugs, treating patients, and improving their quality
of life in the field of gastroenterology.
However, as this study elucidated, the healthcare industry invests the majority of its resources and expense in clinical trials and were
less likely to invest in preclinical research and research driven by
basic knowledge products.5-10 As Scher and Schett
noted,12 the healthcare industry is primarily
motivated by short-term market expansion. However, investments in
knowledge products and innovative ideas lead to long-term growth, known
as ”knowledge spillovers.” Through this strategy, the National
Institutes of Health has invested in these products for many years,
resulting in many innovative drugs and treatments.12 Given there was no change in the industry-sponsored research payments to
gastroenterologists for preclinical research, the healthcare industry
should provide more research payments to gastroenterologists for
preclinical research and developing knowledge products for their
long-term growth.
Meanwhile, physicians would receive financial and non-financial personal
incentives (e.g., promotions, increased professional recognition,
increased revenues, etc.) for participating in industry-sponsored trials
and receiving research funding. Moreover, conflicts of interest are
independently associated with more positive interpretation in
industry-sponsored clinical trials.13 As many
institutions, academic journals, scientific meetings, and medical
societies require physicians and researcher to declare receipt of
research funding as potential conflicts of interest, all
gastroenterologists need to be transparent about their financial
relationships with the healthcare industry and be aware of the impact on
their practice.
The limitations of this study include the possibility of errors in public databases and unmeasured confounding factors that may influence payment trends. There was a difference in the definition of gastroenterologists between this study and the previous study.4 Thus, the number of gastroenterologists included in this study was different from that in the previous study.4 Furthermore, research payments are primarily made to institutions and teaching hospitals: however, the Open Payments Database does not contain information on how these payments were internally distributed among physicians and staff within these institutions and hospitals.