Financial payments from the drug industry to U.S. physicians are common. Payments may influence physicians' clinical decision making and drug prescribing.
To evaluate whether receipt of payments from ...the drug industry is associated with physician prescribing practices.
MEDLINE (Ovid), Embase, the Cochrane Library, Web of Science, and EconLit were searched without language restrictions. The search had no limiting start date and concluded on 16 September 2020.
Studies that estimated the association between receipt of industry payments (exposure) and prescribing (outcome).
Pairs of reviewers extracted the primary analysis or analyses from each study and evaluated risk of bias (ROB).
Thirty-six studies comprising 101 analyses were included. Most studies (
= 30) identified a positive association between payments and prescribing in all analyses; the remainder (
= 6) had a mix of positive and null findings. No study had only null findings. Of 101 individual analyses, 89 identified a positive association. Payments were associated with increased prescribing of the paying company's drug, increased prescribing costs, and increased prescribing of branded drugs. Nine studies assessed and found evidence of a temporal association; 25 assessed and found evidence of a dose-response relationship.
The design was observational, 21 of 36 studies had serious ROB, and publication bias was possible.
The association between industry payments and physician prescribing was consistent across all studies that have evaluated this association. Findings regarding a temporal association and dose-response suggest a causal relationship.
National Cancer Institute.
The Prescription Drug User Fee Act (PDUFA) is due for reauthorization in 2022. Beyond creating the user fee program which now generates a majority of the Food and Drug Administration (FDA) Human ...Drugs Program budget, PDUFA has made numerous additional changes to FDA policy during its 29-year history. FDA's budgetary dependence on user fees may advantage the industry in negotiating favorable policy changes through PDUFA.
The full texts of all prior PDUFA reauthorization bills and all submitted public comments and meeting minutes for the 2022 reauthorization were reviewed. Provisions affecting FDA regulatory authority and processes were identified.
PDUFA legislation has instituted a broad range of changes to FDA policy, including evidentiary standards for drug approval, accelerated pathways for approval, industry involvement in FDA decision-making, rules regarding industry information dissemination to providers, and market entry of generic drugs. Negotiations over the 2022 reauthorization suggest that industry priorities include increased application of real-world evidence, regulatory certainty, and increased communication between FDA and industry during the drug application process.
The need for PDUFA reauthorization every 5 years has created a recurring legislative vehicle through which far-ranging changes to FDA have been enacted, reshaping the agency's interactions and relationship with the regulated industry. The majority of policy changes enacted through PDUFA legislation have favored industry through decreasing regulatory standards, shortening approval times, and increasing industry involvement in FDA decision-making. FDA's budgetary dependence on the industry, the urgency of each PDUFA reauthorization's passage to maintain uninterrupted funding, and the industry's required participation in PDUFA negotiations may advantage the industry.
The September 11, 2001, terrorist attacks on the World Trade Center (WTC) in New York City (9/11) had health‐related consequences, including posttraumatic stress disorder (PTSD). PTSD is associated ...with functional impairment, which varies by symptom severity and other factors. This study aimed to identify predictors of functional impairment in individuals with low versus high PTSD symptom severity levels. WTC Health Registry enrollees exposed to 9/11 were surveyed four times between 2003 and 2015; cumulated data for individuals who endorsed at least one symptom on the PTSD Checklist–Civilian Version (PCL‐C) at Wave 4 (2015–2016) were included (N = 30,287) and examined cross‐sectionally. Individuals were classified based on PCL‐C scores as having low/no (2–29) or high levels of PTSD symptom severity (≥ 44). Functional impairment was defined as subsequent difficulties in daily living. Among low/no PTSD severity participants, adjusted odds ratios (aORs) for the associations between functional impairment and poor self‐rated health (vs. good), low social support (vs. high), and no physical activity (vs. active) were 1.23–1.92. In the same group, low versus high household income was associated with more functional impairment, aOR = 1.34, 95% CI 1.13, 1.59. Among participants with high‐level PTSD symptoms, women, aOR = 1.70, 95% CI 1.31, 2.20, and Hispanic enrollees, aOR = 1.76, 95% CI 1.31, 2.36, were more likely to report an absence of impairment. Self‐rated health, social support, and physical activity emerged as important predictors of PTSD‐related functional impairment across PTSD symptom severity levels, supporting clinical interventions targeting these factors.
AbstractObjectiveTo estimate the association between oncologists’ receipt of payments from the pharmaceutical industry and delivery of non-recommended or low value interventions among their ...patients.DesignCohort study.SettingFee-for-service Medicare claims.ParticipantsMedicare beneficiaries with a diagnosis of incident cancer (new occurrence of a cancer diagnosis code in proximity to claims for cancer treatment, and no such diagnosis codes during a ≥1 year washout period) during 2014-19, who met additional requirements identifying them as at risk for one of four non-recommended or low value interventions: denosumab for castration sensitive prostate cancer, granulocyte colony stimulating factors (GCSF) for patients at low risk for neutropenic fever, nab-paclitaxel for cancers with no evidence of superiority over paclitaxel, and a branded drug in settings where a generic or biosimilar version was available.Main outcome measuresReceipt of the non-recommended or low value drug for which the patient was at risk. The primary association of interest was the assigned oncologist’s receipt of any general payments from the manufacturer of the corresponding non-recommended or low value drug (measured in Open Payments) within 365 days before the patient’s index cancer date. The two modeling approaches used were general linear model controlling for patients’ characteristics and calendar year, and general linear model with physician level indicator variables.ResultsOncologists were in receipt of industry payments for 2962 of 9799 patients (30.2%) at risk for non-recommended denosumab (median $63), 76 747 of 271 485 patients (28.3%) at risk for GCSF (median $60); 18 491 of 86 394 patients (21.4%) at risk for nab-paclitaxel (median $89), and 4170 of 13 386 patients (31.2%) at risk for branded drugs (median $156). The unadjusted proportion of patients who received non-recommended denosumab was 31.4% for those whose oncologist had not received payment and 49.5% for those whose oncologist had (prevalence difference 18.0%); the corresponding values for GCSF were 26.6% v 32.1% (5.5%), for nab-paclitaxel were 7.3% v 15.1% (7.8%), and for branded drugs were 88.3% v 83.5% (−4.8%). Controlling for patients’ characteristics and calendar year, payments from industry were associated with increased use of denosumab (17.5% (95% confidence interval 15.3% to 19.7%)), GCSF (5.8% (5.4% to 6.1%)), and nab-paclitaxel (7.6% (7.1% to 8.1%)), but lower use of branded drugs (−4.6% (−5.8% to −3.3%)). In physician level indicator models, payments from industry were associated with increased use of denosumab (7.4% (2.5% to 12.2%)) and nab-paclitaxel (1.7% (0.9% to 2.5%)), but not with GCSF (0.4% (−0.3% to 1.1%)) or branded drugs (1.2% (−6.0 to 8.5%)).ConclusionsWithin some clinical scenarios, industry payments to physicians are associated with non-recommended and low value drugs. These findings raise quality of care concerns about the financial relationships between physicians and industry.
Drug manufacturers claim that the purpose of financial payments to physicians is to facilitate education about new drugs. This claim suggests 2 testable hypotheses: payments should not be associated ...with drug revenue and payments for each drug should decline over time as physicians become educated.
We used open payments data on industry payments. We included payments for cancer drugs without generic/biosimilar competitors and used federal data sources to measure Medicare spending (a proxy for overall drug revenue) and a number of prescribers. We used generalized estimating equations (GEE) to model the drug-level association between industry payments and Medicare spending. Separately, we used GEE to estimate the change in payments with respect to the duration of time since initial FDA approval.
The sample included 89 drugs and 361 drug-year observations. The total value of industry payments for oncology drugs increased, from $53 333 854 in 2014 to $90 343 731 in 2018. There was no association between log-transformed mean, per-physician industry payments, and per-physician Medicare spending (estimate -0.001, 95%CI, -0.005 to 0.004). Payments for individual drugs decreased over time; estimated payments in the subsequent year for a drug with mean, per-physician payments of $1000 in the index year was: $681* for drugs 0-4 years since approval, $825 for 5-9 years, and $679* for ≥10 years (*P < .05).
Although industry-sponsored education may also serve marketing purposes, the absence of association between industry payments and Medicare spending and the decline in payments subsequent to approval are consistent with claims that industry payments function to facilitate physician education.
Personal payments from the pharmaceutical industry to US physicians are common and are associated with changes in physicians' clinical practice and interpretation of clinical trial results. We ...assessed temporal trends in industry payments to oncologists, with particular emphasis on payments to authors of oncology clinical practice guideline and on payments related to immunotherapy drugs.
We included US physicians with active National Plan and Provider Enumeration System records and demographic data available in the Centers for Medicare & Medicaid Services Physician Compare system who had a specialty type of medical oncology or general internal medicine. Medical oncologists serving on NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) Panels were identified manually. Industry payments, and the subset associated with PD-1/PD-L1 drugs, were identified in Open Payments, the federal repository of all transactions of financial value from industry to physicians and teaching hospitals, from 2014 to 2017.
There were 13,087 medical oncologists and 85,640 internists who received payments. The mean, annual, per-physician value of payments to oncologists increased from $3,811 in 2014 to $5,854 in 2017, and from $444 to $450 for internists; the median payment increased from $152 to $199 for oncologists and remained at $0 for internists. Oncologists who served on NCCN Guidelines Panels received a greater value in payments and experienced a greater relative increase: mean payments increased from $10,820 in 2014 to $18,977 in 2017, and median payments increased from $500 to $1,366. Among companies marketing PD-1/PD-L1 drugs, mean annual per-oncologist payments associated with PD-1/PD-L1 drugs increased from $28 to $773. Total per-oncologist payments from companies marketing PD-1/PD-L1 drugs experienced a 165% increase from 2014 to 2017, compared with a 31% increase among similar companies not marketing PD-1/PD-L1 drugs.
Pharmaceutical industry payments increased for US oncologists from 2014 to 2017 more than for general internists. The increase was greater among oncologists contributing to clinical practice guidelines and among pharmaceutical companies marketing PD-1/PD-L1 drugs. The increasing flow of money from industry to US oncologists supports ongoing concern regarding commercial interests in guideline development and clinical decision-making.
Background
Oncologists who author clinical practice guidelines frequently have financial relationships with the pharmaceutical industry. It is unknown whether participation on clinical practice ...guideline committees is associated with differences in the amounts of industry money received.
Materials and Methods
We conducted a nested case‐control study from August 2013 to December 2018. We manually ed membership records of National Comprehensive Cancer Network (NCCN) Guidelines committees for the 20 most common cancers and linked to Open Payments. The study sample included medical oncologists selected to join an NCCN Guidelines committee (“joiners”) during the study period. Joiners were matched 1:2 to medical oncologists who had no participation on NCCN committees (controls) by gender, NCCN institution, and medical school graduation year. We performed difference‐in‐differences (DiD) estimation to assess whether selection to an NCCN committee was associated with the dollar value of payments received from industry, using generalized estimating equations to address correlation between matched pairs and between repeated observations of the same pair.
Results
During the study period, 54 physicians joined an NCCN Guidelines committee. These physicians received more payments than matched controls in the year prior to joining ($11,259 vs. $3,427; p = .02); this difference did not increase in the year after joining (DiD = $731; p = .45).
Conclusion
Medical oncologists selected to NCCN Guidelines committees had greater financial ties to industry than their peers. The potential influence of industry in oncology clinical practice guidelines may be reduced through the selection of committee members with fewer ties to industry.
Implications for Practice
Oncologists who author clinical practice guidelines frequently have financial conflicts of interest with the pharmaceutical industry. This creates concern about the potential for industry influence on guidelines. However, it is unknown whether oncologists who author guidelines have greater industry relationships than their peers. This study compared medical oncologists who were newly selected to join a National Comprehensive Cancer Network (NCCN) Guidelines panel with medical oncologists at the same institutions and at similar career stages. At the time they joined, oncologists joining NCCN Guidelines panels had received more than three times the dollar value of industry payments than their peers. The potential for industry influence may be reduced by the selection of less‐conflicted panel members.
To assess industry influence on oncologists creating clinical practice guidelines, this study compared medical oncologists who were newly selected to join an NCCN Guidelines panel with medical oncologists at the same institutions and at similar career stages.
Industry payments to US cancer centers are poorly understood.
US National Cancer Institute (NCI)-designated comprehensive cancer centers were identified (n = 51). Industry payments to NCI-designated ...comprehensive cancer centers from 2014 to 2021 were obtained from Open Payments and National Institutes of Health (NIH) grant funding from NIH Research Portfolio Online Reporting Tools (RePORT). Given our focus on cancer centers, we measured the subset of industry payments related to cancer drugs specifically and the subset of NIH funding from the NCI.
Despite a pandemic-related decline in 2020-2021, cancer-related industry payments to NCI-designated comprehensive cancer centers increased from $482 million in 2014 to $972 million in 2021. Over the same period, NCI research grant funding increased from $2 481 million to $2 724 million. The large majority of nonresearch payments were royalties and licensing payments.
Industry payments to NCI-designated comprehensive cancer centers increased substantially more than NCI funding in recent years but were also more variable. These trends raise concerns regarding the influence and instability of industry payments.
The Prescription Drug User Fee Act Mitchell, Aaron P; Trivedi, Niti U; Bach, Peter B
Medical care,
04/2022, Letnik:
60, Številka:
4
Journal Article
Recenzirano
Odprti dostop
Background:The Prescription Drug User Fee Act (PDUFA) is due for reauthorization in 2022. Beyond creating the user fee program which now generates a majority of the Food and Drug Administration (FDA) ...Human Drugs Program budget, PDUFA has made numerous additional changes to FDA policy during its 29-year history. FDA’s budgetary dependence on user fees may advantage the industry in negotiating favorable policy changes through PDUFA.Methods:The full texts of all prior PDUFA reauthorization bills and all submitted public comments and meeting minutes for the 2022 reauthorization were reviewed. Provisions affecting FDA regulatory authority and processes were identified.Findings:PDUFA legislation has instituted a broad range of changes to FDA policy, including evidentiary standards for drug approval, accelerated pathways for approval, industry involvement in FDA decision-making, rules regarding industry information dissemination to providers, and market entry of generic drugs. Negotiations over the 2022 reauthorization suggest that industry priorities include increased application of real-world evidence, regulatory certainty, and increased communication between FDA and industry during the drug application process.Conclusions:The need for PDUFA reauthorization every 5 years has created a recurring legislative vehicle through which far-ranging changes to FDA have been enacted, reshaping the agency’s interactions and relationship with the regulated industry. The majority of policy changes enacted through PDUFA legislation have favored industry through decreasing regulatory standards, shortening approval times, and increasing industry involvement in FDA decision-making. FDA’s budgetary dependence on the industry, the urgency of each PDUFA reauthorization’s passage to maintain uninterrupted funding, and the industry’s required participation in PDUFA negotiations may advantage the industry.
11065 Background: US National Cancer Institute-designated comprehensive cancer centers (NCICCCs) receive federal funding to support their public missions. However, these institutions also receive ...substantial funds (both research and non-research) from the pharmaceutical companies, which have private, for-profit goals. The amount of industry money received by NCICCCs, with respect to their federal funding, is poorly understood. The goal of this study was to examine trends in industry payments to US cancer centers. Methods: NCICCCs were identified (N=51). Industry payments to each NCICCC from 2014-2021 were obtained from Open Payments, and NIH grant funding from NIH RePORT. Given our interest in NCICCCs, we focused on the subset of industry payments (those designated as being related to a cancer drug, both research and non-research) and NIH grant funding (grants awarded by the NCI specifically, as opposed to other institutes) that were likely to be cancer-related (we also measured overall industry payments and overall NIH funding). In order to capture both industry payments and grant funding broadly, we manually identified teaching hospitals and research universities affiliated with each NCICCC and included payments and grants to these as well. All amounts were inflation-adjusted to 2021 dollars. Results: Oncology-related industry payments increased from $320 million in 2014 to $896 million in 2021. NCI funding increased slightly during the same period, from $2,481 million to $2,691 million. Overall industry payments increased from $1,811 million in 2014 to $3,015 million in 2019 (exceeding NCI funding in that year), though overall industry payments subsequently declined to $1,977 million in 2021. Non-research (as opposed to research) payments were the minority of industry payments; the year with the greatest proportion of non-research payments was 2019, at 39%. NCI funding exceeded oncology-related industry payments at all NCICCCs except for two: City of Hope ($1,137 million oncology-related industry payments vs. $311 million in NCI funding) and MD Anderson ($1,040 million vs. $1,001 million). Conclusions: Oncology-related industry payments to NCICCCs has increased substantially more than NCI funding in recent years. Although most industry payments are research-related, a substantial portion are not. A small number of NCICCCs receive comparable or greater amounts of money from industry than they receive in grant funding from the NCI. These trends raise concerns regarding the influence of industry payments and the ability of these institutions to maintain their public missions.
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