Drug company payments to General Practices in England: Cross-sectional and social network analysis

Although there has been extensive research on pharmaceutical industry payments to healthcare professionals, healthcare organisations with key roles in health systems have received little attention. We seek to contribute to addressing this gap in research by examining drug company payments to General Practices in England in 2015. We combine a publicly available payments database managed by the pharmaceutical industry with datasets covering key practice characteristics. We find that practices were an important target of company payments, receiving £2,726,018, equivalent to 6.5% of the value of payments to all healthcare organisations in England. Payments to practices were highly concentrated and specific companies were also highly dominant. The top 10 donors and the top 10 recipients amassed 87.9% and 13.6% of the value of payments, respectively. Practices with more patients, a greater proportion of elderly patients, and those in more affluent areas received significantly more payments on average. However, the patterns of payments were similar across England’s regions. We also found that company networks–established by making payments to the same practices–were largely dominated by a single company, which was also by far the biggest donor. Greater policy attention is required to the risk of financial dependency and conflicts of interests that might arise from payments to practices and to organisational conflicts of interests more broadly. Our research also demonstrates that the comprehensiveness and quality of payment data disclosed via industry self-regulatory arrangements needs improvement. More interconnectivity between payment data and other datasets is needed to capture company marketing strategies systematically.

Accessibility and quality of drug company disclosures of payments to healthcare professionals and organisations in 37 countries: a European policy review

ObjectivesTo examine the accessibility and quality of drug company payment data in Europe.DesignComparative policy review of payment data in countries with different regulatory approaches to disclosure.Setting37 European countries.ParticipantsEuropean Federation of Pharmaceutical Industries and Associations, its trade group and their drug company members; eurosfordocs.eu, an independent database integrating payments disclosed by companies and trade groups; regulatory bodies overseeing payment disclosure.Main outcome measuresRegulatory approaches to disclosure (self-regulation, public regulation, combination of the two); data accessibility (format, structure, searchability, customisable summary statistics, downloadability) and quality (spectrum of disclosed characteristics, payment aggregation, inclusion of taxes, recipient or donor identifiers).ResultsOf 30 countries with self-regulation, five had centralised databases, with Disclosure UK displaying the highest accessibility and quality. In 23 of the remaining countries with self-regulation and available data, disclosures were published in the portable document format (PDF) on individual company websites, preventing the public from understanding payment patterns. Eurosfordocs.eu had greater accessibility than any industry-run database, but the match between the value of payments integrated in eurosfordocs.eu and summarised separately by industry in seven countries ranged between 56% and 100% depending on country. Eurosfordocs.eu shared quality shortcomings with the underlying industry data, including ambiguities in identifying payments and their recipients. Public regulation was found in 15 countries, used either alone (3), in combination (4) or in parallel with (8) self-regulation. Of these countries, 13 established centralised databases with widely ranging accessibility and quality, and sharing some shortcomings with the industry-run databases. The French database, Transparence Santé, had the highest accessibility and quality, exceeding that of Disclosure UK.ConclusionsThe accessibility and quality of payment data disclosed in European countries are typically low, hindering investigation of financial conflicts of interest. Some improvements are straightforward but reaching the standards characterising the widely researched US Open Payments database requires major regulatory change.

Reducing medication has become a privilege of wealth in western settings David Healy

In 20th century healthcare in affluent settings, generating awareness of the hazards of medication followed a rotten apple script. Find patients with a problem, find the documents that a drug company knew about the problem in private but denied it in public, mention the ghost-writing that concealed the problem and lack of access to trial data, perhaps using a clinician or an “insider” to provide dramatic focus and expose the company to media or legal questioning. The sight of a rotten apple being thrown out of the barrel reassured the public that healthcare was now more ethical than before, and gave bioethicists a case example to use in teaching. But what if we have a whole rotten barrel as outlined in this case study? What are the ethics then?

Accelerated Approval of Aducanumab: Where Do We Stand Now?

Aducanumab was approved by the Food and Drug Administration (FDA) in June 2021 to treat Alzheimer disease (AD). Its path to approval has been highly scrutinized, with many experts arguing that the FDA’s decision was premature. Accelerated approval was based on a surrogate end point, with evidence to support clinical effectiveness pending a postapproval trial by the drug company sponsor Biogen. As a result, the role of aducanumab in treating AD remains uncertain. A summary of key areas of controversy to guide informed decisions about use of this drug is provided, along with a timeline describing preapproval and postapproval events.

Industry

The pharmaceutical industry began in 1858, with August Kekulé’s discovery of the benzene ring, which formed the basis of the dye industry that eventually turned into the pharmaceutical industry. Merck and Pfizer bought medicinal chemicals in bulk and processed them into pharmaceuticals for sale to pharmacies or directly to physicians, who dispensed them to patients. The idea of selling medicine was to displace the compounding pharmacist as the manufacturer of pharmaceuticals. The pharmaceutical industry accelerated with the introduction of a new pill-making technology: in 1900, with the aspirin, Bayer in Leverkusen became the first drug company to market a major product in tablet form. Drug manufacture transitioned into an industry that went into full swing in the 1920s.

Companies’ statements about drugs withdrawn from the Canadian market: A descriptive analysis

BACKGROUND: Companies often defending their products when there are concerns about their safety and/or effectiveness. OBJECTIVE: This study looks at drugs removed from the Canadian market from 1990 onward and examines how companies responded. METHODS: This descriptive analysis used a previously published article and a hand search of a Government of Canada website to generate a list of drugs withdrawn from Canada from 1990 onwards. For each product the following information was extracted: brand-name, generic name, company, date of withdrawal and evidence base for withdrawal. Google and Factiva searches were used to identify sources containing statements from the company about the withdrawal. Statements were independently graded by two people into the following categories: company agrees with the withdrawal; drug could be used safely with certain precautions; company may reintroduce the drug; company disagrees with the withdrawal. Searches were carried out between September 15–20, 2020. RESULTS: There were 22 drugs for which there were company statements. In 10 statements, the companies disagreed with the decision to withdraw the drug and in 7 they agreed with the decision. In the other 5 cases they felt that the drug could have been kept on the market with restrictions (2 cases) or they might reintroduce the drug (3 cases). The level of evidence for the withdrawal did not seem to influence the companies’ position. CONCLUSION: In 15 out of 22 cases, the company either disagreed with the decision to withdraw the drug or felt that the drug should continue to be available to Canadian patients.