In recent days, Novo Nordisk has also been suspended from its pharmaceutical trade association and has lost a key partnership with the Royal College of Physicians (RCP). On Friday, the RCP announced that it had severed ties with the company due to violations of the industry code.
Before the arrival of Wegovy in England, the Danish manufacturer of the weight-loss injections that have been hailed as a revolutionary new obesity treatment has recently enjoyed a wave of publicity.
The appetite suppressant semaglutide contained in its weekly injections is said to help patients lose up to 15% of their body weight.
Concerns about the long-term efficacy of the treatment have led to scrutiny of the company’s activities in the United Kingdom, including its payments to obesity experts and “disguised promotion” of its weight-loss drugs via medical training courses.
Clinical experts have referred to the skinny jabs’ as a game-changer.
Revealed: experts who praised the new “skinny jab” were compensated by the drug manufacturer
In a campaign to increase its influence in the United Kingdom, the company paid £21.7m to health organizations and professionals in just three years, according to an Observer investigation published last week.
Those with ties to Novo Nordisk promoted Wegovy in media interviews and submissions to the National Institute for Health and Care Excellence (Nice), the cost-effectiveness watchdog for the NHS, without always disclosing their ties to the company.
The Association of the British Pharmaceutical Industry (ABPI), a trade association, announced days after the Observer’s revelations that it had taken the unusual step of suspending the company for two years over a separate matter.
The action on Thursday followed a 2021 complaint from a “concerned” health professional that the company had violated the ABPI’s code through its sponsorship of obesity medicine training events, which allegedly included attempts to bribe participants into prescribing another of the company’s weight-loss drugs, Saxenda.
A panel investigating the complaint determined that Novo Nordisk’s sponsorship of the event constituted a “disguised promotional campaign” and that the company’s provision of benefits for health professionals, including an offer of funded paperwork support, constituted an illegal “inducement to prescribe, supply, administer, and/or recommend the drug.” Approximately 4,400 British health professionals participated in the training. After these violations and a further “detailed audit” of Novo Nordisk’s compliance practices, the ABPI announced on Thursday that its board had “significant concern” about the company’s activities and had decided to temporarily expel it. This is only the eighth time in the past four decades that the trade association has imposed such a severe penalty.
This weekend, the government’s medicines regulator announced that it is currently evaluating whether additional sanctions are necessary. Typically, the Medicines and Healthcare products Regulatory Agency (MHRA) intervenes only in the most severe cases where the drug industry’s self-regulator is deemed insufficient.
In the case of Novo Nordisk, the breaches were “extremely severe,” according to Laura Squire, the MHRA’s chief healthcare quality and access officer.
“Healthcare professionals should have access to information that supports their prescribing decision for a specific patient. They should not be offered gifts, courses, training, or any other activity that could be construed as an inducement to prescribe a specific medication, she said.
The MHRA review coincides with Nice’s investigation into the process by which Wegovy was approved for use by the NHS.
Experts and organizations that made submissions to the watchdog while it was evaluating Wegovy as a weight-loss aid had ties to Novo Nordisk, according to an investigation conducted by the Observer last week. Prof. John Wilding, a prominent scientist who testified to Nice about the drug, was at the time president of the World Obesity Federation, an organization paid more than £4.3 million by Novo Nordisk in three years. According to his declaration of interest to Nice, these donations were not made public. Wilding stated that he “vehemently refuted” the characterization of his relationship with Novo and his role in the Nice process.
The Royal College of Physicians (RCP) also submitted evidence in support of Wegovy to Nice after receiving over £100,000 in event sponsorship from Novo Nordisk in 2019-21. Nice was not informed of the sponsorship. The RCP stated that it should have volunteered the information and that the funding from Novo Nordisk had “no bearing” on its opinions, which were based solely on its knowledge and expertise.
Nice stated that it was evaluating evidence indicating that some of those who submitted expert opinions did not adhere to its “rigorous policy” regarding declaring their interests.
“In response to concerns raised by the Observer, we are reviewing the declarations of interest from organizations and experts who advised our committee during its evaluation of semaglutide [Wegovy],” the statement read.
The suspension of Novo Nordisk is not anticipated to affect the launch of Wegovy, as the findings about the company’s practices pertain to its promotional activities rather than the safety or efficacy of its drug. However, according to sources, the ABPI suspension would likely impact the company’s commercial operations. It will no longer have access to meetings or briefings hosted by the ABPI, which represents the pharmaceutical industry in the United Kingdom and lobbies the government on crucial industry issues. The company’s return to full membership will depend on the results of additional audits at the end of 2023 and in 2024, according to the ABPI.
Friday, the RCP announced it had severed ties with Novo Nordisk due to the company’s suspension by the ABPI. The college announced that it would return outstanding grants to the company and “pause projects associated with those funds,” including a fellowship program in obesity medicine funded by the pharmaceutical company.
The RCP stated that its criteria for corporate partnerships were “strict.” “Principal to this policy is the requirement that pharmaceutical companies be fully compliant with the ABPI Code, which Novo Nordisk is not at this time,” the statement read.
Novo Nordisk expressed “disappointment” over its suspension from the ABPI but accepted the decision. “We will continue to strengthen our compliance framework in the United Kingdom and remain committed to adhering to the ABPI code of practice and maintaining the highest possible ethical standards demanded by the pharmaceutical industry,” the statement read. The company refuted the accusation made by the complainant that its efforts to promote its weight-loss drug constituted bribery.
Novo Nordisk stated that it operated in a “transparent and ethical manner” in response to the Observer’s findings that it had financial ties to individuals who subsequently praised Wegovy, and that any insinuation that it had “deliberately acted outside of ethical or legal standards and proper processes” was “false and misleading.”
