‘Skinny jab’ drug firm facing fresh inquiries after ‘serious breaches’ of industry code | Pharmaceuticals industry

The maker of weight-loss injection Wegovy faced crisis on several fronts this weekend, with Britain's medicines regulator announcing a review of its operations while investigating whether to approve its injection for use in the NHS.

In the past few days, Novo Nordisk has also been suspended by its pharmaceuticals trade body and lost a key partnership with the Royal College of Physicians (RCP), the Royal College of Physicians (RCP) said on Friday, in violation of the industry code.

The Danish maker behind weight-loss injections once hailed as a blockbuster new obesity treatment recently created a wave of hype ahead of Wegovy's arrival in the UK.

It's a once-weekly injection containing the appetite suppressant semaglutide, which is said to help patients lose up to 15 percent of their body weight.

But the company is facing scrutiny over its activities in the UK, including paying obesity specialists and “disguised promotion” of its weight-loss drugs through medical training courses, amid concerns about the treatment's lasting effectiveness.

last week, a observer The investigation revealed that the company paid £21.7m to health organizations and professionals in just three years as part of a campaign to boost its influence in the UK.

In some cases, those associated with Novo Nordisk have continued to promote Wegovy in media interviews and submissions to the NHS cost-effectiveness watchdog the National Institute for Health and Care Excellence (Nice), but not always Clearly state their affiliation with the company.

a few days later Observer's It was revealed that the Association of the British Pharmaceutical Industry (ABPI), a trade association, announced that it had taken the rare step of suspending the company for two years over a separate incident.

Thursday's action follows a complaint by a “concerned” health professional in 2021 that the company violated ABPI guidelines by sponsoring obesity medicine training events that the complainant said included attempting to bribe participants to prescribe another weight loss drug, Saxonda.

The panel investigating the complaint concluded that the event sponsorship amounted to a “disguised promotion” by Novo Nordisk and ruled that the company's benefits to health professionals, including the provision of funded paperwork support, constituted a prohibited “inducement”. “Prescribing, supplying, administering and/or recommending” the drug. Around 4,400 UK health professionals attended the training. On Thursday, the ABPI said that following these breaches and a further “detailed audit” of Novo Nordisk's compliance , whose board had raised “serious concerns” about the company's activities and decided to temporarily fire it. It was the eighth time in four decades that the trade body had imposed such severe sanctions.

This weekend, the government's pharmaceuticals watchdog said it was assessing the need for further sanctions. The Medicines and Healthcare Products Regulatory Agency (MHRA) usually only intervenes in the most serious cases where the powers of the pharmaceutical industry's self-regulatory body are deemed insufficient.

Laura Squire, the MHRA's chief healthcare quality and access officer, said the breach was “very serious” in the case of Novo Nordisk.

“Healthcare professionals should have access to appropriate information to support their prescribing choices for a particular patient. They should not be offered gifts, courses, training, or opportunities to engage in any other activity that might represent an inducement to prescribe a particular drug, “she says.

The MHRA review comes as Nice reviews the process by which Wegovy was approved for use in the NHS.

last week's observer Experts and organizations that submitted comments to regulators as they evaluated Wegovy as a weight-loss aid have ties to Novo Nordisk, the investigation revealed. One of the experts who provided Nice with evidence about the drug, renowned scientist Professor John Wilding, was then chairman of the World Obesity Federation, an organization to which Novo Nordisk paid more than £4.3m over three years. A declaration of interest he filed with Nice indicated the donations were not made public. Wilding said he “strongly disputed” the explanation for his relationship with Novo and his role in the Nice process.

The Royal College of Physicians (RCP) has also provided Nice with evidence in support of Wegovy, after receiving more than £100,000 in event sponsorship from Novo Nordisk in 2019-21. Sponsorship was not announced to Nice. The RCP said it should have provided the information voluntarily, but that Novo Nordisk's funding had “no influence” on the views it offered, which were based solely on its knowledge and expertise.

Nice said it was assessing evidence that some of the people who provided it with expert advice were not following its “robust policy” on declaring interests.

“Following observerwe are reviewing declarations of interest from organizations and experts who provided recommendations to our committee that conducted the evaluation of semaglutide [Wegovy],” it says.

The suspension of Novo Nordisk is not expected to have any impact on Wegovy's launch, and the findings about the company's practices have more to do with its promotional activities than the safety or effectiveness of its drug. But sources said the suspension of ABPI could affect the company's commercial operations. It will no longer be able to attend meetings or briefings of ABPI, the leading voice of the UK pharmaceutical industry and lobbying the government on key industry issues. ABPI said the company's ability to resume full membership will now depend on the results of further audits in late 2023 and 2024.

On Friday, RCP announced that it had severed its relationship with Novo Nordisk in light of the suspension of Novo Nordisk's ABPI. The college said it would return outstanding grants to the company and “suspend programs related to those funds,” including an obesity medicine fellowship program funded by the drugmaker.

The RCP said it had “strict criteria” for corporate partnerships. “At the heart of this policy is the requirement that pharmaceutical companies fully comply with the ABPI specification to which Novo Nordisk is now non-compliant,” it said.

Novo Nordisk said it was “disappointed” with its ABPI suspension, but accepted the decision. “We will continue to strengthen our compliance framework in the UK and remain committed to complying with the ABPI Code of Conduct and maintaining the highest ethical standards required by the pharmaceutical industry,” it said. The company has denied the complainant's claim that its efforts to promote its diet pill constituted bribery.

about Observer's Novo Nordisk found it had financial ties to those who continued to praise Wegovy, saying it operated in a “transparent and ethical manner” and that any suggestion it “knowingly acted outside ethical or legal standards and due process” is “unsubstantiated” and misleading”.