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News BMJ Investigation

Lax oversight of semaglutide advertising could harm patients, warn critics

BMJ 2023; 383 doi: https://doi.org/10.1136/bmj.p2919 (Published 13 December 2023) Cite this as: BMJ 2023;383:p2919
  1. Hristio Boytchev
  1. The BMJ

UK organisations responsible for protecting the public from advertisements of prescription-only drugs are putting patients at risk from the harms of weight loss drugs by not enforcing the law, critics have told The BMJ.

The UK’s Human Medicines Regulations 2012 prohibit the advertising of prescription drugs to the general public,1 and companies that break the rules can be sanctioned with fines, orders to issue a corrective statement, or prosecution.2

Legal responsibility for regulating advertisements for medicines in the UK rests with the Medicines and Healthcare Products Regulatory Agency (MHRA) on behalf of health ministers. But there is also a system of self-regulation with a number of organisations operating their own codes of practice, including the Advertising Standards Authority.

But The BMJ has found that the MHRA has not issued a single sanction for prescription drugs in the past five years. And among 16 cases where the MHRA took action by requesting changes to advertisements for weight loss drugs from June 2022 to July 2023,3 all were triggered by external complaints, not internal mechanisms, and none resulted in sanctions.

James Cave, editor in chief of the Drug & Therapeutics Bulletin, a BMJ journal with a focus on drug safety, said that the lack of sanctions and internal monitoring provided only a weak incentive for companies to abstain from advertising prescription drugs. He became concerned about inadequate regulation after searching online for the prescription-only weight loss medicine Wegovy (semaglutide).

“Bang, there came up what I considered to be a whole list of adverts,” said Cave. “There’s no such thing as a safe drug, there’s only safe prescribing.” Long term adverse effects of Wegovy were not known, he added.

Complaint

A web search by The BMJ for the terms “Wegovy,” “pharmacy,” and “UK” had hundreds of thousands of hits, including a blog post by Pharmadoctor, a website that supports pharmacists in providing services for patients.

Pharmadoctor’s blog post, entitled “All about Wegovy,” stated that “Wegovy is a weekly weight loss injection made famous by celebrities such as Elon Musk and Boris Johnson. If Wegovy is suitable for you, your pharmacist will be able to provide it.”4 It added, “With celebrity fans and proven weight management benefits, Wegovy is the weight loss jab that has everyone talking.”

Shai Mulinari, associate professor of sociology at Lund University in Sweden, and Piotr Ozieranski, senior lecturer of social and policy sciences at the University of Bath, UK, filed a complaint on 10 October alleging illegal promotion of a prescription drug.

In their formal complaint to the MHRA they said that they were “appalled” that the company was marketing Wegovy “directly to the public” and that there was a prominent link to the “All about Wegovy” blog post from the patient facing home page. The blog post states, “Whether it’s Wegovy or another treatment, your Pharmadoctor partner pharmacist can discuss weight loss options,” and it provides the price of the drug and a link to find local pharmacists.

The MHRA responded to Mulinari and Ozieranski on 22 November saying that after its investigation the reference to Wegovy on Pharmadoctor’s patient home page “has been removed in line with our guidance.” But Mulinari and Ozieranski were dismayed: a link and the word “Wegovy” had been removed from the patient facing home page, but the blog post remained online.

Pharmadoctor’s chief executive, Graham Thoms, told The BMJ that Pharmadoctor aimed only to inform patients about Wegovy and that it had kept the blog post online because the MHRA had not required it be taken down. He referred to his statement to the MHRA, in which he said, “Pharmadoctor is categorically not involved in the marketing, advertising nor promotion of Wegovy.”

Websites

Cave said that the MHRA’s approach to focusing on websites was “completely out of date.” He said that people no longer entered websites through the home page—“they simply use a search engine,” he said.

In the past year Cave has filed over a dozen complaints about semaglutide advertising to the MHRA and the Advertising Standards Authority (ASA), the self-regulatory organisation of the UK’s advertising industry, but he was disappointed with the results. Even though the ASA decided to take action in numerous cases it said that it would not consider websites that were not being promoted through paid advertising on search engines.

All UK companies’ websites are under the ASA’s remit, a spokesperson for the organisation told The BMJ, but the ASA may decide that some complaints are best tackled by the MHRA, with which it collaborates.

The MHRA decided to take action in some cases on the basis of Cave’s complaints, asking companies to make changes to their websites, showed correspondence reviewed by The BMJ. But the changes were minor, said Cave. Sometimes they involved only a few words, while the websites continued to promote semaglutide.

“These companies just wriggle and squirm their way out of any complaint from ASA and MHRA and carry on regardless,” he said. He also criticised the organisations’ apparent reliance on complaints from individuals to highlight online advertisements that broke rules.

Guidance

The MHRA has told The BMJ that it actively monitors advertisements for prescription medicines, but it did not respond to a question about how many people were tasked with this.

Julian Beach, MHRA interim executive director of healthcare quality and access, told The BMJ that when there is no “voluntary compliance” the regulator is prepared to “take robust enforcement action” in line with the MHRA’s Blue Guide,2 its guidance on promoting medicines. The guide states that it is expected that most cases will be resolved without formal procedures, but if not the MHRA can resort to enforcement and prosecution.2

A spokesperson for the ASA said that it too takes advertising of prescription medicine seriously and has scaled up its monitoring of online advertisements with the help of artificial intelligence (AI).

Disappointed with the MHRA, Cave has now submitted new complaints to the ASA and the General Pharmaceutical Council. “We will see where that gets to,” he said.

The Department of Health and Social Care has not replied to The BMJ’s invitation to comment.

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