Slimming injection maker Wegovy is facing a crisis on several fronts this weekend, with the UK drug regulator announcing a review of its operations at the same time it is investigating the approval of its injections for use by the National Health Service.
In the past few days, Novo Nordisk has also been suspended from its pharmaceutical trade organization and is facing the loss of a key partnership with the Royal College of Physicians (RCP), which said on Friday it had cut ties with the company after violating rules. industry code.
The Danish manufacturer of slimming injections, which have been hailed as the new blockbuster in the treatment of obesity, recently received a lot of publicity ahead of the arrival of Wegovy in England.
His weekly injections contain appetite suppressant semaglutide and are said to help patients lose up to 15% of their body weight.
But amid worries about the long-term effectiveness of the treatment, the company has faced scrutiny for its activities in the UK, including payouts to obesity experts and the “disguised promotion” of its weight loss drugs through medical education courses.
Last week, on Observer The investigation found that in just three years, the company paid out £21.7m to healthcare organizations and professionals as part of a campaign to increase its influence in the UK.
In some cases, those with ties to Novo Nordisk continued to promote Wegovy in media interviews and submissions to the National Institute for Health and Care Quality (Nice), which oversees the cost-effectiveness of the NHS, not always making clear their association with company. .
days after Observers Following the revelations, 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 another matter.
Thursday’s action follows a 2021 complaint from a “concerned” healthcare professional that the company violated the ABPI code by sponsoring obesity education events, which the complainant alleges included trying to bribe attendees to prescribe another of his weight loss drugs. . , Saxenda.
The commission investigating the complaint concluded that the sponsorship of the event constituted Novo Nordisk’s “disguised advertising campaign” and ruled that the company’s provision of benefits to medical professionals, including the offer of funded paperwork support, amounted to the prohibited “inducement to prescribe, supply, administer and/or recommend a drug. About 4,400 UK healthcare professionals have taken part in the training. ABPI said Thursday that following these violations and a further “detailed audit” of Novo Nordisk’s compliance practices, its board is “seriously concerned” about the company’s performance and has decided to suspend it. It is only the eighth time in four decades that the trade organization has enforced such a harsh sanction.
The state drug regulator said this weekend that it is now evaluating the need for further sanctions. The Medicines and Healthcare Products Regulatory Agency (MHRA) usually intervenes only in the most serious cases where the authority of the pharmaceutical industry self-regulatory body is deemed insufficient.
In the case of Novo Nordisk, the violations were “very serious,” said Laura Squire, chief healthcare quality and access officer at the MHRA.
“Healthcare professionals must have access to relevant information to support their choice of prescribing for a particular patient. They should not be offered gifts, courses, training, or opportunities to engage in any other activity that might induce them to prescribe a particular drug,” she said.
The MHRA review comes at a time when Nice is looking into the process that resulted in Wegovy being approved for use by the National Health Service.
Novo Nordisk semaglutide injection pen sold under the brand name Wegovy. Photographer: Christian Mihajla/AP
Last week Observer The investigation found that the experts and organizations that filed applications with the regulator when it assessed Wegovy as a weight loss product were linked to Novo Nordisk. One of the experts who gave evidence to Nice about the drug, prominent scientist Professor John Wilding, was at the time president of the World Obesity Federation, the organization that paid Novo Nordisk more than £4.3m over three years. His statement of interest for Nice showed that these donations were not disclosed. Wilding said he “strongly denied” the interpretation of his relationship with Novo and his role in the Nice process.
The Royal College of Physicians (RCP) has also provided evidence to Nice in support of Wegovy after receiving over £100,000 in event sponsorship from Novo Nordisk in 2019-21. No sponsorship has been announced for Nice. RCP said it was supposed to provide the information voluntarily, but Novo Nordisk’s funding “had nothing to do” with the views she expressed, which were entirely based on her knowledge and experience.
Nice said it was evaluating evidence showing that some of those who provided her with expert opinions did not follow her “hard line policy” on declarations of interest.
“After the concerns expressed Observerwe are considering statements of interest from organizations and experts that provided advice to our committee that evaluated semaglutide. [Wegovy]”, – he said.
Novo Nordisk’s suspension is not expected to affect Wegovy’s adoption, and findings about the company’s practices are about its promotional activities, not the safety or effectiveness of its drug. But sources said the ABPI shutdown is likely to impact the company’s business operations. He will no longer have access to meetings or briefings by ABPI, which is the main voice of the pharmaceutical sector in the UK and lobbies the government on key industry issues. The company’s return to full membership will now depend on the results of further reviews in late 2023 and 2024, ABPI said.
On Friday, RCP announced that it was terminating its relationship with Novo Nordisk due to the suspension of ABPI. The college said it would return unpaid grants to the company and “suspend projects associated with these funds,” including a drugmaker-funded obesity scholarship program.
RCP said it has “stringent criteria” for corporate partnerships. “The main element of this policy is the requirement for pharmaceutical companies to fully comply with the ABPI Code, which Novo Nordisk currently does not comply with,” the statement says.
Novo Nordisk said it was “disappointed” with the suspension of ABPI, but has accepted the decision. “We will continue to strengthen our compliance system in the UK and remain committed to adhering to the ABPI code of practice and maintaining the highest ethical standards required by the pharmaceutical industry,” the release reads. The company rejected the complainant’s suggestion that its efforts to promote its weight loss drug amounted to bribery.
Concerning Observers After discovering that the company had financial ties to people who continued to praise Wegovy, Novo Nordisk said it was operating in a “transparent and ethical manner” and that any suggestion that it was “intentionally acting outside of ethical or legal standards and due process” was “unreasonable”. and misleading.”
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WASHINGTON. Science writer Nicholas Wade arrived on Capitol Hill Wednesday to testify before a Republican commission on the origins of the coronavirus, but was instead asked questions about “Troubled Legacy”, his controversial 2014 book on race and genetics, which Democrats noted was endorsed by notorious racist and anti-Semite David Duke, as well as other white supremacists.
“I have nothing to do with white supremacist views,” Wade said at one point during the hearing.
“However, they love you,” retorted Rep. Kweisi Mfume, M.D., arguing that Wade’s presence was an affront to any legitimate inquiry into the origins of the coronavirus — the subject of Wednesday’s hearing.
Former NAACP head Mfume said he was “appalled that this hearing is now about race.”
Writer Nicholas Wade testifies Wednesday before a House subcommittee on the coronavirus pandemic. (Chip Somodeville/Getty Images)
Visibly trembling, Mfume told Wade that he was “absolutely offended that you will have the opportunity to take this platform and add something important to it.”
A tense exchange has cast doubt on whether inviting Wade to testify at the first hearing of the House Subcommittee on the Coronavirus Pandemic was an effective move by the Republican majority, which seeks to legitimize the notion that the coronavirus was the product of a lab accident in China.
Wade proponent of this hypothesisbut his past writings on genetics and race seem to have frustrated his attempts to focus the conversation on the pandemic.
The committee’s leading Democrat, Rep. Raul Ruiz of California, used his opening statement to discredit Wade. “His participation undermines the credibility of this hearing,” he said.
Briefly, Capitol Hill was plunged into a nearly decade-old controversy, though the topics understandably continue to stir deep passions today.
A native of England and a graduate of Cambridge, Wade has worked for the prestigious Science magazine.and naturein the late 1970s and early 80s, by which point he had settled in the United States. Hello joined the New York Times in 1982. and will remain in the newspaper for 30 years.
Rep. Raul Ruiz, D-Calif., expresses concern that the subcommittee has invited Wade to testify. (Chip Somodeville/Getty Images)
Wade has written several books in his career, but none have been as explosive as his 2014 foray into the connection between race and genetics—a connection that by then many came with a discount.
In an attempt to repair the disputed correlation, Wade ventured into some of the most obscene areas of what was once known as scientific expertise. (His supporters would say that he was dragged into this dangerous territory by detractors who had not actually read his book, but some of those critics appeared to be familiar with his arguments.)
Racial Science was a favorite pastime of the Nazis, who sought to collect evidence, such as the shape of the skull, to prove that Jews and other people of non-European descent were inherently inferior. eugenicists in the United States, similar arguments were used to try to restrict immigration or expand civil rights for blacks.
While racial differences may seem huge culturally and socially, genetic differences between populations are actually quite insignificant.
Wade objected to this prevailing view. Intending to “demystify the genetic basis of race”, he attempted to describe distinct racial groups that he claimed originated in Africa, Europe, and East Asia. He then attempted to explain how the three groups evolved different genomes and how these differences shape their respective cultures.
These explanations have led to some highly suspicious claims, such as that the Jews were uniquely “adapted to capitalism” – a classic anti-Semitic cliché. Meanwhile, people of African descent, according to Wade’s analysis, had a “violent propensity”.
During Wednesday’s hearing, Wade was asked questions about his controversial 2014 book on race and genetics, A Troubled Legacy. (Chip Somodeville/Getty Images)
The mainstream reaction to the book was harsh. IN his reviewThe Times called A Troubled Legacy a “deeply flawed, misleading and dangerous book” that gives racists license while accused Wade trade in “marginal racist theories masquerading as mainstream biology”. American conservative found the book unconvincing.
IN letter to the New York Times Book ReviewHe was accused by 139 scientists (including many whose work Wade cited) of “misappropriating” research results to advance discrediting arguments. They stated that “in the field of population genetics, Wade’s hypotheses are not supported.”
He hit the news again with the advent of the coronavirus, becoming one of the first science writers to speak out against the plausibility of the prevailing view that the pathogen originated from an animal before it entered the human population, most likely in the U.S. wildlife market. Chinese city of Wuhan.
Wade detailed the case for the so-called laboratory leak theory. Average post in May 2021. This article remains a milestone for other skeptics of the official Chinese version. However, many scientists believe that the virus originated in animals and then passed to humans.
Wade strenuously defended his record – and his book – on Wednesday. “It was a decidedly non-racist book. As far as I know, there are no scientific errors in it. It contains no racist statements. It emphasizes the theme of unity,” he told the deputies sitting in front of him.
But his Democratic critics remained unconvinced, while some supporters of the lab leak hypothesis expressed frustration on social media that the important question of the origin of the coronavirus is being obscured.
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