Tags: wegovy | ozempic | obesity | novo nordisk

Wegovy, Ozempic Maker Showers Doctors With Money

Wegovy, Ozempic Maker Showers Doctors With Money
(Dreamstime)

Friday, 01 December 2023 07:04 AM EST

Dr. Lee Kaplan took the stage with an urgent message, telling fellow physicians they have a powerful weapon to fight the American obesity crisis: their prescription pads.

Counseling on diet and exercise alone has failed for decades, he told about 400 doctors taking his annual obesity course at a Boston-area hotel. Kaplan, a leading U.S. obesity specialist, urged them to turn to a new generation of weight-loss medicines, including Wegovy from Novo Nordisk , that could help tens of millions of overweight Americans.

Obesity, he said, should be treated as aggressively as other chronic diseases such as high blood pressure or diabetes – with lifelong prescriptions. “We are going to have to use these medications,” he said at the June gathering, “for as long as the body wants to have obesity.”

Kaplan’s solution for America’s weight problem closely tracks Novo Nordisk’s financial ambitions for Wegovy. The Danish drugmaker, long known for diabetes medicines, is transforming itself into the world’s biggest weight-loss company. Novo tells investors its target market is the 764 million people with obesity across the globe. Its most lucrative region is the United States, where more than two-thirds of adults are overweight or have obesity and drugs frequently command the highest prices worldwide. Novo charges U.S. customers $1,300 a month for the weekly injection.

Kaplan, the chief of obesity medicine at Dartmouth College’s medical school, is a powerful standard bearer for Novo’s case. Until last year, the 69-year-old gastroenterologist led the Obesity, Metabolism and Nutrition Institute at Massachusetts General Hospital and taught at Harvard Medical School. He’s also a highly paid messenger: Novo has spent $1.4 million on Kaplan for consulting work and travel between 2013 and 2022, according to a Reuters analysis of federal data.

Those payments are part of a campaign to convince U.S. doctors to make Wegovy one of the most widely prescribed drugs in history – and to persuade skeptical insurers to pay for it. Novo spent at least $25.8 million over the past decade on U.S. medical professionals to promote its two obesity drugs, Wegovy and Saxenda, the analysis found.

That total includes only payments that Novo reported it made specifically related to those two drugs; it sometimes paid far more to obesity specialists without naming any drug in the federal data. The money Novo reported paying Kaplan, for instance, included just $262,038 that the company classified as directly related to the two drugs, and $131,624 for an older diabetes medicine with the same active ingredient as Saxenda. Novo paid Kaplan $976,019 more without specifying any drug. Experts who study these industry payments say drugmakers have latitude on how to classify their spending on doctors.

Reuters examined Novo’s payments for speaking, consulting, food and travel, while excluding those for research. The analysis also excluded payments related to Ozempic, a Novo diabetes drug that is also wildly popular for weight loss because it has the same active ingredient as Wegovy.

Overall, at least 57 U.S. physicians each accepted at least $100,000 from Novo in payments associated with Wegovy or Saxenda over the period. They were an influential group: Forty-one were obesity specialists who run weight-management clinics, work at academic hospitals, write obesity-treatment guidelines or hold top positions at medical societies, according to a Reuters review of their credentials and publications.

Another speaker at the Cambridge conference was Dr. Donna Ryan, a Louisiana researcher and former president of The Obesity Society, a prominent group of clinicians and researchers. She has accepted more than $1 million from Novo over the last decade, including $600,691 related to Wegovy and Saxenda, the analysis found. Ryan was instrumental in persuading the U.S. Office of Personnel Management to cover Wegovy and similar drugs for millions of federal workers, an agency official told Reuters.

Pharmaceutical company payments to physicians for drug promotion, speeches and consulting are legal and common in the United States. Critics of the practice have long argued it encourages doctors to put corporate interests ahead of patients’ well-being.

Ryan and Kaplan said their work with drugmakers is essential to advancing care for a woefully undertreated chronic disease. The newest drugs are highly effective, they said, and drugmaker money does not compromise their medical advice.

“I don’t kowtow to the companies,” Kaplan said. “If I can’t defend what I’m doing as being both appropriate and ethical, then I shouldn’t be doing it.”

In a statement to Reuters, Novo said its work with medical professionals goes beyond drug marketing. “To prevent and defeat a serious chronic condition like obesity, we need to do more than supply the right medicine,” Novo said. “This is why we work with medical professionals, institutions and other experts to conduct research and educate and raise awareness about obesity, a condition that has long been underrecognized and misunderstood.”

Kaplan, Ryan and other Novo-financed colleagues have pushed for urgent prescribing of Wegovy and similar medicines to a large proportion of patients with obesity and for comprehensive coverage by government and private insurers. The company and some of its paid experts have called denying coverage tantamount to discrimination against people with obesity, rooted in the faulty notion that they are to blame for their condition.

The need for mass prescriptions and expansive coverage of these drugs remains a subject of fierce debate. Reuters interviewed 10 clinicians or researchers with obesity expertise who questioned the wisdom of dispensing these drugs so broadly, especially to the many overweight people without other weight-related conditions. They argue the medicines have serious side effects and require more study, and that wide adoption of such expensive drugs would impose crippling costs on the U.S. healthcare system.

Wegovy and similar drugs can cause severe nausea, muscle loss and the potential for intestinal blockages. They are being scrutinized by U.S. and European regulators over a possible link to suicidal thoughts. Some doctors warn that overprescribing these powerful drugs unnecessarily exposes patients to unknown risks that may take years to uncover.

Some specialists advise a more cautious approach, prescribing the drugs first to patients with severe obesity or serious weight-related conditions. The United Kingdom’s National Health Service has adopted that strategy in limiting eligibility. For these patients, the potential benefits outweigh the drugs’ risks and staggering costs, said Dr. Robert Lustig, a professor emeritus of pediatrics and endocrinology at the University of California at San Francisco.

“I’m not against the drugs; what I am against is the indiscriminate use of the drugs for everyone,” said Lustig, who has studied obesity for decades. “But that’s what the drug company wants, because that’s where the money is.”

'LIFELONG TREATMENT'

The excitement around these drugs, collectively known as GLP-1 receptor agonists, is understandable amid soaring global obesity rates.

Originally developed for diabetes, the medicines mimic a natural hormone that slows digestion and makes patients feel more full after eating. Novo is the first company to win approval to market GLP-1 drugs for weight loss. The U.S. Food and Drug Administration (FDA) approved Saxenda for that purpose in 2014 and Wegovy in 2021.

Wegovy, in conjunction with diet and exercise, helped people lose an average of 15% of their body weight in clinical trials. That’s far more than with previous drugs, including Saxenda, another injection with a different active ingredient, liraglutide. Novo also touts trial findings showing a 20% lower incidence of heart attack, stroke or death from heart disease among patients taking Wegovy compared to a placebo.

Such results have sparked a rush on Wegovy and Ozempic. Both drugs are in short supply. The booming sales have made Novo Europe’s most valuable company, worth about 420 billion euros ($457 billion).

Novo said less than 1 million U.S. patients were taking Wegovy as of early November, a number constrained by shortages, spotty insurance coverage and the fact that many people seeking weight loss take Ozempic, which has seen monthly prescriptions rise sharply in the past two years. Others take cheaper knock-offs.

Still, these drugs are a hard sell to many insurers, employers and government agencies. They’re reluctant to pay Novo’s steep price for a drug the company insists should be taken indefinitely. Novo’s trials showed patients who quit usually regained most of the weight.

That’s where Kaplan and other Novo-financed doctors play a role. The Reuters analysis provides unique insight into Novo’s campaign to recruit many of the country’s leading obesity specialists over a decade. Their advice, in training courses, medical conferences and publications, shapes how thousands of physicians treat patients nationwide.

Doctors often take Kaplan’s course, which lasts a few days, to satisfy continuing-education requirements or to prepare for certification in obesity medicine. Novo contributed $10,000 for Kaplan’s course this year.

Wegovy’s U.S. prescribing label, approved by regulators, recommends the drug for anyone with a body mass index (BMI) of 30 or higher, the threshold for obesity. The recommendation also extends to patients with a 27 BMI and at least one weight-related medical condition. In all, that would cover about 46% of American adults — about 120 million people.

One of the doctors accepting Novo money — Dr. Ania Jastreboff of Yale University’s Center for Weight Management — bemoaned the small proportion of overweight Americans taking weight-loss drugs compared to the 46% of eligible adults. She cited a study from 2016, before the latest wave of blockbuster GLP-1 drugs, that found just 2% of that group took weight-loss medicines.

$130K IN CONSULTING FEES

“That is abysmal,” Jastreboff told doctors at the June conference. “Is it OK to treat 2% of people with heart disease, or 2% of people with cancer or 2% of people with HIV or any other disease?”

Since 2017, Novo has highlighted that same 2% figure to Wall Street analysts to illustrate untapped demand. Jastreboff did not respond to requests for comment. In all, she has accepted nearly $130,000 in consulting fees and other payments from Novo since 2014.

At the conference, she emphasized keeping patients on medication long-term to prevent them from regaining weight. "Obesity is a chronic disease,” Jastreboff said. “That necessitates lifelong treatment."

Jastreboff has also worked on clinical trials of obesity drugs for Eli Lilly, which markets a Wegovy competitor. Lilly’s Zepbound, another GLP-1 drug, was approved in November for weight loss and has the same active ingredient as Lilly’s Mounjaro, a diabetes drug also commonly used for weight loss.

In a statement to Reuters, Lilly did not directly address the debate over how widely GLP-1 drugs should be prescribed and their high costs. The extent of Lilly’s payments to doctors to promote Zepbound are not yet clear in federal data because the drug is so new. Lilly said it works with doctors and other health providers on research, drug development and education because “obesity is a serious disease that is often misdiagnosed and mistreated due to misinformation and stigma.”

“We are proud of this work,” Lilly said, “and committed to transparency about it to maintain the trust of those using our medicines.”

Some obesity researchers say Novo’s paid experts go too far in calling for wide adoption. An estimated 40% of adults with obesity are “metabolically healthy,” according to a 2021 paper published in the Journal of the American Medical Association, which echoed the findings of some other recent studies. That means millions of patients might carry extra pounds without extra risk of serious conditions.

“There’s growing evidence that suggests a number on the scale doesn’t lead to poor metabolic health,” said Dr. Ayana April-Sanders, an epidemiologist at Rutgers University’s School of Public Health, who wrote a commentary published alongside the 2021 paper.

'WAY OVER THE LINE'

Reuters examined data from the federal Open Payments database, created more than a decade ago by the Affordable Care Act. Pharmaceutical and medical-device firms are required to report payments to doctors, other medical professionals and teaching hospitals for consulting, speaking, research, travel or meals. The intent of the reporting requirement was to shed light on these financial relationships and to help prevent conflicts of interest that can contribute to unnecessary care and costs.

The increased transparency hasn’t stemmed the flow of industry money. Companies’ annual payments have surged from $6.5 billion in 2014, the first full year data were collected, to $12.6 billion last year.

Some doctors said Novo’s payments exemplify how the flood of industry money can dominate decision-making about care and coverage.

Dr. Arthur Kellermann, a health administrator and former dean of the Uniformed Services University of Health Sciences, the U.S. military’s medical school, reviewed Reuters’ findings on Novo’s spending. The company’s large-scale payments to doctors, he said, illustrate a longstanding problem in the drug industry.

“The pharmaceutical industry still sees value in paying medical thought leaders to promote their products, and too many of them are happy to sign up for a six- or seven-figure check,” he said, calling such lavish payments “morally and ethically way over the line.”

“As sales grow, Medicare and the insurance industry come under intense pressure to pay for these hugely expensive drugs,” Kellermann said. “The end result is that everybody's healthcare costs go up.”

Kaplan, Ryan and other Novo-financed obesity experts dismissed any suggestion that they are pharmaceutical-company mouthpieces.

Kaplan said he accepts money from numerous companies and that he’s not beholden to any one drugmaker. Reuters found that Novo accounted for 64% of the $2.1 million he received overall from medical companies since 2013. Kaplan said that’s because Novo has been one of the few large drugmakers working in obesity for years.

He said some of the money paid expenses for a half-dozen obesity courses Kaplan provided for hundreds of Novo employees. “There is so much need for better education and what I like to call ‘obesity literacy,’” said Kaplan.

Ryan makes no apologies for taking industry money. She said the gravity of the obesity epidemic demands that doctors work closely with companies to help spur medical advances and expand treatment. “Being a purist isn’t helping anyone,” she said in an interview. “I'm proud of the work I've done on behalf of patients with obesity.”

MONEY & INFLUENCE

Novo’s money has flowed to doctors and researchers with broad influence over how weight-loss drugs are dispensed and covered.

Reuters examined Novo’s spending among experts involved in crafting five prominent sets of obesity-treatment guidelines for doctors. Among the 109 authors and reviewers credited in the guidelines, 53 had accepted cash or in-kind payments between 2013 and 2022 from companies that were selling or developing obesity drugs.

Novo accounted for $8 million of the $12.4 million spent on these authors and reviewers, not including payments related to research, the Reuters analysis found.

One of these doctors, Dr. Jamy Ard of Wake Forest University, is the incoming president of The Obesity Society. In that role, he will oversee the group’s effort to write new “standards of care,” which primary-care doctors often use as a quick-reference guide, with advice on Wegovy and similar therapies.

Ard, co-director of the Wake Forest Baptist Health Weight Management Center, said the new standards should also inform coverage decisions by insurers and policymakers. Ard told Reuters he believes the standards should emphasize that the medicines are a long-term treatment.

Ard has accepted more than $200,000 from Novo, the Reuters analysis found. He said The Obesity Society will disclose and manage any conflicts of interest among experts working on the standards, but that such conflicts are hard to avoid in the relatively small obesity field.

Ryan, the former Obesity Society president, helped run the Pennington Biomedical Research Center in Baton Rouge, Louisiana, for more than two decades. She has also conducted diabetes and obesity research for the U.S. National Institutes of Health and co-chaired an NIH panel that wrote guidelines for treating overweight adults.

Ryan was among the experts the U.S. Office of Personnel Management consulted on whether to change its obesity coverage for millions of federal employees, said the agency’s chief pharmacy officer, Dele Solaru.

“She was one of the experts that we reached out to when we were doing our background study,” Solaru told Reuters. “She is very well regarded.”

Ryan was eager to expand coverage for federal workers to include GLP-1 drugs because it could influence other major employers to follow suit, she said at the Cambridge conference. She shared research on the merits of obesity treatment and connected government officials with two key groups with drugmaker ties: the Obesity Action Coalition, a nonprofit advocacy group, and the STOP Obesity Alliance at George Washington University.

Novo, Eli Lilly and other drugmakers are corporate members of the alliance, donating at least $25,000 annually. Novo gave an additional $200,000 for research in 2021, the organization said.

STOP’s medical director is Dr. Scott Kahan, who spoke at Kaplan’s obesity course and plans to assist Ard on The Obesity Society’s updated guidelines. Kahan has accepted more than $300,000 from Novo in the past decade, the Reuters analysis found. He said he has sought to “minimize conflicts of interest.”

The Obesity Action Coalition also relies on funding from Novo, which is the organization’s top corporate donor at more than $500,000 annually, according to the group.

Ryan’s advocacy paid off. Government pharmacy officer Solaru said her agency concluded that the new obesity drugs could be cost-effective by preventing other weight-related diseases and boosting workplace productivity. In January, the personnel office told its health plans they must cover at least one GLP-1 obesity drug for 8 million workers, retirees and family members. The agency hasn’t provided cost projections.

The Obesity Action Coalition celebrated the federal decision as one of its top “advocacy successes.” A coalition spokesperson declined to comment further. Christine Gallagher, research project director at the STOP Obesity Alliance, said her group cites the federal-workers coverage policy “as an example to help influence other decision makers.”

The Office of Personnel Management said agency officials were aware that Ryan had worked with drug companies, which she discloses in research papers and elsewhere, but officials did not know she had accepted more than $1 million from Novo over the past decade. The agency said it based its decision on an objective review of research papers, clinical guidelines and trial results.

MIXED RESULTS, RISING RISKS

Wegovy has been life-changing for some patients. Rebekah Carl, 47, of New Columbia, Pennsylvania, called Wegovy a “godsend” after losing about 90 pounds since October 2021. She now weighs less than 140 pounds.

Carl said at first she had severe nausea, but managed it with another medication. As her weight came down, so did her blood sugar, blood pressure and cholesterol. Her chronic knee pain eased. “It really does affect everything,” she said. “The weight melted off. It’s so much easier to be active.”

Her insurance just agreed to cover Wegovy for another year, easing her worries about being cut off because of its cost, which she can’t afford to pay herself. “I’m absolutely relieved,” she said.

Some patients have not experienced the same success. Jen Wexler, a 31-year-old graphic designer in Florida, is about five feet tall and weighed 154 pounds when she started the drug in late 2021. She lost about 25 pounds in six months, but constant nausea and fatigue made exercise difficult. She didn’t like how she felt or looked; her face looked gaunt, older.

Wexler has regained 15 pounds since stopping Wegovy but feels healthier. She now focuses on eating well and exercising, including weight-lifting. “I’m more muscular,” she said. “I feel so much better.”

Many others have also tried and quit GLP-1 drugs for weight loss. Reuters reported in July that only a third of patients who started Wegovy, Ozempic or similar drugs for weight loss were still taking it a year later, according to a 2021 analysis of U.S. pharmacy claims. The study did not explore why people quit, but health experts cite side effects, shortages, high insurance co-pays and deductibles, or a failure to lose weight.

More health concerns are emerging as tens of thousands of new patients try these drugs each week.

Some patients have suffered rare side effects, such as stomach paralysis and intestinal blockage, from taking medicines containing semaglutide, the active ingredient in Wegovy and Ozempic, according to research published in October. In a statement to Reuters, Novo said the study had limitations and only reflected data collected up to 2020, the year before U.S. regulators approved Wegovy.

In June, the American Society of Anesthesiologists warned that patients taking GLP-1 drugs were at higher risk of a dangerous complication: aspiration during surgery. The slower digestion from the drugs could make patients more likely to regurgitate under anesthesia, the society said. Novo said its clinical-trial and post-marketing safety data have not shown a “causal association” between GLP-1 drugs and pulmonary aspiration.

One reason GLP-1 drugs are so effective is because they reach the brain. That may account for their effectiveness in influencing hunger signals, but could also increase risks of neuropsychiatric side effects, medical experts say.

U.S. and European regulators are studying whether GLP-1 drugs can cause suicidal thoughts. Reuters reported in September that at least 265 reports have been filed with the FDA since 2010 describing suicidal ideation or behavior in patients taking these drugs. Thirty-six reports described a death by suicide or suspected suicide.

Another concern stems from clinical trial results showing that patients taking Wegovy can lose a significant amount of muscle mass. This can be particularly harmful to older adults by exacerbating an age-related loss of strength or mobility, according to obesity specialists including Lustig, the San Francisco researcher.

“Starvation causes an equal loss of muscle and fat,” he said. “That is what these drugs do.”

Such risks could be managed, doctors say. But some patients are getting these medicines through telehealth companies and other providers with minimal screening and follow-up, according to obesity specialists including Dr. Courtney Younglove, medical director of Heartland Weight Loss clinic in Overland Park, Kansas. Patients on GLP-1 drugs, she said, need guidance on nutrition, strength training and mental health.

“Without a comprehensive lifestyle intervention and proper medical oversight, these drugs have the potential to do significant harm,” Younglove said.

Kaplan said that’s why he offers obesity courses to educate primary-care physicians and other providers. Kaplan acknowledged that unexpected side effects could emerge as many more patients take GLP-1 drugs.

“But the benefit to people with obesity is absolutely enormous,” he said. “I don’t think we should shy away from treatment.”

'NOTHING WRONG WITH MONEY'

While Novo pushes for big increases in Wegovy prescriptions, it has held firm on the drug’s lofty U.S. price. The company charges American consumers three or four times the price of those in Europe, where national health systems negotiate better drug prices, in contrast to the U.S. free-market approach.

Novo did not directly address the price differences but referred to a previous statement saying it understood many Americans struggled to pay for its medicines and it was “focused on working collaboratively toward sustainable solutions.”

U.S. insurers and pharmacy benefit managers usually get discounts and rebates from drugmakers, but they don’t disclose the amounts. Wegovy’s cost could still wreak havoc on health budgets and premiums, even with a substantial break on its $1,300-a-month list price, according to benefits consultants and health-policy experts.

Vanderbilt University researchers concluded in March that annual spending on Wegovy alone, with an estimated 23% discount, would total $27 billion to treat just 10% of patients with obesity enrolled in Medicare, the federal health program for the elderly. That would equal nearly a fifth of all current Medicare drug spending, after adjusting for rebates and discounts.

Novo has said Medicare should cover obesity medicines like it does for those treating any other serious disease. Failing to do so, it said, would “validate the stigma and bias that obesity patients face.”

Some federal officials and researchers question whether Novo’s promised future savings on weight-related disease treatment will ever cover the drug’s costs. Congressional Budget Office director Phillip Swagel challenged Novo’s argument in an Oct. 5 blog post, pointing to research showing federal spending did not decrease for patients who lost significant weight from bariatric surgery, an operation that typically makes the stomach smaller. Wisconsin’s state insurance board in May rejected a proposal, supported by Novo, for government-employee coverage after an analysis found that up to $14 million in annual obesity-drug spending would yield only $2 million in savings if members maintained a lower weight.

Ryan, one of Novo’s highest-paid experts, told doctors at the Cambridge conference that the emergence of such blockbuster drugs has been overwhelmingly positive for patients and investors. She cited a Wall Street firm’s report predicting billions of dollars in future drug sales, and said she was consulting with telehealth companies rushing into the field to focus on weight loss.

“There is nothing wrong with money,” Ryan said. “Look, we give a Nobel prize in economics, right? So money can really help. It can help promote good in the world.”

© 2024 Thomson/Reuters. All rights reserved.


StreetTalk
Dr. Lee Kaplan took the stage with an urgent message, telling fellow physicians they have a powerful weapon to fight the American obesity crisis: their prescription pads.
wegovy, ozempic, obesity, novo nordisk
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2023-04-01
Friday, 01 December 2023 07:04 AM
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