Ozempic

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Maker of weight-loss drugs to ask Trump to pause price negotiations: Report

Popular prescriptions

For now, Medicare does not cover drugs prescribed specifically for weight loss, but it will cover GLP-1 class drugs if they’re prescribed for other conditions, such as Type 2 diabetes. Wegovy, for example, is covered if it is prescribed to reduce the risk of heart attack and stroke in adults with either obesity or overweight. But, in November, the Biden administration proposed reinterpreting Medicare prescription-coverage rules to allow for coverage of “anti-obesity medications.”

Such a move is reportedly part of the argument Lilly’s CEO plans to bring to the Trump administration. Rather than using drug price negotiations to reduce health care costs, Ricks aims to play up the potential to reduce long-term health care costs by improving people’s overall health with coverage of GLP-1 drugs now. This argument would presumably be targeted at Mehmet Oz, the TV presenter and heart surgeon Trump has tapped to run the Centers for Medicare and Medicaid Services.

“My argument to Mehmet Oz is that if you want to protect Medicare costs in 10 years, have [the Affordable Care Act] and Medicare plans list these drugs now,” Ricks said to Bloomberg. “We know so much about how much cost savings there will be downstream in heart disease and other conditions.”

An October report from the Congressional Budget Office strongly disputed that claim, however. The CBO estimated that the direct cost of Medicare coverage for anti-obesity drugs between 2026 and 2034 would be nearly $39 billion, while the savings from improved health would total just a little over $3 billion, for a net cost to US taxpayers of about $35.5 billion.

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Drugmaker shut down after black schmutz found in injectable weight-loss drug

It’s unclear how widely the pharmacy’s drugs were distributed. Fullerton Wellness could not be reached for comment.

Bigger battles

This is just the latest warning on weight-loss drugs from the FDA, which has repeatedly cautioned about quality and safety problems related to compounded versions of the drugs. The compounded drugs are intended to be essentially copycat versions of the blockbuster brand-name drugs. Compounding pharmacies can make copycat versions only as long as the drugs are in short supply, acting as a stopgap for patient access. But, with the popularity of the drugs and the high prices of the brand name versions, compounded formulations have become seen as affordable alternatives for many patients.

The situation has become a legal quagmire, with less-than-scrupulous compounding facilities drawing the ire of the FDA, and the big pharmaceutical companies fighting with their compounding competition. Eli Lilly, maker of Zepbound and Mounjaro (tirzepatide), and Novo Nordisk, maker of Wegovy and Ozempic (semaglutide), have both sued multiple compounding pharmacies over copycat versions of their lucrative drugs, which they claim are unsafe and fraudulent.

Meanwhile, in October, a trade organization for large-scale compounding pharmacies sued the FDA after the regulator removed tirzepatide from the drug shortage list, a move that blocks compounders from making copycat versions of the drug. But, the FDA quickly backpedaled in court, saying it would reconsider the removal and would allow compounders to keep producing off-brand versions in the meantime.

Also in October, Novo Nordisk asked the FDA to stop letting compounders make copycat versions of semaglutide, arguing that the drug is too complex for compounders to make and poses too many safety risks to patients. In response, the trade organization for compounders, the Outsourcing Facilities Association, submitted a letter to the FDA asking it to require Novo Nordisk to provide an economic impact statement to assess the cost and price increases that could occur if semaglutide were no longer available through compounding pharmacies.

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Buying shady weight loss drugs online is a bad idea, in case you were wondering

buyer beware —

Risk assessment study of illegal online pharmacies offers some unsurprising data.

Buying shady weight loss drugs online is a bad idea, in case you were wondering

Buying counterfeit weight loss drugs from illegal online pharmacies that don’t require prescriptions is, in fact, a very bad idea, according to a study published Friday in JAMA Network Open.

The counterfeit drugs are sold as equivalents to the blockbuster semaglutide drugs, Ozempic and Wegovy, which are prescription only. When researchers got their hands on three illegal versions, they found that the counterfeit drugs had low-purity semaglutide, had dosages that exceeded the labeled amount, and one had signs of bacterial contamination.

The three substandard drugs tested came from three different illegal online pharmacies, which sold them as generic semaglutide drugs for weight loss, appetite suppression, diabetes, and cardiovascular health. However, the researchers, led by scientists at the University of California, San Diego, and the University of Pécs in Hungary, had initially tried purchasing counterfeit drugs from six such sellers.

Three of the illegal pharmacies, which specifically sold Ozempic knockoffs, never delivered the drugs after researchers paid for them. Instead, the researchers were hit with “nondelivery” scams, in which the sellers requested additional, hefty payments, supposedly needed to get through customs. These extra fees ranged from $650 to $1,200—much more than what the researchers paid for small dosages of the counterfeit drugs, which ranged from $113 to $360 across the six sellers.

Rogue pharmacies

The Ozempic scams were run out of the rogue online pharmacies: weightcrunchshop.com, puremedsonline.com, and genius-pharmacy.com. The three pharmacies that delivered dubious drugs included semaspace.com, uschemlabs.com, and biotechpeptides.com.

Two of the sellers—semaspace.com and uschemlabs.com—have already received warning letters from the Food and Drug Administration for selling unapproved, misbranded drugs. At the time of publication, the Semaspace website was no longer reachable. The US Chem Labs site was still available, but their semaglutide vials were all listed as out of stock.

The study’s findings, while unsurprising, highlight the risk people may take in efforts to get hold of the popular drugs. Steep prices, lack of insurance coverage, and drug shortages have kept the drugs out of reach for many who could benefit from them. Compounding pharmacies have stepped in to make copycat versions. While these are legal and can come from legitimate pharmacies—ones that are properly registered and require prescriptions—they also carry risks. Compounded drugs are not approved by the FDA and may pose safety and efficacy risks. Last week, the FDA warned of increasing reports of people overdosing on semaglutide products made in compounding pharmacies, leading some patients to be hospitalized.

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New weight-loss and diabetes drugs linked to lower risk of 10 cancers

Secondary benefits —

For diabetes patients, GLP-1 drugs linked to lower cancer risks compared to insulin.

Ozempic is a GLP-1 drug for adults with type 2 diabetes.

Enlarge / Ozempic is a GLP-1 drug for adults with type 2 diabetes.

For patients with Type 2 diabetes, taking one of the new GLP-1 drugs, such as Ozempic, is associated with lower risks of developing 10 out of 13 obesity-associated cancers as compared with taking insulin, according to a recent study published in JAMA Network Open.

The study was retrospective, capturing data from over 1.6 million patients with Type 2 diabetes but no history of obesity-associated cancers prior to the study period. Using electronic health records, researchers had follow-up data for up to 15 years after the patients started taking either a GLP-1 drug, insulin, or metformin between 2008 and 2015.

This type of study can’t prove that the GLP-1 drugs caused the lower associated risks, but the results fit with some earlier findings. That includes results from one trial that found a 32 percent overall lower risk of obesity-associated cancers following bariatric surgery for weight loss.

In the new study, led by researchers at Case Western Reserve University School of Medicine, some of the GLP-1-associated risk reductions were quite substantial. Compared with patients taking insulin, patients taking a GLP-1 drug had a 65 percent lower associated risk of gall bladder cancer, a 63 percent lower associated risk of meningioma (a type of brain tumor), a 59 percent lower associated risk for pancreatic cancer, and a 53 percent lower associated risk of hepatocellular carcinoma (liver cancer). The researchers also found lower associated risks for esophageal cancer, colorectal cancer, kidney cancer, ovarian cancer, endometrial cancer, and multiple myeloma.

Compared with insulin, the researchers saw no lowered associated risk for thyroid and breast cancers. There was a lower risk of stomach cancer calculated, but the finding was not statistically significant.

Gaps and goals

The GLP-1 drugs did not show such promising results against metformin in the study. Compared with patients taking metformin, patients on GLP-1 drugs saw lower associated risks of colorectal cancer, gall bladder cancer, and meningioma, but those calculations were not statistically significant. The results also unexpectedly indicated a higher risk of kidney cancer for those taking GLP-1 drugs, but the cause of that potentially higher risk (which was not seen in the comparison with insulins) is unclear. The researchers called for more research to investigate that possible association.

Overall, the researchers call for far more studies to try to confirm a link between GLP-1 drugs and lower cancer risks, as well as studies to try to understand the mechanisms behind those potential risk reductions. It’s unclear if the lower risks may be driven simply by weight loss, or if insulin resistance, blood sugar levels, or some other mechanisms are at play.

The current study had several limitations given its retrospective, records-based design. Perhaps the biggest one is that the data didn’t allow the researchers to track individual patients’ weights throughout the study period. As such, researchers couldn’t examine associated cancer risk reductions with actual weight loss. It’s one more aspect that warrants further research.

Still, the study provides another promising result for the blockbuster, albeit pricy, drugs. The researchers suggest extending their work to assess whether GLP-1 drugs could be used to improve outcomes in patients with Type 2 diabetes or obesity who are already diagnosed with cancer, in addition to understanding if the drugs can help prevent the cancer.

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Drugmaker to testify on why weight-loss drugs cost 15x more in the US

On second thought —

Bernie Sanders cancels subpoena vote.

Lars Fruergaard Jorgensen, chief executive officer Novo Nordisk A/S, during an interview at the company's headquarters in Bagsvaerd, Denmark, on Monday, June 12, 2023.

Enlarge / Lars Fruergaard Jorgensen, chief executive officer Novo Nordisk A/S, during an interview at the company’s headquarters in Bagsvaerd, Denmark, on Monday, June 12, 2023.

After some persuasion from Sen. Bernie Sanders (I-Vt.), the CEO of Novo Nordisk will testify before lawmakers later this year on the “outrageously high cost” of the company’s diabetes and weight-loss drugs—Ozempic and Wegovy—in the US.

CEO Lars Jørgensen will appear before the Senate Committee on Health, Education, Labor, and Pensions (HELP), which is chaired by Sanders, in early September. The agreement came after a conversation with Sanders in which the CEO reportedly “reconsidered his position” and agreed to testify voluntarily. As such, Sanders has canceled a vote scheduled for June 18 on whether to subpoena Novo Nordisk to discuss its US prices, which are considerably higher than those of other countries.

The independent lawmaker has been working for months to pressure Novo Nordisk into lowering its prices and appearing before the committee. In April, Sanders sent Jørgensen a letter announcing an investigation into the prices and included a lengthy set of information requests. In May, the committee’s investigation released a report suggesting that Novo Nordisk’s current pricing threatens to “bankrupt our entire health care system.”

Sanders has repeatedly hammered not only the high prices of Novo Nordisk’s two blockbuster drugs but also the huge disparity between US prices and those in other countries.

Up to 15x more in the US

“Novo Nordisk currently charges Americans with type 2 diabetes $969 a month for Ozempic, while this same exact drug can be purchased for just $155 in Canada and just $59 in Germany,” Sanders wrote in April. “Novo Nordisk also charges Americans with obesity $1,349 a month for Wegovy, while this same exact product can be purchased for just $140 in Germany and $92 in the United Kingdom.”

Yale researchers, meanwhile, published a study in JAMA in March estimating that both drugs could be manufactured for less than $5.

In May, Novo Nordisk responded with a letter to Sanders, arguing that blame for high prices in the US lies with the country’s complex health system and with middle managers who take cuts, according to Bloomberg. Novo Nordisk said in the letter that it is prepared to address “systemic issues so that everyone who can benefit from its medicines is able to get them,” the outlet reported. The company also said it has spent over $10 billion on research and development to bring Wegovy and Ozempic to the market.

Still, that number is small in comparison to the projected revenue from the drugs. Bloomberg noted that analysts estimate that Novo Nordisk will make $27 billion from the two drugs this year alone. The May analysis by the HELP committee found that if just half of the adults in the US with obesity start taking a new weight-loss drug, such as Wegovy, the collective cost would be around $411 billion per year. Another report by the Congressional Budget Office found that the drugs’ costs are so high that they will not be offset by any financial gains from improved health outcomes.

“The Committee looks forward to Mr. Jørgensen explaining why Americans are paying up to 10 or 15 times more for these medications than people in other countries,” Sanders said last week.

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The next food marketing blitz is aimed at people on new weight-loss drugs

GLP-1 friendly —

Taking a weight-loss drug? Food makers have just the new food for you.

The next food marketing blitz is aimed at people on new weight-loss drugs

As new diabetes and weight-loss drugs help patients curb appetites and shed pounds, food manufacturers are looking for new ways to keep their bottom lines plump.

Millions of Americans have begun taking the pricey new drugs—particularly Mounjaro, Ozempic, Wegovy, and Zepbound—and millions more are expected to go on them in the coming years. As such, food makers are bracing for slimmer sales. In a report earlier this month, Morgan Stanley’s tobacco and packaged food analyst Pamela Kaufman said the drugs are expected to affect both the amounts and the types of food people eat, taking a bite out of the food and drink industry’s profits.

“In Morgan Stanley Research surveys, people taking weight-loss drugs were found to eat less food in general, while half slashed their consumption of sugary drinks, alcohol, confections and salty snacks, and nearly a quarter stopped drinking alcohol completely,” Kaufman said. Restaurants that sell unhealthy foods, particularly chains, may face long-term business risks, the report noted. Around 75 percent of survey respondents taking weight-loss drugs said they had cut back on going to pizza and fast food restaurants.

Some food makers aren’t taking the threat lightly. On Tuesday, the massive multinational food and beverage conglomerate Nestlé announced a new line of frozen foods, called Vital Pursuit, aimed directly at people taking GLP-1 weight-loss drugs (Wegovy and Ozempic). Nestlé—maker of DiGiorno frozen pizzas and Stouffer’s frozen entrées—said the new product line will include frozen pizzas, sandwich melts, grain bowls, and pastas that are “portion-aligned to a weight loss medication user’s appetite.” The frozen fare is otherwise said to contain fiber, “essential nutrients,” and high protein, food features not specific for people on GLP-1 drugs.

“As the use of medications to support weight loss continues to rise, we see an opportunity to serve those consumers,” Steve Presley, CEO of Nestlé North America, said in the product line announcement. “Vital Pursuit provides accessible, great-tasting food options that support the needs of consumers in this emerging category.”

Nestlé isn’t alone. At the end of last year, WeightWatchers began offering a membership program for people taking GLP-1 drugs. In January, meal delivery service Daily Harvest announced its “GLP-1 Companion Food Collection.” And last month, GNC announced a “GLP-1 support program” for people on the drugs, which includes a collection of various supplements, coaching, and consultations.

The companies seem to be heeding the advice of analysts. Morgan Stanley’s report noted that food makers can adapt to people’s changing diets by “raising prices, offering ‘better for you’ or weight-management products, or catering to changing trends with vegan or low-sugar options.” Kaufman noted that some companies are already adjusting by selling smaller packages and portions.

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Big Pharma hiked the price of 775 drugs this year so far: Report

up and up —

Meanwhile, Senate to consider subpoenas to force pharma CEOs testify on prices.

Sen. Bernie Sanders (I-Vt.).

Enlarge / Sen. Bernie Sanders (I-Vt.).

Pharmaceutical companies have raised the list prices of 775 brand-name drugs so far this year, with a median increase of 4.5 percent, exceeding the rate of inflation, according to an analysis conducted for the Wall Street Journal.

Drugmakers typically raise prices at the start of the year, and Ars reported on January 2 that companies had plans to raise the list prices of more than 500 prescription medications. The updated analysis, carried out by 46brooklyn Research, a nonprofit drug-pricing analytics group, gives a clearer picture of pharmaceutical companies’ activities this month.

High-profile drugs Ozempic (made by Novo Nordisk) and Mounjaro (Eli Lilly), both used for Type II diabetes and weight loss, were among those that saw price increases. Ozempic’s list price went up 3.5 percent to nearly $970 for a month’s supply, while Mounjaro went up 4.5 percent to almost $1,070 a month. The annual inflation rate in the US was 3.4 percent for 2023.

The asthma medication Xolair (Novartis) and the Shingles vaccine Shingrix (GlaxoSmithKline) saw price increases above 7.5 percent, the Wall Street Journal noted. The highest prices were around 10 percent. For some drugs, the single-digit percentage increases can equal hundreds or even thousands of dollars. For instance, the cystic fibrosis treatment Trikafta (Vertex Pharmaceuticals) went up 5.9 percent to $26,546 for a 28-day supply. And the psoriasis therapy Skyrizi (AbbVie) saw an increase of 5.8 percent, bringing the price to $21,017.

Lawmakers’ responses

The list price is typically not the price that people and health insurance plans pay, and pharmaceutical companies say they sometimes don’t make more money from raising list prices. Instead, they argue that the higher list prices allow them to negotiate large discounts and rebates from pharmacy middle managers, whose revenue and dealings are opaque. Drugmakers who spoke with the Wall Street Journal attributed this year’s price hikes to market conditions, inflation, and the value the drugs provide. Overall, the tactics increase the cost of health care.

The hefty hikes come as the federal government is trying to crack down on the high prices of drugs in the US, which pays far more for prescription medications than other high-income countries. Last year, Medicare began, for the first time, negotiating the prices of 10 costly drugs. The negotiations were a provision of the 2022 Inflation Reduction Act. And a provision in 2021’s American Rescue Plan Act now forces drugmakers to pay Medicaid large rebates if their drug price increases outpace inflation.

But, it’s not enough to provide Americans with relief from high drug prices. On Thursday, Stat reported that Senate health committee chair Bernie Sanders (I-Vt) took steps to subpoena pharmaceutical CEOs regarding a Congressional investigation on high drug prices. Sanders invited Johnson & Johnson CEO Joaquin Duato, Merck CEO Robert Davis, and Bristol Myers Squibb CEO Chris Boerner to testify—but only Boerner agreed, and only on the condition that he would not be the only CEO testifying. The trio were invited to a hearing titled “Why Does the United States Pay, By Far, The Highest Prices In The World For Prescription Drugs?,” which was originally scheduled for January 25. Now, Sanders will hold a committee vote on January 31 on whether to issue subpoenas for the CEOs of Johnson & Johnson and Merck. If the committee votes in favor, it will be the first time it has issued a subpoena in more than 40 years.

All three companies have sued the federal government over the new regulations requiring them to negotiate prices with Medicare. J&J and Merck accused Sanders of calling them to testify as retribution for their legal action.

“You have opted not for the most effective way of securing information relevant to the Committee’s important work on drug prices, but for a broad-ranging public spectacle, with witnesses you can question on pending litigation you disagree with,” Merck wrote to Sanders.

Sanders called the two CEOs’ refusal to testify “absolutely unacceptable.”

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