weight loss drugs

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

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

compounding pharmacies, eli lilly, fda, health, mounjaro, Novo Nordisk, Ozempic, safety, Science, wegovy, weight loss drugs, zepbound / /

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.

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

eli-lilly-raises-price-of-zepbound-while-trumpeting-discount-on-starter-vials

Eli Lilly raises price of Zepbound while trumpeting discount on starter vials

bernie sanders, drug prices, eli lilly, GLP-1, health insurance, lilly, prescription drugs, sanders, Science, weight loss drugs, zepbound / /

Pharma misdirection —

Cost for insured patients without coverage for the drug rises from $550 to $650 a month.

–

An Eli Lilly & Co. Zepbound injection pen arranged in the Brooklyn borough of New York, US, on Thursday, March 28, 2024.

Enlarge / An Eli Lilly & Co. Zepbound injection pen arranged in the Brooklyn borough of New York, US, on Thursday, March 28, 2024.

Pharmaceutical giant Eli Lilly earned praise this week with an announcement that it is now selling starter dosages of its popular weight-loss drug tirzepatide (Zepbound) at a price significantly lower than before. But the cheers were short-lived as critics quickly noticed that Lilly also quietly raised the price on current versions of the drug—a move that was notably missing from the company’s press release this week.

In the past, Lilly sold Zepbound only in injectable pens with a list price of $1,060 for a month’s supply. Several dosages are available—2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg—and patients progressively increase their dosage until they reach a maintenance dosage. The recommended maintenance dosages are 5 mg, 10 mg, or 15 mg. The higher the dose, the more the weight loss. For instance, people using the 15 mg doses lost an average of 21 percent of their weight over 17 months in a clinical trial, while those on 5 mg doses only lost an average of 15 percent of their weight.

On Tuesday, Lilly announced that it will now sell Zepbound in vials, too. And a month’s supply of vials with the 2.5 mg doses will cost $399, while a month’s supply of 5 mg doses is priced at $549—a welcome drop from the $1,060 price tag. These prices are for a self-pay option, meaning that patients with a valid, on-label prescription can buy them directly from Lilly if they have no insurance or have insurance that does not cover the drug.

“This new option helps millions of adults with obesity access the medicine they need,” Lilly said in its announcement of the vials and their prices.

The company also included a quote from James Zervos, chief operating officer of the nonprofit Obesity Action Coalition. “Expanding coverage and affordability of treatments is vital to people living with obesity,” Zervos said. “We commend Lilly for their leadership in offering an innovative solution that brings us closer to making equitable care a reality.” Even President Biden chimed in on social media, saying he was “pleased” by the discount, though he urged drug companies to cut prices “across the board.”

“No rational reason, other than greed”

But, that wasn’t the end of the news. When Lilly released its press release, people noticed that the company had also increased the price of Zepbound pens for those who have insurance plans that don’t cover the drug. In the past, Lilly offered a “savings card” that allowed these patients to buy a month’s supply of any dosage of Zepbound pens for $550. Now the price is $650, a nearly 20 percent increase.

Lilly did not respond to Ars’ request for comment or questions about why the company increased the price for some patients.

Sen. Bernie Sanders (I-Vt.), a longtime critic of the pharmaceutical industry and their drug pricing, was quick to weigh in. He called the vial prices a “modest step forward” but noted that, even with the price reduction, millions of Americans still won’t be able to pay for the drug. At $549 a month, the price of the drug is a little over the average monthly payment for a used car, which was $523 in the first quarter of this year, according to Experian. As for the increase in pen pricing, Sanders called it “bad news.”

“In addition, Eli Lilly has still refused to lower the outrageous price of Mounjaro that Americans struggling with diabetes desperately need,” Sanders went on. “There is no rational reason, other than greed, why Mounjaro should cost $1,069 a month in the United States but just $485 in the United Kingdom and $94 in Japan.”

In May, a Senate committee report concluded that uptake of such weight-loss and diabetes drugs stands to “bankrupt our entire health care system,” given the high prices and large demand in the US. The report was produced by the Senate’s Health, Education, Labor, and Pensions (HELP) committee, which is chaired by Sanders.

Eli Lilly raises price of Zepbound while trumpeting discount on starter vials Read More »

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

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

cancer, GLP-1, obesity-related cancer, Ozempic, Science, Type 2 diabetes, wegovy, weight loss, weight loss drugs / /

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.

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