Enlarge / Lina Khan, chair of the Federal Trade Commission (FTC), testifies before the House Appropriations Subcommittee at the Rayburn House Office Building on May 15, 2024, in Washington, DC. (credit: Getty | Kevin Dietsch)

Firms that serve as intermediaries to negotiate and control prescription drug access in the US "wield enormous power," largely with "extraordinarily opaque" business practices, and may be "inflating drug costs and squeezing Main Street pharmacies" for profit, according to a searing interim report released Tuesday by the Federal Trade Commission.

Amid a national focus on America's uniquely astronomical drug costs, the FTC is taking aim at firms that largely work deep in the bowels of the country's labyrinthine health care system, well hidden from public understanding and scrutiny: pharmacy benefit managers (PBMs).

PBMs were initially hired by various payors—employers, health insurance companies, government health plans, and others—to manage prescription drug benefits through various plans. But PBMs have evolved over the years to also negotiate rebates from drugmakers, set reimbursements for dispensing pharmacies, and develop drug formularies (the list of drugs that a health plan covers.) While those functions alone grant PBMs a large amount of power, consolidation and integration over recent years has concentrated that power in troubling ways, according to the FTC report.

Enlarge / Ozempic is a GLP-1 drug for adults with type 2 diabetes. (credit: Getty | Steve Christo)

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.

Enlarge / The Birthday Cake flavored bar.

One person may have died from eating Diamond Shruumz microdosing candies, which were recalled last week amid a rash of severe illnesses involving seizures, intubation, and intensive care stays.

According to an update this week from the Food and Drug Administration, the cluster of cases continues to increase across the country. To date, 48 people across 24 states have fallen ill after eating the candies, which include chocolate bars, gummies, and candy cones that were sold online and in retail locations, such as smoke and vape shops. Of the 48 people sickened, 46 were ill enough to seek medical care, and 27 were admitted to a hospital.

For now, the death noted in the FDA's latest update is only "potentially associated" with the candies and is still under investigation. No other information is yet available.

Enlarge / Tops of citrus sodas at a manufacturing plant. (credit: Getty | Vincent Mundy)

After more than five decades of limbo, the Food and Drug Administration on Wednesday revoked the authorization of brominated vegetable oil (BVO) in food, banning an additive long known to have toxic effects that is already banned in Europe, Japan, Australia, New Zealand, and California.

BVO—simply vegetable oil that is modified with bromine—has been used in foods since the 1920s. It has often been used as a stabilizer for fruit flavorings, particularly in citrusy beverages, including sodas, to keep the citrus flavoring from separating and floating to the top. The FDA authorized the use of BVO just after gaining the authority to regulate food additives in 1958. By the early 1960s, the FDA had put BVO on its first inventory of food additives it deemed generally safe—designated "generally recognized as safe" or GRAS. But safety concerns quickly surfaced, and by the late 1960s, the FDA had already limited its use to a flavoring stabilizer and capped the amount that could be used to 15 parts per million.

That 15-ppm limit was authorized on an "interim basis," pending more safety studies. In 1970, the FDA revoked the GRAS designation for BVO, but continued to allow the 15-ppm limit—on an interim basis—given that safety studies "did not indicate an immediate health threat from the limited use."

Enlarge (credit: Getty | Justin Sullivan)

The US government will pay Moderna $176 million to develop an mRNA vaccine against a pandemic influenza—an award given as the highly pathogenic bird flu virus H5N1 continues to spread widely among US dairy cattle.

The funding flows through BARDA, the Biomedical Advanced Research and Development Authority, as part of a new Rapid Response Partnership Vehicle (RRPV) Consortium. The program is intended to set up partnerships with industry to help the country better prepare for pandemic threats and develop medical countermeasures, the Department of Health and Human Services said in a press announcement Tuesday.

In its own announcement on Tuesday, Moderna noted that it began a Phase 1/2 trial of a pandemic influenza virus vaccine last year, which included versions targeting H5 and H7 varieties of bird flu viruses. The company said it expects to release the results of that trial this year and that those results will direct the design of a Phase 3 trial, anticipated to begin in 2025.

Enlarge (credit: Getty | Pavlo Gonchar)

A federal grand jury has indicted an embattled Alzheimer's researcher for allegedly falsifying data to fraudulently obtain $16 million in federal research funding from the National Institutes of Health for the development of a controversial Alzheimer's drug and diagnostic test.

Hoau-Yan Wang, 67, a medical professor at the City University of New York, was a paid collaborator with the Austin, Texas-based pharmaceutical company Cassava Sciences. Wang's research and publications provided scientific underpinnings for Cassava's Alzheimer's treatment, Simufilam, which is now in Phase III trials.

Simufilam is a small-molecule drug that Cassava claims can restore the structure and function of a scaffolding protein in the brain of people with Alzheimer's, leading to slowed cognitive decline. But outside researchers have long expressed doubts and concerns about the research.

Enlarge (credit: Diamond Shruumz)

After weeks of reports of severe illnesses across the country, the maker of Diamond Shruumz microdosing chocolates, gummies, and candy cones has finally issued a recall. It covers all lots and all flavors of all the brand's products.

The illnesses have been marked by several severe symptoms, which notably include seizures, loss of consciousness, and the need for intubation and intensive care. To date, there have been 39 people sickened, including 23 hospitalizations across 20 states, according to the Food and Drug Administration and the Centers for Disease Control and Prevention. The FDA first issued a warning on the brand's chocolate bars on June 7, when there were reports of eight cases, including six hospitalizations, in four states.

Diamond Shruumz's parent company, Prophet Premium Blends, said in the recall notice that it had received only two complaints about the products to date and, upon receiving those complaints, reviewed recent laboratory analyses (Certificates of Analysis) of its products. According to the company, those CoAs noted "higher than normal amounts of muscimol," which is one of two key compounds found in hallucinogenic Amanita mushrooms. Muscimol "could be a potential cause of symptoms consistent with those observed in persons who became ill after eating Diamond Shruumz products," the company said in the recall notice.

Enlarge / Bees fly to their hive. (credit: Getty | Federico Gambarini)

In what may be the biological equivalent to getting struck by lightning, a very unlucky man in the Philadelphia area took a very rare bee sting directly to the eyeball—and things went badly from there.

As one might expect, the 55-year-old went to the emergency department, where doctors tried to extract the injurious insect's stinger from the man's right eye. But it soon became apparent that they didn't get it all.

Two days after the bee attack, the man went to the Wills Eye Hospital with worsening vision and pain in the pierced eye. At that point, the vision in his right eye had deteriorated to only being able to count fingers. The eye was swollen, inflamed, and bloodshot. Blood was visibly pooling at the bottom of his iris. And right at the border between the man's cornea and the white of his eye, ophthalmologists spotted the problem: a teeny spear-like fragment of the bee's stinger still stuck in place.

Enlarge / Stephen Ubl, president and chief executive officer of Pharmaceutical Research and Manufacturers of America (PhRMA), speaks during a Bloomberg Live discussion in Washington, DC, in 2017. (credit: Getty | Andrew Harrer)

After a series of decisive court losses, the pharmaceutical industry appears to be taking its fight against Medicare drug price negotiations directly to the people—and the White House is not impressed.

This week, the high-powered industry group PhRMA (the Pharmaceutical Research and Manufacturers of America) released two eye-catching attacks on federal efforts to lower America's singularly astronomical drug prices. In a press release Tuesday, PhRMA announced an analysis suggesting that the Medicare drug price negotiations—part of the Biden administration's 2022 Inflation Reduction Act—could actually cost some seniors and people with disabilities slightly more in out-of-pocket costs. The analysis, however, relies on a key—and questionable—assumption that the federal government will set price limits using the highest possible estimate for maximum fair prices in 2026.

Milliman, the consulting firm PhRMA commissioned to do the study, cautioned that the actual prices "will certainly vary due to differences in unit cost and utilization trend, 2026 benefit designs, and actual 2026 maximum fair prices."

Enlarge / Grace Bisch holds a picture of stepson Eddie Bisch who died as a result of an overdose on outside of the U.S. Supreme Court on December 4, 2023 in Washington, DC. The Supreme Court heard arguments regarding a nationwide settlement with Purdue Pharma, the manufacturer of OxyContin. (credit: Getty | Michael A. McCoy)

In a 5-4 ruling, the US Supreme Court on Thursday rejected an opioid settlement plan worth billions over the deal's stipulation that the billionaire Sackler family would get lifetime immunity from further opioid-related litigation.

While the ruling may offer long-sought schadenfreude over the deeply despised Sackler family, it is a heavy blow to the over 100,000 people affected by opioid epidemic who could have seen compensation from the deal. With the high court's ruling, the settlement talks will have to begin again, with the outcome and possible payouts to plaintiffs uncertain.

Between 1999 and 2019, as nearly 250,000 Americans died from prescription opioid overdoses, members of the Sackler family siphoned approximately $11 billion from the pharmaceutical company they ran, Purdue Pharma, maker of OxyContin, a highly addictive and falsely marketed pain medication, according to the high court's ruling. In 2007, amid the nationwide epidemic of opioid addiction and overdoses, Purdue affiliates pleaded guilty in federal court to falsely branding OxyContin as less addictive and less abusive than other pain medications. Out of fear of future litigation, the Sacklers began a "milking program," the high court noted, draining Purdue of roughly 75 percent of its assets.

Enlarge / A Diamond Shruumz chocolate bar, which comes in a variety of flavors. (credit: diamondshruumz.com)

The US Food and Drug Administration has identified a synthetic psychedelic compound as well as compounds from a potentially toxic plant in the Diamond Shruumz-brand microdosing candies linked to a growing number of severe illnesses nationwide that have included seizures, intubation, and admissions to intensive care units.

As of June 25, the case total has grown to 39, including 23 hospitalizations, across 20 states, the FDA and the Centers for Disease Control and Prevention reported.

It remains unclear what is in the candies and what may be causing the severe illnesses. Diamond Shruumz does not provide a full list of ingredients. The term "microdosing" and other marketing used by Diamond Shruumz suggests the candies contain a psychedelic compound, but the company does not name any. To figure it out, the FDA has been analyzing multiple samples of Diamond Shruumz-brand candies, including chocolates, gummies, and candy cones. On Tuesday, the FDA reported finding the synthetic psychedelic compound 4-AcO-DMT in the company's Dark Chocolate Bar and its Birthday Cake Chocolate Bar.

Enlarge (credit: Getty | RJ Sangosti)

After an MDMA therapy for post-traumatic stress disorder dramatically failed to impress Food and Drug Administration advisers earlier this month, researchers are moving forward with another psychedelic—a slow-release oral dose of the hallucinogenic drug ketamine—as a therapy for treatment-resistant depression.

In a mid-stage, randomized, placebo-controlled clinical trial, researchers tested slow-release ketamine pills, taken twice weekly. The trial, sponsored by New Zealand-based Douglas Pharmaceuticals, found ketamine to be safe compared with placebo. At the trial's highest dose, the treatment showed some efficacy against depression in patients who had previously tried an average of nearly five antidepressants without success, according to the results published Monday in Nature Medicine.

But the Phase II trial, which started with 231 participants, indicated that the pool of patients who may benefit from the treatment could be quite limited. The researchers behind the trial chose an unusual "enrichment" design to test the depression treatment. This was intended to thwart the high failure rates generally seen in trials for depression treatments, even in patients without treatment-resistant cases. But even after selecting patients who initially responded to ketamine, 59.5 percent of the enriched participants still dropped out of the trial before its completion, largely due to a lack of efficacy.

Enlarge / Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research within the Food and Drug Administration on March 18, 2021 in Washington, DC. (credit: Getty | Susan Walsh)

The Food and Drug Administration (FDA) on Thursday announced expanded approval for a gene therapy to treat Duchenne muscular dystrophy (DMD)—despite the fact that it failed a Phase III clinical trial last year and that the approval came over the objections of three of FDA's own expert review teams and two of its directors.

In fact, the decision to expand the approval of the therapy—called Elevidys (delandistrogene moxeparvovec-rokl)—appears to have been decided almost entirely by Peter Marks, Director of the FDA's Center for Biologics Evaluation and Research.

Elevidys initially gained an FDA approval last year, also over objections from staff. The therapy intravenously delivers a transgene that codes for select portions of a protein called dystrophin in healthy muscle cells; the protein is mutated in patients with DMD. Last year's initial approval occurred under an accelerated approval process and was only for use in DMD patients ages 4 and 5 who are able to walk. In the actions Thursday, the FDA granted a traditional approval for the therapy and opened access to DMD patients of all ages, regardless of ambulatory status.

Enlarge (credit: Diamond Shruumz)

Cases of illnesses linked to microdosing candies have more than doubled, with reports of seizures and the need for intubation, mechanical ventilation, and intensive care stays. But, there remains no recall of the products—microdosing chocolates, gummies, and candy cones by Diamond Shruumz—linked to the severe and life-threatening illnesses. In the latest update from the Food and Drug Administration late Tuesday, the agency said that it "has been in contact with the firm about a possible voluntary recall, but these discussions are still ongoing."

In the update, the FDA reported 26 cases across 16 states, up from 12 cases in eight states last week. Of the 26 reported cases, 25 sought medical care and 16 were hospitalized. No deaths have been reported.

Last week, the Centers for Disease Control and Prevention released a health alert about the candies. The agency noted that as of June 11, the people sickened after eating Diamond Shruumz candies presented to health care providers with a host of severe symptoms. Those include: central nervous system depression with sedation, seizures, muscle rigidity, clonus (abnormal reflex responses), tremor, abnormal heart rate (bradycardia or tachycardia), abnormal blood pressure (hypotension or hypertension), gastrointestinal effects (nausea, vomiting, or abdominal pain), skin flushing, diaphoresis (excessive sweating), and metabolic acidosis with increased anion gap (an acid-based disorder linked to poisonings).