FDA panel votes in favor of OTC birth control

After discussing concerns about patients’ ability to follow directions, the panel voted unanimously (17-0) to recommend the FDA approve Perrigo’s Opill for over-the-counter sales.

This is the advisory panel; the FDA itself will probably make its decision this summer.

DEA postpones telehealth rule till late 2024

It’s official, sorta — the DEA says it will keep its “telehealth flexibility” rules in place, or at least grandfather in anyone using them today. Meaning “Any existing provider-patient telehealth relationship established before Nov. 11, 2023 then can continue through November 2024.”

So if you have telehealth patients who get controlled meds, let them know they’re set till at least then.

When the orphan is Bruce Wayne

If a company gets a big ol’ tax credit to develop a drug for a rare disease, but then that drug turns out to be a blockbuster of a money-maker, should the drug companies have to pay the taxes? Yes, argue Harvard researchers. What they found is that “drugs ini­tial­ly ap­proved for an or­phan des­ig­nat­ed con­di­tion were just as lu­cra­tive for their man­u­fac­tur­ers as drugs de­vel­oped for more com­mon con­di­tions.”

So how could the rare dis­ease drugs be just as lu­cra­tive? The aca­d­e­mics point to high­er launch prices, and from 2008 to 2018, launch prices for or­phan-des­ig­nat­ed drugs were sev­en times high­er than for non-or­phan drugs, they wrote.

Their suggestion was simple: “[Require] man­u­fac­tur­ers to re­pay tax cred­its when or­phan-des­ig­nat­ed prod­ucts are com­mer­cial suc­cess­es.”

A lifelong Covid vax?

Even the latest, Omicron-specific Covid vaccinations only last about 9 months, according to the latest data. (Ditto for immunity gotten from infection.)

But Rutgers researchers^*, tired of the thought of getting boosters, say they have an alternative: A new vaccine they developed and tested in animals that they say might “[provide] years of robust protection with fewer booster shots against a variety of SARS-CoV-2 strains.”

Called MT-001, it seems to “elicit ‘broadly neutralizing’ antibodies that confer protection against SARS-CoV-2 strain variants currently circulating in the human population and future variants that have not yet appeared.”

“In theory, it’s possible that a booster shot of our variant-updated version of MT-001 could provide lifelong protection. The animal data indicate that it should, at the very least, provide protective antibody levels for at least a year or more, which is a vast improvement over today’s vaccines

They also say it’s inexpensive to make and doesn’t require special cold storage.

^* I always say that in a Scooby-Doo voice

Polypharma and stimulants

Be on the lookout for patients who are taking stimulants along with drugs like benzos, opioids, or antidepressants. Johns Hopkins researchers are concerned about the number of patients taking two or more drugs that affect the central nervous system.

Close to half of the stimulant users were taking an antidepressant, while close to one third filled prescriptions for anxiolytic/sedative/hypnotic meditations, and one fifth received opioid prescriptions.

Stimulants work for ADHD, sure, but their concern is that they’re being used off-label not as a monotherapy as intended by as an unproven combo therapy. “[B]ecause there are so few studies of these kinds of combination therapy, both the advantages and additional risks remain unknown.”

How statins work

Statins are ostensibly for treating high cholesterol by targeting the liver, but they also seem to have a wide range of other benefits — clearing arteries, reducing inflammation, and more.

How does one class of drug do so much for the cardiovascular system? Stanford researchers think they have the answer. It seems that statins help keep flexible endothelial cells in the lining of blood vessels from becoming rigid mesenchymal cells.

[E]ndothelial cells treated with simvastatin in a dish formed more capillary-like tubes, a sign of their enhanced ability to grow into new blood vessels.

The science is complex to say the least, but the gist is that statins affect the expression of certain genes that affect vascular function, and they even reduce the potential for developing cancer cells.

With the mechanism unearthed, the next step is to develop even more targeted drugs for cardiovascular issues.

Short Takes

Yet another GLP-1 drug

The latest almost-entry into the weight loss drug bonanza comes from Boehringer Ingelheim and Zealand Pharma, which have a drug called BI 456906 that just completed phase-2 (“What’s the right dose?”) trials. Like the others in the category, it does a pretty good job: “up to 14.9% weight loss after 46 weeks.” Of course it has to be taken for life.

Pancreatic cancer predictor

Those shifty Danes — along with Harvard scientists — have developed an artificial intelligence that can predict when someone is at high risk of pancreatic cancer three years before it’s diagnosed.

The computer found combinations of diseases (and their timing), often with nothing to do with the pancreas, that nevertheless indicated at-risk patients.

One particular advantage of the AI tool is that it could be used on any and all patients for whom health records and medical history are available, not just in those with known family history or genetic predisposition for the disease.