Statins vs depression

They don’t just lower cholesterol — it seems statins might also help lower depression. That’s what a British study found, looking at more than 2,000 people during the height (depth?) of the pandemic, when depression was the name of the game.

Okay, they didn’t find that it reduced depression directly. Rather, it made people less likely to interpret facial expressions as negative — and “reducing negative emotional bias can be important for the treatment of depression.”

Mercer breaks the ground

Congrats to Mercer’s College of Pharmacy, which just broke ground on the future home of its Moye Pharmacy and Health Sciences Center — named for GPhA member and 2012 Bowl of Hygeia recipient Tony Moye of McDonough (Mercer 1973), former owner of Moye’s Pharmacy and Home Health Care.

The new $36.8 million building — expected to be completed in late 2023 — will include “state-of-the-art classrooms, a clinical skills and simulation laboratory, dedicated spaces for students, and administrative offices” … and that’s just on the first floor. Add interactive* classrooms with ‘flexible and open designs,’ plus more offices and meeting spaces, and you’ve got a nice bit of architecture.

Tony is in the middle in the spiffy orange and black tie:

Need to know

… about Dupixent

Sanofi’s Dupixent asthma med was approved in 2018, and now Japanese researchers have some real-world data on its effectiveness. Yes, it works well. BUT (and there’s always a but) some patients experienced high eosinophil levels. So if you have patients who switch to Dupixent, suggest they keep an eye on their eosinophil levels.

… about Plan B

For obvious reasons, there’s been a lot of interest lately in Plan B (levonorgestrel), which works about 88 percent of the time to prevent conception after sex. BUT there’s a good chance it doesn’t work well for heavier women — notably those over 165 pounds. The studies are conflicting, and the FDA has no advice.

Interesting fact: According to the CDC, the average American woman over 20 weighs 171 pounds.

An automated naloxone patch

Indiana University engineers are working on a patch — about the size of the ones used for nicotine — that would detect an overdose in progress and administer naloxone.

It measures blood oxygen level, respiratory rate, pulse rate, and blood pressure. If someone is about to develop respiratory depression, it uses sound waves and microneedles to dispense naloxone. (In fact, it can do that more than once.) And yes, they think it could be used to monitor other conditions (e.g., blood sugar) and administer emergency medication (e.g., insulin).

They hope to start human trials within a few years.

Shkreli: Halfway home

‘Pharma bro’ Martin Shkreli, late of Turing Pharmaceuticals, is going to a federal halfway house. He was released from prison, where he was serving time for securities fraud and stifling competition* over Daraprim, the company’s toxoplasmosis treatment. He’ll remain in federal custody until September 14.

The price of breathing freely

Asthma inhalers aren’t new, so why are they still so expensive? Researchers from Harvard and the University of Calgary decided to find out. The short answer: Little generic competition. Between 1986 and 2020 of the 62 inhalers the FDA approved, 53 (85%) were brand-name products.

How’d that happen? Manufacturers keep tweaking their formulas jusssst enough to keep extending their patent protection. For example:

GSK received 35 years of protection from competition after FDA approval on its fluticasone inhalers through the successive release of new inhaler devices containing fluticasone: Flovent (approved in 1996), Flovent Rotadisk (1997), Flovent Diskus (2000), Flovent HFA (2004), and most recently Arnuity Ellipta (2014).

New versions mean generics are no longer interchangeable — presto! — no competition.

You’re beautiful, you’re infected, and you’re mine

People infected with the Toxoplasma gondii parasite become physically more attractive. And it’s not that they give off some kind of pheromone — the parasite actually alters their appearance.

A group of European and Mexican researchers found that the T. gondii changed both the appearance and behavior of its human host, possibly to help itself be transmitted. And it seems to work: After infection, both men and women tended to have more symmetric faces, while…

…infected women had lower body mass, lower body mass index, […] higher self-perceived attractiveness, and a higher number of sexual partners than non-infected ones.

What’s the FDA doing about the baby formula shortage?

It’s “taking important steps.”

• It won’t object to at least some imports formula that were intended for a foreign market.*
• If a formula product was made here for export, it won’t object to keeping it in the U.S.*

The agency intends to prioritize submissions for products that can demonstrate the safety and nutritional adequacy and have the largest volume of product available and/or those who can get product onto U.S. shelves the quickest.

• It’s streamlined the entry-review process at ports of entry for products coming from abroad.
• It’s “Expediting review of notifications of manufacturing changes.”
• And of course it’s working with Abbott to get that contaminated factory back on line.

The Long Read: Little Orphan Firdapse edition

2009

• FDA gives Catalyst’s Firdapse an orphan drug designation for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) — that means exclusivity through 2025.
• FDA then approves Firdapse for the treatment of adult LEMS.

2019

• FDA approves Jacobus’s Ruzurgi for the treatment of pediatric LEMS. There are no more than 30 kids in the country with this condition (and probably just 15–20).
• Catalyst sues FDA for approving the “same drug for the same disease or condition” as Firdapse.

2019–2021

• FDA and Jacobus lose in the courts through the 11th circuit, which hold that the Orphan Drug Act does not allow it to approve Ruzurgi.

The Supreme Court may take up the case. The FDA is lobbying to tweak the Orphan Drug Act. There’s a bipartisan bill in the Senate that would do just that, and similar language in a House bill.

In the meantime, those 15–20 kids with LEMS are just out of luck.