Georgia lawmakers to FDA: What’s with the cancer drugs?

In response to the ongoing shortage of cancer drugs, the FDA is allowing imports from companies such as China’s Qilu Pharmaceutical, which isn’t FDA approved.

That’s good news for cancer patients … almost certainly. But a bipartisan group of Georgia’s federal congressfolks wants the FDA to be more transparent about the whole deal and have written a letter to FDA Commissioner Robert Califf.

[W]e are concerned by the lack of transparency from the FDA about these suppliers, especially since the FDA has begun importing cisplatin injections from Qilu Pharmaceutical, which is not FDA-approved and manufactures the injections in China. We are also alarmed by the lack of timeline and detail on when any new, safe imports of carboplatin will begin and from where they will be imported.

The issue is that at the moment Americans can’t both have the drugs we need and guarantee they meet US standards; both are out of government hands. Too many plants have shut down or failed inspections, and as the AJC article pointed out:

A major part of the problem is that many of these drugs may be useful, but are generic and so have a low profit margin […] So private drug companies don’t prioritize making them like patients and doctors prioritize wanting them.

Click here for the full letter (PDF).

Walmart looks to cut pharmacist hours

Georgia is one of the states where Walmart is looking to cut its pharmacists’ hours in order to reduce costs. “For example, a pharmacist could go from an 80-hour, two-week pay period to one lasting 64 or 72 hours,” Reuters reports.

New weight-loss drugs are incredibly popular, but they’re actually a net loss for the company, meaning the pharmacy business isn’t making as much money.

At a meeting in May, senior Walmart field leadership asked 20 market leaders — directors of 10 to 15 stores in a given area — to start asking pharmacists to voluntarily reduce their base salary hours, the source told Reuters.

Walmart says the cuts are due to decreased prescription volume during the summer, and a desire to give pharmacists better work-life balance. (APhA CEO Michael Hogue pointed out that ‘there was no data to support the assertion that demand for medications falls during the summer.’)

Walmart’s total revenue in the second quarter of this year was $152.9 billion, up 8.4% over the same quarter last year.

Please make a note of it

AmerisourceBergen now identifies as “Cencora.” The company’s pronouns are it/its.

PPIs aren’t for kids

Proton-pump inhibitors are already on the “Are You Sure You Want to Use These?” list, and now there’s another reason to be careful: Kids who use PPIs might find themselves with serious infections anywhere from 4 months to 2 years after they stop using them.

French researchers found that….

Among children who used PPIs rather than another acid suppressant, there was an overall higher rate of serious infections that required hospitalization. There were higher rates of infections in the digestive tract; the ear, nose, and throat; the kidneys or urinary tract; the lower respiratory tract; and the nervous system.

They’re careful to give the common caveat: Their study showed correlation, not causation; it could be that kids who needed PPIs are just sicker in general. But still they recommend that “PPIs should not be used without a clear indication.”

A drug for genetic cholesterol

Statins work against LDL cholesterol, but not all LDL — they don’t affect lipoprotein(a), which is caused by genetics, not diet. There’s no way to treat Lp(a).

Until now … maybe. Aussie researchers say they’ve completed a trial of a drug called Muvalaplin: “the first oral drug ever developed to target Lp(a) — effectively lowering levels by up to 65 percent.”

Bonus: Includes “game changer.”

Overdose vaccine nears human trials

A vaccine against heroin and fentanyl overdoses is about to start its phase 1 human trials.

“Our vaccines are designed to neutralize the target opioid,” said one of the University of Montana researchers leading the effort, “while sparing critical medications such as methadone, buprenorphine, naltrexone and naloxone.”

What’s not clear is whether this is a lifetime vaccine, a once-a-week shot, or something else. Even the researchers aren’t sure: “We will also follow the patients to evaluate how long the antibodies against opioids will last.”

Cancer conversion therapy

If you can’t kill ’em, convert ’em. That’s the logic behind the method developed by scientists at New York’s Cold Spring Harbor Laboratory. It can turn sarcoma cells “into regularly functioning tissue cells.” (They’re specifically looking at rhabdomyosarcoma, a nasty pediatric cancer.)

Using a technique they invented, the researchers were able to find genes within the cancer cells that, when disrupted, allowed those rhabdomyosarcoma cells to turn back into muscle cells. Then they found the specific protein involved. Stopping production of that protein, called NF-Y, turned the cancer from Hyde to Jekyll.

And the technique, they say, “can allow you to take any cancer and go hunting for how to cause it to differentiate.”