Pfizer tornado not so bad

About the Pfizer plant hit by a tornado: Turns out it was the storage part of the plant that was in all the photos, not the production part.

“After an initial assessment, there does not appear to be any major damage to the medicine production areas.” […]

Most of the damage occurred at the site’s warehouse facility, which stores raw materials, packaging supplies and finished medicines awaiting release by quality assurance.

The company and the FDA don’t think there will be long term consequences, so it’s kind of the best possible outcome: A wakeup call to vulnerability without anyone getting hurt. This time.

Bill to help getting ahead of shortages

Speaking of drug shortages, the Senate Health, Energy, Labor, and Pensions committee has passed a bill that would give the FDA more power “to require manufacturers to notify them of potential product shortages outside the scope of a public health emergency.”

Under the bill, manufacturers, including those who produce over-the-counter drugs, would need to notify FDA within 10 business days of a potential shortage if circumstances, such as an increase in demand or export restrictions, would likely cause a shortfall in supply or a meaningful delay in the supply of a drug.

(There’s more to the bill (the Pandemic and All-Hazards Preparedness Act) than that, of course, but that’s by far the most interesting bit.)

Finding the dangerous drugs

If you think you’ve been seeing a lot of stories about artificial intelligence in medicine lately, you’re not wrong. We’ve reached the tipping point where there’s enough data for AIs to draw statistically relevant conclusions.

The latest example: Researchers at Mount Sinai have created an — you can call it an algorithm, an AI, or just a tool — that can “Better Predict Which Drugs May Cause Birth Defects.”

It does what AI does best: It found “previously unknown associations between genes, congenital disabilities, and drugs.” It’s kind of like discovering that Subaru drivers prefer sprinkles on their doughnuts. There’s undoubtedly a reason to be worked out, but for the moment what’s most important is the connection.

Specifically, the data included studies on genetic associations, drug- and preclinical-compound-induced gene expression changes in cell lines, known drug targets, genetic burden scores for human genes, and placental crossing scores for small molecule drugs.

That, they say, can eventually help determine which drugs are safe for moms-to-be and which aren’t — but right now it’s still just a research project.

Just think of them as Mystery Meals

On the one hand, you read about supposedly benign supplements having actual drugs in them. Here’s the flip side: Harvard Med researchers ordered 57 sports supplements each claiming to have “one of five botanical compounds with purported performance-enhancing properties.”

In a shock to no one — the industry is unregulated, after all — 40 out of the 57 (that’s 70%) “did not contain a detectable amount of the ingredient listed.” And just for fun, 12% had illegal additives.

FDA inspections have found that supplement manufacturers often fail to comply with basic manufacturing standards, such as establishing the identity, purity, or composition of the final product.”

Quick prostate cancer ID

Prostate cancer ranges from the slow moving, easier-to-treat variety, to the fast spreading kind where months or weeks can make a difference. It’s critical to know which a patient has.

That’s why it’s a big deal that Aussie researchers have found three biomarkers that can help pathologists differentiate the type of prostate cancer a patient has and how advanced it is.

The new biomarkers, when used together, will assist clinicians in determining which patients require immediate, radical treatment compared to those who need close monitoring.

They’re already in the process of developing a commercial test with Quest “You’ve probably heard of it” Diagnostics.

Bonus: They call it “lifesaving” but not once did anyone utter the phrase “game changing.”

Phages as snitches

So you probably know that bacteriophages are a potential weapon in the War on Germs™ — they’re virus killers that attack specific bacteria. That’s the issue, though: Phages are ultra-specific little buggers, so treating an infection means finding the phage that kills it^*.

Now Swiss researchers are trying the reverse. Or inverse. Converse? Anyway, they’re using phages to identify an infection — in this case a UTI — rather than treat it. They genetically modified phages that attack three different UTI bacteria so they “produce an easy-to-measure light signal.”

Using this method, the researchers were able to reliably detect the pathogenic bacteria directly from a urine sample in less than four hours. In the future, the method could make it possible to prescribe a suitable antibiotic immediately after diagnosis and thus minimize resistance development and improve antibiotic stewardship.

Bonus: If they want to use phages for treatment, they can tell by the strength of the light how well the patient is likely to respond.

^* Interestingly, the US Navy has one of the largest phage libraries in the world. 

You can have Captain Obvious’s Cheetos when you pry them from her cold, dead fingers

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