3 ms·

Had to create a throwaway to touch this, and I am _not_ an anti-vaxxer but... One of the primary arguments of the anti-vax movement is not that "vaccines cause

Had to create a throwaway to touch this, and I am _not_ an anti-vaxxer but... One of the primary arguments of the anti-vax movement is not that "vaccines cause autism" but that the FDA is a poor, industry-captured steward of public health WRT the shit that they give the thumbs up to be fed or injected into kids. This story is a case in point for that argument.

rsynnott 7y ago
The problem claimed in the article was with manufacture, not with the product as a concept. You could definitely argue that the FDA needs a greater supervisory role for manufacture, but this wasn't an issue with the approval.
- rileymat2 7y ago
  The article left that in doubt. They did not rule out the thickener. FTA > Did the cold processing method and the failures in sanitation cause NEC? > Nobody’s sure. The FDA’s current theory is that the problem is the xanthan-gum thickeners themselves, because of the way they interact with an immature gut.
gumby 7y ago
Xanthan gum is on the GRAS list so hard to blame the FadA’s oversight. Having presented before them for study approval they seemed anything but industry captured. I agree that the GMP manufacturing OVERSIGHT could be stronger but I’d say Congress bears more responsibility for that course of affairs. At the time this was written the cause was unclear though.
smegmatoryCptr 7y ago
You're catching a buzzword downvote, but you're not wrong. Hospitals are faceless brick buildings with corridors of mindless worker drones fearing for their jobs, elitist upper echelon flashing status and prestige, and cover-your-ass paperwork crammed into slip and slide audit trails for those moments when staff is disgusted or bored by their patients or an angel-of-death executes the plausibly deniable in their career of serial murder. Moral hazards in hospitals are real. Belligerent negligence and indifference among highly skilled professionals is a reality. To step inside a hospital is to abdicate decision making authority. Doctors frequently fake their level of expertise, even if just to fit in or remain competitive practitioners. Deflecting impostor syndrome, despite any kernel of truth and uncertainty which may lurk subliminally within one's own subconscious intuition is just another part of medical school. Most medical professionals crave any opportunity for condescension or chauvinism. Patients are the laughable bottom rung in the pecking order. Just like with fire fighters, legal representation and police, any gifted moment, any pause in the conversation will be used to steamroll and subordinate an ostensible peer or patron of the art. Emergency responders choose their field out of a desire to command authority and seize upon jurisdiction, for the purpose of ego, right or wrong. This is a strong corollary to profit seeking in the business world. Inside the brick building, you don't know what's best for yourself anymore. And now, low ranking employees will overrule your inclination to ask questions, and dump whatever prescription their boss puts in front of them right into the test subjects body, for fear of looking stupid and getting fired. Pharmaceutical manufacturers are one step beyond even the situational moral hazards of power differential amid workplace social interactions and organizational/institutional depersonalization.

rsynnott 7y ago

The problem claimed in the article was with manufacture, not with the product as a concept. You could definitely argue that the FDA needs a greater supervisory role for manufacture, but this wasn't an issue with the approval.

rileymat2 7y ago
The article left that in doubt. They did not rule out the thickener. FTA > Did the cold processing method and the failures in sanitation cause NEC? > Nobody’s sure. The FDA’s current theory is that the problem is the xanthan-gum thickeners themselves, because of the way they interact with an immature gut.

gumby 7y ago

Xanthan gum is on the GRAS list so hard to blame the FadA’s oversight. Having presented before them for study approval they seemed anything but industry captured. I agree that the GMP manufacturing OVERSIGHT could be stronger but I’d say Congress bears more responsibility for that course of affairs. At the time this was written the cause was unclear though.

smegmatoryCptr 7y ago

You're catching a buzzword downvote, but you're not wrong. Hospitals are faceless brick buildings with corridors of mindless worker drones fearing for their jobs, elitist upper echelon flashing status and prestige, and cover-your-ass paperwork crammed into slip and slide audit trails for those moments when staff is disgusted or bored by their patients or an angel-of-death executes the plausibly deniable in their career of serial murder. Moral hazards in hospitals are real. Belligerent negligence and indifference among highly skilled professionals is a reality. To step inside a hospital is to abdicate decision making authority. Doctors frequently fake their level of expertise, even if just to fit in or remain competitive practitioners. Deflecting impostor syndrome, despite any kernel of truth and uncertainty which may lurk subliminally within one's own subconscious intuition is just another part of medical school. Most medical professionals crave any opportunity for condescension or chauvinism. Patients are the laughable bottom rung in the pecking order. Just like with fire fighters, legal representation and police, any gifted moment, any pause in the conversation will be used to steamroll and subordinate an ostensible peer or patron of the art. Emergency responders choose their field out of a desire to command authority and seize upon jurisdiction, for the purpose of ego, right or wrong. This is a strong corollary to profit seeking in the business world. Inside the brick building, you don't know what's best for yourself anymore. And now, low ranking employees will overrule your inclination to ask questions, and dump whatever prescription their boss puts in front of them right into the test subjects body, for fear of looking stupid and getting fired. Pharmaceutical manufacturers are one step beyond even the situational moral hazards of power differential amid workplace social interactions and organizational/institutional depersonalization.