Washingtonian: Dire shortage of nutrients for premature infants lets some starve to death in intensive care.

Care for premature infants can put enormous strain on hospital resources, and I wouldn't have been surprised to read that doctors with appropriate expertise, say, would sometimes be in short supply.

It's shocking to read, however, that neonatal intensive care units across the country are suffering from acute shortages of basic nutrients to feed the children, and that in some cases children are dying for lack of these nutrients–in effect, starving to death in the intensive care unit. 

Alexandra Robbins makes that case persuasively in Washingtonian, in an article entitled, "Children are Dying."

"Our patients are starving because of drug shortages. How can this happen in this country?” Jay Mirtallo, a professor of clinical pharmacy at Ohio State University, tells Robbins.

The technical phrase for intravenous feeding is parenteral nutrition. Each infant needs his own mix of nutrients, depending upon the specifics of his or her medical condition. Robbins tells the story of one child, Atticus, born at 24 weeks of gestation, who has overcome "his kidneys shutting down, multiple infections, and heart surgery." But one critical problem remains unsolved: He is not getting the nutrients he needs to survive. "Doctors and pharmacists say that because of nationwide shortages caused by a combination of factors—manufacturing problems, a market with few incentives for companies to produce low-profit drugs, and the government’s delayed and inadequate action—thousands of patients are being malnourished," Robbins writes.

The hospital simply can't find these nutrients anywhere. At the time Robbins was writing her story, Atticus's hospital in Virginia was "low on intravenous calcium, zinc, lipids (fat), protein, magnesium, multivitamins, and sodium phosphate; it’s completely out of copper, selenium, chromium, potassium phosphate, vitamin A, and potassium acetate. And so are many other hospitals and pharmacies in the country, leading to complications usually seen only in the developing world, if ever." 

The problem is that these nutrients are a low-profit item, and they are made by only a handful of manufacturers. They are not a priority for drug makers who prefer to switch their production lines to the manufacture of newer, higher-margin drugs, Robbins writes.

This problem has received coverage before and has been the subject of Congressional inquiries, as Robbins points out. But I haven't seen anything that has slapped me in the face the way this article has.

I have a few quibbles about Robbins's article. She spends a bit too much time with anecdotes and individual hospitals' experiences with shortages before getting into the serious reporting about why this is happening. And she delivers a bit of a confused picture of the role and culpability of the FDA. But otherwise it's a powerful, solidly reported piece.

The primary reason that children are starving to death in hospitals seems to be that drug makers cannot make sufficient profits by feeding them. Their allegiance is to their shareholders, not to the children–and that's not their fault; they are doing what they are required to do.

Robbins cites some critics who say the FDA's heightened enforcement of drug-safety rules has interfered with the manufacture of nutrients, but it's hard to blame the FDA for ordering recalls of nutrients "because of visible particulates (such as glass or silicone) in the products" that could disrupt blood flow. FDA does not have the power to force manufacturers to make more nutrients. 

Some drug makers are "building extra capacity," Robbins reports, but it will take at least two years to get the new production online–far too long to save Atticus and other premature babies lacking essential nutrients right now.

And this is not something new. The problem has existed for 2-1/2 years, one doctor tells Robbins. "This is the first time in over 30 years of practicing medicine I’ve ever not been able to give babies the IV nutrition they require. I don’t think the FDA has done all they could in this regard. Why is this going on for so long with no end in sight?"

She explores other potential solutions, such the FDA allowing the import of nutrients in emergencies. As it happens, the FDA has just taken this action, announcing in a press release on May 29th "that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week." 

Members of Congress routinely and smugly refer to the American health care system as the best in the world. Maybe, by some measures, it is. But not by this one.

I wonder whether Robbins's article, published on May 22nd, was the trigger that finally moved the FDA to act?

-Paul Raeburn

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