27 May 2013

How Worship of the Unbridled Market is Taking the United States to 3rd World Nation Status

Premature babies are dieing of starvation because feeding babies is not profitable enough for sufficient stocks to be maintained:
Because of nationwide shortages, Washington hospitals are rationing, hoarding, and bartering critical nutrients premature babies and other patients need to survive. Doctors are reporting conditions normally seen only in developing countries, and there have been deaths. How could this be allowed to happen?


Except for a mind-boggling problem that Atticus’s [A child born 4 months early, and currently in the NICU] hospital—one of the most prominent in the country—has been powerless to solve: Atticus isn’t receiving some of the critical 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.


Experts call the nutrient shortage a public-health crisis and a national emergency—and are astounded that the government and manufacturers have let the situation become so dire.

“Children are dying,” says Steve Plogsted, a clinical pharmacist who chairs the drug-shortage task force of the American Society for Parenteral and Enteral Nutrition (ASPEN). “They’re not getting any calcium or any zinc. Or they’re not getting any phosphorous, and that can lead to heart standstill. I know of a neonate who had seven days without phosphorous, and her little heart stopped.”

“I’ve never seen anything like this in my entire career, and I’ve been a pharmacist for 40-some years,” says Michael Cohen, president of the nonprofit Institute for Safe Medication Practices (ISMP) and a 2005 MacArthur Foundation fellow. “This should never be allowed to happen.”

There are 300 drug, vitamin, and trace-element shortages in the US, the highest number ever recorded by the University of Utah Drug Information Service, which began tracking national shortages in 2001. Approximately 80 percent of these are generic injectables, or drugs given intravenously.


The nutrients in shortage aren’t rare. “We’re talking about zinc, phosphorous, calcium—trace elements,” says CHA president Mark Wietecha. “These aren’t the latest genetically modified drugs or something coming out of modern high-tech environments. These have been around for decades.”


Some hospitals have resorted to bartering with one another to secure even a small supply of nutrients, and many are rationing.

At least one NICU in the District is administering some trace elements only three days a week instead of seven. At Atticus’s hospital, no patients heavier than 2½ kilograms (5½ pounds), including NICU babies, are getting intravenous phosphorous. “You could have a brand-new, full-term baby and they don’t qualify,” a staff member says. “There are really sick babies and one-, two-, three-year-olds that don’t get anything at all because we’re rationing it for our tiniest preemies.”


When Miguel Sáenz de Pipaón, a neonatologist at a prominent hospital in Madrid, arrived in the US for a research visit, he was stunned by the nutrition shortages.

“It’s crazy,” he says. “That doesn’t happen in Europe.” He noted that the US relies on a 25-year-old lipid emulsion, which is in shortage, while European hospitals use a newer version that’s readily available. Rather than import the newer emulsion, the US has left many patients without any lipids at all.

The only shortage Sáenz de Pipaón could recall in Spain occurred two years ago when a Canadian factory stopped making trace elements. His hospital pharmacy immediately secured the product from a Swedish manufacturer and had it for patients within two days.

Hospital staff wonder why the FDA hasn’t already put a process in place to streamline foreign inspections and certifications so that labs abroad can manufacture emergency supplies on short notice.

Jensen says the FDA is working on it and that imported nutrients will be shipped soon: “It took a long time to find companies willing to do it, mainly because they couldn’t meet US needs and didn’t have the ability to ramp up for the US. The good news is we’ve got different firms willing to do this for phosphates, zinc, and trace elements. We moved as quickly as we could.”
Yes, moved as quickly as they could. (Not)

You can be certain that a (castrated over the past few decades) FDA is consulting with the manufacturers, so as to avoid hurting their business models.
“The FDA has repeatedly told us that the shortages are short-term and that they don’t need to import yet,” says neonatologist Steve Abrams of Texas Children’s Hospital. “There’s been a general sense that this problem will go away if we just wait until next Tuesday, and next Tuesday just hasn’t come for the last 2½ years.
They keep kicking the can down the road, because they, and the congressmen who vote on their budget, ahve been captured by pharma.


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