Shortages at Washington-area hospital: Children are Dying

[Anonymous]

I signed.

[Anonymous]

the reason is that FDA has forced companies to slow down with roadblocks

[Anonymous]

Update - FDA just announced they will start importing injectable nutrition drugs:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM354272

[Anonymous]

Update - FDA just announced they will start importing injectable nutrition drugs:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM354272

Well that's good news. And kudos to the Washingtonian (and any other reporters) that may have raised public awareness on this.

I wonder though what this new policy will mean practically - will the IV nutrition be available in the next weeks, months? Is this a long term solution?

[Anonymous]

Anonymous wrote:

Update - FDA just announced they will start importing injectable nutrition drugs:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/UCM354272

Well that's good news. And kudos to the Washingtonian (and any other reporters) that may have raised public awareness on this.

I wonder though what this new policy will mean practically - will the IV nutrition be available in the next weeks, months? Is this a long term solution?

"The U.S. Food and Drug Administration announced today 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."

[Anonymous]

WOW! I have to say I never thought of the Washingtonian as a newsbreaker - but I stand corrected. Well done.

[Anonymous]

"...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. "

What the everloving fuck is this bullshit?!

[Anonymous]

Anonymous wrote:"...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. "

What the everloving fuck is this bullshit?!

+1

[Anonymous]

Anonymous wrote:

Anonymous wrote:This also reminds me of how my progesterone injections during my first pregnancy were available through a compounding pharmacy and were pretty affordable, and then they suddenly became the name brand drug "Makena" and became available only through one company and hugely expensive. I think there was an outcry about it and maybe things have changed since I last looked into it, but the point is - it's just a race for profits no matter what for these drug companies. Here's a link to an article about the controvery if anyone is curious:

http://www.nbcnews.com/id/41994697/ns/health-pregnancy/t/premature-labor-drug-spikes/

The company that produced Makena filed for bankruptcy and the FDA said it will not go after compounding pharmacies who do the p17 injections. It isn't as simple as a company making profits at the expense of women with pregnancy complications, though. Before Makena, there were no real randomized studies to show that p17 was beneficial. It was just used off label. So, there will likely be reduced innovatins in this space now that the value of Makena's research isn't economically protected. This is a complicated issue with no easy solutions. Of course you want women to have access to cheap, efficient drugs that help, but there needs to be a way to incentive companies to innovate.

Interesting. Thanks, PP for explaining and updating me on this issue. I agree there will be reduced innovations in this space if companies cannot charge, and in the long term that is a bad thing - but $1500 a shot? That warranted the outrage, I think.

[Anonymous]

It is insanity that it took a Washingtonian article to generate the most common sense breakthrough - if it not in short supply in other developed countries how was that not a no-brainer?? I think this further points. Finger at the hospitals who were trying so hard to cover this up rather than let natural public outrage at dying premies spur FDA to action on imports.

[Anonymous]

Anonymous wrote:"...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. "

What the everloving fuck is this bullshit?!

Government regulation.

http://www.medpagetoday.com/HospitalBasedMedicine/GeneralHospitalPractice/39475

It was illegal to simply import the European TPN drugs until the FDA gave its ok.

[Anonymous]

Coincidentally, I had just come across this AP story about the FDA stepping in for work before seeing this thread on DCUM.

http://www.bostonglobe.com/news/science/2013/05/29/fda-takes-action-ease-neonatal-drug-shortage/s0ppx2OwhRGfZwF1UoH7eN/story.html

[Anonymous]

If this were really an issue, I find it hard to believe that the major medical organizations were not out in front bringing attention to the issue.
I'm also not sure a pharmacist or dietician is qualified to determine the cause of death of a very fragile, sick baby!

[Anonymous]

Anonymous wrote:

Anonymous wrote:"...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. "

What the everloving fuck is this bullshit?!

Government regulation.

http://www.medpagetoday.com/HospitalBasedMedicine/GeneralHospitalPractice/39475

It was illegal to simply import the European TPN drugs until the FDA gave its ok.

Government regulation bullshit. Fixed that for you.

[Anonymous]

Anonymous wrote:

Anonymous wrote:

Anonymous wrote:As someone who works in pharmaceuticals and recently dealt with a shortage. It's complicated. Part of it is supply & demand. Sometimes demand goes up an manufacturers can't react fast enough. There has been a lot of merging & buying of companies. As an example, 10 companies make a generic drug, but only 2 supply the starting material to make it. Those 2 have trouble manufacturing then everyone suddenly can't manufacture it. Profit is another part of the puzzle. If there is no profit, the incentive to manufacture deminishes. Usually a shortage will drive the price up 10-20x. It's not as though drugs grow in trees. They are subject to many market forces. It's unfortunate, but micro premies are incredibly delicate and I would imagine many things could go wrong besides supplement issues.

If the free market can't handle it, then it has to become a basic "commodity" controlled by the govt. That's how things should work.

+1!

Then the supply would dwindle to nothing. The government really isn't fit to handle every single detail of every single aspect of every single industry.