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Why So Many Drug Shortages?


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Showing 1-19 of 19 posts in this discussion
Initial post: May 27, 2012 11:36:53 AM PDT
Last edited by the author on May 27, 2012 3:23:19 PM PDT
http://www.lasvegassun.com/news/2012/may/27/300-drugs-short-supply-southern-nevada-officials-w/

FDA LISTS 300 DRUGS IN SHORT SUPPLY
The FDA calls it a "perfect storm" of manufacturing plant shut-downs, public demand and price-shock. Hospitals are scrambling, and Congress is working on new regulations.

But there's more to the story of the shortage: "The reason drugs go offline is for a lot of nasty things. They find glass shards in the production line, or they are controlled substances with limits set by the DEA."

Dextrose-50 is a standard drug for EMS and ambulances to stabilize diabetics that have injected too much insulin. The drug is available - but the syringes to package it in aren't.

Taxol is a common chemotherapy drug that suddenly fell into shortage late last year, when two of the drug's manufacturers "voluntarily" (?) stopped making the product. Other producers cited lack of raw materials and increased demand.

So what is really going on here? Either the FDA is seriously falling down on the job with oversight of the availability of our most needed drugs. Or manufacturers are intentionally or unintentionally manipulating supply.

Your thoughts?

Posted on May 27, 2012 1:51:39 PM PDT
Captain says:
You didn't offer an over-zealous FDA as a possibility. Why is that?

Posted on May 27, 2012 3:29:20 PM PDT
Last edited by the author on May 27, 2012 3:30:00 PM PDT
Captain -

Because the last I read, the public was screaming at the FDA to more closely monitor imported substances from China. Guess the FDA forgot about the drugs manufactured and needed in this country.

Then again, our military is the exact opposite. Pilots won't fly our new F-22s, because of an oxygen-deprivation problem that makes our pilots pass out - in flight. And Congress, meanwhile, is grousing about all the poor quality military parts we (or our contractors) buy from China to make our military aircraft.

Meanwhile, China's new attack plane is a couple years ahead of schedule. And no reports of oxygen-deprived pilots ...

In reply to an earlier post on May 27, 2012 4:33:32 PM PDT
Captain says:
Quite a diversion you took there.

Ask drug manufacturers and physicians and pharmacists, and they will tell you it's the FDA.

Posted on May 28, 2012 8:36:23 AM PDT
Captain -

From what I'm reading, there's enough blame to go around. Even the FDA reports that only 11% of the shortages are due to manufacturer shut-down. This NPR transcript from October 2011 is very illuminating - especially regarding oncologists who have to make life/death decisions of who gets the scarce cancer drugs:

http://www.npr.org/2011/10/04/141048466/doctors-and-patients-manage-drug-shortages
DOCTORS AND PATIENTS MANAGE DRUG SHORTAGES

"My oncologist (said) he and his colleagues had to sit down and have kind of a triage meeting and figure out - they set forth a very strict protocol of who would get the (scarce cancer) drugs, based on who needed the drug to survive, and which patients could extend their lives by a couple years, and the people that could tolerate or be helped by an alternative drug. And then they applied that criteria, and luckily, based on that criteria, I was one of the ones that got the drug in question."

Posted on May 28, 2012 8:45:33 AM PDT
Captain -

According to this article from CareAndCost.com, the real culprit is the giant hospital group (GPOs) purchasing organizations, "which have undermined free market competition in drugs, medical devices, and supplies in the U.S. These purchasing cartels ... have rigged this market in favor of a handful of dominant suppliers and distributors, thereby making it unprofitable for other companies to make or sell these inexpensive, hard-to-manufacture drugs."

http://careandcost.com/2012/02/14/connecting-the-dots-how-anticompetitive-contracting-practices-kickbacks-and-self-dealing-by-hospital-group-purchasing-organizations-gpos-caused-the-u-s-drug-shortage/

Posted on May 28, 2012 8:57:39 AM PDT
Last edited by the author on May 29, 2012 7:14:48 AM PDT
Captain -

Working on the idea that if these shortages are possibly being manipulated by TPTB (the-powers-that-be), there would have to be certain hospitals - like military hospitals - that have stockpiled these most necessary drugs, and/or are first-in-line to receive these scarce drugs.

http://www.hcplive.com/conferences/idsa-2011/IDSA-2011-Antimicrobial-Agent-Shortages

(October 2011) INFECTIOUS DISEASE SPECIALISTS ASSOCIATION ON ANTIMICROBIAL DRUG SHORTAGES
A survey found that with antimicrobial drug shortages, the East/North/Central Region of the U.S. had the highest rate of shortages (83%) - and those in the military had the lowest rate of shortages (50%).

"Non-university teaching hospitals had the highest shortage rate (over 80%), while those in VA or military hospitals had the lowest shortage rate (no percentage given)."

Posted on May 28, 2012 5:43:42 PM PDT
J Spiegel says:
When one of our medications was not in supply, and short supply, for several months, our doctor told us it was because the FDA created the situation. Also, there are some drugs that aren't profitable, and unfortunately the manufacturers don't want to make those drugs.

In reply to an earlier post on May 28, 2012 7:53:54 PM PDT
OldAmazonian says:
Either/Or -- maybe both; you're right.

Posted on May 29, 2012 3:42:11 AM PDT
Ken says:
my friend had a shortage of her pain med and when it did come available it was substansially changed to be non crushable and non working. But the original excuse for the shortage was a problem at the factory. A minipulation? No one was told about the change and now she is sick and angry and can't change back. This stuff is very expensive and now dosen't work.

Posted on May 29, 2012 7:32:57 AM PDT
Thanks for all your posts. And the FDA certainly isn't blameless, taking up to a year to review new drug applications and/or check out a new manufacturing plant.

But the government's tight control of what it will pay for Medicare/Medicaid generics is also driving more drug companies to abandon generic manufacturing for more profitable patented medications.

http://healthland.time.com/2012/03/19/where-have-all-our-drugs-gone/
WHERE HAVE ALL OUR DRUGS GONE?
This recent article (March 2012) is where I got the above information. It also claims that the cancer-drug shortage has been eliminated with February shipments of cancer drugs from India and Australia.

So the FDA has a bureaucratic stranglehold on the approval/manufacturing process. But there's also a big problem with generics, from being rendered unprofitable to the "giant hospital groups rigging the system in favor of a handful of dominant suppliers and distributors" (see my May 28th post above).

In reply to an earlier post on May 29, 2012 4:31:00 PM PDT
Captain says:
If by pain meds you means opiates then the FDA has ordered them all to be reformulated and many of them are off the market now for good. Overprescribing and overuse caused this situation.

In reply to an earlier post on May 29, 2012 4:31:55 PM PDT
Captain says:
Generics are mandated now by formularies. Rather than being used less they are being used far more.

In reply to an earlier post on May 29, 2012 5:40:10 PM PDT
OldAmazonian says:
Opiates overprescribed and overused? According to whom? Surely it couldn't be the opinion of greedy fat cats standing to profit from the shortage, now could it?

Posted on May 29, 2012 8:31:00 PM PDT
Michael Duer says:
all very good points!!!! it seems that most of you all are actually "thinkers", and offer some really good points on this issue!!!! however, let's not forget what this whole thing is really, really all about.............. money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money,$$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money,$$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money,$$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money,$$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! oh, and and let's not forget this vital point as well. it is also primarily about.............. money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money, $$$, money,$$$!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! ya'll know i'm right!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

In reply to an earlier post on May 30, 2012 11:53:37 AM PDT
Last edited by the author on May 31, 2012 6:29:27 AM PDT
Captain -

I applaud the use of mandated formulas for generics, which used to be hit and miss in terms of being as good as the patented meds.

http://www.cancer.org/AboutUs/DrLensBlog/post/2012/03/01/FDA-The-Quality-Problems-Causing-The-Drug-Shortage-Were-Not-News-To-Those-Making-The-Medicines.aspx

This physician's blog cites manufacturing quality concerns that are at the root of the drug shortages. According to the FDA, 75% of the shortages are due to product quality concerns and production delays.

In one of my posts above, an emergency drug was available - but not the syringes to deliver it. The FDA doesn't regulate the syringe market, I don't think, unless they come preloaded with insulin or another drug.

Is our drug manufacturing process really this chaotic? And why is all this showing up now? Could certain drug companies be specifically in the fold of the Giant Hospital Groups, so the manufacturers can guarantee them mega-meds for mega-prices - while driving other generic manufacturers out of business?

Is it possible some manufactures have sabotage problems? Glass splinters shut one manufacturer down. And a recent sabotage of cancer cell research lines is still reverberating.

http://www.newser.com/story/144506/cancer-research-held-back-by-wrong-labels.html
CANCER RESEARCH HELD BACK BY ... WRONG LABELS?

http://online.wsj.com/article/SB10001424052970204571404577257513760102538.html?mod=WSJ_hp_LEFTTopStories
LAB MISTAKES HOBBLE CANCER STUDIES, BUT SCIENTISTS SLOW TO TAKE REMEDIES

http://www.ahrp.org/cms/content/view/839/150/
CANCER RESEARCH FALSE CLAIMS

http://classic.the-scientist.com/news/display/55013/
(2008) A CASE OF MISTAKEN IDENTITY

Posted on May 30, 2012 2:30:00 PM PDT
Last edited by the author on May 30, 2012 2:30:16 PM PDT
Captain says:
"In one of my posts above, an emergency drug was available - but not the syringes to deliver it. The FDA doesn't regulate the syringe market, I don't think, unless they come preloaded with insulin or another drug. Is our drug manufacturing process really this chaotic?"

Chaotic? You provide one example, and the system is chaotic?

Marilyn, you know I've defended you against the likes of Ronald Craig in the science-related forums and the lefties on the politics forum, but you've crossed the rubicon here. Let it go. You know not of what you speak, and creating a lack of confidence in the drug industry, while very simple to do as people are incapable of comprehending it's complexity, is not a net positive activity to be engaging in. And I will not participate further in whatever it is you think you are doing here.

In reply to an earlier post on May 30, 2012 9:55:04 PM PDT
Michael,

Could you please stop being vague and tell us what you really think?

Chuck :)

Posted on May 31, 2012 6:21:23 AM PDT
I don't need protectors, in this or any other forum. And I have every right to ask questions about complex issues and submit my own speculations, just as I solicit the same from others.

Curious you sputter "You know not of what your speak" ONLY after I've posted links to multiple articles on possible sabotage in medical research, where research cancer cell lines were switched around, and key cancer studies couldn't be duplicated.
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Discussion in:  Health forum
Participants:  7
Total posts:  19
Initial post:  May 27, 2012
Latest post:  May 31, 2012

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