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Scant Oversight of Drug Maker in Fatal Meningitis Outbreak (NYTimes)

...some doctors and clinics have turned away from major drug manufacturers and have taken their business to so-called compounding pharmacies, like New England Compounding, which mix up batches of drugs on their own, often for much lower prices than major manufacturers charge — and with little of the federal oversight of drug safety and quality that is routine for the big companies.

“The Food and Drug Administration has more regulatory authority over a drug factory in China than over a compounding pharmacy in Massachusetts,” said Kevin Outterson, an associate professor of law at Boston University...

Was it Republican sponsored deregulation?  That's not a certainty, but there is this:
The F.D.A. did develop a clear set of rules for compounding, but subsequent litigation that culminated in a Supreme Court decision in 2002 struck them down,
Now, while that would be the Scalia/Rehnquist court, in fact the decision in Thompson v. Western States had Souter joining the evil 5, with Rehnquist actually leaving them in support of Breyer's dissent along with Stevens and Ginsburg. Not sure of the legal questions therein, but no matter:

[One of the medical practices purchasing the drug]  paid New England Compounding $25 for a vial containing five 80-milligram doses. A similar vial of the Depo-Medrol by Pfizer, with the alcohol preservative, costs about $40 to $46, according to the Web site of Clint Pharmaceuticals, a distributor.
Hmmm. Do you think that alcohol preservative prevents contamination of the drug over time?  And that lack of it in the cheaper drug is what allowed the fungus to grow in it and kill 7 and infect 65?

Using the figures cited above the savings per dose works out to $4 each.  Is a life worth just $4.00?? Well, as A Bain Capital number cruncher might think of it- a $4 savings on 100 patients per week (an actual number cited in the article) works out to $400/week, or $20,000 year.  Now who would do such heartless calculation?

Was it Republican sponsored deregulation?  We can't say for sure yet, but history has shown us all too often where Republicans and Democrats tend to stand on such issues.
And this story line is getting to be way too predictable.
Sadly.  Tragically.

4:22 AM PT: Hold on all you folks who think this is NOT an issue of deregulation.

Please focus on this one simple fact of the story:  Why was the compounder allowed to produce the drug WITHOUT THE PRESERVATIVE (in this case alcohol) ? Lack of which allowed the fungus to grow in storage.
Yes that's right- it was a LACK of regulation. and of course, THAT'S why we have REGULATIONS!!!!



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Comment Preferences

  •  A vote for Romney (28+ / 0-)

    means more of the same.  Lots more.
    I'll bet you $20,000 it does.

    There are very few subjects which do not interest or fascinate me.

    by NYFM on Sat Oct 06, 2012 at 10:44:33 PM PDT

  •  This really needs to go viral! (10+ / 0-)

    Millions of people with back/neck problems have these injections.
    There are risks of course, but Meningitis from contamination?  That was not included on my list.
    We saw 1000s of dogs die, kids and elderly die or get sivk. Bad drugs that kill thousands get to the market. Quick. Then they pull them and then relable them and they get put back on.
    The FDA. Got got gutted.
    And we are all put at risk.
    Even food comes with huge risks.
    Thanks for the diary!  

    If the Fetus you Saved was GAY, would you still fight for it's RIGHT'S?

    by snoopydawg on Sat Oct 06, 2012 at 11:03:20 PM PDT

    •  I'm one of those millions (4+ / 0-)
      Recommended by:
      marykk, bumbi, snoopydawg, UFOH1

      And I am apparently lucky to be alive. I had one of those injections in May, and I am fairly close to the lab in Mass that produced this poison.
      (the 20 minute procedure came to over $5000, but that's another shocker for another time).

      R-Money/R-Ayn, the ENRON Ticket, is not a campaign; it's a hostile takeover bid.

      by kamarvt on Sun Oct 07, 2012 at 05:21:43 AM PDT

      [ Parent ]

      •  Glad you are ok (3+ / 0-)
        Recommended by:
        marykk, thomask, kamarvt

        What a horrible scare you must have had.
        I quit having the injections a decade ago. I would get severe psychological side effects, massive weight gain, and they stopped working.
        If you are interested, I had a treatment called Scenar Therapy. A friend told me about this woman who did this. She couldn't explain it, but gave me a gift certificate for a treatment. I went in on a high pain day with a closed mind. Walked out thinking I had a nice massage.  I woke up the next day pain free. I had nerve damage off the L-5 nerve root for 10 years. One treatment and it was gone.
        To understand the treatment, go here:
        I even got work comp to pay for my treatments and buy me a machine. $3,000..I went from taking 12 meds to just 4.
        See if there is someone in your area that does it.

        If the Fetus you Saved was GAY, would you still fight for it's RIGHT'S?

        by snoopydawg on Sun Oct 07, 2012 at 10:04:15 AM PDT

        [ Parent ]

  •  The same happens in vet medicine I think. (8+ / 0-)

    There was a recent study on a drug being used for a certain cat disease that is a human drug compounded for cat use (an off label use) and this is the only known drug that works.

    I don't know how it turned out, but that they were doing a study says a great deal to me.

    I had to treat 24 cats for this disease which can result in abnormal stool for up to two years which means they cannot be adopted out until they are healthy and their stool is normal given a good diet.

    Believe me when I tell you this is a HUGE, HUGE challenge and if the drugs aren't mixed correctly at a compounding pharmacy, the time, the expense, the testing (all of which is extremely expensive over a long period like I have gone through) is for nothing.

    When I look at the $40K or so I have spent over the last couple of years on this group of cats, I could almost cry. The number of other cats I could have spayed/neutered and saved is astounding. But we get what we get.

    Never again will a cat enter my rescue without being PCR tested for this disease which, they now think, is much more common than previously believed.

    Sometimes there are shortcuts we just shouldn't take but we are tempted by economy. That says, in the human med world, anyway, that something is very wrong.

    202-224-3121 to Congress in D.C. USE it! You can tell how big a person is by what it takes to discourage them. "We're not perfect, but they're nuts."--Barney Frank 01/02/2012

    by cany on Sat Oct 06, 2012 at 11:08:16 PM PDT

    •  Hello cany. Where's you rescue - if you (2+ / 0-)
      Recommended by:
      bumbi, cany

      don't mind me asking? I've been caring for a stray kitty for almost a month now, and I haven't been able to find a rescue here in Rochester NY that can take her. I thought I'd found someone to adopt her, but the person was supposed to have come yesterday morning and she never showed.

      I'm so worried for kitty. It's getting cold. I'm also worried she might become pregnant before someone can get her spayed.

      Any advice?

      "The most American thing you can do is to stand up for the dignity of someone else."

      by marabout40 on Sun Oct 07, 2012 at 04:42:17 AM PDT

      [ Parent ]

      •  I'm in CA, unfortunately, or I would offer my help (0+ / 0-)

        202-224-3121 to Congress in D.C. USE it! You can tell how big a person is by what it takes to discourage them. "We're not perfect, but they're nuts."--Barney Frank 01/02/2012

        by cany on Sun Oct 07, 2012 at 12:20:38 PM PDT

        [ Parent ]

      •  Is she feral? If not, take her in and get her (0+ / 0-)

        spayed, FeLV tested, and give her her first shots (she will need two FVRCPC, (2), 2-3 weeks apart and if living outside, definitely get a rabies and a FELV (also need two of these).

        IF she is NOT feral, why not bring her in and let her live in the bathroom while you do her vetting and find her a home.

        Cats are more properly placed fully vetted which also allows you to ask for a reasonable adoption fee.

        Do you have a shelter there, because if you do, they might be able to refer you to a low cost vet to do the work.

        The main thing: GET HER SPAYED. But if she isn't tested before placing her and she is FeLV positive and placed in another home with another cat, she could infect them, too.

        She will likely need two wormings, also.

        If you can get this done, then you truly have a cat that is easier to place. IF the cat is black, don't place until well after Halloween unless you know the family personally.

        If you need more... kos-mail me and we can talk:)  

        202-224-3121 to Congress in D.C. USE it! You can tell how big a person is by what it takes to discourage them. "We're not perfect, but they're nuts."--Barney Frank 01/02/2012

        by cany on Sun Oct 07, 2012 at 12:25:38 PM PDT

        [ Parent ]

        •  Unfortunately, I can't afford to do (0+ / 0-)

          any of those this. I wish I could. I'd do it in a heartbeat. This community has been keeping me afloat for months now. When I contacted Lollipopfarm they said they'd give her all her shots and spay her for $135, but I don't even have $5.

          I can't bring her anywhere inside. The family I'm staying with forbids it. They have a young baby and are afraid of disease and allergic reaction.

          "The most American thing you can do is to stand up for the dignity of someone else."

          by marabout40 on Mon Oct 08, 2012 at 05:13:10 AM PDT

          [ Parent ]

  •  In favor of compounding (3+ / 0-)

    These are all DKos diaries in favor of compounding

    This is a lose-lose issue.
    If you are in favor of compounding, it will be criticized as deregulation.
    If you are not in favor of compounding, you will be called a Big Pharma shill.

  •  Thought you'd find this website interesting (3+ / 0-)
    Recommended by:
    martyc35, marykk, bumbi

    There's a problem and it is more than Meningitis.  

    Just heard about this issue today.  Was totally unaware until I heard a short interview on CBC with the doctor behind this site.  She became concerned enough that she started this page.  Her pages talk about the shortages and the problems that have happened when substitution of alternative drugs has occurred.

    There is a brief description of who she is on the home page.  Granted, she is speaking about the Canadian experience, but she does say the problem is global.

    Canada drug shortage
    She begins...

    Since late 2010, the public has slowly become aware of a shortage of prescription drugs. This is a global problem,.......
    She says this about meningitis at the end of the Tracking The Problem Page.
    In early October 2012, several cases of meningitis in at least 5 American states were caused by impure products for spinal injections used as substitutes owing to the drug shortage problem.
    There are about 26 stories from patients who have experienced problems because of the drug shortage that is happening.

    Patient's stories

    •  I want to speak to the issue of "shortage of (7+ / 0-)


      I can only speak to the veterinary world here, but it mimics the human drug world and as you know, almost all of the vet world drugs come from human drug companies... the very same ones we all know.

      I have a cat on clindamycin who has to take the drug for a number of months (long story and not relevant). I was told to get it while I could because there was a predicted shortage of the drug as some manufacturers were ceasing production. This could mean a shortage (even temporary for this widely used drug would be terrible) or a sharp increase in cost.

      I can tell you for a FACT that drug manufacturers are benefitting in their manufacturing cessassion. On stops this... another stops that and each picks up the piece and raises the price.

      THIS is what the ever increasing drive for profit does to those who need the drugs.

      And it won't stop until the DOJ actually looks for collusion in the industry.  It's there. I just know it is.

      202-224-3121 to Congress in D.C. USE it! You can tell how big a person is by what it takes to discourage them. "We're not perfect, but they're nuts."--Barney Frank 01/02/2012

      by cany on Sat Oct 06, 2012 at 11:48:04 PM PDT

      [ Parent ]

      •  Just before my husband died of cancer (3+ / 0-)
        Recommended by:
        bumbi, marykk, cany

        11 years ago, I was unable to fill his pain medication prescription as none of the local pharmacies could get his medication.

        Thank god for the compounding pharmacy that was nearby.

        On another occasion my daughter was having difficulties with a prescription and her doctor wanted her to have a smaller dose than what was available at a pharmacy.  Again, we relied on a compounder to provide the needed drug.

        Compounders are necessary.

        I fall down, I get up, I keep dancing.

        by DamselleFly on Sun Oct 07, 2012 at 07:31:59 AM PDT

        [ Parent ]

      •  I wonder if the two issues (1+ / 0-)
        Recommended by:

        are related or even one......  Compounding and Drug Shortage.

        •  Could be. Something needs to be done at (0+ / 0-)

          the corporate level to straighten this out. Seems to me an investigation (much like we do with oil companies though, alas, that never seems to go anywhere) is in order.

          202-224-3121 to Congress in D.C. USE it! You can tell how big a person is by what it takes to discourage them. "We're not perfect, but they're nuts."--Barney Frank 01/02/2012

          by cany on Sun Oct 07, 2012 at 12:18:28 PM PDT

          [ Parent ]

    •  this is one (1+ / 0-)
      Recommended by:

      Link related to recent legislation on price gouging during shortages - - introduced by Shumer.

      "In the depth of winter I finally learned that there was in me an invincible summer."- Albert Camus

      by valadon on Sun Oct 07, 2012 at 03:11:14 AM PDT

      [ Parent ]

  •  But Der Frei Market is infallible! (1+ / 0-)
    Recommended by:

    Everything there is to know about the GOP: They're the Bad Guys.

    by Troubadour on Sat Oct 06, 2012 at 11:48:35 PM PDT

    •  infallible if we change the definition! (1+ / 0-)
      Recommended by:

      Definition of INFALLIBLE

      : incapable of error : unerring [unless used in the case of profit or capitalism in general]
      : not liable to mislead, deceive, or disappoint : certain [unless in the pursuit of capitalism]
      : incapable of error in defining doctrines touching faith or morals [of capitalism]

      I never claimed to be infallible. [I was just seeking a profit!]
      There is no infallible remedy to these problems. [Unless, of course there is a remedy which I will make available at a handsome profit]

      Bolding mine, of course, which is a lot more truthful that the industry is.  

      Apologies to Merriam-Webster.

      202-224-3121 to Congress in D.C. USE it! You can tell how big a person is by what it takes to discourage them. "We're not perfect, but they're nuts."--Barney Frank 01/02/2012

      by cany on Sun Oct 07, 2012 at 12:17:38 AM PDT

      [ Parent ]

  •  my friend (7+ / 0-)

    My friend needs to take a potent steroid.  The manufacturers produce it in only .1 and .2 mg tablets.  My friend needs between .01 and .02 mg per day.  No way to "cut" a .1 mg tablet into 10 equal pieces (in half is difficult).  The only alternative is a compounding pharmacy.

    Government can't restrict free speech, but corporations can? WTF

    by kyoders on Sat Oct 06, 2012 at 11:51:41 PM PDT

    •  Sure you can (4+ / 0-)
      Recommended by:
      ffour, DamselleFly, bumbi, wonderwhy

      If it's soluble, dissolve it in water and take 1/10th of the solution.

      If it's not soluble, grind it and mix it with an inert solid (powdered sugar) and take 1/10th of the powder.

      But then, isn't this just the recipe that compounding pharmacies follow?  And if that's true, isn't it better to have someone who knows what he's doing follow the recipe than let everyone have the freedom to do it in their own kitchen?

  •  According to the report I saw (9+ / 0-)

    The problem is NOT deregulation. The FDA has never had authority over the com ponders; they are overseen by state pharmacy boards with different levels of authority. The problem is a total lack of regulation at the federal level because since these firms don't manufacture the drugs they don't fall under the FDA's purview and never have. That is a completely different issue from deregulation.

    You fell victim to one of the classic blunders, the most famous of which is "Never get involved in a land war in Asia".

    by yellowdog on Sun Oct 07, 2012 at 02:12:14 AM PDT

  •  More like the free market "speaking" (2+ / 0-)
    Recommended by:
    DamselleFly, bumbi

    Big Pharma charges way too much for their copyrighted pills -- money that people don't have.  So they find a way to stay alive that also allows them to buy food.

    Progressive Candidate Obama (now - Nov 6, 2012)
    Bipartisan Obama returns (Nov 7, 2012)

    by The Dead Man on Sun Oct 07, 2012 at 03:29:55 AM PDT

    •  I have thyroid disease. (3+ / 0-)

      My first medication was a synthetic hormone to regulate my thyroid that cost me $15/mth with insurance. Plus, it made my hair fall out. I was constantly having to "tune up" the dosage, depending on fluctuations in my hormone levels, until they had me on such a high dose it was giving me heart palpitations.

      Since my insurance company won't cover natural medications, I went to a local compounding pharmacy to purchase what was essentially desiccated pig thyroid. It costs me $17 every two months, and I don't have the physical problems as caused by synthetics. Not all doctors will allow their patients to do this, but I was lucky to have a nurse practitioner who was openminded. Lots of endocrinologists turn up their noses at "natural remedies", especially when it comes to things like natural hormone replacement therapy.

      If consumers had more of a CHOICE in where to acquire their medications, maybe we wouldn't have these kinds of problems where people are getting sick(er) while trying to save money on treatment.

      An eye for an eye makes the whole world blind. - Gandhi

      by missLotus on Sun Oct 07, 2012 at 05:45:14 AM PDT

      [ Parent ]

  •  I am just wondering if (2+ / 0-)
    Recommended by:
    sillia, marykk

    the compounded med had any labeling that it had to be used within a certain time period, or whether it had to be stored under certain conditions.  

    I fall down, I get up, I keep dancing.

    by DamselleFly on Sun Oct 07, 2012 at 07:35:37 AM PDT

  •  Right (2+ / 0-)
    Recommended by:
    marykk, NYFM

    I get a compounded solution for intra-muscular injection. In my case, I believe it DOES have a preservative in it, but it still says it must be refrigerated and there is an expiration date on it.
    This is just a certain form of B12. This same compounding pharmacy can provide various B12 solutions WITHOUT a preservative--apparently some doctors treating children with autism, for example, feel that their patients are extremely sensitive to the preservative.

    So there are pros and cons to including a preservative and it seems to me patient safety is a matter that is not simple to guarantee. Sure, there should be regulations but doctors will need to be able to get the type and form of medications best suited to their patients.

    I love it that Obama's channeling Harry Truman: "I don't give 'em hell; I just tell the truth and they think it's hell!"

    by sillia on Sun Oct 07, 2012 at 09:57:55 AM PDT

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