Fourteen Dead and 170 Infected: Poor Regulation Built That

The latest figures indicate that fourteen people have died and at least 170 have been sickened by fungal meningitis arising from an injectable form of the steroid drug methylprednisolone. The bulk of the cases have occurred from patients receiving spinal injections for back pain but there is now at least one documented case of an infection arising from injection of an ankle. At a time when Republicans running for office all across the country routinely deride “job killing regulations”, we now have a sadly perfect example of how lack of regulation kills people.

The tainted drug causing the infections in these cases comes from a single compounding pharmacy in Massacusetts. Compounding pharmacies exist in a regulatory gray area and have pushed further and further away from their original form due to an absence of regulatory push-back. The FDA strictly regulates the manufacturing of pharmaceuticals and assures that they are produced without risk of contaminating microorganisms that could cause infection upon use of the drug. However, compounding pharmacies are regulated only at the state level, mostly because their original role was to provide unique mixtures of drugs produced in response to prescriptions for individual patients. Sensing opportunity to operate in a regulatory gray area, “the free market” has moved in and compounding operations now openly flaunt the single patient idea. In the current case, CNN reports a CDC estimate that as many as 13,000 patients may have been injected with the tainted drug compounded by New England Compounding Center in Framingham, Massachusetts.

The CNN article describes that the regulatory gaps are well-known but Congress has refused to act:

If Sarah Sellers’ warnings had been taken seriously 10 years ago, 12 people might be alive today.

Sellers, a pharmacist and expert on the sterile compounding of drugs, testified to Congress in 2003 about non-sterile conditions she’d witnessed.

“Professional standards for sterile compounding have not been consistently applied,” she told the Senate Committee on Health, Education, Labor, and Pensions. “The absence of federal compounding regulations has created vulnerability in our gold standard system for pharmaceutical regulation.”

Nearly 10 years later, there are still no federal sterility guidelines for compounding pharmacies that make and distribute drugs all over the country.

Further, we see that the court system has acted to weaken the poor regulations that previously existed:

In the 1990s, FDA regulators began to more closely scrutinize the industry, as some compounding pharmacies grew into larger operations that resembled small pharmaceutical companies.

In 1997, Congress passed a law bringing compounded drugs under FDA oversight, requiring that they meet certain standards for production, labeling and advertising. Specifically, the law banned compounding pharmacies from advertising their products.

A 9th Circuit court ruled that this last requirement was unconstitutional, and the Supreme Court upheld the decision in 2002. The court did not rule on the other portions of the law, though the FDA has not actively enforced them.

We learn from USA Today that problems from compounding pharmacies lowering safety standards while chasing higher profits through high-volume compounding have led to many known cases of infections and other medical complications over the last ten years or so:

Thousands of these pharmacies play a critical role in providing custom drug mixtures and hard-to-find compounds that might otherwise be unavailable to doctors and their patients. But a proliferation of compounding operations in recent years and the growth of some into de facto manufacturing enterprises that produce and ship thousands of doses of medication all over the country have paved the way for serious problems.

Since 2001, records show that the FDA has issued more than 40 warning letters to compounding pharmacies for sanitary violations and failure to take proper steps to prevent the sale of dangerous or ineffective drugs.


If the NECC drug is implicated in the ongoing meningitis episode, it would be the worst recorded U.S. outbreak of illness associated with medication produced by a compounding pharmacy. But it would be far from the first.

More than two dozen deaths since 2001 have been linked to contaminated or mismeasured doses of medications produced by compounding pharmacies, according to USA TODAY’s review of state and federal records, academic journals, and industry reports. Scores more patients have been badly injured, sometimes resulting in permanent disability.

There also was a highly publicized incident in 2009 when a pharmacy compounding veterinary drugs made an error that led to the deaths of 21 polo horses in Florida.

When it comes to the business of compounding, free marketeers who seek to exploit the poor regulatory environment have demonstrated exactly why strict oversight is needed when it comes to pharmaceuticals. In a bit of irony, though, rather than the regulations being the job killers, in this case it would seem that the thirst for high volumes of sales of compounded materials from large-scale operations most likely squeezed out smaller pharmacies who probably would have been more scrupulous in preparing materials for injection in response to prescriptions for individual patients. By massively inflating the scale of an operation that was designed to work for individual patients, thousands of people who already were suffering from severe pain now have been put at risk for fatal complications arising directly from putting profits over safety.

Many years ago, Jim got a BA in Radiation Biophysics from the University of Kansas. He then got a PhD in Molecular Biology from UCLA and did postdoctoral research in yeast genetics at UC Berkeley and mouse retroviruses at Stanford. He joined biosys in Palo Alto, producing insect parasitic nematodes for pest control. In the early 1990’s, he moved to Gainesville, FL and founded a company that eventually became Entomos. He left the firm as it reorganized into Pasteuria Biosciences and chose not to found a new firm due a clash of values with venture capital investors, who generally lack all values. Upon leaving, he chose to be a stay at home dad, gentleman farmer, cook and horse wrangler. He discovered the online world through commenting at Glenn Greenwald’s blog in the Salon days and was involved in the briefly successful Chris Dodd move to block the bill to renew FISA. He then went on to blog at Firedoglake and served a brief stint as evening editor there. When the Emptywheel blog moved out of Firedoglake back to standalone status, Jim tagged along and blogged on anthrax, viruses, John Galt, Pakistan and Afghanistan. He is now a mostly lapsed blogger looking for a work-around to the depressing realization that pointing out the details of government malfeasance and elite immunity has approximately zero effect.
10 replies
  1. seedeevee says:

    Do you see any way that “medical” marijuana could possibly pass any of your above criticisms? If any “medicine” is manufactured in an relatively uncontrolled way – it is marijuana.

    Your line of reasoning (Not necessarily the big vs. small manufacturers part) is precisely what the anti-marijuana crowd would say. Something like — “It is not made in a controlled sterile environment, not in a scientific manner and needs strict government oversight to protect us all from those evil non-science types.” Thus we get FDA control over a plant.

    Anyways, I did forget about the “polo horse” fiasco and appreciate the reminder. It seems that the animals are the first to get a dose of our inhumanity (greed). Any melamine in our food supply lately?

  2. Jim White says:

    @seedeevee: I agree that there should be strict standards developed and oversight put into place whenever medical marijuana is made available, just as should be the case for any materials that are used in a therpuetic environment.

  3. seedeevee says:

    @Jim White: Medical marijuana is available in my homestate, California. We also have a massive anti-illegal-drug Job Creation scheme in the DEA/Federal, State and local Courts/criminal cartels/police/prisons/etc.

    Do you see any right that an individual has to make their own therapeutic materials and self-medicate/therapy, under his/her own guidelines? I do not see how it could fit into your view from above.

    Cue Granny Clampett and her roomatiz medicine . . . .

  4. Jim White says:

    @seedeevee: No, I almost added in the previous comment that I wouldn’t have a problem for folks who have a prescription growing for their own use. It’s when someone is growing and preparing material for others that I see a need for regulations and oversight.

  5. It'sthedrugs says:

    Thank you for this article.
    Here are some things to think about:

    Scott Brown sent a letter supporting these lightly regulated drug companies.

    If I have cut my way through the verbiage, it seems that COMPOUNDING used to mean preparing individual doses of drugs for an individual, thus the need for a prescription.

    They are doing much more. They are producing bulk shipments.

    Scott Brown and ten other senators support bulk shipments of drugs from lightly regulated drug “compounding” companies.

    Bring out the pixie dust: They are acting as full fledged drug companies – some only regulated on the day they opened and the day of a complaint, that’s it – and they set up shop as prescription by prescription compounding specialty pharmacies.

    Scott Brown and ten other senators are supporting bulk shipping to doctors in the name of SAFETY. Rather than send individual doses to prescription holders, it is so much safer to send bulk shipments across state lines to doctors who what? Foresee prescriptions?

    So if we follow the Billions, we see these compounding companies pixie dusted into major drug companies – lots and lots of PAIN drugs – and they need Senator Brown’s help to be able to BULK ship to doctors’ offices around the country. The world, perhaps? Just wondering.

    One of the owners of NECC lives in Scott Brown’s hometown of Wrentham, Massachusetts. He and the other owner gave a fundraiser for Brown after the July letter went out.

    Scott Brown has said he doesn’t recognize the name of one of the owners. “… doesn’t ring a bell.”

  6. Mick Savage says:

    re Jim White: It’s when someone is growing and preparing material for others that I see a need for regulations and oversight.

    Eeeegads. Doesn’t this “need” fit nicely into the false meme and fearmongering that these materials are “dangerous” “addictive” “cause low IQ” “cause mental problems” (courtesy of assholes like keven sabat, junior rat)?


  7. Jim White says:

    @Mick Savage: Uhm. No.

    The discussion got to that point from the overall proposition that any material that is being provided from one person to another under the guise of the material being a pharmaceutical that is meant to fill a prescription from a doctor deserves regulation and oversight. Doesn’t matter what the material is. I’d say the same thing about someone processing their own willow bark to make aspirin. If they do it from their own tree for their own use, go for it. If they want to sell it to someone whose doctor prescribed aspirin, then that is an entirely different proposition.

  8. Nic108 says:

    Compounding pharmacies are popular because the “well regulated” toxic effuvia of Big Pharma is so bloody expensive.

  9. It'sthedrugs says:

    Off label

    I’m sorry, I forgot to mention how doctors and compounding companies work together:

    Only doctors with MDs get to decide to use an FDA approved drug DIFFERENTLY from what it was tested for.

    Those that have, let’s say, a transdermal approach to pain relief and prefer certain ingredients can order the concoction from the compounding company. Or one might intuit that an eighth grader could benefit from becoming a zombie on drugs tested only on adults. There’s no end to the ways that products can be used and ordered.

    Brought to you by doctors
    with MDs

  10. earlofhuntingdon says:

    Thanks for this. Even NPR’s coverage of this issue has been abysmal. It has focused on a bland number of infected and dead, as if they were describing storm of flood deaths. It has ignored the most obvious and likely issues that lie at the root of this unnatural catastrophe, negligent handling and manufacturing controls, for which corporations are responsible.

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