The New England Compounding Center is based here in New England, so local news media has been providing a steady drip of coverage, from a number of angles. But the NYTimes has a baseline summary:
RANDALL KINNARD’S legal clients had steroids injected into their backs last summer for a wide range of reasons. Of the 25, one got three shots in a two-month period when pain never totally disappeared. Another got one as a preventive measure because she was going on a trip to Europe and was worried that cobblestones would aggravate an old injury.
Now the 25 — or their survivors — have engaged Mr. Kinnard, one of Nashville’s leading lawyers, to sue the New England Compounding Center. Three have died, one is paralyzed, several more are still hospitalized and all suffer blinding headaches — victims of the meningitis that resulted from vials of steroid medicine contaminated by fungus.
The New England Compounding Center certainly seems deserving of its current status as the prime culprit in a tragic outbreak that has killed 32 and sickened 438. The bottles of supposedly sterile steroid medication it shipped were reportedly so tainted that white fuzz could be seen floating in some vials.
But, experts say, the now notorious Compounding Center has a nationwide network of unwitting enablers and accomplices: There are the doctors who overprescribe an invasive back-pain therapy that, in studies, has not proved useful for many of the patients who get it. And there are the patients, living in an increasingly medicalized society, who want a quick fix for life’s aches and pains…
The whole tragedy is playing out as a perfect storm of a lot of bad medico-economic decisions. And while the blame is being parceled out, let’s not forget the MBA-Hospital-Administration mindset where patients are both ‘clients’ whose desire for convenient low-cost medical insta-fixes must be catered to, and ‘care units’ to be processed with the maximum efficiency at the lowest possible cost — but never human beings.
arguingwithsignposts
Oh, fuck that. They’re just trying to spread the blame. That’s like blaming the restaurants who served vegetables that had e-coli, or the stores that sold tainted Tylenol.
ETA: Assuming that such tainted products could not be easily checked on the store/restaurant end.
BruceFromOhio
Gonna swim upstream on this one. MrsFromOhio has a debilitating hip injury from days of yore. Osteopaths and physical therapists took time to understand what was happening, and pushed her along with a painful yet helpful regimen. One time and one time only, she got the magical shot of steroid, well before this tragic mess unfolded. It was like being freed from chains – she was pain-free and fully mobile for the first time in, well, a long fricking time. When the effects began to fade, she lobbied for another, but was told, no, it’s not good for you in the long run: let’s work together to find a sustainable regimen that helps you heal. This has been years in the making, with low-cost, non-invasive techniques that focus on ‘whole health’ and recovery.
So, not everybody rolls with the ‘insta-fix’. There are good healers that do the right thing. Sadly, they do not get the press.
Howard Beale IV
Back in the late 1980s I had the very similar type of steroid injections done against a herniated L4-L5 disc. On the third such set of injections, the doctor who did the injections accidentally ‘nicked’ the pocket where the anesthesia was held next to the nerve root where the depo-Medrol was pressed up against-the nicking of the pocket caused the anesthesic to leak into the spinal cavity, rendering me paralyzed. Thankfully, if was only temporary. After that episode, I decided to just grin and bear it.
Of course, the diagnosis of the herniated disc was left to that oh-so-wonderful procedure known as a myelogram-in my case, the puncture hole didn’t heal and I had the mother of all headaches that was only relived by the ubiquitous blood patch.
As is the case with lawyers, MD’s and for some perverse reason software architects (?!?) these kinds of things are chalked up to one’s ‘practice’.
lumpkin
>>> And there are the patients, living in an increasingly medicalized society, who want a quick fix for life’s aches and pains<<<
Obviously said by someone who never had a pinched nerve in their back. I know the point of this story is about the tainted medicine, but the story itself is tainted by this statement.
At one time, I had a pinched sciatic nerve and I would have jumped off a cliff rather than endure it for the rest of my life. Steroid treatment didn't work for me, but many people find life to be livable once again after this "quick fix". If this writer ever experienced for just an hour what many people suffer with for months, she'd be all over this "quick fix" herself.
Why do these stories in the popular press always have to throw in a gratuitous statement about how weak, lazy and self centered everyone else but them is?
PeakVT
More magic free-market pixie dust would have prevented the whole episode.
jl
I am sure there is plenty of blame to go around. And it is an interesting article.
I’ve talked with docs and pharmacists where I teach, and unanimous opinion is that no responsible anybody in health care should have dealt with the NE Compounding Center. Compounding pharmacies are not supposed to be dealing with long distance customers and operating like mini drug manufacturers. I heard phrases like ‘disaster waiting to happen’, ‘regulators should have shut this scheme down as soon as they knew about it’, ‘should have been hair on fire warnings about this bunch’.
So, not much of surprise that the clinics that used it were sketchy. So, not sure the over use of these meds in this situation says a lot about practice in general.
JoyfulA
I have osteoarthritis of the back (as well as of the hips and knees, which are why they’re all artificial). Every so often (three times now over +/- six years), I have had leg pain from impinged nerves in my back that made walking so painful as to be impossible. Each time a shot in the back cured me enough to walk; a second shot to make me “perfect” provided no improvement.
I’d definitely recommend the treatment if you’re diagnosed with the problem. Then again, I don’t want another shot until I know just where it’s coming from.
Mnemosyne
@lumpkin:
I found the writing to be pretty offensive, frankly. “Haw-haw, this patient didn’t want to be in pain during her fancy European vacation and she deserved to suffer meningitis for trying to avoid it!” Seriously, WTF?
Slugger
The compounding pharmacies are outside the purview of the regulatory agencies that we all love to hate. Not the FDA and not JCAHO.
The steroid is an emulsion and can not be sterilized by heat or ultrafiltration like solutions. Therefore, every step in the compounding must be fool-proof. These things are made in rooms with sterile, filtered air and positive pressure to make the clean air blow out of the room and keep the dirty air out. Someone in the know told me that these guys turned off the positive pressure at the end of the work day to save electricity. Hence the sterile rooms were full of dirty air every morning.
A drug company would have been watched by the FDA, and a hospital pharmacy would have been under the aegis of JCAHO. These guys had no one watching over their shoulder.
Schlemizel
MAYBE there is an issue of misuse or unnecessary prescription but thats not really the problem here is it? Why even pretend it is?
The problem is an SOB who put profits over human life, in an environment where society has not remembered from past experience just how shitty these ‘job creators’ can be if left to their own devices. That means little to no oversight or safety testing.
The son of a bitch will walk away with millions (billions?) and probably broke no laws so twenty years from now when the civil suits are settled he will have had a comfortable life
Mnemosyne
Oh, and it’s especially annoying that the writer is trying to redirect the blame back onto the patients when this paragraph is in the story:
So apparently it’s the patient’s fault if they take the advice of their doctor without knowing that the doctor is making a profit from giving the injection. Gawd forbid we should blame the physicians who are making a quick buck from it — nope, those patients should have known better and just gritted their teeth through the pain.
Gosh, perhaps the problem is our for-profit healthcare system that’s set up to make a buck off patients at every turn? Nope, not possible — it must be the fault of the patients for wanting to be healed. If not for those pesky patients and their demands, the free market for medicine would operate like it’s supposed to, amirite?
arguingwithsignposts
I actually went to a surgical specialist today who said he could go in and do an invasive surgery on my (unspecified medical condition), but it might not help that much, and he didn’t want to put that unnecessary expense on me (and I have insurance). So, anecdote != data.
Schlemizel
I think an entertaining (for us the viewer)solution for the fine folks at NECC is diagrammed here:
bowling for fun
we can work on hospital admins and unethical doctors once we have the real problem fixed
Cob
In a “Just” America, the perpetrators of these crimes against innocent people would be charged with manslaughter at the least. But it was the corporate structure that feeds this madness, and the patients were the victims of the greed of both the coumpounding pharmacy and some of it’s employees, as well as the medical practices that sought out the cheapest available product, regardless of the quality, or lack thereof.
jl
@Mnemosyne: I agree that the tone, and author’s tendency to circle back and piss on the patients at every opportunity was annoying.
Forum Transmitted Disease
@lumpkin: I had it one veterbra down. Imagine agonizing pain like sciatica, but shooting through your balls and down your leg, 24/7. 10 months before it was even diagnosed properly. I literally could not walk.
I don’t know what stopped me from blowing my brains out. I certainly had the means and plenty of motivation.
Mnemosyne
@jl:
There seems to be this weird attitude by a lot of medicine and science writers that somehow doctors are being forced to order very profitable procedures or prescribe expensive patented drugs because the patients demand them. Oh, the poor doctors, how will they ever resist the pressure from their patients to be given procedures they don’t need that just happen to make a lot of money for the doctor?
I don’t know if it’s a blind spot or what, but it drives me up the freakin’ wall every time.
Mnemosyne
Also, too — a week or so after I had knee surgery to replace my torn ACL, the story about infected tissue being transplanted into patients came out and I got to have several days of being paranoid that my new ACL was going to kill me.
Apparently I was supposed to not have the injury repaired because if something bad had happened, it was only my vanity of wanting to have a fully working leg that would have endangered me and not, say, the poor infection control procedures of the companies that were harvesting donated tissue.
Schlemizel
@Mnemosyne:
I think doctors are being pushed into some unnecessary stuff by patients in some cases “Ask your doctor if meningitis is right for you!” and by the need to earn the sorts of money they feel entitled to but have to finagle because of insurance companies putting profit over people.
But lets pretend we had fixed those issues – this situation would have still existed, people would still have dies because of tainted meds sold by a greed bastard who was allowed to operate without proper oversight because HEAVEN FORFEND we wouldn’t want to impede the job creators with unnecessary regulation!
jl
@Mnemosyne:
Unfortunately, you have both unscrupulous doctors and patients who want easy fixes for everything, including bad health habits. So, maybe both deserve stories backed up by data? Maybe?
Every pharmacist and doc I talk to says drug seeking is a huge problem. But do the vast majority of patients engage in drug seeking behavior? No. The vast majority don’t. That is why designing detection methods is so difficult, since unless you have an almost perfect algorithm you will get tons of false positives, which is very bad, especially for opiates. Excellent way to totally piss off a patient.
But, how does the average patient know where the medical group gets the drugs? In some parts of the country, does the patient have easy access to anything put a maybe sketchy for profit specialty medical clinic? Who knows, who cares? The writer just throws in some blame all around. It is irritating.
From what I have heard, the real serious problem that deserves a story is how such an outrageous practice like NECP was allowed to operate. But that might be too touchy a subject, since a lot of money is made off operations like that.
Edit: seriously, everyone who knows about how compounding pharmacies should work says this was a case closed simple situation: as soon as a regulator read about what it doing, should have gone down there and shut the place down and investigated how it managed to get its operation going in the first place.
Compounding pharmacies are supposed to produce specialty meds that are not available otherwise, working in a very face to face local way with client.
Emma Anne
“Experts say”, huh? Experts in how patients who want relief from pain are “enablers and accomplices?” What the fuck?
Wag
@efgoldman:
Actually the FDA cannot regulate compounding pharmacies, in the same way that the FDA cannot oversee the production of herbal supplements. The law forbids their regulation, because the medications are “mixed to meet the needs of individual patients” rather than being marketed for the general public.
Its a BS distinction, with tragic consequences.
Maude
@Forum Transmitted Disease:
I think it’s called screaming pain.
suzanne
@Slugger:
Increasingly, hospitals and pharmacies are using DNV for licensure rather than JCAHO. Whatever. Your point stands.
Yanno, I had one experience with chronic pain. I had a bronchial cleft as big as two fists grow in my neck, causing me monstrous headaches. As there was only one ENT practice in Tucson at the time, I had to wait two months for surgery, and I was told that I could only take aspirin, despite begging for Vicodins. I ended up taking so much aspirin trying to stop the pain that I repeatedly barfed all over myself. One day at work, I finally lost my shit and started sobbing, because I couldn’t eat or sleep, and I threatened to cut the fucking thing open with an Xacto knife myself, because then at least I’d get emergency treatment. I called my mother having a total breakdown, and she called the doctor, and apparently threatened him with bodily harm if he didn’t give me narcotics. He wrote me the prescription, and then had the police sent to her house.
I can’t imagine living like that, and yet, people do. Fuck anybody that dismisses that as indulgent drug-seeking.
Linda
@lumpkin:
This. My sister–besides having the family curse of spine problems and arthritis–got thrown from an ambulance about 30 years ago, and her life is one of constant, unbelievable pain. All sorts of collapsed and fused vertebrae. The steroid shots in her back have made her life liveable for
long periods.
Please, don’t always knock the “fix.” I can’t even imagine living her life without them sometimes.
Roger Moore
@jl:
This. If people are turning to compounding pharmacies to cut costs (rather than for specialty formulations the drug companies don’t make, which is their intended purpose) the savings are almost certainly coming out of quality control. The FDA may be a bit lax in approving new drugs, but they’re very tough about regulating manufacturing. I hate, hate, hate dealing with FDA stuff in my day job because it’s such a PITA, but when it’s my turn to use a drug it’s nice to know the standards the manufacturers have to meet. Skipping that quality control is pretty much the definition of a false economy.
Maude
@Linda:
It’s wonderful that it works for her. It makes the difference between functioning and not functioning.
Roger Moore
@efgoldman:
I’m sure the FDA would love to look at compounding pharmacies, but under current law that isn’t its job. Regulation of compounding pharmacies is left to the states. The problem is that the company in question is skirting the law and acting less like a pharmacy and more like a small-scale drug company. The states don’t have the resources to deal with companies like that, and the FDA doesn’t have the jurisdiction.
suzanne
……aaaand I’m in moderation for using the V word for the narcotic pain relievers that Eminem loves so much.
Roger Moore
@suzanne:
You can apparently be thrown into moderation for using the singular of pharmacies, too. FYWP.
jl
@Wag:
” Actually the FDA cannot regulate compounding pharmacies ”
But states have regulatory authority. The state regulators fell down on this one.
Mnemosyne
@jl:
It seems to me that trying to detect drug-seeking behavior after the fact is closing the barn door when the horse is already well over the horizon. It would probably be better to figure out a way to screen patients for addictive tendencies before they’re prescribed opiates and monitor them.
Unfortunately, we’re dealing with this in my own family right now — my sister-in-law has become addicted to the Vicodin she was prescribed for fibromyalgia and is now drug-shopping at various emergency rooms whenever she runs out before it’s time for her next prescription. But God forbid we should say, “Hmm, that person has a family history of alcoholism — maybe there should be a different protocol for them to follow to try and prevent them from getting addicted to the highly addictive painkillers they’re getting.”
The one and only time I’ve dealt with a compounding (place), that’s exactly what it was. The vet prescribed some steroids for our cat who was dying of cancer to make her more comfortable, so she had us take the prescription to a compounding (place) to have them mix it into fish oil. (Which the cat hated with a passion, but that’s a different story.) Needless to say, that’s not a common way to dispense steroids.
PurpleGirl
@jl: The state regulators fell down on this one.
IIRC, when the story first began, there were some stories about the state regulations becoming more lax under a certain recent governor.
Roger Moore
@PurpleGirl:
Ah, so they didn’t just fall down, they were hamstrung.
lumpkin
@Forum Transmitted Disease:
Minor point here, but sciatica is when your sciatic nerve is irritated where it crosses your butt bone. A pinched sciatic nerve is when it’s squished coming out of your spine. You get pins and needles, numbness, burning pain, leg cramps, weak muscles, sensations like your feet are big lumps, freezing sensations in your skin, on and on. You get pains that we have no words for. The idiot that wrote about “life’s aches and pains” doesn’t have any idea what it is like to experience this. I’m not sure whether I hope they ever experience this or not. They deserve it, though.
David
I work for one of the big pharma companies in a quality control lab and my wife is an oncologist at a teaching hospital. We were reading the the FDA investigation (often just called 483s) and were both horrified. Interestingly, we were horrified by different parts. She was struck by the number of things that would get someone fired from the pharmacy at her hospital that were just another day at the office at this place. I was shocked by the apparent absence of procedures that are routine for my work and we only handle research compounds that are not even going to be given to people. What’s worse is that the manufacturing group across the way thinks that it is the wild, wild west in our lab.
These clowns are part of why medical care is so expensive. Small compounding pharmacies that were doing things the right way were probably driven out of business because they couldn’t compete on cost. Those that weren’t are going to face a much more difficult and expensive environment. Outpatient clinics that could save you money vs hospitalization are going be stigmatized. Stretched FDA budgets will be stretched further, making it that much more expensive (slower review and/or more audits) to bring out a new drug.
I am required to attend yearly traing about my regulatory (FDA) responsibilities which remind me of the various ways that I, personally, can go to jail. The idea that any salaried employee who does not turn into a witness for the government might avoid doing time is crazy. At the same time, I am not holding my breath.
PurpleGirl
@lumpkin: When I had the L5-S1 herniation, my left leg felt like it was on fire, that a little man was inside and running up and down my leg with a blow-torch. And the sensation was constant. The only time it didn’t hurt was when I lay down absolutely still, with my legs propped up on pillows.
lumpkin
@PurpleGirl:
Bet you were hoping for a quick fix for that, weren’t ya, you unwitting accomplice.
Wag
@jl:
So you’re saying we need to accept having 50 different regulatory bodies. Fuck that. If the pharmacy is selling its concoctions across state lines, I want the FDA watching what they do.
Wag
Please release me from moderation.
lumpkin
@Linda:
>>>Please, don’t always knock the “fix.”<<<
Did you read what I wrote?
PurpleGirl
@lumpkin: Pain killers did nothing to ease or stop the pain. Only not moving did. Within seven months of the problem starting I had a hemilaminectomy and woke up pain-free from the surgery. I bless the people who developed MRIs.
eco2geek
I had bursitis in my shoulder where the pain began to interfere with sleep, and went to my doctor. He said he could give me a steroid shot that would act as a lubricant. He said it might have no effect on the pain, or it might work for six months and then stop working, or it might stop the pain long-term. So I got the shot (actually 2 of them, with a very long needle).
Surprise, it worked! Although I may need to top it off in the near future.
But I’m sure I’m just someone who wants a quick fix for my aches and pains.
Why the hell is using medication to ease pain seen as some kind of moral failing on the part of the patient?
tjmn
Whoever wrote the NY Times piece ought to be tased repeatedly to feel what nerve pain is like.
Uriel
Wow!
As former amateur boxer and wrestler who has literally passed out from pain due to construction work related back problems I’ve suffered from for nearly 20 years now, I’m gonna say fuck that shit. You seriously have no idea how fragile the human body is until you bend down to pick up an aluminum pot and find yourself bed-ridden for a week.
Fuck that to hell.
And I say that as someone who considers himself one of the lucky ones- after being reduced to using a cane for half a year, i went through a new years eve where I was writhing in agony despite a steady diet of codeine and vodka, only to wake up (from passing out again, after begging a god I don’t believe in for death) to realize that the pain I felt was what ever it was I screwed up years ago movi
Uriel
(Ok, I tried to edit that last one, but it didn’t work, so pretend this is a continuation of that..;)) moving back into place.
That was three years ago. Since then, I haven’t gone a week where I wasn’t amazed that I can move like a normal person for he first time in almost a quarter of a century.
Tempered by the fear that, one day, it will all come back.
So screw your patronizing quick fix bull shit. Whoever wrote that has no fucking idea. And let me be the first to say, I hope they never do.
Linda
@lumpkin I wasn’t addressing that to you, but the to the knockers.
Kolohe
“And there are the patients, living in an increasingly medicalized society, who want a quick fix for life’s aches and pains. ”
Awesome that the NYT and the original post blames everyone under the sun, *including the victims*, but not the FDA. But that would require government executive accountability and we can’t have that in this day and age.
brantl
Full Metal Wingnut
Overcharge, under deliver.
Best healthcare system in the world!
Mnemosyne
@Wag:
That’s the whole point, though — compounding pharms are not allowed to sell across state lines. G works for a home infusion company that operates as a compounding pharm and if a patient is going to be out of state for more than (I think) three weeks, they are required by law to transfer that patient to a branch of their company that operates in that other state, because, as a compounding pharm, they are not allowed to sell their products across state lines.
Frankly, the state of Massachussetts fell down on the job here, because that company should never have been allowed to send their product across state lines to begin with without being licensed by the FDA as a drug production facility rather than a pharm.
(Trying to avoid moderation here — we’ll see how it goes.)
Lex
If I may slide off on a tangent for a moment, I promise I’ll tie it all back …
I spent a couple of years as a medical writer, and one of the things I learned we REALLY need more of is effectiveness testing for drugs, devices and procedures. We need to test both absolute effectiveness — does something work at all? — and comparative effectiveness — does something work better, as well as, or less well than existing, perhaps cheaper alternatives? Because former CBO director Peter Orszag estimated about six years ago that we spend close a third of our total national health-care bill each year on stuff that either doesn’t work or for which there are equally effective and cheaper substitutes.
Which relates here because one of the medical problems that leads to the greatest waste is back pain. I don’t have the numbers handy, but in a huge percentage of cases, the one thing that really works is the one thing no one makes any money on: rest. A lot of surgeries don’t work. A lot of medications may ease the symptoms but do nothing for the underlying problem. And so on. Multiply that across the spectrum of ailments, and you start to see why we have both the Western world’s highest per-capita health care costs and among its most mediocre outcomes.
So-called “comparative-effectiveness testing” — which would have saved Americans a ton by forbidding Medicare and Medicaid from covering stuff that didn’t work or for which equally effective and cheaper treatments were available — was supposed to be a big part of the ACA. But thanks to (gasp!) lobbying, it was pretty well stripped out.
And Republicans no more want to spend tax dollars to make your food, drugs and cosmetics safe than they do to make your work places safe.