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Photo courtesy Margaret Snopkowski
Margaret Snopkowski, 51, of Michigan, holds her 11-day-old grandson, Ethan Edward Jackson. She missed the baby's birth after becoming gravely ill with fungal infections tied to tainted drugs in a national outbreak.
Margaret Snopkowski was supposed to be in the delivery room on Oct. 24, when her first grandchild, Ethan Edward Jackson, made his debut in Pittsburgh.
Instead, the 51-year-old Fowlerville, Mich., woman was nearly 300 miles away, lying in a hospital room in Ann Arbor, so sick with fungal meningitis that she was barely aware when the baby boy was born.
“For the most part, she wasn’t coherent,” recalled Courtney Jackson, 27, Snopkowski’s daughter. “The greatest moment in my life was being overshadowed by the worst moment in hers.”
Courtesy Snopkowski family
Tom and Margaret Snopkowski before she fell ill with life-threatening fungal infections tied to contaminated back pain shots.
As her daughter gave birth, Snopkowski was grappling with searing headaches, incessant vomiting and lower back pain so severe that a video taken in the hospital shows her whimpering and moaning, “Oh my god, Oh my god, Oh my god,” as a nurse gently advises, “Just breathe.”
Snopkowski was one of the first victims in the still-growing outbreak of fungal meningitis traced to contaminated steroid injections that have sickened 483 people and killed 32, according to federal health officials.
“It’s torturous,” said the previously healthy saleswoman for a concrete contractor, reached by phone in her room at St. Joseph Mercy Hospital in Ann Arbor, where she’s been getting treatment since early October.
Victims and their families hope that their plight will remain the focus of two congressional committee hearings set for Wednesday and Thursday, sessions expected to include Food and Drug Administration chief Dr. Margaret Hamburg and Barry Cadden, the owner and managing pharmacist of the New England Compounding Center, the Massachusetts pharmacy responsible for distributing the contaminated steroid drugs blamed for the infections.
Congressional investigators subpoenaed Cadden last week after he indicated he would not appear voluntarily.
At issue is whether federal and state regulators did enough to control NECC, or whether they let known problems dating to 2002 continue unabated. Federal and state officials have found evidence of environmental mold and fungus dating at least to January at the NECC site, documents show. The firm also was distributing drugs in bulk, contrary to regulations that require that compounding pharmacies to mix custom drugs to order for specific prescriptions.
Not only did Snopkowski contract life-threatening fungal meningitis, which causes inflammation of the membranes that protect the brain and spinal cord, but, like growing numbers of outbreak patients, she also has developed arachnoiditis, a painful, hard-to-treat infection of the nerve roots at the base of her spinal cord. Other patients -- perhaps up to a third of victims -- have also developed abscesses at their injection sites, medical experts say.
Worse, doctors aren’t quite sure what to do about it.
“We’ve never seen this disease before; it’s never been described,” said Dr. Anurag Malani, the infectious disease expert at St. Joseph Mercy Ann Arbor who is treating Snopkowski and others. “The story is being told every day and we continue to turn the page.”
Snopkowski’s trouble started on Sept. 13, when she received an epidural injection of the steroid methylprednisolone at Michigan Pain Specialists of Brighton. She’d been getting the shots every few months for five years to help ease the pain of degenerative disc disease in her lower back.
Sometimes the shots would help, sometimes they wouldn’t, but Snopkowski, an avid cook and gardener, wanted to stay active.
“It was, let’s do this as opposed to taking pills,” she said.
But Michigan Pain Specialists was among 76 clinics in 23 states to receive some 17,000 vials from three lots of NECC methylprednisolone contaminated with fungi. Nearly 14,000 people got the shots.
A week after the injection, Snopkowski said she began to feel like “something wasn’t right,” followed by low-grade headaches and then searing back pain different from anything she’d felt before.
When she got a call from the pain clinic warning that her injections were tied to an emerging outbreak of fungal meningitis, she got scared.
“Of course, I panicked,” she said. “I had all the symptoms.”
A spinal tap showed alarming evidence of infection. Within a day, Snopkowski was sent to St. Joseph Mercy. She was one of the first patients who contracted fungal meningitis caused by the black mold Exserohilum in the tainted drugs.
Snopkowski was placed on powerful antifungal drugs and at first seemed to respond. After 11 days in the hospital, she was sent home, but she was back within a week in unbearable pain.
That’s when doctors found the second infection. Malani, the infectious disease expert, said they can’t drain it, they can’t operate on it and it is responding slowly to the antifungal drugs.
Snopkowski’s treatment is also complicated because she had a bad reaction to one of the drugs, amphotericin B, and her body seems to metabolize the other commonly used medication, voriconazole, too quickly.
“We have to do some devious things to keep her levels up,” said Dr. Carol Kauffman, a University of Michigan expert in fungal infections who is consulting with St. Joseph Mercy on the outbreak, in addition to advising the U.S. Centers for Disease Control and Prevention.
Snopkowski has started taking Prilosec, an antacid, in hopes of helping her body hold on to the antifungal drug. She’s also had problems with plummeting potassium levels that caused heart trouble.
Snopkowski and her husband, Tom Snopkowski, 46, a contractor, say her days alternate between blinding pain and constant uncertainty about what the future holds.
“I’m supposed to be here two more weeks but it could be two months,” she said. “(The doctors) can’t give us anything because they don’t know.”
Courtesy Snopkowski family
Margaret Snopkowski, shown here with daughter Courtney Jackson, was vibrant and healthy before she got tainted back pain shots on Sept. 13.
Snopkowski is frustrated at the interruption in her work and her life, especially time with her daughter and the new baby. She saw Ethan once, when he was 11 days old, when Courtney brought him to the hospital chapel for a 15-minute visit.
“I started crying. She started crying,” Snopkowski said.
The family is outraged that NECC’s actions could have had such dire consequences for Snopkowski and other victims.
“It makes me sick, it honestly does, for someone to be so negligent,” Courtney Jackson said. “It’s 2012; this shouldn’t be happening.”
Snopkowski is suing NECC. Her lawyer, Elizabeth Kaveny of Chicago, also represents two other outbreak victims. She was referred through the InjuryBoard.
“NECC’s disregard for the safety of patients is unforgivable. That extends to its officers, directors and employees,” Kaveny said. “These individuals intentionally allowed filthy conditions and contamination to occur, creating a danger that NECC chose to expose to innocent people.”
Kaveny said she plans to push for criminal penalties for NECC agents. A lawyer for NECC did not respond to an NBC News request for comment.
Kauffman, the fungal disease expert, acknowledged the frustration that Snopkowski and other victims feel.
Doctors, too, are frustrated, she said. Fungal infections are rare in general, and infections with the molds involved in this outbreak are even scarcer.
“This is unlike anything we’ve ever seen before,” Kauffman said. “There’s nothing equal to this in my career.”
Unfortunately, neither she nor anyone can advise patients what to expect next. For now, they’re all trying to get through each day.
“When you’re dealing with people in pain, that’s the best thing,” she said. “We go day by day. This is all new territory.”
Related stories:
- More die in fungal meningitis outbreak; state pharmacy chief fired
- Fallout from fungal meningitis mess: more drug shortages
- First case history shows fungal meningitis can destroy brain fast
Leave a Comment:
Our the FDA inspectors that over worked or under staffed they cannot keep these ( or any ) businesses inspected?
The Food and Drug Act does not presently give the FDA authority to inspect these firms because they are technically pharmacies and not pharmaceutical manufacturers. The Congress must act to close this regulatory loophole.
This is why I try to avoid medications, treatments, etc as much as possible...the medical industry is not that well regulated as much as they would like you to think it is. The medication commercials alone should terrify you when you hear the possible side effects. Obviously some people cannot due to their illness, but if you can tough it out, do it.
There's a lot of loopholes that need to be fixed, for instance James-546195, those side effects are required to be listed because of how the product is advertised, but there's a lot of stuff that are so vaguely advertised as to avoid FDA requirements of disclosing side effects, and even trails to see if your product works. If you've ever heard something advertised to "support a healthy immune system" that's an example, it's a medically meaningless term.
These businesses don't need to be monitored by the FDA they need to police them selves. There are no excuses for this and those responsible need to spend more than a few years in jail. The owner needs to do 20 at least. There was more than one violation and they were not a one time thing. How stupid can you be when you're dealing with a fluid that gets injected directly into some ones spine? Closing the door after making your millions should not be the result. Where are the CRIMINAL charges?
Well, James-546195-1049965, I imagine you try to avoid food as much as possible too, since the food industry is also not that well regulated as much as they would like you to think it is. With outbreaks of salmonella, listeria, e-coli, food poisoning, etc becoming more commonplace, it seems like it doesn't matter what you try to do to protect yourself anymore. Deregulation, insufficient resources, and industry corruption will probably do us all in eventually.
Foods and drugs need regulation and inspections. The FDA is very corrupt, requiring over a million dollar "fee" from the manufacturers of every new drug, but at the same time, they cannot seem to keep us safe.
There is no excuse: so what if it was a "compounding pharmacy," they are still selling a drug or food in the United States, and should have been under the regulations of the government already.
Who took away the regulations? Was it Reagan? I would believe just about anything. I'm tired of hearing reports, almost weekly, of people poisoned by food-borne bacteria or badly made drugs. Congress, meanwhile, spent the last few years trying to defeat the Affordable Health Care Act (Obamacare) instead of regulating food and drugs. Shame on the Republican Congress.
Willie, you presume that there is sufficient inspection staff to appropriately monitor compounding centers such as this. IF the massive egg recall taught us anything, it is that the FDA is one of the most neutered and understaffed federal agencies in the country.
Willie is doing just what his right-wing overlords want him to do; after they effectively gutted the FDA in order to specifically disable them from doing their job, Willie comes rolling in to complain that "gubmint cain't do nuthin," hence needs to be neutered even more. Tell you what, Willie--if you don't like regulation, why not secede yourself to someplace like Somalia? First total anarchy on the right--you can't miss it...
James is not far off. I am a purchaser (in veterinary field) and I have to tell you that many times drugs are unavailable due to plants being shut down for unsterile conditions. You may shrug and say "so those are animal drugs" but you'd be wrong. Veterinarians use mostly the same drugs from the same plants as human doctors. Drugs are recalled weekly. Recalled, meaning they've been distributed and are being used by some patient somewhere already and now someone realized there was an "oopsie". I'm often reluctant to take medications unless it is absolutely necessary, and I would be unlikely to use most compounding pharmacies. There are reputable ones. Do your research.
I hope this poor lady recovers fully.
I hope all the victims of this fungal meningitis recover fully.
And I hope that the owners of the compounding pharmacy that didn't make medicines in a clean place go to jail for life: a life sentence for each person who has died. This is a criminal case as well as a civil case.
If a corporation is a "Person," its owners should be sent to prison for killing people. Why are they still free?
Yes, prayers to everyone sick and suffering from this situation for for those who have lost their loved ones! This is a terrible, avoidable tragedy that should not have happened!
My prayers for the sick also, and their families, and for the families of those who have died. Elizabeth, the wheels of justice grind slowly, but what I am hoping will happen is that criminal charges will be brought. The case must be investigated, and that is as it should be. As imperfect as our justice system is, there isn't one better that I know of.
They need to be put out of business, where is King Obama when we need him. Oh, I'm sorry, he's playing golf in Las Vegas again. My bad.
WTF does Obama have to do with Congressional hearings on this? Nothing, nothing at all. Jeez, if it was one of the Koch brothers in the White House, he still would have absolutely nothing to do with these hearings. The mail wasn't delivered yesterday, you'd blame Obama for that too.
BrazosJack, this compounding pharmacy was regulated by the state, and it was in 2003 that Massachusetts dropped the ball on inspections. Who was governor of Massachusetts when that happened, and why aren't you condemning him?
The 2003 complaint in Mass appears to have disappeared into the bowels of Mitt's administration. The press is searching but since his admin killed all their hard drives, info is missing...
The states regulate med-mixing facilities, not the Feds. And I have no worries, Congress will do nothing about this horrible incident. Lots of grand-standing and face time for TV, but no real solutions or punishments to the companies that have killed people.
I for one am waiting for Louie Gohmert to apologize to Cadden. Hey, he did for BP...
Applying a little faith and belief in the healing power of the Holy Spirit would certainly not hurt!
Screw her! Right my conservative friends?
We don't need more government regulations!
The free market will solve this problem: its simple, word is out and now people won't buy the drug. Done.
Go free market!! Don't tread on me!
Something has to be done about pharma companies - people who are already in pain or sick do not need further damage to their bodies.
Oh, gimme a break, you immature child.
Of all of the millions of treatments performed in this country every single day, a handful have problems and make headlines. You make it sound like the whole industry is out to hurt us.
You want to make Big Pharma safer? Tell the goddamned republicans to EXPAND the FDA and it's budget, not cut it to the bone or do away with it entirely. This is one area where we need more regulation, not less.
Why does the FBI have the authority to view emails, but no authority to investigate deliberate acts of terrorism? Look it up. Al Quaeda medical students in Glasgow, Scotland at the time of a terrorist act, stated that, "those who cure you will kill you." Where's the FBI? Why isn't Democratic Senator John Kerrey not hopping mad and calling for an FBI investigation since it happened in his state? Where are the other Democrats?
Right here, where they should be. What kind of idiot question is that?
Scotland isn't in the USA, and so far there's no evidence of Al Quaeda (or any other terrorist organization) involvement in this incident, unless you have information you're not sharing with the police. If there's any evidence of terrorism, the FBI will get involved.
There. Now you won't have to ask that question again. You're welcome.
Mike--if you've kept up with this case, you will have read that the problems were caused by dirty manufacturing conditions. This is not a case of terrorism, but a case of gross negligence. And I think there is a pretty good chance that before the whole thing is done, we will be reading about gross criminal negligence and negligent homicide.
See, Lisa, Mikey has to blame it ANYONE besides the "job creators" who caused it. And get in a few licks at Obama besides...
Consumers even though they are under the care of medical doctors and while we are in an advancing technical society need to be assured that each step of the way that know measures for safety are employed and are verifiable.
We can either reinvent the wheel by experimenting with sanitary handling, unclean facilities, sloppy practices that predate modern medicine, or we can use the advancing technology to eliminated these hazards as far as possible.
We are obviously between one level and a more advanced level, where the question should be what is holding this technology back?
From various perspectives we can isolate the cause from effects. The effects of the medical suppliers and industry lobbying Congress and Administrations to under fund and ruin inspection agencies and reduce reporting requirements, fits perfectly with high level business notions of lowering costs and maximizing profits, as well as the entrenched mistaken notion from years ago that deregulation is always good. This 'business sense' adds to the limits on corporate liability, using the LLC escape mechanism, as well as the two hundred years old limits in liability of corporate stockholders. These 'business' rules, would allow xenografted goat testicles to address erectile dysfunction, just because a business could be founded on patent medicine does mean that public should be exposed to products better left in medieval times. As far a clean, heath practices we could be better served, by prejudicial liability on any and all who would allow this Congress/Lobby/Business facility to continue.
Any investigation on heath products companies has to consider development cost, certifications costs on their products all that contribute to total cost being high. But the 'business' heads are not satisfied with a factor of 5 markups, when 10 or 100 are possible. New products may be well worth it but for every justifiable breakthrough, there are 99 also ran's for old ancient and venerable techniques that Doctors are going to sued for using. This mixture of good/bad/worse cannot price products appropriately or improve current practice of gouging the heath care industry for expensive equipment that would work better and not cost so much, except for the licensing, patent, copyright profit cycle.
The reduction of modern instrumentation, medical and otherwise, being made available by iPhone applications is rapidly changing the landscape of communications. That same innovation needs to be brought back into the lab, as test equipment, cheap, effective and wide spread communicating contamination situations.
Things need be done, get Congressional corruption separated from regulatory authority, get business corruption away from regulatory authority, delegate regulatory and properly fund. Make it clear that if you are not going to understand and follow standards and regulations, and harm comes to the public, that it is not just the business that is closed, that is the owns and managers that are behind bars and held personally liable for corrupting the system.
The biggest thing to change is how the workforce understands regulations; the current hostile business management approach has to replace by the 'this is how we do things, why we do things, how doing things this way works and how it save the company.'
It is not odd that when I learned of a rule or regulation, I would understand the cost, the benefit and just roll them into the standard operating procedures, build them automatically into day to day operations, and make it benefit, the process, the product and the company. I am always appalled at how easily the get out of whack, and but the fact that bad business habits and bad business attitudes are costly to the whole enterprise. CEO business thinking the United States, is disaster, better addressed with contaminated medical injections?
I have never heard a reason given by any authority, Federal or State, as to why the managers and owners of that compounding pharmacy are not in jail for negligent homicide, or on bond awaiting their criminal trials.
So please inform me, somebody in authority, as to why, with obvious unclean conditions in that company, why are these managers walking around free? These serial killers are as bad as any serial killers America has seen, but they are out in public? WHY?????
And what, praytell, do you think would happen should regulatory oversight be reduced? Sorry, but I would think that the housing bubble would have shown that we cannot trust private enterprise to be self-policing, especially with something such as drug companies, pharmacies(to an extent), and especially the less common compounding centers. And the ambulance chasers they have helped to breed.
Yeah, Willie, trust industry to regulate itself! They wouldn't ever ever EVER be indifferent to human suffering in order to maximize profits, right? Right? Bueller? Bueller?...
This is one reason why the Republican Party has to change course: de-regulation--it doesn't work.
This is exactly why the big drug manufacturers pay millions to the Republican Super Pacs: to keep regulation to a minimum so that their profit margin remains highest. No one wants big government, but when the states don't do their jobs, the Fed has to step in. Now, because of de-regulation, these poor people will suffer the rest of their lives because this all fell through the cracks.
I dont know if it is necessarly government incompetence as much as it is negligence by the companies that prepare the medications. Sounds like that the workers are not being supervised and sterile procedure is not being followed. I wonder if they have a quality control department that does random checks on thier products. Even ciggarette companies do this. I doesent matter now this company is going under.
Quit blaming the cop for the criminal's crime, Williesmith.
With the kind of dirty conditions found, and the fact that the company did not follow accepted procedures in the field, I am hoping that criminal charges will be brought. My prayers and thoughts are with the victims and their families. What a horrible nightmare!
Maybe the best punishment for the owners and whoever was involved in the 'compounding' of the drug would be to receive injections of the contaminated drug. And then not be treated. At leas, before they died, they'd learn how bad pain can be.
At tomorrow's hearing, Congress will do the American people a monumental disservice by permitting the compounding pharmacies to be scapegoats in the meningitis outbreak. The brutal truth is that many thousands of Americans - like beautiful Margaret - contract bacterial, chemical, and now fungal meningitis from epidural steroid shots every year, and many of these victims go on to develop arachnoiditis. I myself contracted the disease from an epidural steroid injection in February 2011. This is not new. The medical community needs to stop expressing 'surprise' at what is going on, and start joining the growing ranks of people trying to DO something about this mess. Let's start funding research into the causes and potential treatments of arachnoiditis, so people like Margaret don't need to live the rest of their lives in agony.
Summary executions in the field for NECC agents.
I dont understand why there is not any kind of inspections or regulations on the pharmacy companies that prepare these medications for distributation???? OSHA inspects factories JACHO inspects healthcare facilities. groceries are inpected by the state as are resturants. WTF. I hope after these hearings are concluded that the pharm companies will be forced to undergo state inpections like the rest of us.
Don't forget that during the Bush Regime, the pharma companies essentially wrote their own rules including the creation of the medicare part D program.
Congress wants all the details so they don't send any family members to the same clinics............
This is an extremely bad thing that has happened. This fungus can lay dormant and the number of people that still do not know if they will get this is in the thousands. Every single person that has this infection is suffering terribly. It is not a 'take a pill"solution the IV medications are extremely hard on the liver and kidneys, they cause vomiting and halucinations with some people and the amount of pain they are going through is undescribable. Sunday I visited a freind in the hospital with this and I know she is going to pull through but it is a long journey with an unknown road ahead. I pray for her and every single person that has been diagnosed .
What is astounding to me is how could such filth be present- why did the workers not say something, were they that desperate for a job? How do the owners of this company live? do they live in filth? I fail to connect the dots here on this one. The owners of this company need to be held accountable. Then new regulations must be placed so this does not happen again.
Thank you JoNel. Firstly for bringing many truths to the attention to the public's eye. Sadly this is only the beginning of this story. this nightmare will continue for many years to come. It is a very sad state of affairs that so many people have been killed of permanently harmed over financial greed. it is no surprise that these victims of this outbreak are developing arachnoiditis. We have been warning the FDA for man years now that Epidural injections carry the real risk of Arachnoiditis with or without tainted medicine. As these newest victims of the injection mills join the ranks of a fast growing community of Arachnoiditis victims, the FDA and other public health officials still seem to drag their feet in stopping this harm.Arachnoiditis is a very cruel iatrogenic disease that has no cure, and very few treatment options. Necc needs to be held criminally liable , But the FDA needs to take some responsibility as well. We sent them another letter asking them to stop this practice in June of 2012 and as usual heard nothing in return until this outbreak happened. Epidural Steroid injections are a $ 3.5 billion a year industry, and i can assure anyone reading this that this profitable business practice will be fiercely defended even as more and more uninformed consumers become victims of Arachnoiditis. I hope that one day soon the media reports on the biggest problem that these people now face. For more information about Arachnoiditis, Please visit www.EndArachNow.org
Remember kids, vote Republican, so you can get free market unregulated tainted drugs injected in you too!