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Centers for Disease Control and Prevention
CDC officials meet at the beginning of the outbreak of fungal meningitis, which has now killed 39 people and made more than 600 ill.
A single phone call from a North Carolina clinic gave a Centers for Disease Control and Prevention investigator the heads up she needed to realize that an outbreak of fungal meningitis, which has now killed 39 people and made 620 sick, was likely going to be a national emergency.
The CDC published its first account on Wednesday of how state and federal investigators have handled the outbreak, and the agency warns the trouble is still not over. The report, published in the New England Journal of Medicine, describes how doctors, public health officials and clinic workers raced to track down patients at risk from lots of contaminated pain medication.
Dr. Rachel Smith had only been working at the CDC’s fungal diseases branch for a year and a half when the reports came in last September about a patient at a Tennessee pain clinic who had a very unusual type of meningitis, apparently caused by a fungus. Dr. April Pettit, an infectious disease expert at Vanderbilt University who treated the patient, had notified the Tennessee Department of Health, which in turn notified CDC.
There was a chance the contamination was a local problem, perhaps from dirty needles at the one clinic.
“We were certainly worried this could be a bigger issue but wanted to do due diligence,” Smith told NBC News in a telephone interview.
They’d already figured out that steroid injections might have been the source of the contamination and started calling pain clinics that may also have bought drugs from the same source: the New England Compounding Center in Framingham, Mass.
They asked the clinics to keep an eye out for patients with symptoms of fungal meningitis, such as headache, fever and pain where they got the injection. At some places, including the North Carolina clinic, Smith had to navigate layers of receptionists and she left multiple voicemails and messages.
“I still remember getting this call back from North Carolina,” Smith said. “They called me like three or four times, trying to get through because they no idea what this woman had, and when I called and said, ‘Hey do you have anyone with these symptoms?’ they said ‘Oh my god. That is what this woman has.'”
The next day, CDC officials started calling and emailing all 50 states. “It was really that one patient who turned the whole thinking about this outbreak,” Smith said.
And what made the CDC extra vigilant about the first few cases was the fact that NECC, the source of the steroids, was a compounding pharmacy. “Compounding pharmacies and compounded products had been the source of other outbreaks. When we saw this drug had been compounded we were a little more worried about it,” Smith said.
Since then, the Food and Drug Administration has found several batches of drugs made by NECC were contaminated with several species of fungus and bacteria. Inspections showed the pharmacy, which has since been closed, was filthy. Congress is investigating how FDA and state regulators allowed the pharmacy to operate far beyond its license, and the FDA is proposing new ways to regulate these companies.
The CDC’s report says it’s essential to make sure that drugs distributed by compounding pharmacies are clean.
“This outbreak shows that we need to make sure that drugs that are used for sterile injections are safe and uncontaminated,” Smith says. “The public has trust in us as public health officials and in the health system as a whole to deliver safe health care.”
Quick action by the public health system likely saved lives, said Smith. In other outbreaks of fungal infections the death rate has been around 40 percent. In this one, although as many as 14,000 people may have been injected with contaminated products, only 6 percent of those who were infected have died.
Without the alerts and publicity, many people may never have known why they were sick. For some patients, the first sign that something was seriously wrong was a stroke. Most had only vague symptoms -- headache, sometimes a fever, and sometimes pain where they were injected.
“Anecdotal data collected during the first week of the outbreak indicated that many of the initial patients had mild-to-moderate symptoms that ordinarily would not have prompted urgent medical evaluation,” the CDC report reads.
“We are still seeing cases and it’s not over yet,” Smith cautioned.
Now, more people are turning up with localized infections such as abscesses at the point of injection. But these can become very serious as the fungus works its way into tissue and even bone, where it is very hard to eradicate using antifungal drugs. Victims will have to take the drugs for weeks or months, and the antifungal medications themselves can damage the liver or kidneys.
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Why aren't the doctors who made these injections being held partly responsible? They should know where the medications they are using come from. And if it is not uncommon for outbreaks to occur from medications from compounding pharmacies, why weren't the doctors more vigilant?
Lovely, I don't understand why you would push back the responsibility to the doctors.....the failures were so rampant at every stage of this process, they would be the last to hold accountable...are you thinking "DEEP POCKETS"???
I recieved the steroid Oct 3rd in an IV after a tongue cancer operation, Houston,Tx it will give you a case of horrors still have problems sleeping, bad headaches Dr said it may continue couple months I'm out of the dangerous period, its very scary
It is silly to blame the doctors. Lets say they knew EXACTLY where the steroids they were using came from. BEFORE there was an identified problem, what difference would that have made to anyone????
People are so quick to blame doctors. How about, in this case, blaming the compounding pharmacy? Makes more sense to me.
And, I've had facet injections under flouroscopy, and trigger point injections done by the doctors' knowledge of where to inject. Both kinds have helped me. A person cannot say that only a certain type of injection is the
"right kind" for everyone.
What I'd look for in a pain management doctor is a board-certification in Anesthesiology, first, then perhaps one in Pain Management. But the board certification in Anesthesiology would be the number 1 thing I'd look for if I had to find a new pain doctor. (am an RN).
At the NECC, the pharmacist in charge was a doctor, and I feel he is the only one responsible for this travesty. He took a hippocratic oath just like physicians do.."First, do no harm." That pharmacist knew the place was filthy, they were mixing huge batches of the medication without a preservative, then letting it sit around in vats for days before being packaged. I read that in a previous report. I am not a doctor, but I am smart enough that I would not drink a glass of water that had sat on my clean kitchen counter for days, much less produce medication in this fashion that I knew was going to be injected into someone! That sad truth is that greed is what caused all this to happen. The pharmacist and his brother-in-law saw that they could make a lot more money by cutting corners. Google NECC documents and you can read actual reports. When all this came to light, I had hoped that the court would freeze NECC assets, because I figured those greedy b@st@rds would pull something like this bankruptcy. They had probably moved most of their money into hidden accounts before they filed.
The problem was not greed, but sheer laziness. The cost of keeping everything clean and sterile would not have been that much. If the place would have been a restaurant, it would have been shut down. I hope the people operating the facility are prosecuted for manslaughter, assault with intention to cause grievous bodily harm, and causing grievous bodily harm.