Meningitis Outbreak Puts Doctors, Regulators In New Territory
There's new information on the ongoing outbreak of a rare meningitis caused by a fungus that somehow got into a steroid drug. Federal officials now say the drug got injected into 14,000 patients — 1,000 more than earlier thought.
All but one of the 169 cases reported thus far were caused by a fungus called Exserohilum that is almost unheard of as a cause of meningitis. One non-meningitis infection in a Michigan patient occurred after the tainted drug was injected into an ankle. Fourteen patients have died so far.
Little is known about how to diagnose and treat this kind of fungal meningitis. It can be slow-growing, so officials from the Centers for Disease Control and Prevention, who previously said the incubation period was a month, are now saying that patients and doctors need to be vigilant for headache, fever and other symptoms for "at least several months following injection."
Moreover, diagnostic tests are unreliable.
"Patients and doctors should not assume that a negative test means there is no infection," the CDC's Todd Weber said on a Thursday conference call. "Patients may be diagnosed with meningitis, but fungal testing may be negative."
Such patients should be treated with powerful anti-fungal drugs anyway, Weber says.
"This is new territory for public health and the clinical community," he says.
A Regulatory Issue
Meanwhile, there were new developments in the investigation into how the drug contamination occurred. It's shaping up to be a spectacular failure of consumer protection.
For instance, Massachusetts officials say the New England Compounding Center, which shipped nearly 18,000 doses of the suspect drug, called methylprednisolone acetate, misled them about its operations. Thus, they didn't realize the company was operating on such a large scale.
"The regulatory authority of the Massachusetts Board of Pharmacy does not include tracking volumes of medicines," says Dr. Madeleine Biondolillo of the Massachusetts Department of Public Health.
Likewise, she says, state officials did not realize until this outbreak that the New England Compounding Center was not following the pharmacy board's requirement that compounding pharmacies dispense drugs only upon receipt of a patient-specific prescription. That is, it's not supposed to ship large quantities of drugs to hospitals, clinics and doctors' offices for administration to anonymous patients.
"It looks, through the investigation, as though they have violated that aspect of the state licensing regulations despite their assertions they were operating under the regulations," Biondolillo says.
But others note the New England Compounding Center advertised openly. One of the company's executives has served for years on the Massachusetts Board of Pharmacy.
Not An Overnight Problem
Lax oversight of compounding pharmacies — a type of drug supplier few Americans have heard of — is not a problem that popped up overnight.
It's a trend that reaches back more than a decade as some compounding pharmacies have gone national. Out of an estimated 3,000 compounding pharmacies in the nation, one pharmacy expert estimates, the number of industrial-scale firms that ship nationally "is in the tens, not the hundreds."
Originally every corner drugstore was a compounding pharmacy, custom-mixing prescriptions patient by patient. Federal and state laws still pretend that's what all compounding pharmacies are.
But Deborah Autor, a deputy commissioner at the Food and Drug Administration, acknowledges that regulatory authority is out-of-date.
"The world has changed a lot since the days of the mortar and pestle," Autor said during the Thursday briefing. "And this is the time for pharmacists, for lawmakers, for regulators, for doctors, to sit down and grapple with this new model and come up with a regulatory scheme that appropriately controls the risk."
Autor clearly believes the FDA needs more authority. Some say the FDA could have done more with the authority it has.
For decades the agency has been aware that compounding pharmacies were morphing into mini-drug companies. And it's been aware that many patients have been injured and killed by their products.
Greed An Underlying Factor?
"Unfortunately, we've been here before," Erin Fox of the University of Utah's Drug Information Service told Shots. "There have been a number of bad patient outcomes related to compounded drugs."
Just last year, contaminated nutritional supplements from an Alabama company killed nine patients and injured 10 others. But pharmacy experts say such episodes stretch back to the 1990s.
Back then, the FDA got Congress to pass a law giving it more authority over compounding pharmacies. But in 2002, the U.S. Supreme Court struck down its no-advertising provisions on First Amendment grounds, and the rest of the statute fell, too.
"After that, the FDA really had the wind knocked out of its sails, in terms of trying to regulate these types of pharmacies," says Kevin Outterson, a Boston University law professor.
So, regulation has largely been left up to 50 state boards of pharmacy.
Jay Campbell, director of the North Carolina board, says a mistake at an industrial-size compounding pharmacy poses a much bigger problem than one at a corner drugstore.
The corner drugstore patient may be harmed, he says, "but there's very little risk of that sort of harm being spread among hundreds or even thousands of patients."
Campbell says the growth of large compounding pharmacies is simply a product of market opportunity and permissive regulation.
"You can't help but look at the scope of some of the things that have been going on and the risk undertaken and not be concerned that greed is an underlying factor here," he says.
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