Our Mixed Up Views On The Mixed Up Medicines Responsible For Deadly Meningitis
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The big drug industry news this morning: at least 35 people have gotten fungal meningitis from steroid injections into their spines, and 5 of them are dead.
The villain in this story: compounding pharmacies, which take existing formulations of drugs and mix them up in new forms and dosages, for instance, taking pills and making them shots or changing dosage formulations.
In this case, the steroid shots, which are available in a more stringently prepared prescription form, apparently actually contained foreign matter.
These pharmacies mix solutions, creams and other medicines used to treat everything from menopause symptoms and back pain to vision loss and cancer. Unlike manufactured drugs, these products are not subject to approval by the Food and Drug Administration. And some have turned out to be dangerously contaminated.
Writes Marilynn Marchionne of the Associated Press, one of my favorite health writers.
And the New York Times strikes an even more cautionary note:
The question is, Why? Why would pain clinics around the country rely on a pharmacy that mixes its own brand of unapproved drugs, especially for a delicate procedure like an epidural injection that has the potential — realized in these awful cases — to infect a patient’s nervous system?
There seems to be no one answer. Some doctors say compounding pharmacies offer specialty products or dosages not easily found elsewhere, or sometimes simply better prices than big drug companies.
About 2% or 3% of drugs are made at compounding pharmacies, and compounded drugs are common in pediatrics, in treatments for women undergoing hormone replacement therapy, for all sorts of reformulated pain and other drugs.
For years, the FDA has been waging a slow war to limit compounding, and this terrible news is obviously going to help in that effort.
Update: Here is the FDA statement recommending that doctors not use any of the medicines made by this compounding pharmacy.
But what is missing in most of the narrative is that over the past few years compounding pharmacies have twice been cast as heroes in the battle to limit health costs.
Avastin, originally developed for colon cancer, is an antibody that restricts blood flow to tumors, but it can also limit blood growth in patients with the wet form of age-related macular degeneration, a leading cause of blindness, and limit the damage to patients’ vision.
But in order to use it in that way, it must be reformulated at compounding pharmacies.
Roche’s Genentech unit, which makes Avastin, thought a better solution was to create a new version of the antibody, Lucentis, which works in the eye. But the compounded Avastin costs just $30 to $50 per dose; Lucentis is $1,950 per injection.
Genentech’s push for Lucentis created a revolt among opthalmologists, and compounded Avastin became the dominant drug in the market. I’d challenge you to find a real discussion of the risks of compounded drugs in articles comparing the two approaches, like this one from AARP.
An even more dramatic example was the approval of Makena, a drug made by KV Pharmaceutical of St. Louis, Mo., which was a new, branded formulation of a drug used to prevent preterm birth.
Patient advocates and the FDA had worked with KV to get Makena approved in the hopes that a safer, branded version would be better for moms and babies.
But KV jacked the price from $1,500 per treatment to $25,000. Obstetricians were the ones who revolted that time. The FDA has taken the course of not preventing the compounding pharmacies from distributing their versions, and KV stock sunk.
KV even sued to try to get the FDA to force the compounded versions off the market – and failed. That led it to cut Makena’s price, but the damage was done. KV shares have fallen nearly 100% from their peak last April.
Compounding has a lot of benefits – it’s also obviously under-regulated, falling between the FDA’s federal regulation and the powers of states. The FDA’s views on compounding have often tended to extreme, wanting to limit the practice.
But there has to be a better way to regulate it than what we are currently doing.
Matthew Herper, Forbes Staff
Hundreds, perhaps thousands, at risk in meningitis outbreak; 5 dead, 17,000 vials recalled