WASHINGTON — When a sepsis patient goes into vasodilatory shock — that is, blood stops flowing to the brain and other vital organs — the intensive care unit springs into action. Alarms blare and frenzied doctors and nurses rush to find a crash cart, scrambling through its contents for a decades-old drug: vasopressin.
Until recently, the drug was so vital and so cheap that hospital staffs kept it stashed in every corner of the ICU. In 2011, a box of 25 tiny vials cost less than $200. But after the Food and Drug Administration granted an Endo Pharmaceuticals subsidiary the exclusive right to make the drug in 2014, the price spiked: the same box, now bearing the brand name Vasostrict, cost over $4,000 in 2018.
It sounds like a time-worn tale in the vein of daraprim and EpiPen: another drug maker cornering the market and spiking the price of an old and vital drug.
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How many times do the US taxpayers need to get fleeced before this “opportunity” to create an expensive branded drug out of a ubiquitous generic (via DESI pathway) is scrapped? Vasopressin and others represent billions of unnecessarily wasted healthcare dollars.
“Solving the problem of high drug prices with untested formulations just trades one problem for another — patients should not have to choose between safety and access,”
Patients are already making the decision between safety and access by opting not to purchase drugs when they are priced too expensively. One has only to look at diabetics rationing insulin. I’m sure patients and their providers would opt for drugs produced “under substandard manufacturing conditions” when the other option is not taking the drug at all or not taking enough of it.
Patients should not be forced to choose between underregulated, low priced drugs that may be unsafe and drugs that are quality controlled but have free rein to price-gouge. Yet in the political climate that has evolved over the past 50 years, the voice of consumers has been drowned out by the idea that free market capitalism is more important than the health of a nation’s citizens. These ideas must be reconceived urgently, or people will continue to die both from lack of drug access and use of inferior products.
Congress can change the law that allows old unapproved (or approved simply for being safe) drugs to be studied and filed for approval, resulting in a term of exclusivity. FDA didn’t make that law.
Literally dozens of people died from unregulated manufacturing by New England Compounding. FDA is responsible for a safe drug supply. I know I wouldn’t want myself or a loved one getting a compounded injectable.
This story presents a false dichotomy. Compounding is not the answer. It simply trades safety for price. There are other solutions, but frankly it falls to legislators to sort this out, not a regulatory agency.
I’m an Academic Physician and can’t find any data saying compounded drugs are less safe. I can find only the one episode of fungal meningitis in 2012. Where is the data that shows compounding to be unsafe or less safe than current FDA approved drug manufacturing. Most of the active ingredients for our pharmaceutical come from other countries, most notably India and China.
That we are all dead men walking around is getting more accurate everyday. The US has become a meat market for wealthy companies and individuals. The various ways our children may die has increased exponentially: synthetic opioids; a shooting in a school, nightclub, church or movie theater; inability to pay for needed drugs with skyrocketing prices, i.e. insulin etc. Shame.