If we had more professional civil servants instead of outsourcing so many government functions, there might have been someone working for the FDA who saw this coming and did something about it:
Doctors, hospitals and federal regulators are struggling to cope with an unprecedented surge in drug shortages in the United States that is endangering cancer patients, heart attack victims, accident survivors and a host of other ill people.
A record 211 medications became scarce in 2010 — triple the number in 2006 — and at least 89 new shortages have been recorded through the end of March, putting the nation on track for far more scarcities.
The paucities are forcing some medical centers to ration drugs — including one urgently needed by leukemia patients — postpone surgeries and other care, and scramble for substitutes, often resorting to alternatives that may be less effective, have more side effects and boost the risk for overdoses and other sometimes-fatal errors.
“It’s a crisis,” said Erin R. Fox, manager of the drug information service at the University of Utah, who monitors drug shortages for the American Society of Health-System Pharmacists. “Patients are at risk.”
The causes vary from drug to drug but experts cite a confluence of factors: Consolidation in the pharmaceutical industry has left only a few manufacturers for many older, less profitable products, meaning that when raw material runs short, equipment breaks down or government regulators crack down, the snags can quickly spiral into shortages.
Oh, my! Efficiencies of consolidation and lack of redundancies.
Way to go, Neo-Libs and Corporatists.
One of my asthma drugs went missing for an entire quarter. I used a different class for a replacement, and it didn’t work as well and I think I lost some lung function. Yay.
It started shipping with an out-of-date fact sheet, but I couldn’t get hold of it for another month. Three of the drugs I take are patented because of the delivery system.
Wow, the collapse I’d happening sooner than I anticipated. Ok, here’s what happens next: the companies discover they can’t make as much money as they thought off of biologicals. Even if they work, and it could be just another fad, they are going to be terrifically expensive. They will try to charge what the market will bear but insurance companies will start to balk.
There will be a scarcity of new small molecule compounds coming to market because 1.) most companies are getting rid of their small molecule chemistry departments wrongly assuming that research is the same as hiring Indian chemists to do routine synthesis in Hyderabad and 2.) because new small molecule drugs can’t get passed FDA requirements that are changing all the time and class action lawyers standing by to take your calls.
That leaves the older generation of drugs that are going off patent and on which pharmas cannot make any profit whatsoever. That’s the downside of the generics racket. If you can’t make money on it, why bother making it at all?
Oh sure, it would be great if drugs were all cheap and/or free. But free doesn’t pay for research. Scientists have to eat too. I take that back. The people in charge have decided scientists are not needed when the shareholders must be appeased.
We ALL have to ask ourselves what part we have played in this catastrophe. Both parties and both political ideologies are responsible.
Unfortunately, patents and scientists are both going to suffer because no one on either side of the spectrum bothered to think these problems through.
Nevertheless, I’m hopeful. The sooner the collapse, the sooner we can try to address it.
What would be the arguments about the U.S. government manufacturing the generics?
No arguments here. But they are what they are- an older generation of drugs that may be harsher to the body, have more side effects and lower efficacy. Recent drugs are much more specific and have better safety profiles. Unfortunately, they are more expensive to produce and discover.
The danger, as I see it, is that generics will be for lower class and poor people. It could be the difference between getting a chemo agent that makes you incredibly sick for weeks or getting something like Gleevec, which is very effective and has negligible side effects. From a cost/benefit perspective, you’d be getting a better deal with Gleevec because patients could return to work more quickly. But you know how our politics go. We must make people suffer or they won’t learn the lesson to never get sick.
What we still need to do is save our scientific infrastructure so we can continue to make new drugs. And you DO want corporate laboratories if not stupid management schemes. Here’s why: the pharmas are now trying to buy new drug entities and patentable compounds from independent sources and small companies. Those companies are going to start charging substantial amounts to surrender their patents. A corporate scientist sells their patents to the corporation for a token fee, typically a crisp dollar bill, in exchange for a salary. Yep, corporations are out to make a profit but they are making a ton of money in mergers and acquisitions and are getting increasingly greedy. Damn. The kid wants the iPad…