Flu versus Bad Vaccine: Let the Public Decide
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It's still unclear exactly why U.K. regulators pulled Chiron's license to manufacture flu vaccine, other than vague pronouncements of "manufacturing problems," "sterility problems" and "contamination." Chiron is responsible for supplying nearly half the flu vaccine doses for the U.S., and no other company can fill the gap before this year's rapidly-approaching flu season.
The Chiron shutdown comes on the heels of Merck's voluntary decision to recall its popular arthritis drug Vioxx due to increased risk of cardiac problems. The drug is not "defective" is any sense of the word, mind you (more on that below) -- it only poses an increased risk of a (very serious) side effect.
I'm not a hyper-anarcho-libertarian and I don't oppose, a priori, the concept of basic governmental approval of pharmaceuticals and medical devices. The standard used by the FDA is of course "safe and effective," which at first glance sounds perfectly reasonable.
But "safe" is a relative term. No drug is ever perfectly "safe." Any decision to use a drug is a cost-benefit analysis, with the "cost" incorporating the probability-weighted risk of negative side effects.
I've had the flu, and I'm pretty good at cost-benefit analysis when I have the requisite information. I'm fairly certain I could make an informed decision as to which is the better option for me: forego the vaccine and risk getting the flu again, or taking the risk of a negative side effect from a tainted vaccine dose.
Unfortunately the U.K. regulators are withholding that information (and the vaccine of course), and it's therefore impossible for me to make that informed decision. Is the risk from the tainted vaccine one of low-probability/high-danger or high-probability/low-danger? What is the danger exactly? Inefficacy? Serious reaction? Death?
The Vioxx situation is exactly the same. Granted, there are many alternatives to Vioxx, from its sister drug Celebrex all the way to plain old aspirin. But was a total recall necessary? Perhaps Vioxx was so beneficial to some arthritis suffers as to be worth the risk. (Of course, Merck's decision may have been motivated not by fear of FDA action, but of lawsuits or simple economics if it concluded that enough consumers would shy away from the drug as to make it unprofitable.)
And now of course we have an ancillary question of interest to libertarians and our central-planner adversaries: how exactly do we ration the vaccine that's available? The government is already telling healthy adults (like me) to forego the vaccine.
To me the best response is "Do you take American Express?" But of course the government would never allow an auction process or other market-based resolution. (Compare and contrast: hurricane-instigated "price gouging.") Who gets to make decisions as to who should get the vaccine, and what should the criteria be?
Perhaps the regulatory framework for pharmaceuticals should be changed from focusing on approval (i.e., showing "safe and effective") to focusing on rejection (i.e., showing "unsafe or ineffective"). If a drug or medical device can be shown to be a reasonable treatment for someone, then it should be approved, with the burden of decision (and consequence) on the patient and his physician.
Incidentally, this is exactly the standard generally used in product liability law regarding drugs. A drug is defectively designed (as opposed to defectively manufactured, labeled or advertised) if and only if no reasonably informed physician would ever prescribe it for any class of patient. If a single reasonable physician would prescribe a drug for a single patient, then the drug cannot be deemed "defectively designed."
A perfectly logical standard for litigation -- why not use the same standard for approval?
Now where can I get my vaccine?
Similar thoughts at Reason. See also Asymmetrical Information.
UPDATE #1: More ominous flu news. Also, here's an update on the beginnings of the emergency rationing chaos (that is only going to get worse). And of course litigation over control of vaccine supplies will be just around the corner.
UPDATE #2: The Wall Street Journal (subscription site) has more: apparently the contamination is "Serratia," a common microbe that was once considered completely harmless, but has now been linked to urinary and upper respiratory infections and pneumonia, but tends not to be lethal outside of the (always dangerous) sepsis context (this stuff is way out of my league). This is the same microbe that apparently causes the "blood on the wafer" phenomenon that causes a stir during Catholic Communion every so often -- see here.
NOTE: Follow-Up Post here.
(Cross-linked at Outside the Beltway.)
The Chiron shutdown comes on the heels of Merck's voluntary decision to recall its popular arthritis drug Vioxx due to increased risk of cardiac problems. The drug is not "defective" is any sense of the word, mind you (more on that below) -- it only poses an increased risk of a (very serious) side effect.
I'm not a hyper-anarcho-libertarian and I don't oppose, a priori, the concept of basic governmental approval of pharmaceuticals and medical devices. The standard used by the FDA is of course "safe and effective," which at first glance sounds perfectly reasonable.
But "safe" is a relative term. No drug is ever perfectly "safe." Any decision to use a drug is a cost-benefit analysis, with the "cost" incorporating the probability-weighted risk of negative side effects.
I've had the flu, and I'm pretty good at cost-benefit analysis when I have the requisite information. I'm fairly certain I could make an informed decision as to which is the better option for me: forego the vaccine and risk getting the flu again, or taking the risk of a negative side effect from a tainted vaccine dose.
Unfortunately the U.K. regulators are withholding that information (and the vaccine of course), and it's therefore impossible for me to make that informed decision. Is the risk from the tainted vaccine one of low-probability/high-danger or high-probability/low-danger? What is the danger exactly? Inefficacy? Serious reaction? Death?
The Vioxx situation is exactly the same. Granted, there are many alternatives to Vioxx, from its sister drug Celebrex all the way to plain old aspirin. But was a total recall necessary? Perhaps Vioxx was so beneficial to some arthritis suffers as to be worth the risk. (Of course, Merck's decision may have been motivated not by fear of FDA action, but of lawsuits or simple economics if it concluded that enough consumers would shy away from the drug as to make it unprofitable.)
And now of course we have an ancillary question of interest to libertarians and our central-planner adversaries: how exactly do we ration the vaccine that's available? The government is already telling healthy adults (like me) to forego the vaccine.
To me the best response is "Do you take American Express?" But of course the government would never allow an auction process or other market-based resolution. (Compare and contrast: hurricane-instigated "price gouging.") Who gets to make decisions as to who should get the vaccine, and what should the criteria be?
Perhaps the regulatory framework for pharmaceuticals should be changed from focusing on approval (i.e., showing "safe and effective") to focusing on rejection (i.e., showing "unsafe or ineffective"). If a drug or medical device can be shown to be a reasonable treatment for someone, then it should be approved, with the burden of decision (and consequence) on the patient and his physician.
Incidentally, this is exactly the standard generally used in product liability law regarding drugs. A drug is defectively designed (as opposed to defectively manufactured, labeled or advertised) if and only if no reasonably informed physician would ever prescribe it for any class of patient. If a single reasonable physician would prescribe a drug for a single patient, then the drug cannot be deemed "defectively designed."
A perfectly logical standard for litigation -- why not use the same standard for approval?
Now where can I get my vaccine?
Similar thoughts at Reason. See also Asymmetrical Information.
UPDATE #1: More ominous flu news. Also, here's an update on the beginnings of the emergency rationing chaos (that is only going to get worse). And of course litigation over control of vaccine supplies will be just around the corner.
UPDATE #2: The Wall Street Journal (subscription site) has more: apparently the contamination is "Serratia," a common microbe that was once considered completely harmless, but has now been linked to urinary and upper respiratory infections and pneumonia, but tends not to be lethal outside of the (always dangerous) sepsis context (this stuff is way out of my league). This is the same microbe that apparently causes the "blood on the wafer" phenomenon that causes a stir during Catholic Communion every so often -- see here.
NOTE: Follow-Up Post here.
(Cross-linked at Outside the Beltway.)
Posted by KipEsquire on
6 October 2004
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