Should it be illegal to sell
cars because some drivers will inevitably choose to drive while intoxicated?
Should the government force glue manufacturers to withdraw their products
becomes some people will hurt themselves sniffing glue to get high? If
the Food and Drug Administration had jurisdiction over cars and glue,
these scenarios just might happen — so far this year, the FDA already
removed two popular, effective drugs because too many doctors and patients
were not using the drugs according to the instructions provided by manufacturers.
Rezulin, a drug produced by
Warner-Lambert, helped patients regulated their diabetes. Patients who
before were injecting themselves with insulin several times a day could
reduce their injection schedules to nice a day. Unfortunately, Rezulin
has a well-documented serious drawback — it can cause liver damage. To
prevent this, the materials Warner Lambert ships with Rezulin and which
it and the FDA have sent to doctors repeatedly, recommends all patients
get a baseline liver screen and then monthly liver monitoring at least
through the first six months of taking the drug.
The result — by and large
the instructions have been ignored. An FDA study found that fewer than
10 percent of patients taking Rezulin were given the full regimen of liver
monitoring. As a result the FDA concluded that the drugs risks more than
outweighed its benefits and forced Warner-Lambert to remove the drug from
the U.S. market.
Much the same thing happened
with Johnson and Johnson’s heartburn medication, Propulsid. LIke many
medications, Propulsid’s label lists a variety of side effects and warns
about potential risks when the drug is taken by people with various medical
conditions. Again, though, these warnings were largely ignored. An FDA
study of 270 adverse events involving Propulsid, including 70 deaths,
found 85 percent of the adverse events occurred in patients with medical
conditions mentioned as risky in the label. As with Rezulin, the FDA decided
to take Propulsid off the market.
The FDA did something similar
last year with a powerful analgesic designed for use in operating rooms
after surgery. The drug in that case was extremely effective, but if taken
for any long period of time could cause kidney failure. The instructions
with the drug clearly stated the drug was to be prescribed only for short
one to two week intervals. Instead doctors ignored the warnings and wrote
6 month and even year long prescriptions. After several people died from
prolonged use of the drug, the FDA pulled it off the market.
Is this a sensible way to manage
the regulation of prescription drugs? In effect, the FDA is setting the
risk threshold at the lowest common denominator of patient behavior. The
satisfied, responsible users of Rezulin, Propulsid and other drugs are
largely ignored while those who choose to ignore FDA and drug manufacturers’
warnings are allowed to drive the drug approval process. What sort of
screwy system denies some patients important medications due entirely
to the recklessness of other patients and doctors?
The optimal solution — get
rid of the FDA and rely on private agencies to certify medications —
is politically untenable at the moment, but there is another option to
increase patient choice while relying on government to protect folks from
themselves. Although the situation varied widely decades ago, today all
the major Western industrial nations rely on very similar methods to certify
drugs as safe and efficacious. Today the main factor that keeps a drug
approved from being approved in all countries is not differing safety
and efficacy data, but rather different ways of interpreting that data
and judging risks and benefits.
Americans should have the best
of both worlds — the FDA should allow the import and sale of any prescription drug approved for sale in modern, industrialized nations.
There’s no reason an American citizen should have to travel to Europe
to buy a drug that’s approved for sale there but not here. To appease
the public health folks, the government could require that all patients
prescribed such medication be informed by both a doctor and a label on
the prescription bottle that the medication has been approved by a foreign
drug agency but not by the FDA.
Thankfully, in the United States
people have relatively more choice over health care than anyplace in the
world. Don’t want to be revived by extraordinary measures if you’re on
the verge? Just fill out a do not resuscitate order. Want to donate a
kidney to the next door neighbor kid who needs a transplant? Not a problem.
Surely if healthy people can decide for themselves to give an organ or
decide not to receive life saving treatment, those some people can decide
for themselves whether the risks of taking Rezulin or Propulsid outweigh
the benefits.
If the FDA really wanted to
improve American’s health, it could start by giving them more choice over
the prescription drugs they can take.