Results for “fda”

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If I were a Democrat…

First, I would not cite evidence about how Western European countries spend less on health and are healthier than U.S. citizens.  This data set, if you take it seriously, also implies that the marginal product of more health care, adjusting for income and a few other variables, is zero.  Expanding health care would not be important.  Now I believe this is an incorrect conclusion, but that is what shows up in this data.  We should not invoke this data selectively.

Second, I would recognize that American policy generally works (or doesn’t work) by building upon existing institutions.  The most likely form of national health care — for better or worse — would extend a version of Medicare to more people.  This would not lower health care costs, whether in gross or quality-adjusted terms.  Keep in mind that negotiating price reductions does not per se lower real resource costs at all. 

I would disaggregate health care systems and see where we could do the most good:

1. Step up R&D subsidies through the NIH and our university system, both high quality institutions.  Their autonomy and micro-fiefdoms provide a good framework for risk-taking and innovation.  The returns to medical R&D are extremely high.  Furthermore the case for market failure, based on the inability to capture the full social gains from a new idea, is simple. 

2. Redo the Medicare drug bill so that people can understand it (even I can’t, nor does my mother), and so more people benefit.  If need be, we can do this in budget-neutral fashion.  The Bush plan is a mess.

3. Invest in local public health systems.  Preventive care is important, especially for the poor.  Price can be an obstacle but often the relevant constraints are behavioral in nature.  Public health care systems should be easy and inviting, and they have to become part of life routines.  Government can be part of the solution.  Strong local public health care also will improve surveillance and later surge capacity if a pandemic comes along; this added benefit is significant.

4. Borrow a page from the libertarian litany about the FDA.

5. Institute prizes for successful vaccines.  We have been discouraging vaccine production when we should be encouraging it; Michael Kremer has some intriguing proposals.

All those options are doable.  All would save lives.  None are fiscal disasters.  They offer something for both rich and poor.  They lay out a positive and constructive role for government, while keeping room for the private sector.  None raise the prospect of excess bureaucracy or discourage innovation.  None rest on the questionable belief that government as single supplier or payer would improve efficiency.  And they are all areas where the Republicans are dropping the ball.

I would cut talk of national health insurance.  I would cease obsessing over the number of "40 million uninsured," however good a debating point it may be.  Many of these people are either linked to immigration or get decent medical coverage in any case.  I would admit that we cannot take care of everyone and that we face tough trade-offs.

Hmmm…these counterfactuals are fun.  What should I try next?  Pretending I am a Republican?  But for now, it is back to normal life…and so we return to your regularly scheduled programming.  But comments are open, in case Kevin Drum’s readers wish to pretend they are libertarians…

It’s a real thrill when the editorial page of the Washington Post starts to sound like, well, me (e.g. here and here).

Politicians and regulators should be asking themselves whether a system of
massive cash awards to people who may or may not have been adversely affected by
Vioxx is a logical, fair or efficient way to run a drug regulatory system. They
should also be asking whether juries that scorn medical evidence are the right
judges of what information should or should not have been on a prescription
label. After all, Vioxx was produced and sold legally. The drug was approved by
the Food and Drug Administration, and its label did warn of coronary side
effects. It is possible, even probable, that Merck was negligent in its decision
to ignore early warnings of the cardiovascular risks of Vioxx. But the company
has already paid a price for that negligence, in the losses it has suffered
after abruptly taking Vioxx off the market. Fair compensation for the injured
needn’t entail disproportionate financial punishment as well.

In the long term, using the courts to "send a message" to Merck isn’t going
to help consumers. If the result is an even more cautious FDA approval system
and a more cautious pharmaceutical industry, that will keep innovative drugs off
the market for much longer. More people will die waiting for new treatments. The
cost of producing new drugs will rise dramatically. Already, there are whole
areas of medicine — women’s health during pregnancy, for example — that are
made so risky by liability issues that companies may stop doing research in
them.

The first principle of reforming this system should be that a company that
follows the FDA’s rather extensive guidelines should be protected from punitive,
if not compensatory, damages.

I went to the doctor yesterday.  I told him that to avoid altitude sickness in Peru I wanted a prescription for Diamox.  He used to be surprised when I self-diagnosed but he knows me now.  He wrote the prescription and I was done in less than four minutes.  I like my doctor but this visit took an hour of my time and probably cost the insurance company at least $100, my deductible was $25.  No big deal for me but a non-trivial expense for someone without insurance.

Why aren’t more pharmaceuticals available over the counter?  In other words, why must we pay the priestly caste known as physicians for the right to treat ourselves?  "Safety," we are told (second only to "for the children" as an excuse for giving up liberty).  But, as Sam Peltzman pointed out long ago, safety runs both ways.  Not getting a pharmaceutical because it’s too expensive and time consuming to go through a doctor has adverse safety consequences and there is no evidence that the costs of potential mistreatment outweigh the costs of undertreatment.  (In anycase, politics not safety is often the reason for restrictions on OTC drugs e.g. the morning after pill.)

In fact, there are many countries where prescriptions are not required for legal medicines and they appear to do just fine.  Writing in Reason, Kerry Howley points out (online version, the print version is longer and I am quoted) that in this respect if no other Myanmar is a bastion of rationality and liberty compared to the United States.

Last year, while living in the Southeast Asian nation of Myanmar,
my phones were tapped, my journals were read, my work was censored, and
for the first time in my life, I was given the authority to care for my
own body.

There is no prescription drug system in Myanmar, but there are plenty of illnesses waiting to befall an effete Western immune system.  My expatriate colleagues and I were free to treat our ailments as we saw fit.
We staved off food poisoning and bouts of malaria with frequent trips to
the local pharmacy, consulting doctors when necessary, but ultimately
responsible for our own medical decisions. We formed doctor-patient
relationships that were partnerships rather than paternalistic
hierarchies, and each of us lived to tell the story.

Coming back to the States in the midst of hand-wringing about direct-to-consumer advertising, the restriction of life-saving cholesterol drugs, a wrenching process to make the morning-after-pill readily available, and now a push to put Sudafed behind the counter, it’s increasingly hard to understand why Americans cede crucial health decisions to the bureaucratic dithering of the FDA. In an age of empowerment through information, it is mind-boggling that patients are still willing to be silent spectators while their doctors call the shots.