Posts tagged ‘fda’

Statism Bites its Creators

A while back, I observed that liberal statists and technocrats were upset that conservative statists were using the machinery of big government they created for the "wrong" ends:

I am reminded of all this because the technocrats that built our
regulatory state are starting to see the danger of what they created.
A public school system was great as long as it was teaching the right
things and its indoctrinational excesses were in a leftish direction.
Now, however, we can see the panic.  The left is freaked that some red
state school districts may start teaching creationism or intelligent
design.  And you can hear the lament - how did we let Bush and these
conservative idiots take control of the beautiful machine we built?  My
answer is that you shouldn't have built the machine in the first place
- it always falls into the wrong hands.  Maybe its time for me to again invite the left to reconsider school choice.

Today, via Instapundit, comes this story about the GAO audit of the decision by the FDA to not allow the plan B morning after pill to be sold over the counter.
And, knock me over with a feather, it appears that the decision was
political, based on a conservative administration's opposition to
abortion.  And again the technocrats on the left are freaked.  Well,
what did you expect?  You applauded the Clinton FDA's politically
motivated ban on breast implants as a sop to NOW and the trial
lawyers.  In
establishing the FDA, it was you on the left that established the
principal, contradictory to the left's own stand on abortion, that the
government does indeed trump the individual on decision making for
their own body
  (other thoughts here).
Again we hear the lament that the game was great until these
conservative yahoos took over.  No, it wasn't.  It was unjust to scheme
to control other people's lives, and just plain stupid to expect that
the machinery of control you created would never fall into your
political enemy's hands.

Suprisingly, James Taranto in Best of the Web, who I sometimes find too partisan and socially conservative for my tastes, makes a similar point:

Liberal Democrats take credit for creating an enormous government, which, according to them, doesn't work--but would work just fine if only the populace were smart enough to elect liberal Democrats.

In sum: Republicans favor small government but embrace big government when they have the power to control it. Democrats favor big government but insist that it can work only when they have the power to control it. Politicians in both parties, then, seem to see government as a means to the same end: their own political power. Little wonder that voters are suspicious of government.

This is Typical

The left was rightly ticked off a while back when the Bush FDA went against the scientific panel's recommendation and refused to approve the Plan B morning after pill for over-the-counter-sales.  But as I discussed here, the typical political response of our two political parties to such abuses of government power is NOT to reduce the government's power, but to try to redirect the abuses for their own ends. 

So, in this case, the left now is not necessarily upset that the FDA is using non-scientific criteria for approving drugs, they are just upset the FDA is not using their pet non-scientific criteria:

Now an interesting article in the Baltimore Sun
suggests that some left-wingers are also hinting that ethical concerns
should be included in FDA regulatory decisions. In a poll last fall,
the Pew Initiative on Food and Agriculture found
"a strong majority (63 percent) of Americans believe government
agencies should include moral and ethical considerations when making
regulatory decisions about cloning and genetically modifying animals,
with 53 percent feeling that way strongly."

Liberal bioethicist, Daniel Callahan, co-founder of the
Hastings Center in Garrison, N.Y., says that he is leery of having the
FDA rule on moral issues, but thinks that it might want to consider the
financial impact of approving new drugs on the health care system.
Presumably, the regulators might decide that a drug is too expensive
and refuse to approve it although it is safe and effective. The problem
is that deciding to withhold a drug from patients because regulators
think it's "too expensive" is a moral judgment. If the government
doesn't want to pay for an expensive drug that's OK, but why should
regulators forbid consumers, who might want to pay for it on their own,
access to drugs that are safe and effective?

Carol Tucker Foreman, director of food policy at the Consumer
Federation of America, points out that the FDA has already taken into
account non-scientific concerns in some of its regulatory system. For
example, she notes that the FDA requires that irradiated food be
labeled even though there is no scientific evidence that irradiation harms human health. The reason for the labels is that activist groups like Public Citizen
managed to scare some consumers into demanding them in the early 1990s.
Now the question is should the FDA be pushed further down this slippery
slope of non-scientific regulation?

The labeling for irradiated foods is stupid but fairly harmless, but the suggestion to hold life-saving drugs off the market if they are deemed too expensive by some bureaucrats is obscene.  I would suggest you run away screaming from anyone who suggests that this is a "moral" decision.

Technocrats and GM

Frequent readers of this blog know that I have a particular disdain for technocrats and the damage they do via government coercion.  Just to make sure that I am not subject to the Princess Bride accusation of "You keep using that word -- I do not think it means what you think it does", I will define my terms.

In my parlance, a technocrat is someone who believes that individuals, either acting alone or in groups, are making the wrong decisions and that a few very smart people can make things better for everyone by overriding everyone else's decision-making. 

Technocrats sometimes have a "macro" flavor, focusing on the broad sweep of the economy, seeing market failures everywhere that they feel they could override if only someone would follow their "plan".  This hubris was of course one of the foundations for that juggernaut Soviet Russian economy, and was in fact the thinking behind America's closest brush with fascism, Roosevelt's NRA, which was modeled on Mussolini's economic work.  My college roommate Brink Lindsey has a lot of background on the early 20th century roots of technocratic opposition to capitalism in his book Against the Dead Hand: The Uncertain Struggle for Global Capitalism.

Technocrats also can have a "micro" flavor, focusing on individuals who they feel are making bad decisions for their own selves.  Classic examples are helmet and seat belt laws, where "smarter" people use government coercion for your own good.  We typically call these micro technocrats nannies.  I discussed governments overriding individual decision-making here.

Just the other day I mentioned in this post that I had had a conversation with a technocrat who was:

lamenting that allowing a company like GM to die is dumb, and that a
little bit of intelligent management would save all those GM jobs and
assets.  Though we did not discuss specifics, I presume in his model
the government would have some role in this new intelligent design (I
guess like it had in Amtrak?)

I went on to describe why it was OK to let GM fail.  In particular I noted that it was bad for everyone to artificially force quality assets (people and facilities) to remain in an under-performing corporate structure, which is what the government in effect does when it tries to override the market's decision that a corporation needs to die.

I bring this all up because I saw this classic example of technocratic statism from David Ignatius in the Washington Post

Economist Philip Verleger was traveling in Asia last month when the news
broke that General Motors was slashing 30,000 jobs to try to reverse its death
spiral. A Japanese economist he had known for many years asked him a stark
question: "What great nation will allow its major manufacturing company to

The convulsions wracking GM are scary, but they're getting surprisingly
little attention amid America's sea of other troubles. Certainly, we've heard
barely a peep out of the Bush administration, which evidently worries more about
keeping energy companies happy than Rust Belt manufacturers. Commentators have
blamed GM management for being too shortsighted and its workers for being too
greedy. But few people seem to appreciate that the nation as a whole has a stake
in maintaining a dynamic industrial base, or that government policies could help
reverse our industrial decline....

But suppose we took GM's near-death experience as a national wake-up call and
decided to get serious about reviving the long-term health of the U.S.
manufacturing sector. What if political leaders treated this as a fundamental
national mission, equivalent to President John F. Kennedy's call to put a man on
the moon? Could government make any difference?

Try this thought exercise: Suppose a government plan could revitalize the
automobile industry and the rest of the transportation sector, encouraging it to
leapfrog several generations of technology; suppose this same plan could cut
U.S. dependence on foreign oil to zero; and suppose, finally, that the plan
could develop new technologies that would bump our economy to a higher growth
path and foster U.S. economic leadership in the 21st century. Would that idea be
worth exploring?

Yes, good idea, lets hand over the automobile industry to the same folks who built and maintained the levees in New Orleans.  It is interesting he quotes a Japanese economist chiding the US for letting its major companies fail.  The author is basically advocating the Japanese MITI approach, making technology choices and managing industries and preventing large organizations in which national pride is somehow tied up from failing.  Which, of course, has resulted in a 15 year recession in Japan.  And Europe.  Don Boudreaux at Cafe Hayek responds further:

I'm tempted to do a long riff here on all the details that Ignatius misses "“
such as, for example, the fact that it's simply not true that as goes GM so goes
America; such as the fact that there is
nothing at all special or inherently better about manufacturing
manufacturing jobs over service-sector production; such as the fact that
infecting decisions about investment and production with politics will reward
political appeal at the expense of genuinely economically sound uses of

But it's late, so I'll just point you to Ignatius's closing paragraph:

I'm no technologist, so I can't evaluate the technical details of Lovins's
proposal. What I like is that it's big, bold and visionary. It would shake an
America that is sitting on its duff as foreign competitors clobber our
industrial giants, and it would send a new message: Get moving, start
innovating, turn this ship around before it really hits the

This paragraph reflects an attitude that is rich soil for totalitarianism to
take root. It ignores individual freedom; it ignores the possibility that the
admired Big Plan might be flawed, either technologically or economically or
both. Ignatius is all orgasmic simply because The Plan is centralized and Big
and (allegedly) will compel or inspire the masses once again to behave in ways
that promote national greatness.

Heaven help us.

If you think he is exaggerating, as many people do, by invoking the threat of fascism, go back and read what the fascists of the 1930's were writing.  It is nearly identical to Ignatius's words.

There are two lessons technocrats never learn:  1) Their grand plans never work and 2) The statist machinery they create via their grand plans is always taken over from the well-meaning by the power-hungry and corrupt.  As I stated before:

Technocratic idealists ALWAYS lose control of the game.  It may feel
good at first when the trains start running on time, but the
technocrats are soon swept away by the thugs, and the patina of
idealism is swept away, and only fascism is left.  Interestingly, the
technocrats always cry "our only mistake was letting those other guys
take control".  No, the mistake was accepting the right to use force on
another man.  Everything after that was inevitable

And, in fact, you are seeing just this today, as technocrats on the left lament that the machinery of state control they created, from the FDA to public schools, is being taken over by their political enemies.  Unfortunately, they lament the loss of control, not creating the all-powerful state in the first place.  Much more on this topic here and here.

Postscript:  I tossed off the statement above about letting the same organization that built the New Orleans levees fix the automobile industry.  That quick joke makes a valid point, but I should mention that Ignatious does try to preempt this argument:

But then, who can expect individuals to act responsibly when we have an
administration that asserts, in apparent sincerity, that the proper response to
our massive deficits is more tax cuts that plunge us even deeper into debt?
We've become so inured to public-sector mismanagement that the idea of
government solving problems is almost laughable.

In effect, he is arguing that yes, the government has mismanaged things, but this is only because they did not let the really smart people run things.  This is a particularly seductive argument for the left, where most technocrats reside, since it lets them say that government is inefficient only because that idiot Bush is in charge. 

But this ignores the fact that the stupid and corrupt always take over the machinery of state.  Technocrats love railroads, and think America is stupid for not riding the train, like those brilliant Europeans are.  Many supposedly smart people, both Democrats and Republicans, have had their shot at Amtrak, and it still sucks and loses money.  One reason among many for this failure is that incentives matter.  The government has the incentive to patronize powerful voting blocks, not to run an efficient operation or serve customers well.  That's why we get half-billion dollar bridges in Alaska to islands with populations of fifty people.  That's why scientific decisions at the FDA get politicized.  That is why have the government backing a technology ostensibly to reduce fossil fuel use (ethanol) that has been proven to actually increase fossil fuel use.  In effect, government always turns smart people stupid.  More on the specific dangers of government industry building here.

Another Postscript: By the way, people smarter than me do change industries all the time.  The are called "entrepeneurs" and they raise capital from people voluntarily and they succeed or fail only if individuals choose to do business with them.  I find it fascinating to compare Sam Walton with Mr. Ignatius.  Sam Walton raised money voluntarily to support a different vision of retailing, and was successful because many, many people have chosen voluntarily to shop at his stores.  Mr. Ignatius wants to change the automobile industry at the point of a gun, using government's coercive power to force companies to adopt certain technologies and build cars in certain ways, funding the effort with tax dollars taken unwillingly from productive Americans.  Isn't it amazing that "progressives" will want to rally around Mr. Ignatius's vision while excoriating Wal-mart at every turn? 

OK, another Postscript:  At the heart of many of Mr. Ignatius's concerns, and of many people on the left, is that America is "losing" to other countries.  Could someone on the planet please provide maybe just one single fact to support what they mean by this.  I mean, I hear this all the time, but what is it referring to?  Other than, of course, the lamentable fact that 43-year-old Ivy League educated men still can't stop ending sentences with a preposition.

Since 1990, the US economic growth rate has dusted that in most of Europe and Japan.  Only developing nations like China have growth rates that outpace us, and I guess that is what these folks are worried about.  But this is what is never said:  If you don't want countries like China to "catch up" with the US in technology and economy, then you have to be willing to consign billions of people to eternal poverty.  It is amazing to me that "progressives"  who ostensibly care about the poor get so upset when countries like China develop real capabilities that can finally pull themselves out of poverty.  Inevitably, as they do this, they will do some things better than we do.  Over time, our economies will shift, as we do the things we are good at and vice versa.  I know this is kind of novel for some - its an idea that has only been around for 200 years or so.  Having other people get wealthier is only a threat if you believe economics are zero-sum, another urban legend popular on the left that can be demolished with about 5 seconds thought.

One of the virtues of being a bit older is that you can start personally observing history repeating itself.  In the late 80's and early 90's everyone was running around screaming that we were "losing" to Japan and we had to imitate their statist technocratic approach.  Fortunately we did not.  Only in politics could you hear people like Mr. Ignatius being taken seriously when they scream "our economy is losing - lets go out and imitate the people losing even worse"

Update: Sorry this is getting so long, but I can't ignore Virginia Postrel on the same topic of technocrats:

Competition provides not only useful criticism but a continuous
source of experiments. It gives people...the ideas with which to create still
more progress and encourages them, too, to come up with incremental
improvements. By picking winners, stasist protectionism eliminates this learning
process, which includes learning what does not work.

"Premature choice," warns the physicist Freeman Dyson, "means betting all
your money on one horse before you have found out whether she is lame."
Protecting established interests from new challengers is one form of premature
choice. But technocratic planners also sometimes kill existing alternatives to
force their new ideas to "succeed." To protect the space shuttle, NASA not only
blocked competition from private space launch companies, it also eliminated its
own expendable launchers. Such pre-emptive verdicts often mark public works
projects. Planners pick an all-purpose winner, squeeze out alternatives, and
eliminate any real chance of experiment and learning.

Consider the infamous Denver International Airport. Aviation officials touted
the $4.9 billion project as essential to keep up with the region's growth. They
promised it would be a vast improvement over the old Stapleton Airport, which
was often socked in by bad weather. But its sponsors foisted DIA on unwilling
customers. The airport is 25 miles outside Denver, pretty much in the middle of
nowhere, while Stapleton was just 15 minutes from downtown. To make matters
worse, there are no hotels near DIA. And the new airport's cost per passenger is
somewhere between $11.75 and $18.14, depending on how you count--substantially
more than either the $4.59 at Stapleton or the $9.91 promised by former Mayor
Federico Pena. Frequent travelers resent the inconvenience and the generally
higher ticket prices. "I liked Stapleton better," one told The Denver Post. "You
could literally leave about 45 minutes before your plane departed. With DIA, you
have to leave an hour and a half before." A flight attendant expressed a common
sentiment: "It's a beautiful airport. But we hate it."

On the airport's first anniversary, journalists had trouble reaching a simple
verdict on DIA. There were complaints all right--lots of them. But some
passengers liked the spiffy new airport, with its marble floors and inviting
shops. And flight delays had in fact dropped dramatically. The first-anniversary
stories were confused, lacking a central theme.

The reporters had missed the main problem: The city had eliminated the most
obvious source of feedback--competition from the old airport. It had made DIA a
protected monopoly rather than an experiment subject to competitive trial. By
shutting down Stapleton, DIA's political sponsors had made it impossible to rule
the new airport a definite error. No matter how many complaints passengers
lodge, officials can always point to other advantages. At the same time,
however, DIA's monopoly keeps it from becoming an accepted success. Without a
genuine trial, we simply have no way to tell whether travelers (or airlines)
would rather trade a convenient location for fewer weather-related delays. One
airport must fit all: Love it or hate it, if you're flying from Denver you don't
have a choice.

Technocrats often decry competition as wasteful, and always use examples of failed companies and poor private technology choices (e.g. dot com bust companies) as an example of inefficiency of a competitive marketplace that technocrats could avoid.  As Postrel points out, though, these individual failures are not failures of the system, but rather are triumphs.  In the immortal words of the Microsoft tech center, they are a feature, not a bug, and a critical feature at that.

Statism Not So Fun When You Aren't In Control

Every once in a while I post something off the cuff and find retroactively that I have tapped into a rich source of blogging material.  Such is the case with my post a couple of days ago about technocrats on the left regretting loss of control of the statist institutions they created.  In that article I cited examples of the left freaking out over a conservative-controlled FDA halting over-the-counter approval of the Plan B morning after pill and the injection of certain conservative dogmas (e.g. intelligent design) into public schools.  The moral was that the left is lamenting the loss of control, when they should be reevaluating the construction of the regulatory state in the first place.

David Bernstein at Volokh brings us another example with the Solomon Amendment, the legislation that requires universities that accept public funds to allow military recruiters on campus.  Folks on the left hate this act, many because they oppose the military at all junctures while others more narrowly oppose recruiting as a protest against the Clinton-era "don't ask, don't tell" policy law brainchild.  Eskridge and Polsby debate the pros and cons at the ACS Blog.  I tend to be sympathetic to the private universities, who rightly don't feel like acceptance of federal money or research grants should negate their control of their institution.

But my point is not the merits of the Solomon Amendment, but to point out the irony, very parallel with the FDA and public schools examples previously:  The Solomon Amendment is built sturdily on the precedent of Federal Title IX legislation, legislation that is a part of the bedrock of leftish politics in America.  Title IX first established the principal that the Federal government could legally override the policy-making and decision-making at private universities if they accepted any federal cash.  It was the left that fought for and celebrated this principal.  The left ruthlessly defended the state's right to meddle in private universities in substantial ways, and passed legislation to shore Title IX up when the Supreme Court weakened state control (from the Bernstein post):

The Court's attempt to preserve some institutional autonomy for universities
from anti-discrimination laws caused uproar among liberal anti-discrimination
activists. They persuaded Congress to pass the "Civil Rights Restoration Act."
This law ensured that if a university receives any federal funds at all,
including tuition payments from students who receive federal aid, as in Grove
City's case, all educational programs at that university are subject to Title

The Solomon Amendment is modeled after the Civil Rights Restoration Act's
interpretation of Title IX.

In fact, in the linked articles, Solomon is being attacked by the left precisely because it does not allow universities the freedom to set their own anti-discrimination policy (in this case, banning recruiters judged discriminatory to gays), when the whole issue of Title IX was precisely to override a university's chosen anti-discrimination policy (or lack thereof).  So again we have the case of the left building an government mechanism to control private decision-making, and then crying foul when their political enemies take control of the machinery.

In my naive youth, I would have assumed that this contradiction would quickly be recognized.  However, the left (and the right too, but that is for another post) has been able for years to maintain the cognitive dissonance necessary to support the FDA's meddling in every single decision about what medical procedures and compounds a person can have access to while at the same time arguing that abortion is untouchable by government and that a woman should make decisions for her own body.  In this case, it will be interesting to see if the left is able to simultaneously decry state control of discrimination policies at private universities in Solomon while continuing to support state control of private university discrimination policies as essential in Title IX.

Correction: You learn something every day.  I called don't-ask-don't-tell a "policy, as I had assumed that it was merely an internal military policy.  Apparently it is a law.

Jury Kills Vioxx. Penicillin Next?

The other day, I wrote about the left of late lamenting that the machinery of state control that they created, agencies like the FDA and public schools, are being taken over by their political enemies, the "Neanderthal southern religious conservatives".  I observed that they were not apologizing for creating a statist structure to control individual decision-making, but just were upset they lost control of it.

In using the FDA as one example:

Today, via Instapundit, comes this story about the GAO audit of the decision by the FDA to not allow the plan B morning after pill to be sold over the counter.
And, knock me over with a feather, it appears that the decision was
political, based on a conservative administration's opposition to
abortion.  And again the technocrats on the left are freaked.  Well,
what did you expect?  You applauded the Clinton FDA's politically
motivated ban on breast implants as a sop to NOW and the trial
lawyers.  In
establishing the FDA, it was you on the left that established the
principal, contradictory to the left's own stand on abortion, that the
government does indeed trump the individual on decision making for
their own body
  (other thoughts here).
Again we hear the lament that the game was great until these
conservative yahoos took over.  No, it wasn't.  It was unjust to scheme
to control other people's lives, and just plain stupid to expect that
the machinery of control you created would never fall into your
political enemy's hands.

That has spurred a lot of email pointing me to other FDA-related articles.  I posted this one in the updates of that same post, pointing out how the FDA process (and the tort process, by the way) puts a much higher value on a life lost to drug side-effects than to a life saved from drug benefits.

Today I was pointed to this article by Derek Lowe who has been a drug development researcher for a number of years:

As a drug discovery researcher, I can tell you something that might sound
crazy: many of these older drugs would have a hard time getting approved today.
Some of them would never even have made it to the FDA at all.

The best example is aspirin itself. It's one of the foundation stones of the
drug industry, and it's hard to even guess how many billions of doses of it have
been taken over the last hundred years. But if you were somehow able to change
history so that aspirin had never been discovered until this year, I can
guarantee you that it would have died in the lab. No modern drug development
organization would touch it.

Thanks in part to advertisements for competing drugs, people know that there
are some stomach problems associated with aspirin. Actually, its use more or
less doubles the risk of a severe gastrointestinal event, which in most cases
means bleeding seriously enough to require hospitalization. Lower doses such as
those prescribed for cardiovascular patients and various formulation
improvements (coatings and the like) only seem to improve these numbers by a
small amount. Such incidents, along with others brought on by other oral
anti-inflammatory drugs, are the most common severe drug side effects seen in
medical practice....

That brings us up to penicillin, a drug with a clean reputation if ever there
was one. But at the same time, everyone has heard of the occasional bad allergic
reaction to it and related antibiotics. Even with the availability of skin tests
for sensitivity, these antibiotics cause about one fatality per 50 to 100,000
patient courses of treatment. Other severe reactions are twenty times as common.
Those are interesting figures to put into today's legal context: over 9 million
prescriptions were written for Vioxx, for example. Any modern drug that directly
caused that number of patient deaths and injuries would bury its company in a
hailstorm of lawsuits, because (unlike the Vioxx cases) there would be little
room to argue about

Statism Comes Back to Bite Technocrats

Over the past fifty years, a powerful driving force for statism in this country has come from technocrats, mainly on the left, who felt that the country would be better off if a few smart people (ie them) made the important decisions and imposed them on the public at large, who were too dumb to make quality decision for themselves.  People aren't smart enough,they felt, to make medication risk trade-off decision for themselves, so the FDA was created to tell them what procedures and compounds they could and could not have access to.  People couldn't be trusted to teach their kids the right things, so technocrats in the left defended government-run schools and fought school choice at every juncture.  People can't be trusted to save for their own retirement, so  the government takes control with Social Security and the left fights giving any control back to individuals.  The technocrats told us what safety equipment our car had to have, what gas mileage it should get, when we needed to where a helmet, what foods to eat, when we could smoke, what wages we could and could not accept, what was and was not acceptable speech on public college campuses, etc. etc.

Throughout these years, libertarians like myself argued that there were at least three problems with all of this technocratic statism:

  • You can't make better decisions for other people, even if you are smarter, because every person has different wants, needs, values, etc., and thus make trade-offs differently.  Tedy Bruschi of the Patriots is willing to take post-stroke risks by playing pro football again I would never take, but that doesn't mean its a incorrect decision for him.
  • Technocratic idealists ALWAYS lose control of the game.  It may feel good at first when the trains start running on time, but the technocrats are soon swept away by the thugs, and the patina of idealism is swept away, and only fascism is left.  Interestingly, the technocrats always cry "our only mistake was letting those other guys take control".  No, the mistake was accepting the right to use force on another man.  Everything after that was inevitable.

I am reminded of all this because the technocrats that built our regulatory state are starting to see the danger of what they created.  A public school system was great as long as it was teaching the right things and its indoctrinational excesses were in a leftish direction.  Now, however, we can see the panic.  The left is freaked that some red state school districts may start teaching creationism or intelligent design.  And you can hear the lament - how did we let Bush and these conservative idiots take control of the beautiful machine we built?  My answer is that you shouldn't have built the machine in the first place - it always falls into the wrong hands.  Maybe its time for me to again invite the left to reconsider school choice.

Today, via Instapundit, comes this story about the GAO audit of the decision by the FDA to not allow the plan B morning after pill to be sold over the counter.  And, knock me over with a feather, it appears that the decision was political, based on a conservative administration's opposition to abortion.  And again the technocrats on the left are freaked.  Well, what did you expect?  You applauded the Clinton FDA's politically motivated ban on breast implants as a sop to NOW and the trial lawyers.  In establishing the FDA, it was you on the left that established the principal, contradictory to the left's own stand on abortion, that the government does indeed trump the individual on decision making for their own body  (other thoughts here).  Again we hear the lament that the game was great until these conservative yahoos took over.  No, it wasn't.  It was unjust to scheme to control other people's lives, and just plain stupid to expect that the machinery of control you created would never fall into your political enemy's hands.

OK, rant over.  No one wants to hear "you asked for it", but that is indeed my answer to many of the left's laments today about conservatives taking over their treasured instruments of state control.  I hate to be a geek here, but even Star Trek figured out this whole technocrat losing control of the fascist state thing 40 years ago.

Update:  Wow, I am not that skilled with reading academix-speak, but I am pretty sure that Ed Glaeser via Margina Revolution is saying the same thing:

Soft paternalism requires a government bureaucracy that is skilled in
manipulating beliefs.  A persuasive government bureaucracy is inherently
dangerous because that apparatus can be used in contexts far away from the
initial paternalistic domain.  Political leaders have a number of goals, only
some of which relate to improving individual well-being.  Investing in the tools
of persuasion enables the government to change perceptions of many things, not
only the behavior in question.  There is great potential for abuse.

Update:  Cafe Hayek discusses how the FDA is failing even technocratic objectives and this is an amazing data-rich in-depth analysis of the FDA vs. markets in managing drug risk/reward choices:

The debate over off-label prescribing is not about perfect safety; it is about
whether unavoidable trade-offs are best made for everyone by a centralized authority
such as the FDA or whether those decisions are best made by patients and doctors
acting independently. Whoever makes a decision to try (patient), prescribe (doctor),
or approve (FDA) a drug must face the trade-off between the costs of prescribing a
potentially unsafe medicine (a type II cost) and the costs of not prescribing a drug
that could have saved a life (a type I cost)....

The FDA tends to overemphasize the cost of using a potentially unsafe medicine,
because type II costs are highly visible and result in punishment of the FDA, whereas
type I costs are invisible and do not result in punishment.

If the FDA approved a drug that killed thousands of people, that story would make
the front page of every newspaper in the nation. Congressional hearings would certainly he held, the head of the FDA would probably lose his or her job, and the agency would be reorganized. But if the FDA rejected a drug that could save thousands of people, who would complain? When a drug kills a patient, that person is identifiable, and family and friends may learn the cause of the death. In contrast, the patient who would have lived, had new drugs been available, is identifiable only in a statistical sense. Family and friends will never know whether their loved one could have survived had the FDA not delayed the introduction of a new drug. In some cases the drug that could have saved the patient's life is never created, because the costs of the FDA's testing procedures make the necessary research and development appear unprofitable...

Patients and doctors do not face the same biased incentives as the FDA and thus
tend to pay more attention to the costs of not using a drug that could save a life.

More Consistency NOW!

The other day in my post on Politics without Philosophy, I mentioned in passing the philosophical inconsistencies on the National Organization for Women (NOW) website.  Specifically, I referred to the premise that women should control the decision-making for their own body (a premise I accept) and noted the inconsistency of some of their positions, notably opposition to breast implants, with this position.  As usual, I got several emails on "my attack on women", which is pretty normal nowadays:  People tend to associate an attack on an organization purporting to represent a certain group with an attack on the group itself. 

Anyway, this post was just going to be an update, to provide the specific links on NOW's seemingly conflicting positions on abortion and breast implants, but in the process, I discovered another very interesting inconsistency, which I will get to in a few moments (its in bold at the bottom if you really can't wait).

In posting on the breast implant - abortion conundrum, I should have linked to this post, where I explained in more detail:

When it comes to defending abortion, women's groups are great
libertarians. They will point out that abortion is about the right to
choose and about protecting the "fundamental civil and human right of
women to make the most intimate decisions about their bodies and their
lives".  Its about not letting the government interfere with individual
decision-making or a "woman's right to privacy".  Its about assuming
women are grown-up enough to make difficult choices about their fetus
and their own health and safety.  Opponents of such choice are
"ultra-conservatives trying to deny women control over their own
bodies".  (all quotes from the NOW web site).

So, women's groups seem to be good libertarians concerned with the primacy of women's decision-making over their own body.  Except when they're not.
NOW has been feverishly campaigning to get the government to limit a
women's right to choose breast augmentation, despite the fact that the
science is overwhelmingly behind the safety of implants.  Sure, as in
any medical procedure, there are some risks, but I defy anyone to tell
me that the risks associated with breast implants are greater than the
risks associated with abortion.  Abortion is a much weightier and more
difficult decision, and, unlike breast implants, it is irreversible.
If women are mature enough to make abortion decisions, they certainly
are mature enough to weigh the risks of breast implants.  Or take the
birth control pill -- the impact to a woman's body of silicone sacks in
their boobs is far less than that of trashing their entire hormone
balance.  Sure, the pill makes sense for a lot of people and its great
that the option exists, but don't tell me that the the changes the pill
engenders in the body are OK but bags of silicone are not.

Note that if you accept the notion of a woman's right to choose for her own body, the risks of breast implants shouldn't matter.  A good government might make sure these risks are revealed, but would leave decision making on the risks vs. rewards to the individual.  For the sake of completeness, though, here is NOW's argument that breast implants are just too risky and here is the counter-argument, supported by most scientists and the medical profession, that there is nothing wrong with them.  Note, however, the NOW would not tolerate casting the abortion debate around safety or risk, arguing in that case that it is up to the woman to make these informed trade-offs.

Anyway, here is what I learned from grabbing a few of the links above.  Consistent with their position on breast implants (and their heavy funding from the tort bar) NOW also is criticizing the FDA for allowing the Vioxx painkiller on the market.

Whether it's Vioxx or Bextra or silicone implants, the rule now
is 'Buyer Beware, said [NOW President Kim] Gandy. The drug and device companies own
the FDA and it is the companies' profit potential that rules the
review and approval process - except when the profit motive is
overridden by the White House morality police, as with the
morning-after pill.

Yep, the FDA is apparently not doing a good job in limiting the number drugs or procedures women choose to put in their bodies (more on Vioxx on the NOW web site).  But this is still not the really funny part, just another illustration of how NOW only seems to apply "Its her body" to abortion, rather than any other decision.  What was really interesting was this (emphasis added):

An assisted suicide
bill (AB 654) passed the Democrat-controlled Assembly Judiciary
Committee on Tuesday, following two hours of debate. It now moves to
the full Assembly, where a vote may come in May.

officially supporting the bill include the pro-euthanasia group
Compassion & Choices; the American Civil Liberties Union, the
California Alliance for Consumer Protection, the California National Organization for Women; the Conference of Delegates of California Bar Associations; Drug Policy Alliance Network; and End-of-Life Choices.

I am OK with legal suicide as the last-ditch pain-relief strategy, though I am uncomfortable allowing doctors to help, given the inherent conflicts (maybe create a new suicide midwife profession?)  Anyway, note from this that while NOW opposes women's access to legal Vioxx, they support legal access to assisted suicide.  In case you are missing the full irony, I will restate it:  NOW supports the legality of a pain-relief strategy (assisted suicide) with a 100% chance of death but opposes the legality of a pain-relief strategy (Vioxx) with a less than 1% chance of death.

I don't really mean to pick on NOW in particular.  As I said before, nearly any organization on the right or left tends tends to espouse contradictory positions in the same manner.  NOW is just a particularly easy target since it takes positions on so many things.  Also, I must admit that they particularly piss me off some, articulating a fine libertarian point of view that women, and not the government, should control decision-making for their own body, and then abandoning this premise on nearly every non-abortion topic they address.

Anyway, you can read more on how the left really doesn't want to address the full implications of the Roe v Wade privacy right here.  If you want to understand why NOW takes the positions it does, beyond the usual we-know-better-what-is-good-for-women-than-they-do-themselves elitism, you might look at the NOW relationship to the tort bar.  NOW is usually prominently featured on the ATLA web site.

Politics without Philosophy

It may surprise some readers to know that I am a conflict avoider when it comes to arguing politics in social gatherings.  There are a variety of reasons for this, not the least of which is often a desire to escape substantive issues in the off-hours of my life. 

However, one important reason I don't like discussing current events or other weighty issues with people (particularly in groups) is that many of the people I meet don't really have an underlying philosophy, but rather a hodge-podge of political positions stitched together from a variety of sources.  This makes it almost impossible to have a substantive conversation with them.

When I have a disagreement with someone on matters of politics or economics or whatever, there are really only two satisfying outcomes:

  1. To discover that we share the same basic premises and philosophy, but have reached different conclusions from these premises.  Trying to figure out where we diverge is an interesting and generally informative exercise
  2. To discover that we have very different fundamental premises or assumptions about the nature of existence.  While perhaps not satisfying, this can at least save a lot of useless discussion.  For example, if you believe that we are all born with an obligation or requirement, kind of like original sin, to provide our fellow man with material comforts, while I do not, there is not a lot of point in the two of us arguing about redistributive taxation.

Unfortunately, it is impossible to reach either of these conclusions with people who have no underlying philosophy that drives their ethics and political positions.  I remember one discussion with a woman who was taking all all comers over abortion, defending a woman's right to choose for her body.  So I asked her if she was therefore opposed to the government ban on breast implants.  "No, that's different, those are totally frivolous.  Women shouldn't have breast implants, its demeaning".  But, I asked,  isn't the FDA telling women what they can and can't put in their bodies.  "But its necessary, she says, because people don't always know enough to make the right decisions".  So, I follow-ed up, its part of the FDA's job to hold up drugs like the morning-after pill?  "No, that's just christian-right bullshit".

How can you argue with this, when there is no consistent underlying philosophy?  Essentially her position boils down to "I support government intervention except when I oppose it".  And this is not unusual.  In fact, the positions she took are entirely consistent with the positions on these same issues taken at the NOW web site.  Hell, the entire Republican and Democratic platform each boil down to "we support government intervention except where our major donors oppose it".

The reason for this brief, really tangential rant was this morning when I was reading through some recent emails from a trade group I belong to called the NACS, or the National Association of Convenience Stores.  Because of changes in the market, the NACS represents a large percentage of the gasoline retailers in this country.  In the last two weeks, the NACS has:

  1. Opposed government "price gouging" regulations aimed at how gas stations price their product.
  2. Advocated government intervention in the pricing of credit card processing services, arguing that gas stations are getting gouged by banks today

Could anything be more stark?  There are no values here, no philosophy, no core assumptions about the nature of man and man's existence.  Just a bald desire to be left alone yourself, but have the government intervene in your favor with everyone you do business with.

PS:  Credit card processing rates piss me off as well, but you don't see me asking for the government to intervene.

Another Limitation on Individual Choice

I won't go too much into the details of the recent Vioxx jury verdict.  Professor Bainbridge has a complete roundup which is worth reading, and Reason had an analysis of the merits of the case a while back.  Though its not really the point of this post, I can't resist a few snippets:

Jurors who voted against Merck said much of the science sailed right over their
heads. "Whenever Merck was up there, it was like wah, wah, wah," said juror John
Ostrom, imitating the sounds Charlie Brown's teacher makes in the television
cartoon. "We didn't know what the heck they were talking about."

One juror considered the fact that the CEO, whose company faces thousands of law suits, didn't show up as an admission of guilt:

... [juror] Ostrom, 49, who has a business remodeling homes, was also disturbed
that former Merck Chief Executive Raymond Gilmartin and another top Merck
official gave videotaped testimony but weren't in the courtroom. "The big guys
didn't show up," said Mr. Ostrom. "That didn't sit well with me. Most definitely
an admission of guilt."

And of course there is this now famous gem:

One juror, Ms. Blas, had written in her questionnaire that she
loves the Oprah Winfrey show and tapes it. "This jury believes they're going to
get on Oprah," Ms. Blue told Mr. Lanier. "They only get on Oprah if they vote
for the plaintiff."

Read the Bainbridge post, it has much more.

Anyway, the point of this post is that this verdict represents a very dangerous assault on individual choice.  Recognize that there are many, many activities in life where individuals are presented with the following choice:

If I choose to do X, my life will be improved in some way but I may statiscally increase my chance of an early death.

You may react at first to say that "I would never risk death to improve my life", but likely you make this choice every day.  For example, if you drive a car, you are certainly increasing your chance of early death via a auto accident, but you accept this risk because driving allows you to get so much more done in your life (vs. walking).  If you ride a bike, swim, snow ski, roller blade, etc. you are making this choice.  Heck, everyone on the California coast is playing Russian Roulette with an earthquake in exchange for a great climate, beautiful scenery, and plentiful jobs.

The vast majority of drugs and medical therapies carry this same value proposition:  A drug will likely improve or extend your life in some way but carries a statistical chance of inducing a side effect that is worse than the original problem, up to and including death.  The problem is that we have structured a liability system in this country such that the few people who evince the side effects can claim more money in damages than the drug was worth to all the people it helped.  For example, if a drug helps 999 people, but kills the thousandth, and that thousandth person's family is awarded $253 million in damages (as in this case), the drug is never going to be put on the market again.  Even if the next 1000 people sign a paper saying we are willing to take the one-in-a-thousand risk to relieve the pain that is ruining our lives, they still are not going to get the drug because the drug companies know that some Oprah-loving jury will buy the argument that they did not understand the risk they were taking and award the next death another quarter of a billion dollars.

This exact same effect nearly killed the vaccination industry.  In the end, Congress had to pass legislation  immunizing (ha ha) vaccine makers from lawsuits when known 1-in-10,000 side effects occur.  While I am not a big fan of the FDA, if it is going to exist and put drugs through 20 years of tests and a forest full of paperwork to get approved, I think that approval process should confer some sort of litigation immunity. 

By the way, have you noticed the odd irony here?  Robert Ernst (the gentleman who died in the Vioxx case) is assumed, both by the FDA and the litigation system, to be unable to make informed decisions about risk and his own health.  But a jury of 12 random people who never experienced his pain can make such decisions for him?  And us?

Richard Epstein said it better than me, in the WSJ but I will like to Reason which is free:

I would like to send my message to [plaintiff's lawyer Mark] Lanier and
those indignant jurors. It's not from an irate tort professor, but from
a scared citizen who is steamed that those "good people" have imperiled
his own health and that of his family and friends. None of you have
ever done a single blessed thing to help relieve anybody's pain and
suffering. Just do the math to grasp the harm that you've done.

Right now there are over 4,000 law suits against Merck for Vioxx.
If each clocks in at $25 million, then your verdict is that the social
harm from Vioxx exceeds $100 billion, before thousands more join in the
treasure hunt. Pfizer's Celebrex and Bextra could easily be next.
Understand that no future drug will be free of adverse side effects,
nor reach market, without the tough calls that Merck had to make with
Vioxx. Your implicit verdict is to shut down the entire quest for new
medical therapies. Your verdict says you think that the American public
is really better off with just hot-water bottles and leftover aspirin

Ah, you will say, but we're only after Vioxx, and not those good
drugs. Sorry, the investment community won't take you at your word. It
realizes that any new drug which treats common chronic conditions can
generate the same ruinous financial losses as Vioxx, because the flimsy
evidence on causation and malice you cobbled together in the Ernst case
can be ginned up in any other. Clever lawyers like Mr. Lanier will be
able to ambush enough large corporations in small, dusty towns where
they will stand the same chance of survival that Custer had at Little
Big Horn. Investors can multiply: They won't bet hundreds of millions
of dollars in new therapies on the off-chance of being proved wrong.
They know they'll go broke if they win 90% of the time.

Your appalling carnage cries out for prompt action. Much as I
disapprove of how the FDA does business, we must enact this hard-edged
no-nonsense legal rule: no drug that makes it through the FDA gauntlet
can be attacked for bad warnings or deficient design.

Why Not Have The Government Approve Our Car Choices Too?

As a follow-on to the issues I raised in this post about the FDA making our risk-reward choices for us, comes this tongue-in-cheek suggestions from Café Hayek:  Lets start the FCA, the Federal Car Administration, to approve cars for consumer use:

Choices would be few.  Because of the high costs of the approval process, only cars that appealed to large numbers of consumers would receive attention from the manufacturers.  On the plus side, the cars that did survive the process would be very safe and very good cars.  They'd have to be.  Manufacturers would want to reduce the odds of failure to avoid a ten year approval process that resulted in rejection.

It would be great, assuming the bureaucrats in Washington would make exactly the same choices that you would.  In other words, it would be great if we all wanted to drive identical Ford Taurus's.

If you think this suggestion is just ridiculous humor, ask yourself whether this is what Ralph Nader has been after all along.

Individual Choice and Vioxx

I mentioned in this post on individual choice the example of the FDA risk-reward decisions for Americans as a whole, an impossible task when each individual's needs and decision making are different (also see here).  This is a couple of weeks old, but is a good article from USAToday about the millions of people who are suffering in the wake of Vioxx's removal from the market. 

Sales of the drug were halted worldwide on Sept. 30, after a study showed it doubled the risk of heart attack and stroke. But, for Rubinstein, relief trumps risk.

Vioxx "was the best pain drug I had been on in 27 years," says the 47-year-old Manhattan resident, who has fibromyalgia, a chronic condition that causes pain in muscles and joints. "I felt good enough to do some exercise. Getting to work was not such a difficult thing.

These people would gladly accept the increased risk of heart problems to reduce their debilitating pain, if only the government and/or the courts would allow them to make this choice.  (yes, I know that Vioxx was pulled by the maker, but this is only anticipation of a tort system that punishes the manufacturer for informed choices made by individual users).


This is a good post from Cafe Hayek on presecription drugs and individual choice