Posts tagged ‘fda’

It's All About Control

I can't think of any justification for the FDA's shutdown of 23andme's genetic testing service except one of pure control.  It is yet another case where you and I are not smart enough or sophisticated enough to be trusted with information about our own bodies.  Because we might use the information in some way with which Maya Shankar might not agree.

Let me be clear, I am not offended by all regulation of genetic tests. Indeed, genetic tests are already regulated. To be precise, the labs that perform genetic tests are regulated by the Clinical Laboratory Improvement Amendments (CLIA) as overseen by the CMS (here is an excellent primer). The CLIA requires all labs, including the labs used by 23andMe, to be inspected for quality control, record keeping and the qualifications of their personnel. The goal is to ensure that the tests are accurate, reliable, timely, confidential and not risky to patients. I am not offended when the goal of regulation is to help consumers buy the product that they have contracted to buy.

What the FDA wants to do is categorically different. The FDA wants to regulate genetic tests as a high-riskmedical device that cannot be sold until and unless the FDA permits it be sold.

Moreover, the FDA wants to judge not the analytic validity of the tests, whether the tests accurately read the genetic code as the firms promise (already regulated under the CLIA) but the clinical validity, whether particular identified alleles are causal for conditions or disease. The latter requirement is the death-knell for the products because of the expense and time it takes to prove specific genes are causal for diseases. Moreover, it means that firms like 23andMe will not be able to tell consumers about their own DNA but instead will only be allowed to offer a peek at the sections of code that the FDA has deemed it ok for consumers to see.

Alternatively, firms may be allowed to sequence a consumer’s genetic code and even report it to them but they will not be allowed to tell consumers what the letters mean. Here is why I think the FDA’s actions are unconstitutional. Reading an individual’s code is safe and effective. Interpreting the code and communicating opinions about it may or may not be safe–just like all communication–but it falls squarely under the First Amendment.

I know that libertarians want to kill the FDA altogether.  That is never going to happen.  But what might be more realistic is to shift their governing law from validating that medical treatments are safe and effective to just safe.

Brad Warbiany has more, including real life examples of how 23andme's service has been useful to his family.

Is Cronyism Private Enterprise's Fault or the Government's?

Oddly enough, this is perhaps the most frequent argument I have with people on the Left in cocktail party conversations.

It begins this way -- some abuse of "private enterprise" is cited.  Almost every time, I have to point out that the abuse in question could not occur if private companies were not availing themselves of government's coercive power to [fill in the blank: step on competitors, limit choice, keep prices high, rake in subsidies, etc.] Michael Moore's Capitalism: A Love Story is very much in this mold, blaming bad outcomes that result in government interventions on free market capitalism.

Kevin Drum has a great example of this.  Asthma inhalers are expensive because certain companies used the government to ban less expensive competitive products.

Nick Baumann picks up the story from there:

The pharma consortium transformed from primarily an R&D outfit searching for substitutes for CFC-based inhalers into a lobbying group intent on eliminating the old inhalers. It set up shop in the K Street offices of Drinker Biddle, a major DC law firm. Between 2005 and 2010, it spent $520,000 on lobbying. (It probably spent even more; as a trade group, it's not required to disclose all of its advocacy spending.) Meanwhile, IPAC lobbied for other countries to enact similar bans, arguing that CFC-based inhalers should be eliminated for environmental reasons and replaced with the new, HFC-based inhalers.

The lobbying paid off. In 2005, the Food and Drug Administration (FDA) approved an outright ban on many CFC-based inhalers starting in 2009. This June, the agency's ban on Aerobid, an inhaler used for acute asthma, took effect. Combivent, another popular treatment, will be phased out by the end of 2013.

In other words, pharmaceutical companies didn't just take advantage of this situation, they actively worked to create this situation. Given the minuscule impact of CFC-based inhalers on the ozone layer, it's likely that an exception could have been agreed to if pharmaceutical companies hadn't lobbied so hard to get rid of them. The result is lower-quality inhalers and fantastically higher profits for Big Pharma.

Rosenthal has a lot more detail in her piece about how the vagaries of patent law make this all even worse, and it's worth reading. But she misses the biggest story of all: none of this would matter if drug companies hadn't worked hard to make sure the old, cheap inhalers were banned. How's your blood doing now, Dr. Saunders?

No one has more disdain than I for companies that attempt to use the coercive power of the government as a competitive weapon in their favor.  Heck, I have barely gone 2 hours since the last time I bashed an industry for doing so.

But the implication that this is all the fault of corporations is just wrong, as is the the inevitable Progressive conclusion that somehow more government regulation and powers are necessary to combat this.

The Left has been the prime cheerleader over the past decades in creating the Federal behemoth that not only allows this to happen, but actively facilitates it.   We have created a government whose primary purpose is to redistribute spoils from one group to another.

Just look at the example he uses.  These drug manufacturers could have protected their markets and products the free market way, by investing tens of millions in more research, manufacturing cost reduction, and customer marketing.   But instead, we have a system where - entirely legally - a company can spend a fraction of this (the chump change amount of half a million dollars) to market to a few dozen people in DC and get the same benefits as investing tens of millions in satisfying customers.    The wonder is not that losers like these drug companies go this route, but that anybody at all still has enough sense of honor to actually invest in the customer rather than in DC bureaucrats.

I put it this way - "invest in customers rather than DC bureaucrats" - because every new regulation, every new government power over commerce is essentially a dis-empowerment of consumers in the marketplace.  Nowhere is this more true than in pharmaceuticals, where the government tells consumers what they can and cannot buy.

In a free market, accountability is enforced by consumers defending their own best interests and new competitors seeking fortunes by striving to serve consumers better than market incumbents.  Every government intervention is essentially saying to consumers that the government is going to make yet another decision for them.  So, having taken over so many decisions of consumers in those huge office buildings in DC, is it any wonder that companies go to DC to market to bureaucrats rather than bother marketing to consumers?

The problem, then, is not that some corporations avail themselves of legal shortcuts to profits.  The problem is that these legal shortcuts exist at all.  The problem is the coercive power of government to intervene in markets, chill competition through incensing, subsidize one competitor over another, etc.  These kinds of stories are going to proliferate endlessly until  that power is scaled back.

The Progressives I argue with come back with one of two answers.

This is a crock, and is the worst bit of enablement for a bad system ever invented.   The folks in government are not bad people -- they are normal people with bad information and bad incentives, and that is never going to change.  After all, something that Drum glosses over here, the agency in hid example went along and did the industry's bidding.  I know why the industry was doing what it did, but why did the agency roll over?  The whole theory is that these are public spirited people without commercial incentives.  Yet they rolled over none-the-less.  And it's not like these government employees are Rothbardian libertarians.  I work with the government all the time.  Their employees are there because they believe in public solutions over private ones.  In outlook and biases and beliefs they look a lot more like Kevin Drum than myself.  So why do they get a pass?  Of the two people here -- the drug company guy and the regulator guy -- which one is not doing his job right for his constituents?  So why does the drug company get the blame?

Response 2:  We just need to ban lobbying and contact with the regulated industry.  The whole theory of regulation is that the regulators are totally knowledgeable about the industry, but they have different incentives so they can work in the public interest.  But how are they going to be totally knowledgeable about the industry without frequent contact?  Or even experience in the industry?  And as to lobbying, lobbying is just speech.  It would be Constitutionally impossible to ban lobbying, and wrong anyway.  Think of it this way-- let's say you ran a restaurant but had to get a government agency's permission for each change in your menu (just as drug companies have to get permission for each change in their product offering).  Would you be happy with a situation in which the government made decisions on your menu without consulting you?  You would want to explain your desired changes and the logic behind them, right?   That's called lobbying, and you would not be happy to see it banned.

On Crazy Government Requests and Subsidizing Economists

There is some chance this may be apocryphal (I don't see any evidence the reporters confirmed this with the FDA), but as someone who has had government inspectors show up on our property demanding to see our license to sell eggs, it wouldn't surprise me if true.  I am bombarded with government insanity of this genre every day.

Apparently, a children's magician who was forced to obtain a government license for his stage rabbit is claiming

My USDA rabbit license requirement has taken another ridiculous twist. I just received an 8 page letter from the USDA, telling me that by July 29 I need to have in place a written disaster plan, detailing all the steps I would take to help get my rabbit through a disaster, such as a tornado, fire, flood, etc. They not only want to know how I will protect my rabbit during a disaster, but also what I will do after the disaster, to make sure my rabbit gets cared for properly.  I am not kidding–before the end of July I need to have this written rabbit disaster plan in place, or I am breaking the law.

The bizarre government requests like this one at least give us a laugh around here.  Less funny are the zillions of other pieces of waste paper that must be supplied to various agencies every month -- for example the 9 different permits which took 3 years to accumulate from Ventura County just to remove a dangerous and rotting deck  (not coincidentally, we are closing all our business in Ventura County at the end of this year).  Just in the last several days the Department of Labor asked for new, more onerous monthly reporting of headcounts and payroll by state (I declined) and the census bureau asked for quarterly rather than annual detailed reports of our lodging business (I declined).

One piece of advice I would give to harried small business people is to say "no" as often as possible to these data requests.  Obviously, you will need to turn in your monthly sales tax reports or you will be going to jail, but do you really need to feed the census?  The department of Commerce?  The Department of Agriculture?  The Labor Department?  Much of this data they gather is used either 1) to craft regulations that will just make your life as a business owner harder in the future or 2) to subsidize academics and economists in the form of free data.  As I told the Labor Department the other day, I am happy to fill out their survey if they want to pay me, say, $100 a month to compensate me for my time.  Otherwise they are just stealing free labor and proprietary data from me to help some grad student write her PHD or help some Wall Street hedge fund manager better call the market.

An Insane Theory of Product Liability

Via the WSJ today:

Can a drug company be held liable for damages caused by generic drugs it didn't produce? That's the expansive new theory of "innovator liability" on parade in Alabama, where a recent ruling by the state Supreme Court could do damage throughout the U.S. economy.

In Wyeth Inc. et al., v. Danny Weeks et al., Mr. Weeks says he suffered from side effects from taking the generic version of an acid-reflux drug called Reglan. He sued Wyeth for fraud and misrepresentation, though the company didn't make the drug he took and had exited the Reglan market in 2002, five years before he took it. The court ruled 8-1 that Wyeth could be held liable for injuries because the generic manufacturer couldn't change the warnings on the product it copied.

First, this is nuts -- being held liable for problems with a product you did not make, simply because you invented it years before.   Are we going to start suing the estate of Thomas Edison every time someone buys a bad lightbulb?

But second, note how helpless Wyeth is now.  Drug makers are used to insane law suits that drain all the profit from helping millions of people to pay off a few folks who had adverse side effects (this same process literally destroyed the vaccination business until the government gave them special liability protection).

But let's accept the court victory - perhaps the drug really has a problem that has been discovered.  If the maker was being sued, he could just pull the drug from the market (as has happened any number of times after adverse suits) either forever or until the FDA will approve new warning language.

But in this case, Wyeth can't do this.  The generic drug makers will keep on selling the product - after all, they are not getting sued, and Wyeth will keep paying.  Wyeth does not even have standing to try to get the FDA to change the warnings on the drug.  If Wyeth tries to buy out the generic maker and shut it down, and new seller will simply takes its place.    If this case stands, Wyeth can be steadily bled to death and there is nothing they can do to stop it.

Finally, I don't want to get away without a mention of just how broken the FDA drug regulation regime is.  The original Supreme Court decision that led to the generic maker being immune to suits really turned on the impossibility of getting the FDA to change even one word on a drug's warning label.

Just How Little Does Government Trust Individuals?

From CNN via Carpe Diem

 

A 24-year scandal was quietly acknowledged last week. On July 3 the U.S. Food and Drug Administration approved the first "rapid home" test for HIV—a test that people can take in the privacy of their own homes to determine whether they have the virus that causes AIDS.

The approval is an unambiguously good thing—or so you would think. The saliva test in question, made by OraSure Technologies and known as OraQuick, costs less than $60 and takes just 20 minutes to self-administer. According to statistics an FDA advisory committee presented at a hearing in May, it holds the potential to prevent the transmission of more than 4,000 new HIV infections in its first year of use alone. That would be about 8 percent of the roughly 50,000 new infections we currently see annually in the United States. (About 1.2 million people in the U.S. are now living with HIV, according to the Centers for Disease Control and Prevention, of whom about 20 percent don't realize they have it. Since the epidemic began in the early 1980s, about 1.1 million people have been diagnosed with AIDS, and more than 619,000 have died from it.)

The scandal is that the approval of a rapid home test for HIV did not occur until last week—about 24 years after the FDA received its first application seeking permission to market one.

Apparently, for years, even decades, only tests of clinical options were allowed to proceed, basically because the government considers Americans to be infants:

There was great concern that the patient receive proper counseling, both before and after the test. The patient needed to appreciate the possibility of false positives, so he wouldn't panic unnecessarily if he got one. He needed to appreciate the danger of false negatives, so he wouldn't become reckless, endangering sexual partners. And he needed to understand the options and support groups available in the event he received a true positive. (On top of all these concerns, many AIDS activists at the time were opposed to almost any form of HIV testing out of fear that results could be used to ostracize and persecute HIV-positive people—though one hopes that public health concerns were paramount to the FDA, rather than political pressure and hysteria.)

Welcome to the Fight, Sort Of

After years of apparently being OK with California's absurd restrictions on development and crazy environmental laws that tied most everything new up in the courts for years, Kevin Drum suddenly thinks they may be flawed now that they are slowing development he likes (wind, solar, high density housing around transit stations).  Drum is a classic technocrat, who is OK with absolute state authority as long as the state is doing what he wants it to do.  I am reminded of what I wrote technocrats 7(!) years ago:

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.

Of Course, the Left Takes No Ownership for This

from Kevin Drum

Today, Aaron Carroll tells us the story of TriCor, aka fenofibrate, a cholesterol drug licensed by Abbott Labs in 1998. Unfortunately, TriCor's patent was due to run out in 2000 and a maker of generic drugs was all set to produce a generic version. So Abbott sued, which delayed the generic version by 30 months:

In the interim, Abbott sought and obtained FDA approval for Tricor-2. That drug was nothing more than a branded reformulation of Tricor-1.Tricor-1 came in 67-mg, 134-mg, and 200-mg capsules; Tricor-2 came in 54-mg and 160-mg tablets. No new trials involving Tricor-2 were submitted to the FDA. But Tricor-2 came out while the generic company was still waiting to make Tricor-1, and thus Tricor-2 began selling with no direct competition.

Six months later, Tricor-2 evidently accounted for 97% of all fenofibrate prescriptions. By the time the generic copies of Tricor-1 came out, no one was taking it anymore, and they couldn’t penetrate the market.

Wash, rinse, repeat. The generic companies petitioned to make generic Tricor-2. Abbott filed a patent infringement suit buying them a 30 month delay. They got to work on Tricor-3. That tablet came in 48-mg and 145-mg doses. No new studies. They got approval. Evidently, 70 days after Tricor-3 was introduced, 70% of users were switched to the new branded drug. By the time the other companies got generic Tricor-2 out, Tricor-3 had 96% of the market.

Apparently, the entire moral blame for this accrues to Abbott, though he admits maybe physicians have some culpability for never prescribing the generic.

Really?  I have no particular desire to defend serial rent-seekers like Abbott, but the farce here seems to be in the regulatory system where small changes in what is essentially the packaging size allow companies to protect a government-enforced monopoly for their product.  Given the enormous difference in earnings between a monopoly product and one with a generic competitor, it is no surprise that Abbott is going to react to these incentives and use the system as presented to it.  In fact, if it did not, its executives would be making a huge ethical lapse in failing in their fiduciary responsibilities.

If you really think this is a corporate greed problem, then why is it that Apple doesn't keep competitors out of the smartphone market by making tiny tweaks to the screen size of the iPhone.  Wait, you say, screen size changes don't act as a barrier to competition?  Of course not.  But then why do changes in capsule size for a given chemical compound?  Because of the involvement of the government.

No, the problem here is not Abbott, the problem is a broken government regulatory system.  And you can pretty much count on Drum and his allies responding to anyone who actually tries to initiate a reform by streamlining this craziness by screaming that they just want to kill people by relaxing government regulations.

Republicans are Just Like Democrats -- AZ Version.

As I mentioned the other day, I sometimes have this fantasy that we have some sort of libertarian streak in the Arizona Republican party.  The Goldwater Institute and Jeff Flake give me hope.  But then the Arizona legislature gets to work and my hopes are dashed.

A big national Republican issue is the excessive power Congress has delegated to the EPA and FDA to regulate and ban substances, from BPA to CO2.  So what do the Republicans do in AZ?  They propose a law to give an un-elected bureaucracy the power to willy nilly ban substances without a bit of legislative oversight.

The legislature had previously outlawed 30 chemicals that could be used to make the "bath salts"-type mixtures, and dropped another eight substances on the bill Governor Jan Brewer signed last month.

As Boca Raton Florida-based attorney Thomas Wright III told New Times shortly before Brewer signed the legislation, "To suggest they're putting a ban on bath salts is dumbing down the general public."

Republican state Senator Linda Gray is now explaining this to everyone, as she's proposed a new method to attempt banning "bath salts."

House Bill 2388 is the new hope, which would allow the state's Board of Pharmacy and the Department of Public Safety to ban the sales of chemical substances at their pleasure.

According to a Senate fact sheet, the pharmacy board "must make a formal finding that the chemical composition defined by the Board has a potential for abuse and submit the finding to DPS."

The pharmacy board then has to "consult" with DPS about its proposed rule, and that's that. The board just has to let the governor and the legislature know once a year which chemicals it's decided to ban.

So after all the concern about regulation voiced by Republicans about the EPA, they are giving even more sweeping powers to... the Board of Pharmacy and the Department of Public Safety?   This should be all the proof you need that the Coke and Pepsi party have equivalent authoritarian streaks.  As many other libertarians have observed, the Republicans have a healthy distrust of government, except when it comes to anyone such as the DPS or military that carries a gun, and then they are willing to hand over infinite trust and authority.

In many ways, this law is exactly like the environmental laws Republicans hate that require detailed analyses of potential harms but no counterveiling analysis of benefits.  In this case, the Pharmacy board is required to analyze the potential for abuse of chemicals but there is absolutely no language  requiring any consideration of the benefits of the substance's use or legality.  By the language of the law, if there is a potential for abuse, it must be banned no matter how otherwise useful the product is or could be.

OMG! Why Didn't We Fully Fund the Government Tiger-Catching Agency?

This via Q&O:

Earlier today, New York Times columnist Nick Kristoff opined on Twitter about cuts in government services. It’s not every day that you see such stupidity displayed so confidently…except from the Left:

Imagine John Boehner home in OH, seeing an escaped tiger–and getting a msg that help is unavailable due to govt cutbacks.

Well, I don’t know about John Boehner. But I do know that if I received such a message, it’d be because I was trying to call up a government flunky to haul a tiger carcass away. And if I did get such a message, my very next call would be to a good taxidermist.

It’s an interesting glimpse into the worldview though. The unspoken assumption is that, without government tiger hunters, we’re all doomed to be mauled by wild beasts. Presumably, this is because we are all tiny, little children, utterly incapable of solving our problems without the intervention of our benevolent government overlords. It’s a worldview that operates on the assumption that the government is the only adult in the room.

A great example of this sort of mentality was the Bruce Willis action filmLive Free or Die Hard.  The movie was a decent thriller, falling into the unlikely-buddy-movie genre (including also 48 Hours and most of the Lethal Weapon movies).

Like most modern techno-thrillers, it required a lot of technical suspension of belief, but what really struck me was the premise -- that somehow, if terrorists were able to really shut down the government, people would go into a panic and be totally lost and forlorn.  Even the strong male hero buys into the premise.  Can you even imagine a Clint Eastwood movie where Clint laments how scared Americans will be if they were to call the FDA to inquire if a certain product is truly organic and no one answered the phone?   It makes for a sort of irony in the movie because in fact the government is completely useless in the face of the terrorists, who are brought down essentially by a few private individuals.

Another Private-Public Contrast

This article on the FDA's propose to regulate medical-related iPhone apps got me thinking.   These bureaucrats are really like marketers in a company.  They are constantly coming up with growth ideas, though in the case of regulators it is ideas to growth the size and scope of their power, rather than sales, but the thought process is probably about the same.

Most new product ideas that come out of these brainstorming sessions in the private industry are a failure - they die in the conference room, or later in funding, or maybe later in the marketplace.  A few survive.  But at the end of the day, what matters is not how much the person who came up with the idea wants it to happen, it is whether the idea proves to be of value to the public.

Unfortunately, there is no such check on the regulatory sphere.  They come up with an idea to expand power, and they just run with it and make it happen.  In fact, general public opposition is generally interpreted by these folks as proof of concept - ie if people are against the new regulations, they must REALLY be necessary.

We would be better off if regulatory ideas were adopted at roughly the same rate that new products ideas are successful.

Regulatory Accumulation

There are certain regulatory agencies where it is clear from the outset that most of the agency's activity is merely aimed at protecting their own jobs and power.

The one such agency I run up against are Alcoholic Beverage Commissions in various states, from whom one must obtain a liquor license.  In the type of small store we run, there are really only two things the state should care about, and even the second is a bit weak

  • That we don't sell alcohol to underage kids
  • That we don't allow alcohol consumption on the premises

But the liquor licensing process can be interminable.  In Arizona, for example, I have had my applications kicked back to me, which resulted in 2-month delays in the process, because I wrote an address as 1313 48th Pl.  rather than 1313 48th Place.  They spend incredible man-hours looking for nit-picky mistakes like this, and then kick it back so that the whole review process must begin again.  Many states and counties have a second layer of review, to make sure that your new competition is "needed" - after all, we wouldn't want to upset the position of incumbent businesses who are entitled to their market share and who make nice campaign contributions.

Each application has to have a drawing of the store layout and where one plans to put the beer.  If you want to move the beer at a later date, you have to get the state's approval.  (Bizarrely, the drawing in most states has to be by hand -- they will kick back an application with a CAD drawing or architect's drawing).  And don't get me started on the fact I have to be finger-printed by the FBI (so they can be sure I am not Al Capone) before a store I own can sell beer.

All this being said -- and I didn't mean to run on so long but liquor licensing just drives me nuts -- it is nothing to this example from the pharmaceutical manufacturing business. I won't repeat it all, but take this example:

a drug manufacturer must get approval for how much of a drug it plans to produce, as well as the timeframe. If a shortage develops (because, say, the FDA shuts down a competitor’s plant), a drug manufacturer cannot increase its output of that drug without another round of approvals. Nor can it alter its timetable production (producing a shortage drug earlier than planned) without FDA approval.

They have to get their production schedules approved?  What possible justification can there be for this?  But even more outlandish is the apparent drive to regulate drugs that have been on the market for over 70 years and have to date been relatively unregulated because they were on the market before the FDA got its current powers.   Why should a bureaucrat lose her job when there are still unregulated items out there?  Besides, some uneducated American might use these examples of safe, unregulated drugs to question the who regulatory mission!

Several drug shortages (e.g., concentrated morphine sulfate solution, levothyroxine injection) have been precipitated by actual or anticipated action by the FDA as part of the Unapproved Drugs Initiative, which is designed to increase enforcement against drugs that lack FDA approval to be marketed in the United States. (These drugs are commonly called pre-1938 drugs, referring to their availability prior to passage of the Food, Drug, and Cosmetic Act of that year.) Some participants noted that the cost and complexity of completing a New Drug Application (NDA) for those unapproved drugs is a disincentive for entering or maintaining a market presence.

I have heard several medical people joke that it would be tough to get aspirin through the FDA today if it were a new drug and not grandfathered.  Don't know if that is true, but it feels believable.

Slowing Progress at the FDA

Econlog tells the story of how the FDA is blocking a drug for Restless Leg Syndrome because massive doses caused cancer in a few rats.  Millions of humans have taken the drug with no ill effect, but let a few rats dies, and the FDA refuses to approve it for a new use.

This reminded me of a story I meant to point out from the winter Olympics.  I think many people saw the US Bobsled team win the gold, piloted by Steve Holcomb.  Perhaps you heard the story of how Holcomb would have had to give up the sport several years ago due to a vision disorder until a new operation restored his sight.  But note the clause I have bolded:

Traditional corneal surgery would have left his eyes susceptible to damage from a jarring bobsled run. So last March he underwent a radical procedure, yet to be approved by the FDA, in which doctors implanted a lens behind each iris. When he woke from the surgery, Holcomb immediately noticed the detail of the palm trees in one of the posters on his doctor's wall. "An hour before, I didn't even know there were posters," he says. "It was a new world."

I wonder how many hoops he had to jump through to get the operation, and whether average people who are not on the Olympic team would have been able to get the same benefits.

Regulation as Incumbent Protection

This is a great example of a point I often make about regulation aiding incumbents and large companies against smaller companies and upstarts.  From the DC Examiner, via Radley Balko

Philip Morris, openly and without qualification, backs Kennedy's and Waxman's bills to heighten regulation of tobacco.

Philip Morris stands to benefit from this regulation in many ways. First, all regulation adds to overhead, and thus falls more heavily on smaller firms. Second, restrictions on advertising help Philip Morris' Marlboro, a brand everyone already knows, by keeping lesser-known brands in the shadows. (Existing restrictions on advertising have already helped Philip Morris in this regard, with an added benefit spelled out in Altria's annual report: "Marketing and selling expenses were lower, reflecting regulatory restrictions on advertising and promotion activities. "¦ ")

Finally, if the bill passes and the FDA gets added control over the industry, Philip Morris, more than any of its competitors, will have access to those bureaucrats and agency heads making the decisions. For all these reasons, RJ Reynolds and other tobacco companies oppose the bills Kennedy and Waxman are pushing.

Dangerous Until Proven Safe

I have been negligent in covering some of the nuttiness that is resulting from the CPSIA, the law last year passed in response to the Chinese toy recalls that allows greatly increased regulatory authority (requiring extensive testing of every lot, aircraft-manufacturing-like supply chain documentation, etc) over the entire toy distribution chain for certain perceived health threats like lead and pthalates.  Worse, the law provides enormous openings for third party groups to sue for ridiculous amounts of money over unproven health risks.  It is not clear to me a group suing under this law even needs to prove injury, but just some mythical small percentage chance of potential injury.

What all the targets of this law have in common are absurd overreactions to trivial risks of ingesting microscopic quantities of certain substances like lead.  Recently, a whole bunch of mini-bikes were taken off the market because 12-year-olds might suddenly start gnawing on the engine parts and ingest some lead.  For reasons that are not really clear to me, this country finds it impossible to rationally assess risks -- we have schools shut down with hazmat teams called out to clean up the mercury when someone drops a thermometer in the lab, while day after day the school probably serves fish in the cafeteria with higher mercury content than any kid would get from being near a broken thermometer.

Overlawyered has been all over this story, for example here.  The most recent episode came the other day when an EPA spokesman suggested that all libraries needed to pull books from the shelves printed before 1985 because there might be a billionth of a gram of lead in the ink:

It's been a day of dramatic developments on the CPSIA-and-libraries front. An Associated Press article out yesterday quoted Scott Wolfson, a spokesman for the Consumer Product Safety Commission (CPSC) as officially urging the nation's libraries to remove from their shelves children's books printed before 1986 until more is known about their possible dangers from lead in their inks, dyes and pigments:

Until the testing is done, the nation's more than 116,000 public and school libraries "should take steps to ensure that the children aren't accessing those books," Wolfson said. "Steps can be taken to put them in an area on hold until the Consumer Product Safety Commission can give further guidance."

Within the day, however, commission chief of staff Joe Martyak said that Wolfson had "misspoke", and that the commission has neither concluded that the books might be dangerous nor recommended that libraries take any action. An early version of the AP story is here, with the Wolfson quote, and a later version here, for purposes of comparison.

It's not as if Wolfson was making things up here. As readers will recall, one of the two CPSC commissioners, Thomas Moore, called weeks ago for some undefinedly large share of old books to be "sequestered" from children for the time being. However, the full commission has left the issue up in the air rather than endorsing Moore's view.

It Sucks to be a Woman

This weekend, I had a conversation with a group of people about the upcoming election.  As is typical in a fairly diverse group, at least one woman said that she was voting for Obama to protect "women's rights."  When pressed, this seemed to boil down to support for abortion rights. 

Boy, I am sure glad that I am a man, where my rights are not narrowly defined around the availability of a single out-patient surgical procedure.  I get to define my rights to include free speech, commerce, property, gun ownership, immunity from arbitrary search and seizure, and habeus corpus.  Even in the narrow world of medical care, I can aspire broadly to rights such as the ability to use medications not necessarily labeled safe and effective by the FDA, the ability to contract for whatever procedures I want even if the government is not willing to pay for them, and the abilty ride my motorcycle with or without a helmet as long as I am willing to bear the cost and consequences of my actions.

I will confess that this broader view of my rights makes voting more difficult, as neither the Coke nor the Pepsi party consistently protects my rights defined this broadly.

Chanelling Milton Friedman

For years I have tried to find the right words to express my frustration with the notion that the problems encountered with government planning and technocratic meddling was merely the fault of having the wrong humans in charge, rather than of the system itself.  For example. I wrote:

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.

Well, it turns out that Milton Friedman said it better decades ago.  Megan Mcardle reminded me of this passage from Free to Choose:

The error of believing that the behavior of the social organism can be
shaped at will is widespread. It is the fundamental error of most
so-called reformers. It explains why they so often feel that the fault
lies in the man, not the "system"; that the way to solve problems is to
"turn the rascals out" and put well-meaning people in charge. It
explains why their reforms, when ostensibly achieved, so often go
astray.

Meet the New Boss

I am reading a fabulous book called "The Rise and Fall of Society" by Frank Chodorov.  It was apparently first published in 1959 and has been republished recently by the Mises Institute.  Here is an early bit I particularly liked:

One indication of how far the integration [between state and society] has gone is the disappearance of any discussion of the State qua State -- a discussion that engaged the best minds of the eighteenth and nineteenth centuries.  The inadequacies of a particular regime, or its personnel, are under constant attack, but there is no faultfinding with the institution itself.  The State is all right, by common agreement, and it would work perfectly well if the "right" people were at its helm.

His next line is clearly aimed at his conservative contemporaries

It does not occur to most critics of the New Deal that all its deficiencies are inherent in any State, under anybody's guidance, or that when the political establishment garners enough power a demagogue will sprout.

I offered up similar observations here, though aimed at the left, who at the time were the minority opposition party:

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.

Libertarian Plea to the Left

My Princeton college roommate Brink Lindsey, now of Cato, has been raising a moderate rumpus by arguing that the traditional libertarian-Right coalition is stale and that libertarians should look for allies on the left as well.  He called it liberaltarianism.  Fair enough.   I will take a shot at the same plea.

I will use this map of the teaching of evolution in schools by state as a jumping off point.  I can't validate whether it is accurate or not, so I won't reproduce it here, but let's accept it as a fair representation of the diversity of approach to teaching evolution by state, even if you don't agree with the implicit value judgments embedded in the chart.  I will use it to reflect on two points I have made in the past to try to interest the left in libertarianism.

1.  Building complex machinery of state may feel good at first, when "your guys" are in control, but your opposition, or outright knaves, will eventually co-opt the system. As I wrote here:

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.... 

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.

2.  As public school boards come under sway of the Christian Right, the left should learn to embrace school choice, just as the Christian Right did a generation ago.  As I wrote here:

After the last election, the Left is increasingly worried that red
state religious beliefs may creep back into public school, as evidenced
in part by this Kevin Drum post on creationism.
My sense is that you can find strange things going on in schools of
every political stripe, from Bible-based creationism to inappropriate environmental advocacy.
I personally would not send my kids to a school that taught creationism
nor would I send them to a school that had 7-year-olds protesting
outside of a Manhattan bank.

At the end of the day, one-size-fits-all public schools are never
going to be able to satisfy everyone on this type thing, as it is
impossible to educate kids in a values-neutral way.  Statist parents
object to too much positive material on the founding fathers and the
Constitution.  Secular parents object to mentions of God and
overly-positive descriptions of religion in history.  Religious parents
object to secularized science and sex education.  Free market parents
object to enforced environmental activism and statist economics.   Some
parents want no grades and an emphasis on feeling good and self-esteem,
while others want tough grading and tough feedback when kids aren't
learning what they are supposed to.

I have always thought that these "softer" issues, rather than just
test scores and class sizes, were the real "killer-app" that might one
day drive acceptance of school choice in this country.  Certainly
increases in home-schooling rates have been driven as much by these
softer values-related issues (mainly to date from the Right) than by
just the three R's.

So here is my invitation to the Left: come over to the dark side.
Reconsider your historic opposition to school choice.  I'm not talking
about rolling back government spending or government commitment to
funding education for all.  I am talking about allowing parents to use
that money that government spends on their behalf at the school of
their choice.  Parents want their kids to learn creationism - fine,
they can find a school for that.  Parents want a strict, secular focus
on basic skills - fine, another school for that.  Parents want their
kids to spend time learning the three R's while also learning to love
nature and protect the environment - fine, do it.

Yes, I know, private schools to fit all these niches don't exist
today.   However, given a few years of parents running around with
$7000 vouchers in their hands, they will.  Yes, there will be
problems.  Some schools will fail, some will be bad, some with be
spectacular (though most will be better than what many urban kids,
particularly blacks, have today).   Some current public schools will
revitalize themselves in the face of competition, others will not. It
may take decades for a new system to emerge, but the Left used to be
the ones with the big, long-term visions.  The ultimate outcome,
though, could be beautiful.  And the end state will be better if the
Left, with its deep respect and support of publicly-funded education,
is a part of the process.

Of course, there is one caveat that trips up both the Left and the
Right:  To accept school choice, you have to be willing to accept that
some parents will choose to educate their kids in a way you do not
agree with, with science you do not necessarily accept, and with values
that you do not hold.  If your response is, fine, as long as my kids
can get the kind of education I want them to, then consider school
choice.  However, if your response is that this is not just about your
kids, this is about other people choosing to teach their
kids in ways you don't agree with, then you are in truth seeking a
collectivist (or fascist I guess, depending on your side of the aisle)
indoctrination system.  Often I find that phrases like "shared public
school experience" in the choice debate really are code words for
retaining such indoctrination.

In other words, are you OK if Bob Jones high school or Adam Smith
high school exist, as long as Greenpeace high school exists as well?
Or do you want to make everyone go to Greenpeace high school
exclusively?

Should Juries Be Able to Ban Products?

I have written on this before on the context of Vioxx, but is it really rational public policy to have juries be allowed to effectively ban products, products that both legislatures and regulatory bodies have explicitly or implicitly deemed as legal?  Ted Frank takes this on at Overlawyered in a nice follow-up post on a $31 million jury verdict against Ford:

SUVs are designed to have high clearance to traverse rugged terrain.
This raises the center of gravity and affects the handling: it's a
known tradeoff of the laws of physics. There are a wide variety of
tests of varying degrees of scientific merit one can use to suggest a
vehicle is "too prone" to roll over, and plaintiffs have the benefit of
cherry-picking which tests to apply to which vehicles. You'll find lots
of lawyers complaining that the Bronco II allegedly responded poorly in
"J-turn tests", where the steering wheel is turned 330 degrees in one
third of a second and held there for another 4.67 seconds. Ford
designed the Explorer to pass the J-turn test to take away this claim,
and the trial lawyers started using different methodologies to claim
that the Explorer was too prone to roll over.

Empirically, however, the Bronco doesn't roll over more than several
other SUVs on the market, which is why NHTSA, in both the Bush I and
Clinton administrations, refused to recall the Bronco when the
plaintiffs' bar asked it to. When I say Ford was held liable for
producing an SUV, I'm not spinning: it was because it was held liable
for producing an SUV.

Moreover, a vehicle should be viewed in totality: an auto that is
more likely to roll over may be safer in other particulars that more
than compensate for that increased propensity. So I question the
premise. One can't change the rollover propensity without creating a
different vehicle entirely. The vehicle should be viewed holistically,
and holistically, the Bronco is a safe car when used as designed.

Perhaps we as a society would be better off taking the nanny-state
step of banning SUVs, forbidding people from wildnerness driving
because too many drivers don't know how to drive SUVs in highway
conditions, but that's a decision that not only would end the American
auto industry, but should be made other than by a 12-person jury of
laypeople. This vehicle rolled over because the driver drove off the
road.

I had similar thoughts about the Vioxx cases:

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....

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?

Alex Tabarrok at Marginal Revolution said it even more succinctly:

How did we arrive at a system in which 12 random Texans are assigned
responsibility for evaluating the scientific merits of statistical evidence of
this type, weighing the costs and benefits, and potentially
sending
a productive blue-chip American company into bankruptcy protection?

The Statist Trap

David Boaz of Cato makes this comment in the context of an article on suppressing speech in modern South Africa:

In the last days of apartheid, some libertarians pointed out to South
Africa's rulers that if they left a government broadcasting operation
in place, they would one day regret the way a different government
would use it. Looks like that day has come.

This is a point I make time and time again.  When statists push their policies, it is always with the assumption that they themselves will be in control of the government machinery they create.  In contrast, the miracle of the US Constitution was that the government was constituted with the assumption that rogues and scoundrels would take control, and the founders put protections in place to limit the damage these scoundrels could do to our individual liberties.

As I said previously
:

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.

As I concluded before, even Star Trek figured out this whole technocrat losing control of the fascist state thing 40 years ago.

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
fail?"

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
and
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
resources.

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
rocks.

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
IX.

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