At first glance this seems to be a truly stupid question. After all it’s bad when people die early. Isn’t it? Well, I certainly don’t want to die and neither do most people but that misses the point. We all die eventually and even if we personally want to put off death as long as possible can we truly say that a society where the average life span is 90 years rather than 70 is a better place? Would a society where the average life span was 200 years be even better? What sort of life span would be optimal?

It’s tempting to answer ‘infinite’ and certainly it would be wonderful if we could all retain our youth for forever and never have to grieve over lost friends and family. However, for the immediate future this simply isn’t possible. No healthy diet or prudent lifestyle can reduce the (average) number of friends we must mourn¹ and no amount of yoga or wheatgrass smoothies can prevent old age from taking it’s toll. Moreover, suppose we really could increase our lifespan indefinitely. At least for the next century or so we would have to virtually stop reproducing to avoid outgrowing our resources.

Ultimately we can’t simply say ‘life is good so we want more of it.’ Almost certainly such a policy would actually demand we divert money from healthcare into programs encouraging reproduction. As a society we’ve already reached the conclusion that it’s better to maintain a relatively small population that can live well than to expand into a great multitude that can barely make do. But rationally applying this insight to this question suggests that investing in longer life spans might not make sense.

Certainly we feel greater pain when someone is snatched from life too early and so we certainly shouldn’t stop pursuing more effective treatments to save people who might otherwise be struck down in the prime of life. Nor would we want to create distress or anger by denying people treatment. However, researching ways to further prolong our life span would likely introduce greater variability (some people die of heart attacks at 65 others make it to 130) and thus prolong the time people would have to endure the loss of loved ones as well as the sense of tragedy and anger at their deaths. Other things being equal a society is better if people spend a smaller proportion of their lives old and frail and since extending old age is unlikely to make people substantially happier (on average²) investing in technologies to lengthen our lifespan seems counterproductive. Of course we should look for technologies that let people be healthy and fit for a greater fraction of their lives and if we are able to make 80 feel like 55 that might justify more investment in keeping people alive till 80.

The observation that merely putting off death is not necessarily a desirable end in and of itself also has substantial consequences to what kind of charity and aid is best to give to the third world. However, that will have to wait for another post.

Now there are real concerns that ought to be addressed by regulation. Any at home genetic test should be regulated to guard against fraudulent misinformation or scientifically unsupported medical advice. They should also be regulated to ensure that they give accurate results and report the chance of type I and type II error to the test taker. However, it seems self-evident to me that as citizens in a free country we ought to have the right to any information about our own genetic profile we wish to receive. So long as the test manufacturer does nothing besides inform the customer of what genetic variants they possess and what the current research suggests about these variants they should have the right to supply us that test.

The doctors on the program raised the valid concerns that people might very well not know how to react to the type of genetic information they receive. For instance they implied that individuals might be better off not being told they have a gene that boosts their change of cancer by 1.2 times since people have trouble understanding what a small effect this is and may then demand extra tests that increase their risk and burden the medical system. Well perhaps these individuals would be better off not knowing this information but is that valid grounds to legally deny it to them? I think not. The doctors kept insisting that we needed studies to determine what information improved public health and what didn’t which is important but in terms of regulation misses the broader point that public policy has broader goals than maximizing public health.

No doubt public health would increase if restaurants and supermarkets were only allowed to sell us food that our doctors approved but obviously we should have the right to buy the food of our choice. The fact that people generally have a poor understanding of the effect of food choice on their health is irrelevant. In the long term we tend to find that the harms to innovation, frustration at being told what to do, and the slippery slope towards further regulation that result from the restriction of freedom are worse than the more obvious immediate harms. In other words if our society believes freedom is so important that we protect racist and bigoted speech then surely we ought not to restrict people’s access to their own genetic information just because they might not understand it.

If I want to find out if I have gene BLAH I should have the legal right to do so and so long as the company offering me the test for this gene doesn’t misrepresent our certainty about the role of BLAH they should have the right to offer me such a test. Of course doctors should be free to discourage us from using such tests just as they are free to discourage us from using tobacco or eating junk food but the law shouldn’t require us to do what our doctor asks. So long as doctors don’t drag their feet on incorporating genetic information into their practices as quickly as the science allows I expect the percentage of people who insist on ignoring their doctor’s advice will remain quite low. Ultimately though, the right to obtain information about our own genetic makeup is so central to our freedom and liberty that nothing short of a plague level public health catastrophe would justify denying this freedom.

Hopefully I merely misinterpreted the doctors on this show and they weren’t proposing that we bar companies from offering genetic information unless it offers a net public health benefit. However, doctors are people too and it’s very easy for people to get caught up in their personal mission (especially when it’s something noble like serving the public health) and forget that this isn’t the only, or even primary, aim of public policy. Of course if you are a doctor and you see people coming into your office with information from genetic tests that you don’t know how to properly interpret and demanding what are likely harmful procedures your likely to want to clamp down on these tests. It’s a natural human reaction to want to control things that interfere with our mission but that just isn’t how we should handle them in a free society.

What I’m talking about is the article in the East Bay Express on the Gardasil vaccine for HPV (thus cervical cancer) titled “One Less“. True, the article describes the ‘controversy’ about the Gardasil vaccine’s deadly side effects for HPV (thus Cervical cancer) without article asserts nothing factually untrue. I don’t doubt the mother of the girl who died as the result of blod clots shortly after taking the vaccine really said the quotes attributed to her nor that the semi-anonymous remarks really do come from someone who had the shots. However, the whole article is set up to portray these as reasonable fears that are on one side of a ‘growing debate’ while plastering a picture of a sweet little 17 year old who died after taking the vaccine on the front of the print magazine with the “One Less” slogan of Gardasil written over it.

I mean the arguments for the involvement of Gardasil are really this bad:

“Some are pretty hard to discount as being a reaction,” Grothe said. “When a patient dies of a blood clot three hours after getting a Gardasil vaccination, that’s pretty consistent to me.”

Of course all the medical professionals interviewed point out that the birth control pills being taken by the girls who died are likely the cause but that doesn’t stop the article from throwing logic overboard to pander to the emotions of a grieving mother and friends or by mixing in real concerns and disadvantages of the vaccine as if they were concessions. Of course even if you grant that the vaccine is as horrible as the grieving mother trying to blame it claims it is hard to see how the harms would overwhelm the 4,000 deaths it could save a year not to mention the suffering it could erase.

Given that newspaper articles like this generate readers and likely convince people not to take the vaccine I have grave doubts about the ability of jurors to evaluate expert testimony in drug and medical device trials.

As one might have guessed there has been an onslaught of editorials and letters to the editor acusing Bush of pandering to the insurance industry, putting a narrow ideology over the health of our children and otherwise just being an all around bad guy who doesn’t care about our kids. Despite my distaste for fox news they had the only story I found that explained the administration’s position that this is really an attempt by the states to get “the federal government to bear the brunt of expanded health coverage and then call it progress.”

Now I tend to favor something like national health care¹ and I agree and sympathize with the point that, “people are fed up with a system full of potholes and twists and turns in coverage along with control issues that make patients mere pawns in the game.” However, SCHIP is hardly a universal solution that gets rid of potholes and twists and hopefully no one is dumb enough to try and expand a stop-gap solution for poor kids to everyone instead of implementing a well architected nationwide plan². Yes it’s wonderful that there has been “a heartwarming drop in the number of uninsured children,” and I don’t think we ought to reverse this trend but none of this shows that the feds ought to pay for some states to insure higher income children.

In this case at least the Bush administration is totally correct. Nothing prevents states from choosing to insure children above 2.5 times the federal poverty line and unlike a true national solution to the health care problem I can’t make out any economies of scale that would make this more efficient on the federal level. I might feel better about this program if it was poor states that were receiving the wavers to extend the federal program but it is states like New York, New Jersey and California who seem particularly eager to extend the coverage to higher incomes. These states argue that cost of living varies by area so children who should really count as poor may be well above the federal poverty line. That may be true but those states where the cost of living is high are also those states with the most money.

Now I think one could criticize the choice of 95 as the percentage of children below twice the poverty line who must be enrolled before the feds will chip in for insured children about 2.5 times the poverty line but at least this policy strongly incentivizes states to guarantee that poor children are actually covered. The fact that 30% of those eligible are not enrolled may show that 95% is an unrealistic goal but it also makes a strong case for conditioning greater support for better off kids on greater enrollment of the poor. I’m open to the argument that congress should extend this program to 3 or 4 times the poverty line for every state who enrolls some (perhaps more reasonable) target percent of the most needy children if only to incentivize the more reluctant states to provide this benefit. However, cutting off an exception program whose primary effect seems to be to transferring money from poor states to rich ones hardly makes one a monster.

Basically I find it really annoying when politicians use this kind of save the children rhetoric to disguise their own unwillingness to do the same. If Bush’s goes through the states could just raise their own damn taxes and fund it if they really think it is important. Spitzer in particular will show himself to be a huge hypocrite if he doesn’t have the balls to suggest the state pay for this insurance after his rhetoric against Bush. I’m already pretty annoyed at him for linking Bush’s failure to spend on this insurance policy to the war. Bush may have been totally fucking incompetent about getting us into war but we are their now and his belief that pulling out now would just make things worse is hardly unreasonable. Spitzer may disagree with Bush about the wisdom of staying in Iraq but suggesting Bush is being extra unreasonable because he thinks that hundreds of thousands (maybe millions) of Iraqi lives are more important than insuring some more kids in the states annoys me. In any case whatever you think about the particular arguments here it’s pretty obvious that this sort of ‘Save The Children’ rhetoric is hardly a good way to decide policy.

The more I see in politics the more I think those studies (can’t remember where I read them) suggesting that the benefits of government aid flow primarily to the middle class are right on the money. I mean there is a fuckton more we could do for the genuinely poor kids and those potential programs trade off against money we might spend on these less poor children but which one are people clamoring for? God I hate democracy.

Now without being able to find a copy of the analysis I can’t opine about their methodology, in particular what costs we would expect other pleasures to chalk up under this sort of analysis. In general I think studies like this without the analysis are pretty useless.

However, even without reading the study it is pretty clear it is downright misleading. Buried in the fact sheet is the remark, “Note the costs included here do not reflect the social or economic costs to society as a whole. For instance, the cost figures do not include any costs or cost savings to the government through social insurance programs.” In other words this report doesn’t include any savings due to early death leading to shortened social security/pension benefits. Additionally it seems clear from the fact sheet that only cost increases in smoking related diseases are included not the cost savings as a result of smokers dieing and not needing end of life care.

In effect this means that if secondhand smoking causes a terminal cancer patient to die after a $1000 dollars of treatment for pneumonia rather than requiring $101,000 dollars of terminal care this is counted as a $1000 dollar cost for secondhand smoke rather than a $100,000 dollar savings. Additionally it counts against secondhand smoke every day someone doesn’t work because of the effects of secondhand smoke but doesn’t credit secondhand smoke with every day people don’t need to work to fund retirement plans for people who die early. It’s like evaluating the costs of a life saving drug and only counting the costs of the side effects and not counting the benefits of the longer life. Interestingly I seem to remember the economist doing a calculation for smoking that included the early death factors and it came up with a pretty small number for the cost of smoking itself.

I suspect this sort of study is never questioned as it seems cold to complain about not counting the savings from death. However, if you have a problem with coldly adding up these costs you shouldn’t be in the business of trying to add up the costs. Certainly you shouldn’t be advertising your study as a tool for policy makers to judge the costs to society. But what disgusts me the most about this sort of thing is that no one would ever make this sort of mistake about say driving cars or any risky activity that is socially approved.

Nearly half of the people responding to an online survey about obesity said they would give up a year of their life rather than be fat, according to a study by the Rudd Center for Food Policy and Obesity at Yale.

The 4,000 respondents in varying numbers between 15% and 30% also said they would rather walk away from their marriage, give up the possibility of having children, be depressed, or become alcoholic rather than be obese. Five percent and four percent, respectively, said they would rather lose a limb or be blind than be overweight.

On reflection I guess I would give up a year of my life if it was a choice between that and being grossly obese (though I would give up a year of my life for a lot of things). I might even prefer giving up a limb or going blind than being really overweight. I mean people missing a limb or who can’t see simply don’t generate the same sort of social disgust that overweight people do and it is difficult to overestimate how horrible that sort of rejection and disgust can be.

I suspect the bit about depression just reflects the difficulty in comparing abstract badness to a concrete bad situation (surely people only want not to be obese to make like more worthwhile). However, this sort of result does suggest serious changes in how we treat obesity. While medically serious obesity is treated often lesser forms of obesity are regarded as merely cosmetic concerns or not really important. However, it doesn’t matter if they are merely cosmetic concerns. If people would rather lose a limb than be obese then we should treat obesity with the same vigor and tolerate the same risks as we would an infection that threatens to destroy a limb.

We have drugs (stimulants among other things) that will treat obesity. These drugs do carry serious risks but we would hand them out without question if they would save someone’s arm and probably hand them out to extend life for a year. Hell, we hand them out just to treat ADD. Thus if it is really worse for people to be obese than to lose an arm or a year of their life then we are just being cruel by insisting this isn’t a serious enough concern to warrant the risks.

Of course it would be better if society didn’t make life so difficult for people who are obese. However, this is not within the power of medicine to change. It is just a fact that even cosmetic obesity has grave psychological consequences, consequences so bad that many people would prefer physical injury. Thus our medical practice should treat obesity as if it was just as serious as these physical ailments.

All the suffering that happens in our modern world that we could prevent if only we didn’t righteously insist that mental/social/cosmetic issues aren’t serious makes me furious. It is unfair to blame the medical profession for this, they are just taking their lead from social attitudes at large. However, it is possible for the medical community to get out in front of this issue and change attitudes thereby eliminating much pain.

I’m inclined to think that the result (allowing doctor assisted suicide in Oregon) is positive. While their are some coherent concerns about the effect on medical practice and doctor-patient relationships of allowing doctors to end life as well as preserve it I actually think the effects would be positive. Indeed, the very perception that just because a life is ended instead of saved assisted suicide is in tension with the a doctors role as a healer or the hippocratic injunction to “do no harm” is reason to believe that medicine suffers from overly simplistic notions of harm/healing and could do with a reminder that the ultimate aim of medicine is to alleviate suffering and improve the human condition. As an aside the common argument that doctors should repudiate assisted suicide in order to comply with the hippocratic oath is just absurd. Not only is this a brute appeal to the minority viewpoint of a small ancient sect but the original oath is obviously inapplicable to modern medical practice (abortion is proscribed, nepotism demanded). As a consequence there is no one hippocratic oath sworn by modern doctors, instead each medical school chooses each own version many of which avoid the controversial prohibitions. However, a full discussion of the consequences of physician assisted suicide will have to wait for another post. Here I want to focus on the legal question.

My motivation in writing about this decision is to correct some common misconceptions on the left (though this link is just the best argument I found on point not someone on the left) about the hypocrisy of Scalia and Thomas in voting to uphold such an obvious federal invasion of state’s rights and illustrate the danger of evaluating the justices and courts with only casual knowledge. I myself fell into this trap when I first heard about the decision in this case. Aware of Scalia’s strong record on state’s rights surpassed only by Thomas’s I was convinced that Scalia’s intellectual integrity had become a victim of his catholicism and that Thomas had also been unduly influenced by personal values. Having found my first impressions radically in error before, and generally (but not always) impressed with Scalia’s arguments (though not his assumptions) I actually went and read the opinion and dissents. Having seen the arguments and issues I find my opinion has changed radically. I now think that Thomas’s dissent was right on target and Scalia’s dissent was required by his judicial philosophy. Lest this seem like too much of a Scalia love fest I want to point out that I have serious doubts about his ability to consistently justify his concurrence (scroll down) in Raich and I am beginning to suspect that Scalia’s focus on the text of statute inadvertently encourages personal bias to sneak in through the choice of definition.

The real problem behind all of this is the decision in Raich. As Thomas points out in his dissent there just isn’t any principled way to distinguish this case and Raich (he is basically saying I told you Raich was a bad decision see what it entails). Despite all the distracting issues the real issue underlying Raich is whether or not the federal government has the power to deem a type of treatment supported by respectable medical organizations and states doesn’t count as a valid medical treatment. The reason there was a conflict between state law and federal law in Raich was not because the federal government deemed marijuana so dangerous that even legitimate medical purposes could not be tolerated. The CSA does not permit that sort of prohibition. The conflict existed only because the government deemed marijuana to both, have no currently accepted medical use in treatment in the US and lack accepted safety for use under medical supervision. While the exact wording may be different this is essentially the same issue at play in Gonzales v. Oregon: does the CSA give the federal government the power to override state judgments about the legitimate use of controlled substances?

Any attempt to argue that it would be unconstitutional to ban assisted suicide also runs directly into Raich (hence the reason this wasn’t really argued). Sure one could argue that congress is seeking to regulate the interstate commerce in marijuana and banning the intrastate use of marijuana is sufficiently related to this end to qualify but this would be mere sophistry. It is plainly obvious that the congress wanted to prevent the use of drugs and the interstate market in drugs was merely a vehicle which let them achieve that end. If one wants to interpret the commerce clause so broadly that the mere connection of the activity to interstate congress is enough to warrant regulation that is fine but the same argument now applies here. The intent of the CSA was to limit the interstate market in controlled substances to those going to legitimate medical purposes and to accomplish this interstate regulation it is necessary to ban the entirely intrastate activity of assisted suicide. Quite simply the court choose to give congress essentially unfettered power to regulate items which are sold on an interstate market and controlled drugs are such an item. I believe the court should distinguish genuine

Basically I think there is more than enough blame to go around on these cases about drug law. The conservative justices should be striking down federal drug laws on federalism grounds and liberal justices should be obligated to uphold a right to drug use for the same reasons they supposedly favor Roe (privacy, right to control your body). However, before one blames anyone remember that the supreme court is in a political bind. It just isn’t politically feasible for a court to dismantle federal drug prohibitions but as their primary intent is to combat an entierly intrastate activity (drug use) not regulate commerce in drugs even a moderate approach to federalism that sought to restrict congress’s intrastate power to just that which is necessery to genuienly regulate commerce or interstate transport would be forced to strike them down.

Ultimately though I think all the opinions in this case are defensible. The majority is right that congress probably did intend the CSA only to infringe on state roles only in regulating drug ‘abuse’ where abuse is not just any misuse but the thing that heroin addicts, steroid users etc.. all have in common. I’m unsure if this is a valid distinction for the court to make as ‘abuse’ in this sense is a moral judgement but it is certainly a reasonable position. However, this is not a deciscion that someone like Scalia with his focus on the text of the statute could consistantly support.

Below I will go into the actual arguments in the decision and explain why the situation is alot more complicated than a quick look would suggest.

UPDATE: Clarified that link is just to someone making the argument that Scalia and Thomas are betraying their federalist principles in this case not someone on the left themselves. The better criticisms usually come from your own side, at least that is what I want to believe given all the liberal arguments I try to repudiate here. In order to understand the opinion in this case it is necessary to understand that the case was primarily about interpretation of statute not the constitutionality of the statute and all the justices reached their conclusions on these grounds. As the respondents (Oregon) did not dispute the ruling in Raich the substantive constitutional issues weren’t really on the table. Rather the dispute centered mostly on whether assisted suicide constituted legitimate medical purpose and the technical issue of whether the attorney general’s interpretation of this term was entitled to the deference a agency’s interpretation normally receives when interpreting its own regulations or establishing statutes.

Pseudo-Constitutional issues do sneak into the case. The majorities most compelling argument (in my opinion) is that congress does not “hide mountains in mole hills,” e.g., congress does not usurp traditional state roles or implicate constitutional issues in subtle or ambiguous ways. In fact in this case the law in question (CSA) specifically says it does not preempt state regulation unless their is a positive conflict. Initially these were the considerations which I found convincing but it seems totally reasonable to say that the CSA was quite explicitly regulating the appropriate use of controlled substances and this is merely a quibble about how the government is regulating that use. In other words this situation is similar to a hypothetical case where the government has passed laws granting special protection from discrimination to blacks, usurping traditional state regulation of employment, and the EEC issues an interpretation declaring people who are half black still fall under the regulation. The mere fact that the EEC’s interpretation enlarges the class of situations where a traditionally state function is usurped surely is not sufficient to reject the interpretation because there was no clear statement by congress. In fact the court’s own words in Raich suggest that the restriction of prescriptions to legitimate medical purposes is a core part of the CSA.

[The CSA was] enacted with the main objectives of combating drug use and controlling the legitimate and illegitimate traffic in controlled substances, the CSA creates a comprehensive, closed regulatory regime criminalizing the unauthorized manufacture, distribution, dispensing, and possession of substances classified in any of the act’s five categories.

Indeed the court has previously deemed it to be within the government’s power to prohibit doctors from prescribing drugs to maintain an addict by deeming it not a legitimate medical purpose. Since this sort of medical usage is supported by many doctors (and indeed is done at methadone clinics) it is clear that the federal government has some authority to decide what constitutes a legitimate medical purpose. The majority tries to distinguish the current case from that of maintaining an addict by suggesting the CSA is focused on combatting addiction and recreational abuse. However, Scalia shrewdly points out that such an interpretation could not support the restrictions on steroids.

As I said above I’m inclined to agree with the majority that congress did not intend to be usurping state power in situations like assisted suicide. However, I think it obviously did intend the CSA to be broad enough to include things like steroid use. The problem is that the class of things which congress probably intended to include seems to be defined by nothing but a moral reaction, e.g., impermissible enjoyment/benefit. Most people, even those who violently oppose assisted suicide, don’t seem to think it is ‘abuse’ in the same sense as using heroin, steroids or trying acid is abuse. I’m uncertain if this kind of intent is a valid subject of analysis by the court. On the one hand we do expect courts to interpret essentially moral words like “cruel” but on the other we would not approve if they started carving out statutory exceptions because congress only intended to punish ‘bad’ behavior of a certain type. Moreover, analysis of this kind can’t provide any bright line distinctions and seems inevitable to draw the justices personal moral beliefs into the deciscion, e.g., is smoking weed because it alleviates your impression ‘abuse’ or not? I think it would be my general inclination to ignore congressional intent which can only be cached out in terms of moral judgement unless it is specifically mentioned in the text but it does seem somewhat perverse to apply that principle so a federal statute restricts more freedoms than intended. In any case it is a complicated unclear area where both sides of the argument are reasonable. Certainly Scalia with his aversion to legislative intent couldn’t be expected to make this distinction so, at least in this case, I think it is wrong to critisize his consistancy. Raich, on the other hand, is another matter.

This sort of governmental usurpation of private decision making is antithetical to a free society but it might be tolerable if it never banned drugs which benefited significant populations. Unfortunately the current situation which either labels a drug as safe — and thus legal for doctors to prescribe off label for any condition regardless of severity — or unsafe virtually guarantees many people are denied drugs which might be beneficial and others feel a false sense of safety about drugs which are on the whole detrimental for them. Quite simply what is an acceptable risk for someone facing death or severe disability just isn’t the same thing as acceptable risk for someone merely avoiding inconvenience. Though the FDA is charged with deciding whether the particular use in question is safe and effective in practice their decision will dictate whether the drug is viewed as safe or unsafe. For instance though anti-psychotics are clearly worthwhile treatments for those with psychosis the binary decision of the FDA to allow their prescription has lead to many doctors prescribing drugs with serious risks of brain damage and death for things as minor as overly aggressive children.

If the FDA really did approve drugs so long as for some group the benefits outweighed the risks we might address the perception of safety FDA approval gives with better physician education. Unfortunately the pragmatics of politics forces the FDA to totally ban drugs which offer real benefits to some patients lest off label or otherwise inappropriate prescriptions give the impression the FDA isn’t adequately protecting public safety. This effect is particularly visible in the recent Vioxx scandal. Certainly the drug was over-prescribed and Merck should be held liable if they withheld important safety information but in fact the risk from Vioxx isn’t that large increasing risk of a heart attack by at most 1 in 100 and this is at the higher end of dosage. While many patients were merely taking Vioxx as a ’safer’ replacement for NSAIDs other people like my mother really found that Vioxx alleviated pain other drugs did not treat. Many of these people feel that their improved quality of life is worth the risk (a risk which is likely lower than their risk from their daily commute) but the FDA is politically obligated to ban Vioxx to protect their (misleading) reputation of only approving safe drugs.

I don’t mean to criticize the FDA. Ultimately they are placed in a totally untenable position. Given the prevalence of off label use and the inherently binary nature of the FDA’s decisions it is inevitable that the public will view FDA approval as an endorsement of the drug as safe. However, one can’t apply the same standard of safety for cancer as one does for hair-loss medication forcing the FDA in practice to balance the various likely uses. Even if the FDA could approve medication only for particular conditions there is the fundamental problem that what is a worthwhile risk for one person may not be for another. For instance faced with the prospect of Alzheimers I would gladly take a drug with a 10% chance of warding off mental decay even if half the people who took it died while my girlfriend would probably be reluctant to take a drug with a 90% chance of success with a 10% chance of death. These decisions can only be reasonably made by the individual in question and a binary governmental approval process interferes with this process. Of course we don’t want to go back to the era of patent medicines or allow new age healers to feed arbitrary ‘natural’ products to gullible patients but below I will offer a suggestions about how we can avoid these consequences will reforming the FDA. Our above analysis illustrated two key problems with the current situations: the false perception that some drugs are safe and others unsafe a binary government approval process creates and the inability of those whose risk/benefit calculation significantly differs from the governments to make informed decisions to take unapproved drugs anyway. The primary danger we need to avoid is allowing quacks, internet rumors or just ignorant doctors from convincing patients into making uninformed choices to take dangerous medications. Luckily I think we can address all these concerns at once.

What I propose is a two-tier drug approval process. As soon as a drug progresses to human trials the FDA would certify the manufacture process of that drug as meeting certain quality control standards (this should already be done to ensure good data from human trials). The FDA would also produce a short fact sheet about the drug summarizing the risks and benefits predicted from animal trials combined with a degree of certainty in these predictions written in plain english. This fact sheet would be updated after each human trial and would be maintained even after the drug had been approved. Anyone wishing to take an experimental drug would be required to sign statements indicating they had read the fact sheet and understood the risks but otherwise it would be perfectly legal for doctors to prescribe unapproved substances. If the drug is believed to be particularly risky or has not been approved for any human use the patient might also be required to call an FDA representative to prove they understand the risks and are not being mislead or coerced.

Instead of the current system where once approved doctors may freely use a drug off label the FDA would specifically approve drugs for particular conditions. So long as a drug is being prescribed for an approved condition things would work as they do now. However, if a doctor wishes to prescribe a medication for an off label use they would follow the same procedure they would for prescribing an experimental treatment. The patient would need to read the plain english summary of the substance and sign a form indicating understanding. Thus avoiding the misleading binary approval process which encourages patients to think a drug which is safe enough and sufficiently effective to treat severe psychosis is safe and effective enough in treat childhood aggression or hyperactivity.

Importantly advertising would only be allowed for on label uses of a drug and not at all for purely experimental drugs. Of course our constitutional guarantees of free speech mean we can’t (and shouldn’t) prevent companies from informing people about a drug or its effects. However, by holding companies liable for any claims about experimental or unapproved uses of a drug which turn out to be false we can in effect prevent deceptive campaigns to convince patients to use unapproved therapies. Of course in the end some people are going to do stupid things but in a free society it is not the governments job to stop the determined idiot from hurting themselves. The government doesn’t outlaw playing football while skiing or hundreds of other risky activities so in the absence of a very compelling reason I don’t see why they should act differently in this situation.

Instead the malpractice system should be replaced by a general government provided insurance for injury and disability regardless of the cause and a system of professional tribunals to discipline medical providers. Only in the case of criminal negligance or malice (delibrate injury or operating while under the influence) should a harmed patient have the right to damages from a medical provider. I argue for such a system below. The purpose of civil suit is twofold. First to recompense the harmed individual for loss of property or injury and secondly to deter inappropriate behavior. This system works well when damages are usually the result of intentional or reckless actions. People are discouraged from setting fires which might spread out of control and damage their neighbor’s property for fear they might be sued. In this situation their is a class of actions (those that endanger other people’s property) which are rightly discouraged by the threat of litigation and society benefits.

The situation seems much different in the case of medical malpractice. Unlike someone recklessly setting fires in their backyard most medical errors probably arise as unforseen mistakes. Few if any doctors say to themselves, “This procedure is probably worse for my patient but what the heck I’m going to do it anyway.” Thus unlike the fire situation there is probably no class of harmful activities doctors would pursue but are disuaded from by the fear of liability. Rather liability is probably applied primarily to mistakes visible only in hindsight and thus not susceptable to deterence.

The proof of this claim is the existance of malpractice insurance. If indeed liability was primarily the result of a recognizeable bad choice doctors would simply resolve not to make such choices and forgo the expense of liability insurance. In fact in such a situation there would be no liability insurance for the same reason there is no insurance for getting drunk and asaulting your neighbor. If the negative outcome is primarily the result of avoidable action instead of random chance the insurance companies would lose money as only those who are likely to commit the action will buy insurance. Hence the fact that all doctors buy malpractice insurance suggests that most liability issues are a matter of random, non-deterable, error.

This is of course not to say that medical liability has no effect on the way doctors practice medicine. Only that there is no recognizeable category of bad treatment it causes doctors to avoid. It is quite possible, likely even, that the allegations it causes doctors to practice defensive medicine are valid. Even if a doctor does not conciouslly sucumb to these effects he may be unconciouslly influenced to take less risky steps to save a patients life, e.g., be less thorough in removing a tumor rather than risk an error in surgery. I myself have seen the caution about liability impede proper treatment.

This is just one of the costs associated with the malpractice system. The legal expenses are quite significant as well not to mention the unpalatable effect that paid expert witnesses have on the medical community. Still one might argue that the court system is generally quite effective and only minor tweaks need to be instituted to make malpractice claims more difficult. I don’t think this is possible since the problem lies at the heart of the system of jury trials and any changes strong enough to prevent inappropriate cases of malpractice would prevent the courts from providing any kind of check on medical practice and thus be strictly inferior to the system I propose.

The difficulty with jury trials in malpractice cases is two-fold. First they don’t know enough about medicine to make informed choices and secondly they are too likely to be influenced by emotionally compelling situations. In particular juries are going to be highly predisposed to give a patient who ends up paralyzed after a surgical error a monetary award. Given the lack of medical knowledge and sympathetic response it seems impossible to suppose juries wouldn’t force the doctor whose ‘fault’ it was to pay and instead dispassionatly evaluate whether the doctor acted within reasonable medical guidelines. Especially when competining medical experts offer testimony the juries can’t hope to evaluate.

Moreover, the entire idea that someone deserves compensation when they are paralyzed as a result of a surgical slip (when presumably they knew the dangers entering surgery) but not when they slip and fall in their own house seems unmotivated. In effect the malpractice system amounts to a very expensive and unreliable system of insurance for those who suffer accidental injury during surgery. Yet since it hardly makes a difference to someone how they end up paralyzed why not simply expand this to a comprehensive government disability insurance?

Now each person, regardless of the cause of their disability, would be granted a certain government stipend (they get a little now but this would need to be raised). This person could bring a complaint against a medical board but unless they proved negligence of level of operating while drunk or malice could not get any cash reward. Thus the medical discipline could be handled by experts untainted by issues of sympathy or cash while care for people with injuries wouldn’t be dependent on the courtroom gamble plus all the useless expense would be eliminated.