None of this was supposed to happen, of course. During the recent UK debate over banning tobacco displays, the government repeatedly assured parliamentarians that not only would such a ban not increase the already large UK illicit market (HMRC estimates that 26 percent of all cigarettes consumed in the UK are non-duty paid and some 70 percent of seized cigarettes are counterfeit), but it would result in a significant decline in smoking, particularly among young people.

But the evidence from across the Irish Sea shows that both of these claims are simply false.

There are several reasons why banning tobacco displays drives the illicit tobacco market. First, by putting all tobacco products under the counter, a display ban undermines the belief that tobacco is a legal, regulated product and that selling and consuming counterfeit and smuggled tobacco products are crimes. Surveys in Canada have found, for example, that a majority of Canadians who buy illicit cigarettes do not believe that they are committing a crime.

Second, display bans fuel the illicit tobacco market by making it more difficult for customers to distinguish between legal and illegal products, since all tobacco is hidden from view. Third, display bans make it easier for dishonest store keepers to mix illicit and untaxed tobacco products and legitimate taxed cigarettes and thus to pass off illicit products.

Fourth, display bans make it more difficult for enforcement agencies, already overtaxed, to identify illicit tobacco products since all tobacco products are hidden from view. Fifth, through blurring the distinction between above and below the counter products, between legal cigarettes and illegal cigarettes, a display ban makes it more likely that smokers will increasingly get their tobacco from illegal as opposed to the legal and regulated tobacco market.

But banning tobacco displays not only drives the illicit cigarette market; it also does nothing to reduce smoking. To return to Ireland again, a just-released EU survey found that 33 percent of the Irish population smoked, which is the highest rate in the last eleven years. Since 2007, tobacco taxes have increased and tobacco displays banned, but smoking prevalence has increased from 29 percent to 33 percent. Even more alarming is the fact that the largest cohort of smokers is now aged 16-30.

The same lack of effectiveness for draconian smoking measures, such as a public smoking ban, is found in England. The NHS recently released a study, 'Statistics on Smoking', which found that the public smoking ban had not resulted in a statistically significant decline in smoking. Indeed, certain groups, such as young males, are in fact smoking more than before the ban.

Part of the reason for these increases in smoking, particularly in the young, is that many smokers find these heavy-handed measures unacceptable. They are what psychologists call 'reactant', that is, they push back against regulation and assert their freedom through engaging in the very activity that the state is trying to prevent.

Hence, far from preventing smoking, measures like a display ban actually encourage it in those young people already most susceptible to begin smoking.

Therefore, in a UK with a tobacco display ban, we can expect to see not only more smokers, particularly young smokers, but also an enormous increase in illegal, unregulated, and untaxed cigarettes. That's quite the public health 'success'.

The truth about second-hand smoking is finally out.

Thanks to some unusual candour on the part of the anti-tobacco brigade in New York City, we now have official confirmation that banning smoking in public has absolutely nothing to do with protecting the health of non-smokers from second-hand smoke, but everything to do with stigmatising both smoking and smokers. Closer to home, new evidence from the National Health Service (NHS) shows that the public smoking ban in England has made absolutely no positive difference in smoking rates, despite claims made by its champions that it would.

In September, Dr Thomas Farley, New York City's Health Commissioner, proposed banning smoking at all of the city's parks and beaches (1). Dr Farley's rationale for the ban has nothing to do with the risks that outdoor smoking pose to non-smokers, but rather with preventing people, particularly children, from having to see anyone smoking in public. Farley says, 'We don't think children should have to watch someone smoking'. Farley also defends the extension of the smoking ban to outdoor areas by arguing that it is 'part of a broader strategy to further curb smoking rates'. New York mayor, Michael Bloomberg, confirmed earlier this month that he would implement Farley's proposal, arguing that the public is 'overwhelmingly in favour' (2).

Why have the champions of banning smoking everywhere, even in private accommodation, suddenly come clean about the driving force behind their crusade? The answer is that they have essentially won the war over public smoking. But why is this the case? The answer, sadly, is that for the past 15 to 20 years, the public has been bombarded with a carefully orchestrated government-funded anti-tobacco campaign to convince them — in contradiction of the scientific evidence — that smokers pose a deadly health risk to non-smokers, particularly children.

The scientific evidence has never supported the case against public smoking. The US Environmental Protection Agency's seminal early 1990s report on second-hand smoke was severely flawed. Its critique of second-hand smoke was only sustained through a careful exclusion of non-confirming evidence and a non-traditional application of the statistical test known as confidence limits. The report was subjected to a scathing analysis by a US federal court, which rejected its scientific claims about the dangers of second-hand smoke, a finding that even on appeal was not reversed (3).

Moreover, a scientific study conducted by the World Health Organisation's International Agency for Research on Cancer found that there was no statistically significant association between smoking in the workplace and social settings and lung cancer in non-smokers. Indeed, the majority of studies about second-hand smoke and lung cancer in non-smokers have found non-statistically significant associations both in workplace and domestic settings.

Of course, none of this startling lack of scientific evidence has moved beyond the scientific journals and into the public domain, which means that the debate about public smoking is a non-scientific debate. And this means that it can proceed on virtually any grounds, unchecked by the need for careful and verifiable scientific evidence. The anti-smoking movement has always known that the evidence about the risks of public smoking, or private smoking for that matter, to non-smokers was marginal, at best, and nonexistent, at worst. But this was fundamentally unimportant.

Preventing people from smoking in public was never about real health risks - that is, it was never about protecting non-smokers so much as it was about stigmatising smoking and smokers and making it difficult for them to smoke. So with the science of second-hand smoke now never discussed, the anti-tobacco movement feels confident in moving the argument forward and revealing the starkness of its real agenda.

There is no compelling evidence that second-hand smoke poses a health risk to anyone in open spaces like public parks and beaches, but that is beside the point. The new push seeks, first, to demonise smoking and, second, to exert a brazen paternalism in which it is made virtually impossible for smokers — for their own good, of course — to light up in any public space.

There are profound difficulties with both of these objectives. For one thing, where is the justification for banning unhealthy behaviours from the public square simply on the grounds that someone might see them? Or, indeed, what is the justification for banning unhealthy behaviours from public viewing full stop? This opens up substantial room for prohibiting an enormous range of other behaviours which are neither immoral nor illegal, but simply unhealthy.

For example, by parity of reasoning it could be argued that children should never have to see anyone eating unhealthy foods in public, or indeed see anyone who is fat in public. Surely, there must be some evidence that seeing someone engaged in unhealthy behaviour puts others at risk. But where is this evidence?

For another thing, there is the issue of whether such measures actually work. For example, the NHS recently released a study on the effectiveness of the public smoking ban (4). The fact is that certain groups, such as young males, are smoking more after the smoking ban than before it. So, not only are such bans not supported by science, they are also not supported by the evidence on their practical effect in changing behaviour.

Finally, any policy by which the government engages in stigmatising the legal behaviour of its adult citizens is repugnant in a democratic society. Fundamental to democratic government is the respect that it owes to its adult citizens' choices about legal behaviour and, more fundamentally, how they choose to live their lives. Paternalistic interventions, whether through stigmatising or other means, can only be justified in the rarest of instances.

What the evolution of the debate over public smoking shows is how little science has to do with the anti-tobacco crusade, how disingenuous that crusade is about its real motives and goals, how easily the crusade on tobacco can be extended to other causes (most notably the war on obesity), and how fundamentally dangerous it is to a society both free and democratic.

(1) New York Eyes 'No Smoking' Outdoors, Too, New York Times, 15 September 2009 (2) Mayor Bloomberg vows to snuff out smoking in parks, beaches, New York Daily News, 1 October 2009 (3) For more on the EPA study, see An epidemic of epidemiology, by Rob Lyons (4) See Statistics on smoking, NHS, 29 September 2009 [pdf]

Unfortunately, neither of these claims nor policies meets the standards of evidence-based policymaking. Both are, instead, products of advocacy-based 'research' carried out by anti-tobacco lobby groups.

In evidence-based policymaking, as in evidence-based clinical medicine, practices and decisions are based on rigorous, systematic reviews of 'best practice', that is, therapies and interventions that work the best in reducing morbidity and mortality. Evidence, and evidence alone, not theory or tradition, drives practice.

The empirical record about tobacco advertising's affect on young people is decidedly mixed. Large independent studies have failed to find a statistically significant connection between tobacco advertising, consumption, and youth smoking. Indeed, the two major UK government-commissioned studies on tobacco advertising and marketing failed to find a causal link between advertising and young people starting to smoke.

This lack of evidence is confirmed by the fact that countries that have had advertising bans for a quarter century or more have not experienced statistically significant declines in youth smoking. Consumption and prevalence data from 145 countries finds little evidence that the entire range of tobacco control measures, including advertising restrictions and bans, has a statistically significant effect on smoking prevalence in any country.

Yet, the government pushes ahead with increasingly draconian restrictions on tobacco advertising through legislation to ban the display of all tobacco products. Even though the Department of Health claims that there is substantial evidence to show that such bans will reduce youth smoking, this is not the case.

The evidence in support of tobacco display bans, just as for tobacco advertising bans, is embarrassingly thin. Most studies show that tobacco displays have no statistically significant effect on youth smoking.

The most frequently quoted studies actually found that seeing tobacco displays had no effect on youth intentions to smoke. None of the so-called evidence about tobacco displays provides compelling behavioural evidence that any young person started smoking after seeing tobacco displays.

The evidence from the experience of other countries who have tried display bans does not support the claim that they reduce youth smoking. The government has repeatedly claimed that Canada, where several provinces have banned tobacco displays, shows that such bans result in fewer tobacco sales and fewer youth smoking.

The government knew that this claim, and the evidence that it was based on, was not true. Recently released DoH correspondence shows that the government was told in a March 2009 email that removing tobacco displays in Canada 'has not caused a decline in tobacco sales or discourage[ed] kids from smoking'.

Yet, the anti-tobacco lobby continues to push for even more far-reaching tobacco control legislation. This past week, Action on Smoking & Health (Ash) trumpeted a new study about the influence of tobacco packages as proof that putting all tobacco products in plain packages was now required. Ash's Deborah Arnott told the BBC that: "This research shows that the only way of putting an end to this misleading marketing is to require all tobacco products to be sold in plain packaging."

What Arnott did not tell the BBC was that she and Martin Dockrell, Ash's campaign manager, were not only two of the authors of the very study they so fulsomely praised, but Ash, along with the DoH, paid for the study.

Considerable previous research has shown that plain packaging of cigarettes will do nothing to reduce youth smoking. A study from Canada's York University, which asked young people about what effect plain packaging would have on their smoking decisions, found that 90 percent of daily smokers said they would smoke more or the same if cigarettes were in plain packages.

What then of high taxes to discourage or prevent youth smoking?

The claim that high tobacco taxes will reduce smoking is an odd one since we have been taught that smoking is addictive. If smoking is addictive, logic dictates that smokers will be insensitive to price increases.

But the claim also runs counter to what most experts say about how young people smoke. Most young smokers are experimental smokers who do not buy their cigarettes, but instead get them from friends or family, which makes them much less sensitive to high tobacco prices.

Data from the US National Household Survey on Drug Abuse recently showed that over 85 percent of 12-18 year old smokers consume the three most expensive brands of cigarettes, a fact that is also difficult to square with the claim that young people are price sensitive.

A series of American longitudinal studies has found tax increases have a statistically insignificant effect on preventing young people smoking. Last year, in a study of tobacco control policies in 27 European countries, it was found that, for adolescents, price was unrelated to smoking prevalence.

Tax increases do succeed, however, in increasing the risk of smoking. Jerome Adda and Francesca of University College London found that a one percent increase in tobacco taxes increases smoking intensity by 0.4 percent, which leads the smoker to inhale more dangerous chemicals and causes cancer deeper in the lung.

The result of public health policymaking absent of evidence is tobacco policy that repeatedly fails to address youth smoking. While the government is entitled to its own opinion about the most effective ways to reduce smoking, it is not entitled to its own evidence.

The government's claims supposedly trump any opposition, on whatever grounds, to this measure. These claims include the following:

1. An objective appraisal of the evidence shows that tobacco advertising and displays lead young people to smoke;

2. Banning display bans will result in fewer youth smokers;

3. Banning tobacco displays in other countries has resulted in fewer youth smokers;

4. Banning tobacco displays will not result in significant costs to retailers.

But now that the Department of Health (DoH), in response to a freedom of information request, has made public much of its correspondence related to the proposed display ban, we know that most of these claims are, in fact, untrue. Further, we know that the DoH has repeatedly violated government policy on the management of risk, and repeatedly misled others about its violations.

Let's begin with the first claim, that the evidence, when objectively and transparently evaluated, shows that tobacco advertising in general, and tobacco displays as one form of advertising, lead young people to smoke.

The requirement that legislation about risks be based on transparent, objective and sound evidence is a key part of government policy on risk. For example, the Treasury's Orange Book on the Management of Risk (2004) requires that measures on risks must be based on 'openness and transparency' and extensive, sound evidence. Similarly, the Risk and Regulation Advisory Council (Tackling Public Risk: A Practical guide for Policy Makers) notes that, in dealing with risk policy, 'It is vital that risk is approached with an open mind and without preconception'.

Further, the House of Lords Select Committee on Economic Affairs' Report on Government Policy on the Management of Risk (2006) noted that 'the most important thing that government can do is to ensure that its own policy decisions [about risk] are soundly based on available evidence and not unduly influenced by transitory or exaggerated opinions, whether formed by the media or vested interests'.

So just who, then, in the DoH was responsible for conducting a wide-ranging, objective, and transparent review of the evidence about tobacco advertising and tobacco displays and their supposed effect on young people? It certainly wasn't regular civil servants with expertise on tobacco issues who approached the issue without a vested interest. Instead, according to an email sent on 23 March 2009 from the DoH to a Canadian equipment company, 4 Solutions Display, the review was a product of Cancer Research UK, a charity that has also acted as an advocacy group consistently calling for bans on tobacco displays.

That email from a DoH manager said: 'We're basing our policy primarily on the work of Cancer Research UK, who have provided a report showing how display drives cigarette smoking among young people in the UK.' Moreover, not only was the display ban based on the work of Cancer Research UK, but the organisation had a senior official working in the DoH two days a week when the display ban policy was being formulated.

In effect, the government's policy about tobacco displays is not the result of wide-ranging research, evaluated objectively and transparently, but rather was based on a single report produced by an advocacy group campaigning for a display ban, and helped along by a senior official from that group working inside the DoH. What's objective, evidence-based, comprehensive, or transparent about that?

This makes clear why the government has consistently neglected its own evidence about tobacco advertising and young people; namely, it was highly inconvenient to the policy put together with Cancer Research UK. For example, Eileen Goddard's Why Children Start Smoking was produced for the DoH in 1990 and, unlike the studies on tobacco advertising cited by Cancer Research UK, is a longitudinal study that followed the same young people over time during the crucial period when they became susceptible to smoking.

Goddard found that becoming a young smoker was not statistically associated with being aware of tobacco advertising or being able to name more brands of cigarettes. Indeed, most young people did not like tobacco advertisements.

It also shows how the government has misled the public about the evidence supporting this legislation. For example, David Taylor, chair of the All-Party Smoking and Health Group, asked the health secretary what research the DoH had commissioned and evaluated on the effects of tobacco displays on youth smoking. Public Health Minister Gillian Merron replied that the DoH had 'assessed the role of tobacco displays on smoking in young people based on a variety of research and evidence', which makes it appear that the government followed the requirements of risk assessment by examining all of the available evidence.

But, as the DoH's March email notes, the minister's comment is highly misleading since the policy is based not on a variety of research and evidence, but almost exclusively on the 'work of Cancer Research UK'.

What about the second claim that banning tobacco displays will result in fewer youth smokers? The government, both in the Lords and in the Commons, has relentlessly advanced this idea. For example, in its 2008 Consultation on the Future of Tobacco Control, the DoH suggested that one of the benefits of a display ban might be a 'three-percentage-point reduction in the number of regular smokers aged 11-15' that would yield 19,500 fewer smokers in 'each annual cohort'.

But we now know, based on the DoH's email correspondence, that this is simply statistical nonsense designed to hide the fact that the DoH could not confidently expect that removing tobacco displays would make any difference to youth smoking. In that same 23 March 2009 email, the DoH manager admits that 'I wouldn't expect to see a significant fall in youth uptake until displays had been removed for approx 10 years'.

If the DoH had bothered to look at the international evidence on the effects of tobacco advertising restrictions, it would have seen that countries that have had advertising bans for 25 years have not experienced statistically significant reductions in youth smoking. In short, the DoH, when not speaking to the Commons or the press, admits that its tobacco display ban will have no immediate effect on youth smoking for a decade, which essentially is to concede that it has absolutely no evidence that it will ever demonstratively work.

Closely aligned to the claim that banning displays will result in fewer young UK smokers is the argument that other countries that have instituted display bans have had declines in youth smoking. The government has repeatedly claimed that the experience of Canada, for example, where several provinces have banned tobacco displays, shows that such bans result in fewer tobacco sales and fewer youth smoking.

The government, however, knew all along that this was simply not true. For example, Canada's 4 Solutions Display told the DoH in a March 2009 email that removing tobacco displays 'has not caused a decline in tobacco sales or discouraging kids from smoking'. The DoH was informed that 'Tobacco sales…across Canada has not felt a negative impact at all since the dark market was legislated'. Indeed, the 'truth' is that display bans have 'hurt small business and they really are the ones who are feeling the pain of lost income stream'.

Moreover, the government's attempt to misrepresent the experience of Canada with display bans is decisively refuted not simply by the DoH's Canadian correspondence, but by the official evidence from Canada. The Canadian data suggest there are no statistically significant differences between those provinces with display bans and those without in terms of the prevalence of youth smoking.

Finally, what about the government's claim that banning displays will not result in significant costs to retailers? The government has repeatedly claimed that the cost for retailers to cover tobacco displays would be minimal. For example, Lord Darzi told the House of Lords in a letter that the costs for removing a typical 25-square-foot retail tobacco display would be £212, based on estimates received from a company (4 Solutions) involved in the Canadian display ban. But the DoH correspondence shows that Action on Smoking and Health (ASH), the most prominent anti-display organisation, was told directly by 4 Solutions that it was not correct.

On 28 April 2009, Phil Beder, vice president of 4 Solutions, emailed ASH's executive director Deborah Arnott to 'clarify some of the issues surrounding the display ban covers that are presently being explored by your organisation in the UK'. Beder makes it clear that 'The original amount of £200 as discussed with you is for a standard three-foot section known as the Gantry and does not include shipping, installation or specific changes to size or dimensions…For individual stores requiring this type of system the costs could be somewhat prohibitive due to the need for specific builds, warehousing and shipping separately to single locations'. He concludes: 'Single shop all-in cost estimates including all the above specifications is approx. £450' – more than double the figures given up by the DoH.

Just in case ASH did not understand these figures, Beder followed up with another email on 30 April to Arnott. He wrote: 'I want to reiterate that the last email I sent to you (April 28) was a complete clarification of all costs associated with covering of tobacco. I also want to make sure you are not making additional assumptions on costs to suit your internal needs. 4 Solutions Displays cannot produce, deliver and install for the minimal dollars you are publishing nor can any other covers for the retailer be represented for delivery in the fashion we are being quoted. We would ask that you remove 4 Solutions Displays from any of your promotional materials as the numbers are misrepresenting the actually [sic] costs to a wide base of retailers in the UK. I trust that your organisation will insure that the entire financial story is told to all and not choose a single number that doesn't represent the actual facts of the past inquires.'

Last month, the Commons' Innovation, Universities, Science and Skills Committee produced a report, Putting Science and Engineering at the Heart of Government Policy, criticising ministers who introduced legislation that they falsely claimed was based on an objective review of the evidence. As The Times (London) noted: 'Government departments should be exposed by their own scientific advisers when they base decisions on political considerations rather than the findings of research.'

What makes the DoH's conduct so reprehensible is not simply that it has consistently misrepresented the evidence about its proposed ban of tobacco displays – to Parliament, to the media and to the public. Far worse, the DoH has abandoned any pretence of objectively collecting and reviewing the evidence about whether such a policy would work, and what its costs would be, by effectively outsourcing this work to an advocacy organisation that already has a well-established position on the matter.

The entire process surrounding the proposed display ban is now so corrupted that the government's only honourable course is to acknowledge this display policy fiasco and withdraw the legislation.

Despite a skeptical literature on the relationship between alcohol advertising and drinking initiation and consumption, there remain powerful public health campaigns to restrict or eliminate alcohol ads. Exhibit A: the British charity Alcohol Concern's declaration last week that alcohol should not be advertised on television before the 9pm watershed. According to Alcohol Concern's spokesman, 'Given the evidence with regard to… the influence of alcohol advertising on young people, it is appropriate that the current rules should be tightened'.

Alcohol Concern's pronouncement is the progeny of two books published a half century ago, journalist Vance Packard's million-selling The Hidden Persuaders and French demographer Sully Ledermann's Alcohol, Alcoholism, Alcoholization. These works shaped today's public health establishment consensus about the effects of alcohol advertising.

Packard asserted that advertising exerts a strong manipulative influence on consumption. Ledermann claimed that there is a fixed relationship between total alcohol consumption and the proportion of heavy drinkers; the only difference between heavy drinkers and the rest of the population being the amount of alcohol consumed. Hence, there is a causal relationship between consumption and misuse.

Between them, Packard and Ledermann provided the basis for the public health establishment's demand that alcohol advertising be either tightly regulated or completely banned. According to the public health view, increases in average alcohol consumption increase the number of problem drinkers and thus the amount of alcohol-related harm, including healthcare costs. Given that alcohol advertising both initiates new consumers and increases total consumption, it should be restricted or banned.

At the very least, this view asserts, exposure to advertising causes individuals to drink who might not otherwise drink and causes people to consume more alcohol than they otherwise would. Restricting or eliminating advertising is justifiable since it would reduce total consumption and with it aggregate alcohol harm.

Are the public health community's claims about alcohol advertising effects true, and are its demands for restrictions or complete bans on alcohol advertising, based as they are to a large degree on Packard and Ledermann, justified?

In order to test these claims, we examined the public health model of advertising's effects, experimental studies, studies of alcohol advertising exposure and recall, econometric studies of alcohol advertising, drinking initiation and consumption, and studies of alcohol advertising restrictions and bans.

The public health model is foundational to the view that advertising affects drinking choices. The empirical evidence for this model is weak and even taken on their own terms studies of alcohol advertising consistently fail to demonstrate that the drinking behaviour of an individual is the causal result of an alcohol advertisement.

Even if we were to allow that this effects model is strongly supported by the empirical evidence, which it is not, there are no studies of alcohol advertising that trace the effect of an advert from exposure to purchase behavior across a sample population in such a fashion to demonstrate that the advert actually caused the behavior. Without such a demonstration, it is impossible to conclude legitimately that alcohol advertising caused a behavior.

As for experimental studies, even allowing for the substantial issues around methodology, small sample sizes, and the appropriateness of drawing conclusions based on artificial settings, it is nonetheless clear that there is no support in the experimental literature for the claim that alcohol advertising causes initial alcohol use or increases alcohol consumption.

Some prominent regulation advocates, such as Professor Gerard Hastings, claim that newer studies provide evidence of the link between alcohol advertising and drinking behavior. Our analysis of 11 cross-sectional and longitudinal studies of advertising exposure and recall suggests otherwise.

Three problems undermine the findings of the alcohol advertising exposure and recall studies. First, and most importantly, none of the studies can justify a causal conclusion about the relationship between advertising and drinking initiation or consumption given their cross-sectional or longitudinal design.

Second, all have significant methodological issues, particularly with respect to warranting that they have in fact accurately measured alcohol advertising exposure, and also in terms of their reliance on unverified subject recall. Finally, the studies generally report data that is either not statistically significant or, if significant, is a weak relationship, or in fact contradicts their thesis.

Together, these studies present virtually no support for the claim that alcohol advertising causes young people to begin drinking. Collectively, these studies suggest that alcohol advertising either does not increase total alcohol consumption, or has an impact that is, in the case of beer advertising, so marginal as to be insignificant.

With respect to econometric studies, out of over 30 such studies over the past two decades, only a handful support the claim that alcohol advertising leads to drinking initiation or increases total consumption.

The imposition of alcohol advertising bans represents a reasonably direct way in which to test the Ledermann-derived public health hypothesis about both the effects of alcohol advertising and the corrective of advertising restrictions and bans. Although the evidence is not completely consistent and has, as we have noted, significant limitations in its ability to control for possible confounding factors, there is still very strong evidence that the imposition of bans has not reduced consumption.

Of 17 cross-sectional and longitudinal studies of the effects of advertising restrictions and bans on drinking initiation and consumption, only three find that such measures have a statistically significant effect on either initiation or consumption. There is strong evidence that restrictions have not reduced consumption and the evidence from jurisdictions that have removed bans shows that consumption has not increased when advertising has resumed.

Nor do such studies provide support for the claim that such restrictions on advertising reduce alcohol abuse or alcohol related-harms such as road fatalities or disease. Indeed, one study found that broadcast bans of spirits advertising resulted in both higher consumption levels and increased levels of traffic fatalities.

Moreover, where alcohol advertising bans have been lifted, there is no evidence that consumption has increased. This does not, of course, mean that advertising is ineffective, as many of these studies, both nationally and internationally, have demonstrated the expected advertising outcome of substitution effects and movements between brands and beverage categories.

Based on the empirical evidence, it is clear that the public health establishment's claims about the effects of alcohol advertising are incorrect. Indeed, the weight of the evidence substantially argues against its assertions about alcohol advertising initiating drinking and increasing consumption and alcohol-related harm. Consequently, there is no public policy justification for measures to restrict or completely ban alcohol advertising that is directed to legal consumers.

But what about warning labels on alcohol? Either instead of or in tandem with advertising restrictions, can they not be an effective deterrent against drinking? In short, no, they cannot.

The main evidence against the effectiveness of such warnings comes from the US. According to the proponents of warnings, they serve both to inform the public about the specific risks of drinking and reduce the drinking of specific groups most at risk, such as pregnant women, adolescents, and problem drinkers. But the research evidence suggests otherwise.

If the warning is to be effective it first has to be noticed. But US telephone surveys have found that only between 20 and 25 percent of respondents noticed the labels in the first six months after introduction, with only 16 percent recalling the content of the warning. Effective warnings, according to Kip Viscusi of Harvard University, must also provide new information. Yet an Ipsos-Reid survey in February 2005 found that 99 per cent of Canadian women of childbearing age knew that there were risks with drinking during pregnancy, suggesting that the proposed warnings would not be providing new information.

Equally unimpressive is the evidence for warnings affecting behavioral change. The US Surgeon General's warnings about the risks to pregnant women from drinking have been mandatory since 1989. A study of alcohol consumption by pregnant women reported by the US Centers for Disease Control noted that almost eight years after the implementation of the warning labels the number of women drinking during pregnancy had risen. As Dr Janet Hankin in a review of fetal alcohol prevention discovered, only the lighter drinkers who were less at risk of having children with fetal alcohol syndrome followed the warning. 'Among high-risk drinkers', Dr Hankin noted, 'the label law clearly has not affected drinking behaviour'.

A similar result has been noted with adolescents. David MacKinnon reported in the American Journal of Public Health that in a group of 16,661 high school students followed from 1989 to 1995, 'there was no beneficial change attributable to the warning in beliefs, alcohol consumption, or driving after drinking'. The World Health Organisation's 2003 study on alcohol noted that warnings failed to increase young people's perceptions of alcohol risks and had 'no direct impacts' on consumption. Studies have also found that heavy drinkers, while aware of the warnings (they see them more frequently), are more likely to consider them less believable and to discount them more than other drinkers.

This suggests that warnings may not only be ineffective, they might also be counterproductive in at least three senses. First, warnings appear to reduce at-risk drinkers' acceptance of the risks associated with their behaviour. The very act of warning actually works against itself.

The reasons for this are various. There is a natural tendency to avoid information that has negative self-implications. People are very good at avoiding processing information like warnings that they perceive as threatening. Through a process known as cognitive readjustment people tend to exempt themselves as subjects who ought to be concerned with the warning.

Then, too, there is the fact that large numbers of risk-takers display what psychologists call 'reactance', in which there is a high level of resistance to the demands of outside authority and control. For these individuals, a label represents an unreasonable attempt to shape their behaviour.

Second, as the WHO study and others have noted, warnings highlight risk and for those attracted to risk this serves to make alcohol more attractive than it might otherwise be. Finally, in pregnant women, research by Professor Ernest Abel, director of reproductive toxicology at Wayne State University, suggests that warnings might provoke stress in pregnant women that in turn may result in stress-related physiological changes that compromise the health of the fetus.

Even if the evidence of failure does not convince, perhaps the strong probability that alcohol warnings and advertising restrictions drive some people to drink might bury these pernicious regulatory instruments.

But how effective are these programs? Not very — so why is the CDC recommending pouring millions of dollars more into programs that are unlikely to have any significant impact on public health? Early tobacco control policy efforts that largely consisted of raising taxes were quite successful in reducing smoking. The effect of more recent tobacco-control policies is much more ambiguous.

Bans on tobacco use in various places have been implemented widely. Bans have been imposed on restaurants and bars in 27 states and Washington. Four other states have imposed bans in restaurants, but exempt bars. Several more states have passed bans that take effect in the near future. Proponents argue that bans lower smoking, although evidence on this is mixed.

"Anti-tobacco" programs are the latest measure used by governments to control tobacco use. These programs fund anti-smoking ads that run in newspapers, magazines and on TV, school programs to educate children about the hazards of smoking, cessation interventions (intensive counseling services and cessation medications) and grants for researchers to demonstrate effectiveness of tobacco-control programs. These programs hire many people and are very expensive.

The CDC provides recommendations for how much money states should spend on anti-tobacco programs. According to the CDC, careful research shows that its recommendations would prevent hundreds of thousands of premature tobacco-related deaths. But the data do not back the CDC's claims.

The CDC recommends that states should spend $15 to $20 per resident each year on anti-smoking programs. Only two states — Maine and Mississippi — have consistently met or exceeded that goal over the years 2000–2007. In contrast, three states — Michigan, Missouri and Tennessee — have spent nothing on anti-smoking programs. Georgia spent just over $2 million in 2008, barely 5 percent of what the CDC now recommends. Nationwide, states have spent a total of $5.3 billion (in inflation-adjusted 2005 dollars) over those years, an average of $18 per person. But all that money has failed to significantly reduce smoking. Nor have the states that spent more seen a more dramatic reduction in smoking than states that have spent less.

Statistical analysis that I've conducted shows that there is a very tenuous link between cigarette sales and state anti-tobacco spending. At best, spending large amounts of money on anti-tobacco programs seems to produce a trivial drop in cigarette sales — less than a pack a year per capita. States would be better advised to put these resources toward other public health policies that produce larger results.

What was the basis of the CDC spending recommendations? Was the agency truly trying to identify anti-smoking policies that work well and use public funds effectively, or did the CDC simply assume that, "If you spend it, they will quit smoking"? If it was the latter, then it is unfortunate for both taxpayers and public health.

The CDC is now arguing that state anti-tobacco programs are underfunded. Tobacco-control advocates — many of whom receive money through these programs — repeat the CDC under-funding claims when pleading their cases for spending increases. It will be truly unfortunate if states simply accept these claims and increase funding without investigating the programs' effectiveness. However difficult it is to look beyond noble intentions, appraisal of a program's effectiveness is vital — particularly in these tight fiscal times — if we truly want to improve public health effectively.

Professor James Heckman, the Nobel Prize-winning economist, has devoted a decade to understanding what makes young people engage in risky behaviours, such as smoking and illegal drug use, and what can be done to prevent this.

Given that a UK House of Commons committee is currently debating how to prevent youth smoking through legislation that requires shopkeepers to hide all tobacco products from sight, it would be reasonable to assume that the committee would talk to Professor Heckman.

But it hasn't. And the reason the committee is not doing so speaks volumes about the debased state of public policy debate.

The basis of the UK government's legislation is the claim that one of the major reasons why young people smoke is that they see tobacco displays in shops. If you find this claim more than a little odd, you are not alone.

When the legislation was debated in the House of Lords, the government was unable to produce any credible and compelling scientific evidence that seeing tobacco displays in shops led anyone to smoke or that removing tobacco displays had led to a decline in youth smoking. Indeed, the international evidence from a variety of countries that had tried this 'silver bullet' to stop youth smoking showed that adolescent tobacco use had either increased following a display ban or stayed the same.

In an attempt to bolster their less than robust case, the government touted a study by professor Gerard Hastings, which argued that the more young people were aware of tobacco brands the more likely they were to 'intend' to smoke (notice, not smoke, but intend to smoke).

Regrettably, the Hastings study (which was not published in a peer-reviewed journal) has several defects. Since it wasn't a study establishing cause and effect, it could never counter the commonsense response that the reason young 'intending' smokers knew more tobacco brands is because they were young intending smokers. Their smoking led to their interest in brands, not the other way round.

It also failed to provide a demonstrated connection between increased awareness of tobacco brands and tobacco displays in shops, which is, after all, what the legislation is about. Finally, Hastings' research is contradicted by a host of other studies, including some cited by the government itself, which showed that tobacco brands are not important in the process of taking up smoking.

Where does this leave Heckman? The reason that Hastings addressed the Commons committee rather than Heckman is because Hastings' research supports the government's tobacco control policy, while Heckman's work exposes the government's nonsensical arguments.

Heckman does this in two ways. First, his work shows that studies like Hastings' and claims about shop displays causing young people to start smoking are instances of flawed science: they don't meet the rigorous standards necessary to establish the government's claim that 'tobacco displays cause young people to begin smoking'.

Heckman argues that the government and public health advocates consistently make both strong assertions about the supposed causes of youth smoking and push draconian policies like display bans based on simplistic and flawed statistical methods that would not pass muster in other areas of public policy. Their studies never show that the particular focus of a policy, such as tobacco displays, is the cause of a problem such as youth smoking.

Nor do they ever consider and control for the role of other factors in initiating youth smoking. Nor are the studies replicable by other researchers. As a result, public policies and enormous resources are being focused on alleged 'causal factors', such as tobacco displays, 'that have not been scientifically established but merely assumed to affect smoking initiation'.

As a result, public policies for dealing with youth smoking and drug use are put forward without any connection to the problem for which they are intended. This means that by their very nature they miss the mark and fail. For example, if tobacco displays don't cause young people to smoke, banning them won't do anything to prevent youth smoking. Such measures are nothing more than window dressing and they fail to come to terms with the root causes of what drives smoking.

Second, Heckman's work provides real answers to the question of what leads young people to start smoking and what can be done to prevent it.

In a series of recently published research studies, Heckman showed that two factors, both malleable — family environment and school environment — are crucial in the development of two skill sets: cognitive skills and non-cognitive skills, such as motivation, determination, self-esteem, and self-regulation.¹

These two skill sets are both strongly and consistently related to the probability of becoming a regular smoker by age 18. Moreover, the foundations for both of these skill sets are developed at an early age. In short, the higher one's cognitive and non-cognitive skills, the less likely it is that one will become a smoker.

Heckman's research finds considerable support in recent research on youth smoking in the UK. Several studies have found that youth smoking is strongly correlated with living in areas of high social and economic deprivation, failing schools and dysfunctional families — precisely the sorts of environments that fail to provide for the development of the cognitive and non-cognitive skills that Heckman finds so important.

The implications of Heckman's research for smoking policy are therefore enormous. Instead of focusing on things like tobacco displays that are unrelated to youth smoking, the essence of the government's tobacco strategy ought to be three-fold:

1. designing early childhood interventions to develop crucial cognitive and non-cognitive skills in those areas with the worst performing schools and the highest youth smoking rates (these tend to overlap);
2. removing the causes of social and economic deprivation in those with the highest youth smoking rates;
3. creating novel interventions to address the sources of family dysfunction in those areas with the highest youth smoking rates.

The great benefit of such a tobacco policy is that, in addition to dramatically reducing smoking, it would reap significant benefits in a host of other areas.

It's a real tragedy that the Commons isn't hearing from James Heckman on youth smoking. This isn't just because his analysis cuts through the government's cant and shows how unsupported its policies, such as a display ban, really are. Far more importantly, his enormous knowledge of what really does cause smoking may help prevent a generation of British kids from lighting up.

¹ See 'An Assessment of Causal Inference in Smoking Initiation Research and a Framework for Future Research, by James Heckman, in Economic Inquiry, January 2008.

The legislation that will be voted on shortly in the Senate was cooked up out of public sight by Philip Morris, Sen. Ted Kennedy, D-Mass, Rep. Henry Waxman, D-Los Angeles, and anti-tobacco lobbyists. During years of covert negotiation, Philip Morris outwitted this coalition of "useful idiots" at every turn. Philip Morris staffers even wrote large portions of the bill.

Philip Morris was ruthlessly successful in pursuing its interests, but the Useful Idiot Coalition consistently failed to further its own. That is why Food and Drug Administration regulation of tobacco serves Philip Morris' corporate interest, not the public interest.

There are significant, and numerous, problems with the FDA regulating tobacco, and virtually no benefits to public health. Kennedy, Waxman, and the public health establishment present their legislation as a masterful regulatory stroke that will end tobacco marketing, prevent kids from starting to smoke, make cigarettes less enjoyable to smoke and reduce adult smoking. But FDA regulation of tobacco will do none of these things.

The bill fails to correctly identify the reasons why young people begin to smoke and concentrates almost exclusively on restricting tobacco marketing, while leaving the other risk factors for adolescent smoking unaddressed. There is nothing in the proposed legislation that shows the FDA understands the well-documented connections between education, poverty and smoking status, connections that provide the key to helping adults stop smoking.

It will not provide Americans with scientifically accurate information about the risks of smoking. Instead of providing accurate information about the risks of low-tar cigarettes, the current legislation requires the FDA to ban the descriptor completely, leaving smokers without any information about how to understand the risks of smoking.

Moreover, in its requirements for graphic warnings, the current legislation commits to fear-based messages that are not only often inaccurate through their overstatement of the risks of smoking, but substantially ineffective in both preventing and reducing smoking.

The process of validating new reduced-risk products appears to be designed to prevent such products from ever reaching the marketplace, thus giving smokers the stark, and for many the impossible, choice of "quit smoking or die." Rather than making smoking safer for those who continue to smoke, it will deny smokers access to new products that might literally save their lives. That is hardly a sterling prescription for good public health.

Even if the idea of FDA regulation were good in theory, in practice several things, including the FDA's competence in tobacco policy and science, its public image, its fit with the tobacco file, its available resources and its overall current competence, argue strongly against giving it regulatory responsibility for the nation's tobacco policy.

Equally important is the fact that, based on past failures, most of the FDA's problems in terms of science, staff and administrative prowess appear to be largely beyond easy repair. Why, indeed, would anyone who cared about effective tobacco control policy want to hand over the responsibility for such policy to such an organization?

FDA regulation of tobacco need not be a public health tragedy, however. By bringing the crafting of tobacco policy out into the light of day, by taking it out of the hands of the special interests and, most importantly, by keeping it away from the FDA, there is every opportunity to begin to create a policy that not only serves the interests of nonsmokers and smokers, but a policy that might really work.

Constructive recommendations about the scope, administrative home and content of tobacco policy would stand in sharp contrast to what is currently being rushed through the Congress under the guise of serving the interests of the American public.

Bush claimed to respect federalism, but his Justice Department repeatedly brought the heavy hand of the law down on desperately sick people who, with the approval of their state governments, used marijuana to ease their pain.

Calling off the raids was the right thing to do, and—for a liberal president vulnerable to the charge of being "soft on drugs"—a politically courageous move ("the Audacity of Dope"?).

Thousands of Americans use marijuana to treat glaucoma, cancer, and other diseases. The federal government has no business coming between them and their doctors. Cancer survivor Richard Brookhiser made that clear when he testified before Congress in 2006.

Brookhiser, a staid senior editor at National Review, hardly resembles the stereotypical pot smoker. But in 1992, he contracted a particularly virulent form of cancer and found that only marijuana would allow him to hold down enough food to survive the treatment.

"God forbid that anyone in this room should ever need chemotherapy," Brookhiser testified, but if you do, "Let me assure you that whatever you think now, or however you vote, if that moment comes to you, you will turn to marijuana. Extend that liberty to your fellow citizens."

In recent years, 13 states have done just that. After California passed the Compassionate Use Act in 1996, the Clinton administration commissioned a comprehensive study on medical marijuana.

That report came out 10 years ago this month, and it indicated that the drug had shown promise as a treatment "for symptoms such as pain relief, control of nausea, and vomiting." The scandal-scarred Clinton worried that his opponents might portray his administration as a klatch of licentious Baby Boomers, so he wasn't entirely happy with the report's result. His administration sued medical marijuana dispensaries, and tried to revoke the licenses of doctors who prescribed the drug.

President Bush was more aggressive still. In the case of Gonzales v. Raich, the Bush Justice Department insisted that, regardless of what California's voters had decided, it had every right to deny use of the drug to a woman with an inoperable brain tumor.

In the process, the Bush team undermined the core constitutional principle that federal power is limited. As Justice Clarence Thomas wrote in his Raich dissent, "If Congress can regulate this under the Commerce Clause, then it can regulate virtually anything—and the Federal Government is no longer one of limited and enumerated powers."

Holder made clear last Wednesday that the Obama administration won't pursue cases like Raich. That's good news, but the new policy doesn't go nearly far enough. There's no good reason to wage war against people who use marijuana as medicine, but neither is there any reason to prosecute recreational users. It's a disgrace that, in the 21st century, in a free country, we continue to send people to prison for using or selling the drug.

Survey data tell us that some 40 percent of Americans have tried pot. Any policy that suggests that 100 million Americans are criminals needs rethinking. Among them are a host of political elites who support the drug war, at least tacitly: Bill Clinton, Al Gore, Newt Gingrich, Sarah Palin, and Barack Obama himself.

Obama's no legalizer. But his early moves—including the appointment of a moderate as drug czar—suggest that he's much less hawkish than his predecessors. There are even some signs of new thinking on Capitol Hill.

Last year Reps. Barney Frank (D-MA) and Ron Paul (R-TX) cosponsored a bill to decriminalize possession of marijuana. Senator Jim Webb (D-VA) recently took to the pages of the Washington Post to lament the fact that the United States locks up more people per capita than any other country in the world—many of them nonviolent drug offenders.

We're still far away from calling an end to our foolish and destructive War on Drugs, but the debate finally seems to be headed in the right direction. The prospects for drug policy reform look better than they have for decades.

The trick, then, is to get the balance between individual liberty and democratic rule right. The Founders and Framers did that with a Declaration of Independence, which set forth their philosophy of government — individual liberty, secured by limited government; a Constitution, which authorized the institutions and powers of the federal government and established the initial relationship between the federal and state governments; a Bill of Rights, which reiterated the libertarian principles of the Declaration, especially through the Ninth and Tenth Amendments, thereby securing ratification by the states; and the Civil War Amendments, which completed the Constitution by incorporating at last the grand principles of the Declaration, providing federal remedies against state violations of our rights.

That is not Franck's constitutional understanding, however, nor is the understanding of many conservatives such as Robert Bork and Antonin Scalia, both of whom I criticize in my op-ed. They are all small "d" democrats, as evidenced by Franck's reading of the Constitution's due-process clauses. For the Framers, he writes, the clauses meant that no one could be deprived of life, liberty, or property "without the deprivation proceeding on the basis of a duly promulgated statute, providing notice, a hearing, and an opportunity in a fair forum to challenge the deprivation (emphasis added). That's it." And he goes on to criticize me and other classical liberals for our adherence to "substantive due process," which "enshrines affirmative limits on the kinds of public policy the government may adopt," calling that idea "a later excrescence on the Constitution that has been employed to defend property in slaves, exploitation of labor, and most notably in our own time, a 'right' to abortion."

Franck is wrong on both history and theory. As the late Bernard Siegan and many others have shown, due-process clauses have been substantive at least since Magna Carta. Were they not, they would be effectively vacuous, exposing one and all to the unbridled will of the king, the aristocracy, the democratic majority, or, as a practical matter, the interests in control on any given subject — here, the cluster of FDA interests who opposed this suit.

In fact, Franck himself gives the game away when he criticizes my citation of Judge Judith Rogers's dissent, which defended the Supreme Court's recognition, under the due-process clauses, of the right to marry, to have children, and to control the education and upbringing of children, among others, calling them "bad ideas!" He would respond, perhaps, that no democratic legislature would deny the right to marry, or to control the education of one's children. No? What were Loving v. Virginia and Pierce v. Society of Sisters about? Or he might say, with Justice Oliver Wendell Holmes, that if society wanted to go to hell in a handbasket, so be it: save for the rights expressly mentioned in the document, the Constitution is otherwise empty — a mere formal distribution of powers authorizing majorities to do as they wish, as Bork believes.

The founding generation would have been surprised by that reading. Before they would ratify the document, after all, they insisted that a Bill of Rights be added. And because not every right could be expressly included in such a bill, to avoid the implication that only the enumerated rights were to be protected they insisted on the Ninth Amendment, which made clear that we have both enumerated and unenumerated rights. Yet Franck dismisses that inconvenient history with a wave of the hand, saying that the Founders contemplated no judicial enforcement of unenumerated rights. (At least he didn't say, as some conservatives do, that they contemplated no judicial enforcement of any rights.) But implying, wrongly, that my argument rested on the Ninth, he adds that Judge Rogers, "in her one wise choice, at least avoids the embarrassment of relying on the Ninth in her argument." She does, and so do I, because there is text enough to support her conclusion.

But "embarrassment"? (As in "the embarrassing Second Amendment"?) The Ninth Amendment, like the Fourteenth Amendment's privileges-or-immunities clause, is there for a reason. It is not mere surplussage. Those conservative "originalists" who purport to take the Constitution seriously need to understand what those reasons are. But to do that, they need to go behind the text, to the theory of the Constitution and the logic of rights. Judge Rogers, joined by Chief Judge Douglas Ginsburg, did that quite nicely. For Franck, however, she and I, rather than describe the right at issue precisely, prefer instead "to talk in sonorous vagaries about the 'fundamental' right to life," followed by "excursions into the common-law right of self-defense, or 'the tort of intentional interference with rescue,'" which Franck calls "extended non sequiturs."

What's missing here is an excursion into Logic 101. Even a Justice Scalia derives the right to burn the flag, say, from the right of free speech. A move from the general to the particular, with due concern for context, is hardly novel. It's the stuff of adjudication. Yet Franck would avoid that deduction with a mere assertion: the FDA's regulatory regime "takes no one's life," he says, and the due-process clause "has only to do with those occasions when the government takes affirmative steps to end the life of a particular individual," not when it blocks people from getting the drugs that might save their lives. His argument is worse than ahistorical: it is circular, and sophistic.

Will judges, armed with the power to stand as "an impenetrable bulwark against every assumption of power in the legislative or executive," abuse that power — Franck's main concern? Of course they will. But so will unbridled legislatures abuse their powers. Franck writes as though I support the right to abortion, seeming to forget my "Alito and Abortion" in the Wall Street Journal, which at the time he called "somewhat strange and unsatisfying." What will satisfy Franck, it seems, is a supine judiciary. Far too often, that's what we have today. It is not Madison's vision. It is Franklin Roosevelt's. Count me a Madisonian.

"No one knows yet whether the treatment was to blame," wrote Rick Weiss of the Washington Post. "But a close look at the events leading to Mohr's death reveals failures in the safety net that is supposed to protect people from the risks of medical experimentation."

Last week, the U.S. Court of Appeals for the District of Columbia ruled that terminally ill patients do not have a constitutional right to use experimental treatments without being enrolled in a clinical trial or participating in other very limited Food and Drug Administration-approved options, even if their doctors believe that such treatment is their best chance for survival. The case is being appealed to the Supreme Court.

The D.C. appeals court and so many others who share a "safety first" approach to experimental treatment are only seeing half the picture. Experimental treatment is inherently risky. But overemphasizing safety prevents patients from taking a calculated risk when they think it's worthwhile.

As my husband and I learned, that freedom is important. Our son was diagnosed with cancer when he was 9 months old. Next week, he leaves for college, and the only visible reminder of his brush with death is a scar from surgery.

No, I'm not saying that an experimental treatment saved his life. What probably saved him was his parents' persistent questions, and events resulting in a course of treatment that changed so often no doctor would have recommended it at the beginning.

Individuals often react unexpectedly even to conventional treatments, let alone experimental ones. What would have happened if someone had told us, "Sorry, that treatment is no longer an option. It has been found unsafe because children have died from it."

At the time, all the treatments — including the experimental ones we were offered but ended up not choosing — resulted in about a 50% chance of death, and in many cases they killed the children before the cancer did. But there were still crucial choices to make. No one was as well suited to make them than we were, in consultation with our son's doctors.

In the appeals court case, the Abigail Alliance for Better Access to Developmental Drugs sued the FDA for refusing to allow terminally ill patients to purchase experimental drugs. Patients who couldn't gain access to the medicines they wanted — because the trials were closed or the patients were too sick or otherwise didn't qualify for FDA permission — petitioned the FDA to be allowed to take medicines under the supervision of their own doctors.

According to the FDA, such treatments would lead to unacceptable risk.

Unacceptable to whom?

In denying patients the right to weigh the risks for themselves, the FDA and the court denied them their only hope for survival. The government essentially told them that it would be better for them to do nothing and die than to take risky experimental treatments.

We do not need a governmental authority involved in medical decisions that are uniquely personal to patients and their families. But along with the right to make decisions comes the obligation to think them through. Any doctor who lies to patients or intentionally misleads them about the risks of certain treatments should be punished, but patients need to read informed-consent forms carefully, ask questions and not assume that their doctors can do risk-benefit analyses without knowing what's most important to the patient.

In our case, each option had its own set of risks, including death, but also a chance at a better life. One experimental protocol we were offered tested a new course of chemotherapy that had a lower chance of stunting our son's growth or causing sterility, but possibly also a lower chance of curing his cancer. But at least we had this option.

I wonder if in this "safety first" climate toward experimental treatment — and with this latest court ruling — any of the protocols we considered would be approved. All had the possibility of deadly side effects. It's frightening to think a government agency might have limited our options because it thought one treatment safer than another.

The proper response to tragedies like the one that befell Jolee Mohr is not to try to make experiments risk-free, but to help patients understand the risks.

Robb Mohr told the Post that "the science seemed good. There's nothing I knew of that could have predicted this." But the consent form his wife signed stated that the experimental therapy had possible "unknown side effects" including "in rare circumstances, death."

Participating in experimental treatments is a decision not to be taken lightly. If the public goes along with the "safety first" mentality and abdicates decision-making authority to government regulators, we will lose an important right. We'll lose the choice to participate in experiments that might kill us, but we'll also lose the option to make a choice that might save our lives.

Represented by the Washington Legal Foundation, Abigail Alliance is named for Abigail Burroughs, a 21-year-old college student who died of cancer in 2001. Their argument could not be more simple or straightforward, nor could Tuesday's dissent, written by Judge Judith Rogers and joined by Chief Judge Douglas Ginsburg, the majority in the earlier opinion. Citing the Fifth Amendment's right to life, the Ninth Amendment's assurance to the Constitution's ratifiers that the rights retained by the people far exceed those named in the document, and the Supreme Court's "fundamental rights" jurisprudence, Judge Rogers argued that the right to life, the right to self-preservation, and the right against interference with those rights — which the FDA is guilty of — are of one piece. They are deeply rooted in common law and the nation's history and traditions, implicit in the concept of ordered liberty, and thus "fundamental."

Indeed, it is startling, she noted, that the rights "to marry, to fornicate, to have children, to control the education and upbringing of children, to perform varied sexual acts in private, and to control one's own body have all been deemed fundamental, but the right to try to save one's life is left out in the cold despite its textual anchor in the right to life." Because the rights at issue here are "fundamental," she concluded, the court must apply, in judicial parlance, "strict scrutiny." The burden is on the FDA to show why its interference is justified — to show that its regulatory interests are compelling and its means narrowly tailored to serve those interests.

There, precisely, is where Tuesday's majority demurred. In a long footnote, Judge Thomas Griffith, who had dissented in the earlier opinion but wrote now for the majority, recast the right at issue as "the right to access experimental and unproven drugs in an attempt to save one's life." Through such "tragic wordplay," as the dissent put it, the right ceases to be "fundamental," under Supreme Court precedents, because it is "not deeply rooted in the Nation's history and traditions."

So described, the right is not "deeply rooted," of course, because the very idea of "experimental and unproven drugs" implies a regulatory regime like the FDA, and that is a recent development. Yet as the dissent detailed, for most of our history individuals were free to take whatever drugs they wanted without a doctor's prescription. It was only in 1951 that Congress created a category of prescription drugs. Then in 1962 it began requiring drug companies to conduct extensive tests to ensure drug "efficacy," which led to long delays for drug approval and to the deaths of countless patients who would gladly have borne the unknown risks for a chance at life.

As a legal matter, what Judge Griffith achieved with his linguistic legerdemain was a shift in the burden of proof: No longer would the government need to justify its restrictions; the dying would have to try to overcome those restrictions. But that would be impossible because now the court would no longer strictly scrutinize the government's rationale. Rather, it would apply a "rational basis" test under which the government would win as long as it had any reason for restricting access. Deference so complete, the dissent noted, amounts to nothing less than "judicial abdication."

Plainly, the issues here go well beyond this case, which is doubtless why the court decided to rehear it en banc. And they go beyond liberal and conservative as well, as the mixed seven who joined Judge Griffith's opinion should indicate. What we have here, arguably, is a revolt of sorts by Judge Rogers and Chief Judge Ginsburg against what passes today for "constitutional law." Reducing that revolt to a simple question: Under a Constitution that expressly protects the right to life, how did we get to where government can effectively restrict the right, and the courts will do nothing?

The answer for liberal jurists is simple. Since the Progressive Era they've worked assiduously to create the modern redistributive and regulatory state, constitutional impediments notwithstanding. Following Franklin Roosevelt's infamous 1937 threat to pack the Supreme Court with six new members, the Court facilitated that agenda by distinguishing "fundamental" and "nonfundamental" rights, protected by "strict scrutiny" and "rational basis scrutiny" respectively. That invention opened the floodgates to ever-expanding legislative schemes. But liberals didn't always win in the legislatures, so they turned increasingly to the courts, urging judges to find "fundamental" rights by consulting "evolving social values."

That led to a conservative backlash and a call for "judicial restraint," especially after the Court found a fundamental "right" to abortion in 1973. Both sides, therefore, have reasons to urge judicial restraint and deference to the administrative state. Modern liberals don't want judges interfering with the legislative creation of the welfare state's social and economic rights. Conservatives hope to frustrate those legislative efforts while forestalling the judicial creation of such rights. Thus, they urge judges to protect only those rights found expressly in the Constitution — and will describe rights, as here, to avoid even the hint of judicial activism.

In a word, then, liberal jurists could rule against Abigail Alliance to ensure the dominance of the regulatory regime. Conservative jurists, viewing that regime as "settled law," could do likewise to avoid even the appearance of judicial activism. The approach of liberals is understandable: Long ago they abandoned the written for the "living" Constitution, which enables ad hoc adjudication, the rule of law notwithstanding. The approach of conservative "originalists," however, is less easily explained, since they purport to take the Constitution seriously.

Yet in Robert Bork's The Tempting of America, where conservatives often turn, we find an answer. Describing what he calls the "Madisonian dilemma," Judge Bork writes that America's "first principle is self-government, which means that in wide areas of life majorities are entitled to rule, if they wish, simply because they are majorities. The second principle is that there are nonetheless some things majorities must not do to minorities, some areas of life in which the individual must be free of majority rule." (emphasis added)

That turns Madison on his head. James Madison stood for limited government, not wide-ranging democracy. His first principle was that in wide areas individuals are entitled to be free simply because they are born free. His second principle was that in some areas majorities are entitled to rule because we have authorized them to. That gets the order right: individual liberty first, self-government second, as a means for securing liberty.

Yet we repeatedly see conservative jurists, as here, ignoring the true Madison — deferring to the legislature when their duty, as Madison put it, is to stand as "an impenetrable bulwark against every assumption of power in the legislative or executive." A perfect example is Justice Antonin Scalia's dissent in a 2000 case, Troxel v. Granville, which found that Washington State's grandparent visitation act violated the right of fit parents to control access to their children. Dissenting, Justice Scalia argued that although the parental right is among the unalienable rights proclaimed by the Declaration of Independence and the unenumerated rights retained pursuant to the Ninth Amendment, that amendment does not authorize "judges to identify what [those rights] might be, and to enforce the judges' list against laws duly enacted by the people." Thus, just as the Abigail Alliance majority did, he would defer to the legislature to tell us what those rights are — the very legislature that had extinguished the parental right that he had just located in the Ninth Amendment.

The problem with that view, of course, is that it renders the Ninth Amendment a nullity — hardly what an originalist wants. Moreover, while recognizing retained unenumerated rights as "constitutional," it reduces them to a second class status since they are unenforceable. And that means they are not rights at all since rights are invoked, in the political context, only defensively, against threats from the majority. Yet on this view they can be extinguished by a mere majority.

There is, of course, no bright line between enumerated and unenumerated rights. In interpreting the Constitution, inferences are essential. As Judge Rogers put it, "were it impermissible to draw any inferences from a broader right to a narrower right, nearly all of the Supreme Court's substantive due process case law would be out of bounds." The only question, therefore, is whether the inferences are drawn correctly, and from sound underlying principles. To do that well, however, judges must have a sure grasp of those principles. That is the main problem today, as Tuesday's decision illustrates. The Framers would be appalled to see federal bureaucrats standing between dying patients and the medicines that might save them — sanctioned by a Constitution turned upside-down. Fortunately, this case will be appealed and the Supreme Court may yet examine it afresh.

In Texas and New York, Merck made campaign contributions to key players in advocating that the vaccine be mandated, and questions were being raised in the press and in prestigious journals such as the New England Journal of Medicine and the Journal of the American Medical Association.

In March, Assemblyman Ed Hernandez, D–Baldwin Park, pulled his bill mandating that seventh–grade girls in California be vaccinated against HPV, which can cause cervical cancer. That age was selected because Merck said Gardasil, to be effective, needs to be given before girls start having sex. The bill ran into considerable opposition inside and outside the Capitol.

Now back without much fanfare, the Assembly approved the Hernandez bill last month. It is scheduled for a hearing Wednesday before the Senate Health Committee.

The arguments against mandating Gardasil haven't changed, but Hernandez's bill has. In fact, it doesn't even mention HPV or seventh–grade girls, but it broadens the scope of mandated vaccines and delegates the authority to compel childhood vaccination to the California Department of Public Health, which the Legislature created last year and came to life July 1.

Hernandez's bill gives the final say on mandating vaccines recommended after Jan. 1, 2006, including Gardasil, up to the state public health officer, who heads the new agency. So now, instead of the Legislature making decisions that should be left up to parents, a new bureaucracy would get to make those decisions.

Gov. Arnold Schwarzenegger appointed Dr. Mark Horton the first state public health officer. Horton's position on Gardasil is not hard to discern. Last January, a state–issued press release quoted Dr. Horton as saying, "Preteen Vaccines Week highlights California's commitment to ensuring that our kids get immunized so they can avoid serious, but preventable infections and reach their full potential." The release then lists the HPV vaccine as one of the vaccines the federal government recommends for all 11– and 12–year– olds.

The Hernandez bill allows parents to have their children opt–out of vaccinations if they meet certain requirements. But, as Karen England, executive director of the Capitol Resource Institute, a parental–rights group, put it, "An opt–out provision is simply the government telling me that they have taken away my parental rights, and in order to regain them I must file an affidavit with the school."

Even the bill's one redeeming feature, its prohibition against mandating vaccines until they've been on the market for five years, does little to assuage the scientific and practical concerns about mandating Gardasil.

The question shouldn't be how effective is Gardasil. The questions should be: How necessary is it, and what unintended consequences may follow from mandating its use?

While approximately half of all females ages 14 to 24 have some form of HPV, a recent study in the Journal of the American Medical Association finds that their rate for carrying HPV16 and 18 — the two variations of HPV that Gardasil is so effective at preventing — are astronomically lower: 1.5 percent and 0.8 percent, respectively, of those teens and women.

And according to the American Cancer Society, most HPV infections, even the carcinogenic ones, resolve without any treatment at all. Approximately 75 percent of HPV infections in adults and 90 percent of those in adolescents disappear on their own. Furthermore, when the precancerous lesions that HPV can (but rarely does) cause are detected early through Pap testing, treatment is generally simple, and the survival rate for the disease is over 90 percent.

Cervical cancer is the world's second–deadliest cancer for women, but only because women in developing countries don't have easy access to regular Pap tests. Eighty–three percent of the world's new cases and 85 percent of cervical–cancer deaths occur in developing countries. Unfortunately for Merck, that is not where the money is.

Gardasil could cause more harm than good by creating a false sense of security. Gardasil doesn't protect against 16 or more types of HPV, responsible for 30 percent of cervical cancers, and women may not realize the necessity of continuing regular Pap tests even once vaccinated. As a result, many precancerous conditions may go undetected until it's too late.

Drug trials on Gardasil followed women for an average of about three years, so we know little of how long the immunity lasts or the long–term risks that may be associated with being vaccinated. Children vaccinated at 12 could potentially lose their immunity before finishing high school.

Whether the order comes from the Legislature or a bureaucrat, mandating HPV vaccines in California may very well be in no one's best interest except Merck's.

Given FDA safety and efficacy standards, it takes on average 12 to 15 years and over $800 million for a company (and most are American) to develop a new drug. But only the U.S. market is free. Abroad, pharmaceutical companies must negotiate prices with socialized medical systems. As a result, foreigners usually pay far less than Americans for their patented drugs. Americans bear the lion's share of R&D costs, subsidizing socialized medical systems in the process, while foreigners are classic "free riders."

When Americans go online, however, or go abroad for cheaper drugs, they encounter the reimportation ban Congress enacted in 1987. Thus the repeated calls, especially from seniors, for lifting the ban, which the Senate measure would do.

But there's also another side. Quite apart from foreign price controls, companies face varying levels of demand and ability to pay, which would lead them in any event to segment markets and price differentially, just like airlines, theaters, and many others do. Whether it's due to foreign price controls or to the perfectly legitimate wish to maximize profits, therefore, companies are going to charge different prices in different markets.

To maintain that market segmentation, however, they have to guard against "parallel markets" -- vendors in low-price markets reselling the drugs (at a profit) to high-price markets. If they don't, their low-price vendors will out-compete them for their own drugs. That's where the reimportation ban comes in. It keeps drugs sold at low prices abroad from coming back and flooding the American market.

The problem with that statutory solution, however, is that it's inconsistent with free market principles. It's a public law solution to a private law problem. If companies want or need to preserve their segmented markets, the right way to do it is through no-resale contracts or, if those prove difficult to enforce or illegal (as in Europe), limitations on supply.

But there, precisely, is where this Senate measure intrudes. It would lift the ban on reimporting drugs from a limited number of developed countries, where drug safety is not an issue. But rather than let markets sort the matter out thereafter -- whether they'd remain segmented, or prices would tend toward equilibrium, we don't know -- this bill would prohibit American companies from defending themselves against parallel markets. They would be prohibited from charging foreign exporters higher prices than they charge foreign firms that do not export. And they would be prohibited from limiting supplies to foreign firms that reshipped those lower-priced drugs back to the U.S. That's how Congress, unwilling itself to directly impose price controls on drugs, is trying to do so indirectly, by "importing" foreign price controls.

There's no question that Congress is responding here to popular will. But the long-term implications are palpable. If companies are forced by the U.S. government to continue supplying cheap drugs to countries from which they are then reimported to the U.S. -- crowding out the higher-priced domestic supply of drugs -- it's only a matter of time until profits are insufficient to support the enormous costs of R&D for future drugs. No one wants to kill that golden goose, but there it is.

The better answer is to simply lift the reimportation ban from a limited number of developed countries and then let the market play out. No one knows for sure how that would work, not least because there are complex and unresolved patent and treaty issues that loom in the background. But at the least, with the ban lifted and the threat of reimportation before them, companies would have far greater incentive than they now have to engage in hard bargaining with foreign governments over prices, no-resale contracts, and supply limits. And under current treaty law, developed countries could not engage in the "compulsory licensing" that would undermine company patents.

Opponents of this measure, as usual, are falling back on the safety issue, despite inspection, packaging and other provisions that address it very well. Thus, a vote is expected today on an amendment by Senator Thad Cochran (R., Miss.) that would require the administration to certify the safety of imported drugs and determine the economic benefit of reimportation, something the administration has said it cannot do, despite a recent Congressional Budget Office report to the contrary. If defeated, a vote will be taken on the reimportation amendment itself. The administration and its remaining supporters in Congress would be better advised to go to the principle of the matter.

Congress created the problem in the first place when it ignored principle and imposed the ban. It's time now to correct that problem, not by ignoring principle again and creating an even greater problem -- undercutting the market's production of miracle drugs -- but by opening up the market, thereby inviting foreign nations to contribute more equitably to the development of those drugs.

Rep. Phil Gingrey, R-Ga., recently introduced a bill to prohibit the use of federal funds for implementing mandatory state vaccination programs against human papillomavirus, or HPV. The vaccine in question is Gardasil, which protects against four types of HPV, two of which are responsible for 70 percent of cervical cancer cases. The FDA approved Gardasil last year for use against HPV in females ages 9 to 26. With a price tag of $360 for a series of three shots, Gardasil is one of the most expensive vaccines on the market.

Both whether such a vaccine should be mandated and the value of administering it in the first place have come under scrutiny. Gingrey's legislation would inject some honest discussion into a debate that has been skewed by financial interests, both on the part of state governments and vaccine companies.

Gingrey, who is an OB-GYN, stated, "I understand the importance of protecting Americans from sexually transmitted diseases, and I applaud the development of an HPV vaccine. But for states to mandate vaccination for young women is both unprecedented and unacceptable."

The proper role of states, Gingrey said, is to "require vaccinations for communicable diseases, like measles and the mumps. But you can't catch HPV if an infected schoolmate coughs on you or shares your juice box at lunch. Whether or not girls get vaccinated against HPV is a decision for parents and physicians, not state governments."

As Gingrey so aptly points out, the efforts to pass mandatory HPV vaccination laws are "unprecedented and unacceptable." But then, why is there such a huge push to pass such laws?

State governments and Merck, the patent holder on the only HPV vaccine currently on the market, both have good reasons for seeking mandatory vaccination — and they have little or nothing to do with the merits of the vaccine.

The lure of free money from the federal government has certainly influenced some state legislators. When a reporter asked Giovanni Casanova, an aide to Florida state Sen. Mike Fasano, why Fasano is arguing so strongly in favor of mandatory vaccination, Casanova said, "So that Florida can get more money from the federal government to help pay for vaccines. ..."

According to state records, Merck's lobbying efforts to convince lawmakers to make its HPV vaccine mandatory total $500,000 in New York , $40,000 in Virginia, and $150,000 to $250,000 in Texas.

Merck refuses to reveal what it has spent lobbying for Gardasil, but with time its contributions in other states will undoubtedly also become public. Whatever the eventual total, there is a great deal of money at issue, and it is self-evident that no one spends that kind of money unless they anticipate huge financial gains.

It's time for state legislatures to stop letting money do the talking and listen to their consciences. The HPV vaccine is new, expensive and relatively untested. It may have unknown or unintended consequences. In 1976, the government mandated swine flu vaccinations. Fewer than half the population was vaccinated and the vaccine ended up killing more people than the flu.

Finally, only last week, the New England Journal of Medicine reported that the vaccine we gave many of our children against chickenpox has an ever-growing break-through rate and vaccinated children who are getting ill are being struck much harder by the disease than those who were never vaccinated.

So kudos to Gingrey. With all that we don't know, and what little we do, parents, not states, should be weighing the costs and benefits of vaccinating their children against HPV.]]> Thu, 29 Mar 2007 00:00:00 EDT http://www.cato.org/pub_display.php?pub_id=8164 http://www.cato.org/pub_display.php?pub_id=8151 There's nothing wrong with drug makers publicizing their products, but the lure of lucrative government contracts can prompt them to play fast and loose. In lobbying state lawmakers to make its latest vaccine mandatory, Merck has greatly exaggerated both the threat of a disease and the ability of a drug to prevent it. (True, Merck has promised to stop lobbying, but lawmakers and the public are still suffering under misconceptions that the drug company has done nothing to correct.)

The drug in question is Gardasil, a vaccine for four types of human papillomavirus, or HPV, two of which are responsible for 70 percent of cervical cancer cases. The Food and Drug Administration approved Gardasil last year for use against HPV in females aged 9 to 26.

Assemblywoman Amy Paulin, a Democrat whose district includes Bronxville, Eastchester, Pelham, Pelham Manor, Scarsdale, Tuckahoe and parts of New Rochelle and White Plains, recently introduced a bill mandating HPV vaccinations for "children born after Jan. 1, 1996." (For now, this bill only applies to girls. If the Food and Drug Administration approves its use for boys, they will be included in the legislation.)

Such mandates are a boon for Merck, as Gardasil is one of the most expensive vaccines on the market. With a price tag of $360 for a series of three shots, vaccination of nearly two million New York children would bring in almost $700 million.

Gardasil is not all it's cracked up to be. A recent study published in The Journal of the American Medical Association found that among women ages 14 to 24, the rate of all 37 types of sexually transmitted HPV combined is 33.8 percent — much lower than the 50 percent figure cited on Merck's Web site. More important, the rates for HPV 16 and 18 — the two types responsible for 70 percent of all cervical cancers — are astronomically lower: only 1.5 percent and 0.8 percent, respectively.

And among those cases, American Cancer Society guidelines published last month report that most HPV infections, even carcinogenic ones, resolve without treatment. About 75 percent of infections in adults and 90 percent of those in adolescents disappear on their own.

It's worth noting that the American Cancer Society sees its fight against cervical cancer as a success story even without Gardasil. When the disease is detected early through Pap testing, the survival rate is more than 90 percent.

In short, even without the vaccine, when early detection methods are used, the number of girls who are actually at risk of dying of cervical cancer from HPV 16 or 18 is extremely low. Most of the time, the body takes care of the virus without any help whatsoever.

Under these circumstances, are we really prepared to spend millions of dollars administering this vaccine for girls, let alone boys? In truth, it may well cause more harm than good.

For instance, what if the vaccine lulls young women into a false sense of security? Gardasil protects only against the viruses responsible for some cervical cancers, and women may not realize they need regular Pap tests even though they've been vaccinated. As a result, many precancerous conditions may go undetected until it's too late.

Merck's drug trials followed women who received Gardasil for an average of only three years, so we know little of how long the immunity lasts or the long-term risks that may be associated with it.

Earlier this month, The New England Journal of Medicine reported similar problems with the chickenpox vaccine. Not only did the incidence of illness among those vaccinated against chickenpox increase over time, so did the severity of the illness.

And what if the HPV vaccine causes some horrible side effect to materialize later? The possibility isn't as far-fetched as you might think. In 1976, swine influenza caused only one documented death in the United States, but the vaccine administered by government mandate seriously injured or killed hundreds. It turned out that the vaccine caused Guillain-Barré syndrome, a rare paralytic disease similar to polio, with a 5 percent fatality rate and a 10 percent rate of permanent paralysis.

Mandatory Gardasil vaccinations certainly brighten Merck's future, but it's not so clear that they're in the best interest of New Yorkers. In all but the clearest cases, health-risk assessments should be left up to individual families, not only because making such determinations rightly rests with families, but because it's simply not sensible policy to experiment on such a large portion of our population all at once.

Not only has Merck left lawmakers in the dark about possible downsides to mandatory HPV vaccination, it has actively lobbied and paid large campaign contributions to politicians willing to support it.

According to records from New York's temporary state commission on lobbying, Merck spent almost $400,000 influencing representatives from 2003 to 2006. Though Assemblywoman Paulin appears to have received only $500 from the company, she met personally with its representatives on several occasions.

This is not to say that Ms. Paulin doesn't sincerely believe that vaccinations are the right policy. But she and her fellow Assembly members should realize that while mandating HPV vaccinations would reap huge profits for the company, they might well come at the expense of New York's children.

The drug in question is Gardasil, a vaccine for four types of human papillomavirus, two of which are responsible for 70% of cervical cancer cases. The FDA approved Gardasil last year for use against HPV in females aged 9 to 26.

Late last month, the Virginia legislature passed a bill requiring all Virginia girls to be vaccinated against HPV before entering sixth grade. Governor Tim Kaine told the Washington Post that he plans to sign the bill, but he hasn't yet done so. Maybe he's having second thoughts -- which he should, considering the most recent data on HPV and Gardasil -- but if he doesn't veto the bill by midnight on Monday, it will automatically become law.

Virginia is only one in a series of states considering similar mandates, which are quite a boon for Merck, as Gardasil is one of the most expensive vaccines on the market. With a price tag of $360 for a series of three shots, vaccinating Virginia's sixth graders would cost about $19 million a year.

Gardasil is not all it's cracked up to be. A recent study in the Journal of the American Medical Association finds that among women ages 14 to 24, the rate of all 37 types of sexually transmitted HPV combined is 33.8% -- much lower than the 50% figure cited on Merck's website. More importantly, the rates for HPV 16 and 18 -- the two types responsible for 70% of all cervical cancers -- are astronomically lower: only 1.5% and 0.8%, respectively.

And even among those cases, American Cancer Society guidelines published last month report that most HPV infections, even carcinogenic ones, resolve without treatment. Approximately 75% of infections in adults and 90% of those in adolescents disappear on their own.

It's worth noting that the American Cancer Society sees its fight against cervical cancer as a success story even without Gardasil. When detected early through Pap testing, the survival rate for the disease is over 90%.

In short, even without the vaccine, when early detection methods are used, the number of girls who are actually at risk of dying of cervical cancer from HPV 16 or 18 is extremely low. Most of the time, the body takes care of the virus without any help whatsoever.

Under these circumstances, is the Virginia legislature really prepared to spend untold millions administering this vaccine? In truth, it may well cause more harm than good.

What if the vaccine lulls young women into a false sense of security? Gardasil only protects against the viruses responsible for 70% of cervical cancers, and women may not realize the necessity of regular Pap tests even when they've been vaccinated. When women go for an annual Pap test, they are getting a general check-up, not just a test for cervical cancer. As a result, many pre-cancerous conditions for anything from cervical cancer to breast cancer may go undetected, before it's too late.

Merck's drug trials followed women who received Gardasil for an average of less than three years, so we know little of how long the immunity lasts or the long-term risks that may be associated with it. Children vaccinated in middle school could potentially lose their immunity by the time they were seniors in high school.

Only last week, the New England Journal of Medicine reported similar problems with the chickenpox vaccine. Not only did the incidence of illness among those vaccinated against chickenpox increase over time, so did the severity of the illness itself.

And what if some horrible side effect were to materialize later? The possibility isn't as far fetched as you might think. In 1976, swine flu caused only one documented death in the U.S., but the vaccine administered by government mandate seriously injured or killed hundreds. It turned out that the vaccine caused Guillain-Barre Syndrome, a rare paralytic disease similar to polio, with a 5% fatality rate and a 10% rate of permanent paralysis.

Mandatory Gardasil vaccinations certainly brighten Merck's future, but it's not so clear that they're in the best interest of Virginians. As a result, many pre-cancerous conditions may go undetected before it's too late. In all but the clearest cases, health risk assessments should be left up to individual families, not only because making such determinations rightly rests with families, but because it's simply not sensible policy to experiment on such a large portion of our population all at once.

Mandating HPV vaccinations would bring Merck huge profits, at the expense of ordinary Virginians -- or at least at the expense of Virginia's little girls.

The drug in question is Gardasil, a vaccine for four types of human papillomavirus, two of which are responsible for 70 percent of cervical cancer cases. The U.S. Food and Drug Administration approved Gardasil last year for use against HPV in females aged 9 to 26. Texas, New Mexico and Virginia have all recently mandated HPV vaccination, and Colorado might be next.

Sen. Suzanne Williams, D-Aurora, is pushing Senate Bill 80, which would require that girls be given the HPV vaccine before they turn 12 or they would not be permitted to attend school.

With a price tag of $360 for a series of three shots, mandatory vaccination would be quite a boon for Merck. If all 11- and 12-year-old Colorado girls were vaccinated, the company could reap almost $150 million.

Gardasil is not all it's cracked up to be. A recent study in the Journal of the American Medical Association finds that among women ages 14 to 24, the rate of all 37 types of sexually transmitted HPV combined is 33.8 percent - much lower than the 50 percent figure cited on Merck's website. More importantly, the rates for HPV 16 and 18 - the two types responsible for 70 percent of all cervical cancers - are astronomically lower: only 1.5 percent and 0.8 percent, respectively. And even among those cases, last month's American Cancer Association guidelines report that most HPV infections, even carcinogenic ones, resolve without treatment. Approximately 75 percent of infections in adults and 90 percent of those in adolescents disappear on their own.

It's worth noting that the American Cancer Society sees its fight against cervical cancer as a success story even without Gardasil. When detected early through Pap testing, the survival rate for the disease is over 90 percent.

In short, even without the vaccine, when early detection methods are used, the number of girls who actually are at risk of dying of cervical cancer from HPV is extremely low. Most of the time, the body takes care of the virus without any help whatsoever.

Under these circumstances, are we really prepared to spend untold millions administering this vaccine? In truth, the vaccine may very well cause more harm than good.

What if the vaccine lulls young women into a false sense of security? Gardasil only protects against the viruses responsible for 70 percent of cervical cancers, and women may not realize the necessity of regular Pap tests even when they've been vaccinated. As a result, many pre-cancerous conditions may go undetected before it is too late.

Merck's drug trials followed women who received Gardasil for an average of less than three years, so we know little of how long the immunity lasts or the long-term risks that may be associated with it. Children vaccinated in middle school could potentially lose their immunity by the time they were seniors in high school.

And what if some horrible unexpected side-effect were to materialize later? The possibility isn't as far fetched as you might think. In 1976, swine flu caused only one documented death in the U.S., but the vaccine administered by government mandate seriously injured or killed hundreds. It turned out that the vaccine caused Guillain-Barré Syndrome, a rare paralytic disease similar to polio, with a 5 percent fatality rate and a 10 percent rate of permanent paralysis.

Mandatory Gardasil vaccinations certainly brighten Merck's future, but it's not so clear that they're in the best interest of the public. In all but the most clear cases, health risk assessments should be left up to individual families, not only because making such determinations rightly rests with families, but because it's simply not sensible policy to experiment on such a large portion of our population all at once.

Mandating HPV vaccinations would bring Merck huge profits, all right, but they might well come at the expense of ordinary Coloradans - or at least at the expense of Colorado's little girls.

The drug in question is Gardasil, a vaccine for four types of human papillomavirus, two of which are responsible for 70 percent of cervical cancer cases. The Food and Drug Administration approved Gardasil last year for use against HPV in females aged 9 to 26. Texas, New Mexico and Virginia have all recently mandated HPV vaccination, and it looks like Florida might be next.

Two bills, one introduced in the Senate by Mike Fasano, a Republican from Pasco County and majority whip, and another introduced in the House by Ed Homan, a Republican from Hillsborough, would require 11- and 12-year-old girls to provide proof of vaccination for HPV to enter school. According to Fasano's office, the Senate bill is on the education committee docket for today.

With a price tag of $360 per series of three shots, mandatory vaccination would be quite a boon for Merck. If every 11- and 12-year-old Florida girl were vaccinated, the company stands to reap almost $200 million.

Gardasil is not all it's cracked up to be. A recent study in the Journal of the American Medical Association finds that among women ages 14 to 24, the rate of all 37 types of sexually transmitted HPV combined is 33.8 percent - a number already much lower than the 50 percent figure cited on Merck's website. More importantly, the rates for HPV 16 and 18 - the two types responsible for 70 percent of all cervical cancers - are astronomically lower: only 1.5 percent and 0.8 percent, respectively.

And even among those cases, the American Cancer Association guidelines reported last month that most HPV infections, even carcinogenic ones, resolve without treatment. Approximately 75 percent of infections in adults and 90 percent of those in adolescents disappear on their own.

It's worth noting that the American Cancer Society sees its fight against cervical cancer as a success story even without Gardasil. When detected early through Pap testing, the survival rate for the disease is over 90 percent.

In short, even without the vaccine, when early detection methods are used, the number of girls who are actually at risk of dying of cervical cancer from HPV is extremely low. Most of the time, the body takes care of the virus without any help whatsoever. The only logical and cost-effective policy is to encourage regular Pap tests so cancer can be detected early if it ever materializes.

Under these circumstances, are we really prepared to spend untold millions administering this vaccine? In truth, it may well cause more harm than good.

What if the vaccine lulls young women into a false sense of security?

Gardasil only protects against the viruses responsible for 70 percent of cervical cancers, and women may not realize the necessity of undergoing regular Pap tests even when they've been vaccinated.

Merck's drug trials followed women who received Gardasil for an average of less than three years, so we don't know either how long the immunity lasts or the long term risks that may be associated with it.

Mandatory Gardasil vaccinations certainly brighten Merck's future, but it's not so clear that they're in the best interest of Floridians. In all but the clearest cases, health risk assessments should be left up to individual families, not only because making such determinations rightly rests with families, but because it's simply not sensible policy to experiment on such a large portion of our population all at once.

The drug in question is Gardasil, a vaccine for four types of human papillomavirus, two of which are responsible for cervical cancer. The federal Food and Drug Administration approved Gardasil last year for use against human HPV in females aged 9 to 26. By a veto-proof majority of 119 to 21, the Texas House of Representatives voted last week against mandating Gardasil for middle school-aged girls, but the Texas Senate has yet to weigh in on the issue, and Gov. Rick Perry is expected to veto the bill.

If he does — and the Texas Legislature doesn't have the votes to override his veto — then his earlier executive order mandating vaccination will stand.

These mandates would be quite a boon for Merck, as Gardasil is one of the most expensive vaccines on the market. With a price tag of $360 for a series of three shots, vaccinating approximately 30 million middle school-aged girls in the United States would bring in more than $10 billion.

Gardasil is not all it is cracked up to be. A recent study in the Journal of the American Medical Association indicates that among women ages 14 to 24, the rate of all 37 types of sexually transmitted HPV combined is 33.8 percent — already a number much lower than the 50 percent figure sited on Merck's Web site. But the rates for the two types of HPV responsible for 70 percent of all cervical cancers (16 and 18), are far lower: only 1.5 percent and 0.8 percent, respectively.

The American Cancer Society sees its fight against cervical cancer as a success story even without Gardasil. When detected early through Pap testing, the survival rate for cervical cancer is over 90 percent. Thus, when early detection methods are used, only around 0.2 percent of the girls being vaccinated are actually at risk of dying of cervical cancer from HPV 16 or 18 even without the vaccine.

Under these circumstances, are we really prepared to spend $10 billion administering this vaccine?

And while it's horrible that anyone at all should die of cervical cancer, the long-term risks that may be associated with Gardasil are totally unknown. Studies followed the women who participated in drug trials for an average of less than three years. What if some horrible unexpected side effect materializes?

This possibility isn't as far fetched as you might think. In 1976, swine flu caused only one documented death in the United States, but the vaccine administered by government mandate seriously injured or killed hundreds. It turned out that the vaccine caused Guillain-Barré Syndrome, a rare paralytic disease similar to polio, with a 5 percent fatality rate and a 10 percent rate of permanent paralysis.

Mandatory Gardasil vaccinations would certainly brighten Merck's future, but it's not so clear that they're in the best interest of American girls. In all but the clearest cases, health risk assessments should be left up to individual families, not only because making such determinations rightly rest with families, but because it's simply not sensible policy to experiment on such a large portion of our population all at once. What if, 10 years from now, we discover that the vaccine causes infertility or another form of cancer?

To add insult to injury, not only has Merck left Texas lawmakers in the dark about the myriad of possible downsides to mandatory HPV vaccination, it has actively lobbied and paid large campaign contributions to politicians willing to support such policies.

According to documents obtained by the the Associated Press last month, Merck donated $5,000 to Gov. Perry on the same day his chief of staff met with his budget director for an "HPV vaccine for Children Briefing."

To the casual observer, it looks a lot like Merck is paying politicians to do its bidding. Mandating HPV vaccinations would bring Merck huge profits, possibly at the expense of ordinary Texans — or at least at the expense of little girls.

The case is far from finished, however: On remand, the FDA will try to show that its prohibition is, in the jargon of such things, "narrowly tailored" to serve a "compelling governmental interest." Still, the court's reasoning in the case -- Abigail Alliance for Better Access to Development Drugs v. Eschenbach -- is rich with implications for medical freedom and constitutional jurisprudence.

For most of our history, as Judge Judith Rogers explained (joined by Chief Judge Douglas Ginsburg), individuals were free to take whatever medication they wanted without a doctor's prescription. It was only in 1951 that Congress created a category of prescription drugs; and, in 1962, it began requiring drug companies to conduct extensive tests to ensure the efficacy of their products. That led to long delays in the release of potentially lifesaving drugs, and to the deaths of countless patients who would gladly have borne the unknown risks for a chance at life.

The Abigail Alliance (named after Abigail Burroughs, a 21-year-old college student who died of cancer) petitioned the FDA on behalf of its terminally ill members, seeking access to drugs that had cleared Phase I of the lengthy testing process. (That's the point at which a new drug is deemed sufficiently safe for more extensive human testing.)

When that effort failed, the alliance sued to stop the FDA from barring the sale of such drugs to its members. (It was joined in its action by the conservative public interest law firm, the Washington Legal Foundation.) The district court dismissed the suit, saying that under the Fifth Amendment -- which prohibits government from depriving people of life, liberty or property without due process of law -- it could find no such right as the alliance was claiming.

Not so, said the appeals court. It found the right -- and found it "in" the Constitution. Given the state of constitutional jurisprudence today, that was no mean feat. Here's why.

At the time the Constitution was sent to the states for ratification, several states balked, insisting that a bill of rights be added. But no such bill could list all of our rights. The failure to do so, however, raised the implication that only the enumerated rights were meant to be protected.

So the Framers gave us the Ninth Amendment, which states that we have unenumerated rights, too -- effectively giving the courts authority to fill in the blanks. But that creative power is hardly unique to the Ninth Amendment: Even enumerated rights -- such as speech, property, due process -- require judicial interpretation.

When they authorized judicial review, the Framers assumed that judges would have a grasp of the Constitution's natural rights and common law foundations. Unfortunately, today's judges are far removed from those foundations. The result is confusion, and divisive controversies.

Liberal judges, often hostile toward our founding principles, invent rights by drawing on their own conceptions of evolving social values. Reacting to the perceived judicial activism, conservative judges go overboard the other way, recognizing only those rights expressly "in" the Constitution -- thus ignoring the presumption of individual liberty at the very foundation of the document. Neither side gets it right. The Constitution no more authorizes judges to invent rights from whole cloth than it allows them to ignore rights plainly meant to be protected.

The D.C. circuit got it right in Abigail. Recognizing, first, that the Due Process Clause has long protected substantive rights, the court noted two distinct approaches in the Supreme Court's rights jurisprudence. One, based in "personal dignity and autonomy," has led the court (sometimes wrongly) to prohibit state intrusion in "the bedroom, the clinic, and the womb" -- e.g., abortion. The other approach, more restrictive, finds a right only if it is "deeply rooted in the Nation's history and tradition."

Carefully following this more restrictive approach (to avoid the charge of activism), the court noted the precise description of the right the Abigail Alliance claimed, and then traced the history in America of the more generally described rights from which it is derived -- the right to potentially life-saving medication, the right to control one's body, the right to self-preservation and the right to life.

Finding those rights in the centuries-old common law, the court concluded that, in contrast to those ancient principles, it is the FDA's regulation of access that is new. Accordingly, if there is a fundamental right to refuse life-sustaining treatment, as the Supreme Court had found in 1990, there is, equally, a right to seek life-sustaining medication free from government interference.

That's hardly pulling a right "out of thin air," as the Washington Post charged editorially in its defense of FDA bureaucrats. It is not the freewheeling stuff of Roe v. Wade, but rather the careful mining of Locke, Blackstone and Madison.

To the layman, such judicial hermeneutics must seem tedious, for a simple question should settle the matter: Whose life is it, anyway? That it doesn't is a mark of how far we've strayed from our founding principles. Statutory schemes today have replaced common law, policy has replaced principle -- and transient majorities tell us what our rights are.

Well, that may be changing. Last year the Canadian Supreme Court struck down two Quebec laws that banned private payment for services covered under its Medicare program (if you live long enough to receive them), as violating constitutional guarantees to life, liberty and security of person. In this country, with often well-to-do baby-boomers aging, access to health care will be a growing issue. Costs aside, demands simply for access -- and for medical freedom -- may yet breathe life into an ailing Constitution.

The Medicare drug benefit will soon set a dangerous trap. In January 2006 the federal government is scheduled to start purchasing prescription drugs for more than 40 million seniors and disabled Americans through that new addition to the Medicare program. The enormous tax burden that will be required to fund the drug benefit will put constant pressure on politicians to limit spending. Some observers argue that the federal government should dictate the prices it pays for drugs. Though cloaked in the rhetoric of "negotiated prices," such proposals in fact amount to price controls. Unless the new benefit is delayed or repealed, it will set the stage for Congress to enact price controls on pharmaceuticals.

Economic theory and empirical evidence show that price controls cause enormous harm. Existing federal price controls have already cost Americans an estimated 140 million life-years. Applying such controls to Medicare purchasing would eliminate approximately 40 percent of all future pharmaceutical research and development and cost another 277 million life-years.

Rather than attempt to fix drug prices, Congress should reform Medicare by converting it to a program that provides premium support for the purchase of private insurance policies offering a broad array of options, including prescription drug coverage. Washington also should pressure other nations to lift their price controls, encourage patients to be more careful drug purchasers, and reduce unnecessary regulatory costs by reforming the federal Food and Drug Administration.

In the meantime, Congress should contain the spread of pharmaceutical price controls by delaying or repealing the Medicare drug benefit before it takes effect.

A lot of people around town made some tough decisions in crafting this program and enacting it into law. Here are a few reasons why they might now want to reconsider those decisions.

1. We can't afford it. Rep. John Boehner (R-Ohio) put it well: "Listen, we're broke. Let's face it." According to the Congressional Budget Office (CBO), the federal government is looking at deficits in excess of $300 billion for the foreseeable future. The budget resolutions working their way through Congress would save at most $50 billion, which would not noticeably change the five-year growth in the national debt ($1.6 trillion). By contrast, delaying implementation of the full Medicare drug program would save an estimated $84 billion in two years.

2. We really can't afford it. Medicare's financial outlook gets even worse at the end of the current five-year budget window. As U.S. Comptroller General David Walker put it last week, "We were already in the hole 15 to 20 trillion dollars before Medicare Part D was enacted, and that's just for Medicare. And we added another [$8 trillion]. If that's not imprudent, I don't know what is." Absent any changes, by 2008 financing Medicare would require a tax increase whose total cost would equal nearly 25 percent of wages.

3. It is poorly targeted. Many of the program's subsidies will go to those who are not exactly needy — to wealthy as well as poor seniors. According to the CBO, three-fourths of senior citizens already have drug coverage. Millions of those seniors will move into the Medicare drug program, where taxpayers will pay bills that seniors and employers are already paying themselves.

4. It is corporate welfare. A back-of-the-envelope estimate (based on CBO numbers) shows that employers will receive direct subsidies of $150 billion over the first 10 years of the program. Taxpayers will cut those corporations a check just for providing the drug coverage they are already providing.

But the program also includes indirect corporate welfare, in that it enables firms to drop their retirees onto the Medicare rolls, as J.C. Penney and Jostens have already done. The CBO estimates that fate will befall nearly 3 million seniors. Another back-of-the-envelope estimate: that adds another $44 billion in corporate welfare.

5. It invites price controls. The cost of this program will lead to perpetual calls for price controls on prescription drugs. Such measures would rob future generations of miracle cures, leaving them exposed to greater pain and suffering.

6. Congress approved the program without all the facts. In 2003, Medicare's chief actuary estimated this program would cost significantly more than Congress believed. Yet his estimates were withheld from the public until after the program became law. That and other aspects of the program's history fell short of the Contract with America's promise to give legislation "a clear and fair vote."

Two House Republicans who voted yea now support delay — a significant loss for a program enacted by a slender five-vote margin. Many more privately sympathize.

7. This may be the only way to make a dent in the deficit. Rep. Tom DeLay (R-Texas) correctly notes that Republicans are receiving almost zero help from Democrats in imposing fiscal restraint. Delaying the drug program, however, is probably the only way that Republicans can get Democrats to help reduce government spending.

8. Seniors aren't angry — yet. Medicare's 1966 rollout probably made new entitlements look easy. About half of seniors already had coverage, but switching them to Medicare took little convincing. Medicare offered a single plan with generous coverage and few restrictions.

Today, more seniors may have to give something up. There are also more choices to make; the drug plans have numerous, unique and shifting coverage restrictions. And seniors are generally older today, which means many more are ill-equipped to make such complex decisions. The grumbling has already begun.

Some of these factors helped doom the Medicare Catastrophic Act (b.1988-d.1989). And that law didn't even have a doughnut hole, in which an estimated 4 million seniors will find themselves without drug coverage on Election Day in 2006.

Thomas Jefferson once wrote to George Washington, "Delay is preferable to error." Responsible members of both parties have an opportunity to choose the better of these two options.

Please, before we swallow this pill.

That's an understatement.

Congress faces annual deficits of $300 billion for the foreseeable future, requests of $200 billion for hurricane relief, and an imminent explosion in entitlement spending. Acknowledging this reality, a growing number of legislators including U.S. Sen. John McCain, R-Ariz., are calling for the delay or cancellation of the Medicare prescription drug entitlement scheduled to take effect in January. It's easy to see why.

Come January, taxpayers will finance drug coverage for all 40 million seniors on Medicare, even though 75% of seniors already have coverage. The program, estimated to cost $850 billion in the first 10 years, includes massive corporate welfare, invites harmful price controls on pharmaceuticals, and was enacted under an ethical cloud. It also imposes on taxpayers an unfunded liability larger than that of the entire Social Security program. If ever a government program were a candidate for repeal, the Medicare drug program is it.

Accordingly, when House conservatives issued a menu of proposed spending cuts last month, the cornerstone was a one-year delay of that program. This month, McCain called on colleagues to "at least delay" the program for two years, which would save $84 billion.

McCain was joined by U.S. Reps. Jim Cooper, D-Tenn., and Jeff Flake, R-Ariz., who recommended dismantling this fiscal time-bomb and starting over. So far, two Republicans who voted for the program -- U.S. Reps. Jeb Hensarling, R-Texas, and Dave Weldon, R-Fla. -- have come out in support of delay. Those are significant defections from a law that passed the House with two votes to spare.

In private, many more Republicans are inclined to support delay or repeal. Yet few have come forward because of fierce opposition from the business community and the Bush administration.

Employers rarely admit it, but they are petrified at the thought of losing some $150 billion in corporate welfare included in the program. Instead, their lobbyists argue that employers are planning changes to retiree benefits that would be tough to reverse, and Medicare has already spent hundreds of millions of dollars to educate seniors. Yet seniors are supposed to enroll in this program in mid-November and most are still overwhelmed by the program's complexity.

Although delay would cause some disruption, the program itself will cause much more. Many seniors will lose the drug coverage they now enjoy, and continuous shifts in coverage could mean they lose coverage of the drugs they need. Moreover, rank-and-file Republicans may decide that repeal is necessary to save their party from its leaders in 2006. A president's party typically loses seats in Congress halfway through his second term.

For the GOP, a number of factors will compound that handicap. Party leaders are having difficulty recruiting top-tier candidates for 2006. The conservative base is upset with the president, but also with Congress for its record spending binge.

Already, GOP candidates are putting distance between themselves and President George W. Bush. Worse, the drug program could foment an anti-Republican backlash. Many seniors will enter the voting booth angry over having lost their prior drug coverage. The Heritage Foundation estimates that by next November, 4 million seniors will be stuck in the program's infamous "doughnut hole" without any coverage.

GOP leaders say repeal is impossible. Political necessity may change their minds. It is also worth noting that repeal is a no-lose issue for perennial GOP insurgent John McCain.

Not only is repeal the right thing to do, it would strike a blow against the GOP establishment. But even an unsuccessful push benefits McCain. The more he has advocated repeal, the more open the GOP leadership has become to restraining spending in other areas. That puts McCain back in the good graces of conservatives and raises his profile in future Medicare debates, of which there will be many.

And pressing for repeal hardly alienates McCain's admirers on the left, who were never enamored of this program to begin with. McCain played a similar role in 1989, when a Democratic Congress quickly repealed another "done deal" after seniors made it painfully clear that they didn't like the change in their Medicare coverage or the higher premiums.

Republicans could spare themselves a world of pain by taking their medicine right now.