Monday, June 15, 2009

Marlboro Protection Act

A Public Health Disaster in the Making

Wednesday, June 3, 2009

Congress is poised to pass one of the worst public health laws ever conceived.

Congress is poised to pass one of the worst public health laws ever conceived. There is no getting around the awfulness of HR 1256, which was passed by the House last month and is now being debated before the full Senate. The topic is Food and Drug Administration (FDA) regulation of tobacco. HR 1256 would create a new FDA division, supported by industry user fees, which would exercise sweeping control over the introduction, manufacturing, and marketing of all tobacco products. Existing products would be grandfathered in—no worries for the Marlboro Man—but new entrants would face something like the FDA’s famously demanding new drug approval standards, except the standards would be even tougher in one very important way to be described later.

HR 1256 pays almost no attention to the most fundamental point in all of tobacco control, if not all of public health: the distinction between tobacco smoke, which causes almost all the harms from smoking, and nicotine, whose dangers are roughly on the order of those from caffeine. Most smokers are interested in the nicotine, a fact that opens the door to all sorts of ways to reduce or practically eliminate the health harms from tobacco. HR 1256 goes in the wrong direction by encouraging the FDA to reduce nicotine yield, which would mean deeper inhaling and more harm rather than less.

Fortunately, there are already some products on the market that pose no more than a tiny proportion of the risks of traditional cigarettes. Smokeless cigarettes heat tobacco rather than burn it, delivering mainly nicotine and flavorings. And there are “smokeless tobacco” products, which are made from tobacco but are delivered by means of tiny pouches that usually dissolve in the mouth. The best-known smokeless niche is occupied by snus (rhymes with moose), which has been widely used in Sweden and is available in the United States but almost nowhere else because of prohibitions. Years of research have shown that the risks of snus are roughly 1 percent or 2 percent of the risks of traditional cigarettes, and maybe less, while both male smoking and lung cancer are at lower levels in Sweden than just about anywhere else. There has also been extensive research on improving traditional cigarettes by, for example, using better filters and altering tobacco itself to remove well-known carcinogens.

All these products involve trade-offs in the sense of sacrificing sensory experience or rapid, controlled flow of nicotine. Those things are greatly valued by many smokers. (Full disclosure: I’ve never smoked, so I’m relying on second-hand accounts.) That is one reason smoking rates have stuck stubbornly at about 15 percent to 20 percent in the United States and other advanced nations despite decades of antismoking information and campaigns and mammoth tax increases.

Most smokers are interested in the nicotine, a fact that opens the door to all sorts of ways to reduce or practically eliminate the health harms from tobacco.

The problem now is that it is almost impossible for manufacturers of safer products to tell consumers about why they are safer and why smokers should switch. The Federal Trade Commission (FTC), which regulates advertising, has resolutely enforced the prevailing views in the public health community, which has invested itself almost exclusively in a decades-long gamble to get smokers to quit rather than resort to safer tobacco use. Any suggestion in marketing materials that a product is safer—even one that emits no smoke whatsoever—is inevitably attacked by the antismoking watchdogs with FTC and FDA action a constant threat. The FDA does not have jurisdiction over tobacco products, of course, but products that are marketed (even indirectly) as a method to quit smoking are classified by the FDA as drugs, which cannot be sold until they pass through years of clinical trials and so forth. The nearly complete suppression of informative marketing of safer tobacco use has two consequences, both profoundly deleterious to the health of current and future smokers. It makes it almost impossible for manufacturers to provide the “reason why” messages that are the primary means for informing smokers of ways to reduce the harm from a difficult-to-quit habit. That impedes massive health-improving switching to safer products.

The upstream effects are even worse, because incentives to develop safer products are severely undermined if (to borrow a quote from the infinitely complicated history of cigarettes and health) “you build a better mousetrap and then they say you can't mention mice or traps.” The federal government has made the problem far worse by promoting the idea that all tobacco products, even smokeless ones, are equally unsafe.

Enter HR 1256, hundreds of pages of it. Two features would have devastating effects. One is the new tobacco product approval apparatus. Manufacturers would have to demonstrate that their products are not merely safer than some of the existing alternatives. They would have to demonstrate that once the products enter the market, they would not have undesirable second-order effects such as encouraging smokers to switch instead of quit, or encouraging non-smokers to start who otherwise would not have started.

Meeting this kind of standard would be extraordinarily difficult; it is nearly a recipe to discourage the development of almost any new product no matter how much safer it would be than what smokers now use. It moves the FDA far beyond the contours of drug regulation. Imagine that a dramatically effective new HIV drug could not be approved until the manufacturer demonstrated that the entry of the drug would not tempt some people into unsafe sex because they knew a better treatment could be used if worse came to worse. Suppose a better diabetes drug was kept on the sidelines while the manufacturer figured out how to show that the availability of the drug would not encourage obesity by discouraging weight loss and the like. No one wants the FDA to do that for drugs because we want better drugs, and we are willing to let consumers make their own decisions about how to revamp their lives accordingly. The imposition of this bizarre standard for new tobacco products reveals an intention to largely dispense with the task of reducing tobacco harm while demeaning the choices of smokers and potential smokers.

The product approval process would be greatly complicated by another of HR 1256’s innovations, the insertion of an outside board to participate in these decisions. The board almost certainly would be dominated by public health representatives who share a long-standing opposition to safer tobacco products and especially to any information about relative safety, stoked by the fear that even the safest products can wreak harm by impeding cessation and indirectly encouraging smoking.

None of this would apply to existing products, of course. The bigger the brand, the greater the benefit of this grandfathering arrangement. No wonder HR 1256 is called the “Marlboro Brand Protection Act.” No wonder the political breakthrough in getting FDA tobacco regulation came in 2004 when Philip Morris (now Altria) came out in support of FDA regulation; Altria remains a bulwark of support for HR 1256.

Imagine that a dramatically effective new HIV drug could not be approved until the manufacturer demonstrated that the entry of the drug would not tempt some people into unsafe sex because they knew a better treatment could be used if worse came to worse.

The same hostility to harm reduction infuses HR 1256’s provisions on marketing. Needless to say, advertising would become even rarer than it is today. The most important information—about the product’s risks and why it might be safer than something else—would be hemmed in by requirements of unknown rigor. Of course manufacturers would have to demonstrate to some degree the relative safety of their product. But most important, there would be another beyond-FDA-drug-regulation requirement to demonstrate that if smokers are told about a safer product, they will not react by failing to quit smoking and so on. Again, one wonders about how the pharmaceutical market would work if heart drug manufacturers had to prove whether telling consumers how to reduce the risk of heart attacks would adversely affect their lifestyle choices about diet and exercise.

Again, the grandfathering effect comes into play. What dominant brands fear most is aggressive marketing by competitors, especially competitors with a good safety story to tell. “Marlboro Brand Protection,” indeed.

Fortunately, there is dissent from all sorts of otherwise incompatible sources. Altria’s biggest competitors have been running full-page newspaper ads in opposition to HR 1256. But some stalwart antismoking figures are also in opposition. Professor Michael Siegel of the Boston University School of Public Health has a piece in today’s Los Angeles Times opposing HR 1256. The American Association of Public Health Physicians has vocally opposed HR 1256. So has William Godshall’s advocacy organization, Smokefree Pennsylvania, which logically enough is against measures that impede the substitution of smokeless for smoked.

Senators Richard Burr and Kay Hagan of North Carolina have introduced a bill that avoids the worst features of HR 1256 and has the virtue of lodging tobacco regulation in a separate agency and therefore avoiding the FDA, whose snail-like pacing in approving wider use of pure nicotine products has been deplorable. An even better alternative would be to unleash the FTC, whose regulatory philosophy is the simple toleration if not encouragement of truthful information in marketing. The FTC could regulate tobacco marketing like it regulates marketing for automobiles, computers, and just about everything else. It would require a reasonable basis for health claims. The standard can be tough when the stakes are high; you do not want to claim your car can stop in 100 feet from 60 mph unless you have solid evidence. But if the FTC were free of an implicit obligation to enforce what public health gurus want (sometimes including FDA staff), we could see an extraordinarily fruitful unleashing of methods for safer tobacco use and a consequent decline in the lamentable toll of cigarette smoking.

Jack Calfee is resident fellow at the American Enterprise Institute.

FURTHER READING: AEI held an event titled “Can Smokeless Tobacco Reduce the Health Consequences of Smoking?

Image by Flickr User Kevin Burkett found here.

Sunday, June 14, 2009

U.S. Clinton Administration Suppressed WHO cocaine report

From Transform Drug Policy Foundation:
The WHO cocaine report the U.S. didn't want you to see

The largest ever study of cocaine use around the globe was carried out in the early 90's by the UN World Health Organisation (WHO) and funded by the UN Inter-regional Crime and Justice Research Institute (UNICRI), but under pressure from the US its publication was suppressed when it became clear the report's findings were in direct conflict with the myths, stereotypes and propaganda that prop up the war on drugs (read the complete leaked report here).

In March 1995 WHO/UNICRI released a briefing kit summarising the key conclusions, as a curtain raiser to the report's imminent publication.

  • "Health problem; from the use of legal substances, particularly alcohol and tobacco, are greater than health problems from cocaine use.
  • Few experts describe cocaine as invariably harmful to health. Cocaine-related problems are widely perceived to be more common and more severe for intensive, high-dosage users and very rare and much less severe for occasional, low-dosage users." (pg. 1)

the coca plant

In a classic example of what happens when public health pragmatism collides with criminal justice dogma, just two months later, at the 48th World Health Assembly, the US representative to the WHO threatened to withdraw US funding for WHO research projects unless they 'would dissociate itself from the conclusions of the study' (read the relevant segment here). He said;

"The United States Government had been surprised to note that the package seemed to make a case for the positive uses of cocaine, claiming that use of the coca leaf did not lead to noticeable damage to mental or physical health, that the positive health effects of coca leaf chewing might be transferable from traditional settings to other countries and cultures, and that coca production provided financial benefits to peasants...

"... it [the US] took the view that the study on cocaine, evidence of WHO's support for harm-reduction programmes and previous WHO association with organizations that supported the legalization of drugs, indicated that its programme on substance abuse was heading in the wrong direction. The press package undermined the efforts of the international community to stamp out the illegal cultivation and production of coca, inter alia through international conventions.

"The United States Government considered that, if WHO activities relating to drugs failed to reinforce proven drug control approaches, funds for the relevant programmes should be curtailed. In view of the gravity of the matter, he asked the Director-General for an assurance that WHO would dissociate itself from the conclusions of the study and that, in substance abuse activities, an approach would not be adopted that could be used to justify the continued production of coca."

It's easy to see why the US would be so opposed to the study being published as it not only challenges a number of myths and stereotypes about cocaine use, but it is highly critical of a number of US-backed policies. The report specifically highlights the criticism that supply reduction and enforcement policies are not working and that alternatives needs to be explored;

"The largest future issue is whether international organisations, such as WHO and the United Nations Drug Control Programme, and national governments will continue to focus on supply reduction approaches such as crop destruction and substitution and law enforcement efforts in the face of mounting criticism and cynicism about the effectiveness of these approaches. Countries such as Australia, Bolivia, Canada and Colombia are now interested in examining a range of options to legalize and decriminalize the personal use and possession of cocaine and other related products. There needs to be more assessment of the adverse effects of current policies and strategies and development of innovative approaches." (pg. 30)

"The studies identified strict limitations to drug control policies which rely almost exclusively on repressive measures. Current national and local approaches which over-emphasize punitive drug control measures may actually contribute to the development of heath-related problems. An increase in the adoption of more humane, compassionate responses such as education, treatment and rehabilitation programmes is seen as a desirable counterbalance to the overreliance on law enforcement measures." (pg. 29)

The study also points out that 'anti-drug' campaigns are not necessarily effective, especially mass media campiagns based on scare tactics;

"Despite a broad range of educational and prevention approaches, most programmes do not prevent myths but perpetuate stereotypes and misinform the general public. Such programmes rely on sensationalized, exaggerated statements about cocaine which misinform about patterns of use, stigmatize users, and destroy the educator's credibility. This has given most education campaigns a na├»ve image and has reduced confidence in the quality and accuracy of these campaigns…" (pg. 23)

With regards to who uses cocaine, the study says,

"It is not possible to describe an "average cocaine user". An enormous variety was found in the types of people who use cocaine, the amount of drug used, the frequency of use, the duration and intensity of use, the reasons for using and any associated problems they experience.’"(pg. 1)

However it does usefully establish a continuum for use, noting that the majority of harms are accrued by the minority of users at the extreme of the continuum;

  • experimental use
  • occasional use
  • situation-specific use
  • intensive use
  • compulsive/dysfunctional use
Experimental and occasional use are by far the most common types of use, and compulsive/dysfunctional is far less common." (pg. 28)

The study additionally notes - in direct conflict with the accepted drug war paradigm that all use equals abuse - that:

"That occasional cocaine use does not typically lead to severe or even minor physical or social problems ... a minority of people start using cocaine or related products, use casually for a short or long period, and suffer little or no negative consequences, even after years of use. ... Use of coca leaves appears to have no negative health effects and has positive, therapeutic, sacred and social functions for indigenous Andean populations."

In addressing the rise in use, the report posits that key drivers are the drug's illicit status combined with both rising wealth (for cocaine powder) and increased poverty (for crack cocaine).

"The increasing attractiveness of cocaine in the past two decades may be related to:

  • the "glamour" of illicit drug use in general;
  • increased wealth allowing more people access to what they believe is the most glamorous of all illicit drugs;
  • widespread poverty or social disadvantage in countries such as the USA at a time when cheap coca preparations like crack have become widely available." (pg. 14)

The report was never officially published and according to the WHO it does not exist, however some of the project advisors are now pushing for it to be formally published. It has only emerged into the public domain because the relevant documents were leaked and found their way into the hands of the Transnational Institute drugs and democracy programme.

The suppression of this detailed, authoritative and independent report is yet more evidence of how certain governments, most conspicuously the US, have willfully refused to
develop rational drug policy based on science and evidence - and worse, when evidence emerges that challenges their political prerogatives and drug war ideologies they will resort to bullying, threats and censorship to ensure it is suppressed. This is anti-science drug war posturing of the worst kind, and can only lead to poor policy development with increased social and personal costs the inevitable result.

Transform has passed this report on to the forthcoming Home Affairs Select Committee inquiry on cocaine in the hope that it might usefully be used to inform policy discussions, albeit only at the UK level for now, and some 13 years late.

Also from Transform: