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.

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