SRNT Newsletter, Vol. 6 No. 1,
April 2000


Reducing harm

Scientists' input is crucial in efforts to limit
exposure and prevent tobacco-related disease


By Mitchell Zeller, J.D.
U.S. Food and Drug Administration

I would like to take you into the world of policy related to harm and exposure reduction. If we think of harm and exposure reduction as a train, then the train has left the station. We would hope that the engine that would be driving it would be good science.

One of my concerns is that the train definitely has left the station, and we still have enormous questions about what kind of science should be driving the debate, and then ultimately the regulatory decisions that will have to be made both for tobacco products and for pharmaceuticals that make claims in the area of harm and exposure reduction.

In the spring of 1996, the R.J. Reynolds Tobacco Company was ready to begin test marketing to unveil the successor product to the failed 1980s cigarette-like product called Premier. The new product was called Eclipse.

According to the company, the main difference between Eclipse and conventional cigarettes was that most of the tobacco in Eclipse was heated rather than burned. This characteristic led Reynolds to promise ultra-low-tar delivery and 80 percent less secondhand smoke for the version of Eclipse currently on the market. (I understand that it may be going down to 75 percent.)

Back in 1996, senior executives at Reynolds were not bashful about what was behind their new product, at least in the interviews they gave to the news media. The company's director of product development said, "People are looking at Eclipse as having some potential to reduce risk."1 The chairman of R.J. Reynolds at the time said, "If you are going to be accused of suppressing work on reducing risk, how can you also be pounded for trying to do it and get it into the marketplace?2

The folks at Reynolds were pretty clear that they viewed Eclipse as a reduced-risk product. They may not have made express claims to this effect on the product label or in the advertising of the product, but these public statements by the company's executives arguably reflect how Reynolds wanted the public to view Eclipse - as a novel product that reduces risk by reducing exposure to certain constituents in tobacco smoke.

Eclipse is one of the better-known examples in the ongoing debate in the public health community surrounding exposure reduction and harm reduction. What needs to emerge from that debate is some consensus on what the research agenda should be to guide the scientists and the regulators who will be struggling with issues for years to come.

The foundation for the regulation of conventional tobacco products is clear. The nicotine in these products is a drug. The products themselves are nothing more than devices for the delivery of that highly addictive drug. The marketplace for the continued use of tobacco products as we know them is based on creating and sustaining an addiction to nicotine.

But there are at least two things missing. First, we lack a clear consensus among public health experts and the tobacco-control community about whether the priority should be to focus on reducing the toxins in tobacco and tobacco smoke, or whether it should be to figure out if it's possible to make nicotine-containing tobacco products not addictive, or whether we should be putting our energies into both areas.

There are the "tar people" who believe that the product cannot be made less addictive or not addictive, and insist that if we can make the product less harmful then it doesn't matter if the product is addictive.

And then there are the "nicotine people" who believe that tobacco products cannot be made less harmful, or safer, and insist that if we can make the product less addictive, or not addictive, then it doesn't matter how harmful the product is, because it will be easier for tobacco users to quit.

I've been at meeting after meeting where this has increasingly become a pitched battle between those who think it's one or the other. I don't understand why there has to be a debate over whether it's the tar or whether it's the nicotine. I don't understand why it can't be both, and why we can't be working on both at the same time.

The second thing that is missing, and is so desperately needed, is an adequate scientific base to support the evaluation of recent changes in the marketing strategies of both the tobacco companies and the pharmaceutical companies. These new strategies may result in products bearing claims that expressly or implicitly promise to reduce the exposure to and harm from tobacco products.

Armed with an adequate scientific base, we will be in the best possible position to answer one of the central questions about nicotine - namely, is there a threshold level of addiction and, if so, should regulatory agencies around the world systematically drive down the nicotine content of tobacco products to non-addictive levels, over time?

While it may take years to get answers to the nicotine exposure-reduction question, we all know that there are new products on the market today that raise many more public health questions than they answer. In addition to R.J. Reynolds, other tobacco companies are testing and marketing so-called "reduced-risk" tobacco products or technologies that purport to reduce the risk associated with tobacco use.

Philip Morris is test-marketing a battery-operated product called Accord that uses a cell-phone-like charger, and another device that has computer chips and heating blades. Eclipse and Accord purport to reduce the risk to the smoker and to greatly reduce the amount of secondhand or sidestream smoke so that nonsmokers will be less annoyed by those who smoke.

Star Scientific, which used to be called Star Tobacco, claims to have a technology that eliminates all tobacco-specific nitrosamines. This company has lobbied the United States Congress on these issues and has mounted a public relations campaign to call attention to its process to rid tobacco of nitrosamines.

Pharmaceutical companies are interested in using nicotine replacement products, such as patches, to reduce a smoker's daily consumption of tobacco. Their theory is that rather than getting a smoker to quit, nicotine replacement products can help smokers smoke less. The assumption is that a reduction in exposure to tobacco will lead to an overall reduction in harm to the smoker.

It is absolutely true that the "dirty" form of nicotine delivery from conventional tobacco products is more dangerous than the "clean" form of nicotine delivery from nicotine replacement therapy products - more dangerous because of the chronic diseases associated with the "tar" that comes with tobacco products.

It is also true that tobacco companies historically have enjoyed an easier and quicker path to market than the makers of nicotine gums and patches. But as the agency in the United States that has hoped to evaluate exposure and harm reduction claims for both tobacco and drug products, the U.S. Food and Drug Administration (FDA) has many questions and - at this point - precious few answers.

The last thing we need with these products and claims is to repeat the mistakes that were made over the past 30 years by governments and public health communities in developed countries, mistakes that have allowed "light" and "low-nicotine" cigarettes to be marketed to smokers under the misimpression that such products are safer and less addictive than conventional full-flavor cigarettes. These mistakes were exploited by the tobacco industry, which converted smokers - who otherwise would have figured out a way to quit using tobacco products entirely - into becoming the new customers for "light' cigarettes.

We need to be careful about the tobacco industry's new-found candor in finally admitting the linkage between tobacco use and disease. Martin Broughton, the chairman of British-American Tobacco, testified before an investigative committee in the British House of Commons recently: "We accept that smoking is the cause of certain serious diseases. Smoking is addictive. But our shareholders are not immoral, and our employers are not villains." He went on to add, "We have encouraged people to smoke fewer and lighter cigarettes and to give up smoking earlier." (Italics added.)

So we need to be sure that a reduction in exposure to tobacco, or to substances in tobacco smoke, translates into some meaningful benefit in terms of actually reducing harm. And the only way we can be sure is if there is an adequate scientific base, first to demonstrate a reduction in exposure, and then to establish the critical linkage that exposure reduction leads to a meaningful reduction in harm.

What should be demanded of tobacco manufacturers that want to market the "reduced risk" products, and pharmaceutical companies that might want to make an exposure or harm-reduction claim?

Here is a preliminary list of questions we have:

-- How does one measure exposure reduction?

-- Are there biomarkers that experts can agree on to give the scientific community comfort that meaningful exposure reduction has been achieved?

-- What steps should be taken immediately to help those experts resolve their differences on that all-important threshold question of identifying the right biomarkers to measure meaningful exposure reduction? (Because if we cannot agree how to measure a reduction in exposure, then we will never get to the key question of whether harm has actually been reduced.)

-- How should the companies and their researchers conduct the studies to help establish that critical linkage between a reduction in exposure and, hopefully, a concomitant reduction in harm?

-- Are there markers or surrogates to establish harm reduction?

-- How do you know when a meaningful reduction in harm has been achieved?

-- What can we do to minimize the possibility that the products marketed to reduce the exposure to and harm from tobacco instead wind up reducing or eliminating any incentive that a tobacco user might otherwise have for quitting?

--What can we do to minimize the chance that these products might create an incentive for nonsmokers or quitters to initiate tobacco use, thinking that with these new products, tobacco can now be safely consumed?

--Above all else, what can we do to avoid having the harm-reduction and exposure-reduction movement simply turning into a more scientifically sophisticated version of the endorsement that "light" and "low tar" cigarettes received 30 years ago?

To help the scientific process along, the FDA recently funded a new expert committee convened by the Institute of Medicine in the United States. Its charge is to study these issues and to make recommendations to the FDA about the appropriate scientific and regulatory framework that needs to be in place to address the complicated questions surrounding harm and exposure reduction.

The Framework Convention process now underway at the World Health Organization also represents an important opportunity for global collaboration among governments and the public health community to address the same question.

We know that the tobacco companies see a global market for their products. We know that addiction to nicotine knows no borders. We all have an interest in getting answers to the harm- and exposure-reduction questions. And we know that the research to get those answers can be conducted on any continent. What better way to collaborate on this and other issues related to tobacco product regulation than by building these issues into the Framework Convention process? That is happening.

We all recall the famous admonition that "Those who cannot remember the past are condemned to repeat it."3. No truer words could have been spoken about the exposure and harm reduction debate underway today, given all we know now about the lessons from "light" and "low-tar" cigarettes.

Let me propose a goal: We should aim to help addicted tobacco users either quit or reduce the harm associated with their continued use of tobacco as long as it is in a significant and meaningful way. This will only happen if we set out together to systematically get answers to all of the questions related to exposure and harm reduction.


Mitchell Zeller has served as director of the Office of Tobacco Programs, U.S. Food and Drug Administration. With the recent decision of the U.S. Supreme Court that tobacco is outside the jurisdiction of FDA regulation, the Office on Tobacco Programs is being disbanded. Zeller and his staff are being assigned to other positions.

References
1 Winston-Salem Journal, 27 April 1996, p. A1.
2 New York Times, 12 April 1996, p. C1.
3 Santayana, G.. (1905). The Life of Reason. New York: Scribners.



President's message:
Matters of balance


By William Corrigall, Ph.D.
SRNT President, 2000-2001

When I told my wife that I had been elected president of SRNT, she provided her usual supportive comment, as I recall, something to the effect of, "Why the hell did you let your name stand for that?!"

Now don't get me wrong. She has nothing against SRNT. But she did remind me of the frequent complaints I make about how busy I am. I was going to tell her that researchers suffer from a genetic defect that predisposes..., but then, you know that, don't you!?

Kidding aside, I thought that a good way to start my term as president would be to tell you a little about what SRNT means to me and what I hope to achieve.

To me, SRNT is first and foremost a research organization, and its strength lies in the diversity of approaches that we as members bring to the problem of nicotine dependence. I want all of these approaches to be represented strongly within the Society. For instance, as a scientist with particular interests in basic research, I want to be sure that there is a continuing place for basic research in SRNT, and to encourage basic scientists to present research findings at the SRNT annual meeting, not just at their particular discipline meetings in neuroscience, cell biology, behavioral pharmacology, and so on.

What is absolutely true, however, is that I do not want to see one area of research prosper at the expense of others. It's a question of balance.

It seems to me that the same diversity that makes us such an interesting research society also sometimes gets us into areas or debates that some members question. We have been around and around on several occasions on the question of advocacy and policy. Personally, I share the opinion of those of my colleagues who believe that the wealth of research carried out by the SRNT membership very naturally informs efforts in these areas, but that we are not a policy or advocacy organization.

However, as members of SRNT, we contribute to a knowledge base that is relevant to a massive health problem, and I do believe that we have an obligation to make our research findings available to a variety of audiences, including other researchers, treatment professionals, educators, and policy makers, to name only a few. I think that we are beginning to explore ways to do so.

Globally, SRNT has done exceptionally well as a young organization, and you will have read of previous successful initiatives in earlier newsletters. I hope that our global efforts are sustained. Nicotine dependence and the health consequences of tobacco use are global health problems, and our efforts should match them in their reach. Thus, I want to encourage the growth of our global membership, and to help various 'chapters' realize their local plans. These colleagues are eager to move ahead with exciting ventures, and we need to help them do so, yet at the same time to foster a collectivism in SRNT as a whole.

At a recent planning meeting involving several past presidents, President-elect Ken Perkins, and Karl Fagerström, as international representative, there was agreement that we need to have representation on our board drawn internationally. Thus, in the near future you will have the opportunity to vote on revised by-laws that will allow the election of board representatives from North America and Europe, as well as at large. This, too, I see as an issue of balance.

Dorothy Hatsukami, as past president, and our colleagues on the SRNT board have done, and continue to do, an overwhelming amount of work to sustain this society.

With regard to operations, I would like to see SRNT become more electronic, and thereby be able to poll members more easily on critical issues. Trust me, please, when I say that I do not have in mind a multitude of e-mail messages about routine issues. However, I do think that the membership deserves a voice in deciding on the involvement of the Society in sensitive activities, in the choice of a location for annual meetings, and in research organizations with whom we might join for an annual meeting or special events.

On that final note of democracy, let me assure you that your views are welcome. Electronic "rotten tomatoes" may be sent to my e-mail address (not to the SRNT e-mail list, please). Just so that my wife does not berate me excessively, however, I might not answer for a few days if I'm busy with other things. This, too, is a question of balance.

I look forward to working with you this year.

Best wishes, Bill Corrigall



Getting science back in the process

Editor's Note: Recently the U.S. Supreme Court determined by a vote of five-to-four that the U.S. Food and Drug Administration did not have jurisdiction over tobacco and tobacco products. The decision leaves the future of federal tobacco regulation in the hands of the U.S. Congress. Former SRNT President Jack Henningfield comments on the process ahead.

By Jack Henningfield, Ph.D.
Pinney Associates, Bethesda, Maryland


The U.S. Food and Drug Administration's Tobacco Rule was driven by public health concerns and built on a foundation of science; political considerations came second. The overarching goal was to reduce death and disease by decreasing the prevalence and adverse consequences of tobacco use.

This had implications for the importance of research in years to come, as the FDA had identified many areas of needed research and had established a dialogue with the Centers for Disease Control and the National Institutes of Health over research needs.
However, now that any prospect for regulatory oversight has been kicked over to the U.S. Congress, political considerations will, by definition, reign supreme.

That does not bode well for science, and it is certainly not a harbinger that public health will be the primary consideration. The overarching goal of the tobacco industry in seeking regulatory reform could not be in greater contrast to that of the FDA - the tobacco industry is seeking a regulatory framework that will give it legitimacy and will provide an environment in which to grow their business, perhaps with even more enticing, albeit possibly somewhat less toxic, products.

SRNT members signed an application form which affirms the goals of SRNT to stimulate new knowledge, foster the exchange of scientific information, and encourage research toward prevention and treatment of tobacco use. Those of us who hold these goals high will need to work very hard to interject scientific and public health considerations back into the process.



NIDA director's message:
'We want you to do more'


Editor's note: Alan Leshner, director of the U.S. National Institute on Drug Abuse, was keynote speaker for the Sixth Annual Meeting of SRNT in February. This is adapted and excerpted from his address.

By Alan Leshner, Director
U.S. National Institute on Drug Abuse

I would like to leave you with one message, and that message is: We love you, and we want you to do more. That's it.

The points that I would like to make frame the tremendous accomplishment that this field has made. But I would argue that holes have to be filled, and answers are yet to be provided.

The science of nicotine and tobacco has been important in a wide variety of realms. This area, among all areas of drug abuse and addiction, has had the most concrete, palpable, and dramatic influence on how drugs of abuse are viewed and handled in the United States and around the world. There is no question in my mind that we have learned much about the nature of drug abuse and addiction because of our understanding of nicotine and tobacco.

We begin with the ever-present, obvious question: Why do people smoke in the first place? The answer is that, as with any other drug, they do it because they like what it does to their brains. One of the things that has been particularly interesting and informative is the commonality between nicotine's effects on some aspects of brain function and the effects of other drugs of abuse.

Our understanding is pushing us to look at commonalities among abusable substances as we open this question: Is there a common essence to addiction itself?

The next question is this: Once people start smoking, why can't they just stop? Fifty percent of those who ever smoke daily will progress to addiction. Of those who ever use nicotine or tobacco, a greater percentage will go on to become addicted than would become addicted if they tried other substances such as alcohol, cocaine, or heroin.

We believe that for all drugs of abuse, the reason people cannot stop is because prolonged drug use changes the brain in fundamental and long-lasting ways. People who are addicted engage in compulsive drug use because their brains have been rewired.

This understanding has led many people to examine the change that occurs in the brain when someone uses tobacco. A smoker begins in a state of voluntary tobacco use, but then the brain changes, and the smoker goes from voluntary use to being a compulsive smoker. We don't know whether the change occurs gradually or precipitously; we don't know whether it's an incremental process, but we know that a person starts in one state and progresses to another state.

Addiction is, at its essence, a brain disease. But it's not just a brain disease; it's more complex than that. Addiction is a brain disease expressed in the form of compulsive behavior, but like every other such brain disease, it is shaped by behavior and social context. And that's why smokers need treatment. If it weren't for that, a smoker could just pull up his or her bootstraps and quit. The reason that people can't quit that easily is because their brains have been changed.

One of the areas that we've become particularly interested in is relapse. It it's a myth that tremendous numbers of people at any one time voluntarily quit smoking. A more accurate statistic is that 3 to 5 percent of those people who try to quit smoking in any one year succeed. Therefore, an issue about which we know very little is the question of relapse, whether to smoking or to other drug use. One of NIDA's major areas of interest in the future is going to be to study the relapse question both from an etiologic point of view and from a treatment point of view.

One of the things that's most striking to me is that very few people know that we know so much about drug use. In October 1999, NIDA released the first-ever science-based guide to drug abuse treatment. It applies to nicotine as well as it applies to other drugs of abuse. This is a simple, 38-page document that speaks about the nature of addiction, the nature of treatment, and the principles that characterize effective treatment.

To be candid, when I first looked at it, I said, this is too simple; this is too straightforward. But it is the most popular document we've ever produced. This speaks not just to the fact that we know a lot, but to the fact that there is a tremendous hunger for people to know about all of addiction.

I will emphasize one point that gets lost frequently, which is that if addiction is a quintessential biobehavioral disorder, then the best treatments ought to combine biological, behavioral, and social-context approaches. The data support that, but the idea is lost on people looking for a simple magic bullet - people who don't understand why treatment has to be as complex as it actually is.

The truth is that there is an awful lot that we don't know. In each of the major arenas that need emphasis, there is a role for nicotine and tobacco. One area in which many people are interested in is the question of individual differences in vulnerability. Why are some people able to use a substance with seeming impunity, and other people use the same substance for a relatively short period of time and become addicted?

We have figured out that the cause is an interaction of genetic and environmental events. We at NIDA have just mounted our first major initiative to look at genetics as we try to understand and identify the genes that make people more vulnerable to addiction.

Another area that our advisory council has urged us to get more involved in is what we're calling the transition to addiction. Basically, we have learned a great deal about initial drug use, and we have learned a great deal about addiction. We know that behavior is different before addiction and that behavior is different after the onset of addiction. The brain is different before; the brain is different after. We know nothing about what happens during the transition period in between.

What is the transition process of converting from being a voluntary drug user to a compulsive drug user? What are the biological mechanisms? If we could figure out how to prevent the transition from voluntary drug use to compulsive drug use, we could make a tremendous public health contribution. I have no idea what that transition is, but we do need to find it. In the next couple of years, we will issue a series of requests for applications to stimulate research on that transition process.

There's a sizable disconnect between what scientists discuss at a scientific meeting and what the rest of the world believes about nicotine and drug abuse and addiction. We have to bridge that disconnect if we are ever going to make progress. This issue of public education and professional education has become an integral part of what NIDA does.

NIDA's tobacco research report (www.nida.nih.gov/researchreports/nicotine/nicotine.html) is one of the most popular reports we've had. Also, a year and a half ago, we sent every public and private school in the United States a little toolbox containing science-based information about drugs and addiction, including nicotine. This series for middle-school children has been adopted by the National Science Teachers Association and is being used all over the United States. We're now in the process of developing a kit for elementary schools.

I hope that the message I came here to give you is clear. The truth is that we love research on nicotine and tobacco. We think it's tremendously important, not only scientifically, but to serve the public health. Do more. You can't do enough.



Web-surfing for help
'How can I stop using tobacco?'
Web has answers - sometimes


By Janet Brigham, Ph.D.
Newsletter Editor

The World Wide Web is an information universe of astonishing proportions, but its vastness also facilitates its greatest hazards. Newly empowered by ingenious search engines that lead users through an immense and continually expanding network of information and commerce, the Web can seem magical.

What happens when a smoker searches for some of that magic as help in quitting smoking? To see what a typical smoker might encounter, I used a popular search engine, Ask Jeeves (www.aj.com), named after the fictional save-the-day butler created by humorist P.J. Wodehouse. I asked Jeeves this question: How do I stop smoking?

I soon learned that, for an unsuspecting smoker simply wanting help in quitting, going to the Web might result in looking for help in all the wrong places. Not that some stop-smoking Web sites aren't excellent - but the excellent ones aren't necessarily at the top of the list in a search-engine retrieval.

The first thing to pop up online in response to my question was a banner advertisement at the top of the screen, asking which cigarette I would be most willing to give up, the first one in the morning or any other. Responding to this question, which was drawn from a well- known test of dependence, took me to a commercial site sponsored by a pharmaceutical company marketing nicotine replacement products.

Some search engines spotlight sites sponsored by paid advertisers, but not all sites make this distinction obvious. Not all search results lead directly to what appear to be noncommercial stop-smoking sites.

Some of these sites offer online communities of electronic chat rooms, bulletin boards, and email lists. Also available are information pages about nicotine and tobacco, FAQs (answers to frequently asked questions), and links to other sites. Information on many of these sites fails to includes the most current research findings, and sometimes perpetuates folk wisdom at the expense of sound science. Sites sponsored by governments and health-related institutions tend to have information that is more accurate and timely.

To its credit, the FAQ for the Usenet group alt.support.stop-smoking contains the following advice and caveat: "The best method to use for quitting is the method that works for you.... Don't let external images get in the way of your success (such as, it's weak to use the patch...). Whatever works for you is a good method - with one big caution: be very wary of using non-medical miracle cures you may see advertised on the WWW or - gasp! - occasionally on [alt.support.stop-smoking]. They can be, at best, very overpriced, and at worst dangerous." The Usenet group does not condone or encourage advertising among its participants.

Among its other functions, the Web is a worldwide library without a librarian. It contains information from questionable sources as well as authoritative sources. Many tobacco users who come to the Web looking for help in quitting are naïve enough that they cannot judge the accuracy of information. Lacking even the most basic knowledge about the quitting process, they can be lured into seeking help from sources that have no effective help to offer. And even among those sites with authoritative, current information, adherence to principles of good site design and ethical presentation can affect a site's impact.

A good Web site does not happen by accident. Designing it, writing material for it, managing it, and maintaining it all require expertise and resources. A good site does not require the newest and flashiest technology; it does require user-friendly organization and a continual dedication to providing information and services that can be accessed readily and understood easily. Lengthy postings of technical material on a site designed to draw visitors from fields outside a narrow area of expertise provide only an experience in frustration for most visitors.

What indicates good site design? On this, experts largely agree, although some Web designers appear to pay little attention to experts.

First, a Web site must work on multiple platforms and must display well on different types of browsers and on both old and new versions of browsers. The material on a Web site should be as readable on an old version of Netscape Navigator as it is on the latest version, and it should display as well on Internet Explorer as it does on Netscape. To be truly ideal, a Web site should also be accessible to browsers on miniature computers such as handheld and palmtop devices. Additionally, its components should be visible and usable with set-top devices such as WebTV.

Equally important is the need for a Web site to load quickly and easily. This means that many of the flashy "bells and whistles" that Web designers may be anxious to use are not suitable for a Web site designed for the browsing public. Although Web access has become easier with the development of faster modems and the spread of direct lines to the Internet (e.g., DSL and ISDN), research shows that most people who access the Web use somewhat outdated browsers and somewhat slow modems.

Thus, a glitzy Web site loaded with graphic-intensive features may look good to developers, but it is unlikely that most of its intended audience will have the equipment to access it readily, or the patience to wait for the site to download - much less the "plug-ins" to run video or audio incorporated into the site. Many people still access the Internet through old, slow computers with limited memory. A Web page demanding even something as basic as the programming language Java can cause a computer to crash.

Another problem with many Web sites is that they use uncommon fonts. While these may look appealing on the high-end equipment Web designers use, the fonts often are substituted with common fonts when the Web site is accessed by a user without those fonts. This can throw off formatting and graphics and can make material unreadable.

Features that make a Web site usable include allowing back and forward movement between pages and sites, since few things irritate a Web user as much as finding oneself on a page that does not allow easy access to the previous page. In addition, a site needs to be frequently updated and checked to make sure that all links to other Web pages are still valid.

Web site content typically also requires frequent updating. In particular, sites with scientific content must be updated continually. This means that maintaining a Web site can be nearly as expensive and time-intensive as designing it in the first place-a reality that appears to be ignored by many who post scientific and medical information. In the research world, even material not yet published might be out of date.

The use of outdated information is listed by Web guru Jakob Nielsen as one of the Top 10 mistakes in Web design. (See Nielsen's writings at www,useit.com.) Other practices he condemns (aside from those already listed here) include long, scrolling Web pages; difficult site navigation; and "gratuitous use of bleeding-edge technology." He explains that Web users have learned to ignore anything that resembles an advertisement, having developed "banner blindness," "animation avoidance," and "pop-up purges." He insists that sites should be designed for users, not designed to please executives of companies sponsoring the sites.
Several stop-smoking sites, both commercial and noncommercial, violate Nielsen's spartan sensibility with rows of multicolored buttons, flashing banners, and cluttered pages.

Among Nielsen's "good deeds" of Web design include having the site originator's name and logo on every page; providing search capability; parsimonious use of photos; accessibility for users with disabilities, particularly blind users; and consistency with common Web site standards.

Equally as important as the mechanics of the site is the ethical standard of the site. Perhaps the most egregious practice among sites purporting to promote health is the practice of presenting commercial information under a pretense of scientifically impartiality.

An example of this occurs on a Web site that invites readers to take a "personality test" that supposedly yields personalized recommendations about the best ways to stop smoking. This test can be taken by a smoker or by someone who loves a smoker. No matter how I answered the test, the result was a recommendation that either I or the smoker about whom I answered the test questions would likely benefit from using a particular stop-smoking medication. This medication, I should add, is not suitable for all smokers.

Is such a "test" ethical? Medical and information experts would say no. The test purports to be scientific and psychometrically meaningful, but in reality it is merely a gimmick for marketing a pharmaceutical agent that might not be appropriate or helpful, and could even be dangerous for some users. In the market-research and survey industries, this practice is called "sugging," for "selling under the guise." Sugging occurs, for example, when a telemarketer engages you on the telephone by pretending to be conducting a survey, but soon launches into a sales pitch. Sugging is rude, unwelcome, and verboten wherever it occurs, both on the telephone and on the Web.

Does this mean that all online advertising for tobacco dependence treatment products is unethical? The answer is an emphatic no - in fact, the Web provides an excellent route for customers to learn the best ways to use products, both from industry-sponsored sites and from other sites that provide useful critiques. Some treatment devices and medications rely heavily on Web-based interaction with customers.

However, ethical sites do not pretend to be something other than what they are. When an ethical site advertises nicotine replacement products and provides outreach to users of those products, the site's industry sponsorship should be posted on every page. Sponsorship also must be acknowledged in the choice of material included on a Web site. Even if a sponsor is not actively involved in creating a site, the content of the site might be limited to whatever the sponsor would approve. Ethical Web site operators openly explain to site visitors the possible conflict of interest arising from any commercial sponsorship.

Another unethical practice involves making pseudo-scientific claims. One stop-smoking site, for example, promotes its product by claiming that it "works as an anti-addiction and nutritional support, to make the taste of tobacco unpleasant and give the body natural energy using a scientific blend of all natural herbs." (Is there such a thing as an unnatural herb? Or an "anti-addiction . . . support?") Using scientifically twisted logic, this site condemns the use of nicotine replacement products on the grounds that one wouldn't treat "an alcohol problem" by giving the person beer or liquor daily to "wean them," despite the fact that that different addictions require different treatments.

The Health on the Network Foundation, based in Switzerland (www.hon.ch), has developed a code of conduct (the HONcode) that provides ethics guidelines for medical and health Web sites. HON's first principle is that health information should be provided only by qualified, trained professionals, unless the site states otherwise. Additionally, Web information should support, not replace, a site visitor's relationship with healthcare providers.

HON states further that all information should be kept confidential, and should honor or exceed legal privacy requirements. Information on the site should be supported by source references and should link to the data sources whenever possible. The date when an information page was last modified should be displayed clearly. In conjunction with that admonition, claims regarding specific treatments of products should be balanced.

Authorship of a site should be immediately evident, as should sponsorship, according to HON. Advertising should be differentiated from original material on the site, and should be indicated clearly.

A few doors down the street from the HON office is the physical home of one of the most scientifically based stop-smoking Web sites, www.stop-tabac.ch. This site features a computerized questionnaire that assesses a tobacco user's readiness and motivation to quit and identifies challenges a specific tobacco user might face.

I tried out this site's questionnaire twice, once as if I were a current daily smoker fearful of relapse, and once as if I were a former smoker confident of my ability to stay tobacco-free. Recommendations, which were based on my responses to the questionnaire, differed according to the profile I presented. The site also features downloadable brochures. Available in several languages, the site is straightforward and authoritative, and the individualized information provides concrete advice. Leading the team that created the site is Swiss researcher Jean-François Etter, who presented a report on the site at the SRNT International Meeting in London, England, in November 1999.

Software programmers custom-created the site's questionnaire and the resulting output. Available at present in French, English, and German, the site will also have Italian and Danish online versions, and the brochures are available in additional languages. The French-language version is the most developed, featuring daily news as well as the questionnaire, feedback, and brochures. Etter and his colleagues attempt to be responsive to feedback from users, some of whom have said that the questionnaire and counseling report are too lengthy.

"There is a trade-off between length and effectiveness," Etter explains. "If we shorten the letters too much, they may not include enough information and may lack effectiveness." Nonetheless, most comments are positive.

Nearly 90,000 visitors have viewed the site since February 1999, with some 12,000 contributing their questionnaire responses to an archived database. (The questionnaire allows try-outs without archiving the data.) A version of the site has been adapted for Novartis, a pharmaceutical company whose nicotine patch soon will be available over-the-counter in Switzerland.

Unfortunately, generic stop-smoking searches on popular search engines do not necessarily bring up this site. This could change as site exposure expands.

Most Web visitors do not know what makes a quality site effective, and many are taken in by unsubstantiated promises, marketing ploys, and inaccurate information. Distinguishing among advocacy sites, treatment sites, and commercial sites is likely to remain elusive for some users.

Ultimately, the task of instigating excellence in stop-smoking Web sites may rest on the shoulders of those who know the field best.



Ken Perkins elected SRNT president

Kenneth A. Perkins of the University of Pittsburgh has been elected president of SRNT for 2001-2002.

Perkins expressed both surprise and delight at his election, which was announced at the Sixth Annual Meeting in Alexandria, Virginia, in February. He expressed his admiration for fellow nominee Ellen Gritz.

Perkins expressed his concern that SRNT continue to grow and expand. "Despite its rapid emergence as a premiere scientific society, SRNT still has a way to go to fully represent the field of nicotine and tobacco research," he stated. "I hope that SRNT will continue to attract more members, especially from diverse areas not yet fully represented in the society.

"In addition, SRNT should continue to work with other organizations sharing common goals to help shape policies relevant to SRNT members, such as funding support for tobacco and nicotine research. SRNT should also actively assist in the development of young investigators."

Perkins has been on the faculty of the University of Pittsburgh School of Medicine, at Pittsburgh, Pennsylvania, USA, since 1986. He also has held appointments in the university's Department of Epidemiology and the clinical and health psychology areas of the Department of Psychology.

A charter member of SRNT, he is a fellow of the Society of Behavioral Medicine and the American Psychological Association. He received the Outstanding New Research Award from the Association for the Advancement of Behavior Therapy.



Researchers create varied forums to inform, communicate, teach

Editor's Note: This new section of the Newsletter features first-hand accounts detailing how SRNT members develop and carry out ideas that further research and implement evidence-based findings in applied settings.

Building a Web resource for a worldwide audience

From the U.S. Office on Smoking and Health
Centers for Disease Control and Prevention

The Office on Smoking and Health (OSH) of the U.S. National Center for Chronic Disease Prevention and Health Promotion has worked diligently to provide information on smoking, tobacco, and health on its Web site at www.cdc.gov/tobacco. The Web site's main focus is to provide information to health professionals, researchers, students, and concerned individuals.

Once you have arrived at the home page, called the Tobacco Information and Prevention Source (TIPS), icons will lead you to the latest OSH projects and issues.
An icon on the home page, or the link to the In the News page, takes you to the State Tobacco Activities Tracking and Evaluation (STATE) system. This electronic data warehouse contains up-to-date and historical state-level data on tobacco use prevention and control. It integrates many data sources to provide comprehensive summary data and facilitate research and consistent interpretation of the data.

Users can search the data for information regarding state legislation, smoking rates, and the health consequences and economic costs of smoking, as well as many other smoking-related topics.

"The beauty of this new system is that it allows public-health workers and policymakers at the state level to compare their states with other states using comparable measures across a wide range of data sources," says CDC Director Jeffrey Koplan. "These data are especially critical now, when states are deciding how to support youth tobacco prevention and control efforts."

The Smoking and Health Database icon located on the home page links users to the database that contains more than 60,000 abstracts of journal articles, books and book chapters, dissertations, reports, conference proceedings and conference papers, government documents, policy or legal documents, editorials, letters, and comments on articles. You may look for specific items of interest using a simple search system. The address for the database is www.cdc.gov/tobacco/search/index.htm.

A new and exciting item on the OSH home page is the Tobacco Industry Documents link web site. This site, designed to implement a U.S. presidential executive memorandum, increases the public's access to these tobacco industry documents by making them readily available on the Internet. Through this Web site, users have direct access to the Minnesota Tobacco Document Directory, which houses the world's largest public cache of tobacco industry documents. Users can also search the full texts of Minnesota Select Set Documents. The address for this Web site is: www.cdc.gov/tobacco/industrydocs.

The U.S. Surgeon General's Reports on Tobacco Use can also be found on the Web site by clicking on the icon on the home page or by going directly to www.cdc.gov/tobacco/sgrpage.htm. Included with each report are press releases, fact sheets, an executive summary, citations, and the entire report, which can be downloaded as one piece or downloaded in sections. You can also order the hard copy of the reports through the Web page.

New Citations is another tool made available to researchers at www.cdc.gov/tobacco/citation.htm. The Office on Smoking and Health Web site contains citations of recently published tobacco-related articles from behavioral, scientific, and technical literature. A user can then consult a technical, medical, or public library to obtain articles of interest.

Many fact sheets, reports, and data are available under the Research, Data and Reports icon on the home page, or at www.cdc.gov/tobacco/data.htm. These materials are arranged according to topic areas, such as adult prevalence, advertising and counter marketing, smokeless (spit) tobacco, etc. This site is link to Morbidity and Mortality Weekly Report (MMWR), journal articles, reports, and available tables.

Other items of interest to researchers are accessible through links from the OSH home page. The latest MMWR articles that are related to smoking and health are located at www.cdc.gov/tobacco/news.htm. Recent MMWRs are listed categorically toward the bottom of the page. In the MMWR, you can find tobacco surveillance reports for states and national programs.

For more information, please feel free to contact OSH staff in the United States at 770-488-5705. Enter 2 for publications or 3 to talk to an information specialist, or leave a message. Also, Web users can contact OSH staff by e-mail at www.cdc.gov/tobacco/question.htm. The staff welcomes questions, compliments, and concerns.



Collaborative team draws international sell-out crowd

By Ann McNeill, Ph.D.
Co-Chair, SRNT European Meeting

In August 1998, Karl Fagerström first approached me with the idea of holding the Second European SRNT conference in England. The Health Education Authority (HEA), where I worked, and the Department of Health in England were both very supportive of the venture and agreed that the HEA could be a co-sponsor and that HEA staff could manage the conference organization. I was also delighted to enlist the support of the European Office of the World Health Organization and the Society for the Study of the Addictions, which both recognized the value of collaboration with SRNT.

The core group of the Europe branch of SRNT met in February 1999, and we agreed to acknowledge the co-sponsors by dividing the program so that one day was allocated to European scientific research and submissions and one day to developments in England.

The meeting itself was held, very successfully, in the Conference Centre at Olympia in London on two days at the end of November 1999. David Balfour developed the program for the European scientific symposium, the focus of which was novel biological targets for the treatment of tobacco dependence. We hope that the abstracts for these presentations will be published. Karl Fagerström managed the invited submissions, and we were very pleased to receive more than 80 high-quality abstracts, nine of which were selected to be given as oral presentations, with the remainder being given as posters. There were no parallel sessions, and dedicated time was given on the program for people to view the poster presentations.

The "English" symposia were developed by myself, in consultation with colleagues in England. We were keen to examine the impact of the White Paper one year after its publication, in particular to look at the progress made with the implementation of treatment services and the smoking cessation guidelines. We also wished to have a symposium on the forthcoming Royal College of Physicians report on Nicotine Addiction due to be published in 2000, to enable delegates to preview its contents.

Pleasingly, the conference was a sell-out, with nearly 600 people attending. The delegates were from a wide range of professional backgrounds, and although mainly from Europe, there was representation from the Americas, Australia, Asia, and Africa. There were also more than 20 exhibitions from the private sector, as well as public and nongovernmental organizations. In addition to SRNT's exhibition, SRNT sponsored and Michelle Ricci hosted a cyberlounge, together with Ruben Israel from GlobaLink.


Pharmacy schools adopt tobacco curriculum

As a primary interface with the health care system for many individuals, pharmacists are in a unique position to help patients quit smoking. Also, research has shown that counseling from a pharmacist can increase a smoker's likelihood of quitting.

However, few pharmacists are trained to provide tobacco cessation counseling. But not for long-at least not in California, USA. Robin Corelli and Karen Hudmon, in collaboration with the Pharmacy Partnership of the California Medical Association Foundation, have orchestrated a project whereby pharmacy faculty members and tobacco researchers have designed a six-hour, comprehensive, tobacco curriculum program for pharmacy students.

According to Hudmon, a cancer prevention researcher at SRI International and assistant clinical professor of Pharmacy at the University of California San Francisco (UCSF) School of Pharmacy, the program was developed "in response to a need for smoking cessation counseling training to become a standard component of pharmacy curricula."

In a recent survey of more than 1,100 licensed pharmacists in Northern California, Hudmon found that less than 9 percent of licensed pharmacists have received formal training for tobacco cessation counseling-yet 88 percent were interested in receiving further training to acquire these skills, 70 percent believed that training would increase the number of patients that they counsel for cessation, and 93 percent believed it would increase the quality of their counseling.

The curriculum program, which is targeted for the first- or second-year of pharmacy school, equips students with the knowledge and skills necessary to provide comprehensive tobacco cessation counseling. Corelli, associate clinical professor of Pharmacy at the UCSF School of Pharmacy, believes the program "is unique because it was created, implemented, and evaluated as a collaborative effort of all four pharmacy schools in California. Its applicability is broad, in that it can be adapted for use by medical, dental, nursing, or other allied health schools."

The three-hour lecture component of the program covers issues such as the prevalence of tobacco use in California and in the United States, the epidemiology of tobacco-related disease, the pharmacology of nicotine, principles of nicotine addiction, the genetics of nicotine addiction, and theory-based methods for helping patients to quit smoking. The three-hour workshop component includes role-playing with case studies and hands-on experience with pharmaceutical aids for cessation and the LifeSign hand-held computer for scheduled, gradual reduction of smoking.

The program is designed to equip pharmacy students with the ability to intervene with all tobacco users, including patients who are not yet considering quitting. The program adheres to principles set forth in the Agency for Health Care Policy and Research Clinical Practice Guideline Smoking Cessation. Students are trained to apply the Transtheoretical Model of Change and the National Cancer Institute's 5 "A"s (anticipate, ask, advise, assist, arrange) when assisting prescription and nonprescription patients with treatment.

Currently, the program is being incorporated into the core curriculum of all four California pharmacy schools, estimated to reach more than 600 pharmacy students annually. To date, the program has been piloted with a group of volunteer students prior to full implementation at UCSF, Western University, and the University of Southern California. Students' evaluations of the course are being used to refine the materials and procedures. This summer, the program materials will go through a second round of external review by researchers and practitioners, including SRNT members Neal Benowitz, Carlo DiClemente, Linda Ferry, and Alex Prokhorov. After finalization, the program will be implemented at the University of the Pacific in November 2000.

The next step? Dissemination to other pharmacy schools across the United States. The program has been designed in a modular format, to ease incorporation into a wide variety of curriculum structures. Program materials include all lecture materials (Microsoft PowerPoint presentation, along with notes and supplemental readings for course instructors); handouts and assigned readings for students; a brief videotape provided by Frank Vitale, MA, director of the University of Pittsburgh School of Pharmacy's International Smoking Cessation Specialist Program; 20 fully-developed case scenarios for role-playing exercises; and sample exam questions.

The dissemination phase for the curriculum program is scheduled to begin in fall 2000, when the course facilitators will teach pharmacy students at Texas Southern University, through an outreach effort funded by The University of Texas M.D. Anderson Cancer Center in Houston, Texas. Additionally, instructors from each of the pharmacy schools across Texas will be invited to participate in a train-the-trainer program, whereby faculty members will gain the experience necessary to implement the program at their schools.

Pharmacists could have a significant impact in reducing smoking rates. Nationwide, approximately 50,000 community pharmacies employ 125,000 pharmacists. If each of these pharmacists were successful in helping just one smoker to quit each week, this would translate into 6.5 million quitters annually. Additionally, pharmacists are employed in various other settings, including health maintenance organizations, hospitals, and clinics. Currently, more than 36,000 students are enrolled in pharmacy schools in the United States.

Because of the increased availability of pharmaceutical agents for smoking cessation, it is increasingly important for pharmacists to have in-depth training in this aspect of patient care. For patients using nonprescription nicotine patches or gum, the pharmacist may be the only contact that a smoker has with a health-care professional prior to or during a quit attempt.

For more information about the program, contact Karen Hudmon, Dr.P.H., R.Ph. at the Center for Health Sciences, SRI International, 333 Ravenswood Avenue BN 115, Menlo Park, CA 94025, 650.859.5110, e-mail khudmon@unix.sri.com.



Future events

11th World Conference on Tobacco or Health, 6-10 August 2000, Chicago, Illinois, USA. Theme: "Tobacco: the growing epidemic." Contact conference secretariat manager, American Medical Association, 515 North State Street, Chicago, Illinois 60612, USA. Phone 312-464-5159, fax 312-464-4111; email 11thWCTOH@ama-assn.org. Hotels for the meeting are the Chicago Hilton and Towers and the Palmer House Hilton. Post-conference tours of the United States cities Washington, D.C., Orlando, Florida, and San Francisco, California, will be available.

Third European SRNT Conference, 20-22 September 2000, Paris, France. Program and organizing committees will announce further plans for the meeting. Information will be available in the Newsletter and on the SRNT Web site, www.srnt.org.

Sixth International Congress of Behavioral Medicine, 15-18 November 2000, Carlton Crest Hotel, Brisbane City Hall, Brisbane, Queensland, Australia. Hosted by the Australian Society of Behavioural Health and Medicine on behalf of the International Society of Behavioral Medicine. Abstract submission deadline was 1 February 2000. Email icbm2000@im.com.au, telephone 61-(0)7-3369-0477, fax 61-(0)7-3369-1512. Early-bird registration deadline is 1 August 2000. The congress theme is Behavioral Medicine and Public Health in the New Millennium.

Seventh SRNT Annual Meeting, 23-25 March 2001, Seattle, Washington. This meeting will be held in conjunction with the annual meeting of the Society of Behavioral Medicine, at the Sheraton Seattle Hotel and Towers.



News and other offerings

Executive departure. SRNT bids a warm farewell to Sarah Evans, SRNT's executive director. Sarah first worked with SRNT when the Society was associated with its former management company, and moved to Wisconsin last year to serve as executive director of the Society.

Her organizational skills, insight, patience, and good will have benefited SRNT through the challenging transition to a different management company and through a period of rapid growth and change. During her tenure, the Society more than doubled in size and expanded internationally. Under her direction, the annual meetings have been run smoothly and efficiently.

SRNT wishes her well as she pursues new public-spirited career goals.

Journal highlights. In its first year of publication, SRNT's journal Nicotine & Tobacco Research tallied 736 printed pages in four regular and two special issues. The rate of submissions increased throughout the year, with 74 papers submitted during 1999. The overall rejection rate at first editorial decision is 25 percent; the rate of acceptance after the first round of review is extremely low, at 1 percent. Many submissions are recommended for revision and further review, with some papers published after second and third reviews.

Some 46 percent of authors were given an initial editorial decision within 75 days of submitting a manuscript. An additional 50 percent of authors were notified within 76 to 120 days. A total of 55 percent of institutional subscribers are in North America, and 38 percent are in Europe. Plans are underway for Web access for subscriptions. The journal editors are providing a full report of the first full year of publication in a current issue of the journal.

Thanks and welcome. Several contributing editors of the Newsletter who have provided editorial guidance to editors for several years are being released from this responsibility, with many thanks. The direction and review offered by outgoing contributing editors Raymond Niaura, Kenneth Kellar, Robert West, and Peter Hajek have been appreciated by both current and past editors.

New contributing editors are Bonnie Spring of the University of Illinois at Chicago, Harry Lando of the University of Minnesota, and Malaika N. Woods of the University of Kansas. Woods is the first student member to serve as a contributing editor. Linda Pederson will continue as a contributing editor. Announcement of additional contributing editors from outside North America will be forthcoming. Contributing editors recommend and solicit articles for the publication, review articles planned for future issues, and contribute original material.