Labeling for nicotine replacement products should direct physician consult, expert suggests.

SMOKING CESSATION PRODUCT LABEL PHYSICIAN CONSULTATION DIRECTION necessary if the product is "not doing what it is supposed to do" as part of materials available to consumers, David Sachs, MD, Palo Alto Center for Pulmonary Disease Prevention, suggested at a June 9 meeting of FDA's Drug Abuse Advisory Committee in Bethesda, Md. Sachs addressed the committee during the open public hearing, saying nicotine replacement product labeling for consumers "must clearly...state, as is done for each and every other OTC category...when patients should see a physician because the medication is not doing what it is supposed to do."

Instances when physician consultation would be prudent, Sachs added, include "not being able to stop smoking in the first two to seven days after starting the medication, or experiencing nicotine withdrawal symptoms that are not readily tolerated." The statement should be placed on the external package -- not, Sachs clarified, on the package insert.

"If space is needed on the bottle or the box" to include this information, Sachs suggested, "I would recommend a substantial reduction from the box package label of the exhaustive listing of the remotely possible...effects that would warrant seeing a physician but which 99%" of users "never experience."

"Front-line, primary care internists, family physicians, psychiatrists, OB/GYNs and pediatricians...perceive tobacco dependency treatment medications as ineffective," Sachs noted. This results, in part, "from...some of the complexities that exist in the label." Professional labeling should retain "the current four-week, objectively validated continuous non-smoking" standard of efficacy because it is a useful "benchmark," he urged, but "four weeks of treatment does not necessarily mean that's what the patient should be getting." To this statement, he suggested adding "six-week to one-year survival data," as well as "one-week point prevalence histograms for six weeks to one year."

"The agency has rightly and appropriately over the years consistently made a distinction between that which is necessary to achieve immediate cessation, versus that which is necessary for long-term maintenance and relapse prevention," Sachs continued. "Clinically, as we all know, those are two totally different animals, and I would certainly not want to put the burden on a company to have to [meet] a one- or two- or three-year outcome standard before they're going to get approved."

Consumers want labeling to tell them information such as whether it is "safe to keep buying these products for a year," whether the products are "successful [after] a month" and whether it is "safe to buy the higher dose for two months," committee consumer representative Dolores Yaroma said. A toll-free hotline number also is helpful, she noted.

"Increasingly, the consumer has more time and is more interested than the physician" in reading labeling and related materials and "has ready access to professional labeling," committee member Elizabeth Khuri, MD, Cornell Medical Center, said, noting her objection to "having one set of directions for the physician and one for the consumer -- we're way beyond that."

Physicians, particularly those working in managed care organizations, have limited time to interpret data from professional labeling, commented committee member Anne Andorn, MD, St. Louis V-A Medical Center. She suggested a "discussion section" in which "the bottom line is reiterated," followed by "some discussion of the salient features, based on the evidence that's given above" in labeling. If the clinician has time, she added, "they can read the whole label; if not, maybe they can just skip to the bottom line, and we'll have them learning from the label rather than the detail man or woman."

Committee member Harriet de Wit, MD, University of Chicago, disagreed, however, saying she "would vote against...having a discussion section in the package insert." Such a section "opens the door for all kinds of unscientific and unsubstantiated claims," she said, adding: "If we don't have room for the actual empirical data, we certainly don't have room for people's opinions."

Andorn presented results of an informal survey of physicians who received National Institutes of Health grants to research smoking addiction. The survey revealed, among other things, that physicians find: a one-month quit rate "unrealistic," but that the data may be useful to let patients "know they're on the right track"; that data on reduction in use are "misleading, both to the provider and the patients" because it is "well-known" that short-term reduction often is followed by "rapid escalation back to the original dose"; and that including a one-day quit rate is "useless." Furthermore, respondents commented that smoking cessation and relapse prevention are two important aspects of treatment -- the current design addresses only cessation; and that the issue of restarting treatment is not addressed.

Assuming the design employed stays the same, the majority of those surveyed recommended inclusion of: point prevalence data (carefully explained in simple language); six-month and one-year abstinence data; application of adjunct treatments; published safety data; a generic statement concerning the need for long-term use based on the literature; and a discussion section. Notably, one participant cited the need for "rates of relapse upon discontinuation" of a study, not just rates of abstinence.

"For years we've had physicians who say `yadda yadda...quit smoking,'" Carol Falkowski, Minnesota Department of Human Services' Chemical Dependency Division, pointed out; "but now we're expecting them...to become more actively involved, and I think there's a big learning curve....Labeling is part of that."

"There is a level of efficacy that can be reached with patient directed therapy," FDA Anesthetic, Critical Care & Addiction Drugs Division Deputy Director Curtis Wright, MD, noted. This includes "OTC products, or...a product that is essentially handed as a scrip to the patient with a suggestion that they use it." This is "currently the standard of care in all but a few centers for smoking intervention," he noted, adding, however, that "there is a real role for learned intermediaries in this."