Exposing The Nitty Gritty About Head Lice

Thirty pharmacists talk to American Druggist
and reveal the questions their patients have about head lice.
by: Russ Colchamiro

Sparring Over Head Lice
Premature release of study results embroils NPA, Harvard School of Public Health and Warner-Lambert in a three-way dispute.

The dispute began when the National Pediculosis Association (NPA), a not-for-profit health education agency, released information suggesting that a study it had funded concluded that head lice in two test markets had developed resistance to permethrin, the active ingredient in Nix cream rinse, marketed by Warner-Lambert, Morris Plains, NJ.

Then in an April 1 article in The Wall Street Journal, a research team from the Harvard School of Public Health, which is conducting the study, confirmed what the NPA had been saying - that some head lice in the U.S. are now resistant to permethrin. Results of the report, however, have not been published in a medical journal, as the study has not been completed.

The ensuing controversy now centers on three fronts: the validity of the conclusions released before the study's completion; sources of funding for the study; and the motivations of the three players - the NPA, which markets The LiceMeister^® head lice comb, the Harvard School of Public Health (HSPH) and Warner-Lambert.

Warner-Lambert and the NPA have accused each other of acting mainly to protect their own financial interests. In The Wall Street Journal article, Warner-Lambert spokesperson Sandy Horner suggested that the NPA released the study information prematurely to discredit chemical treatment, thus promoting sales of its own head lice comb. Deborah Altschuler, president of NPA, counters that Warner-Lambert wanted the information kept from public view to prevent a potential decline in Nix sales.

Richard Pollack, Ph.D., a researcher at HSPH, tells American Druggist that "NPA released the information without our knowledge or consent" and that it "was a terrible mistake. The information should be released in a form that carries an interpretation of the data by those who conducted the research."

Altschuler, who made the unfinished study available to The Wall Street Journal, disagrees. She says that the information was reported in the article prior to the study's completion because "the public needs to have this information for their safety," and that  "the information about permethrin (contained in the article) is correct."

The NPA and HSPH have also clashed over the study's funding. Altschuler insists that the NPA funded the study. "The Harvard School has said - and it's in the The Wall Street Journal article - that there are other (financial) contributors to the study. If so, who are they and why weren't we notified? This was an independent study led by the NPA"

A Nov. 10, 1997, memo from HSPH study researcher Philip Armstrong to Altschuler supports her claims, describing the project as an "NPA-sponsored study." Pollack, however, says funding had also been contributed by Warner-Lambert, HSPH and the Evelyn Lilly Lutz Foundation, Beverly, MA.

"We told Harvard we didn't want any other groups piggybacking on our work," Altschuler says. "It was clear that there was to be no involvement by the manufacturer (of Nix) because it would compromise the study. I was assured it wouldn't happen. And now it has."

The initial head lice study proposal sent to Altschuler form Andrew Spielman, Sc.D., and Kayla Laserson of HSPH was dated Jan. 31, 1996. The proposal called for a "six-month to one-year investigation." But more than two years later, the study has still not been completed. Altschuler questions why.

She suggests the answer may lie in a Sept. 3, 1997, draft of the HSPH report, which, in part, read: "We conclude that head lice from both Boise, ID, and Cambridge, MA (where U.S. lice were tested) lack sensitivity to increasing concentrations of permethrin."

"We don't need to do a rat test to know there's a rat," Altschuler argues. "With the manufacturer involved with the funding, why do you think the study hasn't been finished?"

Jason Ford, spokesperson for Warner-Lambert, declined to comment, saying that all opinions should be withheld until the completed report is available.

Pollack also declined to question Altschuler's motivations. "We are not in the business of selling anything," he says. "Our goal is to do the research carefully and clearly. When we release the information it will include a complete picture of how to interpret the information. At this point, no conclusions have been made."

Additionally, Pollack fears that the premature disclosure will now make it more difficult or even impossible for HSPH to get the study published in either The New England Journal of Medicine or The Journal of the American Medical Association. Both have editorial policies not to run articles whose findings have previously been announced and publicized. That opinion was confirmed in a June 28 Sunday magazine article in The New York Times, which concluded that because of the advance publicity concerning the head lice study, neither of the two prestigious medical journals are likely to publish the report at all.