The following is the lead story from the inaugural edition of Health Tech Review:

Merck's marketing muscle turned Gardasil, a vaccine that prevents the spread of human papillomavirus (HPV), into a must-have accessory for teenage girls. Ubiquitous television and magazine ads led the way by warning kids and their parents that some HPV strains cause cervical cancer, which gets diagnosed in about 12,000 American women annually and kills 4,000. Several leading professional medical societies, each a recipient of Merck's generous financial support, endorsed the campaign.

This vaccine-as-cancer-prevention strategy also received a major boost from the government. Almost immediately after the Food and Drug Administration approved Gardasil in 2006, the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP) unanimously endorsed the HPV vaccine for girls aged 11 and older. The result: Over 23 million doses of the $300-a-shot HPV vaccine (a course of three is required for the best immunity) were administered in its first three years on the market. Worldwide sales for Merck soared to more than $1.4 billion in both 2007 and 2008, more than half outside the U.S.

However, Merck's sales have slowed sharply this year as penetration of the most lucrative market -- well-insured and well-off young girls in the advanced industrial countries -- reached saturation. Over 25 percent of 13-to-17-year-old girls in the U.S. have now been vaccinated. So from Merck's perspective, it makes sense to move on to the next marketing frontier: teenage boys.

Does vaccinating wealthier and well-insured young men make sense from a public health perspective? Is this added financial burden to the nation's health care system necessary? Those questions won't come up at the FDA's Vaccines and Related Biological Products Advisory Committee, which meets on Tuesday, September 9. It will only consider the safety and efficacy of expanding Gardasil's label to include preventing genital warts in boys. The morning session will also consider the safety and efficacy of a competitive HPV vaccine for girls from GlaxoSmithKline called Cervarix.

The likely outcome is approval for both, despite some safety concerns that emerged in the pivotal Cervarix clinical trials and the disconnect between the new indication sought for Gardasil -- prevention of genital warts -- and the most likely subtext of the marketing campaign that is sure to come: that boys should do their part in helping girls prevent cervical cancer by preventing the spread of HPV. As the FDA noted in its background paper  posted September 4: "A comprehensive discussion of prevention and treatment of HPV in males would also include estimates of the impact on transmission to females." Alas, none was offered by the sponsor; and none was included in the FDA documents.

Statistics in the FDA paper suggested that genital warts are a fairly small problem. About two-tenths of one percent of males or 200 per 100,000 get medically treated for genital warts each year. Overall prevalence was estimated at one percent of the sexually active male population. Merck's clinical trial showed a prevalence of slightly above two percent among the 15- to 27-year-olds (mean age 20.5) given a placebo shot during its trial.

While persistent HPV infection in men can in rare cases lead to penile and anal cancers, it poses a smaller cancer risk than persistent HPV infection in women, which is itself a rare disease.

As was frequently pointed out by critics at the time Gardasil was approved for young women, the people who get persistent HPV infections that lead to either genital warts or cervical cancer are highly specific. Minority women in the south and along the U.S.-Mexican border as well as whites in Appalachia are among the highest-risk groups. It's not that these groups engage in riskier sexual behavior as a group (although that is a risk factor for spread of HPV). Rather, they represent poorer populations who have inadequate health insurance and are less likely to get the annual pap smears for early detection that makes cervical cancer an easily treatable disease.

Merck's genital warts clinical trial recruited 4,065 young men recruited on five continents (the marketing of the vaccine in rich countries ignores the international dimensions of the disease -- 80 percent of the half million new cervical cancer cases each year are in the developing countries, where it is usually either the first or second leading cause of cancer death). The results once again convincingly documented the fact that the biggest risk factor for HPV infection is having multiple concomitant sexual partners or engaging in high-turnover serial monogamy. The data in the placebo group showed that 4 percent of young men with four or five sexual partners over the three years of the study contracted genital warts. The number dropped to just 1 percent among young men who had just one or two sexual partners.

Merck admirably went out of its way to recruit a cohort of gay men for its study. And what they showed was equally enlightening. Men who had sex with men were essentially at no greater risk than heterosexuals (1 in 40 got warts in the former group compared to 1 in 46 in the latter). Again, the primary risk factor in either group was multiple partners.

There is no question that the vaccine is effective against the spread of HPV strains that lead to genital warts. In the trial it cut the number of cases by 67.2 percent (47.3 to 80.3 percent if one takes into account statistical margins of error). But that's the relative reduction. The raw numbers are more enlightening. There were just 72 cases of genital warts among the 1,937 young men who got the sham vaccine after three years. That was reduced to 24 cases out of the 1,943 in the group got Gardasil.

Aside from preventing uncomfortable genital warts, what impact would this prevention strategy have on the more significant problems of the spread of HPV to women? The incidence of cervical cancer in women? The rarer cases of penile or anal cancer in men? No one knows. All we know from the raw numbers of the trial is that it would take vaccinating 40 young men to prevent a single case of HPV infection that leads to genital warts. That's anywhere from $20,000 to $40,000 in total health care system costs to prevent a single infection.

Several Harvard researchers who recently took a look at those numbers and estimated the total health benefit including reduced cancers concluded that vaccinating young men was not a cost-effective prevention strategy. They told the CDC's ACIP committee in June that adding an HPV vaccine for young men to the government-approved schedule would cost more than $100,000 for every quality-adjusted life year (QALY) saved. That's more than twice the $50,000 per QALY benchmark usually used by health care economists to judge whether an intervention is deemed "cost-effective."

Merck immediately challenged those numbers, according to Bloomberg News, which covered the meeting. But Merck used a cost of $400 per vaccination with universal protection, while the Harvard study put the cost of vaccination at $500 per child and a 75 percent protection rate. It should be noted that even the Harvard effectiveness number was more generous than the 67 percent reduction shown in the pivotal clinical trial.

Such studies can be persuasive. Not with the FDA, which can only look at safety and efficacy. Nor is it likely to convince the CDC, whose advisory committee includes researchers with either ties to vaccine manufacturers or are infectious disease specialists or public health officials with a professional bias toward promoting vaccines.

But insurers will take note. The same Harvard researchers, led by Jane J. Kim, a recently-minted Ph.D. in "health decision science," last year reported that Gardasil cost $43,600 per QALY for women if administered at age 12 but $152,700 per QALY if administered in their 20s. Merck also challenged that study, which isn't surprising since it is pursuing FDA approval to market the vaccine to women between 27 and 45.

Meanwhile, Merck is about to face more competition in the primary market for the vaccine -- young girls. GlaxoSmithKline claims Cervarix' clinical trials, including one head-to-head trial that looked only at the immune response and not actual outcomes, show that its efficacy profile is superior to Gardasil. On the other hand, the pivotal trials submitted to the FDA showed a disturbing if not statistically significant increase in spontaneous abortions in the three months after the young women were given the vaccine -- 11.6 percent versus 5 percent in the sham vaccine group. Glaxo's discussions with the FDA about conducting a large post-approval trial to gauge whether this was vaccine-related will undoubtedly be a major topic of discussion at Tuesday's advisory committee meeting.

While such post-marketing safety trials are important, it's not the real discussion the public needs at this point. Another company is on the cusp of marketing the vaccine to the teenage and young woman market. Young men are about to be added to the mix. (How Merck markets a vaccine approved only for genital warts when the real public health concern is cancer merits close scrutiny from the FDA's Division of Drug Marketing, Advertising and Communication.)

There is in fact a public health problem here that needs addressing. Women without adequate health insurance, especially in poor and minority communities, need to get routine pap smears. Public health officials need to target their messages (and vaccines) to people who have sex with multiple partners.

Imagine, for a moment, that the government gave $1 billion a year to public health agencies that carried out those twin missions. That far less than the U.S. insurance industry and American parents now spend on vaccines for their well-off and well-insured daughters (and soon sons) who are marginally at risk. Can there be any doubt about which strategy would have the most impact on reducing the incidence of cervical, penile and anal cancer in the U.S. population?