Analysis: Merck’s Vaccine on Solid Ground

By STEVE MITCHELL

Despite some groups’ efforts to block legislation at the state level that would make Merck’s cervical cancer vaccine Gardasil mandatory for adolescent girls, the vaccine’s uptake will probably not be impacted much, if at all, experts said Tuesday.

This might have a short-term effect on the rate of uptake of the vaccine, but I think in the long-term it will have a minimal effect, John Lebbos, an analyst with Decision Resources, told United Press International.

This just might be initial political things going on, but medically I think there’s a real recognition of the benefits of this vaccine that will carry it through to its full market potential, Lebbos added.

Parent and conservative groups, such as the Traditional Values Coalition, have campaigned against legislation that would make the vaccine mandatory for sixth-grade girls, claiming that its long-term efficacy is uncertain and that it may be more dangerous than previously thought.

Last month Merck said it would stop lobbying for state legislatures to pass laws making the vaccine mandatory because health experts were concerned the company’s efforts were undermining the public’s confidence in the vaccine.

Texas Governor Rick Perry signed an executive order in February that makes the vaccine mandatory for sixth-grade girls starting in 2008, and similar legislation is pending in more than 20 other states.

Lebbos said Merck’s decision to back off is unlikely to have much impact on the uptake of the vaccine.

Merck’s lobbying might have been able to speed up how quickly the vaccine was adopted into routine practice, but the medical community has already embraced it, he said. In addition, the necessary factors, such as the recommendation of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, are already in place, thus ensuring widespread use, he added.

The issues left are getting reimbursement ducks aligned and so forth, but that’s just a matter of time, Lebbos said.

Decision Resources forecasts cervical cancer vaccines will become a $3 billion market over the next five to seven years. This includes Merck’s vaccine and GlaxoSmithKline’s Cervarix, for which a new drug application is slated to be filed next month.

The big questions surrounding Glaxo’s vaccine are how much it will cost relative to Merck’s and the outcome of a head-to-head trial Glaxo initiated.

The results of the trial won’t be available for a while so Glaxo may compete with a lower price or find other advantages they can leverage, Lebbos said.

Thomas Wright, professor of pathology and director of obstetrical and gynecological pathology at Columbia University Medical Center, who is leading a project by the American Society for Colposcopy and Cervical Pathology to educate physicians about Merck’s Gardasil, said he thinks the medical community is rapidly accepting the vaccine.

I’m amazed at how rapid the uptake has been, Wright, who said he had no financial ties to Merck, told UPI. I thought it would take a couple of years for Ob/Gyn’s to get on the bandwagon because they don’t generally deal with vaccines.

Wright, who emphasized that the ASCCP has not taken an advocacy role for or against the vaccine but merely seeks to educate physicians about the shot, said the safety appears to be very good.

Every professional society that has looked at this vaccine, based on the data we have available, believes it is a safe and effective vaccine, he said.

Regarding questions about whether the immunity induced by the vaccine may wear off after five years or so, Wright said, I think everybody understands the long-term efficacy is not established, but it’s never established with new vaccines.

He noted that when the hepatitis B vaccine first emerged, it was assumed a booster would be needed in five years. Then, that timeline was moved out to 10 and then 20 years, until now most people think it provides lifetime immunity.

Regarding safety concerns, Wright said there’s always a possibility that widespread vaccination that involves massive numbers of people could reveal rare side effects. But there’s no reason from what we know today to think this vaccine has a safety problem, he added.

The Vaccines for Children program covers the vaccine for uninsured and underinsured children, and most major health insurance companies also cover the shot. There are indications that some physicians are struggling to get reimbursement for their costs, but that’s not unexpected as it generally takes a while with a new treatment to work things out, Wright said.

He emphasized that the benefit of the vaccine is not limited to its potential to prevent the 10,000 cases of cervical cancer diagnosed each year in the United States.

It could also reduce by half the 500,000 women who develop high-grade cervical cancer precursors, cut a significant proportion of the several million women who end up getting a colposcopy for an abnormal pap smear, and eliminate more than 90 percent of the 1 million cases of genital warts that occur annually.