Wall Street Journal - June 2, 2005
Barbara Martinez at barbara.martinez@wsj.com and Sylvia Pagan Westphal

Anyone who has ever had the chicken pox is at risk of getting shingles, which is caused by the reactivation of the chicken-pox virus. There has been no vaccine for the condition, which produces intensely painful rashes that last for weeks and make even the touch of light clothing excruciating. While drug treatments can shorten the duration, they aren't very effective at preventing complications such as long-lasting skin pain. More severe complications can include permanent nerve damage, or even blindness if the rash spreads to the eyes. [Stopping Shingles]

Now, in a study reported today in the New England Journal of Medicine, researchers found that a one-time shot of a vaccine developed by Merck & Co. significantly reduced adults' chances of getting the disease. In the clinical trial of more than 38,000 people over age 60, the rate of shingles among those who were vaccinated was about half that among the group who received a placebo shot. And on average, vaccinated people who did get shingles reported the experience to be less severe and painful compared with shingles cases in the placebo group.

Merck researchers, along with the Department of Veterans Affairs and the National Institutes of Health, studied the live-virus vaccine at 22 locations around the country in people who were considered at risk for shingles because of their age and past exposure to the chicken-pox virus -- known as varicella-zoster. (People who were immunocompromised, such as HIV patients, were excluded.) Based on the findings, Merck submitted an application in April to the Food and Drug Administration to market the vaccine, and the agency could approve it as early as next year.

The vaccine, called Zostavax, is essentially a much stronger version of Merck's chicken-pox vaccine that is commonly given to children. Researchers said complications from the shot were minimal, and largely constituted headache and tenderness at the injection site.

Shingles affects anywhere from 300,000 to 900,000 people a year in this country, according to the Centers for Disease Control and Prevention. Pinning down a more precise number is difficult, because shingles isn't a so-called reportable condition. The CDC keeps track certain infectious diseases, like Lyme disease and measles, and state health laws generally require health-care providers to report cases so the data can be sent to the CDC. But shingles is not on that list. Merck puts its estimate at up to one million cases a year in the U.S. alone.

The disease is most common in people older than 60 as their immune systems age, and in people with compromised immune systems such as cancer patients or those with HIV. It is not known what causes the virus to resurface in some people and not others.

Michael N. Oxman, staff physician in infectious diseases at the VA San Diego Healthcare System and chairman of the group of investigators who performed the study, says that if the vaccine were to be given today to everybody in the U.S. who is 60 and over, a quarter million cases of shingles per year would be eliminated.

But whether millions of Americans will clamor for a shingles shot depends on several factors -- including whether insurers will pay for it, and how convincing Merck can be in getting government and physician organizations to recommend widespread vaccination. Doctors, too, may have to work hard to convince patients that an adult vaccine is necessary for a condition that isn't life-threatening.

Vaccines have been responsible for wiping out deadly diseases like smallpox over the past 100 years. But the widespread use of them can sometimes be a tough sell among older patients, says Jeffrey Silber, senior director of biologics and vaccines at Merck and one of the study's authors. "School requirements have made childhood vaccination a much easier thing to tackle," says Dr. Silber. Merck's chicken-pox vaccine became available in 1995, and about 85% of all U.S. children are now inoculated against the disease.

Robert Schwartz, chairman of the department of family medicine and community health at the University of Miami's Miller School of Medicine, says he sees one or two cases of shingles a week among older patients in his practice. But "a lot of elderly patients are just afraid of getting immunizations," he says, noting that some of his patients believe you can get the flu from a flu shot. But if a vaccine could prevent half of shingles cases, it would be enormously beneficial: "50% is better than no percent," says Dr. Schwartz, who says he receives no funding from Merck or other vaccine makers.

What concerns doctors most is the complications that can arise from shingles. In rare cases, the rash spreads to the face, which can damage the facial nerve, causing intolerable ear pain and facial paralysis, or even lead to blindness if the eye is affected.

A more common complication is a condition called postherpetic neuralgia, where debilitating pain lasts for three months or more after the rash disappears, sometimes requiring epidural injections or large amounts of painkillers. According to studies, almost half of people over 70 who have had shingles can experience pain that lasts more than a year. "You can't work, you can't read a book, you can't enjoy anything," says neurologist Donald Gilden from the University of Colorado Health Sciences Center in Denver. Dr. Gilden, who suffered from shingles himself a few years ago, wrote an editorial accompanying the research article in the NEJM in support of an adult vaccine.

Currently, shingles is treated with medications that stop the varicella virus from replicating, though they work best if started within 48 hours or so of developing symptoms. Three drugs available in the U.S. are: Zovirax and Valtrex by GlaxoSmithKline and Famvir by Novartis. According to Dr. Gilden, the drugs -- which cost around $200 for a week-long treatment -- reduce the number of days that the initial shingles episode lasts. However, several studies suggest the drugs aren't very effective at helping reduce the incidence of postherpetic neuralgia, he adds.

By comparison, the experimental Zostavax vaccine reduced the rate of this complication among participants in the Merck study. Of the 19,254 people in the vaccinated group, 315 got shingles and 27 suffered from pain three months after the rash. Of the 19,247 in the placebo group, 642 got shingles and 80 had long-lasting pain.

A spokeswoman for Merck said the company hasn't yet determined a price for Zostavax. The company's price to private payers for the chicken-pox vaccine is about $69, to which doctors may tack on a markup for administering the drug. Public-sector programs can get it from Merck for about $52 per dose.

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