Study Questions Cost-Effectiveness Of Gardisil Cervical-Cancer Vaccine

A new study suggests that giving Merck & Co.'s cervical-cancer vaccine Gardasil to women through their mid-20s may not be worth the price, despite U.S. recommendations that this age group receive the costly shot.

The study, published online Wednesday by The New England Journal of Medicine, comes as Merck already is having difficulty persuading college-age and older women to get the vaccine, which was introduced in 2006 and costs about $360 for a three-dose regimen.

Ms. Kim and Harvard colleague Sue Goldie concluded that it cost about $43,600 per "quality-adjusted life year" gained, when HPV vaccine is administered to 12-year-old girls. This falls below the $50,000 per quality-adjusted life year threshold that some researchers use as a maximum for cost-effectiveness. Other researchers use a higher maximum benchmark of $100,000 per QALY to gauge cost-effectiveness.

Screening via Pap smear is recommended for women who are sexually active, even with the availability of Gardasil.

Among the differences between the models were that the Harvard researchers included patient time and travel costs, while Merck didn't, and the Harvard researchers didn't include genital warts in males, while Merck did, according to the CDC.

At least one of the factors in the primary Harvard calculations may be a relatively optimistic assumption -- that vaccination would produce lifelong immunity. Because the vaccine was only studied for five years and has been on the market for two years, no one knows for certain if its protection is lifelong, or if it wanes over time.

Still, the study is likely to fuel skepticism about Gardasil, which has already faced questions surrounding its safety and effectiveness (Merck and the CDC maintain it is safe and effective, with the most common side effect being soreness at site of injection.)

HSI e-Alert - Hide Your Daughters

Dear Reader,

Worst Vaccine Bill Ever

That's what some are calling a pending New York Assembly Bill that would require all children in the state to receive EVERY vaccine recommended by the Centers for Disease Control and Prevention (CDC).

Mandatory. A total of twenty vaccinations – some requiring multiple doses.

This is guaranteed to do two things: 1) Make boatloads of money for drug companies, and 2) Put many young women in danger.

Chill pill

Hey, everybody – relax! That was the basic message last month from a CDC/FDA review of problems linked to Gardasil, the vaccine that helps prevent human papillomavirus (HPV) in women. And yes, Gardasil is on the CDC's list of recommended vaccines.

By CDC/FDA estimates, 94 percent of the health issues linked to Gardasil are "nonserious" events (sure – nonserious as long as they don't happen to YOUR daughter), leaving six percent classified as severe.

So let's do the dirty math. The FDA has received more than 9,700 adverse event reports. That means more than 580 young women have suffered severe reactions, including seizure, convulsions, and death.

But not to worry. Why? Because the CDC/FDA report notes that Merck has distributed more than 16 million doses of Gardasil in the U.S., and adds: "Given the large number of doses distributed, it is expected that, by chance alone, serious adverse events and some deaths will be reported in this large population during the time period following vaccinations."

So it's probably just a weird coincidence! That's the best they've got, and they're stickin' to it.

Lulled into thinking

Meanwhile – out here in the reality-based world – there's a growing awareness that something isn't quite right with this vaccine. And that awareness begins in an unlikely place.

Diane Harper, M.D., was one of the principal investigators in the initial Gardasil trials. When the vaccine was approved two years ago, Dr. Harper called the it the biggest advance since the Pap smear.

But last month, in an interview with Medscape Medical News, Dr. Harper said: "The side effects that have been reported are real and they cannot be brushed aside."

She's also concerned that Gardasil is getting a reputation as a cervical cancer vaccine. It's not. It's an HPV vaccine. Dr. Harper: "Even if everyone was vaccinated, we would still have cervical cancer. I don't want people to be lulled into thinking this will prevent cancer."

That's an astonishing comment coming from someone who actually tested and then championed this vaccine. Especially because lulling people into thinking Gardasil will prevent cancer seems to be EXACTLY what Merck's advertising attempts to do. Here's one of the first comments you'll find on the Gardasil web site: "Gardasil is the only cervical cancer vaccine that helps protect against 4 types of human papillomavirus."

Tell your daughters

I hope you'll help us get the word out about Gardasil. Please forward this e-Alert along to any young women or parents of school-age girls to let them know about these four key reasons why they should think long and hard before they accept this vaccine:

HPV is easily detected and treated when women have Pap screening during annual gynecological exams,

Along with Pap screening, adding the HPV Test offers even greater assurance that the virus will be caught early HPV does not always cause cervical cancer

The full scope of the dangers of this vaccine won't be known for several years.

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