Saturday, February 17, 2007

Where Angels Fear to Tread

Here's the problem with doing the right thing for the wrong reasons:

“If the public had enough experience with the vaccine and had enough knowledge about H.P.V., the question about whether to get the vaccine or give it to their daughters wouldn’t be an issue,” Dr. Bocchini said.
But it is; it is because Gov. Rick Perry has ordered that all 6th grade girls in Texas get inoculated with Gardasil, at $400 a person for three shots. Which is already prompting criticism, of course:

One activist who frequently criticizes pharmaceutical companies, Vera Hassner Sharav, and a co-author suggested that the H.P.V. vaccine stood for a campaign to “Help Pay for Vioxx” losses. Vioxx, the painkiller taken off the market in 2004 because it was linked to cardiovascular problems, was also made by Merck.
Hard to disagree, frankly, since Gov. Perry's former chief of staff is now a lobbyist for Merck. And the Texas Legislature has several bills several bills pending, all aimed at overturning the Governor's order. Legislatures don't like executives who get high-handed. The Texas Lege is not the U.S. Congress, and Perry isn't President Shrub. Even those who think Perry did the right thing for the wrong reasons may be disappointed by the set-back this will produce. If the Lege overrides Perry's order (as is likely), it may be several years before Gardasil, or any similar vaccine, gains legislative acceptance.

Which, of course, is the real problem.

This is why:

Typically new vaccines, like the one for chicken pox in the mid-1990’s, have been rolled out gradually in this country, with public health officials endorsing mandatory use only after several years of experience have shown the new products to be generally safe and effective.
Is Gardasil 100% effective and efficacious? Or even as effective and efficacious as the Salk vaccine I took in a sugar cube? I accepted that vaccine because my parents accepted it, and they accepted it because they were convinced it was helpful; not because the Texas Governor owed a huge favor to a major campaign donor. As the NYT article notes:

If the public had enough experience with the vaccine and had enough knowledge about H.P.V., the question about whether to get the vaccine or give it to their daughters wouldn’t be an issue,” Dr. Bocchini said.
So pardon my cynicism but, follow the money:

Analysts see a potential $5 billion a year market for H.P.V. vaccines, and some say that Merck is intent on inoculating as many girls as possible before the introduction of Glaxo’s product, which could become available this year.
Is my daughter's health included in that? Because here are the numbers:

Gardasil protects against two strains of H.P.V. that cause about 70 percent of the cases of cervical cancer as well as two other strains that cause genital warts. In approving the vaccine last June, the Food and Drug Administration said that in the United States each year there were an average of 9,710 new cases of cervical cancer and 3,700 deaths attributed to it.

The disease’s toll is higher in other parts of the world than it is in the United States, where most women get routine Pap smears to detect early precancerous changes in the cervix. Worldwide, cervical cancer is the second-most-common cancer in women. It causes more than 470,000 new cases and 233,000 deaths each year, according to the F.D.A.
But where are the numbers for the side effects of this vaccine, or even it's efficacy? And back to that problem of coverage and acceptance:

Dr. Carol Baker, a professor of pediatrics at Baylor College of Medicine in Houston, said that two other vaccines for adolescents that were approved in recent years — against meningitis and whooping cough — have not yet been mandated in Texas. “To mandate just one, in my view, is a little odd,” she said.

The American Academy of Pediatrics is not advocating mandatory Gardasil vaccination, either. One source of opposition from pediatricians is cost. Buying enough H.P.V. vaccine for 100 girls would require a practice to lay out nearly $40,000 in advance. Many doctors say that the insurance reimbursement for giving the vaccine is not adequate to compensate them for administering it.

Dr. Bocchini of the American Academy of Pediatrics also said too much of the Gardasil focus was being placed on 11- and 12-year-olds, when legislatures should be focusing on trying to obtain funding to vaccinate girls and women in the 13-to-26 age group, many of whom are not covered by the federal vaccine programs aimed at children.

“A number of people are just not going to be able to get this vaccine,” he said.
And here's why:

Paul Purcell, the business administrator for Step Pediatrics in The Woodlands, said many doctors will be lucky to break even. The vaccine, Gardasil, costs $120 a dose and requires three doses to be effective. Most insurance reimbursements top out at $126 a dose, he said.

"Six bucks is not going to cover it," Purcell said.

Like any business, doctors have overhead — from office leases to photocopying. Step Pediatrics serves more than 5,000 patients and has three doctors, one nurse practitioner and 11 other employees, including Purcell.

Purcell estimated that just filing on a patient's insurance probably costs his office about $8 in administrative expenses.


As patients, we tend to forget that doctors' offices, like hospitals, are businesses. They provide an important service, but they also exist to make money. Even if it clears $6 a dose, that business is generating a rather paltry 5 percent return on HPV vaccinations.

Doctors can, of course, charge more for administering Gardasil, and some are, but that leaves patients to bear the rest of the cost under the mandate.

In some cases, patients may not be able to pay.

That's part of the reason that the Texas Medical Association has come out against the governor's mandate that the HPV vaccine be given to all girls entering the sixth grade in 2008.
Perry, you see, has more in common with Shrub than is generally acknowledged. He can order everyone to get the vaccination. He can't authorize the public funds (of which there really aren't any, in Texas) to pay for it.


The governor's mandate also meddles in the free market. Merck, the vaccine's manufacturer, would know that the drug was required for Texas schoolgirls in Texas, giving the company no incentive to offer the price breaks to doctors that often come with new products.

"That really eliminates my bargaining power," Purcell said.
And that's not all!

Parents, of course, could still choose to have their daughters vaccinated. Purcell said his office has had a lot of interest from parents of patients since the vaccine came to market last summer.

A lot of parents, though, decide against it when they see the price, he said. Because of the reimbursement issue, his office has stopped filing on insurance for Gardasil, leaving it up to the patients to seek reimbursement from their insurers.

Gynecologist Fred Ernest said he offers the vaccine but may discontinue it because of the poor reimbursement rate from insurers.

"The cost to do business continues to climb," he said. "There's going to have to be a give somewhere."

Ernest said his financial concerns, though, are outweighed by medical ones.

"I personally feel that there should have been long-term studies and it should have been left up to the parent" whether to vaccinate, he said. "I just don't think there's enough data out there to make a mandatory ruling on this."
There really is no such thing as a free lunch.

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