The Rush to Vaccinate

This article appeared in The New York Times on March 25, 2007.
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There’s nothing wrong with drug makers publicizing their products, but the lure of lucrative government contracts can prompt them to play fast and loose. In lobbying state lawmakers to make its latest vaccine mandatory, Merck has greatly exaggerated both the threat of a disease and the ability of a drug to prevent it. (True, Merck has promised to stop lobbying, but lawmakers and the public are still suffering under misconceptions that the drug company has done nothing to correct.)

The drug in question is Gardasil, a vaccine for four types of human papillomavirus, or HPV, two of which are responsible for 70 percent of cervical cancer cases. The Food and Drug Administration approved Gardasil last year for use against HPV in females aged 9 to 26.

Assemblywoman Amy Paulin, a Democrat whose district includes Bronxville, Eastchester, Pelham, Pelham Manor, Scarsdale, Tuckahoe and parts of New Rochelle and White Plains, recently introduced a bill mandating HPV vaccinations for “children born after Jan. 1, 1996.” (For now, this bill only applies to girls. If the Food and Drug Administration approves its use for boys, they will be included in the legislation.)

Such mandates are a boon for Merck, as Gardasil is one of the most expensive vaccines on the market. With a price tag of $360 for a series of three shots, vaccination of nearly two million New York children would bring in almost $700 million.

Gardasil is not all it’s cracked up to be. A recent study published in The Journal of the American Medical Association found that among women ages 14 to 24, the rate of all 37 types of sexually transmitted HPV combined is 33.8 percent — much lower than the 50 percent figure cited on Merck’s Web site. More important, the rates for HPV 16 and 18 — the two types responsible for 70 percent of all cervical cancers — are astronomically lower: only 1.5 percent and 0.8 percent, respectively.

And among those cases, American Cancer Society guidelines published last month report that most HPV infections, even carcinogenic ones, resolve without treatment. About 75 percent of infections in adults and 90 percent of those in adolescents disappear on their own.

It’s worth noting that the American Cancer Society sees its fight against cervical cancer as a success story even without Gardasil. When the disease is detected early through Pap testing, the survival rate is more than 90 percent.

In short, even without the vaccine, when early detection methods are used, the number of girls who are actually at risk of dying of cervical cancer from HPV 16 or 18 is extremely low. Most of the time, the body takes care of the virus without any help whatsoever.

Under these circumstances, are we really prepared to spend millions of dollars administering this vaccine for girls, let alone boys? In truth, it may well cause more harm than good.

For instance, what if the vaccine lulls young women into a false sense of security? Gardasil protects only against the viruses responsible for some cervical cancers, and women may not realize they need regular Pap tests even though they’ve been vaccinated. As a result, many precancerous conditions may go undetected until it’s too late.

Merck’s drug trials followed women who received Gardasil for an average of only three years, so we know little of how long the immunity lasts or the long‐​term risks that may be associated with it.

Earlier this month, The New England Journal of Medicine reported similar problems with the chickenpox vaccine. Not only did the incidence of illness among those vaccinated against chickenpox increase over time, so did the severity of the illness.

And what if the HPV vaccine causes some horrible side effect to materialize later? The possibility isn’t as far‐​fetched as you might think. In 1976, swine influenza caused only one documented death in the United States, but the vaccine administered by government mandate seriously injured or killed hundreds. It turned out that the vaccine caused Guillain‐​Barré syndrome, a rare paralytic disease similar to polio, with a 5 percent fatality rate and a 10 percent rate of permanent paralysis.

Mandatory Gardasil vaccinations certainly brighten Merck’s future, but it’s not so clear that they’re in the best interest of New Yorkers. In all but the clearest cases, health‐​risk assessments should be left up to individual families, not only because making such determinations rightly rests with families, but because it’s simply not sensible policy to experiment on such a large portion of our population all at once.

Not only has Merck left lawmakers in the dark about possible downsides to mandatory HPV vaccination, it has actively lobbied and paid large campaign contributions to politicians willing to support it.

According to records from New York’s temporary state commission on lobbying, Merck spent almost $400,000 influencing representatives from 2003 to 2006. Though Assemblywoman Paulin appears to have received only $500 from the company, she met personally with its representatives on several occasions.

This is not to say that Ms. Paulin doesn’t sincerely believe that vaccinations are the right policy. But she and her fellow Assembly members should realize that while mandating HPV vaccinations would reap huge profits for the company, they might well come at the expense of New York’s children.