Democrats oddly abet drug drive

0 Comments | Oakland Tribune, May 12, 2007

MERCK & Co. is a very large pharmaceutical company and it's Democratic Party dogma to attack drug companies for their large profit margins.

That's why it was particularly odd when a very liberal Democratic legislator, Assemblywoman Sally Lieber of Mountain View, introduced a bill that would have required every sixth-grade girl in California to have been administered a dose of Merck's vaccine that purports to guard against cervical cancer caused by a sexually transmitted virus.

Lieber gave up the bill after, she said, learning that a family trust owned stock in Merck, and Assemblyman Ed Hernandez, D-West Covina, picked it up. Meanwhile, conservative "pro-family" groups mounted a fierce attack, complaining that the measure usurped parents and assumed that young girls would be sexually active. And it was revealed that California was just one of many states in which Merck had mounted well-financed lobbying and media campaigns to mandate its three-shot regimen.

No small amount of money is involved. There are about a half- million sixth-graders in California, and if half of them are girls, that would mean a quarter-million vaccinations at $350 apiece each year, costing parents, private insurance or public health programs around $90 million. It might be worth it if the vaccine were effective at stopping large numbers of cervical cancer cases. But is it?

A month ago, the Wall Street Journal published a front-page article, revealing that "behind the scenes," the vaccine, called Gardasil, "has been dogged by uncertainty about how effective it really is." Although the Food and Drug Administration agreed that Gardasil was effective against two strains of the human papillomavirus that are thought to cause 70 percent of cervical cancers, the FDA did not ask its reviewers to examine whether the vaccine prevents cancer itself. In fact, the Journal reported, 361 of the 8,817 women who received Gardasil shots went on to develop cancerous lesions, just 14 percent fewer than those administered placebos.

Merck, of course, vigorously defended the efficacy and safety of Gardasil, but with the doubts expressed in the Journal article and elsewhere, one might think that California legislators would adopt a more cautious attitude about helping a big drug company ring up big profits. Not so.

Hernandez changed the bill, eliminating the direct mandate for Gardasil and repealing all other public school student vaccination mandates effective in 2009. Instead, the new version (Assembly Bill 16) would require pupils to receive shots recommended by the federal government's Advisory Committee on Immunization Practices -- a list that happens to include Gardasil -- after approval by the state health officer.

Rick Rollens, a longtime Capitol staffer and lobbyist, pleaded with the Assembly Education Committee to hold up AB 16, saying his son "suffers from vaccine-induced regressive autism" and citing increasing evidence that childhood vaccines play a role in autism. He characterized AB 16 as "an outrageous and arrogant attempt" to shift vaccination mandates from the Legislature to a "non- accountable bureaucrat" and a remote federal committee. Nevertheless, the bill sailed through the Assembly's education and health committees with Democratic votes.

On Thursday, the New England Journal of Medicine published a research article saying the benefits of Gardasil were modest and an editorial advising a cautious approach to its use because of concerns about its efficacy -- a far cry from mass vaccinations costing $90 million a year.

Despite those warnings, a spokesman for Hernandez says he'll pursue the bill, continuing an odd rush to judgment by politicians who are usually leery of drug company marketing.

Dan Walters (dwalters@sacbee.com) writes for the Sacramento Bee.