Merck’s Miracle Vaccine –What Is This Story Really About?

merckBy Maggie Mahar, The Health Care Blog

February 22, 2007 - Yesterday, Merck announced that it is no longer going to try to persuade states to make its new $360 cervical cancer vaccine mandatory for all pre-teens. (At least, not publicly). The company wouldn’t divulge how much it has spent, to date, on its lobbying campaign.

Virtually everyone has heard about “Gardasil.” Planned Parenthood backs it. Women in Government extols its virtues. (Both organizations receive significant contributions from Merck). Not long ago, a glowing New York Times editorial congratulated Texas governor Rick Perry for mandating “A Vaccine To  Save Women’s Lives.”( So far as I know, Merck makes no contributions to The New York Times, but Perry’s former chief of staff is a Merck lobbyist.) At this point, twenty states have drafted plans to follow Perry’s example.

Last summer, I wrote about the vaccine on American Prospect Online. At the time, I tried to make two points. First, while Merck’s vaccine could cost U.S. patients, insurers and state governments billions of dollars, it will not be saving millions of lives—because, in the countries where it will be available, there are not millions of lives to be saved.

In the U.S., we already have come close to winning the war on cervical cancer with the $30 Pap smear -- a simple test that has proven remarkably effective. Thanks to screening, between 1955 and 1992 the number of cervical cancer deaths plunged by 74 percent, and the numbers are still shrinking. From 1997 to 2003, deaths fell by an average of 3.8 percent each year. In 2006, it’s estimated that cervical cancer will account for just less than one percent (.65% to be exact) of the anticipated 273,560 cancer deaths among American women.

That said, the numbers suggest that more than 2000 American women could  die of the disease this year—an  unacceptable number. According to a study published in JAMA, most will be women who rarely had Pap smears; a disproportionate share will be poor or members of minorities. But how many of these women are likely to get a $360 vaccine? Rather than contributing billions to Merck’s coffers, we might better take part of that money to launch a campaign to try make sure that every young woman in the U.S. gets in the habit of going for regular Pap smears.

In the emerging world, where Pap smears are not readily available, cervical cancer remains a scourge.  But, in that world, who can afford a $360 vaccine? Last summer, when I asked Merck whether it planned to make the vaccine available at a discount to women in poorer countries, I was told that the question was “premature.” For now, a company spokesperson explained, the company is eying the “118 to 120 million women in the 11 to 26 age range in the U.S., the EU, and other high-income countries.” Merck still hasn’t announced a plan to make Gardasil affordable where it is needed most.

The second point that I tried to highlight last summer is that Merck’s miracle vaccine guards against viruses that account for just 70 percent of all cases of cervical cancer. In the media, Gardasil is usually described as a vaccine that protects against “most” viruses that lead to the cancer. Okay, 70% is more than 50%, so technically, it’s “most,” but the phrase is misleading.

Girls and young women who are immunized still will be vulnerable to the viral strains that account for 30% of all cases of cervical cancer. This is why, as even Merck acknowledges, girls who receive the vaccine still need regular Pap smears.

Meanwhile, a 2003 study published in JAMA points to the danger that “women who are vaccinated [will] perceive themselves to be at low risk for developing cancer and, as a result [will] not participate in screening as recommended.” If they are lulled into a false sense of complacency, the study acknowledges “gains from the vaccination may be offset.” Last week, Bloomberg News reported that in the U.K. health officials have similar concerns .

Less than weeks ago, a report on NBC put flesh on their fears. It featured a young girl in Texas explaining why she is happy to have been vaccinated: “Now this is one cancer I don’t have to worry about fighting.” No one corrected her.

Finally, as Merrill Goozner (author of The $800 Million Pill: The Truth Behind the Cost of New Drugs and director of the Integrity in Science project at the Center for Science in the Public Interest) ) pointed out on Gooznews last Monday, we don’t know much about the possible side effects of the vaccine. Like Merck’s other famous drug, Vioxx, Gardasil  was “fast-tracked” by the FDA. Goozner, who is the father of a 13-year-old daughter, has no plans to have her vaccinated.

In the mainstream media, the only publication that seems to have truly understood, from the outset, what this story is really about is The Wall Street Journal. This is after all, a business story.  As the Journal explained more than three weeks ago: “Mandatory vaccination across the U.S. would make Gardasil an automatic blockbuster for Merck at a time when the patents on some of its bestselling drugs are expiring and it's desperate to replace their revenue streams.”

Meanwhile, the Journal noted, “A growing number of parents are worried about exposing their children to the unforeseen side effects of a new vaccine to protect them from a disease that is no longer very common in the U.S. and often doesn't develop until much later in life. . . . Adding to some parents' concern, 82 adverse events among both teens and adult women have been reported since Gardasil became available last June. . . . Of the more than 25,000 patients who participated in clinical trials of Gardasil, only 1,184 were preteen girls. ‘That's a thin base of testing upon which to make a vaccine mandatory,’ says Barbara Loe Fisher, co-founder of the National Vaccine Information Center, an advocacy group that lobbies for safer vaccines. . . Merck declined to say how much money it has funneled into its lobbying campaign, or contributed to Women in Government,” the Journal reported..  “A spokeswoman for Women in Government, Tracy Morris, declined to say how much it had received from Merck.” 

The campaign to vaccinate every girl and young women in the U.S. is not about saving women’s lives. It is, as the Journal so clearly understands, about money. It is about Merck’s desperate need to replace the revenue that it lost when it was forced to pull Vioxx off the market.  Some call Gardasil the “Help Merck Pay For Vioxx Vaccine.”

Finally, Merck’s campaign stands as an example of a for-profit corporation trying to set healthcare spending priorities for the nation. This is not Merck’s job.