Okay, so here is the first post for the "virtual" Science of Science Communication course 2.0. Actually, I'll be teaching/learning/attending the first "real world" session in about 30 mins.
Today's readings are in the nature of a "case study" of the introduction of the HPV vaccine in the U.S. & its status today. The material below is in the nature of a "set up" for discussion, which I encourage people to have whereever they want but also in the comments section.
I'm designating this "Session 1.1" in anticipation that I might myself post something-- in the nature of a "follow up" -- in which case I'll designate "Session 1.2." Or maybe I'll do something else, who knows.
BTW check out this super cool & generous invitation if you are looking for "virtual" classmates & course materials!!
The introduction of the HPV vaccine in the US-- or the cost of being innocent & ignorant of the science of science communication. . . .
1. Merck’s application for “fast-track” review of female-only shot. It is late 2005. Merck, the manufacturer of the HPV vaccine Gardasil, has applies for “fast-track” FDA approval of a female-only shot.
HPV—the human papilloma virus—is a sexually transmitted pathogen. Exposure is widespread: some 45% of women in their early 20s have been infected. A comparable percentage of men almost certainly have been, too, although there is at this time no effective test for males.
HPV causes genital warts in some but not all infected individuals.
It is also the sole cause of cervical cancer. A diseases that can normally be detected at an early stage by a routine pap smear and thereafter successfully treated, cervical cancer nevertheless claims the lives of 3,000 women per year in the U.S. (many more in undeveloped countries that lack effective public health systems).
Clinical tests show that Gardasil confers immunity against 70% of the strains of HPV that can cause cervical cancer. This evidence furnishes logical reason to believe that widespread immunization would reduce cervical cancer rates, although the vaccine is in fact too new, and experience with it in nations where it is already in use too limited, for that proposition to have been empirically tested.
The role of HPV in causing cervical cancer is the basis for Merck’s application for “fast track” review, which is available only for drugs that furnish an “unmet medical need” for treatment or prevention of a “serious disease.” The link to cervical cancer is also why the “fast track” application is for a female-only shot: genital warts are not considered a “serious disease,” and while HPV might cause oral or anal cancer in men, there is at this time insufficient evidence to be sure.
If put on the “fast track,” Gardasil will likely be approved for use for women within six months. The FDA review process would otherwise be expected to take three additional years. Within that time frame, in fact, the FDA is likely to approve for males and females both Gardasil and Cervarix, an HPV vaccine manufactured by GlaxoSmithKline and already approved for use in Europe.
2. Health risks? Clinical trials suggest no reason to believe Gardasil poses a risk of dangerous side-effects. Some critics question the quality of this evidence, however, noting the recent withdrawal of Merck’s anti-inflammatory Vioxx based on evidence, known but not initially acknowledged by Merck, that showed the drug increased the risk of heart attacks and strokes.
Other critics suggest that widespread HPV immunization could have perverse behavioral consequences. To be effective, immunization should occur during adolescence, before an individual is likely to have become exposed to the disease through sexual activity. Some groups, including social conservative and religious ones, have voiced concern that immunization will generate a sense of false security in teenage girls, who will therefore be more likely to engage in unprotected sex, exposing themselves to a higher risk of pregnancy or other STDs. There is currently no evidence one way or the other on whether HPV immunization of adolescent girls would have any such effects.
3. The proposed legislative initiative. In addition to seeking fast-track approval of Gardasil, Merck is known to be organizing a nationwide lobbying campaign aimed at securing legislation adding the HPV vaccination to the schedule of universal childhood immunizations treated as a condition of public-school enrollment.
As part of this effort, Merck has reached out to women’s health advocacy groups. These groups strongly support making the HPV vaccine available in the U.S. Merck has proposed that these groups play a lead role in the company’s lobbying campaign, which would be funded by Merck. Merck is also understood to be searching for social conservatives to participate in the campaign.
4. Physicians’ views. There is every reason to believe physicians will view the availability of an HPV vaccination as a very positive development. No major U.S. medical association, however, has taken a position on either Merck’s fast-track proposal or on adding the HPV vaccine to states’ school-enrollment immunization schedules.
At least some physicians, however, have voiced criticism of how the vaccine is being introduced. They assert that Merck’s fast-track application and its planned nationwide legislative campaign are economically motivated: Merck’s goal, they have argued (in various fora, including medical journal commentaries), is to establish a dominant position in the market before the FDA approves of GlaxoSmithKline’s rival Cervarix vaccine. Whatever public health benefits might be associated with accelerating the speed with which Gardasil is approved and HPV vaccine added to universal vaccination schedules, these commentators have warned, will be offset by the increased risk of a political backlash.
5. Political controversy? At this point, there is no meaningful dispute over Gardasil. Indeed, only a minute fraction of the U.S. population has ever heard of the vaccine or even HPV for that matter.
Nevertheless, the prospect of controversy has already been anticipated in the national media. A government-mandated STD shot for adolescent girls, these sources predict, is certain to provoke confrontation between women’s rights groups and religious and social conservatives.
Aside from some women’s’ health groups, the only other advocacy group to address the HPV vaccine is the Family Research Council. Committed to protecting religious values in American life, FRC has played a major role in opposing public-school instruction on birth control. The FRC has stated that it does not oppose—indeed, “welcomes”—the introduction of the HPV vaccine, but views state-mandated vaccination as interfering with parental control of their children’s’ health and their sexual behavior.
5. The HBV vaccine. The HPV vaccine would not be the first STD immunization to be placed on states’ school-enrollment vaccination schedules. A decade ago the FDA approved the HBV vaccine for hepatitis-b, a sexually transmitted disease that causes a lethal form of liver cancer. The CDC quickly recommended that the vaccine, which had been approved for both males and females, be added to the list of universal childhood immunizations. Within several years, almost every state had added the HBV vaccine to its mandatory-immunization schedule via regulations issued by state public health officials, the conventional—and politically low-profile process—for updating such provisions. The addition of the HBV vaccine to the state schedules generated no particular controversy, and the nationwide vaccination rate for HBV, like other childhood immunizations, has consistently been well over 90%.
6. “Public acceptance” research. Public health researchers have conducted studies specifically aimed at assessing the public acceptability of an adolescent HPV shot. These studies, which consist of surveys of parents with adolescent children, uniformly report that parents say they are unfamiliar with the HPV vaccine but will have their children immunized if their pediatricians recommends doing so.
Issues. Should the FDA grant Merck’s application for fast-track review? Should Merck withdraw it? Should women’s’ advocacy groups agree to participate in the company’s nationwide legislative campaign? What position, if any, should medical professional associations take? Is the position of social conservative groups like the FRC relevant to these questions?