This article is more than 5 years old. Information may no longer be current.
Direct marketing of vaccines to state legislators raises questions
Some people believe that mandates represent an infringement on their rights.
Click Here to Manage Email Alerts
Women in Government, an advocacy group made up of female state legislators across the country, has been asked to support mandates for human papillomavirus in their states.
According to The Nation, the advocacy group received support from the manufacturer.
At least 30 state legislatures in this country have introduced legislation to mandate the vaccine as a requirement for school attendance. In addition, Texas Gov. Rick Perry on Feb. 2 issued an executive order requiring girls entering the 6th grade as of 2008 to get the vaccinations, triggering protests from lawmakers in that state. Shortly before press time, Texas state legislature rejected Perry’s executive order.
The governor and several legislators reportedly received campaign contributions from the manufacturer. This seems to me to be over the top. The vaccine is a valuable one and can stand on its own without invoking a mandate, a mechanism that must be used judiciously. The company agreed subsequently to cease this practice.
In the meantime it has fueled groups opposed to this vaccine, vaccines in general and mandates in particular.
Mandating immunization has been an important mechanism invoked by many states, which determine their own immunization for a variety of vaccines.
The rationale has been to prevent epidemics of diseases – such as measles – in the schools and thereby protect children against infection that might be transmitted by those not vaccinated. If an epidemic does occur, the unimmunized children whose parents opted out are excluded from school.
Mandates strike many people as wrong. They believe it infringes upon their rights, particularly their right to make decisions about their own children.
Suggestions that certain government benefits be tied to parents’ documenting that their children have received immunization have been rejected in this country, although other countries have used it.
This gets into the “them vs. us” conflict about who knows best about what is appropriate for one’s children. It is a slippery slope!
Talk of mandates for the HPV vaccine has raised a variety of arguments against the vaccine. One has been that HPV is not a contagious disease such as measles or chickenpox, the effects of which are immediately obvious.
HPV is quite contagious but the immediate signs that infection has occurred are not apparent. This in fact makes it more treacherous. It may take decades between the time infection occurs and cancer develops. It is very communicable. About one-quarter of all post-pubertal females, 45% of those between 20 and 25, harbor the virus (JAMA;2007;297:813) and about 80% of all women have been infected.
Many believe very strongly that protecting their child should be their responsibility by teaching them what is “right.” Unfortunately, some of these folks feel that everyone should be taught what he or she thinks is “right.”
Some groups claim without substantiation that immunizing against a sexually transmitted disease will increase promiscuity. I do not believe that the discovery of penicillin, which was a great treatment for gonorrhea or syphilis at the time, increased promiscuity.
One of the arguments against the use of the HPV vaccine has been that the long-term effects are unknown. However, it has not been stated specifically which effects one might plausibly expect from this inactivated vaccine.
Some opponents propose a longer period of observation before the vaccine should be used routinely. How long? If we wait several decades to observe side effects and its long-term impact on cervical cancer, millions will be infected and hundreds of thousands will develop cervical cancer and tens of thousands may die.
Although I carry no brief for the manufacturers, would you as a shareholder approve of a company investing hundreds of millions of dollars in a product that would not be marketed until decades later?
Development of this and other vaccines against cancer would not occur.
Some believe certain parents cannot take care of their children properly and that they should be forced to give their children vaccine. They argue that it is appropriate to protect “my child against infection by yours” by mandating immunization for everyone.
However, the seminal studies on transmission of HPV were conducted in college women who they might judge “should know better” (Am J Epidemiol;2003;157:218-226).
Some are opposed because that vaccine will not prevent all cervical cancer.
That it does not prevent all cervical cancer is indeed true, and that only a small fraction of the infecting HPV strains are likely to cause cancer is also true.
It will not obviate the need for routine Pap smears to detect the cancers caused by strains not contained in the vaccine.
But, is it reasonable to reject a vaccine that may prevent 2,600 deaths due to cervical cancer annually because it does not prevent 1,100? This is more than the total number of deaths by preventable disease that we now immunize against.
It is an expensive vaccine, which if recommended by states, will carry with it the obligation to fund the program. This may not be the highest priority for use of health care dollars in some states. The cost also leaves some families who want to get this expensive vaccine and have to pay for it out of pocket a difficult choice in budgetary priorities. If girls are required to get it to prevent spread, should boys not be required to get the vaccine as well? Should a boy’s family be required to foot the bill to protect women in the community from infection?
HPV is probably one of the most important vaccines that has come along in decades. Providers should share information about it with their patients and be prepared to answer questions. The CDC has issued recommendations (MMWR; 2007;56:1-24).
Bypassing patients’ health care providers to promote products, no matter how well intentioned, is not the way to go. The manufacturer has stopped their lobbying effort for HPV. When vaccines are considered for approval, manufacturers have ample opportunities to present their data to experts who can evaluate their presentation. They can and do promote their products to physicians. Mandating this vaccine is not necessary. It can and should stand on its own merits.
I find myself in virtually complete agreement with Dr. Brunell’s comments on this issue. Mandates do generate a great deal of public backlash. School immunization mandates have, however, been generally highly successful and a major factor in the success of pediatric immunization. Mandates have been successful, at least in part, because there were “escape” clauses built in for those who had religious or other serious objections to mandated immunizations.
HPV vaccine is a different matter, however. It does not prevent an acute symptomatic and potentially morbid infectious disease; exposure is a matter of personal choice. Clearly, parental input into acceptance of this vaccine is advisable. For the record, I have advised the parents of my own granddaughters, now entering puberty, to receive the vaccine. But mandating this vaccine was not the intent of the American Academy of Pediatrics nor the Advisory Committee on Immunization Practices.
– Theodore C. Eickhoff, MD
Chief Medical Editor
For more information:
- Philip A. Brunell, MD, is a Special Volunteer at the National Institutes for Allergy and Infectious Disease at the NIH and Professor Emeritus at the University of California, Los Angeles. He is also a Member of the Infectious Disease News Editorial Advisory Board and Chief Medical Editor of our sister publication, Infectious Diseases in Children.