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Peggy O'Mara

A Quiet Place

HPV Vaccine

October 12th, 2009

For those of you who want to know more about the HPV vaccine, you may want to order the audio of the NVIC presentation, “Gardasil Vaccine: Informed Consent?” by Diane Harper, MD, MPH, MS. Harper has worked in all aspects of HPV associated diseases, specifically cervical cancer prevention. She is the leading international expert on HPV vaccines and has worked with both Merck and GSK to develop Gardasil and Cervarix.

Before Harald zur Hausen identified HPV as the cause of cervical cancer in 1976, it was the most common cancer in the world, with a rate of 50 cases per 100,000 women. Today, cervical cancer is the fifth cause of death among women in developed countries with a rate of three cases per 100,000 women, but it is still epidemic in developing countries.

Seventy percent of HPV infections resolve within one year; 90 percent resolve within two years. Only 10 percent of infections will persist and 50 percent of these will be cancer precursors.

Of those who get cervical cancer, 50 percent never got a pap smear and ten percent had a pap more than five years before. Mass screening programs for HPV infection have had dramatic effects. Finland saw a 75 percent drop in cervical cancer when women participated in mass screening. When 70 percent of women in a society participate the rate of cervical cancer drops.

There are risks associated with a pap smear, however, including the stress and anxiety of screening, of abnormal results, of false positive results and of the treatments. There are also possible relationship traumas from the diagnosis of sexually transmitted disease (STD). The treatments, colposcopy and biopsy of the cervix, increase the risk of preterm delivery, low birth weight, premature rupture of the membranes and cesarean birth.

The vaccines, Cervarix and Gardasil, are highly effective against most types of HPV viruses, but not all of them; Merck is working on a supplemental vaccine. Coverage requires three doses of the vaccine and is costly⎯$375 for the series. No efficacy trials in girls under fifteen years of age have been done. The duration of efficacy is unknown for all recipients. On the package inserts, Gardisal publishes efficacy of five years and Cervarix publishes 7.5 years. According to Harper, “If HPV vaccines are not effective for at least 15 years, then no cervical cancer is prevented, only postponed.”

In general, the vaccine has proven safe for most women, but results from the Vaccine Adverse Events Reporting System (VAERS) indicate that 29 percent of vaccine recipients feel dizzy and faint. Thirteen cases of Guillain Barre’ have been reported to VAERS, and thirty-two deaths. The risk of adverse events to HPV vaccine is 7 events per 100,000 vaccinated.

At this time, the HPV vaccine may reduce the incidence of HPV, but not cervical cancer. There will be no substantial decrease in cervical cancer until 70 percent are vaccinated. Screening alone is as effective as screening with vaccines in preventing HPV infection. Screening is still essential.

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Informed Consent

October 7th, 2009

George Annas, JD, MPH, delivered the opening keynote address of the 4th international NVIC conference, “False Choices and Worse Case Scenarios: How Taking Informed Consent Seriously Can Improve Public Health.” Annas is the Edward R. Utley Professor and chair of the Department of Health Law, Bioethics and Human Rights of Boston University School of Public Health and professor in the Boston University School of Medicine and School of Law. He is co-founder of Global Lawyers and Physicians, a transnational professional association of lawyers and physicians working together to promote human rights and health.

I was inspired by Annas’ early work, The Rights of Hospital Patients, an American Civil Liberties Union (ACLU) guide and found it invaluable when my son was hospitalized in 1982. This book has been updated and is now published under the title The Rights of Patients.

All 50 states have legislation that delineates the required standards for informed consent. In order for informed consent to occur, the practitioner must disclose to the patient the benefits and risks of and alternatives to any treatment, procedure or drug. It is critical that the patient receive enough information to make a decision and not be coerced into making one.

As a member of the public health community, Annas is a supporter of vaccines, but defends the right of individuals to seek exemptions from them. He says that 90% of people want vaccines and that lack of access to them is the problem, not exemptions from them.

Annas is critical of the military mindset that has crept into public health since the creation of Homeland Security. He would prefer that trusted health officials be in charge of health policy because citizens do not respond well to threats about healthcare policy. A past NY Academy of Sciences study found that if there really were a smallpox epidemic, 60% of people said they would not get a vaccine. Some were afraid of vaccines, and some were afraid of getting smallpox from the vaccine. When asked who could convince them to vaccinate, people said that it would have to be a trusted non-government physician, or a credible public figure. Annas said that all public health experience has shown that there is “no force on earth strong enough to get someone to do something they don’t want to do and think is not in the best interest of their family.”

Currently some states are debating whether or not to require physicians and hospital personnel to be vaccinated for swine flu, but this was not successful with smallpox and Annas does not expect it to be with swine flu. New York is currently the only state to require RNs and MDs to get seasonal and swine flu vaccines and Massachusetts is considering doing so. Current guidelines at Boston Medical Center “require all hospital personnel to be vaccinated unless they refuse vaccination.” According to Annas, one just has to sign a form.

Annas recalled what he called the 1976 “swine flu fiasco” in which 50 million people were vaccinated for a flu that never materialized. Guillain-Barre’, a known risk factor from swine flu vaccine, however, did materialize with an incidence of 1 in 100,000.

Even those who favor aggressive health policy, according to Annas, are in favor of volunteerism, of urging people to get vaccinated rather than attempting to force them. He quoted Obama’s inaugural address in which he said, “It is a false choice between security and liberty.” In a healthy population human rights and dignity are required.

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