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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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Parents Will Fund The Research

October 4th, 2009

Well, the vaccine conference is over, at least for me. There is one last panel tonight on vaccines and political action, but it’s time for me to rest and to catch you up on this amazing event. I had originally intended to blog everyday, but the conference schedule has literally been non-stop and this is the first chance I’ve had to organize my thoughts.

The conference presentations were uniformly excellent, the material diverse and far reaching and the attendees inspired and activated. There is no doubt in my mind that we have reached a critical mass. It is just a matter of time before we resuscitate the informed consent doctrine in the US. Perhaps it is the fear of mandatory vaccines for swine flu that finally will tip the point.

In the spirit of The Seven Traits of Highly Effective People, I want to “start with the end in sight.” I will tell you about the end of the conference and then go back to the beginning. Over the next two weeks, I will blog about what I’ve learned from the sessions.

Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center (NVIC), made her closing remarks joyfully today. Just yesterday, Dawn Richardson, president of Parents Requesting Open Vaccine Education (PROVE), suggested that since the government was unwilling to fund research into comparing health outcomes between vaccinated and unvaccinated children, we do it ourselves.

Barbara offered that NVIC would immediately begin to take donations to fund such a scientific study, to be conducted by independent, credentialed researchers and published in an important medical journal. In just the last 24 hours of this conference, NVIC has raised $110,000 for this study and will issue a press release regarding it tomorrow, Monday 5 October 2009. This is an historic moment.

I would suggest that you go immediately to the NVIC website and sign up for their newsletter so that you can receive the press release. While you’re at it, make a donation to NVIC. Family membership is just $25. Their mostly volunteer staff has been doing so much for all of us since 1982 and they operate on a budget of less than $300,000 a year. Barbara said that if they had more funding for the organization, they could:
Mount a national advertising campaign.
Offer a 24 hour a day national vaccine reaction reporting hotline.
Create statewide legal and medical networks.
Coordinate state leaders working for state exemptions.

Dawn Richardson from Texas, who suggested that parents do the study, has developed model state language for a medical exemption. She did a session Thursday night on “State Organizing To Get & Protect Vaccine Choices” and I’ve asked her to write an article for us on this topic. Look for it in early 2010. More tomorrow.

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At the Vaccine Conference

October 1st, 2009

I’m in Reston, Virginia right now, here to attend the 4th International Public Conference on Vaccination put on by the National Vaccine Information Center (NVIC). The conference is being held from Thursday, October 1st through Sunday, October 4th, 2009. Monday, October 5th, is a group lobbying day on Capitol Hill. The day includes a congressional briefing on the Vaccine Injury Compensation Program (VICP) and time for conference participants to visit their own state legislators to discuss vaccine safety issues.

I always love visiting the DC area, probably because I’ve come here mostly to attend vaccine conferences or congressional hearings on vaccines. I knew that the conference would give me the impetus I wanted to get my blog started because I’m eager to share all of the fabulous information I will be learning during the next three days. It will also be an opportunity for me to solicit great articles for 2010.

I intend to keep you posted on the exciting presentations from the conference. I’m particularly looking forward to hearing George Annas on “Informed Consent,” Vicky Debold on “Vaccinated and Unvaccinated: Measuring Outcomes” and Andy Wakefield on “Vaccines and Inflammation.” I’ll especially watch out for any information to help you quell the swine flu hysteria.

I’ll be giving the opening speech Friday morning on “The New Health Journalism: Challenging the Status Quo” and will post my talk online later that day.

On Friday evening, I’ll be the moderator for the “Mother & Child Panel” with Amy Lansky, Stephen Marini and Jeanne Ohm. What a lineup! On Saturday, I have the honor to moderate Bob Sears, who will talk on “The Alternative Vaccine Schedule’ and Larry Palevsky on “Getting Sick to Stay Well.” And Sunday, I’ll be thrilled to moderate Joe Mercola’s talk, “Take Control of Your Health.” I can’t wait to meet him.

And, Saturday night, I will receive the Courage in Journalism award from NVIC. I cried when I read Barbara Loe Fisher’s email letting me know. She wrote, “I would like to present you with the NVIC’s Courage in Journalism award in recognition of your many years of leadership in framing the paradigm shift that is occurring in child health toward achieving wellness without constant use of multiple vaccines or drugs.”

More on all this soon. Stay tuned.

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