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Director's Comments Transcript: HPV Vaccine's Risks and Benefits 10/19/2009

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Greetings from the National Library of Medicine and MedlinePlus.gov

Regards to all our listeners!

I'm Rob Logan, Ph.D. senior staff National Library of Medicine for Donald Lindberg, M.D, the Director of the U.S. National of Medicine.

Here is what's new this week in MedlinePlus.

To listen to Dr. Lindberg's comments, click herelisten


Two recent articles and an editorial in the Journal of the American Medical Association critique the marketing and side effects of human papillomavirus (HPV) vaccines and ponder the risks versus the benefits of HPV shots.

In the first comprehensive review of side effects since the HPV vaccine was approved in summer 2006, 12 authors note 6.2 percent of reports noted serious adverse events. There have been 32 deaths associated with the reactions to an HPV vaccine. The two available HPV vaccines currently are recommended in the U.S. for girls at ages 11 and 12.

The study's findings are based on the U.S. Vaccine Adverse Event Reporting System, so they cover most post-vaccine reports nationwide and are not estimates.

However, the authors explain the total number of serious side effects and deaths are not unusual. While side effects occur, the authors explain the HPV vaccine's ceiling is within the normal range of a widespread vaccination program for young persons. We should add here that serious side effects can be associated with significant, preexisting medical conditions.

Conversely, the authors report statistically higher than normal post-HPV vaccine rates of lost consciousness and awareness, deep vein thrombosis and pulmonary embolism, as well as triggering other conditions.

An editorial that accompanies the study (as well as the study's authors) note these higher than expected occurrences should trigger some new research about the vaccine's side effects. Dr. Charlotte Haug, editor of the Journal of the Norwegian Medical Association, writes the current research is less a determination of the safety of HPV vaccines than an expression of need for systematic, prospective, controlled studies.

The interesting, second study in JAMA details (among other issues) how three medical societies helped market the HPV vaccine by distributing favorable presentations, slide sets, emails, and letters to professional meetings, public gatherings, educators, and legislators. However, the paper's two authors note some of these supporting materials were distributed before the results of clinical trials were published.

While Dr. Haug defends the promotion of therapeutic health interventions by medical societies, she asks how the materials could have been unbiased, or evidence-based, when the results of trials were unavailable. She notes it is important for medical societies to avoid premature approval or disapproval –since their unbiased opinion is needed to help physicians and patients make difficult decisions about the risks versus the benefits of a vaccine, such as HPV.

In addition, Dr. Haug ponders if the current evidence about the HPV vaccine is sufficiently beneficial to outweigh the vaccine's risks. She explains most young women will not develop cervical cancer if they are screened regularly. As a result, Dr. Haug asks if it makes sense for women to accept a small risk of harmful effects from an HPV vaccine when cancer might be prevented by routine, clinically available procedures.

Some background: the two FDA-approved vaccines that prevent two strains of human papillomavirus (or HPV) in young girls have been available for the past three years. The two prevented strains are linked to an estimated 70 percent of cervical cancer cases among women in the U.S. and the vaccines are the first ever intended to prevent HPV.

An estimated 4,000 women will die in the U.S. in 2009 and about 274,000 women die internationally annually from cervical cancer. The National Cancer Institute estimates 11,300 new cases of cervical cancer will occur in the U.S. in 2009.

HPV vaccines were approved for use in the U.S. in summer 2006 and the shots are available internationally. An advisory committee to the U.S. Centers for Disease Control and Prevention recommends young girls (ages 11-12) receive the required three shot series of HPV vaccinations, which cost an estimated $400 in the U.S.

Full disclosure: Dr. Haug is a critic of public health efforts to inoculate girls with the HPV vaccine. An editorial she wrote in the New England Journal of Medicine in late summer 2007 (which we covered in a podcast at the time) was cautious about recommending large-scale HPV vaccination programs and plead the need for additional research about the vaccine's effectiveness and side effects.

Overall, the series of articles illustrate there can be differences in how medical research is interpreted, as well as the challenges to advise moms, families, girls and young women when there is some uncertainty about evidence, and weighing individual and public health risks versus benefits.

Meanwhile, MedlinePlus.gov provides two health topic pages that can provide background information about cervical cancer and HPV.

Within MedlinePlus.gov's cervical cancer health topic page, you will find an array of information about: diagnosis/symptoms, treatment, prevention and screening, disease management, a self-diagnostic tool to assess cervical cancer risk, a video of a related medical procedure, financial issues, and links to research articles.

Within MedlinePlus.gov's HPV health topic page, you will find an array of information about: diagnosis/symptoms, prevention and screening, coping, links to research articles, and a link to ongoing research trials in your area via clinicaltrials.gov.

HPV vaccine and testing information is provided on both health topic pages.

To find MedlinePlus.gov's HPV health topic page, type �HPV' within the search box at the top of MedlinePlus.gov's home page. Then, click on 'HPV (National Library of Medicine).' Similarly, to find MedlinePlus.gov's cervical cancer health topic page, type 'cervical cancer' within the search box, then, click on 'cervical cancer (National Library of Medicine).'

As we mentioned in our podcast last spring, few areas within medicine have experienced the convergence of new research, public hope, and concern that the HPV vaccine has generated within the past three years. The tide of data and commentary will continue until some of the questions raised by the current studies and editorial are resolved. In the meantime, MedlinePlus.gov will help you stay abreast of news and research and continue to help you make good health decisions.

Before I go, this reminder……. MedlinePlus.gov is authoritative,….. free…. does not accept advertising …and is written to help you.   

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Please email Dr. Lindberg anytime at: NLMDirector@nlm.nih.gov

That's NLMDirector (one word) @nlm.nih.gov

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The National Library of Medicine is one of 27 institutes and centers within the National Institutes of Health. The National Institutes of Health is part of the U.S. Department of Health and Human Services.

A disclaimer –the information presented in this program should not replace the medical advice of your physician. You should not use this information to diagnose or treat any disease without first consulting with your physician or other health care provider.

It was nice to be with you….

Dr. Lindberg returns in the future.

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