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Jewish World Review August 31, 2007 / 17 Elul 5767 Complications arise from HPV vaccine By Drs. Michael A. Glueck & Robert J. Cihak http://www.JewishWorldReview.com | Back in the days of our training at the heavenly hallowed and not-so-humble halls of the Harvard teaching hospitals in Boston, there was a well-known axiom. To paraphrase, "Be neither the first to adopt the new or the last to throw the old aside." Sometimes the Solomon-like wisdom of longevity pays a dividend. The story of the human papillomavirus vaccine is one of them. In an article in JewishWorldReview.com, February 2007, we concluded that until more testing and studies are performed and the public has more knowledge of the safety and efficacy of the HPV vaccine, there is no need to rush to vaccination — and certainly not mandatory premature inoculation. At that time it was also noted that "proof of safety is lacking." The vaccine is claimed to be safe and "well-tolerated," but studies have involved only a few thousand women, most over 16 years of age, for less than five years. In one study, "arthritic symptoms" occurred three times as often in subjects who got the vaccine, compared to subjects who only got the control vaccine. An increased risk of juvenile rheumatoid arthritis, "a deforming, devastating, lifelong disease, is being watched for." A recent August 27, 2007, Association of American Physicians and Surgeons (AAPS) News Release reports additional adverse effects from the HPV vaccine. As of May 31, 2007, there have been 13 cases of Guillain Barr's syndrome (GBS) in association with the HPV vaccine (Gardasil) reported to the Vaccine Adverse Event Reporting System (VAERS). Guillain-Barre syndrome is a serious disorder that occurs when the body's defense (immune) system mistakenly attacks part of the nervous system. This leads to nerve inflammation which continues to get worse. The inflammation usually affects the nerve's covering (myelin sheath). Demyelination slows nerve signaling. Damage to other parts of the nerve can cause the nerve to stop working.This nerve damage causes tingling, muscle weakness, and paralysis. Guillain-Barre syndrome is considered an autoimmune disorder. The exact cause of Guillain-Barre syndrome is unknown. The syndrome may occur at any age, but is most common in people of both sexes between the ages 30 and 50. It often follows a minor infection, usually a respiratory (lung) infection or gastrointestinal (gut) infection. The Centers for Disease Control and Prevention (CDC) notes that six of the patients had received Gardasil alone, and six had also received meningococcal vaccine (Menactra). Since the end of May, an additional two cases have been reported. The CDC states that studies are planned concerning the concomitant administration of Gardasil and Menactra. So far, the combination of Gardasil and hepatitis B vaccine is the only one that has been studied, although one or more other vaccines are frequently given to Gardasil recipients. An analysis of VAERS data by the National Vaccine Information Center (NVIC) concludes that the risk of serious adverse reactions such as GBS is increased by concomitant administration of other vaccines. In patients who made a report to VAERS, the risk of GBS is more than 10 times greater for Gardasil given with Menactra compared to Gardasil given alone (P<.0001). A causal relationship with vaccine administration has not been proved. The background incidence of GBS in persons in the second decade of life is 1-2/100,000. According to an NVIC press release, one of the patients who reported a reaction to VAERS was an 18-year-old athlete who ran six miles that day before receiving Gardasil, Menactra, and Varivax on the same day. She was hospitalized for 22 days with weakness of all limbs but did not require a ventilator. Now receiving physical therapy, she hopes at least to be able to play the guitar, draw, and smile again. The second most commonly reported adverse event is syncope, with 239 reports. Sometimes this has resulted in serious injury, including fractures and subdural hematomas. It is suggested that vaccines be administered with the patient supine and be followed with at least 10 minutes of observation. Syncope has, however, occurred after a longer delay. Gardasil is now involved in 1,5-20 percent of all VAERS reports that are filed. In May, Lawrence Gostin, J.D., of the Georgetown Law Center and Catherine DeAngelis, M.D., M.P.H., editor in chief of JAMA, wrote of "important concerns about mandatory HPV vaccination" that are "not moral," including cost, parental concerns about safety, and potential compensation for injury. They advocated taking a "deliberative approach" rather than mandating the vaccine for school entry at the present time. "Legislation to make HPV vaccine mandatory has undermined public confidence and created a backlash among parents," they write. "There is nothing more important to the success of public health policies than to ensure community acceptability. In the absence of an immediate risk of serous harm, it is preferable to adopt voluntary measures, making state compulsion a last resort" (Gostin LO, DeAngelis CD. Mandatory HPV vaccination: public health vs private wealth. JAMA 2007;297:1921-1923). So we repeat the original conclusion of our February 2007 column that until more testing and studies are performed and the public has more knowledge of the safety and efficacy of the HPV vaccine, there is no need to rush to vaccination — and certainly not mandatory premature inoculation. Editor's Note: Michael Arnold Glueck, M.D., submitted this week's column Every weekday JewishWorldReview.com publishes what many in in the media and Washington consider "must-reading". Sign up for the daily JWR update. It's free. Just click here. Michael Arnold Glueck, M.D., is a multiple award winning writer who comments on medical-legal issues. Robert J. Cihak, M.D., is a Discovery Institute Senior Fellow and a past president of the Association of American Physicians and Surgeons. Both JWR contributors are Harvard trained diagnostic radiologists. Comment by clicking here. Archives © 2007,

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