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
