HPV Vaccine Adverse Events Worrisome Says Key Investigator

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HPV Vaccine Adverse Events Worrisome Says Key Investigator

(26 07 2008)

HPV Vaccine Adverse Events Worrisome Says Key Investigator

Gandey

Medscape Medical News 2008. © 2008 Medscape

July 26, 2008 — Serious neurologic,

thromboembolic, and autoimmune complications have

been reported in patients who received human

papillomavirus (HPV) vaccines. Although

not the norm, experts suggest that the events are

grave enough to encourage caution.

" The side effects that have been reported are

real and they cannot be brushed aside, "

Diane Harper, MD, from the Dartmouth Medical

School, in Hanover, New Hampshire, told

Medscape Oncology. Dr. Harper was a principal

investigator of clinical HPV vaccine trials

for both Merck and GlaxoKline.

News reports of adverse events, teen paralysis,

and death have fueled public concern.

Back-to-school immunization clinics are stocking

up on Merck's Gardasil and more

than16 million doses have reportedly already been

distributed in the United States alone.

But many parents are questioning whether their

children should be vaccinated. And many

women are wondering whether they should be vaccinated too.

According to the US Food and Drug Administration

(FDA), as of June 30, 2008, more than

9700 adverse events have been reported since the

vaccine was approved 2 years ago. Of

these, 94% were classified as nonserious events and 6% as severe.

Serious Adverse Events

* Nervous system disorders, such as Guillain-Barré syndrome and headache *

Thromboembolic events * Musculoskeletal and

connective tissue problems * Lymphatic

system disorders * Gastrointestinal problems *

General disorders and administration site

conditions * Immune system problems, including hypersensitivity reactions,

bronchospasm, and urticaria

Most Commonly Reported Events * Fainting * Pain

at the injection site * Headache *

Nausea * Fever

To prevent fainting, which can sometimes cause

serious harm and lead to head injuries,

Dr. Harper recommends that patients receive

vaccines on a full stomach and be seated

when the shots are administered. The FDA

recommends that patients remain seated for up

to 15 minutes after vaccination.

Dr. Harper also suggests that physicians not

vaccinate patients with personal or family

histories of the more serious conditions outlined

in recent adverse-event reports.

" Physicians have a responsibility to communicate

risks to patients and if patients and

families are concerned, it is reasonable to hold

off on vaccinating, " Dr. Harper said.

It is a sentiment that is echoed by others, such

as Abby Lippman, PhD, from McGill

University, in Montreal, Quebec, who is chair of

the policy committee at the Canadian

Women's Health Network. In this month's issue of

the Journal of Epidemiology and

Community Health, she expresses concern about

public policies that have seemingly

rushed to embrace HPV vaccination. " Why the

hurry, " Dr. Lippman asks. Especially in

developed countries where there is no epidemic of

infection and mortality rates from

cervical cancer have been in decline.

What is Causing Adverse Events ?

The cause of recent complications remains a

mystery and it is difficult to know whether

they are linked to vaccines. " Nobody knows why we

are seeing adverse events, " Dr. Harper

said.

Members of the antivaccine movement point to a

number of potential perils, including the

presence of aluminum in injections. Like many

vaccines, Gardasil contains aluminum salts.

Each 0.5-mL dose contains approximately 225

& #956;g of aluminum, 9.56 mg of sodium

chloride, 0.78 mg of L-histidine, 50 & #956;cg of

polysorbate 80, 35 & #956;g of sodium borate, and

water.

" The scientific work to date seems to suggest

that aluminum salts in vaccines are safe, "

Dr. Harper said. But she told Medscape Oncology

that she heard that 1 lot of Gardasil

might have had an accidentally high yeast

concentration, and this might be why there are

problems. " No one knows for sure, " Dr. Harper said.

The manufacturer was not available to comment

about product yeast concentrations, but

directed Medscape Oncology to an online statement

responding to questions about recent

adverse effects. " Merck has analyzed the adverse

events reported for Gardasil relating to

the recent reports of death and paralysis, and

based on the data available to Merck,

believes that no safety issue related to the

vaccine has been identified. These types of

events are events that could also be seen in the general population. "

Haupt, MD, executive director of clinical

research at Merck's research laboratories

added : " We remain confident in the safety profile of Gardasil. "

FDA and CDC Issue Joint Statement Reassuring

Clinicians and Patients Responding to

public concern, the FDA and the Centers for

Disease Control and Prevention (CDC) issued a

joint statement on Tuesday reassuring clinicians

and patients about the safety of Gardasil.

A second vaccine, GlaxoKline's Cervarix, is

already available in some countries, but is

still being assessed by the FDA.

Despite company and regulatory assurances, some

clinicians, who are also parents, say

they are less confident about the safety of the

vaccines. After reviewing the information,

Ratner, MD, a cardiologist with a practice

in lin Square, New York, and his wife,

a rheumatologist, opted to have their 17-year-old

daughter vaccinated. It is a decision

they say they now regret.

Following vaccination, their teenage daughter

began showing signs and symptoms of

autoimmune disease. " She went from being a

healthy, active teen running, playing

lacrosse, and participating on swim team to

becoming a chronically ill patient, " Dr. Ratner

said.

" I worry about the kids who may be having

problems, are perhaps struggling with immune

damage, and are feeling generally achy and

unwell, but are probably going unreported and

undiagnosed, " he said. Dr. Ratner has 2 younger

daughters and he says he definitely won't

be encouraging either of them to be vaccinated.

Gynecologist Christiane Northrup, MD, told Medscape Oncology that she won't be

advocating that her daughters be vaccinated

either. Dr. Northrup appeared on a recent

episode of the Oprah Winfrey Show, which has an

estimated 20 million viewers per week,

most of them women. She told viewers that

healthcare dollars would be better invested

elsewhere. Questioning the Safety Dr. Northrup

recommended that the money going

toward vaccines and related programs be allocated

to general health and wellness

initiatives and proper nutrition. This harkens

back to the age-old debate between Louis

Pasteur and Antoine Beauchamp, Dr. Northrup

suggests. For most of his career, Pasteur

subscribed to germ theory, while Beauchamp backed the more unpopular theory of

biological terrain. The question : Is it the

germs themselves that make people sick or a

weakened state of immunity that allows germs to

take root ? " Pasteur was widely

supported, but on his death bed conceded that

Beauchamp was right, " Dr. Northrup said

during an interview. She suggests that this is

what experts should be concentrating on

now. Instead of focusing on germ theory by

pouring efforts into HPV vaccines, she says

more resources should be dedicated to fostering

the overall health of the host. Dr.

Lippman makes a similar argument and points to the capacity of healthy,

immunocompetent women to spontaneously clear up to 90% of HPV infections —

infections, she says, almost everyone will one

day acquire — within 1 to 2 years. When

Gardasil was approved in the United States in

June 2006, it was hailed as an important day

for public health and for women's health. Dr.

Harper was quoted as saying that the

vaccine is the biggest advance since the Pap

smear. Dr. Harper told Medscape Oncology

that she still thinks this is the case, but

enthusiasm must be tempered with caution. Dr.

Harper noted that we shouldn't be calling the new

immunizations cervical cancer vaccines.

" Even if everyone was vaccinated, we would still

have cervical cancer, " she said. " I don't

want people to be lulled into thinking this will

prevent cancer. If Pap screening rates

decline, cervical cancer rates will rise, " she

emphasized. If Pap Screening Rates Decline,

Cervical Cancer Rates Will Rise The decline in

cervical cancer in developed countries has

been largely attributed to regular Pap screening

— something Dr. Harper believes has

done a superb job. Women who haven't received an

HPV vaccine, and even those who

have, are still encouraged to undergo regular

screening. At the 2006 American Society of

Clinical Oncology annual meeting, delegates were

enthusiastic. One presenter showed a

series of cervical cancer photos and told

observers that " these types of pictures will soon

disappear in clinical oncology. " Unfortunately,

that utopian prediction is unlikely. " Cervical

cancer is not a vaccine-preventable disease, " Dr.

Lippman said during an interview. And in

her recent editorial, she points out that

surrogate end points — not cervical cancer — were

used to measure the efficacy in the clinical

trials. " No one would want to wait to see

cervical cancer develop in participants, " she

writes. " But the general failure to mention that

the precancerous lesions chosen for study are not

only potentially removable, most (those

that are CIN 2) would probably have resolved on

their own without any intervention, is

arguable. " Many Questions Remain As previously reported by Medscape Oncology,

Sharmila Makhija, MD, from the University of

Alabama School of Medicine, in Birmingham,

pointed to other limitations of HPV vaccines. Dr.

Makhija is the principal investigator on

Merck's FUTURE III trial, looking at the

vaccine's efficacy in women 24 to 45 years old, and

is a coinvestigator on GlaxoKline's vaccine

trials. Dr. Makhija noted that the bulk of

the work to date has focused on just 2 types of

HPV — 16 and 18. She added that, going

forward, more virulent cancer-causing strains

could emerge, making it difficult to

eliminate disease. And other important questions

remain : * How long does the vaccine

last ? * Will it require a booster ? * Who should

be vaccinated and at what age ? " While

vaccine proponents emphasize the many thousands

of women who participated in clinical

trials of the product, they gloss over how few

young girls in the 9 to 13 year age range,

targeted specifically for school-based

immunizations, were included, " Dr. Lippman

argues. She said that only the very short-term

immunogenicity and safety, and not the

efficacy, of Gardasil was studied. " It is a good

vaccine, " Dr. Harper said. " We are simply still

in the early stages of investigation. " The World

Health Organization (WHO) has weighed in

on the vaccines and is recommending that they be

considered only 1 component of any

successful strategy. Immunization will have to be

added to the other aspects of cervical

cancer control, s Ullrich, MD, medical

officer at WHO's department of chronic

diseases and health promotion, said in a news

release. " There is no question that early

detection will continue to be a key element. "

Merck is encouraging healthcare providers

and consumers to report any adverse events

associated with Gardasil to the company and

to the US _Vaccine Adverse Event Reporting

System_ (<http://www.vaers.hhs.gov/>http://www.vaers.hhs.gov/) at 1-

800-822-7967. J Epidemiol Community Health. 2008 ;62:570-571. _Abstract_

(<http://www.ncbi.nlm.nih.gov/sites/e...0Community%20Health.>http://www.ncbi.nlm\

..nih.gov/sites/e...0Community%20Health.[Jour]%20AND%20570[page

]%20AND%202008[pdat])

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Sheri Nakken, former R.N., MA, Hahnemannian Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

Vaccines - http://www.wellwithin1.com/vaccine.htm

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