Fwd: Gardasil Researcher Speaks Out

[Guest guest]

>Paul Scavone <pbscavone

>Sun, 21 Mar 2010 17:55:06 -0400

>Gardasil Researcher Speaks Out

>gar-lin

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>Gardasil Researcher Speaks Out

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>Submitted by

><http://healthfreedoms.org/author/dk/>Drew

>Kaplan<http://healthfreedoms.org2010/03/gard.jpg>

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>Health Freedom Alliance have been skeptical in

>the past about giving young girls the new HPV

>vaccine. It now seems we are joined in our

>criticism by one of the lead researchers for the

>Merck drug who is speaking out about its risks,

>benefits and aggressive marketing.

>

>Dr. Diane Harper says young girls and their

>parents should receive more complete warnings

>before receiving the vaccine to prevent cervical

>cancer. Dr. Harper helped design and carry out

>the Phase II and Phase III safety and

>effectiveness studies to get Gardasil approved,

>and authored many of the published, scholarly

>papers about it. She has been a paid speaker and

>consultant to Merck. It’s highly unusual for a

>researcher to publicly criticize a medicine or

>vaccine she helped get approved. Dr. Harper

>joins a number of consumer watchdogs, vaccine

>safety advocates, and parents who question the

>vaccine’s risk-versus-benefit profile. She says

>data available for Gardasil shows that it lasts

>five years; there is no data showing that it

>remains effective beyond five years. This raises

>questions about the CDC’s recommendation that

>the series of shots be given to girls as young

>as 11-years old. “If we vaccinate 11 year olds

>and the protection doesn’t last… we’ve put them

>at harm from side effects, small but real, for

>no benefit,” says Dr. Harper. “The benefit to

>public health is nothing, there is no reduction

>in cervical cancers, they are just postponed,

>unless the protection lasts for at least 15

>years, and over 70% of all sexually active

>females of all ages are vaccinated.” She also

>says that enough serious side effects have been

>reported after Gardasil use that the vaccine

>could prove riskier than the cervical cancer it

>purports to prevent. Cervical cancer is usually

>entirely curable when detected early through normal Pap screenings.

>

>Dr. Scott Ratner and his wife, who’s also a

>physician, expressed similar concerns as Dr.

>Harper in an interview with CBS News last year.

>One of their teenage daughters became severely

>ill after her first dose of Gardasil. Dr. Ratner

>says she’d have been better off getting cervical

>cancer than the vaccination. “My daughter went

>from a varsity lacrosse player at Choate to a

>chronically ill, steroid-dependent patient with

>autoimmune myofasciitis. I’ve had to ask myself

>why I let my eldest of three daughters get an

>unproven vaccine against a few strains of a

>nonlethal virus that can be dealt with in more effective ways.”

>

>Merck and the Centers for Disease Control and

>Prevention maintain Gardasil is safe and

>effective, and that adequate warnings are

>provided, cautioning about soreness at the

>injection site and risk of fainting after

>vaccination. A new study in the Journal of the

>American Medical Association found while the

>overall risk of side effects appears to be

>comparable to other vaccines, Gardasil has a

>higher incidence of blood clots reported. Merck

>says it continues to have confidence in

>Gardasil’s safety profile. Merck also says it’s

>looking into cases of ALS, commonly known as Lou

>Gehrig’s Disease, reported after vaccination.

>ALS is a progressive neurodegenerative disease

>that attacks motor neurons in the brain and

>spinal cord. Merck and the CDC say there is

>currently no evidence that Gardasil caused ALS

>in the cases reported. Merck is also monitoring

>the number of deaths reported after Gardasil: at

>least 32. Merck and CDC says it’s unclear

>whether the deaths were related to the vaccine,

>and that just because patients died after the

>shots doesn’t mean the shots were necessarily to blame.

>

>According to Dr. Harper, assessing the true

>adverse event risk of Gardasil, and comparing it

>to the risk of cervical cancer can be tricky and

>complex. “The number of women who die from

>cervical cancer in the US every year is small

>but real. It is small because of the success of the Pap screening program.”

>

>“The risks of serious adverse events including

>death reported after Gardasil use in (the JAMA

>article by CDC’s Dr. Barbara Slade) were

>3.4/100,000 doses distributed. The rate of

>serious adverse events on par with the death

>rate of cervical cancer. Gardasil has been

>associated with at least as many serious adverse

>events as there are deaths from cervical cancer

>developing each year. Indeed, the risks of

>vaccination are underreported in Slade’s

>article, as they are based on a denominator of

>doses distributed from Merck’s warehouse. Up to

>a third of those doses may be in refrigerators

>waiting to be dispensed as the autumn onslaught

>of vaccine messages is sent home to parents the

>first day of school. Should the denominator in

>Dr. Slade’s work be adjusted to account for

>this, and then divided by three for the number

>of women who would receive all three doses, the

>incidence rate of serious adverse events

>increases up to five fold. How does a parent

>value that information,” said Harper.

>

>Dr. Harper agrees with Merck and the CDC that

>Gardasil is safe for most girls and women. But

>she says the side effects reported so far call

>for more complete disclosure to patients. She

>says they should be told that protection from

>the vaccination might not last long enough to

>provide a cancer protection benefit, and that

>its risks – “small but real” – could occur more

>often than the cervical cancer itself would.

>

>“Parents and women must know that deaths

>occurred. Not all deaths that have been reported

>were represented in Dr. Slade’s work, one-third

>of the death reports were unavailable to the

>CDC, leaving the parents of the deceased

>teenagers in despair that the CDC is ignoring

>the very rare but real occurrences that need not

>have happened if parents were given information

>stating that there are real, but small risks of

>death surrounding the administration of Gardasil.”

>

>She also worries that Merck’s aggressive

>marketing of the vaccine may have given women a

>false sense of security. “The future

>expectations women hold because they have

>received free doses of Gardasil purchased by

>philanthropic foundations, by public health

>agencies or covered by insurance is the true

>threat to cervical cancer in the future. Should

>women stop Pap screening after vaccination, the

>cervical cancer rate will actually increase per

>year. Should women believe this is preventive

>for all cancers – something never stated, but

>often inferred by many in the population– a

>reduction in all health care will compound our

>current health crisis. Should Gardasil not be

>effective for more than 15 years, the most

>costly public health experiment in cancer control will have failed miserably.”

>

>CDC continues to recommend Gardasil for girls

>and young women. The agency says the vaccine’s

>benefits outweigh its risks and that it is an

>important tool in fighting a serious cancer.

>

>Dr. Harper says the risk-benefit analysis for

>Gardasil in other countries may shape up

>differently than what she believes is true in

>the US. “Of course, in developing countries

>where there is no safety Pap screening for women

>repeatedly over their lifetimes, the risks of

>serious adverse events may be acceptable as the

>incidence rate of cervical cancer is five to 12

>times higher than in the US, dwarfing the risk

>of death reported after Gardasil.”

>

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