Friday, October 16, 2009

Gardasil and What You Should Know

The controversial HPV vaccine distributed by the drug manufacturer Merck, is receiving a lot of negative publicity lately. The controversy actually began back in 2007 when the republican governor of Texas, Rick Perry, mandated that little girls receive the vaccine prior to starting the sixth grade. Governor Perry made the executive decision to require Gardasil to be a mandatory vaccine without allowing it to go to a vote before the Texas legislature. Perry’s former chief of staff was a lobbyist for Merck. Perry also had no qualms about accepting $6000 from Merck for his re-election campaign. The mandate had since been overturned by the Texas Legislature once the financial conflicts were discovered.

HPV is a sexually transmitted disease that is linked to cervical cancer. Many parents had issues with this vaccine being forced on their daughters. Texas law does allow for religious or philosophical objection but like many other states, there is no exemption for using good judgment in making important medical decisions for your children.

Here in the United States we trust that the FDA is looking out for us and for our children. That is not always the case. Dangerous side effects can be minimized for the sake of getting a new drug on the market and putting money in share holder’s pockets. The only thing standing between the pharmaceutical companies and us is FDA approval.

The best example of the FDA doing their job would be former FDA inspector Dr. Francis Kelsey. Germany introduced thalidomide in 1957 as a sleep aid. The manufacturer claimed that it was safe for pregnant women. It even helped with morning sickness; hence the thousands of women that took it in the first trimester of pregnancy while the baby’s limbs were forming. Thalidomide babies are distinguished by a condition called phocomelia. Phocomelia is a congenital malformation with shortening of the long bones of the arms and legs with seal-like flippers. Thousands of children were born with major birth defects because of a combination of inadequate testing, premature approval and greed.

Thalidomide was available over-the-counter in Germany and by the early 1960’s it was available all over Europe, Canada and many other countries. One month after starting her job with the FDA in 1960, Dr. Kelsey was assigned the request for approval to market Thalidomide in the US. Dr. Kelsey had serious concerns about the shortcomings of the studies submitted and refused to grant approval. The pharmaceutical manufacturer and supervisors at the FDA pressured her yet she refused to give in. At the time FDA approval was considered to be a given and Dr. Kelsey single-handedly prevented the tragedy of thalidomide in this country.

By 1962 the horror of thalidomide was known to the world. Dr. Kelsey was recognized by President John F. Kennedy. She was a recipient of the highest civilian award possible, the medal for Distinguished Federal Civilian Service. Dr. Kelsey retired in 2005. Unfortunately there currently is no one at the FDA that has the same ethical or scientific standards that she had. Merck easily gained approval for a vaccine that we know little about.

The FDA allows “fast tracking” of certain drugs that are considered important to human health. Gardasil was allowed through the system this way. This process allowed Gardasil to be available to the public within six months of development. This rush to market happened to coincide with a very heavy push from pharmaceutical giant Merck. Next on the agenda for Merck was to get their new “cash cow” mandated for young girls. Once a vaccine is on the list of required childhood immunizations, the government is responsible for providing it to low-income households. This is a windfall for a drug company, particularly one like Merck that had suffered financially after a previous fiasco with a fast-tracked drug failure. Vioxx was removed from the market after being linked with an increased risk of heart attack and stroke. Merck has had to defend hundreds of lawsuits, including multiple class actions since Vioxx was recalled in 2004.

Gardasil is the most expensive vaccine ever given approval by the FDA.

No one is going to argue that cervical cancer is not a serious concern but there are some facts that you need to know before opting to expose your daughters to Gardasil. Most importantly, Gardasil is not a cervical cancer vaccine. It is a vaccine for a sexually transmitted disease, human papillomavirus.

HPV is an extremely common sexually transmitted disease. It has been reported that almost 80% of people between the ages of fifteen and forty-nine have been infected with HPV. There are over one hundred strains of HPV, with at least fifteen that have the potential to cause cervical cancer. Gardasil will protect against just four strains of HPV. Of those four, two can cause cervical cancer and two may cause genital warts. To be fair, the two strains in the vaccine for cervical cancer are the two that cause seventy percent of cervical cancers.

No one knows how long Gardasil will be effective. It is possible that it confers a brief immunity for as little as two to three years. One of the dangers of Gardasil is that it might give a false sense of security to the girls that receive it. There are many other strains of HPV that the vaccinated population has no immunity for as well as all the other sexually transmitted diseases for which there are no vaccine.

Another concern is the clinical testing done by Merck. Here is that information from Judicial Watch:

An additional testing report shows that Merck tested Gardasil against an aluminum-containing placebo. While most placebos are saline based, the FDA allowed Merck to use a placebo with an undisclosed amount of aluminum in it. Gardasil itself contains 225 mcg of aluminum. Aluminum can cause many serious problems including temporary and permanent nerve damage. Using a reactive aluminum-containing placebo instead of a non-reactive saline base can make vaccines seem safer than they may actually be. While Merck has repeatedly stated that Gardasil is on a comparable safety rate with the placebo, if the placebo itself is responsible for adverse effects then it is more difficult to ascertain the vaccine’s safety. Merck’s testing report shows charts of clinical tests, and compares Gardasil with the aluminum-containing placebo. It is true that the adverse reaction rates are comparable in most of the tests, but since the vaccine is being tested against a reactive, potentially harmful substance, the numbers may overstate the vaccine’s safety and understate its adverse side-effects. The significant differences between the saline placebo and the vaccine raise questions as to how Merck's use of an aluminum-containing placebo may have affected the safety trials. The National Vaccine Information Center reports that “A reactive placebo can artificially increase the appearance of safety of an experimental drug or vaccine in a clinical trial,” adding that “although aluminum adjuvants have been used in vaccines for decades, they were never tested for safety in clinical trials.” It is difficult to draw an accurate conclusion from Merck's data, raising questions about Gardasil vaccine safety.

Gardasil is clearly going to be given to women of childbearing age. Here is what Merck told the FDA on that subject, “It is not known whether Gardasil can cause fetal harm when administered to a pregnant woman.”

The reported adverse reactions from Gardasil are increasing. There is an unusually high incidence of fainting from the vaccine. That has been written off as just teen girls being afraid of needles. However those same teen girls are not reacting that way to other common vaccines in that age group, such as Menactra for meningitis. There have been reports of girls breaking out with warts in various areas of their bodies with no previous history of such outbreaks. There are reports of seizures, blood clots and miscarriages. Guillain-Barre Syndrome has been reported with the majority of cases occurring within two weeks of Gardasil vaccination. There have also been at forty-four deaths reported thus far. Of those reported deaths, the CDC has confirmed twenty-seven. Seventeen reports remain unconfirmed due to missing names or contact information, preventing the CDC from obtaining further information.

Merck is producing and aggressively marketing a vaccine for young girls yet they have done no testing on Gardasil’s effects on fertility. Their only fertility tests were done with rats and even then it was only through a single fertility cycle. Although Merck recommends that pregnant women not receive the vaccine there is no mention of a mandatory pregnancy test prior to vaccination. Merck does have a healthy curiosity regarding what happens to pregnant women that receive the drug. They are hoping that we will keep them posted on that one. Here is what the CDC has to say about pregnant women and Gardasil:

Should pregnant women receive the HPV vaccine?

The vaccine is not recommended for pregnant women. There has been only limited information about how safe the vaccine is for pregnant women and their unborn babies outside of the clinical trials. For now, pregnant women should wait to complete their pregnancy before getting the vaccine. If a woman finds out she is pregnant after she has started getting the vaccine series, she should wait until after her pregnancy is completed to finish the three-dose series. Most importantly, she should continue her routine prenatal care and enroll in the registry the vaccine manufacturer is compiling of pregnant women who have received the HPV vaccine.
The Gardasil pregnancy registry has been established to collect information on the pregnancy outcomes of women who inadvertently receive the vaccine during pregnancy. The data collected will be used to monitor any effects the vaccine might have on pregnancies, so it is important that all eligible patients be enrolled. Individual patient information remains confidential.

The following information is from VAERS, the Vaccine Adverse Event Reporting System.

Pt [Patient] admitted to hospital with chief complaint of
ascending weakness bilaterally, upper and lower
extremities . . . Severe form of Guillain-Barre syndrome
after HPV vaccine . . . Respiratory failure with prolonged
mechanical ventilation and tracheostomy tube
Placement . . . vital capacity deteriorated on day 3 . . . able
to move only jaw and eyes.
VAERS ID: 268143-1 (S)

A 19-year-old female with no previous medical history
reported, who on 19-Sep-2007 was vaccinated with the 1st
dose of Gardasil . . . On the morning of 12-Oct-2007, the
patient was found dead in her bed . . . Contraception was
stopped 3 months before vaccination. No reason for the
death was detected in autopsy.
VAERS ID: 299377-1 (D)

Information has been received from a physician’s assistant
concerning a 12-year-old female with no reported medical
history who on approximately 15-Sep-2007 was vaccinated
with Gardasil . . . On 06-OCT-2007 the patient died in her
sleep. No further information was provided.
VAERS ID: 297528-1 (D)

Sudden unattended death [February 22, 2007] . . . patient
[17-year-old female with no medical history or known
allergies] last seen in office by nurse only on 2/20 for HPV
#3 . . . The autopsy was negative for all findings. Scene
indicated sudden death from collapse and fall.
VAERS ID: 305606-1 (D)

An 18-year-old female patient was vaccinated with the first
dose of Gardasil . . . In the evening of the same day she was
found unconscious (or liveless) [sic] by the mother.
Resuscitation was performed by the emergency doctor but
was unsuccessful, i.e. the patient finally died . . . The cause
of death of this patient remains totally unclear.
VAERS ID: 300741-1 (D).

An 11-year-old female was vaccinated “within the
past month” in approximately May 2007 with a first
dose of Gardasil. Subsequently, 3 days after
vaccination the patient presented to an ER . . . the
physician from the hospital said that “the death was
due to an anaphylactic reaction to Gardasil.”
VAERS ID: 280163-1 (D)

[19 year old female] given Gardasil vaccine dose #1 [on]
3/12/07 . . . Collapsed and died on 3/26/07 . . . autopsy
done at Medical Center . . . states from Death Certificate
COD [cause of death] is sudden cardiac death and
pulmonary embolism. Echocardiogram revealed very
enlarged right ventricle & small left ventricle as well as
large blood clots within both the right atrium & right
VAERS ID: 275438-1 (D)

Information has been received . . . concerning a female
patient who was vaccinated with a dose of Gardasil. The
PA [physician’s assistant] reported that “the patient died of
a blood clot 3 hours after getting the Gardasil vaccine.”
VAERS ID: 275990-1 (D

Information has been received . . . concerning a 22-year-old
female patient with no pertinent medical history or drug
allergies who on 21 May 2007 was vaccinated IM with a
0.5ml dose of Gardasil . . . Concomitant therapy included
hormonal contraceptives (unspecified). On 23 May 2007,
the patient died suddenly. The cause of death was
VAERS ID: 287888-1 (D).

Information has been received from a physician’s assistant
concerning a 12-year-old female with no reported medical
history who on approximately 15-Sep-2007 was vaccinated
with Gardasil . . . On 06-OCT-2007 the patient died in her
sleep. No further information was provided.
VAERS ID: 297528-1 (D)

Sudden unattended death [February 22, 2007] . . . patient
[17-year-old female with no medical history or known
allergies] last seen in office by nurse only on 2/20 for HPV
#3 . . . The autopsy was negative for all findings. Scene
indicated sudden death from collapse and fall.
VAERS ID: 305606-1 (D)

Information has been received from a physician concerning
a 20-year-old female with no medical history reported, who
on 01-APR-2008 was vaccinated with a dose of Gardasil.
On 05-APR-2008, the patient died four days after receiving
Gardasil . . . An autopsy was performed which ruled out
suicide and anything suspicious. The cause of death is
currently unknown.
VAERS ID: 310262-1 (D) 49

Please take a minute to watch the CBS report on Gardasil. Click here to read the CBS story about Gardasil and see why one of the doctors that helped develop it thinks that the vaccine could be more dangerous than previously thought. Click here for the "New York Times" story on the marketing of Gardasil.


Anonymous said...

very good, I'm sure that alot of people aren't aware of this. thank you for keeping us informed

AnnQ said...

Wow.....great post. It's a shame we can't trust the FDA. But no great surprise, as they're the same group who made it okay to bring Silicone Implants back on the market.

S said...

Why do they have to use aluminum in the vaccine anyway?

Julia said...

I am not a person who is vaccine-a-phobic and think the majority of the shots the kids get are really necessary. However, I have been continually hear increasing REAL reasons why not to use this vaccine. I will not be making my daughter have this vaccine due to the safety issues that are still looming...

WE need to teach our daughters to protect themselves in other ways since there are so many other diseases they can get from the same "unprotected" activities anyway...

great post!

Deb S in Iowa said...

Very useful information. Great post!

bernthis said...

I have stumbled this. EVeryone woman needs to read this. Thank you.

Anonamom said...

Thank you SOOOO much for this info. You presented it so well. I appreciate the time you have spent to help us all understand this issue better.