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.

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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
ventricle.
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
unknown.
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.

Hearts are for Smart People and Livers for Famous Alcoholics

The Special Olympics launched a campaign Tuesday to banish the word "retard." Evidently they want the phrase “mentally retarded” eliminated from state and federal laws that still use that terminology. I understand the rationale behind changing “retarded” to something a bit more benign sounding such as “developmentally challenged” but honestly, it becomes difficult to keep up. I find myself struggling to find the politically correct way to say what we used to just call “slow”.

I am a believer in equal rights for everyone. I remember reading a few years ago that babies with Down Syndrome were not eligible to be placed on the transplant list for a new heart. At first I thought that such blatant discrimination could not be happening. I did a little more research and confirmed that it is true and they are denied new hearts. Up to fifty percent of Down Syndrome babies are born with a congenital heart defect. Of the fifty percent, there will be some that simply will not survive without a new heart.

The thinking in the medical community is that someone with DS will have difficulty keeping up the strict medication regimen required for a transplant patient. The obvious problem with that logic is that we are discussing babies. No baby, regardless of IQ, is responsible for their own medication or changing their own diaper for that matter. It seems to come down to placing more value on the life of one over the other, contingent upon intellect.

Families with Down Syndrome children do not love their babies any less than any other family. How can this be acceptable? In light of this information, is it possible that the battle on terminology is the wrong one to fight?

When I was doing some reading on the subject, I came across this story. This baby, Laith, is not a DS baby but is in need of a transplant. If you believe that we don't have any problems with our health care system this will change your mind. The family's health insurance would not pay for a transplant. They were given the choice of coming up with 1.5 million up front or letting their baby die.

Hospital Again

The tonsillectomy saga continues. Claire's cold progressed to asthma, which was bad enough to warrant a visit to the pediatrician yesterday. She had used an inhaler and taken oral medications but was still really struggling to breathe. She wasn't eating and was barely drinking and looked terrible. She didn't even want to walk to the car and had to be carried.

Claire threw up shortly after entering the doctor's office, unfortunately on an upholstered waiting room chair. They got her out of there as quickly as possible, straight to the vinyl furniture equipped exam room. The nurse checked her vitals, included her oxygen level which was 91. The doctor came in and checked her over and wanted to admit her to the hospital.

She is doing better now on breathing treatments, I.V. steroids and antibiotics. She has not needed oxygen so I am thinking that we will be getting out of here this morning after the doctor comes in. I have been here all night and I am counting the minutes until I can go to the cafeteria and get some hospital eggs. Really.

Sick Kids

I was talking to my four year-old daughter a little earlier today and I remembered to ask her about her antibiotic.

Me- “So did Daddy give you your medicine this morning?”

Katie- “Let’s not talk about that right now.”

Claire and Katie have both been suffering with repeated episodes of Strep throat since the end of May. They both have had numerous rounds of antibiotics and it still keeps coming back. They recently finished 30 day of Amoxicillin and within a few days of that, Katie had it again. She is now on Augmentin (again) and she absolutely hates it. It must taste horrible because she frequently gags after taking it. She also hides when she knows it is time for her medicine.

Katie started running a fever a couple of days ago and also complained of her tummy hurting. She was also napping quite a bit and just not feeling well in general. I checked her throat and her tonsils were bright red with the characteristic white patches of Strep. So the Augmentin is not doing the trick and we have to do the Rocephin injection on Monday. She is not going to be happy with us. I really feel sorry for the poor kid.

They both are scheduled to see the ENT at the end of the month. That really means that the ENT will just look at their awful enlarged and infected tonsils and say that they need surgery. I have mixed feelings on that issue. I understand that tonsillectomies are becoming more common after a period of time when they were considered unnecessary. When I was a kid, it was unusual to escape childhood with all your parts.

Now there are new studies on children and obstructive sleep apnea that demonstrate the dangers to children that do not get enough sleep. It is not surprising that kids that become sleep deprived due to enlarged tonsils do not function as well as their peers in school. Their behavior can be problematic, frequently resulting in an inaccurate diagnosis of ADHD. Then you have a kid that is on Ritalin that really just needs some good sleep.

I have mentioned Katie’s wild behavior on here before and I can’t help but wonder if the days that she is out of control if it is really the result of not getting enough sleep. They both have regular bedtimes (7:30-8) but they both snore. Katie has noticeable apnea at times and Claire wakes in the night frequently.

The thought of my little girls having surgery worries me but the thought of letting the enlarged tonsils go worries me as well. At this point it seems that the tonsillectomy is going to be necessary. I’m sure that I will be freaking out when that gets close.

Honey, I Shrunk the Kids

I could not stand it anymore and had to voice my opinion on this issue. The “Ashley Treatment” is generating a lot of controversy with much coverage in the media. In case you haven’t heard of this case, (although I fail to see how that is possible) let’s go over what exactly, this treatment is.

There is a severely disabled little girl named Ashley. The cause of her disability remains unknown but her prognosis is clear. She functions at the three month-old level and that is never going to change. Physically, she was expected to grow normally. The treatment was designed to alter the physical growth and keep Ashley child-sized. This was achieved through a combination of high dose estrogen along with surgery. The surgery included a hysterectomy, appendectomy as well as removal of the breast buds.

The parents maintain a blog that details the procedure as well as their rationale for seeking it out. They believe that the smaller size will benefit their daughter in many ways. It will allow them to keep her in the home and care for her. She will be more easily transportable in order to travel with the family. The hysterectomy will prevent her from suffering from menstrual cramps that serve no purpose and would otherwise cause her pain that she could not understand. The appendectomy was done because it is a simple and convenient to remove the appendix during a hysterectomy. Removing it eliminated the possibility of appendicitis, which could prove be fatal in someone that could not communicate their pain. Finally, there was the breast bud removal. This is one that really gets the hard-core feminists going. That was done for practical reasons as well. Ashley is normally lying down or strapped to a seat. Women in the family tend to have large breasts and that can cause discomfort. There is also a family history of breast cancer. The family also mentions that a child-sized body is more appropriate given Ashley’s mental age. Breasts could sexualize her to a care provider and make her a target for abuse.

So, now let’s get to the controversy. The family and the doctors are being attacks by various groups from feminists to advocates for the disabled. Here is an example of what the feminists have to say. The disabled groups have concerns as well. What gives the parents the right to make this decision for their child? Doesn’t this amount to “mutilation” for the convenience of the family?

It seems like anytime we reach a new medical milestone, we have the people screaming, “Slippery Slope! Slippery Slope! My God, what’s next? I’ll tell you what’s next. We’ll be exterminating old people and the ones that aren’t perfect, that’s what!” In response to that, I would just like to say that this is not about you. This is one family doing what they feel is best for a daughter that they love. Parents make decisions for their children and these parents were confronted with an especially difficult one. Typically, parents want the best for their children and I do not believe that these parents are any different. Let’s not forget, this decision was carefully considered by a full ethics panel before being given approval. I think it is really easy to sit back and say that this is wrong and the parents should be arrested, not to mention the doctors. But really, if you take a look at the parent’s blog and really consider what they are saying, I think you just might get it.