Gardasil Researcher Speaks Out

"Public Should Receive More Complete Warnings"

(CBS)  Amid questions about the safety of the HPV vaccine Gardasil one of the lead researchers for the Merck drug 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.

Read Judicial Watch reports on Gardasil
Dr. LaPook’s Story on HPV
Attkisson's Exclusive Report on Gardasil

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.”

[jodispeaks]

My daughter, Victoria, has been ill since February 2008. She had her first Gardasil vaccination November 2007. Her second vaccination was in the beginning of February 2008. Immediately after her second vaccination, Victoria experienced severe diarrhea, vomiting and was nauseous for about eight weeks. She had blood work done many times and doctors thought it was just a virus. On March 31, 2008, she had her first seizure. My daughter has had several CT scans, MRI's, MRA's, EEG's, blood work and was hospitalized at an epilepsy center in the video EEG monitoring unit for two separate weeks in May 2008 and September 2008. She attempted to undergo a spinal tap in September 2009, but doctors were unable to obtain any fluid. On November 11, 2009, she underwent a lumbar puncture with fluoroscopy. She was put on many different seizure medications, however, after normal EEG results, she was taken off all medications. Her SED rate was high and she did have protein in her urine, but doctors do not seem concerned. I was told that her red blood are small and that she may have Thalasemia, but this apparently is not concerning either.
My daughter has been seen by several neurologists, a psychiatrist, psychologist, several neuropsychologists, an immunologist, several infectious disease doctors, and also treated a at Wellness Center for a period of time. My daughter currently experiences the following symptoms: non-epileptic seizures, severe jerking movements of her whole body, especially her mouth and extremities, migraines, fainting, tremors, twitches, numbness, intermittent leg paralysis, hand/arm paralysis and facial paralysis, tingling, staring or blank episodes, eye pain, joint pain, neck pain, back pain, memory loss, confusion, brain fog, regression, mood swings and severe chronic fatigue. She continues to have bouts of nausea and diarrhea and stomach pain. She has not been in school since April 2008. My daughter cannot be left home alone. She cannot go to school, go out with her friends or work or has little "normalcy" in her life. She has very few good days and always says she doesn't feel good. Victoria should have graduated high school in June 2009 and would have been enrolled in college. I do not know which way to turn for help. We have seen so many doctors and I can't seem to find anyone willing to help my daughter. There are so many other young girls who have the same exact symptoms as my daughter and the one thing that all of the girls seem to have in common is the Gardasil vaccination.
We are on a fixed income, as most people, and we have expended many thousands of dollars in an effort to seek medical opinions and assistance. There are no "traditional medical doctors" who will relate my daughter's symptoms to Gardasil as I am told "there is not enough information available" about the vaccine and doctors believe it to be "safe". However, many doctors are all over the country are beginning to question the safety and also the effectiveness of the vaccine. Other ?doctor? are willing to "try" treatment, most of which is "homeopathic" in nature and extremely costly. Once again, I must reiterate that there are so many other young girls experiencing negative symptoms. Victoria and I have appeared on Fox news in August 2009, the front page of the Philadelphia Inquirer in August 2009 and also the cover of Philadelphia Weekly newspaper. Each and every night, I check on my daughter many times in the middle of the night to make sure she is still breathing (like we ALL did when they were babies). I have a chime on her bedroom door so that every time she opens it, I know she has walked out of her room. I had a deadbolt put on the front door of our home with a key that can be removed from the inside. I never leave the key in the door for fear that Victoria will be confused after a seizure or when she has memory loss, and leave our home. (This has happened many times and she has been missing). When she is in the shower, I have to either stand outside the door and/or keep asking her "are you okay?" Each day, I cry and wonder if Victoria will be next one to die from adverse reactions to Gardasil.
We are in desperate need of medical treatment for my daughter. I have run out of ideas, doctors to treat with and finances have dwindled. I do not know which direction to turn. Any thoughts are most appreciated, especially from the medical community. There are greater than 15,000 reported cases of adverse effects from the vaccine which have been reported to the NVIC (many of the adverse effects are extremely serious) and approximately 38 deaths have been reported. Please feel free to forward this information.
Thank you for your time and attention.
Jodi Speakman
[phone]

[LiamsMommy]

WHY are we still referring to this as protection against "cervical cancer"??? It's for GENITAL WARTS. Call it what it is. For 9 year olds? Really?? And HOW exactly are they proving the efficacy? Are we intentionally exposing girls to genital warts and waiting to see if they get cervical cancer within hours or days...? I just don't understand how in the world they are proving their efficacy?? Prove it to ME! LOL This whole vaccine concept is getting entirely out of hand in this country. Check out Dr. Moulden's website for information on how they are treating children with heavy metal poisoning from over-dosing them w/ vaccines... http://www.brainguardmd.com/

[topview11]

If you only knew that vaccines are all dangerous, most are untested for long term damage and all vaccines are contaminated with foreign substances from the growing host. They could be carrying other dangerous viruses from the growing host, like Monkey kidneys they grow vaccines in.
But the largest information big Pharma is keeping from you is the alternative Natural substance that will destroy all pathogens, which virus and bacteria are known as.
The natural substance is MMS, also known as Chlorine dioxide, and I have been taking it for two years and it will keep your body safe from all pathogens and also removes toxins and heavy metals from your body.
MMS helps build your immune system and kills all bacteria and viruses, even MRSA, Herpies,AIDS, HIV virus, HPV virus and does it in short order.

These vaccines are dangerous and un-necessary. It is just a great money maker for Big Pharma. They are immune from being sued as GW Bush made that a Law last year. They won't tell you about MMS as they don't want you to know about it. Just go here to read about it.

http://www.my-healthy.info/mms.htm

It just may save your life or a loved ones. Copy and paste it in your browser address bar if it isn't live. I take it internally every day and I haven't even had a cold since I have been taken it.

[MOFMARS333]

I'm so sorry for you & others who were trusting. Knowing the facts on Gardasil, I'd cringe every time I heard that terrifying "one less" catch.

We're discussing Gardasil here;

http://www.huffingtonpost.com/dr-bob-sears/vaccines-and-autism-what_b_279745.html?show_comment_id=30756481#comment_30756481

You may have to scroll a few pages to see all the important information & if you decide to join in it's easy to register. We can always use more help to bring truth to everyone. It's important we all do our part & speak out. We have to work towards letting others know the guinea pigs we've allowed our children to be.

There is actually help for our damaged children from the many toxins including too many vaccinations. Many try to keep us from knowing the alternatives now known to be authetinic as everyone can learn about by checking in on the "Living" section at Huffingtonpost.com.

Don't believe everthing your told is snake oil. Check it all out for yourself.

Concerning Merck;

Merck Wrote Drug Studies for Doctors

http://www.blogrunner.com/snapshot/D/4/4/merck_wrote_drug_studies_for_doctors/

Here's a link that could be helpful.

http://www.huffingtonpost.com/jeffrey-bland/chronic-illness-what-work_b_281228.html?show_comment_id=30756567#comment_30756567

[rdmathis2]

My 13 year old daughter was injured by Gardasil and completely disabled for the past year. Merck got it right when they used the slogan "One Less" for Gardasil. Because of Gardasil, my daughter was "One Less". She was "One Less Student", "One Less Active Child", "One Less in every aspect of her life". Take it from a mother who has spent the past year sitting by my child's bedside wondering if she would die in her sleep. INVESTIGATE BEFORE YOU VACCINATE. DO NOT trust your doctor to make this decision. If you want to understand Merck's role in the medical community, investigate some of their former wonderdrugs such as VIOXX and then marvel at how many people died from it before it was pulled off the market. The CDC AND FDA need to do their job and get this off the market before more children are harmed. The public is not aware of VAERS and the #'s are grossly understated. I have had to tell my child's doctors about VAERS and make them file reports or she would not be one of the current statistics in VAERS. Even then, her information has not been entered correctly so I know that VAERS is not what it should be. Please do not let this happen to your child.

[LiamsMommy]

Check out Dr. Moulden's Chelation treatment for flushing toxins from the bodies of injured children... he knows what he's doing. Studying it since 2001... very knowledgeable. I'm sorry for your experience and pray for her complete recovery. The NVIC is a great place for more information, too. Hang in there. and tell everyone!!!

[kmc2424]

As a victim of the harsh side effects of gardasil, it's upsetting to hear how short this vaccine lasts. Being in and out of the doctor and hospital with no answers since the day of my vaccine, I always though to myself that at least I had the benefits of this vaccine even though I'm sick from it, but all of these girls who have reactions are suffering for the vaccine to not even last long at all.

[kenhamlett]

I find it difficult to assess the various risks of vaccination vs cervical cancer without detailed statistics including patterns of the side effects of the vaccine (ie genetic predispositions). Thus the public side of the debate is fueled mostly by innuendo
While I still wonder about the protocol for the vaccinations, I have not seen any information on alternative schedules to see if any differences are observed. It could simply be a matter of time before we know the best course of action.
All I can say at this point is no one should give up on researching the alternatives.

[abrady1]

I appreciate that the article brings uo questions about its effective length of protection and its profile of risk of cancer prevention vs side effects. The misleading parts is it ONLY talks about cancer prevention, it makes no mention of the acutual virus as causing genital warts which is not a pleasant disease to have for many women. So it use is not solely for prevention of cancer from HPV but I presume to prevent HPV? Why no mention of carrier rae before and after the vaccine? The problem with RARE sideffects are that they are rare, if you dont use vaccine on lets say 100,000's of thousands of people you cant get large enough pool to say if it caused by vaccine or not. I dislike that the details RE: Deaths reported or occured were very slim, but maybe that data is not available like was it a allergic reaction anaphylatic shock type situation? Lastly is it a dead or weakened type vaccine? IF dead or not able to cause HPV in itself what is proposed mechanism for the side effects like ALS??? We dont have clue what causes it in people who never got vaccine. I am sick of people scaring thepublic with stories like flu vaccine= will give you... it is simply untrue. This vaccine may or may not be good idea but read these stories carefully and TALK TO YOUR MD or provider who can go over risks benefits with your interests not news selling or anti vaccine or drug company interests at heart.

[Betty2384]

It is used to treat 'certain' HPV strains that lead to cervical cancer. Not all strains that turn into Herpes. Have you ever checked into what is ACTUALLY in vaccines abrady1?
You really should. It isn't just a 'weakened strain'...Most of the time you are getting more then you bargained for.
http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf

[drbiz1]

I like the emphasis on the "talk to your MD" part. Do you mean the same Md's that get their information on the drugs from the pharmaceutical reps that have been found guilty repeatedly for giving false information on these drugs. Are you serious? Do you really think we should listen to them over the lead researcher, and MD, who specifically studied this drug? Wake up! You must have a lot of Merck stock, because anyone who still thinks this vaccine will do anything useful in imacting the health of America is clueless.

[peoplearestupid]

@Betty

I don't think anyone will take your advise seriously when you seem to think that some strains of HPV turn into Herpes.

"Herpes", which in this case we are speaking of the symptom of the leisons on skin (genitals, mouth or otherwise), are caused by the Herpes Simplex Virus, not HPV. HPV has nothing to do Herpes except they are both STDs.

I suggest YOU understand common knowledge surrounding different viruses before lecturing others about vaccines if you wish for more people to listen.

I have my reservations about vaccines, and would go as far to say that I would not be surprised if some of these flu strains were not natural occurences, or at least the mass spread of them. Any time the gov't is willing to dole at $10+ billion sight unseen for the vaccination there is a lot of incentive for corporations to make their own markets if you know what I mean. Not saying that is what or has happened, just that is wouldn't surprise me.

[murzee]

Finally, a voice of reason! It has been truly absurd to stand by and watch this debate unfold -- there has been no logic to it whatsoever.

See http://evimedgroup.blogspot.com/2009/08/hpv-not-smallpox-epidemic.html