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Woman has stroke after Gardasil shot No link has been established but worries increase as reports surface Originally published July 21, 2008
By Ashley Andyshak News-Post Staff
The only vaccine approved to target human papillomavirus is under fire as reports surface of serious side effects and even death among young women who received it.
The Food and Drug Administration approved Gardasil in 2006 for girls and women age 9 to 26. The vaccine is administered in three doses, and targets several strains of HPV that can cause cervical cancer.
Manufacturer Merck & Co. last month added fatigue, weakness and muscle pain to the list of possible adverse reactions to Gardasil, but families like the Davisons, who live in Frederick, don't believe the warnings are enough.
Mary Davison said her mother had cervical cancer, and she wanted to protect her three daughters from the same fate. Katherine Davison, 20, and her two younger sisters received their first Gardasil shots in November 2007, and their second in January.
None of the girls experienced any immediate side effects, but on Feb. 1, her 20th birthday, Katherine began feeling dizzy and developed flu-like symptoms. The next day, her family doctor assumed she had the flu and gave her a phenergan shot to stop her vomiting.
The following day, Katherine lost feeling in the left side of her body. Her left eye was drooping and her pupils were unevenly dilated, and the dizziness persisted. Her parents took her to Frederick Memorial Hospital for a series of CT scans, which helped determine the problem: Katherine had had a stroke.
Neither doctors at FMH or Johns Hopkins could determine what had caused the stroke. They suspected Katherine's other medicines: she was on thyroid medication, as well as a birth control pill.
While the latter increases the risk of developing blood clots in women older than 35 and those who smoke, neither describes Katherine, and she had no previous problems with either medication. Merck doesn't list blood clots as a risk with Gardasil, and doesn't warn of adverse reactions with other drugs.
Eighteen deaths of women who received the vaccine have been reported since Gardasil's approval, and blood clots were responsible for four of these, according to a report released last month by Judicial Watch, a nonprofit conservative government watchdog group. The report also found 140 reported serious adverse reactions, including seizures and trouble breathing. None have been determined to be a direct result of the vaccine, but the Davisons said they're distressed that the possibility of a connection has been so easily dismissed.
Merck officials maintain that the vaccine is safe. "Before the shot I was fine, and there is no reason I should have had a stroke," Katherine said.
The family said doctors should be more informed about Gardasil and its side effects. Katherine said that of the 10 doctors she saw in the months following her stroke, only one knew anything about Gardasil. "They should at least admit the possibility of these problems, and let doctors know they have these reports so they can track the side effects," said Doug Davison. "You can dismiss some of the reports, and say, 'It was this, and it was that,' but can you dismiss them all?"
While the lingering effects of her stroke aren't visible, Katherine said she still can't sense pain or temperature on her left side. She sometimes feels dizzy and tires easily, and she takes seven medications every day.
Doctors want to add Lipitor to that list since they can't determine the cause of her stroke and they want to see her cholesterol level drop from 101 to 80, just to be safe.
Mary Davison said her family doctor told her not to bring her younger two daughters in for their third shot. While the Davisons haven't hired a lawyer and aren't interested in a lawsuit, they do want the FDA to further examine Gardasil's effects.
"Who's checking? It seems like no one's checking," Doug Davison said.
Doc Crow's COMMENTS: Did you read this 20-year old girl was on SEVEN DIFFERENT DRUGS? Here's a good example that responsibility for crisis dis-health (her stroke) belongs to BOTH the medics for prescribing so many different drugs and the patient for taking so many. It is not healthy to be taking SEVEN DIFFERENT DRUGS when you are 20-years old.
Advice: I teach young people in my office to be careful dating anyone who is taking so many drugs. Likely, these people are also taking anti-depressants, and they go POSTAL if their brain chemistry goes out of balance. Wacko people hurt other people. Folks on multiple drugs are dangerous to themselves and anyone around them. Ask your significant others what drugs they are taking and why. Choose to get away from over-medicated people. Also, sick people who take lots of drugs are a HUGE medical liability. If you end up marrying them, you tie yourself into their expensive health problems. Save yourself headaches, date healthy people who are not on drugs!
Adverse Reactions Reported After Gardasil Shots DALLAS (CBS 11 News)
The cervical cancer vaccine called Gardasil has been on the market for about two years. Thousands of girls and women across the country, who've received the series of shots, have reported painful and scary side effects and one Dallas family is going through a similar ordeal. Seizures, temporary paralysis and excruciating pain – those are a few of the symptoms some have reported after taking Gardasil. It took months for a North Texas teen to recover and her family says the Gardasil shots are the only explanation that makes sense.
Dallas mother Michelle Kimzey saw the ads and heard all of the positive news about Gardasil and how it could help prevent cervical cancer. So when she took her 13-year-old daughter, Katherine, to the doctor, getting the vaccine was a 'no-brainer'.
"I thought, wow! When we left the office, I said, I just protected her from one more disease!" Katherine got her first injection of Gardasil along with a Hepatitis-A vaccine and a chicken pox booster. She got the second injection two months later, along with the D-TaP vaccination.
Six weeks after the second injection of Gardasil, Katherine passed out. "I tried to get up and my neck was stiff, and I couldn't move it," the teenager explained. "I couldn't move at all."
Katherine spent five days in the hospital.
Before the Gardasil vaccine, Katherine was a healthy teen. Her mother suspected Gardasil had something to do with the sudden illness, but doctors ran every test they could think of and couldn't make the connection. "The most definitive answer was, that's not it," Michelle Kimzey said. "We can't tell you what's wrong, but that's not it." (Crow-medics routinely deny vaccination as causation for sickness, even though the health problems happened at the time of shots.)
Barbara Loe Fisher is president of the National Vaccine Information Center, an independent, non-profit clearinghouse for information on vaccines and disease. She says nearly 100 parents, including Katherine's, have contacted the organization believing their daughters have suffered an adverse reaction following a Gardasil shot - at times- given in combination with other vaccines.
Fisher says the reports of complication have caused a real 'crisis of trust' in the hearts and minds of parents.
Since Gardasil won FDA approval, eight million shots have been given. Officials with the Centers for Disease Control say more than 9,000 adverse reactions have been reported. But only six-percent of those are considered serious and that's less than half of what is reported for most vaccines.
Dallas OBGYN Dr. Sheila Chhutani says half of all women will be infected with HPV at some point during their lives. She believes the small number of adverse reactions is far outweighed by the vaccine's benefits. "So when you look at those numbers and compare them to the numbers of adverse affects with the Gardasil... to me, right now, there is still no comparison."
Dr. Chhutani offers Gardasil to patients between the ages of nine and 26. She will not however give the injection at the same time as other vaccines. Dr. Chhutani says there should be more investigation into whether Gardasil -- given in combination with other vaccines -- could cause an adverse reaction.
Shannon Nelson, 18, from the Chicago area, got the Gardasil shot and two other vaccines-- at the same time. Within a week the soccer star could barely move. "When I went into the hospital I couldn't walk at all. I had to have a wheelchair. It just got worse each day," she explained.
Nelson spent 23 days in the hospital and while she's better now the teenager believes one of the vaccines she received is responsible for her illness and her neurologist says it's certainly possible.
Katherine Kimzey is back on the soccer field in North Texas. But she still has occasional pain and doesn't know what the future will hold. Thinking about her past experience she says she still worries and so does her mom.
Michelle Kimzey says next time; she won't be so quick to jump on the new vaccine bandwagon. "I think the connection is huge," she said.
The CDC is also looking into 17 reported deaths but denies Gardasil is to blame.
In a statement to CBS 11 News, Merck -- the maker of Gardasil -- said it has analyzed the reports of paralysis and death, and believes: no safety issue related to the vaccine has been identified. (Crow-I don't believe Merck. Of course they are going to deny causation of sickness & death with their vaccination.)
MERCK RESPONDS TO REPORTS OF ADVERSE EFFECTS FOLLOWING GARDASIL IMMUNIZATIONS-
Merck issued the following statement to address questions about adverse events reported in people who had received GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant].
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.
Gardasil Label Will Warn of Minor Side Effects, But Not Death or Paralysis
The labeling for Gardasil will be changed to warn of the drug’s minor side effects, but will not make mention of more serious adverse reactions - including death and paralysis - reported to health officials. The Food & Drug Administration (FDA) contends that there is not enough conclusive evidence linking Gardasil to the more serious side effects to warrant their inclusion on the labeling.
According to the Centers for Disease Control (CDC), there were 7802 reports of Gardasil side effects between June 2006 and April 2008 to the Vaccine Adverse Event Reporting System (VAERS). VAERS is a national program of the CDC and the FDA that monitors the safety of vaccines after they are licensed. About 7 percent of the reported side effects were serious, including 15 deaths and 31 instances of Guillain-Barré Syndrome (GBS), a neurological condition that causes temporary paralysis.
According to The Washington Times, in June, the FDA decided to expand the possible adverse reactions to the drug to include joint and muscle pain, fatigue, physical weakness and general malaise. The new warning will be added to the package insert and to an information sheet given to patients.
But FDA spokeswoman Karen Riley told The Washington Times that the label updates have “nothing to do with” the serious cases that have been reported. She said the updates were made at Merck’s request and touch on possible “mild” symptoms.
“The bottom line is that we have not seen any safety signals in the adverse events other than [fainting],” she said. “We continue to look at these reports.” However, many are not convinced and are calling on the FDA to take another look at Gardasil. Tom Fitton, president of Judicial Watch, a conservative organization that has monitored Gardasil adverse event reports, says he does not believe Merck or federal regulators are taking the side effect reports seriously. “I think we’ve uncovered a lot of disturbing things about Gardasil,” Fitton told the Times. “All we’re asking for is further investigation of its safety.”
Gardasil - 18 Dead, Thousands Suffer Complications Growing opposition and flat sales trigger Gardasil manufacturer Merck stock sell-off
By Thaddeus M. Baklinski
July 8, 2008 (LifeSiteNews.com) - The public interest group Judicial Watch recently obtained more than 8,000 reports, under the US Freedom of Information law, of adverse events in girls and young women after they were injected with the HPV vaccine Gardasil.
The reports reveal everything from massive wart outbreaks to seizures, paralysis and death.
Ten deaths have been reported since September 2007, bringing the total to 18 since the vaccine was approved for use in 2006.
In this year there have been 140 reported "serious" complications, 27 of which were categorized as "life-threatening," as well as ten spontaneous abortions and six cases of Guillain-Barré Syndrome, a very rare (1 in 100,000 in a healthy population) immune response to foreign antigens such as infectious agents or vaccines, that paralyzes the afflicted person.
"Given all the questions about Gardasil, the best public health policy would be to reevaluate its safety and to prohibit its distribution to minors. In the least, governments should rethink any efforts to mandate or promote this vaccine for children," stated Judicial Watch President Tom Fitton.
Gwen Landolt, national vice-president of REAL Women of Canada commented on the lack of proper testing before Gardasil was pushed through the approval process and the consequences of its widespread use.
"The long-term consequences of Gardasil are not known. The manufacturer admits this and agrees it does not know its effect on young girls' cancer risk, on their immunity system, on their reproductive system, or its genetic effects. In due course, we will know this, possibly in twenty or thirty years from now when these young girls, the innocent subjects of the Gardasil experiment have become grown women and then report the consequences of their having taken the medication in their childhood on medical advice."
Cynthia Janak, a freelance journalist and researcher, reported to the American Life League that she found evidence in the FDA's documentation that they knew that HPV is not the actual cause of cervical cancer but that the actual cause is a "persistent HPV infection that may act as a tumor promoter in cancer induction."
Janal explains: "What we have here is proof that there is scientific evidence that has been published in the past 15 years that states that HPV infection does not bear a direct relationship to the forming of cervical cancer. It also tells us that HPV, if allowed to will be taken care of by our own body's natural processes. . ."most infections are short-lived and not associated with cervical cancer." With this being said, why do we need Gardasil when our own body is more than capable of eradicating HPV? What we need is a government policy to assist women with the cost of getting follow-up tests when persistent HPV infection is present. This would make more sense and our government would save so much money on these types of programs instead of $360 each for the Gardasil vaccination."
The Judicial Watch press release concluded that "It could well be that the vaccine may not do a thing to protect anyone from cervical cancer, regardless of the claims being made by Merck Pharmaceutical. What the vaccine is causing is death and immense suffering among those who have been vaccinated."
After CBS News ran a story about the reported side effects of Gardasil, citing the 8,000 adverse event reports and giving details of a few serious complications - seizures, chronic pain, paralysis, and death from blood clots, the Wall Street Journal reported that Merck & Co.'s shares dropped 4.8% triggering a sell-off of the company's stock and a downgrade of their rating on the New York Stock Exchange.
Read related LifeSiteNews.com coverage and articles:
Why Medical Authorities Cannot be Trusted on Gardasil HPV Vaccine By Gwen Landolt http://www.lifesitenews.com/ldn/2007/dec/07121905.html
Ontario Catholic School Board Rejects HPV Vaccine on School Premises http://www.lifesitenews.com/ldn/2007/oct/07101806.html
Controversial HPV Vaccine Causing One Death Per Month: FDA Report http://www.lifesitenews.com/ldn/2008/jul/08070316.html
Gardasil tragedies -- Where are the reports?
Janak Cynthia July 3, 2008
Back in June of 2006, the FDA released this statement:
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01385.html
"Today is an important day for public health and for women's health, and for our continued fight against serious life-threatening diseases like cervical cancer," said Alex Azar, Deputy Secretary, U.S. Department of Health and Human Services (HHS). "HHS is committed to advancing critical health measures such as the development of new and promising vaccines to protect and advance the health of all Americans.""This is the first vaccine licensed specifically to prevent cervical cancer. Its rapid approval underscores FDA's commitment to help make safe and effective vaccines available as quickly as possible. Not only have vaccines dramatically reduced the toll of diseases in infants and children, like polio and measles, but they are playing an increasing role protecting and improving the lives of adolescents and adults," said Jesse Goodman, MD, MPH, Director of FDA's Center for Biologics Evaluation and Research.Four studies, one in the United States and three multinational, were conducted in 21,000 women to show how well Gardasil worked in women between the ages of 16 and 26 by giving them either the vaccine or placebo. The results showed that in women who had not already been infected, Gardasil was nearly 4% percent effective in preventing precancerous cervical lesions, precancerous vaginal and vulvar lesions, and genital warts caused by infection with the HPV types against which the vaccine is directed. (Crow-The shot affects only a few strains of HPV, many strains are not affected by the shot.) While the study period was not long enough for cervical cancer to develop, the prevention of these cervical precancerous lesions is believed highly likely to result in the prevention of those cancers.Since the approval of Gardasil thousands of young women and girls have been adversely affected by this vaccine.
Here are the newest stats.6697 reported incidents + 2141 = 8838 (multiple incidents)
103 were considered life threatening 255 were hospitalized3544 were taken to the ER 1236 had not recovered at the time of the report 159 are disabled at the time of the report 15 have died + 1 = 16 (multiple incident)
I am going to add to this report that there were 12 incidents of blood clots and 3 additional incidents with embolism. As I have done in past articles I am going to use the 10% rule. That means that approximately only 10% of cases are actually reported.
88380 incidents 1030 considered life threatening 2550 were hospitalized 35440 were taken to the ER 12360 had not recovered 1590 are disabled 160 have died.
Doc Crow’s comments: These reports are stunning. And yet, mothers line up and offer up their daughters for this shot. The risk of stroke & sudden death are as dangerous as the concept of cervical uterine cancer. What to do? Up-educate. Keep learning.
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| Posted on Tuesday, July 22, 2008 at 07:09
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