Barbara Mellers' daughter, Jenny, 15, passed away in March 2009. Is Gardasil to blame?
ML: What kind of child was Jenny? Please describe your daughter, prior to her getting sick.
Barbara: Jenny was very active. She played soccer for many years. She enjoyed school. She liked English, science, and struggled a bit with math. She had some friends her own age. Jenny was raised essentially as an only child, because her half-brother is 16 years older than she. She hung around with us a lot and learned to enjoy and relate to grown-ups. One of the most charming things about her was how well she could connect with people of many ages.
ML: When and why did Jenny get the Gardasil vaccine?
Barbara: We had come back from a sabbatical year in New York, and Jenny needed a Hepatitis B vaccine to get registered for school. Her pediatrician mentioned this new vaccine. He said it was good, and recommended we give it to Jenny. Without much thought, I agreed, and we started the 3 vaccinations. Jenny was 12 when she received her first vaccine. That was September 2006. The second was in November 2006, and the third was in March 2007. In May 2007, she began to weaken. She died 20 months later.
ML: When did Jenny start showing symptoms or signs that something was wrong?
Barbara: In May 2007, Jenny came home from school one day having tripped over a hurdle in P.E. class. It was 1 and a half feet high. All the other kids cleared it easily. A few days later, she tripped again on the same hurdle and fell on her knee. She hurt it badly, and stayed home for a few days. Then she developed a limp that never went away. With some degenerative neurological diseases, you can lose as much as 40% of your motor neurons before you even begin to show weakness. That may have happened to Jenny.
We thought it would get better, but when it didn't, we went back to her pediatrician. We thought, perhaps her legs were different lengths. But no, the doctor said things were fine and gave her strengthening exercises. A month or two went by and we didn't see any improvement. The pediatrician suggested sports therapy. We went to Children's Hospital in Oakland and started several months of physical therapy in August 2007.
In October 2007, things weren't getting better. She then went to a pediatric neurologist, who started tests. In December 2007, we took her to another specialist at Children's Hospital in Philadelphia, PA. He immediately started treatment for multifocal motor neuropathy. Jenny received IVIG (intravenous immunoglobulin). We went home and followed up with a specialist at UCSF. The treatment wasn't working. She was getting weaker. By that time, she was falling too much and went from crutches to a walker. She started taking steroids. That didn't seem to work either. We still didn't know what the problem was, and we hoped the Philadelphia doctor was correct in his diagnosis. He thought she'd eventually recover in 9-10 months after extensive treatment.
In January 2008, we took Jenny to Children's Hospital in Stanford. The Stanford doctor immediately put her in the hospital to do testing, imaging, biopsies, and more. We stayed there for two weeks, but the treatments didn't seem to help. After being home for a few weeks, we went back for a few more weeks. Meanwhile, Jenny was losing her ability to hold herself up. She tried going back to school with an electric scooter, but it was just too hard. She couldn't even write or take notes. She stayed home with a tutor. We were going to the hospital and seeing many different doctors to figure out what was going on. Jenny started new treatments -- chemotherapy in March 2008. We didn't see any improvement at that point either.
Around April, we noticed that her breathing was compromised. Her FVC (forced vital capacity) was about half of what it should be. Eventually she needed help with breathing, so she went on a noninvasive ventilator. She was also given a feeding tube.
In June/July 2008, we tried to figure out how to adapt with life at home. We had nursing help. Jenny was losing her ability to turn over in bed. I slept with her and turned her whenever she wanted, trying to keep her happy and comfortable. By now, she was in bed most of the time. We had two goals. One was to find a cure, and the other was to maintain her quality of life. We wanted to keep her busy, happy, and distracted. Friends, family, and specialists came by. We had wonderful friends helping us look for other children who were similar to Jenny. We set up a website. We reached out to doctors all over the world to find treatments, experimental drugs, and medications. We tried so many things. Sometimes we thought she was getting better. Maybe the disease was slowing down or even reversing. Then she'd get a little worse, and we knew we were wrong.
In August/September 2008, school started. We got a tutor for her and overnight nursing help. Jenny had physical and occupational therapy several times a week. She was using the noninvasive ventilator around the clock. She also had a computer to help her communicate. We weren't making a lot of progress, although we kept thinking we might be. Christmas was a low point. She felt miserable. There was nausea from the medications and treatments, air in her stomach from the ventilator, and other types of pain. We worked hard to keep her feeling as good as possible.
Her birthday came on January 12th, 2009. At that point, we felt like there was actually some strengthening in her hands. She was getting more control. Then in early March, she started having trouble breathing -- despite the noninvasive ventilator. We took her to the hospital and brought her home. But things got worse. On March 9th, 2009, we took her to UCSF. She was losing her voice and her breath was very labored. She died on March 15th, 2009.
ML: When Jenny passed away, what was believed to be her cause of death?
Barbara: There was always some degree of controversy between those who favored the motor neuron diagnosis (juvenile ALS) and those who thought the disease process was autoimmune in causation. At this point, medical opinion has swung quite decisively toward the autoimmune theory, which is more consistent with the hypothesis that the Gardasil vaccine was the trigger.
ML: How did you link Gardasil to a possible cause of death?
Barbara: During the Stanford hospital stays, we discussed Jenny's medical history, and initially only a few physicians thought there might be a link. Nonetheless, we filed Jenny's case in a federal database called VAERS (Vaccine Adverse Event Reporting System) and tried to find comparable girls. The system is outdated, underutilized, and extremely hard to use. Now we have found at least one comparable case that we have been told was filed by Merck, the manufacturer of Gardasil. But the information is too vague and incomplete for the CDC to contact the family. To the best of our knowledge, Merck has yet to provide the necessary information. I want to take this opportunity to beg Merck to help our doctors and the government agencies to identify any other cases that might be comparable. I know that Jenny would want us to do everything humanly possible to make sure no other girl ever suffers the pain, humiliation, and misery that she went through in the last two years of her life.
ML: Did anyone from Merck or affiliated with Merck contact you or try to reach you?
Barbara: No. As far as we know, Merck has not responded to requests for information, either from us or from Jenny's doctors. There are two types of information that experts investigating these cases need. First, Merck needs to share widely all information about any other girls with comparable symptoms. Second, Merck needs to answer -- in a transparent and scientific way -- the serious questions that have been raised about batches of vaccines that might be linked to manufacturing problems. There have been reports of bad batches. We have obtained the lot numbers from Jenny's vaccinations and asked how the lot numbers relate to the batches. We have been told that key information that experts need to test hypotheses about bad lots -- key information like how many kids received vaccines from each lot -- is considered proprietary.
ML: Is there a way legally to get them to disclose the information about the lot numbers or bad batches of the vaccine?
Barbara: I don't know, but I hope so. From a humanitarian point of view, Merck should have been much more forthcoming with information that could help the scientists working on this problem. But I see no evidence of it happening. It is a sad state of affairs if our government can't get this important information. It is also ironic, since pharmaceutical companies are protected from lawsuits involving adverse events related to the vaccines. In the 1980s, the government set up a National Vaccine Court, designed to keep pharmaceutical companies investing in vaccinations. Parents pay a surcharge on each vaccine, and that money is used by the National Vaccine Court to pay families who have experienced adverse events that followed the vaccine.
ML: What is being done now in terms of trying to figure out Jenny's cause of
death?
Barbara: Stay tuned. Researchers at major research universities are carefully studying Jenny's case, and those of possible comparables. The evidence should be out in a few months. At least some of the evidence will very likely be published in peer-reviewed scientific journals. I believe it will soon be much more difficult to deny the evidence linking Gardasil to devastating side effects in a small number of high-vulnerability cases.
ML: Have any families contacted you about their daughters? Or have you found anyone else who went through what Jenny did after taking Gardasil?
Barbara: We found another young lady who has since passed away. Her mom contacted us through our blog. She's Mormon, and had the Gardasil vaccine prior to going on her mission. She came home from her mission early due to weakness, and passed away in August 2008. There are many deeply disturbing similarities, and her case is being investigated by the same researchers.
Then another mom contacted us through the website. Her daughter experienced weakness after the Gardasil vaccine, and the young lady is currently in braces and having a great deal of trouble walking.
I think the story will slowly but surely come together. If any of your readers know of teenage girls or young adolescent girls who have experienced severe weakening or paralysis, please ask them to contact us. Jenny's website can be found by Googling "Jenny's Journey." You can reach us from that site.
ML: Is Gardasil to blame for your daughter's death, in your opinion?
Barbara: Personally, I believe that Gardasil is the most plausible explanation. But it doesn't matter what I think. What matters is that a number of prominent medical scientists at leading universities now believe that Gardasil is the most likely explanation for Jenny's case. The next big question is going to be why Jenny and perhaps a small number of other girls? And why do millions of girls who get the vaccine do just fine? That is a mystery waiting to be solved. Important clues are already starting to come to light. And I will be glad to update you again as the story unfolds.
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Gardasil, Part 2: Do the Risks Outweigh the Benefits?
Over 24 million doses have been distributed in the U.S. But how safe is it? Momlogic investigates.
We've all seen the "One Less" commercials promoting Gardasil, the cervical cancer vaccine that helps protect against 4 types of human papillomavirus (HPV). This three-dose vaccine, which was introduced in 2006, is for girls age 9 to 26. Over 24 million doses have been distributed in the U.S.
The momlogic office has been flooded with letters and e-mails from mothers grappling over whether to vaccinate their tweens and teens or not. Some wonder if their kids even need it, since they're not sexually active. ("Will giving my daughter these shots be like giving her a license to have sex?") Others are concerned about the side effects. As of May 1, 2009, more than 24 million doses of Gardasil have been distributed in the United States. There have been 13,758 Vaccine Adverse Event Reporting System (VAERS) reports following vaccination. Ninety-three percent were reports of events considered to be non-serious, like fainting, headache, or fever. But seven percent were considered to be serious -- such as hospitalization, or even death. Yes, death. Thirty-nine women have died after getting the Gardasil vaccine, according to the CDC. To date, none of these deaths has been officially linked directly to the vaccine.
Guillain-Barré Syndrome (GBS), a rare disorder that causes muscle weakness, has been reported to have occurred after vaccination with Gardasil. Barbara Mellers' 15-year-old daughter, Jenny, passed away in March 2009 from what doctors suspect was autoimmune in causation. She started developing muscle weakness shortly after getting her third Gardasil shot in March 2007. "In May 2007, Jenny came home from school one day having tripped over a hurdle in P.E. class. It was 1 and a half feet high. All the other kids cleared it easily," Barbara recalls. By December, Jenny had to use a walker at school, and her muscle weakness was getting progressively worse. No one knew what was wrong with her, and she was sent to countless specialists. By summer 2008, Jenny was a quadriplegic who could breathe only with machine support. "We had wonderful friends helping us look for other children who were similar to Jenny," Barbara says. "We set up a website. We reached out to doctors all over the world to find treatments, experimental drugs, and medications. We tried so many things. Sometimes we thought she was getting better. Maybe the disease was slowing down or even reversing. Then she'd get a little worse, and we knew we were wrong." Despite everyone's Herculean efforts, Jenny died in pediatric ICU on March 15th, 2009. To read more of Jenny's story, click here.
Was Gardasil to blame for Jenny's death? That has yet to be determined. Her family hesitates to declare that Gardasil was the cause of her death, but some prominent medical scientists at leading universities see the connection as possible and even plausible. Jenny's parents, both college professors, would like to persuade the Centers for Disease Control (CDC) to investigate how many Jennys are out there.
Is Gardasil safe for YOUR daughter? We asked two well-respected OB/GYNs, Dr. Hilda Hutcherson and Dr. Suzanne Gilberg-Lenz, to weigh in on this serious issue.
ML: Is Gardasil a must for all teen girls, even if they are not sexually active?
Dr. Hilda: Many people tie this vaccine to sexual activity, but we need to separate it from sexual activity and look at it as cancer prevention. When you look at it as cancer prevention, it's a lot easier to embrace it. I tell moms that you are giving something to your daughter that could potentially save her life in the future.
Dr. Suzanne: I try to explain to moms, in plain English, what HPV is and why it poses problems -- i.e., what the virus is, what the subtypes are, and which are the "bad players." I tell them that Gardasil may reduce the risk of transmission of four specific subtypes of the virus that can cause genital warts and that can cause dysplasia, or potentially pre-cancerous changes of the cervix that may lead to cervical cancer if left untreated in some, not all, women.
Moms should ask themselves: Are they getting their daughters vaccinated with a clear understanding of what the vaccination can and cannot do, or are they doing it out of panic, fear, or guilt?
With all due respect, no one ever knows for sure what another is really up to, and even the best mother-daughter relationships might harbor some secrets. Furthermore, assuming that the non-sexual teen will reliably remain in that state is just an accident waiting to happen. I say give your daughters (and sons!) all the best info and resources, and guide them to trusted grown-ups (counselors, doctors, etc.) ahead of time, if at all possible, so that they do have someone who is not you to talk to just in case. My teen patients who are given these opportunities may feel embarrassed initially (the "mooo-om" syndrome), but also appreciate the respect that their parents are giving them to make decisions safely and wisely.
ML: Many mothers who write to us with hesitancy about the vaccine fear they are hurting their daughters by NOT allowing her the vaccine. Are they?
Dr. Hilda: I don't believe in making mothers feel guilty. I just try to provide the information. I say, "These are the facts we have right now. You use the information given to you and make the best decision based upon this." You as a mom have to make the right decision for your child.
Dr. Suzanne: It is true that rates of STDs among teens are on the rise. According to a 2006 Kaiser Family Foundation report, 25% of 15- to 19-year-olds and nearly 50% of American teens have had chlamydia, trichomoniasis, or HPV, with HPV being most common. 35% of 13- to 19-year-olds are HPV-positive. But it is also true that 80-90% of those infected, even with the highest-risk HPV strains, will clear the infection on their own within two years. In the end, it is a crap shoot!
ML: What about uninsured girls whose parents can't afford the pricey protection?
Dr. Hilda: The people who need it the most aren't getting it. It's an access issue. They don't have access to something that could be life-saving, because they can't afford it. I feel it's something we should provide for women who can't afford it. Children age 18 and younger may be eligible to get vaccines, including the HPV vaccine, for free through the Vaccines for Children program.
Dr. Suzanne: I believe that leveling the field was one of the aims of the bills that some states proposed to require vaccinations for school entry, similar to other more common vaccinations such as measles, hepatitis B, etc. It's also important to note here that 85% of diagnoses and deaths due to cervical cancer occur in developing nations. Clearly, poverty and lack of health care play a big role in this disease and need attention. We should be getting this vaccination to the poor women of the world regardless of their country or residence.
ML: It's a brand-new drug -- why are we lining up our daughters to get these injections without more thought?
Dr. Hilda: The FDA doesn't let anything get through unless it was adequately tested, and I think this vaccine was properly tested. I feel comfortable recommending this vaccine to my family members. There's nothing on this planet that doesn't have risks, but you have to weigh the benefits and the risks.
When you measure the few women who possibly had a bad outcome (that we can't yet directly link to the vaccine) and the thousands of women whose lives can be saved, I come out on the side of the benefits outweighing the risks.
Dr. Suzanne: Why are we lining up our daughters to get these injections? Because as moms, we want to do the right thing, and we got the message loud and clear that this was the right thing.
ML: How do we know the long-term side effects when the drug was so quickly approved and administered in waves?
Dr. Hilda: There are reported short-term side effects and reactions like fainting, but I haven't seen that in my office. In terms of the long-term side effects, the FDA has approved this and deemed it safe. I don't think it was "quickly" approved because they don't "quickly" approve anything! Gardasil was thoroughly tested before it came on the market. And if it protects you from cervical cancer and can potentially save your life, that beneficial effect cannot be disputed and in my opinion, outweighs the risks.
Dr. Suzanne: The FDA approval process involved more than 4,000 vaccinations over 4 years, and this government body felt that this was adequate to bring the product to market. Understanding that there had been no way, prior to this point in time, to prevent the disease -- and the public health and personal impacts of not only cervical cancer, but frequent pap smears, colposcopies, cervical biopsies, the physical and psychological pain, shame, and blame -- is really critical in adding context to the decision to develop the vaccination and bring it to market rapidly. There has been long-term frustration in this area for patients, researchers, and practitioners.
A handful of my patients developed side effects. One developed mysterious neurological symptoms that we cannot diagnose. There is no way to know if this is a coincidence or not, but more than one study, including a 2007 study looking at 270,000 doses administered in Australia, has revealed a five- to ten-fold increase in "reactions" to this vaccination over other common vaccinations. The absolute numbers are quite low -- 7 incidents in 270,000 -- but statistically significant.
ML: What about the reported deaths?
Dr. Hilda: These cannot be directly tied to this vaccine. Millions have received the vaccine, and 39 young people tragically died at some point after receiving the vaccine. Those deaths have not been tied directly to the vaccine at this point. I feel for the families, and no young person should have to die, but this vaccine will save thousands of lives per year.
Dr. Suzanne: It has been very hard to link the reported incidents, reactions, and deaths to the vaccination, partly because there is no obvious pattern and the absolute numbers are low. But for most mothers, they are obviously a cause for concern.
ML: Would you allow your daughter to get the Gardasil vaccine?
Dr. Hilda: Yes.
Dr. Suzanne. She is only 8. The jury is out.
How do you determine whether the benefits outweigh the risks for your daughter? Both doctors agree that this isn't a decision that should be taken lightly. Download momlogic's Should Your Daughter Get the Gardasil Vaccine? Questions Every Mother Should Ask printable guide for more guidance.
Is the Gardasil vaccine safe for your daughter? Tune in to the "Today" show on Friday morning for more information from momlogic OB/GYN Dr. Suzanne Gilberg-Lenz.
Would you allow (or have you allowed) your daughter to get the Gardasil vaccine? Why or why not?
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Dr.
Suzanne Gilberg-Lenz completed her undergraduate education at Wesleyan University and post-baccalaureate pre-med studies at Mills College. She earned her medical degree from the USC School of Medicine and has been in private practice for 9 years. She is the co-founder of Cedar Sinai Medical Center's Green Committee and lives in Los Angeles with her husband and two children. |
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Dr. Hilda
Hutcherson is a clinical professor of Obstetrics and Gynecology at Columbia University. She has written three books, including "Pleasure: A Woman's Guide to Getting the Sex You Want, Need and Deserve." She lives in Pelham, New York with her husband and four children. |
