Sunday, June 22, 2008

Issues Highlighted about CISA investigation

It has been clear for months now that CISA has no intention of investigating the HPV vaccine question aggressively in Jenny's case--or perhaps in others. Meanwhile Jenny's condition gets graver by the day . So, posting a debate about the quality of other CISA investigations is becoming necessary. The concerns fall into the following six categories:

(1) Gardasil was the vaccine that Jenny received shortly before symptom onset--not Menactra. It is unclear therefore why her case was directed to a doctor who had researched GBS-Menactra connections. Even if the adjuvants were identical, the VLPs (hypothesized to be one possible disease trigger) are different. Perhaps most importantly, as the FDA warning letter of April 28, 2008 to Merck on manufacturing process violations reveals, there are grounds for concern about the quality of the lot numbers of Gardasil that our Jenny may have received - grounds that could extend to either the adjuvant or the VLPs.

(2) Even if the correct vaccine had been investigated in the VAERS database, it is unclear that any effort was made to contact MDs who treated the most potentially similar cases. Was such an effort made? And did it take into account such hypothesized pre-existing vulnerabilities in Jenny's case as the presence of pre-vaccination autoimmune diseases (such as pityriasis lichenoides in Jenny's case) and genetic or mitochondrial predispositions (such as a maternal line that includes tauopathy in maternal grandmother and severe autism and seizures in a maternal cousin)

(3) Insofar as Jenny's symptoms appear to have unfolded more gradually than those for most cases of GBS, and insofar as it is hard to set an exact date of onset for Jenny's symptoms (you can apparently lose quite a few motor neurons before it becomes apparent to the untrained eye), there is a real danger that parents and MDs may not link the vaccine to the later emergence of relatively full-blown ALS-type symptoms. Was any effort made to determine whether there has been a spike in motor-neuron-disease symptoms among girls/adolescents in a broader database that does not require perceived possible linkages to vaccines - and then to link back to possible vaccination antecedents? The base rates for MND among girls in Jenny's cohort are extremely small - so this would require access to a large database (one of the reasons we have extended the search for comparables to Jenny's case cross-nationally).

(4) At earlier stages of Jenny's illness - as late as January 2008--she would have probably been classified as some form of GBS (MMN or motor variant of CIDP were the diagnostic bases for the early treatment decisions). It is especially critical therefore that VAERS GBS reports that leave outcome ambiguous or dangling have follow-ups to determine whether initial report captured only the earlier phases of a longer-term deterioration. Was any such effort made in the initial investigation?

(5) Apparently at least one member of the CISA committee was under the misapprehension that it was "a fact" that the onset of weakening was 45 days after the vaccination. We are curious where this fact originated. We have learned the hard way that measuring the rate of loss of strength is amazingly hard: even when Jenny has been under intensive medical scrutiny, there have been diverging assessments of the rate of her decline, and even over whether she has stabilized at various points. And we have always known how much harder it is to quantify retrospectively the onset and rate of weakening in a time period when one did not remotely suspect that a seemingly healthy adolescent girl was weakening. The new CISA committee should be informed that the exact onset of weakening and functional form of the weakening over time is uncertain but that reasonable guesses would date it back to the spring of 2007. (To illustrate the absurdity of positing a known date for an illness of Jenny's sort, suppose that our daughter has been losing motor neuron control at the deeply depressing rate of about 5% per month since the last vaccination. What percentage of parents would notice such a decline in their teenage children within the first one or two months--and if they did notice it, what percentage would attribute their observations to mood or minor illness or...?)

(6) Finally - and we realize this concern is not peculiar to Jenny's case - VAERS is likely to undercount claims due to a mix of factors, including the voluntary nature of the reporting and the effort it requires from busy professionals and the likelihood that many people may not notice the temporal link between vaccination and onset of symptoms (obviously this becomes more problematic, the greater the delay--per points #3,4 and 5). Overall, this undercounting means there will often be a lag in attaining statistical significance even when there is a causal relationship. Moreover, even with this obstacle, the Gardasil-GBS covaraition appears already to have passed statstical significance. Were any statistical analyses conducted with respect to Gardasil?

The follow up has been disappointing and we continue to struggle for answers.


bjfowl said...

Dear Jenny,

My granddaughter Amber is 14 years old and had 2 of the 3 shots in the series of Gardasil Vaccine.
Amber became ill on August 1, 2007. Within 10 hours she went from perfectly normal to completely paralyzed from the waist down. After numerous tests, Dr. Robert Baumann and the neurology staff at the UK Children’s Hospital in Lexington, KY diagnosed her condition as transverse myelitis (TM). Transverse myelitis is a rare neurological disorder of the spine caused by inflammation across both sides of one segment of the spinal cord. TM occurs in both adults and children, and typically begins with a sudden onset of lower back pain, muscle weakness in the legs, spasms in the toes and feet progressing to more severe symptoms which include paralysis, urinary retention and loss of bowel control. She was hospitalized for 21 days and her treatments included steroids, plasmapheresis, IV-IgG and later Rituxan. Please visit Amber's website for more information on her at

Thank you and God Bless,
Betty Fowler

MathMom said...

I am a homeopath and a craniosacral therapist. I studied these disciplines because of my need to help my own vaccine-damaged son.

I recommend that you contact the Upledger Institute ( and arrange to take her to Palm Beach Gardens, Florida, for a week- or two-week-long intensive of craniosacral therapy (CST). They have programs for multiple therapists to use their very sophisticated manual techniques to help her body heal itself. They worked on conjoined Egyptian twins to help them live individually after surgery for separation, and can help many seemingly hopeless problems.

To give you an idea of what benefits can be gained from CST, I have a client in my practice who came to me with the diagnosis of MS, and had been in physical therapy for several years with no obvious improvement. The first time she came to see me it took her nearly 5 minutes to walk the 50 feet from her car to my door. Her left side had the appearance of having had a stroke. After a few weeks of CST she began to walk better, began to build muscle tone, and her PT was able to dramatically increase her exercise regimen. She went from being able to do only one thing a day, such as go to the bank, to doing whatever she wanted to do, groceries and bank and dry cleaner and and and. She could get out of her car and into my office in less than two minutes. Her diagnosis was changed, because the doctor told her that MS patients don't get better, but she was clearly getting better.

This is the sort of thing that can happen for your daughter, only at a much more rapid pace because of the multiple therapist working synergistically.

You should also find a very good homeopath to take her case. Homeopathy can do miraculous things, especially in the hands of a master. You might be able to find a homeopath in Northern California, but you should not trust this case to a dabbler. I might be able to help you find someone if you have an interest in learning about these disciplines.

Whether you try these or not, I will keep your daughter in my prayers.

homeopathcst -at- gmail dot com

Mabissam said...

I just read this article on the and saw there was no mention of the reports of paralysis stemming from the vaccine. Perhaps you could write the editor about this omission?

jenzen said...

My 17 year old daughter had all three shots in 2007. After the last shot she was not feeling well and a month later had a seizure and was taken to the hospital by ambulance. She was previously a straight A student her entire life and now her grades suffer and she has to take medicine 3 times a day in an attempt to prevent more seizures. However, she continues to have seizures because her insurance will not pay for the medicine the doctor wants her to take. The medicine is $330 per month and we are out of money paying for three different neurologists. If we could get the same neurologist to see all of these cases, maybe they will make the connections and someone will do something to help us. She had the last injection in October 2007 and here it is June 2008 and she is 18 years old and still having seizures. I feel helpless. I have never blogged before, but am not sure what else to do. Her case has been reported to the FDA as an adverse reaction to the vaccine Gardasil. The statistics would be higher if the FDA reporting process did not require the lot # amd manufacturer number, etc of the vaccine. Couldn't that information e gathered later? I had to search pn the internet to find the correct form to take to the doctor to fill out becuase I didn't have all the information from her chart. Some people may not be able to return or find all the data required to be reported as a statistic. From what I have seen on the news, internet and newspapers, I know there are thousands out here who may not be counted a "statistic" with the FDA. Is there some way we can all unite even within our states? I have written the governor of Texas but have not yet received a response. We are so scattered across the country. If you are or someone you know has had an symptoms of a possible adverse reaction to the Gardasil vaccine, please report it to VAERS with as much information as you can. Dr. Bruce Jenevein is the third neurologist we've seen. He works out of Baylor Hospital-Dallas , Texas and is one of the best. Something needs to be done. I just started blogging (learning how to get the word out). Here is the beginning of my blog. I will add to it periodically.
Jenny Powley

N said...

Information here about gardasil possibly useful to you (or your lawyers). About one-half of the comments here are from women working in science, and mothers who investigated Gardasil and refused to use it for their daughters. The reason I'm posting it to you is that this is substantiated information useful (as above) and to your commenters who seem to be naive about the science behind Gardasil.

These posters are not religious fundies.

I have sent your request out to feminist and medical 'questioning' blogs.

S said...

This woman posted on the Gardasil thread at Women's Space/The Margins. I wonder how to reach her? She might have good information for you:

66 Susanna Eisenman

My 14 year old daughter just received the HPV vaccine today along with a tetanus booster and the meningiitis vaccine. She had a sever allergic reaction within minutes - including disturbances to her vision (flashing lights, altered colors) and difficulty breathing. It is impossible to know exactly which vaccine caused the reaction but now I am extremely hesitant about subjecting her to any more vaccines in the future.

Jennifer & Robert said...

I really am at a loss for the right things to say! I HOPE & PRAY for these girls. Their families and friends.

Supposedly this is the vacine to keep the girls safe of cervical cancer?! Why would we risk this shot?

Is there no one taking responsibility?

TLC Tugger said...

It seems feasible that any vaccine which has been associated with adverse symptoms could be routinely preceded by exposure to a tiny "indicator" dose or other assay to screen out people who might suffer adverse symptoms.

My daughter has taken all 3 Gardasil doses and she's still a straight A honors student and charismatic artist. I can't imagine my anguish if she had been adversely affected.

For one thing I would want to know the pre-Gardasil background rate for conditions and symptoms like she was suffering from. If drug companies and regulatory agencies refused to cooperate in defining those things, I don't really know what would stop me from becoming homicidal.


Tito Barria said...

Dear Sirs:

I am writting you from Panama, Rep. of Panama. I just watched on TV here on my country, about the possible effects of Gardasil.
Two of my 12 years old triplets daugthers, the other is a kid, just received the third shot about two weeks ago.
You can imagine at this very moment how desperate I am regarding this matter.
Please , let me know for the first symthoms I need to be aware of, and in how many time if there is any relation with the vaccine, are the symthoms expected to appear.
Thank you very much for your blog, and my prays to God for Jenny.

Tito Barria