Aetiology

This is a classic example of the paradox of vaccination: when do you stop vaccinating because the risks outweigh the benefits?

We had the honor of having Donald Henderson, who led the campaign to eradicate smallpox, give a talk here a few years ago. You would not want to go back to those days. After 9/11 and the 10/4 anthrax attacks there was a lot of real concern about smallpox, but does the military really need to keep up this vaccination program now? Would it not be more sensible to stockpile the vaccine, in case it ever is needed, preferable in multiple locations?

Posted by: Andy | May 8, 2007 3:37 PM

Unfortunately, the smallpox vaccination campaign was begun with political spin posing as a scientific decisionmaking process--not untypical of the kind of information our current administration often uses for its decisionmaking process.

Vaccinia was an excellent vaccine for eliminating smallpox. There was no good reason to start vaccinating all of us against it, or even our troops. But as he and his lot built the case for weapons of mass destruction in Iraq, Cheney either became convinced or pretended to become convinced that Iraq had smallpox stores. He pushed the CDC's advisory committee into recommending that 10 million Americans get the vaccine (only 40,000 civilians did).

There was some circular reasoning at work here. If Saddam was evil enough to be stockpiling smallpox, he was evil enough to invade. If he was evil enough to invade, he must be stockpiling smallpox. The evidence? We had decided to start vaccinating against it--which we wouldn't have done if it wasn't a real threat, right? This was a hall of mirrors. DA Henderson initially fed the flames though he has since said there was never any evidence that Iraq had the stuff.

Posted by: arthur allen | May 8, 2007 10:16 PM

Stephen,
The vaccinia virus is not the disease virus. It will give you immunity against the disease, and it's a real virus, but it's not smallpox (variola). Vaccinia can spread, but only rarely and by direct contact like Tara says. Variola spreads by direct contact and can also be airborne.
Which word came first?
Well, they both come from 'cow' since cowpox was used for variolation. I would guess vaccination came first and then 'variola' and 'vaccinia' as the different pathogens were identified. Anyone else know?

Posted by: Adele | May 9, 2007 11:17 AM

It's worse, isn't it? With 40,000 civilians vaccinated, isn't there that much more chance someone we don't want to have real smallpox could get some? It's like telling a thousand people to keep a secret. [make up some embarassing secret and publish it here].

They say you're much more likely to be shot if you own a gun.

So which came first: the word vaccination, or vaccinia?

Posted by: Stephen | May 9, 2007 12:53 PM

This seems really pointless. If someone had been working on small pox as a biological weapon, wouldn't they go to the trouble of tinkering with it so the existing vacciation did not work?

Posted by: Corbs | May 9, 2007 9:46 PM

AIDSBLOG of the month: available online at

http://securebar.secure-tunnel.com/cgi-bin/nph-freebar.cgi/110110A/http/scienceblogs.com/aetiology/2007/04/well_isnt_this_interesting.php

Dear Dale and Adele,

Dale. Suffice it to say, you are right, I am not "a medical doctor" (thank The Intelligent Designer): But I do have to teach pathology at the largest medical school in the United States to second year medical students (about 250/course/year), cell biology (only graduate students these days-thank whom ever), oncology and cancer biology (to young doctors here who work with me on such projects as trying to transform MCF 10A cells, and normal cervical cells with live "HPV" (acquired from patients condemned and whose lives have been ruined by Digene's kit or Merck's fraudulent vaccine). On a daily basis I teach my grad students and post docs about what I have learned about breast cancer and melanoma reversion using simple ECM molecules found in embryos, and oncolytic herpes viruses and CMV. With my bioengineering students (typically small groups of senior undergrad students) we design and build projects in a year-long course-they won both First and Second Place awards in the Chicago-Wide UIC bioengineering EXPO competition two years ago-and yes I was proud of them http://www.uic.edu/depts/enga/current_students/expo2005.htm), and believe it or not, I also teach piano (in 1975 I first went to The University of Iowa as a Freshman on a music scholarship, but got interested in the Iowa Writer's workshop, dropped out of college to live at a commune in Iowa City called Black's Gas Light Village, and then started reading F. Nietzsche, J. Joyce, Nikos Kazantzakis (who I named one of my son's after), and others, but I decided I could never write "as good as them guys" so I got a degree in physical anthropology and primate studies-which couldn't get me a job as Reagan had just been elected and the NIH budget cut so a guy I wanted to study lemers with in Madagascar couldn't take me, so I stayed an extra year at Washington University after I graduated and taught Human Osteology to premed students and archaeology students, and forensic scientists, etc, etc. Then to feed myself and my woman, I started tissue culturing as a lab tech in different labs in St. Louis and Berkeley CA for 5 years before deciding to get my PHD in cell biology. After I got my PhD at Berkeley, I was on Judah Folkman's vascular task force for several years at Harvard as a post-doc while working out the basis of endothelial receptor signaling in the context of normal tissues and cancer. While at The University of Iowa, and contrary to the anti-angiogenesis hypothesis I helped explore with Folkman while a postdoc, I did make a minor discovery that tumors make their own vascular system if they are malignant, and the vasculature is made from tumor cells, and not endothelial cells in a variety of malignant cancers. Some 50 independent groups have confirmed the findings since I first reported the phenomenon in 1999. Unfortuately, the finding predicted the failure of anti-angiogenesis for cancer-a 12 or more billion-dollar industry, which has occurred despite the hype regarding avastin or other so-called anti-angiogenesis inhibitors (Call up Sloan-Kettering, M.D. Anderson, University of Wisconsin Comprehensive Cancer Center, The NIH, Dana Farber, or other leading cancer institutions-and ask them about their trials with Avastin, Endostatin, Angiostatin, or VEGF-inhibitors if you don't believe me). So yes you are correct, I am no DOCTOR and I don't really have any basis for asking a question about medicine, or biology.

Adele, You can tell me to go to hell and that I am a self-deluded fool, and you can make fun of how I spent the money donated at my father's funeral on Alive and Well AIDS alternatives (its amazing how you found this out, but then I remembered it was on his obit-amazing what you can learn on line these days that is potentially damaging to a fellow like me), and how that makes me incapable of thinking rationally. But somehow, I am not at all surprised. You guys like to taunt and terrorize the survivors of dead loved ones, like Christine and Robin, while you advocate such things as The Nazi State taking their children away to test and drug them to death as they did at ICC and elsewhere, despite their good health and parents observations (ever have your own children-better get them "HIV" tested even if you yourself test inconsistently positive 6 different times, as did Christine Maggiore)? Regarding inconsistently testing 6 times in a row, as she did, and this of course is very important to consider regarding the case of Eliza Jane (whose funeral I attended), is that in science, I was taught that if something happens, say in a Petri dish, once, it is a fluke (like testing positive on an Eliza or WB or PCR): if it happens twice, it is a coincidence. If it happens 3 times in a row, then you got a line to draw on a graph-etc. For someone like Christine, who has tested inconclusive, positive, inconclusive, positive, negative, and positive, I don't think that qualifies as any kind of reality regarding her "HIV-status" in any epistemology (except perhaps religion), if you see what I mean.

However, I am disappointed by both of your learned criticisms of me. Once again, and despite all your learned and well-considered responses, you didn't answer my simple question about the T-cells. Just for the record, I forwarded the money to Christine's organization because at that difficult time during the demise and loss of my father from brain cancer at 73, and because of the insistence of his DOCTORS at his hospital who insisted on testing him for "HIV" dementia against my wishes, and my demands to not do so. I felt that Christine Maggiore was at that time the most articulate spokesperson on the subject of how "HIV-positive" folks are stigmatized and brutalized by the AIDS establishment and Public Health Service, and by people such as you and your ilk. As a consequence, I thought that Christine's organization may be able to reach more of the folks whose lives have been victimized and often destroyed- and who have been terrorized by people like you, and I felt that her organization was more worthy of support than all of the quack scientists and Church of Modern Medicine folks:

1. who continue to advocate such things as failed "HIV" vaccines and "HIV" vaccine trials (that contain dangerous adjuvants such as MF-59-or squalene, used to intentially evoke non-specific immune reacions, because, to date, and as Barre-Sinoussi concluded at Toronto last summer in her talk, 15 failed "HIV" vaccine trials (at taxpayers expense exceeding $120,000,000/ for some of them) have not evoked humoral, cellular, or mucosal immunity, or demonstrated T-cell activation to date (see the 1995 Congress of the United States: Office of Technology assessment. Adverse Reactions to HIV Vaccines: Medical, Ethical, and Legal Issues-Roger C. Herdman, Director-a document which claims there were at least 30 such trials conducted before 1995, and as many as 80 trials that were aborted or not fully disclosed-I guess Barre-Sinoussi didn't read the congressional reports detailing adverse reactions and legal issues involved with any "HIV" vaccine, and she only was aware of the recent 15 failed "HIV" trials),

2. who continue to advocate that although almost a million Americans supposedly have antibodies to "HIV" in their bodies and should test "HIV-positive," as demonstrated by the production of antibodies to "HIV," and that contrary to what is understood about how the immune response is supposed to work by first identifying antigens in the universe that are non-self, and which appear to the immune system as non-self (which "HIV" apparently does according to your logic since about 1,000,000 "HIV" positive Americans can't all be artifacts), that somehow, "HIV" vaccines are the way to go if you can only ignore the fact that thousands of people in "HIV" vaccine trials who have been injected with components supposedly derived from "HIV" have not, and will not develop those same "HIV-positive" antibodies to whatever the non-defined shit is that the "HIV" vaccinees are being jabbed and inoculated with, because whatever these molecules are, they are not viewed by the immune system as non-self, and cannot evoke a humoral, cellular, or mucosal responses, or even stimulate T-cells without adding squalene or other toxic adjuvants that cause autoimmune diseases in rats (and soldiers),

3. who continue to advance the idea that although "HIV" vaccine components could not have been derived from anything unique and exogenous because no humoral, mucosal, or cellular immunity is evoked, that adjuvants such as squalene are good for ya because there is evidence that they have evoked autoimmune diseases in every sick Gulf War I veteran tested that have antibodies to squalene found in their blood (P. B. Asa et al., Exp. Mol. Pathol 68, 196-197, 2000; Asa PB, Wilson RB, Garry RF. Antibodies to squalene in recipients of anthrax vaccine. Exp Mol Pathol. Aug;73(1):19-27, 2002; see Gary Matsumoto's book, Vaccine A, Basic Books Publisher), and, in addition, squalene is the molecule of choice if you are trying to get a grant that proposes the induction of arthritis, lupus-like syndromes, or neurodegenerative diseases, or other autoimmune diseases in rats, or other experimental animals,

4. who continue to advocate Nazi-like initiatives such as failed cancer drugs like AZT or other DNA chain terminators that wipe out the immune system at the dosages given to a generation of gay men during the 1980's and early 90's, or in many cases infants and pregnant women, before it was found (by the Veterans Affairs and Concorde study and many, many others) that "AZT disproportionately harmed Blacks and Hispanics, and provided no benefit to the quelling of advancing immune suppression in Caucasians (1); and that "The results of Concorde do not encourage the early use of zidovudine in symptom-free HIV-infected adults, and call into question the uncritical use of CD4 cell counts as a surrogate endpoint for assessment of benefit from long-term antiretroviral therapy (2);" and that children born to ZDV-treated mothers "are more likely to have a rapid course of HIV-1 infection compared with children born to untreated mothers, as disease progression and immunological deterioration are significantly more rapid and the risk of death is actually increased during the first 3 years of life" (3),

5. who continue to advocate smearing microbicides on the genitals of every African is a good thing, despite at least 2 large studies that were stopped because it was found that these microbicides increased the formation of lesions and increased the incidence of "HIV-positivity" in these folks who were told to use them to help curb their wild sexual behavior since they are black,

6. who now advocate we chop off a part of every black-male's penis in Africa as they cheerfully "line up around the clinics" to be circumcised following the recommendations of studies performed on 100% of persons that visited STD clinics for STD treatments (chlamidia, syphilis, etc) according to Robert Bailey, who is at my institution, and who did the recent much touted, circumcision study that was published by newspapers world-wide before the peer review study emerged a month or two ago ( and which Charles Geshekter and I wrote a report that totally demolishes these claims because African statistics are not given by Africans themselves, because when they are, no such numbers come even close to those of the AIDS establishment, or Bailey's),

7. who ignore Max Essex's nevirapine-induced "virological failure" of 41.7% versus 0% in the 875, 000 African mother-child pairs in which nevaripine was "tested" (despite Tremont's admitted fudging of the nevaripine trial results and Fishbein's dismissal for blowing the whistle on him the year before -"AIDS Research Chief Rewrote Safety Report." By John Solomon, Dec 2004. Associated Press Writer. www.ahrp.org/infomail/04/12/15b.php):

"Well over 875,000 women and infants have received a single dose of nevirapine. A single dose of nevirapine is the cornerstone of the regimen recommended by the World Health Organization (WHO) to prevent mother-to-child transmission among women without access to antiretroviral treatment and among those not meeting treatment criteria. However, nevirapine resistance is detected (with the use of standard genotyping techniques) in 20 to 69% of women and 33 to 87% of infants after exposure to a single, peripartum dose of nevirapine. Among 60 women starting antiretroviral treatment within 6 months after receiving placebo or a single dose of nevirapine, no women in the placebo group and 41.7% in the nevirapine group had virologic failure (P

8. who continue to advocate such Nazi-like initiatives as universal "HIV" testing, despite the fact that even "AIDS experts" like Klausner and others have stated that the hapatitis B vaccine [5], the flu vaccine [6,7,], and more than 70 known reasons or syndromes will evoke a positive "HIV" test at rates as high as 2%-5% ?% of "low risk" (read white) populations of soccer moms and golf-enthusiasts living in the suburbs.

Somehow, I ain't surprised by your statements or responses to my simple question. And you still haven't answered my question:

I will state it again: Is AIDS a disease of too few lymphocytes (less than 1000/ul as given by the WHO), or is it a disease of too many lymphocytes, like cancer, or as in the case of Eliza Jane who had 10,800/ul, and who died of a classic delayed hypersensitivity reaction to b-lactams, as described by a huge literature on Medline?

Gee wizz guys-I ain't asking for much here. Don't make fun of my father's death or the fact that I chose to make his funeral contributions go toward helping stigmatized "HIV-positive" folks. Please don't make excuses on how children can have 10,800 T-cells and be considered AIDS patients. Please don't insult our ability to know the difference between the numbers, 1000 and 10,800. For example, 1000 lymphocytes is 1 more that 999 lymphocytes, right? And 10,800 lymphocytes is 1 more than 10,799 lymphocytes, right?

"AIDS" in children is considered to occur according to the WHO publication I referenced above, when T-cells are at or around 1000/ul. You can't have 10,800 lymphocytes and have PCP or a nervous system infection. It don't work that way.

So, it is always good to talk "science" with you on such a "upcoming" "intellectual" website. And no, I ain't A DOCTOR!

Cheers,

andrew

Posted by: Andrew Maniotis | June 7, 2007 1:23 PM

The Eliza-Jane case is sad because a tragic loss of a child was turned into a political football. It is clear that a second autopsy was done on the child with manufactured results for political reasons to intentionally discredit the political activities of the mother.

I agree with Andy Maniotis who has an excellent grasp of this issue, and is an excellent academic molecular biologist. Andy is absolutely correct. PCP requires immunosuppresion to produce pneumonia. A normal lymphocyte count precludes immunosupression and precludes a diagnosis of AIDS.

Andy is not alone in his questions regarding many of the common practices of medicine which are based more on financial gain than on good science.

Indeed, all of science has been up for sale to commercial and political interests for decades. HIV/Aids is merely one example of a pervasive problem. The proposition of treating a retroviral nucleotide base sequence after it has been incorporated into the host genome with cytotoxic drugs is not only wrong, it is ineffective and immoral.

If and when respectability returns to science will remain an open question.

Posted by: Andy's Defender | June 7, 2007 5:03 PM

"The Eliza-Jane case" there's no hyphen idiot, is tragic because if this child had gotten basic standard medical care she'd be alive today.
PLEASE.
If anyone says one more time a child can't die from PCP if they have high total lymphocytes I'm gonna scream so loud they'll hear me in the next province.
Here's something I copied from an article "Science Outsold" on AIDStruth, aidstruth dot org.:

Nevertheless, diagnostic differences do separate adult and pediatric criteria, and for good reason. Quantitatively and qualitatively--and including the response to HIV [74, 75]--the immune systems of infants and toddlers are different from those of older children and adults. It is thus not a particular surprise that an immunodeficient child might fall prey to diseases seen relatively rarely in the immunocompromised adult (and vice versa; see earlier discussion of KS). A pediatrician must be on the lookout for symptoms that might not appear in adults, hence several unique conditions are CDC criteria for a pediatric AIDS diagnosis [76]. Treatment recommendations are also different for young (i.e.

Here are the references.
74. Palumbo, P.E., et al., Predictive value of quantitative plasma HIV RNA and CD4+ lymphocyte count in HIV-infected infants and children. Jama, 1998. 279(10): p. 756-61.
75. Church, J.A., HIV disease in children. The many ways it differs from the disease in adults. Postgrad Med, 2000. 107(4): p. 163-6, 169-71, 175-6 passim.
76. CDC, 1994 Revised Classification System for Human Immunodeficiency Virus Infection in Children Less Than 13 Years of Age, 1994, CDC.
77. Urschel, S., et al., Withdrawal of Pneumocystis jirovecii prophylaxis in HIV-infected children under highly active antiretroviral therapy. Aids, 2005. 19(18): p. 2103-8.
78. Thea, D.M., et al., Benefit of primary prophylaxis before 18 months of age in reducing the incidence of Pneumocystis carinii pneumonia and early death in a cohort of 112 human immunodeficiency virus-infected infants. New York City Perinatal HIV Transmission Collaborative Study Group. Pediatrics, 1996. 97(1): p. 59-64.

There you have it. Kids can die of PCP even with total cell counts like EJ. Now can any of you three denialist out there give me a single report where a child died of Type IV reaction 48 hours after FIRST EXPOSURE EVER to ANYTHING?

PS, hey thanks for the comment on my age I wish I was still 20-something!

Posted by: Adele | June 7, 2007 5:30 PM

Wow. Sorry. I missed the little arrow. Let me try again.
Heres the whole thing.

"Nevertheless, diagnostic differences do separate adult and pediatric criteria, and for good reason. Quantitatively and qualitatively--and including the response to HIV [74, 75]--the immune systems of infants and toddlers are different from those of older children and adults. It is thus not a particular surprise that an immunodeficient child might fall prey to diseases seen relatively rarely in the immunocompromised adult (and vice versa; see earlier discussion of KS). A pediatrician must be on the lookout for symptoms that might not appear in adults, hence several unique conditions are CDC criteria for a pediatric AIDS diagnosis [76]. Treatment recommendations are also different for young (i.e. LESS THAN 6 year old) children. For example, whereas prophylactic treatment for fungal pneumonia is recommended for adults with CD4+ counts under 200/ul, it is encouraged even at higher CD4+ counts for children up to six years of age and for all HIV+ infants in the first year, regardless of CD4+ count. This is because the average young child has a much higher total number of CD4+ lymphocytes than the average adult. In contrast to adult disease, the "risk of developing PCP in this age group is only weakly dependent on the T-helper cell count" [77]. In other words, even children with "high" CD4+ T-cell counts can develop AIDS-defining conditions. One study of perinatally-infected infants found Pneumocystis carinii pneumonia (PCP) in a child with a total lymphocyte count of about 10,000 [78]; several other children with PCP also displayed higher-than-average counts."

Posted by: Adele | June 7, 2007 5:35 PM

Dear Adele,

I felt I needed to respond to your criticisms, and tried several times to post on the http://securebar.secure-tunnel.com/cgi-bin/nph-freebar.cgi/110110A/http/scienceblogs.com/aetiology/2007/04/well_isnt_this_interesting.php
site, but it kept saying "page not found." I saw that you also post on the Aeteology site, so I took a chance that you might see my response. You might want to inform Tara about the other site "isn't it interesting..." being unpostable. She won't respond to any info I send her.

First the info I relayed to you about Christine's inconsistent testing came from reference 3, her book. I have never seen her records, as she is quite private about that sort of thing, probably because she is perfectly healthy. But I have no reason to believe she would lie about her stigmatization and how it occurred over and over again during the 6 inconsistent tests.

Regarding your response to my post this morning: (and I have included refs that are from a much longer analysis I wrote when Eliza Jane died, so they don't begin at 1,2, and there is a gap-you can figure it out:

Nobody can claim to be an expert on adverse reactions to drugs: the science that studies them is at its infancy. However, it is widely appreciated that adverse reactions for all kinds of pharmaceutical interventions are under-reported, or aren't reported at all. No physician or hospital wants to be responsible for the tragic event that a prescription, meant to alleviate suffering, caused an adverse reaction or death of a patient. Yet the history of drug and vaccine trials show that responses to these and other medical interventions are always associated with unpredictable adverse responses, as the physiology of every human is different. When adverse reactions do occur, they may be difficult or impossible to pigeonhole as a stereotypical series of complications. Nevertheless, and despite under reporting, beta-lactam adverse reactions are frequently reported. Most doctors indeed ask, "are you or is your child allergic to penicillins or other antibiotics," before they are prescribed.

The World Health Organization puts the figure of adverse reactions to this class of drugs at around 0.7%-10%, depending on the nation studied (14).

In a 2000 case report, da Fonseca reported that (15):

"Penicillin is the drug that most often leads to allergic reactions and anaphylaxis. The incidence of adverse events triggered by penicillins is believed to be between 1% and 10%. Up to one-tenth of these episodes are life-threatening, with the most serious reactions occurring in patients with no history of allergy."

Investigators who study allergic reactions, such as Gomes et al., reported that: (16):

"The prevalence of self-reported drug allergy was 7.8% (181/2309): 4.5% to penicillins or other betalactams, 1.9% to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) and 1.5% to other drugs. In the group 'allergic to beta-lactams', the most frequently implicated drug was penicillin G or V (76.2%) followed by the association of amoxicillin and clavulanic acids (14.3%)."

"Women were significantly more likely to claim a drug allergy than men (10.2% vs. 5.3%). The most common manifestations were cutaneous (63.5%), followed by cardiovascular symptoms (35.9%). Most of the reactions were immediate, occurring on the first day of treatment (78.5%).

Out of 2409 spontaneous adverse event reporting from 1991-1996 in Bulgaria:

" 29% of the adverse drug reaction reports concerned the patients in the age groups of 0-5 year old, and amoxicillin is a drug with a majority of reports for the period" (17).

A group in Spain reported similar findings where amoxicillin caused the most adverse reactions (18).

So-called delayed reactions with amoxicillin are also frequent, and are a subject of intense investigation. For example, there is a developed literature on the subject with titles such as: "Diagnosing nonimmediate reactions to penicillins by in vivo tests" (19), "A diagnostic protocol for evaluating nonimmediate reactions to aminopenicillins" (20), "Diagnosis of nonimmediate reactions to betalactam antibiotics" (21), "Role of delayed cellular hypersensitivity and adhesion molecules in amoxicillin-induced morbilliform rashes" (22), "Nonimmediate reactions to betalactams: prevalence and role of the different penicillins" (23), "In vitro T-cell responses to beta-lactam drugs in immediate and nonimmediate allergic reactions" (24), "Skin test evaluation in nonimmediate allergic reactions to penicillins" (25), "Two cases of toxic epidermal necrolysis caused by delayed hypersensitivity to beta-lactam antibiotics" (26), "Immediate and delayed hypersensitivity from penicillin (27), "Incidence of beta-lactam-induced delayed hypersensitivity and neutropenia during treatment of infective endocarditis" (28).

Nevertheless, in their allopathic training, most medical students are only taught that "a true amoxicillin allergic reaction" is rapid and stereotypic, would present as tachycardia and produce its symptoms within seconds or minutes instead of hours or days, and would be rapidly reversible by administration of epinephrine. This misinformation ignores the developed literature on delayed hypersensitivity reactions indicated above. The weight of Eliza Jane's heart as reported by the ME at autopsy was 131% of normal. This evidence of ventricular hypertrophy (or edema) is best attributed to loss of pressure due to loss of fluid over a period of hours from the capillaries in the heart, and subsequent widely observed compensation by the heart muscle to pump more fluid. It also ignores the likelihood that electromechanical dissociation (EMD), may have been responsible for the slowed rhythms of her heart and the pulseless state that were noted by the ER staff (rather than tachycardia), in association with hypotensive multiple organ failure accompanying massive edema (loss of fluid from the vasculature). If there is significant loss of blood volume from the vasculature, because 40% of it has leaked out into the tissues due to the toxic effects of amoxicillin, and if the vasculature continues to be permeable, as indicated by the measurements of Eliza Jane's abnormal organ weights, then as long as the antibiotic was present and inducing a series of reactions leading to vascular permeability, it wouldn't matter if the heart was restarted or even working normally, or how much IV solution she was infused with. This hypothesis is supported by the fact that although the ER treatments of epinephrine transiently stimulated the heart to beat on several occasions, before she was given more antibiotics of an undisclosed type at the hospital, and presumably more IV's, the multiple boluses of epinephrine couldn't stabilize her heart for very long, or restore normal blood pressure or normal pulse. The IV fluids repeatedly administered could have killed her by continuing to swell her heart as they leaked out, causing EMD, and drowning her lungs (and kidneys) with extravasated proteins and fluids leaked from the vasculature. However, the fact that her abdomen and liver were protruding by the time she arrived at the ER may have meant that she had already leaked too much fluid from her own vasculature to ever recover normal vascular blood volume, even before the multiple IV's were administered, principally from the delayed adverse reaction to the amoxicillin itself (2):

"On May 14th, in a follow-up visit, one of the physicians found that her lungs were clear, but noted redness in addition to fluid in her right eardrum. He prescribed 400mg of amoxicillin twice a day to the beta-lactam-naïve child" (1).

"After the third dose of amoxicillin, she vomited several times, and she became agitated. Her mother noticed that her face became pale, her arms changed color and were cold to the touch. She became lethargic and ran a low fever. Then she fell unconscious and stopped breathing, and no pulse could be felt by the emergency team or by the admitting physicians" (2). (Do you think this is consistent with the kind of morbidity typically observed by children who are running around happy and healthy hours before and die of "AIDS?")

"The Los Angeles City Fire Department RA 239 was dispatched on May 16th at 0003 and arrived at Eliza Jane's home at 0006 (1,2). Upon the paramedic's arrival, Eliza Jane was found pulseless and apneic on the floor. She was cyanotic with cold extremities and asystolic on the cardiac monitor."

"Eliza Jane was presented at the emergency room of Valley Presbyterian Hospital at 0026 on May 16th. On arrival, she was pulseless, had no spontaneous respiration, and appeared very pale. Her pupils were mid position and fixed."

"The treating physician examined Eliza Jane and found that her abdomen and her liver were distended. Her extremities were cold and poorly perfused with non-palpable pulses. Her oral mucous membranes were pink and there was a lesion on her lower lip."

"At 0105 her heart rate began to slow down into the 40-60 b/min range and she did not have a papable pusle. CPR was restarted. She was bagged with 100% O2 and given high dose epinephrine 1.3mg, atropine 0.26 mg, and sodium bicarbonate 13 mEq. Her heart rate began to increase, it came up to 113 b/minute, and she had a palpable pulse."

"At 0137, no blood pressure could be obtained and Eliza Jane was started on dopamine drip at 5 microgram/kg per hour. Her blood pressure reached to 41/28 and was taken to CT scan. While in CT scan, she had another episode of asystole and she was given atropine, and sodium bicarbonate. She developed a pulse again and was transferred to the Pediatric ICU."

"At the PICU, her heart rate reached approximately 120b/min but she did not have a pulse. She was given fluid boluses, as well as being placed on dopamine 10 microgram/kg/hour and dobutamine 10 microgram/kg per hour. She did not have a pulse and her blood pressure was not obtainable in spite of these treatments. She was also started on antibiotics."

(Jesus H. Christ-I guess people have a lot of faith in antibiotics-that they can reverse cardiac arrest! I wonder what antibiotic they gave her in the ICU????)

The type of antibiotic given in the PICU is not disclosed, but is of concern, given that Eliza Jane presented with classic signs, and a package-insert-perfect description of an adverse reaction to amoxicillin, rather than end-stage AIDS, as stated by the Medical Examiner's office.

Amoxicillin package inserts (29) describe most if not all the reactions manifested by Eliza Jane in their warnings (I have underlined the adverse events manifested by Eliza Jane as described by her parents, the hospital, and the coroner's report)."

Beta lactam antibiotics-
Anaphylactic reactions manifested by urticaria, flushing, pruritus, laryngeal edema, and cardiovascular collapse may occur within minutes or, less frequently, hours after administration of beta lactam antibiotics (ie, drugs that have a common beta lactam ring structure)."

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Gastro-intestinal side effects including diahrroea, nausea and vomiting may occur quite frequently. Pseudomembranous colitis has also been reported.Super-infection is relatively common. Doses should be reduced in severe renal failure.

Nausea and vomiting occurred after Eliza Jane's second dose of amoxicillin. Eliza Jane's kidneys were measured at 146% of normal, without significant damage exhibited microscopically, consistent with massive edema and recent injury.

"The most feared adverse events attributed to beta-lactam antibiotics are IgE type I immediate or accelerated reactions. These develop within minutes to hours of drug administration and cause hypotension, laryngeal edema or bronchospasm. Such reactions occur when patients with preformed beta-lactam-specific IgE antibodies, which are bound to tissue mast cells and circulating basophils, are exposed to the drug or tissue protein complex, resulting in the release of inflammatory mediators."

"Unpredictable reactions occur independent of the dose and route of administration and reflect such factors as drug intolerance, allergy, and other idiosyncratic responses. These reactions seem to preferentially affect certain body systems, most commonly blood, skin, and liver."

Eliza Jane's bood work was abnormal to the extent that she was profoundly anemic and exhibited a low hematocrit (Her hemoglobin and hematocrit counts were low (6.3 g/dl instead of 12-16g/dl, and 21% instead of 37-48%, respectively). (2). Her neutrophils were measured at 12% (normal=45-74%) (2). Her monocyte percentage was in the normal range at 8% (normal is 4-10%) and her platelet count (214 k/µl) was in the normal range (130 k/µl -400 k/µl) (2).

And as indicated on the amoxicillin package insert:

"Additional unique life-threatening reactions caused by beta-lactam antibiotics are referred to as "late" reactions. They include such events as hemolytic anemia, Stevens-Johnson syndrome, and exfoliative dermatitis."

Her liver findings were abnormal as well: Eliza Jane autopsy showed liver changes consistent with an immune reaction to amoxicillin, which in some cases of acute toxicity has been noted to resemble pregnancy-fat-like-accumulation and steatosis (30-33).

It is also now emphasized during the early training of many clinicians, as well as in the literature (16), that the effects of amoxicillin on the liver are usually only found when used with another drug, clavulanate, but this misinformation is not supported by the primary literature in Medline: there are many reports that indicate the rate of acute reactions occur in multiple cohorts of patients who were studied for amoxicillin versus amoxicillin-clavulanate reactions, and both appear quite frequently, judging by the number of reports. Perhaps the most comprehensive report that surveys the growing literature on the subject of amoxicillin versus amoxicillin/ clavulanate is presented by Berg et al, and in connection to both fatal and non-fatal adverse reactions to amoxicillin/amoxicillin clavulanate, which they claim typically occur after antibiotic therapy was discontinued, and serves to reinforce the idea that none of these drugs can be considered as safe, even after they are withdrawn (34).

Eliza Jane was never administered any skin allergy tests for amoxicillin, which may have been a wise thing to do, for a bata-lactam-naïve child. Even so, there have even been references to amoxicillin-induced death when cutaneous sensitivity tests to the beta-lactam drugs are given at allergy testing doses (which are extremely small doses) to determine if someone is allergic to these drugs, before giving them a full dose (35).

One group of allergists have even postulated the technical term "flare-up" to describe these kind of delayed reactions as a Type IV mechanism, and described the difficulty in typifying these kinds of reactions. As stated by Reig Rincon de Arellano I et al., (36).

" We suggest that this phenomenon of Flare up occurs by a Type IV mechanism mediated by T-cells without participation of IgE antibodies. The betalactam hypersensitivity mechanism which has usually been described is an IgE mediated reaction, but there are other not very well known mechanisms that are responsible for the delayed reactions."

And yes, I would doubt Einstein, God, and James Watson if they didn't provide evidence for their claims. Why should I be any less critical about the junk science you call "HIV/AIDS?" You might want to check out a paper I wrote in 1998 regarding the non-activity of "HIV" integrase in a toposomerase study (Because of the extreme censorship of us by the AIDS establishment, I had to bury the "HIV" non-result to get the damn thing published as a negative control for DNA minor groove binding). Also, you might want to read Gallo's book, Virus Hunting, where it describes my former boss, Judah Folkman's dismissal of the fact that Kaposi's sarcoma couldn't have anything to do with "HIV."

Ah, those were the days when it all was still innocent. Well, it ain't innocent anymore. You all have had ample warnings and questions from "deluded" folks like me, Robert Root-Bernstein, Karry Mullis, Walter Gilbert, Lynn Margulis, Michael Lange, Stephan Lanka, Val Turner, about 3000 scientists, physicians, and others (on Crowe's website that signed a rather long document), and oh, how could I forget, Peter Duesberg and his correct mistake regarding the existence of "HIV," and the predictions he made that have all come true (I heard him lecture on it for the first time in 1985 in our departmental weekly seminar, and I was horrified as were many of us at Berkeley, at his suggestion that AIDS is not caused by a human retrovirus.

Regards,

andy

1. Autopsy report (Case No 2005-0367), Department of Coroner, Los Angeles California. September 15, 2005.

2. Medical record # 856441, Valley Presbyterian Hospital, 15107 Vanowen Street, Van Nuys, Ca, 91404.

3. Christine Maggiore. What if everything you thought you knew about AIDS was wrong? American Foundation for AIDS Alterntives. 4th Printing, 2000.

14. Bull World Health Organ. 38(2):159-88, 1968.

15. da Fonseca Pediatr Dent. Adverse reaction to amoxicillin: a case report. Sep-Oct;22(5):401-4, 209, 2000.

16. Gomes et al. Self-reported drug allergy in a general adult Portuguese population. Clin Exp Allergy. Oct;34(10):1597-601, 2004.

17. Getov I, Dimitrova Z. Antibacterials: spontaneous report analysis for a six years period in Bulgaria. Boll Chim Farm. Apr;138(4):186-90, 1999.

18. Minguez MA, Zapatero L, Caloto M, Martinez-Molero MI. A study of allergy to penicillin antibiotics in 1995 in the Child Allergy Department of the Gregorio Maranon University hospital. Allergol Immunopathol (Madr). Mar-Apr;26(2):43-6, 1998.

19. Romano A, Viola M, Mondino C, Pettinato R, Di Fonso M, Papa G, Venuti A, Montuschi P.Int Arch Allergy Immunol. Diagnosing nonimmediate reactions to penicillins by in vivo tests. 1: Int Arch Allergy Immunol. Oct;129(2):169-74, 2002.

20. Romano A, Quaratino D, Di Fonso M, Papa G, Venuti A, Gasbarrini G.A diagnostic protocol for evaluating nonimmediate reactions to aminopenicillins. J Allergy Clin Immunol. Jun;103(6):1186-90, 1999.

21. Romano A, Blanca M, Torres MJ, Bircher A, Aberer W, Brockow K, Pichler WJ, Demoly P; ENDA; EAACI. Diagnosis of nonimmediate reactions to beta-lactam antibiotics. Allergy. Nov; 59(11):1153-60, 2004.

22. Barbaud AM, Bene MC, Schmutz JL, Ehlinger A, Weber M, Faure GC. Role of delayed cellular hypersensitivity and adhesion molecules in amoxicillin-induced morbilliform rashes. Arch Dermatol. Apr;133(4):481-6, 1997.

23.Terrados S, Blanca M, Garcia J, Vega J, Torres MJ, Carmona MJ, Miranda A, Moya M, Juarez C, Fernandez J. Nonimmediate reactions to betalactams: prevalence and role of the different penicillins. Allergy. Jul;50(7):563-7, 1995.

24.Luque I, Leyva L, Jose Torres M, Rosal M, Mayorga C, Segura JM, Blanca M, Juarez C. In vitro T-cell responses to beta-lactam drugs in immediate and nonimmediate allergic reactions. Allergy. Jul;56(7):611-8, 2001.

25.Torres MJ, Sanchez-Sabate E, Alvarez J, Mayorga C, Fernandez J, Padial A, Cornejo-Garcia JA, Bellon T, Blanca M. Skin test evaluation in nonimmediate allergic reactions to penicillins. Allergy. Feb;59(2):219-24, 2004.

26. Romano A, Di Fonso M, Pocobelli D, Giannarini L, Venuti A, Garcovich A; Two cases of toxic epidermal necrolysis caused by delayed hypersensitivity to beta-lactam antibiotics. J Investig Allergol Clin Immunol. Jan-Feb;3(1):53-5, 1993.

27. Fernandez de Corres L, Lobera I, Munoz D. Immediate and delayed hypersensitivity from penicillin. Contact Dermatitis. Mar;14(3):194-5, 1986.

28. Olaison L, Belin L, Hogevik H, Alestig K. Incidence of beta-lactam-induced delayed hypersensitivity and neutropenia during treatment of infective endocarditis. Arch Intern Med. Mar 22;159(6):607-15, 1999.

29. Amoxicillin Package inserts:
-Part 2: Summary Statements Evidence-Based Commentary - VII. Prototypes Of Immunologically Mediated Drug Hypersensitivity Ann Allergy 1999; 83:S665-S700
www.jcaai.org/pp/dh_7_prototypes.asp

30. Hautekeete ML Hepatotoxicity of antibiotics. Acta Gastroenterol Belg. May-Aug;58(3-4):290-6, 1995.

31. George DK, Crawford DH. Antibacterial-induced hepatotoxicity. Incidence, prevention and management.Drug Saf. Jul;15(1):79-85, 1996.

32. Brown SJ, Desmond PV. Hepatotoxicity of antimicrobial agents.
Semin Liver Dis. 22(2):157-67, 2002.

33. Liu ZX, Kaplowitz N. Immune-mediated drug-induced liver disease. Clin Liver Dis. Aug;6(3):755-74, 2002.

34.Berg P, Hahn EG. Hepatotoxic reactions induced by beta-lactamase inhibitors. Eur J Med Res. Dec 17;6(12):535-42, 2001.

35. Valyasevi MA, Van Dellen RG. Frequency of systematic reactions to penicillin skin tests. Ann Allergy Asthma Immunol. Nov;85(5):363-5), 2000.

36. Reig Rincon de Arellano I, Villalon Garcia A, Cimarra Alvarez-Lovell M, Robledo Echarren T, Martinez-Cocera M. Allergol Immunopathol. Flare up to betalactams. Sep-Oct;33(5):282-4, 2005.

Posted by: Andrew Maniotis | June 7, 2007 5:41 PM

Dear Adele,

The article (78) you quote which you feel supports your argument that PCP can occurr in children with normal lymphocyte counts does not in fact support your case.

The study was done on children of DRUG ADDICTS.

The mother of Eliza Jane was NOT a DRUG ADDICT.

This is a very large discrepancy.

In fact, all the studies of pediatric HIV/AIDS are done on drug addict mothers. The children of drug addicted mothers have a high mortality during the first 6 months of life because they are born from DRUG ADDICTS.

So Adele, before you call anyone else an idiot, call yourself one. Look it up.

78. Pediatrics. 1996 Jan;97(1):59-64. Benefit of primary prophylaxis before 18 months of age in reducing the incidence of Pneumocystis carinii pneumonia and early death in a cohort of 112 human immunodeficiency virus-infected infants. New York City Perinatal HIV Transmission Collaborative Study Group. Thea DM, Lambert G, Weedon J, Matheson PB, Abrams EJ, Bamji M, Straus WL, Thomas PA, Krasinski K, Heagarty M.

Posted by: Andy's Defender | June 7, 2007 6:43 PM

Dr. Maniotis,

You are far too gracious in your response to Adele. She's basically just an internet twit, who has done no serious scientific research on any topic, and wastes much of her time twiddling around on the internet.

Don't sweat it.

But, one question: Is there evidence of any girls dying from the HPV vaccination?

Posted by: Keven Tanna | June 7, 2007 7:35 PM

Dear Keven,

Please see the following:
Cheers,

Andy, the Homeopathologist (thanks Chris Noble! What a great title! Beats my current one for sure).

For Immediate Release
May 23, 2007 Contact: Press Office
202-646-5188

Judicial Watch Uncovers Three Deaths Relating to HPV Vaccine

Event Reports Obtained from FDA Detail 1,637 Adverse Reactions to Gardasil

(Washington, DC) -- Judicial Watch, the public interest group that investigates and prosecutes government corruption, today released documents obtained from the U.S.
Food and Drug Administration (FDA) under the provisions of the Freedom of Information Act, detailing 1,637 reports of adverse reactions to the vaccination for
human papillomavirus (HPV), Gardasil. Three deaths were related to the vaccine.
One physician's assistant reported that a female patient "died of a blood clot three
hours after getting the Gardasil vaccine." Two other reports, on girls 12 and 19,
reported deaths relating to heart problems and/or blood clotting.

As of May 11, 2007, the 1,637 adverse vaccination reactions reported to the FDA via
the Vaccine Adverse Event Reporting System (VAERS) included 371 serious reactions.
Of the 42 women who received the vaccine while pregnant, 18 experienced side effects
ranging from spontaneous abortion to fetal abnormities.

Side effects published by Merck & Co. warn the public about potential pain, fever,
nausea, dizziness and itching after receiving the vaccine. Indeed, 77% of the
adverse reactions reported are typical side effects to vaccinations. But other more
serious side effects reported include paralysis, Bells Palsy, Guillain-Barre
Syndrome, and seizures.

"The FDA adverse event reports on the HPV vaccine read like a catalog of horrors,"
stated Judicial Watch President Tom Fitton. "Any state or local government now
beset by Merck's lobbying campaigns to mandate this HPV vaccine for young girls
ought to take a look at these adverse health reports. It looks as if an unproven
vaccine with dangerous side effects is being pushed as a miracle drug."

Judicial Watch filed its request on May 9, 2007, and received the adverse event
reports from the FDA on May 15, 2007. Judicial Watch has posted the adverse event
reports below.

(A recent study, published in the New England Journal of Medicine, also questioned
the general effectiveness of Gardasil.)

###

Click here to
view the Garadsil Related Deaths Reported to VAERS as of May 11, 2007

Click here to
view the Vaccine Adverse Event Reporting System (VAERS)

On July 14th the first report of a serious reaction to the vaccine was filed with the federal Vaccine Adverse Event Reporting System (VAERS). A 16-year-old Illinois girl was vaccinated July 7th and 13 days later developed symptoms eventually diagnosed as Guillian-Barre Syndrome. A 14-year-old girl in the District of Columbia was vaccinated on July 11th and complained of severe pain immediately following the injection, fell off the examining table and experienced a 10 to 15 second fainting spell ending up in the emergency room with a headache and speech problems. The report of this reaction, the first in the nation, was filed on July 14th, 15 days after the ACIP vote.

Six months later, 82 reports of GARDASIL reactions have been submitted to VAERS on behalf of at least 84 young girls and 2 boys.[1] Reaction reports have come in from 21 states and the District of Columbia.[2] Reactions were reported for children and young adults ranging in age from 11 to 27. Of the reports indicating what day the vaccine was given and the reaction occurred, 63 percent stated that the reaction occurred the same day the vaccine was given. All but three of the reports were for reactions that occurred within one week of vaccination.

This document is divided into three sections. The first section describes reaction reports for a number of reported adverse events: neurological symptoms including syncopal episodes and seizures, arthralgia and joint pain, Guillian-Barre Syndrome, and other immunological reactions. The second section addresses concerns related to vaccinating individuals already infected with HPV. The last section discusses issues that need to be
addressed by government regulators and the manufacturer and considerations for clinicians and consumers.

Reported Adverse Events

Presumably, the reactions described below occurred after the first dose of GARDASIL. GARDASIL is given in a three-dose series. None of the reports stated that the children and adults experiencing problems had previously been vaccinated with GARDASIL.

Syncopal Episodes and Seizures. One-quarter of all reports filed after GARDASIL vaccination were for neurologic adverse events including loss of consciousness, syncope, syncopal events and seizures. An additional five reports included symptoms of dizziness and feeling faint.

Syncope is defined as a temporary suspension of consciousness due to generalized cerebral ischemia (inadequate blood flow and lack of oxygen). The reports of syncopal episodes and their descriptions are remarkable. A physician from Washington State reported that in one morning, three patients experienced syncopal episodes. On August 8th another physician's office reported that two patients experienced syncopal episodes on the same day.

Although these reports did not detail what happened to the individuals experiencing these syncopal episodes, other reports did. The 14-year-old DC girl mentioned earlier experienced a syncopal episode combined with amblyopia (poor vision in one eye), abnormal speech, vomiting, and headache. Also experiencing vision problems, a 17-year-old New York girl reported feeling dizzy and her vision went "black for a few seconds" and she turned pale and lips turned purple and she also had fever and chills. Similar to
the DC girl, on July 18th immediately after being vaccinated, a 22-year-old Kentucky woman experienced slurred speech accompanied by pallor and shock. On August 29th, two hours after being vaccinated, a 15-year-old New York girl who had a history of asthma and was on four asthma medications experienced difficulty swallowing prompting a visit to the emergency room. On August 17th, 15 minutes after being vaccinated, a 14-year-old Pennsylvania girl passed out in the car on the way home.

Most of the reports do not describe what happened as a result of the syncopal episode but a few do. One 11-year-old Florida girl fell from the examining table and two Washington girls fell - a 16-year-old girl fell and hit her head on a carpeted concrete surface and a 14-year-old girl fell down and broke her nose.

Whether the 22 girls who experienced syncopal episodes actually experienced atonic seizures cannot be determined from these reports. Four girls, however, displayed observable seizure activity. The 11-year-old Florida girl who fell from the table also displayed "tonic posturing." Tonic posturing is a type of seizure where sustained contraction of muscles in the legs and arms occurs and consciousness is impaired. The 16-year-old Washington girl who fell and hit her head on the floor lost consciousness for one minute and displayed tonic posturing of her right hand. Additionally, a 15-year-old
girl from Virginia was described as having "a mild seizure." In California, a 13-year-old girl was walking down the hall after her vaccination, fell and had a 15-second tonic/clonic seizure. Tonic/clonic seizures are also known as "grand mal" seizures.

Additionally, there were reports of dyskinesia (difficulty or distortion in performing voluntary movements) and hypokinesia (slow or diminished movement of the body musculature) both of which have neurological implications.

Arthralgia, Joint Pain and Fever. Arthralgia is defined as pain in the joints. Concerns about arthritis were raised during the GARDASIL clinical trials. Reports of arthralgia in one or more joints accompanied by fever were noted in five instances from four young girls and women in Wisconsin, Texas and New York, and one 18-year-old New York male.

Guillain-Barre Syndrome. Reports state that two recently vaccinated 16-year-old girls - one from Illinois and the other from Mississippi - were diagnosed with Guillian-Barre Syndrome (GBS) following vaccination with GARDASIL. In both cases, the onset of symptoms occurred 13 days after vaccination. According to the National Institute for Neurological Disorders and Stroke:

GBS is a serious disorder in which the body's immune system attacks part of the peripheral nervous system. The first symptoms of this disorder include varying degrees of weakness or tingling sensations in the legs. In many instances, the weakness and abnormal sensations spread to the arms and upper body. These symptoms can increase in intensity until certain muscles cannot be used at all and, when severe, the patient is almost totally paralyzed. ... Vaccinations can trigger onset of GBS.

The Illinois girl described earlier was vaccinated on July 7th and symptoms were evident by July 20th. The girl also experienced gait abnormalities (trouble walking properly), asthenia (weakness without loss of strength), paresthesia (burning, prickling, tingling or numbness sensation usually felt in the hands, arms, feet and legs), and hyperkinesia (abnormal increase in muscle movement). The Mississippi girl was vaccinated on July 31st and by August 13th she had increasing numbness and tingling in her feet and hands
and was subsequently evaluated by a neurologist and diagnosed with GBS. The current health status of these girls is not known.

In both of these cases, the girls were also vaccinated with Aventis Pasteur's Menactra, a vaccine for meningococcal infections. Menactra has previously been associated with Guillain-Barre Syndrome, and the FDA and others have issued alerts.

Other Adverse Reactions.

Additionally, a number of other reactions to GARDASIL are noted in VAERS reports and they include: urticaria (hives); pruritus (itching); macular and papular rashes; blisters and vesicles near the injection site; swollen arms; lymphadenopathy (swollen lymph nodes); red, hot swollen knots at injection site; burning, stabbing, severe and
radiating pain at the injection site and in the affected limb during and after injection; nausea and vomiting; infections and skin ulcers, and other allergic reactions.

Other Considerations

GARDASIL is marketed as a "cervical cancer vaccine" and intended to prevent infection with specific HPVs - common viruses among sexually active women. It isn't clear what benefits or potential harms could arise from vaccinating sexually active women who have already contracted HPV. Of the 86 reaction reports filed with VAERS so far, 12 reports were generated by young women 18 and older who were taking hormonal contraceptives and presumably sexually active.

With respect to concerns related to vaccinating women with known HPV infections, adverse reaction reports were filed on behalf of a 17-year-old Texas girl who was already diagnosed with HPV and genital warts. Similarly, the 22 year-old Kentucky woman who experienced slurred speech following vaccination already had an abnormal pap smear with evidence of cervical dysplasia.

Implications

The early reports of potential safety problems with GARDASIL raise concerns and questions that need to be addressed by government regulators, manufacturers and prescribing physicians. Specifically, the following concerns need to be addressed:

1. Syncope, seizures and Guillian-Barre Syndrome have now beenreported with hours to a week after GARDASIL vaccination. GARDASIL manufacturer, Merck, should add these serious adverse events to the product manufacturer insert.

2. Considering that over 20 girls have experienced syncopal episodes sometimes combined with seizures and serious injuries, physicians should consider only giving GARDASIL when the patient is safely laying down on the examining table. Because there seems to be syncopal reactions up until 15 minutes after vaccination, patients should be asked to lie down for 15 minutes after receipt of GARDASIL.

3. The information provided by Merck indicates that it is safe to administer GARDASIL with Hepatitis B vaccine. The prescribing information states, "Results for clinical studies indicate that GARDASIL may be administered concomitantly (at a separate injection site) with hepatitis B vaccine (recombinant). Co-administration of GARDASIL with other vaccines has not been studied." Due to the small number of girls aged 9 to 15 who appear to have been evaluated for GARDASIL safety in Merck clinical trials
(fewer than 2,000) and lack of publicly available information about how many of these girls were given GARDASIL and hepatitis B vaccine simultaneously, the safety of administering GARDASIL and hepatitis B vaccine to all pre-adolescent girls is uncertain.

4. Aside from Hepatitis B, Merck does not state that it is safe to simultaneously administer GARDASIL with any other vaccine. Considering that there are ongoing evaluations of a reported association between Menactra (meningococcal vaccine) and Guillain-Barre Syndrome, and Merck does not explicitly indicate that it is safe to administer to administer GARDASIL and Menactra simultaneously, consumers and clinicians should question whether administering both GARDASIL and Menactra at the same time is safe.

5. Similarly, adverse reactions were reported when GARDASIL was administered with eight other vaccines: Hepatitis A, MNQ (?), MEN (Menactra), TD (Tetanus and Diptheria Toxoids), DPP (Diptheria/Pertussis/Polio), PNC Prevnar (Heptavalent pneumococca conjugate), DTaP (Diphtheria And Tetanus Toxoids and Acellular Pertussis Vaccine), and TDAP (Tetanus, Diptheria and Pertussis). Because Merck does not state that it is safe to administer simultaneously GARDASIL with any vaccine other than Hepatitis B, consumers and clinicians should question whether co-administration of GARDASIL and other vaccines is safe.

6. Most, if not all, of the reactions reported to VAERS were in response to the first of the three doses of GARDASIL. The Centers for Disease Control (CDC) Vaccine Information Sheet (VIS) developed for HPV vaccine states that severe reactions include "any unusual condition, such as a high fever or behavior changes. Signs of a serious allergic reaction can include difficulty breathing, hoarseness or wheezing, hives, paleness, weakness, a fast heart beat or dizziness." The CDC also states that "anyone who has ever had a life-threatening allergic reaction to yeast, to any other component of HPV vaccine, or to a previous dose of HPV vaccine should not get the vaccine." Which of the reactions reported to VAERS constitute a "life-threatening allergic reaction" and which, if any, of the children and young adults who experienced reactions should receive additional doses of vaccine? At the October 2006 ACIP meeting, CDC staff stated that only "three serious reports were reported to VAERS after HPV vaccination in females 14 and 16 years of age. One of these patients had vasovagal syncope and was hospitalized overnight for observation." [7]CDC's summary of the first 76 VAERS reports suggests that CDC doesn't regard the remaining reports as "serious." CDC needs to clarify which of the reactions reported to VAERS constitute contraindications to further vaccination with GARDASIL and make this information available to the public and to prescribing physicians.

7. What were the short and longer-term outcomes for the individuals who experienced the reactions reported to VAERS? Is there information available that would help to predict the characteristics that predispose one to be at greatest risk of experiencing a serious reaction?

8. The CDC's Vaccine Information Sheet indicates that allergy to yeast is a reason to avoid taking GARDASIL. Merck notes that contraindications to the vaccine include "hypersensitivity to the active substances or to any of the recipients of the vaccine. Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of GARDASIL should not receive further doses of GARDASIL." The prescribing information provided by Merck does not specifically note that yeast allergy is a contraindication to taking GARDASIL. Government regulators and the manufacturer need to address the discrepancy between these documents and clarify the issues related to yeast allergy and make this information readily available to the public and prescribing physicians.

9. Additionally, Merck notes that vaccine ingredients include 225 mcg of aluminum (as amorphous aluminum hydroxyphosphate sulfate adjuvant), 0.78 mg of L-histidine, 50 mcg of polysorbate 80, and 35 mcg of sodium borate. These ingredients are not listed on the CDC's VIS sheet. The public needs this information so that they can identify whether they have "hypersensitivities" to any of the ingredients and whether they are at risk of experiencing a serious allergic reaction. Hypersensitivities and known allergic reactions are critical pieces of information that need to be communicated to prescribing physicians in order to make the safest possible vaccination decisions.

Government regulators including the CDC and FDA, in combination with Merck, should address the above safety concerns as soon as possible. Medical groups advocating use of GARDASIL should effectively communicate to physicians and patients the potential risks of using GARDASIL along with precautions to improve the safety of patient care.

Posted by: Andrew Maniotis | June 8, 2007 1:14 AM