By Pompilio Martinez, MD
Alumnus, School of Medicine, National University of Colombia
Ex-investigator, Colombian National Institute of Health, Bogota, Colombia
EXECUTIVE SUMMARY (Versión en Español aquí).
The University of Cartagena conducted a clinical study on 283 female adolescents of 16 years of age (average) chosen from a total of 971 participants who developed adverse events after vaccination with Gardasil in El Carmen de Bolívar during 2013-2014. Five pediatricians made the clinical evaluation of 283 adolescents consistent of an anamnesis (recall and narrative of symptom history plus Review of Systems) and a physical examination. Even though most participants complained of severe abnormalities, more than half of them (52.7%) were ruled ‘healthy’ because their physical examinations were normal. None of the presumptive diagnoses were informed nor analyzed except for 50 patients referred for nutrition and mental health complaints. For physical complaints, the anamnesis was ignored, all weight was placed on the physical examination that was inadequate to reveal the disorders suggested by anamneses. The physical examination was of the cursory type used to detect obvious abnormalities that need immediate attention like those typical of people who attend an emergency room with abnormal vital signs, loss of conscienceness or abnormal behavior, sustained loss or worsening of neurological, cardiovascular, respiratory or musculoskeletal functions, or situations that threaten life. – No effort was made to uncover abnormalities suggested by history through a chronic disease approach of eliciting clinical signs such as syncope in a controlled environment. In fact, adolescents with a history of syncope, some who fainted and had seizures in the presence of researchers themselves, also received the diagnosis of ‘healthy patient’. There were zero (0) referrals to cardiology even though 84.4% of the sample complained of syncope. Zero. Referrals were only to psychology (20), psychiatry (10) and nutrition (20) using questionable or erroneous criteria in the majority. None of the relevant laboratory, imaging or specialized testing were carried out to investigate diseases suggested by history, and those performed did not follow a differential diagnosis and thus were inconsequential. Likewise, tests done were irrelevant for this population with vaccination history and likely autoimmune disease, for which there are excellent international publications and prior population-specific data that facilitated a more focused approach. Similar to the outbreak study carried out by the Colombian National Institute of Health in 2014, this 3-4 year follow-up study was designed to broadly implicate irrelevant variables, to fail to make key observations, to be inconclusive, and to leave the impression of mental disorders among victims damaged by Gardasil. ♦
A friend of mine kindly emailed me a study carried out by the University of Cartagena titled “EVALUATION OF THE EFFECTS OF THE VACCINATION PROCESS AGAINST THE HUMAN PAPILLOMA VIRUS IN ADOLESCENTS FROM BOLIVAR” funded by state government of Bolivar in Colombia. I enthusiastically read it and now that I’ve looked at it more than once, I’d like to share my views in case somebody might benefit. I have tried to be succint.
The following evaluation was done to answer the question of whether the study carried out by the University of Cartagena has made advances to solve the health needs of hundreds of adolescents who developed serious and severe adverse events after being vaccinated with Gardasil in the Caribbean town of Carmen de Bolivar. The following evaluation is based on the 108-page report without attachments dated April 2018. Click to download the report in Spanish (Informe niñas de El Carmen).
This summary was translated from Spanish, which accompanies a longer critique on the Universidad de Cartagena study.
Report contents. Chapter 1 touches on generalities about the human papilloma virus (HPV) and the Gardasil vaccine. Chapter 2 covers adverse events reported in the medical literature and international databases due to vaccination with Gardasil and Cervarix. Chapter 3 recounts historical events that unfolded during the implementation of vaccination programs in the country and its impact on Carmen de Bolívar. Chapter 4 is an opinion survey in two towns about people’s views on the vaccination program. Chapter 5 is the clinical study summarized in this op-ed. Chapter 6 is their concluding remarks. This executive summary / op-ed only focuses on their clinical research (Chapter 5 & 6).
Research group: The investigators are specialists in evaluating the environmental impact of coal and gold mining in Colombia through toxicological, environmental, chemical and computational approaches. They had never worked on vaccine adverse events and their main contribution to Colombia has been to demonstrate the need to protect biodiversity. Researchers do not have background in immunology, neurology or cardiovascular disease, which are the medical specialties that can best respond to the needs of this community. None of the researchers is a physician or a pediatrician. –
Study subjects: The researchers developed a consolidated database of 971 female individuals from Carmen de Bolívar who were vaccinated with Gardasil and became ill in 2013-2014. From there, a sample of 283 adolescents was selected, who 71% (200) were chosen randomly and the remaining 29% (83) were chosen because they were severely ill according to the community. The average age was 16.2 years (2.2 standard deviation) of which 86.2% received two or more doses of Gardasil and the remaining 13.8% received a single dose.
Clinical evaluation. Five (5) pediatricians were hired to interview and examine the sample of 283 female adolescents. In that context, a Review of Systems was done (table 5.6) in which the following symptoms stand out:
- 90% had chest pain
- 86.6% had shortness of breath (dyspnea)
- 84.5% had syncope
- 72.8% had palpitations
- 67.5% had muscle pain
- 64% had arthralgia
- 49.1% had gait disturbances
- 45.9% reported vision loss, among a long list of other symptoms.
Although their symptoms revealed severe disease of multiple organ systems, investigators ruled more than half (52.7%) of teenage girls as ‘healthy patients’ because they had a negative physical examination (Fig 5.2, page 77). That is, their individual presumptive diagnoses relied heavily on physical examination that was normal in about half of the sample and so they were diagnosed as ‘healthy’. Their complaints in the anamnesis portion of the clinical encounter were totally disregarded. This is a serious caveat because physical examinations were rather perfunctory and were aimed to detect major deviations in physical health as if patients were being admitted to an emergency room / trauma center. No differential diagnosis is considered, and so no testing nor referral was done to investigate their complaints and this explains why about half of the cohort was diagnosed as healthy despite their serious complaints. We don’t know the specific diagnoses of the other half but a fraction of them were diagnosed with nutritional or mental disorders, some of who were referred to specialist care in this fashion: nutritional (20), psychological (20) or psychiatric complaints (10) (Fig 5.3, page 79). This last group of patients was the only one whose presumptive diagnoses were revealed.
A closer look at these mental health diagnoses indicate a low threshold for inclusion as many girls failed to confirm any psychological problem (7 out of 20), had ‘dysfunctional families’ (7 out of 20) or low self-esteem (1 out of 20). Among the psychiatry referrals, 7 out 10 were diagnosed with depression as a result of current illness but such illness was not diagnosed except for 3 girls who had seizures. Similarly occurred in nutrition referrals, some girls failed to confirm such problem (4 of 20) while other were considered thin or ‘at risk of thinness’ (9 out of 20) and the remainder were overweight. Their inclusion was based on calculation of Quetelet’s or Body Mass Index which is reliable only in adults not on teenagers who in this series were on average 16.2 +/- 2.2 (range 12 to 22) years old. Overall, referrals to mental health or nutrition had a selection bias to include as many girls as possible since many of them failed to confirm any such complaints, their inclusion criteria were loose or questionable. More troublesome is the fact that they belong to a universe of individuals who developed physical adverse events after vaccination with Gardasil but whose physical diagnoses are missing while their mental or nutritional comorbidities are made to stand out as their main health concerns. In summary, the ruling of ‘healthy patient’ in a cohort of symptomatic adolescents, the disregard to the anamnesis portion of the clinical encounter, the lack of differential diagnoses, the failure to order relevant testing to investigate disease etiology, researchers’ reluctance to refer them to specialist care and the emphasis on mental and nutritional comorbidities as their only health concern in some girls, denotes incompetence, malfeasance and intention to obstruct the right to health of these teenagers.
Study of Syncope. Syncope or ‘crisis’ was one of the health complaints that raised most concern among researchers because they witnessed several girls suffer from this unique type of fainting followed by seizures. The researchers called attention to the severity of syncope that exposes girls to extreme vulnerability, both during the seizure because at least 3 people are needed to succor the victim, as well as after because their sense of well-being is totally shattered. Their mental health is particularly impacted as shown by poor school performance, depression, use of psychiatric services, and suicide attempts that currently exceed 10 cases. One girl succeeded at taking her own life with a poison. Of the sample analyzed, 239 adolescents (84.4%) suffer from this type of fainting and seizures, but none were diagnosed with an organ disease nor pediatrician’s presumptive diagnoses were revealed. Likewise, none was referred to a specialist or cardiologist to work up the organic basis of syncope. There were only 4 referrals to neurology but none received care. Please allow me to repeat that there were zero (0) referrals to cardiology despite that cardiovascular collapse is the cause of syncope and moved researchers to state:
¨ … it’s the most important and urgent problem, which must be duly addressed in the teenagers who suffer it …” (page 99).
Despite their sympathy, researchers were silent on the organic causes of syncope nor proposed how to approach it. – As shown in Figure 5.2 (page 77), the subsample of girls diagnosed as ‘healthy patient’ (52.7%) based on “negative physical examination”, greater than 80% complained of syncope plus other overtly abnormal symptoms such as headache, chest pain, dyspnea, palpitations, myalgia, arthralgia and neck discomfort. No attempt was made to refer them to specialized care or work them up through diagnostic testing. They were completely neglected, we don’t know about their pediatric presumptive diagnoses although they were summarily ruled ‘healthy’.
The cover up is even more clear by taking into account that five (5) of these symptoms (chest pain, dyspnea, syncope, palpitations and neck discomfort) suggest damage to cranial nerves that originate in the head, pass through the neck and reach the thorax and abodomen to innervate lungs, heart. large vessels and other viscerae.
My hypothesis. Because autoimmune demyelinating disease has been described in Central and Peripheral Nervous System associated with HPV vaccination with Gardasil, it makes sense to suspect that nerve fibers upon losing their myelin sheath (demyelination) are more susceptible to irritative and inflammatory phenomena in the neck and thorax that can slow down nerve impulses, can transmit pain and fail to adapt to organ demands, especially if environmental stress, increased activity or changes in body position are needed. Such unmet demands, irritative stimuli or disordered responses would explain fainting (syncope), chest pain, palpitations, respiratory difficulty and possibly neuropathic head and neck pain. – In the report, there’s no data to suggest that researchers had a hypothesis to explain the cause of these abnormalities, nor did they seek professional help with a cardiologist, neurologist or immunologist and so their testing does not include key studies like head-up tilting table testing, portable electrocardiographic studies such as ‘event recorder’ or 24-hour Holter.
The words ‘autoimmune’ or ‘autoimmunity’ are absent which suggests this mechanism of disease is not in their radar screen and much less was autoimmune demyelinating disease investigated. No inquiries were made to explain why syncope ended up in seizures, which is quite an unusual presentation. Their conclusion was that these patients are healthy which is dangerously opposite to the well-intended recommendations…
… it’s the most important and urgent problem, which must be duly addressed in the teenagers who suffer it …” (page 99).
Other symptoms. Gait disturbance was reported by 49.1% of adolescents, vision loss in 45.9%, arthralgia in 64% and muscle pain in 87.5% (half of which interfered with gait). In the report by the University of Cartagena there was no evidence that these symptoms were investigated in greater depth or referred to specialists regardless of how disabling they might be to teenagers ready to join the workforce. Interestingly, certain symptoms that were prominent in 2014 as reported by the outbreak study by the Colombian National Institute of Health (INS) (IQEN 2015) were noticeably absent in this report such as lower and upper limb paresthesia (frequency 60.4% and 46.2%) and muscle weakness (15.1%). That would suggest either complete healing possibly due to nerve remyelination. Alternatively, all other symptoms reported by the INS like syncope, chest pain, shortness of breath and palpations appeared in the current study which suggests the presence of autonomic damage by demyelination. Therefore, this apparent contradiction suggests that nerve demyelination is still a problem like it was 4 years ago. The absence of paresthesia or muscle weakness in the current report but prominent in 2014 does NOT have an explanation.
Robustness of the approach. The investigative approach taken by researchers of the Toxicology and Environmental Chemistry team at Universidad de Cartagena does not allow sound decision making on the health of vaccine injured girls and so their approach is not robust. On one hand, there was no organ diagnoses despite patients’ severe health complaints. The summary ruling of ‘healthy patient’ (Fig 5.2, page 77) based on negative physical examination is misleading as investigators themselves stated that they witnessed girls to suffer syncope and described such episodes in great detail (page 58). Because abnormal physical complaints did not trigger work up testing nor referrals, this suggests a hidden agenda. Only mental health and nutrition referrals were revealed and as above, their inclusion was rather forced. On the other hand, the report fails to explain why physical symptoms revealed by the Review of Systems were not investigated or referred to specialist care. Another source of concern are the pointless laboratory tests carried out, the rather haphazard genetic polymorphism study and an opinion survey (Chapter 4) that were totally irrelevant and uncalled for. They don’t respond to any medical-scientific criteria nor were expected to contribute to the understanding this disease.
Another caveat is the lack of continuity with advances made by biomedical scientists worldwide who during the past 4 years have strengthened the link between Gardasil vaccination and autoimmunity, plus the demyelinating neurological syndromes and cardiovascular collapse such as syncope. Their contributions are published in indexed and peer-reviewed scientific journals in countries like Denmark, USA, Canada, Colombia, Mexico, Japan and Israel to name those reviewed in this blog (see references below). There is no excuse to ignore their findings. This is an unethical omission to carry out appropriate research (funded and mandated per agreement).
Déjà vu, back all over again? As you read the report, you notice how certain aspects are highlighted while others are downplayed. Because only complaints related to nutrition (20), psychology (20) and psychiatry (10) were disclosed, it’s noticeable that mental health stands out which reminds us about the 2015 PR campaign launched by the Ministry of Health even before the Colombian National Health Institute released its report with the bizarre verdict of ‘massive psychogenic illness’. It looks like we’re witnessing a new attempt to neglect HPV vaccine-associated autoimmune reactions (of which researchers summarized in Chapter 2) while trying to cast blame on patients’ mental state, genetics or a spurious temporary lie like heavy metal poisoning which now the investigators have ruled out (pages 96 and 102). –
Researchers were not qualified to conduct biomedical research in humans and presumably they lack health care licenses (discussed in a longer article written in Spanish). Their non-medical approach is revealed by absence of medical differential diagnoses, the under-utilization of paraclinical testing and the misleading diagnosis of ‘healthy patient’ in about half of 283 subjects despite their serious physical complaints (Figure 5.2, page 77). Some of these individuals might have been the same ones researchers witnessed to have syncope. This is an unethical omission of medical care.
Magnitude of the health challenge. The consolidated database had 971 affected people from Carmen de Bolívar. If we add girls and women victims in other cities like Barranquilla, Bucaramanga, Bogota, Cali, Cartagena, Medellin, Sincelejo, Valledupar and other places where such reports have been made, we would be looking at a national figure like the one mentioned in the beautiful yet sad song by Mario Lamo and Inti Calapi that says “they were vaccinated and got sick, they are more than one thousand sick girls , Gardasil did it …”. Please also watch Mario Lamo’s documentary to hear the testimony of Colombian girls and women. But the impact is much greater as suggested by one particular figure that University of Cartagena study allows us to estimate. – According to the Review of Systems, syncope was reported by 84.4% of participants. They came from two groups, a majority chosen randomly (71%) and a minority of very sick girls who were selected by the community (29%). That is, a good part of the 283 girls with syncope ( 84.4%) came from the randomly chosen sample. What percentage exactly? We do not know for sure but we can do a conservative calculation: if we assume that all girls chosen by the community suffer from syncope as they are ‘very sick’ while the rest comes from the randomly chosen larger sample, then we can calculate the excess coming from the randomly selected sample, as follows: 84.4 – 29 = 55.4%. That is, about half of the girls chosen randomly suffer from syncope, which extrapolated to the universe of 971 teenage girls in the consolidated database, this translates into 971 * 0.554 = 538 girls who may suffer syncope in Carmen de Bolívar. That’s a catastrophe! And worse if we recognize that syncope causes cardiovascular collapse, that in this population is accompanied by seizures, which in turn cause transient cerebral collapse. If we add the impact on bystander people who are engaged to aid the victim, then the impact is huge!. – In perspective, we see that if researchers had worked up HPV vaccine-related syncope by ordering the correct specialized tests, if they had referred girls to cardiologists and if they had studied the immunological basis of syncope, the researchers could have favorably impacted the life of ~500 innocent victims, which extrapolated to worldwide HPV vaccine victims, its impact would have multiplied by the hundreds! … But it wasn’t done, but there’s a reason.
Bias. Possibly it’s not incompetence, medical ignorance, or refusal to do a good job. But rather … as reflected by the title of the study, its design might have been flawed from the beginning. It diverts attention to irrelevant and accessory issues and not on the specific health needs of Gardasil victims. Hence the interest to include, in addition to the biological factors, those “… environmental, sanitary and social related factors … with behavioral effects on adolescents in the municipalities of Bolivar” – See the title of the Agreement.
Name of Agreement # 50: “Inter-administrative Agreement between the Department of Bolivar and the University of Cartagena, to determine the biological, environmental, health and social factors related to the vaccination process for the prevention of HPV infection that may explain the biological and behavioral effects in adolescents of the municipalities of Bolívar”.
So it is not surprising that accessory aspects were emphasized like mental health (trying to spin it as a cause even if a consequence), mild nutrition complaints, under-powered gene study (page 93), surname association analysis and history of violence in the region (page 101) as well as an opinion poll in two towns (Chapter 4). At the same time, critical initiatives were disregarded, missed or not used at all. – Girls’ physical complaints were ignored, etiological studies by other scientists were disregarded (per references), hypotheses & differential diagnoses were absent, organ-diagnoses were not investigated, highly symptomatic girls were ruled ‘healthy’ even if ill according to researchers’ themselves, physical examinations were misinterpreted, referrals to specialists were minimized, key testing was omitted, and organ complications were not studied.
Now it becomes clear why attention was diverted to external factors or blamed on victims so as to spare the Gardasil vaccine. In 2014 a similar incident happened when allegedly heavy metal poisoning was the culprit with the media being complicit. – But there’s no way to escape the compelling evidence against Gardasil:
- One hundred percent (100%) of affected adolescents were injected with the HPV vaccine
- All of them are female
- Of school age in the range targeted by the Immunization Program
- Attended schools where immunization occurred
- Their symptoms were unknown to the population
- New symptoms appeared in an epidemic fashion
- Soon after vaccination with Gardasil shots
- Illness severity and clinical presentation was very homogeneous
- It was proportional to the number of vaccine doses (first, second and third dose)
- There is biological plausibility as these symptoms have been associated with the HPV vaccine by the manufacturer, the medical literature, and VAERS & CDC databases
- The disease has an autoimmune basis because a few patients have documented auto-antibodies against nervous tissue, one of the most common target organs. Rheumatological disease is usually well-documented.
- Autopsy studies documented profound inflammation in lesions where vaccine molecules were found, thus connecting the vaccine to the fatal injury.
- Removal of harmful antibodies by IVIg and plasmapheresis brings relief to victims.
- Drug immunosuppressive therapies like corticosteroids and antineoplasic therapy also decrease symptoms and physical manifestations.
Hence, it is clear now why the Bolivar State Government was resistant to release the report … because bias was all too clear.
General conclusion. In my opinion, except for researchers’ sympathy that syncope is a serious, important, urgent and high priority problem, I do not see any specific contribution by the Universidad de Cartagena study to advance the health challenges of vaccine injured young women in Carmen de Bolívar. I only see a passive-aggressive and disingenuous attitude to hide the true magnitude of the disease by not carrying out proper clinical evaluation, not ordering relevant laboratory work-up and not making appropriate referrals while at the same time hiding pediatrician’s clinical evaluation. Giving researchers the benefit of the doubt, there is an important lesson: ‘Cobbler, stick to your last’. – It is a pity that precious resources were spent in a biased study that failed to deliver medical research leads and health care diagnoses.
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