Virtual Mentor
American Medical Association Journal of Ethics
January 2012, Volume 14, Number 1: 35-38.
Susanne Sheehy, BM BCh, MRCP, DTM&H, and Joel Meyer, BM BCh, MRCP
Few would argue with Bill Gates when he describes vaccination as “the most effective and cost effective health tool ever invented” [1]. To date vaccination has saved many lives and has the potential to save millions more, especially if vaccines are developed against the “big three”: malaria, HIV, and TB [2-5]. Vaccine development, however, comes at a price that is not only financial but societal. The lack of animal models that can reliably predict vaccine efficacy means that development still unavoidably relies on testing of novel vaccines in healthy individuals. Given the often unquantifiable risks to the recipients of vaccines in early stages of development, clinical trials have traditionally relied on informed and consenting volunteers who appreciate the potential risks but still choose to participate for altruistic reasons [6, 7]. But relying on altruism alone to facilitate clinical trials is potentially unsustainable and ethically contentious.
In recent decades there has been a distressing decline in the numbers of healthy volunteers who participate in clinical trials [7], a decline that has the potential to become a key rate-limiting factor in vaccine development. Reasons for this decline are unclear but are likely to be multifaceted. One familiar problem is the payment of volunteers [8]. To date, the relatively meagre compensation that participants often receive could be seen to belittle and undervalue the contribution of these individuals to global health. The modest financial remuneration commonly provided often means that students and the unemployed make up the bulk of volunteers [6, 8, 9]. As a result, the risks of developing a health intervention that would benefit the whole population are carried disproportionately by some of society’s most poor and vulnerable. This is a situation few would judge to be fair or ethical. However it is hard to increase volunteer payment without creating financial incentives. “Danger money” is frowned upon as an inducement that inevitably clouds an individual’s appreciation of risk, limiting the likelihood that consent is informed [6, 7]. As a result, consensus has generally dictated that payment for volunteers’ trial involvement be modest and limited to compensation for travel, time, and inconvenience only.
If progression of promising vaccines from the lab to the clinic is to remain unaffected and financial inducement is an ethically unacceptable solution to the recruitment shortage, other strategies need to be considered. Compulsory involvement in vaccine studies is one alternative solution that is not as outlandish as it might seem on first consideration. Many societies already mandate that citizens undertake activities for the good of society; in several European countries registration for organ-donation has switched from “opt-in” (the current U.S. system) to “opt-out” systems (in which those who do not specifically register as nondonors are presumed to consent to donation) [10], and most societies expect citizens to undertake jury service when called upon. In these examples, the risks or inconvenience to an individual are usually limited and minor. Mandatory involvement in vaccine trials is therefore perhaps more akin to military conscription, a policy operating today in 66 countries. In both conscription and obligatory trial participation, individuals have little or no choice regarding involvement and face inherent risks over which they have no control, all for the greater good of society.
As ever, then, the debate boils down to a consideration of the “greater good” or the “lesser evil.” A key consideration is the risk benefit ratio—risk to the individual volunteer balanced against the benefit to society. Society is unlikely to accept compulsory recruitment to a trial for a vaccine against the common cold if the vaccine causes severe complications in vaccines. Increase the severity of the disease in question, however, and compulsory recruitment becomes a more palatable option.
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Hilary Butler says
I’ve absolutely no problem with mandatory vaccine trials at all. In the correct people that is: http://www.beyondconformity.co.nz/_blog/Hilary's_Desk/post/Mandatory_vaccine_trials/
Godfrey says
INEFFICACY OF THE VACCINE AGAINST THE HPV SEEN BY DOCTOR OF
PERU DEPHT
From its inception until the appearance of tha uterine carcinoma of the cervix (UCC) take in average 25 to 30 years; the investigation on the vaccine against the human papilloma virus has begun the 2000; the scientific efficacy of this vaccine has just determined in the years 2025-2030
HPV not causes definitely the (UCC); in the onset of this disease are involve multiple risk factors, including suspected HPV, but there are security for epidemiology and statistics that sex generates the disease. Mix in 130.000 nuns not found not any UCC.
To accept that a virus or bacteria cause a disease must indefectible fulfill the 5 Koch postulates:
http://www.xatakaciencia.com/salud/los-postulados-de-koch
1. The agent must be present in each case of the disease and absent in healthy subjects.
2. The agent should not appear in other diseses,
3. The agent must be isolated in pure culture from the lesions of the diseases,
4. The agent has to cause the disease in an animal capable of being incoculated,
5. The agent must be newly in the lesions of animal in experimentation
http://es.scribd.com/doc/44558220/MICROBIOLOGIA-1
Consequently HPV do not fulfill not any of Koch’s postulate; fulfill this postulate is accepted as dogma in medicine, scientifically we can sure that the HPV is not the
causative agent of the UCC
Until June 2012 solely in USA was 263, 328 advers efffects, disabling irreversible 8,860, death 1160, abnormal PAP 4900, dysplasia cervical 1950, cervical cancer 560.
http://du104w.dub104.mail.live.com/default.aspx#!/mail/InboxLight.aspx?n=1668544653!n=1997022391&fid=e71773d143454209a436ace1ced14dca&mid=3cd42a8d-d11d-11e1-af47-00237de3f55e&fv=1 .
To accord of Vaccine advers effects reaction (VAERS) information that is denounced
solely between 1% to 10%
http://www.noticiero.enkoria.com/2011/diez-menores-que-sufrieron-reaccion-adversa-a-la-vacuna-vph-d
Dr. Harper, who helped develop the vaccine for Merck reports that the vaccine was not investigated in children under 15 years and the vaccine given to children under 11 years is a big public experiment.
http://offtheradar.co.nz/vaccines/53-researcher-diane-harper-blasts-gardasil-hpv-marketing.html
The vaccine was approved to give girls not contaminated with HPV; Dr.Howenstinc say if women are vaccinated contaminated with HPV are able to acquire a 44.6% CCU http://www.newswithviews.com / Howenstine/james170.htm.
This vaccine is transgenic; the Sane vax has discover that Gardasil is contaminated with DNA recombinant (DNArPVH) and has raised its concern to the president of the FDA Margaret Hamburg; the FDA replied that its presence does not cause any harm.
A vaccinated girl became ill with rheumatoid arthritis, which is an autoimmune disease. 24 hours after vaccination and found that the DNArPVH adhered to aluminum, two years after vaccination.
http://www.mecfsforums.com/index.php?topic=9331.0
To introduce the vaccine are using the marketing of fear:
http://mujeresenaccion.over-blog.es/article-vph-la-vacuna-del-marketing-del-miedo-67210961.ht http://mujeresenaccion.over- blog.es/article-vph-la-vacuna-del-marketing-del-miedo-67210961.ht
HPV is ubiquitous and lives in wild and domestic animals, we pollute from birth, is on the doorknobs, on towels, on the nails, on fomites, in gloves and specula of gynecologists; sexual intercourse is not the solely means of contamination.
http://spa.myhealthygood.com/cancer-cervical-vacuna-contra-el-vph/investigadores-descubren-el-v
HPV also lives in the 400 nm outermost of our skin and mucous membranes. ,
If live on our skin, our immune system produces cellular and humoral immunity; our body is naturally being vaccinated for HPV to live on our skin and mucous ..
http://www.conganat.org/seap/bibliografia/HPVToday/HPVToday007SEAP.pdf
The cervical carcinoma, neither the HPV are infections, contagious, epidemical, nor infectd only by the coitus
Gardasil is genetically modified;; known vaccines are made from killed or attenuated original bacterial or virus; it is UNKNOWN damage that produce in the future and is prepared to prevent infection only of HPVs 16 and 18; it is know that exist 200 species of HPV.
http://quimicaclinicauv.blogspot.com/2006/08/virus-del-papiloma-humano.html http://www-lab.biomedicas.unam.mx/smpv/queeshpv.htm
The HPVs are not distributed uniformly over the world. It was found that in Canada the HPV 18 solely less than 3%, more prevalent is HPV 31, in my country Peru there are no studies that established the predominant types of HPV, gardasiul contains 225 mcg and cervarix 500 mcg aluminum that produce Alzheimer’s, it is a mayor neurotoxine, disrupter of neurological funtion and immunoexcitotoxicity and polisorbato 80 which is a potent contraceptive that in the experimental animals produces sterility, atrophy of the testicles and funtional and morphological disturbance of the reproductive organs; are carcinogenic and mutagenic; also contains sodium borate considered poison, not used in medicinal preparations. http://www.telefonica.net/web2/paramahamsa/vacunaninosalerta.html http://detenganlavacuna.wordpress.com/2010/11/09/gardasil-cervarix/
Until now it is know 200 types og PVHs
http://quimicaclinicauv.blogspot.com/2006/08/virus-del-papiloma-humano.html http://www-lab.biomedicas.unam.mx/smpv/queeshpv.htm
December 2012 FDA approved the gradasil to boys since 9 to 26 years to prevent the anal cancer and wart. It is a excess.
http://www.saludpanama.com/la-fda-aprueba-gardasil-para-su-uso-en-ninos-y-hombres-jovenes
http://salud.aollatino.com/2011/02/02/aprueba-fda-nueva-indicacion-vacuna-tetravalente-vph-eeuu/
For the reasons from Peru, depth, Huancayo, I believe that this vaccine is a Fraud?, Robbery?, Swindle?, Rough Joke?; it is not scientifically proven at this time, its effectiveness will be verified just the years of 2025-2030.
Dr. Godfrey Arauzo
E mail: godo.ara@gmail.com
Tel.: 05164252052