So again with the rubella vaccine we have the typical vaccine scenario; evidence of antibody production used as evidence of the success of the vaccine without relating that to numbers of real disease cases, over exaggeration of the numbers of cases before the vaccine, no systemised screening for adverse effects of the vaccine, with many adverse effects found later but not used in an assessment of vaccine risk versus benefit and finally under-reporting of the disease in the vaccinated. Clearly adequately controlled trials are desperately needed.
Why are vaccine promoters avoiding controlled trials when there is an obvious opportunity to conduct them?
The definitive answers we are always told could be found by running prospective controlled trials, vaccinating half and compare to a non-vaccinated group, but the creation of a placebo (i.e. non-vaccinated) group is said to be unethical; unethical because we would be with-holding the vaccine from a group and thereby creating an avoidable risk of exposure to disease by with-holding a safe and effective vaccine. As discussed earlier, describing the creation of an unvaccinated group as being unethical presupposes that the vaccine is safer and more effective than natural immunity, which of course we do not know, unless we do the trials. This situation is even more questionable when we consider that many countries do not even use rubella vaccine. According to the Pan American Health Organization, (PAHO) Family and Community Health, immunization Unit, Washington, D.C. USA (a regional office of the World Health Organisation):
… 42% of the countries around the world that report to the World Health Organization (WHO) still have not introduced rubella vaccine into their national immunization programs Pan American Journal of Public Health 15(3), 2004
PAHO have therefore conducted various studies to determine if there is an ‘unrecognised’ problem of CRS in one such country Haiti and therefore is there a case for introducing the vaccine in their public health program. An interesting use of resources considering the magnitude of their known health problems; according to a PAHO report “Health in the Americas 1998” commenting on conditions in Haiti:
Water supply and basic sanitation services are still very deficient. No city has a public sewerage system…”
The leading causes of child mortality in Haiti are diarrheal diseases, acute respiratory infections, and malnutrition…”
The health and social problems in Haiti are difficult to envisage for most people unaccustomed to such deprivation, the same report on Haiti elaborates:
In 1991, the Center for Research on Human Resources conducted a survey in three cities in three different departments. The survey provided an overview of the plight of children (boys and girls under 18 years of age) in especially difficult circumstances, including several groups: children employed as domestics, abandoned children, orphans, incarcerated juvenile offenders, child prostitutes (male and female), abused children, and street children. The term “street children” refers to children whose only home is the streets and who only find food and shelter there. In 1991, the number of street children in Haiti ranged from 1,500 to 2,000 in Port-au-Prince,more than 100 in Le Cap Haïtien, and just under 100 in Les Cayes. Most of them are boys, but the number of girls appears to be increasing, accounting for 18% of the children surveyed in Port-au-Prince. The mean age of these children is about 11 years; 55% of them are aged 12 to 18 years old, and 14% are 5 years old or less. Their health problems include headaches, fatigue, insomnia, and anxiety. They are particularly vulnerable to tuberculosis, anemia, skin diseases, and sexually transmitted diseases. Many of these children are drug users (53% of the inner-city sample).”
Yet this regional office of the WHO feel justified in looking for other, as yet unrecognised problems in order to introduce more vaccinations, vaccines that they cannot afford, given their comment of: “…the relatively high cost of the rubella vaccine for the average Haitian and the low socioeconomic status…”
In spite of this, studies were conducted to provide estimates of rubella susceptible women finding that 95.2% were sero-positive and therefore as they conclude, leaving a relatively low group (4.8%) of susceptible individuals their report states that:
Even with an overall low susceptibility (seronegativity) rate of 4.8%, congenital rubella syndrome could still occur in Haiti.”
So on the possibility of the syndrome occurring further studies are conducted to assess the cost effectiveness of a mass rubella vaccination program. One such study reported in Pan American Journal of Public Health, Volume 12 (4), Oct 2002, tries to assess the possibility of this as yet unrecognised problem of CRS looking at “three orphanages in Haiti that accept disabled children”.
They came to the conclusion that a probable 6 cases of CRS may have occurred and using data from USA prior to rubella vaccination and surrounding Caribbean countries they arrive at the conclusion that the rubella vaccine would be a cost-effective strategy in reducing the CRS disease burden of Haiti. PAHO are therefore promoting a vaccine to reduce an estimated disease burden that has so far been unrecognised, and even if real is completely dwarfed by the known health problems in Haiti, using a vaccine that they cannot afford which would inevitably remove resources from other areas of health care in a situation where they are desperately short of funds for even the most basic health provisions.
There does appear to be an issue of ethics in the promotion of vaccines under these circumstances, but the avoidance of placebo controlled trials for ‘ethical’ reasons in countries where the vaccine is not used is a pharmaceutical ploy to drastically reduce the level of analysis of their vaccines.
It would in fact be far simpler to conduct a prospective trial to really assess the worth of rubella vaccine, one would not be introducing a ‘non-vaccinated’ group; one would be introducing a vaccinated group and therefore be making assessments of the value of the vaccine against comparable controls i.e. against non-vaccinated individuals with natural immunity. In fact there are many opportunities world wide to conduct such studies, these studies would put to rest the criticisms of vaccines and address the issues of non-compliance in people that continually question the value of vaccines.
These countries provide a genuine opportunity for vaccinators to demonstrate the real value of vaccines. Yet these organisations still persist in using worthless estimates of antibody levels, extrapolating data from other geographical areas to estimate possible disease rates, using no controls to assess the impact of the vaccine on actual disease rates, ignore confounding factors for example pregnancy terminations and conduct no health screening of vaccinated individuals when assessing vaccine safety once the vaccine is introduced into the population.
Individual health professionals and members of the public are then left to prove beyond a shadow of doubt that a vaccine is not safe and effective and could on balance create more problems than it is solving. Whereas vaccine promoters use sloppy non-science to introduce a vaccine into public health policy without the need for proper studies, shielded by the circular reasoning of their ‘ethical’ argument for not conducting studies with proper controls.