Govinda Rizal 2010-01-17, Kyoto Japan email@example.comLast September, infants in Bhutan were immunized using new brand of life saving ‘5 in 1’ vaccine named ‘Pentavalent’. Gross of children succumbed to the vaccine and others suffered from acute side effects. The samples of vaccines were sent to advance laboratories for test. The result took unexpectedly long time to come out. In the mean time, the health minister who introduced the killer vaccine was conferred a distinguished award for the same. The health ministry received a dozen ambulances in gift. The parents who lost children are neither compensated, nor consoled. The entire episode was explained by the government as a “mere coincidence”. If people have to digest it casually, the word “ethics” should get a new definition. GAVIGlobal alliance for vaccines and immunization (GAVI), an alliance of government, UN agencies, vaccine makers and charities was formed in 2000 AD with a globally appreciated altruistic motive. The motive was to provide life saving vaccines at subsidized cost to people in poor countries. Three prong approaches were adopted to fulfill the noble mission. Firstly, it was to raise awareness among people in the poor countries to make them seek the vaccines and increase the demands. Secondly, it was to encourage more vaccine makers to get into competition. Lastly and subsequently, it was to reduce the cost of vaccines. The public private partnership, GAVI, based in Geneva was set up with a seed fund of US$ 750 million from Bill and Milinda Gates Foundation. When it began in 2000, there was only one company producing Pentavalent. Today there are at least four companies reaping profits from the alliance. The price has come down from $3.65 to $ 3.0 per dose, and profit swollen to 10 digits.Two Indian vaccines makers, Shantha Biotechnics Ltd acquired by French drug maker Sonofi Aventis SA, and Panacae Biotech limited joined the competition in 2008. Two more Indian companies, Serum Institute of India Ltd and Bharat Biotech International Ltd are knocking at the door of World Health Organization (WHO) for pre-qualification approval. Unicef buys drugs from companies which have pre-qualification approval from WHO. Unicef then gives to GAVI, which in turn supplies to member countries at subsidized rates. The vaccine is supplied to 72 countries chosen on the basis of their low economic standards. Children sacrificeWithout a pilot test or with no means to test, immunization using GAVI’s subsidized vaccine Pentavalent was started nationwide in Bhutan on September 1, 2009. Within a month 8 children were reported killed by the vaccine. The parents of all these children are highly educated, who could track the cause. The actual deaths within this period are yet to be known. An unpublished draft mentions that the ministry of health has registered at least 31 cases of deaths and hundreds of children immunized during this period sick. Bhutan government responded very fast to the deaths, suspended the vaccines and resorted to previous doses. It ensured total collection of the unused and used veils to prevent possible test by private groups. Though fast, Bhutan is not the first country to suspend the immunization using Pentavalent. Sri Lanka and Pakistan had stopped, too. However, despite reports of deaths in their countries, Afganinthan, Bangladesh, Nepal and many more countries are continuing with it. Even if all the Pentavalent immunized children did not succumb to injection, they are not out of other dangers. The actual antigens used in the vaccines are unknown and protected by patents. The vaccine comes in a solution with aluminium thimerosal, a mercury based compound, and formaldehyde as preservatives. These cause inflammation of brain, cancer, encephalitis, etc. Either when a child is in poor health condition or when the amount of these preservatives crosses a certain threshold level, the chemicals show their effect.Pentavalent is an untested vaccine hypothetically meant to protect children against five killer diseases, Haemophilus influenza type B(Hib) disease, DPT( diphtheria, pertussis and tetanus) and Hipatitis B. Pentavalent replaces the separate use of DPT, Hib and Hepatities B. But the numbers of time parents need to visit clinic remain the same as Pentavalent is given thrice; after 6, 10 and 14 weeks. This is independent of BCG and measles vaccines. Child sacrifice brings awards to ministersDuring the third week of November, GAVI partners’ forum awarded health ministers from the GAVI recipient countries. They were conferred various awards and titles. The Bhutan’s minister for health Professor Zangley Drukpa was recognized for obtaining over 95 percent immunization in four years. While statistics (95 percent) is fiction based, the minister was in this job for a little more than a year. This was a month after the killer vaccine was suspended from use in Bhutan. The award ceremony in Hanoi, Vietnam on November 19, 2009 was grander than any of the past Oscar film award ceremonies. The event was moderated by singer Yvonne Chaka Chaka from South Africa. The purpose was to make the event more of entertainment than of purpose. In the grand program no mention was made regarding the children who lost their life to the vaccines and no prayers were offered. No leader raised a word on the compensation to the grieved parents. The ministers retuned with heavy medals.. The Pentavalent recipient countries have no access or techniques to verify the constituent and quality of the vaccines. The recipients accept them on the trust and mercy of the donors, makers and the governments. While it was introduced in many countries Bhutan was a fore runner to suspend and withdraw the use and go for a cross check. There are many chances for Bhutan’s health minister to fall under the influence of the drug dealers. Health minister of BhutanAcademically, Professor Zanglay Drukpa comes from education management background. Beside a few interactions with his family physicians, he had hardly any time and opportunity to know anything related to health and medicine, until he became health minister a year ago. He was convinced to save state’s budget when vaccines costing $ 3.65 per dose were given to him at $ 0. 23 per dose. He accepted without a second thought. A dose of Pentavalent vaccine costs US$3.65 to Unicef when it buys from companies. Through GAVI initiative Bhutan received at a subsidized rate of $0.23 per dose. The huge difference adds to the suspicion that the vaccines are being used for test. Research companies bribe influential people for favors. Economically Professor Zanglay lives with a silver spoon in his mouth. However, chances that he walked an extra mile to rescue his debt ridden party from bankruptcy, cannot be ruled out. If so, it is not just the health minister who is acknowledgeable, the entire cabinet and the DPT’s top members are aware, informed and under influence. Ethics in biomedical researchBiomedical tests or test of drugs and vaccines on humans are highly sensitive protocols often provoking human right issues. Drugs are tested for their effects and side effects starting from small animals like bacteria, nematodes, mice, rabbits, etc. When they pass all these stages they are tested in primates like monkeys and chimpanzees, which are closer to humans. However, their actual effects cannot be specified without testing in humans. There are various protocols to be followed to test any drugs in humans. The human must be a volunteer, fully informed of the test and consequences, and free from expectations of any forms of rewards and benefits. Legally, bio medical test on humans is next to impossible. Moreover, Pentavalent is meant for the infants, their tests and report of tests in informed volunteer adults give no meaning. Thus somehow or the other, illegally or Para-legally they are tested through the influence of authorities. The common practice is that the drugs are tested on prisoners, refugees, soldiers, street dwellers, beggars and ignorant people. For the test either authorities, where absolute authorities exist like in army, or politicians who influence large masses are taken into confidence through various means. For the test, drugs or vaccines with different combinations of constituents are mixed and the samples are identified using codes. The code of the Penatvalent used in Bhutan was ‘EasyFive’ a trade name used by Panacae Biotec, India. Each vial of vaccine has an identifier encoded in the barcode. Since different combinations are used, some of which are placebo, different receipient get different symptoms. Some are not given any treatment. When the dose is completed in an area, epidemic is spread. After the epidemic like the recent H1N1 swine flue epidemic, recipients susceptible to disease are noted and compared against the dose they received. After the tests are successfully carried out, the drugs with best results are replicated and sold in developed countries, which have reliable techniques to test and verify drugs. These selected drugs are usually a bit expensive.Vial in fileBhutan government took a bold step by sending the collected samples to test to different undisclosed laboratories. If the results from the tests prove the vaccines faulty, it shall be the worlds’ first most notorious scandal of the 21st century. To resist it Bhutanese people have to tighten their belt. However as the symptoms show, the government is ready to subside the issue proclaiming that the killer vaccine and death from the injection were coincidental. The government cannot hide the mal practice so easily; the people of Bhutan know exactly when the iron is hot. Delay in releasing the laboratory reports is an unexpected event taking place. Any good laboratory can analyze chemical composition of vaccines in a day. However, it takes long time to study the effects, which is not expected from them. It has been a month already that the samples were dispatched for test. The reports are still in the file.Gift diplomacyEasy five, the Pentavalent received by Bhutan was the product of Panacea Biotech Ltd in New Delhi. The company must not be waiting with fingers crossed for the lab results. The government seems seriously evaluating the pros and cons of the report and its release. When the lab result is still in the file and peoples’ eyes are focused on it, there was a distraction. Bhutan received a dozen ultra sophisticated ambulances from New Delhi as gift with promises of some more such gifts soon. The addition of ambulances will certainly ease the people’s trouble, and save many who would otherwise breath their last, untimely, on the way to hospitals. But it cannot bring the children sacrificed to illegal vaccines back to life. Mission ahead GAVI’s noble mission to keep the future population healthy should continue. They should see that their altruism adds, not subtract, health and life to the children. They should buy only those drugs and vaccines that are accepted in developed countries. Bill and Melinda Gates Foundation have spent billions of dollars in charities to improve health and agriculture. They should ensure that their charities are used for the just cause and not to siphon dollars into billionaires eyeing to take up Bill Gates position in Forbex index. Not every government can follow Bhutan, Sri Lanka or Pakistan to act fast to save lives, but they should not be tempted by low prices, rewards and gifts. Unicef, WHO, PAHO, etc. are globally trusted, international organizations to which people and governments resort to at times of need and controversies. All the people working in these organizations may not be immunized against corruption and unethical partnership with drug makers and testers. The government of Bhutan must be confident that people will support them if they stand with the actual result of the test even if it mean losing cost subsidized vaccines, ambulances and awards, and will not support the fabrication for a vein glory. The civil societies must be bold enough to ensure that all the parents who lost their children get proper compensation and other children who survived the killer vaccine get medical supervision for good.