As mentioned by several newspapers including NFB, the International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B) has launched recently (February 17, 2011) a large scale field trial of an Indian oral cholera vaccine on the inhabitants of Mirpur, a suburb of Dhaka. The vaccine had offered poor protection (only 40-45 percent) when tested in Kolkata during the first year of follow-up. Contrary to what ICDDR, B has stated, the vaccine is far from being cheap. It is sold for Indian rupees six hundred (12 US Dollars). It is absurd that a vaccine that costs 12 US Dollars in India should be regarded cheap. Besides, the vaccine contains the toxic mercury containing compound thiomersal as preservative. Has the Government of Bangladesh examined this vaccine critically before allowing it to be swallowed by large number of Bangladeshis? One wonders!
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Earlier in 1985 ICDDR,B had conducted a highly expensively oral cholera vaccine trial using poor 90,000 rural women and children as experimental animals in order to produce a vaccine for rich tourists. This vaccine is currently sold in Europe by the trade name of Dukoral at an exorbitant price of 70 US Dollars. What is the hidden agenda of ICDDR,B now? The same scientists who had earlier cheated Bangladeshis are now behind the on-going vaccine trial in Mirpur.
How long poor Bangladeshis would be used as experimental animals by foreign drug and vaccine companies? One questions. Therefore it is essential that the cholera vaccine trial of ICDDR,B in Mirpur should be transparent and monitored by impartial observers.
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The cholera vaccine trial of ICDDR,B should be monitored by impartial observers
by Ahmed Sadiq
The composition of the vaccine and its effectiveness:
The International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B)
has launched on February 17, 2011 a large scale field trial of an Indian oral cholera vaccine on 160,000 inhabitants of Mirpur, a suburb of capital Dhaka (1). The vaccine, earlier tested in 2006 among poor slum dwellers of Kolkata, the capital of West Bengal (India), contains large amount of two groups of killed cholera bacteria (Vibrio cholerae O1 and O139). It is administered orally in two doses separated by a two week interval. Immunity develops one week after the second dose. The vaccine requires cold chain as it is to be stored at 4-8 degree Celsius. As reported in the British Medical journal the Lancet (2), the effectiveness of the vaccine against cholera was poor during the first year of follow-up as it registered only 40-45 percent protection. Besides, it contains the toxic mercury containing compound thiomersal as preservative (3). Because of the controversies associated with the use of mercury containing thiomersal, the World Health Organization recommends the use of non-mercury based compounds as vaccine preservatives (4). Scientists associated with this vaccine have launched a media campaign claiming that the vaccine is very cheap (1, 5). A few years ago Director-General Dr. Hiroshi Nakajima of WHO had mentioned that the price of a vaccine should not be above one dollar per dose, other wise it would be out of reach for much of the world. But as reported widely in the Indian press (6), the two-dose Indian oral cholera vaccine would be sold by the vaccine producer (Shantha Biotechnics) at the cost of the Indian Rupees 600 (12 US Dollars). It is absurd that a vaccine that costs 12 US Dollars in India should be regarded cheap. Has the Government of Bangladesh examined this vaccine critically before allowing it to be swallowed by large number of Bangladeshis? One wonders!
Scientists behind the so-called Indian cholera vaccine:
Although termed as an Indian oral cholera vaccine, the scientists behind this vaccine are not Indians. Rather a group of American and Swedish scientists based in South Korea and Sweden (John Clemens of the International Vaccine Institute, South Korea and Jan Holmgren, Gothenburg University, Sweden) are the prime pushers of the vaccine (2). They had been working on this vaccine for several years in Vietnam (7). The Vietnamese drug agency is not recognized internationally. They decided to exploit the Indian drug agency as it is globally accepted. Hence they moved their operations to Kolkata (India) with a view to capture the global cholera vaccine market. The vaccine is produced in India by Shantha Biotechnics, owned by French drug maker Sanofi-Aventis.
Necessity to monitor the trial by impartial observers:
It is important that the cholera vaccine trial should be monitored by impartial observers with no conflict of interest. This is essential in order to obtain accurate information out of the vaccine trial. If vaccine developers or their associates are involved in monitoring the trial, there is a strong possibility that false and fabricated claims on the vaccine trial will emerge as had happened in the 1985 oral cholera vaccine trial of ICDDR,B. If national elections in Bangladesh and elsewhere can be monitored by impartial observers, vaccine trials should also be conducted with impartial monitors who have no conflict of interest and are in no way associated with the vaccine developers or manufacturers.
Cheating the poor Bangladeshi women and children in a previous cholera vaccine trial:
Drs. John Clemens and Jan Holmgren are associated with ICCDR,B for several decades. In 1985, they tested a highly expensive Swedish oral cholera vaccine on 90,000 poor rural women and children at Matlab, the field station of ICDDR,B. The vaccine trial was regarded unethical as it had violated the Declaration of Helsinki concerning ethics in biomedical research involving human subjects on several counts (8). Strong criticisms were launched in the Bangladeshi press at that time. Details of these events have been described in a book published by UBINIG, the Bangladeshi organization that had followed the trial (8). John Clemens, Jan Holmgren and a few of their expatriate ICCDR,B colleagues published false results in the Lancet (9). They cheated the financial donors (governments of USA, Canada, Japan and Bangladesh) who had provided millions of dollars supporting the vaccine trials (9, 10, 11). The vaccine had produced short term protection that did not last even for one year. The vaccine was practically ineffective in children, the targeted population in heavily endemic areas such as Bangladesh (10, 11). But the Swedish scientists (Jan Holmgren and his wife Ann-Mari Svenerholm) used the trial results for marketing an expensive vaccine (sold at approximately 70 US Dollars in Europe) for rich tourists visiting cholera endemic countries (12, 13). But the trial was carried out in Bangladesh to produce a cholera vaccine for poor people and not for rich tourists. As documents reveal, Jan Holmgren had made millions of dollars in cheating the 90,000 poor women and children of Bangladesh using them as experimental animals (14). These unfortunate women and children could not speak for themselves and became easy preys to those with little respect for ethical values.
Incidentally, this oral cholera has not been approved by the U.S. Food and Drug Administration (FDA) and is not available in the U.S.A.
Scientist linked to the vaccine always claimed highly successful results:
The results of field trials of oral cholera vaccines have been variable, dependent on who conducted them – scientists associated with the vaccine or others with more independent scientific judgment. Thus when John Clemens, intimately linked to the vaccine, tested the combination cholera vaccine in Mozambique, high levels of protection were declared (15). When the same vaccine was field tested in Peru by a group of American scientists with independent judgment, dismal results were obtained (16). Wherever John Clemens had been involved in cholera vaccine trials, in Bangladesh or Mozambique, mass protests had taken place (8, 17). Similar to Bangladesh, people of Mozambique also protested as they felt being treated as experimental animals. This suggests the need of impartial observers to monitor cholera vaccine trials. Otherwise, credible results will not come out.
Hidden agenda to be disclosed:
As evident from the 1985 oral cholera vaccine trial in Bangladesh, John Clemens and Jan Holmgren had hidden agenda that they had kept secret from local authorities. Are they keeping their agenda secret from the Bangladeshi authorities and trial participants now? Financial interest of the key scientists and the vaccine manufacturer behind the trial must be made transparent. Making money out of human misery has become the motto of some cholera vaccine researchers as demonstrated in the 1985 oral cholera vaccine trial of ICDDR,B.
Concluding remarks:
Since the oral cholera vaccine currently undergoing trial in Mirpur is a spaced two-dose vaccine with immunity developing one week after the final dose, the vaccine is of little use to control cholera epidemics. Besides it has a cold chain requirement that is difficult to maintain in tropical and subtropical climates prevailing in countries where cholera epidemics occur. Besides, cholera is a treatable disease. With proper treatment, mortality can be reduced to less than 1 percent.
So far as controlling endemic cholera is concerned, it is a vaccine of poor efficacy offering only 40-45 percent protection during the first year of follow-up as shown in the Indian study (2). There is little justification for this vaccine trial unless the developers of this vaccine have their own agenda to fulfill.
Diarrhoea can be caused by various microorganisms other than those causing cholera. Other diarrhoeas are 80 to 90 times more frequent than cholera (18). Therefore, instead of developing strategy to combat only cholera causing diarrhoea, a comprehensive diarrhoeal disease control programme encompassing all diarrhoeas should be launched. Such a programme should include proper treatment of cases to reduce mortality from all diarrhoeas, and the promotion of appropriate material and child health and sanitation practices to reduce morbidity (18).
References:
1. Agence France-Presse. Bangladesh to hold massive cholera vaccine trial.
February 16, 2011.
2. Sur D, Lopez AL, Kanungo S, Paisley A, Manna B, Ali M, Niyogi SK, Park JK, Sarkar B, Puri MK, Kim DR, Deen JL, Holmgren J, Carbis R, Rao R, Nguyen TV, Donner A, Ganguly NK, Nair GB, Bhattacharya SK, Clemens JD. Efficacy and safety of a modified killed-whole-cell oral cholera vaccine in India: an interim analysis of a cluster-randomised, double-blind, placebo-controlled trial. Lancet. 2009, 374(9702):1694-702.
3. A Radomized Controlled Trial of the Bivalent Killed Whole Cell Oral Cholera Vaccine
in Eastern Kolkata, West Bengal, India. Protocol/Version Number C-8-Pill version 3.0
Section 6.1 Study agents (Vaccine and placebo)
4. WHO Expert Committee on Biological Standardization. 52nd Report, page 137.
5. The Times of India, Oral Cholera vaccine may soon be used in India, 11 April 2009
6. Business Daily from The Hindu group of publications, Oral cholera vaccine Shanchol from Shantha for India, 27 April 2009.
7. Thiem VD, Deen JL, von Seidlein L, Canh do G, Anh DD, Park JK, Ali M, Danovaro-Holliday MC, Son ND, Hoa NT, Holmgren J, Clemens JD. Long-term effectiveness against cholera of oral killed whole-cell vaccine produced in Vietnam. Vaccine. 2006 24:4297-303.
8. Mazhar F. 1996. Women and children of Bangladesh as experimental animals.
Dhaka (ISBN No. 984-467-050-0).
9. Clemens JD, Sack DA, Harris JR, Chakraborty J, Khan MR, Stanton BF, Kay BA, Khan MU, Yunus M, Atkinson W, Svennerholm AM and Holmgren J. Field trial of oral cholera vaccines in Bangladesh. Lancet. 1986; 2(8499):124-7.
10. Clemens JD, Harris JR, Sack DA, Chakraborty J, Ahmed F, Stanton BF, Khan MU, Kay BA, Huda N, Khan MR, Yunus M, Rao RM, Svennerholm AM and Holmgren J. Field trial of oral cholera vaccines in Bangladesh: results of one year of follow-up. J Infect Dis. 1988; 158:60-9.
11. Clemens JD, Sack DA, Harris JR, Chakrobarty J, Khan MR, Stanton BF, Ali M, Ahmed F, Younus M, Kay BA, Khan MU, Rao MR, Svennerholm AM and Holmgren J. Impact of B subunit killed whole-cell and killed whole-cell-only oral vaccines against cholera upon treated diarrhoeal illness and mortality in an area endemic for cholera. Lancet. 1988; 1(8599): 1375-79.
12. DUKORAL: Resevacciner fran SBL Vaccin (Travel vaccines from SBL Vaccin), 105 21 Stockholm, Sweden. 1996.
13. Sadiq A. Marketing of the Oral Cholera Vaccine Dukoral using Misleading Information and the Exploitation of Women and Children of Bangladesh as Experimental Animals. News from Bangladesh. January 24, 2011.
(
http://bangladesh-web.com/view.php?hidRecord=346593)
14. The Internet press release, Active Biotech/SBL Vaccin AB, June 29, 1998.
15. Lucas ME, Deen JL, von Seidlein L, Wang XY, Ampuero J, Puri M, Ali M, Ansaruzzaman M, Amos J, Macuamule A, Cavailler P, Guerin PJ, Mahoudeau C, Kahozi-Sangwa P, Chaignat CL, Barreto A, Songane FF, Clemens JD. Effectiveness of mass oral cholera vaccination in Beira, Mozambique. N Engl J Med. 2005; 352:757-67.
16. Taylor DN, Cárdenas V, Sanchez JL, Bégué RE, Gilman R, Bautista C, Perez J, Puga R, Gaillour A, Meza R, Echeverria P, Sadoff J. Two-year study of the protective efficacy of the oral whole cell plus recombinant B subunit cholera vaccine in Peru. J Infect Dis. 2000; 181:1667-73.
17. Agencia de Informacao de Mocambique (Maputo) News, March 4, 2004
18. Barakamfitiye, D., Barua D, Buriot D: Cholera control. The World Health (WHO) 1986, April: 21-2.
http://newsfrombangladesh.net/view.php?hidRecord=350185
