VIEWPOINT

IAP should protect children from wrong policies

Dr Yash Paul

In a chapter 'Rethinking Medical Ethics: A View From Below' By Dr. Paul Farmer a Physician-anthropologist and Nicole Gastineau Compos, a Scholar, Health Policy, in a book 'Ethics and Infectious Disease' published by Blackwell[1] it is tated: The fact remains that many studies are done in the Third World that simply could not be done in the countries sponsoring the work. The authors cite two examples.

A woman suffering from HIV infection from Haiti, one of the poorest countries was made a subject for study by a US research university. She was not administered drugs but was given placebo. For ten years she was subjected to blood examinations, but given no medicine. When she came to know about the truth she made hue and cry stating that it's as if poor people are animals. But we won't serve as their guinea pigs. Then she was put in the group receiving drugs, and survived. Subsequently the research project was terminated (pages 267 - 268).

Second example is from Russian prisons where prisoners were suffering from first line resistant tuberculosis, but second line of treatment is very expensive so could not be provided. The reported incidence occurred during mid-1990s, after split of USSR. The non-governmental organisations were mostly European and North American, and in the post-perestroika disarray they had something their Russion (and Azeri and Georgian and Kazakh, etc.) partners did not have: money and clout. The ability of these aid organisations to shape responses to epidemic tuberculosis in Siberia was significant, and they insisted on what they termed the most 'cost-effective' approach, the one endorsed by international tuberculosis experts, including the World Health Organization, directly observed therapy with 'first line' anti-tuberculosis drugs. But some of the Russian prison physicians objected, as did members of Russia's large and crumbling tuberculosis-treatment infrastructure: the prisoner-patients had drug resistant tuberculosis and would not be cured by standard first-line regimens; some Russian specialists made other objections. These voices were drowned.

In Siberia and in other pilot sites, treatment outcomes were nothing short of catastrophic: less than half of all patients were deemed cured (expected cure rates for supervised therapy of drug-susceptible tuberculosis exceed 95%). Worse, prisoner patients who were not cured by therapy with first-line drugs emerged from the treatment, if they survived, with 'amplified' resistance. That is, their prognosis had worsened dramatically even if they were to be offered care with the right drugs. But the non-Russian groups, whether international tuberculosis experts or aid groups, did not concede that they had made an error. Instead, they pressed on, delivering precisely the same medications even to prisoner patients with documented multidrug-resistant tuberculosis.

In 1998 sputum samples of some prisoner patients were sent for drug-susceptibility testing to two references laboratories in Western Europe. Both laboratories confirmed that patients within Siberian prisons were sick from highly resistant strains of M tuberculosis-strains resistant to precisely those drugs being administered, under direct supervision, by the non-governmental organisations who had been chastising Russian experts for their lack of knowledge of modern tuberculosis control (pages 272 - 276).

I have highlighted some wrong policies of WHO and the Government of India regarding immunization of young children in our country.

1. Polio Eradication Program.

  (i) Some False Claims:

    A. Reduction in polio incidence. According to NPSP (National Polio Surveillance Project), OPV had brought down the number of polio cases which varied from 13000 to 38000 cases per year during 1980s to 1,126 cases in 1999. Pulse Polio Immunization was launched in 1995 in India. The year 1999 was projected as a bench mark in polio eradication. Three different criteria have been used at different times to label acute flaccid paralysis (AFP) cases as polio cases:

      (a) Reported cases of flaccid paralysis upto 1996.

      (b) Presence of one or more of the following :

        (i) Wild polio virus detected in stool sample, (ii) residual paralysis observed after a period of 60 days of onset of paralysis, (iii) patient died, or (iv) patient lost to follow-up for 1997 and 1998.

      (c) Wild polio virus detected in stool sample, 1999 onwards. There were 10408 and 9587 reported AFP cases during 1990 and 1999, respectively. In 1990 all 10408 AFP cases (100%) were labeled as polio cases, but in 1999 only 1,126 cases were labeled as polio cases. I had raised this issue in 2003 in BMJ-South Asia Edition (pages 499 - 501)[2]. In his response by Dr. Jay Wenger the then Project Manager, NPSP published on pages 684 - 687, he did not comment on this issue[3].

    B. Reduction in Polio incidence occurred because of OPV. Administration of any vaccine results in lowering the incidence of that disease. Role of improvement in hygiene and sanitation cannot be negated. It is pertinent to state that the incidence of polio disease declined appreciably from the third decade of the twentieth century (1930s) in England, America and industrialized countries of Europe, i.e. long before polio vaccines became available during the late 1950s.

    C. OPV is absolutely safe vaccine. It is a well established and known fact that OPV may cause vaccine associated paralytic polio (VAPP) in some children.

    D. India has become Polio Free Country. Last polio case by wild polio virus was reported on 13th January 2011, but polio cases caused by OPV have been reported even after 13th January 2011 as can be seen in Table 1, and as OPV is to be administered till year 2018, some more cases of polio disease caused by OPV may occur in future. Thus, India has become wild polio free country but not polio free country.

2. Discontinuation of Mumps vaccine in National Immunisation Program.

A vaccine under use is discontinued if the disease has been eradicated, example is Small Pox vaccine. A vaccine found to cause some serious adverse reactions is also discontinued; example is Rotashield vaccine against Rotavirus infection, was discontinued when it was found to be responsible for high incidence of intussusception in vaccine recipients. Similarly nerve tissue rabies vaccine has been discontinued due to its poor efficacy and various adverse reactions.

Measles, Mumps and Rubella (MMR) vaccine has been in use in our country for over two decades. Ministry of Health and Family Welfare, Government of India has introduced Measles and Rubella (MR) vaccine in the National Immunization Program. Following issues need serious considerations, Mumps disease can cause some serious complication like Meningitis, Pancreatitis, Orchitis and Oopheritis. Mumps vaccine is not available. Number of children who visit government medical centres is higher than those who visit private medical centres for vaccination. After few years we may have large number cases of Mumps disease in community because large population would have received MR vaccine only.

3. IPV in National Immunization Program.

Large scale studies are done to find which drug or vaccine provides higher benefit and/less side effects. In documents "Polio End Game, Role of IPV Strategic Plan, 9 Version October 2015" Table 2 states: Immune response to IPV is similar between industrialized and tropical developing settings:

• 3 doses: nearly 100% serconversion rates to all 3 serotypes.
• 2 doses: 40% - 93% against the 3 serotypes, but exceeds 90% when vaccination is initiated after 8 weeks of age.
• 1 dose: 19% - 46% against type 1, 32 - 63% against Type 2, and 28% - 54% against Type 3 poliovirus.
• It is important to note that immune response to one dose is substantially higher, particularly against Type 2 poliovirus (63%) when administered at 4 months of age compared to 6 weeks to 2 months of age.

Logic would suggest that to reduce expenses studies should have been done to compare 3 doses IPV schedule with 2 doses IPV given at 8 and 16 weeks. But, India was divided in groups: (i) Eight states to administer 2 doses of 0.1ml. subcutaneously at 6 and 14 weeks and (ii) 1 dose of 0.5ml intramuscularly at 14 weeks. Though it is known that response of 1 dose of intramuscular IPV at 16 weeks provides higher seroconversion.

This shows that for children in India intention of study was not to find the best and second best schedule but to find the worst and second worst schedule. The efforts should be made to find 'cost-effective' and not most cheap regime, with poor benefits. Even PETA (people for ethical treatment of animals) would not permit such studies to be done on rats and dogs.

4. Compensation to children who have developed paralytic poliomyelitis during Polio Eradication Program.

In any mass public health program some participants may not derive benefits due to some reasons, but, harm should not occur to any participant. The facts that OPV may cause polio disease (VAPP) in some children and some children may develop polio disease by wild polio virus despite taking many doses of OPV, were not disclosed to the people. It was not only a right policy but necessary also, so that parents may not refuse to administer OPV to their children. However, if it is indeed to be accepted that the benefits of polio eradication outweigh the with-holding of information about the risks of harm, then, at the very least, an adequate compensation scheme should have been formulated. Natural justice demands this [4].

Since December 2005 I have been raising this issue with different authorities including the Ministry of Health and Family Welfare, Government of India, National Human Rights Commission, Rajya Sabha (Parliament of India), and Standing Committee of Parliament on Health and Family Welfare. Response from the Ministry of Health and Family Welfare, Government of India has been same as given below:

"Under the Public Health System established in India, all types of Acute Flaccid Paralysis cases, whether Polio or Non-polio, are provided free medical care at all health facilities including corrective surgery, regular physiotherapy and rehabilitation." It is a right policy to provide above mentioned facilities to all people with disability because of polio disease or other reasons. Disability in persons due to non-polio conditions include congenital anomalies, birth injury, neonatal asphyxia, neonatal infections, Kernicterus etc. in a neonate which may result in permanent disability. Such disabilities can occur later also because of brain infection, brain injury, accidents etc. Occurrence of polio disease prior to national polio eradication program needs to be treated differently from polio disease which occurred during the eradication program.

During the polio eradication program every case of polio disease as VAPP or by wild polio virus had developed disability because he/she had participated in the national program. The harm in form of disability which occurred to thousands of children was unintentional, but, never the less expected, so it should not be treated as a case of bad luck for these children or a 'price to be paid' by these children for a noble cause. The Governments give compensation to affected persons or their families following accidents and calamities. Every person who develops harm due to failure of a drug or adverse drug reaction is entitled for damages for drug trial volunteers or cases depending on phase of trial and compensation from Pharmaceutical industry or medical personnel or the hospitals. Should the children who have been harmed by OPV and affected by lifelong disability be deprived of legitimate compensation on the ground that this polio eradication program was part of a global program under aegis of WHO ?

On June 10, 2013 I had written to Dr. Sailesh Gupta, the then Secretary General, Indian Academy of Pediatrics that IAP should take up case for compensation to polio cases. I did not get any response, not even acknowledgement of receipt of my letter. During the recently concluded IAP elections every candidate was stressing on ethics and need to take IAP to great heights, so once against on 11th December 2017 I wrote to the Secretary General of IAP with copies to some of Executive Board Members and some of the newly elected members in 2017 elections. But, I have not received any communication from any one till 22nd December.

In fact it is obligatory on the part of IAP to protect children from wrong policies or actions by anyone. Deafening silence observed by IAP is beyond any comprehension.

Dr. Yash Paul
Jaipur
E-mail : dryashpaul2003@yahoo.com

REFERENCES

1. Farmer P, Compos NG. Rethinking Medical Ethics: A View From Below. Eds. Selegelid MJ, Battin MP, Smith CB. In Ethics and Infectious Disease. Blackwell Publishing Ltd. 2006: 246 - 258.

2. Paul Y. Can polio be eradicated from India through present Polio Eradication Program? BMJ - South Asia Edn. 2003; 19: 499 - 50.

3. Wenger J. Polio Eradication in India. BMJ-South Asia Edn. 2003; 19: 684 - 687.

4. Paul Y, Dawson A. Some Ethical Issues Arising from Polio Eradication Programmes in India. Eds. Selgelid MJ, Battin MP, Smith CB. In: Ethics and Infectious Disease. Blackwell Publishing Ltd. 2006; 246 - 258.

Note: This article is based on the presentation titled "Protection of Children from wrong policies" made on 29th October, 2017 during 3rd National Conference of Indian Medico Legal & Ethical Association at Bhubaneshwar.

TABLE No. I: Number of polio cases for year 1998 - 2014

	1998	1999	2000	2001	2002	2003	2004	2005	2006	2007	2008	2009	2010	2011	2012	2013	2014
Virologically Confirmed	1934	1126	265	269	1600	225	136	66	676	874	559	741	42	1	0	0	0
Compatible Cases	2286	1680	362	286	681	370	361	397	494	447	538	473	190	54	31	23	0
VDPVs												21	5	7	1	5	2

** Presently no data regarding polio cases is being displayed on NPSP Website as on 14.04.2014.