Pharmaceutical surveys
An agency called C MARC (2 Bhaskar Mansion, 31 Sitladevi Temple Road, Mahim, Mumbai 400 016) sent its representative to ‘survey’ doctors regarding the kind of prescriptions that are written against a type of disease /disorder/ condition. The aim is to collect 100 successive prescriptions from one doctor, analyse the kind of drugs prescribed for a particular disease and analyse the trends of prescription and the consistency of prescribing. Patients’ names are kept confidential.

It is expected that in one year, 600 prescriptions will have been submitted. For this, A4- sized prescriptions in duplicate are provided to doctors, with their names, degrees and appointments printed on the main page (not the duplicate), free of cost by C MARC. The original copy goes to the patient; the duplicate is returned to the agency. Should the doctor finish his quota of 600 prescriptions in a year, more stationery is provided.

Will the Forum for Medical Ethics Society inform us if this practice is ethical? Is it right to enter into such a liaison with an agency and give away prescriptions for “analysis”? Would not doctors be enticed to write more- than- necessary drugs to show how busy and heavy their practice is?

I do not mind any kind of research activity and am more than willing to help, provided that it is ethical and ultimately helps the patient, not the doctor.

Please let me know if you are aware of such a scheme.

Abortion in India: not a right but a state-sponsored programme
Our population control measures with their top-down, state-enforced approach, and their coercive, autonomy-violating components, need re-examination.

Non-therapeutic abortions (abortions other than those performed to save the life of the mother) are freely promoted, aggressively marketed and effectively enforced by state- co- opted medical professionals. Their unabashed enthusiasm to undertake non-therapeutic interventions is unethical, to say the least. But then, ethics are the first casualty when the state drafts the medical profession to solve social problems.

I do not oppose all abortions, but I am certainly against the state sponsored abortion programme. The state encourages unsafe abortions by default, when it does not enforce the safety provisions of the Medical Termination of Pregnancy Act. It also does the same thing by design, by tacitly approving unsafe abortion as a population control (read family planning) measure.

Any abortion involves the fundamental rights of two individuals - the mother and the foetus. While a woman has a right to privacy — the right not to have her own body interfered with — I believe that the foetus, too, has a right to life, a right to survive. To reconcile these two conflicting rights, and in deference to the rights of women, it has been legally decided that the woman’s right takes precedence till the foetus reaches 12 weeks of age. After that, the foetus is a legal person whose life cannot be taken away except by due process of law.

Women’s demands for contraception and abortion have been assiduously manipulated by the State towards its population control strategy. The medical termination of pregnancy is not provided as a reproductive right of women for unwanted pregnancies (to be exercised in the first 12 weeks). It is aggressively promoted as part of the state’s population policy (up to 20 weeks by law and after that by default).

Thanks to the pressure of the international community (read developed nations), Indian women of the reproductive age are at the mercy of the state and state- co- opted nongovernment organisations. No means are considered improper for the great cause of population control, promoted and financed by international agencies. Ethics are considered senseless niceties and safety norms are impractical in the face of the urgent need for population control. In fact, the state- sponsored programme for contraception and medical termination of pregnancy is a state- enforced medical solution to the social problem of poverty.
I am not against contraception, but it has to be as a freely available and accessible choice of individuals and not a state enforced or coerced measure. In India, contraception is promoted not as an individual choice but as a demand of the state.
Infanticide for reasons of poverty was justly considered barbaric. But the elimination of five million foetuses through MTPs, for the same reasons, brings international acclaim and rewards of funds. The deaths of thousands of women from septic abortions and improperly performed tubectomies are overlooked with impunity. The right of the state to eliminate foetuses, or to prevent children from being born alive, has no explicit or implicit sanction in the constitution. Let there be a debate on this subject.

Ethics in private hospitals
Recent times have seen a great spurt in the growth of privately, owned hospitals (including private trusts) in our city. Most of these start with noble ideas of providing advanced medical treatment to our citizens. Some even have collaborations with major hospitals of global fame. After a few years they peter out to the same format.

Although called research centres, no research is carried out. None is published. It appears that this may be a tax dodge.
15 % of the beds that are promised for the weaker sections of society to the government, to obtain extra FSI and / or relief from customs duties are being manipulated. These 15% beds are either non- existent or disbursed on a community basis or to personal favourites.

Industrialists and management experts control the appointments of doctors, which is usually on a hire and fire basis. Initially they appoint a large number of consultants and slowly weed out the non- crowd pullers. Later on they opt for full- timers who can earn for the hospital on an income-sharing basis.

Recognition is sought from the Medical Council of India, university and other educational institutions, in order to facilitate getting residents at a junior level. These residents get no training or experience, and are not exposed to any responsibility, and there is no teaching programme for them.

In my opinion, every private hospital should have an ethics committee that should go into such issues. The committee should even be empowered to listen to complaints of excessive billing, which is quite frequent in these five- seven star hospitals.

Routine medical circumcision
I am an American social worker seeking information on the ethics of routine medical circumcision. I find lots of medical arguments for and against the practice, but almost nothing on its ethics.

The practice entails many ethically questionable aspects: Surgery is done in the absence of any pathology. The patient is unable to consent, a problem compounded by the fact that the practice is controversial. Surgery is not delayed until the patient comes of age. It is not the least intrusive, restrictive treatment for urinary tract infection. It results in irreversible infringement of bodily integrity and loss of erogenous tissue. It is done for the family’s preference, rather than the patient’s medical needs. There is also the question of paternalism: individual doctors “know better” than the American Academy of Pediatrics and other medical societies, none of which recommend circumcision.

This seems worthy of ethicists’ attention. Are you aware of any literature on this topic?

Tom Morris,tmorris@gene.com

Hepatitis B campaigns
Two and a half years ago, we put out a press release jointly signed by health professionals and voluntary organisations, excerpts of which are reproduced below:

“There is a major ongoing campaign initiated by some commercial agencies towards Hepatitis- B vaccination through vaccination camps, by providing injections of such vaccines as Engerix- B, Shanvac- B and Hepavac. These are being conducted along with very wide publicity by nonprofessional agencies, exploiting the ignorance of well- meaning social organisations. The claims made by these agencies do not present an accurate picture of the incidence of this disease, or the imperative for such a massive vaccination programme.

“Such campaigns are continuing without intervention from the relevant health agencies. Instances have been reported of excessive money making by exploiting the public’s ignorance. We take strong objection to such developments and aim to awaken the relevant health authorities, local and state governments, and public interest agencies and public- spirited individuals to join us in evolving a relevant and rational policy of immunisation.

“Hepatitis B is only one form of jaundice, and not the most widely communicable or of immediate public health importance. For instance, there are various other types of viruses that cause jaundice, spread through water and foodstuffs, which affect the public more. Other diseases of the liver also cause jaundice.

“Hence, the needless alarm created by the mass vaccination drive and associated information disseminated by the various agencies involved is wholly unjustified in its proportion and not relevant at all from the public health point of view. The ignorance of the people is being exploited, spreading fear and a wrong impression about the disease as well as the effectiveness of the vaccine.

“People have been led to believe that the vaccine guarantees protection against all forms of “jaundice” and “cancer” of the liver. Dissemination of such misguided opinion gravely limits possibilities of effective community intervention for even more serious diseases prevalent in our society, which are being ignored to the detriment of the public’s health.

“The introduction of these vaccines is highly questionable considering that there is no evidence based on community studies to justify their use on a mass scale in Indian conditions. Studies quoted in justification of the present campaign are extrapolations of very limited research based on hospital data, largely supported by drug companies with vested interests. Further, any documented evidence in our context has not proved the extraordinary claims that are being made about the effectiveness of the vaccine. On the contrary, small local studies negate the claims to efficacy of the vaccine.

“The department of health has been silent on the essential facts relating to the disease, vaccine quality, the product’s cost and the promotional methods used. This silence has been exploited to the detriment of the public. People feel swindled by the varying costs of the different vaccines at different camps. Most dangerously, there is no legal and medical responsibility being taken in case the vaccines react adversely or if the vaccination is ineffective.

“Considering the gravity of the situation, we demand that:
“Mass vaccination in schools, at public camps and to non- risk groups, must be stopped immediately.
“Drug control authorities and relevant government agencies should take action against the prevailing vaccination campaign and launch an information dissemination exercise presenting the facts of the disease as part of a rational disease control approach.
“The vaccination programme should be conducted only under proper medical supervision and not at all for profit, as is currently the case.
“The government must constitute a committee of experts to prepare guidelines for the prevention of the disease and introduce vaccination only where needed.
“The government should subsidise the cost of the vaccine so that high risk groups are protected from contracting or transmitting this virus.
“This statement is being made to prevent public confusion over the disease and to refute the exaggerated need for vaccination. This is also a strong entreaty to the government to end its ambivalent attitude to ongoing campaigns, and to prevent exploitation of the public by vested interests. Finally, this is meant to inform the public to guard itself against ongoing campaigns and approach the right people for accurate information on the disease and its control.”

Following this press release and the resulting press publicity, the government of Karnataka was pressurised by public attention and the media to set up a high- level committee to investigate into the affair in a “time bound” manner. When no report was forthcoming after a month, we wrote to the minister asking for the report to be produced in the Assembly. I also raised this issue before the new government’s task force on health. However, the report has not been made public.

It would help if your journal writes to the present health minister and as well to the task force, demanding that the report be made public. It would help establish the need for transparency on such critical issues. This will also help raise the ethical questions involved in the renewed attempts by SmithKline Beecham to campaign again (and with extraordinary claims and publicity) for not just their Hepatitis B vaccine, but also the chicken pox vaccine.

HBV vaccine: need for debate
It is learnt that the central government is about to include Hepatitis B vaccination in the Expanded Programme of Imunisation. The Expenditure Finance Committee has recommended an allotment of Rs. 2,825 crore during the Ninth Plan for this purpose. This decision involves an annual expenditure of Rs. 565 crore, whereas the Central Government’s allotment in 1998- 99 for control of malaria and tuberculosis was Rs. 290 crore and Rs. 105 crore receptively. In our view, the decision to commit hundreds of crores of rupees of taxpayers’ money is being taken without critically assessing the risk due to Hepatitis B virus (HBV) in the overall health scenario in our country; without estimating the cost- efficacy of this vaccine; without adequately studying its protective efficacy in Indian infants, and without seriously considering ways to substantially reduce the cost of the programme.

It is a matter of great concern that vaccine manufacturers have launched an aggressive and unethical campaign in favour of universal vaccination. As a result, HBV vaccination is being made almost compulsory in schools; doctors are being given one vial free for buying 10, and claims are made that Hepatitis- B is an important public health problem compared to AIDS. This campaign has been joined by politicians like Kirit Somaiya and Uddhav Thackarey. Many experts seem consciously or unconsciously unduly influenced by this campaign. The decision to include the HBV vaccine in universal immunisation is being taken at the behest of vested interests.

It is claimed that 4.7 per cent of the Indian population are HBV carriers, and 25 per cent of these carriers will die due to the effects of this carrier- status. Alternative, detailed estimates suggest that only about 1.4 per cent of Indians are carriers. Second, the majority of carriers eventually eliminate the virus from their body. Only a minuscule proportion develop cirrhosis or cancer of the liver in later years. Liver cancer takes 40 years to develop. As a result, untimely deaths due to the long term consequences of HBV are comparatively few. It is estimated that not more than 0.1 per cent of newborns in India today will eventually die of hepatitis B. (Seven per cent die of other diseases during the first year of life!)

Moreover, the vaccine is comparatively costly, reducing its cost efficacy when compared to other vaccines such as measles. It is more important to increase the budget for the control of tuberculosis, malaria and other more significant killer diseases, and only then to consider Hepatitis- B vaccination as a part of the childhood immunisation schedule. If HBV vaccination is introduced, the following cost- saving and effective measures must be considered:

Intradermal vaccination, which uses smaller doses, will reduce the vaccine cost by 80 per cent, and has been established to be as effective as intramuscular vaccination. Vaccine manufacturers and their experts are suppressing this fact.

Selective Immunisation: in countries like the UK and Japan, all pregnant women have their blood tested for the presence of the HBV’s surface antigen. Only the small proportion of surface antigen- positive mothers are followed up to have their babies immunised immediately after birth. A modified version of this strategy in India would selectively detect and immunise the most vulnerable and most infectious newborns born to “envelope- antigen positive” mothers. This strategy, would entail an annual expenditure one- sixth to one- twentieth of that required to immunise all newborns.

In consumers’ and the national interest, we demand that there be an adequate public debate on this issue in various fora, where experts present statistics which can be cross checked. Experts and consumer representatives from various organisations should be properly consulted before taking a decision on universal HBV vaccination. Guidelines also need to be formed and strictly implemented on the relationship between medical experts, medical conferences, and the drug industry.