Articles

Biotech Ventures and Ethics

The vision group of Karnataka should blaze a new trail in benchmarking ethics in biotech ventures.

Writing in the latest issue of The Bulletin of the Institute for Business, Technology and Ethics, USA(March-April 2003)Prof David W Gill of New College Berkely, argues that "violating a legal regulation and violating an ethical principle are not the same thing. Ethics and law are related ofcourse or atleast we hope they are. But confusing them, not seeing the diffeence, or worst of reducing an ethics programmes to a compliance programme (usually staffed by attorneys rather than ethicists) is a big mistake. Infact reducing ethics to little more than compliance may lead to more nom-compliance and more regulatory infractions than if ethics(the real thing) were allowed to share the corporate agenda with compliance. Compliance means operating in conformity with. Compliance is not ethics."

Drug Trials

This is precisely what is happening in the case of The Millenium Biotechnology Policy in Karnataka announced in 2000. Every year the Bio events are held with fanfare and Government claims that almost every month a biotech venture is coming to Karnataka. If we examine ethical side of each venture it leaves much to be desired. The objectives of Millennium Biotech Policy in Karnataka, among others are
1. to spread the awareness about the investment opportunities in biotechnology, genomics, bioinformatics, biofuels, contract research etc. to the entrepreneurial community.
2. to outline a set of incentives and concessions for the biotechnology industry to attract the investments in the state.
3. to provide the specific infrastructure as well as enhance human resources for the development of biotechnology.
4. to provide appropriate institutional framework to achieve the objectives.

It is also mentioned that each Biotech company shall constitute a bioetics committee to consider legal and ethical issues in the area of their work. The public is not aware of how many bioethics committees have been formed in which companies and with what consequences.

Since the announcement of the Millennium Biotech Policy in 2000 many Biotech events and processes in the field of agriculture and medicine are emerging in Karnataka and one does not know the regulatory and ethics monitoring processes established in the Department of Biotechnolgy.

There is total ignorance and non-involvement of the Department of Agriculture either in Promotion or in regulating or in benchmarking ethics in GM cotton crop technology. More GM crops like GM tomato, GM rice, GM potato are all in the pipeline and nobody knows who, how and when they will be regulated. The cost of mismanaged, mis-regulated technology is going to be high. In the case of GM cotton crop it was all the way Monsanto / Mahyco driven BT Cotton technology that was pushed right in the farmers fields. Right from the sale of BT Cotton seeds to the cultivation and subsequent harvest there was neither regulation nor any ethical assessment of the BT cotton cultivation by the farmers. More and more new drugs will be released in the market and the Government of Karnataka and the contract research companies have to declare their ethical practices to research subjects / individuals who are subjected to drug trials.

Sensitive Area

Biotech affects animals, human beings and their livelihood. It is not like regulating Electricity generation and distribution. Regulating new and emerging biotech products and processes are highly people sensitive. It is very easy to benchmark the financial and product standards but most difficult to benchmark the ethics in biotech products. It is hoped that the Vision Group of Karnataka headed by Kiran Muzumadar would benchmark ethics in biotec ventures more stringently and share it with public.

Mother's Milk, HIV and the Feeding Fiasco

Every year the Breast feeding Promotion Network of India(BPNI) orgainises mother's empowerment week in various parts of the country where the virtues of mother's milk and the importance of breast feeding are highlighted so that the health of the baby and the mother is promoted and protected. There is medical, social and clinical evidence worldwide to show that wherever the babies are put to mother's breast both the health of the mother and the baby is forever protected and growth ensured.

There is another agency called Federation of Obstericians and Gynaecologists of India(FOGSI) and in one of its brochures it is emphasized that HIV is transmitted to the baby before, during and soon after the birth. WHO has concluded in many parts of its publications "breast feeding is associated with a significant additional risk of HIV transmission from mother to child as compared to non breast feeding. The risk of mother to child transmission (MCTC) appears to be the greatest during the first few months of infant life but persists as long as breast feeding continues. When replacement feeding is acceptable, feasible, affordable, sustainable and safe, avoidance of all breast feeding by HIV-infected mothers is recommended."

National Aids Control Organisation (NACO) has conveniently said "the option of beast feeding is left to the mother to decide after counselling on the risks and and benefits of various options of infant feeding practices." The Government of India with good intention to promote breast feeding and stop the sale of commercial infant milk substitutes like baby foods and infant milk powder , passed a law, Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of production, supply and distribution) Act, in 1992. this has been to implemented to stop the sale of baby foods, and in the 90's UNICEF spearheaded the Baby Friendly Hospital Initiative(BFHI) under which Government hospitals converted into BFHI . During 1992 - 98, as UNICEF representative, I converted as many as 20 Government hospitals in Madhya Pradesh in to BFHI ones. Under the 1992 Act, manufacturers who sell Lactogen 1&2, Amul Spray, Glacto 1, Milk Care, Nusobee, etc could be prosecuted under the provision of the Act.

Confusion

One of the BPNI publication says " the intention of manufacturer is to persuade doctors to advise the pregnant women and mothers of infants to bottlefeed their new born by providing them with free samples of their products. Once the infants start bottle feeding it affects natural breastfeeding and the infant would be caught in this trap. So we have to promote the breastfeeding come what may! This was the situation before the MCTC was confirmed . The anti-retroviral drug companies which are in the business of selling them to protect the mother's from MCTC, have not been as yet allowed in a big way to sell them because the health departments do not know whether to administer them or not.

Neveripine is the drug that can stop the MCTC if given at the right time, according to Boehringer Ingelheim - the manufacturer of Neveripine. This has been added to the WHO model List of essential drugs for the indication of prevention of MCTC. This company declares that " HIV may be transmitted from the mother to the child at various stages of pregnancy , including in utero. A single dose if Noveripine can be given to mothers during labour and to their infants within 48-72 hours of birth. Neveripine levels in breast milk would maintain above 100ng.ml in most of the mothers through out the first week. The amount of Neveripine provided to the infants via breast feeding although small, would have the potential to offer some protection against MCTC."

Scary Situation

Against this background of emerging and scary situation we can imagine the fate of ordinary ill-informed mothers who are affected by the HIV. MCTC has already kille d and is going to kill hundreds of mothers and their babies and the Health Department in the state and Our Medical Fraternity are not able to come out with a clear stand on how to arrest MCTC and at the same time help the mothers provide care and protection to themselves and to their newborns. There is no clear policy on providing anti-retroviral in large number of antenatal care centers in the State and the moribund Karnatka State Aids Society does not even know about the MCTC and how to face it in hundreds of our health centers across the state.

A typical mother is faced with many dilemmas. She does not know whether to breastfeed or not, if so how much and when, if not what else to feed. The law prohibits to substitute feeding in hospitals. In some hospitals human milk banks are established to help the babies who cannot get mother's milk for some reasons. Can this milk be used by mothers affected by HIV? There is no answer forthcoming from anywhere. Even NACO appears helpless.

In Bangalore and Mumbai, hundreds of HIV positive mothers have committed suicide after abandoning their babies. There is no proper counselling to these affected mothers and the hospital staff themselves scare them away from hospitals. Thus we can see several paradoxes and conflicting statements by different agencies involved in protecting the health of the child and the mother. There is a saying in medical fraternity that if two doctors disagree the patient dies! Southern States are floating on HIV / AIDS and Karnataka is no exception. There is no sense of urgency among our policy makers and legislators although there is a Legislator's Forum in Karnataka to fight HIV / AIDS. The State Health Department must bring out a white paper on the HIV / AIDS situation, particularly highlighting MCTC, so that our mothers would know what to do to fight this dreaded disease.