Indian Journal of Medical Ethics

FROM THE PRESS

A deadline to wait for
The Delhi government has constituted a committee to review existing free treatment facilities extended by charitable and other hospitals allotted land on concessional terms by the government.

The committee will suggest suitable policy guidelines for free treatment facilities for needy and deserving patients uniformly in the beneficiary institutions. It will also recommend a proper referral system for optimum utilisation of free treatment by needy patients and a suitable enforcement and monitoring mechanism for this, including a legal framework.

It should submit its recommendations within three months.

UNI: Panel to review free treatment facilities. The Times of India, September 10, 2000.

IVF to get around the law
A public interest litigation in the Supreme Court calls for action to stop clinics from offering sex-selection with in-vitro fertilisation. Sabu George (co-petitioners include CEHAT, Mumbai and MASUM, Pune) has called for a move to ban this effort to bypass the law preventing prenatal sex selection.

Rakesh Bhatnagar: SC urged to intervene against feminicide The Times of India, September 11, 2000.

Remember the oath you took?
The chairperson of the Indian National Human Rights Commission urged members of the medical profession to adhere strictly to the Hippocratic oath to protect the human rights of patients and of people as a whole. Speaking at a seminar in Bhopal on human rights and the medical profession, Mr Justice JS Verma called the medical profession one of the noblest of vocations since it deals directly with the right to life and physical and mental security. Referring to the report of an AIDS patient who was turned away by hospital authorities in Sagar, Madhya Pradesh, the chairperson said that doctors had a great responsibility to appreciate the human rights of AIDS patients.

NHMRC chairperson calls upon medical professionals to protect human rights of patients NHRC newsletter, July 2000.

The guardians of our health
A drunk government doctor created havoc in a primary health centre at Mahim near Palghar, Maharashtra. Dr VV Patil, newly transferred from Talasari, used to be drunk all day. On one occasion, he entered the PHC, threw papers around and abused staff. After the incident was reported the police took a blood tests to check his alcohol level. The district health officer has promised ‘stringent action´ against the doctor once the test report is received. The remote location of this PHC apparently encourages doctors to play truant. More interesting details: the compounder, Ramesh Pander, on whose complaint the police took action, apparently did so because he wanted to assert his political clout; he´s known for his ‘roving eye´. And another, senior doctor at the PHC, Dr Raut, passes his time gambling with medical workers while on duty.

Ram Parmer. Docs drinking and gambling on duty. Mid-day, September 16, 2000.

To observe from afar?
The Indian Medical Association elections for the post of national president degenerated into fisticuffs between an impassioned observer and contestant at the Tardeo office in Mumbai. Some 1,800 members of the IMA were to cast their vote by secret ballot. However, the three observers authorised by various candidates to ensure that no unfair practice was followed, were prevented from entering the voting room. A verbal duel ensued, and the police were called in.

Express News Service: Fisticuffs erupt at IMA election. Indian Express, August 10, 2000

Out of stock
More than 300 nurses from the Sassoon hospital in Pune, and part of the Maharashtra Government Nurses Federation demonstrated outside the hospital to protest the inadequate supply of basic equipment. Basic items like bed sheets, soaps and life-saving drugs are in short supply. “When a patient is admitted we can´t give them a clean mattress.” Even sterilisation facilities are inadequate, and needles and saline sets are in short supply. About 5,000 patients visit the hospital on any given day.

Staff reporter: Sassoon nurses allege inadequate supply of health care items. The Times of India, August 8, 2000

Panel for genome research
The Indian government´s department of biotechnology has set up a National Bioethics Committee to prepare guidelines for research in genomics. The committee has been set up to fulfill obligations under the UNESCO Declaration on the Human Genome and Human Rights, to which India is a signatory.

The panel will be different from the proposed Ethical Review Committee to be set up by the Indian Council of Medical Research (ICMR), which is currently finalising a comprehensive set of ethical guidelines to regulate biomedical research involving human participants.

“There will be some overlap in functioning of the two panels. Probably there could be some sort of co-operation between them later on”, commented an ICMR official . However, the biotechnology department feels that ICMR will be providing only broad guidelines and that will apply to all medical research. The panel set up by the department will focus on genomic research alone and will have powers of implementation.

Dinesh Sharma: India creates bioethics panel for genomics research. Lancet, August 5, 2000.

Doctor versus doctor? Sorry…
Patients claiming damages for medical negligence are often unable to prove their allegations because doctors are unwilling to testify against other doctors. This was one of the conclusions of a study by the Voluntary Organisation in Interest of Consumer Education, New Delhi, after examining grievance redressal mechanisms in 81 large hospitals and small clinics and 86 cases of alleged medical negligence filed in consumer courts in Delhi, Hyderabad, and Lucknow. The study was supported by the Indian health ministry and the World Bank.

More than half the hospitals surveyed did not have mechanisms to manage complaints from patients or their relatives. Patients usually turned to consumer courts only after trying to resolve their grievances with their doctors or hospitals, according to the study. Yet doctors refuse to testify, and hospitals refuse to provide patients their medical records.

Ganapati Mudur: Indian doctors not accountable, says consumer report. BMJ, September 9, 2000.

Infected material kills
The use of infected, date expired items in the Gobind Ballabh Pant hospital in Delhi contributed to the deaths of at least 26 patients in the 1990s, an expert inquiry team has found.

The team was appointed on the basis of complaints filed in 1998 by the People´s Union of Civil Liberties against the hospital, several of its doctors, and a former health minister of Delhi. The case refers to major corruption deals through irregular purchases in the 1990s running into several crores of rupees.

The date expired material implicated in hospital acquired infections and deaths was purchased in the early 1990s and used on patients until around 1998.

The expert committee said that hospital records demonstrated an organised attempt by the hospital administration, through orders and circulars, to use the expired materials, which included catheters and heart valves, many of which were more than five years old. There was damage, discoloration, visible fungal growth, and overall contamination of these items.

Hospital records showed that some non-expired materials also had growth of Staphylococcus aureus. Date expired materials were sterilised again but still tested positive for contamination and were used anyway.

Rohit Sharma: Time expired materials “contributed to 26 deaths”. BMJ, September 9, 2000

Rules for hospitals at last!
Country-wide guidelines for minimum standards in hospitals and nursing homes will be the first step towards regulation of these health facilities, several of which function without laboratories, technical assistants and the minimum equipment. Out of 23 cities with populations of above one million, only nursing homes in Delhi and Mumbai are covered under certain municipal laws, says the Voluntary Health Association of India, and these deal more with the housing facilities than technical requirements.

The guidelines will need to be adopted by the states and the monitoring authority will be the state governments. However, they will not cover the conduct of medical professionals — an area which the Medical Council of India has to take up.
The guidelines provide a schedule of the basic infrastructure for a hospital including blood banking facilities, laboratory support, operation theatres and equipment. If adopted and enforced through adequate regulatory mechanisms, several hospitals in the country would be forced to either update their equipment or simply close down.

Kalpana Jain: Govt framing rules for hospitals, nursing homes. The Times of India, August 28, 2000.

Counseling AIDS patients
The recent suicide attempt in Mumbai by an AIDS patient who also poisoned his wife and killed his two minor children, has raised concern regarding the counselling given to HIV positive patients in public hospitals.

While counselling is mandatory in all public hospitals, there are not many professionally qualified counsellors, especially compared to the number of patients coming to these hospitals every day, and the time spent with each patient is insufficient to discuss all aspects of the disease and coping with it.

“Counselling of HIV positive patients requires skilled counsellors and it cannot be done by the junior-most person in the department, which is the case in hospitals at present,´´ says a senior doctor in a public hospital, adding that the counselling patients get when the doctor gives them the report is not enough. Patients should be told they can lead a normal life with proper diet and exercise, and take charge of their lives..

Roli Srivastava: AIDS patients get little counseling. The Times of India, August 28, 2000.

We get it free and charge you..
Patients in the Jaslok Hospital cardiology department are being charged Rs 40,000 for coronary stents that the company supplied free to the doctors for “pre-marketing trials”. When Mr GNV died following treatment by Dr AB Mehta, his son noticed that the hospital bill included two S-7 coronary stents worth Rs 40,500 each and two angioplasty balloons worth Rs 15,000 each. The S-7 stent manufactured by Medtronics Inc is under pre-marketing trials and supplied free to cardiologists. Dr Mehta claims this was a billing mistake.

Why is the company conducting trials in India for a product which has not yet been cleared for marketing in the West? Because in the West, clinical trials can only be conducted with FDA permission or after the hospital ethics committee examines the proposal in excruciating detail and satisfies itself that proper safeguards are in place. In India, patients often do not know they are being treated by trial equipment.

Sumit Ghosal: Angioplasty patients being exploited by trial stents, http://www.healthindia.com/, July 28, 2000.

The poor pay more
The Rajkumar kidnapping has overshadowed a prolonged agitation launched by various organisations in Mysore to protest the hike in consultation, treatment and ward charges at government-run hospitals. Dalit leader Govindaraju said, “Although the state government feels it has calculated the new rates scientifically, and the lower middle class may not feel the effect, just think of the community below that line.” He alleged that hospital staff collect double the amount of fees prescribed from the poor. S.O. Palekar, chief secretary of Health and family planning department, medical education, claims the government has implemented the decision only after talking to all sections of people besides considering the hi-tech services provided at the hospital and increase in the cost of manufacturing medicines.

TOINS: Hike in govt hospitals; poor worst hit. The Times of India, Bangalore. August 26, 2000

A supportive fraternity
An income-tax raid on Ketan Desai, president of the Medical Council of India (MCI), president-elect of the Indian Medical Association (IMA), and chairman of the Academic Committee of the All India Institute of Medical Sciences (AIIMS) led to calls for his resignation, but Dr Desai says he will not quit because none of the allegations have been proved. The IMA´s secretary general says, “A mere income tax raid does not prove anything. If he is prosecuted, then the matter would go to our ethics committee.” The health minister responded to a demand to remove him from various posts with the comment: “Let the investigations be over then we will see.” Desai said “it was not a tax raid, but a routine survey.”

Dinesh C Sharma: Medical body chief under cloud of suspicion in India. Lancet August 12, 2000

Something´s glowing in the dark
The government-run Mehdi Nawaz Jung cancer hospital has lost 73 million milliCurie of radioactive seeds used for treating tumours. Anyone in close contact with them could develop serious health problems. The seeds are Caesium 137 with a half-life of over 30 years. They went missing in June-end but hospital authorities kept the incident under wraps for fear of public outcry.

R Shankar: Radioactive material missing from hospital: loss of lethal 73 milliCurie of radio-active seeds sends the N-establishment into a tizzy. The Indian Express, August 17, 2000.

Drug deal
The United States has offered 24 countries in sub-Saharan Africa five-year loans totalling $1billion, at 7% annual interest, to buy anti-AIDS drugs. The drug would have to be bought from US manufacturers. The offer has been condemned by Oxfam as “a debt that tomorrow´s AIDS orphans will be forced to pay.”

“The deal amounts to a credit-line which locks poor countries into buying expensive patented drugs, when what they need is help to make or buy low cost generic equivalents,” Oxfam said in a press release.

Oxfam accused the United States of setting up the deal to help the drug companies fight off competition from generic drugs that can be manufactured locally. Brazil and India, for example, currently manufacture anti-AIDS drugs at a fraction of the cost of those marketed by multinational pharmaceutical companies.

Annabel Ferriman: $1bn drug deal creates debt for “tomorrow´s AIDS orphans”. BMJ, July 29, 2000

Cloning is okay
An expert panel´s recommendations for a limited form of human cloning have been endorsed by the UK government. The panel´s proposals include: approval for the use of early embryos to investigate the potential of new medical treatments; scrutiny of all research proposals by the Human Fertilisation and Embryology Authority; approval only if there are no other ways of getting the information; embryos should not be retained for more than 14 days in the growth cycle; no cloning technology mixing cell materials of humans with those of other animals; specific consent from donors for use of eggs or sperm in stem cell research; and cloning for the purpose of creating a baby remains illegal.

Stem Cell Research: Medical Progress with Responsibility is available free from the Department of Health, PO Box 777, London SE1 6XH, or can be accessed at www.doh.gov.uk/cegc/

Akil Fazal: UK government approves limited cloning of human embryos. BMJ, September 2, 2000

Advertising or public announcement?
SmithKline Beecham Mackwoods is accused of breaking guidelines of Sri Lanka´s Cosmetic Devices and Drugs Authority because television advertisements and hoardings for its drug Panadol do not mention the drug´s generic name, paracetamol. The guidelines are based on the WHO´s ethical criteria for medicinal drug promotion.

The brand name appears hourly on Sri Lanka´s national television on a clock face announcing the time.

The company claims, however, that neither the clock face nor the name boards are advertisements since they do not list the product´s benefits; the clock face is a ‘public service message´

Regulators suspect that SmithKline Beecham, which is forced to include generic names in advertisements worldwide, is making an exception in the case of Sri Lanka because it has limited resources to police the industry.

Dinali Goonewardene: Sri Lanka accuses drug company of flouting advertising rules. BMJ, September 16, 2000

Awkward alliance
Back to SmithKline…. The manufacturer of a chickenpox vaccine has linked up with associations of paediatricians and family physicians in Israel for an ad campaign urging parents to get their children vaccinated against chickenpox. The health ministry fears it will be pressurised by parents to include the expensive vaccine in the state-subsidised immunisation programme despite the high natural immunity to the disease. The head of the public health service commented that “any immunisation effort financed by the pharmaceutical company that produces the vaccine poses ethical problems.” Extra money should be spent on a newer safer vaccine against whooping cough; chickenpox is a low priority. Also, the public health service favours giving all children a uniform basket of vaccinations, and not encouraging well-off parents to give their offspring shots that poor families cannot afford.

Judy Siegel-Itzkovich: Drug company pays for campaign for chicken pox vaccination. BMJ, September 16, 2000

Unsafe research
The US government halted all federally funded human research at the University of Oklahoma College of Medicine charging that researchers in a melanoma vaccine trial had breached safety regulations and the university´s institutional review board (IRB) failed to provide adequate supervision.

Independent auditors found personnel producing the vaccine were unqualified; participants received vaccines improperly tested for viral and bacterial contaminants.

Though the trial was stopped following auditors´ recommendations, the principal investigator wrote to patients and investigators that there were no safety issues. In addition to this misrepresentation, the Office of Human Research Protections found that the trial´s informed-consent documents overstated the possible benefits of participation in the trial, a phase I safety study. The university´s IRB had not monitored the trial properly, and changes were made to the trial´s protocol without IRB approval.

Restructuring the university´s system for protecting human participants would include “changes in leadership and an enhanced institutional commitment to human subject protections”.

Michael McCarthy: US government suspends clinical research at another university. Lancet July 22, 2000

The will of God or the law?
As we go to press, the dilemma continues on whether conjoined twins can be surgically separated so that one can survive resulting in the certain death of the other twin.

In August, a UK high court judge ruled that the twins can be separated against their parents´ wishes to save the life of the stronger baby, even though the operation will kill the weaker twin. The parents have appealed the ruling and further consultations are now on.

The twins — “Mary” and “Jodie” are the names assigned for the public — were born to Roman Catholic parents in southern Europe who came to Britain for the birth after it was realised that the foetuses were conjoined.

Both twins will die within six months unless separated. With an operation, Jodie is likely to live with some disability, but Mary will die, because she relies on Jodie´s heart and lungs for her blood supply.

The babies´ parents asked that no operation should be carried out and that “God´s will” should prevail. They said that their community did not have the facilities to cope with Jodie´s disabilities and they would have to leave her in Britain.

A key issue in the case is whether it would be lawful to end Mary´s life to save Jodie or whether this would amount to unlawful killing. It could come down to whether Mary, who has a primitive brain, a useless heart, and non-functioning lungs and relies on Jodie as her life support system, is a person in her own right.

Clare Dyer: Siamese twins to be separated against parents´ will. BMJ, September 2, 2000; Parents of Siamese twins appeal against separation. BMJ, September 9, 2000; Doctrine of necessity could allow separation of twins. BMJ, September 16, 2000