The Indian Medical Association’s newly formulated guidelines on gifts for doctors state that gifts should not be of substantial value, and should primarily entail benefit to patients. Textbooks, ‘modest meals’ and other gifts are okay if they serve a genuine educational function. Individual gifts of minimal value, like pens and notepads, are permitted as long as they are related to the physician’s work. Subsidies to continuing medical education conferences or professional meetings are okay because they help patient care. Likewise funds for medical students to attend selected educational conferences are okay as long as the academic institute selected the beneficiaries.
Payments to defray the costs of a conference should not be accepted directly from the company by the physicians attending the meet. “And cash payments are absolutely unacceptable,” said IMA national president Sudipto Roy. So are industry subsidies for travel, lodging or other personal expenses of physicians attending conferences or meetings.
Twenty years after the leak of methyl isocyanate gas from the Union Carbide factory in Bhopal, the government is acknowledging that its research was incomplete. More than half a million people were exposed to MIC; around 120,000 continue to suffer from chronic respiratory, ophthalmic, reproductive, endocrine, gastro-intestinal, musculo-skeletal, neurological, and mental disorders.
The Indian Council of Medical Research, which followed over 80,000 people exposed to the gas from 1985 to 1994 – but published its first report only in November 2004 – now wants the super-speciality Bhopal Memorial Hospital and Research Centre to continue tracking this cohort. But the hospital director states that this report is of “no public health value” and plans to track 270,000 gas victims to whom the hospital has issued smart cards, for public-health research in MIC-related ailments as well as unrelated problems.
In response to NGOs’ pleas, the Supreme Court appointed a panel to develop treatment protocols for gas-related disorders. The panel will suggest research projects to investigate the long-term health impact of the gas exposure, including the effect on children born to gas-affected parents. Another panel was formed to monitor health-care facilities in Bhopal and to look into complaints from gas-affected patients.
Doctors at the Institute of Immunohaematology in Mumbai used a stem cell therapy developed by the Dublin- and London-based TriStem Corporation to treat four patients with aplastic anaemia at King Edward Memorial Hospital. The treatment was supposed to transform peripheral white blood cells into pluripotent stem cells which were re-infused into the patients.
The hospital’s ethics committee suspended the study after it discovered the company scientist had contacted the patients and posted details of the study and the patients’ photographs on TriStem’s website. One patient died from a respiratory infection that hospital doctors said was a complication of the disease not the treatment.
Critics say that the study has exposed “loopholes” in existing approval mechanisms. They also point out that the Indian government rejects clinical trials of experimental treatments developed abroad when they are carried out exclusively on Indian patients.
The Institute’s director said that before the study the institute had conducted animal tests to establish the safety of the transformed cells. But regulatory experts argue that stem cells from reverse differentiation are “bioengineered” entities and should have been approved by the advisory committee on genetic engineering.
The Hyderabad-based Aurobindo pharmaceutical company has been accused of exploiting Dalit youth to test its anti-diabetic drug Metformin. Unemployed youth were promised between Rs 3,000 and Rs 5,000 to take part in bio-availability tests of the drug – a large sum of money, particularly in an area affected by drought and severe unemployment.
The district medical and health officer said he was satisfied with the company’s answer that Metformin was not hazardous and had deferred further investigation till he received the relevant documents.
In a landmark judgement, the Supreme Court held that employees who get free medical treatment as part of their perks are covered by the Consumer Protection Act and can file cases relating to medical negligence.
The story goes back 15 years when Mrs KL Kotgiri, the wife of a Central Railway worker, died during post-partum tubal ligation at the Byculla railway hospital in Mumbai. The hospital claimed no responsibility but someone directed Mr Kotgiri to medico-legal activist MS Kamath, who took the case to the state consumer forum. But the case was dismissed on the ground that Mr Kotgiri was not a consumer as he did not have to pay for his treatment.
The case went from the state forum to the national commission and finally to the Supreme Court. The Court ruled that since Mr Kotgiri’s wife received medical treatment as part of the conditions of his service, and since the hospital is subsidised by the Union of India, he is covered by the Consumer Protection Act. The national commission must now decide whether Mrs Kotgiri’s death was due to medical negligence, and if so, award compensation.
Under the Bombay Public Trusts Act, charitable hospitals in Mumbai must reserve a portion of their facilities for free or subsidised treatment for poor patients. But, according to a report of the Charity Commissioner, none of the 70 such hospitals in the city provides free treatment. This was discovered when an ex-mill worker went to court after being refused treatment by a charitable hospital.
Charitable hospitals receive various concessions in tax, electricity rates and additional floor space index for their buildings. Only one hospital, Bombay Hospital, provided treatment to poor patients at a concessional rate. And violators can currently be penalised just Rs 2,000 per case.
The High Court asked the hospitals to come up with a policy for poor patients by March 16, 2005.
And in Delhi, some corporate groups are wooing charitable hospitals for their subsidised land and other such assets. Since Delhi Development Authority land allotment rules do not allow charitable institutions to sell their land corporate groups enter into ‘management contracts’ to run the hospital.
The first to go corporate is Jessa Ram Hospital, now renamed ‘Fortis Jessa Ram Hospital’. Devki Devi Foundation and Balaji Trust have entered into management contracts with Max Healthcare.
Twenty-eight-year-old Ramu Burman is one of the four persons, including two minors, who came forward with complaints of forced sterilisation in Madhya Pradesh’s Satna district where the doctors performed nearly 3,100 vasectomy operations in five days to create a world record under the leadership of a maverick IAS officer, Uma Kant Umrao.
Ramu had been seeking fertility treatment when he met a man who promised to inject a medicine to give him strength. On the way to this treatment, he was waylaid by a local anganwadi worker who needed to meet her quota for a sterilisation camp. After the operation, he was given Rs 265 and a blanket.
When the story broke, others came forward. A 17-year-old rickshaw puller was tricked into undergoing the surgery; he was told it was an injection for ‘strength’ as part of a new government scheme for poor people.
“These isolated incidents have negatively impacted the morale of the district administration which is involved in a huge task,” said Umrao. Uma Shankar Gupta, minister in-charge of the district, felt there was nothing wrong in sterilisation targets but said that he would order an inquiry.
Until April 4, 1999, Unbanked Directed (to a specific patient only) Blood Transfusion (UDBT) was legal. After an amendment to the Drugs and Cosmetics Act smaller peripheral hospitals may not transfuse blood unless they have authorised blood banks.
Many rural hospitals do life-saving surgeries, treatment of complicated childbirths and other critical interventions, depending on fresh blood transfusion. Rural surgeons will have to turn away critically ill patients or ask them to purchase blood at great expense and inconvenience from an authorised blood bank far away. Thousands of doctors are faced with this choice: Should they follow the rules and disregard the lives of patients who come to them for treatment? Or should they ignore a blatantly unjust law, help patients in distress and risk punishment?
According to an exemption in the Act, UDBT may be done by Armed Forces Medical Personnel in border areas and smaller hospitals. But it is not ethical to use it on a farm worker whose arm was pulped in a threshing machine or a tribal woman with a ruptured pregnancy.
The Association of Rural Surgeons of India has submitted a petition to the Human Rights Commission requesting it to study the problems of blood transfusion in villages and make it legal for doctors to practise giving blood in a safe manner.
Resident doctors at Sion hospital were assaulted by the relatives of a newborn baby who died shortly after birth, provoking them to go on mass casual leave.
“Many life-saving injections such as adrenalin, efcorlin and liquid soda bicarbonate used to revive a cardiac arrest patient are not available 90% of the time,” says a resident. Patients’ relatives therefore have to be told to fetch the drugs from outside. “This often consumes time and agitates the relatives who take out their anger on us.”
Then there are ‘note’ cases – cases given special attention because of political influence. “Every few days we’re asked to attend to one special patient, sometimes at the expense of emergency cases,” says one doctor.
In February 2005 the government of Cameroon suspended a study of 400 HIV-negative sex workers to evaluate the long-term prophylactic value of the anti-retroviral tenofovir. Activists had argued sex workers on whom the drug was being tested were not made fully aware of the potential risks of participation, and they were not provided adequate health care. Similar protests had led to suspension of the same trial in Cambodia last year.
On March 11, Family Health International, the US-based nonprofit organisation that had organised the Cameroon trial, announced that it was withdrawing from a Nigerian study of sex workers, citing technical, not ethical, concerns.
A day earlier, critics of a pending Thailand study involving injecting drug users (IDUs) funded by the US Centers for Disease Control and Prevention charged that it “ignores international ethical standards.” The study plans to enroll 1,600 uninfected IDUs who visit methadone clinics. Critics charged that such recruitment plans would be coercive; that participants who get infected would not receive anti-HIV drugs, and that they must receive clean needles and syringes to help prevent HIV infection. This is disputed by the head of the CDC programme in Bangkok.
The Pakistan Medical Association has demanded autonomous status for the Pakistan Medical and Dental Council (PMDC) to improve standards of medical and dental education in country.
Because of interference in PMDC affairs, the council had been recognising medical and dental colleges functioning in apartments and small bungalows and producing quacks. The PMDC, meant to monitor the situation, was being rendered ineffective.
The PMA demanded that PMDC start inspecting colleges and de-recognise institutions delivering low-quality education. The council should also take notice of the exorbitant fees being charged by private practitioners and take action against hospitals where patients would die due to negligence. Doctors coming from abroad should not be allowed to practice without permission or provisional registration from the PMDC.
A guarded ward in the Xishan Workers Sanatorium in west Beijing has become home to foreign patients with nervous-system disorders who come for a treatment forbidden in any other country: the injection of cells from aborted foetuses into their brains and spines.
The surgery is carried out by Huang Hongyun, a Chinese neurosurgeon who studied in the USA. Dr Huang admits he cannot fully explain his results but says he has seen so many improvements in the patients he has treated that he has no doubt about his method.
Although he has taken video film of patients before and after surgery and did a survey of 139 patients based on the criteria for function assessment laid down by the American Spinal Injury Association, much of Dr Huang’s work lacks statistical validity because he has not tested the method in a trial.
“I don’t know anyone who doesn’t have an interest in what he’s doing – and I don’t know anyone who approves,” says Geoffrey Raisman at the National Institute of Medical Research. Others warn that Huang is exploiting desperate people to hone a technique that has not undergone rigorous testing and lacks any long-term follow-up.
Dr Huang has prominent backers who urge him to conduct double-blind trials to meet western scientific standards. He refuses, asserting that such studies would be unethical. “These patients are already suffering. If we open them up just for a placebo test, it will only do them harm. We would be doing it for ourselves, not for the patient.”
New internet clearinghouses connecting patients needing organ transplants with altruistic strangers are raising ethical dilemmas for Canadian physicians.
Transplant centres are re-examining their policies regarding altruistic and anonymous donation, under the pressure of long waiting lists, the apparently growing number of people willing to donate a kidney or piece of their liver, and the advent of non-profit and fee-based internet donor matching services.
Given that most transplants involve “improving the quality of somebody’s life, rather than saving a life,” society must determine whether the benefits of living anonymous donations outweigh the risks, particularly to the donor, says Dr Christopher Doig, associate professor of critical care medicine and community health at the University of Calgary.
Anonymous donations and internet brokering may be viable alternatives to long waiting lists, says Dr Ed Cole, director of nephrology for the University Health Network at Toronto’s Mount Sinai Hospital. “I’m not sure we all feel this is the ideal solution to the problem but we’re not prepared to say, no, we won’t consider any of this.”
At an inquiry into the influence of drug companies, UK members of parliament were told that the companies’s influence extends far beyond doctors. Since nurses got the right to prescribe, drug companies have been sponsoring meetings and running ‘diploma’ courses for them, and there is evidence that they are changing their prescribing practices accordingly. Patient groups are turning to the industry of sponsorship – it is likely that drug companies will use this to raise awareness of their products.