Safety concerns over the use of selective serotonin reuptake inhibitors
There are serious concerns in the West about the use of certain selective serotonin reuptake inhibitors (SSRIs). In the summer of 2003, the UK MHRA (Medicine and Healthcare Regulatory Agency) issued warnings against the use of paroxetine and venlafaxine in patients under 18 years of age because of increased suicidal ideation. In December 2003, the MHRA declared all SSRIs, except fluoxetine, unsuitable for use in that age group, finding the balance of risks and benefits unfavourable for these agents. The US Food and Drug Administration (FDA) recommended that paroxetine should not be used in children and adolescents, citing safety concerns and lack of efficacy. It also issued a public health advisory in October 2003, calling attention to the entire issue and announced an advisory committee meeting in February 2004 to address concerns about the safety of SSRI treatment in children. While the issue was still unresolved, another public advisory was issued on 22 March 2004, asking the manufacturers of all newer antidepressant drugs to include a warning statement on their labels, which recommends close observation of adult and paediatric patients treated with these agents for worsening depression or suicidal thoughts.

Now, the safety concern about SSRIs is in the elderly. A review of SSRI use in the elderly, conducted by researchers from the Consumers’ Association and reported in the Drug and Therapeutic Bulletin, found an increased risk of gastrointestinal bleeding in SSRI users, especially in certain groups (see quote below). Most SSRI package inserts do warn about the potential risk of gastrointestinal bleeding with SSRI use. BBC news reported that the Health Department was considering strengthening these warnings in view of the new information on the topic. There has been no comment on the issue so far from the US FDA. Once again, this is likely to open up the debate regarding safety concerns with SSRIs versus the risk of untreated depression. ‘This report is likely to make our lives more complicated,’ says David Steffens (Head of the Division of Geriatric Psychiatry, Duke University Medical Center, Durham, USA). According to Dr Steffens, ‘The findings clearly point to an increased risk of gastrointestinal bleeding among older people prescribed SSRIs, especially in those over 80, or with concomitant use of aspirin or nonsteroidals.’ Dr Steffens urges psychiatrists and other clinicians to take a careful medical history, review current medications with an aim to identify patients at risk for gastrointestinal bleeding. ‘Overall, SSRIs have a good track record. Clinicians should feel comfortable using them, but they need to be aware of those at high risk of this serious adverse event.’
For more information on SSRI regulations visit: www.mhra.gov.uk for the UK, www.fda.gov for the US.

Mugdha Thakur, Durham, USA

Waste management: Flexible rules will improve compliance
In India, biomedical waste management is regulated under the Biomedical Waste (Management and Handling) Rules, 1998 (Second Amendment, 2000), of the Ministry of Environment and Forests, Government of India. The final deadline for all healthcare units in India to act and comply with these rules was 31 December 2002. In their attempts to comply with these rules, most healthcare facilities are currently facing teething problems. With this in view, the Department of Microbiology at the Choitram Hospital and Research Centre, Indore, organized a national workshop on biomedical waste management on 21–22 February 2004. Various issues pertaining to solid and liquid waste treatment and disposal were discussed. The existing guidelines were reviewed and suggestions for amendments were put forward. The consensus at the end of the workshop was that the rules—and the enforcing authorities—need to be made more user-friendly. The delegates felt that the current set of rules was difficult to interpret. They stated the need for more flexibility in the rules to enable incorporation of indigenous methodologies. This would enable greater compliance with the regulations and help make our environment cleaner and safer.

In its drive to create awareness about a clean environment, the Supreme Court of India issued a directive on 18 December 2003, stating that environmental education has to be made compulsory at all levels of education. It has directed the Central Government, states, union territories and educational organizations responsible for prescribing syllabi to comply with its ruling by the academic year 2004–05. This is essentially a repetition of the Supreme Court directive issued on 22 November 1991. Since that directive was not honoured, the court has promised a closer supervision this time.

Prabha Desikan, Bhopal, Madhya Pradesh

New guidelines for renal transplantation in Tamil Nadu
The Tamil Nadu government has issued new guidelines in relation to the Transplantation of Human Organs Act. These have been necessitated by the fact that kidney sales have been continuing in spite of having been made illegal by the Act. A study by the Centre for Sustainable Development, Indian Institute of Technology, Chennai, among others, shows that the sale of kidneys continues unchecked and the present regulatory system is incapable of preventing it. A major reason for this is that the authorization committee which is supposed to verify the authenticity of the transaction between donor and recipient has been singularly ineffective.
The new guidelines require that private hospitals performing the transplant must produce the donors before the authorization committee 1–3 months after the surgery to assess their well-being. Another guideline requires authorization for the donor from the state of domicile. Yet another guideline requires that human leucocyte antigen (HLA) match, which is crucial to the transplant, must be done in a laboratory not attached to the hospital where the transplant is to be performed.
Despite good intentions, the guidelines are unlikely to be implemented even in those hospitals which perform ethical transplants because of the absence of an effective regulatory mechanism.

Thomas George, Chennai, Tamil Nadu

Canadian physician to lead international campaign on academic medicine
Peter Tugwell (Professor of Medicine and Canada Research Chair in Health Equity at the Centre for Global Health, Institute of Population Health, University of Ottawa, Canada) has been appointed the leader of the international campaign to promote and revitalize academic medicine (bmj.com/academicmedicine). Dr Jocalyn Clark, Assistant Editor, BMJ is the project manager. The campaign was launched by the BMJ, the Lancet, Croatian Medical Journal, Canadian Medical Association Journal, Medical Journal of Australia and about 15 other organizations and journals in November 2003. The goals of the project are to develop strategies about how academic medicine should ‘look’ in this century; to increase the impact of academic medicine on the rest of medicine and on healthcare; appropriate positioning of the field within medicine and outside it and means of increasing recruitment to, and job satisfaction of, those in academic medicine.
An editorial and various articles have been published in these and other journals. To enhance the impact of the project and to ensure its success, inputs will be accepted not only from physicians but also patients, bureaucrats and others who are interested in the subject and wish to comment on the BMJ website. A meeting will be held in June 2004 in London to address the exact role of academic medicine, its future, its problems and solutions.
Dr Clark says ‘Because we believe that academic medicine is in crisis around the world, the campaign begins from the position that “more of the same” is not enough. Our approach will be inclusive and is designed to ensure a broad input of opinions. Rather than allowing the process to be taken over by a few experts with vested interests, we want to build consensus by inviting a range of global stakeholders to contribute their views. We are especially interested in the views of the “customers” of academic medicine—patients, politicians, practitioners, the public.’

Sanjay A. Pai, Bangalore, Karnataka

Wanted: Correspondents
The National Medical Journal of India is looking for corres-pondents for the ‘News from here and there’ section. We are particularly interested in getting newswriters from the north and northeast regions of India as well as from other countries. By news, we refer to anything that might have happened in your region that will impact on the practice of medicine or will be of interest to physicians in other parts of India. The emphasis of the column, which is usually from 200 to 450 words, is on factual reporting; comments and personal opinions should be kept to a minimum, if at all. Interested correspondents should contact Sanjay A. Pai at s_pai@vsnl.com or nmji@aiims.ac.in