Evidence-based National Vaccine Policy.

India has over a century old tradition of development and production of vaccines. The Government rightly adopted self-sufficiency in vaccine production and self-reliance in vaccine technology as its policy objectives in 1986. However, in the absence of a full-fledged vaccine policy, there have been concerns related to demand and supply, manufacture vs. import, role of public and private sectors, choice of vaccines, new and combination vaccines, universal vs. selective vaccination, routine immunization vs. special drives, cost-benefit aspects, regulatory issues, logistics etc. The need for a comprehensive and evidence based vaccine policy that enables informed decisions on all these aspects from the public health point of view brought together doctors, scientists, policy analysts, lawyers and civil society representatives to formulate this policy paper for the consideration of the Government. This paper evolved out of the first ever ICMR-NISTADS national brainstorming workshop on vaccine policy held during 4-5 June, 2009 in New Delhi, and subsequent discussions over email for several weeks, before being adopted unanimously in the present form.

Giant vestibular schwannomas: focusing on the differences between the solid and the cystic variants.

In vestibular schwannomas (VS), the tumour size, as well as the size of the cystic component, have a considerable bearing on the outcome. This study addresses the differences between the cystic and solid variants of giant vestibular schwannomas. The study included 62 patients with giant VSs, of which 40 were solid and 22 were cystic (those in which cystic component greater or equal to 30% of the total tumour volume). The cystic tumour group was further divided into type A (31-60% volume of the cyst within tumour), type B (61-90% intra-tumoural cyst volume) and type C (more than 90% volume of the cyst). The clinicoradiological features, operative findings, histopathological characteristics and outcome of surgery of the two groups were compared. The mean duration of symptoms for the solid and cystic tumours were 21.1 and 26.2 months, respectively. However, six patients with cystic tumours showed recent and rapid neurological deterioration after a protracted existence. Papilloedema, lower cranial nerve involvement, facial paraesthesias and preoperative hydrocephalus were significantly more in cystic tumours. Total excision was achieved in 38 of the solid and 18 of the cystic tumours. VIIth nerve preservation was higher in the cystic lesions [solid 33/40 (82.5%), cystic 21/22 (95.4%)]. Myxoid degeneration, lobular growth patterns and cellular atypia were more prominent in the cystic variants. The giant vestibular schwannomas were associated with a higher incidence of cystic degeneration than has been reported for smaller tumours in literature. In cystic lesions, VIIth nerve preservation was higher due to early decompression of the lesion that facilitated in early identification of the VIIth nerve, except in patients with type C cystic tumour.

Politics of rural health in India.

The setting up of the National Rural Health Mission is yet another political move by the present government of India to make yet another promise to the long suffering rural population to improve their health status. As has happened so often in the past, it is based on questionable premises. It adopts a simplistic approach to a highly complex problem. The Union Ministry of Health and Family Welfare and its advisors, either because of ignorance or otherwise, have doggedly refused to learn from the many experiences of the past, both in terms of the efforts to earlier somewhat sincere efforts to develop endogenous mechanisms to offer access to health services as well as from the devastative impact on the painstakingly built rural health services of the imposition of prefabricated, ill-conceived, ill-formulated, techno-centric vertical programmes on the people of India. The also ignore some of the basic postulates of public health practice in a country like India. That did not substantiate the bases of some of their substantive contentions with scientific data obtained from health systems research reveals that they are not serious about their promise to rural population. This is yet another instance of what Romesh Thaper had called 'Baba Log playing government government'.

A controlled trial of chlorofluorocarbon-free triamcinolone acetonide inhalation aerosol in the treatment of adult patients with persistent asthma. Azmacort HFA Study Group.

STUDY OBJECTIVE: To compare the dose response, efficacy, and safety of inhaled triamcinolone acetonide (TAA) with a hydrofluoroalkane (HFA) propellant (75 microg/puff), TAA with a chlorofluorocarbon propellant (dichlorodifluoromethane [P-12]; 75 microg/puff), and placebo in adult patients with persistent asthma. DESIGN: Multicenter, randomized, double-blind, placebo-controlled, parallel-group study of 514 adult patients with persistent asthma. INTERVENTIONS AND MEASUREMENTS: Patients received 8 weeks of treatment with 150, 300, or 600 microg/d of TAA HFA, the same doses of TAA P-12, or placebo following a 5- to 21-day baseline period. Efficacy was assessed by spirometry, and by daily recordings of albuterol use, peak expiratory flow (PEF), asthma symptom ratings, and nighttime awakenings throughout the study. RESULTS: Linear trend analysis showed that both formulations of TAA at all doses produced statistically significant improvements compared with placebo in spirometry, asthma symptom scores, albuterol use, and PEF. Significant improvement was seen as early as 24 h for morning PEF and as early as 1 week for FEV(1) (TAA HFA, 600 microg/d; TAA P-12, 300 and 600 microg/d) and albuterol use (all doses of both formulations). The P-12 and HFA formulations had comparable efficacy. A dose response showing greater improvement with higher doses was evident for the majority of parameters for both formulations. The incidences of adverse events were similar across all treatment groups with no dose-related trends. CONCLUSION: HFA and P-12 formulations of TAA inhalation aerosol were therapeutically equivalent and showed comparable safety and dose-related efficacy in the treatment of patients with persistent asthma.

In vitro and in vivo techniques used in drug development for evaluation of dose delivery of inhaled corticosteroids.

Oral inhaled corticosteroids are important in the treatment of asthma since their delivery is targeted directly to the lung, which is the site of action. Triamcinolone acetonide (TAA) is an effective and safe corticosteroid that is marketed as a metered-dose inhaler (MDI) with an integrated spacer (Azmacort) for the treatment of asthma. Due to the phasing out of chlorofluorocarbon (CFC) propellants, Azmacort has been reformulated with a non-CFC propellant. Due to the complexities of oral inhaled formulations and the topical nature of drug delivery to the lung for efficacy, the reformulation of oral inhaled MDIs requires careful consideration and support throughout their development, using a combination of in vitro and in vivo studies to ensure clinical comparability for both efficacy and safety. This paper describes a chronological series of studies designed to support the reformulation of Azmacort. These included in vitro studies to estimate respirable fraction, in vivo pulmonary deposition studies, in vivo pharmacokinetic-pharmacodynamic studies to estimate the systemic effects of each formulation, and final clinical studies in adult and pediatric patients to confirm the clinical comparability of the new formulation of Azmacort. The results of these studies, performed at various stages during the development of new formulations, were critical in guiding the reformulation efforts for Azmacort.

Primary intraosseous orbital hemangioma: a case report and review of the literature.

Primary intraosseous orbital hemangiomas are rare tumors. Only 25 cases have been reported in the literature. Very few of them have multiple orbital bone involvement. We report a case with extensive involvement of the orbital roof, the medial and lateral walls of the orbit, and the lesser and greater wings of the sphenoid, and describe a unilateral extradural frontotemporal approach to excise the tumor and decompress the right superior orbital fissure and both optic nerves. A brief clinical and radiological review of the literature is presented.

Posterior occipitoaxial fusion for atlantoaxial dislocation associated with occipitalized atlas.

Between 1989 and 1994, 50 patients suffering from congenital atlantoaxial dislocation with either an assimilated atlas or a thin or deficient posterior arch of the atlas were treated with occipitocervical fusion using the technique described by Jain and colleagues in 1993 with a few modifications. An artificial bridge created from the occipital bone along the margin of the foramen magnum was fused to the axis using sublaminar wiring and interposed strut and lateral onlay bone grafts. Ten patients (20%) also underwent atlantoaxial lateral joint fusion by intraarticular instillation of bone chips. In 22 patients (44%) with irreducible dislocation, posterior fusion was preceded by transoral odontoidectomy. In seven patients (14%) with ventral compression, who showed marked clinical improvement on traction despite radiological evidence of persisting atlantoaxial dislocation, occipitocervical fusion was performed without ventral decompression. Seven patients (14%) underwent a single-stage transoral odontoidectomy and posterior fusion. There was no perioperative mortality and the osseous fusion rate was 88%. Of the 43 patients available at follow-up examination (range 3-12 months), 31 patients (72.09%) improved, seven (16.28%) remained the same, and five (11.6%) deteriorated in comparison with their preoperative status. Hence, this technique achieves a stable occipitocervical arthrodesis without supplemental external orthoses and facilitates early postoperative mobilization.

Giant cell tumor of sphenoid-diverse presentation: report of two cases.

Two rare cases of giant cell tumors of the sphenoid bone are presented. We discuss their imaging, unpredictable biological behavior and management together with a review of the pertinent literature.

Multiple infected extradural parasellar hydatid cysts.

BACKGROUND: Intracranial hydatid disease constitutes 1%-2% of all cases of hydatid disease. Multiple, infected, extradural, parasellar hydatid cysts in a patient constitutes an extremely rare presentation. CASE REPORT: This 21-year-old man presented with a progressive left supraclavicular swelling of 3 years duration and raised intracranial pressure of 6 months duration with a past history of left-sided chronic suppurative otitis media that had resolved with antibiotics. On neurologic examination, he had bilateral deterioration of vision with optic atrophy; right temporal field defect; left III, IV, VI, VI, and V2 cranial nerves palsy; and left ear conductive deafness. The patient's E.S.R was raised. His computed tomography (CT) scan showed a hypodense, lobulated lesion in the middle cranial fossa with a hypodense, nonenhancing rim, septations, and focal calcification without perifocal edema. A purulent fluid was aspirated from the left supraclavicular swelling, which did not reveal any organism on staining and culture. Aspiration of the left temporal swelling showed whitish watery fluid, the cytology of which revealed an infected hydatid cyst. Excision of the left temporal extradural, hydatid cysts was done, except the portion of the capsule adherent to the dura, and albendazole was started. One month later, the supraclavicular hydatid cysts were removed. Six months later, a left mastoidectomy was performed for chronic suppurative otitis media. A repeat CT scan showed complete resolution of the hydatid cysts. There was no recurrence at 1 year follow-up. CONCLUSIONS: A rare case of multiple infected extradural hydatid cysts of the parasellar region is reported. The unusual CT picture of a hypodense lobulated mass with septations and a hyperdense rims is presented. The difficulties in its complete excision and successful management with long-term albendazole therapy are discussed.

Growth hormone-producing pituitary tumours: clinical profile and results of surgery.

BACKGROUND: Growth hormone-producing pituitary tumours present with a wide variety of manifestations. The optimum diagnostic work up, management and follow up of such patients is complex and involves a multidisciplinary approach. There is paucity of data from India with regard to the clinical presentation and results of surgery for growth hormone-producing tumours. METHODS: We studied the first 50 patients presenting during 1989-94 with growth hormone-producing pituitary tumours to our centre. The work up included detailed endocrine and radiological assessment. The surgical outcome was analysed for 35 patients who were operated (trans-sphenoidal 29, transcranial 6) at our centre. RESULTS: All the patients had macroadenomas [mean (SD) diameter 3.12 (0.87) cm]. Seventy-five per cent of the patients had supra- and/or parasellar extension and 57% had visual field defects. Tumour size correlated with the preoperative basal (r = 0.57) and glucose-suppressed (r = 0.54) growth hormone levels. Thirty-three of the 35 patients operated at our centre (trans-sphenoidal 28, transcranial 5) were available for follow up (median duration 34 months). After trans-sphenoidal surgery alone, 12 of the 28 (43%) patients had normalization of growth hormone levels (post-glucose growth hormone < 5 ng/ml), and 9 of 11 (82%) showed improvement in visual fields. CONCLUSION: In India, growth hormone-producing pituitary tumours are usually large in size. The growth hormone levels correlate with the size of the tumour. These tumours can be effectively treated by trans-sphenoidal or transcranial surgery.

Visual status in suprasellar pituitary tumours.

A retrospective analysis of 29 cases of pituitary tumours with suprasellar extension that had undergone surgery by transsphenoidal or transcranial route, was done. The correlation between age, duration of symptoms, pre- and post-operative visual acuity, visual field and suprasellar height of the tumour were analyzed. The age and duration of visual loss were found to have a bearing on the final postoperative visual outcome.

India's voiceless and the new population policy.

Since the early 1950s, India's family planning program has failed to achieve the expected results, has entailed a massive waste of the country's resources, and has had a devastating effect on the health service system. Now the bureaucrats who have drawn up the New National Population Policy (NPP) have, again, decided what is best for the country's voiceless population. In setting out the NPP's "sociodemographic goals" and "strategic themes," the authors have ignored the recommendations made six years ago by the well-respected Swaminathan Committee and the sensible policy framework propounded ten years ago by then Prime Minister Rajiv Gandhi. The outcome is a policy resulting from a process that has failed to take into account the complexity of the policy-formulation process, the necessary inputs from a wide array of disciplines, and the experiences of the past.

A simplistic approach to health policy analysis: the World Bank team on the Indian health sector.

A World Bank report on the health sector in India has set out to offer an alternative policy framework to cushion the impact of structural adjustment programs on health services. By choosing health financing as a tool for policy analysis, it has arrived at highly questionable conclusions.

Report of the commission on health research for development and the countries of the south.

Of late, governments of affluent countries have become more brazen in using United Nations organizations and other global commissions as tools to serve their political and economic interests. WHO and UNICEF have been used by these governments to impose technocentric and dependence-promoting programs on countries of the South. The report of the Commission on Health Research for Development is yet another effort in that direction. It advocates international cooperation in health research. It merely adds to the bulk of documents on international health research. It is ahistorical. It does not analyze why WHO and UNICEF and the governments of affluent countries imposed global programs on immunization and diarrheal and respiratory diseases without bothering to gather even the most elementary data about them. There is a method in the brashness. Worse still, it ignores the rich heritage of health research of the past half a century in countries such as India, Indonesia, and Thailand. It is yet another effort to obscure the message of self-reliance contained in the Alma-Ata Declaration on Primary Health Care.

A fundamental shift in the approach to international health by WHO, UNICEF, and the World Bank: instances of the practice of "intellectual fascism" and totalitarianism in some Asian countries.

Navarro has used the term "intellectual fascism" to depict the intellectual situation in the McCarthy era. Intellectual fascism is now more malignant in the poor countries of the world. The Indian Subcontinent, China, and some other Asian countries provide the context. The struggles of the working class culminated in the Alma-Ata Declaration of self-reliance in health by the peoples of the world. To protect their commercial and political interests, retribution from the rich countries was sharp and swift, they "invented" Selective Primary Health Care and used WHO, UNICEF, the World Bank, and other agencies to let loose on poor countries a barrage of "international initiatives" as global programs on immunization, AIDS, and tuberculosis. These programs were astonishingly defective in concept, design, and implementation. The agencies refused to take note of such criticisms when they were published by others. They have been fascistic, ahistorical, grossly unscientific, and Goebbelsian propagandists. The conscience keepers of public health have mostly kept quiet.

Place of the indigenous and the western systems of medicine in the health services of India.

The interrelationships of the indigenous (traditional and western (modern) systems of medicine are a function of the interplay of social, economic, and political forces in the community. In India, western medicine was used as a political weapon by the colonialists to strengthen the oppressing classes and to weaken the oppressed. Not only were the masses denied access to the western system of medicine, but this system contributed to the decay and degeneration of the preexisting indigenous systems. This western and privileged-class orientation of the health services has been actively perpetuated and promoted by the postcolonial leadership of India. The issue in formulating an alternative health care system for India is essentially that of rectifying the distortions which have been brought about by various forces. The basic premise for such an alternative will be to start with the people. Action in this field will lead to a more harmonious mix between the indigenous and western systems of medicine.

PIP: This is a discussion of the ways in which social, economic, and political factors interrelate to influence health delivery systems in a community. A general social history of health services is presented. It is seen that health services influence the health status of a population; so do, and even more significantly, socioeconomic forces. Health services are, in turn, used as a political weapon to increase the dependence of 1 class on another and to promote certain vested market interests. With industrialization came dislocation of elements of the population. Health services were developed to treat these dislocated people's needs and also to maintain dependency relationships. The industrialized business world also realized that health itself could become an industry. In India, Western medicine was used by the colonialists to strengthen the oppressing classes and weaken the oppressed classes. The colonial system denied access of the masses to this Western medical system. Introduction of so-called "modern" medicine caused the traditional, indigenous medical system to decay and degenerate. The postcolonial leadership in India has continued to use the medical delivery system for its own benefit. Formulation of an alternative health care delivery system must rectify the distortions in the present system. The new system must meet the people's needs.

Population planning in India: national and foreign priorities.

PIP: Dr. Banerji believes that the reason for India's heavy dependence on foreign experts in formulating its population policy is the fact that domestic leaders are unfamiliar with the masses and with social problems, have yielded to outside pressures, and lack competence in technical skills. Birth control has been equated with family planning and therefore the intended results have not been accomplished. Social and economic development must go hand in hand with family planning and the former has to be achieved before the latter can be hoped to produce a drop in the birth rates. The responsibility for population control should be shared widely by all the departments concerned with social and economic development.^ieng

Crash of the immunization program: consequences of a totalitarian approach.

India's Universal Immunization Program, which was to cover a population of more than 90 million pregnant mothers and 83 million infants living in more than 575,000 villages during 1986-90, has failed dismally. The coverage has been less than one-fifth of the requirement in more than half of the population. The situation in most third world countries, which have even weaker political clout and weaker health service infrastructures, is even more catastrophic. From a purely public health standpoint, the disaster was inevitable. No efforts were made even to define the problem of the six immunizable diseases; there was no question of understanding their natural history; the efficacy of the vaccines used was not well-known; the cold chain, which is meant to retain the potency of the vaccines at the time of inoculation, frequently broke down; there was confusion about the dosage; and even where the program is most successful, ecological conditions will erode much of the benefits from immunization. That such a technocentric program was imposed on the peoples of the third world by their governments was bad enough; even more frightening is that these countries were persuaded to follow the line developed in affluent countries by influential agencies such as UNICEF, WHO, the World Bank, the Rockefeller Foundation, and Rotary International. This is an awe-inspiring manifestation of the power of the affluent countries to impose their will on the weak and helpless peoples of the world. It is a bitter irony that UNICEF and WHO, which sponsored the famous global conference at Alma-Ata, should have lent their weight to a program that is the very antithesis of the Declaration. To embark on such a venture, the exponents had to ignore weighty scientific evidence that raised serious doubts about the program. They had to stoop to suppression of information, disinformation, and distortion of information. What is even worse, efforts will be made to erase this experience from memory, and similar efforts will again be made to launch such ill-conceived programs in the name of the welfare of the oppressed peoples of the world. Scholars who have concern for the oppressed must remain vigilant.

C1-C2 rotary subluxation following posterior stabilization for congenital atlantoaxial dislocation.

The authors report a rare complication of C1-C2 rotary subluxation in two children following posterior stabilization for congenital atlantoaxial dislocation (AAD). A patient, with mobile AAD, underwent Brook's C1-C2 fusion while the other, with fixed AAD, underwent transoral decompression followed by Jain's occipitocervical fusion. A pre-existing ligamentous laxity associated with an asymmetrical wire tightening or slippage of the wires due to rotation of the neck in the former, and the drilling of the C1-C2 lateral joints during the transoral procedure in the latter, could have contributed to the rotary subluxation. Both patients presented with persistent torticollis due to fusion in an asymmetrical position with dislocated facet joints. Rotary C1-C2 subluxation, when coexisting with anterior dislocation, has the potential to cause severe and occasionally fatal cord compression. Well defined criteria to diagnose this entity by conventional radiology exist, however, due to the overlap of anatomy, the condition is often overlooked. In the present study, three dimensional reconstruction images using helical computerized tomography were very useful in delineating the subluxation and in planning its surgical reduction and arthrodesis.

Transoral decompression for craniovertebral osseous anomalies: perioperative management dilemmas.

The surgical outcome of 74 patients, who underwent transoral decompression (TOD) for ventral irreducible craniovertebral junction anomalies between January 1989 to September 1997, was studied to evaluate the perioperative complications and problems encountered. The indications for TOD included irreducible atlantoaxial dislocation (n=24), basilar invagination (n=16), and a combination of both (n=35). Following TOD, occipitocervical stabilization using Jain's technique was carried out in 50 (67.5%) and atlantoaxial fusion using Brooks' construct in 18 (24.3%) patients. The pre- and postoperative radiology was compared to assess the adequacy of decompression and stability. The major morbidity included pharyngeal wound sepsis leading to dehiscence (20.3%) and haemorrhage (4%), valopharyngeal insufficiency (8.1%), CSF leak (6.7%) and inadequate decompression (6.7%). Neurological deterioration occurred transiently in 17 (22.9%) and was sustained in 7 (9.4%) patients. The mortality in six cases was due to operative trauma, exanguination from pharyngeal wound (one each), postoperative instability and inability to be weaned off from the ventilator (two each). Of the 47 (63.5%) patients available at follow up ranging from 3 months to 2 years, 26 (55.3%) showed improvement from their preoperative status while 14 (29.8%) demonstrated stabilization of their neurological deficits. Seven (14.9%) of them deteriorated. Though TOD is logical and effective in relieving ventral compression due to craniovertebral junction anomalies, it carries the formidable risks of instability, incomplete decompression, neurological deterioration, CSF leak, infection and palatopharyngeal dysfunction.