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.

Intracranial aneurysms in patients 18 years of age or under, are they different from aneurysms in adult population?

BACKGROUND: Intracranial aneurysms are extremely uncommon in the first two decades of life. This study was undertaken to assess the clinicoradiological features and surgical outcome of intracranial aneurysms in patients less than or equal to 18 years of age; and, to highlight the differences between these and intracranial aneurysms seen in adult patients. METHODS AND MATERIAL: Twenty-two patients, 18 years of age or under (male:female ratio=1.75:1; mean age 14.18+/-3.8 years, age range 5 to 18 years) and 451 adult patients aged older than 18 years (male:female ratio=1:1.05; mean age 48.21+/-12.71 years, age range, 19 to 81 years) were treated for intracranial aneurysms at our center between January 1991 and July 2003. The univariate statistical analysis was used to compare differences between the two groups. FINDINGS: The patients under 18 years constituted 4.6% of the total patient population having intracranial aneurysms. The incidence of associated medical diseases was greater in patients under 18 years than in the adults (9% versus 0.26%, p<0.05). The incidence of seizures was more than double in patients under 18 years (36% versus 17%, p<0.05). The incidence of intracerebral haematoma (ICH; 41% versus 22.5%, p>0.05), intraventricular haemorrhage (IVH; 45% versus 34%, p>0.05), and hydrocephalus (36% versus 25%, p>0.05) were higher in patients under 18 years. In adult patients, anterior communicating artery (AcoA) and in children, ICA bifurcation were the most frequent sites of aneurysm formation respectively (p<0.05). The incidence of giant aneurysms was nearly double in children (13.6% versus 6.5%, p>0.05). The incidence of clinical vasospasm was almost the same in both groups. The overall outcome was favourable in 82% of patients under 18 years and 58.8% in adults. The management mortality in patients under 18 years was 9.1%, while in the adult patients, it was 19%. CONCLUSION: In patients under 18 years of age, there was a definite male predominance; a higher incidence of seizures; and, the ICA bifurcation formed the most frequent site of intracranial aneurysms. In adults, AcoA a was the commonest site. Rebleeding and delayed ischaemic deficits were the major causes of morbidity. Favorable outcome after surgery in young patients was better in comparison to their adult counterparts.

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'.

Chiari I malformation related syringomyelia: radionuclide cisternography as a predictor of outcome.

BACKGROUND: This prospective study, conducted in patients with Chiari I malformation (C I) related syringomyelia who underwent posterior decompression and duroplasty, utilizes radionuclide cisternography in order to study the cerebrospinal fluid (CSF) dynamics at the foramen magnum and to predict the clinical outcome following surgery. METHODS: 17 consecutive patients of C I with syringomyelia (but without hydrocephalus or fixed atlanto-axial dislocation), underwent a detailed neurological examination and were assigned a clinical disability score based on the modified Klekamp and Samii score. A radionuclide cisternography (using Tc99m-DTPA) was performed via the lumbar route and the ascent of the tracer was followed utilizing a gamma camera immediately after injection and then sequentially after 1, 2, 4, 6 and 24 hours. After posterior decompression and duroplasty, the modified Klekamp and Samii score was repeated at follow-up visits (range: 3 months to one year) along with radionuclide cisternography at 3 months, and MR imaging at 6 months. FINDINGS: Three patterns of tracer flow were observed: a). rapid flow (n=7); b). supratentorial subarachnoid delay (n=7); and, c). foramen magnum block (n=3). The patients having foramen magnum block had the poorest clinical scores on admission. At follow up, there was an improvement in the clinical scores so that the mean scores in all three categories reached nearly the same level. Following posterior decompression, the radionuclide cisternography performed in 10 patients showed a rapid flow of the tracer without any obstruction. The syrinx resolved in 4 of the 11 patients in whom an MRI was done. INTERPRETATION: The patients with C I with syringomyelia may often have a free flow of tracer across the FM. Posterior decompression and duroplasty provides maximum clinical relief in patients with a demonstrable foramen magnum block on radionuclide cisternography while those with a normal flow have less relief. The symptomatology related to brain-stem compression immediately responds to the surgical procedure but the syrinx-induced signs and symptoms of spinal cord dysfunction persist.

Congenital reducible atlantoaxial dislocation: classification and surgical considerations.

BACKGROUND: Reducible atlanto-axial dislocation (AAD) may cause severe motor and respiratory compromise due to recurrent spinal cord and/or brain stem impingement. To the best of the authors' knowledge, this is the first study concentrating on the classification, the protocol of the surgical management and the outcome of congenital, reducible AAD. METHODS: 109 patients with congenital, reducible AAD underwent posterior stabilization. Their preoperative disability was graded as: I (n=11, 10.09%) no functional disability (a history of minor trauma led to quadriparesis that subsequently improved); II (n=31, 28.44%) independent for activities of daily living with minor disability; III (n=42, 38.53%) partially dependent on others for their daily needs; and, IV (n=25, 22.93%) totally dependent. They were classified into 4 groups depending upon their association with: a normal odontoid and posterior arch of atlas (n=27); a dysplastic odontoid and normal posterior arch (n=25); an assimilated posterior arch (n=49); and, Arnold Chiari malformation type I (n=8). Nine patients with a dysplastic odontoid had a "hypermobile" AAD with an unrestricted backward and forward movement of the axis relative to the atlas in flexion as well as in extension of the neck, respectively. The surgical procedures included Brooks' (n=12) or modified Brooks' C1-2 fusion (n=39); Goel's C1-2 fusion (3); Ransford's contoured rod fusion (n=7); Jain's occipitocervical fusion (n=47); and, transoral decompression and Jain's occipitocervical fusion (n=1). There were 6 peri-operative mortalities in the series. FINDINGS: At follow-up (ranging from 3 months to 6 years; n=86), 64 patients had shown improvement by one grade or more; 8 patients, who had a history of transient quadriparesis but were without neurological deficits at presentation, remained in grade I; 11 had achieved stabilization of neurological functions; while 3 had deteriorated despite adequate radiological reduction of AAD and fusion of the construct. A follow-up of 6 months or more was available in 79 of these 86 patients, in whom a dynamic intrathecal CT scan showed a good osseous union. INTERPRETATION: The patients with congenital reducible AAD, depending on their surgical management, may be classified into four groups. Some patients with a dysplastic odontoid have a "hypermobile" AAD and require special care during intubation, positioning and stabilization. An assimilated posterior arch is often associated with asymmetrical lateral occipito-C1-C2 joint synostosis rendering transarticular screw placement difficult. The various causes of failure of constructs are discussed.

Syringomyelia with syringobulbia presenting only with paralysis of 9th and 10th cranial nerves.

We report a case of syringomyelia with syringobulbia, in a patient who presented only with involvement of the 9th and 10th cranial nerves.

Thoracic myelopathy secondary to ossified ligamentum flavum.

BACKGROUND: Focal ossification of the ligamentum flavum (OLF) forms one of the rare causes of thoracic myelopathy. The lower thoracic spine is most frequently affected and the patients present with initial posterior column disturbances followed by progressively increasing spastic paraparesis. The pathogenesis of OLF has not been conclusively established. METHOD: Five patients with thoracic myelopathy due to OLF underwent decompressive laminectomy and excision of the ligamentum flavum. Their MRI delineated a linear or beak like excrescence, uniformly hypo-intense on T1 and T2 weighted images, situated posterior to the thecal sac. A comparison between the preoperative neurological status and the status at follow-up was done using Harsh's myelopathic grading. FINDING: Decompressive laminectomy followed by the drilling of the OLF and its excision, occasionally along with the adherent outer layer of the dura, resulted in significant improvement in motor weakness and tingling sensations. However, at the last available follow-up, none of the patients had retained their ability to run briskly (grade I) and all of them had residual spasticity. INTERPRETATION: OLF may significantly contribute to a spatial reduction of the thoracic spinal canal resulting in paraparesis. The T2 weighted sagittal image of the magnetic resonance imaging (MRI) is the modality of choice for screening of the longitudinal extent of the OLF. A rapid neurological improvement occurs following decompressive laminectomy and excision of the OLF. However, the persistence of residual spasticity at follow-up may be due to irreversible changes within the cord by the significant thecal compression and the delay between the onset of initial symptoms and signs and surgical decompression.

Extended frontobasal approach to the skull base.

The extended frontobasal approach provides an adequate midline exposure from the anterior cranial fossa to the sphenoclival region. Between November 1991 and August 1999, 13 patients with extensive anterior and anterolateral skull base tumours extending to supra and parasellar regions, cavernous sinus and sphenoclival regions were operated upon using this approach alone (7 patients) or in combination with subtemporal -infratemporal (4 patients) or transfacial (2 patients) approaches. Gross total excision was performed in 8 patients while in 4 patients with malignant tumours and in a patient with extensive skull base fungal granuloma, only partial excision was possible. Basal repair was performed using pedicled pericranium, temporalis muscle or fascia lata. The complications included increase in the cranial nerve paresis, endophthalmitis, facial oedema, CSF leak, frontal haematoma and internal carotid artery injury. This study reviews the operative technique, the indications and the complications of extended frontobasal approach.

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.

Anterior retropharyngeal approach to the cervical spine.

The anterior retropharyngeal approach (ARPA) accesses anteriorly situated lesions from the clivus to C3, in patients with a short neck, Klippel Feil anomaly or those in whom the C2-3 and C3-4 disc spaces are situated higher in relation to the hyoid bone and the angle of mandible where it is difficult to approach this region using the conventional anterior approach, due to the superomedial obliquity of the trajectory. The ARPA avoids the potentially contaminated oropharyngeal cavity providing for a simultaneous arthrodesis and instrumentation during the primary surgical procedure. Experience of five patients with high cervical extradural compression, who underwent surgery using this approach between 1994 and 1999, is presented. The surgical procedures included excision of ossified posterior longitudinal ligament (n=2); excision of prolapsed disc and osteophytes (n=2); and excision of a vertebral body neoplasm (n=1). Following the procedure, vertebral arthrodesis was achieved using an iliac graft in all the patients. Only one patient with vertebral body neoplasm required an additional anterior cervical plating procedure for stabilisation the construct. The complications included transient respiratory insufficiency and neurological deterioration in two patients; and, pharyngeal fistula and donor site infection in one patient.

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.

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.

Long-term safety of a non-chlorofluorocarbon-containing triamcinolone acetonide inhalation aerosol in patients with asthma. Azmacort HFA Study Group.

In response to environmental concerns regarding chlorofluorocarbon (CFC), two new triamcinolone acetonide (TAA) inhalation aerosol (Azmacort Inhalation Aerosol) formulations have been developed using a more environmentally favorable propellant, HFA-134a (1,1,1,2-tetrafluoroethane). This multicenter, open-label study evaluated the safety of switching asthma patients from TAA-CFC to one of two TAA-HFA formulations. After a 2- or 4-week baseline period during which patients received only CFC-containing TAA Inhaler, 552 patients were randomized to receive TAA-HFA 75 or 225 microg for 6 or 12 months. A total of 493 patients completed treatment. Seven patients discontinued because of adverse events and two because of ineffective asthma control. The incidence of adverse events was similar in the two treatment groups, and most events were mild to moderate in severity and were not considered related to study medication. No clinically relevant suppression of the hypophyseal-pituitary-adrenal (HPA) axis was observed. Pulmonary function tests were not adversely affected by use of either study medication, and improvements were noted in forced expiratory volume in 1 sec (FEV1) and forced expiratory flow between 25% and 75% of forced vital capacity (FEF25%-75%) throughout the course of treatment. This study confirms that TAA-HFA provides effective, long-term asthma control and can safely be substituted for the currently marketed CFC-containing TAA product.

The voiceless and the new population policy. Camouflaging development.

PIP: In light of the rapid population growth, the rulers of independent India came to a conclusion that the masses should be made to accept a birth control without undertaking the task of remaking a derelict people. They also concluded that such a job of sterilizing people on a large scale be better handed over to the bureaucrats, who carried a long British heritage of imposing the will of the rulers on the hapless masses. Such forms of coercion of the people became a routine in the implementation of family planning in democratic India, amidst the commitment to upholding human rights of all the people. Masses of people of independent India became a target for sterilization of its own government. However, despite taking recourse to mass sterilization and use of more overt physical force to vasectomize more than nine million people during the Emergency period of 1975-76, the population of the country grew relentlessly.^ieng

The voiceless and the new population policy. Misguided family planning priorities.

PIP: Over three decades and a half, the family planning program in India has caused depredations on its state of health services, particularly in the rural health services. The preoccupation with the implementation of birth control has corroded the vitals of the health service system, leaving the entire organization and management in shambles. It is noted that the family program has inflicted three major blows to the country. It repeatedly failed to yield the expected results; a huge quantity of resources was wasted in its implementation; and it dealt a devastating blow on the health service system of the country. Ultimate accountability for these failures and the consequent neglect of health services are put on the hands of those in the political arena. These include the minister in-charge, the cabinet, the National Council for Health and Family Planning, the National Development Council, the Planning Commission and finally, the Parliament.^ieng

The voiceless and the new population policy. Flaws in the population policy.

PIP: In the process of formulating a National Population Policy (NPP) for a vast and a complex country like India, three major considerations are taken into account: 1) policy formulation is a highly complex academic exercise; 2) it is logical that before a new policy is given shape, earlier efforts made in that context should be put together; 3) a new policy must be based on a thorough analysis of the past experience in India and elsewhere. However, it is noted that no effort has been made by the department to take into account the issues mentioned in these sets of considerations. Although the NPP has given an Action Plan which described sociodemographic goals and specific operational strategies, the authors have chosen to ignore the recommendations of the Swaminathan Committee of 1994 and the 1989 policy framework propounded by the then Prime Minister Rajiv Ghandi. These publications had eminently sensible points for a population policy, but have failed to impress the authors of the Action Plan.^ieng

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.

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.