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News Article | February 15, 2017
Site: motherboard.vice.com

Professor Sujoy K. Guha is undeniably stylish. A short, slender man, he is among the select few who can pull off a pair of sneakers with formal shirts and trousers. At 76, he is deceptively brisk, guiding me around the Indian Institute of Technology (IIT) Kharagpur campus to show off his new projects: an artificial heart modeled on the 13-chamber heart of the cockroach; a road transport system to lower vehicular pollution. Guha is cheerful and poised with a birdlike quaver in his voice, not at all how I expected a man who has waited 37 years for his work to be introduced to the world. In 1979, Guha published a paper in the scientific journal Contraception  laying out the idea for his original drug molecule Risug, a non-hormonal, reversible male contraceptive. His idea is simple: All particles carry an electric charge and can be defused by the opposing charge. Sperm are negatively charged and can be defused by the positive ions of the Risug drug polymer. This polymer is inserted with a single injection to the scrotum, which forms an indissoluble film inside the vas deferens—the duct connecting the testes to the penis. The drug formulation for this injection is styrene maleic acid anhydride with dimethyl sulfoxide (SMA+DMSO). A male contraceptive is an unusual thing. Almost the entire range of contraceptive methods available target the female body. The UK's National Health Service website sums up this state of affairs well: out of 16 choices listed for 'methods of contraception', 13 are female. The options for men are condoms (a method whose effect is very limited-term), vasectomy (whose effect is irreversible) and withdrawal. In October of 2016, there was news that the clinical trial of a hormonal male contraceptive, in development for several years, was being stopped on account of side-effects experienced by trial subjects. As of this moment, Risug is possibly the only long-term, reversible male contraceptive in development in the world. (And it's non-hormonal and cheap to boot.) Two years ago, Motherboard wondered why Risug wasn't on the market yet. The average time for a drug to go from idea to market is 10 to 15 years (presumably in the developed world). Now, half of Guha's life later, the word from the Indian Council of Medical Research is that Risug is finally on the cusp of approval. Testing has been completed on 282 subjects across ten hospitals, and the results are nothing short of miraculous—Risug has shown complete effectiveness with zero side effects. A 2011 report by the Ministry of Health and Family Welfare mentioned finding no side effects for the drug in the long-term (a period of nine to ten years), as well as full efficacy. When the 300th volunteer is tested, the Indian Council of Medical Research will formally submit the application for approval to the Central Drugs Standard Control Organization, which is similar to the American FDA. An original drug molecule devised by an Indian individual is a very rare thing. Only two Indians have been credited with such an accomplishment—Dr. U.N. Brahmachari introduced Urea Stibamine to treat Kala Zar, a deadly tropical diseases carried through sand flies; and Dr. Amiyo B. Kar for Centchroman, a nonsteroidal female contraceptive. Guha will be the third. "I have shortlisted two sites for production in Delhi. The knowhow is ready, we just have to scale up from my lab workshop. The sale of my flat is almost finalized," Guha told me. "I am not waiting for a company any longer. I am a scientist, not a marketing man." The professor has been at this juncture before. Fourteen years ago, the then Union Health minister, who oversees public health programs, had announced the imminent availability of Risug in the market, and the news was published in leading national dailies. Just before this, the Ministry of Health and Family Welfare had announced an extension of the clinical trials in support of the drug's imminent production. Then, someone in the Indian Council of Medical Research (ICMR) raised an alarm that Risug led to higher levels of albumin in urine. Guha countered with evidence that albumin levels in men increased across the hot, thirsty months of the Indian summer, when the heat robs bodies of vital nutrients. There was also another problem. In the early 2000s, the Indian government set about tightening the rules for drug approvals among other intellectual property (IP) rights requirements. The timeline granted under the defining Trade-Related Aspects of Intellectual Property Rights (TRIPs) agreement of the World Trade Organisation (WTO), framed in 1995 by the WTO's former avatar known as the General Agreement on Tariffs and Trade, was drawing to a close. The ICMR decided to adopt a set of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) for clinical drug trials. Even if there had been a case for allowing Risug to be tested in the older framework of rules, the drug had been discredited. Everything had to start over. At that time, Guha approached then Indian President Abdul Kalam for help. Kalam is a famous orator, known as a man of science himself, having spent his life working for the Indian national program on nuclear weapons. "He told me, 'Sujoy, you know this is not a scientific block. You have to solve this in other ways'," Guha said. Rejection. Anger. Mellowing. Acceptance. "Sir used to say that every invention takes its maker through four stages," said Dr. Sohini Roy, a biologist who did her PhD under Guha and is now a postdoctoral fellow at UCLA. "He prepared us well for life." When Guha and his co-authors published the first paper on Risug in the international research journal Contraception, he was just 40 years old. He was a professor with both the Indian Institute of Technology Delhi and the All India Institute of Medical Sciences (AIIMS), two of the most renowned institutions in the country, and already had the reputation of a maverick. But he was not a medical doctor, and the ICMR would not consider a drug molecule devised by a non-medically trained individual for clinical trials. At the age of 41, Guha took the medical entrance examination for Delhi University and passed. He completed his medical degree studies while continuing to teach electrical engineering at IIT and biomedical engineering at All India Institute of Medical Sciences (AIIMS). When the clinical testing process began, trials on rats and rabbits (smaller animals) and monkeys (larger animals) moved fairly fast and proved successful. Phase-one of the human clinical trials on 17 volunteers was completed in 1993. It went perfectly. Then, someone photocopied sections from a book called Hazardous Chemicals: Desk Reference and sent them to the national research council. The sections in question listed styrene and maleic anhydride, both part of Risug's formulation, as carcinogens. Guha had to counter again: he argued that substances can be individually toxic in nature but harmless as compounds. He gave the example of pure chlorine, which can melt human flesh on its own, but combined with sodium, it becomes sodium chloride, the basic salt that we consume in our diets. When trials did not resume by 1996, the professor petitioned the Supreme Court. The court dismissed Guha's petition in five minutes, saying they were not the competent authority to rule on it. But it seemed to have sent a message to the government. Phase-two resumed. The antagonist in Risug's story is not the Indian government, according to Guha, but the international pharmaceutical lobby. "The government has, in fact, put in a lot of time and money for the clinical trials," he said. "In the first place, there would be no trials without them." Many of the questions raised about Risug and the resultant delays have been instigated by the National Institutes of Health (NIH) in the US, he contends. For several years, the agency wanted to promote a drug for men that involved regular ingestion like the female pill, Guha said. The first medical practitioner to administer Risug for clinical trials, Dr Gulshanjit Singh, told me a similar thing some years ago. The NIH, he said,  was batting for a hormone-based, repeat-use drug developed by a US-based firm. He remembered meetings where a section of the ICMR argued strongly in favour of this American drug, and pointed out problems with Risug. Singh served as the head of the department of surgery in Safdarjung Hospital and Deen Dayal Upadhyay hospital, two prestigious publicly-funded hospitals in New Delhi. Recent developments seem to support this claim. The drug whose trials were stopped in October 2016 was a hormone-based solution, relying on regular ingestion to control the production of hormones. Regular use implies long-term sales, a steady guarantee of profit. Risug, on the other hand, requires a maximum of two doses--one injection to put the polymer film in place, and another to flush it out of the vas deferens. "In fact, even in the World Health Organization (WHO), there are people who don't want the drug [Risug] to come through," A.R. Nanda, the Union health secretary from 1999-2002, told me. Then, in 2002 came the albumin charge that halted Risug trials, and subsequently the ICMR decided to put Risug through the new framework for clinical drug trials. The clock turned back to the start. Soon after 2002, the professor came away to IIT Kharagpur. He had enrolled in the seventh batch of IIT Kharagpur in 1957. It was the first IIT to be established in India--the first child of prime minister Jawaharlal Nehru's technology-centric national project--and when the professor attended, it was still suffused with a romantic sense of national service. Here in Kharagpur, he established the Risug Center With a new batch of students and researchers. This includes a laboratory, where they produce the drug used in the clinical trials of Risug. When the approval comes through, Guha's team has the knowhow to scale up from the few hundred units they currently produce, to several thousands for market production. There's also another personal history: his maternal uncle was imprisoned for eight years (in three separate terms) by the British colonial administration at the infamous Hijli detention camp here. But he survived it. "From my mother's side of the family, I get my obstinacy. And my father, I saw him kill himself looking after his patients in Patna [the capital of Bihar]. I learned how to keep a job from him," he said. Guha is both a good storyteller, frank without being self-deprecating, realistic and philosophical. He rarely answers a question when you ask it; he gives every question thought and more often than not, he decides it's not worth his time to answer. It takes a certain kind of temper to be a scientist in the Third World. To not be worn out by the waiting, and form-filling, and inevitable jealousies--among peers, bureaucrats, and scientists in other countries. Guha knows this. He makes sure to sleep. He jogs every night because it makes him feel like himself. He tucks his shirt in and combs his silver hair carefully. When I asked Guha if he felt more anxious now than he had in 2002, he walked ahead of me without answering. I thought he wasn't going to answer, but he turned around some seconds later. "One hopes that I have learnt something. I am no longer an angry man." A longer profile of Prof Guha and Risug was published in The Wire .


Millo T.,AIIMS
Journal of Indian Academy of Forensic Medicine | Year: 2014

Custody related deaths are not uncommon in India. A meticulous autopsy becomes a necessary part of the investigation. A retrospective study was done to analyze the prevalence and demographic pattern of custodial related deaths, whose autopsy were conducted at AIIMS, New Delhi. The autopsy reports of 13 years (1999-2011) were analyzed retrospectively. There were total 15 cases of custodial related deaths. All cases were male and majority was in the age group of 25-35 years (8 cases). 9 cases belonged to Hindu and 6 cases belong to Muslim. 10 cases died due to natural disease and 3 cases due to unnatural causes. 10 cases died in the hospital and 5 cases in the custody. Among the 3 unnatural deaths 1 died due to hanging, 1 due to fall from height and 1 from blunt injuries. In 2 cases no exact cause of death could be determined. In India there is overcrowding of prisoners in the jail. In spite of medical screening of the prisoners the infectious diseases like TB is very prevalent in jails. The national human rights commission is taking up the issues to improve the jail conditions in India.


Mahapatra A.K.,AIIMS
Journal of Pediatric Neurosciences | Year: 2011

Background: Anterior encephaloceles are rare conditions. Except for a few places from South East Asia, no large series has been published in the World literature. Materials and Methods: At AIIMS, we have managed 133 cases over a 40-year-period from 1971 to 2010. Frontoethmoidal type was the most frequent, noticed in 104 patients, followed by nasopharyngeal nasal in 12 and orbital encephaloceles in 6 patients. Observation: Ten patients were adults over the age of 18 years and 15 patients were between 5 and 18 years of age. Swelling over the nose was reported in all 104 patients with frontoethmoid type. In nasopharyngeal type, patients presented with respiratory problem. Patients with orbital mass had proptosis, on the side of encephalocele. Computed tomography (CT)/Magnetic resonance imaging (MRI) was performed in 127 patients, which was able to delineate the bone defect and associated brain anomalies. All the patients were subjected to repair of encephalocele. Patients with hypertelorism required orbital osteotomies and correction of deformity. Outcome: There were four deaths, all prior to 2000. No death was encountered in the last 10 years. CSF leak was the commonest postoperative complication, noticed in 24 patients. Overall cosmetic outcome was good.


Mahapatra A.K.,AIIMS
Journal of Pediatric Neurosciences | Year: 2011

Background: Split cord malformation (SCM) is a rare condition. With decreasing incidence of neural tube defect (NTD) in the West, the reports of SCM are getting lesser and lesser. However, in India, spinal dysraphism is still a major problem encountered by the neurosurgeons. Objective: Our aim was to analyze 300 patients of SCM for their clinical features, radiological findings and outcome of surgery, which can throw light on the subject to others, who have less scope of finding these cases frequently. Materials and Methods: Over a 16-year period, we encountered 300 cases of SCM at AIIMS. Over the same period, more than 1500 cases of NTD were managed. SCM was noticed in 20% of cases with NTD. Skin stigmata were noted in two-third of the cases, and scoliosis and foot deformity were observed in 50% and 48% cases, respectively. Motor and sensory deficits were observed in 80% and 70% cases, respectively. Commonest site affected was lumbar or dorsolumbar (55% and 23%, respectively). In 3% cases, it was cervical in location. Magnetic resonance imaging (MRI) scan revealed a large number of anomalies like lipoma, neuroenteric cyst, thick filum and dermoid or epidermoid cysts. All the patients were surgically treated. In type I, bony spurs were excised, and in type II, bands tethering the cord were released. Associated anomalies were managed in the same sitting. Patients were followed up from 3 months to 3 years. Results: Overall improvement was noticed in 50% and stabilization in 44% cases and deterioration of neurological status was recorded in 6% cases. However, 50% of those who deteriorated improved to preop status prior to discharge, 7-10 days following surgery. Conclusions: SCM is rare and not many large series are available. We operated 300 cases and noticed a large number of associated anomalies and also multilevel and multisite splits. Improvement or stabilization was noted in 94% and deterioration in 6% cases. We recommended prophylactic surgery for our asymptomatic patients.


Mishra S.,AIIMS
Indian Heart Journal | Year: 2015

Medical practice is currently at crossroads due to several ills that have crept into the profession. The malaise may have its genesis traced down right from the time of entrance into medical school due at least in part to inadequacy and lack of contemporariness in current medical curricula. There could be several limitations of the medical course at present. The first problem is that rapid technological advances in the practice of medicine have led to an exponential increase in the amount of information and skills that needs to be acquired by the student. Broadly it is a question of dropping vestigial knowledge and re-prioritization of education according to the requirement of the day. The second problem is the alienation of the prospective physician from the society. However, perhaps the most alarming problem is lack of inculcation of empathy, rather a steady decline in its level over the course of medical school. We discuss how these issues can be appropriately addressed in a new curriculum.


Mishra S.,AIIMS
Indian Heart Journal | Year: 2015

The current curriculum is behind its time and urgently requires to be reformed. The changes required are not only in the amount and type of desired information but also in the way this knowledge is acquired. Further, literature, art and philosophy require to be integrated in the curriculum so that a medical student can find his/her bearings in the society. Finally, but most importantly focus must be on developing empathy so that a prospective physician can correlate with the pain of patients and act towards relieving it rather than intellectualizing it. Copyright © 2015, Cardiological Society of India. All rights reserved.


Mishra S.,AIIMS
Indian Heart Journal | Year: 2015

Cerebrovascular disease is the number one killer worldwide. It is increasing in epidemic proportion in developing countries as well, including India. Trained cardiologists are few and scattered in urban areas and there exists a huge shortage of personnel in clinical arena of cardiology specialty. The problem is manifest not only in diagnostics but also in treatment. This space is appropriated by a large number of clinical professionals posing as true cardiologists. Thus, currently there is a critical need to define who can be called a cardiologist and who can be accorded the privilege to treat and even perform interventional procedures. Further, the only credible way to fill this gap is to increase the infrastructure, the staff and the number of teaching, academic hospitals so that there could be an increase in the number of trained cardiologists. Alternate approach to dilute the educational, skill, and experience requirements of the physicians so that more can qualify to be called as cardiologists is likely to be counter-productive since this approach will lead to dilution in the quality of cardiologists which will consequently lead to dilution in the quality of health-care delivery. Further, the irony of matter is that while the pool of cardiologist is increased with the plea of serving rural areas, the hard reality is that very few if any of these so-called trained physicians ever serve the rural area. Thus, it is in this context the tendency to follow the second course should be firmly resisted as also the need to define "who is a cardiologist." 2015 Published by Elsevier B.V. on behalf of Cardiological Society of India.


Mishra S.,AIIMS
Indian Heart Journal | Year: 2015

Abstract Health-care providers are currently facing a huge challenge. At one end they are expending a huge amount of time and energies on health-care delivery including time spent on upgradation of their knowledge and skills (to remain abreast with the field and be able to provide state-of-art patient care), sometimes even at the expense of themselves and their families. On the other hand they are not receiving adequate re-imbursement for their efforts. To compound the problem several "traders" have entered the profession who are well adept in the materialistic approach abandoning the ethics (which currently happens to be the flavor of society in general), giving a bad name to the whole profession and causing severe grief, embarrassment and even dis-illusion to an average physician. The solution to the problem may lie in weeding out these "black sheep" as also realization by the society that the whole profession should not be wrongly labeled, rather a hard toiling and a morally driven practioner should be given his/her due worth Copyright © 2015, Cardiological Society of India. All rights reserved.


Mishra S.,AIIMS | Chaturvedi V.,GB Pant Hospital
Indian Heart Journal | Year: 2015

Physicians in an attempt to give their patients the best possible care need to be updated on the evolving body of scientific research, trials, case reports, and combine this evidence with their own clinical experience keeping in mind each individual patient's circumstances and preferences. To address this felt need, guidelines are systematically developed statements designed to help clinicians make management decisions. While a multitude of guidelines are available from developed world they might not exactly fit into developing world context. Thus a host of fresh guidelines might be required to fill this void or the existing guidelines modified (supplemented, altered or deleted) to be relevant to this part of the world. © 2015 Cardiological Society of India.


Mahapatra A.K.,AIIMS
Pediatric Neurosurgery | Year: 2011

Background: Giant encephalocele is a rare condition and few published reports are available in the English literature. It is a challenge to neurosurgeons, even today. This series consists of 14 patients with giant encephaloceles treated at our institute. Material and Observation: Over a period of 8 years, from 2002 to 2009, 110 patients with encephaloceles were managed at our institute. Amongst them, 14 were children with giant encephaloceles. All patients had CT/MRI or both prior to surgery, and all were operated upon. Four patients were neonates, under 1 month of age, and 9/14 patients (64%) were under 3 months. The youngest child was a newborn baby aged 2 days. Except for 1 with an anterior encephalocele, the rest were patients with occipital encephaloceles. A CT scan was performed on 5 and an MRI on 1 patient. Both CT and MRI scans were performed on the other 8 patients. MRI/CT showed hydrocephalus in 10/14 patients. Of these, 7 required ventriculoperitoneal (VP) shunt, and the remaining 3 with mild to moderate hydrocephalus did not. Of the 7 patients who underwent VP shunt, 5 had a shunt during the encephalocele repair and 2 had a postoperative shunt for increasing hydrocephalus. Results: Other associated anomalies recorded were acquired Chiari malformation in 3 patients, secondary craniostenosis with microcephaly in 5, and syringomyelia in 1 patient. All the patients underwent repair of encephalocele and 4 had suturectomy of coronal suture for the secondary craniostenosis. There were 2 postoperative deaths due to hypothermia. Among the 12 surviving patients, 9 had a good outcome and 3 had poor mental development. The present study shows overall good outcomes in 9/14 (66%) patients. Copyright © 2012 S. Karger AG, Basel.

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