|
|
|
|
|
Back to Finance
Coming home |
|
|
Now for the test IITs hope to take analytical minds That the IIT fracas has been brought to a close is itself a relief. The public spat over the revision of the entrance exam system was doing no good to the premium institutes or the man in the middle of it all, Union HRD Minister Kapil Sibal.
Deepening crisis in Syria
Loving and losing parents
Need for drug trials in India
|
Back to Finance A day after taking over the Finance portfolio from Pranab Mukherjee, Prime Minister Manmohan Singh assessed the economic situation with team members Montek Singh Ahluwalia and C. Rangarajan, and gave a clear message: “Reverse the climate of pessimism” and “… revive the animal spirit in the country’s economy”.
This has raised expectations from the “original reformers”. Hopefully, their moves would not be defeated by Congressmen with socialist leanings. UPA chief Sonia Gandhi needs to be more supportive, and manage more effectively reform opponents — either in her own party or among the allies. For the Prime Minister, this is perhaps the last chance to carry forward the process of liberalisation he initiated in 1991. He has a choice to end his term quietly or with a bang — the way he did when he pushed through the nuclear deal with the US. No one knows better than him what needs to be done to rescue the sinking economy. After all, his views are heard with respect by presidents and prime ministers at international forums. The immediate task before him is to turn investor sentiment from negative to positive. If no steps are taken in the short term to control fiscal deficit by undertaking revenue-raising measures, there is a possibility of a downgrade of India’s rating to junk status, which could negate perceptions of foreign investors. The first test before the government is whether it is able to cut the fuel subsidy. The falling rupee value has sent a wrong signal across the country. Measures announced so far to check currency depreciation have proved to be inadequate. Foreign capital outflows, caused partly by the European crisis, may halt if confusion over tax changes from back date is cleared and foreign direct investment is allowed in insurance, aviation and multi-brand retail. In the long term the goods and services tax needs to be pushed through. Controlling inflation should also be high on the government’s priority list. Even if allies or opposition parties hold up some of these steps, Dr Manmohan Singh would, at least, be credited with making a genuine attempt. |
|
Coming home Surjeet Singh, an Indian prisoner whose 30-year-long jail term had come to an end in 2004, has been released by the Pakistan government and sent back to India amid much celebration and media attention at the Wagha border crossing. As he walked back home, the focus shifted to another prisoner lodged in the same jail in Lahore, Sarabjit Singh, who is on a death row.
His family has made repeated pleas for clemency to the Pakistani authorities. While these high-profile prisoners get attention, there are hundreds in Indian and Pakistani jails who stay on even after their sentence has been served. Along with Surjeet Singh came the news of the release from Karachi jail of 311 Indian fishermen – 289 adults and 22 children set free by the Sindh High Court. This would be the largest number of prisoners released by Pakistan in one go. Both India and Pakistan need to take measures that would ensure humane treatment of prisoners. There should be a mechanism to ensure prompt repatriation of a prisoner to the nation of origin after the judicial sentence has been served. The two nations share a long border, and even with strong security measures, there are instances when people from one side stray into the other, especially in the case of boats fishing in Sir Creek. There has been a new willingness from the Pakistani side to improve relations with India and discuss contentious issues, though on combating terror its record continues to be dodgy. In such an environment, the two sides must work together to find ways to reduce human misery caused by delays in releasing prisoners. It needed only a glance at Surjeet Singh’s face to see the ecstasy of being reunited with one’s family. On the other hand, the pall of gloom at Sarabjit Singh’s village after it was made known that he was not being released was heart-wrenching. Both instances underline the fact that nations must not lose focus of the human dimensions of the decisions they take. |
|
|
Now for the test That the IIT fracas has been brought to a close is itself a relief. The public spat over the revision of the entrance exam system was doing no good to the premium institutes or the man in the middle of it all, Union HRD Minister Kapil Sibal.
The second round of negotiations to iron out the differences has been more inclusive — taking on board the IIT Council as well as the senates of the various IITs — and should have been done in the first place to save the government embarrassment and students the anxiety. There was pressure from the Prime Minister too to settle the matter quickly, which may have helped. This is, however, only the beginning of the long process of implementing the changes, and then reviewing the outcome. It will be a while before we realise if the goals of easing the pressure on students and improving the intake at the IITs have been achieved. Aspirants will now have to be among the top 20 per cent scorers in their board exam result to qualify for an IIT. Besides, the entrance exam will also have a component to test their analytical ability, which means there will be ‘subjective’ questions too. There were doubts being expressed about the kind of students joining the IITs, as many had been hatched in coaching centres, which excelled in teaching how to ‘crack’ the exam, as different from increasing students’ comprehension of the subject. This brings us to the wider question of education in the time of job pressure. Students are advised to take up courses that offer greater assurance of employment. While this industry-oriented learning is critical for a country that sees income generation as a priority, it denies pure sciences and humanities courses, such as physics or philosophy, the best of students. These academic studies are the basis of all future development of subjects like IT or even management. India at the moment depends on the ‘developed countries’ for this essential knowledge base. That’s not a good idea if we, too, hope to be a developed nation.
|
|
|
The way to love anything is to realise that it may be lost. — Gilbert K. Chesterton
|
Deepening crisis in Syria
It
is not official, but by any reckoning Syria has lurched into a civil war. The recent downing of a Turkish warplane by Syria could have escalated into the beginning of a war, but Prime Minister Recep Tayyip Erdogan held his hand and the North Atlantic Treaty Organisation stopped at condemning Damascus. But each day there is telling evidence that outside forces are arming the rebels and the nature of the fighting in the country signifies a higher level of casualties by heavy weapons. Turkey, meanwhile, is hosting an increasing number of Syrian refugees. The Kofi Annan peace plan is in tatters and some 300 unarmed UN observers are cooling their heels in a Damascus hotel because it is too dangerous for them to observe the fighting with partisan passions running high. Russia, once bitten by the passage of a UN Security Council resolution on Libya, which was stretched by the US and other Western powers to wage a virtual air war to support the Libyan rebels leading them to victory, has been clear in not giving the West a fig leaf to repeat the exercise in Syria. With the Security Council thus stalemated, the crisis is defining itself on the ground. The Western dilemma is that there are no easy options, given the diverse ethnic and tribal nature of Syria and the apparent resolve of President Bashar Assad and his coterie to fight to the finish because they realise that the alternative is either their decimation or exile. The Gulf monarchies, particularly Saudi Arabia and Qatar, have made no secret of where their sympathies lie and have been funding arms supplies to the Syrian rebels. And Turkey, Syria’s immediate neighbour and one-time friend, has come out more and openly against the Assad regime, an attitude heightened by the shooting down of its warplane. With casualties mounting on both sides of the divide in Syria, the danger is that, much as the world does not want a new war in the region, it could take a match to trigger a new conflagration. At present the Syrian armed forces have the upper hand because of their superior training and fire power, but the rebels are now receiving more sophisticated weapons and the fighting is less uneven. There is, of course, the larger geopolitical picture, with Syria recognised as the only Arab ally of Iran, which supports the Hezbollah in Lebanon and the Hamas in the Gaza Strip. While the Western view of the Syrian crisis is well known in wanting to see the end of the Assad regime — in fact, an offer was made for his safe passage — there seems to be no immediate viable option in accomplishing this objective except at a formidable cost. Debates in the UN Security Council have assumed a repetitive character, with the West blaming Russia and China for blocking decisive measures and the latter equally clear that they will not repeat the Libyan mistake. The question, therefore, boils down to: What will give? In regional terms, Turkey remains a major player. It has, indeed, come full circle. It was not so long ago that its Foreign Minister had pronounced its policy as one of “zero problems” with neighbours. Initially, Prime Minister Erdogan was miffed with President Assad for totally disregarding his advice in dealing with rebels, and as the Assad regime’s hard line policy progressed, Turkey became more and more of an antagonist. Today it is providing refuge to the fractious opposition and army defectors and the Turkish-Syrian border is porous and is a well-worn route for smuggling weapons and rebel fighters. Wisely, Ankara held its hand in not responding to the shooting down of its warplane in kind, but the atmosphere is supercharged and any inadvertent action on either side could lead to a war. The Arab Spring is a new element in this equation. Egypt is on a new experiment with democracy, despite the overseeing role the armed forces have assumed. The problem with applying it to Syria is that the ruling Alawite minority and the Sunni majority are only two elements of a mix of communities and no one wants to see a splintered Syria. One option the West floated was the Yemen solution, that President Assad goes into exile while his vice-president assumes temporary charge in a transition during which the various parties sit down to find a solution. The catch, of course, is that President Assad does not want to go into exile. The options are narrowing for the divided international community and a solution, if it is to be found, must go beyond the present parameters. Despite Mr Annan’s considerable diplomatic skills, his peace plan has proved to be still-born. The UN route can succeed only if Russia changes its stand, which seems unlikely. A BRICS initiative would be handicapped because two of its members have taken a public stand. The most likely immediate outcome is that the fighting will get much worse before a new round of diplomatic initiative can be undertaken. Among regional powers, Turkey is at the forefront in the crisis and it has the highest stakes in the outcome. After the stability brought about by the Justice and Development Party with its repeated decisive electoral victories and its success in subduing the armed forces, the traditional rulers of the country since the days of Mustafa Kemal Ataturk, the ruling party was spreading its regional wings. Turkey has always considered itself as the natural regional super power and its Foreign Minister, Mr Ahmet Davutoglu, earned for himself the sobriquet of being a neo-Ottoman, harking back to the days of the Ottoman Empire. Suddenly, Ankara looks diminished, caught up as it has become in a next-door civil war. Short of waiting for a miracle, the world can only hope that the major powers will come to the realisation that they must go beyond their stated positions and goals to get to grips with a worsening regional conflict that can waylay the Arab Spring and bring greater misery to hundreds of thousands, if not millions, of people living a hand-to-mouth
existence.
|
|||||
Loving and losing parents One out of every three senior citizens in our country being subjected to abuse, ill-treatment, dishonour and disrespect, and nearly 60 percentile of their total population being made parties in property-related disputes, compels me to think as to whose property they themselves are. Whether you love your children is never a question; but whether you love your parents when they are middle-aged or really old generally varies from person to person. When my mother died, I was surprised to see a doctor-friend of mine, who was treating her till then, breaking down inconsolably. I have always since then known him to be a parent-lover-worshipper rather! A colleague of mine does his mother’s nursing himself who is now 80 years old, despite the doctors’ advice to engage a professional female nursing attendant. I have always found a typical glow on his face, which is surely the result of his basking in the glory of his mother’s blessings - unsaid and not conveyed though, for she is incapacitated even to that extent. An uncle of mine, whose father was murdered when he was just 18, fought valiantly all the legal battles with his mother being around. He said he was actually orphaned when his mother died. I remember what happened when he was to celebrate his son being commissioned in the Army. He cried with his face buried in a pillow, whispering to himself, "O’ God! Only if Bebe were alive today!" A friend’s wife living in the UK lost her mother at home. Condoling and consoling her as is the custom, I said, "Take heart, at least you have had your mother by your side till the ripe age of 82!" "What are you trying to tell me, please!" she said being more upset. I realised then that I should not have said that a ripe age is the right age for some one’s parent to go from our midst. Now a senior bureaucrat, once a childhood buddy of mine, went to call on his parents staying back in his village. Having met his father first, he ushered in an ante-room to meet his mother lying on her cot, struggling for breath and coughing due to an attack of asthma. Holding her skinny hands, the son assuaged her by saying that she would be alright soon, but that his father too was worried about his mother. "Why? Did the old man say that? And does he really think about me, himself being unwell? Take care, O’ son, he is going to be gathered to his ancestors soon!" Believe it; my friend informed me that his father breathed his last the following day. And his mother died day after. He was a broken man. When we were shifting Bau Ji, my father, from a local hospital to the PGI, Chandigarh, after he suffered a heart attack, the paramedics holding the wheeled stretcher dragged him inside the ambulance so unprofessionally that one of his hands got stuck in a latch and his skin tore off. I couldn’t bear the sight of seeing blood on the hand of my unconscious father, who might have at that time not felt any pain. But it pains me till date - his loss apart! Emotions, bonds, tags and values enhance our love for parents. Skirmishes, demands, expectations, environment, place, sacraments, biases, circumstances and your own becoming parents make all the difference. But parents do deserve the desirable, if not equal amount of love, compassion, care and respect. Remember your father’s finger that you held while trying to toddle, now has fissures on its skin, and the cushiony lap of your mother has only bones to make no bones about it. Take care before it’s too late!
|
|||||
Need for drug trials in India A new drug enters the market after going through a long and tenuous process. The initial pre-clinical development takes place in the laboratory either by modification of the existing molecules or by creating an entirely new molecule, which is based on the identification of possible micro-targets in causation of a particular disease. This is a laborious process undertaken by basic medical scientists through many biochemical and pharmaceutical experiments. These experiments are usually done on animals in the initial stages. Several hundred molecules, about 1,000-odd drugs are experimented upon and discarded before a ‘successful’ molecule is selected for the clinical trials. We all are familiar with the chance discovery of penicillin by Alexander Fleming. There are many similar stories of accidental discoveries of drugs like quinine (used to treat malaria) and insulin (used in treatment of diabetes mellitus). But such examples are rather exceptional which cannot be applied to routine discovery of new drugs. The molecule development takes place behind the scenes in laboratories hidden from the public view. It rarely becomes a matter of concern unless there happens to be a disaster or a serious problem occurs with the drug during the trial phases. The use of trial drug in human volunteers and/or patients, at times, causes concerns and doubts in the public mind. Phase II studies involve relatively larger number of people to assess the efficacy of the drug as well as its safety. Both phase I and phase II studies, to be done on human subjects, carry the potential risks of drug-toxicity, which obviously, can’t be anticipated. The trials require a great degree of caution and supervision so as to avoid unintended damages to the volunteers. Phase III studies consist of trials on larger groups of patients at multiple centres usually located in multiple countries. These consist of “final trials” to study a drug for the treatment of a disease before it gets the final approval for marketing. Most of the drugs, which pass through phase III, later become available for commercial use. Some drug companies may also go in for phase IV post-approval studies to assess the drug in actual field-use. Phase IV study may also be undertaken in case of reports of adverse effects and misuses in the community.
Difficulties of clinical trials There are strict regulatory and monitoring provisions applicable to all trials. Most countries, including India, have their own ethical guidelines to follow and Institutional Review Boards to oversee the approval and progress of a trial. Some of the major difficulties that are faced before or during clinical trials of a new drug can be the enormity of costs, long time periods, especially for drugs to be used in treatment of chronic diseases where the end points for control or drug efficacy are poorly defined. Similarly, the time-period for trial of a drug for an uncommon disease is also likely to be long. The inclusion criteria as well as the trial protocol are bound to be rigid, and are required to be religiously adhered. The rate of recruitment of patients is therefore quite slow.
Concerns about drug trials Phase I and phase II trials are generally undertaken by the clinical investigators engaged in the development of a particular drug on behalf of a pharmaceutical company or other sponsors of the drug. It is risky to outsource such trials to external investigators. On the other hand, phase III trials are done by multiple collaborators, most of whom have no direct involvement with the development of the drug. A large number of centres are usually required for recruitment of a few thousand patients who are needed for a phase III trial. To complete the target number of patients required for a phase III trial, the drug companies often choose small or private nursing homes or investigators, who are not necessarily trained in trial protocols. Moreover, the regulatory and monitoring provisions at such places are often lax. This may also be true for many large hospitals or institutional set ups in both the governmental and the private sectors. Financial incentives tend to override the true science of a drug protocol.
Need for trials The Parliamentary Committee, in its recent report, has pointed out that a large number of clinical trials are being done in India — a total of 2,282 trials were approved between 2005-2010. This has been an obvious cause of concern for the people in this country, including those in the medical fraternity. Many of these studies consist of phase III trials involving participants from multiple countries, including from India. What is, however, surprising is the provision that every drug, even if internationally marketed (obviously after phase III trials), should undergo a clinical trial in India before approval for release in the Indian markets. This has the potential of multiplying the number of clinical trials in India by several folds. This provision is unnecessary and one of the reasons for the large number of clinical trials in India. A drug in the developed countries is approved for marketing after extensive research and all phases of trials. All over the world, including in India, the health-care institutions rely on investigators and laboratories of those countries for almost all new drugs. Unfortunately, India can hardly boast of an innovative brand of its own. Re-trials of all such drugs in India are bound to pose problems of increased costs and delays in the availability of the drug in the market. Moreover, some drug companies, in their effort to expedite matters tend to resort to short-cut procedures or even indulge in unethical practices to seek approval for drugs. One of the important reasons cited for this need is the likely possibility of ethnic differences in the effects of many drugs, i.e. a drug, already tested on American volunteers, may cause different reactions in an Indian person. But the issue of ethnic differences in the action of drugs is largely hypothetical. In the past hundred years of pharmaceutical research, there is hardly such an example of a drug with such a propensity. The ethnic or racial variations may explain some of the social, psychological or genetic differences of a disease. But the biochemical and physiological structures of human beings are similar, through and on which the drugs act. From the current evidence which is available, the race cannot be treated as a biological-category. Furthermore, the ethnicity within Indians is highly variable. Possibly in the future, one might even see the era of “personalised medicine” with therapies designed to benefit individual patients with certain genetic characteristic. But race is a poor proxy for wide genetic variability among humans. Globally, blacks, whites, Hispanics and Orientals do not consist of separate ethnic groups which can be used to test for drug effects. Similarly in India, there are no ethnic differences in drug-effects among North, South and North-East Indians or Hindus, Muslims, Sikhs and Christians, or among tribal people and people of different castes. What is more important in the Indian scenario is to check the scientific evidence available globally about the drug to be released and critically analyse the commercial and marketing aspects with reference to the Indian patients; avoid combinations of drugs and other unscientific products which tend to flood the market with poor justification. Any new preparation or fixed dose combination not marketed elsewhere obviously needs an adequate evidence justified with the help of clinical trials. The writer is Professor & Head, Department of Pulmonary Medicine, Postgraduate Institute of Medical Education & Research, Chandigarh |
|
| HOME PAGE | |
Punjab | Haryana | Jammu & Kashmir |
Himachal Pradesh | Regional Briefs |
Nation | Opinions | | Business | Sports | World | Letters | Chandigarh | Ludhiana | Delhi | | Calendar | Weather | Archive | Subscribe | Suggestion | E-mail | |
The
Factually speaking, the basic research constitutes the core and innovative component of a new drug’s development. A lot of this data remains buried on the shelves of laboratories. The development of a drug molecule is often the result of well-thought and planned experiments. Though occasionally, it may happen by chance. 
There are four phases of a clinical trial of which three are done prior to the release of a drug in the market. Phase I studies are done on a limited number of people to evaluate the safety of the drug. It is administered in different therapeutic dosages. All side-effects reported in the “experimental group” are duly identified.