Is God’s Own Country the land of Ginea pigs? Friday, Aug 17 2012

IndiaVision television channel has reported on large scale clinical trials of drug trials in Kerala. http://www.indiavisiontv.com/2012/08/16/101958.html

It claims that about 100 people have died during drug trials. This and other allegations are not well corroborated.  Given the number of trials that have taken place in the State, this is, however, not an improbable figure though many of them may have died during the trial due to other causes. But were they well investigated?

Given the number of trials being done in a few of the institutions, it is clear that sufficient attention is not being paid to obtaining informed consent of the patients and proper monitoring of their health and side effects.

The report raises several questions: Is it ethical to use free medical camps as a recruiting ground for clinical trials?

It is seen that old and unhealthy patients have been used for testing new drugs. Though such patients can be subjected to studies on efficacy of approved drugs, is it ethical to try new drugs on them?

It appears that Trivandrum had at least two institutions that were exclusively engaged in drug trials. Is it right for institutions without facilities for emergency care to undertake such tests?

It is reported that a hospital used to obtain consent for testing medicines after patients have been administered with anesthetics and such medicines are injected when they are unconscious. If true, this calls for a criminal investigation.

Should not the ethical committees in hospitals be appointed and controlled by the government. Should not they at least have representatives of government in them? Should not an independent agency be recording informed consent of patients? Or, there should be a government controlled depository for such consents with authority to verify consents randomly. Details of clinical trials being done by each institution should be well-publicised and transparent.

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Endosulfan, a Kerala story Saturday, Apr 23 2011

Cover of the book published by Kerala Government, Endosulfan: the Kerala story

Chief Minister of Kerala V. S. Achuthanandan should be congratulated for offering fast on April 25 to press for ban on endosulfan. However, it only becomes penance for four years of inaction after he assumed office.

Despite the sympathies expressed for endosulfan campaign while he was the Opposition leader, Mr. Achuthanandan did hardly anything for the endosulfan victims for four years. He could not excuse himself that his party was in the way as this was one of the few issues on which the party was not at odds with him.

However, he scrambled back into action by the time the elections were around the corner. The Cabinet entrusted the State Council for Science, Technology and Environment with a quick assessment of the damage. However, the time available was very limited for a scientific study and the expert committee could not submit its report till now. It faced problems about sampling, testing and selection of control populations.

So, the all-party delegation went to Delhi without a scientifically prepared dossier but with a brochure on endosulfan to persuade the Centre to support an on endosulfan. The Centre took refuge on need for further studies though further studies are not really needed for the purpose of ban. There is ample evidence that endosulfan causes many diseases though it can be debated whether a particular case is caused by endosulfan. However, considering the known mechanisms of its causing diseases and known status of endosulfan persistent organic pollutant and one that can gravely affect the brain and reproductive systems, the precautionary principle applies. The principle has been upheld by courts in India, yet it has not been forcefully raised by the delegation.

The government claims to have provided much assistance to the victims in recent months. However, it did not match even non-governmental organisations like Solidarity (youth arm of Jama ate Islami) . However, it is to be acknowledged that it did provide considerable medical assistance though it did not reach all. Though it has announced Rs. 2000 a month each to the victims in this year’s budget, the job of distributing it actually falls on the next government.  Even the Rs. 300 a month announced for by-standers are yet to reach many affected families. There are complaints that the survey done by the government to identify victims were not exhaustive even while it allowed some people affected by non-endosulfan related diseases to get into the list.

Though the problem in Kasaragod was known to governments for two decades, they had done nothing to decontaminate the area, supply pure drinking water or promote replacement of food crops with cash crops as food crops in the area also carried endosulfan residues according to some studies.

It is known that the officials of the Plantation Corporation of Kerala violated several laws in spraying endosulfan over large areas with little precautions. Though the Chief Minister promised action against them six months ago, no steps had actually been taken. A police investigation would be needed to find out whether they have also dumped stocks in pits and covered them up.  If the Corporation and its officials are allowed to go scot free, tragedies like that in Kasaragod would recur. In fact, it is already happening in Idukki district and elsewhere as motorised pumps are used to spray deadly pesticides.

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Much-hyped swine flu problem Saturday, Jun 19 2010

Sunil Gupta, Central team leader

It was unprecedented. The Centre responded to an SOS from Health Secretary of Kerala for vaccines and medicines and Central team to study the spread of swine flu in the State the same day. The team lands in the State the next day and the medicines and vaccines within a few days.

Never before had the Centre sent in a team to the State so quickly, whether it was epidemic or natural calamities.

The Health Secretary had requested 31000 vaccines in addition to 45000 already received and 6.5 lakh tablets of tamilflu to augment the stock of 1.5 lakhs. The vaccines were for use on health personnel who were considered a high risk group. The Secretary had also sought one lakh imported Sanafu vaccines for administration to pregnant women. This, the Centre is yet to concede because of safety and other implications, though the lobbying for its release is on.

What was the hullabaloo all about? About 200 H1N1 cases were confirmed from Trivandrum and Kollam districts of Kerala over a month. Some cases had been reported from Malappuram and elsewhere. 16 persons had died of whom nine were pregnant women. They had died because they were not administered Tamiflue in time. (The Secretary admits that. Then, what was the need for vaccines?). Later, the confirmed H1N1 cases rose to 275 and deaths were about 20. Around the same time, more than 200 persons had died of other variants of influenza and fever.

Do we see a hand behind the hype about H1N1 in Kerala?

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SCT Institute and quality of services Sunday, Dec 20 2009

Newspapers have carried detailed biographies and achievements of K. Mohandas as Director of Sree Chitra Tirunal Institute of Medical Sciences and Technology as he is being appointed as the Vice Chancellor of new Kerala University of Health and Allied Sciences in Thrissur.

However, the grapevine is that the new director at the Institute Dr. Radhakrishnan is bent on undoing what has been done by Dr. Mohandas. This may be pure canard and result of factionalism among staff. However, it has becoming increasingly clear that the Institute is not maintaining its old standards. It is not clear whose legacy this is. But, overcrowding is indeed one of the main reasons.

Long waiting time for patients is usual at the hospital and it can be explained as the result of overcrowding. However, how can one explain hour-long queues before the cash counter? Why do doctors fail to visit patients admitted to the hospital for days?

Postponement of procedures are becoming routine in the cardiology wing. Patients are readied for surgeries, angiograms and the like and then abruptly told that the procedures has been postponed (without any medical reasons). They are often administered preparatory medicines and made to forgo food for hours, only to be told that all that was in vain. (When something like that had happened in a government hospital at Neyyattinkara, the government had ordered an enquiry). This causes considerable stress among patients and that could even be fatal for cardiac patients. A few patients sob.

Patients, whose surgeries or angioplasty is postponed, simply remain in their beds — no doctor may visit them and no nurse would take their blood pressure. This happens when the Institute is short of beds to admit all those on the waiting list.

Well, the food may be good for most patients– the hospital provides eggs to patients on medication for cholesterol. Some say that there are rats in the intensive care units of the Institute. One indeed finds syringes and waste materials on the sun shades.

The doctors, especially those of the neurological wing, seems to be devoted to their work despite overcrowding and other problems. The nurses are qualified and experienced, but tend to ignore safety in minor matters like administration of IV fluids. So, one may find air bubbles in the tube used for administration of IV fluids.

The hospital system is indeed stressed and it is high time that the Central government pumped in more money to expand the facilities. A new building need to constructed to meet the demand for beds.

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The disease of doctors’ strike in Kerala Wednesday, May 14 2008

Doctors under the Kerala Government have been on a serial agitation for quite some time now. Today, they are on strike for the nth time.

The off and on stir, which began in December 2007 over pay revision, has been disrupting medical services in the State for long. Most of these days, barring some intervals, the doctors were on what they call the “non-cooperation’ or work to rule agitation. Crucial campaigns of the government were held at ransom.

Doctors may have a reason to ask for more especially when the prices are going up. The Government says it cannot revise the pay scales of just one category of government service on preferential basis. Instead, it agreed to pay some additional sums as allowances.

That did not satisfy the doctors. So, they have decided to put the patients at risk. It is high time that the Government either settled or suppressed the strike once for all. The people cannot be victims of perennial strikes.

There also seems to be a game plan by some quarters to keep the medical services in disarray to help the private hospitals. Besides doctors, equipments also strike work in government hospitals so often. Medicines and para medical staff are always in short supply.

The financial stringency of the government will not allow it to increase the salaries of government doctors on par with those in the private sector. The job market today is increasingly becoming competitive. If the doctors feel that they are competitive, they should quit government service and join the private hospital, instead of going on strike. If shortage of doctors in government service becomes acute, the government will increase salaries without the doctors having to launch an agitation. Will the doctors take the challenge instead of trying to undermine the system from within?

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Creating a mass market for drugs Thursday, Nov 15 2007

The Government is administering potent drugs to about 25 million people of Kerala (India) today just because a small fraction of them are infected with filaria. This, it claims, would help to eradicate filariasis. The claim has never been proven though the mass drug administration had been going on for years now.

(Mass drug administration is a national programme and the Government claims that nearly five per cent of the population is infected. Idukki, Pathanamthitta and Wayanad districts of Kerala are excluded as the disease is not endemic there. According to the Government, about 6.3 million people are at the risk of catching the disease in Kerala.)

Side effects:
A government that cannot even bring down the density of mosquitoes sufficiently is claiming that it could eliminate the parasites carried by them. If it had checked the mosquito population, several diseases such as Dengue fever, chikungunya and malaria besides filariasis could have been controlled. (KeralaViews is not forgetting that there are different varieties of mosquitoes involved. But the strategy for their elimination could be largely common).

The drugs being administered massively are diethyl carbamazene citrate and albendazole. Both are known to cause a variety of side effects. Though such side effects are not common, the number of incidents would be quite a number in a population of 25 million. While the side effects of DEC would be minimal in uninfected people, its administration could result in severe allergies in infected people. The allergy is caused by microfilaria killed by the drug.

Much more worrisome is the warning that albendazole should not be taken by pregnant women as it could harm the fetus and cause birth defects. Women are advised to take contraceptives for one month after administration of the drug. They should also not take it if they doubt that they are a few weeks pregnant. The general public is not aware of the needed precautions, and even if they are, many may not know that they are pregnant or may ignore the warning. The result would be a higher number of deformed babies.

It may be recalled that doctors used to prescribe DEC to infected persons for 12 days. Now, they say that a single dose would do. Then they want everybody to take it irrespective of whether a person has an infection or not. (A drug, it is to be remembered, is no vitamin supplement). So, the market for the drug would never be dull.

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