Clinical trials in US is both time consuming and expensive. They have to spend millions of dollars for it. Also, they have to insure volunteers for a hefty amount. So, they prefer overseas volunteers to the native ones. US based multinational companies are behind the trials in India.
Prajesh Sen. G, sub-editor at Madhyamam Daily, won the prestigious Ramnath Goenka Excellence in Journalism Award for his exhaustive series on drug trials in India and the loopholes that exist.
We are republishing the award-winning story here:
Kerala’s Guinea Pigs
Outside the lobby of a private hospital on the outskirt of Bangalore city, some young Malayalees wait impatiently. In their best outfit they appear like waiting for a job interview. Each of them has a dossier of medical reports, which declares that they are in best of their health. They go into a room that has name board ‘lab’. Later they come out lying on stretchers with green blankets. In the adjoining room, Nurses monitored them closely. Changes on their bodies were noted in a dairy. When they wake up, nurses help them with ‘glucose water’. That is followed by another round of body check up; temperature taken, and blood samples collected. Glucose is served 4 times in 24 hours. The morning of their stay everybody gets a card. They produce it at the reception and pocket Rs 10,000 each. While leaving they are reminded of the upcoming appointment.
These young men were on duty of a ‘new job’. With slump in IT firms and the upscale city life, they are at their wit’s end. Their salary and perks took a downhill. Many have become paid-volunteers to drug trials. It is now like a ‘special economic zone’. Many students and jobless ones go for drug trials. New drugs need clinically prove their efficacy before marketed. Drugs initially tried on rats, and pigs should later be tested on humans. As per norms drug trials can only be done convincing volunteers about all side effects. But most private hospitals by pass all such clinical guidelines. Volunteers know little about the pitfalls they are about step in. The lure of money gets them to line up before recruiting companies.
They die like rats and pigs
Drug trials are not an easy walk. Data available show that it is a risky affair. In 2007 about 132 volunteers died in India. The toll in 2008 was 288. And in 2009 numbers of people lost to drug trials were 308. As per the official data about 728 people died in three years. The data showcases situation until August 2009. But the grape vine is that about 1000 youths died until August 2010. Both government and drug companies keep things under wraps.
US based multinational companies are behind the trials in India. Back home, they have to spend millions of dollars. Also they have to insure volunteers for a hefty amount. The entire process is both time consuming and expensive. So they prefer overseas volunteers to the native ones.
In 2005, Drugs Controller of India gave nod to 100 drug trials from abroad. Of them only 80 drugs were clinically proven good for marketing. Remaining 20 drugs could cause side-effects. But none cared to ask what happened to those volunteers. Higher ups in the government always have fingers in the pie. So, India is now a ‘drug-trial –hub’. Its population and diseases are just eye-candy for companies. This risky game might lead to more serious situations. Look, why India has been facing many pandemics for over a decade now? Any connection?
Baiting for the wretched
Companies failed in their bid to hook China in the drug trial binge. But, in India, they found youths who forgo work for easy money. Giving a fillip, in 2006 government gave nod to 143 trails. And In 2007 there were 259 drug trials. In 2008 it stood at 246, and 2009 the number was 258. Since 2005, a total of 1006 drugs have been put to trial. A disturbing fact most authorities shy away from.
Of them 613 medicines got market clearance. But it means 393 drugs proved substandard. Drugs once failed to clear might come again in new labels. Companies somehow get clearance to any substandard drug. There are many agents who help companies see through. They forge clinical clearance certificates recruiting healthy youths. Volunteers are kept in the dark about the health hazards.
Every year, USA pump about 300 crore dollars in India for drug trials. WHO states that it will spiral up to $1000 crore this year. The seamy side is Malayalees have hand in this mafia. Hit by costly city life many youths turn to easy money. Drug trails may fetch them Rs 5000 to several lakhs monthly. The secret dealings of this ring are quite awful.
Malayalees, or the research animals
1) Sunil Kumar ( Palakad, kerala)
Age: 24, Healthy
Montly salary: 30,000
2)Joji Agastine ( Kottayam, kerala)
Age: 19, Healthy.
Monthly salary: 25,000.
They are in a list that a drug trial agent showed me. Agents hook youths by showing the list of those already took drug trial. Later, he gave me a telephone number that would connect me to a middle man. Posing as a potential volunteer I called up the number beginning with digits 09343.... . A Malayalee on the other side answered the call. He wanted me to reach at a hospital in the Industrial Estate Area. It wasn’t like a regular hospital with crowded ‘outpatient clinic and wards’. I said that I was badly in need of money for mother’s bypass surgery. Soon I had a brief medical test there. Then, the agent advised me to sell my kidney, if I wanted “big bucks”. He said it frankly that he could get me Rs 2 lakhs on a kidney sale. I said that I was too scared to part with my kidney. Instead I would go for drug trial. They took me to the ‘counselling’ ahead of the trial. Then, the agent gave me a list on types of drug trial and money each would fetch. Monthly payment for trials varied from Rs I lakhs to 1.5 lakhs . The agent was hanging around me with a hint. He was ready to make me into a ‘rewarding list’. But he should get Rs 50,000 as commission.
Now, an American drug for HIV Aids is very ‘rewarding’. At first virus is injected on a healthy person. And the virus will be eliminated before the incubation period. For Aids, the period is about 10 to 15 years. Initially, body mass index of volunteers is taken. Ideal age limits for volunteers is between 20 and 30. In the next stage volunteers have several health screening. They are; testing of glucose in blood, cholesterol, E.S.R, and Bilirubin. Those tested positive for diabetes, Tuberculosis, and increased bilirubin are shunted from the list. Then, Xray of chest is taken to screen pneumonia. Eventually they monitor heart’s function. Qualifying volunteers have to sign a contract. The company will meet all expenses of the tests. Failing volunteers will also get a consolation of Rs 500 each. The contract ensures the company to walk out clean of all responsibilities. No matter if a patient ails or dies. Theywould be made to sign clauses that keep company off all legal liabilities.
Day of Trial
On the day of drug trial volunteers are closely monitored. Body temperature is taken every hour. Heart is checked every four hours. Twice in 24 hours both blood and urine is tested. After the meal the next day, volunteers take a shot of HIV virus. When virus enters, they develop fever. Soon it will disappear. After blood screening through the day volunteers can go home. One month later, they have to take first of 12dose of injections. They stay there for three days .The dose is on a periodicity of one in each month. During this period the “trial animal’ should not leave the nation. For each injection the company will provide one lakh. Also, they get 6 months insurance coverage and medical expenses. Shortly later the agent came up with contract documents. But I fled the scene promising him that I would meet him later.
Adivasis too are exploited
Earlier, Para medical and engineering students volunteered to drug trails. Now, many former IT professionals turn to drug trials. About 15 IT professionals were taken to drug trials at the lab I visited. Of them 12 were Malayalees. An agent admitted that those already into the ring attract more people. Many Adivasi youths from Wayanad are already into drug trials. Some students from Kozhikode do this.
Side story: Unknown deaths
Recently a Malayalee engineering student in Bangalore died dubiously. He was a regular volunteer at a “lab”. He took trial of a new entrant medicine for Melenchities. He developed swelling in the brain leading to serious complications. He was later admitted to a private hospital here. As his condition worsened the student was bundled off to Kerala. Later he died at Calicut Medical college. There was nobody to step in to speak for him. Death was counted in the ‘fever cases’ rampant in the state. Many malayalee youths in Bangalore are ailing from Uraemia. It is a fatal renal complication. Some of them begged the hospitals where they took trials for help. Authorities turned their back on them.
All drug trials in humans are for ensuring the quality of drugs. But, volunteer’s safety is of great importance. But the tendency exist now is quite appalling. Both drug companies and hospitals are only motivated by money. They care little about safety of volunteers. Turning human body into laboratories, they offer wads of currencies.
Auctioning of Patients
In India there are 200 medical colleges. About 22,000 doctors pass out each year. There are 15,622 major hospitals. A total of 903,952 hospitals in urban segment alone. Around 700,000 science and engineer students pass out each year. Now 45 million asthmatic patients, 30 million diabetes cases, 10 million HIV patients, 3 million Cancer patients, and 1.5 million Alzheimer’s patients.
This can be better considered as a bidding list. A covetous list that Indian agents place before foreign drug companies. Both population and diseases attract overseas companies. And toothless laws also create a bad situation.
Drug trials are done in three phases. First phase, ‘trial-drug’ is given to a group of about 20 to 50 volunteers. This is to study drug’s safety and dosage. It costs about $20 million in US. But in India it takes only half the amount. In the second phase, it costs about $50 million in US. In India, it comes around Rs 30 crore .About 100 to 300 healthy people are put to trial. Now, drug’s efficacy and side effects are monitored. The third phase is the most expensive of all. It needs about 1000 people to study various aspects. Clearing three phases the drug comes for licensed for marketing. The entire process is downright tiring. In USA the total cost likely to be about $100 million. But, in India it comes around Rs 60 crore. This makes many overseas companies to eye India. Since 2003 govt has waived import taxes on ‘trial-drugs’ and equipments. So companies get easy accessibility. This lax approach makes India a major ‘drug-trial’ zone. With the trial agents baiting the poor the scene is complete.
The agents contract ‘the work’ from overseas companies. They in turn sub-contract works to a network of agents. Agents target major hospital and professionally adept doctors. Doctors get hefty amounts and gifts. They only have to file test reports ensuring license to the ‘trial-drug’.
Many drug trials currently go on in Bangalore. Since they are either in the first or second phase only a few volunteers can do. But the third phase may call for more people. In that case they will look for big hospitals. It is known that ‘drug-trials’ are underway in many hospital in Kerala.
Drug trials for London School of Tropical Medicine, and La Jolla Pharmaceuticals were done in Thirivanthapuram Govt. Medical College, and the Govt. Eye Hospital. During 2007-08, drug trials for Maif Pristol, and Miso pristol, medicines for abortion, got done. In the same period, Govt. Eye Hospital put to test Moxi Flaccine , a drug for Conjunctivitis. It is manufactured by ‘Squint less’, an American company. Authorities revealed that the drug was trial-tested on about 20-25 people. In Calicut Medical College, a medicine for spine injuries, manufactured by American company ‘Aventine’, was trial tested. Details of the test overseen by Dr. George Joseph are available via Right to Information Act. Recently, five Gastroenterology students of the university conducted three trials part of their study.
There was no causality in these curricular trials. And 18 trials were done in pulmonary segment in 2006-08 here.
In Alazpuzha medical college drug trials for Elephantiasis are on. The hosptial Supredentendent admitted to it. In a letter on January 15, he promised to provide ‘trial’ details. But nothing is heard from him since. While Kottayam, and Thrissure Medical Colleges denied any trial being done now. Govt. Hospitals have to follow many protocols ahead of ‘trials’. And ‘trials’ must be green signalled by an ethical committee. And the chairman of this committee must not be an ‘ insider’. But, the member secretary should be one from hospital. This independent committee must be true to the guidelines of Indian Council of Medical Research. Govt. Medical colleges conduct drug trials falling in line with guidelines. The entire process is quite a time consuming one. So, a pharmaceutical company looks for easy prey, private hospitals. Most ethical committees are made up of ‘insiders’. By passing guidelines is just easy and they get ‘things’ done.
Many drug trials are now underway in the state. So patients in private hospitals are victimised without their knowledge. Hospitals conduct clinical trials already registered in ICMR . Who knows patients queue up with fevers are waiting to be hooked?
Womens body at Clinical Trail Lab
On a bright January morning. In a poor neighbourhood of Khammam district of Andra Pradesh, Venkitamma finds her 13 year old daughter dead in the bed. The upset woman rushes the girl to the nearby hospital. Doctors quickly dubbed the case a ‘suicide’ by ‘pesticides’. They said the girl might be upset by ‘broken love affair’. The mother collapsed on the hospital veranda.
But shortly later, girls her age started dying in the neighbourhood. The postmortem reports got all deaths as ‘ suicide’. People raised doubts. Then the story of a ‘preventive medicine’ came out. In the beginning there was an awareness campaign on ‘cervical cancer’. Doctors got villagers in tenterhooks with data on increasing cancer deaths. They alerted villagers about 130 million cervical cancer cases reported each year. And also about 78,000 cancer deaths yearly. Prevention was the only way out, they taught villagers. Trusting their words villagers took girls to hospitals for ‘vaccination’. Then, US based pharmaceutical company Merk Sharp Anti Domi( MASD) came to ‘vaccinate’ girls. On July 9 last year, they trial tested a vaccine for Papiloma Virus both in Gujarat and Andra Pradesh. The trial was done on girls without their knowledge. Sideeffects claimed many lives. Both doctors and healthcare activists continued to brand deaths as ‘suicides’. Papiloma Virus is sexually transmitted one. And it is quite unlikely for 14year old girls to have the virus infection. The company only wanted to trialrun the drug. They did it by covering up the fact. During its US trials 15,000 people had side effects and 61 died. So, the medicine kicked up controversy there. A girl in UK also died in the December 2009 drug trial. But the company got free run in India. Gujarat Chief Minister allegedly knew about the trials. It could be difficult to conduct such a massive trial without the nod of the state government. During the vaccination girls were given cards with the logo of National Rural Mission (NRHM). Nobody knows why girls aged 1014 alone were selected. While internationally accepted guidelines suggest an extended age group 926.
The first legal frame work for drug trials dates back to Nuremburg code of 1947. The code warrants drug trial only with the consent of a person. In 1980 as per the recommendations of Justice Venkita Chellayya ICMR’s guideline came into effect. Drug trials in India needs to satisfy Drug Council General’s criteria. Most doctors and hospital authorities are ignorant these criteria. Exploiting this, drug trials conducted in areas where Dalits live. Prior to the trials, volunteer must know several factors. They include health risk, difference between regular treatment, and drug trials.
Doubt that most medicals camps are covert drug trial centres. Camps are set up in areas where the poor and the illiterate live. Equally, many drug companies conduct ‘free medical camps’ in slums in Maharashtra. But, in Kerala they can’t try similar ways.
Drug trials in Kerala take place both covertly and overtly. Also many special trial clinics are on the go. At a shantycentre in Thiruvanthapuram about 6 trials are now underway. And people from Maldives are increasingly becoming victims. Private hospitals covertly conduct trials and shamelessly levy charges of medicine on ‘patient’ .On each trial victim hospital gains about Rs 30,000 to 1lakh. Nobody knows exactly how many trailruns are done in a hospital. Drug controller is quite clueless about drug trials currently done in the state. When contacted via right to information, authorities remained silent. Many private medical colleges in the state survive on drug trials.
For the last ten years Kerala has increasingly been visited by various pandemics. Why Kerala famous for both individual and social hygiene face that number of fever cases? State tops in the consumption of medicines. And it is a habit of Malayalees to seek medical help for all ailments. Most people seek specialists. So this is a shot in the arm of drug companies.
In the last two years drug trials about 49 children died in All India Medical Science. Since 2006 January 4,142 were put to drug trials. A total of 2,728 children aged below one were also in the trials. Later through a RI number of deaths came out. As many as 48 drugs of various overseas companies were illegally put to test. AIMS is the premier medical institute of the nation. If it is found fraudulent any multispecialty hospital could be more dangerous.
Patient or Guinea pig ?
A retired school teacher from Malapuram recently was down with Urinary Tract Infection. She went to a private hospital in the district. After preliminary check up, she was referred to a nephrologist. The visiting doctor used to have crowd of patients at his weekly clinic. Studying her medical reports, the doctor prescribed costly drugs. Medicines did not help ease her condition. In one session he frankly said that the disease was in a ‘different’ stage, and wanted her to try an ‘expensive’ drug. The next day doctor himself brought the medicine and injected on her. He said the drug costs Rs2000 and is only available in Calicut. He would get her a reduction of Rs 100. Since the doctor was directly selling the drug, nobody in the hospital had any idea about it. He kept a special notebook to keep tract of the treatment. Every two week he got her an ‘injection’. Reports of periodic blood test duly noted down in the book. Other regular patients also had the same ‘injection’. Doubts clouded, they mobbed the doctor for details of the drug. He shrugged off their demand .Instead he would reduce the drug price to Rs1500. Doctor convinced them the medicine is a very rare one. After getting a marginal reduction, they again started taking ‘injection’. Meanwhile govt affected ban on private practice of government doctors. The doctor had to quit his practice in the private hospital. But he called up patients to continue with the injection. To those visited him, the doctor promised them three doses in one go at Rs4500. Charging the amount he gave one injection each. But nobody knew that they were taking the last dose for a ‘drug trial’. He still continues with his ‘injection binge’ on many patients. He must be availing junket foreign trips from the drug company. This is not a rare instance. Drugs trials are taking place on a massive scale at many hospitals in Malabar region. Since 2008, there have been 86 authentic drug trials in the state. But unofficial trials might go several folds. It is known that specialists’ doctors victimise patients.
The 2001 drug trials at RCC done with consent and otherwise rocked the nation. John Hopkins University in US got the trials done. Close to it, the drug trials at Amrita Institute of Medical Science in cochin kicked up dust. A drug for erectile dysfunction was trial run on newly born. Drug trials were done for companies; Hoffman and Pfizer. It was aimed at proving that ‘Viagra’ could cure pulmonary illness in newborn. The truth came to light during a press meet for announcing the ‘success’. About 90 per cent of doctors travelled abroad in the last five years were on ‘free trip’. Companies gift them with ‘junket trips’.
A directive from Drug Control General of India wanted all ‘trials’ since 2009 June 15 entered in ICMR’s clinical trial register. Most of the trials now going are done without registration. By antedating trials before 2009 June 15, fake trials are on under the noses. Drug trials are overseen by CRO( Contract Research Organisation). It is a private agency that contract ‘works’ from overseas companies. It submits reports to companies doing drug trials via network of doctors, hospitals and labs. How dangerous it is to licence drugs trusting them blindly. There are about 2000 CROs currently operating in the nation. Of them only less than 150 are registered. In 200708, they registered about 789 drug trials in India. Of them 140 were conducted in Kerala. Official data says as many as 168 people died during the trials. But toll might be far more than this. It is known that drug trials are taking place at a meditation therapy centre in Kerala. Many mysterious deaths were reported here. When contacted authorities declined to comment. The Centre drawing funds from US reportedly conduct trials for leprosy.
The simple question is who will bell the cat? Given the outreach and strength of this mafia, it needs mass movement to keep tabs on them. Many innocent lives are spoilt by the criminal nexus of drug companies, hospitals and doctors. How could a layman trust the medical system? Can our judiciary and govt do something about it?
Prajesh Sen. G receives the RNG award from CJI P Sathasivam.