Society ~ Magazine | Jul 04, 2011
Poor Andhra villagers now victims of clinical drug trials
By Madhavi Tata
Karunamma, a victim and also a former drugs trials tout
No Drug Resistance
- 35 women, some men from Guntur district put through clinical trials of a breast cancer drug. They later complain of joint pains, nausea and chest pains.
- Biotech industry in Andhra is worth about Rs 455 crore
- Touts operating on behalf of pharma companies get people from the poorer districts to Hyderabad for the tests
Some 35 women and a few men in Piduguralla village of Guntur district have become unwitting guinea pigs to what looks like clinical trials for breast cancer drugs. The women, all lime kiln workers, were recruited by brokers and taken to Axis Clinical Labs in Miyapur area of Hyderabad sometime between February-April where they were kept for four days. They were given medicines, their urine and blood samples taken at regular intervals and then sent home.
The victims earned around Rs 10,000 each and were promised up to Rs 30,000 more if they “passed the test”. It was only when one of the women, wracked by severe joint pains, dizziness, nausea and chest pains complained to a local leader that the truth was out. She bore on her a slip showing that she had been tested for a drug by Axis Lab on behalf of GVK Bio, a leading pharmaceutical firm. The rest of the women soon followed with a litany of similar complaints. A check on their profiles showed that all the women were poor, some were widows, some single mothers with ailing kids, others were deep in microfinance debts and some needed the Rs 10,000 to finish building their houses.
Surprisingly, the state government’s reaction has been to play down events. Health secretary P.V. Ramesh even claimed that “the condition of the women is not too serious. Clinical trials on humans are not uncommon. How do you think we are now taking drugs like paracetamol and amoxycillin? But we are ordering an inquiry because of the keen media interest.” Ramesh refused to name the pharma company or the kind of drugs used (said to be for treating breast cancer). Axis Lab officials have said that it was a generic drug and not a breakthrough one and the studies were “bio-equivalent in nature”. This means what was tested was a new drug with the same composition as an existing one, but with some additives.
Andhra seems to be a favoured lab for pharma majors for there have been instances of botched clinical trials earlier too. In ’09, teenage girls in the tribal welfare hostels in Khammam district were given HPV vaccines (to prevent cervical cancer) like Gardasil (from MAD Pharmaceuticals) and Cervarix (GSK Pharmaceuticals). Seattle-based NGO PATH wanted to inject 14,000 girls with the vaccine as part of its Phase III trials (the last stage of a clinical trial where a large section of people are tested). It was only after the death of five girls that the trials stopped. “The consent forms were all signed by hostel wardens and the remaining had thumb prints. This shows that the experiment was conducted on vulnerable people who had no knowledge of what they were getting into,” says Babu Gogineni, founder of the Humanist Center for Bioethics in New York.
“MNCs are attracted to India because of the huge human patient pool. Also, ethics committees are not robust here, neither are the compensation/insurance policies huge as in the West. So companies find it easy to cut corners here and get clinical trials done quickly,” says Dr P. Raghu Ram, director and consultant oncoplastic breast surgeon at the KIMS-Ushalakshmi Centre for Breast Diseases.
The doctor points to the fact that Hyderabad has more corporate hospitals that Mumbai or Delhi. “Almost every corporate hospital has some form of research going on,” he says. Unofficial estimates say that clinical trials in India cost 60 per cent less than in Europe or the US.
June 18, 2011
Six Andhra women hospitalised after unauthorised drug trial
By A. Srinivasa Rao Hyderabad
(From left) Rangamma Parvathi and Dhanalakshmi were made part of the clinical trial.
They are poor, illiterate and gullible - in other words, perfect guinea pigs for unauthorised drug trials. A Hyderabad-based drug research laboratory thought as much. Axis Clinicals Limited allegedly administered trial drugs to a group of poor women from the Piduguralla town of Andhra Pradesh's Guntur district by promising them to pay a pittance but did not take their informed consent.
Axis Labs, which conducted the illegal trials.
Many of the women - mostly daily wage labourers - have developed complications after taking the drugs. On Friday, six of the affected women were hospitalised in Guntur. The Andhra Pradesh health department on Friday raided Hyderabad premises of Axis Laboratories and sealed it.
The police also arrested two women, Kommu Karunamma and Shaik Jameela, in Guntur. They were brokers who provided 'testers' to Axis Labs for the clinical trials. The episode came to light on Thursday when at least nine women from Piduguralla complained of severe body ache, joint pain, chest pain and extreme weakness. A few of them even had difficulty walking.
The women, all of whom were part of the trials, consulted a local doctor who told them they could have been tested for breast cancer drugs without their knowledge. The women claimed they were not told which drug was being tested on them. Soon, they filed a complaint with the state health department, whose officials then raided Axis Laboratories at Miyapur, on the outskirts of Hyderabad.
On questioning, laboratory officials admitted to have conducted the trials on one P. Dhanalakshmi of Adarsh Colony in Piduguralla town, but feigned ignorance on giving the experimental medicines to a large group.
The officials asked the lab authorities to stop further drug trials until they completed their investigation.
State health minister D.L. Ravindra Reddy said the government has ordered an inquiry into the incident and asked the officials to take stern action against those who conducted illegal clinical trials. He said the authorities will focus on finding out the names of the drug companies for which Axis Labs was conducting the trials.
The victims said they were taken to the laboratory several times. There, they were administered "some unknown tablets and injections" and a day later, their blood samples were taken. The women claimed the laboratory authorities told them that they would get about `10,000 each at the end of the trial.
However, only those women who did not develop any complication were retained for the trials. The rest were sent back without being paid the promised amount. "I was told I would get Rs.9,000 for undergoing the tests, but I was not paid even half the amount," 55-year old Shaik Bibi, who ekes out her livelihood by working in a lime kiln, said. She developed severe pain in her knees and chest after taking the drug thrice.
Dhanalakshmi said she is no longer able to walk properly. "I have severe pain in the knees. I used to be healthy earlier. The problems started only after I underwent medical tests in Hyderabad," she said. Dhanalakshmi was sent back within three weeks after being paid Rs.7,000. At least 40-50 people from Adarsh Colony, Chandrapalem and Indiramma Colony in Piduguralla have been visiting the lab for the past few months. Everything went off so secretly that the victims did not even know that they were being paid to be part of a drug trial.
"We were also forced to sign on a bond paper before taking the medicine and injection," another victim J. Kumari said. SUCH clinical trials are called bioavailability tests. "They are conducted on healthy persons aged 18-55 years to find out whether the drug being tested has side-effects and whether a healthy human body has the capacity to absorb the drug," a GVK Bio Laboratory scientist said.
"If everything goes well after taking the drug, the person is asked to revisit the lab after 10 days and another dose of drug is given. It is repeated after another 10 days. Only after that the efficacy of the drug is certified." Guntur district health and medical officer Dr M. Gopi Naik said: "We will conduct a comprehensive survey to find out if there are any more victims of such illegal clinical trials in other parts of the district. We will conduct special medical camps to treat the affected women," he said.
June 18, 2011
Clinical trial: India an easy target for foreign drug companies
By Savita Verma New Delhi
There is no law to effectively monitor clinical trials in India.
It is not just the inexpensive, world class medical facilities which attract foreigners to India. The country has emerged as a hotspot for foreign drug companies, which unhesitatingly flout all rules and regulations to test their products.
This blatant violation of norms and ethics while conducting clinical trials is largely because of lax rules and absence of provisions for effective monitoring during each stage of the trial.
According to an estimate, the value of clinical trials in India stood at Rs.1,500 crore in 2010 and can touch Rs.2,760 crore by 2012.
All clinical trials, approved by the Drug Controller General of India (DCGI), must be noted in the Clinical Trial Registry of India, launched in 2007.
However, the registry only gives information on the purpose of the trial, the number of people participating in the trial, the date on which it will start and end, and the places or sites where the trial will be conducted.
"There is no mechanism to monitor clinical trials," Dr C. M. Gulati, editor, Monthly Index of Medical Specialities, said.
"After approval by the DCGI, a trial has to be approved by an ethics committee. But, there are no guidelines on who can set it up. This has resulted in random manipulations and inducements where approvals for clinical trials are being given for Rs.25,000 while sites for conducting the trials are being added in the registry by paying Rs.5,000 per site," Gulati said.
Though the Indian Council of Medical Research (ICMR) has framed guidelines on conducting clinical trials on humans, a draft bill on the guidelines is yet to be examined before it is tabled in Parliament.
There are a number of areas where rules are flouted while conducting a clinical trial.
It all begins with the filing of the consent forms. There have been cases where the consent of the participant was not taken, or where the consent form has been filled by a person other than the participant, or where the forms have been filled incorrectly.
In such cases, it becomes difficult to trace those who participated in the trial.
Also, the testing of foreign drugs has become much easier in India after changes were made to the Drugs and Cosmetics Rules in 2005.
Earlier, the rules required a "phase lag" in the testing of drugs. Thus, if Phase III study had been completed elsewhere, Phase II study was permitted in India.
This was done to protect Indians from being used as guinea pigs in the testing of unproved drugs of foreign origin.
With the change of rules, Phase II or III trial can be conducted concurrently, even if the drug has not undergone a Phase I or II trial in India.
The change was ostensibly made in response to demands from multinational drug companies and private organisations that conduct clinical research.
That these clinical trials often prove lethal can be gauged from the fact that there have been 1,514 deaths over the past 28 months.
Laxity of norms governing these trials has resulted in gross injustice to the poor as the drug companies have accepted only 25 cases where death was caused because of the trial.
Moreover, compensation has been given only in five cases, with the maximum amount being Rs.3 lakh.
"There are lots of concerns on the ethical aspects of clinical trials. The proposed law will clear issues such as consent forms, post trial benefits and compensation to participants in case of adverse events. Though the current law talks of compensation, it does not specify the details," Dr Vasantha Muthswamy, former senior director general of ICMR, said.
"Clinical trials have now emerged as a business opportunity and lucrative way to make money for researchers," Gulati said.
Saturday June 25 2011
Clinical trials: lab's approval suspended
accused of administering drug to poor women without their informed consent
DCGI to investigate working of all bio-availability and bio-equivalence study centres in the State
HYDERABAD: The Drugs Controller General (India) has suspended approval of M/s Axis Clinicals Ltd., Hyderabad, to conduct all bio-availability and bio-equivalence studies at their centres at Miyapur here in “public interest” after investigations revealed irregularities in the conduct of clinical studies recently.
Following media reports that women who were administered an anti-cancer drug during the trials developed side-effects at Piduguralla, the DCGI's South Zone office, Chennai, and sub-zonal office, Hyderabad, conducted investigations. It was alleged that the firm conducted the study by administering the drug to poor women without obtaining their informed consent.
According to an official release, the investigations revealed irregularities in the conduct of the studies with regard to subject recruitment process, informed consent process, independence of Ethics Committee and its review and decision-making process.
The investigations were conducted on June 20 and 21 at the bio-equivalence study centre situated at Serilingampally.
The firm conducted bio-equivalence studies on Exemestane tablets from January 27 to February 15 this year. The DCGI also decided to investigate the working of all bio-availability and bio-equivalence study centres in Andhra Pradesh in two months.
The DGCI's move is to ensure that such studies were performed strictly in accordance with the applicable regulatory provisions and prescribed guidelines, the release added.