IIPM Mumbai Campus
In collusion with pharma biggies, doctors in government hospitals across Madhya Pradesh are conducting dubious drug trials on unsuspecting patients, thus endangering lives and the reputation of a noble profession
For the last few years, drug trials have been carried out in some hospitals of Madhya Pradesh in a hush hush manner. This is apparently being done by multinational companies hand in glove with some doctors. Patients are neither informed, nor is their consent taken. The matter has been brought to light of late, and the government has started looking into the issue seriously now.
If you are going to a Madhya Pradesh hospital for treatment of a serious disease and are made to sign a consent form in English, beware. It is quite possible that you unknowingly become the guinea pig for a vaccine trial. In the last five years, thousands of patients in Madhya Pradesh have faced this fate.
Sharad Geete’s wife Sheela Geete died on August 8, 2010. She was suffering from Alzheimers. Her husband had brought her to Indore’s MGM Medical College’s neurology department. After his wife passed away, Sharad came to know through local media reports that the doctor in question was deep into drug trials. He then collected material which indicated that Eisai Pharma’s Donepezil Immediate Release and Donepezil Sustained Release were being tried on her. Geete subsequently complained to the state’s health minister Mahendra Hardia.
Similarly, Ajay Nayak of Indore complained that in the name of ordinary vaccination, one doctor at Chacha Nehru Hospital conducted a vaccine trial on his newborn. He was made to sign a consent form in English which he did in good faith. When he took the infant home, the newborn fell sick and developed white marks all over his body. In yet another case in Jabalpur, cancer patient Rammani Upadhya died of another drug trial as well.
Despite these deaths, information received on the calling attention motion of Congress MLAs Pratap Singh and Pratap Grewal and Independent MLA Paras Saklecha reveals that there are no such trials taking place in the state nor have there been any deaths related to drug or vaccine trials.
This goes against the fact that many doctors independently confirm that such trials are one – in fact, one particular doctor is even reported to have conducted 30 drug and vaccine trials on 1,700 patients (yet, the doctor in question did not disclose the names of any patient). Dr Anand Rai of MP’s Resident Doctor’s Association says, “This [not disclosing of patients’ names] has been done deliberately so that it cannot be found out what the condition of the patient is post trial.”
In the monsoon session of the Madhya Pradesh Assembly when this matter became public, a committee was formed under the principal secretary of the Assembly. After two meetings, the committee recommended that new drug trials should not be conducted but those being conducted should not be stopped. Hence the drug and vaccine trial business continues to flourish in the state.
In the winter session of the Assembly, Paras Saklecha questioned the trials of the HPV vaccine. The response was that trials were conducted on 39 people at the Chacha Nehru Hospital, Indore. It is surprising that the trial for a drug, HPV Vaccine V 503, which is to be used on women with cervical cancer, is being done by a child specialist and not by a gynaecologist. According to Dr Anand Rai, “Many doctors in MP are taking money from pharma companies to conduct drug trials. Almost all the doctors present in the local ethical committees are involved in the trials. How can it then be imagined that they are taking the right decision? This is the reason why the cervical cancer vaccine was tried by a child specialist on females between the ages of 15 and 26 when patients above the age of 12 should not even have come under the purview of treatment.”
Drug trials are happening for diseases which are not even found in the state, whereas there is no concern about the diseases the state is battling with. Cervical cancer, for instance, is more common in American and European women. In those countries, strict laws govern drug trials. This is why multinationals prefer to conduct drug trials in India. The trial for V 503 vaccine is a result of this.
Even in the past, trials for cervical cancer vaccines have triggered controversy in the country. Pharma major Merck’s Gardasil vaccine was tried in Andhra Pradesh’s Khammam area and Gujarat's Vadodara on girls aged 10-14. Two girls died in Vadodara and four in Khammam as a result of the trial. That had caused health workers across the country to unite against the propriety use, negative effects and costs of the vaccine, forcing the government to end all such trials. Merck then graduated to trials of V-503.
In summary, the fact is that the two big multinationals, Merck and Glaxo, are in a race to find a cure for cervical cancer. So, trials in Indore are on in full swing. The control mechanism is not well defined and the government needs to set up definite rules as soon as possible.
State minister for health Dr Mahendra Hardia says, “A separate committee has been formed in the Madhya Pradesh Assembly to look into the matter. Its directives shall be followed. An investigation by the state human rights commission is also being considered. There is also consultation about drafting a drug trial law in the state. Drug trials are necessary for the availability of common drugs. But no new drug trials will be conducted in the state.”
Saklecha says, “There must be a health research policy in the state. Patients who are going to hospitals for treatment are being tricked into drug and vaccine trials. The V503 trial has terrible side effects. It uses sodium borate which is a chemical used to kill rats. The polis argon eti used in it is a detergent which can cause cancer. It also contains aluminium salts which cause heart diseases.”
While the government might be right in holding that drug trials are necessary, conducting such tests on unknowing patients is not only unethical but also absolutely uncalled for.
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In collusion with pharma biggies, doctors in government hospitals across Madhya Pradesh are conducting dubious drug trials on unsuspecting patients, thus endangering lives and the reputation of a noble profession
For the last few years, drug trials have been carried out in some hospitals of Madhya Pradesh in a hush hush manner. This is apparently being done by multinational companies hand in glove with some doctors. Patients are neither informed, nor is their consent taken. The matter has been brought to light of late, and the government has started looking into the issue seriously now.
If you are going to a Madhya Pradesh hospital for treatment of a serious disease and are made to sign a consent form in English, beware. It is quite possible that you unknowingly become the guinea pig for a vaccine trial. In the last five years, thousands of patients in Madhya Pradesh have faced this fate.
Sharad Geete’s wife Sheela Geete died on August 8, 2010. She was suffering from Alzheimers. Her husband had brought her to Indore’s MGM Medical College’s neurology department. After his wife passed away, Sharad came to know through local media reports that the doctor in question was deep into drug trials. He then collected material which indicated that Eisai Pharma’s Donepezil Immediate Release and Donepezil Sustained Release were being tried on her. Geete subsequently complained to the state’s health minister Mahendra Hardia.
Similarly, Ajay Nayak of Indore complained that in the name of ordinary vaccination, one doctor at Chacha Nehru Hospital conducted a vaccine trial on his newborn. He was made to sign a consent form in English which he did in good faith. When he took the infant home, the newborn fell sick and developed white marks all over his body. In yet another case in Jabalpur, cancer patient Rammani Upadhya died of another drug trial as well.
Despite these deaths, information received on the calling attention motion of Congress MLAs Pratap Singh and Pratap Grewal and Independent MLA Paras Saklecha reveals that there are no such trials taking place in the state nor have there been any deaths related to drug or vaccine trials.
This goes against the fact that many doctors independently confirm that such trials are one – in fact, one particular doctor is even reported to have conducted 30 drug and vaccine trials on 1,700 patients (yet, the doctor in question did not disclose the names of any patient). Dr Anand Rai of MP’s Resident Doctor’s Association says, “This [not disclosing of patients’ names] has been done deliberately so that it cannot be found out what the condition of the patient is post trial.”
In the monsoon session of the Madhya Pradesh Assembly when this matter became public, a committee was formed under the principal secretary of the Assembly. After two meetings, the committee recommended that new drug trials should not be conducted but those being conducted should not be stopped. Hence the drug and vaccine trial business continues to flourish in the state.
In the winter session of the Assembly, Paras Saklecha questioned the trials of the HPV vaccine. The response was that trials were conducted on 39 people at the Chacha Nehru Hospital, Indore. It is surprising that the trial for a drug, HPV Vaccine V 503, which is to be used on women with cervical cancer, is being done by a child specialist and not by a gynaecologist. According to Dr Anand Rai, “Many doctors in MP are taking money from pharma companies to conduct drug trials. Almost all the doctors present in the local ethical committees are involved in the trials. How can it then be imagined that they are taking the right decision? This is the reason why the cervical cancer vaccine was tried by a child specialist on females between the ages of 15 and 26 when patients above the age of 12 should not even have come under the purview of treatment.”
Drug trials are happening for diseases which are not even found in the state, whereas there is no concern about the diseases the state is battling with. Cervical cancer, for instance, is more common in American and European women. In those countries, strict laws govern drug trials. This is why multinationals prefer to conduct drug trials in India. The trial for V 503 vaccine is a result of this.
Even in the past, trials for cervical cancer vaccines have triggered controversy in the country. Pharma major Merck’s Gardasil vaccine was tried in Andhra Pradesh’s Khammam area and Gujarat's Vadodara on girls aged 10-14. Two girls died in Vadodara and four in Khammam as a result of the trial. That had caused health workers across the country to unite against the propriety use, negative effects and costs of the vaccine, forcing the government to end all such trials. Merck then graduated to trials of V-503.
In summary, the fact is that the two big multinationals, Merck and Glaxo, are in a race to find a cure for cervical cancer. So, trials in Indore are on in full swing. The control mechanism is not well defined and the government needs to set up definite rules as soon as possible.
State minister for health Dr Mahendra Hardia says, “A separate committee has been formed in the Madhya Pradesh Assembly to look into the matter. Its directives shall be followed. An investigation by the state human rights commission is also being considered. There is also consultation about drafting a drug trial law in the state. Drug trials are necessary for the availability of common drugs. But no new drug trials will be conducted in the state.”
Saklecha says, “There must be a health research policy in the state. Patients who are going to hospitals for treatment are being tricked into drug and vaccine trials. The V503 trial has terrible side effects. It uses sodium borate which is a chemical used to kill rats. The polis argon eti used in it is a detergent which can cause cancer. It also contains aluminium salts which cause heart diseases.”
While the government might be right in holding that drug trials are necessary, conducting such tests on unknowing patients is not only unethical but also absolutely uncalled for.
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