Clinical trials in the state came under the radar after two doctors were suspended for undertaking trials under suspicious conditions. In a letter obtained under RTI, the suspended doctor Dr A M Mesquita admitted to conducting the testing and accepting money along with equipment used in the process.
The Clinical Trials Registry- India (CTRI) lists Goa as having undertaken over 45 clinical trials both in the state run Goa Medical College (GMC) and private hospitals including Vintage Hospital and Medical Research Centre Pvt. Ltd. and Vrundavan Hospital Research Centre.
What is surprising however is the amount of money involved in the trials and where they’re going. In recent news, professor and head of the department of TB and chest diseases of GMC, Dr Mesquita and his colleague, Dr Lalita Fernandes were suspended for indulging in unauthorised clinical trials to test the efficacy of the drug Ciclesonide.
The investigation by the vigilance department was based on a complaint filed by Sanjay Harmalkar who said the trials were being conducted in government premises using office facilities.
“These trials are done on patients suffering from various chest illnesses and are sponsored by different national and multinational pharma companies. The trials which are being done by these two doctors are going on for more than 11 years. The doctors are being paid huge amount of money by the pharma companies for conducting such trials on patients,” says Harmalkar in his letter.
He adds that the trials are being conducted in the government premises using office facilities, water, electricity, equipment, paramedical staff as well as the doctors who are students doing specialist courses in the same hospital.
He also claimed that the trials were being done during working hours when doctors were supposed to be working and attending to patients.
In his letter explaining the accusations, Dr Mesquita admitted to the clinical testing in the hospital but also that such tests formed a part and parcel of all medical colleges in the country.
“Clinical trials/research form a part and parcel of all Medical Colleges in the world and are conducted by government colleges in India as per directives of the Drug Controller General of India (DCGI) wherein 50 percent have to be in Government Medical Colleges and remaining in corporate hospitals,” he said.
He went on to say that over the past few decades, departments like Medicine, surgery, obstetric and gynaecology, skin, paediatrics and orthopedic were conducted and involved in testing.
Staff used in the testing, he added, was trained by the sponsors and consisted of principal investigators, co-investigators and a study coordinator of the department. No post-graduate student or paramedic was involved in the testing as they were not permitted to do so by the sponsor.
Another alarming figure that came up in the letter was the amount of grants received during the period. Rs 86,60,500 was the total amount of grants received and Dr Mesquita claims the grants were audited and taxes were paid. “Balance of approximately Rs 34,00,000 remained as studies are still ongoing. This balance fund can be utilized by the department/ institution for any research oriented work,” said Mesquita.
One factor Harmalkar insisted on was the travel trips of Dr Fernandes where she presented papers at international conferences. Her trips included conferences to France, Spain, Amsterdam, Austria and Denver, Colarado.
While most hospitals that undertake clinical trials in private hospitals and government ones too in the country have a research wing, the GMC has none. Currently there are over 15 clinical trials being undertaken by the hospital, some starting from as early as 2009. However Harmalkar claims it to be from 2005 onwards.
In his letter, Mesquita said funds given were being used to purchase equipment for the use of the hospital. These included 12 lead ECG machine and one PFT machine as a backup, one cold centrifuge -80 degree Celsius for research purpose, one computer, LCD screen and UPS for the bronchosciopy room, one portable finger pulse oximeter for bedside use of patients and two air conditioners: one in the study room and the other in the seminar room.
Another factor that will come to haunt the case and Dr Mesquita is the ethics committee. Mesquita himself was on the committee as Chairman during the time of granting of consent. As per MCI norms, the committee has to scrutinize applications from researchers and ascertain that there is no harm to any human subject undergoing the trial.
Their approval however does not allow for financial approvals.
