INDORE : Days after several government doctors of Indore were penalised for illegally conducting drug trials on mentally ill patients, some doctors admitted on camera to the ongoing unethical practices in the profession.
The Madhya Pradesh government washed off its hands by imposing a meagre fine of Rs.5,000 each on five doctors for conducting trials on mentally ill patients between 2008 and 2010. It has now passed on the buck to the Centre to take further action.
Headlines Today recorded on hidden cameras how doctors, motivated by blind ambition and greed for money, conducted trials on patients and found out how patients were duped into volunteering for trials and later abandoned to suffer.
Hemant Jain, one of the leading psychiatrists in Indore, shares the credit for inventing the bivalent polio vaccine. However, according to an Economic Offences Wing (EOW) report submitted to the chief secretary of the state, 18 deaths were recorded during the trials conducted by Dr Jain.
Headlines Today asked Dr Jain on hidden cameras what was the scope of making a profit per case by conducting drug trials.
Headlines Today: Doctor, this whole thing about money… Can you give me a rough break up?
Dr Hemant Jain: I will tell you. It is about 18-20 per cent margin.
Amongst several others, Dr Jain conducted a trial on Ajay Naik’s newborn son, Yatharth in 2010 for a polio vaccine. Ajay was informed by Dr Jain’s assistants that the government has started a scheme under which it was vaccinating the newborn babies for free.
“We were not told about the trial at all. Had I known, do you think I would have gone,” asked Naik.
Naik’s son was just two-day-old when Dr Jain tried for a vaccine meant for one-month-olds. The newborn developed white spots all over his body. When Dr Jain was contacted, he refused to acknowledge the side effects. Naik still did not know that it was a drug trial until he started getting his son treated by a skin specialist.
Naik said that when his case was taken up by the media, Dr Jain threatened him and even tried to bribe him.
“After there was uproar in the media, Hemant Jain called me to his clinic and said that writing to the National Human Rights Commission will not help my case. He offered me a help of Rs.40,000 and a job and asked me to keep shut,” Naik said.
He, however, rejected the offer and since then has been paying for it. Now no doctor agrees to vaccinate his one-and-a-half-year-old son for basic ailments. “They ask me to get a written permission from Dr Jain first,” Naik said.
Trials for career progression
While money has been a driving force behind these trials, there was another major factor. Pali Rastogi, one of the psychiatrists who conducted clinical trials on 20 patients, revealed on spy camera that apart from the money that was paid to him per patient for the trial, why the trials were so important for the doctors.
Headlines Today: Apart from the money aspect, how else do the trials benefit you?
Dr Pali Rastogi: Our promotions depend on the number of international researches we have conducted. That is why they are very important.
Death of trial victim
In the frenzy to conduct such trials, patients are often duped into volunteering for the trial. Krishna Kumar Gehlot, 80, died within a week of Headlines Today’s interaction with him. Known as an extremely skilled tailor at one point of time, he was confined to his bed for the last seven years before finally succumbing to death.
In 2007, Dr Apoorva Puranik and his team of assistants told Gehlot that he should volunteer for an asthma trial and it would treat him fully because it was as American medicine.
Gehlot, enticed by the foreign remedy for his lung infection, volunteered. For months on end, he was supposed to use several TFT pumps and record the data. When the trial ended, he could hardly walk on his feet.
“When I told the doctors, they said they cannot do anything. I should go die in my bed and not bother them,” Gehlot, who struggled to survive and with no money to pay for the medical expenses died, had said before his death.
Violation of guidelines
According to the Indian Council of Medical Research (ICMR) rules, all patients should have a copy of the insurance under which they are covered for the trial. Moreover, they should be fully informed about the side effects of the trial.
Niranjan Lal Pathak, 70, suffered a massive heart attack in 2008. He was taken to the MYM Hospital for treatment.
“We were told that his case has been selected for a special government project for free treatment. So we agreed,” said Niranjan’s nephew Alok Pathak.
Headlines Today found that the one-page consent form suggested that it was for a “study” and not for a trial. Headlines Today has a copy of the original 16-page form in English that should be signed by the patients instead. The original form has details about the side effects, risks and the insurance terms. In none of the cases above, the patients were made to sign the original form. Pathak was actually made a part of a trial for cardiac problems. As a side effect, Pathak was later diagnosed with dementia.
“They have turned a hail hearty man into a dependant. Sometimes, he loses the way to his own house, refuses to recognise his family members,” Alok alleged.
Dr Apporva Puranik refused to help him or acknowledge the side effect.
Headlines Today also got exclusive copy of the insurance papers that say that “mentally ill patients are only insured for a physical injury during the trial”. As a result, volunteers are not eligible for any compensation if they suffer from any mental illness as a side effect. When Headlines Today tried to contact the doctors, they refused to comment.
’81 deaths in 3 years’
The EOW report also mentions 81 deaths between 2008 and 2010 due to drug trials in Indore. No post-mortem examinations were conducted on the dead. As a result, doctors are getting away by calling them natural deaths, like Dr Hemant Jain did when Headlines Today questioned him on spy camera.
Headlines Today: Tell us something about the deaths during your trial.
Dr Hemant Jain: There were no deaths.
Headlines Today: But the Vidhan Sabha papers show that there were 18 deaths.
Dr Hemant Jain: They were natural deaths.
Another loophole that is exploited across the country is the Schedule Y of the Drugs and Cosmetics Act. It can be used to form an independent ethics committee with a minimum of seven members who can approve a drug trial in any part of the country. Once the trial is approved the doctors conduct them by duping the patients and make money. An ethics committee is also supposed to monitor the progress of the trial, which never happens. Dr Hemant Jain himself admitted on the spy camera that they were ineffective.
Headlines Today: How much can an ethics committee monitor a trial?
Dr Hemant Jain: They cannot do much. It is difficult for them.
Retired judge Justice P Mulye, a member of the institutional ethics committee, said, “We are open to suggestions. We understand there are loopholes and we are contemplating action.”
Despite many people dying between due to drug trials hardly any action has been taken so far and patients continue to be used as guinea pigs in the name of advancement of medical science.
By- Neha Dixt
- Two Indore doctors penalised for conducting unapproved drug trials (thehindu.com)
- 12 M.P. doctors fined for conducting drug trials (thehindu.com)
- Activists in India outraged over secret drug trials on children (news.nationalpost.com)