Drug trials: A father moves Drug Controller General of India (DCGI)


Feb 12, 2012 INDORE : In yet another complaint against the unethicaldrug trials that took place in the city, a local resident lodged a complaint with the Drug Controller General of India (DCGI), Medical Council of India (MCI) and National Human Rights Commission on Saturday accusing some city-based doctors with a clinic of making his son a trial subject after keeping him in the dark.
Om Prakash Agrawal, a resident of Rajmohalla here, alleged that the people involved in the controversial drug trials kept him in the dark. He alleged that the drug had severe side-effects and the health condition of his son, Nitin, continued deteriorating. “After my son failed in examination, his mental health became unstable. He was not a healthy volunteer. Then, how could the doctors conduct trial on him,” asked Agrawal.
The complainant stated that a medical store owner referred him to Dr Abhay Paliwal at his clinic in Geeta Bhawan. “Nitin was admitted in May 2010 and we were told that he would be alright in a few days. They asked me to sign on some forms, which were in English. Though I could not understand the content, I signed on it trusting the doctors. My son was admitted to the hospital for 10 days,” stated Agrawal in his complaint.
Informing that the ‘treatment’ did not yield any result as per the promise, Agrawal complained that the doctors used to take blood samples 8-10 times a day.
“We even opposed when doctors collected blood samples frequently but no one listened,” alleged Agrawal.
The complaint alleged that an Ahmedabad-based company, Intas, sponsored the trial for which approval was taken from city-based Naitik independent ethics committee and ethics committee of CHL-Apollo Hospital.
Nitin was also not insured against clinical trial liability and is still taking the medicines for his ailment. He was not given patient information sheet and a copy of informed consent form, the complainant added.
However, the doctor involved in the particular case clarified that no trial was conducted without informing patient or family member. “I do not remember the case. I have to check the records. However, no trial was conducted without taking consent of the patient or family members,” added Dr Paliwal.
After my son failed in examination, his mental health became unstable. Then, how could the doctors conduct trial on him.

Drug trials : Madhya Pradesh chief secretary fails to report to NHRC


 Feb1, 2012, Asish Gaur TOI

INDORE : The National Human Rights Commission (NHRC)’s order to the Madhya Pradesh chief secretary to report to it the details of the controversial human drug trials in Indore, has run into a procedural wall.

Taking suo motu cognisance of a TOI report on drug trials conducted on 233 patients of the government-run mental hospital attached to the Mahatma Gandhi Medical College in Indore, the NHRC had asked the chief secretary to furnish the details by last Tuesday. But the latter has not obliged, maintaining that the laws allow the concerned doctors to keep all details of the trials confidential.

Forty two of these patients were given Dapoxetine, a drug to cure premature ejaculation. However, an earlier report of the Drug Controller General of India (DCGI) had said they were not mentally ill, but were seeking psychiatric help for premature ejaculation.

Among other points. the NHRC had also specifically asked the MP chief secretary to report if the doctors had followed Indian Council of Medical Research (ICMR) guidelines, while conducting the trials on the basis of approval obtained from independent ethics committees attached to private hospitals _ bypassing the medical college’s own institutional ethics committee.

The chief secretary, Avni Vaishya, told TOI that he was not in a position to submit the report.”The doctors have kept the trial documents under wraps. The details are confidential according to the laws for the conduct of clinical trials. Only central regulatory bodies such as the DCGI or MCI can investigate the matter,” he said.

The NHRC, however, has decided to press the issue. NHRC spokesperson Jaimini Kumar Srivastava said the commission will write to the chief secretary again. “We have not received any communication from the chief secretary as of now. The time allowed to submit report has lapsed. We are going to write again asking to submit the report at the earliest.”

2-FEB-2012

NEW DELHI : Union health minister Ghulam Nabi Azad on Wednesday asked an explanation from the Madhya Pradesh government on the malpractices surrounding the recent clinical trials conducted in Indore.

“Irregularities were found in the clinical trials conducted there and the state government needs to explain what action has been taken against the doctors involved,” he said.

The drug controller general of India (DCGI) had recently issued a stern show cause notice to five doctors of Indore’s Mahatma Gandhi Medical College for not following good clinical trials (GCT) norms, while conducting clinical trials on 241 patients visiting the College’s psychiatry ward.

Notices had also been sent to three companies – Cadilla, Mcure and Intas – to explain the deficiencies at the earliest.

The DCGI has threatened blacklisting of the doctors from all other trials they are involved in if they fail to reply at the earliest. Two hundred and forty one patients in Indore were subjected to clinical trials to check the efficacy of various drugs, including 42 for Dapoxetine, a drug used to cure premature ejaculation.

An independent team of investigators sent by the DCGI submitted its report to the health ministry recently.

The report has cleared the investigators of carrying out the trial on “mentally ill” patients. The investigating team however took serious cognizance to the fact that investigators did not posses with them the original informed consent forms.

The forms were taken away by the sponsors of the trial, “which is a serious offence”.

A ministry official said, “Most of the patients were suffering from erectile dysfunctions and were being treated by psychiatrists from that medical college. That is why they were visiting the psychiatric ward and not because they were suffering from any mental illness.”

“However, show cause notices have been served on the doctors for the serious administrative lapses and deviation from GCT guidelines while carrying out the trial,” the official added.

Indore psychiatrists admit to conducting drug trials on mentally ill patients



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.

Headlines Today conducted a sting operation to exposes how doctors have been actively violating drug trial laws, converting patients into guinea pigs and then abandoning them to die.

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

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