'DNA' special: The shocking medical scam

Some of the top doctors in the country are likely to land in deep trouble as a parliamentary committee has indicated possible nexus between them and drugs-manufacturers to promote the companies’ interests.

Among many other issues, the Parliamentary standing committee on health and family welfare, while looking into the functioning of the Central Drugs Standard Control Organisation (CDSCO), found that doctors from different parts of the country have sent identical letters on certain drugs — as if the letters have been written by a common entity while the doctors just signed them.

The MCI’s ethics committee will soon begin a probe into the issue on a suo motu basis. Chairman of the MCI’s board of governors, Dr KK Talwar, said the action on doctors will be based on the recommendations of the committee and depending on the gravity of the alleged offence, besides the evidence found against them.

While the MCI will ask the Drug Controller General of India (DCGI) to reveal the names of all the doctors involved in the supposed scam, DNA has in possession all the letters and names of the doctors named by the Parliamentary Standing  Committee.

In one of the cases, three experts (Dr Randeep Guleria, Professor of medicine, All India Institutes of Medical Sciences (AIIMS); Dr Satish Lahoti, KBN medical College, Gulbarga (Karnataka) and; Dr Appoorva Mukherjee, RG Kar Medical College, Kolkata) based in three different places allegedly sent almost identical letters of recommendation for the drug Clevudine.

These doctors wrote that clinical trials were not even required for the drug. “Is it sheer co-incidence that doctors, sitting miles away from each other, gave opinions on a drug which is word-by-word identical,” the committee said. DNA made several attempts to reach Dr Guleria but could not hear from him.

“There is adequate documentary evidence to come to the conclusion that many opinions were actually written by the invisible hands of drug manufacturers and experts merely obliged by putting their signatures.

They went out of the way to give unsoliticited advice, in identical language, to the DCGI to give permission to the company to market the drug without conducting mandatory clinical trials in India,” the committee said.

In another case, seven doctors from different cities are believed to have given opinion over a drug which, the committee said, was banned abroad. The doctors allegedly involved in this case were: Dr Kalpana Ernest of CMC Vellore, Dr Bansari Goswami of NS Medical College Hospital, Kolkata; Dr D Arvind Kumar and Dr B Prahlad of Gandhi Medical College, Secunderabad; Dr Pramod Kumr Mallick of SCB Medical College, Cuttack; Dr Satish B Dharap of LTM Medical College and General Hospital, Mumbai and; Dr Promila Pandhi of PGIER Chandigarh.

“Nothing can be more outrageous than clinical trial approval given to the fixed dose combination of Aceclofenac with Drotaverine which is not permitted in any developed country of North America, Europe or Australasia,” the committee found.

In this case, the Committee pointed out that vide letter number 12-298/06-DC dated 12-2-2007, an official of CDSCO advised the manufacturer, Themis Medicare Ltd, not only to select experts but get their opinions and deliver them to the office of DCGI. “No wonder that many experts gave letters of recommendation in identical language apparently drafted by the interested drug manufacturer,” the committee noted.

Responding to a query, Dr Kalpana Ernest acknowledged that a “private party” sought her opinion on the drug combination but denied any influence or malpractice. “I and another doctor read the literature and gave our opinion based on it for clinical trials,” she said. When asked how the contents of the letter were identical to those written by others, Dr Ernest said someone from the company came back to pick up the letter. “I do not remember the contents of the letter as this happened in 2007,” Dr Ernest added.

DNA tried to talk to Dr Pandhi, but she could not talk as she was unwell. Some other doctors DNA tried to reach included Dr Malhotra (AIIMS) and Dr Anil Arora (Ganga Ram Hospital Delhi).

In the case of Doxofylline, an anti-asthmatic, opinions of two doctors - Dr Ashok Bajpai of MGM Medical College, Indore and Dr RK Mani, consultant with Indraprastha Apollo Hospital, New Delhi - are exactly same. Dr Mani said the committee’s report was a damning document.

“Doxofylline is a generic name not a brand name. I don’t even know which company makes it. An opinion on generic drug cannot mean endorsing it. I wrote that letter in good faith for welfare of patients since I was asked to give my opinion by the DCGI. The words alleged to be ditto are technical words. How can they be seen as collusion? You cannot jump to conclusion merely based on this. Doctors were given no chance to clarify their positions before the committee and now they are being ridiculed. If such observations are made against doctors then no one will come forward to give their advice and honest opinion. Suspicion should be kept away from accusation and allegations should be made on hard evidence and not on mere technical similarities,” said Dr Mani.