Drugs scam: Pharmaceutical companies wrote letters signed by doctors?

May 10, 2012

drug

New Delhi, May 10: In a shocking disclosure, some drug companies have been caught red-handed writing scientific recommendations of their own products and submitting them to the Drug Controller General of India (DCGI) after getting them endorsed by top doctors for a quicker marketing approval.

Usually, scientific recommendations are submitted by experts after they have studied a drug's content.

The endorsement is considered a crucial testimony that convinces India's Central Drugs Standard Control Organization (CDSCO) to trust the drug's effectiveness, in turn, allowing it to be launched in the market.

Clear evidence has been unearthed, whereby the scientific recommendations submitted to the CDSCO were being written by drug companies themselves with "experts merely putting their signatures".

What's worse, some of India's top medicine experts - some are even head of departments - from the country's most iconic medical institutes like PGI Chandigarh; CMC Vellore; AIIMS Delhi and St John's Medical College, Bangalore had signed these recommendations.

The parliamentary standing committee on health and family welfare has found that in case of several drugs, "expert advise and letters of recommendation" from these experts read the same - word by word - and were submitted on the same day.

The committee, which placed its scathing report on the functioning of the CDSCO in Rajya Sabha on Tuesday, says there is "ample evidence to show that several scientific recommendations submitted to the CDSCO to push a drug were actually written by invisible hands of drug companies themselves and experts merely obliged by putting their signatures."

It says, "There is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts."

Drug expert Dr CM Gulati says, "This is a big scam. It has unveiled how the crucial testimonies, some as long as 500 pages were written by drug companies themselves and signed by top doctors. The DCGI does not have doctors in his staff, and so tends to believe these testimonies before allowing a drug to hit the market."

He adds, "In one case, letters written in March, April and May by three separate experts land up in the DCGI's officer together on the same day. Some letters read the same, word by word. These experts are supposed to give sound scientific evidence. Instead, they are working for these drug companies."

The panel says, "Actions by experts listed above are clearly unethical and may be in violation of the Code of Ethics of the Medical Council of India applicable to doctors. Hence, the matter should be referred to MCI for necessary action. In the case of government employed doctors, the matter must also be taken up with medical colleges/hospital authorities for suitable action. In the case involving a drug named Clevudine (Phamasset Inc), three professors of medicine - from AIIMS, KBN Medical College, Gulbarga and RG Kar Medical College, Kolkata - located at different places and thousands of miles apart from each other sent a word for word identical letters of recommendation. Besides, all of them went out of the way and gave unsolicited advice, in identical language, to the DCGI to give permission to the company to market the drug without conducting mandatory clinical trials in India."

Letters read same

In another case, involving Sertindole (Lundbeck), an anti-psychotic drug, three experts located at three different places (head of the department of psychiatry of Stanley Medical College, Chennai, doctor from Psychiatric Nursing Home, Ahmedabad and HoD psychiatry of LTM Medical College, Mumbai) wrote letters of recommendation in nearly word-by-word, identical language.

Ironically, all of them used the incorrect form of DGCI.

The Committee says, "Is such a coincidence possible unless the person behind the scene who actually drafted the letters is one and the same person?"

Letters of opinion recommending approval for Pirfenidone of Cipla from professor of pulmonary medicine, AIIMS; a chest physician from Lilavati Hospital, Mumbai; an additional professor of pulmonary medicine from PGI, Chandigarh and a pulmonologist of Yashoda Hospital, Secunderabad, "were all received exactly on the same day and diarized by DCGI office under consecutive references 4877, 4878, 4879 and 4880."

"Is the committee mistaken in coming to the conclusion that all these letters were collected by interested party from New Delhi, Mumbai, Chandigarh and Secunderabad and handed over to office of the DCGI on the same day? If so, it is obvious that the interested party was in the loop in the entire process of consultation with experts," the report adds.

The committee says that if these cases are not enough to prove the apparent nexus that exists between drug manufacturers and many experts whose opinion matters so much in the decision making process at the CDSCO, "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."

In this case, through his letter, 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. These experts include HoD of department of pharmacology, PGI (Chandigarh); HOD department of pharmacology at Christian Medical College (Vellore); professor of surgery LTM Medical College (Mumbai) professor of medicine, Gandhi Medical College (Secunderabad), head of postgraduate department of surgery, S C B Medical College (Cuttack) and professor of medicine, Gandhi Medical College (Secunderabad)," the report says.

Now, the Committee has asked the Union health ministry to direct the DCGI to conduct an enquiry and take appropriate action against the officials, who gave authority to the interested party to select and obtain expert opinion and finally approved the drug.

Remarkable coincidence?

* Three opinions from Prof of orthopedics, AIIMS; consultant at Dayanand Medical College, Ludhiana and professor of orthopedics from St Johns Medical College, Bangalore, on rivaroxaban ( Bayer), a drug for prevention of clotting, "are ditto copies of each other".

* In the case of doxofylline, an anti-asthmatic, two opinions (from Prof of medicine of MGM Medical College, Indore and a consultant from Indraprastha Apollo Hospital, New Delhi) are also "word-by-word identical".

* In case of Ademetionine, all four letters of recommendation (from doctors belonging to Lokmanya Tilak Medical College, Mumbai; Medical College, Thiruvananthapuram; IPGMER Kolkata and chairman and chief of hepatology of Sir Ganga Ram Hospital, Delhi) made similar comments.

* Letters of opinion recommending approval of nimesulide injection from HoD of medicine, Government Medical College, Aurangabad and senior consultant orthopedic surgeon of Indraprastha Apollo Hospital, Delhi, reached on the same day and were mentioned in the records under consecutive reference 3537 and 3538.

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News Network
June 2,2020

New Delhi, Jun 2: India on Tuesday reported 8,171 more COVID-19 cases and 204 deaths in the last 24 hours as the country's virus count inches closer to two lakh, according to the Union Ministry of Health and Family Welfare.

The total number of cases in the country now stands at 1,98,706 including 97,581 active cases, 95,527 cured/discharged/migrated and 5,598 deaths.

Cases in Maharashtra have crossed 70,000 including over 30,000 recovered while Tamil Nadu's COVID-19 tally jumped to 23,495.

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News Network
May 20,2020

Thiruvananthapuram, May 20: As COVID-19 count surges to 666 with 24 new cases reported on Wednesday, Kerala Chief Minister Pinarayi Vijayan has said that if cases keep increasing in this manner, then the State will be in a 'serious situation.'

Out of 24 new patients, 12 have returned from abroad, 11 others from other States and one has been infected by a contact. Now, total positive cases in the State stand at 666 including 161 active cases, Chief Minister Vijayan said at press meet.

"If the number of COVID-19 cases increases like this, then the State will be in a serious situation. We have given more relaxations in lockdown guidelines. We need to have more strict measures in some areas," he said.

Speaking about the people who are coming to Kerala from other States, he stressed that all people coming from outside are "not carriers." However, the State has to tighten the security as some among those people are "carriers."

The Chief Minister while clearing that there is no restriction for the people to come back to Kerala, said: "Lakhs of people residing in other states cannot come together."

"There is no relaxation in containment areas. Those who came from outside have to be in quarantine. This is their moral responsibility. The State has implemented home quarantine successfully. Various level committees like ward committee, neighbours and residential associations are monitoring the people in quarantine," he said.

Chief Minister Vijayan has directed the police to visit people under home quarantine to take their report and district panchayat to make sure that all panchayats are working in a proper manner.

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News Network
May 28,2020

May 28: Abdul Kareem was forced out of school and into a life of odd jobs like repairing bicycles before he finally managed to pull his family out of abject poverty transporting goods across Delhi in a mini truck.

The job, and the slim financial security that came with it, was the first stepping stone to a better life.

All that is now gone as India reels under the economic impact of its protracted coronavirus lockdown. Mr Kareem's out of a job and stranded in his village in Uttar Pradesh with his wife and two children. Their minuscule savings from his Rs 9,000 a month job have been exhausted, and the money he saved for books and school uniforms is spent.

"I don't know what the job situation will be in Delhi once we go back," Mr Kareem said. "We can't stay hungry so I will do whatever I find."

At least 49 million people across the world are expected to plunge into "extreme poverty" -- those living on less than $1.90 per day -- as a direct result of the pandemic's economic destruction and India leads that projection, with the World Bank estimating some 12 million of its citizens will be pushed to the very margins this year.

Some 122 million Indians were forced out of jobs last month alone, according to estimates from the Center for Monitoring Indian Economy, a private sector think tank. Daily wage workers and those employed by small businesses have taken the worst hit. These include hawkers, roadside vendors, workers employed in the construction industry and many who eke out a living by pushing handcarts and rickshaws.

For Prime Minister Narendra Modi, who came to power in 2014 promising to lift the poorest citizens out of poverty, the fallout from the lockdown brings with it significant political risk. He won an even larger second term majority last year on the strength of his government's popular social programs that directly targeted the poor, such as the provision of cooking gas cylinders, power and public housing. The breadth and depth of this renewed economic pain will only increase the pressure on his government as it works to steer the country's economy back on track.

"Much of the Indian government's efforts to mitigate poverty over the years could be negated in a matter of just a few months," said Ashwajit Singh, managing director of IPE Global, a development sector consultancy that advises several multinational aid agencies. Noting that he did not expect unemployment rates to improve this year, Singh said: "More people could die from hunger than the virus."

Desperate Times

Mr Singh points to a United Nations University study estimating 104 million Indians could fall below the World Bank-determined poverty line of $3.2 a day for lower-middle-income countries. This will take the proportion of people living in poverty from 60% -- or 812 million currently, to 68% or 920 million -- a situation last seen in the country more than a decade ago, he said.

A World Bank report found the country had been making significant progress and was close to losing its status as the country with the most poor citizens. The impact of PM Modi's lockdown risks reversing those gains.

The World Bank and the CMIE estimates were published in late April and early May respectively. Since then the situation has only become grimmer, with harrowing images of people making desperate attempts to reach their villages, on crowded buses, the flatbeds of trucks and even on foot or on bicycles dominating media coverage.

The Rustandy Center for Social Sector Innovation at the University of Chicago Booth School of Business analyzed the unemployment data from the CMIE, collected through surveys covering about 5,800 homes across 27 states in April.

Researchers found rural areas were the hardest hit, and the economic misery was the result of the lockdown, rather than the spread of infections in the hinterland. More than 80% of households had experienced a drop income and many won't survive much longer without aid, they wrote in a report.

The government has promised cheap credit to farmers, direct transfer of money to the poor and eased access to food security programs -- but these help people who have some documentation, which many of the poorest don't. With millions of impoverished people now in transit across the country, the food security situation is dire -- news reports are emerging of people foraging through piles of rotting fruit or eating leaves.

Shattered Economy

The economy was already growing at its slowest pace in over a decade when the virus struck. The lockdown, which came into effect on March 25, has hammered it, stalling business activity and putting a lid on consumption, pushing the economy to what may be its first full-year contraction in more than four decades.

It's dire enough to warrant the country exiting its lockdown, as it has been doing incrementally since May 4, even as its infections are surging. India is now Asia's virus hotspot with infections crossing 151,000 according to data from Johns Hopkins University.

PM Modi, who has come under criticism for the pain inflicted on the poor, has said his government will spend $265 billion or about 10% of its GDP to help Asia's third-largest economy weather the pandemic's fallout. But experts say only a part of it is direct fiscal stimulus, and probably smaller than the total damage done to the economy during the lockdown period.

"What is especially worrying is the government's response," said Reetika Khera, an economics professor at the Indian Institute of Technology in Delhi. "The epidemic will magnify existing -- and already high -- inequalities in India."

Still, the economic measures aren't going to kick in for some time and industry will likely struggle to restart because of the flight of labour from industrial hubs.

And as the harsh summer unfolds more pain lies in store in the villages now dealing with returning migrant workers.

"There are no factories or industries here, there are just hills," said Surendra Hadia Damor, who had walked nearly 100 km from Ahmedabad, Gujarat, before a voluntary organisation drove him to his village in the neighboring state of Rajasthan. "We can survive for a month or two and then try and find a job nearby -- we will see what happens."

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