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
March 18,2020

Muzaffarpur, Mar 18: Prisoners in the central jail here are working overtime to produce facemasks to prevent the deadly COVID-19 striking. In addition to providing protection to fellow inmates and prison staff, the produce will be shared with nine district and sub jails falling under Muzaffarpur Central Prison as well, Deputy Superintendent of the jail Sunil Kumar Maurya said. From supplications at places of worship to hectic activities at the biggest hospital, this north Bihar district is witnessing invocation of all powers, human and otherwise, to prevent novel coronavirus hitting them.

Although nobody has so far tested positive for the dreaded virus in Bihar, where the state government has imposed a semi-lockdown as a preventive measure, Muzaffarpur which hit the headlines last year for losing close to 200 children to an outbreak of brain fever seems determined not to fall prey to yet another virulent affliction.

On making of facemasks by about 50 prisoners, the Deputy Superintendent of the jail said, "We have had a tradition of producing fabric at the Muzaffarpur Central Jail. An idea was floated why not use the skills acquired for producing masks which are in great demand but in short supply.

The local administration seems impressed with the endeavour of the social outcasts to rise to a global challenge.

"It is a welcome step. Despite all precautions, we never know who is going to catch the infection at which place. The efforts by prisoners to protect themselves and the staff manning their premises is laudable. "Full assistance will be provided to Central Jail authorities in supply of the masks to other prisons," Sub Divisional Magistrate (East) Kundan Kumar said.

A conservative town inhabited by a deeply religious citizenry, Muzaffarpur is also witnessing prayer congregations at temples and mosques in keeping with the tradition here of people of all faiths coming together when faced with a major challenge.

The Garib Nath temple, a renowned shrine devoted to Lord Shiva which attracts devotees from far and wide, is witness to the power of faith trumping the biggest fears as the footfall seems to have increased since the outbreak.

The temples mahant Vinay Pathak says, "faith can move mountains. People come here in search of strength to face a crisis which has caused worldwide scare. We advise the visitors to conduct regular 'havans' at their houses just like we have been performing here. "The smoke emitted by burning of purified offerings cleanses the air and, who knows, could be an antidote as well," Pathak added.

Chanting of 'Mahamrityunjay mantra', which the faith believe to be potent enough to dispel illness and untimely death, is taking place round the clock at the shrine in addition to 'havans', the mahant said.

Just a few yards away stands the Chhata Chowk mosque where large number of devotees appear in skull-caps to offer namaz.

"It is a pandemic threatening to engulf the entire world and dua (prayers) are needed as much as dawa (medicines). May God, who is one, listen to the common wish expressed by humanity in myriad ways," says Imtiaz Ahmed, a devout local resident.

Meanwhile, the health authorities are busy with their own efforts, not leaving prevention and cure to divine intervention.

District Medical Officer Shailesh Kumar Singh says a total of 42 people here who have come from abroad, have been tested but their results have been negative.

"Nonetheless, a five-bed special ward has been set up at the Sadar Hospital, manned by medical staff armed with a special kit comprising medicines and other logistics required for primary care of those with suspected symptoms," he said.

The SKMCH referral hospital, which bore the brunt of last years brain fever epidemic accounting for over 120 deaths is fully geared up to meet the latest challenge.

SKMCH superintendent Sunil Shahi says "we have a 30- ward insulation ward ready. Samples of patients with suspected symptoms are being routinely sent to RMRI, Patna. We appeal to all to remain alert, but avoid panic."

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News Network
January 1,2020

New Delhi, Jan 1: Union Minister Prakash Javadekar launched a scathing attack on the Aam Aadmi Party and the Congress for allegedly inciting violence in Delhi against the Citizenship (Amendment) Act. Mr Javadekar said the violence over the amended citizenship law that broke out in areas like Jamia Nagar, Seelampur and Jama Masjid "cannot be forgiven".

"In Jamia, the Congress' Asib Khan and AAP's Amanatullah Khan delivered inciting speeches. They spread disinformation. The law is to give citizenship to people and not take citizenship away," Mr Javadekar told reporters.

He said the people of India understand the plans of the Congress and the AAP and both parties should apologise.

"We will bring out the truth. The fight is between anarchists and those who oppose them. Our agenda would be wholesome development of Delhi. The AAP strangulated municipal corporations' attempt on development. Rs 900 crore was not given. Today, the people of Delhi are surprised that the AAP slept through all these 4.5 years and in the remaining six months they have launched schemes," Mr Javadekar said.

"The work is done by someone else and the credit is taken by a different individual," the Union Minister said, referring to allegations that the government led by Chief Minister Arvind Kejriwal took credit for work done by BJP-ruled municipal agencies.

"Who did fogging in dengue season? Our corporations organised an awareness drive against water accumulation and dengue cases went down. During corporation polls, Kejriwal said don't choose BJP as dengue will claim lives. Now he is also claiming credit for decrease in dengue cases because of the work done by these corporations," Mr Javadekar said.

"I am an environment minister. We worked on pollution control. There is no limit to their (AAP's) lies. About unauthorised colonies, the AAP says we have not regularised it. We made a law signed by the President, yet they spread lies," Mr Javadekar said.

The election in Delhi will be held before the end of February.

Comments

Angry Indian
 - 
Wednesday, 1 Jan 2020

Wash you face with cow urine !!!

sorry sorry with DOG URINE...

you will be enlightened...

 

get lost moron...from wher u came....rat hole or A@@ hole

Fairman
 - 
Wednesday, 1 Jan 2020

Don’t pollute Delhi. Leave them alone.

Every citizen including your own BJP minded people all are very happy with Kerjrival and Aam Admi Party.

 

Every citizen in Delhi are very very happy.

For God sake leave alone, don’t disturb them as spoiled in other parts of the country.

 

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News Network
March 16,2020

Mar 16: An investigation into Coffee Day Enterprises Ltd., initiated by its board after the death of founder V.G. Siddhartha, is likely to conclude that at least Rs 2,000 crore is missing from its accounts, according to people familiar with the matter.

The months-long probe following the suicide of Siddhartha in July examined the financial transactions of India’s largest coffee chain and its dealings with dozens of private companies owned by the entrepreneur. The draft report, running more than a hundred pages, points to thousands of rupees that have gone missing, said the people, asking not to be named because the details aren’t public. It also details hundreds of transactions between the founder’s listed and personal businesses that were not conducted at arm’s length, they said.

Though the report is in its final stages, the precise details could change before its release, expected as early as this week, the people said. The missing funds could total more than Rs 2500 crore, one person said.

“The investigation report is still a work in progress, and not finalized,” a spokesman for the company said. “The board of directors and the company are unaware of its content at this point of time. Hence it would be premature to speculate on the investigation findings.”

The priority for management and Siddhartha’s family “is to keep the business running in a challenging environment and meet all stakeholder commitments, including 30,000 jobs associated with the group,” the spokesman added.

The disappearance of the 59-year-old founder last year stunned India’s business community. He had last been seen telling his driver he was going for an evening walk along a bridge in southern India; his body was found by local fishermen two days later. A letter delivered to Coffee Day’s board and employees, which appeared to be signed by Siddhartha, described massive debts and complained of pressure from lenders and tax authorities. It claimed he bore sole responsibility for the company’s financial transactions.

The probe began about a month later when the company brought in Ashok Kumar Malhotra, a retired senior official from India’s federal enforcement agency, to investigate. A senior lawyer practicing in India’s top court is assisting, the company said in a regulatory filing at the time.

The publicly traded Coffee Day was supposed to be India’s answer to Starbucks Corp. More than 1,500 of its Café Coffee Day outlets blanketed cities and highways, with affordable options for the country’s aspiring middle classes. The chain’s tagline: “A lot can happen over coffee.”

But the empire has been battered since the founder’s death. Its shares plummeted about 90% and its market value dropped to about $80 million. Trading was suspended in February.

India’s regulators are tracking the situation and may use the company’s final report as part of a deeper dive into its internal affairs, the people said. Coffee Day showed about Rs 2400 crore in cash and cash equivalents on its balance sheet as of March 2019, the most recent figures the company has issued.

After the death of Siddhartha however, the company faced a severe liquidity crunch and had “zero cash in the bank,” according to one of the people. It struggled with day-to-day expenses and paying salaries has been a strain, the person said.

The draft report details personal guarantees by Siddhartha for loans taken by Coffee Day, and his unsecured loans at high interest rates from local money lenders, the people said. It also probes Coffee Day’s defaults to coffee growers and other vendors, they said.

A related issue is that coffee estates owned by Siddhartha and several employees had been used as collateral for bank loans. The report found that valuations for properties were inflated to get the loans, one person said.

Investigators have examined several theories about what happened to the company’s money, including whether Coffee Day was manipulating its finances to show cash and profit and whether Siddhartha was taking cash out of the listed company to pay off a large investor to whom he had guaranteed a return, the person said. From the filings of his listed and private companies, the entrepreneur’s loans had totaled more than Rs 10,000 crore, and he had been squeezed by borrowing to repay interest on earlier loans, the person said.

In the letter purportedly from Siddhartha, the entrepreneur said he had tried his best but failed as an entrepreneur. “I am solely responsible for all mistakes,” the letter read. “Every financial transaction is my responsibility. My team, auditors and senior management are totally unaware of all my transactions. The law should hold me and only me accountable, as I have withheld this information from everybody including my family.”

As the report nears release, Coffee Day is finalizing a deal with Blackstone Group Inc. for real estate assets. A large tranche of the payment is due in about a week, one person said.

Coffee Day said it is working to reduce its debt load by divesting non-core enterprises.

“The aim is to save employment and preserve this iconic Indian brand,” the spokesman said.

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