Press Release – People’s Convention Against Onslaught on #FOE and Association


Need to change the judicial and political system, resolves people’s convention

 

New Delhi, May 18, 2013: A people’s convention on the State’s Onslaught On Right to Freedom of Expression and Association organized here in the backdrop of suspension of INSAF’s FCRA and freezing of its bank account resolved to fight against the demonizing and draconian laws of Indian state in favor of dispossessed people and their basic rights.

 

Speaking on the occasion in the Constitution Club of India, NCP spokesperson Devi Prasad Tripathi informed the packed house that he has recently written a letter to the Home Minister of India Sushil Kumar Shinde to revoke its FCRA orders against INSAF unconditionally as this step may cause embarrassment to the government. The letter states, “…I apprehend that you actions against INSAF may appear to be motivated and may cause embarrassment to the government…INSAF and its allies are engaged in defending democratic rights of deprived communities and in strengthening secular spirit of the nation”. Tripathi said that the judicial and political system of this country needs to be transformed completely.

 

The convention started with paying homage to Dr. Asghar Ali Engineer, the founder President of INSAF who passed away two days back. Delhi University Professor Achin Vinaik elaborated on the life and works of Dr. Engineer. After this, senior journalist Anand Swaroop Verma gave a detailed backgrounder of the corporate-security establishment nexus in India that started with a report of FICCI and ASSOCHAM and including the “wise” suggestion of the Prime Minister to “co-opt” the media in a meeting with home ministers of states way back in 2006. Manisha Sethi of Jamia Teachers Solidarity Association updated the same issue with new facts regarding defence deals and media-corporate nexus where Reliance group has a shareholding in  25 news channels.

 

Forward Block General Secretary Devbrat Biswas emphasized on continuing the struggles and people’s movements with people’s resources and leadership whether FCRA is continued or not. Educationist Anil Chowdhary categorically said that if the government vows not to take any foreign funding for development, then INSAF will be the first to surrender its FCRA and continue struggles without foreign funding. He said that since the government does not have the courage to do so, hence it may categorically state on its website whether which struggles are not applicable for foreign funding. Chowdhary satirically said that the government has a last and very easy resort to add a footnote in the constitution that all the rights apply to just 15 percent population of this country.

 

Other speakers including Kalyani Menon Sen, Ramesh Dixit, Anil Singh, Ashok Chowdhary, Ranjana Padhi and John Dayal expressed solidarity with the struggling pro-people forces and  condemned the state’s onslaught on people’s basic rights. The convention concluded by passing a five point resolution condemning the recent arrests of anti-POSCO leader Abhay Sahoo, social activists Madhuri and PUCL activist Jaya Vindhyala.

 

#India- The Vanishing Crores- massive swindling in the Rs74,000-crore farm loan waiver


Finance

 

 

 

Devinder Sharma, March 7, 2013:

 

The financial outlay is not matching the outcome. If institutional credit is not reaching the farmers, where is it going?

 

 

Following the disclosure by the Comptroller & Auditor General (CAG) of the massive swindling in the Rs74,000-crore farm loan waiver, announced in the 2009 budget with a lot of fanfare, the entire provisioning of the farm credit allocations have come under a cloud.

Roughly 8-10 per cent of the beneficiary farmers, which means no less than 35.5 lakh farmers did not get any advantage of the loan waiver, and similarly a large number of undeserving farmers walked away with the exemption to repay.

This exposure comes at a time when questions are being asked about who benefits from the significant increases in farm credit being provided for in every budget. In 2012-13, a budgetary provision of Rs 5,75,000-crore for farm credit was made. A year earlier, in 2011-12, Rs 4,75,000-crore was provided. According to Reserve Bank of India, between 2000 and 2010, farm loans increased by 755 per cent. Certainly this is a mammoth growth, and it provides all the reasons to cheer.

This year, finance minister P Chidambaram further enhanced the budgetary allocation for farm credit to Rs 700,000-crore. This is certainly a quantum jump. It gives an impression as if such large availability of farm credit is serving the small and marginal farmers very well, and that all is well on the farm front.

But somehow the growth in the disbursement of farm loans does not match with the real performance on the ground. With over 2.90 lakh farmers committing suicide in the past 15 years, and with another 42 per cent farmers wanting to quit agriculture if given a choice, the continuing agrarian crisis on the farm front is a clear indication that the massive farm credit year after year is either not reaching the beneficiaries or being thoroughly misutilised.

The outlay is not matching the outcome. If institutional credit is not reaching the farmers, where is it going? Time and again we have heard that agricultural credit plays an important role in improving farm production, productivity and mitigating farmer’s distress. Such exuberance in loan disbursal comes at a time when in a recent study on ‘Farm Credit’, the industry association Assocham analysing the disbursement of credit over the last decade, has listed misdirection in farm loans, increase in proportion of indirect credit by banks, misuse of interest rate subvention for diverting credit to other sectors, imbalances in quantity of credit in relation to size of the farm and crops they raise, and virtual exclusion of small and marginal farmers from institutional credit as some of the major problems besetting this sector.

Mute spectator

If you have underlined the last point in Assocham report, it tells us very clearly where institutional credit has failed to deliver. By excluding small and marginal farmers, which forms nearly 80 per cent of the agricultural workforce, hasn’t the government actually failed to reach the benefits to those who need it more? How can the Reserve Bank of India be a mute spectator to the visible misdirection, which in reality should be more visible to them, all these years? Isn’t it a callous oversight or is it deliberate?

A damming news report in a Hindi daily brought out startling reality. According to the report, a confidential document available with the ministry of finance categorically states that despite the increase in farm credit by over 2.5 times in past five years, less than 6 per cent of the total institutional credit is made available to small and marginal farmers. Ironically, the prime minister, the finance minister, the agriculture minister and the ruling party along with its army of economists and planners never get tired of telling the nation of the remarkable strides taken in reaching credit to small and marginal farmers.

In other words, less than Rs 50,000-crore of the Rs 7 lakh crore provided for farm credit will actually benefit small farmers. Remaining amount of Rs 6.5 lakh crore at 4 per cent interest will be misappropriated by agribusiness companies, warehousing corporations and state electricity boards. Why can’t the finance minister therefore segregate the farm credit to tell us how much of it actually goes to farmers, and how much in the name of farmers to other allied activities?

In 2007, of the total credit of Rs 2,29,400-crore advanced by banks, small farmers share was a mere 3.77 per cent. In other words, 96.23 per cent of the farm credit disbursed in 2007 was actually cornered by big farmers or agribusiness companies. In 2011-12, while total farm credit had swelled to Rs 5,09,000-crore (against a target of 4,75,000-crore) small and marginal farmers got only 5.71 per cent. It is therefore obvious that despite knowing where the fault lies the government had deliberately supported agribusiness companies (an increase in indirect credit by banks by enlarging the definition of agriculture) in the name of small and marginal farmers.

It is primarily for this reason that small farmers have been left high and dry. They are left with no choice but to depend on the money lenders who charge exorbitant interests. No wonder, the serial death dance on the farms in the form of suicides show no signs of ending. It has a lot to do with the non-availability of institutional credit.
(The writer is a noted food and agricultural policy expert)

 

 

 

 

The dark underbelly of India’s clinical trials business- #medical ethics #humanrights


Incidents at Bhopal and Indore highlight irregularities and ethical violations in some trials
Malia Politzer  |   Vidya Krishnan

First Published: Wed, Oct 10 2012. , at Live Mint

Protesters outside the Bhopal Memorial Hospital and Research Centre. Photo: Sayeed Farooqui/Mint
Updated: Thu, Oct 11 2012. 12 20 AM IST
New Delhi: In 2004, doctors at the Bhopal Memorial Hospital and Research Centre (BMHRC), established exclusively for treating the victims of the 1984 gas leak, recruited unsuspecting survivors for clinical trials without their knowledge or consent; 14 participants died during the course of the trials.
Together with the episode in Indore’s Maharaja Yashwantrao Hospital (that Mint reported on 10 October), where 32 people have died in clinical trials between 2005 and 2010, this incident highlights irregularities and ethical violations in some trials conducted by clinical research firms and pharma companies—the dark underbelly of the booming clinical trial business in India.
In 2005, India introduced patent protection laws. Since then, it has become a global hub for clinical trials, drawing companies because of its ethnically diverse pool of potential test subjects, while bringing down research and development (R&D) costs by nearly 60% in phase II and III trials, according to lobby group Confederation of Indian Industry.
A phase II trial establishes the protocol for testing and a phase III one is the final testing prior to approval.
Regulatory failures have marred the clinical trial business in India, experts said, pointing to lapses in the functioning of so-called ethical committees that are required by law for each trial, contract research organizations (CROs) and the Central Drug Standard Control Organization (CDSCO).
A parliamentary panel in May found CDSCO to be in collusion with drug companies and doctors, and approving at least one drug every month without conducting clinical trials or seeking expert medical opinion. Concerns over the conduct of clinical trials prompted the same panel to look into the rapidly growing industry, and the international and domestic pharmaceutical companies sponsoring them.

“Many issues have been raised in Parliament—people being treated as guinea pigs, lack of informed consent and unattributed deaths during trials,” said Sanjay Jaiswal, a Lok Sabha member and a physician himself. “We are not against clinical trials. The issue is about how these trials are being done. Rules need to be followed.”

A report on this will be presented to Parliament in the winter session, he said.
Medical ethicists are concerned that the rapid growth— without trained manpower or a clear-cut regulatory framework —could be a “race to the bottom”, with global ramifications and not just confined to one country.
“What the media doesn’t get straight is that drug companies aren’t using poor Indians as guinea pigs for Americans,” said Arthur Caplan, a bioethicist at the New York University Langone Medical Center. “The more common thing is that say Vietnam competes with India to see if the companies will come and bring in their studies, bring in the doctors, bring some relief if the drug or vaccine works—maybe spend some money in these places, give a bribe or two to the local health ministry to recruit in the local mental hospital. So, if India tightens regulation, companies will just go to Vietnam. This is not just an India problem—it’s a global issue.”
A globalized market
International boundaries blurred substantially when the US food and drug administration (FDA) relaxed regulations allowing drug companies to submit results of foreign trials in applications for new drugs to be marketed in the US.
Between 1990 and 2008, the number of clinical trials conducted largely by US companies shot up about 24 times to 6,465 from 271, according to a 2011 article in Vanity Fair. The 20 largest US-based drug makers conduct about one-third of their phase III clinical trials outside the country, and a majority of their study sites also are elsewhere, according to American Medical News.
A large genetic pool, high-quality hospitals, English-speaking staff and low costs make India an attractive destination for pharma firms looking to conduct clinical trials.
According to CDSCO, there are an estimated 150,000 people enrolled in clinical trials in India. According to a 2011 Associated Chambers of Commerce and Industry of India (Assocham) report, nearly 100 domestic and multinational pharmaceutical companies are conducting trials in the country and the business is worth Rs.8,000 crore.
Trials in countries such as India are cheaper to run: According to a 2008 Harvard Business Reviewarticle, tracking Indian test subjects costs between $1,500 and $2,000, (Rs.79,500 and Rs.1.06 lakh today), while in the US, it would cost $20,000.
When clinical trials are conducted ethically, India’s poor also stand to gain. With only 20% of India’s 1.2 billion people covered by health insurance and 35% living below the poverty line, the bulk of the population pays from the pocket for healthcare, according to health industry data provided by Assocham.
“A lot of patients don’t have access to healthcare otherwise,” said Irene Schipper, a researcher at the Netherlands-based Centre for Research on Multinational Corporations (SOMO). “But the problem, of course, is that when the clinical trial is over, they don’t have access anymore.”
Many clinical trials aren’t conducted ethically.
Schipper is concerned that tight regulatory policies in the US and the European Union (EU) appear to be driving high-risk trials to developing countries such as India, where rules or their enforcement may be lax. In 2008, SOMO released a report, Ethics for drug testing in low and middle-income countries, cataloguing a trend of offshoring risky clinical trials to developing countries that would be prohibited by ethics committees in the EU.
In one case, AstraZaneca Plc sponsored large, multi-centred placebo-controlled trials for Seroquel XR, an anti-psychotic drug for the treatment of patients with schizophrenia. The drug was tested against a placebo, which meant that roughly half the participants—all diagnosed schizophrenics—went without any treatment for the duration of the trial.
Due to the worsening of their conditions, 8.3% of the patients receiving the placebo required hospitalization. After 173 days of placebo treatment, one 25-year-old man committed suicide. “The consequences of this practice are serious,” Schipper said in the report. “According to the Declaration of Helsinki, this type of trial can never justify the use of a placebo because it involves withholding treatment from seriously ill patients risking irreversible harm. Nevertheless, the Dutch Medicines Evaluation Board approved Seroquel XR for the EU market.”
The multi-centre trials were conducted in India, Bulgaria, Poland, Russia and the Ukraine. While companies also continue to conduct such clinical trials elsewhere, “these days you’re seeing a lot more of these sorts of trials in India”, she said.
“At AstraZeneca, we take very seriously our responsibility towards the patients participating in our studies and our responsibility to deliver consistently high standards of ethical practice and scientific conduct in all our trials wherever they take place,” Andrew Higgins, a spokesperson for AstraZeneca, said in a statement.
“A placebo treatment does not imply a deficient standard of care. In accordance with the Good Clinical Practice rules, all patients in our clinical trials are provided with the same amount of care and are strictly monitored with the option to switch to another therapy or to be discontinued from the study where it becomes necessary,” he said.
Offshoring responsibility
Central to the growth of off-shoring clinical trials is the role of CROs—independent companies hired by sponsors to undertake clinical trials. Nearly 90% of trials in India are conducted by CROs, favoured by sponsors for their ability to form partnerships with local research organizations, recruit large numbers of participants and quickly conduct trials.
But medical ethicists worry this comes with a dark side. “To put it in a somewhat less polite way, the big company outsources the responsibility to the CRO. If something goes wrong, they say the CRO is completely responsible for this,” bioethicist Caplan said.
In 2011, CDSCO suspended the licence of Hyderabad-based CRO Axis Clinicals Ltd for recruiting illiterate women for a trial without obtaining proper consent. Following the incident, DCGI ordered an investigation into the operation of all 10 CROs in Andhra Pradesh.
Axis failed to respond to Mint’s repeated requests for comment.
“The problem with outsourcing to CROs is that oversight can be problematic,” said Schipper. Many CROs will divide tasks, such as administration, recruitment and research among various other CROs, making monitoring the process difficult for sponsors who are often based overseas, she said. “In our research, we’ve interviewed sponsors who have stopped using CROs entirely because they found that the cost of effectively monitoring them was greater than the money saved by hiring them.”
Caplan further worries that market incentives can drive CROs to complete trials at any cost. “There’s a conflict of interest when you hire a CRO, to act as a scientific and an ethical committee in India,” he said. “The sponsor wants the data—and wants it fast, and every day a study goes past its predicted date of completion, because they don’t have subjects enrolled, costs millions and millions of dollars—perhaps then they don’t continue to pay as much attention to informed consent or eligibility criteria.”
No functional regulatory system
Axis is not the first CRO in India to be facing hard questions: Quintiles, one of the largest global companies in the segment and based out of North Carolina, received a polite warning letter from DCGI for the clinical trials on Bhopal gas victims. “It should be noted that the studies conducted at BMHRC were approved by the Institutional Ethics Committee that was completely aware of the medical status of the patients visiting the hospital and participating in these trials,” Quintiles wrote in response to Mint’s inquiries.
Doctors, activists and researchers note that Indian ethics committees are often flawed. “Ethics committees are the front line regulators for clinical trials. If they were functional, they would be a major factor in preventing unethical trials,” said Amar Jasani, a researcher and trainer in the field of bioethics and public health. “The problem is the ethics committees are completely controlled by the institutions—they are not at all independent, the people on the committees are not trained, nor do they have the resources or independence to do their job.”
According to Jasani, Indian law allows for commercial ethics committees to be hired by the very CROs they are meant to monitor. “There’s a double conflict-of-interest,” he said. “They are governed by the CROs or the pharma companies. At the same time they are profit making—so they are more motivated by financial interest than (the safety of participants).”
While international standards governing clinical trials do exist, most are voluntary and lack regulatory teeth. The Delcaration of Helsinki, of which India is a signatory, says that potential research subjects need to be informed of the risks involved prior to participation, and reserve the right to refuse to participate.
Foreign drug authorities, such as FDA, have also made efforts to curtail unethical trials, by requiring that drug companies abide by certain guidelines. But their reach is limited. A 2010 report by the US Government Accountability Office found that FDA inspects fewer than 1% of clinical trials abroad, and that in many cases, it isn’t aware where clinical trials are being conducted until drug companies submit applications to market the new drug.
“There is no registry or international database—so I don’t think anyone knows what percentage of clinical trials are happening in the developing world. How many participants are men or women, old or young is also hard to know,” said Caplan. “We don’t have good information about what is really going on there, until there is a scandal, a problem or a death—but the overall picture is tough to know, because no one is responsible for monitoring it.”
The impact, though, is widespread: Nearly 80% of drug applications to FDA for marketing approval include tests done on foreign soil. With an FDA stamp of approval, many of the drugs end up being sold all over the world. “Seeing this as Americans exploiting Indians is not accurate,” said Caplan. “Drug companies are equally happy to sell to wealthy Indians. Drugs tested in these trials are eventually sold everywhere—studies in poor nations affect everyone.”

 

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