India's Drug Trials-Thousands have died since rules were eased

In the January 2011 Issue Of Vanity Fair, in the article "Deadly Medicine" the authors Donald L. Barlett and James B. Steele investigated clinical trials conducted overseas. According to the piece some clinical trial participants were;

"Sick Russians, homeless Poles, and slum-dwelling Chinese—in places where regulation is virtually nonexistent, the F.D.A. doesn’t reach, and “mistakes” can end up in pauper’s graves?

This month the Wall Street Journal has brought to light the same unethical trials taking place across India.

India's Drug Trials Fuel Consent Controversy

Thousands have died since rules were eased

Rama Lakshmi
(The Washington Post, January 2, 2012)

"Since India eased guidelines for conducting drug trials in 2005, the number of Indians participating has shot up to 150,000 from close to zero, as international drug companies take advantage of lower costs here. But questions about the consent process have fueled fears that many Indians are entering the trials without knowing the risks...In the wake of the recent controversies, the Indian Council for Medical Research invited public feedback on draft guidelines about compensation for injuries that occur during clinical research…Across India, 1,700 people who participated in clinical drug trials died between 2007 and 2010, the government’s drug regulatory agency said, although no autopsies were carried out to determine the causes of the deaths. In 2010, 22 families of the dead were compensated by U.S. and European drug companies, ranging from $2,000 to $20,000. Clinical drug trials in 2010 generated business worth $300 million in India, according to the Confederation of Indian Industry. Conducting drug trials here saves the companies almost 40 percent of the total cost of drug development because health-care professionals are cheaper and liability is not very high, analysts said. The large pool of patients with diverse illnesses and doctors who speak English also make it an attractive destination for outsourcing trials. 'India is emerging as a hub for drug trials, and Indian patients are like guinea pigs,' said C.M. Gulhati, editor of the Monthly Index of Medical Specialities journal."

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India outrage over low fine for drug trials

Authorities in the Indian state of Madhya Pradesh have been criticised for letting off lightly 12 doctors who conducted drug trials on children and patients with learning disabilities.

The doctors were fined 5,000 rupees ($94; £60) each for failing to inform the authorities about the tests.

Activists and opposition parties said the fine was a "joke" and called for an investigation by the federal police.

The trials of the drug to treat sexual dysfunction were in the city of Indore.

Millions of people in India are thought to be on clinical trials.

Correspondents say patients are often unaware that they are being experimented on, and that when they are told the high levels of illiteracy mean they are unable to give informed consent.

'Inhuman crime'

It was unclear how the latest case came to light.

However, one Madhya Pradesh doctor who lodged a complaint over the case, Dr Anand Rai, told the Times of India: "Drug trials were performed on patients who had gone to the hospitals for routine treatment. It's a criminal offence to put them under drug trials without consent."

He said the maximum penalty for the offence was 50,000 rupees.

The Congress party, which is the main opposition in Madhya Pradesh, also criticised the state government for levying such a low fine for "a grave, inhuman crime", The Hindu newspaper reported.

"The lives of the poor patients who were victimised in the name of drug trials is just 5,000 rupees? We demand an inquiry by the Central Bureau of Investigation," the paper quoted leader of the opposition in the state assembly, Ajay Singh, as saying.

The authorities said the doctors were fined for failing to inform health officials about the drug trials, not for failing to inform the patients.

Further action would require knowing the identities of the patients and the doctors who carried out the trials cited a law that requires them to keep the identities secret.

India:Poor women fall victim to clinical trials

TNN | Jun 17, 2011, 06.29am IST

PIDUGURALLA (GUNTUR): Exactly a decade after farmers in Palnadu region sold their kidneys to clear their mounting debts, poverty-stricken women from the backward Palnadu region have fallen prey to clinical trials by a Hyderabad-based pharma company.

The clinical tests on human beings, reportedly without the requisite permission of the state government, came to light on Thursday when some of the victims fell seriously ill in Piduguralla town. Many of those who returned from the lab after the tests developed acute joint pains, swelling in arms and throat infections. Acting swiftly, district collector V N Vishnu directed district medical and health officer Gopi Naik to rush to Piduguralla and probe the incident.

"Though the pharma company promised to pay us huge amounts before conducting the tests, they paid me only 9,000," rued Shaik Bibi, who underwent the tests along with several other women in the lab in Miyapur, Hyderabad. The firm, breaking all rules, did not provide any information to the women on the nature of tests conducted on them.

"Some middlemen engaged by the company take the illiterate women directly to the lab. This has been going on for some time now," sources said.

Though the women returned home without any complications, side-effects of the pills they had consumed at the lab nearly 3-4 months back are showing now. "I was perplexed when I could not walk even a couple of yards a few days ago. Initially I thought it was a routine sickness. After going through medical tests here, I came to know that it was the result of the drug administered at the lab in Hyderabad," said Paila Dhanalakshmi.

Sources said the people selected for the clinical trials are `detained' in the lab for four continuous days. According to the women, they came across people from north Indian states also in the lab. "But we were strictly not allowed to interact with others," a woman revealed. Most of the women who went from Piduguralla are farm workers and daily wagers.

A counselling session is conducted for the selected people and later they are forced to sign on a bond before undergoing the tests. "If everything goes well after taking a tablet, the person is asked to visit the lab again after 10 days when an injection is given. Another dose of injection is administered after 10 days. We were paid Rs 9,000 for the three rounds of tests," said a victim Jakka Kumari.

"If any abnormalities in the blood samples are found or the volunteer develops complications, he/she is sent back by handing over a mere Rs 1,000," stated a weeping Kommu Karunamma.

Sources said more than 40-50 people from Adarsh Colony, Chandrapalem and Indiramma Colony in Piduguralla have been visiting the lab for the past few months.

When contacted, one of the brokers, Shaik Jameela, who reportedly took some women to the Hyderabad-based lab, shot back: "The women are selling their own blood and not anyone else's. What's the problem." She claimed that the women she had taken did not complain of any side-effects.

Meanwhile, six of the affected women are being shifted to the Guntur government hospital. "If we come across any irregularities, we will slap a case against the pharma company," warned the DM&HO.

http://timesofindia.indiatimes.com/india/Poor-women-fall-victim-to-clinical-trials/articleshow/8881808.cms

Outsourced Clinical Trials; Critics question ethics of testing in poor countries

Some pharmaceutical companies are cutting costs by conducting clinical trials outside the U.S., thus also avoiding strict policies put in place here. Consumers may start to wonder if drugs in the U.S. will be less safe when companies are increasingly seeking other nations to conduct trials in, places like Eastern Europe, Africa and Asia. Maybe its good science, or maybe its just great profits. Today we have three articles which discuss many of these concerns.

Published online in April over at Outsource portfolio is the first of two articles, "the first critiquing the second", both in reference to a report on the dangers involved with outsourcing clinical trials. The report is from the "Center for Research on Multinational Corporations". 
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The second article criticized the centers paper for a lack of evidence, but said the guidelines in the report had merit, in particular these proposed guidelines; the number of regulatory tests or inspections done on non-traditional areas should be hiked. In order to obtain 100 percent transparent along these lines, all audit results should be made 100% public. Also, disclosing all parties involved in each study, including all contractors and subs.

In the third article, "a must read" Ben Hirschler from Reuters covers the pros and cons of outsourcing in more detail. The author points out the increase of outsourcing clinical trials to other countries like Poland and Hungary, look at the numbers;

In the United States, the widespread "off-shoring" of research was highlighted in a report last year by the inspector general of the Department of Health and Human Services, which revealed just how reliant the country has become on foreign testing. In 2008, a total of 78 percent of all subjects participating in trials to support drug applications submitted to the Food and Drug Administration (FDA) were enrolled at foreign sites -- and as more experimental medicines move through the pipeline the numbers are set to increase further. In Europe, the picture is similar, with 61 percent of patients in pivotal trials submitted to the European Medicines Agency (EMA) between 2005 and 2009 coming from third countries. A further 11 percent of patients were enrolled in studies in Eastern European countries that are now members of the European Union. The number of Polishh the pipeline the numbers are set to increase further. In Europe, the picture is similar, with 61 percent of patients in pivotal trials submitted to the European Medicines Agency (EMA) between 2005 and 2009 coming from third countries. A further 11 percent of patients were enrolled in studies in Eastern European countries that are now members of the European Union. The number of Polish patients involved in such trials rose fivefold over the period, while Hungary was up 3-1/2 times.

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More From The Author; Drug makers seeking global guinea pigs
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"Off-shoring" clinical trials helps drug makers cut costs
Growing reliance on Eastern Europe, Asia, Latin America
U.S. doctors worried by decline in U.S. trial subjects
Critics question ethics of testing in poor countries
The Polish port city of Gdansk is famous for its shipyards. Hungary's fifth largest city, Pecs, is known for its ancient architecture and brewery. Neither is particularly renowned for medicine. Yet when AstraZeneca Plc tested its big new drug hope Brilinta on heart attack patients in a major clinical study, it was hospitals in these places that enrolled some of the highest number of patients anywhere in the world. In fact, Poland and Hungary together accounted for 21 percent of all subjects studied in the pivotal 18,000-patient trial -- more than double the United States and Canada combined.

A few years ago that would have been unthinkable. Major drug companies, with an eye on the commercial promise of the world's largest and most profitable market, would have run half their tests on a major cardiovascular medicine like this in U.S. hospitals under the supervision of U.S. doctors.

Today, the clinical trials business has gone global as drug makers seek cheaper venues for studies and cast their net further afield for big pools of "treatment-naive" patients who are not already taking other drugs that could make them unsuitable subjects for testing new ones. And it is not only the practicalities of running big clinical trials as efficiently and cheaply as possible that is driving the change. The drug industry is also paying a lot more attention these days to the promise of emerging markets, whose healthcare authorities, just like those in the United States and Western Europe, are keen to see cutting-edge science conducted in their backyards.
"The motivation to involve lots of patients is very high in Eastern European countries and also in Asia," says Dr. Ivan Horvath, head of interventional cardiology at the University of Pecs. "There are three factors driving this. Our patients get access to a new drug, which is free during the trial. It is also very important for scientific reasons. And we get paid."

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Of Interest: From The January 2011 Issue Of Vanity Fair; Deadly Medicine

Prescription drugs kill some 200,000 Americans every year. Will that number go up, now that most clinical trials are conducted overseas—on sick Russians, homeless Poles, and slum-dwelling Chinese—in places where regulation is virtually nonexistent, the F.D.A. doesn’t reach, and “mistakes” can end up in pauper’s graves? The authors investigate the globalization of the pharmaceutical industry, and the U.S. Government’s failure to rein in a lethal profit machine.