I don’t know why I’m fixated with India and the unetical pharmaceutical situation over there but I am. Perhaps it’s something to do with Shane’s trip to Kolkatā (formerly known as Calcuttā) and the trip that never came about. I suppose I will always wonder what if!
In 2008, the “All India Institute of Medical Sciences” revealed that Forty-nine babies had died in drug tests at one of India’s top hospitals, raising concerns that ethical standards are being compromised as the country becomes the world’s leading destination for clinical trials. Link.
Rampant unethical drug trials were exposed in 2010 when the Bhopal Gas Disaster verdict was returned and five gas victims at the Bhopal Memorial Hospital and Research Centre claimed they weren’t even aware they had undergone trials. The state government has instituted an inquiry headed by its joint director, health. An NGO claims that 16 deaths at the end of 2006/early 2007 were due to the trials. The administration has also admitted that one of the four deaths at a government cancer hospital at Jabalpur in 2009 was linked to the drug trials. Link.
For the first six months of of 2010, nearly 500 deaths have been attributed to trials, which is more than the combined total for 2007 and 2008.
In 1999/2000, an experimental drug from the US called M4N was injected into cancer patients in India without being properly tested on animals first. Later it was discovered that several patients had not even been aware that they were taking part in a clinical trial. Link.
The cost of testing drugs is significantly lower in India, but many say the system needs an overhaul as the human cost is far too high. India’s government-run hospitals provide low-cost treatment to the poor, but there are increasing claims that patients are being used as guinea pigs in drug trials for western pharmaceuticals without their knowledge.
According to the Indian Pharmaceutical Alliance, GlaxoSmithKline, the London-listed pharmaceutical giant, and Johnson & Johnson, its US-based peer, are the two leading groups engaged in testing new drugs in India, each conducting 22 trials in 2008.
Allegations have surfaced in the media that the Indore hospital is conducting illegal drug trials on patients. Police are investigating the complaint, though hospital officials say any trials are being conducted in accordance with government guidelines. In India, two million people are estimated to be taking part in clinical trials, with or without their consent. Link. Human rights groups are raising concern over India turning into a hot spot for drug trials, where hospital patients are being used as guinea pigs for the world’s pharmaceutical companies, sometimes without consent.
Last month, the drug controller general of India — the top industry regulator — officially censured nine firms for failing to compensate the families of patients who died during clinical trials over the past year. But critics say the real story lies in the overall numbers, and the drug controller’s tardiness in taking action.
According to the official figures, more than 1,500 Indians have died in the course of clinical trials since 2008 — 670 last year alone. And even though few of those deaths were reported to be treatment-related, there is no independent audit system to investigate the fatalities that occur during clinical trials. Link. With over 1,300 drug trials currently being conducted in India, this industry is already said to be worth $1 billion.
The women, most of whom were daily wage labourers, widows or the wives of invalid husbands, were desperate for money. This made them particularly vulnerable to the touts or broker recruiting in rural areas to find “testers”. The women were promised a sum of around Rs. 9000 (about 140 euro or 200 U.S Dollars) but most of them either received nothing, or much smaller sums. Link.
In June this year the State drug control authorities carried out inspections of Axis Chemical Laboratories in Hyderabad and two women working as brokers were arrested in connection with the unregistered trials.
How it works
A group of 20 women – all of them healthy – were lured to take part in the trial without actually being told of the consequences. Each put her mark on a paper and then were given pills or an injection.
Some of the women got sick and were bumped off the trial without any compensation. The healthy ones received another dose. A group of women suffering from body ache, joint and chest pain went to the local health authority and the case came to light. What makes this case particularly shocking, is that it’s nothing new. Link.
Deanxit, another one of Lundbeck’s dangerous drugs, which by the way has not been approved by the FDA or it’s country of origin Denmark and did not pass the mandatory clinicals trials in India, is still however being proudly advertised on Lundbeck India’s website. Deanxit withdrawal can include agression, hostility and worsening of depression…Link
The pharmaceutical companies who are taking advantage of the Indian people are the same pharmaceutical companies who have their offices and factories here, no difference, just a different country!
Among the pharmaceutical companies doing drug trials in India are Lundbeck, AstraZeneca, Novo Nordisk, Johnson and Johnson, GlaxoSmithKline, Pfizer, Eli-lilly, AstraZeneca, Bristol-Myers Squibb, Allergan, Forest Labs, Norvartis, and Hoffmann-La Roche.
I really hope that some of the above companies will treat the Indian people with the respect they deserve.
Clinical trials website. Link.
Compensation for clinical trials: Just 50 lakh for kin of 22 dead…Link.
Anger at Nigerian drug trials. Link.
The companies, who paid compensation included well known names like Wyeth, Merck, Quintiles, Lilly, Amgen, Bayer, Bristol Mayer, Sanofi, PPD and Pfizer.