By Stuart Chaifetz
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And now back to our regularly scheduled blog.
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Over There
The outsourcing of Human Clinical Trials (HCT) to third world countries is big; big business for Big Pharma with big risks to the humans being experimented on.
Always bear in mind that HCT’s are “it,” meaning that the results of these trials literally hold billions of dollars in the balance. We’ve already seen how data from these trials have sometimes been falsified, or other fraud has occurred - and that’s just here in the United States, where there is supposed to be some form of protection. Imagine what it must be like over there...
One of the most notorious cases of an outsourced drug trial gone horribly wrong is the Pfizer/Nigerian Drug Trial disaster:
“Pfizer has reached a broad agreement to pay millions of dollars to Nigeria's Kano state to settle a criminal case alleging that the drug company illegally tested an experimental drug on gravely ill children during a 1996 meningitis epidemic.”
“Nigerian authorities say Pfizer's infamous trial of the antibiotic Trovan killed 11 children and disabled scores more.”
Here’s a little more info on the drug in question, Trovan, which, of course, was tested for safety using animals:
“Trovan was never approved for use by American children. The Food and Drug Administration approved it for adults in 1998 but later severely restricted its use after reports of liver failure. The European Union banned the drug in 1999.”
Once again, animal experimentation failed to protect people from harm.
Though this was just one high profile case, there are many serious problems with HCT abuse in third world countries. Things were so bad that a Chinese and European consortium, BIONET, was founded to create some ethical guidelines.
“The starting point for ethical concerns about clinical trials is that they raise questions of therapeutic misconception and informed consent, especially among ‘vulnerable populations’ who may be susceptible to wrongful involvement either because they live under unfortunate socio-economic conditions or because they are in a desperate situation when suffering from certain diseases with little treatment options.”
“Another important general issue...is the conflict of interest between researchers and
clinicians: a clear differentiation should be made between provision of healthcare and clinical research. Yet, in practice, this has proved very difficult to achieve especially in situations where healthcare resources are scarce and institutions serve both purposes.”
This probably isn’t a big surprise. I think we all know that the poor people of the world are often treated as expendable or are considered to be not worthy of the same rights and protections as the rest of us. So when the conflict between pharmaceutical researchers and doctors trying to save patients lives arises, we can guess who loses.
To add insult to injury, even if these human tests lead to a successful drug, these vulnerable populations aren’t going to see a benefit --- because they can’t afford the cost of the drugs that their suffering helped create.
I’ll get back to the Bionet report in a future blog, but for now I want to stay with the issue of the exploitation of vulnerable people for pharmaceutical experiments.
India, like China and Africa, where there are huge numbers of poor people, is seen like a gold mine to the pharmaceutical industry. From Asia Times online:
“Yet even as India increasingly emerges as a preferred destination for outsourcing clinical trials - testing of new drugs on humans - the country may also be heading toward providing the greatest source of human guinea pigs for the global drug industry.”
“Almost all top names, including Novo Nordisk, Aventis, Novartis and GlaxoSmithKline, have started running clinical drug trials in India lately, while some, such as Eli Lilly and Pfizer, which started much earlier, conduct tests on a number of their new drugs.”
“However, in India particularly, unethical and illegal clinical trials are most rampant and are conducted without fear because, say critics, there is no law to safeguard the interests of volunteers, while regulatory authorities,"by design or default", fail to take action against such trials.”
Here’s one of the few times when someone did get caught in India:
“A government doctor and a nurse from Saurashtra’s largest civil hospital...have been booked on charges of carrying out illegal drug trials using health department resources.”
“...some staff members of the hospital had raised the issue claiming that lives of unsuspecting patients had been put on stake to benefit a private company’s research.
The poor and the sick are easy victims for abuse, but so are the elderly. Here’s what happened in Greece:
“The government has ordered an in-depth inquiry into the operations of all old-age homes in Greece after an inspection at the Athens Old Age Home found that residents had been subjected to clinical trials without their written consent.”
Why are human experiments so in demand? Why are large populations of “human guinea pigs” being exploited?
Because experiments on animals are ineffective, faulty, and lead to dead ends...especially of human lives.
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