Last year my company started outsourcing part of research and development to  pharmaceutical company in India. Cost reduction is definitely a key to better net revenue and that was definitely a plus point but it really got me thinking about other facet of pharmaceutical outsourcing. I started searching for pharmaceutical outsourcing and found out that there is a trend of clinical trial outsourcing to different developing countries like India. Clinical trial outsourcing is very sensitive and questionable. Clinical trials in US are FDA regulated and laws and regulations are in place. Patients can quit the trial period or can be in trial until complete at their discretion. Clinical trials are carefully conducted and patients are well informed about side effects and covered for all the treatments due to side effects. With increased awareness about the risk and side effects of testing drugs under development, the volunteers in developed countries have shriveled. Due to the reason, the drug industry is exponentially moving to underdeveloped and developing countries like India where enrolling uninformed, non consenting poor people are readily available. Looking at the clinical trial outsourcing data from 1997-2007, US clinical trial declined from 86% to 57% as it is very expensive due to law suits, and other clinical trial related expense. Clinical trial in developing countries has climbed from 5% to 29% where law suits are unheard of and compensation is minimal.

I was researching about clinical trial in developing countries and I was shocked to find news about reputed pharmaceutical company Pfizer. Pfizer completed two week trial of an antibiotic during a 1996 meningitis epidemic in Kano, Nigeria. A 2000 Washington Post story criticized trial investigators for allegedly allowing children to die while taking the study drug, sparking lawsuits from families and the Nigerian government. Pfizer reached a $75 million settlement with Kano in July, according to the reports.

Outsourcing to developing countries have issues, the patient population is different, where there is no strong FDA regulation, no long term monitoring system and clinical trials illiteracy. Minor side effects are hard to monitor as in those countries patient come to medical representative or hospital only after major issues. In India, unethical and even illegal clinical trials has prevailed without fear as there is no law to safeguard the interest of volunteer patients and regulatory authorities fail to take actions against such trials. The example of illegal and unethical trial conducted in India involved Sun Pharmaceutical and Novartis in 2006 and conducted similar documented illegal trials in countries like Russia, Nepal, Uganda, Peru, China, Nigeria, and Argentina.

In developing countries, people do not understand the concept of clinical trials. Their concept of clinical trial is free drug to ease their pain and cure their disease. There is no formal way of informed consent. The data collected in these clinical trials are highly doubtful as the patient population is entirely different and the result of the trial may not apply to the targeted population. This means that we will put targeted population at risk. Taking another example of Hepatitis E trial in Nepal, investigators failed to get patients’ consent about changes in the experiment and administered wrong doses. There were serious problems in record keeping and delays and underreporting of fatal and life threatening problems. Fourteen deaths were not reported. Researchers acknowledged thousands of side effects and adverse reactions were not disclosed. Procedures for divulging Serious Adverse Events (SAEs) were not followed. Boehringer Ingelheim, the company that markets the drug and audited the trial, asked the US National Institutes of Health to destroy an early copy of the research report in case the study would be audited by FDA. There were many violations such as adverse event notification, destroying documentation regarding research findings, and side effects were not properly discussed with patient population.

GlaxoSmithKline has unethically tested breast cancer drug in India. About 400 thousand Indian women have breast cancer and the clinical trial was the only option as they were vulnerable and poor. The only option was to accept the trial and even the drug is proved to be safe, they cannot afford the drug and the total population the trial was done is unethical. In every controversy regarding outsourcing clinical trials, I have seen reputed pharmaceuticals involved and I wonder how many of these other unknown clinical trials are currently conducting in poor countries.  

There are cases of cheating in clinical trial documentation and it has been an issue so FDA should properly regulate clinical trial outsourcing. There comes an issue of transparency between pharmaceutical company and patient population. I am not against outsourcing clinical trials but I would like to plead pharmaceuticals not to accept unethical or questionable clinical trial offered in poor countries where people are treated like guinea pigs. They should comply strickly with FDA rules and regulations.