| Last year my company started outsourcing part | | | | conducted similar documented illegal trials in |
| of research and development to pharmaceutical | | | | countries like Russia, Nepal, Uganda, Peru, China, |
| company in India. Cost reduction is definitely a | | | | Nigeria, and Argentina. |
| key to better net revenue and that was definitely | | | | In developing countries, people do not understand |
| a plus point but it really got me thinking about | | | | the concept of clinical trials. Their concept of |
| other facet of pharmaceutical outsourcing. I | | | | clinical trial is free drug to ease their pain and cure |
| started searching for pharmaceutical outsourcing | | | | their disease. There is no formal way of informed |
| and found out that there is a trend of clinical trial | | | | consent. The data collected in these clinical trials |
| outsourcing to different developing countries like | | | | are highly doubtful as the patient population is |
| India. Clinical trial outsourcing is very sensitive and | | | | entirely different and the result of the trial may |
| questionable. Clinical trials in US are FDA regulated | | | | not apply to the targeted population. This means |
| and laws and regulations are in place. Patients can | | | | that we will put targeted population at risk. Taking |
| quit the trial period or can be in trial until complete | | | | another example of Hepatitis E trial in Nepal, |
| at their discretion. Clinical trials are carefully | | | | investigators failed to get patients’ consent |
| conducted and patients are well informed about | | | | about changes in the experiment and administered |
| side effects and covered for all the treatments | | | | wrong doses. There were serious problems in |
| due to side effects. With increased awareness | | | | record keeping and delays and underreporting of |
| about the risk and side effects of testing drugs | | | | fatal and life threatening problems. Fourteen |
| under development, the volunteers in developed | | | | deaths were not reported. Researchers |
| countries have shriveled. Due to the reason, the | | | | acknowledged thousands of side effects and |
| drug industry is exponentially moving to | | | | adverse reactions were not disclosed. Procedures |
| underdeveloped and developing countries like India | | | | for divulging Serious Adverse Events (SAEs) were |
| where enrolling uninformed, non consenting poor | | | | not followed. Boehringer Ingelheim, the company |
| people are readily available. Looking at the clinical | | | | that markets the drug and audited the trial, asked |
| trial outsourcing data from 1997-2007, US clinical | | | | the US National Institutes of Health to destroy an |
| trial declined from 86% to 57% as it is very | | | | early copy of the research report in case the |
| expensive due to law suits, and other clinical trial | | | | study would be audited by FDA. There were |
| related expense. Clinical trial in developing countries | | | | many violations such as adverse event |
| has climbed from 5% to 29% where law suits | | | | notification, destroying documentation regarding |
| are unheard of and compensation is minimal. | | | | research findings, and side effects were not |
| I was researching about clinical trial in developing | | | | properly discussed with patient population. |
| countries and I was shocked to find news about | | | | GlaxoSmithKline has unethically tested breast |
| reputed pharmaceutical company Pfizer. Pfizer | | | | cancer drug in India. About 400 thousand Indian |
| completed two week trial of an antibiotic during a | | | | women have breast cancer and the clinical trial |
| 1996 meningitis epidemic in Kano, Nigeria. A 2000 | | | | was the only option as they were vulnerable and |
| Washington Post story criticized trial investigators | | | | poor. The only option was to accept the trial and |
| for allegedly allowing children to die while taking | | | | even the drug is proved to be safe, they cannot |
| the study drug, sparking lawsuits from families | | | | afford the drug and the total population the trial |
| and the Nigerian government. Pfizer reached a | | | | was done is unethical. In every controversy |
| $75 million settlement with Kano in July, according | | | | regarding outsourcing clinical trials, I have seen |
| to the reports. | | | | reputed pharmaceuticals involved and I wonder |
| Outsourcing to developing countries have issues, | | | | how many of these other unknown clinical trials |
| the patient population is different, where there is | | | | are currently conducting in poor countries. |
| no strong FDA regulation, no long term monitoring | | | | There are cases of cheating in clinical trial |
| system and clinical trials illiteracy. Minor side | | | | documentation and it has been an issue so FDA |
| effects are hard to monitor as in those countries | | | | should properly regulate clinical trial outsourcing. |
| patient come to medical representative or hospital | | | | There comes an issue of transparency between |
| only after major issues. In India, unethical and | | | | pharmaceutical company and patient population. I |
| even illegal clinical trials has prevailed without fear | | | | am not against outsourcing clinical trials but I would |
| as there is no law to safeguard the interest of | | | | like to plead pharmaceuticals not to accept |
| volunteer patients and regulatory authorities fail to | | | | unethical or questionable clinical trial offered in poor |
| take actions against such trials. The example of | | | | countries where people are treated like guinea |
| illegal and unethical trial conducted in India involved | | | | pigs. They should comply strickly with FDA rules |
| Sun Pharmaceutical and Novartis in 2006 and | | | | and regulations. |