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Rapid Responses: Rapid Responses published:
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A guinea pig
- Sri S Varman (24 March 2006)
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Incorrect Assumptions
- Aidan P Gill (24 March 2006)
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Drug Trials
- Aaron Kian Wee Chai (25 March 2006)
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Guinea pigs for the sake of research
- Biji T Kurien (1 April 2006)
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The role of ethics committees
- sreerekha srinath (3 October 2006)
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Sri S Varman, Surgeon Cleveland, Australia 4163
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35 years ago we, the final year medical students, were invited by our Senior lecturer, to take part in a study of the 'normal' duodenal mucosa. There was no offer of money. We were asked to spare two hours of our free time, to swallow the capsule which biopsied the duodenum. After over night fasting and swallowing the capsule, we had to lie on our right side for about 90 minutes. The reward was a glass of orange juice, courtesy of the senior lecturer. But, we got to know our teacher, potential examiner at the finals and possible future boss, a lot more at a personal level. Competing interests: None declared |
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Aidan P Gill, Medical Director Omnicare Clinical Research
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Despite Kate Mandeville's recognition the "Compensation is only for time and inconvenience,", Personal View, 25th March 2006, she repeats the widely held misconception when she states that "I felt that the money offered to me didn't compensate for three weeks of feeling awful". It is one of the roles of the Ethics Committee to ensure that the level of compensation is appropriate to the level of inconvenience, not the perceived potential for harm and that it does not constitute inducement. It is, therefore, not the job of the university to 'cap' the payment either. It appears she also misunderstands the role of the 'doctor running the unit'. Of course they would not "push me into completing the study". Their primary responsibility is the health of the patients, not to ensure that nobody drops out. Does she not appreciate that if a study is halted late, due to adverse events that were seen at an early stage, the costs to the Pharma company can run to the tens if not hundred of millions of pounds. There is no benefit to either patient or company if that were to happen. That said, I appreciate her personal sacrifice in the 16 studies she enrolled onto, despite, or maybe because of my current job I have never volunteered for a clinical trial. Competing interests: Previously Principal Investigator in Phase I unit, currently Medical Director in CRO |
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Aaron Kian Wee Chai, Dental Student Cardiff University
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Most drug trials are bound to obtain subjects from a particular group.For example people who are in need of money or are suffering from a certain disease.In a drug trial i participated in, almost all the subjects were students. All i had to do was try some new medication and report back twice a week. I received a payment of 100 pounds for it.Apart from the money, it was more flexible compared to other kinds of work.If people opted not to participate in drug trials due to risks, pharmaceutical companies would definitely have a problem in developing new drugs for the future. Competing interests: None declared |
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Biji T Kurien, Sr. Research Scientist Oklahoma Medical Research Foundation, Oklahoma City, OK 73104
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"My life as a guinea pig" proved to be very interesting (1). It reminded me of something we did during our pre-doctoral days. It was about 20 years ago, before there was any active Institutional Review Boards monitoring research activities of investigators. It was also the days when there was no nutritional labeling of foods. A group of research scholars were volunteers in a study that required a one-time drinking of a cup of ghee (clarified butter from which all water and milk solids were removed by careful heating). Ghee was an expensive item in India and a delicacy when used appropriately in specific foods. But to drink it as such was not a pleasant thing. And we knew that butter was bad, since it was rich in saturated fat and we did it for the sake of research. There was no monetary benefit to participants, but it was an opportunity to learn about our blood cholesterol levels. But little did we know that we had consumed about 175 g of total fat of which about 110 g were of the saturated kind. Included in that was about 475 mg of cholesterol. This was about 11 times the daily amount of saturated fat that was allowed of a hyperlipidemic subject. We were young and we did not care much at that time. Reference 1) Mandeville K. My life as a guinea pig. BMJ 2006; 332: 735. Competing interests: None declared |
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sreerekha srinath, Principal Investigator in a CRO India
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The composition of independent ethics committees (IEC) leaves much to be desired. In my personal experience, I have seen non scientific members of the IEC struggling to understand the protocol or the properties of the drug. In most ethics committees, there are just 2 doctors out of 8 to 10 members. Doesn't it make more sense if at least 50% of the IEC comprises of medically qualified people and the rest could include legal, non scientific people, social workers and so on. One developed country has just 40 IRBs. In India, we seem to have 40 in every state. There is a TGN 1412-like disaster waiting to happen. S.Sree Rekha Competing interests: None declared |
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