2. Guinea Pigging refers to soliciting the participation of healthy individuals

Question

2. Guinea Pigging refers to soliciting the participation of healthy individuals in clinical drug trials for financial incentives. Do you agree with this practice? Defend your position with supporting facts and references. ****response should be at least 300 words in length. All sources used, including the textbook, must be referenced; paraphrased and quoted material must have accompanying citations. Any references or citations used should be in APA style. Please include at least two peer-reviewed articles as references.

Explanation / Answer

This kind of practice is illegal as it infringes the human rights of a person. I completely disagree with his practice. A well-designed trial should answer important public health questions without impairing the welfare of individuals. Emanuel et al., 2008 has listed seven criteria that they considered essential to all the conduct of clinical research. These include value, scientific validity, fair selection of participants, favorable benefit/risk balance, independent review, informed consent and respect for participants. Two kinds of trials raise ethical issues because of concerns about the balance between potential benefits to society and also to participants. The risks of harm and discomfort to participants are also high. Trials such "me too" or "marketing" also known as seeding trials, which are conducted to show that a new drug or new version of the drug is atleast a good as to drug already proven to be beneficial. This kind of trials are just for enhancing the financial status of the industry sponsor, but does not have any benefit to the new drug nor the trial is significant. This kind of trials put the participants life at risk from the adverse effects of the unknown drug. If the trial has a better impact for the mankind it should be properly justified. People may argue that having more than a drug with similar benefits is better for the economy as it will bring down the medical care costs but at the same time conducting such trials should also justify how important and meaningful are the benefits for the patients. A second kind of trial where these studies are performed in healthy volunteers, where the chances of them being harmed is very low, but they have no opportunity to benefit other than from whatever payment they receive as a result of their participation. The persons enrolling in these kinds of trials is just for the payment (Elliott, 2008).

Many clinical trials are international. However, trials that are conducted in developing areas raise ethical issues (Love et al., 2002).

1. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? JAMA 2000;283:2701–2711.

2. Elliott C. Guinea-pigging. New Yorker. January 7, 2008.

3. Love RR, Duc NB, Allred DC, et al. Oophorectomy and tamoxifen adjuvant therapy in premenopausal Vietnamese and Chinese women with operable breast cancer. J Clin Oncol 2002;20:2559–2566.

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