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July 2, 2013 | Posted By Bruce D. White, DO, JD

Recall the June 7, 2013 New York Times article by Andrew Pollock titled “An Experimental Drug’s Bitter End”? The author reminds us again about how difficult it is for patients and those involved in their care to understand that new drug clinical trials are experiments and not therapeutic interventions.

The goals of researchers in conducting new drug clinical trials – experiments – are clearly not the same as the goals of a physician who prescribes an approved drug as a therapeutic modality. How better can we help patients and their families understand this primary goal of medical research? In clinical trials, when the experiment ends, the patient may worsen clinically, or the patient may get better clinically, and the improving patient probably will no longer have access to the perceived beneficial drug as a therapy option. Regardless, after sufficient data is collected – whether good or bad – the experiment ends.

Some patients and their caregivers are not as clear about the research goal. Some patients see the intervention primarily as a therapeutic intervention, offered to cure or ameliorate a disease or symptom. Clinical ethicists or bioethics refer to this as “therapeutic misconception.” Of course, this is a continuing informed consent issue. Try as we might, or regulate as much as we do, or have as many lengthy conversations as it takes, and we still have problems as this New York Times piece shows.

Moreover, in this particular case, it was unclear why this project may be ending now, perhaps earlier than was originally anticipated. It may be because the comparative data between arboclofen and the standard treatment or a placebo showed no difference, or any perceived therapeutic benefit was marginal at best, or some patients had unexpected and complicated side effects, or the sponsor failed to raise continuing capital or identified business model flaws in production or marketing, or it became less expensive to conduct the trial elsewhere. The extensive list of valid and reasonable possibilities may include many others as well.

Unfortunately, the mother of the Fragile X patient highlighted in the article apparently sees the arboclofen trial not as an experiment but as a therapeutic treatment. Happily, the mother sees great benefit. All can understand her frustration and heartache.

One immediate thought for some researchers may be: is the patient actually receiving the active drug? This may not be important, but it may be very important in this case. In a double-blinded, randomized, placebo-controlled trial, it’s just as likely as not that the patient is receiving a placebo or “standard treatment” rather than the experimental drug. However, if this patient is a subject in the placebo arm, rather than the active drug cohort, will that information bring solace and comfort to the mother or even more heartache?

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

0 comments | Topics: Research Ethics, Clinical Ethics, Consent, Drug Safety


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BIOETHICS TODAY is the blog of the Alden March Bioethics Institute, presenting topical and timely commentary on issues, trends, and breaking news in the broad arena of bioethics. BIOETHICS TODAY presents interviews, opinion pieces, and ongoing articles on health care policy, end-of-life decision making, emerging issues in genetics and genomics, procreative liberty and reproductive health, ethics in clinical trials, medicine and the media, distributive justice and health care delivery in developing nations, and the intersection of environmental conservation and bioethics.
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