Should The Terminally Ill Have Access To Experimental Drugs?

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Main Category: Cancer / Oncology
Also Included In: Regulatory Affairs / Drug Approvals;  Lymphoma / Leukemia / Myeloma;  Breast Cancer
Article Date: 08 Sep 2007 - 0:00 PDT

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The USA is considering allowing terminally ill patients to have access to treatments using experimental drugs, drugs which have reached Phase I trials, an article in the British Medical Journal debates this very subject.

Professor Emil Freireich, University of Texas is in favor, while Dr. Dean Gesme, a medical oncologist in Minneapolis, is against.

Prof. Freireich explains that about 500,000 people will die from cancer and cancer related causes in the USA, while many more receive depressing prognoses. The only chance a terminally ill patient currently has to try an experimental drug is to take part in a clinical trial. Many, however, never get a chance to do so and die.

Freireich wonders why these patients should not get a chance to be offered these drugs on a compassionate basis.

He understands that there may be safety issues, as well as the possibility that the development of the drug could be interfered with, and that the clinical trial process could be affected. However, he rejects these arguments, saying that a terminally ill patient should have the same rights as any individual in a free society - i.e. to weigh up the odds himself/herself and make a decision.

He believes it is a tragedy that regulatory bodies have made it such that a patient has to live in an aura of hopelessness, even though he/she would like to, has the resources to, and could expose himself/herself to the risks involved when taking part in investigational studies and enjoy the potential for benefit.

The only solution, he writes, is to introduce legislation or judicial access which widens the terminally ill patient's access to experimental treatments.

Dr. Dean Gesme, on the other hand, believes that widening access to drugs at the completion of Phase I will not only damage science, but also individuals. 90% of Phase I drugs never make it to the market because of safety problems, side-effects, etc. Those that do usually only provide minor improvements; not lifesaving treatments.

Encouraging false hopes in terminally ill patients with the allure of promising new drugs and treatments, a troubling idea in itself, could delay approval and undermine the clinical trials system. Clinical enthusiasm and wishful thinking might take the place of evidence based medicine, he argues.

What about the costs that open access would create? Who would pay for them? Would the government, a body which is currently trying to cut down on payments for marginally beneficial therapies dig deep into its pockets for this?

Every doctor dreams of a miracle cure for his/her terminally ill patients. Nevertheless, there is no getting away from the fact that the principles of evidence based medicines and the precepts of appropriate end of life care must be accepted, Gesme concludes.

"Head to Head: Should terminally ill patients have the right to take drugs that pass phase I testing?"
-- Yes: Professor Emil Freireich
BMJ 2007;335:478 (8 September), doi:10.1136/bmj.39244.451192.AD (Yes)
-- No: Dr. Dean Gesme
BMJ 2007;335:479 (8 September), doi:10.1136/bmj.39245.429525.AD (No)

Written by: Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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