Saturday, September 8, 2007

Should Terminally Ill Patients Have the Right to Take Unapproved Drugs?

The United States is currently considering allowing experimental drugs to be given to people at their end of life. I found the discussion on this subject from the British Medical Journal fascinating. What do you think? Should terminally ill patients have the right to take drugs after the initial safety trials but before final approval?

Professor Emil Freireich at the University of Texas believes that patients should be allowed to judge the risks for themselves. Around half a million people will die from cancer-related causes in the Unites States alone this year, and many are given a hopeless prognosis. Most cancer patients are unable to participate in clinical trials of new therapies.

So why not offer these drugs to these patients on a compassionate basis?

Freireich points to several objections that include safety and interference with the development of the drug or the clinical trial process. But he rejects these. He argues that patients with advanced cancer and limited life expectancy should have the same privilege as all individuals in a free society – that is, to decide their own benefit-to-risk ratio.

It is tragic, he says, that regulatory bodies have created a circumstance where people have to live in an aura of hopelessness even though they have the will, the resources, and the ability to expose themselves to the risk of participating in investigational studies and to enjoy the potential for benefit. He ends his argument by saying that the solution is legislation or judicial action to permit expanded access to experimental treatments for patients with limited life expectancy.

On the other side of this ethical divide, Dr. Dean Gesme, a medical oncologist in Minneapolis, believes that use of drugs after phase I testing and outside clinical trials will damage both individuals and science. He points out that more than 90% of drugs entering phase I trials are found unacceptable, and, of those approved, most provide only incremental improvements as opposed to lifesaving treatments.

Gesme believes the allure of promising new drugs continues to engender false hope, which may delay approval and erode the clinical trials system by substituting clinical enthusiasm and wishful thinking for evidence-based medicine. And who will bear the costs of open access to these partially-tested drugs, he asks? Will government and HMO's be willing to pay for unproved drugs outside of formal clinical trials? Society is having a hard enough time getting them to pay for marginally beneficial therapies.

While we all dream of the miracle cure for each terminally ill patient, appropriate end of life care remains one of the most challenging questions there is for society.


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