acceleration of drug approval process a dangerous move

Inpharma 1546 - 15 Jul 2006 Acceleration of drug approval process a dangerous move Allowing terminally ill cancer patients access to drugs that have only completed phase I trials is a "potentially disastrous" decision, according to the New Scientist. The US Court of Appeals for the District of Columbia recently ruled that such patients have a constitutional right to treatments that have not been approved by the FDA, but have completed phase I clinical trials. This decision was the result of a suit brought by the Abigail Alliance for Better Access to Developmental Drugs. In addition, a bill was introduced into the Senate last November that aims to accelerate the approval system. These measures could undermine the drug evaluation process, and lead to an abundance of ineffective and possibly unsafe treatments on the market. The basis for the Court of Appeals’ decision was that the regulatory process interferes with efforts to save a terminally ill patient’s life. However, when combined with chemotherapy, most new drugs only extend a patient’s life by a few months at best. Despite this, targeted drugs are perceived as a revolutionary treatment for cancer. The New Scientist states that phase II and III trials are necessary for drugs to be proven beneficial, and to obtain information on their effectiveness, safety and toxicity. Without this process, "cancer patients will increasingly fall prey to exaggerated claims for various half-baked drugs". Moss RW. No way to save a life. New Scientist 190: 21, No. 2554, 3 Jun 2006 801002894 1 Inpharma 15 Jul 2006 No. 1546 1173-8324/10/1546-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

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Inpharma 1546 - 15 Jul 2006

Acceleration of drug approvalprocess a dangerous move

Allowing terminally ill cancer patients access to drugsthat have only completed phase I trials is a "potentiallydisastrous" decision, according to the New Scientist.

The US Court of Appeals for the District of Columbiarecently ruled that such patients have a constitutionalright to treatments that have not been approved by theFDA, but have completed phase I clinical trials. Thisdecision was the result of a suit brought by the AbigailAlliance for Better Access to Developmental Drugs. Inaddition, a bill was introduced into the Senate lastNovember that aims to accelerate the approval system.

These measures could undermine the drug evaluationprocess, and lead to an abundance of ineffective andpossibly unsafe treatments on the market. The basis forthe Court of Appeals’ decision was that the regulatoryprocess interferes with efforts to save a terminally illpatient’s life. However, when combined withchemotherapy, most new drugs only extend a patient’slife by a few months at best. Despite this, targeted drugsare perceived as a revolutionary treatment for cancer.

The New Scientist states that phase II and III trials arenecessary for drugs to be proven beneficial, and toobtain information on their effectiveness, safety andtoxicity. Without this process, "cancer patients willincreasingly fall prey to exaggerated claims for varioushalf-baked drugs".Moss RW. No way to save a life. New Scientist 190: 21, No. 2554, 3 Jun2006 801002894

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