Thousands will die awaiting clinical drug trials

Each year, the U.S. Food and Drug Administration's (FDA) antiquated drug approval process denies thousands of Americans treatments with new drugs that might save their lives, critics charge. A case in point involves the cancer non-Hodgkins lymphoma (NHL).

Approximately 54,000 patients will be diagnosed with the incurable disease this year. As many as 25,000 will die of it. A subset of NHL called follicular lymphoma has an average survival time of some seven to eight years, but is ultimately incurable – resulting in 4,000 to 5,000 deaths each year.

New, biologically-based, personalised treatments have an excellent likelihood of effectively treating – even curing – this cancer. But the FDA's usual standard of randomised clinical trials to test the new treatment will make it unavailable to patients who need it – and thousands will die while awaiting the results.

A 1999 cancer vaccine study showed 90 percent of the 22 NHL patients who received it had long remissions – and 77 percent were in remission up to 74 months post treatment, as of 2001.

The National Cancer Institute – with FDA guidance and consent – is now planning an extensive five-year, randomised clinical trial of the vaccine involving 563 patients.

Since half the participants will receive the active vaccine, and half will get a vaccine with no known activity in lymphoma patients, 282 patients will be denied the active vaccine.

Moreover, 4,000 NHL patients will die each year during the study without ever having the opportunity to try the vaccine.

Medical specialists suggest it would be far preferable to allow individualised cancer therapies to be prepared by biotechnology companies under the guidance of experienced oncologists. One could then judge their long-term effectiveness by standard clinical means.

Source: Robert Oldham (South Carolina Biotechnology Association), FDA Trials Cost Lives, Wall Street Journal, April 3, 2002.

For text (WSJ subscribers) http://online.wsj.com/article/0,,SB1017794695449945360,00.htm
For more on FDA Drug approval http://www.ncpa.org/iss/hea


FMF Policy Bulletin\9 April 2002