Clinical Trials Save Lives
April 12, 2002
Disputing the claim that patients are dying unnecessarily due to delayed access to life-saving new drugs while pharmaceutical companies conduct clinical trials required by Food and Drug Administration (FDA) regulations, researchers say that clinical trials are necessary. In fact, says cancer researcher Gary I. Cohen, when political and legal pressure has short-circuited clinical trials and patients are given experimental, unproven drugs and other treatments, patients die.
- For example, patients sought legal mandates to get stem cell transplants for women with breast cancer treatment despite huge costs and substantial toxicity.
- Because of the ubiquitous availability of transplants for women with breast cancer, it took an additional 10 years to complete the clinical trials that ultimately failed to show any benefit for that treatment.
- Another recent example is drugs that target angiogenesis, which is the growth of blood vessels that feed tumor growth; preliminary research targeting this process for cancer therapy seemed promising -- but studies with anti-angiogenesis drugs have been disappointing, especially for the highly touted Angiostatin and Endostatin.
Effective medications based on anti-angiogenesis will come soon, but we must wait for the proof, says Cohen. And vaccine therapy will one day offer an effective and nontoxic individualized treatment for lymphomas. But giving patients unproven treatments reduces the pool of potential clinical trial participants and prolongs them, thus delaying statistically valid results.
The scientific method has brought results, says Cohen. For instance, it has produced "cures" in about 50 percent of patients with aggressive lymphomas since the mid-1980s. Recent progress has further improved survival and quality of life for patients with most forms of lymphoma.
Source: Gary I. Cohen (Director, Cancer Center at Greater Baltimore Medical Center), "Be Patient, Cancer Cure Will Come," Letters, April 12, 2002.
For WSJ text
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