Posts Tagged treatment

Within a decade, cancer is expected to surpass heart disease as America’s biggest killer.  Currently, the disease strikes one in three Americans and kills one in four; it claims the lives about 1,500 Americans daily.

To combat these climbing numbers, the government has channeled about $75 billion into oncology studies since 1971. But even in the midst of generous funding and tireless research, the cancer death rate has only dropped by 7% over the past three decades. Why?

As this question becomes more pressing, attention is shifting to the FDA and its methods of approving cancer treatments. Some authorities believe the FDA is so wrought with red tape and inefficiency that it is significantly jeopardizing the survival capacity of American cancer patients. A recent study at Tufts revealed that only 8% of experimental cancer drugs receive FDA approval, compared to 20% of medicines for all other diseases. Steven Creel of Austin, Texas, can speak to this problem personally.

Steven was diagnosed with an aggressive form of kidney cancer in 2003. Because he was at high risk of the cancer recurring after surgery, he began to explore other options. Steven entered a clinical trial for the experimental treatment Oncophage and encountered impressive results. Essentially, Oncophage is a vaccine that summons the immune system to fight off cancer cells. “There were literally no side effects. I would have the treatment and then play tennis,” he said. Steven has been cancer-free for five years. “I feel very, very fortunate.”

Despite success with patients such as Steven, Oncophage–like so many other experimental cancer drugs–hit a wall late in the clinical trial stages. Because of FDA criteria, 124 patients had to be removed from the trial, rendering the results less definitive. Oncophage’s developer, Antigenics, suffered a huge financial loss because the study’s outcome was consequentially inconclusive; the drug showed an increase in life span for only a small margin of patients–possibly because of the diminished pool of subjects–so the FDA did not deem the improvement substantial. Antigenics uprooted and moved to a country more receptive to their research needs: Russia. Within 10 months, the drug that saved Steven’s life but was rejected in America became approved for use in Russia. Now, Antigenics is working the European Union for approval abroad. The company hopes to establish solid financial footing so it can return to America for another round of clinical trials in order to satisfy the FDA.

The FDA knows there is a problem with the slow and infrequent approval of cancer drugs, but is unwilling to adjust trial requirements. Richard Padzur heads the FDA’s Office of Oncology Drug Products. Dr. Padzur has garnered criticism for his unrelenting and decisive views on cancer drug approvals, but he insists that the patient’s safety and the drug’s efficacy are the FDA’s top priorities. “Believe me, if there were a clear survival effect, the drug would be approved,” says Pazdur.

For many, the solution lies in the manner in which the FDA examines clinical trials. In 2004, the FDA launched the Critical Path Initiative to expedite and streamline clinical trials for cancer drugs, but since 2005 only 18 new treatments have been approved while hundreds wait in the pipeline. Many FDA officials hope to see the agency overhaul its approval methods for cancer medicines, much like it did for AIDS drugs in the ’80s and ’90s.

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