The cruel economics of cancer
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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An excellent summary of the problem. In fact, Dr. Pazdur’s policies have been highly reactionary and inflexible. Instead of seeking modernization of the agency’s cancer drug development policies and approval criteria to better fit the emerging science, he has instead regressed into rigid application of arcane statistical rules and metrics that don’t fit the new knowledge of disease biology and drug invention. Under Dr. Pazdur, FDA’s handling of cancer drugs has become a profound barrier to progress against cancer.
Dr. Pazdur has his supporters. Most of them are people whose continued financial and professional status in our clinical trials system depend on maintaining the failing status quo. However, the more direct and obvious problem is the failure of FDA’s leadership to supervise the sharp decline of competence and progress in FDA’s handling of cancer drugs. That abdication of responsibility continues today, evidenced by Dr. Pazdur’s continuing policies, and some would argue, his continued employment. He is very much a hands-on manager, directly responsible for the decisions to delay and deny the approvals of numerous safe and effective cancer drugs over the last 7 years. His policies and approval decisions are not required by law or regulation. They are quite simply, and by his own admission, his policies. An example is his decision to create and enforce a policy we call his “Decelerated Approval Initiative.” Dr. Pazdur’s Decelerated Approval Initiative has effectively eliminated the Congressionally-created Accelerated Approval pathway (a major part of the success in treating HIV/AIDS) as a viable approval mechansim for cancer drugs. He announced his cancer-drug “slow down” policies in the spring of 2003 with ensuing devastating effect. The most compellingly effective new cancer drugs now take years longer to reach patients who die waiting for them, victims of progressive terminal diseases that do not stop progressing while the FDA dithers. The result has been hundreds of thousands of unnecessarily premature deaths from cancer. No less an authority than David Kessler, the former Commisisoner of the FDA, who established Accelerated Approval at the FDA in 1997 at the direction of Congress, is asking why FDA leadership allowed the erosion of this critically-needed and highly successful approval authority.
Legislation directed at fixing the serious (and deadly) problems with FDA’s handling of new drugs intended to treat serious and life-threatening diseases like cancer, called the Access Act, was re-introduced in Congress last week with bipartisan support. The bill contains provisions that firmly re-establishes Accelerated Approval, and would provide patients with serious and life-threatening diseases the same access to progress that now reaches HIV/AIDs patients by increases the role of those patients and their doctors in making health care decisions when all FDA approved options have been exhausted. The bill also requires modernization of FDA’s drug development and approval science, and requires an Institute of Medicine study to begin the process of modernization.
The Access Act, when passed, will be a crucial step toward bringing the FDA into alignment with accelerating progress against cancer and other serious diseases. If it does not pass, FDA will continue to function as a barrier to progress. Agency leadership has for years turned a deaf ear to patients suffering and dying from cancer and other serious conditions, preferring the counsel of those who unconditionally agree with the culture of scientific and regulatory stagnation that exists at FDA. The result is an agency focused on defending the failing status quo as a much higher priority than keeping up with rapidly advancing fundamental science that offers boundless potential for making progress against the diseases that kill us.
The FDA has a long track record of being incapable of internal change. Change comes to the FDA only when imposed from the outside by Congress, the courts or overwhelming public pressure, and it usually takes a combination of all three before the FDA manages to get out of its own way and begin a process of real change.
Support the Access Act. It could save your life.
Steve Walker
Abigail Alliance
[...] Americans, however, will have difficulty accessing CimaVax. The trade embargo enacted in 1962 restricts travel to Cuba and will serious impede Americans’ ability to try this new therapy. In the US, CimaVax is in clinical trials and is not slated to finish for another two to three years. [...]