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Cancer Cure Coalition Chief Addresses Right-To-Live Day Rally 9/18/07, along with Frank Burroughs and Bruce Towers
CHARLES A. REINWALD
You have just heard from Frank Burroughs, the president of the Abigail Alliance, for better access to developmental drugs. He lost his daughter, his only child, a beautiful twenty one year old girl to cancer. The FDA denied her access to a drug that might have saved her life. My wife would likely have died from cancer and was only able to survive by getting access to an experimental drug. I agree with what Frank said about giving critically ill patients the right to access new drugs, and my foundation The Cancer Cure Coalition has this goal as well. Each year in the United States approximately 220,000 new cases of prostate cancer are diagnosed and 30,000 men die of this disease. It is the most common non-skin cancer found in this country. While helpful the standard treatments, surgery, radiation, chemotherapy and hormonal treatment all tend to reduce the quality of life. Some men even die from the treatment itself. Two prostate cancer patients, Ray Matyshyn and Bruce Towers have told you their stories. They both participated in the clinical trials of Provenge. Provenge is a vaccine that stimulates the immune system to better fight prostate cancer. They are advanced stage prostate cancer patients who have suffered both from the cancer itself and from the treatments they received. Radiation can damage internal organs and hormonal treatments effectively make patients eunuchs. The hormonal treatment in blocking testosterone production takes away masculinity and sex drive, weakens the bones and muscles, reduces mental capability, causes a loss of energy and even changes the personality. Because the heart is a muscle, it too is weakened by the hormonal therapy and therefore there is a significant increase in the risk of death from a heart attack. Because of this the longevity improvement resulting from the slowing of the cancers progress is diminished by the higher incidence of heart attack deaths. For those patients who have failed primary therapies and reached a hormonal resistant state there is no cure from the currently approved therapies. For this reason I believe Provenge should be approved. There is a critical need for new and better therapies, particularly those that are not so toxic. Provenge has been proven to be safe and to have only minimal side effects. It is a therapy that can help all prostate cancer patients, not only those who are in the late stages of the disease. I believe the FDA’s trial of Provenge was unfair because it only tested the product on late stage patients, those who had failed all standard therapies. The candidates for the trial were required to have had either radiation or surgery and all received hormonal therapy. All of these patients had an immune system that had been severely damaged by the cancer itself and also by the treatment they received. They all had a large bulk of prostate cancer cells and damaged immune systems. Researchers know that the body will respond better to a vaccine designed to improve the immune system, when the immune system is stronger and the cancer cells are smaller in bulk. It is almost as if the FDA designed the clinical trial of Provenge with the hope that it would fail because they insisted that the patients tested would be those least likely to respond. Yet in spite of that the trial did show a benefit with an average four and a half month improvement in patient longevity over the placebo group. For the men who received Provenge there was a 41% overall reduction in the risk of death. This improvement occurred even though over 50% of the patients tested were expected to die within 36 months of starting the trial. It is well known from the Provenge trial as well as from trials of other cancer vaccines that the patients receiving the vaccines tend to live longer and that they respond better to subsequent treatments. Researchers believe that increased longevity is the best measure of a vaccine therapy result because of the systemic nature of the treatment. It affects the whole body not just the tumor and therefore an increase in longevity not the shrinkage of the tumor is the better measurement of benefit. Published guidance in 2005 and 2006 by the FDA concurs in this. We also know not only from clinical trails but from the actual usage of cancer vaccines in other countries that vaccines work well in conjunction with other therapies including hyperthermia, radiation and chemotherapy. If Provenge were approved early stage patients would have the opportunity to receive its benefit and that benefit would be enhanced by its use with other treatment modalities. Yet the FDA has denied patients this opportunity. The FDA has called for further testing which will delay the approval of Provenge for at least two years. Many prostate cancer patients will die before approval is granted. A similar testing bias in the selection of patients for the trial is being used by the FDA for another promising prostate cancer vaccine, Cell Genesys’s G-Vax which is currently in Phase III testing. Over 1200 men are enrolled in the Phase III trials and the testing of this product has also been prolonged by the FDA. Not only was the Provenge trial itself biased and unfairly constituted but serious allegations have been made in a lawsuit filed by Care to Live against the FDA and specifically against Dr. Richard Pazdur and Dr. Howard Scher. The lawsuit charges that Dr. Pazdur applied improper pressure on the advisory committee members to cause them to deny approval. It also alleges that Dr. Scher participated in the decision making even though he had a conflict of interest in that he was the lead investigator for Novacea a company with a product competing with Provenge. It also alleges that he has an interest in Proquest Investments, which stood to reap windfall profits if Provenge was not approved. If these allegations are accurate it appears the decision was improperly made. It has long been thought that the FDA is not open to new therapies for the treatment of cancer. The bureaucrats at the FDA are afraid to make decisions dealing with novel therapies. They don’t like dealing with small biotechs and independent researchers and they prefer to deal with large pharmaceutical companies requesting minor improvements of existing therapies. The fact that large pharmaceutical companies under federal law help fund the FDA and that some of the FDA’s employees after retirement go to work for those same companies creates an inherent bias in the system. It has been claimed that some of the employees of the FDA act to further their own self interests and not that of the sick and dying patients. In order to avoid the risk of being criticized for a wrong decision they keep asking for more and more testing thereby keeping important new therapies from reaching patients who desperately need them. The additional testing escalates the cost of the clinical trials. The clinical trials required by the FDA now take an average of ten years and cost upwards of eight hundred million dollars for completion. Many of the drugs are not approved and the cost of those trials tends to increase the cost of the products that do make it to market. The enormous cost of the trials is one of the major causes of the high cost of medical treatment in the United States. That cost is now of such a magnitude that it is adversely affecting our economy. There are also vaccines being developed in the United States for treating other cancers. These vaccines include among others Neuvenge for breast, ovarian and colon cancers and G-Vax for pancreatic and leukemia cancers. There are also vaccines under development by Opexa for the treatment of autoimmune diseases such as multiple sclerosis and rheumatoid arthritis. These vaccines have great promise. The FDA should encourage their development and not subject them to prolonged and unfair trials. Cancer vaccines are also under development in Europe by major companies such as Sanofi-Aventis SA, Glaxo Smith Kline and Germany’s Merck. If the FDA denies U.S. Companies approval for their products, foreign companies will take the lead. When Frank Burroughs said “Doctor von Eschenbach tear down this wall”, he was recalling the words of Ronald Reagan who in his speech in Berlin in 1987 said “Mr. Gorbachev tear down this wall. … this wall will fall. For it cannot withstand faith, it cannot withstand truth … it cannot with stand freedom.” So it is not enough to do research that finds cures for cancer. To benefit people, those cures must be approved by the FDA. But there is a wall of bureaucracy at the FDA that is blocking approval. Doctor von Eschenbach tear down this wall! There is a need for improvement at the FDA. We need an agency that will work to help bring forward new and better treatments. If the agency can not or will not reform itself voluntarily then I believe that the Congress and the President must make it do so. Charles A. Reinwald, President For more information on the law suit and rally, go to www.CareToLive.com
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