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Life Extension Magazine

LE Magazine August 2003

FDA's Lethal Impediment

Not only do FDA policies delay life-saving drugs from being approved, but they often keep effective medications off the market forever! If a small company like Geron were to run out of money before they could conclude the expensive clinical trials, their vaccine research program could come to a grinding halt.

Contrast this with a libertarian policy of giving dying cancer patients the choice to try Geron's new vaccine immediately. Under this system, it could be possible to determine whether the vaccine worked within months, as opposed to the multi-year period currently mandated by the FDA. If it worked, then millions of cancer patients lives would be saved. If the vaccine failed, then these terminally ill cancer patients will have died, as they would have anyway.

The FDA does have a "compassionate use" exemption that allows cancer patients access to experimental therapies. The problem is that the FDA mandates that these cancer patients first fail so-called "proven" therapies. When cancer cells are exposed to "proven" therapies like radiation or chemotherapy, they mutate in a way that causes them to become super-resistant to future therapies. The patient's healthy cells (including dendritic cells of the immune system) are often seriously impaired when exposed to these "proven" therapies, thus making therapies like Geron's telomerase vaccine less likely to be effective.

Promising ovarian cancer drug
Ovarian cancer kills more than 14,000 women each year. What makes this type of cancer so insidious is that there are few early warning signs, meaning the disease is usually well advanced when diagnosed.

In May 2003, an announcement was made about a drug called phenoxodiol that induced cell death in 100% of ovarian cancer cells, including those cells resistant to chemotherapy drugs such as Taxol® and carboplatin. The tests were conducted on human cell lines at Yale University School of Medicine.

Phenoxodiol was discovered when scientists were studying the anti-cancer properties of isoflavonoid plant extracts. They used data collected from this research to synthesize phenoxodiol. This drug works by altering a signal pathway in cancerous cells that prevent them from undergoing apoptosis (programmed cell death). These findings indicate that the drug could be successful at treating other cancer types as well. The study was published in the May 1, 2003, issue of Oncogene.

As stated earlier in this article, FDA-mandated Phase I studies involve giving advanced cancer patients low doses of a new drug to verify safety. The dose is usually so small that the drug has no chance of curing end-stage cancer victims. In the case of phenoxodiol, five Phase I human trials have been completed with few if any side effects. Preliminary results of a trial conducted at the Cleveland Clinic found that more than half of the 10 patients tested on the experimental drug showed some response. Each of these patients had different types of advanced cancer that did not respond to chemotherapy.

It is very difficult to kill cancer cells once they have become resistant to chemotherapy. That is because the cancer cells not killed by chemo develop multi-survival mechanisms that make them extremely difficult to eradicate. What has surprised researchers at Yale was that phenoxodiol killed all ovarian cancer cells (in the laboratory setting), regardless of their immunity to chemo agents.

A phase II trial using phenoxodiol is under way at Yale for women with chemo-resistant ovarian cancer. In this Phase II study, a therapeutic dose of the drug is given with the hope of improving survival or achieving a complete response. The researchers also tested phenoxodiol in mice and found that when dosed at 20 mg/kg every day for six days there was a three-fold reduction in tumor mass compared to a control group. No side effects were noted.

Phenoxodiol functions via several unique mechanisms to induce cancer cells to undergo programmed cell death (apoptosis). Normal cells undergo apoptosis in a controlled manner so they can be replaced with healthier functioning cells. Cancer cells, on the other hand, have gene mutations that prevent them from self-destructing. The ultimate goal of a cancer therapy is to induce malignant cells to undergo apoptosis, instead of indefinitely proliferating out of control.

Under today's antiquated system, a new drug cannot be marketed until it has been thoroughly investigated in clinical trials. These trials can take many years to complete. The results of these numerous trials are then submitted in a new drug application to the FDA. The FDA sends these results to a committee for review. The committee may ask for more studies, reject the application or recommend the drug be approved. The FDA then takes the committee's report and decides whether to approve the drug as safe and effective. This can happen quickly, or it can become bogged down in the FDA's regulatory quagmire. Until the FDA reaches its final verdict, no marketing can take place. It can take 10 or more years after a promising cancer drug has been discovered before the FDA is even in a position to approve it. One reason for this long delay is that after the drug as been discovered, money has to be raised to fund the clinical studies and negotiations with the FDA have to be completed to get approval for the study design itself.

Every month, more than 1,000 women succumb to ovarian cancer. Phenoxodiol was discovered in April 2002. If this drug turns out to be even partially effective, the delay in getting it into cancer victims' hands would have caused thousands of needless deaths.

Saving cancer patients' lives
Large amounts of monies have been spent on cancer research, yet the findings from this research are not being incorporated into clinical oncology practice. To help remedy this problem, The Life Extension Foundation searches the peer-reviewed scientific literature in order to interpret and compile this data into life-saving protocols.

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We have completely updated our reference book, Disease Prevention and Treatment. This 1,500-page "edifice" contains an abundance of information about better ways to treat cancer that are often overlooked by oncologists. While this book provides novel guidance about many different disorders, there are 295 pages dedicated to informing cancer patients of what they should do to improve their chances of achieving a remission or complete response.

It is sad to think of how many cancer patients die when potential solutions to their disease are already published in the scientific literature. The new Disease Prevention and Treatment reference book breaks down the barriers of ignorance that causes those with cancer and other life-threatening diseases to die while effective therapies already exist to better treat their disease.

The research, writing and editing of the 2003 edition of Disease Prevention and Treatment consumed tens of thousands of hours at a cost of over one million dollars. Commercial publishers do not spend this kind of time or money producing health books. It is our intense dedication to finding solutions for our members' health problems that motivated us to publish such a comprehensive text.

For longer life,

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William Faloon.

Editor's Note: Just as we were going to press, the FDA released news of an intitiative to speed the identification and development of new cancer drugs. It appears that the FDA is in the beginning stages of a long overdue reform of Byzantine bureaucracy in order to properly fulfill its public service mission. We have printed the news release in its entirety on this page. As you will read, what the FDA proposes is not nearly enough. The FDA, in essence, is trying to put out a forest fire with a garden hose.


NCI and FDA Announce Joint Program to Streamline Cancer Drug Development

Under an agreement between the Food and Drug Administration (FDA) and the National Cancer Institute (NCI), which is part of the National Institutes of Health (NIH), the two agencies will share knowledge and resources to facilitate the development of new cancer drugs and speed their delivery to patients.

FDA Commissioner Mark McClellan, M.D., Ph.D., and NCI Director Andrew von Eschenbach, M.D., said today that they will establish a multi-part Interagency Agreement to enhance the efficiency of clinical research and the scientific evaluation of new cancer medications. The planned agreement, to be announced formally at this week's meeting of the American Society of Clinical Oncology in Chicago, will enhance existing programs and add new joint programs to the existing close cooperative relationship between NCI and FDA, both of which are part of the Department of Health and Human Services (HHS).

"This new collaboration between two key HHS agencies means that federal researchers and regulators will be working together more effectively than ever before," said HHS Secretary Tommy Thompson. "The result will be a more unified, integrated, and efficient approach to the technology development and approval process at a critical time for a disease that affects too many lives," Secretary Thompson said.

The agreement offers potential benefits for the more than one million Americans who are diagnosed with cancer each year. "The FDA is committed to finding better ways to get safe and effective treatments to patients with life-threatening diseases as quickly as possible," said McClellan. "At a time when the opportunities to reduce the burden of cancer are greater than ever, sharing tools and resources with our colleagues at the National Cancer Institute will help us fulfill that mission," he said.

"The effort between NCI and FDA in cancer therapies is a prototype that should inform and eventually be applied across all areas of research," said NIH Director Elias A. Zerhouni, M.D. "Dr. McClellan and I are committed to NIH and FDA working closely to find innovative ways to more rapidly make the fruits of our discoveries available to the public."

"The collaboration will help the two agencies take full advantage of their combined knowledge base at a time when many new kinds of anti-cancer agents are in the pipeline," said von Eschenbach. "Molecularly targeted drugs and other novel agents offer great promise, but they also present new challenges that require more collaboration between those involved in their discovery and development," he said.

References

1. Wang Z, Ramin SA, Tsai C, et al. Telomerase activity in prostate sextant needle cores from radical prostatectomy specimens. Urol Oncol 6:57-62, 2001.

2. A Life-Saving Drug Discovered In the United States Over 20 Years Ago Is Saving Lives Around the World…But Not Yet Here. Life Extension magazine, July 2001, p. 54-62.