Life Extension Magazine August 2003
As We See It
|FDA's Lethal Impediment|
The FDA stifles the discovery and availability of life-saving therapies by making the cost of getting them approved prohibitively expensive. The FDA is a major obstacle that prevents scientific findings from being translated into therapies to stave off age-related disease.
Compared to the advancement of other technologies over the past 40 years, medicine has progressed the slowest as far as finding solutions for lethal diseases. Those in the medical establishment may debate this assertion, but the undeniable fact is that for most types of cancer and neurological diseases, there have been few substantive improvements in survival, let alone a cure.
Most of you remember attending funerals in the 1960s to 1970s of those who perished from cancer. If you thought the way I do, you would have been certain that a cure for cancer would have been found by year 2000. In fact, the propaganda being released by the cancer establishment at that time was that doctors were on the verge of eradicating most cancers. (This misguided optimism was primarily based on the premise that chemotherapy was the solution.)
When it comes to therapies designed to slow or reverse aging, the FDA still does not officially recognize aging as a disease process. That means when a company tries to gain approval to market an anti-aging therapy, it first has to overcome the hurdle of educating the FDA that aging is indeed a lethal disease. The new therapy then has to show sufficient efficacy to warrant approval. To date, no one has succeeded in convincing the FDA to approve an anti-aging drug.
In today's world of ever-expanding technological achievement, the fact that medicine remains bogged down in a regulatory quagmire is a disgrace. More than 6,000 Americans die every single day, yet most of these deaths could be prevented if it were not for the strangulation of innovation caused by the FDA, State regulatory agencies, HMOs and apathetic physicians.
In each issue of Life Extension magazine, we seek to uncover therapies that have shown efficacy in well-controlled studies, but have not yet been translated into conventional medical practice. We know our efforts have lengthened the lives of tens of thousands of Life Extension members, yet what we offer is only the tip of the iceberg when one looks at the many life-extending drugs that are denied to human beings in need.
Does Geron have an effective cancer vaccine?
Geron's vaccine works in a relatively simple manner. It programs powerful dendritic immune cells to attack cells that express high levels of an enzyme called telomerase. It just so happens that 85% of human tumor cells overly express telomerase1 whereas normal healthy adult cells express very low and/or transient telomerase levels. Using telomerase as the target for dendritic cells, Geron's vaccine was shown to provoke a massive attack against prostate and kidney cancer cells as well as breast, melanoma and bladder cancer.
Most cancer cells require high levels of telomerase to prevent them from undergoing a healthy cellular removal process called apoptosis (programmed cell death). The concept of attacking cells high in telomerase makes cancer cells particularly vulnerable, because if they try to hide from this vaccine by making less telomerase, then they will die via normal apoptosis.
There are 558,000 people in the United States who will die of cancer over the next 12 months. Most of them know they are likely to die. We believe these cancer-stricken individuals should have the right to access any potentially effective therapy under the guidelines of an objective yet humanistic formal scientific protocol. While there is no assurance that Geron's new vaccine will cure cancer, we vehemently oppose the power given to the FDA to withhold this and other potential cancer therapies.
The cancer establishment maintains that only carefully controlled studies can establish safety and efficacy. This sounds reasonable and Life Extension agrees with this concept. The reality, however, is that the FDA's current clinical trial requirement has produced flawed data that enabled bad drugs to be approved while potentially effective drugs are denied.2,3,4
It takes so long for a new drug to make it through the FDA approval process, that if Geron's new drug is effective, most cancer patients reading this column today will perish long before the vaccine ever became available. A real world example of this occurred with an anti-cancer agent for childhood leukemia called Vumon®. This drug was first studied in 1972, but only attained FDA approval in 1992.
A Phase I study of Geron's telomerase vaccine is currently underway in patients with prostate cancer at Duke University in North Carolina. As described in previous issues of Life Extension magazine, there are two fundamental problems with Phase I studies. First of all, they usually mandate that cancer patients fail all "proven" therapies first. As has been repeatedly shown in published scientific studies, most so-called "proven" cancer therapies do not cure the disease. Since Phase I studies only test for safety, extremely small doses of the anti-cancer agent are used. This dooms virtually all the terminal cancer patients who participate in Phase I trials to certain death, but it does supply the FDA with the safety data it mandates. In other words, as long as the patient dies of their cancer and not the new drug, it is now permissible to move on from Phase I to Phase II studies where a potentially effective dose of the anti-cancer drug can be given.
How the FDA perpetuates the cancer epidemic
For example, it took years for Taxotere, one of the most impressive anti-cancer agents used to treat breast and prostate cancer, to finally gain FDA approval in the United States. This occurred despite hundreds of studies supporting its efficacy published in the European literature that were not acceptable to the FDA.
Ironically, now that Taxotere has gained FDA approval for the treatment of metastatic prostate cancer in the USA, countries such as Germany do not permit its use in the treatment of prostate cancer because no published papers on this subject have emanated from Germany. This becomes even more incredulous when one realizes that the pioneering research on Taxotere emanated from Germany's next-door neighbor France. The approval agencies such as the FDA here and its counterparts abroad are allowing bureaucratic ego, and perhaps economics, to interfere with the saving of life. Think about this! American and German physicians and scientists are engaged in a battle against a common enemy (cancer) while the respective regulatory agencies (those that approve the use of a drug) of each country use national borders to say "yes" or "no" to a live-saving drug or therapy. This is a violation of human rights within so-called civilized societies. People from all over the world should unite in protest to such atrocity.