Scientists have identified novel ways of treating cancer, but too little of this new technology is being used in clinical practice. When new discoveries are made, drug companies spend years seeking a patent, and then more years carrying it through the cumbersome bureaucratic approval process. A major reason so many cancer patients die today is an antiquated regulatory system that causes effective therapies to be delayed (or suppressed altogether).
This system must be changed, if the 1,500 American cancer patients who perish each day are to have a realistic chance of being saved. Our long-standing proposal has been to change the law so that anyone can opt out of the FDA’s umbrella of “protection.” This approach will allow companies to sell drugs that have demonstrated safety and a reasonable likelihood of effectiveness, which are clearly labeled “Not Approved by the FDA”. Patients who wish can still use only FDA-approved drugs, while those willing to take a risk, in consultation with their doctors, will be allowed to try drugs shown to be safe that are still not approved.
We believe that this initiative will result in a renaissance in the practice of medicine similar to the computer technology revolution of the past three decades. In this environment, many lethal diseases will succumb to cures that are less expensive than is presently the case. And greater competition will help eliminate the health care cost crisis that exists today.
Today’s broken system results in terminally ill people learning of scientific discoveries that might well cure their disease, but are quickly advised by the newscaster that the therapy is years away from FDA approval. We think that seriously ill people, in consultation with their doctors, should be able to make up their own minds about what drugs they are willing to try.
What Cancer Patients and Their Families Must Do
There are millions of cancer patients alive right now who face possible or probable death in the next twelve months. If you add their family members and friends, there are tens of millions of Americans who should be outraged by an outdated regulatory system that bans access to potentially life-saving therapies.
The FDA continues to suppress innovative therapies because the public has failed to demand that our elected officials rein in the FDA’s arbitrary authority. The first step in changing today’s outmoded system is for those who understand the magnitude of this problem to communicate the urgent need for change to Congress.
Those concerned about this serious issue should log on to www.lef.org/lac to insist that their Representative and two Senators help enact legislation that will enable cancer patients to obtain therapies far enough along in the clinical trials process to be deemed safe, but not yet approved by the FDA.
Those without computer access can photocopy the next page and mail it to their Representative at The US House of Representatives, Washington, DC 20515 and two Senators at The US Senate, Washington, DC 20510. We also ask that you phone your Congress-ional members at 1-202-224-3121 to let them know how disgusted you are that doctors and patients are not allowed to choose drugs that may be effective against an often fatal disease.
I am writing to ask that you sponsor or co-sponsor legislation to enable cancer patients (and those with other serious diseases) to purchase medications while they are pending final approval by the FDA. This approach will allow companies to sell novel drugs with a label clearly stating that they are “Not Approved by the FDA”.
Consumers who wish to rely on the FDA can limit their choices to fully approved drugs only, while those willing to take a risk (in consultation with their doctors) will be allowed to try what they choose. (Companies that make fraudulent claims for products can be prosecuted under the laws that exist today.)
This initiative can result in a renaissance in the practice of medicine, similar to the computer technology revolution that has occurred over the past three decades. In this environment free of regulatory burden, many inexpensive cures will very likely be found for lethal diseases. And greater competition will help eliminate the health care cost crisis that exists today.
I am tired about reading about medical breakthroughs, only to be told that I will have to wait years before the therapy might become available. As 1,500 Americans die of cancer each day, I consider the introduction and passage of such a law an extremely high priority.
Seriously ill people have the fundamental right to make up their own minds about what drugs they are allowed to try, in consultation with their physicians. Please let me know that you will sponsor or co-sponsor such legislation, which will provide us with quicker access to drugs that the FDA has found safe and potentially effective, but have not yet received final approval.
City: ST: Zip: