CMPI in participating in a national awareness campaign to accelerate the fight against cancer.
Mylifeisworthit.org, our patient-centered project to promote access to innovative medicine was featured today in a USA Today supplement. It can be found at http://futureofcancercare.com
Each year a quarter of million people, many of them children, die from cancer or cancer related complications because of delay and indifference.
Many have as little as a 6 percent chance of living five years and none have more than a 50 percent chance of living that long.
Meanwhile, it takes two years just to put together a clinical trial to study potential treatments for cancer and another 8 years to complete one. In the time it takes to organize a clinical trial over 200000 people with cancer will die. By the time a clinical trial is finished, 2.5 million people, including 200,000 children with cancer will die.
Defenders of the status quo claim we need to go slow to ensure patient safety. But it is evident that millions of people are being protected to death.
In fact, the situation facing people living with many tumor types is just like the challenge people living with HIV faced nearly 40 years ago. Then, as now, people without effective therapies are dying in less time than it takes to test new medicines.
At the height of the movement to speed up access to HIV drugs, people living with HIV forced the Food and Drug Administration to dramatically slash the time required to study potential HIV medicines. These changes were made to allow patient’s maximum hope for cure and the opportunity for some control over our destiny.
Today, researchers and doctors know more about the underlying mechanisms of cancer than they did about HIV. It is now possible to deliver precise therapy to people on the basis of that individual's tumor. There are no 2 different cancers that are the same anywhere. Just like there are no 2 individuals who have the same DNA, that's the same for a tumor.
And while HIV patients used notebooks and faxes to share data, today’s patients have the digital ability to learn, join, share and take part in advocacy and research faster than ever before.
Cancer is the current system of clinical trials. These require any new drug/treatment to successfully complete three phases of trials aimed primarily at assuring the safety of new drugs. The phase 1 trial is frequently completed in a few months, involves only a few patients and a few hundred thousand dollar investment. The phase 2 and 3 trials for any given new treatments however take up to ten years or more and tens of millions of dollars, all to obtain additional safety data on a few hundreds to a thousand or so patients.
Yet, most cancer trials are conducted as if these technological advances did not exist. People are herded into studies that replace a deep understanding of how to match medicines to tumors with randomized trials (including placebos) that assume everyone responds the same way and for the same amount of time. It’s as if we ignored someone’s shoe size and instead told everyone to try on the same to try a size 6 to see if a shoe fits.
There are treatments now in phase 3 trial with years to go before any possibility of approval, but where the early phase I results of ten years ago are still big improvements over the treatments approved by the FDA many years ago known for these cancers. Only those lucky few are can qualify for the phase 2 and phase 3 trials will get this treatment until the treatment receives FDA approval years from now. What is gained by denying such a treatment to patients right now? Today. What justifies the withholding of a possibly life extending treatment to anyone who needs it and is willing to accept any the possibility that it might not help?
Such an approach and such delay is neither scientifically or morally supportable particularly to people living with a tumor types without effective therapies. Indeed, what we seek has been for HIV drugs and can be done under FDA’s existing regulatory authority.
Nearly 500,000 people each year are told they have a form of cancer that will kill them in two years or less because there is no effective treatment. Each year, half of all people who die of cancer. Yet it takes ten years to bring a new cancer therapy to patients. We can save lives faster and give people living with cancer hope that can last a lifetime.
Here's some actions we can take to reduce the time drastically.
• Empower the Food and Drug Administration to approve new drugs after phase 1 for patients whose tumors respond to a specific treatment in those early studies. Such treatments should be granted conditional approval with the requirement that they are then monitored very carefully in real world settings. NCI funding should be increased to support this approach.
• Increase funding for cancer prevention programs, including early detection and identification of genetic mutations that increase cancer risk.
• Accelerate access to and reduce the cost of experimental treatments to patients, especially children, who have run out of treatment options and can’t wait for or excluded from clinical trials. Patients should be able to use any experimental treatment provided that all data (except the patient’s identity) is made freely available to other patients, researchers and the FDA. Companies that make products available under this program could receive accelerated approval for that drug or another drug under FDA review.
• Eliminate health insurance cost-sharing schemes that create barriers to cancer patients’ ability to access potentially life-saving medicines by passing legislation that provides equal access and insurance coverage for ALL anti-cancer regimens and eliminates fail first policies forcing patients to switch from one drug to another.
If you believe it's important to accelerate access to innovative therapies, join us at http://www.mylifeisworthit.org
