As founder of the Value of Medical Innovation project, I support Lord Saatchi and his bill to end the legal obstacles to medical progress as reported in The Telegraph, U.K.
Lord Saatchi lost his wife in 2011 to ovarian cancer. He knows through painful, personal experience that new laws are needed to enable doctors to carry out alternative treatments without fear of being sued. He knows what many experts, economists, patients, and physicians know through study and research — that continued insistence on large, randomized clinical trials as the only format for research, does not and cannot keep pace with 21st century medicine.
Let’s look at medical innovation from
There is the science: Large-scale trials requiring thousands of patients cannot meet the needs of niche, genomic treatments — the direction modern medical science is now taking. See how cancer survival rates are on the rise with new targeted therapies.
There are the ethics: Can we justify giving patients with a fatal condition a placebo, letting them die just so we can decide if another treatment works? Legitimate science can leave the decision up to each patient as to whether or not to accept risk when the alternative is near certain death. Dr. Eric Topol suggests a better way. View the video.
There are the alternatives: Today, we have surrogate markers that can indicate progress toward disease progression without actually waiting for the disease to get worse. We have informatics to digitally monitor patients and their treatments to track progress. We are developing new ways to assess pharmaceuticals at the molecular level, without waiting for patients to get sick or sicker. Look how death rates have decreased as research & development has increased over the years.
Another article in The Telegraph, U.K., titled Without Innovation, We’ll Never Cure Cancer, has our support as well. Medical innovation is not intended to remove regulatory guidance designed to protect patients. The EU black triangle warning makes critically needed drugs available, while alerting patients that further evaluation continues. The UK yellow card system to monitor possible side effects could facilitate provisional access to a drug that could be saving lives.
Patients need personal options, not one-size-fits-all government mandates
Let us leave behind legislation that locks us into the past and replace it with an accelerated approach to developing new cancer medicines. Effective medical research can be efficiently fueled by an environment that values and supports the entire ecosystem of innovation. This includes academic medical centers, voluntary health organizations, government agencies, and biopharmaceutical industry scientists, entrepreneurs, and investors.
All of these entities working together can promote meaningful innovation, share information, and learn from each step we take beyond our comfort zone, trapped in tradition. In this way, we can add years to the lives of people with cancer.
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