Personalized medicine for quicker cures
As we listen to presidential candidates and Congress debate how to control health care and drug costs and raise drug safety standards, most solutions lead to increased government regulation. That is underlined when debate turns to cancer care with high-cost drugs and low returns in quality of life and survival.
But more government regulation on reimbursement rates and overly burdensome drug development requirements will result in less medical innovation and rationing of medical care. What's missing from the debate is the public policy encouragement to produce more "smart" medicine.
One of the hardest parts about being an oncologist is telling patients they have cancer. Even harder, though, is knowing that the drugs prescribed don't work well in most patients and/or will cause severe side effects in others.
That is changing. Scientists working at biotechnology companies are using the knowledge of the human genome to develop drugs targeted to help individual patients. That concept -- known as personalized medicine -- holds the promise of improving care for patients and quickening the pace of drug development so we can "hurt the cancer more than the patient."
The human genome has shown us how our genes affect our health -- including whether we are at risk of disease. Recent advances in DNA research also have taught us how to examine what happens to a cancer tumor's gene or set of genes when they are turned on or off in the presence of a drug.
At my company, Cell Therapeutics Inc., one of our subsidiaries, Systems Medicine, is examining the function of genes in a tumor through a process called genetic profiling. SM examines about 30,000 relevant genes from tumor cells and tests them to determine which gene or genes make the tumor susceptible to the effects of different cancer drugs. Using that technique, we can identify which cancers are sensitive to which drugs. It is a fundamental shift in approaching the dilemma of which is the right drug for the right patient while exposing the least number of patients to a drug's severe side effects.
The power of this technology is enormous. Rather than imposing new regulations on manufacturers or physicians, the most effective way to ensure safety is to use scientific advances to better understand why some patients react badly to some drugs, and encourage development of new diagnostics and therapies that take that into account.
Adoption of personalized medicine will mean that patients will get quicker access to the newest cancer therapies. The current time and cost of drug development is about 16 years and $1.7 billion. Cancer drug development is actually the least-efficient in all of medicine. Genetic profiling could shorten clinical development time and costs because only those patients likely to benefit will be enrolled in clinical trials, making it easier for regulators to make safety and efficacy decisions more quickly.
But, federal regulators need to understand the value personalized medicine can bring and develop policies that encourage development of these new drugs and diagnostics, while doctors need to understand the power of genetic profiling so they can make good prescribing decisions. Some day, instead of physicians diagnosing lung cancer or colon cancer based on where the tissue is from and the way a tissue looks under the microscope, we may be referring to a genetic profile of a tumor in your lung or colon tissue recognizing that the genes that make each of us unique also makes our cancers unique.
