By Cindy Atoji
September 16, 2008 | When it comes to the future of personalized medicine, leadership from the highest political level is needed to speed the field along, says Edward Abrahams, executive director of the Personalized Medicine Coalition (PMC), the Washington, D.C.-based organization that is shouldering the task of “educating federal and state policymakers, helping them understand the science, the issues, and what is needed for the positive evolution of personalized medicine (PM).”
Both presidential candidates have endorsed the principles of personalized medicine. “So that’s a good sign,” says Abrahams. But much work lies ahead, because without the proper funding and policies in place, personalized medicine will be a long haul. Government regulation of clinical trials, intellectual property rights, privacy, licensing practices, and health care reimbursement are all public policy issues that need a PM-friendly revamping. Abrahams spoke with Digital HealthCare and Productivity about the political landscape of personalized medicine and its viability as a business strategy.
DHP: What is the Personalized Medicine Coalition and what is its mission?
Personalized Medicine Coalition represents a broad spectrum of academic, industrial, patient, provider and payer communities who are united around their wish to advance the understanding and adoption of personalized medicine, as well as the concepts and products that will benefit patients. That in a nutshell is our mission. Again, the key point is that we represent a cross section of stakeholders. We explain to public, policy makers, and physicians, the power of the new paradigm, and why they should introduce changes and create a friendly landscape for its development and adoption.
DHP: How do you see health-IT working with personalized medicine?
The future of personalized medicine depends on our ability to aggregate an enormous amount of data; the ability to do that depends upon the power of computing and health-IT. There’s a lot of knowledge in medical records if they could be aggregated and digitalized, and that data would yield greater insights into how different patients respond to various therapies and thereby how we might be able to better tailor medicine for the future. The first thing we is need electronic medical records, and interoperability to gather the data so it’s seamless. This is a lot of work. And a major effort needs to be done, but it’s been slow getting off ground. It’s been one of the priorities of Secretary Levitt.
We’re developing a white paper as we speak on demonstrating the value of health-IT to improve clinical trials, patient records, and all of the areas of medicine, which right now are each in its own silo. The Personalized Medicine Coalition recognizes that HIT and electronic health records provide the bedrock for future advancement.
DHP: Where does personalized medicine hold the most promise?
Not just the most promise but greatest reality is in oncology—there are many products available. Other diseases have yet to have the development and progress we see in cancer. Cardiovascular and central nervous system diseases, neurology, psychiatry—there is lot of movement in the personalized medicine direction. HIV is also treated through personalized medicine. The virus mutates and you need to understand its mutation in order to prescribe the right cocktail of drugs. One size doesn’t fit all anymore. You can’t develop one therapy and expect everyone to benefit.
DHP: How can personalized medicine lead to cost savings and how is it a viable business strategy?
First of all, even if the products are more expensive, they save the system money because their usage avoids costly treatments. So if you know breast cancer is more likely to occur, you don’t have to do the chemotherapy, which is expensive and painful. That’s an example. If you know a heart transplant is not rejected because you’ve done a genetic test, you don’t have to do expensive biopsy. Those are real examples with real products. But generally the larger picture is: If you can avoid adverse events, you save money. If you get right the first time, you don’t have to repeat. We haven’t proven or demonstrated this, since we haven’t done enough studies, but this is the argument and the vision.
Developing a new drug is costly and lengthy, and personalized medicine could also help reduce the time, cost, and failure rate of clinical trials. It also has the potential to revive drugs that failed clinical trials or were withdrawn from the market; improve the selection of targets for drug discovery, and enable the selection of optimal therapy and reduce trial-and error prescribing.
DHP: Has the U.S. regulatory climate been supportive of trends in personalized medicine?
In general, the FDA is moving in this direction. They’re charged with developing safer, more efficacious drugs, and they recognize that individual variation is a big piece of this. They are trying, albeit more slowly than some of us would like, to make it easier for companies to move in that direction.
DHP: What are some other barriers to the adoption of personalized medicine?
There is no shortage of [ethical, legal, and societal questions.] The biggest one is: If is determined that patient is not likely to benefit from a drug or treatment, can or should that therapy be denied to that patient?
[Another] big barrier is education, to know what’s available, know how to use it, to be willing to accept that biology is complex and complicated, and that tests need to be done. The other is reimbursement for those tests. The reimbursement system was set up long before personalized medicine came on the scene and it isn’t structured to facilitate it. We’d like to change that. That’s the biggest hurdle. Someone has to pay for all of this. We’re very interested in getting reimbursement for diagnostic products that are value based and we want clearer and better regulation of genetic products.