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Personalized medicine is like any other commercial product—its success depends on delivering returns to its investors. At least this is what our poll, “Personalized Medicine: So Close and Yet So Far,” seems to suggest. According to 47 percent of those polled, “reimbursement” is a roadblock to commercialization, followed by “availability of outcome data,” which received 35 percent of the votes.

All of this makes sense in a way. Reimbursement drives utilization and outcome drives reimbursement, at least in a rational world. Financial returns and the ability to invest in future offerings then follow. Related to this, our poll also identified “diagnostic company incentive” and “relevant markers available,” each of which was checked by 29 percent of those participating in the poll, as roadblocks to personalized medicine.

I was surprised to see that only 17 percent of the participants checked “resistance from clinicians,” in light of the tradition of slow adoption of new technologies. Randy Scott, CEO of Genomic Health, commented at the recent Burrill Personalized Medicine Conference that, despite compelling proof of clinical utility, only one third of breast cancer patients today receive the Oncotype Dx test. Rational businesspeople like us sometimes forget the “first do no harm” and in many ways risk-averse culture of the clinical community. And in the emerging world of preventive medicine, risk stratification and risk reduction, which calls for a new framework for financial incentives, clinicians will be at the center of this push toward rewards for wellness. Who will lead the charge to convince the clinical community of this need for change?

Another surprise to me was that just as few people (17 percent) identified pharma-diagnostic collaboration as a potential roadblock. Either this collaboration is so well in place that it is no longer a roadblock (unlikely), or we’re resigned to a more opportunistic partnership, which seems to be the case today, with pharmaceutical companies looking for a diagnostic company to provide biomarker assay(s) in a more advanced stage of development. I believe that this will change, as pharmaceutical and diagnostic industries will come together when companies realize the stakes are so high that the benefits of collaboration far outweigh the risk of an unproductive partnership. And one key ingredient is the change in mindset of the diagnostic industry to claim its place at the negotiating table—not as a vendor of biomarker assays but as a true partner in the advancement of medicine.

Last but not least, in the interest of good science, I should disclose that the data summarized above came from 17 participants casting a total of 35 votes (the maximum allowed was three) over the period from November 24 through December 14. Our sample is small, and all the typical market research disclaimers apply. However, I like to believe that our audience is an educated and experienced one, and the poll results offer insight if not answers. To everyone who took the time to complete the survey, thank you.

Five years ago, I was a starry-eyed admirer of personalized medicine and one of the first in the healthcare communication industry to write an article about this exciting topic. In June, the American Society of Clinical Oncology (ASCO) meeting gave me insights into the complexity and enormity of the challenges just in designing and implementing clinical trials for targeted therapies. No wonder the conversation at ASCO’s 2008 meeting buzzed around just one single marker, the KRAS. No wonder so few targeted therapies have been introduced since the approval of Herceptin® (trastuzumab) ten years ago.

My curiosity about the pace of new product launches took me to the recent Burrill Personalized Medicine Meeting. I got an even better sense of the multitude of scientific, technological, economic, cultural and sociopolitical issues surrounding personalized medicine. I particularly appreciated the insight of Dr. Susan Desmond-Hellmann, president, Product Development, Genentech. She stated that our knowledge of molecular genetics far exceeds what we know about biology, with the latter being the rate-limiting step. Thus, a key reason for the dearth of targeted therapies today is the deficit in our fund of scientific knowledge. Once a target and the corresponding therapy are identified, one of the challenges in therapeutic development is in developing and validating a suitable, robust assay for the target. The financial incentives for the diagnostic and pharmaceutical companies have to be there, as does reimbursement and acceptance by the clinical community.

But targeted therapy is only one component of personalized medicine. Much of the unharnessed power of personalized medicine—defined more broadly as individualized healthcare based on genetic variations—lies in identifying and understanding risk factors and developing a plan for mitigating those risks. This shift toward a focus on wellness from our current mindset of intervention and treatment requires more than a change in attitude among consumers and physicians. It demands new health policies that provide financial rewards for wellness. Toward that end, it will not be surprising to see an increasing role for the consumer as the seeker of the additional information that genetic testing can provide. In fact, recent history with BRCA1 and BRCA2 testing, and now the emergence of companies such as Navigenics and 23andMe, point to consumers’ appetite for personal genetic information and, more important, their willingness to pay. Perhaps the consumer will be the one leading the charge as champion and advocate for personalized medicine?