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Letter from the President

“I am dying. We all die someday, but my expiration date is sooner than most. At age 41 I am facing my second recurrence of cancer. I was first diagnosed with an advanced and rare type of breast cancer in 2001. This led to a large tumor in my brain last year. Now the cancer has spread to my spinal fluid, which will likely seal my fate within weeks”.

So writes Adriana Jenkins in a column published by Forbes on 28 February called “A Dying Wish”.

Unfortunately, Ms Jenkins died on 9 February, just before the article was published, although she did see the final piece, which pleased her.

She had sent the Personalized Medicine Coalition (PMC) her draft 10 days earlier. We were very moved by her essay, and recognizing the power of her argument, told her that PMC would like to publish it in our next newsletter, which, with Forbes‘ permission, we did.

In her article, Adriana notes that she participated in the original Herceptin^® trial, a drug she credits with extending her life by nearly a decade. As she describes it: “A targeted cancer drug kept me alive for 9 years. Congress must ensure that future patients get the same chance to live”.

She asks why there are not more personalized medicines on the market, and points to some of the business model challenges inherent in discovering and developing targeted treatments linked to advanced diagnostic tests for subpopulations. She calls for better incentives to speed the development of personalized medicine, pointing to the Orphan Drug Act in the USA (which grants longer market exclusivity and other incentives for drugs targeting small populations) as one potential model.

Although the pharmaceutical industry may have been slow to embrace personalized medicine, many signs, as I wrote in my Letter for the January issue [1], point to its increased investment in the new paradigm, despite the problem Adriana identifies. Drugs like Herceptin, as she notes, can indeed become ‘blockbusters‘. According to the Tufts Center for the Study of Drug Development‘s survey of 25 pharmaceutical and biotechnology companies, between 12 and 50% of medicines in pharmaceutical pipelines are targeted therapeutics, although as compounds move closer to the market, those tied to a biomarker strategy decline to 30% and only 10% have a companion diagnostic in codevelopment.

The pharmaceutical industry‘s growing commitment to personalized medicine does not make Adriana‘s message less compelling. PMC knows that incentives to encourage more investment in personalized medicine products can hasten progress for patients, perhaps even more powerfully than any other measure. Not insignificantly, such incentives may also help industry increase its productivity, which has declined in recent years despite dramatically higher investments in research and development, leading not only to fewer new life-saving drugs but to fewer jobs as well.

Concluding her article, Adriana wrote, “I am so grateful for the extra time a [personalized medicine] drug gave me. My hope is that future patients have the same chance to benefit from personalized medicine”.

As Adriana argues, we must incentivize industry, using every governmental lever at our command, to encourage the development of more drugs like Herceptin, Gleevec^® and other medicines that offer a better future for patients.

Among the ideas PMC is exploring, in addition to longer market exclusivity for companies that develop personalized medicine products, are fast-track status at the US FDA and guaranteed market-based reimbursement when reasonable standards are met. These changes in the law would go a long way to offer patients like Adriana much more hope than they now have.

Edward Abrahams, President, Personalized Medicine Coalition