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When Genentech presented the results of a colorectal cancer drug trial at the 2003 American Society of Clinical Oncology conference, there came a moment of “daylight,” as Malcolm Gladwell describes it — an Aha moment. A Kaplan-Meier graph prompted a standing ovation because what the audience saw hadn’t until then been possible for that patient population.
Something similar happened at this year’s ASCO meeting when major presentations highlighted new immunotherapy and specialty drug combinations. But along with Aha came Wow when the cost implications were considered. As Mike Dalzell very aptly states in his ASCO roundup in this issue of Biotechnology Healthcare, none of the drugs will come cheap, and payers will balk, asking: Is survival at any cost justified?
Another kind of balking is taking place as healthcare reform continues. The attempted integration of a major hospital system and an insurer in an attempt to control costs and improve outcomes has raised serious questions as to how far payers should go to lower cost trends. Ed Silverman covers the messy issues that vertical integration in Pittsburgh has unleashed and what it may mean for payers, patients, and biotechs.
Jack McCain lays out the challenges that specialty drug distributors face as more, and pricey, specialty drugs hit the market and biosimilars hover on the horizon.
What happened at Duke University recently in an effort to personalize cancer treatment — and elevate the reputations of the investigators and of Duke — is another example of how the “war on cancer” can make for strange bedfellows. Bob Carlson carefully lays out the series of events that eventually led to Duke’s embarrassment and the investigators’ disgrace. He explains what “omics” is all about — the scientific study of global sets of biological molecules — and the missteps the landmark Institute of Medicine report on Omics intends to prevent.
Comparative effectiveness research (CER) underscores the need to find the most efficacious therapy in treating any medical ailment. But CER faces an uphill battle and the cost of therapy jangles in the background, as Blackstone, Fuhr, and Ziernicki explain in their fine article.
And, as always, we cover the latest advancements in personalized medicine, recent developments on the federal scene, and current legal issues that affect biologics and their management.
All articles are available in digital format in our Nxtbook edition and on our website and through social media.
Please contact me about other topics you would like covered at editor/at/biotechnologyhealthcare.com.