Comparative Effectiveness May Have Influenced Pfizer Already
Pfizer announced last week that it was terminating its Phase 3 development programs for the investigational compounds esreboxetine, meant to treat fibromyalgia, and PD 332,334, targeted to treat generalized anxiety disorder.
The company claims in its Feb. 24 statement that the decision to end the programs was based on enabling Pfizer’s “Business Unit to allocate additional resources to higher-potential development programs as part of its continuing effort to deliver greater value to patients and Pfizer shareholders” and because “it was considered unlikely that either compound would provide meaningful benefit to patients beyond the current standard of care.” Neither compound was terminated due to safety reasons, according to the statement.
Looking at the second part of that statement, I can’t help but wonder whether new support and funding for comparative effectiveness research coming out of the Obama administration had something—if not, a lot—to do with this decision. Pfizer specifically notes that its two Phase-3 compounds could not likely help patients more than the “current standard of care” (i.e., other available therapies). The economic stimulus package that passed the week before Pfizer released this statement announced $1.1 billion for comparative effectiveness research to focus on the safety and effectiveness of drugs compared with therapies already on the market.
“In Primary Care, we continually review our portfolio to ensure we are developing medicines in areas of unmet need…,” said Pedro Lichtinger, president and general manager of Pfizer’s Primary Care Business Unit in the statement. Some pharmaceutical companies have expressed concern that the information obtained from comparative effectiveness research may lead insurance companies or the government to deny coverage of more expensive treatments (see back story). But it looks as though the new push for comparative effectiveness research is already making its mark on industry practice.
Yes, despite Pedro Lichtinger’s statement, it does seem to be something of an epiphany for Pfizer; where every product has been wonderful and better than that of everyone else…..until now.
Not only do patients (and payers) want products that are genuine improvements, but even companies as large as Pfizer can no longer afford to throw money away on ‘only invented here’ jingoism, and need to establish spending priorities for realistic targets. ‘Cut’ to the action…..as they say!
I have long been disturbed by the amount of the FDA’s time that is taken up by “Me, Too” products. The way the regulatory process is currently structured, it is just too financially tempting for pharmaceutical companies to copy a competitor’s successful product.
I hope this signals a move toward research based on something other than market share.