Can a billion dollars in extra research money ever be a bad thing? A new article in the New England Journal of Medicine, from three American academics raises this question.
When the $787-billion US stimulus package was unveiled last year many scientists were extremely pleased to see that huge wads of dollar bills would be flung their way. Among the happiest were medical researchers working in comparative effectiveness research (CER).
Their historically underfunded discipline was awarded a cool $1.1 billion. Now Daniel Martin, Maureen Maguire and Stuart Fine look this gift horse in the mouth.
Without some changes, they warn, “it is difficult to imagine that the $1.1 billion of [stimulus package] funding for CER will be used effectively”.
They detail the experience of one comparative effectiveness trial looking at bevacizumab and ranibizumab. The latter is a $2,000 a month treatment for a common cause for blindness. The former is a similar compound that costs just $50 a dose.
One major problem with comparing these two treatments was the issue of who paid for them. Patients in trials can be liable for some drug costs but what is to be done when the drugs being compared have vastly different costs? In addition, how can studies be properly blinded when health insurance companies send through ‘explanations of benefits’?
These and other roadblocks slowed down initiation and enrolment in a hugely important trial. This resulted in clinicians making decisions without valuable data, say Martin, of the Cleveland Clinic, and Maguire and Fine, of the University of Pennsylvania, Philadelphia.
“Despite our efforts, there is still insufficient infrastructure for the implementation of federally sponsored CER trials,” they write. “Not only is there no established pathway for navigating issues of payment and masking for clinical trials involving Medicare beneficiaries, but trials focused on conditions that affect patients of all ages face the more daunting task of coordinating these logistics with hundreds of insurance plans.”
They call on the Federal Coordinating Council for Comparative Effectiveness Research to deal with these problems and for a federal policy to cover all drug-related costs.
“Without such a policy, it is difficult to imagine that the $1.1 billion of ARRA funding for CER will be used effectively,” warns their paper.