Grant Requests May Not Be Reviewed by Headache Experts
NIH’s Center for Scientific Review examines most grant requests for headache research, but only one of the Center’s study section panels includes a permanent member who is a headache research scientist. The other study section panels maintain open slots for ad hoc members whose expertise is not consistently needed. When a grant application for headache research needs review, the study section panels try to find headache experts to fill these ad hoc slots but do not always succeed. The AHDA is urging NIH to install at least three headache specialists as permanent members of the study section panels so that these grant requests receive “fair peer review,” said Dr. Young.
It has been difficult to find reviewers with headache expertise to join the study section panels, partly because of the size of the community of headache experts, said Dr. Porter. And adding these experts to the panels may be problematic, she continued. Depending on the type of research described in an application, a grant request might be reviewed by a study section that focuses on epidemiology or basic molecular science, for example. “Trying to keep an expert on each one of those panels when those panels don’t get a steady flow of headache research grant [requests] is a difficult thing for the Center for Scientific Review to maintain,” said Dr. Porter.
The NIH is willing to give headache organizations the criteria for serving as a reviewer for the Center for Scientific Review. In turn, the organizations could post the information on their websites, prescreen their members who would like to serve, and forward names to the NIH for consideration. This tactic would “open the communication up a little bit more,” said Dr. Porter.
Neurologists Seek Reimbursement for Oxygen Treatment
Some of the AHDA’s lobbying efforts this year related not to research, but to an effective and safe treatment already available for patients with cluster headache. The only FDA-approved drug for this disease is an injection of sumatriptan. Neurologists may hesitate to prescribe sumatriptan to patients who are 50 or older, have blood vessel disease, or have uncontrolled hypertension because it is a vasoconstrictor and may cause adverse events such as heart attacks or strokes.
An alternative treatment is oxygen. Research and clinical experience indicate that breathing pure oxygen at 12 L/min through a rebreathing mask over the nose and mouth can reduce or stop the pain of cluster headache. The treatment is effective between 70% and 80% of the time, Alan Rapoport, MD, Clinical Professor of Neurology at the David Geffen School of Medicine at the University of California, Los Angeles, told Neurology Reviews. In a double-blind, randomized, placebo-controlled crossover trial, 78% of patients breathing oxygen were pain-free at 15 minutes, compared with 20% of patients breathing air.
Nevertheless, the Department of Health and Human Services (HHS) decided not to reimburse oxygen for Medicaid and Medicare patients, saying that the treatment was experimental and unproven in the Medicare population. A randomized trial of oxygen in older patients with cluster headache might persuade HHS to change its decision, but “it’s extremely difficult to do studies on cluster headache because there are so few people” with the disease, said Dr. Rapoport. “Also, is it ethical to give any cluster patient a placebo, especially those of Medicare age?” To test the treatment in 150 elderly participants with cluster headache would require an international study, and enrollment could take two years, he added. Furthermore, because no pharmaceutical company owns oxygen, the government would be the only likely source of funding for such a study, but “it has no interest in it.”
HHS’s decision is “a terrible mistake,” continued Dr. Rapoport. “The effectiveness of oxygen in cluster headache may not be proven beyond a shadow of a doubt, but if you ask any cluster patient who has used it or any headache specialist, he or she is going to tell you that oxygen works. It does not cost a lot of money to rent an oxygen tank for home use, and it is the safest treatment one can give for cluster headache. The AHDA is just focusing on a ruling that is clearly wrong and trying to get it changed.”
Lawmakers Respond Positively
Lawmakers responded “quite positively, overall,” said Dr. Young. “Everyone’s sense is [that] we were better received overall than in any previous year.”
“Many of the Congressmen and -women do understand and believe in what we’re talking about,” said Dr. Rapoport. “I think we have made some headway.”