Abstract
Dear Sir,
The fact that BOL-148 has central side effects is indisputable (1,2), and whether or not these side effects are labeled mild is open for discussion. I agree with Dr Halpern (3) that patients who undergo an experimental therapy should at least have seen first-line therapy, which includes but is not restricted to verapamil in adequate dosage. I disagree that introducing an experimental therapy in patients who have only tried verapamil in a mostly insufficient dose of 240 mg per day and have never been introduced to lithium, topiramate or any of the other therapies recommended in European guidelines (4) is acceptable, given that we should follow international consensus on that matter (5,6). Three out of six patients in Dr Halpern’s open-label case series have never been introduced to anything else than verapamil 240 mg/die, which is stated clearly in the above quoted paper (7). Dr Halpern quotes now that these patients ‘had many other standard treatments’ but unfortunately has neither mentioned these substances in the original paper, nor does he do so now.
I certainly agree with Dr Halpern that ethical issues are involved when we introduce new experimental substances which are closely linked to illicit drugs. I thank Dr Halpern that he verbally quotes one of the key sentences of the editorial which originally discussed the findings by Rossi et al. (8). This sentence touches the crucial question how we, as physicians, interpret our role and position regarding the undisputed recent hype promoting the use of illicit drugs in cluster headache when we are faced with the fact that addiction as such may be more common in cluster headache patients than in the general population (8). The answer is certainly not black or white but we should take a stand. As physicians our first duty is still that we must cause no harm. And we should keep to the facts: as long as there are no controlled studies substantiating the proposed efficacy of BOL-148 (or related substances), we should rely on those drugs and medical devices which have proven their therapeutic potential in controlled studies.
