Originally appeared at: http://www.bizjournals.com/boston/news/2010/11/05/harvards-headache-cure-lsd.html Move over, Advil. A Harvard Medical School researcher says LSD, the hallucinogen at the heart of the 1960s drug counterculture, holds a better treatment for humanity’s worst headaches. Harvard researcher John Halpern has formed a company he hopes will bring to market a drug based on his research into the effects of lysergic acid diethylamide on cluster headaches, a rare but devastating condition that is as bad as it sounds. Halpern, a noted expert in the long-term effects of drug use, said research suggests chemicals present in LSD are an astonishingly effective cure for cluster headaches. His company, Entheogen Corp., is seeking $10 million to bring the drug through to FDA approval, according to a regulatory filing this week. Entheogen’s drug does not cause triptastic visions, Halpern said. It is based on BOL-148, a non-hallucinogenic LSD derivative developed in the 1950s and 60s for research into the effects of LSD on the brain, when such was last in vogue. “Trying to do a double-blind, placebo-controlled trial with a drug that’s as psychoactive as LSD is impossible,” Halpern explained. Then, grant funding for such research dried up. Halpern’s Harvard antecedent, Professor Timothy Leary, was expelled from the university, and the culture at large adopted a zero-tolerance policy to drug experimentation. Fast forward half a century. Having studied the long-term effects of ritual mescaline use by Native American tribes, Halpern was approached earlier this decade by cluster headache sufferers who said they had found LSD an effective medicine. “It was interesting to hear people talk about the benefits of these drugs,” he said. “You just don’t hear that from alcoholics or heroin addicts.” Halpern published an article on the cluster headache sufferers’ experience in 2006, and got grants from Harvard and the National Institute on Drug Abuse to study the impact of BOL-148 on cluster-headache patients. He didn’t expect it to work, he said, but it did. He said the results show the drug could be an epigenetic medication, meaning it took some patients from chronic symptoms to episodic with one or two doses. One participant in the study, who had suffered 40 attacks a week for 30 years went to zero a week, Halpern said. Cluster headaches are so named because they attack in cycles, coming one after another in waves that can last weeks to months. Patients usually experience long remissions between clusters. Existing treatments are limited, Halpern said – but in spite of exposure his work has gotten with articles in scientific journals and a mention on the National Geographic Channel, he’s gotten no interest from big pharma. So, Halpern and Entheogen co-founders Torsten Passie, a professor at Hannover Medical School in Germany, and Ari Mello, a former investment banker with a background in Chinese medicine, hope to bring the product to market themselves. The company name comes from Greek roots meaning ‘God within,’ and refers to any psychoactive substance used in a religious context. The climate has changed since the late-1960s backlash, Halpern said. Now, although the danger of abuse is widely recognized, drugs like the painkiller OxyContin and the sedative thalidomide are prescribed. The same could be true of Halpern’s non-hallucinogenic LSD derivative, he said. “The difficulty is not anything political or regulatory. It’s just dotting the i’s and crossing the t’s, just as you would for any drug,” Halpern said. “[There is] a little more scrutiny to be sure, but the scrutiny is welcome,” he said. An article in the Boson Business Journal discussing a new company formed by Harvard researcher John Halpern to market a drug based on his research on LSD for the treatment of cluster headaches.
