Gregory Goldstein, HHS Senior Public Health Advisor, Office of the Assistant Secretary of Health, sent a letter to Chemic on January 23, 2009, saying that HHS would require a validation study showing that Chemic could reliably measure various cannabinoids before it would even review Chemic’s November 6, 2008 reply to the June 18, 2008 PHS/NIDA critique of Chemic’s January 16, 2008 protocol.
However, there is no guarantee that PHS/NIDA would approve the protocol after funds for the validation study had been spent. Furthermore, a validation study could cost $40,000 and isn’t really necessary for the sort of academic study we’re seeking to conduct. A validation study is more appropriate for developing the Volcano vaporizer as a medical device, a task best left to the manufacturer of that vaporizer. We’re exploring a collaboration with Dutch scientists already studying the constituents of the vapors produced by the Volcano vaporizers. We may perhaps be able to conduct a cross-validation study at less then half the cost of the validation study.
Chemic initially submitted a protocol in June, 2003, seeking to purchase 10 grams from NIDA. That protocol was rejected on July 27, 2005, more than two years later. Chemic’s reply to that rejection was submitted on September 9, 2005, and was ignored by NIDA for over two years and four months, prompting us to submit a new protocol on January 16, 2008, to see if it might somehow catalyze a review process.
Progress is slow in Chemic’s efforts to purchase 10 grams of marijuana from the government’s monopoly provider, NIDA. It’s encouraging that the first hint in over 5 1/2 years that NIDA might actually sell Chemic 10 grams for its research took place on January 23, 2009, three days after Obama became President.