Sativex, a prescription marijuana extract applied via sublingual spray manufactured by British drug company GW Pharmaceuticals, went on sale last week in Canada after being approved there earlier this year. This week, a Multiple Sclerosis victim from Illinois and her doctor announced they are seeking access to the drug through the US Food and Drug Administration's (FDA) Investigational New Drug (IND) program.
Under federal law, drugs that have been approved in another country but not yet in the US may be used under a doctor's direction if the FDA approves. Under a Compassionate Use IND, the US government has provided medical marijuana to a handful of patients for nearly 30 years, but has refused to accept any new patients into the program since 1992.
At a Wednesday press conference in Chicago, Julie Falco and her physician, Dr. Anthony Reder, backed by the medical marijuana defense organization Americans for Safe Access, unveiled the effort. "Patients in states that don't have laws allowing the medical use of marijuana need access to a safe and legal form of natural cannabis. Access to Sativex® will provide the pain relief I need without the threat of incarceration that hangs over all us all," said Falco, who said she uses marijuana to relieve the symptoms of MS.
The state of Illinois does not have a functioning medical marijuana program. A 33-year-old law allowed the state to create such a program, but it never did. This year, a group called IDEAL Reform came close to pushing a medical marijuana bill through the state legislature. But strong opposition that included a blitzkrieg visit to the statehouse by drug czar John Walters and campaigning against the bill -- and the very notion of medical marijuana -- by former deputy drug czar Andrea Barthwell helped kill the bill.
Marijuana is currently scheduled as a Schedule I drug, along with heroin and LSD, meaning it cannot be prescribed. The application to the IND is part of a larger strategy to reschedule marijuana in the US, said ASA executive director Steph Sherer in a statement Tuesday. "The introduction of Sativex® to Canadian markets vindicates what patients, doctors, and medical associations have been saying for centuries: marijuana is a safe and effective medication," said Sherer. "The bottom line is marijuana must be rescheduled so that we can have an honest conversation about the best uses of marijuana as medicine, including the introduction of Sativex® to the US market."
Falco will not be the only patient applying through the IND program for permission to use Sativex, said ASA. The group "will be assisting a number of MS patients and their doctors through this application process, while they continue in their quest to change the schedule of marijuana from its current status, in the same category as heroin, to another category that recognizes the medicinal value of marijuana."
GW Pharmaceuticals, meanwhile, has announced it will apply for FDA approval this year, a process that will take a minimum of three years. In a move that has caused shudders among drug reform activists, the British company has hired none other than the above-mentioned Andrea Barthwell to shepherd Sativex through the approval process.