Dot Calm Has the FDA opened the door to the black market sale of on the Internet? How ironic would that be? Half baked If you'd like to buy generic versions of Lipitor, Celebrex or Ambien, they're easy to purchase without a prescription through online sources. But here's the catch: No generic versions of those drugs are available yet. That is, no LEGAL generic versions are available, so you'll be purchasing drugs made by outlaw manufacturers. As I mentioned in yesterday's e-Alert ("Doobie Brothers" 6/7/06), the FDA recently gave Valeant Pharmaceuticals International an approval to resume selling Cesamet, a prescription drug for the treatment of nausea and vomiting associated with chemotherapy. (Cesamet was on the market for a while in the late 80s, but was removed due to "commercial reasons," according to the Associated Press.) The active ingredient of Cesamet is a synthetic version of THC, the chemical in marijuana that causes people to become "drowsy, dizzy, or lightheaded, or to feel a false sense of well-being." (Actually, that's the Mayo Clinic's description of how you might feel when taking Cesamet.) Now…if you can purchase a handful of Ambien pills that have been manufactured in someone's basement, what are the chances that a "generic" Cesamet will soon be available? Considering the worldwide demand for THC products, I'd say the chances will be pretty good. And I expect that many college students (and, sure, even some old timers) will be saying: Whoa! Thanks, FDA! Something's burning Less than two months ago, out of the blue, FDA officials announced that research does not support the medicinal use of marijuana. And as I noted in yesterday's e-Alert, this position completely contradicts the conclusions of a 1999 report by the Institute of Medicine. So how can the FDA reconcile that position with their decision to bring Cesamet back to market? Here's a statement from FDA spokesperson Susan Bro, quoted in the New York Times last April: "Smoked marijuana has no currently accepted or proven medical use in the United States and is not an approved medical treatment." Did you spot the key word? It's "smoked" - which completely ignores the fact that marijuana can also be eaten with food or placed in a capsule and swallowed. Those inconvenient omissions aside, apparently the "logic" goes like this: When THC is burned and inhaled it has no medicinal value. But when THC is synthesized, allowing it to be regulated by the FDA, THEN it has medicinal value. See? The trick is to think like the FDA. It's all about regulation. The science is no problem: It can be tweaked, bent, shaped and dismissed as needed. Didn't see THAT coming Ah, but sometimes science just stubbornly refuses to cooperate. Researchers at the University of California at Los Angeles were sure that they would discover an association between marijuana use (the smoked kind) and lung cancer when they asked more than 2,200 people in Los Angeles about their lifetime use of marijuana, tobacco and alcohol. A little more than half of the subjects had cancers of the lung, neck or head. The researchers defined moderate-to-heavy marijuana use as smoking between 11,000 and 22,000 marijuana cigarettes. Heavy use was anything over 22,000 - that's more than two marijuana cigarettes per day for 30 years! How do these people tie their shoes? The results were surprising: Not only was heavy marijuana use NOT associated with an increased incidence of any of the three cancers; there was even what one researcher called "a suggestion of some protective effect." According to the Washington Post, UCLA pulmonologist Donald Tashkin speculated that THC might kill aging cells, preventing them from becoming cancerous. Face value I'll repeat my disclaimer from yesterday: I'm not opening a debate about whether or not marijuana should be legalized. Marijuana is a controlled substance and that is the law. BUT…taken at face value, marijuana is an herb, a plant…like so many others that natural medicine has come to rely on. This one contains a chemical that has been found to give some cancer patients relief. But, because it also happens to give college students and others a different kind of relief, it's been demonized and dismissed - until the FDA found a way to make it patentable, that is. Sources:
"F.D.A. Dismisses Medical Benefit from Marijuana" Gardiner Harris, The New York Times, 4/20/06, nytimes.com
"Synthetic Marijuana Returning to Market" Associated Press, 5/16/06, ap.org
"Study Finds No Marijuana Link to Lung Cancer" Marc Kaufman, The Washington Post, 5/26/06, washingtonpost.com | 
