In its official response to the AMA’s recent call for a review of marijuana’s status as a Schedule I drug (barring any medical use) under federal law, the White House Office of National Drug Control Policy stated that it would defer to “the FDA’s judgment that the raw marijuana plant cannot meet the standards for identity, strength, quality, purity, packaging and labeling required of medicine.”

While we’re not used to factual accuracy from ONDCP, in this case they’re wrong not once, but twice.

First, there is absolutely no reason that plant medicines can’t be standardized and controlled for purity and potency. Indeed, the Netherlands has been doing just that for years, with medical marijuana distributed in Dutch pharmacies that is “of pharmaceutical quality and complies with the strictest requirements,” according to the Dutch government.

Second, the FDA has never said that a natural plant product can’t be a medicine. Indeed the agency has a lengthy “Guidance for Industry: Botanical Drug Products,” specifically designed to aid developers of plant medicines. The document not only doesn’t rule out plants as medicines, it even states, “In the initial stage of clinical studies of a botanical drug, it is generally not necessary to identify the active constituents or other biological markers or to have a chemical identification and assay for a particular constituent or marker.” Given that the active components of marijuana are already well-known and extensively researched, marijuana is well ahead of where the FDA says plant products need to be to start the process of seeking FDA licensing.

Yes, the FDA did put out a press release in 2006 saying that “smoked marijuana” had not been shown to be a safe and effective medicine. That statement was utterly unscientific, as we pointed out at the time, but it was absolutely not a declaration that the plant could never be a medicine.

ProCon.org, whose goal is to “promote critical thinking, education, and informed citizenship” by presenting information on controversial issues “in a straightforward, nonpartisan, primarily pro-con format,” did an interesting experiment recently. They filed a Freedom of Information Act request with the Food and Drug Administration seeking information on reported deaths due to marijuana and 17 FDA-approved prescription drugs. Five of those drugs were chosen because they are widely used and well known, while the other 12 are used to treat many of the symptoms for which medical marijuana is also used.

The folks at ProCon.org took the FDA’s figures and put them into a detailed report, and the results don’t look good for the pharmaceutical industry. [Read more →]

An FDA panel just recommended reducing the maximum dose of acetaminophen, the active ingredient in Tylenol. Taken by millions of Americans every day as either a stand-alone medication or as an ingredient in various over-the-counter cold remedies, acetaminophen is the leading cause of liver failure in the U.S., resulting in hundreds of deaths by overdose every year.

And they say marijuana is too dangerous to be medicine?

Medical marijuana advocates often hear that marijuana can’t be a real medicine because it hasn’t been approved by the FDA. One common response to this is that the Drug Enforcement Administration continues to block the only avenue that could produce the research needed to seek FDA approval for medical marijuana, over a year and half after an administrative law judge ruled that the project should go ahead. 

But that’s just the start. The Journal of the American Medical Association recently published a scathing critique of the drug company research that does lead to FDA approval,  demonstrating that the system is even more fundamentally rotten than most of us suspected. The author is Marcia Angell, former editor-in-chief of the New England Journal of Medicine, arguably the most prestigious medical journal on the planet, and now a professor at Harvard Medical School. [Read more →]