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.

The approved drugs, which included anti-nausea drugs, anti-spasmodics, anti-psychotics, and such well-known drugs as Vioxx, Ritalin, and Viagra, were suspected as the primary cause of 10,008 deaths and as a secondary cause in 1,679 more. Marijuana was the primary suspect in zero deaths and a suspected secondary factor in 279.

A few disclaimers are needed here: First, the FDA’s reporting system does not attempt to prove definitively that a given drug caused a particular death. It’s designed to warn of possible dangers, and physicians are encouraged to report suspected reactions. The numbers may well be overestimates of actual deaths related to various drugs.

Second, the list of drugs compared by ProCon.org doesn’t completely reflect the pharmaceuticals for which marijuana might substitute. Some might complain, for example, about the inclusion of Vioxx, which was taken off the market due to health risks and which was the suspected main cause of some 4,500 deaths. On the other hand, plenty of other pain drugs that can be toxic weren’t included, including acetaminophen (the active ingredient in Tylenol), a drug about which an FDA advisory committee recently sounded a warning and which is reported to cause hundreds of overdose deaths annually.

A few weeks ago a TV network news producer told me she found published studies of medical marijuana “unpersuasive” because “they didn’t show marijuana was better than the other drugs.” I don’t know about you, but I think “less deadly” pretty definitely qualifies as “better.”

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.

“Drug companies now finance most clinical research on prescription drugs,” Angell writes, “and there is mounting evidence that they often skew the research they sponsor to make their drugs look better and safer.” Angell walks readers through a depressing litany of conflicts of interest, showing how researchers, the academic institutions they work for, and even members of FDA review panels are financially in bed with the drug companies whose products they test and evaluate. Drug company control of research on their products is now so complete, she explains, that the companies “often design the studies; perform the analysis; write the papers; and decide whether, when, and in what form to publish the results.”

Companies controlling research on their products not only skew that research to produce positive results, they suppress negative results that would interfere with marketing — suppression that, Angell explains, has often only been uncovered as a result of lawsuits or congressional hearings. The bottom line, this esteemed physician and journal editor writes, is that bias in favor of drug company products “permeates the entire system. Physicians can no longer rely on the medical literature for valid and reliable information [italics mine].”

Natural marijuana, of course, has no drug company sponsor. And yet we’re told it can’t be a real medicine because it hasn’t been fully run through this broken, biased, dysfunctional system.