Tag Archives: FDA

Inventor of Fake Marijuana Wants the Real Thing Taxed and Regulated

The news has been all abuzz for the last several months about various forms of designer drugs meant to mimic marijuana. Called Spice, K2, and a million other mildly clever names, these substances usually consist of a synthetic cannabinoid sprayed over plant matter. The resulting euphoria is supposed to be similar to the effects of marijuana. Unfortunately, it is also untested and has been reported to have all sorts of nasty side effects. Enter the DEA, who recently asked the FDA to temporarily ban several of these chemicals, pending a more permanent solution.

Needless to say, most people probably wouldn’t use these chemicals if they could legally use marijuana. Many users of the synthetics report drug tests for probation or work to be their main reason for using it. The Navy had to start testing for it regularly, so prevalent was its use among the oft-drug-tested sailors. Once again, we have prohibition encouraging people to use drugs more dangerous than marijuana.

The inventor of these substances, John W. Huffman of Clemson University, strongly warns against using them and thinks they should be banned. What does he think should be legal?

 

In an interview this week with the L.A. Times, Huffman said marijuana should be taxed and regulated, and had this to say:

“You can’t overdose on marijuana, but you might on these compounds,” he said. “These things are dangerous, and marijuana isn’t, really.”

I wonder if the DEA will listen. Probably just the “dangerous” part.

Since Feds Won’t Change Policy, We Must Change Federal Law

The last two weeks have been full of announcements from the federal government about marijuana policy. None of them has been positive, and none of them should be surprising.

First, the Department of Justice stated that it retained the ability to prosecute anyone who cultivates, processes, or distributes medical marijuana, regardless of state law. As noted earlier on this blog, this is not really a change in policy, but it is certainly disappointing to see the Department of Justice is unwilling to publicly recognize the legitimacy of state medical marijuana laws and would rather have patients purchasing their medicine from dangerous, illicit dealers.

Then, in a move that shouldn’t have surprised anyone, the Drug Enforcement Administration, the agency tasked with determining the legal status of drugs according to the Controlled Substances Act, decided to keep marijuana as a Schedule I substance. This classification means that the DEA will continue to assert that marijuana has no accepted medical use and should continue to be a high enforcement priority. Never mind the growing mountain of peer-reviewed studies that show the medical efficacy and relative safety of marijuana. The DEA will only pay attention to government studies, which are not approved unless the goal is to find negative effects, not medical benefits. We should not expect them to reschedule marijuana in the foreseeable future, especially since marijuana enforcement is an easy source of cash and prestige. Americans for Safe Access is currently appealing the decision in federal court, however, and hopefully they will gain some traction on this point and force the DEA to recognize the evidence in support of medical marijuana.

All this was followed by the release of the National Drug Control Strategy, which basically states that the Obama administration will continue to use scarce resources to combat the use of marijuana through criminal justice means, as well as a slightly increased program of harm reduction (which the President has said was going to be his primary focus). The strategy admits that marijuana use is at its highest in the last eight years, yet wants to continue the same strategy it has been utilizing during that same period!

The new strategy also mentions medical marijuana and, while admitting that there may be some medical uses for individual components of marijuana, continues to say that it should pass through the FDA approval process. This would be nice, if we could get all the federal agencies whose stamps of approval are needed to actually allow such research. So far the efforts of those trying to go through the official research and approval process have been blocked. In addition, the new strategy claims that medical marijuana “sends the wrong message to children” and increases the likelihood of adolescents using marijuana. This point ignores the fact that in most medical marijuana states, teen use has actually decreased since passing medical marijuana laws. Data supporting this can be found in the Marijuana Policy Project’s Teen Use Report.

So what does all this mean?

It means that all we can expect from the federal government is support of the status quo. We might get some minor concessions here and there, and the fact that the Ogden Memo has been (mostly) followed by the DOJ should not be overlooked. However, we should not look to the federal government to change policy in any drastic way simply of its own free will. They must be legally compelled to do so.

This is why we don’t need statements of policy, nice as they may be. We need different laws. We need something much more binding than policy statements, which can be distorted and rescinded at any moment without legal backing. It is imperative that we convince our legislators to support bills that will weaken the federal government’s control over marijuana policy and enforcement.

Please contact your representative in Congress, and tell them to support H.R. 2306. This bill would remove the federal government’s ability to interfere with state marijuana laws and policies. Legal change is what we really need if we want to see positive change in federal behavior.

 

Medical Marijuana: The Drug Czar is Wrong (Again)

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.

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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.

Drugs That Kill and a Drug That Doesn’t

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. Continue reading