Feature: Politics Trumps Science as DEA Rejects Researcher's Request to Grow Marijuana for FDA-Approved Studies

The US Drug Enforcement Administration (DEA) Wednesday blocked the years-long effort of a University of Massachusetts-Amherst researcher to end the federal government's monopoly on the supply of marijuana available for research. In doing so, the agency overruled its own Administrative Law Judge, Mary Ellen Bittner, who nearly two years ago formally recommended that the project be approved.

https://stopthedrugwar.org/files/lylecraker.jpg
Lyle Craker (courtesy aclu.org/drugpolicy/)
UMass-Amherst Professor Lyle Craker initially filed a petition in June 2001 seeking to cultivate research-grade marijuana for use by researchers in Food and Drug Administration (FDA)-approved studies aimed at developing the plant as legal prescription medicine. Currently, the National Institute on Drug Abuse (NIDA) is the sole source of marijuana for researchers, but that agency has repeatedly refused to make it available for privately-funded, FDA-approved studies seeking to develop smoked or vaporized marijuana into a prescription medication. Researchers have also complained about the quality of the marijuana produced at the federal government's Mississippi pot farm.

From the beginning, Bush administration officials have been unresponsive or sought to delay the proceedings in the Craker case. The DEA first did not respond to Craker's requests for status reports on his request, then told him it had lost his filing. When he submitted a photocopy, the DEA rejected that as improper. It took until 2004 for the agency to get around to rejecting Craker's request, and ever since then for that rejection to go through the administrative appeal process.

It was during that process that DEA Administrative Law Judge Bittner made her formal recommendation supporting Craker's request: "I conclude that granting Respondent's petition would not be inconsistent with the Single Convention, there would be minimal risk of diversion of marijuana..., that there is currently an inadequate supply of marijuana available for research purposes, that competition in the provision of marijuana for such purposes is inadequate, and that the Respondent has complied with applicable laws and has never been convicted of any violation of any law pertaining to controlled substances," Bittner wrote as she weighed the factors involved in her decision. "I find there that Respondent's registration to cultivate marijuana would be in the public interest."

Judge Bittner's recommendation was based largely on the fact that marijuana is the only Schedule I drug that the DEA prohibits from being produced by private laboratories for scientific research, which has resulted in a unique government monopoly that fundamentally obstructs appropriate research and regulatory channels. Other controlled substances, including LSD, MDMA, heroin and cocaine, are available to researchers from DEA-licensed private laboratories.

In contrast, the National Institute on Drug Abuse (NIDA) remains scientists' sole source of marijuana, despite the agency's repeated refusal to make marijuana available for privately-funded, FDA-approved studies that seek to develop smoked or vaporized marijuana into a legal, prescription medicine.

As Judge Bittner concluded, "NIDA's system for evaluating requests for marijuana has resulted in some researchers who hold DEA registrations and requisite approval from [HHS and FDA] being unable to conduct their research because NIDA has refused to provide them with marijuana. I therefore find that the existing supply is not adequate."

But just as was the case with DEA Administrative Law Judge Francis Young's famous 1988 recommendation that marijuana was among the safest therapeutically active substances known to man and should be rescheduled, Bittner's recommendation was also ignored by her own agency. In the final decision issued this week, the DEA simply rejected most of Bittner's findings, and rejected Craker's petition.

"I am saddened that the DEA is ignoring the best interests of so many seriously ill people who wish for scientific investigations that could lead to development of the marijuana plant as a prescription medicine," said Professor Craker. "Patients with serious illnesses deserve legitimate research that might establish medical marijuana as a fully legal, FDA-approved treatment. Today, that effort has been dealt a serious blow."

Craker wasn't the only one protesting. The ACLU Drug Law Reform Project, the Marijuana Policy Project (MPP), and the Multidisciplinary Association for Psychedelic Studies (MAPS) all supported Craker's quest, and all blasted the DEA decision.

"It's no surprise that an administration that has rejected science again and again has, as one of its final acts, blocked a critical research project," said MPP director of government relations Aaron Houston. "With the new administration publicly committed to respecting scientific research and valuing data over dogma, this final act of desperation isn't surprising, but the true victims are the millions of patients who might benefit."

"With one foot out the door, the Bush administration has once again found time to undermine scientific freedom," said Allen Hopper, litigation director for the ACLU Drug Law Reform Project. "In stubbornly retaining the unique government monopoly over the supply of research marijuana over the objections of DEA's own administrative law judge, the Bush administration has effectively blocked the proper regulatory channels that would allow the drug to become a wholly legitimate prescription medication."

"The DEA and NIDA, but not the FDA, are clearly frightened of permitting privately-funded, scientific research into the risks and benefits of the medical uses of marijuana," said Rick Doblin, president of MAPS. "We need the Obama Administration to reverse this egregious suppression of scientific research that the outgoing administration so fears will reveal inconvenient truths."

Despite the DEA rejection, these are the waning days of the Bush administration, and this isn't over yet. Look for another lawsuit or an appeal to the Obama administration, said Doblin.

Permission to Reprint: This article is licensed under a modified Creative Commons Attribution license.
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Not the FDA?

The FDA is likely urging the DEA and NIDA to block research. The FDA works for big pharma and is not interested in advancing medical science. Big pharma hates medical marijuana because they cannot make money on it and will lose market share for their drugs. The FDA is just protecting big pharma profits.

fuck the dea and the us

fuck the dea and the us goverment fucking hipocrits

Marijuana has accepted medical use in the United States

How can marijuana be in schedule I of the Controlled Substances Act which says it has "no accepted medical use in treatment in the United States" when 13 states in the United States have accepted it's medical use by state law? Has anyone ever asked this question and gotten a response from the DEA or a U.S. District Court on it? If not, why not? It's not obvious to me.

Carl Olsen
Iowans for Medical Marijuana
Post Office Box 4091
Des Moines, Iowa 50333
515-288-5798
http://www.iowamedicalmarijuana.org/

Someone has

There is an ongoing lawsuit about exactly this:

http://www.mapinc.org/drugnews/v09.n052.a05.html

Cannabis is a safe and effective medication!

Cannabis is very safe and effective for the treatment of a variety of medical conditions. It is non-toxic, not lethal, and not physically addictive. There is no logical reason for the DEA to classify it in schedule 1. There is also no reason to atttack and persecute sick people who use it for treatment. It is a waste of our tax dollars and precious resouces. It sends a bad message to our children who see cowardly DEA agents dressed and acting like the Nazi Gestapo assaulting, intimidating and attacking sick people and their providers with automatic weapons for using such a benign subtance. Our children know the facts and know the government lies and intimidates. This fosters valid disrespect for our government, police and prosecutors especially when alcohol and tobacco are lethal, more dangerous, highly addictive and are 100% legal!. Enough is enough! We need major changes in our so called leaders! I have no idea what useful purpose the DEA even serves.

Norman Lepoff, M.D. retired

statement by Norman Lepoff, M.D.

I love your use of the phrase "valid disrespect for our government, police and prosecutors". The aforementioned entities have shown blatant and obvious disrespect for the citizens of the United States and for the Constitution. The disregard of the Constitution has been so blatant by the people who have sworn to protect and defend that same document that it is sickening to me that that American people at large aren't even cognizant of these acts. I ask people at the corporation where I work what they think about these facts and they are either completely ignorant or just so self-involved with their own problems that they simply don't care. The occupants of this country are already in dire straits and if we all don't wake up and do something, we'll effectively be living in a socialist state. I, for one, am not willing to give up my Constitutional rights, and this administration and the new, incoming adminstration are no different in their disregard for our rights. The founders of this great country are spinning in their graves. It was summed up by George Washington in his speech when he departed from the office of president. He simply stated that the two-party system that we are living under now will destroy this country because the winners of any election will only work for the good of their party, as opposed to working for the good of the people as a whole. That declaration has turned out to be so true as to be almost unbelievable. The Dems and the GOP will never allow any other party to compete on a level field. I am at a complete and total loss as to how to proceed. The incoming administration WILL seek to disarm the populace as soon as possible, which has historically been the first move of all socialist regimes. Once the people are disarmed, the government and the criminals will be in complete control. The Dems, in general, are so ignorant of the fact that gun control laws never affect the criminals, that they will never give up on this completely unconstitutional path. They refuse to accept the facts. The Constitution has become just another document to ignore with the stroke of a pen. I can only do my best to try to enlighten people regarding the new administration's true intentions and the shortcomings of their ideas. I urge anyone who respects the Constitution to join the NRA. This is the only organization that I know of that only seeks to enforce the Constitution of the United States. The ACLU has some good ideas, but they have become so politicized (read: politically correct) as to be almost meaningless. Please join the NRA and help us defend the Constitution. When the home-invasion robbers kick in you door, calling 911 is a fantasy of getting any true help at that moment. When a man or woman cannot lawfully defend their family, then we will have become a true socialist country, and will have become not citizens of a free country with a meaningful Constitution, just subjects hostage to the will of the politicians and the criminals. Cannabis is a very useful tool in helping a great number of people with many different illnesses. President Nixon requested, paid for, and received a report that showed some of the very beneficial uses of cannabis. Since the facts didn't agree with his opinion, the report, which cost the taxpayers a great deal of money, was discarded. Soon-to-be president Obama has the very same opinions towards firearms, and will not be confused by the facts and FBI reports and statistics concerning the self-defense use of firearms. This man will swear on the bible to support and defend the Constitution of the United States, knowing that the statement is a falsehood. No one should be above the law, and no one should be allowed to abrogate the Constitution of the United States.

You have some good ideas . . . but

Joining the NRA isn't one of them. If you want to protect only 2nd Amendment rights, join Gun Owners of America (GOA). Unlike the NRA, they don't accept anything less than full rights to keep and bear arms, they do not compromise on liberty. But the 2nd Amendment is their only focus.

If you want to protect the Constitution and ALL rights (for everyone, even those people who do things you don't like), then work with the various libertarian organizations -- LewRockwell.com, self-gov.org, fff.org, The Independent Institute, the Libertarian Party, etc.. As for how to get a third party past the hoops and obstructions set up by the duopoly (for every party but them), we can begin by never again voting for a Democrat or Republican unless s/he has a Ron Paul type philosophy. Vote ONLY for libertarians at every level of government. If there is no libertarian in a race on your ballot write in NOTA (none of the above). For this to have impact, everyone has to do it, not just a few, it has to be a large enough number to show them we the people mean business -- if they don't end the war on drugs we will not vote for them, period! We need to become "one issue voters" until Prohibition 2.0 is repealed!

Ignoring their own law judge? ...again?

This would't be the first time the DEA said fuck off to their own administrative law judge. Of course I'm refering to Judge Francis Young's decision of Sep 6, 1988:

Based upon the foregoing facts and reasoning, the administrative law
judge concludes that the provisions of the Act permit and require the
transfer of marijuana from Schedule I to Schedule II. The Judge realizes
that strong emotions are aroused on both sides of any discussion
concerning the use of marijuana. Nonetheless it is essential for this
Agency, and its Administrator, calmly and dispassionately to review the
evidence of record, correctly apply the law, and act accordingly.

...

The administrative law judge recommends that the Administrator
conclude that the marijuana plant considered as a whole has a currently
accepted medical use in treatment in the United States, that there is no
lack of accepted safety for use of it under medical supervision and that
it may lawfully be transferred from Schedule I to Schedule II. The judge
recommends that the Administrator transfer marijuana from Schedule I to
Schedule II.

Quoted from his original decision, pgs 67-68. Search "francis young ruling" on Google to read the whole ruling.

Job security

It's called job security. Take away marijuana from their "no" list and you now have a whole lot of DEA agents with nothing to do. They also are putting off having to explain away a whole lot of false propaganda and questionable raids. They're trying to save face

And as for Big Pharma not being able to make money off pot -- hogwash! They could rake in billions. Most people won't grow their own -- much like most people don't brew their own beer or grow their own food. It's easier to buy commerical grade anything. And there is a whole untapped market of people who don't like the idea of smoking -- where a prescription inhaler, nasal spray or under the tongue application will be available for a price from our friends the drug makers.

It just takes time to reverse 80 years of lies. It just takes time.

No taxes on Marijuana

And people want to tax marijuana so the government pursuing these stupid policies can have MORE money to do more idiotic things?

no more taxes

You have a very valid point. They are trillions in debt. So, why should we let them have more tax money, if they can't use what they get, already, wisely?! I read today that each man, woman, and child is $129,000 in debt to pay of the government debt! Sorry guys. I don't make any money anymore! Can't help you out. Why not use all that money they are wasting, or giving away, and use it to pay off the deficit?

Medical Marijuana

1. if marijuana does not have any medical benefits; then why does the gov. lease a marijuana plantation from the U. of Mississippi to do research on medical marijuana?

2. if marijuana is not a medicine; then why is Marinol; synthetic marijuana approved for various symptons anorexia

3. if not a medciine then why MMJ Glaucoma eye drops ok ?

You must understand

You must understand that the DEA is mostly made up of folks that are extremely close minded and afraid of change. Besides that, who'd be out of work if marijuana got legalized?.. Go figure!!

DEA more restrictive on marijuana research than other illegal

drugs. Why would they allow private labs to supply other illegal drugs but not weed? Presumably because they have so much more to fear from the study of marijuana and from public opinion that is overwhelmingly in support of MMJ. What cruel jokers these bad boys are.

Dump the “Cowboys”

When Jimmy Carter assumed the presidency in 1976, one of the first things he did was to rid the CIA of all the “cowboys” in the agency.  For instance, he fired the sociopathic half-wits who created havoc and destruction in places such as Guatemala.  Carter’s response to the CIA problem was the end game of a Senate investigation of the agency which was originally chaired by Senator Frank Church.

Another Senate investigation, this time focusing on the ONDCP, DEA and NIDA; would be helpful in once more identifying, isolating and removing the drug warrior “cowboys” who disrupt and sabotage legitimate legal motions and court directives.  Adding to the urgency of the measure is the threat such people pose to public health when they act to block scientific research useful not only for determining the benefits of cannabis, but also that which is useful for gathering the data needed to more fully understand general human physiology and biochemistry.

The ONDCP, DEA, and NIDA represent true threats to private individuals and to world society in the same way that opponents of stem cell research threaten our health by causing the withholding of needed research and development of new medical techniques.  Our lives are at stake here, and three of the agencies responsible for the threat to our well-being cannot even justify their existence to nearly half the U.S. population, more than that if the issue of medical marijuana is included.  If the ONDCP, DEA and NIDA cannot be abolished, then at least they can be legally and politically hamstrung so they do less harm.

Giordano

Dump all three agencies, and more . . .

like the FDA the USDA, the IRS, to name only a few. None of these agencies is truly helpful, and actually do real harm to individuals and to our Constitution. They MUST be abolished, or we are doomed as a nation of free individuals. We are already living is the early stages of a police state, if we don't stop it now, we may not be capable of stopping it later.

Dear Senator

Dear Sen. Dianne Feinstein,

I read the "Mexican marijuana cartels sully US forests, parks" report recently. I saw that our parks are being damaged by illegal Mexican marijuana-growing cartels. You are looking into the environmental damages of this.
“"People light up a joint, and they have no idea the amount of environmental damage associated with it," said Cicely Muldoon, deputy regional director of the Pacific West Region of the National Park Service.”
Now this high profile smuggling incident involving a Mexican official has occurred in Lukeville, Arizona.
These are important issues to be dealt with, but the current way the government deals with this problem only prolongs the problem. Legalizing marijuana would solve many current problems and actually create some benefits for the public good.

It seems clear to me that the "War on Drugs" as it relates to marijuana is a fool’s errand. Marijuana never should have been included on the list of dangerous drugs. Marijuana isn’t at all dangerous. Cotton growers and synthetic cloth manufactures, such as Dupont, were partly to blame for this inclusion to eliminate hemp fiber competition.

By not legalizing:
-If profit is to be made a black market will always exist.
-Keeping marijuana illegal causes huge amounts of money to flow out of the country and into the hands of people that work against our national interests.
-our parks are being damaged and damages to the environment
-As long as marijuana is illegal it justifies a larger than needed expenditure devoted to enforcement, prosecution, and incarceration.
-People’s unwise use of legal alcohol causes deaths and injury….and much purely stupid sloppy behavior.

Legalizing marijuana would:
-Cause the black market in marijuana to be gone… …gone!; along with the violence related to it. You can’t beat that.
-All of the money going south would stop, and remain to be spent here legally in our own economy.
-Law enforcement, judicial and incarceration expenditures of public funds for this would no longer be needed.
-The growing on and damaging of public lands would end, as people would rather grow it at home, ending the illegal cartels involvement.
-People with medical needs would be able to seek some small comfort there
- (In My Opinion) A decrease drunk driving statistics would occur, people would soon realize that they enjoy marijuana more than the oncoming sickness of drinking, thus the non alcoholic would drink much less, and be much safer to the public concern overall.

Another very important factor: Legalizing marijuana would allow for the acceptance of a large group of productive and responsible American citizens who only differ from everyone else in one intelligent way: they intuitively prefer thought stimulating marijuana to the dangerous sloppiness and oncoming sickness of drinking.
Liquor lobbyists would fight against legalization for their self preservation reasons. Let me stress that marijuana is safer and more enjoyable and liquor companies know this, but do not want the public to adapt and adopt a safer smarter way.

The government’s issue is: Who will grow it and sell it? How do we manage it? How do we tax it? Those are selfish interests, and as usual the government should leave it alone and stop looking at things in that manner. The government needs to stop playing God. In most cases government regulation creates more problems than it solves.

I propose that American citizens be allowed to "grow their own". If every citizen of age that desired could grow say 12 mature plants for personal use, then all illegal black markets would dry up. The surplus would cause marijuana to not have much monetary value. You could give it away, but not sell it.

One very big economic plus for my proposal is that good citizens who enjoy marijuana are a smart proud group of sociable people and will invest money into growing supplies. I bet that your average proud grower will invest a few hundred dollars, or more, in the domestic economy to be able to properly grow, and show off, their little crop. This expenditure times 20 million people and you have a major boost in our economy, instead of the current hemorrhage of funds going to illegal drug lords, and all of the ugliness that comes with that.

In conclusion: the current way the government deals with marijuana only prolongs the problem. If profit is to be made a black market will always exist.
Give marijuana back to the people and freedom and liberty itself will turn what was an ugly problem into a favorable outcome.

Cannabis and Glaucoma: The DEA lets our citizens go blind!

When I studied to take my Ophthalmology Boards for certification by The American Board of Ophthalmology in 1981, there was a “Board Question” regarding Marijuana. It specifically regarded its effects on our eyes. The question was “What are the ocular effects of Marijuana?” The answer is: lowering intra-ocular pressure, redness and dryness.

It has long been known that cannabis lowers eye pressure, yet this fact is neglected thanks to our government. Many people with Glaucoma, a disease in which elevated eye pressure damages the delicate nerve fibers inside our eyes leading to blindness, are losing their vision who may not have to if they had safe access to cannabis. Instead, Many people are taking dangerous prescription drugs with disastrous side effects who could possibly benefit from a medication with the highest safety profile of them all; cannabis.

I used to always ask the representatives from the pharmaceutical companies why they don’t research marijuana to treat Glaucoma so we can offer it to our patients? The answer was always the same. “The Federal Government will not allow that. We would like to. We know it has benefits. We can’t.”

About 50% of patients with Glaucoma will suffer irreversible vision loss despite all current medical and surgical therapies. Most glaucoma drops and pills have severe, and even life threatening, side effects. They can be toxic and are poorly effective in the long run.

It is a disgrace that our government and the DEA will not allow valid research and access to such a relatively harmless and safe medicine as cannabis. I think vision is precious and dedicated my life to preserving and restoring it. I wish our elected officials and the DEA shared my perspective.

Norman Lepoff, M.D. retired

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