“We should not deny the thousands of Americans who rely on the benefits that marijuana provides,” Cohen wrote. “There is no evidence that marijuana has the same addictive qualities or damaging consequences as cocaine, heroin or methamphetamine and should not be treated as such.”

On Monday, October 3, Drug Czar Kerlikowske responded to Rep. Cohen. In his reply, summarized here, Kerlikowske alleged that the Congressman’s concerns regarding the federal scheduling of cannabis are unwarranted because, “We ardently support research into determining what components of the marijuana plant can be used as medicine.”

Kerlikowske added, “In fact, the federal government is the largest source of funding for research into the potential therapeutic benefits of marijuana, and every valid request for the use of marijuana for research has been approved by the Drug Enforcement Administration.”

Really? So how does the Drug Czar explain this headline — from Saturday’s edition of The Washington Post?

Marijuana study of traumatized veterans stuck in regulatory limbo

Getting pot on the street is easy. Just ask the 17 million Americans who smoked the federally illegal drug in 2010.

Obtaining weed from the government? That’s a lot harder.

In April, the Food and Drug Administration approved a first-of-its kind study to test whether marijuana can ease the nightmares, insomnia, anxiety and flashbacks common in combat veterans with post-traumatic stress disorder.

But now another branch of the federal government has stymied the study. The Health and Human Services Department is refusing to sell government-grown marijuana to the nonprofit group proposing the research, the Multidisciplinary Association for Psychedelic Studies.

That’s right, the Drug Czar is claiming that the federal government ‘ardently supports’ medical marijuana research just days after the US government formally denied a request for an FDA-approved clinical trial to assess cannabis’ therapeutic safety and efficacy.

Wait, it gets worse. The ugly truth is that the U.S. National Institute on Drug Abuse (NIDA), the agency that oversees 85 percent of the world’s research on controlled substances, is on record stating that its institutional policy is to reject any and all medical marijuana research. “As the National Institute on Drug Abuse, our focus is primarily on the negative consequences of marijuana use,” a NIDA spokesperson told The New York Times in 2010. “We generally do not fund research focused on the potential beneficial medical effects of marijuana.”

For once a government agency was telling the truth regarding cannabis. NIDA categorically does not support such research — despite the Obama administration in 2010 publicly issuing its “Scientific Integrity” memorandum stating, “Science and the scientific process must inform and guide decisions of my Administration.”

That is why an online search of ongoing FDA-approved clinical trials using the keyword “cannabinoids” yields only six studies (two of which have already been completed) worldwide involving subjects’ use of actual cannabis despite hundreds of favorable preclinical and observational studies clearly demonstrating its benefit.

Just how blatant is Kerlikowske’s latest lie? Consider this. According to the White House’s 2011 National Drug Control Strategy, released in July, only fourteen researchers in the United States are legally permitted to conduct research assessing the effect of inhaled cannabis in human subjects. That’s right, only fourteen! And even among this absurdly limited group of investigators, most are involved in research to assess the drug’s “abuse potential, physical/psychological effects, [and] adverse effects.” So says the White House.

Ardent support for medical marijuana research? Please Gil, don’t make us laugh.

The United States Drug Enforcement Administration (DEA) has issued its final order rejecting a ruling from the agency’s own Administrative Law Judge finding that it would be ‘in the public interest’ to grant the University of Massachusetts a license to grow marijuana for federally regulated research.

The rejection preserves the monopoly held by National Institute on Drug Abuse (NIDA) on the supply of marijuana for Food and Drug Administration (FDA)-regulated research. In 2010, a spokesperson for the agency told the New York Times, “We generally do not fund research focused on the potential beneficial medical effects of marijuana.”

In 2007, after extensive hearings, DEA Judge Mary Ellen Bittner opined in favor of allowing a researcher at the University of Massachusetts at Amherst legal permission to cultivate marijuana for use in FDA-approved clinical trials.

She determined: “I conclude that granting Respondent’s application would not be inconsistent with the Single Convention, that there would be minimal risk of diversion of marijuana resulting from Respondent’s registration, 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 Respondent has complied with applicable laws and has never been convicted of any violation of any law pertaining to controlled substances. I therefore find that Respondent’s registration to cultivate marijuana would be in the public interest.”

DEA director Michele Leonhart initially set aside Judge Bittner’s ruling in 2009.

The agency’s ruling may be appealed in the First Circuit US Court of Appeals.

In July, the DEA denied a nine-year-old petition seeking to initiate hearings regarding the federal classification of cannabis as a schedule I controlled substance, stating in part, “[T]here are no adequate and well-controlled studies proving efficacy.”

As usual, the White House’s official justification for the ongoing multigenerational drug war was light on facts and heavy on rhetoric, particularly as it pertained to the federal government’s fixation with criminalizing cannabis. Here are just a few examples (all of which are excerpted from a section of the report, entitled ironically enough, ‘The Facts About Marijuana‘) of your government on pot.

“[C]onfusing messages being conveyed by the entertainment industry, media, proponents of ‘medical’ marijuana, and political campaigns to legalize all marijuana use perpetuate the false notion that marijuana use is harmless and aim to establish commercial access to the drug. This significantly diminishes efforts to keep our young people drug free and hampers the struggle of those recovering from addiction.”

“Marijuana and other illicit drugs are addictive and unsafe. … The science, though still evolving in terms of long-term consequences, is clear: marijuana use is harmful. Independent from the so called ‘gateway effect’ — marijuana on its own is associated with addiction, respiratory and mental illness, poor motor performance, and cognitive impairment, among other negative effects.”

“The Administration steadfastly opposes drug legalization. Legalization runs counter to a public health approach to drug control because it would increase the availability of drugs, reduce their price, undermine prevention activities, hinder recovery support efforts, and pose a significant health and safety risk to all Americans, especially our youth.”

You get the idea.

Of course, none of these allegations represent anything new for this (or previous) administrations, and NORML has responded in detail to most of the Drug Czar’s claims previously. I did, however, take notice of this particular paragraph in the report, which appears under the title ‘Medical’ Marijuana.’

“In the United States, the Drug Enforcement Administration (DEA) has approved 109 researchers to perform bona fide research with marijuana, marijuana extracts, and marijuana derivatives such as cannabidiol and cannabinol. Studies include evaluation of abuse potential, physical/psychological effects, adverse effects, therapeutic potential, and detection. Fourteen researchers are approved to conduct research with smoked marijuana on human subjects.”

Only in an environment of absolute criminal prohibition can the administration imply, with a straight face, that allowing a grand total of 14 legally permitted scientists to study a substance consumed by tens of millions of Americans for therapeutic and/or recreational purposes is somehow to be construed as ‘progress.’ That total doesn’t even legally allow for one scientist per medical marijuana state to actively assess how cannabis is impacting that state’s patient population.

Moreover, this acknowledgment comes from the very same administration that on Friday flat out rejected the notion of even allowing hearings on the question of marijuana’s schedule I classification because, in their opinion, “there are no adequate and well-controlled studies proving efficacy.” Of course, with only a dozen or so scientists in the whole county even permitted to interact with pot and humans can there be any wonder why such studies aren’t more prevalent?

(By the way, remember the results last year of the series of FDA-approved ‘gold standard’ clinical trials assessing the safety and efficacy of inhaled cannabis in severely ill patients? Apparently neither does the DEA. Nor are they aware of these ‘well-controlled’ studies of medical cannabis. Or these.)

Interestingly, according to the DEA’s 2010 white paper on cannabis (no longer online), last year there were a total of 18 scientists licensed by the government to work with marijuana in a clinical setting. Perhaps next year there will only be ten. If the DEA and NIDA have there way perhaps by 2013 there will be zero.

As for the other 95 US scientists legally authorized by the federal government to assess the efficacy of ‘marijuana extracts and marijuana derivatives’ in animals, most of them were here last week — at the annual meeting of the International Cannabinoid Research Society. But even these ‘chosen few’ acknowledge that their work has next to no influence on the very administration that authorizes it.

Marijuana Researchers Meet At Pheasant Run
Researchers from around the world studying the effects of marijuana and exploring possible medical uses meet each year to compare notes and share their findings

About 250 scientists from around the world have gathered this weekend at Pheasant Run Resort sitting through seminars titled “Endocannabinoid Signaling in Periimplantation Biology,” and “Cannabinoids and HIV Pathogenicity,” to name a few, for the 21st Annual Symposium of the International Cannabinoid Research Society.

ICRS members meet once a year to compare notes on research studying how cannabinoids, compounds from the cannabis plant (more commonly known as marijuana) or from the brain called endocannabinoids, affect the body and how it functions.

While most attendees are scientists, many are graduate students or training scientists as well as physicians interested in learning how these chemicals might be useful in treating human disease.

“We are all around the world working on our own projects,” said Cecilia Hillard, ICRS executive director, professor of pharmacology and director of the Neuroscience Research Center at the Medical College of Wisconsin.

“That’s why it’s so wonderful for us to get together once a year so we can really share things that we learn,” she said.

For example, she said someone may be studying how bone is formed, and she is studying how the brain works.

“I learn a lot by learning how the bone is formed, and they learn about how neurons work,” Hillard said. “It’s really a lot of what we call a ‘cross-fertilization’ of ideas.”

While the society is not political, Hillard says the type of research that is done on the controversial topic of medical and personal use of marijuana is nonetheless important.

“We’re carrying out scientific investigations trying to understand what these molecules do,” Hillard said. “What we try to contribute to the debate is the reality.”

She said scientific investigation is done in a very neutral way, trying to understand what these molecules do.

“The mass appeal is, ‘is there a good use for this in the treatment of human disease?’” Hillard said. “Most of us really have a passion for looking at these molecules because there is a lot of potential for treatment of human disease.”

The findings of this research are published in scientific journals so that the information is available to anyone. She said sometimes “you have no idea the impact your work is having.” Hillard said part of the mission of the ICRS is to educate the public.

“I wish the politicians would (look at the data) but I don’t think they do,” she said.

Riggs asked the Czar some tough questions, including this one specific to medical cannabis: “You’ve said before that you don’t see medical benefits to smoked marijuana and also that the jury is still out on medical marijuana. What sort of scientific consensus does the ONDCP require? How many studies have to come out arguing for medical benefits? What do you need to see?”

The Czar’s reply? “[Y]ou know there are over 100 groups doing marijuana research, and they’re getting their marijuana from the University of Mississippi. There are several things in clinical trials right now. So we’ll just have to wait for those.”

To which I reply ‘Bulls–t!’

As I write today on Alternet.org, a review of the U.S. National Institutes of Health website clinicaltrials.gov shows that there are presently only six FDA-approved trials taking place anywhere in the world involving subjects’ use of actual cannabis. Of these, two are completed, one is assessing the plant’s pharmacokinetics, and one is assessing pot’s alleged harms.

Memo to the Drug Czar: That leaves a grand total of — not “over 100″ — but rather just two ongoing clinical trials to assess the medical efficacy of cannabis. You sir, are a liar (but then again, I suppose we all knew that already).

Pot May Be Instrumental in Combating Cancer, MS and Other Diseases But the Gov’t Refuses to Fund the Necessary Research

via Alternet

[excerpt] A review of the U.S. National Institutes of Health website clinicaltrials.gov shows that NIDA’s kibosh on medical marijuana trials continues unabated. Though a search of ongoing FDA-approved clinical trials using the keyword ‘cannabinoids’ (the active components in marijuana) yields 65 worldwide hits, only six involve subjects’ use of actual cannabis. (The others involve the use of synthetic cannabinoid agonists like dronabinol or nabilone, the commercially marketed marijuana extract Sativex, or the cannabinoid receptor blocking agent Rimonabant.)

Of the six, two of the studies are already completed: ‘Opioid and Cannabinoid Pharmacokinetic Interactions‘ and ‘Vaporization as a Smokeless Cannabis Delivery System,’ both of which were spearheaded by researchers (primarily Dr. Donald Abrams) at the University of California at San Francisco.

The four remaining studies are still in the ‘recruitment’ phase. Of these, only two pertain to the potential medical use of cannabis: ‘Cannabis for Spasticity of Multiple Sclerosis,’ which is taking place at the University of California at Davis and is likely the final clinical trial associated with the soon-to-be-defunct/defunded California Center for Medicinal Cannabis Research, and ‘Cannabis for Inflammatory Bowel Disease,’ led by researchers at the Meir Medical Center in Israel.

Of the remaining studies, one focuses on the detection of cannabinoids and their metabolites on drug screens, while the other, entitled ‘Effects of Smoked Marijuana on Risk Taking and Decision Making Tasks,’ seeks to establish pot-related harms — hypothesizing that subjects “demonstrate poorer decision-making abilities and increased risk-taking behaviors” after smoking marijuana.

You can read the full text of my Alternet.org story here.

You can read the full interview with Drug Czar Kerlikowske here.

For example, last week the Obama administration called for the expansion of states to enact laws criminalizing motorists who drive with the residual presence of drug or inactive drug metabolites in their body. In the case of marijuana, these policies are especially egregious because its metabolites may remain present in urine for weeks or months after past use. Further, studies have consistently reported that the presence of marijuana metabolites is not associated with psychomotor impairment or an elevated risk of motor accident — a result that should be self-evident given that cannabis metabolites only form in urine after the drug’s primary psychoactive compound, THC, has been broken down and converted by the body over a period of several hours.

So how does the federal government justify its call for implementing such an inane and discriminatory policy? Simple. By claiming that supposed ‘marijuana and driving menace’ is so prevalent and severe that lawmakers have no other choice but to enact such inflexible and nonsensical policies to halt it.

Now I’ve written on the subject of cannabis use and psychomotor performance numerous times, including recently authoring the white paper Cannabis and Driving: A Scientific and Rational Review. In short the science says this: there appears to be a positive association between very recent cannabis exposure and a gradually increased risk of vehicle accident; however, this elevated risk is below the risk presented by drivers who have consumed even small (read ‘legal’) quantities of alcohol.

Does this conclusion support the blanket criminalization of marijuana or the enactment of the sort of zero-tolerant per se driving laws outlined above? No more so than such a conclusion advocates for a return to alcohol prohibition.

So what’s the administration to do? That’s easy — just fund more research. And what to do when that federally funded research fails to produce the results they were looking for? That’s even easier: just claim that they do anyway.

Such is the case with a just-published study in the Journal of Psychoactive Drugs assessing the psychomotor skills of subjects on a battery of off-road driving simulator tests both before and after smoking marijuana (and/or placebo).

During the course study, subjects were asked to respond to various simulated events associated with automobile crash risk — such as avoiding a driver who was entering an intersection illegally, deciding to stop or go through changing traffic lights, responding to the presence of emergency vehicles, avoiding colliding a dog who entered into traffic, and maintaining safe driving during a secondary (in-the-car) auditory distraction. Subjects performed these tests sober, and then shortly (30 minutes) after smoking a single marijuana cigarettes (or placebo).

So how did the subjects perform? Much to the apparent chagrin of the investigators, just fine.

“No sex differences or interactions of sex and marijuana were observed for any of the driving tasks. Participants receiving active marijuana decreased their speed more so than those receiving the placebo cigarette during a distracted section of the drive. An overall effect of marijuana was seen for the mean speed during the distracted driving (PASAT section). [N]o other changes in driving performance were found.”

In short, subjects had no greater likelihood of responding adversely to any of the simulated events after smoking marijuana than they had prior to consuming cannabis.

Of course, these are not the sort of results that NIDA — who provided funding for the study — or the Drug Czar’s office are looking for. Therefore, the authors are required find some outcome — any outcome — supporting the administration’s claim that driving under the influence of cannabis is a serious and significant threat. How do they do that in this case? Simple; by stating subjects lack of impairment was, in fact, implicit evidence of their impairment!

“Persons smoking the placebo cigarette showed an improvement in performance of the PASAT during the driving task, likely attributable to practice effects. Under the influence of marijuana, however, no differences were found between PASAT performance during practice testing and while driving. Participants who smoked active marijuana decreased their speed during this section of the drive, suggesting additional compensatory skills were used.”

In other words, the authors are claiming that because subjects on one specific test (the auditory distraction test) drove more slowly when completing the task after smoking marijuana than they did prior to consuming cannabis, but otherwise manifested no difference in the outcome of said test — or on any other test for that matter — that this is somehow strong evidence that marijuana has a significant and adverse impact on driving.

SUMMARY AND CONCLUSIONS

Under the influence of active marijuana, participants exhibited increased drowsiness, although this did not appear to affect their driving [emphasis mine]. Participants under the influence of marijuana failed to benefit from prior experience on a distracter task [what the authors want the reader to emphasize] as evidenced by a decrease in speed and a failure to show expected practice effects. This study supports the existing literature that marijuana does affect simulated driving performance [ditto], particularly on complex tasks such as divided attention. It is anticipated that many teenagers and young adults driving under the influence of marijuana are doing so while conversing with friends in the car, listening to music, talking on the cell phone and/or text messaging others. These behaviors divide the driver’s attention and are particularly dangerous under the influence of marijuana [what the authors really, really want the reader to emphasize].”

And that, my friends, is just the latest example of how marijuana prohibition corrupts, and how absolute marijuana prohibition corrupts absolutely.

But it took until now for the federal government to finally admit it.

A spokesperson for the U.S. National Institute on Drug Abuse (NIDA) told The New York Times last week that the agency does “not fund research focused on the potential medical benefits of marijuana.”

Why is this admission so significant? Here’s why.

Under federal law, NIDA (along with the U.S. Drug Enforcement Administration) must approve all clinical and preclinical research involving marijuana. NIDA strictly controls which investigators are allowed access to the federal government’s lone research supply of pot – which is authorized via a NIDA contract and cultivated and stored at the University of Mississippi.

In short, no NIDA approval = no marijuana = no scientific studies. And that is, and always has been, the problem.

But to the folks over at NIDA, there’s no problem at all.

Speaking to The New York Times in a January 19, 2010 article entitled, “Researchers Find Medical Study of Marijuana Discouraged,” NIDA spokeswoman Shirley Simson said: “As the National Institute on Drug Abuse, our focus is primarily on the negative consequences of marijuana use. We generally do not fund research focused on the potential beneficial medical effects of marijuana.”

Since NIDA presently oversees an estimated 85 percent of the world’s research on controlled substances, the agency’s ban on medical marijuana research isn’t just limited to the United States’ borders; it extends throughout the planet.

Previous legal attempts to break NIDA’s bureaucratic logjam have failed to weaken the agency’s iron grip.

In 2007, U.S. DEA Administrative Law Judge Mary Ellen Bittner ruled that NIDA’s monopolization of marijuana research is not “in the public interest,” and ordered the federal government to allow private manufacturers to produce the drug for research purposes. But in January of last year, DEA Deputy Administrator Michele Leonhart set aside Judge Bittner’s ruling – stating that NIDA possesses “adequate” quantities of cannabis to meet the needs of clinical investigators, and that the agency monopoly on the distribution of marijuana for research is compliant with America’s international treaty obligations. (Notably, on January 26, 2010 President Barack Obama selected Leonhart to be the DEA’s full time Director.)

Most recently, in November 2009 the American Medical Association’s (AMA) Council on Science and Public Health declared, “Results of short term controlled trials indicate that smoked cannabis reduces neuropathic pain, improves appetite and caloric intake especially in patients with reduced muscle mass, and may relieve spasticity and pain in patients with multiple sclerosis.”

However, the Council lamented that despite these encouraging preliminary results, “[T]here is a contrast between the relatively small number of patients who have been studied over the past 30 years in controlled clinical trials involving smoked cannabis and survey data from patients with chronic pain, multiple sclerosis, and amyotrophic lateral sclerosis that indicates a significant use of cannabis for self management.”

And just what is the precise reason for this “contrast?” The AMA failed to specify, but to anyone who has followed this issue, the answer is painfully obvious.

Nevertheless, the AMA still resolved, “[The] AMA urges that marijuana’s status as a federal Schedule I controlled substance be reviewed with the goal of facilitating the conduct of clinical research and development of cannabinoid-based medicines.”

But since any future clinical trials would still require NIDA approval — approval that the agency admits won’t be coming any time soon — it remains unclear what effect, if any, the AMA’s declaration will have on facilitating medical marijuana research. If history is any guide, it’s unlikely that the AMA request — much like the cries of tens of thousands of patients before it — will have any effect on NIDA at all.

[FYI... You can also comment on this essay on Alternet.org's newly launched SpeakEasy blog here or on the Huffington Post here.]

RESEARCHERS FIND STUDY OF MEDICAL MARIJUANA DISCOURAGED
by Gardiner Harris
January 19, 2010
——-
Despite the Obama administration’s tacit support of more liberal state medical marijuana laws, the federal government still discourages research into the medicinal uses of smoked marijuana.  That may be one reason that — even though some patients swear by it – — there is no good scientific evidence that legalizing marijuana’s use provides any benefits over current therapies.

Lyle E.  Craker, a professor of plant sciences at the University of Massachusetts, has been trying to get permission from federal authorities for nearly nine years to grow a supply of the plant that he could study and provide to researchers for clinical trials.

But the Drug Enforcement Administration — more concerned about abuse than potential benefits — has refused, even after the agency’s own administrative law judge ruled in 2007 that Dr.  Craker’s application should be approved, and even after Attorney General Eric H.  Holder Jr.  in March ended the Bush administration’s policy of raiding dispensers of medical marijuana that comply with state laws.

“All I want to be able to do is grow it so that it can be tested,” Dr.  Craker said in comments echoed by other researchers.

Marijuana is the only major drug for which the federal government controls the only legal research supply and for which the government requires a special scientific review.

“The more it becomes clear to people that the federal government is blocking these studies, the more people are willing to defect by using politics instead of science to legalize medicinal uses at the state level,” said Rick Doblin, executive director of a nonprofit group dedicated to researching psychedelics for medical uses.

On Monday, his last full day in office, Gov.  Jon S.  Corzine of New Jersey signed a measure passed by the Legislature last week that made the state the 14th in the nation to legalize the use of marijuana to help with chronic illnesses.

The measure was pushed by a loose coalition of patients suffering from chronic illnesses like Lou Gehrig’s disease and multiple sclerosis who said marijuana eased their symptoms.

Studies have shown convincingly that marijuana can relieve nausea and improve appetite among cancer patients undergoing chemotherapy.  Studies also prove that marijuana can alleviate the aching and numbness that patients with H.I.V.  and AIDS suffer.

There are strong hints that marijuana may ameliorate some of the neurological problems associated with such degenerative diseases as multiple sclerosis, said Dr.  Igor Grant, director of the Center for Medicinal Cannabis Research at the University of California, San Diego.

But there is no good evidence that legalizing the smoking of marijuana is needed to provide these effects.  The Food and Drug Administration in 1985 approved Marinol, a prescription pill of marijuana’s active ingredient, T.H.C.  Although a few small-scale studies done decades ago suggest that smoked marijuana may prove effective when Marinol does not, no conclusive research has confirmed this finding.

And Marinol is no panacea.  There are at least three medicines that in most patients provide better relief from nausea and vomiting than Marinol, studies show.

Buddy Coolen, 31, of Warwick, R.I., said he tried or continued to use some of those medicines.  “Smoking for me is as good as any medicine I have,” he said.

Eight years ago, Mr.  Coolen contracted gastroparesis and cyclic vomiting syndrome.  He lost 50 pounds and, despite being 5 foot 11, weighed 120 pounds.

His doctors gave him myriad anti-emetics, many of which he still takes.  They also prescribed Marinol, but it did not work for him, Mr.  Coolen said.

“My stepdad is old school and was really against marijuana, but then he saw what it did for me and totally changed his way of thinking,” Mr.  Coolen said.

Some doctors and law enforcement officials say such anecdotes should not drive public policy.  Dr.  Eric Braverman, medical director of a multispecialty clinic in Manhattan, said legalizing marijuana was unnecessary and dangerous since Marinol provided the medicinal effects of the plant.  “Our society will deteriorate,” he said.

Patients who call Dr.  Braverman’s clinic are, when put on hold, told that the clinic may prescribe supplements and other alternative treatments that have even less scientific justification than marijuana.  Dr.  Braverman said such alternatives rendered marijuana unnecessary, but his embrace of alternatives is a reminder that medicine has long been driven by more than science.

About 20 percent of drug prescriptions are written for uses that are not approved by federal drug regulators; about half of the nation’s adults regularly take supplements; herbal and homeopathic remedies are popular.

The nation’s growing embrace of medical marijuana has stemmed from these alternative traditions.

The University of Mississippi has the nation’s only federally approved marijuana plantation.  If they wish to investigate marijuana, researchers must apply to the National Institute on Drug Abuse to use the Mississippi marijuana and must get approvals from a special Public Health Service panel, the Drug Enforcement Administration and the Food and Drug Administration.

But federal officials have repeatedly failed to act on marijuana research requests in a timely manner or have denied them, according to a 2007 ruling by an administrative law judge at the Drug Enforcement Administration.  While refusing to approve a second marijuana producer, the government allowed the University of Mississippi to supply Mallinckrodt, a drug maker, with enough marijuana to eventually produce a generic version of Marinol.

“As the National Institute on Drug Abuse, our focus is primarily on the negative consequences of marijuana use,” said Shirley Simson, a spokeswoman for the drug abuse institute, known as NIDA.  “We generally do not fund research focused on the potential beneficial medical effects of marijuana.”

The Drug Enforcement Administration said it was just following NIDA’s lead.  “D.E.A.  has never denied a research registration for marijuana and/or THC if NIDA approved the protocols for that individual entity,” a supervisory special agent, Gary Boggs, said by e-mail.

Researchers investigating LSD, Ecstasy and other illegal drugs can use any of a number of suppliers licensed by the Drug Enforcement Administration, Dr.  Doblin said.  And if a researcher wants to use a variety of marijuana that the University of Mississippi does not grow – — and there are many with differing medicinal properties — they are out of luck, Dr.  Doblin said.

Law enforcement tends to emphasize the abuse potential of medicines without regard to their positive effects.  Bureaucratic battles between the D.E.A.  and the F.D.A.  over the availability of narcotics – — highly effective but addictive medicines — have gone on for decades.

So medical marijuana may never have good science underlying its use.  But for patients in desperate need, the ethics of providing access to the drug are clear, said Dr.  Richard Payne, a professor of medicine and divinity and director of the Institute for Care on the End of Life at Duke Divinity School.

“It’s not a great drug,” he said, “but what’s the harm?”

* * * * * * * * * * *

IS MARIJUANA A MEDICINE?
by Anna Wilde Mathews, (Source:Wall Street Journal)
19 Jan 2010
Share This Article

United States
——-
Charlene DeGidio never smoked marijuana in the 1960s, or afterward.  But a year ago, after medications failed to relieve the pain in her legs and feet, a doctor suggested that the Adna, Wash., retiree try the drug.

Ms.  DeGidio, 69 years old, bought candy with marijuana mixed in.  It worked in easing her neuropathic pain, for which doctors haven’t been able to pinpoint a cause, she says.  Now, Ms.  DeGidio, who had previously tried without success other drugs including Neurontin and lidocaine patches, nibbles marijuana-laced peppermint bars before sleep, and keeps a bag in her refrigerator that she’s warned her grandchildren to avoid.

“It’s not like you’re out smoking pot for enjoyment or to get high,” says the former social worker, who won’t take the drug during the day because she doesn’t want to feel disoriented.  “It’s a medicine.”

For many patients like Ms.  DeGidio, it’s getting easier to access marijuana for medical use.  The U.S.  Department of Justice has said it will not generally prosecute ill people under doctors’ care whose use of the drug complies with state rules.  New Jersey will become the 14th state to allow therapeutic use of marijuana, and the number is likely to grow.  Illinois and New York, among others, are considering new laws.

As the legal landscape for patients clears somewhat, the medical one remains confusing, largely because of limited scientific studies.  A recent American Medical Association review found fewer than 20 randomized, controlled clinical trials of smoked marijuana for all possible uses.  These involved around 300 people in all–well short of the evidence typically required for a pharmaceutical to be marketed in the U.S.

Doctors say the studies that have been done suggest marijuana can benefit patients in the areas of managing neuropathic pain, which is caused by certain types of nerve injury, and in bolstering appetite and treating nausea, for instance in cancer patients undergoing chemotherapy.  “The evidence is mounting” for those uses, says Igor Grant, director of the Center for Medicinal Cannabis Research at the University of California, San Diego.

But in a range of other conditions for which marijuana has been considered, such as epilepsy and immune diseases like lupus, there’s scant and inconclusive research to show the drug’s effectiveness.  Marijuana also has been tied to side effects including a racing heart and short-term memory loss and, in at least a few cases, anxiety and psychotic experiences such as hallucinations.  The Food and Drug Administration doesn’t regulate marijuana, so the quality and potency of the product available in medical-marijuana dispensaries can vary.

Though states have been legalizing medical use of marijuana since 1996, when California passed a ballot initiative, the idea remains controversial.  Opponents say such laws can open a door to wider cultivation and use of the drug by people without serious medical conditions.  That concern is heightened, they say, when broadly written statutes, such as California’s, allow wide leeway for doctors to decide when to write marijuana recommendations.

But advocates of medical-marijuana laws say certain seriously ill patients can benefit from the drug and should be able to access it with a doctor’s permission.  They argue that some patients may get better results from marijuana than from available prescription drugs.

Glenn Osaki, 51, a technology consultant from Pleasanton, Calif., says he smokes marijuana to counter nausea and pain.  Diagnosed in 2005 with advanced colon cancer, he has had his entire colon removed, creating digestive problems, and suffers neuropathic pain in his hands and feet from a chemotherapy drug.  He says smoking marijuana was more effective and faster than prescription drugs he tried, including one that is a synthetic version of marijuana’s most active ingredient, known as THC.

The relatively limited research supporting medical marijuana poses practical challenges for doctors and patients who want to consider it as a therapeutic option.  It’s often unclear when, or whether, it might work better than traditional drugs for particular people.  Unlike prescription drugs it comes with no established dosing regimen.

“I don’t know what to recommend to patients about what to use, how much to use, where to get it,” says Scott Fishman, chief of pain medicine at the University of California, Davis medical school, who says he rarely writes marijuana recommendations, typically only at a patient’s request.

Researchers say it’s difficult to get funding and federal approval for marijuana research.  In November, the AMA urged the federal government to review marijuana’s position in the most-restricted category of drugs, so it could be studied more easily.

Gregory T.  Carter, a University of Washington professor of rehabilitation medicine, says he’s developed his own procedures for recommending marijuana, which he does for some patients with serious neuromuscular conditions such as amyotrophic lateral sclerosis, or Lou Gehrig’s disease, to treat pain and other symptoms.  He typically urges those who haven’t tried it before to start with a few puffs using a vaporizer, which heats the marijuana to release its active chemicals, then wait 10 minutes.  He warns them to have family nearby and to avoid driving, and he checks back with them after a few days.  Many are “surprised at how mild” the drug’s psychotropic effects are, he says.

States’ rules on growing and dispensing medical marijuana vary.  Some states license specialized dispensaries.  These can range from small storefronts to bigger operations that feel more like pharmacies.  Typically, they have security procedures to limit walk-in visitors.

At least a few dispensaries say they inspect their suppliers and use labs to check the potency of their product, though states don’t generally require such measures.  “It’s difficult to understand how we can call it medicine if we don’t know what’s in it,” says Stephen DeAngelo, executive director of the Harborside Health Center, a medical-marijuana dispensary in Oakland, Calif.

Some of the strongest research results support the idea of using marijuana to relieve neuropathic pain.  For example, a trial of 50 AIDS patients published in the journal Neurology in 2007 found that 52% of those who smoked marijuana reported a 30% or greater reduction in pain.  Just 24% of those who got placebo cigarettes reported the same lessening of pain.

Marijuana has also been shown to affect nausea and appetite.  The AMA review said three controlled studies with 43 total participants showed a “modest” anti-nausea effect of smoked marijuana in cancer patients undergoing chemotherapy.  Studies of HIV-positive patients have suggested that smoked marijuana can improve appetite and trigger weight gain.

Donald Abrams, a doctor and professor at the University of California, San Francisco who has studied marijuana, says he recommends it to some cancer patients, including those who haven’t found standard anti-nausea drugs effective and some with loss of appetite.

Side effects can be a problem for some people.  Thea Sagen, 62, an advanced neuroendocrine cancer patient in Seaside, Calif., says she expected something like a pharmacy when she went to a marijuana dispensary mentioned by her oncologist.  She says she was disappointed to find that the staffers couldn’t say which of the products, with names like Pot ‘o Gold and Blockbuster, might boost her flagging appetite or soothe her anxiety.  “They said, ‘it’s trial and error,’ “she says.  “I was in there flying blind, looking at all this stuff.”

Ms.  Sagen says she bought several items and tried one-eighth teaspoon of marijuana-infused honey.  After a few hours, she was hallucinating , too dizzy and confused to dress herself for a doctor’s appointment.  Then came vomiting far worse than her stomach upset before she took the drug.  When she reported the side effects to her oncologist’s nurse and her primary-care physician, she got no guidance.  She doesn’t take the drug now.  But with advice from a nutritionist, her appetite and food intake have improved, she says.

Other marijuana users may experience the well-known reduction in ability to concentrate.  At least a few users suffer troubling short-term psychiatric side effects, which can include anxiety and panic.  More controversially, an analysis published in the journal Lancet in 2007 tied marijuana use to a higher rate of psychotic conditions such as schizophrenia.  But the analysis noted that such a link doesn’t necessarily show marijuana is a cause of the conditions.

Long-term marijuana use can lead to physical dependence, though it is not as addictive as nicotine or alcohol, says Margaret Haney, a professor at Columbia University’s medical school.  Smoked marijuana may also risk lung irritation, but a large 2006 study, published in Cancer Epidemiology, Biomarkers & Prevention, found no tie to lung cancer.

“Cannabis-related disorders (CRDs), including cannabis abuse or dependence and cannabis induced disorders … are a major public health issue. … Nearly one million people are seeking treatment for marijuana dependence every year and sufficient research has been carried out to confirm that the use of cannabis can produce serious physical and psychological consequences.

“Currently, there are no medications approved by the Food and Drug Administration for the treatment of CRDs. Given the extent of the use of cannabis in the general population, and the medical and psychological consequences of its use … there is a great public health need to develop safe and effective therapeutic interventions. The need to develop treatments targeting adolescents and young adults is particularly relevant in view of their disproportionate use patterns.”

In other words, the federal government is spending millions upon millions of your dollars to solicit research to find a supposed ‘cure’ for alleged ‘marijuana addiction‘ — at the same time that it is spending virtually no money on clinical trials to assess the medical value of cannabis itself.

I try my best to cut through the BS (“One million people are seeking treatment?!” Um, more like 287,933 — and six out of ten of them were referred by the criminal justice system following an arrest.) in my latest Alternet essay, “The Feds Are Addicted to Pot — Even If You Aren’t,” which you can read and comment on here.

Here’s an excerpt:

The Feds Are Addicted to Pot — Even If You Aren’t
via Alternet

Marijuana’s addiction potential may be no big deal, but it’s certainly big business.

According to a widely publicized 1999 Institute of Medicine report, fewer than 10 percent of those who try cannabis ever meet the clinical criteria for a diagnosis of “drug dependence” (based on DSM-III-R criteria). By contrast, 32 percent of tobacco users and 15 percent of alcohol users meet the criteria for “drug dependence.”

Nevertheless, it is pot — not booze or cigarettes — that has the federal government seeing red and clinical investigators seeing green.

Read the entire article here.

The United States federal government has supplied Rosenfeld and three other US citizens for decades with a smokable cannabis medicine. Irv Rosenfeld has received his medicine for 27 years and is the longest known cannabis patient.

One of four patients intensely tested  in 2001 by Patients Out of Time as part of the “Missoula Study” Irv was found to be in excellent health for a man of his age. All physiological systems were examined by neutral investigators since the US federal government had never required or requested such a complete overview to discover the efficacy of the plant product they were medically administering under the “Compassionate New Drug Program”of the FDA.

Irv will consume his number one hundred and fifteen thousand  “joint” or marijuana cigarette sometime on November 20, 2009. All 115,000 cigarettes have been prescribed by US federally approved medical doctors from cannabis plants grown at the University of Mississippi in a test location and prepared for consumption in the research triangle area of North Carolina.

Speaking as a cannabis patient and Director of the cannabis patient advocacy organization Patients Out of Time Irv stated, “I cannot fathom the reluctance of my federal government to allow the use of medical cannabis for the sick and dying of the US. My experience of use, the calming of my negative symptoms, that has allowed me to be a useful, contributing member of society must be extended to all the ill based on the judgment of medical professionals and not guided or restrained by the dictates of law enforcement who have no empathy for the ill nor the education to appropriately enter into doctor-patient relationships and treatment options.”

115,000 and counting. When do the sick not named Rosenfeld, receive their cannabis medicine?

As president, Obama can also support scientific, clinical research into the medical properties of cannabis by encouraging the DEA to abide by the February 2007 ruling of the agency’s own administrative law judge, which found that it would be “in the public interest” to allow private entities to grow medical-grade cannabis for FDA-approved trials.

Thanks to a parting shot by outgoing DEA Deputy Administrator Michele Leonhart, the new administration may never get that opportunity.

On Wednesday, January 7th, Ms. Leonhart published a 118-page decision setting aside DEA Administrative Law Judge Mary Ellen Bittner’s 2007 ruling. The DEA’s decision constitutes a formal rejection of University of Massachusetts at Amherst Professor Lyle Craker’s petition, filed initially June 24, 2001, to cultivate research-grade marijuana for use by scientists in FDA-approved studies aimed at developing the drug as a legal, prescription medication.

To those not wholly familiar with this case and Judge Bittner’s ruling, here’s how I initially reported on it:

[Judge Bittner's] ruling affirms that the DEA in 2004 improperly rejected an application from the University of Massachusetts (UMass) at Amherst to manufacture cannabis for FDA-approved research.

Bittner opined: “I conclude that granting Respondent’s application would not be inconsistent with the Single Convention, that there would be minimal risk of diversion of marijuana resulting from Respondent’s registration, 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 Respondent has complied with applicable laws and has never been convicted of any violation of any law pertaining to controlled substances. I therefore find that Respondent’s registration to cultivate marijuana would be in the public interest.” (emphasis mine)

… Because Judge Bittner’s 2007 ruling is non-binding, the DEA has no deadline to act on it.

Under current policy, all federally approved research on marijuana must utilize cannabis supplied by and grown under contract with the US National Institute on Drug Abuse (NIDA). By contrast, other controlled substances – including LSD, heroin, and MDMA (Ecstasy) – are available to researchers from multiple private manufacturers.

In 2004, the agency’s director, Nora Volkow, stated that it is “not NIDA’s mission to study the medical uses of marijuana.”

In her rejection of Judge Bittner’s ruling, Deputy Administrator Leonhart makes it clear once again that politics — not science — continue to govern America’s policies toward the research and use of medicinal cannabis.

For further information on this breaking story, please tune in to this evening’s edition of the NORML Daily Audio Stash.