Archive for the ‘FDA/HHS’ Category

LA Times Editorial Nails Federal Monopoly on Research Marijuana and Urges Change

Friday, September 4th, 2009
Posted by Kris Hermes

Kudos to the Los Angeles Times for publishing an editorial today on medical marijuana that gets at the heart of the federal obstruction of meaningful research into one of the most promising therapeutic substances.

Despite a press release recently issued by Americans for Safe Access on the federal solicitation of proposals for the production and distribution of medical marijuana, and a report published in April highlighting the government’s monopoly on marijuana research, mainstream media coverage has been scant. (more…)

Drug Czar’s Clarification on Medical Marijuana is Still Problematic

Friday, August 7th, 2009
Posted by Kris Hermes

Last month, Drug Czar Gil Kerlikowske came under fire for his statement, reported in the Fresno Bee, that marijuana “has no medicinal value.” Giving him the chance to clear up any confusion on the matter, KOMO TV aired a follow-up interview today with Kerlikowske. The Drug Czar had this to say:

Sometimes you make a mistake and you work very hard to correct it. That happens. I should’ve clearly said ’smoked’ marijuana and then gone on to say that this is clearly a question that should be answered by the medical community.

Kerlikowske also said:

[T]he FDA has not determined that smoked marijuana has a (medical) value…

Although it’s nice to see a correction to his previous statement, and leaving it to the medical community is favorable to harmful and unnecessary law enforcement actions, the Drug Czar’s position is still problematic. (more…)

Feds Solicit Medical Marijuana Cultivators

Thursday, August 6th, 2009
Posted by Kris Hermes

A Request for Proposals issued yesterday by the Department of Health and Human Services (HHS) for the “Production, Analysis, & Distribution of Cannabis & Marijuana Cigarettes” begged the question of whether the federal government was getting into the business of cultivating and distributing medical cannabis. The answer is both “yes” and “no.”

The National Institute on Drug Abuse is soliciting proposals from qualified organizations having the capability to (1) grow, harvest, analyze, store and distribute GMP grade cannabis (marijuana) on large and small scales; (2) extract cannabis to obtain purified phytocannabinoids including delta-9-tetrahydrocannabinol (delta-9-THC), analyze, and store; (3) prepare marijuana cigarettes and related products; and (4) distribute marijuana, marijuana cigarettes and cannabinoids, and other related products for research and other Government programs upon NIDA authorization.

The truth is the federal government has a schizophrenic position on the issue. (more…)

Drug Czar Gets it Wrong — “Medicinal Benefit” of Marijuana is Clear

Thursday, July 23rd, 2009
Posted by Kris Hermes

Gil Kerlikowske, the Director of the White House Office of National Drug Control Policy, the country’s new Drug Czar was in Fresno, California this week for Operation S.O.S. (Save Our Sierras). The multi-agency effort to eradicate marijuana in eastern Fresno County has nothing to do with medical marijuana. However, that did not stop Kerlikowske from declaring (erroneously) to the Fresno Bee that marijuana “has no medicinal benefit.”

Certainly, Kerlikowske should have limited his public comments to the (non-medical) marijuana being pursued by local and federal agents under Operation S.O.S. But, if he really felt compelled to stray from the issues of recreational marijuana enforcement to comment on the medicinal use of marijuana he should have at least done his homework. (more…)

Sen. Coburn Issues Challenge to Med-Can Supporters

Monday, June 15th, 2009
Posted by Caren Woodson

Sen. Tom Coburn (R-OK) recently introduced an amendment aimed at obstructing the effective implementation of state medical cannabis laws.  Fortunately, ASA helped to kill the amendment.

However, during debate on the measure, Sen. Coburn issued an open challenge to produce even a single research article to demonstrate that smoked cannabis may be effective treatment for any condition.  Apparently, Sen. Coburn hasn’t read these medical journal articles, which clearly demonstrate that smoking cannabis (even in low doses) can effectively reduce the pain associated with HIV/AIDS.

Sen. Coburn:  Ask and you shall recieve!

ASA invites our readers to take Sen. Coburn up on his challenge! Please visit www.SafeAccessNow.org/SpankCoburn to send links of this research to Senator Coburn’s office.  Or, better yet, take a minute to print out the studies and mail them directly to his office at:

The Honorable Senator Tom Coburn
172 Russell Senate Office Bldg.
Washington, DC 20510.

So, what does the research really say?

Wednesday, June 3rd, 2009
Posted by Caren Woodson

Since beginning my tenure with ASA, the question I am most frequently asked is, “So, what does the research really say about the benefits of smoking marijuana?”

It’s understandable that Members of Congress, their staff, and even advocates who support medical marijuana don’t know or can’t find all the research. The results of these research trials are rarely reported by media. And, much of what is reported concerns the exaggerated harms that may be associated with smoking large amounts of marijuana by the non-medical user — which is often not the case for individuals who smoke cannabis for therapeutic purposes.

It can be difficult – but not impossible – to locate information about the safety and therapeutic value of cannabis. The unfortunate result of the federal prohibition of cannabis is limited clinical research to investigate the safety and efficacy of cannabis to control symptoms of serious and chronic illness. As noted by the American College of Physicians cannabis research is “hindered by a complicated federal approval process, limited availability of research grade marijuana, and the debate over legalization.”

So, what does the research really say?

Since 2007, the Center for Medical Cannabis Research (CMCR) has sponsored four double-blind, placebo-controlled, FDA-approved clinical trials which demonstrate that smoking cannabis (marijuana), even in low doses, effectively alleviates the neuropathy pain associated with HIV/AIDS. So there is no mistake, let me repeat that: smoking marijuana, even in low doses, effectively controls the neuropathy pain associated with HIV/AIDS. The results of these clinical trials have been reviewed and published by reputable medical journals.

  • In February 2007, Neurology published the results of a Phase I clinical trial which concluded smoked cannabis was well tolerated and effectively relieved chronic neuropathic pain from HIV-associated sensory neuropathy. The findings are comparable to oral drugs used for chronic neuropathic pain.
  • In November 2007, Anesthesiology published results of a clinical trial conducted by researchers at UCSDCenter for Pain Medicine which concluded that normal volunteers subjected to chemically induced pain which mimics neuropathy also responded to medium doses of smoked cannabis.
  • In June 2008, the Journal of Pain, published the results of a clinical trial conducted by researchers at UC Davis which also concluded that even low doses of smoked cannabis can be effective in managing hard-to-treat neuropathic pain. In fact, investigators found that low- and high-dose cannabis produced similar levels of pain relief, reducing the intensity of the severe nerve pain. The researchers specifically noted that cannabis not only fights pain itself but also interacts with opiate-based painkillers to increase their effectiveness, particularly in neuropathic pain. They also note that using isolated synthetic cannabinoids such as THC (dronabinol) did not provide the same degree of efficacy as a whole-plant preparation of cannabis.
  • In August 2008, Neuropsychopharmacology, published the results of a Phase II clinical trial conducted by researchers at UCSD School of Medicine which concluded, once again, that smoked cannabis was generally well tolerated and effective when added to concomitant analgesic therapy in patients with HIV-related neuropathy pain not adequately controlled by other pain-relievers.

Now, go spread the word!

Coburn Amendment Round II

Wednesday, May 20th, 2009
Posted by Caren Woodson

I am blogging with good news from Washington, DC.  Today, ASA helped to kill an amendment aimed at obstructing the effective implementation of duly enacted state medical cannabis laws!

Earlier this week, ASA’s National Office was notified that Sen. Coburn (R-OK) intended to add a medical marijuana amendment to S. 982, the Family Smoking Prevention and Tobacco Control Act. Frustrated by the Obama Administration’s continued pledge to not interfere with state medical marijuana laws, Sen. Coburn (R-OK) attempted to slip in legislation designed to undermine these programs.

The text of Sen. Coburn’s amendment is as follows:

SEC._. MEDICAL MARIJUANA. The Secretary of Health and Human Services shall- (1) require that State-legalized medical marijuana shall be subject to the full regulatory requirements of the Food and Drug Administration, including a risk evaluation and mitigation strategy and all other requirements and penalties of the Federal Food, Drug and Cosmetic Act (21 USC 301 et seq.) regarding safe and effective reviews, approval, sale, marketing, and use of pharmaceuticals; and (2) require that any State-legalized marijuana likely to be offered to, or purchase by, consumers as marijuana intended to be consumed as a cigarette or through the oral cavity will be subject to section 900 of the Food, Drug, and Cosmetic Act (as amended by section 101).”

At present, the ONLY way for medical marijuana to be properly evaluated by the FDA is for privately-funded sponsors to conduct FDA-approved clinical trials (like any other drug evaluation).   If Senator Coburn’s intentions with regard to the medical efficacy of marijuana were genuine, he would consider first removing the monopoly imposed by the Drug Enforcement Administration (DEA) on licenses for the cultivation of medical-grade cannabis for research purposes. Currently, the DEA exclusively licenses the cultivation of medical-grade cannabis to the National Institute for Drug Abuse (NIDA), which primarily investigates only the negative effects of cannabis. This monopoly obstructs any investigation and research in the U.S. into the medical properties of cannabis and thwarts the normal drug approval process.

This isn’t the first time Sen. Coburn has attempted to add this amendment to unrelated legislation. Recall, he made a similar attempt in 2007 when he tried to append the amendment to an unrelated FDA prescription drug bill.  In fact, then-Senators Obama and Clinton voted against the measure. While Sen Coburn managed to slip it in at committee level, ASA managed to get it removed during conference committee.

Today, in a 10-13 party-line vote, we managed to kill the amendment in Committee!  Senators Dodd (D-CT) and Reed (D-RI) were key opponents to the amendment.

SEND YOUR THANKS and PRAISE to the each of the following offices:

Senator Bingaman (D, NM)
Phone: (202) 224-5521
Email: senator_bingaman@bingaman.senate.gov

Senator Brown (D, OH)
Phone: (202) 224-2315
Email: http://brown.senate.gov/contact/

Senator Casey (D, PA)
Phone: (202) 224-6324
Email: http://casey.senate.gov/contact/

Senator Dodd (D, CT)
Phone: (202) 224-2823
Email: http://dodd.senate.gov/index.php?q=node/3128

Senator Hagan (D, NC)
Phone: (202) 224-6342
Email: http://hagan.senate.gov/?p=contact

Senator Harkin (D, IA)
Phone: (202) 224-3254
Email: http://harkin.senate.gov/c/

Senator Kennedy (D, MA)
Phone: (202) 224-4543
Email: http://kennedy.senate.gov/senator/contact.cfm

Senator Merkley (D, OR)
Phone: (202) 224-3753
Email: http://merkley.senate.gov/contact/

Senator Mikulski (D, MD)
Phone: (202) 224-4654
Email: http://mikulski.senate.gov/Contact/contact.cfm

Senator Murray (D, WA)
Phone: (202) 224-2621
Email: http://murray.senate.gov/email/index.cfm

Senator Reed (D, RI)
Phone: (202) 224-4642
Email: http://reed.senate.gov/contact/contact-share.cfm

Senator Sanders (I, VT)
Phone: (202) 224-5141
Email: http://sanders.senate.gov/comments/

Senator Whitehouse (D, RI)
Phone: (202) 224-2921
Email: http://whitehouse.senate.gov/contact/

Ninth Circuit Hears Data Quality Act Appeal

Tuesday, April 14th, 2009
Posted by Joe Elford

The federal government is lying when it states that “there have been no studies that have scientifically assessed the efficacy of marijuana for any condition” and we have called them on this.  Under a little known law called the “Data Quality Act” or “Information Quality Act,” federal agencies have an obligation to disseminate truthful information.  So, back in October of 2004, Americans for Safe Access (ASA) filed a Petition with the Department of Health and Human Services (HHS) requesting that it correct the above statement, and three others, regarding the efficacy of marijuana for medical use.  After years of evasion and delay, HHS told us that it would defer consideration of our request to a different agency proceeding, which may take years, so we took them to court.

In February of 2007, we sued HHS under the Data Quality Act in order to achieve two goals — first, the force HHS to give us a substantive response to our Petition and, second, if necessary, have the court decide whether that response is arbitrary and capricious.  Three months later, we filed a motion for summary judgment accompanied by dozens of scientific studies, which contradict the federal government’s claims that such studies don’t exist.  Unfortunately, the district court gave our suit short shrift a dismissed the suit on the government’s motion based on the contention that there is no right to judicial review under the Data Quality Act.  In other words, the court reduced the Data Quality Act to an exhortation to federal agencies to disseminate truthful information, not a command.  But, despite what several people have written in our discussion forums, that was not the end of the line.

The case would continue on appeal in the Ninth Circuit and, luckily, our big gun, Alan Morrison, would stay on the case.  Alan co-founded the Public Citizen Litigation Group with Ralph Nader nearly forty years ago and was, until recently, an administrative law professor at Stanford.  As proven today, he’s an extremely effective oral advocate.

When I first came to ASA, I had few demands.  One of them was that I would argue every case I briefed, but to have Alan Morrison on behalf of ASA warranted an exception.

The oral argument was held today and the sparks flew.  Alan went first and the three-judge panel peppered him with questions on standing, whether there is a right to judicial review under the Data Quality Act, and whether ASA had an alternative remedy under the Controlled Substances Act (through rescheduling) that would preclude judicial review under the Data Quality Act.  Alan answered all of the questions eloquently and succinctly.  Near the end of Alan’s presentation, Judge Berzon lamented that the Court should have allotted more time for oral argument because this was such an interesting case.  The audio of the argument can be found here .

Ultimately, in addition to the medical marijuana issue, the case puts President Obama’s statements that the federal government will make scientific decisions based on science, rather than politics, to the test.  It does not seem too much to ask that federal agencies tell the truth and for courts to ensure this when it is demonstrated that they are lying.

The LA Times pushes the Obama Administration toward a sensible, long-term medical marijuana policy

Tuesday, March 10th, 2009
Posted by Kris Hermes

Americans for Safe Access (ASA) is currently working with the Obama Administration to change federal policy with regard to medical cannabis (marijuana). So, it was with unbridled enthusiasm that I explained to the editorial department of the Los Angeles Times last week what it meant for the recently seated Attorney General Eric Holder to embrace a “new American policy.” As I extolled the virtues of suspending the federal government’s enforcement policy of raiding medical cannabis dispensaries in California, I also explained that we were not stopping there with what we expected from a new federal policy.

In advance of President Obama taking office, ASA put together a set of policy recommendations so that we had a vehicle to advance sensible changes to what has been an incredibly harmful strategy of attacking medical cannabis patients and undermining the laws of California and other states. With President Obama’s campaign promise that he “would not have the Justice Department prosecuting and raiding medical marijuana users,” advocates had something with which to hold the new president’s feet to the fire. It was further gratifying for the White House to make a statement to the Washington Times after President Obama took office clarifying that, “federal resources should not be used to circumvent state laws.” And, most recently, in a press conference on February 25th, Holder affirmed earlier statements in regard to suspending the use of Justice Department funds to enforce federal marijuana laws in states that have adopted protections for medical cannabis patients.

Therefore, it was with great excitement that I read in Monday’s Los Angeles Times an editorial that agreed with the direction of the Justice Department in this regard, but also stated the need to advance beyond simply suspending enforcement. If the new Administration wanted to curtail enforcement, why would it want to continue prosecuting the more than twenty pending federal cases involving medical cannabis? And, why would it want to let state law-abiding citizens languish in federal prison for sentences ranging from 5 to 20 years? And, why was the Justice Department still threatening landlords of medical cannabis providers with criminal prosecution and seizure of their property? The Times rightly concluded that, “Stopping the raids is certainly worthwhile…but as a long-term policy, it is unworkable,” and that, “The country needs a comprehensive policy, not just a wink and a nod.”

And, it was with even greater excitement that I read in today’s Los Angeles Times a follow-up editorial that the federal government should end its monopoly on the cultivation of medical cannabis used for research, which has created “a dearth of academic research into its therapeutic properties.” Again, the Times rightly concluded that instead of obstructing it, “the DEA should encourage cannabis research.”

It is opinions like that of the Los Angeles Times editorial board that will help push the Obama Administration into an era of common sense and compassion for our most vulnerable citizens. Medical marijuana is not a band-aid for otherwise effective treatment protocols; it is a treatment protocol itself. Likewise, Holder and the rest of the Obama Administration should not look to a band-aid-like quick fix for medical marijuana. It should develop the long-term comprehensive policies being called for by advocates and the Los Angeles Times alike.

State Law & the People vs. the DEA

Monday, February 9th, 2009
Posted by Kris Hermes

The San Diego Union-Tribune published opposing op-eds yesterday, one from Alex Kreit, an assistant professor and director of the Center for Law and Social Justice at the Thomas Jefferson School of Law in San Diego, and another from Ralph W. Partridge, the special agent in charge of the San Diego Field Division of the Drug Enforcement Administration.

I helped get Kreit’s op-ed published, but we were not able to directly refute the comments by DEA agent Partridge. Unexpectedly, Partridge recycles the same old tired claims about the danger of medical marijuana and the lack of evidence of its therapeutic value. Unfortunately, the DEA continues to ignore the mountain of evidence from studies around the world and even in the United States.

And yet, as these op-eds are printed, a new policy is emerging; one in which compassion for our most vulnerable citizens is given priority over political expediency. ASA is working with the Obama Administration and Congress to craft both short and long term strategies for ending federal raids on state-sanctioned medical marijuana dispensaries, expanding research into this promising medicine, and a comprehensive federal policy to establish access for all of the sick Americans that would benefit from its medical qualities.