Pages tagged "FDA/HHS"


Will New Hampshire live up to its state motto by adopting compassionate use?

Over the past twelve years, New Hampshire has attempted several times to legislate the usage of cannabis for medical purposes. A 2009 bill was vetoed by Governor John Lynch. From 2000 to 2007 there were four attempts but the measure did not pass the New Hampshire House. But yesterday's passage of SB 409 through the State Senate and House conference committee is a new opportunity.

The New Hampshire state motto is “Live Free or Die,” however to those who live in New Hampshire and are sick, hurt and longing for a better quality of life, the state motto may feel like the “To Live or Die” state. But we can change that now.

SB 409, the 2012 New Hampshire Medical Marijuana Bill sponsored by Republican Senator Jim Forsythe, differs from previous attempts. The language is different, the key politicians are different, the activism is different. In the end, will the result be same or is 2012 the year to achieve success?

We think this may be the best chance we have!

New Hampshire has the largest state legislature in the union with 400 House members and 24 Senators. Republicans outnumber Democrats in the legislature, but, perhaps ironically, medical marijuana has found great support among Republicans.

Legislators who in the past voted against medical marijuana, such as Senator Jeb Bradley, Gary Lambert and Peter Bragdon, now support SB 409. Senator Bradley even publicly stated to New Hampshire Chiefs of Police Association representative Richard Crate at the Senate hearing that their opposition to the issue, “does not reflect the fact that for some, medical marijuana works.”

NH Compassion Executive Director Kirk McNeil and Matt Simon, a Marijuana Policy Project [9] Legislative Analyst, have been working alongside activists like me and other various groups to pass the bill. We built a broad coalition including NH Students for Sensible Drug Policy led by Jennifer Hall, NH Disabled American Veterans, NH Vets for Peace, and Americans for Safe Access, just to name a few.

Patients, veterans and students bravely gave public testimony

Over the past few months members of the public have testified at open public hearings on the effectiveness of medical marijuana in helping them battle disease and disability. The most dramatic and passionate testimony has come from New Hampshire veterans, many of whom have said without the ability to use cannabis for medical reasons, they and their families would have been destroyed. The one thing that frightens them and the main reason why they are speaking out is because in order to get medical marijuana, the patient must put their family members at risk to procure the medicine.

Governor Lynch cites the federal ban on cannabis as listed on CSA schedule 1 - that cannabis has no accepted medicinal use - as the reason why he continues to oppose a compassionate use law. Well, with the Food and Drug Administration allows international companies like GW Pharmaceuticals in England to offer a phase III clinical study on human patients in the United States And of course there is the famous Compassionate Individual New Drug Program, the federal program that allows qualifying patients to use cannabis for palliative and therapeutic relief. Today there are only two surviving patients out of the initial 34 patients who receive 200 pre-rolled marijuana cigarettes a month. One vocal program member, Irvin Rosenfeld, attended a press conference and met with legislators in Concord in May to discuss this program and support state efforts on SB 409.

While our own federal government ignores these studies and continues to put sick patients, veterans and others behind bars for using or providing medical cannabis, our state legislators are attempting to help New Hampshire residents to have a better quality of life. Pharmaceuticals which have been prescribed by doctors and pushed by the “Big Pharma” can have unacceptable side affects or not work well for everyone. The opportunity to legally use cannabis for medical purposes is a chance to allow our sick the ability to be productive parents, husbands and wives - not to mention a healthier person.

How can Governor Lynch continue to say he is the leader of New Hampshire, the original freedom-loving state, when he fails to lead in being compassionate to the sick? Do the special interests of big business, health care networks and others mean more to him than the ability for a NH veteran or a single mother of three to be healthier individuals using medical cannabis as an alternative medicine?

Without compassion toward suffering patients who want to use medical cannabis, The “Live Free or Die” state is not practicing what the state motto preaches. Until the Governor changes his position, New Hampshire residents will just have to “Live or Die.” It is obvious over the past twelve years that New Hampshire has been walking down a road to legalize medical marijuana. With 71% of New Hampshire residents supporting safe access, how can the governor maintain his heartless position?

If you live in New Hampshire, please contact Governor Lynch at 603-271-2121, or tweet at him @GovJohnLynch, and ask him to have compassion for patients and sign SB 409 into law.

Gregory Pawlowski is a patient and advocate in New Hampshire.

Medical Cannabis helps ALS Patient Outlive Support Groups and Neurologists

Guest blog by Jahan Marcu. Cathy Jordan was on a panel with Jahan Marcu at the Cannabis Therapeutics Conference in Arizona.  Before taking the stage, she discussed the medical use of cannabis for ALS with the Vice Chair of ASA's Medical and Scientific Advisory Board. Cathy Jordan first noticed something was wrong in summer of 1985 when she couldn’t pick things up. Her muscles weren’t responding. A year later, in 1986 she was diagnosed with ALS (Amyotrophic Lateral Sclerosis). ALS is a disease characterized by the death of motor neurons leading to loss of limb control, breathing, swallowing, speech, and widespread cellular dysfunction. Most cases of ALS are sporadic; it is not a viral or autoimmune disease. “Most people (ALS patients) start using a feeding tube because they are afraid of choking to death”, says Cathy. After her diagnosis, she was given an expiration date; In 1986, she was given 3-5 years to live/die according to her neurologist,  Dr.Fink. Nearly 3 decades later she is still alive, living with ALS. “All my docs are retiring or dead, I’ve outlived 5 support groups and 4 neurologists,” said Cathy. This actually posed a problem for Cathy, who basically lost her social security benefits because she lived passed her expiration date. The state of Florida said her ID and regular documentation wasn’t good enough to prove she was alive and to continue to receive benefits. She had to ask her neurologist at the time, to fill out paperwork to prove she was still alive. Mrs. Jordan began using Cannabis from a Florida grower to treat her ALS in the late 80’s. “Donny Clark provided my medicine, grown in the Myakka River Valley…he was busted and sentenced to life in prison, and that strain of Cannabis was lost. Years later he was pardoned on the last day of the last term of President Clinton,” says Cathy, “You know they say the fountain of youth is in Florida, maybe it was something in the soil that made this plant help me…I don’t understand why Doctors wouldn’t study me—I want to know why this is helping me.” At first Doctors would not accept Cathy’s marijuana smoking and extended life span. Regardless of what she did, “a UPENN doctor told me bluntly, I would die either from suffocation or drowning in my own fluid.” Other Doctors also thought that smoking anything would impair her lung function, and threatened to have this paralyzed women committed because she must be crazy if she thought Cannabis was helping her. “I visited a neurologist at Duke University…when I told him that I was smoking Cannabis he turned into PeeWee Herman. He didn’t know what to do with me, he was afraid. He wouldn’t even take my blood pressure because I was using an illegal drug.” “I asked my docs: would you like a drug that is neuroprotective, an antioxidant, and an anti-inflammatory?,” says Cathy, “They then said Yes and asked me if I knew of one. I said yes, [it’s] Cannabis.”   There are ALS patients associations that fight for the right of patients to die with dignity, “But what about my right to life?” says Cathy. “Keeping my medicine illegal removes my right to life.” Nearly three decades later, the science has caught up with this patient. Scientists created a mouse with ALS, which was very exciting for Cathy. Research has shown that THC and other cannabinoids can benefit mice with ALS. The mounting evidence of cannabinoids halting the progression of ALS has started to change the attitudes of Doctors, prominent researchers have recently called for ALS clinical trials with Cannabis or cannabinoids. “They all agree today that I should smoke Cannabis,” says Cathy, “26 years later my original neurologist, fought [successfully] to make sure Cannabis is legal for patients in Delaware.” Researchers think Cannabis may help ALS patients relieving pain, spasticity, drooling, appetite loss, and has minimal drug-drug interactions and toxicity.

Medical Marijuana Week - Day 2: Congress can Protect Patients and Safe Access with HR 1983

On May 25, 2011, Congressman Barney Frank (D-MA) introduced HR 1983, a bill that in many respects would end the federal government's assault on safe access for patients. Known as the States’ Medical Marijuana Patient Protection Act, the legislation would force the executive branch to stop dragging their feet on reclassifying marijuana under the Controlled Substances Act. It would also prevent the federal government from imposing penalties on anyone legitimately participating in a state medical marijuana program. The bill would further prevent the federal government from interfering with state medical marijuana through the Food, Drug and Cosmetics Act. While this fantastic bill was able to attract 21 cosponsors - several of whom signed a letter to Obama in support of HR 1983 - it has since languished after being referred to committee.

The seemingly permanent classification of marijuana in Schedule I has got to be one of the most notable examples of the federal government sticking its head in the sand in recent US history. To keep marijuana under Schedule I, the federal government is literally saying that:

  1. Marijuana has a high potential for abuse.

  2. Marijuana has no currently accepted medical use in treatment in the United States.

  3. There is a lack of accepted safety for use of marijuana under medical supervision.

Really? Given that 16 states and the District of Columbia have passed medical marijuana laws, with at least another 16 states considering new legislation, it is patently absurd for the federal government to maintain that marijuana “has no currently accepted medical use in treatment in the United States.” Indeed, countless doctors in these states have recommended marijuana as a treatment to their patients because they are confident in its safety and efficacy. In terms of potential for abuse, not a single medical marijuana patient has died as a result of using marijuana for medical purposes. What’s more is that several apparently safe drugs under Schedule III or lower have caused fatalities in patients, such as hydrocodone, vicodon or benzodiazepines. This situation might be laughable if not for all of the patients who must suffer at the mercy of a federal government which refuses to listen to reason and ever-mounting scientific evidence in favor of medical marijuana

Congress should be embarrassed by its failure to protect safe access for patients. For Day 2 of Medical Marijuana Week, ASA is asking you to remind your members of Congress about this absurdity, so please take a moment to call Congress and demand your member’s support for HR 1983.  Americans for Safe Access is moving forward with the decade-long court battle with the federal government to marijuana rescheduling, but passage of HR 1983 would mean the government would have to complete the rescheduling process in 12 months. The election year presents a wonderful opportunity to put pressure on members of Congress, so please take time today to call, demand passage of HR 1983, and remind them that your vote is not to be taken for granted.

ASA Fact Sheet on HR 1983: http://www.safeaccessnow.org/downloads/1983FactSheet.pdf

National Action Alert - Urge Congress to Co-Sponsor HR1983: http://americansforsafeaccess.org/article.php?id=7066

Medical Marijuana Week: http://www.safeaccessnow.org/article.php?id=7061

 

A cancer cure in waiting

When people ask why I’m certain the federal laws preventing medical use of cannabis must change, my answer is simple: cancer. Curing it is the holy grail of modern medicine, and cannabinoids hold the most promise.

The latest study showing the cancer-fighting properties of one of the constituent components of the cannabis plant is out of Italy, where University of Naples researchers demonstrated that cannabidiol, better known as CBD, helps prevent the spread of colon cancer in an animal model of the human disease. Since colon cancer affects millions of people, this is a big deal.

But it’s not big news.



Many, many other studies have demonstrated that CBD’s antioxidant and anti-inflammatory actions, as well as its ability to inhibit the breakdown of the body’s own endocannabinoids, have a cancer-fighting effect. CBD has been shown to kill glioma cells (the most deadly form of brain cancer), reduce the growth of lung and breast cancer cells, and inhibit the spread of cancer. And that’s just CBD.

Add in THC, the psychoactive component of cannabis available by prescription in synthetic form as dronabinol or Marinol, and scientists have demonstrated that the plant holds the potential to fight or prevent cancers of the breast, prostate, skin, lung, uterus, cervix, pancreas, mouth and biliary track, as well as leukemia, neuroblastoma, thyroid epithelioma, and gastric adenocarcinoma. All by selectively targeting cancerous cells and leaving healthy cells alone.

That’s in contrast to conventional cancer treatments that largely work by creating a toxic environment in the body with the hope that it kills the cancer before it kills the patient. And as hard as chemotherapy and radiation treatments are to tolerate, cannabinoid treatments have exceptionally low impact.

Now, to be clear: we’re not talking about a patent-medicine approach that says cannabis will cure whatever ails you, and there have been no clinical studies done with cancer patients that would show us anything conclusive one way or another.

But there is a mountain of evidence that the immune-modulating function of cannabinoids has everything to do with regulating how our bodies respond to cancers of all varieties. And it’s worth noting the federal government’s own National Cancer Institute recently published a guide for physicians that noted the cancer-fighting properties of cannabinoids and stated that cannabis could be a tool for controlling the disease.

Five days of media attention later, the NCI removed that particular bit of guidance, but what we now know about the mechanisms of cannabinoids on cancers raises significant questions about when best to use cannabis therapeutics. Most wait until the disease reaches an advanced stage, and for them the role of cannabis or dronabinol is almost entirely palliative – a tool to ease the suffering and nausea. But we have compelling evidence that cannabinoids exercise a profound prophylactic effect – potentially preventing cancers from developing in the first place.

So will people with family histories of cancer or other risk factors benefit from cannabinoids? Maybe. There are population studies that suggest so, but general results cannot predict outcomes for a particular individual. In other words, consuming lots of cannabis won’t necessarily protect you. Bob Marley died of cancer, after all.

How much might help is a serious question. We know that many of the actions of cannabinoids are dose-specific, but without qualitatively different research, we can’t know how much might be optimal to achieve any particular biologic objective, even if we know categorically that cannabis is non-toxic and well-tolerated.

Will we see that research soon? Seems likely. There’s a Nobel prize in it for someone. Sure, there are political and economic barriers. But it’s a politics of fear and an economics of greed. Neither can survive with millions of lives in the balance.

Ironically, given the vast economic engine prohibition has wrought, cannabinoids are problematic for pharmaceutical company profits, since plants are not novel compounds they can patent for the purpose of extracting return on their research investment. That means real clinical research, the kind that can develop the cancer treatments current studies promise, requires massive public funding.

Devoting hundreds of millions of taxpayer dollars to cannabis every year may seem daunting. But we already do.

We just spend it on eradication and incarceration instead of research and development.

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Research study discussed:
Aviello G, et al. Chemopreventive effect of the non-psychotropic phytocannabinoid cannabidiol on experimental colon cancer. Journal of Molecular Medicine. 2012 Jan 10.

ASA’s booklet on Cannabis and Cancer

California Medical Association Says U.S. Has “Failed Public Health Policy” on Medical Marijuana, Urges Rescheduling



The first broad marijuana policy statement by a state medical association has become a hot topic of conversation, repeatedly referring to the current federal approach as a “failed public health policy.” Indeed, the October 14, 2011 official policy statement by the California Medical Association (CMA) is gathering significant interest from medical marijuana advocates as well as the broader reform movement. While certain portions of the statement focus on full legalization, the CMA has geared its policy recommendations for those in Washington with the power to reschedule medical marijuana under the Controlled Substances Act (CSA).

The prevailing theme of the CMA policy is that marijuana’s current placement under Schedule I of the CSA has directly and severely hindered researchers from fully establishing marijuana’s medical value. Specifically, the CMA states without equivocation that:
[C]annabis must be moved out of its current Schedule I status.

Notably, the CMA points out that Schedule I classification of cannabis is the principle reason the growing body of international evidence in favor of medical marijuana’s efficacy has been limited in the U.S. to approximately one dozen clinical trials. The CMA ultimately recommends that:
Rescheduling cannabis will allow for further clinical research to determine the utility and risks of cannabis.

By urging the federal government to reclassify marijuana out of Schedule I, the CMA are in effect stating that marijuana does in fact have medical value. While some may choose to play up the reference to “risks,” the CMA was confident enough in medical marijuana’s safety to have issued an August 2011 “Physician Recommendation of Medical Cannabis,” which provides guidance to doctors on how they may treat their sick and dying patients with medical marijuana. In other words, the CMA has asserted that marijuana, even in the absence of FDA approval, is safe enough for physicians to recommend to their patients.

The CMA policy recommendation to reclassify marijuana is one that ASA not only supports, but has also been actively working to implement. As part of the Coalition for Rescheduling  Cannabis (CRC), ASA has appealed a July 2011 denial by the DEA of the CRC rescheduling petition. With this policy statement by the CMA, patients and advocates have gained an important champion on the critical issue of federal rescheduling of marijuana. The question now becomes, will Washington officials listen to doctors' orders?

Research Approved to Study Effects of Medical Marijuana on PTSD



 

 

 

 

 

 

 

 

 

 

 

After a lengthy approval process, the Food and Drug Administration (FDA)  has granted research to study the effects of medical marijuana on people living with Post Traumatic Stress Disorder (PTSD). This summer, the research group MAPS was given the go-ahead by FDA to conduct a:
Placebo-Controlled, Triple-Blind, Randomized Crossover Pilot Study of the Safety and Efficacy of Five Different Potencies of Smoked or Vaporized Marijuana in 50 Veterans with Chronic, Treatment-Resistant [PTSD].

The effects of medical marijuana on PTSD has been a growing area of inquiry given the difficulty of treating the condition and its prevalence among U.S. troops coming back from Iraq and Afghanistan, as well as others. PTSD affects as many as 7.8 percent of Americans and according to the New York Times:
Currently, nearly a third of the 4,982 patients approved for medical marijuana in New Mexico suffer from post-traumatic stress disorder, more than any other condition, according to the state’s health department.

Preceding final approval by the federal government to conduct PTSD research using medical marijuana, the Journal Frontiers in Behavioral Neuroscience published an article in June 2011 on “The role of cannabinoids [the compounds found in the marijuana plant] in modulating emotional and emotional memory processes in the hippocampus.”

Unfortunately, MAPS still needs approval from the National Institute on Drug Abuse (NIDA) before it can begin trials, but Americans for Safe Access looks forward to the eventual completion of this research and the greater acceptability of using marijuana to treat a debilitating condition that affects millions of people in the U.S.

Tennessee Congressman Calls Federal Medical Marijuana Policy “Misguided”



Congressman Steve Cohen (D-TN) wrote a letter to Drug Czar Gil Kerlikowske on Monday, urging a change to the country’s drug policy with regard to marijuana. In addition to calling the federal policy on medical marijuana “misguided,” Cohen said, “Marijuana does not belong on Schedule I of the Controlled Substances Act.”
There is no evidence that marijuana has the same addictive qualities or damaging consequences as these harder drugs and it should not be treated as such.

Cohen, who has taken FBI Director Robert Mueller to task over the federal government’s policy, called for compassion in his letter to Kerlikowske:
We should not deny the thousands of Americans who rely on marijuana to treat the effects of AIDS, cancer, glaucoma, multiple sclerosis, and other illnesses the benefits that marijuana provides.

Cohen also described a personal experience he had with medical marijuana:
I have personally witnessed a close friend who was suffering in the last days of pancreatic cancer benefit tremendously from smoking marijuana. It increased his appetite, eased his pain, and allowed him to smile. It allowed him to deal with death with a little more dignity.

Fortunately, there is a bill currently in Congress that would reclassify medical marijuana. Americans for Safe Access (ASA) is mobilizing people to urge their Members of Congress to pass HR 1983, a bill that would reclassify marijuana to Schedule III and allow states to pass their own laws.

ASA has also taken the Obama Administration to court over its refusal to reclassify marijuana. After a 2002 petition filed by the Coalition for Rescheduling Cannabis (CRC) was denied earlier this year, ASA and the CRC filed an appeal in the D.C. Circuit. Advocates are hopeful that either Congress or the courts will push the federal government to address medical marijuana with a sensible public health policy.

It's About Time



 

 

 

 

 

 

 

 

 

After nine years of delay, the DEA finally denied the Coalition for Rescheduling Cannabis (CRC) petition to reschedule marijuana.  While this may superficially seem like a setback, it now allows us to get a more fair hearing in federal court.  We even had to to file a lawsuit in federal court to compel any action on this decision, so it is a step in the right direction that we received a final administrative action on the rescheduling petition to set the stage for a court battle.  Now, we can present our evidence to a tribunal that will listen.

Already, Time posted an article concluding that science demonstrates the following:
if an appeals judgment were based on scientific evidence, rather than political considerations this time around, it's easy to imagine a very different outcome.

Similarly, the International Business Report posted an article entiled, "Did U.S Government Miss the Mark with Medical Marijuana Ruling?"  You can guess the answer (or click on the link for the result).  The short of it is that we are getting a chance in court and we need to make the most of it.  And we will.

A Small Step Forward



 

 

 

 

 

 

 

 

The District of Columbia Circuit issued an order yesterday requiring the Drug Enforcement Administration to answer our petition for writ of mandamus. While this doesn't require the government to actually answer the rescheduling petition filed in 2002 by the Coalition for Rescheduling Cannabis, it is certainly a step in the right direction.

Cannabis and Pain

Chronic pain conditions are the most prevalent form of disease in many countries. In the US, the American Pain Foundation estimates that 76.5 million people suffer from persistent pain. With few alternatives and a lack of safe and effective treatments for disabling pain, millions will continue struggling to function in their daily lives. Many people suffering from chronic pain have turned to medical cannabis, but the practice is still frowned upon by some lawmakers.

Montana recently passed a law to restrict the number of people living with chronic pain from taking part in the state’s medical cannabis program. Some states, such as New Jersey, arbitrarily prohibit the use of medical cannabis for chronic pain due to a failure by public officials to grasp the therapeutic benefits in this area.



Several new scientific articles examined the ability of cannabis and cannabinoids to treat pain. Clinical trials using cannabis in various forms (smoked, extracts, oral THC, synthetic analogues) were reviewed by different research teams. Three recent reviews of the clinical trials on cannabinoids and pain, demonstrate that cannabis and cannabinoids are effective for treating certain types of chronic pain with acceptable side effects.

After reviewing the scientific evidence, researchers from Canada concluded, that:
overall the quality of trials was excellent. Fifteen of the eighteen trials that met inclusion criteria demonstrated a significant analgesic effect of cannabinoid as compared to placebo, several reported significant improvements in sleep. There were no serious adverse effects. Adverse effects most commonly reported were generally well tolerated, mild to moderate in severity and led to withdrawal from the studies in only a few cases (Lynch et al).

These researchers go on to say:
this systematic review of 18 recent good quality randomized trials demonstrates that cannabinoids are a modestly effective and safe treatment option for chronic non-cancer (predominantly neuropathic) pain (Lynch et al).

Another research group from the University of Pennsylvania published a similar review concluding that:
there is strong evidence for a moderate analgesic effect in peripheral neuropathic and central pain conditions, and conflicting evidence for their use in nociceptive pain. For spasticity, most controlled studies demonstrate significant improvement. Adverse effects are not uncommon with cannabinoids, though most are not serious and self-limiting.

Both groups call for trials with cannabis or cannabinoids for the treatment of pain. Furthermore, a review on the treatments for HIV neuropathic pain concluded that:
evidence of efficacy exists only for capsaicin, smoked cannabis and rhNGF. However, rhNGF is clinically unavailable and smoked cannabis cannot be recommended as routine therapy (Phillips et al).

Meaning, the only medications that have been shown to effectively alleviate HIV/AIDS neuropathic pain are not available on the market. Notably, smoked cannabis was shown to be effective for the treatment of HIV neuropathy, a condition that affects upwards of 40% of the estimated 33 million people currently living with HIV (Phillips et al).

Neuropathic pain, pain from multiple sclerosis, various chronic pain conditions, and often cancer pain are routinely treated with opiates, anticonvulsants, and antidepressants (Russo 2008), but are difficult types of pain to treat. Cannabis extracts have been shown to treat difficult-to-manage pain in patients that is non-responsive to more conventional treatments. Furthermore, medical cannabis researcher Ethan Russo suggests that the use of Cannabis preparations offers "side benefits" due to the presence of additional compounds:
These include anti-emetic effects, well established with THC, but additionally demonstrated for CBD (Pertwee 2005), the ability of THC and CBD to produce apoptosis in malignant cells and inhibit cancer-induced angiogenesis (Kogan 2005; Ligresti et al 2006), as well as the neuroprotective antioxidant properties of the two substances (Hampson et al 1998), and improvements in symptomatic insomnia (Russo et al 2007).

The therapeutic benefits of cannabis for pain are evident both scientifically and anecdotally. Public officials should develop policies that correspond to such benefits and stop restricting access for people with debilitating pain.

This guest blog was written by Jahan Marcu, a researcher in the field of cannabinoid pharmacology, vice-chair of the medical and scientific advisory board of Americans for Safe Access, and science editor at freedomisgreen.com. He was part of a research team which published a study in the journal of Molecular Cancer Therapeutics on how CBD can enhance the anti-cancer effects of THC in aggressive brain cancer in 2010.