Posts Tagged ‘debilitating conditions’

New M2 Petitions on Horizon Again

January 23rd, 2013

Last January we accepted petitions from the public to add PTSD 1; PTSD 2; Depression; Migraines; and Generalized Anxiety Disorder to the list of conditions that qualify patients to receive a Medical Marijuana Registration Card.  Because my guiding principle for making the decision was to use science and research to make the decision, we contracted with the U of A College of Public Health to do an evidence review of published scientific studies to help us to make a more informed decision.  You can see the UA’s analyses for Depression; Generalized Anxiety Disorder; Migraine Headaches; and Post Traumatic Stress Disorder (PTSD) on our petition website.   Our literature review found limited scientific evidence to document whether Cannabis is helpful or not for the petitioned conditions or that support permanently adding the petitioned conditions to the statutory list of qualifying debilitating conditions identified in the Act.  In short- I didn’t approve the petitions last year because of the lack of published data regarding the risks and benefits of using Cannabis to treat or provide relief for the petitioned conditions. 

The AZ Medical Marijuana Act requires us to periodically accept petitions to add new medical conditions- and we are once again accepting petitions to add new debilitating medical conditions this week (January 25 – 31) on our petition website. Our medical team will meet after January 31st and will be providing me with an initial analysis regarding whether any petitions we receive meet the screening criteria…  and we’ll be using the UA College of Public Health to review the scientific literature for any that pass the screening test.  Assuming we receive qualified petitions, I’ll need to make a final decision by July 2013.  Our website shows folks how, what, where, and when to submit petitions.

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M2 Petition Decision

July 19th, 2012

The voter approved list of conditions that already qualify patients for an AZ Medical Marijuana Registration Card (with a doctor’s certification) includes any of the following: any chronic or debilitating disease or medical condition (or its treatment) that causes severe and chronic pain, severe nausea, severe and persistent muscle spasms, wasting, or seizures, cancer, glaucoma, HIV, Hepatitis C, ALS, Crohn’s disease, agitation of Alzheimer’s disease.  The AZ Medical Marijuana Act also requires us to periodically accept petitions to permanently add new medical conditions to the list of conditions that qualify folks for a card.  

We accepted petitions from the public to add new medical conditions back in January.  Folks submitted numerous articles as a part their petitions for PTSD 1; PTSD 2; Depression; Migraines; and Generalized Anxiety Disorder.  We also received lots of informal comments regarding adding PTSD; Depression; Migraines; Generalized Anxiety Disorder and General comments.  We also heard in person testimony from dozens of folks at our public hearing in May.

Because my guiding principle for making the decision was to use science and research, we contracted with the U of A College of Public Health to do an evidence review of published scientific studies to help us to make a more informed decision.  You can see the UA’s analyses for Depression; Generalized Anxiety Disorder; Migraine Headaches; and Post Traumatic Stress Disorder (PTSD) on our petition website.   The UA used the GRADE methodology to evaluate the quality of the studies looking at the benefits and harms of using Cannabis to treat or provide relief for the conditions that were petitioned to add to the list of qualifying conditions for a Medical Marijuana Registration card.  Also, our ADHS Medical Advisory Committee reviewed and analyzed the data and provided me with recommendations earlier this week.

We heard and received a host of moving stories from the public both on-line and during our a public hearing in May.  Many of the commenters and folks that testified self-reported that they believe Cannabis provided relief for the petitioned conditions.  However, our literature review found limited scientific evidence to document whether Cannabis is helpful or not for the petitioned conditions or that support permanently adding the petitioned conditions to the statutory list of qualifying debilitating conditions identified in the Act.  In short- I didn’t approve the petitions because of the lack of published data regarding the risks and benefits of using Cannabis to treat or provide relief for the petitioned conditions. 

However, some of the petitioned conditions (such as migraine headaches) already qualify patients for a medical marijuana registration card if they cause severe and chronic pain, severe nausea, severe and persistent muscle spasms, wasting, or seizures.

Whatever you think of the decision, just know that our team and I really took an objective and close look at the scientific evidence before making this decision.  And remember, the Act provides for a judicial review of this decision and a continuing petition process.  In fact, we’ll be accepting petitions again next week.

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GRADEing Studies & Evidence

July 19th, 2012

As I mentioned in my previous post, scientific studies (e.g. experimental v. observational design) have different strengths and weaknesses. Sources of evidence range from case reports at the lower end to well-designed large randomized experimental clinical studies that minimize bias.  Relying on poor quality evidence can lead to policy decisions that aren’t in patients’ best interests- and it’s super important to figure out the actual “weight of evidence” that published studies provide- so public health can make good evidence-based decisions. 

That’s where the Grading of Recommendations Assessment, Development and Evaluation- or GRADE system comes in.  The GRADE system was developed to provide researchers and policy makers a systematic way of grading the strength of studies to help policy makers in medicine and public health to interpret studies and make better decisions.  The GRADE system has all kinds of applications.  For example, the U of A used the GRADE methodology to evaluate the quality of the studies looking at the benefits and harms of using Cannabis to treat the conditions that were petitioned to add to the list of qualifying conditions for a medical marijuana card.

You can read alot more about the GRADE system and how it works in this article in the British Medical Journal (unfortunately you need to pay to read the whole thing).

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“It’s a Wrap”

May 25th, 2012

It’s been a busy week for our medical marijuana team.  Our 2-week dispensary application period ended a couple of hours ago…  as did the hearing regarding adding new debilitating medical conditions.

We received 484 dispensary applications over the last 2 weeks.  As you know, we have 126 Community Health Analysis Areas (CHAAs) and a maximum of 126 possible dispensaries (one per CHAA).   Some of our CHAA’s received multiple applications- for example, the Estrella CHAA had 16 applicants and the Flagstaff E  CHAA 13 had applicants.  Many other CHAAs had only 1 applicant. 27 areas didn’t receive any applications.  You can see the number of applications by CHAA on our website.

Our team just finished logging all of the applications that we received and has already started reviewing some of the applications for “Administrative Completeness”.  Any applications that are “Administratively Incomplete” (in other words, if they’re missing something) will be returned to the applicants so they can correct whatever is wrong.  In June, we’ll be checking for “Substantive Completeness” (which is a more thorough, quality review), and the applicants will have another chance to make corrections.  We expect to award all of the Registration Certificates on August 7.

Registration Certificates will be awarded to applicants in CHAAs with only 1 applicant on August 7 as long as their application is Administratively and Substantively complete.  We’ll be holding a random drawing on August 7 to award Certificates in the CHAAs with more than 1 qualified applicant.   Of course, some CHAAs will not have a dispensary this year because we didn’t have an applicant.

We also had our hearing regarding adding debilitating medical conditions this afternoon at our Laboratory.  We heard from dozens of folks – some urged us to add the conditions and some that urged us not to.  We have also received hundreds of comments on-line.  We have several more weeks before we need to make a decision.  If you’d like to view the public comment session, we have a link on our website.

 

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Debilitating Conditions Hearing

May 24th, 2012

Friday afternoon we’re holding a public comment session about whether or not to add four new debilitating conditions to the medical marijuana program.  The comments should center on scientific studies done on how marijuana affects Post Traumatic Stress Disorder, Migraines, Depression and Generalized Anxiety Disorder.  We’re looking for peer-reviewed, published studies that show the benefit or the danger of marijuana specific to these four conditions.

For almost a month, folks have been commenting on line about the petitions to add conditions.  More than 80 people have provided input so far.  At the hearing on Friday, speakers will have two minutes to address one of the conditions.  (The hearing will be broken into two segments – the first is to hear about the PTSD studies and runs from 1 until 2:30.  The second half from 2:30 until 4 is for the other three.)   We’ll open the doors at 12:55. 

We’re also streaming the audio from the session on our website for people that can’t make it to Health Services (we’re having technical difficulties with the video- but that might work too by then).  Anybody can use the online comment tool to provide input to the final decision.  There’ll be a room at ADHS to listen to the live stream of comments in our 1740 W. Adams, Phoenix, AZ 85007 building in case the meeting room is over capacity.  The time will be the same as the public comment session – 12:55 – 4 p.m.

Changing anything the voters have created comes with a heavy responsibility – one we take seriously.  We’ll listen to the folks who come to ADHS and read the written comments before we make any decisions about adding new conditions.  The decisions will likely come in July.

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What’s Debilitating?

April 20th, 2012

The voter approved language in the AZ Medical Marijuana Act directs us to periodically accept and evaluate petitions to add new debilitating medical conditions.  We’ve made it through the first phase of considering whether to add 4 new debilitating conditions… 1) Post Traumatic Stress Disorder; 2) Generalized Anxiety Disorder; 3) Migraines; and 4) Depression.  You’ll be able to give us your thoughts about these four conditions at a public hearing next month (May 25th from 1 – 4 p.m. at our State Lab).  You can read the information we already have about these four starting next week.

If we decide to add PTSD or any other debilitating conditions, we want to make sure we’re on solid medical ground.  I’m heading down to a conference in Tucson next weekend where physicians can get Continuing Medical Education credits for learning about medical cannabis.

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New Debilitating Medical Condition Applications

January 17th, 2012

The Arizona Medical Marijuana Act (36-2801.01) directs us to accept and review applications to add new debilitating medical conditions that qualify folks to hold patient registration cards.  We outlined the requirements and review procedures in the Rules we adopted (R9-17-106)- which say that we’ll accept applications every January and July.  We’re planning to accept applications during the last week of January (January 23-27th).

Here’s the process: Once we receive an application, we’ll notify the requester that the application was received, and we’ll begin our review.  In order for an application to be successful, the submitters will need to provide evidence as outlined in the R9-17-106 Rule, including: 1) evidence that the medical condition impairs the ability of the individual to accomplish activities of daily living; 2) evidence that marijuana provides a therapeutic or palliative benefit for the condition; and 3) whether conventional medical treatments provide a benefit for the medical condition.  Applicants need to include data from peer-reviewed scientific journals to support the application.

We plan on partnering with the U of A’s Mel & Enid Zuckerman College of Public Health and Biomedical Campus teams to review the requests. They’ll be providing us with valuable support, including researching the applications and providing us with summary reports and recommendations using students, faculty and their extensive public health and medical expertise.

If the information provided by the applicant meets the requirements, we’ll schedule a public hearing to discuss the request and provide a date for the hearing.  If the information provided doesn’t meet the requirements, we’ll notify the requester with reasons and provide for a process for requesting judicial review.  You can see more information about the process in our Fact Sheet on submitting petitions.

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