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FDA Moves Forward With Marijuana-Based Drug To Fight Childhood Epilepsy

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Rapunzel:

--- Quote from: Oceander on March 09, 2014, 12:20:23 am ---Please don't take offense, but ...

I believe the active ingredient in pot is THC.  PCP is phencyclidine, otherwise known as angel dust.

--- End quote ---

No offense - you are correct.   I knew it was some initial, though.... :silly:  anyway, for medicinal purposes the THC isn't the ingredient they are looking for.

Rapunzel:
This is a segment he did on the subject a while back.....

http://www.cnn.com/2013/08/08/health/gupta-changed-mind-marijuana/

Why I changed my mind on weed
By Dr. Sanjay Gupta, CNN Chief Medical Correspondent
updated 8:44 PM EDT, Thu August 8, 2013
Watch this video

Dr. Sanjay Gupta: I've tried marijuana

    Dr. Sanjay Gupta says we have been "systematically misled" on marijuana
    DEA lists marijuana as a schedule 1 substance with "high potential for abuse"
    Most recent research on marijuana has been on its negative effects, Gupta says
    Studies on marijuana require approval from National Institute on Drug Abuse

(CNN) -- Over the last year, I have been working on a new documentary called "Weed." The title "Weed" may sound cavalier, but the content is not.

I traveled around the world to interview medical leaders, experts, growers and patients. I spoke candidly to them, asking tough questions. What I found was stunning.

Long before I began this project, I had steadily reviewed the scientific literature on medical marijuana from the United States and thought it was fairly unimpressive. Reading these papers five years ago, it was hard to make a case for medicinal marijuana. I even wrote about this in a TIME magazine article, back in 2009, titled "Why I would Vote No on Pot."

Well, I am here to apologize.

I apologize because I didn't look hard enough, until now. I didn't look far enough. I didn't review papers from smaller labs in other countries doing some remarkable research, and I was too dismissive of the loud chorus of legitimate patients whose symptoms improved on cannabis.

Instead, I lumped them with the high-visibility malingerers, just looking to get high. I mistakenly believed the Drug Enforcement Agency listed marijuana as a schedule 1 substance because of sound scientific proof. Surely, they must have quality reasoning as to why marijuana is in the category of the most dangerous drugs that have "no accepted medicinal use and a high potential for abuse."


--- Quote ---Dr. Sanjay Gupta is a neurosurgeon and CNN\'s chief medical correspondent.
--- End quote ---


They didn't have the science to support that claim, and I now know that when it comes to marijuana neither of those things are true. It doesn't have a high potential for abuse, and there are very legitimate medical applications. In fact, sometimes marijuana is the only thing that works. Take the case of Charlotte Figi, who I met in Colorado. She started having seizures soon after birth. By age 3, she was having 300 a week, despite being on seven different medications. Medical marijuana has calmed her brain, limiting her seizures to 2 or 3 per month.

I have seen more patients like Charlotte first hand, spent time with them and come to the realization that it is irresponsible not to provide the best care we can as a medical community, care that could involve marijuana.

We have been terribly and systematically misled for nearly 70 years in the United States, and I apologize for my own role in that.

Medical facts of Marijuana
WEED: A Dr. Sanjay Gupta Special

I hope this article and upcoming documentary will help set the record straight.

On August 14, 1970, the Assistant Secretary of Health, Dr. Roger O. Egeberg wrote a letter recommending the plant, marijuana, be classified as a schedule 1 substance, and it has remained that way for nearly 45 years. My research started with a careful reading of that decades old letter. What I found was unsettling. Egeberg had carefully chosen his words:

"Since there is still a considerable void in our knowledge of the plant and effects of the active drug contained in it, our recommendation is that marijuana be retained within schedule 1 at least until the completion of certain studies now underway to resolve the issue."

Not because of sound science, but because of its absence, marijuana was classified as a schedule 1 substance. Again, the year was 1970. Egeberg mentions studies that are underway, but many were never completed. As my investigation continued, however, I realized Egeberg did in fact have important research already available to him, some of it from more than 25 years earlier.

High risk of abuse

In 1944, New York Mayor Fiorello LaGuardia commissioned research to be performed by the New York Academy of Science. Among their conclusions: they found marijuana did not lead to significant addiction in the medical sense of the word. They also did not find any evidence marijuana led to morphine, heroin or cocaine addiction.

We now know that while estimates vary, marijuana leads to dependence in around 9 to 10% of its adult users. By comparison, cocaine, a schedule 2 substance "with less abuse potential than schedule 1 drugs" hooks 20% of those who use it. Around 25% of heroin users become addicted.

The worst is tobacco, where the number is closer to 30% of smokers, many of whom go on to die because of their addiction.

There is clear evidence that in some people marijuana use can lead to withdrawal symptoms, including insomnia, anxiety and nausea. Even considering this, it is hard to make a case that it has a high potential for abuse. The physical symptoms of marijuana addiction are nothing like those of the other drugs I've mentioned. I have seen the withdrawal from alcohol, and it can be life threatening.

I do want to mention a concern that I think about as a father. Young, developing brains are likely more susceptible to harm from marijuana than adult brains. Some recent studies suggest that regular use in teenage years leads to a permanent decrease in IQ. Other research hints at a possible heightened risk of developing psychosis.

Much in the same way I wouldn't let my own children drink alcohol, I wouldn't permit marijuana until they are adults. If they are adamant about trying marijuana, I will urge them to wait until they're in their mid-20s when their brains are fully developed.

Medical benefit

While investigating, I realized something else quite important. Medical marijuana is not new, and the medical community has been writing about it for a long time. There were in fact hundreds of journal articles, mostly documenting the benefits. Most of those papers, however, were written between the years 1840 and 1930. The papers described the use of medical marijuana to treat "neuralgia, convulsive disorders, emaciation," among other things.

A search through the U.S. National Library of Medicine this past year pulled up nearly 2,000 more recent papers. But the majority were research into the harm of marijuana, such as "Bad trip due to anticholinergic effect of cannabis," or "Cannabis induced pancreatitits" and "Marijuana use and risk of lung cancer."

In my quick running of the numbers, I calculated about 6% of the current U.S. marijuana studies investigate the benefits of medical marijuana. The rest are designed to investigate harm. That imbalance paints a highly distorted picture.

The challenges of marijuana research

To do studies on marijuana in the United States today, you need two important things.

First of all, you need marijuana. And marijuana is illegal. You see the problem. Scientists can get research marijuana from a special farm in Mississippi, which is astonishingly located in the middle of the Ole Miss campus, but it is challenging. When I visited this year, there was no marijuana being grown.

The second thing you need is approval, and the scientists I interviewed kept reminding me how tedious that can be. While a cancer study may first be evaluated by the National Cancer Institute, or a pain study may go through the National Institute for Neurological Disorders, there is one more approval required for marijuana: NIDA, the National Institute on Drug Abuse. It is an organization that has a core mission of studying drug abuse, as opposed to benefit.

Stuck in the middle are the legitimate patients who depend on marijuana as a medicine, oftentimes as their only good option.

Keep in mind that up until 1943, marijuana was part of the United States drug pharmacopeia. One of the conditions for which it was prescribed was neuropathic pain. It is a miserable pain that's tough to treat. My own patients have described it as "lancinating, burning and a barrage of pins and needles." While marijuana has long been documented to be effective for this awful pain, the most common medications prescribed today come from the poppy plant, including morphine, oxycodone and dilaudid.

Here is the problem. Most of these medications don't work very well for this kind of pain, and tolerance is a real problem.

Most frightening to me is that someone dies in the United States every 19 minutes from a prescription drug overdose, mostly accidental. Every 19 minutes. It is a horrifying statistic. As much as I searched, I could not find a documented case of death from marijuana overdose.

It is perhaps no surprise then that 76% of physicians recently surveyed said they would approve the use of marijuana to help ease a woman's pain from breast cancer.

When marijuana became a schedule 1 substance, there was a request to fill a "void in our knowledge." In the United States, that has been challenging because of the infrastructure surrounding the study of an illegal substance, with a drug abuse organization at the heart of the approval process. And yet, despite the hurdles, we have made considerable progress that continues today.

Looking forward, I am especially intrigued by studies like those in Spain and Israel looking at the anti-cancer effects of marijuana and its components. I'm intrigued by the neuro-protective study by Raphael Meschoulam in Israel, and research in Israel and the United States on whether the drug might help alleviate symptoms of PTSD. I promise to do my part to help, genuinely and honestly, fill the remaining void in our knowledge.

Citizens in 20 states and the District of Columbia have now voted to approve marijuana for medical applications, and more states will be making that choice soon. As for Dr. Roger Egeberg, who wrote that letter in 1970, he passed away 16 years ago.

I wonder what he would think if he were alive today.

Rapunzel:
This is his segment today:

http://www.cnn.com/2014/03/05/health/gupta-medical-marijuana/

Gupta: 'I am doubling down' on medical marijuana
By Dr. Sanjay Gupta, CNN Chief Medical Correspondent
updated 8:40 AM EST, Thu March 6, 2014
Watch this video

Dr. Sanjay Gupta explores politics of pot

    A growing number of patients want cannabis as a medicine
    "It is irresponsible to not provide the best care we can," Sanjay Gupta says
    Those with influence are paying attention to the debate
    The public has become intensely engaged

Editor's note: Don't miss "Weed 2: Cannabis Madness: Dr. Sanjay Gupta Reports," at 10 p.m. ET on Tuesday. Also, Dr. Gupta will be answering your questions on Reddit at noon ET Tuesday.

(CNN) -- It's been eight months since I last wrote about medical marijuana, apologizing for having not dug deeply into the beneficial effects of this plant and for writing articles dismissing its potential. I apologized for my own role in previously misleading people, and I feel very badly that people have suffered for too long, unable to obtain the legitimate medicine that may have helped them.

I have been reminded that a true and productive scientific journey involves a willingness to let go of established notions and get at the truth, even if it is uncomfortable and even it means having to say "sorry."

It is not easy to apologize and take your lumps, but this was never about me.

This scientific journey is about a growing number of patients who want the cannabis plant as a genuine medicine, not to get high.


It is about emerging science that not only shows and proves what marijuana can do for the body but provides better insights into the mechanisms of marijuana in the brain, helping us better understand a plant whose benefits have been documented for thousands of years. This journey is also about a Draconian system where politics override science and patients are caught in the middle.

Since our documentary "Weed" aired in August, I have continued to travel the world, investigating and asking tough questions about marijuana.

I have met with hundreds of patients, dozens of scientists and the curious majority who simply want a deeper understanding of this ancient plant. I have sat in labs and personally analyzed the molecules in marijuana that have such potential but are also a source of intense controversy. I have seen those molecules turned into medicine that has quelled epilepsy in a child and pain in a grown adult. I've seen it help a woman at the peak of her life to overcome the ravages of multiple sclerosis.


--- Quote ---Georgia House approves medical marijuana
Fla. to vote on medical marijuana
Can medical marijuana help seizures?
--- End quote ---

I am more convinced than ever that it is irresponsible to not provide the best care we can, care that often may involve marijuana.

I am not backing down on medical marijuana; I am doubling down.

I should add that, although I've taken some heat for my reporting on marijuana, it hasn't been as lonely a position as I expected. Legislators from several states have reached out to me, eager to inform their own positions and asking to show the documentary to their fellow lawmakers.

I've avoided any lobbying, but of course it is gratifying to know that people with influence are paying attention to the film. One place where lawmakers saw a long clip was Georgia, where the state House just passed a medical marijuana bill by a vote of 171-4. Before the legislative session started, most people didn't think this bill had a chance.

More remarkable, many doctors and scientists, worried about being ostracized for even discussing the potential of marijuana, called me confidentially to share their own stories of the drug and the benefit it has provided to their patients. I will honor my promise not to name them, but I hope this next documentary will enable a more open discussion and advance science in the process.

Marijuana is classified as a Schedule I substance, defined as "the most dangerous" drugs "with no currently accepted medical use."

Neither of those statements has ever been factual. Even many of the most ardent critics of medical marijuana don't agree with the Schedule I classification, knowing how it's impeded the ability to conduct needed research on the plant.

Even the head of the National Institute on Drug Abuse, Dr. Nora Volkow, seems to have softened her stance; she told me she believes we need to loosen restrictions for researchers.

Along the way, the public has become intensely engaged. Our collective society has paid closer attention to this issue than ever before, and with that increased education, support for medical marijuana has only grown, including in some unexpected places.

Pete Carroll, the coach of the Super Bowl-winning Seattle Seahawks, said the National Football League should explore medical marijuana if it helps players. NFL Commissioner Roger Goodell hasn't dismissed the idea, saying that if marijuana is reconsidered by the medical establishment, the league would treat it the same as any other medicine. Goodell also says the NFL is following the science that suggests marijuana may help recovery from concussions.


--- Quote ---Recently, I had the chance to tell him that the United States already holds a patent on medical marijuana for that very purpose. Patent No. 6630507: Cannabinoids are found to have particular application as neuroprotectants, for example in limiting neurological damage following ischemic insults, such as stroke or trauma.
--- End quote ---

However, this particular issue still bothers me: How can the government deny the benefits of medical marijuana even as it holds a patent for those very same benefits? Members of the Food and Drug Administration declined my repeated requests for an interview.

This past year, President Barack Obama told the New Yorker magazine, "I don't think (marijuana) is more dangerous than alcohol." And yet, as alcohol remains available to any adult, the president has not moved to remove marijuana from the list of the most tightly controlled substances in the country.

Since I started my reporting on this topic, I have mostly resisted temptation to inject a subjective moral equivalency into this discussion, such as pitting alcohol against marijuana or reminding you that cocaine and methamphetamine are actually more available than marijuana to patients, physicians and medical researchers: They are Schedule II drugs, with recognized medical uses. Or telling you that on average, a person dies every 19 minutes in this country from a legal prescription drug overdose, while it is virtually unheard-of to die from a marijuana overdose.

But, with a discussion like this, consistency does matter. Terms matter, too.

We are talking about a medicine, known scientifically as cannabis. In order for people to start thinking of this substance as a medicine, perhaps we should start calling it by its medical name, something that was suggested to me by medical marijuana advocates pretty much everywhere I went this year.

I've tried to pull together these latest developments in our new documentary, "Cannabis Madness." Although the 1936 film "Reefer Madness" was propaganda made to advance an agenda with dramatic falsehoods and hyperbole, I hope you will find "Cannabis Madness" an accurate reflection of what is happening today, injected with the best current science.

You will meet families all across the country -- a stay-at-home mom from Ohio, a nurse practitioner from Florida, an insurance salesman from Alabama -- more than 100 families who have all left jobs, homes, friends and family behind and moved to Colorado to get the medicine that relieves their suffering.

As things stand now, many of these good people don't ever get to return home. Why? Because transporting their medicine, even if it is a non-psychoactive cannabis oil, could get them arrested for drug trafficking. And so they are stuck, cannabis refugees.

You will meet them, and if you're like me, you'll be heartbroken to hear their stories, but you'll also have a lump in your throat when you see the raw, true love these parents have for their sick children.

History books may one day draw a parallel between this chapter of medical marijuana and the story of David and Goliath. Playing the role of David's slingshot, which ultimately brought Goliath to his knees, would be a 2-year-old girl named Vivian Wilson. She inspired her father to challenge the system in a spectacular way that caused a nation to stop for a moment and take note.

For months, we have filmed and followed the Wilson family with all of their trials and tribulations, and you will meet the whole family in the upcoming documentary.

I am a father myself, first and foremost. I don't want my children taking or being offered a psychoactive substance. As a neurosurgeon, I know that the developing brain is more susceptible to the most harmful effects of cannabis and that brain development continues well into our mid-20s.

I also worry that generations from now, my great-grandkids will find Internet headlines referring to me as the "pot doc." I do hope they will also read the rest of the story and understand the lives of the countless people who have suffered needlessly when a plant could have helped. I hope they know that I have dedicated my time to researching the medical literature, speaking to the scientists in person and piecing together a fact-based presentation meant to educate, not frighten.

I hope future generations won't consider me naive. Yes, I know there is a concern that many people out there will feign ailments just to get marijuana. But withholding legitimate treatment for the needy is a very unjust way of addressing that concern.

As a physician and reporter, I feel a deeper obligation to present the real stories, soundly supported with the science from all over the world.


--- Quote ---When I first apologized for my previous marijuana reporting, I was thinking about the impact that reporting may have had on Charlotte Figi. She is a sweet little girl whose brain was locked in nearly nonstop seizure activity. Without success, she tried seven different medications, stringent diets and high-dose supplements. Modern medicine had nothing more to offer, which is why her parents turned to an ancient plant. As you know, it worked.

And, as you will see, she is one of so many patients out there, suffering from different ailments, who believe cannabis rescued them when nothing else did.

For conditions like Charlotte's, the American Epilepsy Society says that there are a million people for whom existing therapies do not control their seizures. The society recently said anecdotes about medical marijuana "give reason for hope" and said it supports "well-controlled studies that will lead to a better understanding of the disease and the development of safe and effective treatments."

You should know that Charlotte continues to do well. When I saw her around the holidays, she ran over and gave me a hug. She looked me in the eyes, took me by the hand and led me all around to meet her friends. She is a delightful, happy and now healthy little girl.
--- End quote ---

I know the discussion around this topic will no doubt get heated. I have felt that heat. But I feel a greater responsibility than ever to make sure those heated discussions are also well-informed by science.

And, with that: I hope you get a chance to watch on March 11 at 10 p.m. Eastern.

aligncare:
The point is we should be making policy based on factual information and peer-reviewed research, not Reefer Madness hysteria from the 1930s.

At every level and juncture marijuana is a safer intoxicant than alcohol. Yet, only one is prohibited. Makes no sense. And it's expensive policy to chase down recreational users as lawbreakers.

But worst of all is that it's criminal to withhold potentially beneficial medicinal uses of marijuana from ever reaching the market.

Rapunzel:

--- Quote from: aligncare on March 09, 2014, 02:20:30 am ---The point is we should be making policy based on factual information and peer-reviewed research, not Reefer Madness hysteria from the 1930s.

At every level and juncture marijuana is a safer intoxicant than alcohol. Yet, only one is prohibited. Makes no sense. And it's expensive policy to chase down recreational users as lawbreakers.

But worst of all is that it's criminal to withhold potentially beneficial medicinal uses of marijuana from ever reaching the market.

--- End quote ---

Did you read the two Dr. Gupta articles I posted on this thread?  He agrees with you.

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