The Real Dope On Marinol and Sativex + Bonus Stock Tip!

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GW Pharmaceuticals
Just how is it that the approval of a medicine for multiple sclerosis “should” end the debate over medical marijuana?

By Bob Starrett
All I had to do is see the headline “The Real Dope On Medical Marijuana,” and the vehicle, Forbes, to know what the article said. But I read it anyway and it said just what I thought it would say. I didn’t want to get caught in the “didn’t read it” trap. Just google “didn’t read the bill”  to see what happens when people do that.
Now, I didn’t know that writers had taglines, but Forbes contributor Dr. Henry I. Miller’s tagline is “I debunk the worst, most damaging, most hypocritical junk science.” Dr. Miller is a Robert Wesson Fellow in Scientific Philosophy and Public Policy at Stanford University’s Hoover Institution. That’s a mouthful. So is what he says.

Dr. Miller, citing a 1999 report by the Institute of Medicine, states that marijuana is “modestly effective in treating the nausea and vomiting induced by chemotherapy and the wasting caused by AIDS — though not as effective as some approved medicines are.” I assume that here he means Marinol.  Those who have had experience with Marinol will tell you that it is not effective or pleasant.

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Genetic Engineering & Biotechnology News
Perhaps Dr. Henry I. Miller should see a few patients and ask them about their experiences

​Dr. Miller complains that advocates of medical marijuana play down the “significant side effects” of the substance.
Drugs.com notes the side effects of Marinol as:
Confusion; decreased coordination; dizziness; drowsiness; elevated or relaxed mood; headache; nausea; stomach pain; trouble concentrating; vomiting; weakness, severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; behavioral changes; fast or irregular heartbeat; hallucinations; memory problems; mental or mood changes (eg, feelings of anxiety, depression, detachment, panic, paranoia); seizures; severe or persistent dizziness; vision changes.
Now comes a pitch for Sativex:
“Sativex offers a model for making a genuine pharmaceutical out of crude plant material. Sativex is already approved in Canada, New Zealand, and eight European countries, including the United Kingdom, Czech Republic, Germany, Spain, Denmark and Sweden for relieving muscle spasticity in patients with multiple sclerosis.”
That’s great for patients in those countries who have multiple sclerosis but it doesn’t help any MS patients in this country. As for any other ills that medical marijuana might help, I guess those folks are out of luck.
Miller continues the pitch:
“When it is granted, the FDA’s approval of Sativex should — but won’t — end the rancorous debate over medical marijuana in a way that would both benefit patients and satisfy the legal requirement that marketed medicines must be proven safe and effective.”

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Cannabis.com
Speaking of high prices, Dr. Miller has apparently not checked the pricing on Marinol and Sativex lately

​That is apparently a stock tip — FDA approval of Sativex is assured. Note that Dr. Miller says “when”, not “if.” GWP on the London exchange if you are interested. And Marinol is produced by Unimed Pharmaceuticals which is owned by Savoy Pharmaceuticals which is owned by Abbott Laboratories [NYSE:ABT]
The reason it must be a stock tip is because it makes no sense as anything else. Just how is it that the approval of a medicine for multiple sclerosis “should” end the debate over medical marijuana? An MS drug will cure or help with everything? Talk about off-label use.
Dr. Miller says that “Sativex offers a model for making a genuine pharmaceutical out of crude plant material.” It seems to me that if making a “genuine pharmaceutical” were so simple, we would have more than a total of one drug approved for use in the United States since the “Investigational New Drug Program” began in 1978. Thirty-four years.
One FDA approved drug for two limited uses.  And if the FDA approves Sativex, we will then have 34 years and two drugs approved for three limited uses. People just are not buying it anymore.
Dr. Miller, like so many others urges FDA approval (read: “turn the whole thing over to Big Pharma”) of marijuana and marijuana infused products, stating “If marijuana has therapeutic potential, it should be required to pass muster with the FDA like any other medicine (leaving aside how well FDA regulation works overall).”
I suppose that qualifier is there for a reason and I expect that Dr. Miller knows some things that we don’t know, having worked for the FDA from 1977 to 1994.
So what about the side effects of Sativex? You thought Marinol was rough. According to canoe.ca, the possible side effects are:
Abdominal pain, burning sensation in the mouth, constipation, diarrhea, dizziness, dry mouth, flushing, forgetfulness or poor concentration, headache, increased appetite, mood changes, nausea, sore throat, soreness or stinging sensation in mouth, tiredness, trouble sleeping, unusual taste in the mouth, vomiting, weakness, anxiety, blurred vision, confusion, fainting, falls, or difficulty with balance, hallucinations (seeing, hearing, or feeling things that are not there) or strange ideas intoxication (a feeling of being drunk; e.g., difficulty paying attention, dizziness, sleepiness, disorientation, changes in mood, a feeling of unreality, or a feeling of general happiness or a “high,” such as easy laughter or heightened awareness) loss of appetite, mouth sores, rapid heartbeat, severe dizziness, severe tiredness, signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide).
Dr. Miller also complains about the high cost of medical marijuana.
“Controversy continues over whether state laws should permit the existence of marijuana dispensaries — which charge high prices for marijuana products, including the leaves themselves, tinctures, baked goods and candies — without government supervision or other assurance of quality.”
Now, I am not aware that dispensaries are charging high prices; in fact, the free market is happily at work here in Colorado where there is a price war going on at the moment. Speaking of high prices, Dr. Miller has apparently not checked the pricing on Marinol and Sativex lately.
If a dispensary sells bad product they are going to go out of business. If Merck, for example, sells bad product they just have to pay $4.8 billion to settle consumer claims and almost a billion dollars in civil and criminal penalties and plead guilty to a crime. That was likely already in the reserves. Merck is too big to fail.
Miller concludes, “Patients who are genuinely in need deserve safe and effective medicines, and rigorous testing and
oversight are the best ways to provide them.” And the FDA can deliver on that. Yeah, sort of like when it approved Vioxx.
Instead of debunking the worst, most damaging, most hypocritical junk science, perhaps Dr. Miller should see a few patients and ask them about their experiences.
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Editor’s note: Bob Starrett, with 22 years of experience with Optical Disc and Drive technology, is co-author of six books on CD and CD-ROM technology, and his published magazine work includes more than 250 articles, reviews and columns on CD-ROM, CD Recordable, DVD-ROM and DVD Recordable technology for publications including PC Magazine, EMedia Magazine, CD-ROM Professional, Digital Video Magazine, Digital Content Creator, One To One, Online, Tape-Disc Business and others. He holds a J.D. from the University of Colorado School of Law.


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