Andrea Barthwell, Snake Oil Salesman

(4/20/05)
CANNABIS SATIVAEX
Former Deputy Drug Czar Andrea Barthwell (more about her here) is the new spokesperson for getting GW Pharmaceuticals’ Sativex approved for use in the United States.

This is SO right for so many wrong reasons.

Andrea has always been willing to sell her services to the right bidder, and then spread whatever lies are necessary, regardless of what she said or believed before. When she went to the Drug Czar’s office, she said it was because she wanted to improve the nation’s emphasis on treatment and then actually went around selling the Drug Czar’s new treatment budget that was increased only because they changed the method of accounting. She went around Illinois spreading lies about marijuana and even lying about her sponsorship. She’s called those who favor medical marijuana cruel, and snake oil salesmen.

She’s just what GW Pharmaceuticals needs.

Here’s what makes all this fun:

  1. Sativex is marijuana, in liquid form
  2. I am strongly in favor of Sativex and getting it approved in the United States. In this, GW and I are together.
  3. I also believe that marijuana as a plant should be legalized for medical purposes (and other purposes). In this, GW is opposed to me, because what they can charge for Sativex is, to a large degree, dependent on people not being able to substitute marijuana plants for the prescription liquid marijuana.
  4. Therefore GW needs someone to both promote the safety and efficacy of liquid marijuana so that our officials will accept it, while at the same time demonizing the exact same stuff in plant form. Andrea’s the perfect choice. Logic and truth are no barriers for her.
  5. After some delay, the government will respond to Andrea’s lobbying (after consulting with their contributors in the pharmaceutical lobbies) and then Sativex will be rushed through FDA approval in two weeks, and in a stunning display of hypocrisy, Sativex will be removed from Schedule 1 of the CSA, while Cannabis Sativa remains there.

So Andrea has started her work.

To help press for approval, the company has turned to former Bush administration assistant drug czar Andrew Barthwell, a longtime opponent of medical use of marijuana. “Having this product available will certainly slow down the dash to make the crude plant material available to patients across the country,” said Barthwell. “Comparing crude marijuana to Sativex is like comparing a raging forest fire to the fire in your home’s furnace. While both provide heat, one is out of control. [link]

So just how different is Sativex from marijuana? Rob Kampia has the answer

Make no mistake: Sativex is liquid marijuana. It is nothing like Marinol, the synthetic THC pill sold in the U.S. and sometimes falsely touted as an adequate substitute for marijuana.

Sativex is a whole-plant extract, containing the rich variety of naturally occurring compounds called cannabinoids that are unique to marijuana. It also contains trace elements of other compounds contained in the plant, which scientists believe contribute to its therapeutic value.

On its web site, GW Pharmaceuticals explains, “We believe very strongly that many of the advantages of using the whole plant come from the inclusion of other components of cannabis [marijuana],” not just THC. “In the cannabis plant, it appears that some of the components added together give better effect. Some components seem to work to counteract some of the side effects of others, and the whole plant is generally well tolerated by humans.”

Has Andrea talked about efforts like GW’s in the past? Let’s take a look back in time:

At the more controversial end of the aboveground marijuana economy, developers are using the plant itself instead of synthetic compounds. “At least in the near future, it seems extremely unlikely that one of these companies will come up with a single synthetic agent that’s as widely applicable as a cannabis-based medicine,” says Russo. GW is taking whole extracts from the marijuana plant and recombining them to produce drugs that treat specific ailments. This plant-based approach has enabled the company to develop and test Sativex in five years, at a price tag of about $60 million. It’s a remarkable feat, considering that Big Pharma on average shells out $800 million on a new drug and can easily devote a decade or more to animal research and first-dose-in-man testing. GW did minimal animal testing, taking Sativex rapidly to controlled, double-blind human trials. “Something like 400 million people a year take cannabis in one form or another, and yet there’s never been a recorded fatality from it,” says Guy.

But you won’t find any commercial development of plant-based marijuana medicines being pursued in the United States. Andrea Barthwell, a deputy director in the White House Office of National Drug Control Policy and President Bush’s point person on medical marijuana, says cannabis medicines aren’t compatible with modern science. They do not constitute “a serious line of research,” she says.

“The people who are advancing marijuana as a medicine are perpetuating a cruel hoax that exploits our compassion for the sick,” Barthwell says. “They are using patients’ pain and suffering in an attempt to change America’s drug control policy. Marijuana is a crude plant product that most definitely is not a medicine.”

Not a serious line of research, huh, Andrea? But you’re working for them now. Are you perpetuating a cruel hoax? Are you exploiting compassion for the sick?

Let’s see what else Andrea has had to say about marijuana, the drug she’s now selling in liquid form.

“I doubt it was in the scheme that the Great Creator would put one plant on Earth that could cure everything wrong with you,” said Barthwell as the audience laughed. [link]

“It is not a medicine,” she said. “You don’t know what’s in it,” she said. [link]

“If there were compelling scientific and medical data supporting marijuana’s medical benefits that would be one thing,” Barthwell said. “But the data is not there. The claim of one individual who has used marijuana does not medical data make. Marijuana has not gone through the test of science because it is a botanical and it doesn’t have the same effect on every individual.” [link]

“A crude plant is definitely not a medicine,” Barthwell said. “A surgeon doesn’t come to a patient recovering from surgery and give them a pipe of opium – you give them a derivative.” [link]

“While there are no proven benefits to marijuana use, there are many short- and long-term risks associated with marijuana use,” said Dr. Andrea Barthwell of the Office of National Drug Control Policy. “Even if smoking marijuana makes people feel better, that’s not enough to call it a medicine.” [link]

As a crude plant, marijuana is so complex, unstable, and harmful that sensible physicians and researchers consider it unethical to expose individuals to the risks associated with smoking it. [link]

I witnessed firsthand the impact of the “medical marijuana” movement when I was medical director for the largest youth addiction treatment system in Illinois . Children entering drug abuse treatment routinely report that they heard that “pot is medicine” and, therefore, believed it to be good for them. …
The biggest threat to creating an effective environment of prohibition is the active campaign of legalizers to blur the line between dangerous, illegal drugs and medicine.
[link]

“The people that have this as an agenda are not concerned for the sick or dying,” Barthwell said. [link]

Dr. Andrea Barthwell, deputy director for demand reduction at the White House Office of National Drug Control Policy, rejects the term “medical marijuana,” instead calling it “medical excuse marijuana.” She says those who push for laws like Maryland’s are “feeding off the pain and suffering of people” in pursuit of their real goal: complete legalization of marijuana. “There’s no basis in medical [knowledge] for taking a crude plant material and providing it as medicine,” she said. [link]

Oh, it’s going to be fun having Andrea around.

GW Pharmaceuticals

F.A.Q excerpts:

What is a “whole plant extract”?
When we talk about a “whole plant extract” we mean an extract of the chosen part of the plant, and here we are talking about the aerial part of the plant, not the roots. We do not actually have to strip one part of the plant away; we are quite content to make extracts from all of the aerial parts of the plant – the leaf and the bud. Since our bud to leaf ratio is ten to one, we do not have much leaf.

By extraction we arrive at a pharmaceutical grade material which is a clear liquid in a bottle and from there we can than proceed to formulation work and continue to incorporate those materials in the appropriate drug delivery modalities.

What are cannabinoids?
Cannabinoids are a group of molecules found only in the cannabis plant. Different cannabinoids appear to have different pharmaceological effects but certain cannabinoids have been shown to have analgesic, anti-spasmodic, anti-convulsant, anti-tremor, anti-psychotic, anti-inflammatory, anti-oxidant, anti-emetic and appetite-stimulant properties and research is ongoing into neuroprotective and immunomodulatory effects.

What are GW’s medicines?
GW’s medicines are derived from standardised whole extracts of proprietary cannabis plant varieties bred to exhibit a pre-determined content of cannabinoids. These extracts are incorporated into non-smoked drug delivery technologies and then undergo pre-clinical and clinical testing prior to submitting applications to pharmaceutical regulatory authorities.

How is cannabis likely to be administered to patients?
GW’s first product, Sativex┬«, is an oro-mucosal spray. GW is also evaluating tablet and capsule formulations and is developing an inhaler.

Why not just let patients smoke cannabis?
In GW’s opinion, smoking is not an acceptable means of delivery for a medicine. Patients wish to use a medicine that is legally prescribed, does not require smoking, is of guaranteed quality, has been developed and approved by regulatory authorities for use in their specific medical condition and is dispensed by pharmacists under the supervision of their doctor.

Are cannabis medicines safe?
Data from GW’s clinical trials confirm that its medicines are generally well tolerated. The trials have generated over 600 patient-years of safety data and adverse events have been predictable and generally well tolerated.

Do patients get high?
By careful self-titration (dose adjustment), most patients are able to separate the thresholds for symptom relief and intoxication, the “therapeutic window”, so enabling them to obtain symptom relief without experiencing a “high”. Patients emphasise that they seek to obtain the medical benefits without intoxication.

Is GW looking at different forms of cannabis from those known to recreational users of the drug?
Recreationally, everybody has been trying to produce high THC varieties. We believe very strongly that many of the advantages of using the whole plant come from the inclusion of other components of cannabis in addition to THC, specifically CBD.

In the cannabis plant, it appears that some of the components added together give better effect. Some components seem to work to counteract some of the side effects of others, and the whole plant is generally well tolerated by humans. The relationship between the dose required for medicine and the dose required to kill somebody is about 20-40,000 times. A standard pharmaceutical ratio might be in the order of 50 or 100, so cannabis is in relative terms very well tolerated.

GW is interested in researching as many of the cannabinoids as possible. We are also interested in some of the non-cannabinoid contents. There are some ingredients in cannabis that have very potent pharmacological activity but which are not cannabinoids.

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