Drug WarRant

At the Drug War Chronicle

A week after the US Food and Drug Adminstration (FDA) issued a one-page opinion claiming marijuana has no proven medical uses — a position that ignores the much more comprehensive analysis done by the National Academy of Science’s Institute of Medicine in 1999 — a bipartisan group of 24 House members led by Rep. Maurice Hinchey (D-NY) has called on the agency to explain its reasoning and offer scientific proof for its position.
“Despite the fact that you are responding to a scientific question, your press release failed to provide any scientific expertise,” the representatives wrote in a Thursday letter to FDA Acting Commissioner Andrew von Eschenbach. “We call on you to show us the purported scientific evidence for the basis of this response. There is no evidence that you have new scientific proof or that you oversaw clinical trials. It perplexes us that even though the FDA is responsible for protecting public health, the agency has failed to respond adequately to the IOM’s findings seven years after the study’s publication date.”

Representatives who signed the letter: Maurice Hinchey, Ron Paul, Barney Frank, Sam Farr, Tammy Baldwin, Raþl Grijalva, Robert Wexler, Dennis Kucinich, John Conyers, Maxine Waters, Dana Rohrabacher, Jim McDermott, Tom Lantos, Jerrold Nadler, John Olver, Lois Capps, Julia Carson, Peter Stark, Jan Schakowsky, George Miller, Zoe Lofgren, Tom Allen, Barbara Lee, Gary Ackerman

Via NORML

Leiden, the Netherlands: Vaporization is a “safe and effective”
cannabinoid delivery system for patients desiring the rapid onset of
action associated with inhalation, but who are seeking to avoid the
respiratory risks of smoking, according to clinical trial data to be
published in the Journal of Pharamceutical Sciences.
Researchers at Leiden University’s Institute of Biology (the
Netherlands) found that use of the Volcano vaporizing device delivered
set doses of THC to subjects in a reproducible manner while
suppressing the intake of respiratory toxins.
“Our results show that with the Volcano, a safe and effective
cannabinoid delivery system seems to be available to patients,”
investigators concluded. “The final pulmonal uptake of THC is
comparable to the smoking of cannabis, while avoiding the respiratory
disadvantages of smoking.”
Cannabis smoke contains many of the same carcinogens as tobacco smoke,
including greater concentrations of certain aromatic hydrocarbons such
as benzopyrene, prompting concerns that chronic marijuana inhalation
may be a risk factor for tobacco-use related cancers. Previous
research by California NORML and others have demonstrated that
cannabis vaporization suppresses many potentially harmful respiratory
toxins by heating cannabis to a temperature where active cannabinoid
vapors form (typically around 180-190 degrees Celsius), but below the
point of combustion where noxious smoke and associated toxins (i.e.,
carcinogenic hydrocarbons) are produced (near 230 degrees Celsius).
A 2004 protocol by California NORML and MAPS (Multidisciplinary
Association for Psychedelic Studies) to investigate the types of
emissions produced by cannabis vaporization was recently rejected
after an 18-month regulatory delay by NIDA (US National Institute on
Drug Abuse), which stated that the study would “not add to the
scientific knowledge base in a significant way.”
“The US Institute of Medicine and others have repeatedly called for
the creation of a non-smoked, rapid-onset cannabis delivery system to
administer reproducible doses of active cannabinoids to patients,”
said NORML Advisory Board member Dr. Mitch Earleywine, author of
Understanding Marijuana: A New Look at the Scientific Evidence. “These
data confirm that vaporization can deliver all the essential
components of medical marijuana safely and effectively while
suppressing the intake of carcinogenic smoke. Now the Drug Czar’s
office and the Food and Drug Administration can rest assured that
patients may receive the therapeutic relief they need without
suffering from the unwanted health risks associated with smoking.”

Gee, I don’t think the Drug Czar and the FDA are going to be that happy about it.
The government refuses to allow vaporization studies, claims that “smoked” marijuana can never be a medicine and now we’ve had to go to another country to get a study done that shows the truth. If this were an accountable government, people would be fired for this.
Lawsuits should be filed for intentionally blocking research that could save lives (except, of course, that the government automatically immunizes itself from such lawsuits).
Write your representatives. Demand some action.
Oh, and for those interested, after a recent increase in the stock prices for GW Pharmaceuticals, it closed today down 2.7% in Online Trading. Probably just a coincidence.
And here’s where you can get the Volcano.

These have been widely reported elsewhere, but in case you missed them, I wanted to give you the links:
“bullet” Torturing Drug War Suspects: I talked about it some time ago, but Radley brings back to the net the case of the torture of Eugene Siler. Cops torture him to get him to sign a consent form for their search of his place. Siler’s wife, however, had turned on a tape recorder and now the audio is available online (Note: The address is an mp3 file being forced to play on Windows Media. If Mac users have trouble making it work, install Windows Media Components for Quicktime).
It’s truly sickening. And how many times has something like this happened when there wasn’t a tape recording? Would a court believe the word of a drug suspect over a cop without such direct evidence?
This is an indictment of those specific cops, but it’s also an indictment of the drug war in general that fosters such behavior.
“bullet” Life in prison? A 17 year-old man takes part in a robbery that nets $2 (they returned the wallet), pleads guilty, and gets 10 years probation. During his probation, he smokes a joint and flunks a drug test. Judge sentences him to life in prison.
I don’t know how anyone can claim that makes a bit of sense from a moral, criminal justice, practical, or financial basis. (Read the rest of the article for information on how the judge handles different cases.) [Thanks, David]

Des Moines Register today

In a conference call with Iowa reporters, Grassley [R-Iowa] said: “I think the president ought to fire the drug czar.” He said that he wrote Walters calling for more action on meth and the response he received was “basically, bureaucratic mumbo-jumbo.”
Walters and the Office of National Drug Control Policy continue to place much more emphasis on fighting marijuana use, said Grassley.

Now, this doesn’t make Grassley a friend of Drug Policy Reform by any means — he’s still a hard-liner who doesn’t get how the drug war works. But it’s nice to see the falling out — Grassley thinks he’s actually fighting the drug war, while Walters knows it’s about demonizing marijuana for political and financial reasons.

“bullet”

I’m recommending that you advance order Glenn Greenwald’s new book “How Would a Patriot Act? Defending American Values from a President Run Amok.” While I don’t know if the drug war is specifically mentioned in the book, it has a lot of relevancy, as the book deals extensively with the further destruction of the fourth amendment. I also know that Glenn is strongly opposed to the Drug War (as he has demonstrated through his willingness to let me post about the drug war at his highly popular site).
The book is currently #2 in the Amazon best-seller list and it doesn’t even come out until May.


“bullet” The big discussion today in the blogs is Net Neutrality. See Libby’s post for an overview and some excellent links. Congress is acting this week, and they may be acting without thinking it through very well (surprise, surprise). While I’m not a big fan of government regulation, it seems possible that, in this case, government regulation may be needed to prevent private regulation and to insure the continued free flow of the internet.
“bullet” Posting here has been slightly sporadic and will continue to be so, as this is an extremely busy time for me. End of the semester extra work, plus:

• Last week a student group I advise held a four-square marathon to raise money for scholarships. They went for 61 consecutive hours (and I was there for about 50 of them).
• I’ve been Musical Director and Pianist (actually, the entire orchestra) for a delightful student-directed production of “You’re A Good Man, Charlie Brown” that was performed this past weekend.
• This Friday, I’m playing background jazz piano for a stylish art exhibition and sale.
• Saturday, I’m going to Iowa to get back together for the first time with the cover rock band I played with in the early 1980s. We’ll be playing a lot of Doors and Wilson Pickett music, as well as preparing for a gig in May where we’ll back up the incredible Becca Sutlive (who also happens to be our lead guitarist’s daughter).
• I’m also busy with lots of photography work.

But I’ll try to keep posting as much as I can. Be sure to read the comments, as many of the regulars here provide more good material there, and visit the messageboard as well.

Boy, I wonder if anyone at the FDA foresaw this. The FDA statement against medical marijuana has been received around the nation (and even the world), as if NASA had proclaimed that the earth is flat.
It was such an obvious political lie (especially when the FDA is facing criticism for political decisions in a number of other areas), that nobody with a shred of credibility has accepted it. Editorials all over the country have slammed the FDA.
Here are just a few examples.
Here’s a classic. It begins:

The credibility of the U.S. Food and Drug Administration is dead.

and ends:

The reliability of the government to give a straight answer drawn from its huge resources is an embarrassment.

It’s time to pile on. Let’s drive the nails in the coffin. Put another shovel of dirt on them.
Go to MAPinc. Check out the huge list of newspapers that published an article about this. Pick one close to you and write a letter to the editor that responds to the FDA statement. It’s a perfect opportunity.
Go ahead. Do it now. I’ll wait….

First, it’s important to note (as major media outlets have already) that the recent controversial FDA comments were politically motivated, were wrong, and ignored scientific evidence.
But it’s also important to understand that, in practical terms, the FDA’s opinion regarding medical marijuana has as much relevance as if they had made a statement regarding whether ice cream tastes good.
And here’s why.
The purpose of FDA approval of medicines is to insure their safety and efficacy. In fact, versions of the phrase “safe and effective” were used 8 times in the FDA release. So let’s take a look at those two terms.
Efficacy:
Efficacy is another way of asking “Does it work?” Why this is important to know is that choices are made in medical treatment. If you choose one course and it’s not effective, then you may not be following a course that is effective. In treating major illnesses, this could mean life or death.
The prime example here is the controversial drug laetrile, an un-approved drug derived from apricot pits which was promoted heavily as a cure for cancer. By most scientific evidence, it did not work, and it meant that desperate patients who were looking for a cure and turned to laetrile may therefore have missed out on treatments that were less radical, but might have provided some value. Preventing “quack” cures is therefore a logical reason for the FDA’s efficacy standard (although there are also those who say that a government agency is not the right solution to that potential problem).
It is also important to understand the difference between a cure and a symptom reliever. Laetrile was promoted as being a cure for cancer, and that made its overall efficacy critical. You needed verifiable and reproducible data — you couldn’t just decide on an individual case-by-case basis to use it, because by the time you found out whether it worked or not, it was likely too late to do anything about it. A symptom reliever, on the other hand, gives immediate feedback.
When people have a cold, many of them take chicken soup as “medicine.” As far as I know, chicken soup is not an FDA approved medicine, and it’s not certain that it has any actual medical value. But there is no “cure” for a cold — all you can do is try to relieve the symptoms so you can function through the course of it. If chicken soup makes someone feel better when they have a cold, then it is an effective symptom reliever. No other measurement is necessary.
The same is true, for the most part, with medical marijuana. While there is a ton of fascinating potential for marijuana to function as a “cure” in some conditions, and much more research needs to be done (and not blocked by the FDA) to learn about this potential, the primary current use of medical marijuana is as a symptom reliever. It is used to reduce nausea for those taking toxic drugs during chemotherapy treatments. It is used to reduce pain in a variety of conditions. In all of these cases, it is not necessary to conduct large studies to prove efficacy.
Different symptom relief treatments work for different people, and the best way to determine the best treatment is between patient and doctor. And it’s very easy. Let’s say that you have nausea from chemotherapy that is preventing you from taking or keeping down necessary medicine. So you try marijuana. If it doesn’t work, then you and your doctor try something else. If it works — if it relieves the nausea so you can take your other medicine — then it is efficacious. Period. Regardless of what the FDA says.
And medical marijuana has been proven to work in thousands of cases.
The only question is whether it works on its own, or whether it works psychologically (you believe in it so it works). Testing of new drugs uses control groups with placebos to measure this factor, and in the case of very expensive drugs, this information is useful even with symptom relievers (why spend thousands of dollars on something that only works because you believe it does?) But in the case of medical marijuana, it doesn’t matter. If it works because it works, or because you believe it works, it still works. And the cost is so minimal that, just like chicken soup, nobody really cares if it is only psychological.
So when drug warriors claim that the medical marijuana movement is perpetuating a “cruel hoax” on patients (the phrase has been used by many, from McCaffrey to Barthwell), they are clearly and obviously lying. There can be no cruel hoax when it comes to symptom relief. If something relieves the symptoms, then it was successful, and cannot be a hoax. The only thing “cruel” would be to withhold a genuine symptom reliever from a patient.
Safety:
The second factor in evaluating medicines is “safety.” Chicken soup helps relieve cold symptoms, and is also safe (unless you’re allergic to chicken). But let’s assume for a moment that cyanide relieved cold symptoms. That would make it efficacious, but not safe. (Note: Laetrile contained cyanide, and several patients being treated with laetrile died of cyanide poisoning.)
So the FDA also checks medicine for safety through drug trials, which includes coming up with the often voluminous list of side-effects. Causing side-effects up to, or even including, death, is not necessarily an impediment to FDA approval, depending on the intended use (or the amount of political or economic pressure wielded by the pharmaceutical company).
With a new drug, testing for safety is important. You’d hate to take a medicine for headache relief, only to find out a few years later that it causes mutations and you’ve got a third arm growing out of your forehead.
Marijuana, however, is not a new drug. It has been used extensively for thousands of years. There has probably been more informal safety testing done on marijuana than any drug that the FDA has approved.
Where are the bodies? With thousands of years of use, there has not been a single fatality directly resulting from marijuana use. And with all the various studies that have been done, the worst that has been found is that heavy smoking of marijuana (if you choose that method of ingestion) can cause bronchial conditions (although not as much as legal tobacco).
So the real question is, with all the information we have, can a doctor make an informed decision as to the safety of marijuana for symptom relief? The answer is clearly “yes.” There’s very little that an FDA approval could add to the voluminous information we already have as to the safety of marijuana.
Conclusion:
The FDA approval process may have some value insuring a control on the safety and efficacy of many pharmaceutical drugs, but when it comes to medical marijuana, FDA opinion is irrelevant, and their recent statement is nothing more than absurd political grandstanding.

New York Times editorial today

The Bush administration’s habit of politicizing its scientific agencies was on display again this week when the Food and Drug Administration, for no compelling reason, unexpectedly issued a brief, poorly documented statement disputing the therapeutic value of marijuana.

Under pressure from drug warriors, the FDA, released a statement opposing the use of medical marijuana. After a series of false statements claiming that “no sound scientific studies supported medical use of marijuana for treatment in the United States, and no animal or human data supported the safety or efficacy of marijuana for general medical use,” the FDA concluded:

A growing number of states have passed voter referenda (or legislative actions) making smoked marijuana available for a variety of medical conditions upon a doctor’s recommendation. These measures are inconsistent with efforts to ensure that medications undergo the rigorous scientific scrutiny of the FDA approval process and are proven safe and effective under the standards of the FD&C Act. Accordingly, FDA, as the federal agency responsible for reviewing the safety and efficacy of drugs, DEA as the federal agency charged with enforcing the CSA, and the Office of National Drug Control Policy, as the federal coordinator of drug control policy, do not support the use of smoked marijuana for medical purposes.

The New York Times has done a nice job responding and pointing out how political this move is:

The announcement inserts the health agency into yet another fierce political fight. […] Congressional opponents and supporters of medical marijuana use have each tried to enlist the F.D.A. to support their views.

The ONDCP’s Tom Riley’s response was moronic, as usual:

Tom Riley, a spokesman for Mr. Walters, hailed the food and drug agency’s statement, saying it would put to rest what he called “the bizarre public discussion” that has led to some legalization of medical marijuana.

That statement was eerily reminiscent of his boss’ wishful thinking after the Raich decision:

“Today’s decision marks the end of medical marijuana as a political issue.”

Right.
The Times also provides useful rebuttals to the FDA piece.

Dr. John Benson, co-chairman of the Institute of Medicine committee that examined the research into marijuana’s effects, said in an interview that the statement on Thursday and the combined review by other agencies were wrong.
The federal government “loves to ignore our report,” said Dr. Benson, a professor of internal medicine at the University of Nebraska Medical Center. “They would rather it never happened.” […]
“Unfortunately, this is yet another example of the F.D.A. making pronouncements that seem to be driven more by ideology than by science,” said Dr. Jerry Avorn, a medical professor at Harvard Medical School. […]
…scientists who study the medical use of marijuana said in interviews that the federal government had actively discouraged research. […]
Dr. Donald Abrams, a professor of clinical medicine at the University of California, San Francisco, said he had studied marijuana’s medicinal effects for years but had been frustrated because the National Institutes of Health, the leading government medical research agency, had refused to finance such work.[…]
“One wonders how anyone” could fulfill the Food and Drug Administration request for well-controlled trials to prove marijuana’s benefits, he said. […]
…the Institute of Medicine report concluded there was no evidence that marijuana acted as a gateway to harder drugs. And it said there was no evidence that medical use of marijuana would increase its use among the general population.
Dr. Daniele Piomelli, a professor of pharmacology at the University of California, Irvine, said he had “never met a scientist who would say that marijuana is either dangerous or useless.”
Studies clearly show that marijuana has some benefits for some patients, Dr. Piomelli said.
“We all agree on that,” he said.

So how do you respond to that, FDA?
Update:
“bullet” Davis Sweet has fun with the FDA statement at the Huffington Post

Citizens: I know a lot of people who smoke marijuana, and they seem like they’re doing all right.
Gummint: AAAAAAAAAAAAAAAAAAAAH! AAAAAAAAAAAAAAAAH!
Citizens: Seems like more than half of me has tried it, even the past couple of presidents.
Gummint: AAAAAAAAAAAAAAAAH! HIPPIEEEEEEEEEEEEES! HIPPIES EVERYWHERE!
Citizens: But Shining Example Bush isn’t running around in funky costumes preaching love and stuff, is he? Oh, wait…

“bullet” ONDCP pod-people-cast tries to defend and crow about the FDA statement. ONDCP policy analyst stooge David Murray is “interviewed” (I love the fact that they introduce him as “Doctor David Murray” as if to imply that he has medical knowledge.) His argument included such gems as the fact that the FDA verified that marijuana is still a Schedule 1 drug — by definition having no medical value and being prone to abuse — as if this was an evaluation by the FDA, and not simply a Congressional definition that has no connection to reality.
Murray also claims that the Institute of Medicine report did not show medical value from marijuana (he has to really pick selectively through the report to support his claim). He can only do it by ignoring the final conclusions of IOM’s report that recommends n-of-1 trials of marijuana. He also pushes hard the notion of promoting the development of drugs from marijuana, but not smoked marijuana itself.
“bullet” AmericaBlog:

It’s called science, you freaks. It doesn’t change, it doesn’t go away, simply because it makes you uncomfortable. It’s not about you. It’s about objective facts. Is this what you people teach your children? Lie your way to heaven?

“bullet” Bruce Mirken via WebMD:

“This is a political statement, not a scientific statement, and the FDA should be embarrassed,” Bruce Mirken, director of communications for the Marijuana Policy Project, tells WebMD. […]
“I truly think that years from now, this is going to be looked at as a very sad day and a milestone in the decline of the FDA as a scientific agency,” Mirken says.

“bullet” Rush Limbaugh:

“The FDA says there’s no — zilch, zero, nada — shred of medicinal value to the evil weed marijuana. This is going to be a setback to the long-haired, maggot-infested, dope-smoking crowd.”

The story so far…
The Alaskan Supreme Court rules that the state constitution’s privacy provision prevents arresting individuals for possessing up to four ounces of marijuana in their home, under the notion that marijuana isn’t dangerous enough to justify the privacy intrusion.
This pisses Governor Murkowski who really wants to go after marijuana users more than anything. So he holds some sham hearings to try to make the case that marijuana is now much more dangerous. He then slips in a marijuana re-criminalization bill and gets it attached to a meth bill. The idea is that he’ll fight it up to the State Supreme Court again — this time proving that the “new” marijuana is really, really dangerous. It looked like it was a sure battle, until…

JUNEAU, Alaska (AP) – The Alaska House dealt a setback on Wednesday to Gov. Frank Murkowski’s efforts to recriminalize marijuana.
Eight Republicans joined thirteen Democrats to reject a compromise measure that linked what the governor called a “must-have” marijuana bill with a measure that restricts the sale of over-the-counter drugs used in making methamphetamine.
The vote was 19-21.
House majority leader John Coghill, R-North Pole, described the vote as a “surprise.”
Coghill, who supported the measure, earlier said he was confident that lawmakers would embrace tougher measures dealing with methamphetamine, despite some opposition over the marijuana provisions.
“Obviously some other things happened. There was tension between the House and the Senate and I think that’s where we ended up,” he said.[…]
While many expressed strong support for the methamphetamine provisions, they said the governor’s attempt to recriminalize marijuana needed a thorough vetting in the House, something that was denied when the Senate combined the bills. […]
The drug bill contains a series of findings that Murkowski plans to use as a tool to overturn a 31-year-old Supreme Court ruling that makes it legal to possess small amounts of marijuana in the home.
The court had ruled that Alaskan’s right to privacy was far more important than any harm that could be caused by the drug.

Way to go, Alaska.