Why the FDA is irrelevant

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.

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More on the FDA

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.

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FDA moves even further away from science and toward politics

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.”

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Alaska Governor Murkowski dealt a set-back

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.

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A range of opinions on marijuana

A very thoughtful article by William W. Savage III in the oudaily about the different viewpoints that emerge in a discussion about legalizing medical marijuana in Oklahoma.
I think it’s well written because it really get to the heart of where people are coming from on these issues, from the hardcore opposition:

Asked if there is a way to use marijuana responsibly, Balkman said, “Not that I’m aware of. I don’t think there is.” […]
Balkman said he is unaware of marijuana having medical benefits.

… to the enlightened:

“The drug war is very profitable,” said Ron Shewey, president of the Drug Policy Forum of Oklahoma and advocate of Oklahoma’s Compassionate Care Campaign.
“The police and prisons are the two largest growing industries in America today,” Shewey said. “We’ve now got 2.2 million people behind bars in America. We’re No. 1 in incarceration per capita in the world, and a substantial amount of that is drug war. Here in Oklahoma, 32 percent of our prison population is there for drugs.”

and the moderate:

“There would have to be a big educational effort with the public because the public still views marijuana in the same class as other dangerous drugs,” said District 44 State Rep. Bill Nations, D-Norman. “What happened to marijuana is that, it may be much more innocent than methamphetamine and heroin, but in the ’60s, it got put into that dangerous category of drugs.”

It’s important for us to understand and see all the perspectives out there, even when, in the case of Balkman, they have no connection to reality.

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Sun came out today. ONDCP takes credit.

Via The Drug Update — ONDCP Press Release ECSTACY MARKET COLLAPSING: Use of the Drug Dramatically Down in the United States; International Seizures Drop Dramatically

Director Walters said, “Thanks to the work of parents, communities, and law enforcement, we are seeing a dramatic decline in the threat that Ecstasy poses to our nation. Conventional wisdom from the late nineties convinced many Americans that there was nothing we could do to stop the spread of Ecstasy abuse among young people. Once again, we have proved that balanced strategies against our drug threats make the drug problem smaller.”

It’s called a fad, John. You had nothing to do with it.
Many drugs go through fad stages. Researchers are just now dealing with how much crack was a fad (and how little laws and law enforcement affected its decline). Years from now, we’ll have the same discussion about meth, and states that built specialized “meth prisons” will be trying to find some other use for them.
Ecstasy, though it had been around for a while, had the freshness of a “new” drug in the late 90’s and got a spike of popularity (fueled in part by media frenzy). After a few years of peak popularity, the newness wore off, casual users went back to other favorite drugs, and the burnouts of the minority who used ecstasy to excess turned off many who otherwise might have tried it. Ecstasy use will level off and stabilize, until some future spike in popularity.
The drug czar has a tough job. He has to justify all the taxpayer money he’s spending, despite the fact that the drug war doesn’t work in the long run. So he has a staff that sifts through stacks of numbers and picks ones he can use. The good thing for John is that he can often use both kinds. If a number shows an increase in use? Well, then, we need to re-double our efforts with an increase in budget. A decrease in use? See, we’re winning the drug war. (Note that they don’t even track changes in levels of abuse since they consider all illegal drug use to be equal to abuse.)
The information contained in the government’s numbers is interesting. The spin is worn-out and tired.

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Dick’s advice to George

Dick Morris is recycling his moronic advice to President Bush. He thinks he has the answer to get Bush to bounce back, including:

Put the drug fight front and center: Demand drug testing in schools with parental consent, and tax incentives for workplace drug testing. Link cocaine to terrorism, and build a national consensus for tough measures to cut demand.

Maia Szalavitz responds at Huffington Post:

Finally, although in the past, it was quite easy to scream “drug” and have everyone get distracted and drop everything including their pants and their civil liberties, I don’t think Bush will find it especially easy to build the national consensus Morris wants these days.
Attorney general Ashcroft was widely ridiculed for his emphasis on fighting bongs, not bombs when he cracked down on drug paraphernalia merchants after 9/11. And the Superbowl ads that linked teen drug users to terrorists didn’t do much better.
I’m afraid you can’t use fear to sell more than one war at a time, and Bush is stuck with the war he’s got.

I hope she’s right.
And to the extent that she is, it’s got to be partly due to the large number of drug policy reformers who have been tirelessly not letting the drug warriors get away with it.

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State by state aid elimination reports from SSDP

Go to the DARE Generation Diary — SSDP has released its state by state report on the financial aid elimination penalty.
USA today ran an article on it yesterday, including a quote from our friend Tom Angell:

“I think it’s important that all members (of Congress) know exactly how many of their constituents’ lives have been ruined by this policy,” says Tom Angell, campaigns director for Students for Sensible Drug Policy.

Go get ’em, Tom!

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The ONDCP attempts to put a good face on Colombia coca estimates

[Note: This is via The Drug Update — a new site to me that could be a good resource. The Drug Update is developing a drug policy news aggregator. I’m looking forward to seeing how it develops.]
Check out the opening of the Drug Czar’s report:

This year we are reporting mixed results for the U.S. government’s just concluded annual survey of coca cultivation in Colombia.

  1. Coca cultivation declined by 8 percent, from 114,100 to 105,400 hectares, when those areas surveyed by the US government in 2004 were compared with the same areas in 2005
  2. Nevertheless, the survey also found 144,000 hectares of coca under cultivation in 2005 in a search area that was 81 percent larger than that used in 2004. The potential production for the 144,000 hectares of coca found by this year’s survey is 545 metric tons of pure cocaine

In an effort to improve the accuracy and comprehensiveness of the estimate, this year’s survey expanded by 81 percent the size of the landmass that was imaged and sampled for coca cultivation. The newly imaged areas show about 39,000 additional hectares of coca. Because these areas were not previously surveyed, it is impossible to determine for how long they have been under coca cultivation. Because of this uncertainty and the significantly expanded survey area, a direct year-to-year comparison is not possible. The higher cultivation figure in this year’s estimate does not necessarily mean that coca cultivation increased in the last year; but rather reflects an improved understanding of where coca is now growing in Colombia.

Translation: There was an increase in cultivation from last year to this year, but it doesn’t really count, because we didn’t look in some of those places last year.
So here’s what the report should read.

  1. Cultivation that we’re aware of increased by 26% from 114,100 hectares to 144,400 hectares from 2004 to 2005.
  2. In areas where we already knew there was cultivation, we were only able to reduce cultivation by 8%.
  3. Despite spraying 139,400 hectares of coca this year, we were only able to reduce cultivation in sprayed areas by 10%, and in areas where we haven’t sprayed, cultivation has increased by 12%, showing that we have no ability to keep up with cultivation despite all the effort and money.
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A message for tax day

Your Tax Dollars on Drugs, by Rob Kampia of the Marijuana Policy Project.

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