Next time you're thinking to yourself, "Hey, I'll do my part for science and sign up for a clinical trial of a new drug," you might want to consider... well, a couple things, including how much are they paying and will you get high, but also consider this:

In a report due to be released Friday, the inspector general of the Department of Health and Human Services, Daniel R. Levinson, said federal health officials did not know how many clinical trials were being conducted, audited fewer than 1 percent of the testing sites and, on the rare occasions when inspectors did appear, generally showed up long after the tests had been completed.

The F.D.A. has 200 inspectors, some of whom audit clinical trials part time, to police an estimated 350,000 testing sites. Even when those inspectors found serious problems in human trials, top drug officials in Washington downgraded their findings 68 percent of the time, the report found. Among the remaining cases, the agency almost never followed up with inspections to determine whether the corrective actions that the agency demanded had occurred, the report found.

“In many ways, rats and mice get greater protection as research subjects in the United States than do humans,” said Arthur L. Caplan, chairman of the department of medical ethics at the University of Pennsylvania.

Nice!

A new installment of my increasingly sporadic column for Erowid, eScottology, has just been posted. Entitled "That Kind Of Night," the piece explores the perils of failing to control your set & setting while blasting your consciousness with nitrous oxide.

With notable enthusiasm, he puts the canister to his mouth and presses the trigger, inhaling as deeply as humanly possible. His lungs expand, his eyes close, shooting stars begin to ricochet around the inside of his head. The inside of his head begins to shimmer and his extremities begin to tingle; eventually he exhales in a burst, and gasps for air, which only seems to bring on the full flowering of the hit of nitrous. He keeps hearing strange and delightful sounds, music being played on alien instruments, the resonant hum of inner space. Whatever stimulating effect remains from the alphabetamine he took earlier in the evening is serving as a launch platform to send him deeper into the recesses of consciousness than a single nitrous cartridge could otherwise do. He is deep, he is surfing feedback signals from his own brain, he is coming close to some kind of unity. And in the midst of it, he hears–

“You can’t just ignore such a dangerous betrayal,” a voice behind him calls out. “You have to rely on the strength of your own convictions.”

–which, but wait, does this even yet make sense? Because, honestly, you can’t ignore dangerous betrayal… you just can’t, especially when you’re sliding through fractal realms and all your pleasure circuits are activated and firing at full throttle. When you’re on the verge of actually losing consciousness, or rather finding your consciousness subsumed by the larger “it” that can only be the thing that does that kind of subsuming in the first place, isn’t it obvious that you have to rely on the strength of your convictions? Or is it the case that this fact is being pointed out right here, right now, because it’s not obvious, because it’s a true danger, a spiral, one in which the betrayal comes from within?

Are these people even ground control or what?

In case news of this study hasn't crossed your path yet, here's something for all you caffeine addicts to pay a little attention to: a recent study would have you believe that combining caffeine with acetaminophen might not be so good for you.

Consuming large amounts of caffeine while taking acetaminophen, one of the most widely used painkillers in the United States, could potentially cause liver damage, according to a preliminary laboratory study reported in the Oct. 15 print issue of ACS’ Chemical Research in Toxicology, a monthly journal. The toxic interaction could occur not only from drinking caffeinated beverages while taking the painkiller but also from using large amounts of medications that intentionally combine caffeine and acetaminophen for the treatment of migraine headaches, menstrual discomfort and other conditions, the researchers say.

Health experts have warned for years that consuming excess alcohol while taking acetaminophen can trigger toxic interactions and cause liver damage and even death. However, this is the first time scientists have reported a potentially harmful interaction while taking the painkiller with caffeine, the researchers say.

Now before you take these claims at face value (which of course is exactly the kind of thing I always do), let's see what Drugs and Poisons has to say on this subject:

The investigators used doses of acetaminophen and caffeine that far exceed the levels of typical daily consumption of these drugs by most people, so even if CYP 3A4 does indeed convert acetaminophen into a toxic metabolite and caffeine enhances this process, it is likely only relevant to a small group of people: Those who take too much Tylenol on a regular basis AND consume coffee like a marathon runner consumes water.

Whew, that was close!

At a time when drug scare stories are never more than a local affiliate news truck away, it's nice to see that the freaking out extends to I-Doser, which, as you may recall, is a set of CDs that supposedly stimulate drug-like effects. In this case, the Des Moines Register reports on how I-Doser is sweeping one dormitory by storm.

The product works by allowing customers to download an audio file that contains a strange mix of beats and whooshes that the company claims can create a high, similar to being on drugs or under the influence of alcohol.

Chris Peck, an Iowa State University freshman from Marion, said he estimated 100 people in his dormitory alone have tried it....

Late at night in his dorm room, Peck said he selected a track titled "Nitrous Oxide."

"I cleared my mind, sat back and relaxed and pretty much vegged out," he said. "The people around me said I was giggling and twitching a little. When I came to, I was really, really happy."

Compact discs from the company range from about $17 to $20, and individual audio tracks sport titles such as "Peyote," "Ecstasy," "Orgasm" and "LSD." The tracks cost between $3 and $4.50, three or four times the cost of standard music on iTunes.

Wotta racket! On the other hand, looking for peyote has never been easier thanks to peer to peer file sharing networks. Naturally some folks are concerned:

Jim Clayton, chairman of executive committee of the Stepping Up Project, a coalition in the University of Iowa and Iowa City/Coralville communities that works to reduce high-risk drinking, said even though I-Doser sounds like "bunk," he has some concerns.

"I do object that we have people who would go out into the world with a marketing plan that would try to glorify or sanctify the use of illegal or mind-altering substances," he said.

Whew, thank goodness someone in a position of responsibility has weighed in on the important topic of whether naming your binaural sound wave product after an illegal drug is a good idea or not. Honestly I was just about to order the whole set for my two-year-old cousin, but now I'll think twice, and just order it for my seven-year-old cousin. Thanks, Des Moines Register!

The Cincinnati Enquirer is running an entertaining little piece about how pharmaceuticals are named. I've seen similar stories about how cars are named; however, the naming of cars is rarely so crucial to, uh, not killing people.

In the past decade, the drug-brand consulting industry has grown dramatically to help companies find the right name for a new drug. The price often runs $200,000 to $500,000 per product. The right name can give a drug cachet. The wrong name can lead to serious medical errors.

According to the Food and Drug Administration’s Web site, an 8-year-old died after receiving methadone instead of methylphenidate. A 19-year-old man showed signs of potentially fatal complications after he was given clozapine instead of olanzapine.

A 50-year-old woman was hospitalized after taking Flomax, used to treat an enlarged prostate, instead of Volmax, used to relieve bronchospasm.

So yeah, maybe this is a case where high-paid consultants aren't exactly a bad idea. At any rate, the article goes on to dig into the artistry of naming techniques:

“A lot of it is more art than science,” said William Trombetta, professor of pharmaceutical marketing at St. Joseph’s University in Philadelphia. “There are certain letters that express power and control, like Z, M or P. Other letters, like S, are more passive. Depending on what the drug does, you want to give the name certain features.”

Want to sound high-tech? Go for lots of Z’s and X’s, such as Xanax, Xalatan, Zyban and Zostrix.

Want to sound poetic? Try Lyrica, Truvada and Femara.

Want to suggest what it does? Flonase is an allergy medicine that aims to stop nasal flow. Lunesta, a sleeping drug, implies “luna,” the Latin word for moon - a full night’s sleep.

And then there’s Viagra, the erectile-dysfunction drug made by Pfizer. It uses the prefix “vi” to suggest vigor and vitality. The word rhymes with Niagara, suggesting a mighty flow.

“You know exactly what Pfizer was trying to say with that,” said Andy Valvur, senior brand strategist at Igor, a San Francisco branding company.

And of course, here's my favorite little snippet:

Drug names can suggest, but under FDA rules they can’t come right out and make medical claims. That’s why you won’t see TumorBeGone or CureAll.

That explains that...

Another absinthe story in the mainstream press makes me wonder when this trend is truly going to hit the local hipster scene. USA Today takes a look at the four labels that are currently approved in the States:

Four labels (Lucid, Green Moon and two from Kübler) have been approved by the Alcohol and Tobacco Tax and Trade Bureau this year. Each contains such an insignificant level of thujone that all are said to be thujone-free, which, by government regulations, amounts to 10 parts or less per million.

Lucid ($59.99 for a 750-milliliter bottle) — made with grande wormwood (Artemisia absinthium), distilled in France without dyes, artificial additives or oils like some of the faux brands sold in the USA — is one of the two labels now available.

Kübler, (106-proof, $49.99 for one liter), also made with grande wormwood and produced in the region where absinthe was invented and produced until a ban in the early 1900s, arrived this week. Green Moon, which calls itself absinthe but is really anise-flavored vodka made with southern wormwood and green coloring, makes its debut in October.

Absente, Absinthe Refined, another brand (110-proof, $35 for a 750-milliliter bottle) made with southern wormwood and available throughout North America, was approved by the bureau in 1999. However, experts say absinthe made with southern wormwood (Artemisia abrotanum), a less bitter cousin of grande wormwood and therefore more palatable for Americans' taste buds, is not genuine.

"We've always had to fight the stigma that it's not a real absinthe," says Jim Nikola, vice president of marketing for Crillon Importers, which imports Absente, Absinthe Refined. "We did the best we could to stick to the original formula. It's a modern absinthe."

But... but is it really absinthe without thujone?

"A person would die several times over from alcohol poisoning before they would feel the effects of thujone" in absinthe, Breaux says.

Well, there you have it. It's popping up in swank cocktail clubs and could be spreading; USA Today opens their piece with this description of a nice little ritual at the Waverly Inn in New York:

Heads turned when a waiter brought a traditional absinthe fountain, filled with ice water, to a dining table here at the trendy Waverly Inn on a recent Friday night. Three stylish women in their 20s, sitting nearby, watched as the waiter placed a glass of Lucid-brand absinthe under the spigot, rested a perforated spoon on the rim of the glass, placed a sugar cube atop the spoon, then gently turned the spigot to allow the water to trickle onto the sugar cube and melt its content into the glass.

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Wired has a neat little story about the possibility of partially commercializing the International Space Station in the interest of improved drug discovery:

Drug discovery is an arduous and extremely expensive project. But in space, molecules do miraculous things. Disease-causing proteins crystallize so well -- growing larger and clearer -- that finding a drug to stop the protein's damaging activities could happen months, if not years, faster....

"Up in space, the crystals grow bigger and better," said Tim Osslund, who specializes in protein formulation at Amgen. "The end result is higher resolution." And that resolution is a very valuable thing.

Osslund sent some of the company's proteins to the Mir space station in 1998. His crystals grew 32 times larger in space than in an earth-grown control environment. Larger, better crystals allow scientists to see a protein at the atomic level. That kind of detail can significantly accelerate drug discovery.

Given that money is in short supply for funding the ISS, and that profit margins on successful new drugs are rather vast, this seems like an ideal fit in certain ways. Certainly the promise of the ISS, that of scientific discovery in orbit, would be fulfilled by this turn of events. Plus, space pills would be, like, super cool.

File this under "wish I'd heard about it sooner": a recent production of a new opera on the topic of MK-ULTRA, which ran only four performances over the past weekend. Entitled Man: Biology Of A Fall, the show sounds like it dove right into the inherent pathos of the CIA dosing its own operatives:

There’s a juncture in Evan Hause’s new opera, Man: Biology of a Fall, when Army chemist Frank Olson confronts the popular magician John Mullholland. These characters are based on historical figures: Olson served in the Special Operations Division at Fort Detrick, Maryland, around the time of the Korean War, participating in biological weapons research including the infamous MKULTRA mind-control experiments. As Hause said in an interview, Mulholland “was famous in his day for his books and pamphlets, and employed by the CIA to teach sleight-of-hand tricks so they could slip LSD into people’s drinks.” In their scene, Olson (played by tenor Steven Ebel) acknowledges having read the magician’s tracts, and the latter (countertenor Jeffrey Mandelbaum) replies: “Maybe you’ll learn something else today.” “Like why you’re working for the CIA,” Olson counters. Mulholland retorts with soaring embellishments, “Aren’t you?” The angry, anxious doctor has to acknowledge that he doesn’t know.

The opera apparently hinges around the question of whether Olson killed himself by hurling himself off a balcony while high on LSD, or in a more sinister, conspiratorial take, was pushed:

Olson’s colleagues had argued over the cause of the Army chemist’s death, and the family began investigating the remaining evidence. “It was Rumsfeld and Cheney who drew up the statement that the family signed in 1975. Cheney said, ‘We can’t have them starting up suits,’ and $750,000 was offered once they signed away the right to prosecute, with Cheney advising Rumsfeld, who passed it on to [then President] Ford.... Back in the 1950s, Olson’s case had made it into the training manual for the Massad, Hause said, as the textbook case for concluding a murder: a blow to the head, then thrown out the window. “After rehearsal last night, I went for the first time to the hotel room in the Hotel Pennsylvania [then the New York Statler Hotel], Room 1018A, and went immediately to the window, put my head on it and looked down at the Seventh Avenue sidewalk. The fall didn’t kill him immediately—the watchman who found him down there said he died still trying to say something.”

As I am the least political person alive, I need to give props to Jesse for sending this one my way.

Surprising anti-drug-war sentiments coming out of the Republican Forum:

*Williams*: . . .You realize about 50 percent of young Black and Latino people dropping out of high school, 35 percent poverty rate, nearly 60 percent of America's prison population Black and brown.

The one area of these problems touching on federal government policy has to do with criminal justice. Today, in Jena, Louisiana, it was announced that one of the Jena 6, originally convicted as an adult, will be tried now as a juvenile.

Name one reform, Senator, that you would endorse to assure young Black and Latino people in America that they will have equal justice in America's courts.

**

*Mike Huckabee:* Well, first of all, we really don't have so much a crime problem in this country. We have a drug and alcohol problem. Eighty percent of the people who are in our prisons and jails are there for a drug or alcohol crime. They either were high or drunk when they committed the crime, or they committed the crime to get high or drunk.

And what has made a huge mistake is that we've incarcerated so many of the people who really need drug rehab more than they need long-term incarceration.

In our state, we established over 20 drug courts, that gave people an alternative course, rather than just putting them in prison, giving them the opportunity to get what they really needed, which is off the addiction.

We've got to quit locking up all the people that we're mad at and lock up the people that we're really afraid of, the people who are sexual predators and violent offenders.

But the nonsense of three strikes and you're out has created a system that is overrun with people, and the cost is choking us.

I would go for more drug courts and for a lot less incarceration of drug-addicted people.

*Tavis:* Thank you, Governor. Congressman Paul?

*Ron Paul:* A system designed to protect individual liberty will have no punishments for any group and no privileges. Today, I think inner-city folks and minorities are punished unfairly in the war on drugs.

For instance, Blacks make up 14 percent of those who use drugs, yet 36 percent of those arrested are Blacks and it ends up that 63 percent of those who finally end up in prison are Blacks. This has to change.

We don't have to have more courts and more prisons. We need to repeal the whole war on drugs. It isn't working.

We have already spent over $400 billion since the early 1970s, and it is wasted money. Prohibition didn't work. Prohibition on drugs doesn't work. So we need to come to our senses.

And, absolutely, it's a disease. We don't treat alcoholics like this. This is a disease, and we should orient ourselves to this. That is one way you could have equal justice under the law.

And now, imagine a world where top quality drugs are delivered straight to your door - free of charge! It's the final sketch from the drug comedy DVD Tales From The Tripside. UPDATE: I see I forgot to make this public when I first posted this. Doh! It's good now.