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Pain Relief: FDA Panel Urges Ban on Darvon, Related Drugs

Acting on a petition from the public interest group Public Citizen, a Food & Drug Administration (FDA) advisory panel last Friday voted narrowly to recommend that a widely used opioid pain medication be removed from the market. The drug is prophoxyphene, which has been in the pharmacopeia for more than a half century, and is most widely prescribed under the brand names Darvon and Darvocet.

http://stopthedrugwar.com/files/darvon65mg.jpg
65 mg Darvon pills (usdoj.gov)
Prescribed for the relief of mild to moderate pain, prophoxyphene is used in dozens of generic pain medications, too. According to a briefing paper prepared by Xanodyne Pharmaceuticals, the manufacturer of Darvon and Darvocet, some 26 million prescriptions for the pain-fighting pair were written in 2005.

The FDA approved new Darvon formulations as recently as 2003 and a generic phophoxyphen pain medication in 2005. The drug has also passed a number of FDA reviews in the past half-century, including one occasioned by another Public Citizen petition in 1978. The FDA can ban a drug if it is proven unsafe or ineffective when taken as directed.

The agency collected reports of more than 1,400 deaths in people who had taken the drug since 1957, though experts stressed the figure does not prove the drug was the cause of death in all cases. Nor does it seem an exceptionally large figure for an opioid drug prescribed millions of times a year for more than 50 years.

The panel also relied on a Florida Medical Examiner Commission report on 2007 drug-related deaths that showed 87 deaths linked to prophoxyphene.

"If that's not a risk, I don't know what is," said Dr. Sidney Wolfe, head doctor for Public Citizen.

There may be a risk, but it's relative. That same report listed 476 deaths caused by alcohol poisoning, 743 from tranquilizer overdoses, and 843 from cocaine. Among opiate-caused deaths, methadone led with 785, then Oxycontin with 705, hydrocodone with 264, morphine with 255, Fentanyl with 117, and heroin with 93 -- all greater than the number of deaths attributed to Darvon and its generic equivalents. Even the tranquilizer Meprobamate killed more people with 88 deaths listed. (Cannabis was listed as the cause of death in zero deaths.)

Still, despite weak evidence to justify removing Darvon and its brothers from the pharmacopeia, the FDA advisory panel voted to recommend that 14-12 last Friday. A final decision will come in a few weeks.

"It's not a very clear-cut picture," Sharon Hertz, MD, deputy director of the agency's analgesia drugs division, said at a press briefing after the decision. "It's not straightforward that it should or shouldn't come off the market."

Some panel members saw little benefit in keeping Darvon on the market. "I would say, little 'b', big 'r' for this drug. That's little benefit and lots of risk. And that's unsettling," said Ruth Day, PhD, who voted to remove the drug.

It "looks like it offers placebo benefits with opioid risks," saids Sean Hennessey, PhD, a panel member and epidemiologist from the University of Pennsylvania.

But other panel members warned that banning prophoxyphene could leave pain patients in the lurch. It could also drive them to other pain, more potent pain medications, like Oxycontin, they warned.

"Every drug you're talking about that's going to deal with pain has difficulty," said Mary Tinetti, MD, a professor of medicine at Yale University. "There is the possibility that the drugs that would take its place would cause at least as much harm in some people."

Xanodyne hopes it can keep the drug on the market. "I'm hoping to do everything we can to keep this product available to the 22 million people who need it," the company's vice president for clinical development and medical affairs, James Jones, told WebMD.

Random Drug Testing Won’t Save the Children From Heroin

Here’s drug czar John Walters shamelessly using a young woman’s death as an opportunity to plug student drug testing:

Heroin killed 19-year-old Alicia Lannes, and her parents say she got the drug from a boyfriend.  Experts say that's how most young kids get introduced to drugs: by friends or relatives.

While teen drug use is declining, Walters says a Fairfax County heroin ring busted in connection with Lannes' death proves it's still a problem.  He supports a federal program used in more than 4,000 schools to randomly drug test students.

"There's no question in my mind had this young woman been in a school, middle school or high school with random testing," said Walters, "She would not be dead today." [FOX DC]

Walters sounds supremely confident, as usual, yet the reality is that random drug testing is often impotent when it comes to discovering heroin use. Student drug testing programs typically rely on urine tests, which can only detect heroin for 3-4 days after use. Only marijuana -- which stays in your system for up to a month – can be effectively detected this way. Thus, random testing actually incentivizes students to experiment with more dangerous drugs like heroin that increase your chances of passing a drug test.


And thanks to the complete failure of the drug war, heroin is stronger today than ever before:

The drug enforcement agency says the purity of heroin found in Virginia is typically higher than usual—making it more deadly.

"They tend not to know how to gauge the strength and they usually take more than they need to," said Patrick McConnel, who oversees Treatment for Youth Services Administration Alcohol and Drug Services.

There are no easy answers here, to be sure, and I don’t claim any monopoly on the solutions to youth drug abuse. But I guarantee you that the problem isn’t our failure to collect more urine from young people. As long as the most dangerous substances continue to be manufactured, distributed, and controlled by criminals, the face of our drug problem will remain the same.

Marijuana: SAFER Takes on the NFL, Cites "Hypocrisy" of Player's Huge Fine for Marijuana Possession

New England Patriots running back Kevin Faulk was suspended for one week and fined two weekly paychecks, or about $300,000, by NFL Commissioner Roger Goodell this week after pleading guilty in July to misdemeanor marijuana possession charges. That has the marijuana reform group SAFER (Safer Alternatives for Enjoyable Recreation) crying foul.

http://www.stopthedrugwar.org/files/saferbillboard.jpg
SAFER Ricky Williams billboard, 2007 (saferchoice.org)
SAFER, whose primary argument is that marijuana is safer than alcohol and should not be treated more harshly, announced Thursday that it would deliver an online petition and letter calling for changes to the NFL's marijuana policy to Goodell today in New York City. For SAFER, the huge fine assessed against Faulk is rank hypocrisy from a sporting organization that accepts hundreds of millions of dollars in alcohol advertising.

The petition reads as follows:

"Players with the National Football League who use marijuana instead of alcohol to relax and recreate are making a rational choice to use a less harmful substance.

"Suspending these players and taking away hundreds of thousands (or sometimes millions) of dollars for using marijuana is driving them to use alcohol, a drug that -- unlike marijuana -- contributes to violent and aggressive behavior. Unless the NFL plans to suspend every player who receives a speeding ticket -- which is considered an offense on par with marijuana possession in some states -- it has absolutely no reason to suspend players for the simple use and possession of marijuana. Doing so is not only irrational, but given the NFL's acceptance and blatant promotion of alcohol, it is exceptionally hypocritical.

"Marijuana is safer than alcohol and the National Football League's substance abuse policy should be changed immediately to reflect that fact."

"The NFL has no problem with players using alcohol and it accepts hundreds of millions of dollars to promote booze to football fans of all ages," said SAFER executive director Mason Tvert. "Yet the league punishes those players who make the safer choice to use marijuana instead of alcohol to relax and recreate. The NFL is driving its players to drink. Every objective study on marijuana has concluded that it is far less harmful than alcohol both to those who use it and to others around them," Tvert said. "It is a mystery why Commissioner Goodell and the NFL would want to steer the biggest, toughest guys in the country away from using marijuana and toward using alcohol, which contributes to aggressive behavior and countless violent crimes."

This isn't the first time SAFER has gone after the NFL's marijuana policy. Last October, the group erected a billboard across the street from Invesco Field in Denver that featured an image of NFL superstar Ricky Williams in a Denver Broncos jersey, urging the recently reinstated player to "Come to Denver: Where the people support your SAFER choice."

Australia: Drug Researcher Says Ecstasy Safer Than Binge Drinking, Causes Flap

Responding to recent data suggesting that young Queenslanders are switching to ecstasy in the wake of a steep increase in the state government's tax on popular "alcopops," a leading drug researcher said the young people would be better off taking small amounts of ecstasy than going on drinking binges. Unsurprisingly, the comments have attracted criticism from some quarters.

http://stopthedrugwar.org/files/ecstasypills.jpg
ecstasy pills
Professor Jake Najman, director of Queensland's Alcohol and Drug Research Center, said ecstasy was "a lesser evil" than binge drinking, long a popular Australian pastime. Ecstasy is "relatively benign if taken in small quantities," he said. "When young people switch from a substantial amount of alcohol to a small amount of ecstasy... I don't think that's a bad trade at all. It is not likely that one pill on a Saturday night poses the same dangers as frequent binge drinking."

Illegal drugs kill about a thousand Australians a year, but alcohol kills around 20,000. According to a 2004 government study, 19% of 18-to-24-year-old men and 11% of women in the same age group had engaged in binge drinking -- defined as seven drinks or more at a sitting -- at least once a week over the past year.

Ecstasy is "cheaper and safer" than excessive alcohol consumption, Najman said. "Even drug-related problems, including psychotic episodes and violent behaviour are not seen with ecstasy, as they are with amphetamines and alcohol," he said.

University of Adelaide PhD student Emily Jaehne attacked Najman's statement on two counts. She said ecstasy was often adulterated, but that is an artifact of prohibition, not a property of the drug itself. Her second count, that ecstasy causes potentially serious increases in body temperature, was stronger. "When taken at hot nightclubs or rave parties the heightened effects could lead to severe brain damage or death," Ms. Jaehne said.

But while the risk of death from using ecstasy is real, it is also infinitesimal. According to a 2004 study of national death statistics, 12 people died of ecstasy-related causes in Australia between 2001 and 2004.

Still, that didn't stop Jo Baxter, director of Drug Free Australia, from calling Najman's comments "irresponsible" and dangerous. "There is no guarantee that if young people hear a message of so-called 'safe use' from people in authority, that they will use only small quantities. Taking ecstasy is like Russian roulette. No one individual knows exactly what it will do to their body chemistry," she said.

"A person in Professor Najman's position and with his qualifications is showing an extraordinary lack of responsibility, if his views have been reported accurately," Baxter continued. "The other aspect is that we seriously have to question why our young people are feeling the need to take drugs in order to 'have a good time.' We need to be giving our young people reasons not to have to rely on drugs for their social events. If we can reduce the demand, the huge volumes of ecstasy now coming into Australia would have no market."

Good luck with that, Mrs. Baxter.

Marijuana: Hawaii County Council Rejects "Green Harvest" Eradication Program

By the narrowest of margins, the Aloha State's Big Island Hawaii County Council has rejected a state and federally funded marijuana eradication program known as "Green Harvest." The action came during a council meeting last week, when the council tied 4-4 on whether to continue to support the widely criticized program. The tie vote meant the motion to accept the funding failed.

http://www.stopthedrugwar.org/files/volcano-national-park.jpg
Volcano National Park, Hawaii Island
"Green Harvest" began in Hawaii three decades ago and has been controversial ever since. Many residents opposed the program, saying low-flying helicopters searching for pot fields disrupted rural life and invaded their privacy. Others argued that the program has done little to eradicate marijuana and even promoted the use of other, more dangerous drugs.

By the 1990s, council members heeding public complaints began expressing reservations about the helicopter missions. In 2000, they rejected $265,000 in federal eradication funds, two-thirds of the program's money that year. But the following year, they once again accepted the full amount offered.

But last week's vote means the council will say "no thanks" to $441,000 in state and federal funds for "Green Harvest." It also means the county will save the $53,000 from its own budget that would have been its share of the operation's financial burden.

Last month, the council had narrowly approved "Green Harvest" on a 5-3 vote, but that vote had to be redone because the council failed to publish the legislation in local newspapers, as required by law. That provided the opportunity for Councilman Angel Pilago to change his vote and kill the program.

"This will have long-term impacts," Pilago said. "When we institute programs we, the county government, need to look at if they are detrimental to people's rights and the health and safety of the community. That's what we do," he told the Associated Press after the vote. "It's about home rule," he said. "The county must be assertive and aggressive and not defer certain powers to the state and federal governments. We must not cede those powers."

Pilago is running for mayor of Hawaii County, and his vote on "Green Harvest," as well as his support for a lowest law enforcement priority initiative currently underway there, could help him draw a contrast between himself and incumbent Mayor Harry Kim, who is a "Green Harvest" supporter.

"My position is no secret," Kim told the AP. "I support eradication, as long as it's done in a way that is not harmful to people who should not be harmed, as far as noise and catchment systems and all those concerns. I'm against all drugs. Marijuana is an illegal drug."

Drug Czar Creates Handy Guide For Teens on Where To Obtain Prescription Drugs

Oddly, the Drug Czar has created a new webpage that offers great tips for any teen looking to catch a buzz. The page claims to be a warning guide for parents, but the potentially deadly secrets contained within it are available for anyone to see. I was able to access all of the site's content without even being asked to verify that I'm over 18.

I've learned to steal drugs from the elderly because they don't monitor their pill count or throw away leftovers because they're super old and confused. Also, there's like a billion websites that don't even check prescriptions and will send me anything. I'm gonna go cure my boreditis now. Thanks, Office of National Drug Control Policy!
Location: 
United States

Drug Scare: Kids in Florida are Getting High by Sniffing Feces

You can urine test them. You can take away their financial aid for college. But you can't stop the kids from getting high. Some people will try anything, and I don't think arresting them is going to help:
Information Bulletin
New Drug – JENKEM

On 09/19/07 Cpl. Disarro received and email from a concerned parent regarding a new drug called “Jenkem”. The parent advised their child learned about this drug through various conversations with several students at Palmetto Ridge High.

Jenkem originated in Africa and other third world countries by fermenting raw sewage to create a gas which is inhaled to achieve a high. Jenkem is now a popular drug in American Schools. Jenkem is a homemade substance which consists of fecal matter and urine. The fecal matter and urine are placed in a bottle or jar and covered most commonly with a balloon. The container is then placed in a sunny area for several hours or days until fermented. The contents of the container will separate and release a gas, which is captured in the balloon. Inhaling the gas is said to have a euphoric high similar to ingesting cocaine but with strong hallucinations of times past. [Snopes]

This doesn't sound like a good idea. But what shall we do about it? You can't pop people for poop possession, or piss-test people for piss sniffing. Should we launch a massive public education campaign warning kids that fermenting their excrement and breathing in the resulting fumes will get them wasted? That could backfire.

So I don't know what the solution is. For starters, we should wait to see if this is a real problem or just another hysterical response to a couple gross, though isolated, incidents. If there really is a rising trend of Florida youths sniffing fermented feces, maybe it's just an overreaction to the Miami DEA Chief's recent claim that marijuana will kill you.

Update: The rumor site Snopes, from which this story emerged, has updated the accuracy status of this rumor from "undetermined" to "false." It's unclear what prompted the change, but it looks like this whole story might just be a crock of...

Location: 
United States

'Drug Czar' Makes Pitch for Random Drug Testing in Schools

Location: 
NV
United States
Publication/Source: 
KLAS-TV (NV)
URL: 
http://www.klas-tv.com/Global/story.asp?S=6421839&pass=1#poll60562

Mexican alliance drives drug flow

Location: 
Ciudad Juarez
Mexico
Publication/Source: 
The Dallas Morning News
URL: 
http://www.dallasnews.com/sharedcontent/dws/news/world/mexico/stories/DN-heroin_08int.ART.North.Edition1.441bb93.html

Risk-taking kiwis protest looming "party pill" ban

Location: 
Wellington
New Zealand
Publication/Source: 
The Scotsman (UK)
URL: 
http://news.scotsman.com/latest.cfm?id=365012007

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