Harm Intensification

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The Need for Prescription Drug Harm-Reduction

Today I had the second appointment with my psychiatrist. In ten minutes, I was prescribed a 5 month supply of the stimulant medication Adderall. I'm concerned at how casually I was just prescribed a schedule II drug with a “high potential for abuse” that “may lead to severe psychological or physical dependence". As our movement looks beyond the the Marijuana legalization debate, I think it is important to discuss the future of regulating all types of drugs. Considering the current hysteria about prescription drug abuse, there is clearly something wrong with today's prescription drug regulations. Here I would like to share my own experience and concerns about legally obtaining a drug which is not so different from Cocaine. Let me begin one year ago when I first set out to get an Adderall prescription. At college, I had bought Adderall from friends to use as a study-aid. I don't believe ADD is a disease, but I do believe certain people have more difficulty concentrating than others, and I think I am one of those people. Having an immense respect for drugs, I researched the potential harms of Adderall before I used it. I knew there was abuse potential, so I used it once or twice per week at the most. Last year, I decided to get my own prescription to save money. I found a psychiatrist though my insurance. Before I met with him, he sent me a 20 page questionnaire asking me various questions about my mental health. I honestly answered questions concerning my concentration, anxiety, and overall mental health. I brought the questionnaire to the first appointment. He spent about ten minutes reviewing my answers, and diagnosed me with general anxiety and ADD. Five minutes later, I left with a prescriptions for four months worth of Adderall and Paxil, the latter one I never filled because I don't believe I have an anxiety disorder. I didn't talk to him again until today, one year later, when we met for 10 minutes and he refilled my prescriptions. He asked me two questions: if school was stressful, and if I experienced any bad side effects. Yes, school is stressful, no, no debilitating side effects. I see several concerning issues with my experience. This might sound hypocritical, considering I set out to legally obtain a drug, and I did. Why should I be complaining about how easy it was? Because I'm worried about society treating powerful substances so casually. I believe the increase in prescription drug abuse, especially among youth, has to do with precisely this lack of oversight and nonchalant attitude among some psychiatrists at passing out drugs. Here are my concerns: 1) The diagnosis process. It's not okay for a doctor to spend 15 minutes with a person and determine they have a psychiatric disorder in need of medication. This is a process which should take several visits and discussions between patient and doctor on the unique needs of the patient, not a generic questionnaire. 2) The prescription. Right off the bat, I was prescribed 30 mg a day of Adderall. This is way too much Adderall for anyone to be taking, in my opinion, never mind someone just beginning. 3) No follow-up. My situation was complicated because I was going to college, but still, to give me a 4 month supply of powerful drugs and make no effort to contact me on how I am tolerating the treatment is ridiculous and dangerous. 4) No education. He should have given me warning signs to expect if I am having problems with the drug. Not everyone would have done the extra research I did, he should have told me how the drug effects my brain and body. It is easy to build up tolerance to Adderall, which is why it is important to start with low doses and never take more than you need. He never told me that unlike drugs for depression or anxiety which you must take everyday because the effects are gradual, Adderall works instantly and it is okay not to take it everyday. In fact, in my experience it is best not to take Adderall everyday, but instead only when you need it. I'm not sure how common my psychiatric experience is. I'm guessing my psychiatrist is more irresponsible than most, and I hope that the average psychiatrist spends more time with patients. Still, my experience points to a general lack of proper procedure among psychiatrists at doling out drugs, and the lack of any sort of oversight on the actions of psychiatrists. If a psychiatrist has their heart set on making money, they will squeeze as many patients as in as possible, meaning no patient will receive adequate care. I'm struggling to figure out exactly how I feel about my experience. I am a firm believer in my right over my own body. I want to be able to obtain any substances which I please, I want it to be my choice. At the same time, like everything else in society, we need drug specialists to facilitate the decisions we make regarding drug usage. There is a necessary place in a legalized drug market for "psychiatrist" type people, we can't expect everyone to research which drugs they need and how to use them safely on their own. If we truly want to reduce the harms of drugs, we need to start being proactive by making sure psychiatrists educate patients about drugs from the moment they can obtain them. There is a common conception that certain people have "addictive personalities" or are simply prone to abusing drugs, as if a certain group of genes are programed to abuse drugs. I believe this philosophy severely underestimates humans. We have much more will-power than we give ourselves credit for, the problem is that we don't have the necessary resources to make smart decisions concerning drugs. It is the psychiatrist's job to educate patients on their bodies and substances. As much as I hate the government exaggerating the harms of drugs, I wish psychiatrists would make people more scared of truly dangerous drugs. I'm worried about the people who visit my psychiatrist who are oblivious to the nature of drugs and addiction and blindly follow the word of an incompetent doctor. As drug policy reformers, it is in our interest to assess current legal drug regulations if we hope to eventually move all substances into a regulated market. This is important for transforming public opinion on legalization. The public is being bombarded with stories about how harmful prescription drugs are, take Michael Jackson's case. We can't expect people to support moving Cocaine, MDMA, or Heroin into a regulated market, when the current market looks pretty scary and problematic.

India: Moonshine Deaths Stir Alcohol Prohibition Debate in Gujarat

Last week, 136 people died in the Indian state of Gujarat after drinking tainted alcohol, and the incident has stirred debate over the state's alcohol prohibition policy, in existence since 1960. One of India's "liquor barons" has invited the state government to do away with prohibition, and the state government has invited him to shut up about it.

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moonshine still (courtesy Hagley Library)
The deaths occurred in Ahmedabad, about 35 miles from the state capital, Gandhinagar. Most of the dead were common laborers who had allegedly purchased illicit liquor produced or distributed by one Vinod Dagri, currently a fugitive, and described in local media as "the key mastermind in the hooch tragedy case."

It's not the first time contaminated black market alcohol has killed people in Gujarat. And as Gujarat officials were quick to point out, moonshine deaths also occur in Indian states without alcohol prohibition. In a Monday statement, Gujarat government spokesperson Jaynarayan Vyas noted that tainted alcohol had killed 31 people in Kerala in October 2000, 10 were killed and four blinded by bad hooch in Bhubaneswar in February of this year, 13 people died in of bad booze in Kolkata in May 2008, and 142 people in Karnataka had died from illicit liquor over the course of last year.

[Ed: Deaths from tainted alcohol in states that don't have prohibition are comparable to those in Gujarat, only because people in those states have access to alcoholic beverages that were legally produced, then smuggled into their states. If alcohol prohibition were to become more widespread, or nationwide, legally produced alcohol would become a scarcer commodity, and tainted alcohol would likely cause proportionally many more deaths in places like Kerala or Kolkata or Karnataka than it does today.]

Still, Vijay Mallya, chairman of the UB Group, India's largest liquor conglomerate, couldn't resist taking the opportunity to jab at the state's political leadership for its adherence to prohibitionist policies. Mallya offered to help the state craft a "responsible alcoholic beverages policy" in a statement cited in the Hindustan Times. "The deaths are not only tragic but should serve as a wake-up call to our political hypocrites. [Gujarat Chief Minister] Narendra Modi knows full well that every brand of alcohol is available in Gujarat," Mallya said. "The farce of prohibition, which cannot be enforced, leads to illegal, unhygienic and unsupervised production of deadly cocktails which claim innocent lives. It is time that political masters face reality in the interests of people's health," he added.

Minister Modi was not amused. "Many elements are giving the tragic incident political color and are trying to ruin the peaceful atmosphere in Gujarat," he said. "My government is sincere about eliminating the vice of illicit liquor."

State Health Minister Jay Narayan Vyas also suggested that Mallya butt out. "This is an internal matter of the Gujarat government and Mr. Mallya should avoid making suggestions on what should be done in Gujarat," Vyas told reporters in Gandhinagar.

Early this week, the Gujarat government was standing firm. "There is no question of any rethink on easing or lifting the prohibition laws," Vyas said on Monday. "The government is committed to implementing the prohibition laws for the peace, prosperity and security of the people of Gujarat."

Harm Reduction: Overdose Prevention Bill Introduced, Study Released

In response to a rapid increase in the number of drug overdose fatalities -- doubling from 11,000 in 1999 to 22,000 in 2005 -- US Rep. Donna Edwards (D-MD) Wednesday introduced the Drug Overdose Reduction Act, which would allocate $27 million a year to cities, states, tribal governments, and nonprofits to implement overdose reduction strategies. Accidental drug overdoses are now the second leading cause of accidental deaths, second only to auto accidents.

Edwards introduced the bill in conjunction with a new report from the Drug Policy Alliance, Preventing Overdose, Saving Lives: Strategies for Combating a National Crisis, which lays out a number of ways in which the overdose toll can be reduced:

  1. Enhance overdose prevention education.
  2. Improve monitoring, research, outreach and coordination to build awareness of the overdose crisis, its ramifications and public health approaches to reducing it.
  3. Remove barriers to naloxone (Narcan) access.
  4. Promote 911 Good Samaritan immunity law reform.
  5. Establish trial supervised injection facilities.

"We've got the science, we've got the technology and the medicine to do this," said Dr. Donald Kurth, head of the American Society of Addiction Medicine during a Wednesday conference call. Yet despite a national overdose death toll "like a jumbo jetliner crashing every three days," the US "as a nation hasn't had the political will to let physicians use what's already available."

Feature: Effort to Bring Safe Injection Facility to New York City Getting Underway

Last Friday, more than 150 people gathered at John Jay College of Criminal Justice in New York City for a daylong conference on the science, politics, and law of safe injection facilities (SIFs) as part of a budding movement to bring the effective but controversial harm reduction measure to the Big Apple. Sponsored, among others, by the college, the Harm Reduction Coalition, and an amalgam of 17 different New York City needle exchange and harm reduction programs known as the Injection Drug User Health Alliance (IDUHA), the conference targeted not only harm reductionists but public health advocates and officials, law enforcement, service providers, and the general public.

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John Jay College, NYC (courtesy wikipedia.org)
The Safe Injection Facilities in New York conference aimed to create public awareness of SIFs, provide evidence that they are cost-effective, and start developing a plan for implementing SIFS in New York. As the conference program indicates, organizers relied heavily on experts from Vancouver, where the Downtown Eastside Insite SIF has been in operation -- and under evaluation -- since 2003, to provide the evidence base.

The first SIFs opened in Switzerland in the mid-1980s. Since then, they have spread slowly and there are now 65 SIFS operating in 27 cities in eight countries: Switzerland, Germany, the Netherlands, Spain, Australia, Norway, Luxembourg, and Canada. Although advocates have been working for the past year-and-a-half to bring an SIF to San Francisco, that effort has yet to bear fruit.

SIFS are credited with saving lives through overdose prevention, reducing the spread of blood-borne disease, reducing public drug use and attendant drug litter, and creating entryways to treatment and other services for hard-core drug users not ready to abstain. The results reported by the Vancouver delegation on Insite were typical:

  • No fatal overdoses at the SIF.
  • No increase in local drug trafficking.
  • No substantial increase in the rate of relapse into injection drug use.
  • Reductions in public drug use, publicly discarded syringes and syringe sharing.
  • SIF users 1.7 times more likely to enter detox programs.
  • More than 2,000 referrals to counseling and other support services since opening.
  • Collaboration with police to meet public health and public order objectives.

But despite such research results, the United States remains without an operating SIF. The obstacles range from the legal, such as the federal crack house law and its counterparts in many states, to the political and the moral. But for harm reduction and public health advocates, it is the failure to embrace such proven life-saving measures that has the stench of the immoral.

"The reality is that we have people shooting up in unsafe injection facilities as we speak," said Joyce Rivera, executive director of St. Ann's Corner of Harm Reduction and chair of the conference. "The reality is they are not shooting up in a safe, hygienic environment with the possibility of a transition into a range of care. That's what's not happening. As public health advocates, we are saying let's recognize that reality and create those safe facilities. Let these people enter through the portal of public health into a safe environment and start to pace their own change," she said.

"We have to acknowledge the social fact that people are shooting up in unsafe venues," Rivera said. "It's not some esoteric or academic argument. The question is what do we do about it? Public health is supposed to protect the community, and SIFs are a necessary evolution in our public health policy."

"The big issue here is that we know we have about 200,000 injection drug users in the city, and the needle exchange programs only serve a few thousand of them," said Robert Childs of Positive Health Project, one of the members of the IDUAH. "Most of them are getting needles from unregulated needle exchanges, shooting galleries, from friends. That is a large part of why New York City has the most HIV and Hepatitis C cases in the US and one of the highest rates of infection in North America," he said.

"The other big issue is that we're giving injectors the tools to inject, but not a safe space to do it," Childs pointed out. "Many shoot up in the public domain, in the bathrooms at Starbucks or McDonalds or White Castle, in libraries, parks, alleys, phone booths. They leave their syringes in locations that aren't evident to a non-injector, and that's a public health issue."

They also overdose. Drug overdose is the fourth leading cause of death in the city. While it is a tragedy for the victim, overdoses both lethal and non-lethal are also a burden to the city. "Taxpayers have to pay these costs," said Childs. "For an ambulance to respond to an overdose costs between $400 and $1,200, and that's going on many times a day every day."

It's not just ambulances. Failing to address injection drug use under prohibition conditions costs real dollars in other ways as well. Each new diagnosis of HIV in the city comes with a $648,000 price tag for life-long medications and medical care, and even that may be on a low end estimate. A case of hepatitis C often requires $280,000 to $380,000 for a liver transplant; for those cases that do not warrant a liver transplant, treatment costs anywhere from $60,000 to $100,000.

And it's not just taxpayers paying. According to Childs, local businesses, including service providers, spend thousands of dollars a year on plumbing repairs -- from needles disposed of in toilets for lack of biohazard containers.

Now, said advocates, it is time to move forward. The conference was but the opening shot in what will likely be a long and frustrating campaign.

"The conference went very well and it will be a bit of a lift," said John Jay Professor Richard Curtis, who addressed the topic of moving forward from here at the conference. "The evidence is piling up from Sydney and Vancouver and Europe, and that is helping us, too. But this isn't something the health departments and the politicians aren't quickly going to jump on the bandwagon for. We have to give them a push, and if we don't start working on it now, it'll never happen. We didn't get where we are today by behaving ourselves," he added, relating how his own needle exchange effort first faced official opposition before being accepted.

The audience included people from the city and state health departments, Curtis said. "The health officials are all very supportive... unofficially," he said. "They didn't want to be on the agenda, but they say they're supportive. But this is an election year, and that makes it hard for them."

There will be an organizing meeting in two weeks to map out strategy, Curtis said. "We'll see who is willing and able, whether there is an existing agency bold enough to forge ahead or whether we will have to create some alternative organizations. We want to put this issue on the table now."

"We're forming an action group to bring this into New Yorkers' consciousness," said Childs. "The people who do know about -- drug users -- are one of the most stigmatized populations in the city. We are going to a campaign similar to Vancouver about how these people are not bogeymen, but our sons and daughters. We're also trying to organize some media events around it. A group of lawyers will help by challenging some codes. And we'll be trying to work with our legislators and city councilors," he said.

But Curtis and others are not willing to wait forever. "I'm not hopeful that federal crack house laws will end any time soon," he said. "But we started needle exchanges by just doing it. If it has to come to that, we'll have to make them arrest us again. We need to back them into a corner at the very least."

Harm Reduction Coalition Western Coordinator Hilary McQuie has been involved in the ongoing SIF effort in San Francisco. Just because something isn't happening officially doesn't mean it isn't happening, she noted.

"I don't know much about shooting galleries in New York," she said, "but out here, it's no big secret that the bathrooms of service providers, drop-in centers, homeless shelters, soup kitchens are used for shooting up. What people are doing to try to make these current injection spaces safer is perhaps having safe injection instructions, syringe disposal devices, soap and water, things like that," she said. "Also, it's sort of semi-supervised. If someone's in the bathroom and doesn't come out, you can open the door and save them from an overdose. That happens every day in San Francisco."

Feature: Legislatures Take Up "Good Samaritan" Overdose Bills in Bid to Reduce Deaths

Last year, in suburban Washington, DC, 19-year-old Alicia Lannes overdosed on heroin. The girl was in her bedroom and text messaging her boyfriend and heroin supplier, Skylar Schnippel, when he realized something was wrong. But when he realized Lannes was in trouble, he didn't call 911 or her parents. Instead, he called some friends and asked them to check up on her. At 4:00am, they peered through her window, saw her unconscious, and called paramedics. Shortly after 5:00am, her father, Greg Lannes, was awakened by paramedics pounding on his front door.

"We found my daughter lying next to her bed," Lannes told the Washington Post. "She had passed away. She had gone through a lot in her little life."

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Dr. Reardon and son Danny
Six years earlier, Washington dentist Daniel Reardon went through something similar. His son, Danny, 19, a freshman at the University of Maryland, passed out after a night of drinking. Fraternity members laid him on a sofa, took his pulse, and took turns watching him. But young Reardon quit breathing at some point during the night, and by the time fraternity members called an ambulance at 3:30am, Reardon was brain dead. He died six days later without gaining consciousness.

In both cases, people who might have saved the lives of the victims with fast action hesitated to call for help, largely out of fear of legal repercussions. Whether it was using heroin or underage consumption of alcohol, friends as well as the victims themselves faced the possibility of prosecution for drinking or drug use.

Yesterday, Daniel Reardon testified before a Maryland General Assembly committee to urge members to pass a bill that might have saved his son's life. The House Judiciary Committee was holding hearings on HB 1273, a Good Samaritan overdose bill, which would protect overdose victims and the people seeking help for them from facing criminal prosecution.

Although New Mexico is the only state to have passed such legislation, numerous college and universities have instituted similar policies. "There are about 90 schools across the country that have these medical emergency amnesties," said Stacia Cosner, a University of Maryland senior and member of Students for Sensible Drug Policy (SSDP), which has endorsed the Maryland legislation. "About one third are public; the rest are private, usually small colleges."

Unfortunately, the University of Maryland isn't one of them -- yet. "We have been working on this here for a couple of years, and there has been some progress, but there is nothing formally adopted yet," said Cosner.

It is working at George Washington University in Washington, said Cosner, citing ongoing research there. "Since they instituted the program, 911 medical emergency calls have gone way up," she said.

The movement is spreading beyond the college campus now. This year, besides Maryland, legislatures in at least seven other states -- Connecticut, Hawaii, Illinois, Nebraska, New York, Rhode Island, and Washington -- are considering Good Samaritan overdose laws. (The Washington state effort died earlier this month after failing to move out of committee.)

There is good reason for such laws. According to the Centers for Disease Control, more than 22,000 people died of drug overdoses (both licit and illicit) nationwide in 2005, the last year for which statistics are available, making ODs second only to traffic accidents as a cause of death for young people. Only about 15% of fatal overdoses result in immediate death, meaning quick action could save lives.

"It should never be a crime to call 911", said Naomi Long, director of the Drug Policy Alliance DC and Maryland Project, which is leading the charge for the bill in Annapolis. "This bill is about saving lives without compromising public safety. In these hard economic times, Maryland should focus resources on saving lives not arresting Good Samaritans."

The Good Samaritan bill "is about giving countless Marylanders a second chance at life," said Del. Kris Valderrama, the bill's sponsor. "We should pass laws that send the message that saving lives is our first priority."

"We need these laws to protect lives and to help people in confusing situations make the right decision to call for help if necessary," said Amber Langston, SSDP eastern regional outreach director. "People may hesitate to call 911 or not call at all out of fear of punishment, and even a few moments of hesitation can cost someone's life. If the goals of our drug policies are to save lives, then enacting Good Samaritan laws is good drug policy."

As a student organization, SSDP is particularly concerned about young people, said Langston. "This is an issue that particularly affects young people, who are generally less experienced and more fearful of retribution," she argued.

"We know that people are dying of overdoses, and these are preventable, unnecessary deaths," said DPA's Long. "We need to be creating the kind of situation where people immediately call for help. The bills in Maryland and elsewhere are an attempt to remove the perceived threat of prosecution from people who want to do the right thing, but are in a difficult situation."

Whether the Maryland bill passes this year remains to be seen, but the hearings have been an opportunity to open lawmakers' eyes to the problem, said Long. "We have been able to educate lawmakers about how the fear of arrest and punishment makes people hesitate to call 911, we have some really powerful stories, but the bottom line is that the bill still faces an uphill fight," she said.

"I think it's great that some state legislatures are trying to catch up with a good harm reduction program," said Hilary McQuie, western director of the Harm Reduction Coalition. "People frequently cite the fear of retribution as the main reason they didn't seek help. If these laws can get passed and accepted so they change people's behavior around what happens with an overdose situation, this could really make a difference in people's lives. It could save their lives."

But passing a Good Samaritan bill is just the beginning, said McQuie. "There is a lag between changes in the law and changes in 911 calls," she said. "It takes a little time for people to build trust in the system. You also have to educate police and the people around drug users that the law exists, and there is no funding for that. These efforts are wonderful, but they need more resources to be effectively implemented."

Drug War Allies: Russia, Cuba, Pakistan… USA?

Tell our United Nations delegation to stop opposing harm reduction.

http://ssdp.org/unitednations/act

Friend,

President Obama recently announced that his administration would no longer allow ideology to trump science in policy-making decision. Yet, the very same week, the Obama administration publicly supported worn out Drug War ideology over harm reduction practices that have been proven to save and improve the lives of drug users.

I was back in Vienna, Austria last week to witness the United Nations' final deliberation over a new political declaration and action plan that will guide global drug policy for the next ten years.

Unfortunately, despite recommendations made by 300 Non-Governmental Organizations form around the world, including SSDP, the declaration included no mention of harm reduction.

(Harm reduction is like contraceptives, but for drugs. It's a scientifically proven set of policies and practices that keep drug users alive and healthy, without relying on abstinence-only messaging.)

After final approval of the declaration, 26 nations including Great Britain, Germany, and Australia, courageously spoke up to register their support for harm reduction in the official UN record, setting off a firestorm of debate on the floor of the United Nations.

While most countries chose to remain silent on the issue, a handful chose to speak up and denounce support for harm reduction.  These included Russia, Cuba, Pakistan… and the United States!

We must send a message to President Obama and Secretary of State Clinton that the American people will no longer stand idly by as they allow 20th century Drug War ideology to trump science and evidence!

Please visit this action page to send a message to President Obama and Secretary of State Clinton, read the final approved U.N. declaration, and watch video of SSDP participating in a protest and press conference outside the United Nations.

Thank you for your support of SSDP's efforts to bring science and reason to national and global drug policies.

Sincerely,

Kris Krane
Executive Director
Students for Sensible Drug Policy

P.S. Like the work SSDP is doing to influence President Obama and the United Nations to change drug policy? If so, please let us know by making a donation today. http://www.ssdp.org/donate

Location: 
Vienna
Austria

Harm Reduction: Washington State Good Samaritan Bill Would Protect Those Bringing Overdosed Friends to Medical Care

More than 700 people died of drug overdoses in Washington state in 2006, up from a little over 400 in 1999. In an effort to blunt that trend, state Rep. Roger Goodman (D-Kirkland) has introduced HB 1796, which would provide limited immunity from prosecution for drug possession for people seeking assistance for friends or relatives suffering from a drug overdose. At present, New Mexico is the only state to have passed such a "Good Samaritan" law.

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Roger Goodman
Many overdose deaths occur because friends of the victim delay or completely avoid seeking medical treatment for fear they will end up being arrested themselves. That fear is one of the most significant barriers to getting help for OD victims.

The bill would prevent Good Samaritans from being prosecuted for drug possession, but not drug manufacture or distribution offenses. The bill also provides the same immunities for drug overdose victims. A second section of the bill legalizes the use of the opioid antagonist naloxone to treat overdoses.

Before becoming an elected official, Goodman earned an impressive reputation in the drug law reform community and the legal community as head of the King County Bar Association Drug Policy Project. Now, he has moved from advocating change to legislating change.

The bill was introduced January 29 and passed the House Committee on Public Safety and Emergency Preparedness on February 18 in amended version. On Thursday, it was returned to the Rules Committee for a second reading.

Update: HB 1796, and its companion bill sponsored by Sen. Rosa Franklin, SB 5516, did not come up for a vote before Thursday's cutoff.

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.

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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.

Tainted Cocaine is a Consequence of Drug Prohibition

I don’t particularly mind the drug czar pointing out that cocaine can kill you. While far from the deadliest thing on earth, the stuff ain’t good for you, especially given the way some folks get carried away with it. I agree that a sensible drug policy includes telling people that cocaine pretty much sucks.

But here we have the drug czar highlighting reports of tainted cocaine in Canada and proposing drug treatment as the solution to that. Isn’t it ironic that, after tirelessly advocating policies which drive drug distribution underground, the drug czar then cites a poisoned drug supply as an argument for abstinence?

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.

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