Darvocet decision a prelude a warm up for banning methadone?

Christian Sinclair over at Pallimed does some sleuthing into the FDA's rationale for pulling propoxyphene and comes away concerned:

He notes that

* Propoxyphene is a synthetic derivative of methadone.

* Methadone causes QT prolongation of questionable clinical significance in palliative care patients.

* QT prolongation is a risk factor for ventricular arrhythmias.

Combined with some FDA memo analysis (go read the post) he concludes

Well all this may be a whole lot of nothing but my real concern is that methadone may be a drug in the crosshairs of the FDA soon. It already has four strikes against it:

1) documented QT prolongation

2) stigma of heroin treatment programs

3) accelerating percent of all deaths related to opioids

4) methadone could be considered an orphan drug

This would be bad news indeed.

(Via: Pallimed: A Hospice & Palliative Medicine Blog: Are You Glad Darvocet Got Pulled by the FDA? Are You Sure?)

New warning labels on NASIDs

Medical News Today News Article: "FDA Requires Additional Labeling For Over-the-Counter Pain Relievers And Fever Reducers To Help Consumers Use Products Safely

29 Apr 2009   

The Food and Drug Administration issued a final rule today that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks, such as internal bleeding and liver damage, associated with the use of these popular drugs.

Products covered by the FDA action include acetaminophen, and a class of drugs known as the nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs include aspirin, ibuprofen, naproxen, and ketoprofen. Acetaminophen is in a class by itself. The revised labeling applies to all OTC pain relievers and fever reducers, including those that contain one of these ingredients in combination with other ingredients, such as in cold medicines containing pain relievers or fever reducers.

'Acetaminophen and NSAIDs are commonly used drugs for both children and adults because they are effective in reducing fevers and relieving minor aches and pain, such as headaches and muscle aches, ' said Charles Ganley, M.D., director, FDA's Office of Nonprescription Drugs in the Center for Drug Evaluation and Research. 'However, the risks associated with their use, need to be clearly identified on the label so that consumers taking these drugs are fully aware of the potential harm they can cause. It is important that they know how to take these medications safely to reduce their risk.'

Under the final rule, manufacturers must ensure that the active ingredients of these drugs are prominently displayed on the drug labels on both the packages and bottles. The labeling also must warn of the risks of stomach bleeding for NSAIDs and severe liver damage for acetaminophen.

Since 2006, some manufacturers have voluntarily revised their product labeling to identify these potential safety concerns. However, the voluntary changes to labeling do not address all of the labeling requirements in the new rule. For example, the new rule includes a warning on products containing acetaminophen that instructs consumers to ask a doctor before they are taking the blood thinning drug warfarin. The new rule requires all manufacturers to relabel their products within one year of today's date.

Safety data reported in medical literature indicate that people sometimes take more acetaminophen than the labeling recommends. Others unknowingly take multiple products containing acetaminophen at the same time. Exceeding the recommended dosage of acetaminophen may increase the risks for severe liver damage. Alcohol use can also increase the risk of liver damage with acetaminophen.

The risk for stomach bleeding may increase in people who use NSAIDs and who are taking blood-thinning drugs (anticoagulants) or steroids. Stomach bleeding risks also increase for people who take multiple NSAIDs at the same time, or in people who take them longer than directed. Alcohol use can increase the risk for stomach bleeding with NSAIDs use.

An FDA Advisory Committee meeting will be convened on June 29 & 30, 2009, to discuss further steps the FDA could take to reduce the risk of liver damage associated with acetaminophen overdoses.

To read the final rule on the relabeling of OTC pain relievers and fever reducers, go here.

To read the FR Notice announcing the FDA Advisory Committee meeting, see link.

Source
Food and Drug Administration
Article URL: http://www.medicalnewstoday.com/articles/148085.php"

Scalia on torture

Sometimes its obvious why I'm not cut out for the judiciary. My little mind is not capable of such genius:

From Harpers:

Justice Scalia said it was “extraordinary” to assume that the ban on “cruel and unusual punishment”—the US Constitution’s Eighth Amendment—also applied to “so-called” torture. “To begin with the constitution… is referring to punishment for crime. And, for example, incarcerating someone indefinitely would certainly be cruel and unusual punishment for a crime.”

Justice Scalia argued that courts could take stronger measures when a witness refused to answer questions. “I suppose it’s the same thing about so-called torture. Is it really so easy to determine that smacking someone in the face to determine where he has hidden the bomb that is about to blow up Los Angeles is prohibited in the constitution?” he asked.

“It would be absurd to say you couldn’t do that. And once you acknowledge that, we’re into a different game. “How close does the threat have to be? And how severe can the infliction of pain be?”

Just so we're clear. We've now learned that the 8th Amendment is only about punishment. It does not cover what the state can do to you before they get around to punishing you.

The subjective experience of punishment

Friend of PFP has an intriguing article on sensitivity to punishment and punitive practices here.

Abstract:
Suppose two people commit the same crime and are sentenced to equal terms in the same prison facility. I argue that they have identical punishments in name only. One may experience incarceration as challenging but tolerable while the other is thoroughly tormented by it. Our sentencing policies seek to equalize the duration of their incarceration, yet largely ignore the differences in their experiences of isolation, stigma, and confinement. In this article, I argue that, according to our prevailing theories of punishment, the subjective experience of punishment matters. There is, therefore, a disconnect between our punishment practices and our best attempts to justify those practices.

There are three possible responses. First, we could try to modify or expand our theories to avoid the obligation to calibrate punishment. I show why this approach is unlikely to succeed. Second, we could conclude that, even though we ought to calibrate our punishments, doing so would be too costly or difficult to administer. This response is too hasty. In civil litigation, we do make subjective assessments of damages. Advances in neuroscience may someday make these assessments more accurate and less expensive. Even if we cannot individually calibrate punishments, we can surely enact sentencing policies that are more subjectively-sensitive than the policies we have now. We are left, then, with only the third response: to recognize that subjective experience matters in assessments of punishment severity and to take at least modest steps toward calibrating punishment, either through individual measurement or, more feasibly, by enacting punishment policies that are subjectively sensitive.

Brain imaging for pain in the courtroom

Law Professor Adam Kolber has an interesting paper on attempts to use brain imaging as evidence that a person is in fact in pain. The abstract:

Pain is a fundamentally subjective experience. We have uniquely direct access to our own pain but can only make rough inferences about the pain of others. Nevertheless, such inferences are made all the time by doctors, insurers, judges, juries, and administrative agencies. Advances in brain imaging may someday improve our pain assessments by bolstering the claims of those genuinely experiencing pain while impugning the claims of those who are faking or exaggerating symptoms. These possibilities raise concerns about the privacy of our pain. I suggest that while the use of neuroimaging to detect pain implicates significant privacy concerns, our interests in keeping pain private are likely to be weaker than our interests in keeping private certain other subjective experiences that permit more intrusive inferences about our thoughts and character

I expect to have a bit to say about this later when I've had the chance to digest the paper. And, yes, I'll share.

Balkan et al. on toture

The legal blog Balkanization has compiled a list of all their posts on torture here. Definitely worth checking out.

Sensory deprivation torture

From Salon:

The CIA's favorite form of torture
By Mark Benjamin

Jun. 07, 2007 | According to news reports, the White House is preparing to issue an executive order that will set new ground rules for the CIA's secret program for interrogating captured al-Qaida types. Constrained by the 2006 Military Commissions Act, which contains a strict ban on abuse, it is anticipated that the order will jettison waterboarding and other brutal interrogation techniques.

[....]

The answer is most likely a measure long favored by the CIA -- sensory deprivation. The benign-sounding form of psychological coercion has been considered effective for most of the life of the agency, and its slippery definition might allow it to squeeze through loopholes in a law that seeks to ban prisoner abuse. Interviews with former CIA officials and experts on interrogation suggest that it is an obvious choice for interrogators newly constrained by law. The technique has already been employed during the "war on terror," and, Salon has learned, was apparently used on 14 high-value detainees now held at Guantánamo Bay.

A former top CIA official predicted to Salon that sensory deprivation would remain available to the agency as an interrogation tool in the future. "I'd be surprised if [sensory deprivation] came out of the toolbox," said A.B. Krongard, who was the No. 3 official at the CIA until late 2004. Alfred McCoy, a history professor at the University of Wisconsin-Madison who has written extensively about the history of CIA interrogation, agrees with Krongard that the CIA will continue to employ sensory deprivation. "Of course they will," predicted McCoy. "It is embedded in the doctrine." For the CIA to stop using sensory deprivation, McCoy says, "The leopard would have to change his spots." And he warned that a practice that may sound innocuous to some was sharpened by the agency over the years into a horrifying torture technique.

Sensory deprivation, as CIA research and other agency interrogation materials demonstrate, is a remarkably simple concept. It can be inflicted by immobilizing individuals in small, soundproof rooms and fitting them with blacked-out goggles and earmuffs. "The first thing that happens is extraordinary hallucinations akin to mescaline," explained McCoy. "I mean extreme hallucinations" of sight and sound. It is followed, in some cases within just two days, by what McCoy called a "breakdown akin to psychosis."

[....]

Just like waterboarding, Massimino said, extreme sensory deprivation techniques "push people beyond the brink of what they can bear, physically and mentally. Once you understand that, the veneer of acceptability -- the myth that 'it's not torture, it's just harsh' -- completely falls apart." But compared to the outcry over physical torture, she described a "deafening silence" about techniques like sensory deprivation.

The issue, said Massimino, is that sensory deprivation is relative -- she compared it to a "rheostat." Former CIA executive director Krongard made the same point about sensory deprivation's variability, saying that the techniques exist on a spectrum. The term could refer to anything from being left alone in a room to being subjected to complex get-ups combining goggles, earmuffs, mittens and darkened cells that quickly drive subjects into psychotic states.

On the low end, said Krongard, sensory deprivation techniques would pass muster with most observers. But he admitted that taken to extremes, some methods "would not pass anybody's muster." Sensory deprivation techniques taken to extremes would clearly violate the Geneva Conventions, according to international law experts, and would appear to be illegal under the Military Commissions Act, which bans "severe or serious mental pain and suffering." McCoy stated that based on his experience tracking down and interviewing subjects from the CIA's early research, some subjects never fully recover.

Sensory deprivation has apparently already been employed during the so-called war on terror. The prevalence of its use has been hinted at in images of alleged terror-plotter Jose Padilla and of detainees at Guantánamo shown wearing blacked-out goggles and earmuffs -- basic deprivation tools intended to soften prisoners up mentally by plunging them into a sensory void. A source familiar with the 14 high-value detainees interrogated at the CIA's so-called black sites and transferred to military custody at Guantánamo late last year, said the CIA appeared to have used some form of sensory deprivation techniques on most, if not all, of those 14 high-value detainees.

But the CIA's reliance on sensory deprivation goes all the way back to the early days of the Cold War. It is a big part of the CIA's 1963 "KUBARK" interrogation manual, obtained in 1997 by the Baltimore Sun. That agency manual describes sensory deprivation as a central tenet of coercive interrogations. For particularly rapid results, the manual endorses the use of a "cell which has no light (or weak artificial light which never varies), which is sound-proofed, in which odors are eliminated, etc." Following that plan, the manual says, "induces stress; the stress becomes unbearable for most subjects." The manual adds, "The subject has a growing need for physical and social stimuli; and some subjects progressively lose touch with reality, focus inwardly, and produce delusions, hallucinations, and other pathological effects."

As proof, the KUBARK manual refers to a raft of CIA-sponsored Cold War research on sensory deprivation, including studies at McGill University in Montreal and the National Institute of Mental Health. Subjects in that research were placed in isolated water tanks or confined to silent rooms on soft mattresses, wearing blacked-out goggles and earmuffs. In one study, subjects experienced "visual imagery somewhat resembling hallucinations" within three hours. In another study, only 6 of 17 subjects could last 36 hours on a mattress in a quiet tank that prohibited movement. The stress is described in the KUBARK manual as "unbearable."

The dark world of CIA-sponsored sensory deprivation research is plumbed in depth in the book "A Question of Torture: CIA Interrogation From the Cold War to the War on Terror," written by McCoy. "They've been doing this for 50 years," McCoy explained. His book discusses more CIA-sponsored research at McGill by Dr. Donald O. Hebb, who during the same era placed 22 college students in small, sound-proof cubicles, wearing translucent goggles, thick gloves and a U-shaped pillow around the head. Most subjects quit within two days and all experienced hallucinations and "deterioration in the capacity to think systematically."

The theory behind the CIA's fascination with sensory deprivation, McCoy said, is that subjects are so starved for stimulation that they will even crave interaction with their interrogator. "The idea is that they break down and then they cling to the interrogator, because you are hungry for stimulus," McCoy explained.

[....]

Bauer, who was the most forward-deployed Army interrogator during Operation Desert Storm, said sensory deprivation can drive people to come up with lies "based on ending the harsh treatment. That is not an effective way to conduct intelligence collection operations."

[....]

If the White House chooses to go the sensory deprivation route, it is unclear what, if anything, Congress could do to put a stop to it. There are limited tools available to the Senate Intelligence Committee, the committee with direct oversight of the agency, to step in. As one committee aide explained, "We don't have a veto over it."

-- By Mark Benjamin
Copyright ©2007 Salon Media Group, Inc.

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