Ethics: June 2010 Archives
The recuperating blogger's method of easy blogging: Link to another story.
For today: A report from the NY Times, which revisits the dubious idea of stenting jugular veins in patients with multiple sclerosis. According to the paper, interest in the unproven procedure remains fueled by unknown numbers of desperate, logged-on MS patients and a few rogue physicians—some of whom market, in cringe-inducing fashion, a "liberation package."
Oh my ugh.
But neurologist Stephen Hauser of UCSF correctly tells the NYT that evidence for the procedure "is quite scanty" and that its "biological plausibility is low."
Previous posts at this blog highlight 1) a conclusion from US neurologist John Corboy that the small drop in pressure provided by these jugular-vein procedures is unlikely to be pathologically significant; and 2) the correct decision by Stanford to shut down the jugular-stent program of a vascular surgeon until well-controlled data are available to support the treatment.
Image of neck veins from Gray's Anatomy (1918).
Okay, maybe it's a cloying move by Pfizer to protest the absurdity of government oversight. But it's also kind of funny.
The world's largest drug company is advising US physicians who visit its exhibit booth at the ongoing ASCO meeting that they will have to swipe their registration cards if they want a freebie latte, reports Reuters. And oh no, you di'int: MDs from Minnesota and Vermont can't have one at all, thanks to their state laws that prohibit all swag—no matter how trivial.
Moreover, if you do accept a latte from Pfizer, the company may provide your name to US regulators and post the fact that you received caffeinated remuneration at its disclosure website. God knows, you could end up scribbling scores of prescriptions for Aromasin during your 20-minute Pfizer-propagated caffeine buzz.
At least the oversight measures are keeping somebody employed...and amused.
ASCO = American Society of Clinical Oncology.
06/10/10 addendum: It's hard to keep up, but Vermont recently amended its existing, relevant law to allow the "provision of coffee and other snacks or refreshments at a booth at a conference or seminar." The bill became effective on March 27th (without the governor's signature, according to the FDA Law Blog).
An expert panel of the American Academy of Neurology (AAN), the flagship organization of US neurologists, confirms the 1995 criteria for establishing brain death and has little to add on the basis of the interim literature. The panel's assessment is available in the latest issue of Neurology.
Among the findings:
- There have been no published reports of neurologic recovery once brain death has been diagnosed by using the 1995 criteria.
- There is insufficient evidence to define a minimal observation period for diagnosing brain death, once brain function has ceased.
- Complex, spontaneous movements, like facial myokymia, and ventilator triggering can be seen in brain death.
- The various tests for determining apnea have not been compared—so one test has not been shown to be preferable.
- Data supporting the use of newer ancillary tests, like MR angiography, to confirm brain death are not sufficiently compelling.
The steps to determining brain death include the prerequisites (eg, excluding the use of CNS depressants and neuromuscular blockers, establishing a normal core body temperature and blood pressure), the clinical evaluation (eg, documenting a lack of responsiveness, assessing brainstem reflexes, performing an apnea test), and ancillary tests (eg, performing an EEG or imaging study). A useful appendix checklist is provided in the article.
In addition, the AAN web site provides a Q&A with one of the panel members, Eelco Wijdicks of the Mayo Clinic, regarding the reassessment of brain-death criteria. In addition to discussing clinical and other parameters, Dr. Wijdicks provides all-important guidance for communicating the diagnosis of brain death to the victim's family. (In my experience, a particularly difficult concept for many family members to understand is the idea that brain death equals death, both functionally and legally. Conveying this information firmly and compassionately can be a challenge.)
After the diagnosis of brain death is made, the attending physician should meet with the family, accompanied by nursing staff and, often, hospital clergy. Considerable time for conversation and a quiet place to sit are needed. The family members are told that their loved one has passed on and that the medical staff deeply regrets the loss. The family members will have ample time to say their good-byes. The medical staff will be available for support. The family, however, will have to make a decision about possible organ donation and is invited to speak with an organ donation agency. The medical staff is keeping the rest of the organs working with medication and the mechanical ventilator, and if there is no wish for organ donation, the staff will stop the ventilator and other treatments.
Let's make no mistake: Disclosing potential pharma-related conflicts of interest among healthcare professionals, when possible, is desirable. But the idea that a few thousand pounds, Euros, or whatever from Roche or GSK led any WHO-advising expert to recommend the government stockpiling of Tamiflu and Relenza (the only drugs that exist to treat influenza symptoms), stretches credulity.
Nevertheless, that's what Deborah Cohen and Philip Carter would evidently like us to entertain in their BMJ "investigative" piece of last week. The writers also float the idea that WHO-advising physicians should have no industry ties whatsoever—a both unrealistic and unwise proposal. In such cases, WHO would be basing its recommendations for the planet on the thoughts of physicians who are actually less knowledgeable about proprietary drugs.
In an ABCNews report on the BMJ article, John Treanor, a vaccine expert from the University of Rochester essentially concurred: "[I]ndividuals with the greatest experience and insight into these interventions will almost always either be employees of industry or individuals paid by industry to conduct studies."* Likewise, John Bartlett of Johns Hopkins said, "[T]he people in medicine who know most about flu are often conflicted because they also are advisors to pharma and often do the big trials that are funded by pharma."
Let's also remember that Cohen and Carter are in the cushy position of being able to make their anti-WHO criticisms in the aftermath of what was a mild influenza pandemic.** Would they have had any problem lambasting WHO for a lack of preparedness if the pandemic had been far worse and the supplies of anti-influenza drugs had been limited? Probably not.
This specter of journalistic duplicity was echoed by ABC's quoted experts:
Treanor: "I think even [Cohen and Carter] would have to agree that there really was no choice here but to prepare for a pandemic. If there had been a severe pandemic and there had been no preparations, the outcome (and the outcry) would have been far worse."
John Barry, author of The Great Influenza: "This is a classic case of 20-20 hindsight, with some witch hunting thrown in."
Last, biosecurity expert Donald A. Henderson concluded about Cohen's and Carter's angle: "WHO is a handy whipping post. I would characterize this focus on WHO as a 'cheap shot.'"
* Treanor also acknowledged that a lack of industry ties doesn't necessarily remove bias. Researchers "will always view the product they do work on in a positive light, even if they weren't paid by industry," he said.
** At least as of now.
06/09/10 addendum: Responding to the BMJ accusations, WHO Director-General, Margaret Chan, denies that commercial interests were considered in WHO's decision-making process "for one second," reports Canada's Globe and Mail. "The bottom line...is that decisions to raise the level of pandemic alert were based on clearly defined virological and epidemiological criteria. It is hard to bend these criteria, no matter what the motive," Chan rebutted. (The full text of Chan's letter to the BMJ can be found here.)
Chan also responded that the continued anonymity of 3 members of WHO's "emergency" committee is to protect them from undue influence, including undue commercial influence. It is reported that their identities will be revealed once their service is complete.
In the meantime, an independent committee is reviewing WHO's handling of the 2009 H1N1 pandemic.