Saturday, July 30, 2005
CNS Update: Riluzole For Depression and OCD?
Occasionally, pharmaceuticals developed for one purpose turn out to
have applications that differ from the original use. This may
turn out to be the case with riluzole
(Rilutek® - Aventis Pharmaceuticals Products Inc.). [Package
insert (PI)] I've blogged
about this before, but this post has some new information,
and presents a different perspective.
Riluzole was approved by the US FDA in December 2004 for treatment of motor neuron disease, known primarily as Amyotrophic Lateral Sclerosis (ALS, Lou Gehrig disease). The chemical structure of riluzole is shown below:
2-amino-6-(trifluoromethoxy)benzothiazole
Recently, a few articles have appeared, suggesting that riluzole might be helpful for some patients with depression and/or obsessive-compulsive disorder. First, a disclaimer: the research is in a very early stage, and it would be advisable to consider such treatment only within the context of a formal clinical trial (1 2).
Current pharmaceutical treatment for depression and OCD involve almost exclusively agents that modify the action of serotonin and/or norepinephrine. In contrast, riluzole modifies the action of a different neurotransmitter: glutamate.
Glutamate is an amino acid. Its primary function in humans is
to serve as a component of protein. It is often the case,
however, that most things in the body serve more than one function.
Glutamate serves also as a chemical messenger, sending
signals between nerve cells. It is the most
widely-distributed neurotransmitter in the human brain.
Because it is an excitatory transmitter, excessive amounts
can lead to neuronal death. It is thought that this is part
of the pathophysiology of ALS, in that excessive glutamate may lead to
premature death of motor neurons. Therefore, it would make
sense to try to find something that inhibits the action of glutamate,
and see if that helps patients with ALS.
Note that riluzole has several actions, only one of which is to inhibit release of glutamate from nerve cells in the brain. This may or may not have anything to do with how or why it works. From the package insert:
A lot of people with depression or OCD have a satisfactory response to standard treatments. However, a lot of people don't. Therefore, when a drug becomes available that does something to the brain, usually it is only a short time before somebody tries to use it to treat those patients who have not shown satisfactory response to standard treatments.
Currently, it is not known what role glutamate plays in either depression or OCD. However, since it is so widely distributed in the brain, it would not surprise anyone to learn that it was involved in some way. See this study in ANAS for discussion. In accordance with the notions described above, people now are trying riluzole to see if it can help treatment-resistant patients with depression and/or OCD.
The American Journal of Psychiatry has published a couple of items on the use of riluzole for depression.
Regarding the potential use of riluzole for OCD, there is one preliminary study:
It happens all the time that such preliminary results are reported, patients flock to their doctors wanting the new treatment, and the results may turn out to be poor. Even worse, patients may end up worse off than they were before. In the case of riluzole, there are many reasons for caution.
Recall that the FDA has been criticized recently, due to allegations that they have been too lax in assessing the safety of new drugs. Although Rilutek® has been approved by the FDA, it was approved for use in a condition that is rare, rapidly progressive, and invariably fatal. The threshold for approval in such cases is different than the threshold for other drugs. Although it is common for physicians to use drugs off-label, there are good reasons to be especially careful when doing so. The FDA thinks that Rilutek® is safe, in relative terms; that is, it is safe in relation to the disease for which it was approved. For an invariably-fatal disease, that threshold is fairly easy to meet. Note that in the Kaplan-Meier survival curve, the improvement seen in ALS patients is significant, but hardly impressive. Since all the patients died eventually, we have no way of knowing if there would have been an late-onset adverse events.
Note also that the approved dose of Rilutek® is 100mg per day. The patients in the monotherapy study got more than that; some got 200mg per day.
The Rilutek® package information contains warnings about variability in metabolism of riluzole in Japanese patients, men vs. women, smokers, the elderly, and patients with liver disease.
They also note that there were a few patients on Rilutek® who developed low white blood cell counts.
Riluzole is broken down in the liver by several different pathways, and there are many active and inactive metabolites. It is highly bound to plasma protein. Those are indications that it has a high potential for drug interactions. Aventis did not do clinical studies to check for interactions. It is likely that they would have to do more safety and interaction studies if they asked the FDA for approval to market Rilutek® for treatment of something common, such as depression or OCD.
There has been some concern in the media about the impact of direct-to-consumer advertising of pharmaceutical products. Blog posts, such as this one, raise a more complicated issue. Most people reading this have either no idea, or only a vague idea, of who I am. The fact that I use a lot of jargon and cite reputable journals may give the impression that I actually know what I am talking about. In this post, I've tried to convey an appropriate level of caution. I am not trying to sell anything. (Note the absence of blog ads.) I don't own stock in Aventis, except maybe there is some in my 401k; I deliberately don't invest directly in pharmaceutical companies. But you don't know any of that, and you have no way of checking. You could send an email to joseph.j7uy5-at-gmail/dot/com, but even that would not provide you with any information that is more reliable that what you are reading now.
There are many sites on the Internet that include a lot of jargon and cite reputable journals, yet contain all kinds of misleading, commercially-motivated, and/or downright dangerous statements. I suggest thinking of it this way: If you might consider making a potentially life-changing medical decision based upon some anonymous blog post, ask yourself this: would you consider investing a large amount of money in an unknown company, based upon an anonymous blog post that reads like this: ΡΗΛUΤΕΚ, ακόμη και στους ασθενείς χωρίς μια προγενέστερη ιστορία της ασθένειας ήπαρ, aminotransferase ορών αιτιών ανυψώσεις? If not, good for you; if so, I suggest that you disconnect from the Internet immediately, and don't connect ever again.
No, the point here is not to urge anyone to go out and ask for a prescription. Rather, I am hopeful that some health care professionals will read this and learn something that might be useful at some later date. Nonmedical readers should take away a couple of points. One, there is ongoing research into difficult-to-treat psychiatric conditions, so there always is hope that those who do not respond to conventional treatments may, someday, have more options available. Two, there are some skills that one must acquire in order to assess medical claims. Reading this post might help sharpen those skills. And finally, always be skeptical of anything you read on the Internet, no matter how authoritative it may seem.
Спасибо за чтение Корпус Коллозум. Возвратитесь скоро. До свидания. Vielen dank dafür, Das Korpus Callosum zu lesen. Kommen Sie bald zurück. Auf Wiedersehen!. Gracias por leer la Recopilación Callosum. Vuelto pronto. ¡Adiós!. Merci de lire le Corpus Callosum. Revenu bientôt. Au revoir! These translations courtesy of Paralink.com. (I hope I didn't just insult somebody.)
Riluzole was approved by the US FDA in December 2004 for treatment of motor neuron disease, known primarily as Amyotrophic Lateral Sclerosis (ALS, Lou Gehrig disease). The chemical structure of riluzole is shown below:
2-amino-6-(trifluoromethoxy)benzothiazole
Recently, a few articles have appeared, suggesting that riluzole might be helpful for some patients with depression and/or obsessive-compulsive disorder. First, a disclaimer: the research is in a very early stage, and it would be advisable to consider such treatment only within the context of a formal clinical trial (1 2).
Current pharmaceutical treatment for depression and OCD involve almost exclusively agents that modify the action of serotonin and/or norepinephrine. In contrast, riluzole modifies the action of a different neurotransmitter: glutamate.
Note that riluzole has several actions, only one of which is to inhibit release of glutamate from nerve cells in the brain. This may or may not have anything to do with how or why it works. From the package insert:
Mechanism of ActionSuperoxide dismutase is an enzyme containing in cells that protects them from damage, under certain conditions.
The etiology and pathogenesis of amyotrophic lateral sclerosis (ALS) are not known, although a number of hypotheses have been advanced. One hypothesis is that motor neurons, made vulnerable through either genetic predisposition or environmental factors, are injured by glutamate. In some cases of familial ALS the enzyme superoxide dismutase has been found to be defective.
The mode of action of RILUTEK is unknown. Its pharmacological properties include the following, some of which may be related to its effect: 1) an inhibitory effect on glutamate release, 2) inactivation of voltage-dependent sodium channels, and 3) ability to interfere with intracellular events that follow transmitter binding at excitatory amino acid receptors. [...]
A lot of people with depression or OCD have a satisfactory response to standard treatments. However, a lot of people don't. Therefore, when a drug becomes available that does something to the brain, usually it is only a short time before somebody tries to use it to treat those patients who have not shown satisfactory response to standard treatments.
Currently, it is not known what role glutamate plays in either depression or OCD. However, since it is so widely distributed in the brain, it would not surprise anyone to learn that it was involved in some way. See this study in ANAS for discussion. In accordance with the notions described above, people now are trying riluzole to see if it can help treatment-resistant patients with depression and/or OCD.
The American Journal of Psychiatry has published a couple of items on the use of riluzole for depression.
Riluzole Augmentation for Treatment-Resistant Depression
Am J Psychiatry 161:2132, November 2004
Letter to the Editor
GERARD SANACORA, M.D., Ph.D., STEVEN F. KENDELL, M.D., LISA FENTON, Psy.D., VLADIMIR CORIC, M.D., and JOHN H. KRYSTAL, M.D.
New Haven, Conn.
To the Editor: Glutamate is implicated in the pathophysiology and treatment of mood disorders (1). The following case reports pertain to the use of riluzole, a putative antiglutamatergic agent indicated for the treatment of amyotrophic lateral sclerosis, as add-on therapy for treatment-resistant major depressive disorder. [...]
An Open-Label Trial of Riluzole in Patients With Treatment-Resistant Major DepressionThe "letter to the editor" is a semi-formal report of two cases in which depressed patients got better when riluzole was added on to their existing antidepressant regimen. The "Brief Report" is a description of the outcome for 19 patients who received riluzole as the sole treatment. The results are encouraging. However, it is very important that the results be interpreted with caution. That is why Zarate et. al. conclude with the statement: "Although preliminary, these results indicate that riluzole may have antidepressant properties in some patients."
Am J Psychiatry 161:171-174, January 2004
Brief Report
Carlos A. Zarate, Jr., M.D., Jennifer L. Payne, M.D., Jorge Quiroz, M.D., Jonathan Sporn, M.D., Kirk K. Denicoff, M.D., David Luckenbaugh, M.S., Dennis S. Charney, M.D., and Husseini K. Manji, M.D., F.R.C.P.C.
OBJECTIVE: This study was conducted to determine the efficacy and safety of riluzole, a glutamate-modulating agent, in patients with recurrent major depression. METHOD: After a 1-week drug-free period, subjects 18 years or older with a diagnosis of recurrent major depression and a Montgomery-Åsberg Depression Rating Scale score >=20 received riluzole monotherapy (100–200 mg/day) openly for 6 weeks. RESULTS: Nineteen treatment-resistant depressed patients, 53% of whom were classified as having stage 2 treatment resistance or greater, received riluzole at a mean dose of 169 mg/day. Significant improvement occurred during weeks 3 through 6 for all patients and weeks 2 through 6 for completers. CONCLUSIONS: Although preliminary, these results indicate that riluzole may have antidepressant properties in some patients.
Regarding the potential use of riluzole for OCD, there is one preliminary study:
Riluzole Augmentation in Treatment-Resistant Obsessive–Compulsive Disorder: An Open-Label TrialIn this study, results were more modest, but still significant. Note that in all cases, riluzole was added to pre-existing treatment. It was used in the dose that is standard for ALS, 100mg per day. The study was not designed specifically to assess the effect of riluzole on depression, or on anxiety symptoms not related to OCD, but they did find a significant effect in those symptom clusters as well.
j.biopsych.2005.04.043
Vladimir Coric, Sarper Taskiran, Christopher Pittenger, Suzanne Wasylink, Daniel H. Mathalon, Gerald Valentine, John Saksa, Yu-te Wu, Ralitza Gueorguieva, Gerard Sanacora, Robert T. Malison and John H. Krystal
Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut
Case report
Background
Most patients with obsessive–compulsive disorder (OCD) show only partial reduction of symptoms with standard therapy. Recent imaging data suggests glutamatergic dysfunction in the corticostriatal pathway in OCD. We investigated the efficacy of augmentation therapy with riluzole, a glutamate-modulating agent, in treatment-resistant OCD.
Methods
Thirteen patients aged between 18 and 65 years with a primary diagnosis of OCD that had proven resistant to standard treatment were treated with the addition of riluzole to their existing pharmacotherapy. Yale–Brown Obsessive Compulsive Scale (Y-BOCS), Hamilton Depression Inventory (HAM-D), and Hamilton Anxiety Inventory (HAM-A) scores were obtained weekly.
Results
Thirteen treatment-resistant OCD patients received riluzole 50 mg twice a day. Y-BOCS scores improved significantly over time. Of 13 patients, 7 (54%) demonstrated a >35% reduction in Y-BOCS scores, and 5 (39%) were categorized as treatment responders. HAM-D and HAM-A scores for the group also significantly improved over time. Riluzole was well tolerated with no serious adverse effects noted.
Conclusions
Riluzole appears to have significant antiobsessional, antidepressant, and antianxiety properties. The addition of this agent may be of practical clinical benefit in patients with OCD.
It happens all the time that such preliminary results are reported, patients flock to their doctors wanting the new treatment, and the results may turn out to be poor. Even worse, patients may end up worse off than they were before. In the case of riluzole, there are many reasons for caution.
Recall that the FDA has been criticized recently, due to allegations that they have been too lax in assessing the safety of new drugs. Although Rilutek® has been approved by the FDA, it was approved for use in a condition that is rare, rapidly progressive, and invariably fatal. The threshold for approval in such cases is different than the threshold for other drugs. Although it is common for physicians to use drugs off-label, there are good reasons to be especially careful when doing so. The FDA thinks that Rilutek® is safe, in relative terms; that is, it is safe in relation to the disease for which it was approved. For an invariably-fatal disease, that threshold is fairly easy to meet. Note that in the Kaplan-Meier survival curve, the improvement seen in ALS patients is significant, but hardly impressive. Since all the patients died eventually, we have no way of knowing if there would have been an late-onset adverse events.
Note also that the approved dose of Rilutek® is 100mg per day. The patients in the monotherapy study got more than that; some got 200mg per day.
The Rilutek® package information contains warnings about variability in metabolism of riluzole in Japanese patients, men vs. women, smokers, the elderly, and patients with liver disease.
RILUTEK, even in patients without a prior history of liver disease, causes serum aminotransferase elevations. Experience in almost 800 ALS patients indicates that about 50% of riluzole-treated patients will experience at least one ALT/SGPT level above the upper limit of normal, about 8% will have elevations > 3 X ULN, and about 2% of patients will have elevations > 5 X ULN. A single non-ALS patient with epilepsy treated with concomitant carbamazepine and phenobarbital experienced marked, rapid elevations of liver enzymes with jaundice (ALT 26 X ULN, AST 17 X ULN, and bilirubin 11 X ULN) four months after starting RILUTEK; these returned to normal 7 weeks after treatment discontinuation.In case that's all Greek to you...
ΡΗΛUΤΕΚ, ακόμη και στους ασθενείς χωρίς μια προγενέστερη ιστορία της ασθένειας ήπαρ, aminotransferase ορών αιτιών ανυψώσεις. Η εμπειρία σε σχεδόν 800 ασθενείς νόσου του Alsheimer δείχνει ότι περίπου 50% των ρηλuζολε-αντιμετωπισμένων ασθενών θα δοκιμάσει τουλάχιστον ένα επίπεδο ALT/$l*SGPT επάνω από το ανώτερο όριο κανονικού, περίπου 8% θα έχει τις ανυψώσεις 3 Χ UΛΝ, και περίπου 2% των ασθενών θα έχει τις ανυψώσεις 5 Χ UΛΝ. _ ένας ενιαίος μη-νόσος του Alsheimer ασθενής με επιληψία μεταχειρίζομαι με συνακόλουθος θαρψαμαζεπηνε και πχενοψαρψηταλ δοκιμάζω χαρακτηρίζω, γρήγορος ανύψωση συκώτι ένζυμο με ίκτερος (ALT 26 Χ UΛΝ, ΑΣΤ 17 Χ UΛΝ, και ψηληρuψην 11 Χ UΛΝ) τέσσερις μήνας μετά από αρχίζω ΡΗΛUΤΕΚ αυτοί επέστρεψαν σε κανονικές 7 εβδομάδες μετά από την αναστολή επεξεργασίας....what this means is that there is a risk of liver damage with riluzole. (I have no idea why Babelfish thinks "riluzole-treated patients" are "patients of illness of Alsheimer.") It is pointed out that about half of the ALS patients have at least some elevation of liver enzymes when they are treated with Rilutek®. They recommend regular monitoring of the levels of these enzymes, in case some patients develop overt liver damage.
They also note that there were a few patients on Rilutek® who developed low white blood cell counts.
Riluzole is broken down in the liver by several different pathways, and there are many active and inactive metabolites. It is highly bound to plasma protein. Those are indications that it has a high potential for drug interactions. Aventis did not do clinical studies to check for interactions. It is likely that they would have to do more safety and interaction studies if they asked the FDA for approval to market Rilutek® for treatment of something common, such as depression or OCD.
There has been some concern in the media about the impact of direct-to-consumer advertising of pharmaceutical products. Blog posts, such as this one, raise a more complicated issue. Most people reading this have either no idea, or only a vague idea, of who I am. The fact that I use a lot of jargon and cite reputable journals may give the impression that I actually know what I am talking about. In this post, I've tried to convey an appropriate level of caution. I am not trying to sell anything. (Note the absence of blog ads.) I don't own stock in Aventis, except maybe there is some in my 401k; I deliberately don't invest directly in pharmaceutical companies. But you don't know any of that, and you have no way of checking. You could send an email to joseph.j7uy5-at-gmail/dot/com, but even that would not provide you with any information that is more reliable that what you are reading now.
There are many sites on the Internet that include a lot of jargon and cite reputable journals, yet contain all kinds of misleading, commercially-motivated, and/or downright dangerous statements. I suggest thinking of it this way: If you might consider making a potentially life-changing medical decision based upon some anonymous blog post, ask yourself this: would you consider investing a large amount of money in an unknown company, based upon an anonymous blog post that reads like this: ΡΗΛUΤΕΚ, ακόμη και στους ασθενείς χωρίς μια προγενέστερη ιστορία της ασθένειας ήπαρ, aminotransferase ορών αιτιών ανυψώσεις? If not, good for you; if so, I suggest that you disconnect from the Internet immediately, and don't connect ever again.
No, the point here is not to urge anyone to go out and ask for a prescription. Rather, I am hopeful that some health care professionals will read this and learn something that might be useful at some later date. Nonmedical readers should take away a couple of points. One, there is ongoing research into difficult-to-treat psychiatric conditions, so there always is hope that those who do not respond to conventional treatments may, someday, have more options available. Two, there are some skills that one must acquire in order to assess medical claims. Reading this post might help sharpen those skills. And finally, always be skeptical of anything you read on the Internet, no matter how authoritative it may seem.
Спасибо за чтение Корпус Коллозум. Возвратитесь скоро. До свидания. Vielen dank dafür, Das Korpus Callosum zu lesen. Kommen Sie bald zurück. Auf Wiedersehen!. Gracias por leer la Recopilación Callosum. Vuelto pronto. ¡Adiós!. Merci de lire le Corpus Callosum. Revenu bientôt. Au revoir! These translations courtesy of Paralink.com. (I hope I didn't just insult somebody.)
Categories: Science, medicine
Tags: depression, obsessive compulsive disorder, medicine, psychiatry, mental health, amyotrophic lateral sclerosis
(Note: The Rest of the Story/Corpus Callosum has moved. Visit the new site here.)
E-mail a link that points to this post:
Thursday, July 28, 2005
Resolution of Inquiry
House Resolution 375, proposed by the Honorable Barbara Lee (D-CA),
calls for Congress to exercise its Constitutional oversight of the
executive branch, by investigating the communication that took place
between the USA and the UK in the run-up to the Iraq War.
Although this is unlikely to go anywhere, given the
yellow-hammerlock that the Republican Party has on Congress, it is a
serious matter nonetheless.
If our President indeed lied to the American people prior to the war, that would be a High Crime, by any definition. Recall that he stated, on numerous occasions, that the decision for war had not been decided until a few days before hostilities began. The gravity of the situation was underscored by the nation-wide recognition given to the Downing Street memos. This is analogous to the situation with the 16 words about "uranium from Africa." Those words were contained in a State of the Union Address, which is a Constitutionally-mandated official report to Congress. Knowingly including a lie in report to Congress is no small matter. Ol' Cranky at The Disenchanted Forest has the latest on that.
One of our servicemen, Rob, posting at The Online Magazine formerly known as Rob's Blog, provides us with an easy way to speak up:
Submarines have always fascinated me. The Ohio-class Trident II-bearing boomers are, arguably, the most powerful killing machines ever devised. Despite that satanic distinction, it is entirely possible that it was our superiority in undersea warfare that prevented the Cold War from killing us all. Accordingly, I have a certain kind of ambivalent respect for submariners. Rob is one of them, although I don't know what kind of boat he mans.
In fact, one of our horses, Vivid October, was named after the submarine in The Hunt for Red October. Well, at least the name was inspired by the fictional sub. His mare is named Vivid April Maiden. Yvonne's birthday is in April; mine is in October. April is female; October is male. Yvonne was not fond of the other proposed names: Trident, etc., but she could live with October, and it sort of made sense, for the reasons noted above.
Nostalgic tangents aside, I sometimes think that certain political figures fancy themselves to be as powerful and as secretive as the Ohio-class SSBN's, as they rove the halls of the West Wing. HR 375 may well torpedo that fantasy.
Others fancy themselves to be bucking stallions. I think this is a more accurate depiction:
Kinda reminds you of a certain joke told by the First Lady, about our President, doesn't it?
If our President indeed lied to the American people prior to the war, that would be a High Crime, by any definition. Recall that he stated, on numerous occasions, that the decision for war had not been decided until a few days before hostilities began. The gravity of the situation was underscored by the nation-wide recognition given to the Downing Street memos. This is analogous to the situation with the 16 words about "uranium from Africa." Those words were contained in a State of the Union Address, which is a Constitutionally-mandated official report to Congress. Knowingly including a lie in report to Congress is no small matter. Ol' Cranky at The Disenchanted Forest has the latest on that.
One of our servicemen, Rob, posting at The Online Magazine formerly known as Rob's Blog, provides us with an easy way to speak up:
If your Representative is not a co-sponsor, we need you to ask him or her to become a co-sponsor of H.Res. 375. Many, even possibly some Republicans, will co-sponsor this, but they have to be asked.The link goes to a page at Democrats.com, and it provides a form that simplifies the process of sending an email to your congresspersons. It even figures out the appropriate recipients, based upon your own zip code.
Submarines have always fascinated me. The Ohio-class Trident II-bearing boomers are, arguably, the most powerful killing machines ever devised. Despite that satanic distinction, it is entirely possible that it was our superiority in undersea warfare that prevented the Cold War from killing us all. Accordingly, I have a certain kind of ambivalent respect for submariners. Rob is one of them, although I don't know what kind of boat he mans.
In fact, one of our horses, Vivid October, was named after the submarine in The Hunt for Red October. Well, at least the name was inspired by the fictional sub. His mare is named Vivid April Maiden. Yvonne's birthday is in April; mine is in October. April is female; October is male. Yvonne was not fond of the other proposed names: Trident, etc., but she could live with October, and it sort of made sense, for the reasons noted above.
Nostalgic tangents aside, I sometimes think that certain political figures fancy themselves to be as powerful and as secretive as the Ohio-class SSBN's, as they rove the halls of the West Wing. HR 375 may well torpedo that fantasy.
Others fancy themselves to be bucking stallions. I think this is a more accurate depiction:
Kinda reminds you of a certain joke told by the First Lady, about our President, doesn't it?
Categories: rants, politics
Tags: politics, Downing Street Memo, BBA, impeachment, Valerie Plame
(Note: The Rest of the Story/Corpus Callosum has moved. Visit the new site here.)
E-mail a link that points to this post:
Tuesday, July 26, 2005
What Health Insurance Is, Really
I had other things to do,
did not get anything written for Grand Rounds this week. But
at least I can link to it: Pharyngula
is the host this week. He even managed to find a unique
format for the presentation, and to make an observation that must have
seemed profound:
His use of the percentages of medblogging topics as an indicator of how doctors spend their time fails in two areas: it does not account for time spent sleeping, since hardly anyone blogs about sleeping. Unless you count dreaming, and doctors rarely reveal their dreams. And it does not account for time spent doing paperwork, which is what I am supposed to be doing right now.
I know my syntax is lousy tonight but that is because I am listening to my new Patti Smith CD; Mother Rose is brilliant, by the way. As is Radio Baghdad: "They're robbing/The cradle/of civil-/-ization."
If I had gotten to it, I would have submitted this:
The study is fascinating, because it points out a couple of sociological issues. For one: it points out the divergence in understanding, between insurers and everyone else, of the purpose of health insurance. Insurers think that the purpose of insurance is to protect people from unexpected costs. Typically those would be costs associated with some unpredictable, potentially-catastrophic event. Everyone else thinks that the purpose of health insurance is to pay for the cost of health care.
One implication is that people who get health insurance are not getting what they think they are paying for. Put another way, people think are paying for something else, when what they get is health insurance. This simple misunderstanding is a source of great consternation on both sides. Insured people complain that they are not getting what they paid for, and people who provide insurance are frustrated endlessly when people complain, endlessly. This is inevitable when people think they are buying apples, but the merchant is selling oranges.
This brings us to the second sociological issue: there isn't an objective way to settle the question of what health insurance "really" is. Some people think it is one thing; others think it's another. Despite attempts over the millennia, no one had been able to come up with an ultimate arbiter for the meaning of words or phrases. So what to do?
The study suggests what we should do. Throw out both definitions of the phrase "health insurance." Think of it in a new way. On an abstract level, health insurance is a mechanism that civilized societies have, of redistributing wealth in such a way that most people end up better off. More specifically, it is a way of allocating a certain percentage of finite resources, in such a way as to improve the average health of the population in the most cost-effective way possible.
I suppose that some may argue that the concept of "fairness" should be in there somewhere, but that's a big can of worms I'm leaving unopened at the present time.
Doctors seem to spend a fair amount of time wondering why they became a doctor, and how to train more doctors.Indeed.
His use of the percentages of medblogging topics as an indicator of how doctors spend their time fails in two areas: it does not account for time spent sleeping, since hardly anyone blogs about sleeping. Unless you count dreaming, and doctors rarely reveal their dreams. And it does not account for time spent doing paperwork, which is what I am supposed to be doing right now.
I know my syntax is lousy tonight but that is because I am listening to my new Patti Smith CD; Mother Rose is brilliant, by the way. As is Radio Baghdad: "They're robbing/The cradle/of civil-/-ization."
If I had gotten to it, I would have submitted this:
Are some medicines so good they should be free? In diabetes, U-M study finds, the answer can be yesWhy is this so fascinating? After all, it is totally unsurprising. Note that I don't mean to imply criticism of the study: even if the result was entirely congruent with expectations, the study still had to be done, in order to have any hope of convincing anyone to actually do what obviously makes sense to do.
Lives and money could be saved if co-pays for ACE inhibitors were eliminated Result has implications for Medicare drug plan that begins in 2006
Written by Kara Gavin
July 19, 2005
ANN ARBOR, MI - Nothing in life is free, the old saying goes. But maybe some things should be, according to a new University of Michigan Health System study. Specifically, researchers find, a group of medicines called ACE inhibitors should be available at no cost to the 8 million Americans over age 65 who have diabetes. These drugs are so beneficial for these patients that even giving them away ultimately would save the Medicare system and society large amounts of money by preventing heart attacks, strokes and kidney failure, the study shows.
And of course, the drugs would save lives, and make life better for patients. The findings, based on a sophisticated computer analysis, appear in the July 19 Annals of Internal Medicine [abstract]. [...]
Says lead author Allison Rosen, M.D., M.P.H., Sc.D., “Patients' out-of-pocket costs such as co-pays are a blunt instrument designed to keep patients from over-using medications, but they create barriers to the use of essential and non-essential medications alike. Our analysis shows that removing all patient costs for diabetes patients taking ACE inhibitors could save Medicare both lives and money.”
The same may be true for other drugs that have a major preventive benefit, she says; future studies will assess what would happen if patients could get them free or at a reduced cost.
That principle, called the “benefit-based co-pay,” is gaining more attention in the insurance field as a more sophisticated way to structure prescription drug benefits. But Medicare's new drug plan currently doesn't provide for the approach. [...]
The study is fascinating, because it points out a couple of sociological issues. For one: it points out the divergence in understanding, between insurers and everyone else, of the purpose of health insurance. Insurers think that the purpose of insurance is to protect people from unexpected costs. Typically those would be costs associated with some unpredictable, potentially-catastrophic event. Everyone else thinks that the purpose of health insurance is to pay for the cost of health care.
One implication is that people who get health insurance are not getting what they think they are paying for. Put another way, people think are paying for something else, when what they get is health insurance. This simple misunderstanding is a source of great consternation on both sides. Insured people complain that they are not getting what they paid for, and people who provide insurance are frustrated endlessly when people complain, endlessly. This is inevitable when people think they are buying apples, but the merchant is selling oranges.
This brings us to the second sociological issue: there isn't an objective way to settle the question of what health insurance "really" is. Some people think it is one thing; others think it's another. Despite attempts over the millennia, no one had been able to come up with an ultimate arbiter for the meaning of words or phrases. So what to do?
The study suggests what we should do. Throw out both definitions of the phrase "health insurance." Think of it in a new way. On an abstract level, health insurance is a mechanism that civilized societies have, of redistributing wealth in such a way that most people end up better off. More specifically, it is a way of allocating a certain percentage of finite resources, in such a way as to improve the average health of the population in the most cost-effective way possible.
I suppose that some may argue that the concept of "fairness" should be in there somewhere, but that's a big can of worms I'm leaving unopened at the present time.
Topics: science, medicine, health policy
Tags: medicine, health insurance, health policy
(Note: The Rest of the Story/Corpus Callosum has moved. Visit the new site here.)
E-mail a link that points to this post:
Sunday, July 24, 2005
Skeptic Poseurs
I have a bumper sticker that says "Question Skepticism."
There's a reason for that. Primary, it's my idea of
a joke. Secondarily, it is a reminder that skepticism can be
mean-spirited. Today I encountered a particularly good
example of that.
In the one and a half years of the Corpus Callosum, there has been only one winner of the Yellow Hammer Award: Tom DeLay. At the end of this post, I will announce the awarding of the second YHA.
Like most topics in science, global warming started life as an hypothesis, underwent extensive testing, and has matured to the status of a well-established theory. In other words, the only sensible course of action is to act as though it is the truth. Sure, there's more work to be done. Sure, mini-controversies will persist within the field. Sure, from time to time, people with credentials will stand up and question the validity of the concept. There always will be a shadow of doubt, of course; but by now, there is no room for reasonable doubt.
One of the favorite tactics of mean-spirited skeptics is to try to make use of unreasonable doubt. We see this, for example, in the seemingly-endless debate over evolution. (See Getting the Monkey off Darwin's Back for discussion.) Politicians, lobbyists, and industry moguls likewise are using this tactic against the notion of global warming. Only now, it gets ugly. As reported in The Scientist:
The obvious conclusion is that they are not planning to conduct any real investigation. Congress already has established mechanisms for conducting investigations, and what these two are doing is unprecedented:
Based upon all of this evidence, it is clear that Barton and Whitfield easily meet the rigorous criteria* for the 2005 Yellow Hammer Award.
_______
*They piss me off.
In the one and a half years of the Corpus Callosum, there has been only one winner of the Yellow Hammer Award: Tom DeLay. At the end of this post, I will announce the awarding of the second YHA.
Like most topics in science, global warming started life as an hypothesis, underwent extensive testing, and has matured to the status of a well-established theory. In other words, the only sensible course of action is to act as though it is the truth. Sure, there's more work to be done. Sure, mini-controversies will persist within the field. Sure, from time to time, people with credentials will stand up and question the validity of the concept. There always will be a shadow of doubt, of course; but by now, there is no room for reasonable doubt.
One of the favorite tactics of mean-spirited skeptics is to try to make use of unreasonable doubt. We see this, for example, in the seemingly-endless debate over evolution. (See Getting the Monkey off Darwin's Back for discussion.) Politicians, lobbyists, and industry moguls likewise are using this tactic against the notion of global warming. Only now, it gets ugly. As reported in The Scientist:
Members of Congress probe climate researchersAt first glance, the action taken by Barton (R-Texas) and Whitfield (R - KY) may seem innocent enough. But the fact is, Mann, Bradley, and Hughes have been working on climate change for thirty years. It would take months for them to gather all that information. During that time, they would not be able to do anything of any real use. And the likelihood that Barton and Whitfield would even be able to understand any of the "supporting material" is rather small. So just what, exactly, do they plan to do with boxcars full of papers that they do not understand?
Inquiry sparks Republican infighting and widespread scientific protest over 'intimidation'
By Alison McCook
Jul. 22, 2005
Scientists and a Republican member of Congress are protesting other members' attempts to investigate three researchers who have produced climate data that support global warming, arguing the investigation is designed to intimidate scientists who don't generate politically favorable data.
In 1998, Michael Mann of the University of Virginia, Raymond Bradley of the University of Massachusetts, and Malcolm Hughes of the University of Arizona published a paper in Nature showing that temperatures in the Northern Hemisphere rose precipitously in the 20th century. This, along with an additional report, created the so-called "hockey stick" graph of rising temperatures from global warming. The team's results were among the many included in the United Nations Intergovernmental Panel on Climate Change's third assessment report in 2001, which found that the world is, indeed, experiencing global warming. In June 2004, the group published a Corrigendum to their paper.
Last month, Mann, Bradley, and Hughes received a letter from US Congressmen Joe Barton, chair of the House Committee of Energy and Commerce, and Ed Whitfield, chair of the subcommittee on Oversight and Investigations, with a two-page list of requests for material to support their conclusions, such as all financial support for their research, including–but not limited to–honoraria and financial awards. [...]
The obvious conclusion is that they are not planning to conduct any real investigation. Congress already has established mechanisms for conducting investigations, and what these two are doing is unprecedented:
[S]ome experts noted that this is the first time they have seen individual congressmen question individual scientists. "I have never seen anything quite as egregious as this," Linda Rosenstock, director of the National Institute for Occupational Safety and Health from 1994 through 2000, told The Scientist.Both the American Association for the Advancement of Science and the National Academies of Science (The two most prestigious and influential scientific organizations in the USA) have joined Mann, Bradley, and Hughes in protest. The consensus among scientists is that Barton and Whitfield are trying to intimidate the scientists, obstruct their work, and that it amounts to a "fishing expedition." From the Stanford Center for Environmental Policy:
"I've never seen anything like this," said Stephen H. Schneider, co-director of the Stanford University Center for Environmental Science and Policy. "Congress is the last place to look for quality peer review. These guys (Barton and Whitfield) are conducting a fishing expedition in hopes they'll find some little thing that can be used to discredit and intimidate science."David Appell, a freelance science writer and author of the blog Quark Soup, has collected several choice comments from the scientific community. I especially like this one:
The Kansas City Infozine reports:Schmidt Response
Here are Gavin Schmidt's thoughts on the Barton/Whitfield letters received by Mann, Bradley, and Hughes. He's a climate scientist at NASA's Goddard Institute for Space Studies:My only thoughts really relate to how appropriate it is for Congressional committees to get involved in reviewing technical details of scientific results. They obviously have valid jurisdiction over process, funding and how the IPCC functions, but asking individual researchers for specific statistical measures from their data seems excessive. However, the tone of the letters, and the extremely selective results that they cite are clearly indicative of a rather contrarian bias that does not speak highly for their 'scientific' advisors in this matter (if indeed they have any).
David Appell @ 06:50 AM EST [link]
Twenty leading climate scientists - including Nobel and National Medal of Science laureates, members of the U.S. National Academy of Sciences and the Intergovernmental Panel on Climate Change, and other highly regarded researchers - sent a letter to Congress expressing concern over the approach of a Congressional investigation into a global warming study. Rep. Joe Barton (R-TX), in his capacity as the chairman of the Committee on Energy and Commerce, is conducting the investigation. [...]We all are familiar with those poseurs who pretend to be patriotic, but are not; who pretend to be religious, but really are pressing a personal agenda; who pretend to have a romantic interest, but really have their mind in the gutter. This is a reminder that there are those who would pretend to take on the prestigious mantle of the Skeptic, but who really are just a pain in the ass.
The scientists' letter also notes "that much of the information that you have requested from the scientists involved is unrelated to the stated purpose of your investigation. Requests to provide all working materials related to hundreds of publications stretching back decades can be seen as intimidation - intentional or not - and thereby risks compromising the independence of scientific opinion that is vital to the preeminence of American science as well as to the flow of objective advice to the government."
Based upon all of this evidence, it is clear that Barton and Whitfield easily meet the rigorous criteria* for the 2005 Yellow Hammer Award.
_______
*They piss me off.
Categories: Science, rants, idiot politicians
Tags: skeptic, Joe Barton, Ed Whitfield, global warming , climate change
(Note: The Rest of the Story/Corpus Callosum has moved. Visit the new site here.)
E-mail a link that points to this post: