The American Journal of Psychiatry just chimed in on the reporting of author conflicts of interest and they seem to be moving toward taking a harder line.
"Many people do not believe that they are influenced by pharmaceutical industry funding and therefore do not see a need for self-disclosure of other funding. However, as the reaction to the JAMA article illustrates, our credibility as a field requires complete disclosure of authors'’ sources of income from the pharmaceutical and biomedical industry."
"Given the absence of a standard for the influence of pharmaceutical companies in our practice, it is not surprising that we do not have one for our journals. Indeed, the journals would seem to be ahead of medical practice, since most of us do not disclose to our patients the extent to which we have had interactions with the companies from whom we ask them to buy their medications"
BUT...
"Consultation with the pharmaceutical industry for meaningful research and clinical purposes, not just for marketing goals, needs to continue to ensure that the enormous investment of the pharmaceutical companies in the development of new drugs is spent for the best purposes. "
My View: The track record of academic psychiatrists in steering the drug companies toward spending their R & D on the "best purposes" isn't too impressive. We'll see if this latest move toward openness in journals is anything more than PR.
Full text available here:
Friday, September 08, 2006
There's Always A Silver Lining...
I have been wondering aloud for years when someone was going to make an SSRI into a treatment for premature ejaculation. Well, it seems I need to wonder no longer.
To some, a pesky side effect of impaired ability to ejaculate is just what the doctor ordered. If you can get men to last a whopping three minutes in the sack, then you've obviously created a winner!
My bold prediction: As another new generation of "miracle" antidepressants (read: AD's that are about as effective as SSRI's but with new, slick marketing, and equally importantly, many years of patent protection) hits the market in the next few years, look for the SSRI's to be coming (bad pun possibly intended) to a sex therapy clinic or a general practitioner near you.
As usual, PhamaGossip is on top of the story:
PharmaGossip
To some, a pesky side effect of impaired ability to ejaculate is just what the doctor ordered. If you can get men to last a whopping three minutes in the sack, then you've obviously created a winner!
My bold prediction: As another new generation of "miracle" antidepressants (read: AD's that are about as effective as SSRI's but with new, slick marketing, and equally importantly, many years of patent protection) hits the market in the next few years, look for the SSRI's to be coming (bad pun possibly intended) to a sex therapy clinic or a general practitioner near you.
As usual, PhamaGossip is on top of the story:
Suicide and Antidepressants: More Bad News for Kids
I wanted to make certain that everyone had at least checked the abstract of the latest study regarding antidepressant medication and suicide in children/adolescents. It's worth a full read if you can get your hands on it. It was a case-control study looking at suicidality and actual suicide among both children/adolescents and adults
"...in children and adolescents (aged 6-18 years), antidepressant drug treatment was significantly associated with suicide attempts (OR, 1.52; 95% CI, 1.12-2.07 [263 cases and 1241 controls]) and suicide deaths (OR, 15.62; 95% CI, 1.65-infinity [8 cases and 39 controls])."
I suppose the only good news that could come from this is that the data did not support a connection between suicidality and antidepressant use in adults. Sertraline (Zoloft) seemed to have a protective effect on adults, which was surprising in the light of David Healy's various examinations of SSRI's and suicide.
Child practitioners: PLEASE let the research on antidepressants and youth suicidality/suicide inform your work.
http://archpsyc.ama-assn.org/cgi/content/short/63/8/865
"...in children and adolescents (aged 6-18 years), antidepressant drug treatment was significantly associated with suicide attempts (OR, 1.52; 95% CI, 1.12-2.07 [263 cases and 1241 controls]) and suicide deaths (OR, 15.62; 95% CI, 1.65-infinity [8 cases and 39 controls])."
I suppose the only good news that could come from this is that the data did not support a connection between suicidality and antidepressant use in adults. Sertraline (Zoloft) seemed to have a protective effect on adults, which was surprising in the light of David Healy's various examinations of SSRI's and suicide.
Child practitioners: PLEASE let the research on antidepressants and youth suicidality/suicide inform your work.
http://archpsyc.ama-assn.org/cgi/content/short/63/8/865
Thursday, September 07, 2006
Neurontin For All of Your (Non-FDA Indicated) Ills
Absolutely spot on article from Steinman, Bero, Chren, and Landefeld. Of course, the Lisa Bero train has been publishing a gold mine of fascinating research on the tobacco and drug industries for years, so this is what I've come to expect from them.
As some of my practicing mental health professional colleagues are aware, Neurontin (gabapentin) was never approved for use with psychiatric populations. That, of course, did not stop reps from aggressively marketing the drug for psych populations. I'm only including part of the story here -- there's much more in the article.
Steinman, MA, Bero, LA, Chren, M, & Landefeld CS (2006) Narrative Review: The promotion of gabapentin: An analysis of internal industry documents. Annals of Internal Medicine, 145, 284-293.
Here's an interesting quote from the article regarding the intersection of marketing and research in the case of Neurontin...
"However, in other cases Parke-Davis employed a “publication strategy, the goal of which was to use research not as a means to gain FDA approval for new indications but “to disseminate the information as widely as possible through the world's medical literature (77), generating excitement in the market and stimulating off-label prescribing despite the lack of FDA approval (78, 79). This strategy focused primarily on expanding gabapentin use in neuropathic
pain and bipolar disorders, for which detailed decision analyses projected the greatest revenue potential (80-83). The success of this strategy depended in part on publications being favorable to gabapentin. Some employees of Parke-Davis felt an obligation to publish studies with unfavorable results (80, 84), and in a number of instances such results were published (85-87). However, management expressed concern that negative results could harm promotional efforts (88), and several documents indicate the intention to publish and publicize results only if they
reflected favorably on gabapentin (78, 79). As stated in a marketing assessment, "“The results of the recommended exploratory trials in neuropathic pain, if positive, will be publicized in medical congresses and published" (italics added) (78). Similarly, in discussing 2 nearly identical trials
that yielded conflicting results on gabapentin as seizure monotherapy, the "“core marketing team”" concluded that "“the results of [the negative trial] will not be published" (89). (The positive trial was published [90], but we could not locate the negative trial on a PubMed search.) (p. 288)."
As some of my practicing mental health professional colleagues are aware, Neurontin (gabapentin) was never approved for use with psychiatric populations. That, of course, did not stop reps from aggressively marketing the drug for psych populations. I'm only including part of the story here -- there's much more in the article.
Steinman, MA, Bero, LA, Chren, M, & Landefeld CS (2006) Narrative Review: The promotion of gabapentin: An analysis of internal industry documents. Annals of Internal Medicine, 145, 284-293.
Here's an interesting quote from the article regarding the intersection of marketing and research in the case of Neurontin...
"However, in other cases Parke-Davis employed a “publication strategy, the goal of which was to use research not as a means to gain FDA approval for new indications but “to disseminate the information as widely as possible through the world's medical literature (77), generating excitement in the market and stimulating off-label prescribing despite the lack of FDA approval (78, 79). This strategy focused primarily on expanding gabapentin use in neuropathic
pain and bipolar disorders, for which detailed decision analyses projected the greatest revenue potential (80-83). The success of this strategy depended in part on publications being favorable to gabapentin. Some employees of Parke-Davis felt an obligation to publish studies with unfavorable results (80, 84), and in a number of instances such results were published (85-87). However, management expressed concern that negative results could harm promotional efforts (88), and several documents indicate the intention to publish and publicize results only if they
reflected favorably on gabapentin (78, 79). As stated in a marketing assessment, "“The results of the recommended exploratory trials in neuropathic pain, if positive, will be publicized in medical congresses and published" (italics added) (78). Similarly, in discussing 2 nearly identical trials
that yielded conflicting results on gabapentin as seizure monotherapy, the "“core marketing team”" concluded that "“the results of [the negative trial] will not be published" (89). (The positive trial was published [90], but we could not locate the negative trial on a PubMed search.) (p. 288)."
Marsha Marsha Marsha
If you're interested in treatment of Borderline Personality Disorder, you really should read the latest article in the Archives of General Psychiatry (abstract included below). What is not mentioned in the abstract is that the DBT therapists received 45 hours of training in DBT. They also received mandatory weekly supervision during the course of the study. Oh, and during the study, DBT provided both individual and group therapy, whereas the so-called expert treatment consisted of only individual sessions. However, in a move of remarkable statistical legerdemain, the authors add in the additional treatment sessions that the "expert"-treated clients received in inpatient settings to note that there was no significant difference in treatment time between groups.
That's clever. Give one group of therapists extensive training in treating BPD with a sensible treatment model and then have the other group receive no formal training and likely no supervision -- the article is not clear about the amount of supervision received by the "experts". While on a roll, give the DBT clients extra group treatment not received by the "expert"-treated clients. When the confounds of less treatment time up front and lesser-trained (and likely less confident) therapists creep up, the "expert"-treated folks end up in more inpatient treatment. This is one of those studies that really backs up what the common factors camp has been saying for ages -- studies that show one therapy is better than another are generally fraught with numerous confounds, leaving us to only logically conclude that therapists who are especially well-trained and perform a high intensity therapy beat lesser-trained therapists providing a low-intensity treatment. This article will likely ring through the academic clinical psychology circles as a loud endorsement of DBT's specific efficacy for BPD, which is unfortunately inaccurate.
Don't get me wrong. I like DBT. It is based on a sensible model and has strong empirical support. However, whether it is any more efficacious than an equally intensive treatment performed by equally well-trained therapists is still essentially unaddressed.
The abstract is yours to peruse below...
Two-Year Randomized Controlled Trial and Follow-up of Dialectical Behavior Therapy vs Therapy by Experts for Suicidal Behaviors and Borderline Personality Disorder
That's clever. Give one group of therapists extensive training in treating BPD with a sensible treatment model and then have the other group receive no formal training and likely no supervision -- the article is not clear about the amount of supervision received by the "experts". While on a roll, give the DBT clients extra group treatment not received by the "expert"-treated clients. When the confounds of less treatment time up front and lesser-trained (and likely less confident) therapists creep up, the "expert"-treated folks end up in more inpatient treatment. This is one of those studies that really backs up what the common factors camp has been saying for ages -- studies that show one therapy is better than another are generally fraught with numerous confounds, leaving us to only logically conclude that therapists who are especially well-trained and perform a high intensity therapy beat lesser-trained therapists providing a low-intensity treatment. This article will likely ring through the academic clinical psychology circles as a loud endorsement of DBT's specific efficacy for BPD, which is unfortunately inaccurate.
Don't get me wrong. I like DBT. It is based on a sensible model and has strong empirical support. However, whether it is any more efficacious than an equally intensive treatment performed by equally well-trained therapists is still essentially unaddressed.
The abstract is yours to peruse below...
Two-Year Randomized Controlled Trial and Follow-up of Dialectical Behavior Therapy vs Therapy by Experts for Suicidal Behaviors and Borderline Personality Disorder
Arch Gen Psychiatry. 2006;63:757-766.
Context Dialectical behavior therapy (DBT) is a treatment for suicidal behavior and borderline personality disorder with well-documented efficacy.
Objective To evaluate the hypothesis that unique aspects of DBT are more efficacious compared with treatment offered by non–behavioral psychotherapy experts.
Design One-year randomized controlled trial, plus 1 year of posttreatment follow-up.
Setting University outpatient clinic and community practice.
Participants One hundred one clinically referred women with recent suicidal and self-injurious behaviors meeting DSM-IV criteria, matched to condition on age, suicide attempt history, negative prognostic indication, and number of lifetime intentional self-injuries and psychiatric hospitalizations.
Intervention One year of DBT or 1 year of community treatment by experts (developed to maximize internal validity by controlling for therapist sex, availability, expertise, allegiance, training and experience, consultation availability, and institutional prestige).
Main Outcome Measures Trimester assessments of suicidal behaviors, emergency services use, and general psychological functioning. Measures were selected based on previous outcome studies of DBT. Outcome variables were evaluated by blinded assessors.
Results Dialectical behavior therapy was associated with better outcomes in the intent-to-treat analysis than community treatment by experts in most target areas during the 2-year treatment and follow-up period. Subjects receiving DBT were half as likely to make a suicide attempt (hazard ratio, 2.66; P = .005), required less hospitalization for suicide ideation (F1,92=7.3; P = .004), and had lower medical risk (F1,50=3.2; P = .04) across all suicide attempts and self-injurious acts combined. Subjects receiving DBT were less likely to drop out of treatment (hazard ratio, 3.2; P<.001) and had fewer psychiatric hospitalizations (F1,92=6.0; P = .007) and psychiatric emergency department visits (F1,92=2.9; P = .04).
Conclusions Our findings replicate those of previous studies of DBT and suggest that the effectiveness of DBT cannot reasonably be attributed to general factors associated with expert psychotherapy. Dialectical behavior therapy appears to be uniquely effective in reducing suicide attempts.
Wednesday, September 06, 2006
A place for the latest and greatest (and worst) in the field
Soon, posts will be coming regarding the big issues in clinical psychology and psychiatry. Issues specifically surrounding treatment of various mental disorders from both a psychological and psychopharmacological perspective will be addressed and (hopefully) updated frequently. Issues surrounding marketing, data dredging, and inaccurate advertising in the drug industry will also be forthcoming. Stay tuned...
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