Dr. Ken Carter

Information sourced from Journal Watch:

Antidepressants Work, and Depression Severity Does Not Matter

Effects are greatest in children, but are significant for all, in a study examining patient-level data from 41 studies focusing on two antidepressants.

Suggestions that antidepressants work only in severely depressed patients have been based largely on analyses comparing different study outcomes — i.e., fewer overall study effects were found in studies that had, on average, less-depressed patients — and on the existence of many unpublished studies that did not show antidepressant efficacy, suggesting that published studies overestimated efficacy. Only one small analysis (JW Psychiatry Feb 1 2010) of six already published and highly selected studies used individual patient-level data (N=718) to examine the issue of less effect in less-depressed patients.

These researchers obtained longitudinal, patient-specific data from all sponsored, published and unpublished, placebo-controlled studies on fluoxetine (20 trials; 705 youths, 2635 adults, and 960 geriatric patients) and venlafaxine (21 trials; 4882 adults). All patients had at least minimal depression severity at baseline. Rates of change through 6 weeks were significantly greater with antidepressant than with placebo overall and in each age group. Overall response and remission rates yielded number needed to treat (NNT) of 5 and 7, respectively. Response and remission rates were significantly greater for fluoxetine than placebo for youth (NNT, 4 and 3) and adults (NNT, 5 and 6) but not geriatric patients (NNT, 17 and 39). Most important, no relationship was found between how depressed a patient was and that patient’s response to antidepressants.

Comment: This analysis of more than 9000 patients shows that antidepressants work regardless of the severity of the depression. Moreover, antidepressant response often takes more than the 6 weeks analyzed here, suggesting that these effects may be underestimated. That older populations showed the lowest rate of change is interesting, but this finding must be considered preliminary because only four geriatric studies contributed data. Finally, these results add to concerns that meta-analyses summarizing effects across studies with different designs and outcomes, while sometimes useful, can lead to erroneous conclusions.

— Peter Roy-Byrne, MD

Published in Journal Watch Psychiatry March 12, 2012

Citation(s):

Gibbons RD et al. Benefits from antidepressants: Synthesis of 6-week patient-level outcomes from double-blind placebo-controlled randomized trials of fluoxetine and venlafaxine. Arch Gen Psychiatry 2012 March 5 [Medline® Abstract]

Copyright © 2012. Massachusetts Medical Society. All rights reserved.

The above message comes from "Journal Watch", who is solely responsible for its content.

You have received this email because you requested follow-up information to an Epocrates DocAlert® Message. For more information about DocAlert® Messages, please click here.

Best wishes,
The Epocrates Team
1100 Park Place, #300
San Mateo, CA 94403

Kenneth Carter, PhD, ABPP Associate Professor of Psychology
Oxford College, Emory University

Board Certified in Clinical Psychology

[e] kenneth.carter
[o] 770/784/8439

-sent via -iPad-

Contact: Jim Newman

newmanj@ohsu.edu

503-494-8231

Oregon Health & Science University

Publication bias involving psychiatric medications may provide physicians with an incomplete picture

PORTLAND, Ore. — Physicians who prescribe antipsychotic medications may be basing their decisions on incomplete information, according to new research published by scientists at Oregon Health & Science University. The study is published in PLoS Medicine, a peer-reviewed open-access journal published by the Public Library of Science.

This latest research follows a highly publicized 2008 report in the New England Journal of Medicine demonstrating that antidepressant drug trials were selectively published, exaggerating their apparent effectiveness. This follow-up study suggests that similar concerns exist, though to a somewhat lesser extent, with antipsychotic drugs.

The authors reached these conclusions by reviewing 24 FDA-registered premarketing trials for eight second-generation antipsychotics—aripiprazole (Abilify), iloperidone (Fanapt), olanzapine (Zyprexa), paliperidone (Invega), quetiapine (Seroquel), risperidone (Risperdal), risperidone long-acting injection (Consta), and ziprasidone (Geodon). They then compared the results in the FDA’s review documents to the results presented to clinicians and researchers in medical journals.

The authors found that four premarketing trials submitted to the FDA remained unpublished and that all of them yielded unflattering results. Three showed the new antipsychotic had no significant advantage over placebo. In the fourth, the drug was superior to placebo, but it was significantly inferior to a much less expensive competing drug.

In the published trials, there was some evidence that the journal articles over-emphasized efficacy of the new drug. For example, an FDA review revealed that one of the newer drugs, iloperidone (Fanapt), was statistically inferior to three different competing drugs, but this information was not mentioned in the corresponding journal articles.

On the other hand, when the authors used meta-analysis to combine trial data and compare all eight drugs to placebo, they found that publication bias had little impact on the drugs’ overall apparent efficacy. This stood in contrast to the researchers’ previous study on antidepressants, for which publication bias had a much more substantial impact.

“When you compare between drug classes and use FDA data, it’s clear that, overall, antipsychotics are more effective than antidepressants. But when you rely on the data in medical journals, the difference between these two drug classes is obscured,” said Erick Turner, M.D., an assistant professor in the Department of Psychiatry and the Department of Pharmacology in the OHSU School of Medicine. Turner also serves as a staff psychiatrist at the Portland Veterans Affairs Medical Center’s Mood Disorders Program.

The authors wrote in the paper, “Publication bias can blur distinctions between effective and ineffective drugs.”

The authors concluded: “With further studies investigating publication bias in other drug classes, a more accurate evidence base can emerge.”

###

The Stanley Medical Research Institute funded the research.

Reporter note: The paper will be available for download/viewing for the public at this Web link once the embargo lifts.

About OHSU (www.ohsu.edu)

Oregon Health & Science University is the state’s only academic health and research university. As Portland’s largest employer with nearly 14,000 employees, OHSU’s size contributes to its ability to provide many services and community support not found anywhere else in the state. OHSU serves patients from every corner of Oregon and is a conduit for learning for more than 4,300 students and trainees. OHSU is the source of more than 200 community outreach programs that bring health and education services to each county in the state.

via Publication bias involving psychiatric medications may provide physicians with an incomplete picture.

Information sourced from Journal Watch:

How Well Are We Treating Depression?

Despite a broader range of antidepressants and psychotherapies and more generic medications, this analysis of Medicaid data shows that the treatment of depression has not become cheaper and better.

To determine trends in depression treatment, these researchers reviewed Florida Medicaid records of 56,805 adults diagnosed with depression in 1996–2006.

After adjustments for inflation and clinical factors such as comorbidity, the cost of mental health care per patient increased by 29% from 1996 to 2006, even though spending for inpatient mental health treatment decreased by 42% (because the hospitalization rate decreased from 9.1% to 5.1%) and spending on outpatient visits increased only 21%. Spending on antidepressants increased by 22%, while the cost of antianxiety drugs decreased, probably because almost all of these medications became generic. Fewer patients received psychotherapy (decrease from 57% to 38%). Prescriptions for antipsychotic drugs increased substantially; the increase of their costs by 949% accounted for most of the increased cost of pharmacotherapy and therefore of mental health care overall.

In proxy measures of quality of acute treatment, more patients in 2006 than in 1996 received antidepressants (75% vs. 65%) and received minimally adequate pharmacotherapy (68% vs. 59%), and fewer received psychotherapy (27% vs. 43%; 10%–14% receiving ≥4 sessions). Follow-up visits for pharmacotherapy and posthospitalization decreased.

Comment: Increased spending on depression treatments in this study (largely attributable to antipsychotic prescriptions, especially quetiapine and risperidone) did not result in better care. Although more patients got adequate doses of antidepressants, fewer were followed regularly or received evidence-based psychotherapy for depression. The increased use of antipsychotics, which was probably a function of both the approval of aripiprazole and quetiapine for refractory depression and vigorous industry marketing, is worth careful consideration: No evidence exists for the superiority of this augmentation strategy, and adverse effects can be substantial. Without following patients adequately, it seems impossible to know whether recent approaches to pharmacotherapy are effective, let alone cost-effective.

— Steven Dubovsky, MD

Published in Journal Watch Psychiatry January 13, 2012

CITATION:

Fullerton CA et al. Ten-year trends in quality of care and spending for depression: 1996 through 2005. Arch Gen Psychiatry 2011 Dec; 68:1218. [Medline® Abstract]

Copyright © 2011. Massachusetts Medical Society. All rights reserved.

The above message comes from "Journal Watch", who is solely responsible for its content.

You have received this email because you requested follow-up information to an Epocrates DocAlert® Message. For more information about DocAlert® Messages, please click here.

Best wishes,
The Epocrates Team
1100 Park Place, #300
San Mateo, CA 94403

—
Kenneth Carter, PhD, MSCP
Associate Professor of Psychology
Oxford College, Emory University

[e] kenneth.carter
[o] 770-784-8439
-Sent via iPhone-

From The New York Times:

PRESCRIPTIONS BLOG: Despite Generic Rivals, Branded Drugs Still Sell Well

Drug companies are finding lucrative foreign markets for their brand-name drugs after patents expire in the United States and unleash generic competition.

http://nyti.ms/xhkjTZ

February 2, 2012, 6:27 PM

Drug Makers Dial Down TV Advertising

By BRUCE JAPSEN

Spending on the advertising of brand-name prescription drugs on television  — which not long ago was a fast-growing marketing venue for the pharmaceutical industry in the United States — has dropped more than 20 percent in the last five years.

According to new figures from Nielsen, spending on television advertising fell 23 percent to $2.4 billion from the beginning of 2007 to the end of last year. Spending in 2011 dropped 2 percent from 2010, and last year was the fourth consecutive year that such spending fell. Drug companies in the United States spent more than $3.1 billion on advertising pharmaceuticals on television in 2007, Nielsen said.

The decline is in sharp contrast to the decade-long drug-industry advertising spree that began in 1997, when the Food and Drug Administration loosened its regulations and allowed direct-to-consumer advertising of prescription drugs on TV.

Some industry analysts attribute part of the decline to controversy over such ads. Employers and health insurance companies have long complained that TV ads drive consumers to the latest, often most expensive, pills. And doctors complain that their patients often pressure them into prescribing these heavily advertised drugs.

Perhaps the most well-known criticism of  TV advertising of pharmaceuticals arose in 2004 when Merck withdrew the once heavily advertised painkiller Vioxx after studies showed it increased the risk of heart attacks and strokes.

Such controversies have led to greater scrutiny of drug ads by the F.D.A. as well as by doctor groups like the American Medical Association.

Analysts say spending on brand-name drug ads on television could deteriorate further because of generic competition to some top-selling drugs that have been widely advertised, like Pfizer’s Lipitor for cholesterol.

From 2011 to the end of 2015, more than $100 billion of brand-name drug sales will be exposed to generic competition, IMS Health said.

Pharmacies and health insurance companies offer incentives to patients with drug coverage to choose cheaper generics over brand-name drugs, limiting the power of television advertising.

This week, Pfizer said fourth-quarter sales of its Lipitor fell more than 40 percent in the United States, where the drug lost patent protection in late November.

Though Nielsen said the $156 million Pfizer spent on TV ads for Lipitor last year was more than the amount spent on any other branded prescription drug, the figure was down 14 percent from the Lipitor advertising in 2010.

Pfizer just entered the third month of a 180-day period of market exclusivity in which Lipitor is competing against just two generic versions, so it has continued to advertise on TV. But the company said it has not yet decided to make a long-term commitment to advertising Lipitor on television after that.

“We will continue to listen to patients over time and adjust our plans for Lipitor, including advertising, as needed to determine how we can continue to best meet the needs of patients,” said a Pfizer spokesman, MacKay Jimeson.

via Drug Makers Dial Down TV Advertising – NYTimes.com.

From The New York Times:

DOCTOR AND PATIENT: Have These Symptoms? Buy This Drug

Checklists of symptoms have become a critical part of every major pharmaceutical marketing campaign, making it easy for patients to diagnose their own ailments — and making it easy for drug makers to sell drugs.

http://nyti.ms/xNjLwa

Dr. Ken Carter
Associate Professor of Psychology
Oxford College of Emory University

Depression’s Criteria May Be Changed to Include Grieving – NYTimes.com.