Antidepressant drugs Used as Placebos

Antidepressant drugs Used as Placebos!

Fri, 10 Oct 2003

Increased use of antidepressant drugs during the 1990s, has increased national spending on antidepressant drugs by a walloping 600%! Dr. Jay Pomerantz of Harvard writes, “inappropriate use of antidepressant drugs may lead to a deterioration of clinical course with no clear benefit…even a theoretical possibility that antidepressants may make patients more likely to relapse,”

SSRI antidepressants are advertised and prescribed as safe for a myriad of complaints that have nothing to do with severe, clinical depression for which the drugs were approved.

Since antidepressants have severe adverse side effects, most patients stop taking them before they might have any positive effect. Dr. Pomerantz notes that “SSRIs in particular, have replaced benzodiazepines as the drugs of choice when the physician is at a loss for what to do to get a patient out of the office.”

This has led several doctors to wonder whether SSRIs are being prescribed like sugar pills or a placebo?

“If what we are seeing is a pattern of widespread antidepressant prescribing for a multitude of subsyndromal, amorphous, patient complaints, it suggests that antidepressants have become the modern-day sugar pill, or placebo. It is quite likely that antidepressants have largely replaced benzodiazepines in this regard. Not only is there inappropriate use of antidepressants for subsyndromal conditions, but widespread off-label use is also worrisome.”

If antidepressants are being prescribed as a placebo, taxpayers are paying the pharmaceutical industry a mighty high price for fool’s gold.

~~~~~~~~~~~~~~~~

Antidepressants Used as Placebos: Is That Good Practice?

Jay M. Pomerantz, MD
Drug Benefit Trends 15(8):32-33, 2003.
© 2003 Cliggott Publishing, Division of SCP Communications
Posted 09/30/2003

National spending for all antidepressants increased 600% during the 1990s.[1] In 2000, annual expenditures for SSRIs alone exceeded $7 billion.[2] According to statistics from the National Ambulatory Medical Care Survey comparing data from 1999 with similar data from 1985, antidepressants accounted for 13.5% of the entire increase in pharmaceutical prescribing.[3] Yet, a recent study conducted by researchers in northwest Italy showed nearly 50% of antidepressant users filled a prescription for such an agent (or any other monthly antidepressant prescription) only once or twice.[4] Data from the United States are not much different; almost 50% of patients stop taking their medication as early as 3 months after beginning antidepressant therapy.[5]

This short-term use of antidepressants contrasts with almost all clinical indications for this class of medication. Whether one is prescribing for mental health disorders – such as major depression, dysthymia, panic disorder, obsessive-compulsive disorder, generalized anxiety disorder, or social phobia – or other conditions – such as migraine headache, chronic pain, fibromyalgia, or overactive bladder – the story is the same. Antidepressants are slow to work and most useful in treating chronic conditions. Aside from possible short-term (a few months) use to aid smoking cessation or to manage certain forms of sleep disorder, antidepressants need to be taken for at least 6 months (per the guidelines for the minimal treatment of major depression[6]).

So what is going on? A recent article by Fava[7] reminds us that Carroll[8] warned about the inappropriate use of antidepressant drugs 2 decades ago: “[We] strongly suspect that many patients who are simply unhappy or dysphoric receive these drugs, with predictable consequences in terms of morbidity from side effects, mortality from overdose, economic waste, and irrational, unproductive clinical management.”

Fava continues by warning that to the same extent that tardive dyskinesia has limited inappropriate use of antipsychotics and that antibiotics should not be routinely prescribed for minor viral ailments, inappropriate use of antidepressant drugs may lead to a deterioration of clinical course with no clear benefit. There is even a theoretical possibility that antidepressants may make patients more likely to relapse. Whether or not that is true, studies clearly show that antidepressants are no more effective than placebo in treating mild depression.

In the National Institute of Mental Health Treatment of Depression Collaborative Research Program, participants with mild depression who received imipramine plus clinical management fared no better than those who received clinical management alone.[9] Similar results have been obtained in primary care patients treated with paroxetine.[10]

Not only is there inappropriate use of antidepressants for subsyndromal conditions, but widespread off-label use is also worrisome. Streator and Moss[11] performed a retrospective claims analysis of 1080 patients in a network model HMO and found that 56% of medical claims for members taking an SSRI were linked to non-FDA-approved indications. An acknowledged weakness of this study was the inability to determine whether claim-form diagnoses accurately reflected the real reason for the antidepressant prescription.

Within the Practice Partner Research Network, 6.3% of a total of 149,327 active patients of 389 participating primary care physicians (PCPs) received a prescription for an antidepressant in 1996, according to data from an electronic patient record system.[12] Of these patients, 40% did not receive a diagnosis of depression. None of this off-label use is surprising if we remember that antidepressants are no longer limited to use in specialty mental health care. Most antidepressants are prescribed by PCPs rather than psychiatrists: a national MCO recently reported that 77% of all antidepressant prescriptions were written by PCPs participating in the MCO’s 31 health plans.[13]

If what we are seeing is a pattern of widespread antidepressant prescribing for a multitude of subsyndromal, amorphous, patient complaints, it suggests that antidepressants have become the modern-day sugar pill, or placebo. It is quite likely that antidepressants have largely replaced benzodiazepines in this regard. Since the 1980s, benzodiazepines – previously the drugs of choice for anxiety, sleep disorders, and nonspecific emotional upset – have been vilified as addictive and harmful. It seems that antidepressants, SSRIs in particular, have replaced benzodiazepines as the drugs of choice when the physician is at a loss for what to do to get a patient out of the office.

Barbui and colleagues[14] wonder if the definition of depression used by clinicians to justify an antidepressant prescription may have changed in order to accommodate the large population of primary care patients who present with relatively mild symptoms of sleep disturbance and anxiety. Whether such use of antidepressants represents good practice I leave for others to determine, especially since SSRIs are associated with numerous side effects. I will discuss the topic of SSRI-related side effects in next month’s column.

Although my feelings about the possible overuse of antidepressants are clear in this article, I cannot end without also warning against underuse of antidepressants. It may be that while some practitioners are overtreating with antidepressants, many symptomatic persons never go to a clinician’s office, or when they do show up are not recognized as having depression or some other antidepressant-responsive disorder.

I agree with Croghan’s cautionary comments in the March/April 2001 issue of Health Affairs: “Spending for antidepressants has increased by about 600%, or more than $6 billion during the 1990s, driven in large part by increased use. Although restrictions on this use might seem good fiscal management, we must challenge ourselves to remember the equally important problem that depressive disorders are undertreated. We do not yet know the degree to which unnecessary care contributes to rising expenditures. Until we understand the magnitude of the problem and how to encourage proper matching of treatment and patient, overzealous cost-cutting directed at reducing utilization could result in reducing medication treatment for those truly in need.”[1]

References

Croghan TW. The controversy of increased spending for antidepressants. Health Aff (Millwood). 2001;20:129-135.

Latner AW. Top 200 drugs by retail sales in 2000. Drug Topics. 2001;6:18. Burt CW. National trends in use of medications in office-based practice, 1985-1999. Health Aff (Millwood). 2002;21:206-214.

Barbui C, Broglio E, Laia AC, et al. Cross-sectional database analysis of antidepressant prescribing in Italy. J Clin Psychopharmacol. 2003;23:31-34.

Lin EH, Von Korff M, Katon W, et al. The role of the primary care physician in patients’ adherence to antidepressant therapy. Med Care. 1995;33:67-74.

Clinical Practice Guideline Number 5: Depression in Primary Care, 2: Treatment of Major Depression. Rockville, Md: Agency for Health Care Policy and Research, US Dept of Health and Human Services; 1993. AHCPR publication 93-0551.

Fava GA. Can long-term treatment with antidepressant drugs worsen the course of depression? J Clin Psychiatry. 2003;64:123-133.

Carroll BJ. Neurobiologic dimension of depression and mania. In: Angst J, ed. The Origins of Depression. Berlin: Springer-Verlag; 1983:163-186.

Elkin I, Gibbons RD, Shea MT, et al. Initial severity and differential treatment outcome in the National Institute of Mental Health Treatment of Depression Collaborative Research Program. J Consult Clin Psychol.1995;63:841-847.

Barrett JE, Williams JW Jr, Oxman TE, et al. Treatment of dysthymia and minor depression in primary care: a randomized trial in patients aged 18 to 59 years. J Fam Pract. 2001;50:405-412.

Streator SE, Moss JT Jr. Identification of off-label antidepressant use and costs in a network model HMO. Drug Benefit Trends. 1997;9:42, 48-50, 55-56.

Ornstein S, Stuart G, Jenkins R. Depression diagnoses and antidepressant use in primary care practices: a study from the Practice Partner Research Network (PPRNet). J Fam Pract. 2000;49:68-72.

Way K, Young CH, Opia E, et al. Antidepressant utilization patterns in a managed care organization. Drug Benefit Trends. 1999; 11(9):6BH-11BH.

Barbui C, Tognoni G, Garattini S. Clinical databases of patients receiving antidepressants: the missing link between research and practice. J Affect Disord. 2002;70:191-196.

Dr Pomerantz practices psychiatry in Longmeadow, Mass, and is assistant clinical professor of psychiatry at Harvard Medical School in Boston.

FAIR USE NOTICE: This may contain copyrighted (© ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available to advance understanding of ecological, political, human rights, economic, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a ‘fair use’ of any such copyrighted material as provided for in section 107 of the US Copyright Law. In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior general interest in receiving similar information for research and educational purposes. For more information go to: http://www.law.cornell.edu/uscode/17/107.shtml If you wish to use copyrighted material for purposes of your own that go beyond ‘fair use’, you must obtain permission from the copyright owner.