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 The pharmaceutical industry is successfully marketing their products to consumers and professionals as the most effective form of therapy for an increasing number of mental health problems. The media joins in this misinformation by constantly hyping the latest biochemical "discovery" while under-reporting advances in psychotherapy. Worse yet, several non-medical helping professional organizations are joining the marketing rhetoric of the drug companies, either explicitly endorsing the superiority of drug treatment over psychotherapy or seeking prescription privileges. The real issue appears to be money. The research evidence is clear: drugs are no more effective than psychotherapy for the majority of complaints that bring people into treatment.
 For over a year or so, ISTC provided a comprehensive review regarding the efficacy of psychotropic medication as compared to psychotherapy. The motivation for this review came out of genuine concern for the future of the non-medical helping profession.
On this page you will find a summary of important data regarding the efficacy of psychotropic drugs. On related pages, you can find data regarding the use of psychotropic medications with children. Here's a hint: there isn't any! Click here or the button on the left to update your knowledge about this important and growing issue. If you'd like to check out what the research says about therapy versus chemical intervention, click here or the button to the left. Finally, ISTC is gathering data on how the marketing practices of the pharmaceutical industry are impacting treatment, clients, professional organizations, and researchers. Click here for the shock of your professional life!
Casting Warts on St. John
"Oh what tangled webs we weave...". You know how the old saying ends. But in our modern pharmaceutically-driven culture, the new ending goes, "when the possibility of big bucks makes us deceive." Researchers compared the effectiveness of popular anti-depressant sertraline (Zoloft) with a placebo and St. John's wort. Using a number of measures of depression, this large (n = 340) randomized clinical trial found no difference in outcome between the three treatments!The only difference was on a secondary outcome measure and that only showed a benefit of the drug over placebo. So what's the big deal, you ask? Well, reports of the results did not focus on the equivalence of the three treatments–including the placebo–but rather the failure of St. John's wort to help people experiencing moderate to severe depression! Given the equivalence of the results, however, the same conclusion could have been drawn about the drug. On this, the study (an related media reports) is silent. Makes you wonder, eh?
And while you're chewing on that one, consider the following: nearly half of the medical school faculty members that sit on boards designed to protect patients have financial ties to drug companies. Apparently, fox uarding the hen house is OK as long as s/he is being paid enough!
Hypercium Depression Trial Study Group (2002). Effect of hypercium perforatum in major depressive disorder. JAMA, 287, 1807-1814.
Friend, T. & Bourne, C. (August 14, 2003). Research oversight boards are full of biomedical industry consultants. USA Today, page 7D.
Medication and Suicide
Do psychotropic drugs decrease suicide? Take a moment and think about it. Do they or don't they? And, think by the way, what is the received wisdom on this topic? Well, the answer is...they DON'T! A review of 71,000 client records in clinical trials of 52 psychotropic drugs found an equal suicide risk among those put on drugs and those taking placebos. Indeed, no class of medication showed a significant difference in the risk of suicide or attempted suicide. Oh well...so much for the received wisdom.
Perina, K. (2002). Meds are no defense against suicide. Psychology Today, 35, 5, 20.
Psychotropics...the latest bad news...
"If we could just get them to comply, to take their meds," you often hear treatment professionals lamenting, "then they would be fine." Faith in psychotropic drugs is on the increase, not only among professionals but also among the general public. Is this belief warranted. As reviewed in detail on this site, the facts are often obscured in the rush to embrace the "latest" pharmaceutical advance. So, here's the latest...
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A study examining the treatment of people diagnosed with obsessive-compulsive disorder found no advantage of combining medication with psychotherapy. Using a real world clinical sample, the study found that the outcomes of clients in both groups were the same. Can you say, "save money by lowering formulary costs!"
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Which anti-depressant should a client take? The answer is, "Roll the dice." A recent study found no significant difference in outcome between three SSRI's (fluoxetine, proxetine, & sertraline). So much for the science of treatment matching.
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Heard about drug treatment for alcohol dependence? Naltrexone has been touted as the substance du jour to treat substance abuse. Research says: no difference in outcome between people treated with the drug and a placebo.
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Thinking about the benefits of antipsychotics for your SMI clients? Think again. A HUGE study found that woman who take the drugs are much more likely to develop breast cancer as a result of elevated prolactin levels. Can you imagine that little disclosure coming at the end of those heart warming TV ads for drugs?
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Are you the parent of a boy? Watch out! Teachers want your kid on Ritalin. It's true. A study found that teachers were significantly more likely to say a boy needs drugs than girls who display the same symptoms.
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Franklin, M. (2002). Concomitant use of medication does not significantly improve outcomes of CBT of OCD. Professional Psychology, 33, 162-168.
Kroenke, K. et al. Similar effectiveness of SSRI's in primary care. JAMA, 286, 2947-55.
Fuller, R.K. et al. Naltrexone treatment for alcohol dependence. New England Journal of Medicine, 345, 1770-1.
Wang, P.S., et al. Dopamine antagonists and the development of breast cancer. Archives of General Psychiatr, 59, 1147-54.
Piesecco, S. (2001). The effect of child characteristics on teachers' acceptability of classroom related behavioral strategies...Journal of Child Clinical Psychology, 30, 413-421.
Experts change their minds about the "biochemical imbalance" theory: Dare we say the whole theory resulted from a biochemical imbalance?
Researchers are now questioning the received wisdom regarding depression. For years, medical researchers and their backers in the pharmaceutical industry have claimed in print and television media that depression (and other so-called mental disorders) results from a biochemical imbalance in the brain. The theory has caught on among the public and non-medical mental health practitioners who clamor for the drugs and often extol their amazing healing properties. Now, however, researchers investigating alternate therapies (e.g., transcranial magnetic stimulation [medicalese for hooking magnets on a person's head]) are saying that "depression is no longer believed to be a mere deficiency of key brain chemicals–norepinephrine, dopamine, and perhaps the most important, serotonin." "In truth," a recent article on the subject discloses, "there never was much proof that depression was merely a serotonin deficiency." Whoa! What?! Someone better tell the makers of those lovely, heart rending ads for anti-depressants that are currently running on television. Alas, it seems that the whole idea of an imbalance was in the heads of those who invented it in the first place.
Wouldn't it be nice if the medical researchers and industry sponsors made a public disclaimer of their previous assertions? Don't hold your breath. Expect instead, a newly revised theory–explainifiction–to support whatever product comes to market.
Foreman, J. (Dcember 24, 2001). Research on depression focuses on brain circuitry. Los Angeles Times, S4.
S.S.R.I.'s and T.C.A.'s: The B.S.
SSRi's are being touted as more effective than the old tricyclic anti-depressants. The data indicate, however, that the only difference may be cost! Indeed, the older drugs may not only be equally but actually more effective than the new designer anti-depressants. Researchers looked at several recent studies and found that the older tricyclic anti-depressants appeared equally effective in head-to-head comparisons but were superior when a more rigorous (double-blind, cross-over, placebo controlled) research design was employed. Indeed, in people suffering post stroke depression, nortriptyline was far more effective (77%) than fluoxetine (14%) or placebo (31%). Will anybody believe this though?
American Journal of Psychiatry (March, 2000). 157, 338-43, 344-50, 351-9.
The White House White-Wash on Drugs
You've seen them: Tipper Gore, Al Gore, and Bill Clinton. One the one hand, they criticize the pharmaceutical industry for price-gouging while on lining their campaign war chests with drug company money. Recently, the White House hosted the White House Conference on Mental Health. Reports indicate, however, that it was mostly an advertisement for the pharmaceutical industry. Mental health issues were viewed through a single lens: the biological one. Professor Stanley Sue noted that, "There was a real push for a simple disease model where you have an illness and take pills. There was little discussed about the exciting research on the outcomes of psychotherapy." Then again, what really did they expect? Therapists don't have mega-bucks to donate to political opportunists and the 60's generation has always sought salvation through a pill.
Rabasca, L. (July/August, 1999). White House Conference an Important 'First Step." APA Monitor, 11.
Prozac: Eighty-nine percent placebo
Oh, how psychiatry dislikes the findings of Dr. Irving Kirsch. A recent meta-analytic study found that response to Prozac's was highly correlated with response to placebo (.90). In response to criticisms by the "drug-em-dano" group of clinicians and researchers, Kirsh and colleagues replicated the study with data submitted by the pharmaceutical companies to the FDA. The analyses were the same for all of the drugs examined. For example, the FDA data on Prozac found that 89% of its effect is duplicated by an inert placebo! The data are slated for publication in Science where they have undergone rigorous peer review. One might hope the data have some impact but, alas, commerce always trumps science.
Kirsch, I. (2000). The placebo effect in antidepressant medication. Ericksonian Newsletter, 20(1), 12-13.
But people want to take their meds . . . right? WRONG AGAIN!
With all the hype about drugs–from television ads, to positive media coverage, to politicians and their "prescription drug benefits"–one would think that everyone wants to take drugs. Well, the data tell another story. Not only do people taking the drugs stop for a variety of reasons but many don't even start treatment because they don't want to be put on drugs. Researchers Hoffman et al. found that while a small percentage of participants in studies were excluded because they didn't meet "inclusion criteria" (~20%), a much larger percentage (~50%) actively chose not to participate because they either didn't want to take medication or change their current medication. The researchers also found that people did not refuse because they wanted to avoid being given a placebo treatment. Importantly, such results indicate that studies are pre-disposed to find in favor of medication as a significant percentage of people "opt-out" thereby leaving more "medication-friendly" participants in study samples.
Hofmann, S. et al. (1998). Pretreatment attrition in a comparative treatment outcome study on panic disorder. American Journal of Psychiatry, 155(1), 43-47.
More on St. John's Wort . . .
Recently, the media has carried several negative stories about St. John's wort–specifically, a story about possible interactions with other medications. When was the last time you heard such a story about pharmaceutical products? Given that researchers estimate 100,000 to 200,000 deaths per year result from such drugs, one would think that at least a few stories would be run. Well here's the "equal time" that cheap, non-patented products like St. John's won't get in the mainstream media market. Another methodologically sound study found that the natural alternative was superior in outcome to a tri-cyclic antidepressant and had fewer "adverse" events (in other words, side-effects). Interestingly, the placebo used in the study was remarkably effective, though not as much as either the tri-cylcic or St. John's.
Philipp, M. et al. (1999). Hypericum extract versus imipramine or placebo in patients with moderate depression. British Medical Journal, 319, 1534-7.
Maximizing Serotonin . . . the key to Ecstasy
By now, we've all heard about that drug which increases serotonin, makes people happier, decreases appetite but has that pesky and unfortunate side effect of sexual dysfunction. No, not SSRI's, Ecstacy. Yup, first patented under a different name as an appetite suppressant, the drug is actually a prescription medication gone bad. With the effect being an increase in serotonin and the side effects being so similar to the SSRI antidepressants some are wondering why Ecstasy use is considered an "epidemic" when one eighth of the population of America is on SSRIs? Chief copy editor George Ellis wondered, "isn't this a case of the government putting an alarm label on Ecstasy while the SSRIs get a clean bill of health for doing exactly the same thing? I mean, isn't the real difference a matter of whether a company and its army of lawyers and paid researchers have spent what it takes to get FDA approval vs. someone who skips all that and just makes the pills and sells them to partygoers?
Blakemore, B. (June 26, 2000). Dangers of Ecstasy. Associated Press. Public and Professional Trust in Reports of Side Effects and Negative Drug Reactions . . .
You hear how the newer drugs are safer and have fewer side effects than older drugs. This may be one reason why the public is consuming drugs in record numbers. The question is, "How do you know?" An recent editorial in the Boston Globe insists that the public trust in such safety reports may be misplaced. While the drug companies and the US Food and Drug Administration have a system for maintaining an adverse-event database, doctors–those on the front lines of clinical practice–are not required to report the serious problems patients have with a drug. As a result, there are distinct limitations in the system to track bad reactions. Public Citizen, a watchdog group in Washington, D.C., reports that actual surveys of medical records turn up 10 times as many drug reactions as are reported voluntarily by doctors. Closer monitoring could give both health professionals and the public a greater awareness of what to be alert for as they make use of the drugs that are changing American medicine.
Boston Globe (5/15/00), A10.
The New SSRI's have Fewer Side Effects . . . right?.
Tell someone that the newer anti-depressants are no more effective than the older tricyclic anti-depressants and they will likely respond, "yeah, but they don't have as many side-effects." The statement and belief,however, say more about the successful marketing of these drugs than about the facts. The truth is, these drugs have just as many–though different– "side-effects" as the older drugs. Researcher pointed out in a recent article that the most common long term side effects are Insomnia, weight gain, and sexual dysfunction. Significant insomnia affects 15%-20% of patients taking SSRIs, twice the rate with placebo. Polysomnography has consistently found that these drugs cause activation during the night: In addition to insomnia, bruxism, sweating, and periodic limb movement are common. Vivid dreams and nightmares also occur. With ongoing treatment, increasing numbers of patients report lethargy and fatigue. Sexual dysfunctions are among the most distressing SSRI side effects. Decreased libido and delayed or absent orgasm are the best known, but there are others, such as the "yawning-excitement syndrome." Patients experience sexual arousal when they yawn, often progressing to orgasm. Perhaps the most unexpected SSRI-related problem to emerge has been weight gain, which often begins only after several months of therapy. This side effect has not been shown to be frequent or severe in controlled studies but has been reported to occur in 18%-50% of patients in some open-label studies. You may wonder, "why wasn't this known?" The answer is
Sherman, C. (1998). Clinical Psychiatry News 26(5):1. The Warts on St. John
One chemical that has grown in popularity and is viewed as a non-synthetic "healthy" alternative to anti-depressants is St. John's Wort. The urban legend going around has it that the substance has been used effectively for years in Europe (especially in Germany). Well, the data are coming in and, so far, they're looking good. Six studies of the substance (five of which were conducted in Germany) found the chemical superior to placebo (78% versus 38%) and equivalent to tricyclics (62%). Moreover, those taking St. John's experienced significantly fewer side effects! Critics keep highlighting potential warts on St. John, however, noting that the studies used low doses of the tricyclics and included no SSRI's. The latter criticism is especially curious given that even the pharmaceutical companies generally admit there is no difference in efficacy between old tricyclics and the newer SSRI's.
Kim, H.L. et al. (1999). St. John's Wort for Depression. Journal of Nervous and Mental Disease, 187, 532-9.
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what the Data say . . .
 =No evidence
 =Some not so good evidence
=Some good evidence
= Lots of good evidence
Important note: Regardless of the equality or superiority of psychotherapy over medication demonstrated by the research, improper discontinuation of a legally prescribed medication can be dangerous and even fatal. Any decision to discontinue or alter a prescribed dosage should only be made in conjunction with and under the care and supervision of a medical professional.
Sources:
++Blatt, S.J., Sanislow, C.A., Zuroff, D.C., and Pilkonis, P.A. (1996). Characteristics of effective therapists: Further analysis of data from the national institute of mental health treatment of depression collaborative research project. Journal of Consulting and Clinical Psychology, 64(6), 1276-1284.
+Antonuccio, D.O. (1997). A cost-effectiveness analysis of cognitive-behavioral therapy and fluoxetine (Prozac) in the treatment of depression. Behavior Therapy, 28, 187-210.
**Firshein, R. (1998). Lifting spirits, Psychology Today, 31(5), 24-26; Dworkin, N. (1999). Not the Sam-e Old Drug, Psychology Today, 32(4), 26.
*Seligman, M.E.P. (1998). Is depression biochemical? APA Monitor, 29(9), 2.
@Shulberg, H.C., Pilkonis, P., and Houck, P. (1998). The severity of major depression and choice of treatment in primary care practice. Journal of Consulting and Clinical Psychology, 66(6), 932-938.
&DeRubeis, R.J. et al. (1999). Medications versus cognitive behavior therapy for severely depressed outpatients. American Journal of Psychiatry, 156, 1007-1013.
***Krupnick, J.L., Sotsky, S.M., Simmons, S., Moyer, J. et al. (1996). The role of the therapeutic alliance in psychotherapy and pharmacotherapy outcome. Journal of Consulting and Clinical Psychology, 64(3), 532-539.
$USA Today (January 12, 1999). Drug ads bring in patients, 1.
$$Psychology Today. Fish Food for your Mood, 32(5), 22
!!Healthnotes Review of Contemporary and Integrative Medicine (Winter, 1999).
%Psychology Today. DHEA: The new blues buster? (Jan/Feb 2000).
^^Masaki, K.H. et al. (March 28, 2000). Association of vitamin E and C supplement use with cognitive function and dementia in elderly men. Neurology, 54, 1265-71.
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