Research focused upon effectiveness of new drugs could save billions of dollars in health care costs each year. Antidepressant medications are a prime example.
Depression is one of the most common conditions to afflict Americans. Symptoms of mild depression include fatigue, sleeplessness and loss of interest in normal activities.
Severe depression may be disabling and life-threatening. Accurate assessment of depression requires time and thought by health care providers experienced in psychological disorders. Psychotherapy, or "talk therapy," is one effective path of diagnosis and treatment. Psychotherapy, however, may require considerable time and expense; and some health insurance plans limit coverage.
In recent years, a remarkable array of new, prescription medications has been introduced for treating depression. Because almost every licensed physician may prescribe anti-depressant medications; mental health professionals may be left out of the management loop. Consequently, powerful new drugs may be casually prescribed by providers with little background or experience in the deployment of the new agent.
Skillfully produced televised commercials promote new Drug X directly to consumers. TV ads suggest that the diagnosis of depression is simple, and that the new drug will quickly eradicate troubling symptoms. Side-effects of Drug X are presented with the rushed cadence of an auctioneer.
Suicidal thoughts, homicidal tendencies, interactions with other medications and a variety of other serious symptoms are hurried through. Cost is never mentioned. No studies are presented to either care providers or patients that permit a comparison of effectiveness or side-effects with older anti-depressant medications. Few comparative studies exist.
When a pharmaceutical company conducts a clinical trial for Drug X, the new agent is compared against a placebo or inactive substance. Often, Drug X will exhibit only slight advantages over the placebo. The great majority of these studies are sponsored by industry.
A study in 2008 in the New England Journal of Medicine reviewed 74 FDA-registered, clinical trials of antidepressant medications. Thirty-one percent were never published. In general, unpublished reports placed the drug under study in a less favorable light. Some studies that showed little or no benefit for the drug under study were published in a way to suggest the drug was effective.
A January article in The Journal of the American Medical Association evaluated the benefit of anti-depressant medications over the full spectrum of depression from mild to severe. Compared to placebo, medication offered minimal to no benefit to many patients with mild or moderate symptoms.
New anti-depressants are expensive compared to older medications, many of which are available in generic forms. Newer drugs may cost from $4 to $15 per day. Without comparative studies neither care provider nor patient can determine if new Drug X is safer and more effective than its predecessors. Advertisements relentlessly push the message that drugs are necessary for treating all cases of depression and that the newest drug is automatically the best.
Management of depression requires the thoughtful engagement of an experienced therapist. Medication may be appropriate but only after careful consideration of risks, benefits and alternatives. Drug companies should provide us with less glitz and more facts when promoting their latest discoveries. Better still would be a Congressional ban on direct-to-consumer advertisements for prescription drugs. These ads are a major driving force in over-use of all medications.
More importantly, the FDA needs the authority and funding to mandate comparative studies for all prescription medications. I suspect that billions of dollars could be saved and the safety of patients enhanced through the identification of safe, generic alternatives to drugs whose only claim is that they are new.
Contact Clif Cleaveland at firstname.lastname@example.org.