Current medical information of interest to the dental profession.

Healthline

Irv Feferman MD

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The Marketing of Antidepressants I recently attended a pharmaceutical company-sponsored dinner at which the guest speaker presented data on new oral anticoagulants, possible replacements for warfarin. At the end of the evening I was convinced of the benefits of these new medications and will likely begin incorporating them into my practice. However, one has to be very cautious not to be swayed by fancy presentations and data that bias the prescriber and consumer. Take for example the prescription of antidepressants (SSRIs selective serotonin re-uptake inhibitors) in the 1990s. Here are some facts: The pharmaceutical industry is Americas most profitable business, generating $250 billion annually worldwide. In 2001, the industry spent $19 billion in the USA on advertising. It has 625 registered lobbyists and underwrites about 70 percent of clinical trials. In 1999, three of the top 10 medications were anti-depressants producing revenues of $6.7 billion. One in eight Americans has taken antidepressants during the last 10 years 3.5 billion doses and about 46 percent of those who took antidepressants did so for a year or more.
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Revenues generated from these drugs are increasing by 25 percent per year. The statistics are impressive. The question is: Are they are the result of superb marketing or a confirmation of the drugs efficacy and positive therapeutic benefit? Researchers in 2002 reviewed the data base of studies submitted to the US Food & Drug Administration (FDA) for initial approval of these medications. Thirty-eight studies were reviewed involving 6,944 patients. Surprisingly, the findings showed that antidepressants (at any dose) offer a marginal benefit when compared with placebos, they are no more effective than psychotherapy and there is no evidence that they reduce the risk of suicide. Despite the data, these medications are still widely prescribed. As clinicians, it is important to consider whether the medications we prescribe are the result of slick marketing, patient pressure or reliable data confirming their efficacy. Are we getting all the facts and can we be sure that what is presented is the whole picture rather than a triumph of marketing over science? Prevention and Treatment 5(25), July 15, 2002

Bipolar Disorder A New Epidemic? When I began practising medicine, the diagnosis of manic depression was rare. It was a debilitating and a serious adult psychiatric illness treated almost exclusively with lithium. Patients often went from the hyper-manic phase to profound depression with a high risk of suicide. In 1980, the DSM (Diagnostic and Statistical Manual of Mental Disorders) redefined manic depression as bipolar disorder with looser criteria affixed to the diagnosis. This was followed by the emergence of new anti-psychotic medications termed mood stabilizers: olanzapine, risperidone and quetiapine. It is estimated the incidence of bipolar disorder has risen from 0.1 to approximately five percent of the population. More alarming, the diagnosis of bipolar disorder in children has increased significantly. Here is some recent data: In one survey the diagnosis of bipolar disorder increased 40-fold in youths and two-fold in adults during a 10-year study period. Outpatient treatment increased 67 percent and inpatient treatment by 74 percent from 1995-2000. Most youths (90.6 percent) and adults (86.4 percent) were prescribed psychotropic medication or mood stabilizers.

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There are no randomized studies that confirm the long-term efficacy of these medications. Anti-psychotic drugs have been associated with an increased mortality and higher suicide rates. The diagnosis of bipolar disorder is particularly difficult in children because there are often other associated conditions (most commonly ADHD). Research is scant with little data on the efficacy of medication and long-term follow up. The surge in the diagnosis of bipolar disorder is worrisome. Children and young adults may become labeled and put on medication with little evidence, theoretical or empirical, for the use of anti-psychotics or mood stabilizers. Yet, these drugs continue to be widely prescribed. Further studies, detailed research and stricter diagnostic criteria may arrest what some have termed an epidemic. PLOS Medicine 3(4): April 2006 Arch Gen Psychiatry, 64(9): September 2007

screened group was 22 percent higher than the control. However, the death rate at the end of seven years was the same for both groups. A larger multi-center European study involving 182,000 patients screened men every four years for abnormal PSA (> 3.0 ng). The screened group had a 20 percent reduction in the death rate at the end of nine years. However, there was a high incidence of over-diagnosis leading to increased surgeries. Although both studies are beginning to document the natural history of prostate cancer, it is difficult to interpret these results. The European group used a lower cut-off value for the PSA test, increasing the sensitivity but decreasing the specificity, resulting in earlier diagnosis and better survival. Most physicians still suggest screening although the type of screening, the time interval and the accepted PSA values may differ. Longer follow-up in both these large studies will ultimately yield new data and more specific screening guidelines. New Engl J Med 360; 13, March 26, 2009

Dr. Feferman is an emergency physician at Scarborough General Hospital and North York General Hospital and an Assistant Professor in the Department of Family and Community Medicine at the University of Toronto. He may be reached at irvfef@hotmail.com or at 416-322-9313.

Prostate Screening the Debate Continues Despite numerous studies the benefit of screening for prostate cancer remains controversial. Annual digital rectal exam (DRE) with PSA (prostate specific antigen <4.0 ng) testing for men over the age of 50 is the recommendation most widely accepted. The results of two recent studies offer new data but fail to resolve the differences of opinion: An American study enrolled 76,693 men from 1993 through 2001. Approximately half were screened annually with DRE and PSA (85 percent screened and followed for seven years); the other half was the control group (40 to 52 percent screened and followed). The incidence of prostate cancer in the

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