Meridia Withdrawn from Market

Andrew Pollack outlines the withdrawal of the weight loss drug Meridia from the market because of the risk of heart attack and stroke in an article from The New York Times (Abbott Labs Withdraws Meridia From the Market). 

The Food and Drug Administration came to the decision to encourage Abbott Laboratories to recall Meridia because of the results of a clinical trial requested by regulators in Europe called the Sibutramine Cardiovascular Outcomes Trial (SCOUT) (FDA). 

SCOUT followed the guidelines of a classical experiment with all three components, as listed by Babbie: independent and dependent variables, pretesting and posttesting and experimental and control groups (Babbie 247).  The independent variable in SCOUT was the administration of the drug, Meridia, and there were two dependent variables; one was weight and the other was cardiovascular health, which were measured by pretests.  Weight was simply determined by weighing the population, and cardiovascular health was determined by the history of cardiovascular disease, the existence of extra weight in the waist, history of type 2 diabetes mellitus and what was called  “cardiovascular risk factors,” such as hypertension, dyslipidemia, smoking, and diabetic nephropathy (FDA).

SCOUT had a randomized sample of about 10,000 men and women aged 55 or older from Europe, Latin America and Australia.  There was a control group and an experimental group; the control group received placebos and the experimental group received Meridia.  The study was also double-blind, meaning that “neither the subjects nor the experimenters [knew] which [was] the experimental group and which [was] the control group" (Babbie, 250).  The study began in January of 2003 and ended in March 2009 (FDA). 

The posttest again measured weight and cardiovascular health after the 5-year period of SCOUT (FDA).  “SCOUT demonstrated there was a 16% increase in the risk of a composite or combined set of serious events—non-fatal heart attack (myocardial infarction), non-fatal stroke, resuscitation after cardiac arrest, and cardiovascular death—in the Meridia group compared to the placebo group” (FDA).  Through the posttesting they also discovered that the loss of body weight of the people taking Meridia compared to those taking the placebo was only 2.5%, which isn’t very significant for a weight loss drug (FDA). 

Abbott contends that the results from SCOUT aren’t applicable because the majority of subjects had cardiovascular disease and Meridia is not meant for such people.  However, Abbott did voluntarily withdraw the drug from the market because its harms outweigh its benefits (Pollack).

I think that the clinical trial, SCOUT, was effective because it was set up according to the guidelines of a classic experiment, according to Babbie, and was conducted fairly through the use of randomization of subjects and making it a double-blind experiment.  While Abbott argues that Meridia shouldn’t be pulled off the market based on this one clinical trial because the majority of subjects had cardiovascular disease, I think that SCOUT was smart to use subjects with cardiovascular disease because Meridia is mostly prescribed to patients who are obese, and those that are obese are more likely to have cardiovascular disease.  This experiment fairly tested Meridia on a sample of people who closely resemble the population of people who were or would have been prescribed the drug.  Abbott agreeing to withdraw Meridia voluntarily was a good public relations move because it shows that they care more about the safety of their customers than their bottom line.