GlaxoSmithKline and the FDA are coming under intense criticism after an article in the New England Journal of Medicine last week reported that a meta-analysis of 42 published clinical trials found that Glaxo's diabetes drug Avandia may increase heart attack risks for some patients.
Although even the Journal authors admit that their study is based on incomplete and perhaps flawed data, Congress is already crying that Avandia may be "another Vioxx" and asking why the FDA didn't slap a "black box" - its strongest warning label - on the drug at the first hint of trouble.
What critics are forgetting is that knee-jerk safety warnings come with their own dangerous side effects. In the long run, if companies and regulators cry wolf at every potential safety signal, patients and physicians won't know what information to trust, or what risks they need to be most concerned about. And scaring patients with serious diseases away from effective therapies costs lives.
Take, for example, the much debated link between antidepressants and teen suicide. It has long been recognized that antidepressants can temporarily increase the risk of suicide in some patients when they are first prescribed. It is thought that these drugs alleviate the lethargy that accompanies severe depression before the depression itself abates. Accordingly, psychiatrists have long known to monitor patients carefully when beginning drug treatment.
Despite this risk, the benefits of the drugs - including a class of medicines known as selective serotonin reuptake inhibitors or SSRIs - have been widely viewed as outweighing their dangers. After all, suicide is an even greater risk of untreated depression. And after SSRIs came on market in the 1990s, teen suicides went on a decade-long decline.
Still, this didn't prevent some distraught parents of teens who fell victim to suicide from blaming the drugs for their children's deaths. Public criticism and lawsuits mounted and, in 2004, the FDA held acrimonious hearings to review available data on the drugs.
The next day, the New York Times ran a headline declaring "F.D.A. Links Drugs to Being Suicidal." Under intense pressure, the FDA decided to apply its "black box" warning on the labels of all antidepressants, to warn of a possible increased suicide risk.
Fast forward three years to January 2007, when the Centers for Disease Control released data showing that prescribing rates for antidepressants dropped precipitously following the FDA hearings and black box warning. The CDC also found that - for the first time in a decade - teen suicide rates rose by 18% from 2003 to 2004.
There is also emerging evidence that the risks of the drugs - rare to begin with - have been overstated. On April 18th, the Journal of the American Medical Association released a report analyzing nearly 30 studies of adolescents treated with antidepressants for depression, obsessive compulsive disorder, and anxiety disorders. The study found that the risk of suicidal behavior potentially associated with the medicines is much smaller than previously estimated, with less than one out of every 100 patients (.7%) showing an increased risk of suicidal thoughts.
Today, experts think that the "black box" may be scaring families with depressed teens away from the medicines. Harold Koplewicz, founder and director of the New York University Child Study Center, told the Wall Street Journal that "the take-home question is what is the risk to your child of not taking the medicine...with depression, we absolutely know it can be lethal."
Diabetes is no less dangerous. More than 20 million adults and children in the U.S. have diabetes, and it is the fifth leading cause of mortality. Patients with diabetes are at increased risk for heart disease and stroke, high blood pressure, kidney disease, blindness, and amputation - to name just a few of its many complications.
Patients with diabetes have to work closely with their physicians to find the right combination of diet, exercise, and prescription medicines to avoid these life threatening ailments. The more therapeutic options that are available to patients, the more likely they are to find an effective regimen.
The FDA is right to wait for more conclusive data on the safety of Avandia rather than jump at media headlines or Congressional grandstanding. The British journal The Lancet put it this way: "To avoid unnecessary panic among patients, a calmer and more considered approach to the safety of [Avandia] is needed...Alarmist headlines and confident declarations help nobody."
The reality is that all drugs have risks, some of them serious. But we must remember to be cautious in how we evaluate and communicate those risks, because fear itself can have lethal side effects.
Original Source: http://www.realclearpolitics.com/articles/2007/06/fear_is_side_effect_of_drug_wa.html