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How Does The FDA Decide Whether A Drug Is Safe And Effective?

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By RICHARD F. LOCKEY, MD Tribune correspondent

The Tampa Tribune

Published: June 14, 2008

Breathe Easier: Side Effect Risk Low

The Food and Drug Administration's recent announcement that it is reviewing the safety of the widely used allergy drug Singulair received plenty of media attention.

The drug's maker hasn't reported any cases of suicide or suicidal thoughts among the more than 11,000 patients in over 40 clinical studies. And the three suicides of patients using Singulair reported to the FDA following the drug's approval are a small fraction of the 31 million prescriptions written for the drug last year. Because the evidence for such an association is extremely poor, I've advised my patients on Singulair not to stop using it as the FDA gathers more information.

As a physician who has treated patients with allergies for the past 35 years, I feel confident that the dangers of uncontrolled allergies, especially asthma, are far more documented and likely than side effects from FDA-approved allergy medicines. In the Tampa Bay area alone, more than 17,000 people were hospitalized for asthma between 2004 and 2006.

The FDA's drug review process is one of the world's most rigorous, and assures that a new medication is safe and effective for most people most of the time. It takes an average of 12 years for a drug to travel from the research laboratory to the patient. Only 10 percent of the drugs that begin preclinical testing ever make it to human testing, and only one in five of these is ever approved for human use, according to the Congressional Office of Technology Assessment.

Our University of South Florida Division of Allergy and Immunology has participated in pharmaceutical trials evaluating new drugs for asthma and other allergies since 1973. When a pharmaceutical company identifies a medication with the potential to treat a specific disease, that drug is first tested in animals to make sure it causes no significant side effects. The company then seeks FDA approval to study the new medication with human volunteers. These clinical studies are usually "double-blind-placebo-controlled." Volunteers receiving the investigational medication, as well as the physicians and staff monitoring the study for effectiveness and safety, do not know which volunteer is receiving the investigational drug or the placebo (sugar pill).

When the study is completed, the code blinding the study is broken, and the data is analyzed to determine whether the new product is more effective than the placebo and to compare side effects. It takes thousands of volunteers and many studies to prove safety and effectiveness.

Both doctor and patient must weigh the benefits and risks of taking the drug compared with not treating the disease. For example, a group of asthma medications that are extremely effective long-acting dilators of the tubes of the lungs carry the FDA's "black box" warning. The warning was provided because some experts question whether these long-acting beta agonists may increase risk for cardiac problems in some patients with asthma. Yet, the drugs work very well for patients with moderate-to-severe asthma, particularly when combined with inhaled steroids. Because asthma can be a severely debilitating, and even deadly, I always balance the benefits against the risks when I prescribe one of these medications. For patients with more severe asthma, the benefit of treatment overwhelmingly outweighs the risk.

A problem occasionally arises only after a medication is approved and used by literally millions of people in the general population, but this is rare. In fact, the side effects of most medications are generally minimal and easily avoidable, especially when compared with the risks of riding in a car. About 45,000 people die in car accidents yearly in this country and many more are injured. Yet, most of us continue using cars.

If you have questions about a medication's potential side effects, consult your physician or other health care professional. Medications used as intended are absolutely essential for your health. Taking them properly not only prolongs life but increases the quality of life. The benefits almost always outweigh the risks.

Dr. Lockey is professor of medicine, pediatrics and public health at USF Health, where he directs the Division of Allergy and Immunology and holds the Joy McCann Culverhouse Chair in Allergy and Immunology.

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