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Closer scrutiny of prescription drugs recommended to protect public

Robin Wulffson MD's picture
drug approval, side-effects, bad drugs, safety, FDA, IOM

According to the Institute of Medicine (IOM), in any given month, an estimated 48% of Americans take at least one prescription drug. Although these medications may be essential for treating and illness, they also may possess serious side effects. To insure the safety of pharmaceuticals, the Food and Drug Administration (FDA) requires their manufacturer conduct clinical trials that demonstrate both their safety and effectiveness.

Not uncommonly, however, harmful effects become apparent months and even years after the drug receives approval. This is because of the fact that a group of patients in a clinical trial may not fully represent all the characteristics of the general population; furthermore, over the long-term, problems may surface that were not apparent during the follow-up period of the clinical trials. For this reason, the FDA requested the IOM to aid it in determining when it is appropriate to require a postmarketing study, which types of studies to require, how to best protect the rights and interests of patients who participate in research, and how to use research in making regulatory decisions. The IOM released the results of their study on May 1.

A number of high-profile drugs were found to be harmful once they were in general use. Examples include Avandia (rosiglitazone; GlaxoSmithKline), selective serotonin uptake inhibitors (SSRIs) in children, and Vioxx (rofecoxib; Merck). Therefore, the IOM determined that merely evaluating untoward events from a postmarketing perspective was not enough and recommended that the FDA should develop a way to prevent these events from occurring in in the first place.

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The IOM recommended that the FDA should prospectively determine and publicly identify the risk factors associated with a medication’s risks versus benefits. When the FDA finds higher risk, the agency should consider requiring further postmarketing research and should make public the reasons whether further scrutiny should be required. The IOM noted that the risk factors should include:

Medications that have been approved using several surrogate endpoints, where there is conflicting evidence about probable health outcomes. (Surrogate endpoints serve as substitute guidelines for checking on the total health of a patient in a medical trial. Clinical endpoints provide exact data relating to overall health and the efficacy of a treatment; however, surrogate endpoints can serve as stand-ins, providing needed information that correlates with possible diseases and complications. Surrogate endpoints allow treatment options to be planned in advance of more severe.)
A first-in-class drug approval that used surrogate endpoints intended for medicines belonging to a different drug class.
A drug associated with a troubling safety profile that could affect many people, that has to potential for severe adverse effects, or that has a strong biological rationale for a certain adverse effect.

The IOM concluded that current FDA guidelines fall short of the mark. The report notes: “The FDA’s current approach to drug oversight in the postmarket setting is not sufficiently systematic and does not ensure that it assesses the benefits and risks of drugs consistently over the drug’s life cycle. Adopting a regulatory framework that is standardized across all drugs, yet flexible enough to adapt to regulatory decisions of differing complexity, could help make the agency’s decision-making process more predictable, transparent, and proactive. These changes could allow the FDA to better anticipate post-approval research needs and improve drug safety for all Americans.”

Take home message:
A current phenomenon in American society is the widespread marketing of new drugs on TV and other media. These ads tout the many benefits of a drug for a medical condition you might have. They then ask you to query your physician whether you should take the medication. Interestingly, they also rattle off a number of serious adverse effects that can occur. Apparently, many listeners tune out this information and ask their physician for a prescription. All drugs, even over-the-counter drugs such as aspirin can have serious, even fatal, side effects. Before embarking on a medication regimen, apprise yourself of the benefits vs. risks. Ask yourself, and a healthcare professional, if the medication is definitely warranted with your condition. Also investigate healthier alternatives. For example, a diet and exercise program is preferable to taking antidiabetic or antihypertensive medication.

Reference: Institute of Medicine