Americans like to think they are Number One in everything. Our politicians frequently tell us that we have the best health care system and the safest drugs in the world.
Myths die hard. In truth, we are nowhere near the top when it comes to providing health care for all our citizens. And a new report on the FDA suggests that this watchdog agency is in disarray.
The Institute of Medicine (IOM) is a prestigious panel of experts that advises the nation on critical health matters. A committee of the IOM was asked to review the Food and Drug Administration. The results of this analysis are shocking.
The committee observed, “There is a perception of crisis that has compromised the credibility of FDA and of the pharmaceutical industry.��? That might be due to highly publicized drug scandals such as the Vioxx withdrawal.
The fact that the FDA did not catch this drug disaster itself and was slow to respond has left lingering doubts about the agency’s ability to protect the public health.
The IOM found that the drug safety system in America is threatened by organizational problems such as poor management, infighting, low morale and unclear and insufficient regulatory authority.
These are aggravated because FDA lacks adequate funds to carry out its mission. In recent years the agency has taken huge sums from the pharmaceutical industry in the form of “user fees.��? This money goes mostly towards facilitating the drug approval process. Drug companies want their products moved through regulatory hurdles quickly. Very little funding, however, is available to monitor safety once these drugs hit the marketplace.
Perhaps most worrisome, the IOM committee concluded that FDA does not “consistently demonstrate accountability and transparency to the public by communicating safety concerns in a timely and effective fashion.��? As a consequence, the FDA has lost the trust of the American people.
Patients who have lost confidence in the nation’s medicines may be more likely to stop taking potentially life-saving medicines. A study in the Archives of Internal Medicine (Sept. 25, 2006) shows that one patient in eight quit crucial heart medicines within a month of hospital discharge after a heart attack. Such patients increase the likelihood that they will die within the year.
To restore faith in the FDA the IOM committee made a number of valuable recommendations. Physicians and patients need better information about both risks and benefits of medications. To this end, the committee suggested a moratorium on TV ads during the first two years after a drug is approved for sale.
When a drug first appears on pharmacy shelves information is often missing about side effects and dangerous interactions. These may only be uncovered after many more people have taken it. The IOM suggested that during this critical early period the packaging for a new medicine should have a special symbol. This would alert patients and physicians alike to the fact that it is new and may cause unexpected effects.
Until these new guidelines are adopted, the drug watchdog agency may not be up to its task. To stay safe, people need to be well informed and alert for the effects, both good and bad, of any medicine they take.
