When Is a Medical Product Too Risky? : Part 3

by Food and Drug Administration (FDA)

(Page 3 of 3)

We're making an assumption there, though, that the prescriber, who is the primary risk manager once the drug is on the market, is going to make rational choices, taking into account all the information available. The whole system will not work unless each part of the system does its part properly.

It's important to point out that the majority of injuries and deaths in this country from medical products are from known side effects, not from the unexpected ones. Therefore, although it is important to evaluate FDA's standards and how much clinical study we require, it's also important to look at other parts of the system. Are we managing the known side effects adequately, as a system? Are we dealing with medication errors adequately, as a system? FDA doesn't really control the care delivery part of the system.

Personally, as a physician, I think that patients need to have a greater role. Obviously, most of them haven't gone to medical school, but they really need to keep track of their medications, keep track of the basic side effects, ask questions, and be involved as much as they can. People can be seriously harmed by drug-drug interactions, and if they're going to a bunch of different doctors and they don't tell each doctor what they're on, they can get into trouble.

Even if patients do keep their doctors informed, doctors alone, with the complexity of medical care and medical information, will not be able to keep all that information in their heads. If you've looked at a recent drug label, like for one of the AIDS drugs we've approved recently, it may be 20 pages of all that is known about using the drug properly. With all that information, it's almost impossible to keep, say, 50 drugs straight in your head.

The health-care delivery system — HMOs, hospitals, pharmacy systems, everything — probably needs to get more involved in helping health-care providers to manage the risks of pharmaceuticals. I think we're seeing an evolution in that direction, and toward better harnessing the power of computers to assist prescribers in making the right choices.

Beyond Drugs: Risks from Devices and Biological Products

Benefits must outweigh risks. This predominant theme of drug approval applies equally to the other medical products FDA regulates, namely devices and biologics (vaccines, blood products, and biotechnology products).

Like drugs, devices and biologics all have some risk associated with them, and FDA and patients are willing to tolerate more risk the more serious the disease. "People are willing to get a little closer to the edge when the stakes are high," says David Feigal Jr., M.D., director of FDA's Center for Devices and Radiological Health. "Obviously, you'd like to manufacture everything without risk, but you can't. It's the same for drugs: With cancer drugs, you have side effects that would be unacceptable if you were treating a mild condition."

Susan Alpert, M.D., director of the center's Office of Device Evaluation, also emphasizes the parallels between risk control for devices and drugs: "If you think about the ways that problems can happen, all medical products are very much alike," she says. "You can have functional problems with the product, or users can make errors. With drugs, the user asks, 'Is the drug the right drug?' 'Is the dose the right dose?' You ask those same kinds of questions with devices; you must match the right device with the right patient with the right disease."

Despite all the similarities in risk issues, Feigal's center and the agency's Center for Biologics Evaluation and Research, headed by Kathryn Zoon, Ph.D., must also grapple with some questions that are unique to their types of medical products.

Biologics, for example, are particularly vulnerable to unwanted bacteria, viruses, and other microorganisms. "Blood products and other biologics, by their nature, have certain risk factors based on where the products come from and how they're made," Zoon explains. "A lot of the products we review are cutting-edge technology, and because they're derived from living organisms, they're very susceptible to contamination during the manufacturing process."

Because of this vulnerability, the Center for Biologics places great emphasis on a carefully controlled manufacturing process, which demands extensive product testing, by both the manufacturer and the agency.

The fact that many vaccines are given to healthy people for disease prevention is another important factor, Zoon says, for her center to consider. "You have a product that's going into a large number of healthy people, often babies, so we have to be vigilant to maintain consumers' health and confidence."

For the Center for Devices' part, the "Y2K bug" is adding an altogether new dimension to the center's risk management activities. With the approach of the new millennium, the focus is on pacemakers and other devices that have built-in computers.

"There was misinformation being put out on the World Wide Web that everybody's pacemaker was going to fail on January 1," Alpert says. "And it scared a lot of people."

Feigal assures patients it was just that — misinformation. The year 2000 shouldn't seriously interfere with the functioning of these devices because they operate by tracking information minute-to-minute rather than relying on annual calculations.

"Manufacturers are working very hard to have their devices ready," says Feigal, who encourages patients to visit FDA's Website click on the "Year 2000" button for more information. "Some pacemakers' reporting or other functions may be confused by the dates at the turn of the century," he adds, "which could be an inconvenience, but nothing that should create a health hazard." For those medical devices that could pose a risk, FDA has the authority to issue public warnings, suggest a product recall, or seize the dangerous devices.

Both Feigal and Zoon say increased resources are needed to take full advantage of important new computer technology, such as databases within and outside the agency for analyzing adverse reaction reports. Overall, however, both are encouraged by the findings of the recent risk management report to the commissioner. "FDA's risk management system is working well," Feigal says. "The very nature of the medical product withdrawals — for adverse reactions that are either very rare or occur with long-term use — shows the strength of FDA's premarket approval process."

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.