IOM report makes major drug safety recommendation
IOM report makes major drug safety recommendation
Ongoing monitoring is needed
One of the biggest ethical challenges with drug safety is the need for patients and providers to understand that even after a drug is approved, there is still more to learn about its benefits and potential harms, according to Ruth R. Faden, PhD, MPH, Philip Franklin Wagley Professor of Biomedical Ethics and Director of the Johns Hopkins Berman Institute of Bioethics in Baltimore, MD.
"We can't know everything about a drug's safety after the drug is approved, even under the best circumstances," she says. "People need to come to understand that we are making a judgment that at this point in time, on balance, it is a good drug for patients to take. Information could change as we have more experience with the drug."
The Food and Drug Administration's (FDA) current approach to drug oversight in the post-market 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, according to a May 2012 report from the Institute of Medicine (IOM).1
"We are now the second IOM committee to have promoted a full lifecycle approach to drug regulation, and the FDA has accepted it," says Faden, co-chair of the IOM committee that wrote the report. "People need to stop thinking that everything is uncertain only until the drug is approved, and of post-market as falling off a cliff."
There is just as intense an obligation to vigilantly monitor a drug's effectiveness after it enters the marketplace as there is before the drug is approved, says Faden. "Maybe with some additional understanding about the kind of provisional approvals that could be provided, we can make that artificial divide disappear," she adds. This approach would give more flexibility in allowing drugs to go forward when there are very pressing health care needs, but allow for careful monitoring as to whether the drug has an acceptable benefit-risk profile, Faden explains.
Both patients and providers might have difficulty accepting the fact that decisions are sometimes made about drug safety without complete scientific information. "We don't want to undermine people's confidence in their medical care unduly. We want people to have confidence that the clinician is making a recommendation based on the best available evidence," says Faden. "But they also need to understand that the evidence is not always very good, and that it is changing over time."
FDA's ethical challenges
The FDA has a "profound moral obligation" to promote the safety and effectiveness of the drug supply, which means requiring manufacturers to conduct both pre-market and post-market research to protect the public's health, according to Faden. "On the other hand, the FDA also has a moral obligation to people that participate in the research that it requires, to make sure that the research is ethically acceptable," she says. A related ethical challenge faced by the FDA is how to strike a balance between having enough good evidence to allow a drug to enter the marketplace and responding to pressing unmet health needs where new or better pharmaceuticals are desperately needed, says Faden.
The IOM report recommends adopting a regulatory framework that is standardized across all drugs, yet flexible enough to adapt to regulatory decisions of differing complexity, to make the agency's decision-making process more predictable, transparent, and proactive. "One issue is that recommendations to do non-required post-approval safety research often fall on deaf ears within pharmaceutical companies," says Sean Hennessy, PharmD, PhD, associate professor of epidemiology and of pharmacology at University of Pennsylvania's Perelman School of Medicine and director of the Center for Pharmacoepidemiology Research and Training.
"This is because those who control the money can be too concerned about short-term profits and not concerned enough about the company's long-term sustainability," says Hennessy. Another issue is that despite clinical trial registry requirements, not all studies involving human subjects are reported publicly. "This is because the companies who paid for these studies think of the resulting data as belonging to them and proprietary," he says. "However, research involving human subjects is ethical only if it advances science, which means that it needs to be published."
Institutional review boards should require as a condition of approval that any human subjects research be published or otherwise made available, argues Hennessy, who favors banning direct-to-consumer advertising of prescription drugs in the United States. "There are theoretical health benefits to allowing prescription drugs to be advertised, such as public awareness of treatable disease, but I haven't seen evidence that this theoretical benefit is realized," he says. "It certainly has unintended adverse consequences."
Reference
- Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs, Institute of Medicine. Ethical and scientific issues in studying the safety of approved drugs. Washington, DC: National Academies Press, 2012 (http://www.iom.edu/Reports/2012/Ethical-and-Scientific-Issues-in-Studying-the-Safety-of-Aprroved-Drugs.aspx.)
Sources
Ruth R. Faden, PhD, MPH, Philip Franklin Wagley Professor of Biomedical Ethics and Director, Johns Hopkins Berman Institute of Bioethics, Baltimore. Phone: (410) 614-5553. Fax: (410) 614-5360. E-mail: [email protected].
Sean Hennessy, PharmD, PhD, Associate Professor of Epidemiology, Department of Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia. Phone: (215) 898-9112. E-mail: [email protected].
One of the biggest ethical challenges with drug safety is the need for patients and providers to understand that even after a drug is approved, there is still more to learn about its benefits and potential harms, according to Ruth R. Faden, PhD, MPH, Philip Franklin Wagley Professor of Biomedical Ethics and Director of the Johns Hopkins Berman Institute of Bioethics in Baltimore, MD.Subscribe Now for Access
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