John Jenkins, MD
John Jenkins, MD, is director of the Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration.
Over and over again we’ve seen that we cannot assume that all is known about efficacy and safety when a new drug emerges from the approval pipeline. In fact, even the drug companies and regulators acknowledge that some of the most important information about a new drug is revealed after it is approved in post-market studies that explore the drug’s safety, efficacy and usage patterns in a wide population. But in spite of their obvious value, a new report shows that many post-market studies are incomplete, and many more have not yet even begun. As a result, many unanswered questions persist about new drugs even after they are approved… and in use… by the general public.
It is an uneasy notion, but even the Food and Drug Administration (FDA) acknowledges that when a new drug is approved, questions concerning its efficacy, safety or usage remain unanswered. “No drug is completely safe and it is not possible for the FDA or the manufacturer to know everything about the safety and effectiveness of a drug at the time it is approved,” explained John Jenkins, MD, director of the Office of New Drugs at the Center for Drug Evaluation and Research (CDER) at the FDA. “Even drugs that have been marketed for years or decades can be found to have unexpected safety issues.”
For this reason, the FDA has historically asked drug companies to conduct post-market studies at the time of a drug’s approval. However, the FDA reported that as of September 30, 2007, out of a total of 1,682 Post-marketing Study Commitments for new drug and biological products, 1,044 (62%) are “pending,” meaning they have not even started.
Dr. Jenkins listed for me some of the factors that can impact the ability of sponsors to initiate and complete post-marketing studies, including patient enrollment difficulties and issues concerning the study’s methodology, as well as funding available for the study. Those reasons served well enough until recently — it was only a year ago that the FDA was given authority and funds to enforce follow-through on the safety studies. Dr. Jenkins says he’s hopeful that the situation will improve due to the passage of the Food and Drug Administration Amendments Act of 2007 (FDAAA) in September 2007. “With the approval of FDAAA, the FDA now has the authority to require (as opposed to request) certain safety studies and to impose civil and monetary penalties if they are not conducted with due diligence,” he said. “This new authority will assist in ensuring that post-marketing studies are completed, submitted and reviewed in a timely manner.”
For perspective, I spoke with Marcia Angell, MD, senior lecturer in the department of social medicine at Harvard Medical School and author of The Truth About the Drug Companies: How They Deceive Us and What to Do About It. Safety and efficacy are two separate issues, she told me. “When a drug is approved by the FDA, it means it has been found in clinical trials to be reasonably safe and effective. However, while the effectiveness of a drug can be more easily shown in clinical trials, the safety must be tested among a much larger population and over a longer period of time.” That’s what the post-market data is supposed to show. Furthermore, she added, “drugs now come to market faster, which makes it all the more important that these studies are done.”
Time will tell whether that actually happens. In the meantime, the best advice for consumers is to stick with the tried and true — the older drugs that have long and established track records for safety. “My recommendation is to avoid drugs that have not been on market for three years or more,” said Dr. Angell. “Otherwise, you are a guinea pig, testing the new drug along with everyone else who’s using it.” It’s also important to realize that not infrequently, the “breakthrough” a new drug promises is just marketing. Often the manufacturer changes the product just slightly in order to protect its patent. And clinical trials don’t compare apples to apples, she points out: “New drugs are usually compared with sugar pills, not with existing drugs to treat the same condition, so there is no way of knowing whether a new drug in a class is better, worse, or (most likely) the same as an old drug at an equivalent dose.”
Regardless of whether the drug you are taking is old or new, if you are unsure about a medication’s side effects or safety record, ask your doctor and do your own research online (see resources below). Don’t assume that the doctor has more information than what the drug company representative has provided — and realize that often the drug company view is rosier than reality.
Post-marketing Study Commitments Database: Search the Center for Drug Evaluation and Research (CDER) site for outstanding post-market studies, www.accessdata.fda.gov/scripts/cder/pmc/index.cfm.
Index to Drug-Specific Information: This index features an alphabetical listing of drugs that have been the subject of a Public Health Advisory, Healthcare Professional, Patient and Consumer Information sheets, an Early Communication of an Ongoing Safety Review, or other important information, www.fda.gov/cder/drug/drugsafety/DrugIndex.htm.
MedWatch Alerts: MedWatch provides important and timely drug and medical product information, and includes reporting of safety information. You can sign up to receive MedWatch notices by e-mail, www.fda.gov/medwatch/.
Medicines In My Home: The FDA Medicines In My Home Web site may also have helpful information about drugs, www.fda.gov/cder/medsinmyhome/.