Cultivating Safety
January 2008
Axel Olsen, Ph.D., executive director of global pharmacovigilance and risk management at Quintiles, discusses the need for a new culture of safety in the life sciences sector.
Ensuring the safety of medicines has always been a primary concern of our industry. With so much attention now being focused on safety-related issues, however, the current need to reform our pharmacovigilance practices has never been greater or more urgent. The pharmaceutical industry needs to respond appropriately and quickly in order to preserve the public’s trust, protect patients and safeguard the health of the industry as a whole.
It’s widely accepted that the existing adverse event reporting systems and methods the U.S. Food and Drug Administration (FDA) and other regulators use are not adequate for the current state of global drug distribution. The recently renewed Prescription Drug User Fee Act tries to address this area. The legislation has very specific language about increasing the technical capabilities of the FDA, and we’re also seeing efforts by the agency to use publicly available data to strengthen their analytical capabilities.
But strengthening the tools and methods for capturing adverse event data is not just an issue for regulators, nor is it the only means necessary to improve drug safety. Pharmaceutical manufacturers must be involved as well. The global medical community is always looking for better information related to the use of the products in their specific patient populations, and we’re likely to see studies that are conducted in special populations or in very broad, post-marketing programs. From outcomes-related studies to large, randomized clinical trials, a number of different methods can be used to improve the body of safety knowledge for marketed drugs.
A proactive example is how Pfizer is responding to cardiovascular risk questions related to the arthritis drug Celebrex. The company has engaged in an extraordinarily large clinical trial that is looking specifically at cardiovascular endpoints. The new thought process here is not in the way that the clinical trial is designed, or being conducted, but much more in the size of the trial. They’re using relatively standard clinical trial methods and applying them to tens of thousands of patients. In the past, it would’ve been at hundreds to a few thousands. But Pfizer is undertaking this study in response to the need to better understand the cardiovascular risks of the drug. And communicating that risk in a practical and understandable manner to the general public is the real key component.
For example, a post-marketing study may show a drug carrying a risk for any given adverse event as increasing by a small percentage. But that’s rarely the true situation, and it’s very difficult to quantify—to the public and to the media—what the risk actually means in a real world setting.
The term that’s used frequently is “number of patients to observe.” If you have a small incremental increase in an adverse event, you may see it in one out of 100 patients, compared to one out of 150 patients. This is a much better way of communicating that risk, rather than by risks of increased incidence. This is an example of the kinds of things that need to be very carefully communicated and done so at the right level. Informed consent materials, for example, are written typically at an eighth grade level, yet risk communication typically goes out as though it’s being written for the medical community.
At the Table
In terms of cooperative efforts to improve the global climate of drug safety, we’re now seeing the U.S. Congress engaged in revising the laws and regulations; we’re seeing the FDA and other regulatory agencies enhancing their access to information and their ability to analyze it; and we’re also seeing changes on the pharma side, where the industry now recognizes the need to be much more proactive on signal detection and evaluation. We’re seeing the major companies develop some very well-designed and thorough solutions. GlaxoSmithKline, for example, recently presented its global signal detection system that will soon be in place. And the World Health Organization—through the Uppsala Monitoring Centre in Sweden—is doing the same thing. They’re doing detection using methods to look for signals in their spontaneous reporting systems.
These are all great and welcome developments, but pharma can still do more, particularly with regard to providing transparency in their decision-making process. Manufacturers need to look beyond the constraints of the science, and look more broadly at the impact of the information at hand. And then they need to be much more transparent in how they deal with that information. Part of the problem is the extreme silo structure of most large pharmaceutical companies. If information isn’t transmitted from one part of the organization to another, it never gets dealt with appropriately. That type of silo mentality really needs to be broken down.
In fact, one of the solutions may include pharma companies creating a very high-level office or group responsible for the overall safety of a product. And this role or group should have board of directors’ or CEO level of access so it can get beyond those barriers and look at what’s going on inside the silos. And we’re actually seeing signs that pharma is responding and creating positions such as a Chief Safety Officer, or something very similar, in the near future. In addition to maintaining an ongoing, cooperative dialogue with regulators and the rest of the global health community, pharma needs to embrace newer methodologies and systems to truly develop a new culture of safety.
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