Backpage: Under Surveillance

Doctors and consumers don't doubt that pharma benefits society. But in the eyes of the public, industry efforts to monitor postmarket safety come up short.
Oct 01, 2005

Philip A. George
You hear it often these days: Recent drug recalls have shaken the confidence people place in the pharmaceutical industry. While there's some truth to it, the reality is much more complex.

This spring, Accenture conducted an Internet survey of about 100 physicians and 500 consumers. We covered a broad array of topics, in order to capture their overall views of the industry. We focused on their perspectives on pharmacovigilance, adverse events, and drug safety post-Vioxx.

There was an interesting split in the results. On the one hand, 93 percent of consumers believe that pharmaceutical products have had a positive impact on their health, and almost 90 percent believe that pharmaceutical companies provide an extremely or very valuable service to society. In a year when the industry has been continuously under fire, that's good news. On the other hand, the safety scares of the past few years have obviously taken their toll: Only 32 percent of physicians and 30 percent of consumers have confidence in the current postmarket monitoring system. What is more, 80 percent of physicians and almost 90 percent of consumers believe that more should be done to monitor the safety of drugs in the marketplace. About 66 percent of doctors believe that the government should be doing much more in terms of monitoring safety.

Admittedly, there is a lot that patients—and even physicians—don't know about how drugs are developed, tested, and monitored. The concerns people express about the monitoring system may not be entirely rooted in fact. But those of us who understand the surveillance system are well aware that it really does have significant flaws. We have a system where there are multiple stakeholders, but no overarching set of processes for pulling all their data together. We need a much more systematic and robust system with integrated infrastructure and real-time monitoring. And that will require cross-stakeholder collaboration among government, providers, and the pharmaceutical industry.

In today's system, the pharmaceutical companies have a role in mining the data they get and informing the government about it. Nothing in our research suggests that they are not performing their role in a satisfactory way. But physicians and consumers alike made it clear that they want the government to do more—because government looks across the whole healthcare system, and has the authority and regulatory powers to restore confidence in the system.

Many of the elements for a robust surveillance system are already in place. Others will be available soon.

For example, Medicare's prescription-drug plan promises to be an important source of data that can be mined for safety information. Add in the data collected by the big healthcare companies, plus well-coordinated input from the pharmaceutical industry, and it won't be long before a significant majority of people taking prescription drugs will be covered by a monitoring system.

If Medicare, the major providers and health plans, and the pharmaceutical companies would collaborate, using the technology that's available today or, like electronic medical records, is emerging now, there would be reason to expect a much more robust system five to 10 years down the road.

What needs to happen?

  • First we need agreement that something needs to be done to improve drug safety, and that it can be done. The launch of the Medicare drug benefit, with the data it will provide, is a good landmark for action. But pharma needs to play a role here.
  • Industry players need to identify the systems that must be put in place—or systems already in place that need to be leveraged.
  • As the system gets up and running, managing the analysis of data and the flow of information to the public will be a key issue. An effective, automated system for mining safety data will inevitably turn up more warnings and more false alarms than the current system.

It's already clear how much consumers and physicians are affected by a nonstop run of panic stories. And it's important to ensure that a surveillance system actually accomplishes the greater goal of making people feel more secure—as they actually will be—not less.

Survey says... 93 percent of consumers believe that pharmaceutical products have had a positive impact on their health, and almost 90 percent believe that pharmaceutical companies provide an extremely or very valuable service to society. But only 30 percent of consumers and 32 percent of physicians have confidence in the current postmarket monitoring system.

Philip A. George is a managing partner, health and life sciences, at Accenture. He can be reached at

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