How safe and useful are the drugs that we use? Physician Richard Gliklich, CEO of Outcome Sciences, was researching the real-world clinical outcomes of approved drugs and devices in the 1990s before there was much of market for that kind of information. Now the FDA and more than 2,000 other healthcare organizations around the world use the technology and services of Cambridge, MA-based Outcome to gather and analyze data that is shaping important healthcare decisions. And President Obama is making evidence-based medicine, and comparisons of treatments, a cornerstone of his healthcare reform plan.
Outcome Sciences got a big boost earlier this year when Congress passed the $789 billion economic stimulus package, which designated $1.1 billion for studies that compare the effectiveness of one treatment to another for the same illnesses—something known as “comparative effectiveness.” Add the current and potential business Gliklich expects from that appropriation to the demand for his firm’s technology and services for post-market safety and physician performance studies, and it’s no wonder why he said the company has generated greater than 50 percent annual growth in the past few years. (Outcome is privately held and does not release specific financial information.)
Drug companies traditionally have poured the vast majority of their resources into clinical trials that can directly lead to FDA approval of new products. But once products are on the market, the R&D budgets tend to thin out, since there’s a lot of risk, and little potential reward, for companies to test their products head-to-head against competitors. That situation often leaves physicians wondering about important questions like whether a marketed drug is still considered safe when it’s given to way more people than those who got it in the original clinical trials. The FDA sometimes tries to require companies to ask these questions in “post-marketing” studies, but doctors often find these trials never get done, or drag on for years.
Gliklich, who is also a surgeon at Massachusetts Eye & Ear Infirmary, is a heavy hitter in the world of post-market studies. He and Nancy Dreyer, chief of scientific affairs at Outcome, were authors and senior editors for a definitive guide—published in 2007 by the Agency for Healthcare Research and Quality (AHRQ)—on how to develop and operate patient registries to report the outcomes of certain treatments. His company is also providing the patient-management software for the MassHealth Hospital Pay-for-Performance (P4P) Measures initiative launched in 2008 to improve care at hospitals in Massachusetts.
Gliklich led the spinout of Outcome from research done in Harvard Medical School lab and the formation of the company in 1998. The company has built a Web-based platform for collecting patient and other clinical outcomes data. It also works with most of the largest pharmaceutical firms and many major medical devices manufacturers to conduct post-market studies of drugs and devices after they are approved. The FDA and its counterpart the European Medicines Agency have increasingly mandated that drug and device providers conduct post-market studies to provide information on the safety and effectiveness of their products in a real-world setting that clinical trials alone may not provide. To handle its workload, Outcome employs between 200 and 300 people at its operations in Cambridge, Washington, D.C., California, Switzerland, and India.
We caught up with Gliklich on a recent afternoon for an interview, and he had plenty to say about the role of his company in helping governments and healthcare organizations to monitor how well medical products and physicians are doing their jobs. Here are some excerpts from that interview:
Xconomy: Why are patient registries and analyzing clinical outcomes important to you?
Richard Gliklich: I took time off from medical school to be a fellow at the University of Pennsylvania in this evolving area, which became outcomes research, and I became very focused on the idea of real-world results and that the results might be different from what we see in the clinical trials arena. I almost had a vision that there needed to be a consumer report in healthcare
