Finding a Common Ground
There’s no question that times have changed a great deal in medicine, especially when it comes to prescription drugs. When I started and managed the Matthew Thornton Health Plan in New Hampshire in the early 1970s, we didn’t think of including any prescription coverage as part of the plan because drugs were so cheap. The average drug back then cost about $4, as I recall.
Now, the U.S. pharmaceutical industry does something like $400 billion in business annually. Drugs are markedly more expensive. Prescription costs for certain rare medical conditions can run thousands of dollars a month. We’ve all seen the headlines decrying the latest high prices—that happens frequently. But amid all the criticism, we sometimes forget that people are living longer because of the historic change, and living better, too.
The Center for the Study of Drug Development (CSDD), which Lou Lasagna, then dean of the Sackler School, brought to Tufts in 1984, represents a valuable national resource housed on our campus in a time of dramatic change in U.S. medicine. It is unique in the country as an organization whose role is to study the process of drug development and lend perspective to its continuing evolution.
Ken Kaitin, director of the CSDD, has relayed some of the interesting history behind the center’s creation. It seems that back in the 1970s, Lasagna was the first to recognize and document a remarkable phenomenon: U.S. physicians and their patients did not have access to a broad array of critical medicines that were approved and available to patients in the U.K. Because of the different regulatory environments in the two countries, patients in England were getting access to new drugs about eight years sooner than patients in the U.S.
Lasagna, a physician widely known as the father of clinical pharmacology, testified before Congress on the evident disparity, but the “drug lag”—a term he coined—showed just how little was understood about the inner workings of the American pharmaceutical market and the role of regulatory agencies in public health. The CSDD, an independent, academic, nonprofit research group founded by Lou in 1976, while he was on the faculty at the University of Rochester, was the logical answer to the question of how to learn more, inform the public debate and improve health care in the process.
Today, with a team of 13 researchers and three administrative staff, the CSDD has many sides to its operation. It conducts analyses of economic, legal and scientific trends in bioinnovation for peer-reviewed publication. It monitors and reports on the development, regulation and use of medicines. And it explores public policy issues related to drug development.
In addition, by bringing together diverse stakeholders from government, industry, academia and public health, CSDD provides a neutral forum for valuable discussion of critical topics in bioinnovation. The goal is to generate understanding and increase productivity in bioinnovation.
Getting people around a table and sharing data can pay unexpected dividends. For example, folks from the FDA have told Kaitin more than once that studies conducted here at Tufts have helped the agency understand the impact of their regulations. The CSDD team exerts further influence through frequent appearances at pharmaceutical conferences around the world and public testimony before Congress.
Nothing stays the same, and the drug industry is no exception. Although the industry may have a public reputation as a highly profitable business, and it certainly does continue to be so, to a large degree, significant changes are afoot these days as lucrative patents expire and companies cast around for the next “blockbuster” drug. Many pharmaceutical giants are looking to form new partnerships—both with each other and with universities—in this regard.
We, of course, have our own distinct strategic needs to consider. At a time of reduced NIH funding that is not apt to change over the near term, all medical schools, including our own, are in a position where we need to seek increased financial support for our scientists. I believe a newfound affiliation between academia and pharmaceutical interests can be profitable for both sides.
Harris A. Berman, M.D., is the dean of Tufts University School of Medicine.