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KALAMAZOO, Mich.—The director of the National Institutes of Health, a top Food and Drug Administration official and executives from leading medical innovation companies were among the health industry "all stars" that converged at the Western Michigan University Homer Stryker M.D. School of Medicine Tuesday, Oct. 7, to discuss how the federal government could help them quicken the pace at which cures and medical therapies reach patients.

21st Century Cures

Making it easier for patient enrollment in clinical trials, reforming informed consent procedures, using electronic health records to better effect and reducing some bureaucratic requirements were among the ideas that surfaced at this roundtable discussion convened by Michigan Congressman Fred Upton, chairman of the House Energy and Commerce Committee.

The chief executive of Stryker Corp., Pfizer's vice president of worldwide policy and Dr. Hal Jenson, dean of the 51¸£ÀûÉç School of Medicine, also were on the panel.

The health industry leaders were invited to coalesce in Kalamazoo as part of Upton's initiative, a legislative project he formally unveiled last spring.

Upton has said that to save more lives and to ensure that the United States continues to lead both in medical innovation and job creation in the life sciences, "We've got to make sure that there's not a major gap between the science of cures and the way that we actually regulate these therapies."

To that end, initiative leaders have convened several meetings across the country gathering input from researchers, medical professionals, patients and others about how laws or bureaucratic systems may impede clinical research.

The panel's audience Tuesday included researchers, medical school faculty and students just beginning their medical educations.

Research challenges

Jenson spoke to how appropriate a setting the new medical school was for this important discussion.

The school, named for medical device inventor Dr. Homer Stryker, is housed in a building that was once part of the downtown Kalamazoo campuses of pharmaceutical companies, Upjohn, Pharmacia and Pfizer.

"A lot of drugs were discovered within the walls of this building and a lot of treatments that we offer to patients had some roots in this building," Jenson says.

"And when you look at both Dr. Stryker and Dr. Upjohn … even though one was focused on drug development and one was focused on device development, they shared that passion for making the lives of their patients better. That's really what the medical school is about as well."

But he says the new school, which welcomed its first class of students in August, already is experiencing some of the challenges facing those across the country involved in clinical research.
 
"In a good way, every patient experience is an experiment," Jenson says. "You're looking to see: Did the intervention that I provided as a physician make a difference to the life of that patient?"

But he says that, "As we work to learn and bring that information so that it can advance science faster, we run into the obstacles of informed consent and how do patients get enrolled and engaged in (clinical) trials that can advance medicine and bring discoveries and treatments to patients."

Along the same theme, FDA official Dr. Jeffrey Shuren says that while a lot of knowledge about health conditions is generated through those daily encounters between patients and doctors "we don't make good use of it."

"We can leverage those encounters and the data captured in electronic health records," says Shuren, who is the director of the FDA's Center for Devices and Radiological Research.

"If we do that, we can actually lower time and cost in clinical trials."

Funding constraints

Dr. Francis Collins, NIH director, spoke to the funding constraints on medical research. He says though the world has never seen a more exciting time in scientific discovery than today, the life sciences research system is under stress.

NIH allocates some $30 billion to medical research annually, but Collins says that over the past 10 years, the agency has lost about 23 percent of its purchasing power for research due to "essentially flat budgets" that have been eroded by inflation.

"Your chance when you send a grant to NIH, which traditionally has been about 1 in 3, has gone down to about 1 in 6, making this a very difficult time for laboratories to keep themselves going at the level we would like to see," Collins says.

"We are leaving, as a result of that, some really good science on the table because we can't support it."

"It's all the more reason that we have to be really efficient in the way in which we use resources, working with other partners in the private sector and with foundations and I think, as is a major focus of this roundtable, identifying things that are getting in the way of our ability to be efficient with the resources that we have," he says.

Speaking to the 21st Century Cures initiative's mission to remove hindrances to medical research and cures, Collins offered a few ideas for Congress, including making it easier for patients to participate in clinical trials while still protecting their privacy and making it easier for scientists to spend less of their time on paper work.

After gathering input from discussions like Tuesday's, Upton says his committee's goal is to introduce legislation by early next year and to have a bill ready for President Barack Obama to sign before the end of the year.

For more news, arts and events, visit wmich.edu/news.

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