Food and Drug Administration

There’s no easy fix for the challenges facing today’s health care system. But there are some steps that can improve its overall performance, panelists said at a roundtable discussion hosted by U.S. Rep. Gus Bilirakis.

Bilirakis hosted two 21st Century Cures roundtables at The Bethany Center in Lutz last week. One focused on health care from a patient’s perspective. The other took a look at the issue from a provider’s point of view.

At the Aug. 22 session, “Spurring Innovation, Advancing Treatments, and Incentivizing Investment,” Bilirakis asked panelists to talk about regulatory roadblocks and other issues that hinder patient care.

The providers had plenty of suggestions for Bilirakis and his congressional colleagues to consider as they set policy in Washington, D.C.

Dr. David Morgan, the chief executive of the University of South Florida’s Byrd Alzheimer’s Institute, told Bilirakis the diagnosis of Alzheimer’s patients must improve. About one in five people diagnosed with Alzheimer’s do not have the disease, Morgan said.

The disease can be accurately diagnosed with PET — positron emission tomography — scans, but those are expensive and generally not covered by insurance, Morgan said. Proper diagnosis is important not only for treatment of patients, but also to ensure that clinical trial results are not skewed by including patients in the trials who do not have the disease.

Morgan also sees reform needed in the way clinical trials are conducted. The current approach takes too long and costs too much, he said.

Other health care providers agreed that changes are needed regarding clinical trials. They also called for changing the Food and Drug Administration’s regulatory practices.

Dr. Clifton Gooch, of USF’s Morsani College of Medicine, said the FDA needs to focus on simplicity, transparency and consistency. Standards for clinical trials must become more flexible. The current approach looks for a particular outcome with a specific group of people, but it fails to consider how the drug benefits a sub-population.

As the nation moves toward more personalized medicine, “we need to approach nontraditional trials,” agreed Dr. Thomas Sellers, the center director and executive vice president for the H. Lee Moffitt Cancer Center & Research Institute.

“We really need to bring the right drug to the right patient at the right time,” Sellers said.

Dr. Richard Finkel, chief neurologist at Nemours Children’s Hospital of Orlando, said the focus must be greater on patient-centered cures.

“Patients are willing to accept different levels of risk. But the FDA doesn’t look at it that way,” he said. “They are very risk averse.”

A patient with a short life expectancy, for instance, may be willing to accept a much higher risk than someone who has a slow-developing disease, Finkel said.

There are various roadblocks in the research arena, panelists said.

“Funding is dismal,” Sellers said. Not only is that hurting research on specific treatments, it’s also hurting the entire research arena.

“A lot of people are getting out of the (research) game,” Sellers said, which he characterized as a “major casualty.”

Even when there is money, the grant process takes too long, panelists said. Those selecting grant winners also need to broaden their thinking, Sellers said.

“They’re not selecting for innovation. They’re not selecting for bold ideas,” Sellers said.  “Somebody has to be pushing the envelope.”

Finding money to pay for pilot trials is difficult, too.

“The trouble with pilot trials is that nobody wants to pay for them,” Gooch said.

There’s also a need to reform the regulatory process used by the FDA, panelists said. Improvements are needed not only in speeding the time it takes to get a new drug to market, but also in regulatory processes involving the development of new medical devices.

Lisa Novorska, chief financial officer for Rochester Electro Medical Inc., said her company can know how to improve a device, but can’t pursue those improvements because of the costs to comply with FDA requirements. The FDA plays a valuable role in protecting the public, but it also creates paperwork nightmares for small businesses, she added.

The agency’s inspections also can force small companies to lose valuable work time as employees are occupied answering questions on issues that seem compelling.

Geary Havran, president of NDH Medical and chairman of the Florida Medical Manufacturers Consortium, agreed. The FDA should focus on high-risk issues, not those with little or no risk, he said.

As Sellers put it: “I think the question is: What’s a reasonable amount of oversight?”

The medical device manufacturers also are calling to an end of the medical device tax, which they say has a disproportionate negative impact on smaller companies.

Payment for medical services is another huge issue.

“The payment issue is sometimes as much of a barrier as regulations,” said Glen Hortin, clinical pathology medical director of the southeast region for Quest Diagnostics.

Diagnostic tests play a substantial role in guiding physician decisions, Hortin said.

“There’s a possibility of destroying people’s access to lab tests, if the payments are cut too much,” Hortin said.

Many tests that have been developed could help doctors diagnose their patients more accurately, but are too expensive for patients to afford and are not covered by their insurance plans.

In the long-term, the nation needs to shift from operating on a “sick-care” model to placing a greater emphasis on prevention, Hortin said.

Bilirakis believes the private sector can help solve some of the problems facing patients today. Incentives are needed to spur private investments in health care, he added.

“Regulations can stand in the way of private investments in health care,” Bilirakis said. “The bottom line is the potential for reform is huge.”

Published August 27, 2014

See this story in print: Click Here