Health Care Is Undergoing a ‘Metamorphosis,’ FDA Commissioner Says

Cary, N.C. — Health care is in the midst of a “metamorphosis” that is changing it from a “caterpillar into a butterfly,” and technology is an essential part of that process, federal Commissioner of Food and Drugs Andrew von Eschenbach said Thursday.

In an interview with WRAL.com and Local Tech Wire, von Eschenbach said a wide variety of challenges confront scientists, researchers, doctors and leaders trying to direct the changes, ranging from costs to regulation. He stressed, however, that he is excited to be a part of the experience.

“We’re in the midst of the metamorphosis of health care,” von Eschenbach said in the interview after delivering the keynote addresses at a global health care technology conference put on by SAS.

“We’re not there yet,” he cautioned. “The butterfly is emerging from the cocoon as we speak, but it’s happening. Our challenge is to guide it, to direct this process.

“We have a chance to decide what the butterfly will look like, but we don’t get to decide if it will be a butterfly.”

Three Ps: Pre-emptive, Personalized, Participatory

A urologic surgeon, cancer survivor and former director of the National Cancer Institute, von Eschenbach said he is enthusiastic about the changes both as a medical doctor and as head of the FDA.

“We have a profound opportunity and challenge to change health care,” he told the SAS audience of health science executives. Medicine is becoming “much more pre-emptive, personalized and, I would add, much more participatory. We no longer have to wait for the manifestation of the disease.”

With the wider access to medical knowledge made available through the Internet and the portability of medical records, von Eschenbach pointed out that people can choose to be much more involved in their own care.

What health care providers, leaders, governments and technology creators must do, von Eschenbach stressed in the interview, is strive to be sure that the emerging health care butterfly “does indeed resemble a butterfly rather than a bloated caterpillar.”

A “convergence” of technology is creating opportunities to help enhance the butterfly, he said. From software and electronic health care records that enable data mining to genomics and metabolmics to enhanced medical devices and imaging technology, von Eschenbach said a new age is at hand for medical science.

And in the future, he added, “Health care will look no more like it is today than a butterfly looks like a caterpillar.”

Technology Enables Pre-Emption, Interventions

In both his address and during the interview, von Eschenbach stressed that technology enables health care providers now to tackle cancer at a molecular level rather than waiting to detect it “as a manifestation of an event … We no longer treat it as an event but as a process.” If a “susceptibility” is determined in that process in a person at a genetic level or through technology such as a positron emission tomography (PT) scan then preventative measures or treatment can be implemented at an earlier stage.

“What is opening up for us is an enormous opportunity for us to design not by empirical research or trial and error, which is the old way,” he explained.

Technology can help doctors discover “inhibitors” that can “shut that pathway off” through which a tumor digests nutrients and grows, he added.

“It’s changing our understanding of how the disease process,” he added. “It’s opening up the opportunity to envision and create STRATEGICALLY targeted interventions that detect or eliminate the cause that leads to the suffering and the deaths.”

Drug Approval: Balancing Safety, Effectiveness

As the recent international debate about the dangers of GlaxoSmithKline’s diabetes drug Avandia showed, however, the FDA continues to face challenges of drug approval and regulation. Von Eschenbach said the agency would not compromise safety for effectiveness in drug treatments.

“What we are trying to do is to create a regulatory pathway that will enable us to use modern tools to understand that process and to make decisions more rapidly – but based on science,” he explained. “These will enable us to be sure we understand not just effectiveness of a drug but also its risks.”

On Tuesday, the FDA granted approval to a migraine drug from GSK and Pozen, which is based in Chapel Hill. But that approval came after three rejections, one of which was based on observed genetic damage in lab rats.

Von Eschenbach said the FDA would continue to explore the entire impact a drug has on the human body.

“I don’t believe these are polar, safety on one and efficacy on the other,” he explained. “I believe these are mirror images in our understanding the drug and the interaction with the patient. We are developing tools to understand the interaction between the two to give us insight into safety and efficacy.”

For example, if a drug is effective in treating a tumor yet is “hitting the liver” then “that’s toxicity,” he said. But advances in genetic profiles are helping researchers develop “optimal [drug] quality and eliminate problems in under dosing and over dosing,” he added. “We are understanding the drug at the genetic level.”

‘From Discovery to the Bedside’

In his address, von Eschenbach said the FDA itself must change and modernize if the agency is to help the life science industry, health care providers and individuals capitalize on the convergence that he described.

Those changes include a chief information officer, a new data center coming online in 2009 and the appointment of a bioinformatics board. The commissioner also said “antiquated and inadequate” technology within the FDA also is being replaced to combat “fragmented, siloed information.” The FDA is “radically overhauling” information technology that is continue through 2010.

However, von Eschenbach also said the FDA can’t compromise patient safety and won’t rush to improve drugs or technology for the sake of speed.

“We have to rapidly accelerate but at the same time ensure quality,” he explained in his address. “The FDA must be at the center of the collaboration, from discovery to the bedside.”