CLEVELAND — As a panel on Wednesday, the final day of the Cleveland Clinic Medical Innovation Summit, discussed ways healthcare reform will change life for medical innovators, an interesting theme emerged: Innovation is not at the healthcare reform table.
It was a point made Tuesday night by David Brooks, a New York Times columnist who has recently emerged as a voice in the healthcare reform debate. Panel moderator Debra Lappin, president of the Council for American Medical Innovation (Washington), used Brooks' statement to kick off the discussion about healthcare reform and its potential impact on innovation.
David Nexon, senior executive VP at the Advanced Medical Technology Association (Washington), said that a "huge issue" in the healthcare reform debate is that innovation is not something people In Washington are paying much attention to. Innovation is a "huge blind spot" in the debate, Nexon said.
"I think what our audience doesn't realize is that great innovation is built through incremental steps," said Richard Smith, senior VP of Pharmaceutical Research and Manufacturers of America (Washington). "[We need to] make sure that as we go forward we are putting the systems in place that recognize that."
When the discussion turned to comparative effectiveness another panel member, Beth Seidenberg, MD, a partner with Kleiner Perkins Caufield & Byers, made a startling statement – one that she later admitted she hopes won't come true. She said that venture capital investors won't invest in things for five to 10 years, until there is clarity on how things are going to play out, which in turn would stall innovation. "And I think that would be a crime," Seidenberg added.
Later, in response to a question from an audience member, she said that she is "hoping my comment will not come to fruition." She encouraged the summit attendees to "have a voice" in the healthcare reform debate. "It is important that physicians and scientists speak up and are active in the debate," Seidenberg said. "We all, as leaders in the industry, need to have a voice at the table."
Edward Buckley, director of economic policy at the Biotechnology Industry Organization (Washington), said that comparative effectiveness could be an "incredibly powerful tool to help drive forward scientific knowledge." He added that if done properly, comparative effectiveness could be an "incredible gift" to society. However, he said, if not done properly, it could be a "detriment of innovation."
Seidenberg said the idea of comparative effectiveness is "truly a double-edged sword." To use a specific example, she talked about the National Institute for Health and Clinical Excellence (NICE; London) in the UK. According to its web site, NICE is "an independent organization responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health." As Seidenberg described it, however, it is a gatekeeper organization that has the power to say which products the public should or should not have access to – even after the product has received regulatory approval.
While Seidenberg raised some concerns about the issue of comparative effectiveness and what might happen if the U.S. healthcare system included an organization similar to NICE, Smith said he does not think that is likely to happen. "I'm optimistic about where this issue is going to end up," he said. "I think there is a consensus that we don't want to end up ... with something like NICE." In fact, he added, there is a proposal already on the table that is superior in terms of continued access to innovative products for patients.
This particular panel session, called "five ways healthcare reform will change your life as an innovator" is one that the summit planning committee put a lot of time into, according to Chris Coburn, the executive director of Cleveland Clinic Innovations. Coburn said, as he introduced Lappin, that the idea of the panel topic was to "push the notion of how healthcare reform issues are going to affect innovation at the level of venture-backed companies and, more broadly, in the industry." He said he wanted the panel to get into the "specifics about how life will be different."
At the start of the panel session, Lappin put up a rather complicated flow chart titled "the road to passage of healthcare reform legislation" and then asked the panel members to predict where the healthcare reform legislation will be by the end of the year.
"Change is coming, despite the complexity of that chart," Nexon said. The question is, he said, is "will the bill pass before Thanksgiving or before Christmas?"
Smith agreed with Nexon that a healthcare reform bill would probably pass by the end of the year. He said at this stage the legislation is probably "at the end of the beginning," although he added that he believes "there is a great deal that will get moved around" before we see passage of a bill.
Buckley agreed that, "something will happen," but again said the question remains "what and when." He added that he believes the passage of a healthcare reform bill will "certainly increase access for today's patients for today's innovation." However, he said, "What it does for future patients ... right now is in a state of flux."
Seidenberg simply responded that there are three things she is never willing to make projections on: the weather, the FDA, and "whether we'll have healthcare reform."
As time ran out Lappin concluded the discussion by encouraging the audience – which was comprised primarily of innovators – to get involved with the healthcare reform debate. "Get innovation into this dialog," she said, "it's never been more needed."
Amanda Pedersen; 229-471-4212