Washington Editor

WASHINGTON – In 2005 – the year Hurricane Katrina struck the Gulf Coast – the National Academy of Sciences (NAS) reported that the U.S. was facing a "gathering storm" of falling increasingly behind in the global competition for scientific and technological innovation. Five years later, that lack of innovative competitiveness has gone from a tempest to a tsunami, NAS said last week in an updated report.

The hurricane confronting American innovators is China, which has replaced the U.S. as the world's top high-tech exporter.

China also now ranks second in biomedical research.

The NAS report noted that 51 percent of U.S. patents in 2009 were awarded to foreign companies, with only four of the top 10 companies receiving U.S. patents last year actually based here.

Meanwhile, U.S. innovators are worried about the funding cliff that awaits them if Congress fails to reauthorize the America COMPETES Act of 2007, which expires at the end of this year. Plus, the $787 billion from last year's economic stimulus package – which funded many of the COMPETES initiatives – will soon end.

The NAS authors specifically noted a drop in the past decade of new drug approvals from U.S. companies compared with the decade before as a sign of the decline in American ingenuity.

While progress has been made in certain areas since NAS' 2005 Gathering Storm report, "the latitude to fix the problems being confronted has been severely diminished by the economic recession and the growth of the national debt over this period from $8 trillion to $13 trillion," the authors of the updated report declared.

And although the U.S. in the past has shown "considerable prowess," it has "increasingly placed shackles on that prowess, such that, if not relieved, the nation's ability to provide financially and personally rewarding jobs for its own citizens can be expected to decline at an accelerating pace," they asserted.

"In spite of the efforts of both those in government and the private sector, the outlook for America to compete for quality jobs has further deteriorated over the past five years," the NAS committee concluded.

The "gathering storm" in 2005, the authors of the revised report said, "increasingly appears to be a Category 5" – the designation given by the National Weather Service to hurricanes with the strongest wind intensity, in which catastrophic damage is expected to occur.

"America's economic destiny lies in innovation, technology, science and research," said John Edward Porter, a former Republican Illinois congressman and chairman of Research!America, a Washington-based advocacy group, of which the Biotechnology Industry Organization (BIO) and the Pharmaceutical Research and Manufacturers of America are members.

Porter called on Congress to pass legislation reauthorizing the America COMPETES Act, which passed the House in a 262-to-150 vote on May 28, but has stalled in the Senate.

The Task Force on American Innovation, a coalition of high-tech firms, universities and scientific societies, said reauthorizing the America COMPETES Act would "underline our nation's commitment to policies that strengthen America's talent pool and provide continued support for long-term basic science and engineering, ensuring that American innovators continue to produce the discoveries that create new technologies, new industries and high value jobs for Americans."

Porter argued that "substantial and ongoing investments in science research and education are needed or our lead will disappear and our economy and living standards will decline."

Bill Alleviates Rare Disease Trial Burden

Patients with rare diseases no longer have to worry about losing their public health benefits thanks to legislation passed last week by Congress.

"No one should have to choose between participating in a clinical trial and accessing the essential benefits they need," said Rep. Edward Markey (D-Mass.), a co-sponsor of the House bill, known as the "Improving Access to Clinical Trials Act," which was supported by the Cystic Fibrosis Foundation and the National Organization for Rare Diseases (NORD). (See BioWorld Today, June 16, 2009.)

Current law prevents many people who receive Supplemental Security Income (SSI) from accepting clinical trial research compensation, which CFF and NORD contended has stopped numerous rare disease patients from participating in studies.

But the legislation changes the eligibility requirements so that compensation of up to $2,000 for participating in clinical trials will not be considered income in SSI or Medicaid determinations.

"This is a victory for the rare disease community," said NORD CEO Peter Saltonstall.

Comparative Effectiveness Board Named

The Government Accountability Office last week revealed 19 board members for the new comparative effectiveness research center, known as the Patient-Centered Outcomes Research Institute (PCORI), which was authorized under the Patient Protection and Affordable Care Act of 2010. (See BioWorld Today, March 23, 2010.)

PCORI, established as a nonprofit group, is charged with carrying out research projects intended to provide evidence for the best medical treatments, or comparative effectiveness research – one of the most contentious measures debated among the provisions in the new health reform law. (See BioWorld Today, March 23, 2009, and June 10, 2009.)

The terms of the PCORI board members are staggered, with the first set of appointments made this year set at two, four and six years.

Among those named to the board was Freda Lewis-Hall, chief medical officer at Pfizer Inc., whose nomination was backed by BIO. (See BioWorld Today, July 1, 2010.)

ACT's Lanza Wins NIH Award

The National Institutes of Health last week named Advanced Cell Technology Inc. Chief Scientific Officer Robert Lanza and Kwang-Soo Kim, of Harvard University and McLean Hospital, the winners of the NIH Director's Opportunity Award for research in translating basic science discoveries into new and better treatments.

The award provides McLean Hospital and ACT's joint venture with CHA Biotech and Stem Cell & Regenerative Medicine International a $1.9 million prize to explore the potential of protein-induced pluripotent stem cells as a source of universal red blood cells and platelets for transfusion.