Outgoing Dept HHS Secretary Tevi Troy leaves Washington today for a well-deserved rest (rumors about a Yankee spring training contract can neither be confirmed nor denied) but not without an important parting word about the future of biomedical innovation in America.
This past year Dr. Troy held a series of town hall meetings throughout the country on the future of biomedical innovation. The account of his meetings were published today in a report entitled: Healthcare Innovation in the 21st Century.
He found:
"New and exciting technologies provide hope that pioneering new diagnostics, devices, drugs, and therapeutic interventions will be developed and made available to the public. However, the need to assess standards, clinical utility, safety, and cost all provide significant challenges and delays in translating scientific discovery to a marketable product. Biomedical innovation is fraught with uncertainty, risk, and a high probability of failure. Many new technologies – genomics, nanotechnology, advanced imaging, bioinformatics – offer great possibilities for the development of biomedical innovations. Yet these new technologies have also amplified the risk and uncertainty in the regulatory and payment pathways. Each of these new technologies raises questions about the safety, efficacy, and clinical use of products derived from these technologies. In many cases, the new technologies also challenge existing notions of how a biomedical innovation should be treated if it does not fall into a traditional regulatory or payment pathway, or straddles two existing pathways. In many cases, there may be a long lag between the emergence of a new technology and the issuance of regulatory guidance clarifying the pathway for product approval. Attendees noted that uncertainty can contribute to delays in the development and diffusion of new innovations, and can diminish investors’ willingness to invest in new technologies."
At a time when Congress is pouring buckets of money on failing and floundering sectors of our economy, considering legislation to force banks to issue risky loans (once again) and proposals to restrict access to new medicines while showering tax credits on green technologies some of Dr. Troy's recommendations to remedy these solutions should be adopted:
Requiring that certain funds be set aside for purely
basic research, and that other NIH grants go to basic
and translation research that has a demonstrated or
probable connection to an improved health care
outcome.
􀂾 Moving away from a binary model of safety versus
effectiveness, by having the FDA make sure
consumers have information available to them about
the spectrum of risks and benefit inherent in every
drug, biological, and device – and how these risks and
benefits may vary from person to person.
􀂾 Allowing FDA to approve applications on the basis of
inferences from known biomedical effects, rather than
always requiring clinical trial data on sizeable
populations.
􀂾 Implementing value-based purchasing across different
parts of Medicare, so that Medicare pays providers for
value or outcomes provided to a beneficiary rather
than for each service or good.
Sadly, Congress and the media marches in another direction. That's because they hate innovation...or the innovators to be more precise. And mining the innovation highway to make it riskier and more dangerous to innovate is part of the game plan. Tevi has highlighted the threats to innovation. To the extent that they are turned into policies, we will know who the enemies of progress really are.
This past year Dr. Troy held a series of town hall meetings throughout the country on the future of biomedical innovation. The account of his meetings were published today in a report entitled: Healthcare Innovation in the 21st Century.
He found:
"New and exciting technologies provide hope that pioneering new diagnostics, devices, drugs, and therapeutic interventions will be developed and made available to the public. However, the need to assess standards, clinical utility, safety, and cost all provide significant challenges and delays in translating scientific discovery to a marketable product. Biomedical innovation is fraught with uncertainty, risk, and a high probability of failure. Many new technologies – genomics, nanotechnology, advanced imaging, bioinformatics – offer great possibilities for the development of biomedical innovations. Yet these new technologies have also amplified the risk and uncertainty in the regulatory and payment pathways. Each of these new technologies raises questions about the safety, efficacy, and clinical use of products derived from these technologies. In many cases, the new technologies also challenge existing notions of how a biomedical innovation should be treated if it does not fall into a traditional regulatory or payment pathway, or straddles two existing pathways. In many cases, there may be a long lag between the emergence of a new technology and the issuance of regulatory guidance clarifying the pathway for product approval. Attendees noted that uncertainty can contribute to delays in the development and diffusion of new innovations, and can diminish investors’ willingness to invest in new technologies."
At a time when Congress is pouring buckets of money on failing and floundering sectors of our economy, considering legislation to force banks to issue risky loans (once again) and proposals to restrict access to new medicines while showering tax credits on green technologies some of Dr. Troy's recommendations to remedy these solutions should be adopted:
Requiring that certain funds be set aside for purely
basic research, and that other NIH grants go to basic
and translation research that has a demonstrated or
probable connection to an improved health care
outcome.
􀂾 Moving away from a binary model of safety versus
effectiveness, by having the FDA make sure
consumers have information available to them about
the spectrum of risks and benefit inherent in every
drug, biological, and device – and how these risks and
benefits may vary from person to person.
􀂾 Allowing FDA to approve applications on the basis of
inferences from known biomedical effects, rather than
always requiring clinical trial data on sizeable
populations.
􀂾 Implementing value-based purchasing across different
parts of Medicare, so that Medicare pays providers for
value or outcomes provided to a beneficiary rather
than for each service or good.
Sadly, Congress and the media marches in another direction. That's because they hate innovation...or the innovators to be more precise. And mining the innovation highway to make it riskier and more dangerous to innovate is part of the game plan. Tevi has highlighted the threats to innovation. To the extent that they are turned into policies, we will know who the enemies of progress really are.
