The skinny jean-wearing, backyard hen-raising, social media-bantering FDA honcho can predict the future rather accurately, actually. It’s a proven fact.
In 2003, as a resident fellow at the Washington, D.C.-based American Enterprise Institute, Gottlieb wrote an article for the premiere (June) issue of The New Atlantis, a quarterly journal examining the social, ethical, political, and policy implications of modern science and technology. In his 3,800-word piece—titled “The Future of Medical Technology”—Gottlieb charted medtech’s destined path, specifically noting the paradigm shift toward individualized medicine. “The result will be a new age of medical therapy, dominated not by cell, tissue, and organ replacements but by early diagnosis and individualized drug treatments,” he wrote.
Gottlieb’s most telling forecasts, however, are strategically planted at the end of his article:
Taken together, the marriage of biology and silicon and the shift from species-based to individualized therapy will change the face of medicine forever. Traditional human efforts to treat disease are being empowered with digital tools that annotate life with silicon technology. The enormous material effort to find symptoms is being replaced by a combined genetic and artificial intelligence that knows where to look and how to find problems before we do...In the future, a supercomputer sitting in an air-conditioned room will work day and night, crunching billions of bits of information to design new drugs. Multiplying at the speed of Moore’s Law...this drug discovery machine...will shape how we use the abundance of genomic information that we are uncovering and it will be the deciding factor for the success of medicine in an age of digitally driven research.
Gottlieb couldn’t have been more spot-on with his vision: The “supercomputer” he portended 15 years ago is now the very real and fully functional IBM Watson, an artificial intelligence (AI) system perhaps best known for beating “Jeopardy!” game show champions in 2011. As predicted, IBM Watson sits in a climate-controlled room and processes data at incredible speeds (80 teraflops, which translates into a trillion floating-point operations per second). Although the system is being used to more effectively manage healthcare and better match patients to clinical trials, it also is helping to accelerate drug discovery, as Gottlieb correctly anticipated in his article. The Barrow Neurological Institute, for example, leveraged IBM Watson’s data processing prowess to rank 1,500 proteins for their association with amyotrophic lateral sclerosis (ALS), otherwise known as Lou Gehrig’s disease. Of the top 10 proteins IBM Watson ranked, eight were linked to ALS and five of them had never before been connected to the disease.
Perhaps equally as remarkable as Gottlieb’s unerring portrayal of medtech’s digitally-driven future, though, is his insight into the challenges AI potentially could trigger for the industry.
Regulatory procedures need to keep pace with technological change...Many parts of this new technology still need to be validated in the clinical setting. Scientists still need to prove that their cool new tools can also make important new medicines.
Another bulls-eye: Though the FDA has taken steps to modernize its regulatory programs through efforts like the Innovation Initiative, in silico clinical trials and regulatory models, natural history databases, and a Scientific Computing Board, the agency nevertheless struggles to keep up with the accelerating pace of technological change.
And while IBM Watson has proven itself to be a reliable, speedy data-cruncher, clinicians are still unsure about the quality of its results. “...the unknown thing here is how good are the results,” Babu Guda, a researcher who has used IBM Watson for genomic analytics at the University of Nebraska Medical Center for two and a half years, told the technology website Gizmodo last summer. “There is no way to validate what we’re getting from IBM is accurate unless we test the real patients in an experiment. It’s very difficult for researchers. Without publications, we can’t trust anything.”
That trust is bound to come with time and credible, proven data. Eventually, that trust might also help foster an improved version of IBM Watson—one in which the system processes medical journal data, personal information, symptoms and gene sequencing to diagnose and treat disease. Gottlieb certainly thinks it’s possible.
But if one had to guess where the future of medicine really lies, it is in DNA chips, supercomputers, and new drugs, not embryo research, tissue transplants, or stem cells. It is time for our public debate to pay more attention to this fact, since a medical and technological revolution of this significance is sure to have lasting political, economic, and social consequences.
Some sage words from a sage man. And expert futurist.
[Author's note: In the June 2018 issue of MPO, this appeared as a sidebar within the 15th Anniversary article, which can be read by clicking here.]