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Convergence: Where art thou?
In June of 2016, MIT issued an influential report entitled “Convergence: The Future of Healthcare,” authored by Tyler Jacks, Susan Hockfield and Philip Sharp, with input from many others. This was presented at the National Academies (of Science, Engineering and Medicine). This white paper followed an earlier report in 2011, “The Third Revolution: The Convergence of the Life Sciences, Physical Sciences and Engineering.”
The word convergence is potent and has stimulated much debate on how the great issues are attended to by innovators across academia, government and business. The word reflects the origins of the most dramatic successes of recent decades. MIT has been fortunate to be able to devote substantial resources to fund institutes that cross disciplinary lines. The Koch Institute for Integrative Cancer Research is convergent. Yes, David Koch is one of the famous brothers who support doing good by doing well. Nearby, there is the Wyss Institute for Biologically Inspired Engineering, affiliated with Harvard. Then we have the Broad Institute bridging both Harvard and MIT.
Convergence has thus attracted substantial resources in Boston and the concept is delivering innovations. These are translated to practice with both startups and the mature firms that have been attracted to the area for several decades. There is nothing like success to breed more success, and there is no better life-sciences cluster than this one.
Let’s travel 400 miles southwest to Washington, D.C. In December, the 21st Century Cures Act was signed into law, further facilitating a Cancer Moonshot, more funding for NIH, more efficient FDA procedures and as much else as could be cobbled together in a largely bipartisan effort. Within a week, alternative voices decried the shortcutting of drug approvals endangering patients, with no indication of the mechanism by which this would happen. Within a few months, a new administration proposed reducing the NIH budget by 18 percent for the 2018 budget. That’s odd, tiny to the federal budget, but huge to academic life-sciences research where many worthy innovations begin. Divergence on steroids.
The newly nominated FDA commissioner Dr. Scott Gottlieb has FDA operating experience and has spent a decade commenting on the potential for improving the agency. I’ve followed his writing with interest and at 44 he has energy. He would like to increase the pace at FDA. As a cancer survivor, he also has perspective. The CEO of Regeneron Pharmaceuticals, Dr. Leonard Schleifer, has noted that “Scott is science-based, he’s patient-focused, he’s got strong management skills and he’s intellectually tough, so he will use all of that to make sure the FDA and industry are all acting in the interest of patients.” Meanwhile, his affiliation with venture capital investing, biotech and pharmaceutical companies suggest to some that Gottlieb is going to put industry before patients. A guy who knows the agency, knows the industry and knows how it is funded is disqualified? In other words, convergence is a bad thing.
These confluences of interest are what facilitate good judgement in an agency engendered with ambiguities of safety, efficacy, speed to market and cost. The FDA authority covers thousands of human diseases which vary in frequency, intensity, morbidity and mortality. The agency has responsibilities from preclinical assessment to clinical trials, manufacturing and post-market surveillance. That this is done from aspirin and bandages to antibody-drug conjugates and implanted devices is daunting. It is simply not possible to satisfy all interest groups without an occasional miss or squabble. A leader with interest in company and patient success is not going to willfully cut corners that matter. There are corners to cut that matter very little.
This coming September, the user fee components that help fund FDA personnel will need reauthorization. These are for prescription drugs (PDUFA), generic drugs (GDUFA) and medical devices (MDUFA). The administration has suggested substantial increases in these fees to facilitate FDA staffing and faster assessment of applications. Will that be a fair exchange? The job can’t be done without qualified staff, and the patients are waiting long enough. On the other hand, the opposition sees a bargain with the devil that will once more put patients at risk.
Patients are already at risk. They are patients. There is no benefit to biopharma to have drugs approved that are dangerous and ineffective to a high degree, although all of them are both to some degree. Extend the UFAs or FDA headcount must drop. More divergence.
Convergence can bring us a lot in medicine, as it has in communications. A smartphone is a convergent device between aerospace, organic chemistry, metallurgy, electrochemistry, semiconductors and IT. Convergence will facilitate individualized medicine and track data post-market. Imagine the learning possibility from the many millions of largely unmonitored clinical trials we do each year, whenever a patient is prescribed a drug for the first time. Nearly all DDNews readers have participated in such trials. We are close today to having data for each of these trials. Each year the reservoir of data in individual medical records is increasing and tools to examine it, while not without controversy, are improving.
Convergence. Doing good by doing well. Why is that so often disparaged? This spring we’ve heard a lot of yelling in Washington. Opposing whatever the other tribe favors is proven to not be safe and effective. The same for holding agreeable ideas hostage unless all your more controversial ideas are also accepted. A lot of good ideas are thus left on the table. Years are lost. To come to a middle, it works best to listen, ask questions and stop assuming evil intent simply because you belong to different tribes. After some highly contentious 16 years in this millennium, a lot of convergence in Boston will be needed given the divergence in Washington.