Academic Medicine – What’s To Become of the Triple Mission Under Universal Health Care?

Posted on | September 18, 2017 | Comments Off on Academic Medicine – What’s To Become of the Triple Mission Under Universal Health Care?

Hopkins Alumni Careers
1980-2012.

Mike Magee

A New York Times banner headline in 2016 read, “Harnessing the U.S. Taxpayer to Fight Cancer and Make Profits”. It documented the unusual partnership between Kite Pharma, a cancer immunotherapy start-up run by serial entrepreneur, Arie Nelldegrun, and the U.S. government. The underlying immunotherapy research was the output of Nelldegrun’s mentor, Steven Rosenberg, at the National Cancer Institute (N.C.I.). Taxpayers contributed about $10 million to Rosenberg’s lab since 2012. Kite kicked in an additional $3 million a year to accelerate drug development by the N.C.I., but not for free. They own rights to future profitability. In some of the deals (there have been 8 contracts since 2012), Kite receives patent use in return for promises of royalties paid to the N.C.I.

All this proceeds as daily we absorb case after case of over-marketing, over-pricing and over-selling of drugs and medical devices into an American market that consumes them at twice the rate of most civilized nations. Scientific progress appears to have been uniquely decoupled in our nation from human progress. How did we get here?

Since Vannevar Bush presented his “Science the Endless Frontier” to President Truman, and the President insisted on strong government control of federally sponsored research, there had been a prohibition on private ownership of patents that emerged from research discoveries supported by federal grant dollars.

So the federally funded discoveries and their patents sat in the government vaults, largely unused and undeveloped. In fact, by 1978, with the economy in chronic recession, 28,000 scientific patents had accumulated. Over the years, fewer than 5% had been commercialized. At that time, Indiana’s Purdue University was sitting on a number of new health related discoveries that had emerged from their research departments, supported by NIH grants. They approached their senator, Birch Bayh (D-IN), to help them control their patents and profitability.

At about the same time, the lobbyists discovered that Bob Dole had been exploring the same legislative territory. Bob was delighted to conspire with Bayh on a possible fix for the problem. Together they fashioned a solution that would allow individuals, small businesses and academic institutions to maintain ownership of their own intellectual property, even if it derived from government grant money.

The results of the Bayh-Dole Act were dramatic, at least for health care institutions. While 380 patents were granted to them in 1980, that number soared to 3088 by 2009. Those patents, now under the control of individual scientists and their parent academic institutions, were subsequently licensed to corporations for the development of a range of products and applications. According to one estimate, the resultant impact on the nation’s Gross Domestic Product (GDP) reached $47 billion in 1996, and soared to $187 billion a decade later.

Since 1980, over 2,200 new companies have appeared and generated more than 1000 new products. As important, the new technologies spawned entirely new industries in the United States including the field of biotechnology.

Of course, over time, it became clear that the legislation did have some unintended consequences. The licensing bounty for industry and academics was not insignificant. It rapidly grew from just over $7 million in 1981 to $3.4 billion by 2008. And major pharmaceutical companies were at the top of the food chain. Over the first three decades with the Bayh-Dole Act in place, 154 new drugs were approved by the FDA with worldwide sales attributed to these products of $103 billion.

This led The Economist, in 2005, to headline their reappraisal of the Bill, “Bayhing for blood or Doling out cash?”(7) As the article states, “Many scientists, economists and lawyers believe the act distorts the mission of universities, diverting them from the pursuit of basic knowledge, which is freely disseminated, to a focused search for results that have practical and industrial purposes.”

What’s to become of Academic Medicine’s triple mission – medical education, patient care and research? Giant, for all practical purposes, “for-profit” research institutes increasingly marginalize patient care and medical education just when we need leadership in these areas the most. As a nation, we are attempting to correct historic health care missteps in universality, efficiency, transparency, effectiveness and justice.

In this modern era, the triple mission is delivering an integrative and at times collusive professional career ladder, but not much else. What should Academic Medicine leadership and governance look like within a universal health care system?