NEJM Perspective Calls for Recalibration of Bayh-Dole Act

By Donald Zuhn --

In a perspective published in the August 29 issue of the New England Journal of Medicine, Dr. Howard Markel outlines the events leading up to the enactment of the Bayh-Dole Act and states that "a review of [the Act's] origins and consequences supports the idea that policies governing the fast-changing worlds of medicine and biotechnology merit frequent reappraisal and reform."  In the article, entitled "Patents, Profits, and the American People -- The Bayh–Dole Act of 1980," Dr. Markel, the George E. Wantz Distinguished Professor of the History of Medicine, and Director for the Center for the History of Medicine at the University of Michigan, notes that "Bayh–Dole's inspiration was not a perceived need to transform the conduct of research but the economic doldrums of the 1970s."  Following a helpful summary of the history of the Act, Dr. Markel explains that "[w]hen the Bayh–Dole Act was written, its aim was primarily to stimulate economic growth by more efficiently mining the untapped scientific riches of hospitals, laboratories, and universities."  He argues, however, that "[m]uch has changed since then."

While Dr. Markel provides no proposed changes to the Act, he contends that "some of the most vexing quandaries weren't fully addressed in the original legislation."  As for examples of such "quandaries," he suggests that revised legislation should address several questions:

Who should benefit from discoveries pertaining to nature or the human body?  . . .  [W]hat conflicts of interest must be identified and contained in order to protect patients?  How can scientific discovery proceed if all innovations and research tools are patented and the discoverers control access to them?

Dr. Markel (at left) concludes his article by declaring that "[i]t's time for Congress to recalibrate Bayh–Dole," adding that "[p]rofits and patents can be powerful incentives for scientists, businesspeople, and universities, but new and ongoing risks -- including high prices that limit access to lifesaving technologies, reduced sharing of scientific data, marked shifts of focus from basic to applied research, and conflicts of interests for doctors and academic medical centers -- should be mitigated or averted through revisions of the law."

Comments

[EG]

Don,

Here's the link to Joe Allen's reply to this malarkey being spewed by Markel regarding Bayh-Dole: http://www.ipwatchdog.com/2013/09/10/a-reply-to-the-new-england-journal-of-medicine/id=45085/ . Unlike Markel, Joe speaks from experience (supported by facts) when it comes to the impact and value of Bayh-Dole. Markel may be the "George E. Wantz Distinguished Professor of the History of Medicine, and Director for the Center for the History of Medicine" at University of Michigan, but he's undeserving of having any expertise regarding Bayh-Dole.

[Skeptical]

I wouldn't mind it so much if Dr. Markel actually shared some solid points to back up his call for recalibrating the Bayh-Dole act.

But after reading his article I was left with the distinct impression that the man simply has no clue as to what he is talking about. Mind you, he might. He might know a lot. But that is not what is coming across when I read his article.

He makes some pretty broad accusations, but presents no backing or support at all.

Such diatribes leave me rather disappointed. Evidently he feels strongly about the topic, but without more, I simply cannot understand why, and I am not compelled in the least that his cause is just. Change 'just because' has never sat well with me, especially when you are changing from something with such a DOCUMENTED history of success, and based on what amounts to being only feelings that some nebulous better path exists.

Perhaps he will respond with something.

Perhaps not.