Doctors should be free to collaborate in medical technology development

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  • 08/21/2022

A 16th Century German author, medical innovation and a fallacious definition have one thing in common: overreaction. ???Don???t throw the baby out with the bathwater??? does not, as Internet-lore would suggest, have anything to do with bathing, and subsequently losing the youngest child in water previously muddied by other family members.

It derives from Thomas Murner???s 1512 Die Narrenbeschwörung (Appeal to Fools), a satirical plea against overreaction.  I wonder what Murner would make of the current polemic against conflict of interest, relationships between physicians and the ???medical industrial complex;??? a case of overreaction in muddied waters, demonizing good people and inducing consequences those responsible cannot imagine. And the baby being discarded is a cherished infant indeed-American industry, innovation and of most importance, great medical care.

Conflict of interest is where discharge of official responsibilities by a trusted individual is potentially corrupted when personal interests may lie in another direction. The key word there is ???potential.???

Enjoying wine and driving does not make one a drunk driver. When a surgeon sees a patient and uses their position of ???undue influence??? to recommend an operation for which he or she will be paid, is that not a conflict? One interest is the patient???s well being, the other is the surgeon???s pocketbook. This is, of course, an odious example that should offend all of us; physicians are professionals and do what is right for the patient. When they exploit that privilege they are suitably sanctioned, vilified and sued. Well-intentioned doctors - the vast majority - have the patient as the sun in their universe; all decisions are made with the individual patient at the core.

???Conflict of interest????

Recent legislation and hyperbole decreeing that physicians should have no dialogue with life science companies, should not receive royalties for inventions or fees for running clinical trials or delivering speeches and such activities due to concerns of ???conflict of interest??? are blatantly absurd ??? in what other branch of human enterprise is effort not rewarded?

But it goes further than that, some are demanding that such thought-leaders should be discounted from holding leadership positions in academia or on National Institutes of Health advisory panels to prevent potential problems.

That is truly smart ??? let???s exclude the best minds from guiding us. There is already a good system in place to deal with abuses of power, all we have to do is use it - prosecute to the full extent of the law and not ???settle??? thereby strongly discouraging others who may follow. But to prevent dialogue just in case an abuse might take place is truly ludicrous; the innovation pathway will fragment, corporations implode, exports will decrease, jobs will be lost and of greatest import, patients will suffer. And that is intolerable.

Setting aside reasoned argument, there is something fundamentally anti-American going on here. As a naturalized citizen I took the time and effort to learn about my adopted country. Born in Britain and educated as a surgeon there, I moved to the United States due to my frustration with academic stagnation in the old country and having seen how my American colleagues were liberated to think, work and innovate, free of the shackles of ill-conceived legislation of which we had plenty. I read and absorbed the U.S. Constitution, proudly aware of how the basis in the Magna Carta had been improved and enhanced. I paid special heed to embodied concepts like freedom of speech and innocence assumed until guilt was proven. It would seem my faith was ill-placed.

Current moves to impose restraints on free exchange of ideas between clinicians and the medical industry are misguided and serve no one well. When I emigrated to the United States, I came to the capitalist powerhouse of the world, labor is rewarded and originality esteemed ??? America runs the risk of adopting all that Britain did poorly in the 1970s. If this ill-conceived trend is not halted and reversed. Let me expand with a few examples.

How collaboration leads to innovation

???You have cancer.??? Three words to change a life. But academic-industry collaboration resulted in the development of Gleevec, enhancing hope. How did this come about? Scientists at the University of Pennsylvania noted that patients with chronic myeloid leukemia had abnormal chromosomes.

Fast forward to the advent of gene mapping and scientists at the University of Chicago determined that those aberrant genes made a cancer-inducing protein. Enter Novartis scientists led by Drs. Zimmerman and Buchdunger. Millions of dollars, 10 years and 400 molecules later we have Gleevec and lives have been saved. Tommy Thompson, Secretary of Health and Human Services called it ???the wave of the future.??? Dr. Harmon Eyre of the American Cancer Society stated ???a huge breakthrough???a great drug, a great new discovery.??? A collaboration between academics and industry. Job done, lives saved.

We now have a diabetes epidemic and need to make urgent changes as a society ??? what we eat, how we exercise and so on. But at least diabetics can count on insulin to rescue them. But roll the clock back to 1922 and thank Elizabeth Hughes, daughter of the Secretary of State, a graduate student, young physician, physiologist, biochemist and an astute Indiana corporation.

When Hughes was diagnosed with diabetes at age 12, the best option was a starvation diet and early death the likely outcome. A young Canadian doctor, Frederick Banting had an idea, closed his growing medical practice and collaborated with scientist Charles Best, Professor Macleod and Dr. Collip. The concept? Take pig pancreas and purify what came to be known as Insulin. The Eli Lilly Company of Indianapolis agreed to help and the rest is history. One bright idea from a young man prepared to take a chance. One senior scientist prepared to help, collaboration by others with different skill sets and a company prepared to risk capital and effort. Result? Game changing.

Other examples? How many do you want? Heart valves, dialysis machines, angioplasty, all the clever procedures now done with minimal invasion, countless diagnostic tests, numerous therapeutic drugs and on and on. Clinicians spotting an unmet clinical need, scientists who collaborated to solve a problem, financiers who took a chance, companies who invested time, money and resources. And patients who benefited. We are going to throw all of this away because, why, exactly? Because certain individuals think certain physicians might use undue influence to pervert medical therapies. Lets ban cars ??? poor drivers may cause accidents. And here???s one that resonates for Americans, let???s ban guns.

No exploitation of positions of influence

My contributions have been miniscule in comparison, but my joyous and fulfilling collaboration with Dr. Yulun Wang, formed the foundation for robotically enhanced surgery, dialogue with engineers at one medical technology company brought a device that shaved time off surgical operations and another collaboration saw operating room safety improved. I openly disclose my ???conflicts??? to all and let their good judgment ascertain if I abused my position of influence as a surgeon. I am proud of these ??? and other ??? collaborations with industry and have personally seen no examples of exploitation of positions of influence.

On the contrary ??? I have met and interacted with smart, ethical and industrious men and women who have helped make this country great, improving the lives of the patients we all serve. I will be damned if I will stand by and watch them and those of my colleagues who collaborate with industry vilified by ill-advised agents of change. Change should be about movement toward something better, not necessarily something new and to effect change, doctors need to be allowed to have free discourse with their industry colleagues, the free speech guaranteed to all in our Constitution.

I am an American now and proud to be one. This nation was founded on inscrutable tenets of decency and humanity, we were respected the world over for our industry and industriousness. Our healthcare was the finest in the world. We are losing our grip on reality and tilting at windmills.

I came here to help make a difference and not to joust with imaginary dragons. When H.G. Wells said, ???Every time Europe looks across the Atlantic to see the American eagle it observes only the rear end of an ostrich.??? I believe he was referring to our habit of burying our heads in the sand rather than any issue of physical resemblance. Please do not allow our country to make the same errors the British have made ??? the brain and commerce drain from Europe in the latter part of the last century could easily flow in the opposite direction. If this tide is not halted, patients will suffer. And we are all patients sooner or later.

Dr. Jonathan Mark Sackier is Visiting Professor Surgery & Medicine at the University of Virginia and serves as a director of Hemoshear and Rex Bionics. Dr. Sackier has consulted to medical technology companies and developed and licensed products to companies such as Valleylab, and Applied Medical and advised others such as the Veterans Administration and the Royal College of Surgeons of England.