Life Science Compliance Update

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December 10, 2012

Surgeon Asks: Not Throw the Baby of Innovation Out with the Bathwater of COI Regulations

A recent article discussed “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.”

This overreaction, has caused many to throw the “baby out with the bathwater,” and the baby being discarded is a cherished infant indeed–American industry, innovation and of most importance, great medical care. 

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.

The article was written by Dr. Jonathan Mark Sackier, a Visiting Professor Surgery & Medicine at the University of Virginia and 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.

“Conflict of interest?”

Recent legislation (the Sunshine Act) 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,” Sackier wrote.

Dr. Sackier, who was born in Britain and educated as a surgeon there, came to America to work and innovate, free of the shackles of “ill-conceived legislation of which we had plenty.”  But his faith was “ill-placed” when he learned of this “conflict of interest mania.”

“Current moves to impose restraints on free exchange of ideas between clinicians and the medical industry are misguided and serve no one well,” he asserted.

How collaboration leads to innovation

Sackier then discussed the importance of industry-academia-physician collaboration.

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, former 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—Eli Lilly.

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.”

Sackier maintained that “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.”

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The the Sunshine Act does NOT decree "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." That statement is false and absurd. It calls for transparency-period. Acamdemic Medical Centers do not tell their faculty that they cannot participate in innovation and development. They prohibit marketing/promoting and decison making that is designed to line their pockets in lieu of what is best for the patients. Development is encouraged.

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