Milwaukee Journal Sentinel Reporter, John Fauber, Uncovered the Appearance of Blatant Corruption at the University of Wisconsin’s School of Medicine and Public Health — another Instance of the Medical-Industrial Complex’s Distortion of Objectively Delivered Medicine

06 January 2012

Corruption and the appearance of corruption should matter to medical patients, and not in just a philosophical sense

I have written repeatedly about the distorting influence of corporate money on scientific and medical objectivity.

Note

The most recent article is here. Its concluding section contains a list of links to other essays in the series.

Today, I add John Fauber’s University of Wisconsin investigation, which documents the appearance of corruption in medicine.

His report is enough to make reasonable people question the objectivity and morality of a system that seems to be constructed to benefit everyone but medical patients.

First — defining “corruption”

Merriam-Webster defines corruption as:

impairment of integrity, virtue, or moral principle . . .

inducement to wrong by improper or unlawful means (as bribery) . . .

a departure from the original or from what is pure or correct.

Wikipedia said more contextually:

In philosophical, theological, or moral discussions, corruption is spiritual or moral impurity or deviation from an ideal.

In economy, corruption is payment for services or material which the recipient is not due, under law. This may be called bribery, kickback, or, in the Middle East, baksheesh.

< http://en.wikipedia.org/wiki/Corruption> (visited 06 January 2011)

Pertinent elements of these definitions

Notice that both sources emphasize the primacy of moral principle.

Medicine and science are “moral” disciplines because both proclaim themselves to be about standards that go beyond self-interest:

(1) The scientific method is about pursuing Truth, wherever the journey leads. That seeking requires objectivity, as well as transparency.

Objectivity — says the Free Dictionary — is “judgment based on observable phenomena and uninfluenced by emotions or personal prejudices.”

(2) Medicine is about serving patients’ health care in a fiduciary capacity. The Free Dictionary explains that a fiduciary is “a person bound to act for another's benefit.”

Medicine, these days, pretends to be scientific. Consequently, medical researchers are bound by objectivity requirements, and medical practitioners are bound by objectivity and fiduciary standards.

Now that we know what I am talking about, let’s proceed.

The professional “stink” that John Fauber uncovered

Fauber’s exposé begins:

Paul Anderson, an orthopedic surgeon at the University of Wisconsin-Madison, gets so much money from the medical device firm Medtronic that the university put its most stringent oversight on the relationship.

One of the requirements is that Anderson, who has received $225,000 in consulting fees from Medtronic in 2008 through 2010, has to meet annually with his department chairman to review the relationship and its potential influence on his university activities.

But the chairman, Thomas Zdeblick, got more than 25 times that amount from Medtronic himself during the three years. And a new accounting by the Journal Sentinel and MedPage Today shows he received more than $25 million in royalties from the company since 2003.

What's more, UW Hospital spent $27 million for Medtronic spinal products from 2004 to 2010, according to documents obtained through an open records request. And Zdeblick, a renowned spinal surgeon, has co-authored several positive research papers about the company's spine products.

Academic leaders questioned whether Zdeblick could objectively serve as a department chairman.

Fauber’s article goes into detail about money in academic medicine and the ethical implications it poses. For those interested, his is an excellent piece of work.

“But Pete, if Medtronic products work, who cares if the University is riddled with the corporation’s money?”

Medtronic products don’t always work properly. At least occasionally, they kill people. (See the next section of this essay.)

Even if Medtronics’ products always worked reasonably well, the corporation’s objectivity-defeating monetary influence could easily sway surgeon and Department of Orthopedics and Rehabilitation Chairman, Dr. Thomas A. Zdeblick — and his equally “bought” colleague — to work against market penetration by other corporations’ possibly better products.

This is not the behavior — or the appearance of behavior — that we should expect from people who are allegedly (a) working for medical patients’ best interests or (b) attempting to uphold the objectivity of the scientific method.

Not-so-hunky-dory facts about Medtronics’ recent history

I picked the following example because it was once well publicized, and readers may remember it.

Electrical leads on different models of Medtronics’ implantable cardiac defibrillators very probably killed at least 13 people in the recent past. Alarming written reports (from apparently credible sources) about the company’s implantable defibrillators circulated during my tenure as an assistant attorney general.

These writings alleged that the company had known about the allegedly fracture-prone nature of the company’s “Sprint Fidelis” electrical leads for some time before it finally made physicians aware of the potential for death in their more vulnerable patients.

According to the Food and Drug Administration, Medtronics removed the problematic leads from the market in October 2007. WebMD posted an explanation about the recall, here.

The harm allegedly done went beyond “just” 13 deaths

The law firm, Parker Waichman Alonso LLP, synopsized the medico-legal situation as of the time of recall:

Medtronic decided to suspend sales of the Sprint Fidelis lead after a company review of 30 months of data showed that the defibrillator lead had a continuing fracture problem.

According to the company’s own estimate, approximately 2.3%, or 4,000 to 5,000 people with a Sprint Fidelis lead will experience fracture within 30 months of having a Medtronic defibrillator implanted. Those patients whose Sprint Fidelis lead fractures will require a dangerous surgical procedure to have the wire replaced.

For the unlucky patients who experience a fracture of a Sprint Fidelis lead, three things can happen.

If they are fortunate, the implantable defibrillator will beep, alerting the patient to seek immediate medical attention.

Or, the fracture can create a massive electrical shock that causes the patient extreme and sudden chest pain.

But most disturbingly, the fracture of a Sprint Fidelis lead can deplete the Medtronic defibrillator’s battery. If this happens, the Medtronic defibrillator can fail to deliver a necessary, life-saving shock to the heart.

Can one infer blame or responsibility in this matter?

In October 2010, Medtronics agreed to a $268 million litigation settlement.

A settlement of this size is not trivial. The fact that the corporation tumbled to it is an indicator that holding itself out as “Clean Hands Molly” in these circumstances was impossible.

An aside about the secrecy problem with the majority of legal settlements — confidentiality leaves non-involved patients and public “in the dark”

This section is divided into two parts:

(i) why litigation is necessary

and

(ii) why confidential corporate legal settlements generally leave the public ignorant about who harmed whom.

Part One — Litigation is often necessary

Not all lawsuits are frivolous. Litigation is frequently the only avenue to compensating people for physical and emotional damage that was negligently, recklessly, or even purposefully done them. Many people have difficulty seeing the validity of this proposition, until they fall victim to blame-worthy or legitimately compensable misfortune.

My experience as an assistant attorney general and multi-state litigator made me especially aware that a good deal of atrocious business behavior takes place outside the public’s knowledge.

Note

Government and corporate litigators are privy to a good deal of investigative evidence that the public and “academics” almost never see.

Like police, “big money at stake” attorneys get to see how people and society really are. Neither profession leaves room for illusion.

In my case, antitrust and consumer/patient protection litigation regularly brought ethically offensive corporate behavior to light. Along the lines of, “we knew we were killing people, but we didn’t care, and we certainly didn’t try to warn anyone.”

These not uncommon industry practices put honorable doctors in the bad position of ignorantly treating patients with medical devices and pharmaceuticals that did not work. In a significant number of instances, medical devices and drugs actually made patients’ medical conditions worse. Or killed them.

Part Two — Corporate litigation settlements almost always leave the public ignorant

Civil litigation settlements involving sizeable corporations almost always work to keep everybody outside the agreement ignorant about the evils being covered up with the exchange of money.

For example, Parker Waichman Alonso LLP explained what happened in the Medtronics Sprint Fidelis settlement. This pattern characterizes the overwhelming majority of corporate legal settlements:

As per the new settlement, Medtronic will not be admitting any liability, nor will plaintiffs’ attorneys be admitting that the device maker has a valid defense.

After settlements are reached, fact-filled papers that had been filed in the cases effectively disappear from public view. Participants on both sides of the issue are contractually blocked from speaking about the elements of the conflict or the avenues to its solution.

On the positive side, settlement confidentiality certainly works to get compensation for damaged people. It cuts short the all-out (and very expensive) legal warfare that failing to settle requires.

Most plaintiffs and their lawyers don’t have the money to engage wealthy corporations for any length of time. Therefore, they agree to conceal corporations’ alleged wrong-doing in exchange for being monetarily compensated for the harm the business ostensibly did them.

On the negative side, there is a societal price that offsets confidentiality’s benefits. Contractually enforced secrecy means that no one can assess actual culpability on either side of the dispute.

In the Medtronics instance, the corporation got to walk away from its accused misbehavior. And no one, outside the legal case itself, can now easily find out whether the corporation knowingly made or concealed defective products.

Nor will the public discover whether Medtronics was blameless. Perhaps its electrical leads’ failures were simply a statistically unavoidable “ripple of death” that society has to bear as the price of medical progress.

Not having answers to “who did what to whom” poses a significant obstacle in a world that generally benefits from transparency.

Not so incidentally, we tend to know more about the effectiveness and safety of our cars, than we do about the medical devices and drugs we use. Doesn’t that seem backwards?

Returning to the University of Wisconsin example — why even the appearance of corruption is important

Would you accept, as objective, medical advice from a doctor, who had received $25 million from the corporation that manufactures the products he is advising you to use?

Would you trust the science-based reasonableness of a university hospital that had used $27 million of that one company’s spinal devices — in preference to competitors’ offerings — in its operating rooms over a period of only six years?

Would you admire the ethics of a university that pretends to monitor conflicts of interest by having lesser examples of greed report to significantly greater embodiments of the same thing?

The moral? — To the degree that medical schools and university hospitals allow the Medical-Industrial Complex to buy them, they dishonor Medicine’s foundational ethos

Given the objectivity required in science and the patient-centered ethics required in medicine, there is no reasonable argument to be made for allowing obvious conflicts of interest in the academic versions of either profession.

John Fauber’s exposure of blatant conflicts of interest at the University of Wisconsin exemplifies the miserable state that some teaching institutions’ medical ethics have fallen to.

Simple disclosure of financial interests is not a solution. Millions of dollars will slant virtually anyone’s perspective — especially those belonging to people who went after the millions in the first place.

Greed is an increasingly relevant sin in this not-so-brave new world.

PeteFree.com

Milwaukee Journal Sentinel Reporter, John Fauber, Uncovered the Appearance of Blatant Corruption at the University of Wisconsin’s School of Medicine and Public Health — another Instance of the Medical-Industrial Complex’s Distortion of Objectively Delivered Medicine