Prison: Accountability Comes to the Medical Industry

One is occasionally encouraged to read of the healthcare industry making sincere efforts to produce more cost-effective and more efficient treatments for patients. However those initiatives are generally overwhelmed by accounts of physicians, drug companies, and medical device companies willing to break any moral or legal rule in order to maximize profit. This has been one of the dark days.

The Milwaukee Journal-Sentinel reports on the activities of the device maker Medtronic who produces a biological agent named Infuse that is used in spinal fusion surgery.

"Doctors who received millions of dollars from device maker Medtronic repeatedly failed to reveal serious complication linked to the company's lucrative back surgery product in 13 papers they co-authored for medical journals over the course of nearly a decade, according to a scathing new review."

"The review, published....in the Spine Journal, found complication rates that were 10 to 50 times greater than the estimated complication rates revealed in the papers co-authored by the doctors, who had financial ties to the company."

"The analysis is part of an unprecedented event in medicine: The entire issue of a medical journal devoted to a scientific and financial exposé of a product, the practices of the company that markets it and the financially conflicted doctors who tested and promoted it."

And what are the potential complications that the Medtronic-paid physicians neglected to mention or downplayed?

"It also found the studies co-authored by the Medtronic-associated doctors indicated there were no complications related to Infuse when they knew the product was linked to several serious side effects."

"Among those problems: Uncontrolled bone formation and the need for additional surgery; life-threatening inflammation; infections; implant movement; cancer risk; and effects on nerves leading to radiating leg pain, bladder retention and a complication that causes sterility in men."

The financial gain for many of the doctors living on the Medtronic tab amounted to millions of dollars.

How does one punish the guilty at Medtronic? How does one even identify the guilty?

A Reuters article came out today describing yet another case in which a drug company was fined for criminal behavior in marketing a medication for unapproved uses.

"Merck & Co will pay roughly $950 million to settle criminal and civil charges that it promoted the painkiller Vioxx for an unapproved use, the U.S. Justice Department said on Tuesday."

"The fine will conclude a long-running investigation into Merck's promotion of its one-time blockbuster drug, which was withdrawn from the market in September 2004 after being linked to heart risks."

"The Justice Department alleged that Merck promoted the drug for treating rheumatoid arthritis before it had been approved for that condition by the U.S. Food and Drug Administration."

There have been so many similar cases that paying fines has come to be considered a cost of doing business by the pharmaceutical business. If one sells $10B of a drug and pays a $1B fine, a healthy profit is made—particularly when the cost of the fine can be passed on to consumers.

Government agencies have grown frustrated with this process. Prosecution has been deemed not appropriate. Perhaps the relevant laws are too vague, or perhaps the possibility of convicting any one responsible individual is too small. The Office of Inspector General is contemplating the approach of holding the CEO of the company responsible. After Forest Laboratories pled guilty and was fined for improper marketing and for withholding data on side effects for the drug Celexa, the OIG let it be known that it was considering applying "exclusion" to the CEO. Exclusion is a way of prohibiting the excluded person from participating in government programs. If the CEO is excluded, then the company is also excluded. This is a way of assigning accountability to the leaders of the criminal corporations. This approach is not as efficacious as a prison sentence, but at least it is a step in the right direction.

A third case has appeared in the news. This one has behavior so egregious that people are actually going to go to prison. An Associated Press article provides the relevant information.

"The Synthes North America officials wanted to beat their competitors to market without going through the lengthy process of getting their products approved by the U.S. Food and Drug Administration, the judge found. So they plotted to train select surgeons in the off-label use of their bone cement and then have the doctors publish their findings, U.S. District Judge Legrome D. Davis said."

"The program continued even after a patient died in surgery in Texas in 2003 and another in California. The patients suffered a sharp drop in blood pressure after the bone-cement compound was injected into their spines. Synthes only halted the training after a third death in 2004."

"The pursuit of profits blinded medical company officials to the "the sanctity of human life," a federal judge said Monday in sentencing them [Synthes executives] to nine months in prison for unapproved testing of a bone-cement product that left three people dead."

There was little doubt that the actions of the then executives involved inappropriate and unacceptable risks.

"The bone cement, Norian XR, had been approved for surgical use in the arm, but not in the weight-bearing spine."

"Pilot studies had shown it could cause blood clots in humans, and pig research suggested the clots could move to the lungs, causing death within 30 seconds, government experts said. Synthes used the cement in about 200 spine patients."

The government was able to show that the company executives had direct responsibility for this effort.

"They became the rare corporate officials sent to prison after pleading guilty to a misdemeanor as ‘responsible corporate officers’ under the so-called Park Doctrine. The statute typically involves corporate leaders taking the fall for things that happened under their watch. In this case, Davis said they planned and executed the scheme, and sentenced them above the zero- to six-month guidelines."

These prison sentences form a wonderful precedent that will hopefully inhibit this sort of behavior in the future. It would have been even more effective if the precedent had involved merely criminal negligence on the part of the executives in overseeing company activities. That would have put the fear of God in many an executive.