HEALTH CARE/Joan Retsinas

Medical Skullduggery in Medtronic Clinics

This tale pits Hippocrates against Mammon. The garden variety financial skullduggery is perpetrated by con-artists. Think Ivan Boesky or Bernie Madoff: their legerdemain propelled them into billionairehood –and, ultimately, to jail. Think too of the suits behind Enron, AIG and similar debacles. The scheme is generally illegal; the victims are duped not just by the promoters’ glibness, but by their own eagerness to capture the chimera of great wealth with no risk. The tales of deception roll forth with a depressing sameness.

Those perps, though, never pretended to virtues beyond financial savvy. So when an auditor or a detective exposes the scheme, the victims feel taken, but not truly betrayed. And the suffering is financial, not physical.

The tale of Medtronic features betrayal, as well as physical suffering.

Medtronic is a corporation that hoped it had found in Infuse Bone Graft (rhBMP-2 recombinant bone morphogenetic protein-2) a major breakthrough in spine surgery – one that would alleviate suffering, but also enrich the corporation’s shareholders, investors, and management. A corporation makes money; that is its raison d’etre. If it can marry virtue and profit, wonderful. But the prime directive of Medtronics is clear: make money. At this point in the story, all is well. The treatment was promising enough for surgeons to test it in clinical trials.

In clinical trials, manufacturers must prove the efficacy of the treatment: it does what it claims. Just as crucially, researchers test for side effects, short and long-term. Researchers have developed treatments that are worse than the targeted diseases; the trials seek to weed out those harmful cures.

The data from 13 clinical trials, from 2000 to 2010, pointed to risks, including cancer, sterility, bone dissolution and heightened pain. The physicians who conducted the trials were bound by their Hippocratic oath to alleviate suffering. The public – comprising present and future patients, along with their families – relied on physicians’ impartial assessment of Infuse. Bluntly, we trust the people in white suits far more than the ones in 3-piece ones.

At this point the story of Medtronic should have ended with the publication of articles in peer-reviewed journals that highlighted the risks. Medtronic would have gone back to its drawing board, to correct problems in this not-so-major breakthrough.

But Mammon entered the plot. The surgeons writing up the trials did not mention the risks. They cited “no adverse events.” They also did not mention their financial ties to Medtronic, even though journals routinely ask authors to disclose ties. The Wall Street Journal (June 29) calculated those ties for “unrelated work” to 15 surgeons at $62 million.

So peer-reviewed publications spread the good news about Infuse. Medtronic thrived. Two thousand surgeons administered Infuse to an estimated half-million patients. Medtronic made almost a billion dollars last year.

But, predictably, some of the patients developed side effects.

This tale, though, ends with a few heroes. They deserve mention.

The Wall Street Journal dug into data bases to report the money link. The Spine Journal devoted its June issue to Infuse; articles discussed the discrepancy between earlier published reports and the actual data. The editors conceded: “…identification of problems during the early industry trials may have averted … complications before significant morbidity and mortality were eventually seen with widespread use.” In the world of medicine, physicians rarely criticize each other so blatantly. Finally, the Senate Finance Committee is investigating Medtronic, as is the Department of Justice.

The corporate faces behind Medtronic are familiar perps. After all, corporations bow to Mammon. It is not surprising that Medtronic schemed to market its would-be-blockbuster in the best light.

But physicians were supposed to stand between us and corporate greed. We trusted physicians. Their motto is primum non nocere (first, do no harm). That is the betrayal of Medtronic.

Joan Retsinas is a sociologist who writes about health care in Providence, R.I. Email retsinas@verizon.net.

From The Progressive Populist, August 15, 2011