Dubious Innovative Device: Renal Denervation
SYMPLICITY HTN-3 was the trial that finally ended the massive hype over renal denervation, the novel blood-pressure lowering technology. The trial followed in the wake of the publication and appearance of hundreds of articles and CME programs virtually guaranteeing that renal denervation would be a cure for treatment-resistant hypertension. Instead the trial showed, definitively and absolutely, that renal denervation, in its current form, and as it had been used in earlier less rigorous trials and in clinical practice in Europe, was no better than sham treatment.
Medtronic, the trial's sponsor, and the trial principal investigators, Deepak Bhatt and David Kandzari, deserve credit for supporting the trial and faithfully reporting the results. Credit is also due Darrel Francis and his colleagues for having the courage to publicly predict that the trial would fail to show a large benefit for the device. At the time they were a voice in the wilderness and have still not received nearly enough credit for their analysis of why the trial would likely fail. Prophets, alas, often go unheeded.
Perhaps, after a lot more basic research and development, renal denervation will prove to be a useful tool. But for now there is simply no excuse for its still being available for clinical use in Europe outside of a research setting.
Another lesson from the trial: truly rigorous trials of devices may require the use of sham procedures in the control arm. Conservative ideologues like Scott Gottlieb should be smart enough to know that this was absolutely the worst example to use in decrying the use of sham procedures in clinical trials. But Gottlieb appears to be far more interested in the health of industry than in the health of patients.
Dubious Innovative Business Strategy: Health Diagnostics Laboratory
Since its founding in 2008 HDL Laboratory enjoyed explosive growth, fueled largely by a spectacular increase in the use of novel tests for cardiovascular risk. But it turns out that physicians weren't ordering these tests only because they thought the tests might benefit their patients. It turns out that these physicians were benefiting themselves. News came out this year that the US government was investigating the company for giving kickbacks to these physicians for ordering the tests.
In response to my initial story about the government investigation, new allegations emerged suggesting a broader pattern of serious misconduct based on questionable sales, marketing, and billing practices involving unnecessary testing. We learned that salesmen representing the company, by combining multiple tests from multiple companies, delivered kickbacks to physicians, in the form of processing and handling fees, as high as $100 per patient. Then, to prevent patients and insurers from looking too closely at these practices, the company had a policy of rarely if ever requesting co-payments from patients.
There are widespread rumors that the company is now on the verge of collapse. Just this fall the CEO resigned and the large insurance company Cigna sued HDL for “a business model designed to game the healthcare system by submitting grossly inflated, phantom ‘charges’ to Cigna that do not reflect the actual amount HDL bills patients.” Many also expect the company to try to negotiate a settlement with the US, though it is unclear how much money the company has available for settlement, given the collapse in its business over the past year and past profits taken by the company owners and leaders. Close observers also wonder if the US government might break tradition and file criminal charges against the company and its leaders.
Dubious Innovations In Leadership (Tie): The European Society of Cardiology and The Institute of Medicine
The European Society of Cardiology announced earlier this year that it had elected Jeroen Bax, a Dutch cardiologist, as its President Elect. Bax is known for his very close collaboration with Don Poldermans, the disgraced Dutch researcher who has been accused of significant and multiple examples of scientific misconduct. Bax and Poldermans were coauthors on hundreds of papers. When Bax became a full professor he expressed gratitude to Poldermans in his inaugural lecture. He even stated at the time that “although I was frequently asked to reduce cooperation [with Poldermans], I have never done so.”
Bax may well be completely innocent of any scientific or ethical misconduct. His home institution, the Leiden University Medical Center, conducted an investigation and did not find him guilty of any wrongdoing. But neither Bax nor the ESC has made any effort to publicly address the issue of Bax's close association with Poldermans. At the very least this creates the impression that the ESC is insensitive to concerns about scientific misconduct. At worst it leads us to believe that the fox is now thoroughly in control of the henhouse.
The Institute of Medicine announced that it had chosen cardiologist Victor Dzau, the chancellor for health affairs at Duke University and the CEO of the Duke University Health System, as its new president. Just one problem: while he was at Duke Dzau also served on the Board of Directors of Pepsico. Following the announcement Dzau resigned from the Pepsi board. But many people believe that board membership on a soda company should be a disqualification for the presidency of the IOM. I'm surprised there wasn't at least more discussion about the issue.
Dubious Innovative Breakthrough Therapy That Never Actually Breaks Through Anything (repeat winner): Cardiac Stem Cell Therapy
See also: Cardiology Drugs Of The Year: New, Old, And Not-So-Funny
