2014 Dubious Innovations In Cardiology

Dubious Innovative Device: Renal Denervation

SYMPLICITY HTN-3wasthe trial that finallyendedthe massive hype over renal denervation, the novel blood-pressure lowering technology.The trial followed in the wake ofthe publication and appearance of hundreds of articles and CME programs virtually guaranteeing that renal denervation would bea 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, wasno better than sham treatment.

Medtronic, the trials sponsor, and the trial principal investigators, Deepak Bhatt and David Kandzari, deserve credit for supporting the trial andfaithfully reporting the results. Credit is also dueDarrel Francis and his colleagues for having the courage to publicly predictthat the trial would fail to show a large benefit for the device. At the time theywere 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 simplyno excuse for its still being available for clinical use in Europeoutside of a researchsetting.

Another lesson from the trial: truly rigorous trials of devices may require the use ofsham proceduresin the control arm.Conservative ideologues like Scott Gottliebshould 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 befar more interested in the health ofindustrythan in the health of patients.

Dubious Innovative Business Strategy:Health Diagnostics Laboratory

Since its founding in 2008HDL Laboratory enjoyed explosive growth, fueled largely by a spectacular increase in the use ofnovel tests for cardiovascular risk. But it turns out that physicians werent ordering these tests only because they thoughtthe testsmight benefit their patients. It turns out that thesephysicians were benefiting themselves. News came out this year thatthe US government was investigating the company for giving kickbacks to these physicians for ordering the tests.

In response tomy initialstory about the government investigation, new allegations emerged suggestinga broader pattern of serious misconductbased on questionable sales, marketing, and billing practices involvingunnecessary 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 highas $100 per patient.Then, to prevent patients and insurers from looking too closely at these practices, the company hada policy of rarely if ever requesting co-payments from patients. There are widespread rumors that the company is now onthe verge of collapse. Just this fallthe CEO resignedand the large insurance companyCigna sued HDLfora 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 filecriminal chargesagainst the company and its leaders.

Dubious Innovations In Leadership (Tie): The European Society of Cardiology and The Institute of Medicine

The European Society of Cardiologyannounced earlier this yearthat it had electedJeroen Bax, a Dutch cardiologist, as itsPresident Elect. Baxisknown for his very closecollaboration withDon 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.

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2014 Dubious Innovations In Cardiology