MASSDEVICE ON CALL — Two former Novartis AG (NYSE:NVS) employees were involved in a massive data fabrication scandal surrounding the Kyoto Heart Study, a post-market trial examining the company’s Valsartan drug in more than 3,0000 patients.
The scandal broke when prominent Japanese cardiologist Dr. Hiroaki Matsubara was accused of fabricating study results, prompting medical journals Circulation, Circulation Research, and Hypertension to retract 5 studies connected to the doctor’s Kyoto Heart Study research, according to TheHeart.org.
Novartis has since announced that it wrapped up a 3rd-party investigation of its employees’ involvement, confirming their role in the analysis of the heart study results. The accused doctors are no longer employed at Novartis.
A company statement said the "former employees and their managers misunderstood the appropriate level of involvement," and confirmed conflict of interest issues.
Stealthy AMA panel artificially boosts price of surgery
A committee within the American Medical Assn. meets secretly every year to set the price of surgeries, a relatively unknown practice catching media scrutiny. The AMA sets prices based on exaggerated estimates of how long surgery takes, according to a Washington Post investigation. Although the committee’s estimates are merely guidelines for federally-set prices, the government almost always uses these figures, which artificially boost the cost of surgery, according to the report.
Insurance status is a risk factor after surgery
An analysis of spine surgeries found insurance status was a big risk factor in post-surgery health problems. Study investigators concluded that patients with Medicaid have more complications and other negative outcomes than patients with private insurance. In addition, patients without insurance had the worst outcome overall. The study was based on the Spine End Results Registry, a detailed database of 1591 spine surgeries and patient demographics.
Company uses tear duct scaffold rather than eye drops to treat glaucoma
Ivantis, a California-based device company, presented 1-year results for its tiny tear-duct insert, designed to open up the eye canal and allow natural rehydration without prescription eye drops. The 100-patient study evaluated the mechanical treatment for glaucoma without the confounding factor of topical medication. The Hydrus Microstent is a minuscule eye canal insert, and Ivantis calls it the world’s 1st
"intracanalicular scaffold" to treat primary open angle glaucoma.