The story allows both the enthusiasm and the reservations to be perfectly clear to the reader. Nice job.
The story estimates that more than 7 million Americans have hypertension that is resistant to drug therapy. That resistance may be the result of inadequate drug dosing, incorrect drug combination, poor compliance and adherence or underlying physiology. A new approach for patients with truly resistant hypertension is clearly needed. Renal denervation is not new or novel as the story notes. A new device that reduces the risks of the original procedure may bring the approach to many more patients if it truly works, is durable and is not associated with kidney damage. While preliminary studies appear to be promising, the true test of multiyear durability has yet to be demonstrated.
The story noted, “In Europe, Medtronic’s hypertension procedure costs about $14,000, sticker shock compared with the generic prices of standard hypertension medications and another reason for careful study to prove its effects.”
The story explained, “In small Medtronic studies, those treated saw the key top number of a blood pressure reading drop an average of 33 points, although they still needed their medications. Medtronic reported in March that the improvements were lasting up to three years.”
The story reported, “Although pilot studies show few side effects, potential risks include bleeding, an injured blood vessel, immediate blood pressure or heartbeat problems, or complications from medications used in the procedure. ”
Also: “But “what we don’t know is the long-term effect” of nerve zapping, Tomaselli cautioned. “It’s going to take a little bit of time to make sure there are not adverse effects two years, three years, 10 years down the line.”
One thing the story didn’t discuss: A major concern with this type of procedure is damage to kidney function. The clinical trials to date, have excluded people with already damaged kidneys for their high blood pressure or diabetes. There is evidence from early trials that kidney function is reduced in patients who have undergone the procedure so it remains to be seen if the approach is safe in people with preexisting kidney dysfunction.
The story explained that small studies have been done so far, and that “The U.S. Food and Drug Administration required a more rigorous study, now enrolling more than 500 people, that includes an unusual step to prove if it really works. Some patients receive the real procedure and some get a fake — just the catheter, no zapping. Patel describes patients wearing a blindfold and earphones while lying sedated on the treatment table, to ensure they don’t know which they’re getting.”
No disease mongering of hard-to-treat hypertension.
The story didn’t mention that Dr. Oparil is a paid consultant for Medtronic. But since a number of independent sources were quoted, we’ll give this a satisfactory score.
There was no mention of ongoing efforts to use deep brain stimulation to reduce blood pressure in this same patient population.
The story explained the investigational nature of the approach and “more than 60 medical centers around the country studying Medtronic Inc.’s nerve-zapping procedure. “
The story explained that “More than five dozen companies are pursuing devices for hypertension, from catheters similar to Medtronic’s to permanent implants left in arteries to regulate blood pressure. “
It’s clear the story did not rely on a news release.