More Star Tribune home cooking on medical device stories about Medtronic, St. Jude

If there is an editorial bias in a newspaper one can look for it in many ways. For example: what a paper chooses to write about, how it does so, and what a paper chooses not to write about.  Just 3 weeks ago I wrote, “Reporting on Medtronic mess – recipe for home cooking in Twin Cities?” – reflecting on why the Minneapolis Star Tribune doesn’t appear to be as aggressive on negative stories about hometown industry Medtronic as a smaller paper in another state.

Now two more episodes caught my eye:

• Last Wednesday (and subsequently) the Star Tribune apparently didn’t do any original reporting on a story the New York Times reported about local St. Jude Medical Inc. (device company), but, instead, the Strib just published the NYT story online. OK, we could look the other way.  Day before a holiday.  Limited staffing…well, we’ll let them make their own excuses.
• But then Friday, the Star Tribune reports, “Firms chase new blood pressure treatment.”  Front page story. It struck me as cheerleading – without sufficient context, caveats and evidence – for local Medtronic, local St. Jude, and Boston Scientific “which has 5,000 Minnesota employees.”

Now, because I live in Minneapolis-St. Paul and because I’ve commented on my perception of Star Tribune home cooking before, I asked an out-of-town expert, Harold DeMonaco, MS, who’s one of our most active story reviewers and guest bloggers, to take an independent look at the story. Here are his thoughts:

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I read the front page story in the Star Tribune with interest for a variety of reasons.  The story has many redeeming features.  It provides readers with the notion that the high blood pressure treatment approach known as renal artery denervation is still in development, has demonstrated promising early results and will provide a much needed market for a local device manufacturer.  It is what is not mentioned that is perhaps of greater importance.

Hypertension is a common disease effecting a significant percentage of adults in the US and elsewhere.  According to the most recent National Health and Nutrition Examination Survey,  about 29% of US adults are hypertensive and about three quarters of them are currently taking blood pressure drugs.  Despite the multitude of very effective drugs that have been demonstrated to both reduce blood pressure and reduce cardiovascular events, a number of patients fail to achieve what most would consider adequate blood pressure.  The latest estimate is about 50% of patients.

The reasons for treatment failures are complex and likely to be multifactorial including patient non-compliance, inadequate drug dosing and/or drug combinations, falsely elevated blood pressure (called white coat hypertension), undiagnosed renal artery stenosis and finally truly resistant disease.  This last group is presumably at risk for cardiovascular events including heart attack and stroke. While the pharmaceutical industry appears to run out of treatment options at the moment, the medical device industry has now stepped in with two new approaches; carotid sinus pacemakers and renal artery denervation.  The early trials with both approaches have been promising but the road to demonstrating value is going to be long and uphill.  Both approaches have similar limitations.  The story does not mention carotid sinus pacemakers directly (which require implanting a device).  It does however provide a bit of marketing for the local company’s claim for its approach – “One treatment, no implants.”

Up until the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack (ALLHAT)  trial, we assumed that lowering blood pressure by any mechanism would result in reduction in the risk of cardiovascular disease.  The ALLHAT hypertension study enrolled 42,000 subjects and followed patients for an average of about 5 years.  The results provided a very rude awakening to many. Despite what appeared to be adequate blood pressure control, the group that took the drug doxazosin had a 25% increase in cardiovascular events and twice the incidence of heart failure compared to those taking a diuretic drug.  Not all drugs that lowered blood pressure were equal.  Thus far the trials looking at renal artery denervation and carotid sinus pacing have only demonstrated blood pressure reductions.  It remains to be seen if lowering blood pressure by renal artery denervation will lower risk of cardiovascular events.  And isn’t that the point?

This is a classic case of surrogate endpoints – something we’ve often written about on this site.

The story quotes one of the device investigators indicating the “…procedure is safe…” without any clarification of what the procedure is and what the potential for untoward events is.  To be clear, to date a small number of very selected interventionalists have performed the procedure in a small number of subjects.  The catheter is inserted into the femoral artery in the groin and threaded into the renal artery and the renal nerves are destroyed by applying radiofrequency current.  The procedure is then repeated on the other side.  There is a potential for damage to the renal artery, formation of blood clots and damage to the kidney to name a few of the potential downsides to the procedure.  Most patients experience back pain after the procedure. So, indeed the procedure in a small number of patients treated thus far appears to be safe.

At the moment, the durability of the procedure is unclear.  Suggesting that the duration of  the effect is not an issue since the procedure can be redone is pure speculation on the part of the quoted physician since no studies have demonstrated this effect.  He may be right but there’s no data to support the statement.

As we have said repeatedly, we don’t think that you can tell a complete story about a new medical device, drug or procedure without commenting on the financial implications.  What will the cost of the device and the procedure be and is it going to be cost effective especially if its use extends beyond simply those who are truly resistant?

And finally, the story suggests that one reason that the market “hasn’t developed yet” for the catheter in Europe despite its regulatory approval  is, in part, due to a “…lack of awareness.”  The lack of demonstrated value is perhaps the issue.  At the moment, the safety of the device in the hands of the average interventionalist is unclear, the durability of blood pressure lowering is unclear and the impact of lowering of blood pressure by this method has not been demonstrated to reduce cardiovascular events.

This is indeed an interesting approach and if demonstrated to be safe, effective and durable will provide a needed option for the minority of patients whose blood pressure cannot be controlled with available drugs.  As I noted earlier however, the jury is still out.

Publisher’s addendum on November 28:

It appears that I’m just going to continue to be provided with new examples by the Star Tribune.  The front page of today’s Business section has a story, “Lifesaver doesn’t touch the heart,” about “the first Minnesotan to be implanted with Boston Scientific’s subcutaneous implantable cardioverter defibrillator.”  Count the glowing terms in the story:

• “Officials at Boston Scientific Corp. say the S-ICD will not only attract patients who have not been able to benefit from such technology in the past because of complications; they think it will attract doctors and patients who have been scared off by problems associated with leads.” (Our question:  is this an ad or a news story?)
• “Leads that run through the vascular system into the heart have come under increasing scrutiny in the past few years. Short circuits caused by faulty wires have been associated with several deaths. Inner wires working through the outer insulation of St. Jude Medical’s recalled Riata leads have raised fears that some ICDs will fail to deliver a shock to the heart when needed.” (Our question:  How about fears that the wireless approach will fail to shock?  Hard to answer after it’s just been implanted in the first Minnesotan, isn’t it?)
• “It does give Boston Scientific a unique product that no one else has.”  (Ad or journalism?)
• “It also could mean up to $1 billion in revenue for Boston Scientific, which employs 5,000 workers in Minnesota” (Ad or journalism?)
• “The device that Valek received Tuesday is the only one in the state. More will come as the company begins a phased launch that will expand as doctors are trained in its use.” (Unaddressed question:  What’s the learning curve for doctors with this approach?  Do you want to be the first patient?  The 50th?  The 500th?)
• “The S-ICD has been available in many countries in Europe as well as in New Zealand. More than 1,400 devices have been implanted in patients around the world.” (This gets at my earlier question about evidence for this device.  With all that track record, why didn’t the story include ANY evidence, ANY data about how it’s worked in 1,400+ people around the globe?)

Journalists must do a better job in reporting on new medical devices.  Data/evidence trumps company hopes/projections.

Another addendum – December 3:

See the Wall Street Journal story, “Heart Gadgets Test Privacy-Law Limits.”   All sorts of local angles for a local newspaper covering the local medical device companies.  But I read it in the WSJ.

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