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:


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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November 28, 2012 at 12:37 am

The Star Tribune’s very survival depends on sucking up to AdvaMed, St. Jude, Medtronic and Stryker to name a few. I would be wary of what they write, even if it comes across as ‘original reporting’.

Larry Husten

November 28, 2012 at 1:16 pm

I don’t dispute any of Gary’s points about the coverage of the subcutaneous ICD but it should be pointed out that this may be one case where calling something a “breakthrough” is deserved. It is still very early in the game, and there are still all sorts of problems that may occur, but the S-ICD does appear to represent a genuine advance in technology. I guess the ideal situation would be to report this as a possible breakthrough but also include all the caveats and warnings.

    Gary Schwitzer

    November 28, 2012 at 1:24 pm


    Thanks for your note. Anyone who follows your careful reporting on cardiovascular research should heed your advice. The pattern of story selection – in what is covered and in what is not covered – and in how things are worded when they are covered – is at the core of this analysis. You are correct: the ideal is not what was realized in this story or the series of stories we highlighted.

    There are ways to report on promising developments with balance, with evidence, with data, and with caveats and context.

    Gary Schwitzer

Erin Robertson

December 5, 2012 at 1:55 pm

I just want to point out that you seem to be critiquing publications like the Trib for not publishing data. Is that the point of your website? If so, I can see the reason for all the low ratings, but it seems a bit of a waste of time. Because no one considers the Star Tribune to be a scientific publication. The point of these articles is simply to highlight local companies and report what they’re working on. It’s not an outlet for scientific data, cost analysis, etc. I’m sure these companies publish data for peer review in the appropriate scientific journals.

    Gary Schwitzer

    December 5, 2012 at 3:29 pm


    I almost don’t know where to begin to respond. So we’ll address your comment line by line.

    1. “You seem to be critiquing publications like the Trib for not publishing data. Is that the point of your website?” That is only one point of our project. A quick look at the site shows that we apply 10 criteria to the review of stories. Some address data. Some address whether stories use independent sources, look for conflicts of interest, rely on news release, independently evaluate the quality of the evidence they’re reporting, etc.

    2. “It seems a bit of a waste of time.” You’re entitled to your opinion. Sorry you feel that way. Thousands of other regular visitors to our site don’t share your opinion. Neither do the folks who honored us with a Knight-Batten Award for Innovations in Journalism or a Mirror Award for holding up a mirror to the news industry. Or the people at NIH, NCI, US Agency for Healthcare Research & Quality, Institute of Medicine, FDA, etc.…or those at MIT, Dartmouth, UNC-Chapel Hill, University of Washington, etc. …who have invited us to present our work to them.

    3. “The point of these articles is simply to highlight local companies and report what they’re working on.” You’re kidding, right? The code of ethics of the Society of Professional Journalists states that journalists should: “Test the accuracy of information from all sources and exercise care to avoid inadvertent error.” There was little to no such testing of accuracy in the stories we wrote about. The Association of Health Care Journalists Statement of Principles states that journalists should:

    • Be vigilant in selecting sources, asking about, weighing and disclosing relevant financial, advocacy, personal or other interests of those we interview as a routine part of story research and interviews.
    • Investigate and report possible links between sources of information (studies or experts) and those (such as the manufacturers) who promote a new idea or therapy. Investigate and report the possible links between researchers and private companies, researchers and public institutions, patient advocacy groups and their sponsors, celebrity spokespersons and their sponsors, non-profit health and professional organizations and their sponsors.
    • Recognize that most stories involve a degree of nuance and complexity that no single source could provide. Journalists have a responsibility to present diverse viewpoints in context. In addition, anyone with knowledge of the health care industry, of medicine, and of the scientific community knows that many vested interests reside among government health spokespersons, researchers, universities, drug companies, device manufacturers, providers, insurers and so on. To reflect only one perspective of only one source is not wise. Most one-source stories lack depth and meaning. Avoid single-source stories.
    • Quantify the magnitude of the benefit or the risk in the story. Explain absolute risk or benefit, along with relative risk or benefit whenever possible. A 50 percent increase in relative risk may not mean much if the absolute numbers are small. Consider explaining the “number needed to treat” – the number of people you would have to treat with the experimental intervention (compared with the control) to prevent one event. (See information from the Cochrane Collaboration.)
    • Report the complete risks and benefits of any treatment, along with the possible outcomes of alternative approaches, including the choices of “watchful waiting.”
    • Clearly define and communicate areas of doubt and uncertainty. Explain what doctors don’t know as well as what they do know.
    • Seek out independent experts to scrutinize claims and evaluate the quality of evidence presented by sources. Apply the same scrutiny and skepticism that would be applied in any other news story. Avoid uncritical acceptance of official or expert pronouncements. Be skeptical about all emphatic claims, particularly about claims that an intervention has few or no adverse side effects.
    • Strive to include information about cost and insurance coverage in any reporting of new ideas in medicine.

    Each of these tenets of the AHCJ Statement of Principles was violated in one or more of the stories we wrote about.

    We hope you learn from this review of just two professional codes/statements that address the kinds of problems we found in recent Star Tribune medical device industry stories. It’s not just we who feel this way. And we don’t think it’s a waste of time to try to improve health care journalism and to improve the quality and flow of information to American health care consumers, who are so often misled by news and other media messages.

    Gary Schwitzer