Health News Review

Minnesota is the home of several medical device makers.  So there’s been a lot of editorializing about the medical device tax in the Affordable Care Act. There has been some criticism of Minnesota politicians over whose interests they represent on the issue.

Today’s Star Tribune carries a commentary from an industry spokesman – Dale Wahlstrom, president and CEO of LifeScience Alley. He retired from Medtronic in 2006 after 24 years.  His commentary includes this claim:

“Medical devices save and improve lives. Between 1980 and 2000, medical device technology slashed the death rate from heart disease by a stunning 50 percent and cut the death rate from stroke by 30 percent. As a result, life expectancy was extended by more than three years.”

Please note: I’ve written to a contact at LifeScience Alley asking for the source of that data.  In fairness, he hasn’t had much time to respond but I don’t expect an answer on the data source because I don’t think there is one. I’ll be happy to post an amendment/addendum if/when an answer is forthcoming. That editorial has been published for hours already and I think it’s important to publish even this quick analysis as quickly as I can.

This quote attributes ALL cardiovascular health improvements to devices rather than siphoning off the mere fraction that might be attributable to devices versus drug therapies versus lifestyle changes.

One analysis published in the New England Journal of Medicine concluded:

Approximately 47% of this decrease (in coronary disease death rate) was attributed to treatments, including secondary preventive therapies after myocardial infarction or revascularization (11%), initial treatments for acute myocardial infarction or unstable angina (10%), treatments for heart failure (9%), revascularization for chronic angina (5%), and other therapies (12%). Approximately 44% was attributed to changes in risk factors, including reductions in total cholesterol (24%), systolic blood pressure (20%), smoking prevalence (12%), and physical inactivity (5%), although these reductions were partially offset by increases in the body-mass index and the prevalence of diabetes, which accounted for an increased number of deaths (8% and 10%, respectively).

So a little less than half is attributable to changes in risk factors.  A little more than half to ALL treatments – including drugs, surgery, etc.

The largest reductions in deaths came from the use of secondary-prevention medications or rehabilitation after acute myocardial infarction or after revascularization (a total reduction of approximately 35,800 deaths) and from the use of initial treatments for acute myocardial infarction or unstable angina (approximately 35,145 deaths), followed by treatments for heart failure and hypertension, statin therapy for primary prevention, and treatments for chronic angina.

The editorial is more than a matter of playing loose with the numbers; it is a vast overstatement and a distortion of the evidence. There’s no question that medical devices have contributed to the decline.  It is disingenuous to attribute ALL of the benefit to devices.

I’m not going to comment on the medical device tax.  For now, I’ll leave that to the politicians and special interests.

But on this site, we address and try to correct any misleading claims about medical interventions whenever we see them – whatever the source.  And this editorial made a whopper!

I only hope that such whopping misleading claims aren’t misleading politicians into positions they wouldn’t take if they evaluated the claims.

Comments

Harold DeMonaco posted on June 15, 2012 at 2:24 pm

Suggesting a component of the health care delivery system is singularly responsible for a reduction in cardiovascular related deaths is simply nonsense. This totally ignores the role of smoking rate reduction, primary and secondary preventive drugs, antiarrhythmic drugs and other modalities. Indeed, medical devices have made a substantial impact on both longevity and the quality of life of people with cardiovascular disease. The discussion around the proposed tax on medical devices should be based on facts and not on exaggerated claims of effectiveness

Gary Schwitzer posted on June 19, 2012 at 9:23 am

Susan Perry of MinnPost.com has written her own piece on this issue. Excerpt:

“To get more clarification, I called one of the authors of (the 2007 NEJM analysis cited above), Minnesota cardiologist and researcher Dr. Thomas Kottke, and asked him about Wahlstrom’s claim about the impact of medical devices on lowering the heart-disease death rate.

Was there any truth to it?

He laughed. “There has been a big decline in heart disease mortality,” he acknowledged, but it had “hardly anything to do with medical devices.”

The reduction in deaths “was mostly because of risk-factor changes,” he said, as well as “improved care and drugs.”

“He’s overstating the case for devices,” Kottke added.”

http://www.minnpost.com/second-opinion/2012/06/medical-device-spokesmans-claim-heart-disease-termed-overstated-outlandish

Paul Stein posted on June 19, 2012 at 6:38 pm

Gary Schwitzer is quite incorrect in his editorial title and conclusions, and he REALLY should have contacted Dale Wahlstrom before he wrote this piece. I know how Mr. Wahlstrom came up with the statistics, as would anyone in the cardiovascular medical device industry. What is said is true if he is talking about what happens to a specific population of people with heart disease AFTER they get their medical device. Of course, Mr. Wahlstrom was then only talking about what happens to people after they got their stents, implantable cardioverter-defibrillators (ICDs), cardiac resynchronization devices, heart valves, etc. Then, the statistics he cites are not outlandish at all, and many long-term device studies, particularly those for ICD’s, have actually cited just such data in comparison to “medical treatment” such as what occurs in a separate study population getting pharmaceuticals. Also, because these people have been caught in time so as to get advanced treatment, they also go to their doctors more often to keep track of themselves, and that also extends their lives. Mr. Schwitzer just didn’t figure this out, but I’m sure the editor of the Star Tribune must have prior to printing their article. Both Forbes:
http://www.forbes.com/sites/larryhusten/2012/06/15/guest-post-industry-editorial-makes-outlandish-claim-about-impact-of-medical-devices/
and another blog:
http://worldofdtcmarketing.com/ooops-medical-device-industry-makes-unsubstantiated-claim/bad-practices/comment-page-1/#comment-5336
unfortunately, have already picked up on Mr. Schwitzer’s hair-trigger, so, he needs to make an apology and a retraction fast.

    Gary Schwitzer posted on June 19, 2012 at 8:01 pm

    Paul,

    I did contact LifeScience Alley prior to posting this piece. My contact there could not cite a source for Wahlstrom’s claims. It’s now 4 days later and no one there has come forward with source documentation. You, also, did not cite a source.

    Meantime, I have contacted several experts familiar with the cardiovascular disease literature who have said there is no basis for Wahlstrom’s claims.

    What you claim he was referring to is not what he stated in the article. The words are there for anyone to judge. I didn’t write them. He – or some ghostwriter – did.

    So I have nothing to apologize for and nothing to retract.

Paul Stein posted on June 21, 2012 at 6:11 pm

It took me about one minute to find this 2008 review article on Google (keywords: ICD life extension) which indicates an older meta-analysis life extension of 1 to 3 years for ICD’s:

http://content.onlinejacc.org/cgi/content/full/52/14/1111

I could find a whole lot more to back up Mr. Wahlstrom’s claims, with a bunch of different keyword combinations, but I figured that’s your job to verify what an article says. As Mr. Wahlstrom came from Medtronic, a place that makes a whole lot of different medical devices for heart disease, you should have at least called up their press people for verification of the facts rather than depending on some busy LifeScience Alley admin. I’m sure that company’s people would have provided you with much better and more recent citations than I did. I do understand that you spoke to experts in cardiovascular disease, but you did not frame your questions using the exact wording that Dale Wahlstrom placed in the article. If you did that, in light of my explanation, i.e. effects on heart disease patients of medical devices AFTER they get them implanted, you would have gotten completely different answers, especially if you spoke with cardiologists who know the medical device literature. I’m sorry, but I still see a whole lot of egg on your face, so, go back to everyone, and ask this question, paraphrased from Mr. Wahlstrom’s wording, “For those heart disease patients who get a medical device, does their later, afterwards death rate from heart disease decrease by 50 percent and does their death rate from stroke decrease by 30 percent, and as a result, does their life expectancy extend by more than three years?”

    Gary Schwitzer posted on June 21, 2012 at 9:17 pm

    Paul,

    It took me only a few minutes to see that the article you cite does not support the statement that Wahlstrom made in his opinion piece, which was:

    “Between 1980 and 2000, medical device technology slashed the death rate from heart disease by a stunning 50 percent and cut the death rate from stroke by 30 percent. As a result, life expectancy was extended by more than three years.”

    The article you cite – “A Critical Appraisal of Implantable Cardioverter-Defibrillator Therapy for the Prevention of Sudden Cardiac Death” – does nothing to support the claim that this technology – or any device – “slashed the death rate from heart disease by a stunning 50 percent and cut the death rate from stroke by 30 percent.” That statement – and that statement alone – is what I wrote about. In fact, the article you cite actually raises questions about whether modest benefits (those are the words of the authors you cite – not my words!) from this type of device outweigh “potential adverse effects on morbidity, quality of life and the mode of death.” The article you cite raises questions about overestimation of clinical benefits from this device therapy, underestimation of risks and overestimation of cost-effectiveness.

    In other words, it’s a curious citation for you to make as the only source of data to support the claim in question. It comes nowhere close to doing that.

    You questioned why I turned to a LifeScience Alley staffer for documentation of Wahlstrom’s sources. Wahlstrom is identified in the Star Tribune opinion piece as “president and CEO of LifeScience Alley.” Why would I turn to anyone else BESIDES LifeScience Alley for a response?

    Finally, you are absolutely wrong when you say that I did not pose the question to cardiovascular disease experts using Wahlstrom’s own wording. That is precisely what I did. They read the article. They saw the words and judged the context for themselves – as any reasonable person would do. The thing about publishing an editorial like this in a major newspaper is that the words are there for anyone to read.