HealthNewsReview.org | Independent Expert Reviews of News Stories | Holding Health and Medical Journalism Accountable

Device's trial run gets high praise

September 16, 2009

Read The Story
RATING:

This is not the way journalism should cover new medical devices. The story failed to scrutinize evidence, discuss potential harms or costs, or seek independent perspectives.

Our Review Summary

There's nothing inherently wrong with a local newspaper story that lets readers know about local medical centers participating in a multi-center trial.

But what can be wrong with such a story was seen in this story.  It failed to: 

  • provide any data on harms or benefits
  • go beyond a single positive anecdote of patient success
  • offer any independent perspective, interviewing only a single conflicted source
  • include any estimate of costs of this approach which could be considerable.

There must be a big promotional campaign underway for this device, since the substance of this story - and the timing of it - is very similar to one we reviewed on NBC just a few weeks ago.

This is not the way journalism should cover new medical devices.  What kind of an environment does such unquestioning storytelling create for public discussion and understanding of medical technology assessment and comparative effectiveness research? Journalism can help the public understand more about scrutinizing evidence, about potential harms and about costs.  These factors were sorely missing in this story. 


 

Click on Criteria for definitions.

The story made it clear that the device is being tested "at up to 50 clinical sites worldwide" and listed the two local medical centers participating in the trial.

X-mark
Discuss costs? - NOT SATISFACTORY

The story didn't mention any of the costs of treatment involved - not the known nor projected costs of the device, of its implantation, of followup care, nor of battery replacement.

There was no overt disease-mongering of the condition of difficult-to-control high blood pressure.

The story presented no evidence - only anecdotes - yet it let one of the investigators get away with saying "It's only with this device that (patients are) able to bring their blood pressure under control."  Where are the data to back that up?

X-mark

The story mentioned the need for periodic battery replacement, but didn't describe what that entails.  Is it another operation?

The story quotes one researcher saying "We ask that (patients) don't lift more than 10 pounds for a month."  Why?  What happens if they do?  What's the track record of complications? 

The one patient profiled said she had swelling in her neck after the surgery.  How often does that happen? How often do any complications occur with this device?  

The story was silent on quantifying the frequency or severity of the potential harms of this approach.

There wasn't any explicit discussion of the novelty of this approach, so this criterion is not applicable in this case.

No data - no evidence - was provided.

We can't be sure of the extent to which the story may have been influenced by a news release.  An Iowa Heart Center news release had this line:

The Rheos® Hypertension Therapy System™ is a high blood pressure treatment which consists of an implantable device designed to electrically activate the body’s own natural blood pressure regulation system in order to treat drug resistant hypertension.

The story had this line:  

 The Rheos system is a high blood pressure treatment that is being tested for use in drug-resistant cases. It consists of an implantable device that electrically activates the body's own natural blood pressure regulation system. 

Suspicious, but not evidence of total reliance on a news release.  

Interviewing only the principal investigator of a trial, who has a vested interest in a successful outcome - without including the perspective of any independent expert - is not sufficient sourcing.

Drug therapy for the control of hypertension was mentioned in the story but the emphasis was on the side effects of medications.  Yet the story didn't give sufficient details about the side effects of the device implantation or its operation. So there was an imbalance in the discussion of treatment options.  There was also no discussion of other medical devices currently being investigated for the purpose of controlling blood pressure or lifestyle factors that affect blood pressure and cardiovascular risk.

Total Score: 2 of 8 Satisfactory

The U.S. Preventive Services Task Force is considered the gold standard of preventive health recommendations - including on screening tests. It's a good source for journalists and consumers.

Read More

About 70% of the stories reviewed from 2006-9 failed to adequately discuss costs, or to explain how big (or small) are the potential benefits and harms of treatments, tests, products and procedures.

Read More

We have documented a disturbing trend of news stories taking an advocacy stance, promoting certain screening tests outside the boundaries of scientific evidence.

Read More

Stories on new technologies like Cyberknife, DaVinci robotic surgery systems, and proton beam cancer therapy often fail to scrutinize the evidence and/or to discuss the costs involved.

Read More

Rather than suggesting that everyone should be screened for everything, news stories could explain: "All screening tests cause harm; some may do good."

Read More

The first 38 network TV network morning health news stories reviewed in 2009 earned an average score of 1.2 stars. 13 of the 38 stories got ZERO stars.

Read More

Both TIME magazine and BusinessWeek have published terrific stories explaining the importance of the Number Needed to Treat - or NNT.

Read More

Knowing relative risk reduction is like knowing you have a 50% off coupon but not knowing whether it's for a Lexus or a lollipop. Absolute risk reduction tells you what the "coupon" is worth. Read more.

Read More

The website NoFreeLunch.org posts "a database of health care professionals who have pledged to accept no gifts from industry and to rely on non-promotional sources of information."

Read More

To help journalists cover stories responsibly, we post a list of independent experts who state that they do not have financial ties to drug or medical device manufacturers.

Read More

We apply the same ten standardized criteria to the review of every story.

Read More

We have about 30 story reviewers. Each story is reviewed by 3 different people.

Read More

Gary Schwitzer's seven words you shouldn't use in medical news: cure, miracle, breakthrough, promising, dramatic, hope, victim. Read why.

Read More

Our reviewers include two former CNN medical reporters and a former editor of the Washington Post health section.

Read More