Health News Review

We applaud this story’s attention to an issue than transcends the “study of the day” mentality of most health reporting, but we wish it had attacked the subject with a more careful and evidence-based perspective.

Our Review Summary

This premise of this story is that the insurance industry may be dragging its feet on coverage for a new FDA approved treatment for severe asthma called bronchial thermoplasty. Unfortunately, this promising argument is undermined by an inappropriate reliance on anecdotes and a highly selective reporting of the evidence that supports this treatment. The story refers to study outcomes that favor the treatment but omits findings that cut the other way. It reports results in relative rather than absolute terms. Long-term saftey is emphasized at the expense of serious short-term risks that could land patients in the hospital.


Why This Matters

Severe asthma takes a considerable toll in both human and financial terms, and certainly any treatment that has the potential to reduce that burden is worthy of attention from health care journalists. In this case, though, the story examined the issue through the prism of best-case anecdotes and relative risk comparisons. And it failed to explain that the treatment seems to work only slightly better than a sham procedure for improving key health-related outcomes. We wish the story had included more useful information for readers.


Criteria

Satisfactory

Does the story adequately discuss the costs of the intervention?

Satisfactory

The story discusses the high price of the procedure and the unwillingness of most insurers to cover it. One could argue that the story is off base when it suggests that the procedure would be highly cost effective, without citing any supporting evidence or allowing a rejoinder from the opposing camp. However, we’ll give the benefit of the doubt here.

Not Satisfactory

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The anecdotes and statistical reporting in this piece are skewed. Two anecdotes describe patients whose symptoms are almost totally resolved following treatment, but this is not representative of the experience of most patients who receive bronchial thermoplasty. In the most rigorously conducted trial to date, the average improvement in asthma-related quality of life after a year was about 1.4 points on a 7-point scale in the active treatment group compared with 1.2 points in patients who received a sham treatment (a 0.2-point difference favoring the procedure). In addition, the percentage of patients who experienced a clinically meaningful improvement in that study was only slightly lower among those received a sham treatment (64%) compared with those receiving the real treatment (79%).  When reporting on this study, the story does not convey these findings (which were the study’s primary outcome measures), and instead reports only on secondary outcomes for asthma attacks, emergency room visits, and the number of days lost from work and school. The story uses relative improvements to describe these benefits and does not provide absolute percentages. These choices lead to an overemphasis on the benefits of the procedure.

Not Satisfactory

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

The story refers to 5-year studies suggesting that the procedure is safe, and suggests that short-term problems consist of “temporary coughing, mucus and other respiratory symptoms brought on by irritation of airways.” This understates the severity of adverse effects seen while patients are receiving active treatment. In the trial mentioned above, 16 patients in the bronchial thermoplasty group had to be hospitalized for asthma-related complications during treatment, compared with only 2 patients in the control group.

Not Satisfactory

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

Although it never outright says so, the story suggests that the evidence is sufficient for insurers to pay for bronchial thermoplasty. When an insurance industry representative describes the procedure as “experimental,” the story counters (in its own editorial voice) that three 5-year studies of the procedure have already been completed. The implication is that the insurance companies are dragging their feet. That’s certainly one way to view the situation, but it wouldn’t have been difficult to find experts outside the insurance industry who believe the procedure is not yet ready to be rolled out to patients. In this editorial, for example, a researcher who has been funded by the thermoplasty device manufacturer argued that the benefits compared with a sham procedure are small and the long-term safety uncertain. He and a colleague wrote that this “provocative treatment is not yet ready for prime time but, instead, requires more study.” Another editorialist wrote that the findings of the most recent trial were “somewhat disappointing” and she called for more research to clarify the procedure’s effects. We don’t think these legitimate concerns about the procedure’s supporting evidence were given an appropriate voice in the story.

Satisfactory

Does the story commit disease-mongering?

Satisfactory

The story notes that the procedure “is only for severe asthmatics, who — unlike a vast majority of asthma patients — cannot keep flare-ups at bay with standard medications.”

Satisfactory

Does the story use independent sources and identify conflicts of interest?

Satisfactory

The story includes quotes from several independent sources and from an insurance industry spokesperson, thereby satisfying our criteria. As noted above, however, we don’t think it would have been difficult to find a clinical expert with a more skeptical view of the evidence supporting bronchial thermoplasty.

Satisfactory

Does the story compare the new approach with existing alternatives?

Satisfactory

The story notes that avoiding allergens and using inhaled medications are enough to keep asthma under control in most patients.

Not Satisfactory

Does the story establish the availability of the treatment/test/product/procedure?

Not Satisfactory

Although the story states that about 650 people have been treated, and although it discusses lack of insurance coverage, it never explicitly explains how widespread is its availability.  Do only high-tech teaching hospitals provide it?

Satisfactory

Does the story establish the true novelty of the approach?

Satisfactory

The story doesn’t make any inappropriate claims regarding the treatment’s novelty.

Satisfactory

Does the story appear to rely solely or largely on a news release?

Satisfactory

The story has plenty of original reporting. No doubts here.

Total Score: 6 of 10 Satisfactory


Comments

TGrier posted on June 6, 2013 at 8:19 pm

TGrier posted on June 6, 2013 at 8:09 pm
SATISFACTORY

In the United States, asthma affects almost 25 million Americans. In 2007 approximately

• 12.8 million people experiencing asthma attacks
• 1.75 million emergency room visits
• 456,000 hospitalizations
• 3,447 asthma-related deaths
Source: Centers for Disease Control and Prevention National Center for Health Statistics, National Health Statistics Report: Asthma Prevalence, Health Care Use, and Mortality: United States, 2005–2009: http://www.cdc.gov/nchs/data/nhsr/nhsr032.pdf

Since the FDA approval of this procedure in 2010 after the positive reports of the clinical trials Medicair and two other private insurance companies have stepped up to cover the bronchial thermoplasty.

Medicaid http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/mm7443.pdf
HealthPartners http://www.healthpartners.com/public/coverage-criteria/bronchial-thermoplasty/
Priority Health http://www.priorityhealth.com/provider/manual/auths/~/media/documents/medical-policies/91577.pdf

Other insurance companies such as United Health Care continue to call the procedure “experimental” and continue to deny coverage to policy holders and their dependents even when they meet all of the criteria approved by the FDA. https://www.unitedhealthcareonline.com/ccmcontent/ProviderII/UHC/en-US/Assets/ProviderStaticFiles/ProviderStaticFilesPdf/Tools%20and%20Resources/Policies%20and%20Protocols/Medical%20Policies/Medical%20Policies/bronchial_thermoplasty.pdf

Food and Drug Administration

Department of Health and Human Services, Food and Drug Administration, Approves Alair Bronchial Thermoplasty System, April 27, 2010
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf8/P080032A.pdf

Alair Bronchial Thermoplassty System description and report of clinical studies http://www.accessdata.fda.gov/cdrh_docs/pdf8/P080032c.pdf

FDA Adviosry Committee Meeting Materials on AdlarBronchial Theormplasty part 1 http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/AnesthesiologyandRespiratoryTherapyDevicesPanel/UCM187830.pdf

FDA Advisory Committee Meeting Materials on Bronchial Thermoplasty part 2 http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/AnesthesiologyandRespiratoryTherapyDevicesPanel/UCM187822.pdf

Summary of Safety and Effectiveness Data http://www.accessdata.fda.gov/cdrh_docs/pdf8/P080032b.pdf

The following precautions were submitted to the FDA by Alair and were used in their control groups in determining who would qualify for their clinical trials? http://www.accessdata.fda.gov/cdrh_docs/pdf8/P080032c.pdf

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