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High-tech help for fibroid tumors

Rating

2 Star

High-tech help for fibroid tumors

Our Review Summary

The decision by the FDA in 2004 to approve the ExAblate system for uterine fibroids represented a new option for women who are suffering from symptomatic fibroids but who want to avoid hysterectomy or other invasive treatments. However, little is known about the long-term safety and efficacy of the procedure. Furthermore, the procedure is expensive and availability is limited. This story does not adequately cover these issues and is flawed in many ways.

Although the story mentions hysterectomy and briefly mentions medications and other procedures, the story does not comment on the advantages and disadvantages of the alternatives or explain how this new treatment would fit with existing approaches. The story quotes two Mayo doctors and a representative of the company. This is insufficient. The story should have quoted clinicians or researchers who do not have a stake in the claims being made to provide some context about how this treatment will fit within the context of existing approaches. By quoting biased sources, it is likely that the benefits of this treatment have been inflated and the potential harms have been downplayed.

The story also does not attempt to quantify the benefits of treatment, nor does it mention harms of the treatment, which can include skin burns, thermal injury to surrounding tissue, and the need for repeat procedures. The story does not comment on the strength of the available evidence, which is limited given that the procedure is so new. Although the story does mention that the procedure is expensive and not usually covered by insurance, this is not sufficient information on costs. What does it cost?

The story clearly states that this treatment was recently approved by the FDA and is only available in a dozen or so clinics in the U.S. The story should have mentioned where the clinics are located. The story clearly states that this is a novel approach to treating fibroids and it accurately describes the prevalence of fibroids. However, the story highlights one extreme case of fibroids. Most women with fibroids do not have trouble walking or have chronic pain.

By focusing on one woman’s positive experience, the story misses the complete picture of what is known about what this procedure can or can’t do for women with symptomatic fibroids.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

Although the story does mention that the procedure is expensive and not usually covered by insurance, this is not sufficient information on costs. And it’s not good enough to say, “Mayo Clinic officials said the cost of the procedure varies for each patient, and declined to provide any estimates. They said patients can receive individual cost estimates before the procedure.” If it’s worth publicizing, it’s worth getting cost estimates.

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

Not Satisfactory

The story does not attempt to quantify the benefits of treatment. The story also doesn’t even explain whether women who have undergone this treatment actually have less menorrhagia.

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

Not Satisfactory

The story does not mention harms of the treatment, which can include skin burns, thermal injury to surrounding tissue, and the need for repeat procedures.

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

Not Satisfactory

The story does not comment on the strength of the available evidence, which is limited given that the procedure is so new. The story gives no comparison of outcomes (either positive or negative) from any of the other accepted therapies to treat fibroids.

Does the story commit disease-mongering?

Satisfactory

The story accurately describes the prevalence of fibroids. However, the story also provides one extreme case of fibroids. Most women with fibroids are not as limited as the woman in the story and do not have continuous chronic pain. Nonetheless, we’ll give the story the benefit of the doubt and give it a satisfactory score here.

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

Not Satisfactory

The story quotes two Mayo doctors and a representative of the company. This is insufficient. The story should have quoted clinicians or researchers who do not have a stake in the claims being made to provide some context about how this treatment will fit within the context of existing approaches. By quoting biased sources, it is likely that the benefits of this treatment have been inflated and the potential harms have been downplayed.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

Although the story mentions hysterectomy and briefly mentions medications and other procedures, the story does not comment on the advantages and disadvantages of the alternatives or explain how this new treatment would fit within the context of existing approaches.

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

Satisfactory

The story clearly states that this treatment was recently approved by the FDA and is only available in a dozen or so clinics in the U.S. It would have been more helpful to indicate where these other centers are located.

Does the story establish the true novelty of the approach?

Satisfactory

The story clearly states that this is a novel approach for treating fibroids.

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

Not Applicable

There is no way to know if the story relied on a press release as the sole source of information. However, the story did rely on the story of one patient, from one institution, using one technology from one company.

Total Score: 3 of 9 Satisfactory

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