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AP story says new drug ‘cures’ hepatitis C, but that’s no guarantee patients will be spared cirrhosis or liver cancer

Rating

3 Star

Categories

FDA OKs new drug to treat all forms of hepatitis C

Our Review Summary

This AP story on the latest hepatitis C drug was strong on one point that’s often weak in health care news reporting: The price of treatment.

But, it missed the opportunity to go beyond a standard quick report on the new drug, known as Mavyret, and give readers the kind of context that will help them make more informed decisions. For example, missing was a description of the type of research that was done, so patients could have a better sense of the strength of the results reported–as well as the limitations. Additionally, perspectives from a scientist or physician unaffiliated with the drug company would have made this article much more balanced.

Most importantly, we think stories like this need to be far more cautious when using the word “cure” to describe a reduction in measurable viral levels in a person. Despite lowering the viral load, it remains to be seen if this drug–and many others like it–actually lower the rate of liver cancer, cirrhosis or early death.

 

Why This Matters

A flurry of new drugs have been developed for hepatitis C in the past few years. While this may seem like good news for patients, many of these drugs are expensive and their long-term benefit to patients remain unknown (such as: Do they actually prevent liver cancer or cirrhosis?)

 

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

The article nicely spells out the costs of drug treatment for eight, 12, and 16 weeks. Readers are also told these would be the costs incurred by uninsured patients.

One detail to note, though: The story says that Maryvet is cheaper than all other drugs in the market, but only mentions the price of Harvoni and not that of the other six competitors, so readers have to do their own legwork to verify that claim.

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

Not Satisfactory

Readers learn that 97.5% of patients without cirrhosis and 98% of patients with severe kidney damage were “cured” of hepatitis C (i.e. had undetectable levels of the virus in their blood) after treatment.

This overlooks the realities of hepatitis C treatment, however. Very reduced viral loads after a short course of treatment sounds like a good thing, however as we reported in 2016, this is what’s known as a “surrogate outcome.”

We don’t know yet if reduced viral load has any impact on patient health. Yet what patients want and need to know is: Do they drugs help anyone live longer or have reduced rates of complications of like cirrhosis or liver cancer?

The story should have made it very clear that until longer studies are conducted, no one knows.

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

Satisfactory

Both mild and more serious potential side effects of the drug are mentioned including nausea, headache, fatigue, itchiness, and reactivation of the virus in patients who previously had hepatitis B infections. That’s enough to merit a satisfactory rating.

Ideally, though the story also discussed how many patients experienced these side effects in the studies.

It also should have noted that there has never been good evidence that new hepatitis c drugs’ clinical benefits outweigh their harms, as this healthcare blogger pointed out last year.

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

Not Satisfactory

While the article notes that some “testing” was done to determine the drug’s effectiveness, it doesn’t describe the type of study conducted, the length of the study, or the number of patients who fell into the two categories (i.e. those without cirrhosis, and those with severe kidney damage).

Was there a control or comparison group? Did the study go beyond the 12-week follow up that was mentioned? Readers don’t know from this article.

Does the story commit disease-mongering?

Satisfactory

There is no disease mongering in this piece. However, language like the following

“…grueling shots and pills that gave patients flu-like symptoms and still barely cured half of them,”

is potentially biasing and should be limited.

The story also used the word “breakthrough” without explaining that this isn’t what many patients think it means.

Also, it would have been helpful for the article to better explain that hepatitis C leads to cirrhosis (relevant to the fact that this drug is not indicated for patients who develop cirrhosis).

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

Not Satisfactory

The only sources mentioned in the article are a company spokesperson and an analyst discussing the drug’s potential market share. There is no context provided about the research results by any independent experts.

Does the story compare the new approach with existing alternatives?

Satisfactory

The article discusses several treatment alternatives describing how they compare to this newest drug. Based on the information provided, the newest drug appears to be both a cheaper and more effective treatment option in comparison to others currently on the market. (However, see the cost criterion for why the pricing claim may not be accurate.)

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

Not Satisfactory

The article does a good job discussing the complexities of how an insurance company might decide to cover the drug. It is much less clear when the drug will most likely be available for use (FDA approval is just one step) and patients will definitely want to know more about that.

Does the story establish the true novelty of the approach?

Satisfactory

This article implies that’s what novel here is the drug’s cost (cited as being significantly cheaper than other options) and success rate. We’ll give the benefit of the doubt here and consider this satisfactory.

But, the drug is a combination of two existing medications. The article doesn’t discuss how those individual medications were being used before and why this combo is novel (were doctors not combining them before?)

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

Satisfactory

The story did not appear to rely solely on the news releases from the FDA and AbbVie, though it missed an opportunity to go beyond the information shared in the news releases.

Total Score: 6 of 10 Satisfactory

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