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Multiple conflicts of interest left out in summary of Bayer-sponsored study of liver cancer drug

Mount Sinai researchers involved in successful phase 3 trial of drug for liver cancer

Our Review Summary

The news release focuses on a phase 3 clinical trial that evaluated how effective the drug regorafenib was at treating patients who had a form of liver cancer called hepatocellular carcinoma (HCC), and whose HCC had gotten worse despite taking sorafenib — which is currently the only available form of targeted drug therapy for treating HCC. The study, which was recently written up in The Lancet, found that regorafenib extended a patient’s life by just under three months, compared to the use of a placebo. The release addresses these findings in a straight-forward way, which is good. However, the release does not adequately address conflicts of interest related to the study, nor does it sufficiently address cost or potential harms associated with the use of regorafenib.

 

Why This Matters

When patients or their loved ones hear about a “successful” drug trial for a disease they are fighting, it is easy for them to jump to the conclusion that “success” means the disease is cured. That’s not the case for a study like this one. It’s important for people to know that “success” in this case means that patients survive for an additional 2.8 months. We’re glad the release states this clearly. But in order for people to truly make informed choices, they need to understand how a treatment could effect their quality of life. For many patients, it’s also important for them to understand whether a treatment option could create a significant financial burden for their families. And when evaluating any drug study’s findings, it’s important to know what sort of financial ties the researchers have with the pharmaceutical manufacturer.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

Cost is not addressed at all. This is particularly problematic because regorafenib (brand name Stivarga) has already been approved, and is on the market, for treating other forms of cancer. For example, an online price guide shows that 84 40-milligram tablets of regorafenib cost $15,817. This is a fair estimate of the cost of treatment, given that the initial treatment regime for patients in the clinical trial receiving regorafenib was 84 40-milligram tablets (four 40-milligram tablets per day for 21 days).

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

Satisfactory

The release is pretty clear on this point, noting that patients who received regorafenib had an overall survival of 10.6 months, compared to 7.8 months for patients who received a placebo.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

The release states only that “regorafenib was well-tolerated with manageable adverse events” [emphasis added]. This is an example of the disconnect that can occur between language commonly used among researchers and language that people use in everyday life. For example, of the 374 patients who received regorafenib, seven had deaths that, according to the journal article, “were considered by the investigator to be related to study drug.” Few members of the lay public would be likely to automatically assume that death is a manageable adverse event, even when talking about last-ditch medical treatments for advanced cancers. Other side effects that cropped up in the study, and which could significantly affect quality of life for patients, included hypertension, pain and swelling in the hands and feet, diarrhea and severe bleeding. Fatigue was also present as a side effect but the degree of fatigue is not mentioned.

Does the news release seem to grasp the quality of the evidence?

Satisfactory

The release gives a concise, accurate, overview of the study. But the study reports a lot of other issues that aren’t mentioned in the news release. It appears that 75% of the patients in both groups had cirrhosis. The effect of this is not likely to be important since the percentage was the same in both groups.  An open question on the study is that the authors used a one-sided statistical test, making it more likely that they would find statistical significance, when it would not be so if they had used the more common two-tailed test (which tests for the possibility of a relationship in both directions). How this statistical change would affect the results is not clear.

Does the news release commit disease-mongering?

Satisfactory

No disease mongering here.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

The release does note that Bayer funded the clinical trial. However, the release doesn’t tell readers that Bayer manufactures regorafenib. We might be able to let this slide, assuming that Bayer’s ties to regorafenib are inferred, but there’s another problem. The journal article makes clear that a number of the researchers involved in the clinical trial have not only received grants from Bayer, but are also paid advisors and/or consultants for Bayer. That sort of potential conflict of interest is important to note.

Does the news release compare the new approach with existing alternatives?

Satisfactory

The release notes that patients in the study had already been treated with sorafenib, and that sorafenib is the “only other drug with proven clinical benefit” in treating HCC. That’s enough to earn it a satisfactory rating here. However, it would have been stronger if it had mentioned other elements of treatment, such as surgery, chemotherapy and radiation therapy. In addition, hospice or palliative care programs for patients who had run out of treatment options might result in improvement in outcomes.

Does the news release establish the availability of the treatment/test/product/procedure?

Not Satisfactory

The release does tell readers that “In January, Bayer announced that the U.S. Food and Drug Administration had granted priority review status for Stivarga (regorafenib) as a second-line systemic treatment for patients with hepatocellular carcinoma.” However, the release doesn’t tell readers that regorafenib has already passed FDA review for treatment of other cancers, nor does it explain to readers what “priority review status” means in terms of when the drug might be used for HCC treatment on a widespread basis.

Does the news release establish the true novelty of the approach?

Satisfactory

The release makes clear that this is only the second pharmaceutical treatment for HCC proven to affect patient survival, and outlines what the study findings may mean for future research on how regorafenib may be used in treating earlier stages of HCC.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Not Satisfactory

There are two issues here. First, as noted above under “Why This Matters,” writers need to be cautious when throwing around terms like “successful” — because they can mean different things to different people. When a headline trumpets a “successful” cancer drug, many readers may assume that the drug does more than extend life for 2.8 months. The fact that the release makes clear, in the third paragraph, that we’re talking about an extra couple of months (rather than remission) doesn’t forgive the headline. It would have been much better to have a headline that focuses on specifics, such as “extends life by 2.8 months,” rather than vague terms that can be easily misunderstood. Second, while the clinical trial’s findings are certainly worth reporting, we are rarely pleased to see a news release use vague, over-hyped (and overused) terms like “breakthrough,” as was done here.

Total Score: 5 of 10 Satisfactory

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