Problematic PR releases: Publicizing phase 1 trials

Joy Victory is Deputy Managing Editor of HealthNewsReview.org. She tweets at @thejoyvictory.

Last week we introduced our new ongoing series looking at problematic PR releases, surfacing trends in news releases that discuss health care interventions.

We found, for example, that news releases sometimes fail to include the most basic data findings from the research they’re promoting, leaving it to journalists to sift through (often paywalled) studies to find that information.

Our latest concern: News releases announcing results from phase 1 clinical trials, which is the first of several trials a drug or intervention must undergo before it can be approved for use.

Phase 1 is not meant to determine if a drug works. As clinicaltrials.gov explains they are “studies that are usually conducted with healthy volunteers and that emphasize safety. The goal is to find out what the drug’s most frequent and serious adverse events are and, often, how the drug is metabolized and excreted.”

For this reason, rarely do phase 1 trial results merit widespread media attention–though you wouldn’t know that by perusing websites that publish news releases, where it’s a common topic.

Worryingly, these releases sometimes bury the whole “safety” aspect of phase 1 trials and instead make it sound like the drug or intervention was shown to be effective. Framing the results of a phase 1 trial this way might be good for the drugmaker’s stock prices, but it’s not good for conveying science accurately.

Let’s take a look at a few examples:

Poliovirus therapy for recurrent glioblastoma has three year survival rate of 21 percent

Duke University Medical Center

The news release focuses on the secondary results of the study–the survival rates. And it frames those rates as showing a “survival benefit” in a subheadline. Yet, as the published paper explains, it was a “dose-finding and toxicity” study to primarily determine side effects and proper dosing. Tellingly, the headline published in the New England Journal of Medicine (“Recurrent Glioblastoma Treated with Recombinant Poliovirus”) shies away from making any claims of benefit.

By focusing on the three-year survival rates, the news release makes the research sound more advanced than it is. But since researchers are still at the stage where they are trying to figure out the best dose, we don’t really know 1) if that 21 percent survival rate will hold true once the researchers pick the safest dose, and then test it on a wider group of people, nor 2) if the survival rate will be worth it when compared to the adverse event rate, nor 3) if patients receiving the experimental treatment are truly similar enough to the control group to make this a fair comparison.

Fortunately, in our reviews of the NPR and NBC News coverage, we noticed the stories didn’t back away from these limitations. One fact that no outlet emphasized, but is important to keep in mind: Despite receiving this therapy, the experimental group’s median survival rate was just 12.5 months, compared with 11.3 months for the control group.

 

Tolero Pharmaceuticals Announces First Patient Dosed with Investigational Agent TP-0184, an Activin A Receptor Type 1 (ACVR1) Inhibitor, in Phase 1 Study of Patients with Advanced Solid Tumors

Tolero Pharmaceuticals

doctor-patient communicationThat’s a mouthful of a headline, so we’ll strip it down to the news nugget: Pharma company announces that one patient has received an experimental drug.

Yes, you read that right. This news release isn’t even announcing study results from a completed trial. It’s announcing that one patient in the trial has received the medicine they’re testing.

One. Patient.

How is this news? What are journalists supposed to do with this information? We’re not sure.

On the upside, the release is at least clear about what the study will measure: Safe dosing levels and any toxic side effects. That one patient is brave, in other words.

 

Rapid responses, few adverse effects in targeted agent in Phase 1 trial in rare blood disorder

Dana Farber Cancer Institute

This one is from last December, but we wanted to include it here to show how it did some things right–and how it did some things wrong.

Thumbs up: The headline is upfront that this was a phase 1 trial, and it mentions adverse events.

Thumbs down: The first five paragraphs focus on how the experimental drug worked quickly and robustly to treat a blood disorder. The lead researcher gushes that “the rapidity of the improvement is extremely dramatic.”

Thumbs down: The “few” adverse events mentioned in the headline were never explained. But a “few” can turn into “a lot” when tested on larger groups of patients, so these details matter.

Thumbs up: Although it’s not until the final paragraph, we learn this:

“This Phase 1 trial was designed primarily to identify a safe dose of BLU-285, not to evaluate the drug’s effectiveness.”

Considering that the news release spent so much time discussing effectiveness, that line felt dissonant, but at least it’s there.

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John D

August 9, 2018 at 11:42 am

Nice summary of an ongoing issue regarding clinical trials. What should be mentioned is that Phase 1 are not required to report data to clinicaltrials.gov. However, starting next year scientists are required to upload the study protocol when registering a study. I guess that counts for something…

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