Health News Review

Two news releases come out on the same study.

One comes from Merck, the company making the drug being studied.

The other comes from Oxford and the highly-respected Clinical Trials Services Unit that ran the trial.

Which news release would you expect to be better?

Duh? Right?

Wrong, at least in the eyes of veteran science journalist Larry Husten on his Cardiobrief blog.

Among Husten’s sharp-eyed observations are the following:

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“It is astonishing that the Oxford press release has so much to say about things that weren’t tested in the trial and has nothing to say about a number of major issues that were addressed in the trial. In particular, the press release doesn’t report the primary endpoint of the trial. As has been discussed on CardioBrief and elsewhere, earlier this year, near the completion of the trial, the SHARP investigators sought to change the primary endpoint (from first major vascular event to first major atherosclerotic event) and the planned statistical analysis of the trial to avoid producing a false negative result. The trial sponsor, Merck, did not endorse their plan, and officially the primary endpoint remains unchanged. The SHARP investigators, however, chose to ignore the actual primary endpoint, or any discussion about the change in the primary endpoint, in the press release.

The Oxford press release is severely deficient in another way: it presents no hard numbers for the results, including the actual number or percentage of events of either the primary or alternate endpoint or the individual components of the composite endpoints. The press release also includes no discussion about the statistical power of the trial or any of the findings. In essence, the investigators ask the readers of the press release to take their conclusions on faith.

By contrast, the Merck press release is both more detailed and restrained. It explains (in a slightly confusing manner) the issue about the attempted change in endpoint and presents the actual percentages and p values for both the original primary endpoint and the alternate Oxford endpoint. The Merck press release also includes the information, completely absent in the Oxford press release, that in this study of patients with kidney disease, treatment with Vytorin had absolutely no effect on the progression of kidney disease.

In the past I’ve been as critical as anyone of Merck’s handling of the Vytorin controversy. The interesting thing here is that Merck appears to have played it straight, while the Oxford CTSU doesn’t seem to have learned any of the lessons from earlier episodes of this long-running imbroglio.”

Clearly, there’s room for improvement by anyone who writes and disseminates news releases.

I’ve been trying to get anyone – ANYONE – to publish our 10 criteria from HealthNewsReview.org as part of their news releases. Let readers – or recipients – judge how good a job the news release did in addressing those criteria. It would then also be a reminder to the journalist to pay attention to those criteria. I’m still waiting for the first taker. Free mousepads to any who try it.

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Comments

Andrew Holtz posted on November 22, 2010 at 2:27 pm

I suspect regulatory oversight (and tort considerations) might have something to do with the relative caution of the Merck release. Since Oxford doesn’t sell prescription drugs, it is not subject to the kind of FDA scrutiny that Merck could face.
Ideally, an academic institution would hold itself to a high standard in its public statement about medical research results.

Jerome Hoffman posted on November 29, 2010 at 1:00 pm

When I first read your comments about Larry Husten’s blog, I thought you were taking him to task for trying to take the obviously absurd position that we should trust an industry press release more than one from a famous university — only to find out, when I read his blog, that his observations are in truth absolutely dead on. Perhaps I didn’t read you correctly, but when you called him a “sharp eyed journalist” I thought you were being sarcastic — though that is exactly what (in this instance, at least) he is.
I’m bothering to write because if, as I now suspect, you weren’t actually criticizing Mr. Husten, you should know that it’s easy to misinterpret what you wrote … and those of us who do misread you will miss the important point that the one press release was better than the other not because Merck did such a good job, but because “highly respected” Oxford University did such a terrible one — reminding us how important it is to be critical even when reading from “academic” sources. (That is, after all, the reason why such sources are so valuable to the drug companies …)

Gary Schwitzer posted on November 29, 2010 at 1:18 pm

Jerry,
Wow, I would never have guessed that anyone would have found my post about Husten’s article as ambiguous.
Let there be no misinterpretation: I thought he did a solid job raising an important issue that is not merely an isolated instance of inferior academic news releases.