I represent clients in the consolidated Actos litigation, and so I’m well-versed with the science linking the drug’s use to bladder cancer. As the federal court overseeing the litigation held in a Daubert order, there’s ample scientific evidence demonstrating that even just one year of Actos use can increase the risk of bladder cancer. So, the headline at MedPage on August 29, 2014 was quite a surprise: “No Actos Cancer Link in Long Term Data.” I assumed that the headline reflected some new scientific study showing the absence of a link to bladder cancer.
Then I read the actual article:
A 10-year analysis of patients with type 2 diabetes treated with pioglitazone (Actos) found no statistically significant increased risk of bladder cancer, either with any exposure or for long duration of use, the drug’s manufacturer said.
Emphasis mine. As the article continues:
No association with bladder cancer was seen in the 10-year data with higher cumulative doses of the drug or with longer time since initiation of therapy, Takeda [the company that makes Actos] said.
Other details were not released. Takeda promised that the full results would be submitted for publication and shared with regulatory authorities in the U.S., Europe, and Japan.
The refusal to release “other details” kind of says it all, doesn’t it? You can say smoking doesn’t cause lung cancer if you don’t bother to release the “other details” explaining why you think so. The timing is just a bit suspicious as well: they released that statement on the same day the court upheld a multi-billion-dollar punitive damages judgment against them, a judgment based on part on Takeda hiding a link between Actos and bladder cancer.
The essence of science, as Richard Feynman explained decades ago, is whether our guesses about how the world works agree with our observations about how the world actually works. To tell whether a particular hypothesis lines up with the real world, you need to see the details of both the guess and the observation — which, I suppose, explains why the manufacturer of Actos doesn’t want to show us those details.
The old saying, “There are three kinds of lies: lies, damned lies, and statistics,” applies nowhere so forcefully as when a for-profit company is describing the safety of its own product. Unfortunately, the rich, complex world of epidemiology gives companies more than enough mathematical and scientific tools to pretend that their products are safe. The math behind “pharmacovigilance” (i.e., the epidemiological monitoring of drugs to look for problems) is insanely complicated, so that seemingly small changes — a “misreported” case here or there, or perhaps a slight tweak to the Bayesian filter used — can completely change the outcome.
And that’s why I’m so disappointed with MedPage Today. A statement by a for-profit company about its product without any supporting analysis or data to back it up isn’t “science” or “medical news,” it’s just marketing.