“Be careful about reading health books. You might die of a misprint.”
Imagine what it would be like if your favourite movies somehow merged. Characters competing for their own plot lines trying to cut off actors from the other movie. Basically, it would be a disaster most of the time.
That’s how I feel when I read health journalism now that I have experience in both the health and journalism worlds. I see the carefully crafted, precise, sometimes boring scenes of Stanley Kubrick’s Space Odyssey 2001 being injected with the Hollywood likes of Liv Tyler and Bruce Willis. I saw the same thing when I read, “New Drugs Stir Debate on Rules of Clinical Trials” in the NY Times: a deeply nuanced, complex story being reduced, somewhat, to emotional appeal. Both are good things, the emotion and nuance, but when you try mashing them together into the same story, something’s gotta give.
The feature claims that a new melanoma drug, PLX 4032, appears to be so effective that people think we should do away with the clinical trial intended to test it. Should we put aside the Kubrick-esque rigour with which we test new drugs when our Hollywood emotions tell us we already know the truth?
Firstly, we have trials that are designed to change treatments or even end if it becomes obvious that a patient or groups of patients is responding particularly well or poorly to a treatment. David Gorski from Science-Based Medicine had this to say about the study itself:
One thing that puzzled me initially is why the design for this trial was chosen. It’s a straightforward open label randomized trial comparing PLX4032 against dacarbazine [chemotherapy] that does not allow patients in the dacarbazine arm to cross over if they are receiving no benefit.
Sounds complicated but it just means that patients not seeing an effect after a specific amount of time on either therapy would be allowed to switch to the other therapy. It makes the data more difficult to analyze but it does make some of the ethical implication of the study easier to swallow. A lot of these types of studies also have times when the study can be stopped before the study is over. If the results up to that point are convincing (statistically convincing), it becomes unethical to keep giving placebo (or standard care in this case) to the people not receiving the new drug, the trial ends early and everyone in the trial receives the new treatment. Why doesn’t the article talk about these options in more detail?
And why was this study design even chosen given these other options? Again, Science-Based Medicine gets to a fact that is only touched on tangentially in the NY Times article:
On the other hand, it appears that the drug company (Roche) feared that [a trial on only the sickest patients] would only provide justification for approval for PLX4032 only in that small group of the sickest patients. It wanted approval for the widest indications possible, which requires a large, phase III randomized clinical trial.
In other words, economics appears to have trumped science and ethics.
Economic motives can drive people to do good things and it can drive them to do questionable things. This, I think, falls into the latter category. There are good reasons to believe that, without the profit motive in the picture, a different trial would have been selected and the NY Times would have had to look elsewhere for a story.
The other thing that comes to mind when I read this story is that it suffers from identifiable victim bias (which I’ve written about before). The story follows a pair of cousins who both have melanoma but only one of which ended up getting the drug–the other ended up in the standard treatment arm of the trial meaning he only received chemotherapy. It’s a sad story if the drug proves to be as effective as it’s supposed to be–remember, we don’t know for sure. The NY Times feature gives us an easily identifiable victim but it doesn’t, nor can it, portray the benefit to the thousand upon millions of people who could potentially benefit from the knowledge the such a trial can produce. It’s easy to feel bad for a victim whose name we can know and face we can see, and we should, but it’s much more difficult to feel bad for people in the future who are currently only statistics.
But then again, if this story were written the way I wanted it written, would anybody read it? Maybe the problem is that all media suffers from publication bias–but that’s another story.