Ralph Moss: The Procrustean Bed

[Guest guest]

BlankThe Procrustean Bed

Sunday, 12 December 2010

Oncologists sometimes try to recruit patients into Phase I (toxicity)

clinical trials. But how effective are the experimental treatments provided in

such trials? In a recent 2010 study that pooled data from various phase I

chemotherapy trials for sarcoma, the partial response rate was 1.6 percent (2

out of 133 subjects) and the complete response (CR) rate was 0.8 percent (1 out

of 133). The median progression-free survival was 2.1 months and the median

overall survival was 7.6 months. Meanwhile, 18 percent of patients experienced

grade 3 or 4 (i.e., critical or life-threatening) toxicity and 12 percent

dropped the trial treatment because of toxicity.

Yet here’s the amazing part. The authors of this study, at the Royal

Marsden Hospital, London, concluded: “Phase I clinical trials could be

considered a therapeutic option in sarcoma…due to the low risk of toxicity”

( RL, Olmos D, Thway K, et al. Clinical benefit of early phase clinical

trial participation for advanced sarcoma patients. Cancer Chemother Pharmacol.

2010. Available at PubMed, emphasis added).

Pardon me for being blunt, but what universe do these scientists inhabit?

I wonder if they themselves would submit to such toxic drugs for a less than one

percent chance of a “cure” (a “cure” that in any case may last a month or so).

And—it seems almost too obvious to ask—how do these scientists define a “low

risk of toxicity”? Grade 4 toxicity classically includes such things as massive

hemorrhages, life-threatening infection, more than ten episodes of vomiting in a

24 hour period, etc. Even grade 3 toxicity includes such things as “painful

erythema, edema or ulcers and (patients) cannot eat”

(http://www.rtog.org/members/toxicity/tox.html)

Sometimes I get the impression that various authors reach their

conclusions first and then force their data to fit a preconceived notion. The

Greeks had a term for this, a “Procrustean bed.” This term came from a myth

about a highwayman named Procrustes, who physically either cut or stretched the

limbs of his victims to fit the predetermined length of his torture bed. This

term has stuck for any situation in which people stretch (or minimize) the data

to conform to some preconceived notion.

--Ralph W. Moss, PhD