Pharmaceutical Testing and Its Placebos ─ Even the Most Basic Utilitarian and Scientific Principles Are Often Ignored

© 2010 Peter Free

 

23 October 2010

 

Pharmaceutical testing is often neither sensible nor scientific

 

Readers are probably aware that pharmaceutical testing has increasingly obvious problems with financially motivated bias in designing and/or reporting clinical trials.

 

Two less obvious methodological problems potentially reinforce financially induced bias.

 

The first of these is the question of whether pharmaceutical testing protocols actually make utilitarian social sense.

 

Trials are often criticized for comparing a new drug to a placebo (which is supposed to be a physiologically near-inert substance), rather than to an older drug that has a proven record of success.

 

Critics argue that there is no utilitarian point to creating a “me-too” drug, when the goal should be to come up with something safer, more effective, or both.

 

The second problem is even more basic.  It asks whether the testing protocol makes defensible scientific sense.

 

The absurdity here is that researchers are too often disinclined even to describe and physiologically characterize the placebo they are comparing the new drug to.

 

In essence, collected trials data is comparing a new drug to an arguably non-inert placebo that either has, or may have, effects that the trial was not designed to detect.  In effect, the clinical trial is comparing an unknown to an arguable unknown.

 

That’s a big “no-no” in scientific medicine and science of any kind.

 

Beatrice Golomb et al.’s surprising revelation about placebos

 

Beatrice A. Golomb et al., writing in the Annals of Internal Medicine:

 

Data Synthesis: Most studies did not disclose the composition of the study placebo. Disclosure was less common for pills than for injections and other treatments (8.2% vs. 26.7%; P = 0.002).

 

Conclusion: Placebos were seldom described in randomized, controlled trials of pills or capsules. Because the nature of the placebo can influence trial outcomes, placebo formulation should be disclosed in reports of placebo-controlled trials.

 

© 2010 Beatrice A. Golomb et al., What’s in Placebos: Who Knows? Analysis of Randomized, Controlled Trials, Annals of Internal Medicine 153(8): 532-535 (19 October 2010)

 

These findings came from the group’s review of four well-regarded English language general and internal medicine journals from January 2008 through December 2009.

 

The team’s reviewers examined the introduction and methods sections of placebo-controlled trials, looking for routes of drug administration and whether the placebo’s composition was stated.

 

So what?

 

It’s pretty difficult to do good science, or medicine, if one ignores the fundamental scientific principles that both are predicated on.

 

As a medical consumer, be a little skeptical of pharmaceutical claims for efficacy and safety.