Over the past couple of years, "Big Pharma" has largely moved away from psychiatric drug development. This shift has been widely discussed.
But another trend has been happening over the same time period - or so it seems to me. This is the rise ofsmall companies who offer techniques for diagnosing mental illness, or predicting which drugs will work best. Generally (it seems) partnerships between venture capitalists and psychiatry (ex-)researchers, these enterprises might be dubbed "Little Pharma".
The latest is a company called AssureRx Health, Inc. According to a paper just published, they offer
a pharmacogenomic algorithm designed to improve the safety and ef?cacy of prescribing antidepressant and antipsychotic medication... based on the genotyping of both copies of ?ve genes.
From this, you end up with a report giving each drug a rating of green, yellow, or red (see above).
The price is not provided on their website.
According to the paper, they gave 26 depressed patients normal treatment at the discretion of their psychiatrist, while 25 got treatment guided by the AssureRx algorithm. It was non-randomized, and unblinded so there's a clear possibility of a placebo effect.
Anyway, the results were...
For the first 4 weeks of treatment, there was no difference between the two groups whatsoeverin terms of depression symptom scores - they both improved. But then by week 8, the unguided patients abruptly got worse, while the AssureRx-guided ones continued to benefit. This is an unusual pattern of improvement in an antidepressant trial.
Previously, I wrote about another Little Pharma antidepressant prediction scheme. It used a different approach, measuring brain electrical activity using a technique called "rEEG", rather than genetics. But the basic idea is the same... and so are the problems.
As I said last time:
There were two groups and they got entirely different sets of drugs. One group also got rEEG-based treatment personalization. That group did better, but that might have nothing to do with the rEEG: they might have done equally well if they'd just been assigned to [those drugs] by flipping a coin. We cannot tell, from these data, whether rEEG offered any benefits at all.
In the AssureRx paper, we can't even tell whether the two groups got different kinds of drugs, because the meds used aren't reported, but if they did differ then that would offer an alternative explanation for the differences in outcome: maybe the 'guidance' just recommended better drugs overall, with the genes being just a sideshow. Or maybe it's a placebo, as I said.
Moving on, I also wrote...
What's curious is that it would have been very simple to avoid this issue. Just give everyone rEEG, but shuffle the assignments in the control group, so that everyone was guided by someone else's EEG. So you'd give control Patient 2 the drugs that Patient 1 should have got, and vice versa; swap 3 and 4, 5 and 6, etc.
This would be a genuinely controlled test of the personalization, because both groups would get the same kinds of drugs... and it would allow the trial to be double-blind: in this study the investigators knew which group people were in, because it was obvious from the drug choice...It is odd that Little Pharma never seem to do such real vs. muddled prediction studies, as they'd be really informative as to whether their approach is a helpful innovation as opposed to an expensive, meaningless red herring. Hmm.
Hall-Flavin, D., Winner, J., Allen, J., Jordan, J., Nesheim, R., Snyder, K., Drews, M., Eisterhold, L., Biernacka, J., and Mrazek, D. (2012). Using a pharmacogenomic algorithm to guide the treatment of depression Translational Psychiatry, 2 (10) DOI: 10.1038/tp.2012.99
