Monday, September 6, 2010

The murky side of physician prescribed LDTs

Apparently the LDT community are not too happy with DTC genomics for having stirred up the regulatory hornets nest, well maybe that’s not such a bad thing. I have argued previously that physician prescribed tests can be more dangerous and more necessary of regulation than DTC and below is a good case for the argument.

First a huge huge thanks to @laikas for a) her excellent beautifully detailed and analytical posts on the CFS virus story (XMRV & MRV: here, here and here) and b) for specifically asking me and others to comment. I had been aware of the controversy but no more than that so Laika’s request made me read more – my first inclination was that it reminded me of the helicobacter story, scepticism followed by acceptance, cures and nobel prizes, but reading further it unfortunately looks more like the MMR / Autism debacle which was Laika’s comparison.

I’m not going to discuss the various findings here, no point as Laika has done that far better – what I do want to talk about is the commercial test that was put on the market as soon as the paper was published – it’s not a pretty story.

1. Lombardi et al of the Whittemore Peterson Institute (WPI) published in Science. They report the detection of a retrovirus, XMRV, in 68 of 101 CFS patients (67%) and 8 of 218 (3.7%) healthy controls - http://www.ncbi.nlm.nih.gov/pubmed/19815723

2. In the Science paper there is a “Note added in proof”: V.C.L. [Lombardi] is operations manager of Viral Immune Pathologies Laboratory, which is in negotiations with the Whittemore Peterson Institute to offer a dianostic test for XMRV.

3. In the same month www.vipdx.com began offering a $650 test for the XMRV – “essentially 100% accurate…”

4. Four independent follow-up studies failed to find the virus and a 5th found a virus, not the XMRV but related MLV sequences were detected (all detailed here by Laika)

5. WPI group now say that they also find similar variants

6. Vipdx update their test so it now detects “other human MLV-related viruses” (so now essentially even more 100% accurate…)

7. Some things were missed out on the Science “note added in proof”, but they are in Laika’s blog posts, such as:

“Furthermore there is an intimate link between WPI and VIP Dx, both housed in Reno. Vip DX is licensed by WPI to provide the XMRV-test. Vipdx.com links to the same site as redlabsusa.com, for Vip Dx is the new name of the former RedLabs.

Interestingly Lombardi (the first author of the paper) co-founded Redlabs USA Inc. and served as the Director of Operations at Redlabs, Harvey Whittemore owns 100% of VIP Dx, and was the company President until this year and Mikovits is the Vice President of VIP Dx. (ME-forum). They didn’t disclose this in the Science paper.”

So that’s it – basically an unregulated clinical test is being offered to a very vulnerable and exploitable group based on 1 paper on a small isolated sample, with no independent confirmation…on the contrary…and some unfortunate conflicts of interest that were not reported when and where they should have been. They say all profits go back into research but that is irrelevant and meaningless (what are profits? What is left after paying everyone? Also the sales will increase the value of the company they own). But even without the COI – what would happen if 23andMe et al offered a “100% accurate” genetic test for CFS risk (or autism, yes, WPI are getting XMRV into that as well…ouch, just got hit by another bandwagon).

What exactly is wrong:

  • No independent confirmation
  • No demonstration of human-human infection
  • It’s a hypothesis that the viral presence is causal (it could be there, if it is, due to reduced immunity in CFS)
  • Test positive what do you do? Answer: of course some doctors are prescribing anti-retrovirals already
  • Some patients will naturally feel better even if by placebo, leading to testimonials of success
  • There will be alarms about infecting family members to drive sales (and fear). In fact this already goes on, by the senior author (Mikovitz) who says in an email to an individual: “To be clear..I do think even if you tested negative now that you are likely still infected with XMRV or its closest cousin..”

In retrospect this last sentence in the Science paper has an interesting tone:

“Finally, it is worth noting that 3.7% of the healthy donors in our study tested positive for XMRV sequences. This suggests that several million Americans may be infected with a retrovirus of as yet unknown pathogenic potential”.

Updates:

  • Via Twitter: @Vansteenwinckel: yet another commercial test for #xmrv ? pfff http://bit.ly/bFJBlV #mecfs
  • Via Carlitos, who comments below: 1st International Workshop on XMRV. Tuesday and Wednesday, September 7 & 8, 2010, Bethesda, Washington, DC – please go to Carlitos’ blog for more details, it will also be partially videocast