We get mail - the QXCI/EPFX/SCIO silliness

Intrigued by the SCIO/QXCI/EPFX machine we mentioned in Mmegi this week, I emailed one of the South African web sites advertising it.  I said:

We have been asked by a number of consumers in Botswana to investigate whether the SCIO device you advertise on your web site at www.100percenthealth.co.za is the same as the QXCI/EPFX/SCIO device that is currently banned from importation into the USA by their Food and Drug Administration.

Can you also please confirm the connection between the SCIO device and "Professor" Bill Nelson who is currently a fugitive in Hungary, on the run from fraud charges in the USA?

I plan to discuss this in this coming week's Consumer Watchdog column in Mmegi, the national newspaper in Botswana, so I would appreciate a rapid response.

Instead of a response from South Africa I got a reply all the way from Hungary.  It goes like this:

Thank you for sending your email.  Having read through your Consumer Watchdog website, I greatly respect your statement on your Right of Reply page, “It is critically important to us that we get our facts right.”   Therefore, I look forward to you printing the facts as follows.

I think you can live without it being printed.  Here on the blog will suffice.

The regulatory requirements for each country and each device are quite different.  The device that was sold in the USA called the EPFX was very similar to the SCIO, but the registration (granted in the USA in 1989) was different between the USA and the rest of the world (which is typical of many devices).   A summary of the FDA’s reasons are shown on the FDA’s Import Alert link which you reference below in which the FDA state what the device was and was not given marketing clearance.  Therefore, the FDA have put the device on the Import List and it is no longer manufactured.  The manufacturer of the EPFX closed in February 2009.

"Very similar" to the EPFX?  They're the same thing as far I can tell.

The SCIO has a different registration in Europe and the rest of the world as a Universal Electrophysiological System which covers many indications for use approved in Europe.  The website you mention below www.100percenthealth.co.za is advertising the SCIO under the indications for use as approved in the registration. 

William Nelson is the creator of the device.  The situation with his legal status in the USA should not bear a reflection on the device and its safe and effective use.  

Logically, yes, that's true.  It IS possible for a fraud on the run to have invented a device that works. However as he is on the run precisely because this device does NOT work and the claims made about it were (and remain) fraudulent, I think it IS relevant, don't you?

However, William Nelson has expressed an interest to chat with you on the phone if you wish.  To organize this, please write to [email address removed]. 

I've given this a lot of thought but I don't think I can do it.  Talk to him without laughing I mean.

As the Regulatory Manager, I’m responsible for ensuring the safe and effective use of the SCIO in all countries and areas where it is registered and used.  Every year in the Spring we complete an audit to ensure the safe and effective use of the SCIO.  The current registration in Europe expires in April 2011 as European registrations are granted for 5 years at a time.  I am more than happy to answer any more of your questions regarding the SCIO.  However, please keep in mind that I will be at a conference from Wednesday – Sunday October 7-11 and will not get the chance to respond until after the conference..

There you go.  Right of Reply respected.

I still can't see any reason not to describe the SCIO/QXCI/EPFX as a piece of nonsensical, charlatan quackery.  Avoid it.