Thread by @triptogenetica

So @getadrip deleted their tweet about IV and IM medicines for £50, after I asked about regulatory issues.
Emails from "Richard" @getadrip are bizarre.
"We are not currently CQC registered as we do not fall within their scope and have not been informed otherwise by the CQC."

Again from @getadrip :

"All our products are MHRA approved and are prescribed by GMC Registered Doctors or Advanced Nurse Practitioners, all of whom have 10 - 25 years experience in the NHS individually.
"

And:
"There are many Vitamin Drip providers within the UK, some of which have been operating for up to 10 years, they are also not regulated by the CQC ..., please see an example below:
cqc.org.uk/location/1-353…
"
#bonkersMedicine
This is the strangest @CareQualityComm report ever.

And
"We provide Vitamin Drips and Booster Shots to help improve a person's overall health and wellness. There are many articles available with more information on how gut health can affect the absorption of vitamins and nutrients due to various physical and mental stress factors"

And:
"An example of another providers’ page with more detailed information than I currently have to hand is:

revivme.com/clinical-scien…
"
It just gets worse and worse.

And:
"We are currently working very closely with Nutritionists to help develop and further research into the area of gut health and gut absorption of Vitamins and Nutrients.

Please let me know if you have any further questions"

Um, yes?
I've replied as politely as I can.

#EBM

About that bizarre CQC report:

It is for a different service, the "Elixir Clinic":
"The Elixir Clinic Limited is registered to provide the regulated activities of Diagnostic and screening procedures and Treatment of disease, disorder or injury. At the time of our inspection...

...no regulated activities were being provided in the service."
(I think this is probably at least partially because "When the service was started, the founders had intended to offer a private doctor service, but have been unable to retain a practitioner to date.").  
...

And:

"the services provided ... were out of CQC scope of registration and regulation. The service specialised in intravenous and intramuscular vitamin therapy intended to promote and sustain long term wellbeing. None of their services were provided to treat medical conditions."

This is crazy.  The complications of IM or IV administration of anything include local and systemic infection, haematoma etc.  

These are not worth risking, in the pursuit of some nebulous concept of "wellness".

Well humans receive nutrition enterally, not parenterally.  If parenteral nutrition is needed, there's something wrong - intestinal failure, pernicious anaemia, etc - and we're now into "Treatment of disease, disorder or injury", which I thought was regulated by the CQC.

From their own (the @CQCProf's) own guidance on "the scope of registration"

cqc.org.uk/sites/default/…

"
The following WILL constitute the activity of 'Treatment of disease, disorder or Injury':
...
Administration of an intravenous (IV) antibiotic or other IV drug..."

But from the Elixir Clinic report, it seems that isn't actually quite enough to be a regulated activity.  If you claim you're sticking needles and drugs in people to "promote and sustain long term wellbeing" rather than "treat medical conditions", you seem to be in the clear...

Perhaps because the CQC won't touch complementary and alternative medicine with a barge pole?

("What is excluded from... regulated activity?
...
Most alternative and complementary therapy...")

So it comes down to WHY you're doing it, not just what you're doing.

Looking at that bizarre CQC report for the Elixir Clinic helps.
CQC tie themselves in knots to conclude that regulation isn't necessary:

"The products administered at the service were not supported by clinical evidence as they were not intended to treat disease or injury...

Oh, ok!

"The service did not carry out audits to assess the effectiveness of the treatment. Prior to their administration, client treatment choices were reviewed by a clinician to determine if the treatment would be suitable for them" - based on "pursuit of wellness", I guess?

I am genuinely fascinated by this whole business.

Until now I considered parenteral therapies to be entirely "medical", with known risks, which we expose patients to only where we're convinced that there's a specific treatment benefit intended.

Otherwise, what's the point?

Yet the business model basically REQUIRES there to be no clear medical reason for the intervention - to avoid needing CQC regulation - and so @getadrip have to be careful to keep any reasons vague.  

Despite this, you then need doctors to prescribe the IV/IM therapies.

In fact, this highlights the special nature of medical consent.  

Normally our society lets consenting adults do pretty much anything they want to eachother, as long as they consent.  There are very few exceptions. 

Regulated medical activities are one such exception,
...

... because as a society we know these are difficult decisions, and doctor and patient meet as unequal experts.  The doctor, the expert in medicine, and the patient, the expert in themselves. This is the model proposed by Tuckett in "Meetings Between Experts").

I would suggest that safe interventions for general wellness and health are not the sole domain of registered medical practitioners.   

However, specific risky interventions, as treatment for specific conditions, have been reserved as requiring the involvement of a doctor.

The special nature of medical consent recognises that doctors deal with inherently high risk, complex situations.

So, if @getadrip is really only providing benign health and wellness interventions, why would doctors need to be involved at all?

If the special nature of the intervention - IV/IM therapy - requires a registered medical practitioner to assess risk and suitability, then surely you are in the area of medical treatment? 

Otherwise how on earth are these doctors deciding which therapies are suitable?

So, what have I learned?

@getadrip et al highlight an odd quirk in our current regulatory and medical ethical framework.  

Namely, there are some specific interventions that are considered so specialist, or risky, that they legally need to involve a doctor, yet as long as...

...they are not done for any specific treatment goal, but in pursuit of "general health and wellness", they avoid CQC regulation.  If, however, there is clear medical justification for the intervention, then we would be providing medical treatment, which does require regulation!

This has pushed the boundaries of my understanding of medical ethics and regulation.

I'd be intrigued to hear from doctors able to practice in this environment - how does one gain informed consent?

And from patients (customers?) - what are the IM/IVs for? "Wellness"?

The #GP role (in the GMS contract) is "care for the ill, or those believing themselves to be ill". Wellness is therefore beyond my usual scope of practice - but I'm willing to learn!

#EvidenceBasedMedicine #EBM

@CareQualityComm or @getadrip - care to comment?

@threadreaderapp unroll please