My letter to the CDC concerning Kaiser Permanente still recommending GET

But of course it's treatment (GET much more so) that might benefit some (albeit very likely misdiagnosed in the first place) but will in much more likelihood cause harm (maybe serious harm) to others, who they have no way of identifying prior to being harmed; in effect a form of destructive testing ... on humans! If we could only convince people of this, they might then see the stupidity of recommending an exercise based treatment that has absolutely not been proven to be safe! Using treatments with strong indications of harm, yet never been proven safe, is incredibly irresponsible and callous. Hopefully they might - for their own preservation from future litigation at least - see sense. If they could be convinced to remove GET, then that would be the biggest achievement - the rest would follow on from there.

 

Note PACE reanalysis showed them to be ineffective for any group.

 

I'm convinced you are correct: GET harm is the key. PACE has been discredited, but that isn't enough.

We need an official statement that GET can cause patient harm. In my email to Healthwise, the evidence I used was a quote from the New York State Health Commisioner, Howard A. Zucker, M.D., J.D.:

But Healthwise didn't seem to acknowledge the authority of a state health commissioner.

The IOM report never directly discussed the dangers of GET. And so far, the CDC has been mostly silent on this topic as well.

In my opinion, we need the CDC (or NICE) to step up to the plate and make a statement about potential harms from GET for ME/CFS patients. Perhaps (very optimistically) the CDC will include a GET warning when they update their guidelines for healthcare professionals.

 

Perhaps thats where you could refocus your energies?

 

Yep. Which is why I am in favour of Sarah Myhill's efforts to get people's written confirmations of harm due to GET. Maybe she has a few less than perfect characteristics, but if she could pull that off it would be fantastic. Proving treatments to be ineffective doesn't seem to be enough to pull down the BPS faction, which seems to be a stupefyingly abominable truth (bullsh*t baffles brains). But there is a major shift in culpability between:

• Using a treatment that you claim is effective, but is not actually proven to be. (People will argue the worst is that people don't benefit).
• ... versus ...
• Using a treatment that has not been proven adequately safe, whilst wilfully ignoring all manner of indications it is harmful, in some cases very harmful. In any other arena, people would be hauled before the judge for this - vehicle design, civil engineering, etc.

It's the major difference between passive non-effectiveness of a treatment, versus actively harmful effect of a treatment. Surely this must have some precedent in law! People can prevaricate until the cows come home (as they are doing for ME) over the former, but much harder to do so if a solid case can be demonstrated for the latter.

As I've said before, it is not about proving the safety of GET before anything can be done, because the burden of proof falls on the transgressors to prove the safety of GET (to within adequate safety thresholds) once sufficient indications of harm make it clear such safety investigation is needed.

When I look on the information leaflet of any medication I take, it will have relative risks of side effects included, even down to "Frequency not known". Rarely is anything 100% safe, but the homework has been done to include such information on the leaflet. If we (i.e. the whole ME/CFS community) could force the need for formal collation and documentation of potential harms for GET, then the very recognition and process of having to recognise the existence of such risks of harm ... would become a self-fulfilling exercise in discrediting GET as a treatment for ME, and discrediting the those so wedded to it.

We need a tighter focus on a less defensible target, and GET is it I think. (Maybe call it TarGET ).

 

Here are few scrambled ideas. I am having trouble thinking tonight.

Yes agree, similar to a “black box warning”

You could also try reading about IRB’s and informed consent to get some ideas.
https://en.wikipedia.org/wiki/Institutional_review_board

Essentially without a bio marker, and no FDA approved treatments, we are all human guinea pigs.

Maybe you could try writing Health and Human Services, since they are the largest government body (CDC, FDA, NIH, all report up to HHS).

Possibly we could also ask that a PwME be required to sign an informed consent form because using exercise as a prescription, (when no FDA drugs are approved) may cause death or permanent damage.

I wish I could formulate better, what I am trying to say. Quoting sources of existing rules and regulations may be your best best, in convincing HHS, to step up.

And... how about contacting CFSAC? Possibly they might have an idea of where to start?

 

I'm a bit sceptical about this when, in the UK, hospital departments are being closed - A&E and maternity services for example - and when in some cases hospitals and ambulance stations closed/merged to save money. I suspect it's more that something has to be seen to be done about us without costing anyone too much financially or politically. It suits them (so far).

 

An update. As recommended in the CDC response email, I did contact the California Department of Public Health with a complaint about my healthcare provider continuing to recommend GET for ME/CFS.

I received a simple reply: "Thank you for contacting the California Department of Public Health. You will receive a response within two business days."

It's now been 2 weeks, and still no answer. The email was sent from moss-donotreply@cdph.ca.gov, so apparently I can't reply to tell them they forgot to send a response within 2 business days.

 

Use your original method of communication. I have no idea if they work this way but in some organizations the inquiry determines which department a communication is sent to, your unanswered message probably went to one department and a subsequent one saying there was no reply may go to an ombudsman department.

 

May I suggest you call them starting today, and every day, until you get an answer?

https://www.cdph.ca.gov/Pages/contact_us.aspx

If you are able to set up a meeting with them, in person, I will attend it and be your spokesperson. I have a personal grudge against KP, so am highly motivated.

 

It would have been nice if somewhere along the process I was given a case tracking number that I could refer to. Not to mention I had to submit 3 times on CDPH website before it went through without an error.

When I have more energy, I may revisit this.

 

Indeed

fair enough

 

@Webdog

Did you see this thread? It might be good information (references) to include in a letter.



https://www.s4me.info/threads/artic...cians-winter-2018-family-doctor-journal.2315/

http://www.nysafp.org/NYSAFP/media/PDFs/Family Doctor/Family-Physician-Winter-2018WEB.pdf

Start at page 23

 

@MErmaid

Sorry to hear they are still bricks but grateful you are still pushing on this.

I was going to suggest the New York State Family Physician article. Also, if they need additional evidence, this article provides a more detailed summary with references of why recommendations for CBT and GET in ME/CFS clinical guidance such as this are a problem.

 

Wow!!! That’s impressive!!

 

Good suggestion, I will include this when I have contact again with the California Department of Public Health. I did, however, already include the NY State Health Commissioner comments, which were from last May.

The CDC made it rather clear in their letter to me that they were leaving it up to individual states to determine ME/CFS treatment recommendations.

NY is one state down. Only 49 to go. But hopefully it's like dominoes, and other states will follow New York's lead.

 

In the letters Simon Wessley wrote re GET, I'm sure there is a statement where he admits that the treatment may harm some ( but then did not do anything to mitigate this risk) @Valentijn , @Esther12 may be able to point you in the right direction. Hopefully my memory is not completely shot!

 

I don't remember him saying that. Sorry. Do you mean one of his letters about the PACE controversy, or before that?

 

No. Someone quoted him saying something sort of like that, but Wessely was raising the possibility solely to dismiss it. He was not stating or agreeing that GET could be harmful.