My letter to NICE re- outdated guidelines and their reply

[Flecmac]

In reverse........

Dear

Thank you for contacting NICE about the guideline in development on thyroid disease.

I was sorry to read of your health problems and fully appreciate that you are very keen that we publish a guideline as soon as possible, however we have to follow a set process and so it will be some time before we publish final guidance.

This guideline is in the very early stages so there isn’t any current information about what the recommendations may look like. We have consulted on the draft scope and following the consultation we published the final scope, this is the document that outlines what the guideline will, and will not cover. You can access all of the documents that are available so far in the project documents tab.

The guideline committee (which includes lay members) will now meet to put together the draft recommendations. The cornerstone of our guidance is that it is evidence based, we search specialist healthcare databases and journals for robust, high quality evidence to inform our recommendations. There is more information about how we develop NICE guidelines on our website. So the next stage in the process is a public consultation where stakeholder organisations are invited to comment on the draft guidance. The date for this consultation is to be advised, however the consultation papers (including the draft guidance) will be published on the consultations page. Please revisit the website for updates.

We expect to publish final guidance in November 2019.

In the meantime if you have any further queries you are welcome to contact us again, via email: [e-mail] or telephone: [phone].

Kind regards

Janet

Janet Fahie

Communications Executive

Corporate Communications

National Institute for Health and Care

Sent: 20 May 2018 22:05

To: ThyroidDisease <[e-mail]>

Subject: Query

Dear Sir or Madam

I would be very grateful if you could give me as much information as possible about the content of the publication concerning the assessment and management of thyroid disease which is due November 2019.

I am particularly concerned as I have suffered ill health for 12-15 years due to autoimmune thyroiditis for which my GP and endocrinologist have been unable to offer correct diagnosis, relevant tests and treatment owing to the outdated guidelines set out by NICE.

The hands of the medical professionals are tied because of the existing guidelines and thousands of patients like me are suffering horrendous debilitating health problems as a result. We all have the right to know what is proposed in this publication and we need this as soon as possible.

My GP has tried to request bloods for T3 several times in order to know how to treat with T4, but the labs refuse to give this result based on the TSH result, however this is not a thyroid hormone, it’s a pituitary hormone and is irrelevant when taking thyroxine. It’s T3 that the body depends on for optimal function of every cell!!! T3 must be towards the top of the range but must not go over range, so how can Doctors treat correctly without this vital information?

The whole assessment and management of thyroid disease requires a complete overhaul. There would be an uproar if diabetic patients were treated in the same negligent way!

I would appreciate a prompt informative response as soon as possible.

Yours faithfully

[trelemorele]

November 2019?

Ha ha

I like your letter though. Thx for sharing.

[diogenes Remembering]

The basic problem with the reply to you is that the socalled evidence they rely on is fatally flawed. Note their essential statement - "The cornerstone of our guidance is that it is evidence based, we search specialist healthcare databases and journals for robust, high quality evidence to inform our recommendations". The trouble is that this evidence is largely from randomised clinical trials and meta-analyses (multiple trials put together). These we have found to be uniformly invalidated as to their conclusions because of faulty statistical analysis. Too much to expand on here, except to say that all their analyses fall foul of Simpson's paradox, and data amalgamation error. We have papers in submission fully explaining this situation, which I hope will be accepted; though it will take some humble pie from the mainstream.

[Flecmac in reply to diogenes]

I know. Thanks for your reply. Good luck in your quest!!!

[Andyb1205 in reply to diogenes]

Please be sure to post the papers once they’re available! I look forward to reading them.

[Flecmac in reply to diogenes]

Could you expand on Simpson’s paradox, and who have the papers in submission that you mention? Could I access any of this information anywhere please? Many thanks.

[diogenes Remembering]

This is a bit difficult but I'll try to describe the situation in terms of thyroid function. In virtually all cases other than thyroid, hormone levels (like say insulin and cortisol) can change very widely in one human from time to time according to circumstances (diet & stress). There is in health no widely changing values of FT4 and FT3 in blood over time. Furthermore though for TSH, there is a more strongly changing circadian rhythm, the extent of a change for the individual is much smaller than the extent of the overall statistical healthy range for everyone. This means that for each person, there is a pairing of TSH and FT4/FT3 values, where the pairing is strong, constant and unique to that person. This again means that different people will have different pairings, so that say, a FT4 value suitable for one person is not suitable for another. This also applies to TSH and FT3. That is, the same FT3/FT4/TSH values can have very different implications for different people.

Now let's apply this fact to a randomised clinical trial to discover if T4/T3 combined therapy is superior to T4 only. Suppose we have in our randomised trial 15% of patients who are very good converters of T4 to T3 and don't need high FT3 levels to be properly treated. Then we have 70% who are "in the middle". And finally 15% who need higher FT3 and are poor T4/T3 converters. Now let's give them T4/T3 to compare against T4 only. The sensitive 15% probably will tend to be hostile to T3 because they are good converters and could be easily overdosed. The 70% in the middle will be either hostile, indifferent or supportive, but mainly indifferent. The top 15% will tend to be supportive of T3. But mix all these together and the patients who benefit are swamped out by the large number who are either indifferent or hostile. So the usual finding will show lack of support for combined therapy. But suppose in a group of randomised trials, the proportions of low, middle and high groups are different. So therefore one trial might show a positive response if the poor converters are in a higher number and a negative (hostile)response if the sensitives were in higher proportion. You can get any answer you like, because of the crime of amalgamation bias putting groups of people each with their own unique FT4/FT3/TSH pairings all together and destroying any chance of a valid calculation. This in summary means that ALL randomised trials to test the acceptability of T4/T3 combo treatment fall into this trap. And this argument applies equally to relating TSH, or FT4 or FT3 to propensities for AF or osteoporosis.

This is only the briefest summary with an example, and it forms the basis of our submitted papers described in more detail. In such cases, the higher frequency of say sensitive cases in a panel of random subjects can actually indicate that there are fewer of them (Simpson's paradox). It is a well known phenomenon of false statistical argument using randomisation where it is inappropriate.

[Flecmac in reply to diogenes]

Thank you. It’s a travesty that the guidelines are so unhelpful for us. I am totally stuck!!! Like so many others!!