TMJ 'dysfunction' - Health implications

"The NHS is paying for thousands of patients with multiple sclerosis to receive drugs that monitoring data suggest are not effective. James Raftery examines what went wrong with the access scheme that facilitated their use

Failings:
The first report on the scheme was published in late 2009, with details of patients’ outcomes for 2005-7.3 Disease progression was not only worse than predicted by the model used by NICE, it was worse than that in the untreated control group.

The primary outcome—the difference between actual and expected benefit as a percentage of expected benefit—was 113%, well above the 20% tolerance for price changes (any value above 0 indicates that benefit is less than expected). The report stated, "The outcomes so far obtained in the pre-specified primary analysis suggest a lack of delay in disease progression."

http://www.facebook.com/notes/ccsvi-in- ... 1295097210

An interesting response from a patient:

"I was diagnosed in 2002 and was enrolled into the drug scheme, I actually thought that I was privileged at the time!
After 18 months on Betaferon I suddenly started to progress a lot faster, unfortunately this coincided with my partner of 24 years leaving me for another man. I put the sudden progression down to the stress I was under, as stress is known to make MS worse. I was seeing my neuro who was running the scheme once a year for about 15 mins, all he did was check my EDSS and write some notes.
I had asked him how the scheme was doing and if the results were good, he told me that it was all going well!
I never had an MRI from diagnosis until 2007, and that was only because I saw a different neuro at my local hospital. I never really got a follow-up to that scan as the neuro moved on, all I had was a copy of a letter that I did not understand anyway.
I have recently seen another neuro at King's College and had another MRI, this time I had a follow-up and the results of my MRI are very good. I have a very low lesion load and no signs of brain atrophy! Pretty much the same as in 2002.

When I asked the neuro why there was no change in my MRI over 7 years, but my disabilities are 20 times worse, he replied by saying, "lesions are only a marker and there are many other things that are involved which they don't understand" He advised me to stay on the Betaferon and not take LDN which I wanted to try, he also dismissed CCSVI and said "I have seen this all before with goats serum and snake venom, it will come to nothing and don't waste your money"

Easy for him to say, he can't tell me why I have progressed or what is the cause of disability, but will gladly keep me on drugs that I now know don't do jack s**t.

He must be aware of this report, the same as my neuro that is running the risk sharing scheme? I have had enough now and will not take any more Betaferon, I will continue to try and get LDN and write to everybody I can get on board with CCSVI.
A procedure to correct an abnormality makes 1000 times more sense than Autoimmune does."

Another respondent says:
"At a meeting here in Ottawa a few days after the CCSVI program on CTV in November, Dr Freedman said, and I quote, "The disease modifying drugs are next to useless". My friend who was there was completely shocked. This report has been around for a while among the neurological community."

This is what professor Ebers said recently about DMD's:
Professor Ebers Wrote
"David Baker ('MOUSEDOCTOR' From Barts, this extract taken from Multiple Sclerosis Research Blog - my comment) kindly sent me some comments attributed to me to which I have pleasure in replying.

The comments are slightly out of context coming from a debate where I was taking the polarised side of there being major doubts about the outcomes used in MS trials.

This is not a matter of opinion really since they have been subjected to careful study by the Sylvia Lawry Centre in Munich using results from some 40 trials, and have also been carefully evaluated in our studies on the natural history of MS where approx. 1000 patients were followed untreated for nearly 30 years on average.

This population evaded so-called disease-modifying drugs as accrual ended in 1984 and by the time they were being promoted they were either too disabled to be considered or had done too well to want them.

In the first instance relapses were unrelated to long term outcome and surely no study should now be published with this as the outcome nor should studies be done in which patients are subjected to risk where this is the primary outcome.

It is clearly unethical by consensus criteria, which reasonably insists that the outcomes have to be meaningful for risk to be taken on, otherwise no result of value to patients can come out of such trials.

This result is supported by there being little from long term followup of the original treatment trials to indicate that relapses are a meaningful indicator of treatment effect when long term disability is considered. After all Long Term disability is the overwhelming medical social and economic impact of MS.

When the Sylvia Lawry results became apparent the response of the International Federation of MS Societies was to withdraw their funding. As contrary to the goals of MS patients and families this might have been, the following points need be made:

1) It was the only databank capable of assessing the results of all clinical trials leading to drug approval at the time and the only one with the raw data – only the placebo arms

2) Contrary to consensus recommendations by journals, almost all the large studies had been carried out with the investigators never having been given the raw data

3) The pharmaco-economics data from Scharr leading to the UK risk-sharing scheme had shown the outcomes were flimsy at best.

So I stand by what I said in the debate but rather than saying the outcomes are worthless it seems more appropriate to say they have not been validated. Frankly this is damning enough and if patients have been promised benefit in the long term, this is overstating the evidence.

Turning to disability, it was clear from the Sylvia Lawry Centre analyses that the definitions used for disability in the trials could not be validated either.

The response of the companies in general was to ignore these findings and continue to execute studies using unvalidated outcomes primarily because they were outcomes they knew they could beat. The Lancet has published several studies using unvalidated outcomes having had its industry funded reviewers reject the papers clearly showing these outcomes have little meaning in the context of the real disability patients fear.

If anyone wants the primary documents showing the flimsiness of the trial outcomes then please have someone who is prepared to distribute them email me for copies of the key papers, almost all of which have attracted editorial commentary, something indicating the editors thought them important.

I think the lesson from CCSVI which cannot be ignored is that the price of losing confidence in the medical system can be great and damaging on both sides of this debate. Physicians who are mystified by all this should keep this obvious conclusion in mind.

Best wishes

Prof GC Ebers

University of Oxford"

Sylvia Lawry founded the US National MS society USA in 1946 and by 1967 the worldwide Multiple Sclerosis International Federation (MSIF) with headquarters in London. The Sylvia Lawry Centre is a repository for clinical trial placebo data, because at some stage it will not be ethical to do any placebo arm to trials, when you have active drugs.