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James Raftery: The judicial review of NICE’s appraisal of drugs for secondary treatment of osteoporosis

9 Apr, 09 | by BMJ

The report of this judgment made me laugh out loud several times. Mr Justice Holman twice describes proceedings  as “bizarre”. A key confidentiality agreement with Dr Kanis  could not be found. “Perceived conflicts of interest” led the  removal of  Dr Kanis  from NICE’s Guideline Development Group. Dr Kanis  went on to make a statement expressly “on behalf of Servier”, the company which brought the judicial review. The findings of the judicial review do not appear to go further than  making the confidential data available to consultees.

NICE does not escape without criticism. The Justice stated:
“In my very clear opinion, NICE in general, and Mr Dillon in particular, failed to take all reasonable steps to seek permission from Professor Kanis to release the data … Whilst I afford a margin of appreciation to NICE, they fell outside it. My overall impression is that NICE moved rapidly … (to) … merely going through the motions so they could claim they had done their duty.”

What was going on?
The topic is NICE’s appraisal of drugs for secondary treatment of osteoporosis. Specifically its review of its 2005 appraisal eventually published in October 2008.

That appraisal considered six drugs, recommending  one as first line – alendronate –   in women with confirmed osteoporosis. It recommended use of strontium ranelate only as third line, that is  for those unable to use either alendronate or two other second line  drugs (risedronate or etidronate)  and had specified risk factors.

The issue has to do with  release (again) of the cost effectiveness model. Servier, maker of strontium ranelate, lost an appeal to NICE on this in 2007.

The report of the judicial review brought by Servier shows  that Professor John Kanis, from Sheffield University, provided data to Dr Stevenson, lead modeller at SCHARR, also at University of Sheffield,  “on an unqualifed academic in confidence undertaking as long as the data remained unpublished”. The Justice noted:
“Rather bizarrely, neither Professor Kanis nor Dr Stevenson can now locate     their copy of the signed undertaking… ” (Para 63.)

The other bizarre incident has to do with Dr Kanis publishing an editorial in Osteoporosis International accusing NICE of not replying to him and having a consultation process that was dysfunctional. The report shows that both sides now agree that NICE did send a letter but that Dr Kanis never received it. Nor did he check with NICE as to the delay.

Clearly relations were poor, as described by the report:

“It is part of the background of this case that there had earlier been some falling out between Professor Kanis and NICE. Since 2001 he, with his great expertise in this field, had been part of the original Guideline Development Group (GDG) for this     appraisal. Several years later, in late 2006, NICE removed him from the GDG     because of perceived conflicts of interest, although Professor Kanis had declared all the relevant interests at the outset. By his later letter dated 15 March 2007 … Mr Dillon effectively accepted (and apologised) that he, Mr Dillon, had been at fault in permitting Professor Kanis to become a member of the GDG in the first place. Professor Kanis frankly says at paragraph 11 of his first statement … that he ‘was upset to have been removed from such an important project without what I considered to be a good reason.’ … I am not prepared to impute or assume that Professor Kanis has been motivated in anything he has said or done by ‘a grudge’. But I do bear in  mind in a general way that Mr Dillon had removed him from the GDG. Mr Dillon felt that he, Mr Dillon, had erred and owed an apology to Professor Kanis. Professor Kanis was upset. So relations between the two men may have been strained, and     that seems to be part of the background to the somewhat obtuse correspondence between them.”  (Para 125)

What did the judicial review decide?
The Justice stated that:
“I proceed on the basis that Professor Kanis is a man of integrity who will not now resile or wriggle from what he has said. If, therefore, I were to quash the revised    FAD (Final Appraisal Determination) dated 30 June 2008 I have every reason to suppose, first, that Professor Kanis would permit, on suitable terms, disclosure to all consultees of the fully executable  model and the key data therein; second, that consistent with their avowed aim and  their legal duty of transparency, NICE would give that disclosure on those terms to all consultees; third, that NICE would receive and evaluate any comments that any consultee may submit in response thereto; and fourth, that in the light thereof NICE would reconsider and, if they think fit, further revise the FADs.” (Para 144)

(What does  “resile” mean?

resile

1. To spring back, especially to resume a former position or structure after being stretched or compressed. 2. To draw back; recoil.)
http://www.thefreedictionary.com/resile )

What is one to make of all this?
Be careful – these people sue!. Note my use of “…”as indicating   omission of irrelevant detail in the quotes.

But try the following questions?

Can one not be impressed by the Justice calling Dr Kanis “a man of integrity who will not now resile or wriggle from what he has said”. Won’t Dr Kanis  have to permit disclosure of the model and key data therein? And won’t NICE disclose it to stakeholders in confidence, receive and evaluate comments, reconsider and if they think fit, revise the Appraisal?

Will it make any difference? Given  that the most recent technology appraisal reached largely  the same conclusions as the earlier appraisal, does this not  indicate that the WHO data made little difference?

What was the relation between the technology appraisal and the guideline development group?

And what did it all cost? Surely is a question for Servier Laboratories?

James Raftery is a health economist with several decades’ experience of the NHS. He is professor of health technology assessment at Southampton University. A keen “NICE watcher,” he has provided economic input to technical assessment reports for NICE but has never been a member of any of its committees. The opinions expressed here are his personal views. He welcomes comments to his blog.

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