Monday, 3 September 2007

The letter of the Law (but what of the spirit?)

In the light of the previous post, I thought it might be worth reminding everybody just how excoriating (if one was paying attention) some of the commentary of the Health Select Committee's report into the influence of the pharmaceutical industry was. It's a riveting read, if you're into that sort of thing...

The Report is available at, if any readers feel inclined to trawl through the 100+ pages for themselves. Pertinent extracts, in support of my last post, follow:

282. The relationship between the industry and the MHRA is naturally close. There are regular interchanges of staff, common policy objectives, agreed processes, shared perspectives and routine contact and consultation. Many of the senior staff of the MHRA have previously worked with the industry, the main exception being Prof Woods, who became chief executive of the MHRA in 2004. Overwhelmingly, the different parties appeared to speak the same language, with companies determined to observe the letter of the law and the regulators determined to uphold it. Dr Herxheimer stated:

…when the agency was hived off from the Department of Health…the culture became confirmed that the industry is the client and the client must be looked after: quick service, good service, easy contact, etcetera - so it is a closed community in a sense.

283. Such closeness provides the basis of the trust that the MHRA said it relied on as an integral part of the regulatory process. The MHRA Chairman suggested that trust underpinned the stance of the MHRA towards the companies they regulate [my emphasis]. We inferred that this extended to the routine acceptance of companies’ summaries of the results of tests on their drugs as true reflections of the raw data on which they were based.

284. Trust is critical in the relationship between regulators and industry. However, at the heart of this inquiry are the concerns of those who believe that the MHRA is too trusting. Trust should be based on robust evidence; it should be earned rather than presupposed. The evidence indicated that the MHRA examined primary (raw) data on drug effects only if it suspected some misrepresentation in the summary data supplied. It was argued that such trust in regulated companies goes too far: reliance on company summaries is neither sufficient nor appropriate, in the absence of effective audit and verification of data that companies provide. The secrecy surrounding this information is also unacceptable, as Sir Iain Chalmers [co-conveners of the James Lind Alliance] commented:

Denial of access to information held by the [MHRA] puts the interests of pharmaceutical companies ahead of those of patients and prescribers. This is particularly indefensible in the light of evidence that regulatory agencies, supposedly established to protect the public, are acquiescing in biased later publication of the information they hold.

285. Regulatory inertia was clearly illustrated through publication of the findings of the UK’s first ever public investigation into a drug safety problem: the December 2004 report of the CSM’s Expert Working Group (EWG) into the safety of SSRI antidepressants. The Group’s main findings pointed to lack of evidence of risk (rather than risk itself) not least because a number of essential studies had never been performed...


Radagast said...

To my knowledge, the only recommendation of the HSC that was implemented was the introduction of patient reporting of side effects, and we know only too well from Stephen Fawbert's commentary what the limitations of the Yellow Card scheme are.

An utterly inadequate response to the concerns raised. The question is "why?".


Aubrey Blumsohn said...

Well in terms of "spirit" the reported conversation between Galileo and the current head of the MHRA is pertinent:

Gallileo: 'if you won't look through my telescope, how can you deny the existence of the moons of Jupiter?

Head of MHRA: 'if you won't drink my absinthe, how can you deny the existence of pink elephants?'

Honesty be damned.

Aubrey Blumsohn

Radagast said...

Poor Gallileo, he really didn't understand, did he? The reason that the good Professor wouldn't look through Gallileo's telescope was so that he COULD deny the existence of Jupiter's moons!

That, I imagine, was Gallileo's chief problem: Breckenridge and he could think about exactly the same things, even believe in the same objectives, but it is the journey that a person takes to reach a certain conclusion that is more interesting, because it is that that informs on the way that that person thinks.

"Motivation". That was the word I was looking for.


Radagast said...

A stop press on this. It seems that patient reporting had already been introduced by the time the HSC wrote up its report (the pilot scheme is mentioned in the report, anyway).

Looks like the HSC report was completely ignored, then. I wonder why, given that I know from my own experience that many of the concerns raised therein are perfectly valid. It rather looks like the Worshipful Company has used its influence (money) to protect a thoroughly inefficient system.


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