Did NZ drug regulator do some laundering for GlaxoSmithKline?

I wrote previously about the hidden bioavailability analysis of GSK's new formulation of Eltroxin (thyroxine). These concerns followed multiple complaints from patients about side effects on the new formulation. Medsafe (the New Zealand drug regulator) had issued an alert, stating that:
"In response to these reports, Medsafe has reassessed the change in Eltroxin formulation and can confirm that the new formulation satisfies all quality, safety, and bioequivalence criteria. In addition, all excipients and excipient quantities present in the new formulation are commonly used in medicines."
GSK stated that
"extensive testing and retesting by GSK has shown that the tablets should be safe and effective when used as prescribed"
However in response to my communications Medsafe refused to discuss what GSK's supposedly "extensive testing" was, the study design or the actual results - citing that the science "is commercial in confidence". Nor it seems were any of the data published in the scientific literature.

Now we have some information about these so called "extensive" tests, courtesy, not of usual science, but through response to a New Zealand parliamentary written question. Still no data, but it now seems that:
  1. Only 36 "test subjects" were studied.
  2. Studies lasted only 48 hours (perhaps long enough to determine bioavailability using measurements of T3 and T4 in blood - but in the absence of any details of study design or the actual results one cannot tell).
  3. It seems that "Almost 25% of the subjects experienced an adverse event when taking the new formulation of Eltroxin, compared to just 8% taking the standard formulation".
Parliamentarians are asking questions.

Member of Parliament Jackie Blue says "the authorities need to explain why this information did not ring alarm bells for them".

My questions would be more fundamental, regardless of the data. Why are we in this position in the first place, and what is the role of a scientific regulator?

See also the excellent Pharmalot on some aspects of this story

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Comments on: Did NZ drug regulator do some laundering for GlaxoSmithKline?

 

Blogger Fiddy said ... (September 17, 2008) : 

"safe and effective"

"commercial in confidence"

"utterly refute allegations"

Do they have a handbook called 'Statements to mislead the public'?

Fid

 

Anonymous busby seo test said ... (November 07, 2008) : 

"safe and effective"

"commercial in confidence"

"utterly refute allegations"

 

Anonymous Dana said ... (December 04, 2008) : 

I think this is the study (scroll way down) you requested via email from medsafe

http://www.medsafe.govt.nz/hot/alerts/EltroxinInfo.asp

not sure when it was made publicly available

 

Blogger Aubrey Blumsohn said ... (December 04, 2008) : 

Well that is a study report but it's not data. It is GSK's representation of some data.

A scientist would want to see

- the data
- the formal study report, methods, detailed methodology
- the data
- the protocol
- the data

This isn't science as usually understood. It isn't even close to a rat's arse of being science.

 

Anonymous Busby SEO said ... (December 16, 2008) : 

If this material is already 100% proved with many different methodology, i think the production and distribution should stop.

 

Blogger Stephany said ... (December 31, 2008) : 

Wishing you a Happy New Year, Aubrey.

Stephany

 

Anonymous Fix Registry Errors said ... (February 16, 2009) : 

They better not show it to public if they are still not sure about it..

 

Anonymous tnomeralc web design toys said ... (March 23, 2009) : 

"safe and effective"

"commercial in confidence"

"utterly refute allegations"

Do they have a handbook called 'Statements to mislead the public'?

 

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