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Thursday, September 23, 2010

GSK's AVANDIA IS TOAST... IN EUROPE ONLY

Image: dgmslaw.com



The European Medicines Agency [EMA] announced earlier today that GlaxoSmithKline's Anti-diabetes medication, Avandia is to be taken off the market.

The EMA press statement reads:

The current review of rosiglitazone by the Agency’s Committee for Medicinal Products for Human Use (CHMP) was initiated on 9 July 2010 following the availability of new studies questioning the cardiovascular safety of the medicine.

Since its first authorisation, rosiglitazone has been recognised to be associated with fluid retention and increased risk of heart failure and its cardiovascular safety has always been kept under close review. Consequently, the use of rosiglitazone was restricted to a second-line treatment and contra-indicated in patients with heart failure or a history of heart failure when it was first granted a marketing authorisation as Avandia in 2000.

Data from clinical trials, observational studies and meta-analyses of existing studies that have become available over the last three years have suggested a possibly increased risk of ischaemic heart disease associated with the use of rosiglitazone. Further restrictions on the use of these medicines in patients with ischaemic heart disease were introduced.

So, nothing to do with Shelley Jofre's exposé, "A Risk Worth Taking?" the other week then?

The Yellow Card reports regarding Avandia's adverse effects should have raised alarm bells. If it wasn't for the tenacity of investigative journalist, Jofre, then I'm pretty sure Avandia would be being prescribed today. MHRA/EMA will argue that they knew about it before Jofre's programme - I hope they do because the next question should be, "Why didn't you do anything about it then?"

It took the courage of Cardiologist, Steven Nissen, to confront GlaxoSmithKline officials by unearthing heart risks in piles of seemingly innocuous clinical data.

Today, at least with the EMA announcement, sees Nissen's vindication and leaves Glaxo with red faces.

Remember, Glaxo made an announcement 24 hours ahead of Jofre's Avandia exposé.

On the 'secret tape' the BBC aired, Glaxo issued the following statement:

In pre-publicity materials for the programme, BBC Panorama suggests that this recording is the "secret tape the drug company would rather you didn't hear."

On Friday 3 September 2010, following the issuing of a subpoena (legal request) to Dr Nissen, GSK obtained a copy of the audio recording. The company today (6 September) posted the recording to its website www.gsk.com.

The company has taken this action so that all interested parties can hear all the comments made at this meeting in their full context.

For our part, we regret if any comments made by GSK during this meeting might be misinterpreted as seeking to stifle an independent view of the science around Avandia.

Will there be an investigation into the way Glaxo failed to disclose clinical trial data about cardiovascular risks whilst taking Avandia?

Don't hold your breath folks.

They are Glaxo, they can pretty much do as they please...because the medicine regulators let them until a half hour programme aired on the BBC by a little Scots ankle-biter starts kicking ass.

So what about Americans?

Well, apparently, the FDA are not banning it. They are allowing it to remain on the market with "new restrictions."

It comes to something when the people looking out for the patient can't even agree on whether or not a drug should be banned. Then again, the FDA are a stick of rock, bite into it and see the letters P-H-A-R-M-A written right through it.

For more on Avandia [if you are unfortunate enough to be under the junta of the FDA], read Evelyn Pringle's articles on Avandia . There's 18 of them, some written many years ago.

The regulators have no excuses this time. They, like Glaxo, knew about the risks with this drug. They sat back and touted that the benefits outweighed the risks.

Yeh, right.

In the words of Alan Partidge, "Unberbloodyleieveable"

Fid

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