Saturday, July 25, 2009

Swine Flu - A beneficial crisis

Swine Flu - the beneficial crisis
With swine flu hysteria in full flow, we've seen a strange consensus amongst western governments which would seem to fly in the face of the facts. Normal common-or-garden seasonal flu has a mortality rate of around 1 in 1,000, while swine flu at the current time has an apparent mortality rate of between 1 in 4,000 and 1 in 12,000. OK, so it's silly season for the media. Parliament is in recess, government ministers are relaxing in Tuscany, and there's very little for the phalanx of journalists remaining in Westminster to report. But is this sufficient to explain the hysteria?Not really.

There is a clue as to the reason why contained within a little publicised decision by the European Medicines Agency (EMEA), the London based EU organisation which dictates what can and cannot be used in the EUs national health services. On the 8th May, it authorised an extension to the shelf-life of Tamiflu from its current 5 years to 7 years. Although it was reported in specialist trade publications directed at the pharmaceutical industry, there was no wider announcement, and in fact this alteration, which required the approval of the European Commission, did not appear directly in the Official Journal of the European Union in its own right. Instead, it appeared as an amendment to the marketing authorisation in summary form only, along with amendments to 65 other approved medicines - in effect, it was hidden in the middle of a list of trade names, with no indications as to what action had in fact been approved. Tamiflu is the primary antiviral drug used to combat Influenza A virii, and is the trade name of oseltamivir or oseltamivir phosphate. I have used the trade name throughout as it is easier to type!

The tale, however, got even more interesting. The EMEA had authorised this extension for all doses of tamiflu manufactured since 2002. Since 2002? Doses manufactured in 2002 would have date expired in 2007, so why on earth was it still held in stock, given that it would, by the date of the EMEA decision, have been 2 years out of date?

The answer can be found in the governments purchasing of antiviral stockpiles following the 2005 H5N1 Avian Flu scare. By late 2005, the British government had 14.6 million treatment doses (at a cost of around £238m, according to NICE costings of £16.36 per dose). This stockpile had been purchased on the open market, and included stocks held by manufacturer Roche, some of it dating back to its first authorisation for the European market in 2002, and having a date expiry in 2007. This must have been the case, as Roche themselves admitted to a 12 month lead time on the preparation of Tamiflu caused by the source of its active ingredient which comes from Star Anise. While it is not possible to be precise as to what percentage of these stocks expired in which year, a clue could be contained within a further order, placed by the British government in 2007 for an additional 14.7m doses of antiviral drugs, predominantly Tamiflu. While the public reason was to extend the stockpile of antiviral drugs available for public use, it is inescapable that at least some of this was to replace date expired stocks from the 2005 purchase. The real question must be why those date expired stocks were not disposed of at the time of expiry unless the government already had some indication that a future extension to shelf life would be granted ahead of the 'clinical' inquiry by the EMEA two years later?

Was this a purely British problem? It would seem highly unlikely. The French government had built up a similar stockpile of Tamiflu in 2005, and while the German government only held 3m doses because of a lack of availability, it had purchased a considerable stockpile of Relenza, another antiviral drug. Does this mean the German government had escaped? No. Relenza was noted by the Canadian Broadcasting Corporation as having a shorter shelf life than Tamiflu and, indeed, the EMEA, on the 8th June 2009, agreed to allow a shelf life extension to Relenza along the lines of that previously granted to Tamiflu, meaning that the German governments considerable stockpile could also be used up rather than discarded.

To put this into perspective, one must look at the cost involved. The British governments 2005 stockpile, as mentioned above, cost UK taxpayers around £238m. The French governments stockpile is of a similar size and cost, while the German governments Relenza stockpile would have cost rather more, as Relenza is difficult to administer and has a higher base cost than Tamiflu. Just these three governments stockpiles are worth more than £750m and, as WHO guidelines recommend similar coverage levels of antiviral drug stockpiles, it is not unreasonable to assume that across the EU governments are sitting on date expired stockpiles worth in excess of £2.5 billion. These figures reflect only those drugs purchased in 2005, not the subsequent increase in stockpile sizes of 2007, which must contain drugs manufactured in 2005/6 and worth, in the UK, the same again: raising British government exposure to almost £500m!

I am not familiar with the allocation of resources in national health services outside of the UK except in the broadest sense, so I can not comment on whether they have the same problems with the 'postcode lottery' of available treatments which the British NHS suffers from. However, the political fallout in the UK from having to dispose of almost a quarter of a billion pounds worth of date expired medicines would have been considerable, especially to those denied cancer treatments on cost grounds: particularly as there would be further disposals required as the 2007 purchased stockpile approached its expiry dates from 2010 onwards. The solution? Keep it in stock, cross your fingers, and hope for the sort of beneficial crisis which the European Union excels in exploiting.

And then along came Swine Flu, an H1N1 strain of the Influenza A virus. By far the largest group of at-risk patients is the over 60's, and yet this group already has an in-built immunity to this strain, as it was prevalent in the 1950's. Governments who had invested heavily in now date-expired Tamiflu must have breathed an enormous sigh of relief, for although Swine Flu was less dangerous than seasonal flu, and although Tamiflu only shortens the symptoms of those already infected by a day, it provided an excuse to rid themselves of what had become an enormous white elephant without political repercussions. By stirring up the media, a not difficult task for newspapers who otherwise face a summer of newspapers to fill without political content because of parliamentary recess, a huge increase in public demand for Tamiflu can be created which will not only clear date expired government stockpiles, but also manufacturers stockpiles. The net effect? Tamiflu can be re-ordered to replace the soon to be depleted depleted stockpiles, the political embarassment of disposing of upwards of £250m of otherwise useless medicines is avoided, and the problem is safely shuffled off 5 years into the future.

Is this the full extent of the story? No, not exactly. Leaving aside the political ramifications of the use of Tamiflu, there are other dangers inherent in widespread public use: side effects include suicidal behaviour, cyanosis and sudden infant death syndrome, amongst others. For more details on this and other associated issues, please check back here tomorrow, or subscribe to this blog for automated updates.

Reference Material:
EMEA extension of shelf life:

Official Journal of the European Union announcement:

CBC article discussing shorter shelf-life of Relenza:

NICE treatment costings for Tamiflu:

Details of UK stockpile:

Details of stockpile size in 2005 and its manufacturing dates: - the final paragraph quotes Roche as stating that because of manufacturing lead times, stocks must be anticipated at least 1 year in advance

Government announcement of further purchase in 2007:

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