Bending the Curve on the Swine Flu Outbreak

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  • 04/28/2009
For all the talk about slowing down the use of marginally effective techologies to "bend the curve" on rising  health care costs I am surprised (not really) that advocates of comparative effectiveness have not brought up the near mothballing of both Relenza and Tamiflu back in 1999 after NICE nixed both as no better than placebo in reducing death in high risk populations.   That year sadly the UK had an outbreak of flu, Relenza and Tamiflu were in short supply and thousands were sent to hospitals where there was no room.  Hundreds died, waiting in freezer trucks because morgues were filled.  Meanwhile Relenza went on life support and Tamiflu did come back to fight another day, but barely...

Today of course both drugs are the last line of defense against every possible pandemic, from avian flu to today's swine flu outbreak.  Those who think economists can predict with certainty what will work and will be effective for all and for all times now and in the future should remember that human lives are in the balance and, as one NIH scientist has said with regard to developing a vaccine conjugant for swine flu, "this is biology, not mathematics."

Read more here

"GSK sued for 'abandoning' Relenza

Friday , May 14, 2004

Biota, the Australian biotech company that discovered Relenza, is taking GlaxoSmithKline to court, alleging that it failed to properly launch and support the influenza treatment.

After the breakdown of two years of talks between the companies, Biota is seeking an unspecified amount in damages for lost royalty revenues to date as well as future losses for the rest of Relenza's patent life.

John Grant, chairman of Biota, said: "Litigation was the only reasonable option left to us to retrieve the substantial value we believe exists in Relenza."

GSK licensed the product from Biota in 1990 and after its launch, captured 50% of the then emerging market for neuraminidase inhibitor (NAI) flu drugs in 1999/2000. But Biota said product sales went into free fall the following year after GSK cut virtually all its promotional efforts for the drug.

Four years later, Relenza held just 3% of the NAI global market, which in 2003 was worth an estimated $330 million.

In the UK, Relenza suffered the effects of a government-backed campaign promoting free flu immunisations for at risk groups and restrictive rulings from NICE.

In its first ever appraisal in 1999, NICE controversially ruled that Relenza was neither cost nor clinical effective, although it did subsequently recommend use of the drug for at risk groups. A further appraisal in 2002 gave a highly restricted recommendation for both Relenza and its main rival, Roche's Tamiflu.

GSK chose not to challenge that guidance, but Roche went on to win an appeal, gaining a new recommendation relating to flu prevention. But NICE stressed that vaccination remained the most cost-effective defence against flu.

Last year Tamiflu increased its global sales by 184% to CHF431 million after a severe influenza outbreak in Japan and an early start to the US flu season.

Biota's agreement with GSK entitles it to a 7% royalty on GSK sales of Relenza, which last year brought it less than $1 million in revenue. If the drug had achieved Tamiflu's market penetration, Biota says its royalty revenue from the drug would have been $35 million.

Chief executive of Biota and former head of Pharmacia Australia Peter Molloy said: "Relenza was a breakthrough influenza drug that had great potential, but it was effectively abandoned at birth."


CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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