Flu Update: Tamiflu resistance and Ukraine update
by ilene - December 20th, 2009 12:52 pm
Roche’s Tamiflu and the Swine Flu
By Ilene
Part I: Tamiflu resistance
Part 2: Flu virus changes/Ukraine/update
Tamiflu (oseltamivir) has been a big seller this year, with global sales soaring 362% to $1.93 billion in the first nine months. Driven by the threats of a swine flu pandemic, governments have been stockpiling the drug to the tune of $1.32 billion. (See Efficacy of Roche’s Flu Drug Tamiflu In Doubt, David Phillips):
According to David Phillips:
Allegations have surfaced that Swiss drug maker Roche has misled governments and physicians alike on the efficacy of its popular drug Tamiflu in preventing complications, such as hospitalization from pneumonia or death, in otherwise healthy people afflicted with the flu — seasonal or the H1N1 (swine flu) version. If the company is unconvincing in refuting such claims, more than its reputation could be sullied.
Leveraging global concerns over avian and swine flu, Roche has seamlessly raised awareness of the purported need to treat the complications associated with the seasonal flu too. The company has successfully challenged conventional wisdom — that “rest and aspirin” be the preferred treatment option for seasonal flu — with marketing campaigns that resonate with reassuring efficacy claims for Tamiflu (oseltamivir)… [See Tamiflu media updates].
A scarcity of published data in the medical literature motivated the nonprofit research group Cochrane Collaboration to investigate — and verify — Tamiflu’s alleged efficacy claims, particularly on the drug’s effect on the risk of hospital admission and complications in otherwise healthy people with influenza. The Cochrane review and a linked investigation undertaken jointly by the British Medical Journal and the local Channel 4 News cast doubt on the efficacy and safety of Tamiflu — and also raises disturbing questions on the drug’s promotional and marketing activities condoned by regulators on both sides of the Atlantic.
Investigators disclosed that an often cited meta-analysis used as evidentiary support was based entirely on ten trials funded by Roche, only two of which were published in peer reviewed journals. The Cochrane reviewers could find no independently funded trials of Tamiflu for healthy adults. Troubling, too, former employees of the medical communcations company hired by Roche were alleged to have ghost written some of the manuscripts….
Continue reading Efficacy of Roche’s Flu Drug Tamiflu In Doubt here .
Flu News: D225G Follow-up
by ilene - November 28th, 2009 2:56 pm
In case you missed my latest update on the flu, I’ve added to it here. – Ilene
Flu News: D225G Follow-up
By Ilene with guest expert Dr. Henry Niman
Dr. Henry Niman heads the research company Recombinomics Inc. Recombinomics has a small group of researchers who analyze the sequence data from viral samples isolated from patients diagnosed with swine flu.
I spoke with Dr. Niman last week about the evolution of the H1N1 virus as it circulates through the world’s population. These changes are natural—and Dr. Niman’s research on the subject allowed him to predict how the virus would change as infection rates increase and time goes on. The outbreak in Ukraine was initially described in many media reports as a new lung-blackening "mystery disease," leading to many false and misleading Internet stories. According to Dr. Niman, it was clear from the start that H1N1 was killing an unusually high number of previously healthy young adults.
H1N1 infection seemed to cause more severe illness in Ukraine, and Ukraine officials asked the WHO for assistance. The WHO interfaced with Ukraine labs in Kiev and sent groups into western Ukraine to survey the problem and gather information. As part of the investigation, the WHO sent samples to Mill Hill in London, one of several regional centers that performs genetic analysis for the WHO.
Subsequently, the WHO issued several non-informative reports but held the sequences at Mill Hill for analysis. Dr. Niman wrote a number of commentaries on the rising death toll and the need to make the sequences public. He predicted the deaths would be associated with a receptor binding domain change in the wild-type H1N1 virus (the predominant virus) to a variant form, characterized by the D225G genetic marker. Wild-type H1N1 has a D at position 225 of the viral protein Hemagglutinin (HA), and is referred to as D225. The variant protein, D225G, has a genetic change causing a change in position 225 of the protein. "D" is the symbol for the aspartic acid which is present at position 225 of the wild-type protein. Glycine, symbol G, replaces aspartic acid in D225G variants. Hemagglutinin is one of two surface proteins projecting out from the surface of the virus. The function of the HA protein is to bind viral particles to susceptible cells in the host animal.