Efficacy of Roche's Flu Drug Tamiflu In Doubt

(MoneyWatch)  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): reductions in hospital admissions, secondary complications (including bronchitis, pneumonia, and sinusitis), and respiratory tract infections (requiring antibiotics) in otherwise healthy individuals of 61 percent, 67 percent, and 55 percent, respectively, according to 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.

"The right timing is in all things the most important factor," said Hesiod. The folks over at Roche may have never heard of this ancient Greek poet (thought to have lived circa 800 B.C.) but they assuredly know the importance of timing: global sales of Tamiflu (oseltamivir) soared 362 percent to $1.93 billion in the first nine months of 2009 -- driven by the pandemic flu stockpiling of governments worldwide, which totaled $1.32 billion.

As timing can work for you, it can also betray you. Through 2010, Roche is looking for continued strength in Tamiflu prescription growth to help offset mixed sales growth expected from its oncology portfolio and sales declines from the anti-rejection drug CellCept (patent expiry) and the anemia treatment for cancer patients called NeoRecormon (price erosion). Roche recently raised its 2009 and year 2010 sales outlook for Tamiflu from $2 billion to around $2.6 billion and from $385 million to $673 million. If the company is unsuccessful in rebutting the Cochrane Collaboration's conclusion -- scant justification to stockpile a drug unlikely to prevent complications or hospitalization of otherwise healthy flu patients -- Roche could find itself in the middle of a new global pandemic: customer returns of their Tamiflu stockpiles.