{"id":47731,"date":"2014-07-02T20:30:29","date_gmt":"2014-07-03T00:30:29","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=47731"},"modified":"2014-07-02T20:37:06","modified_gmt":"2014-07-03T00:37:06","slug":"wisdom-here","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2014\/07\/02\/wisdom-here\/","title":{"rendered":"wisdom here…"},"content":{"rendered":"
Before now, J&J et al’s TMAP scheme to sell Atypical Antipsychotics to our government programs held the lead in pharmaceutical greed. But they only replaced a "just as good" generic with expensive in patent<\/em> drugs. Roche jumped way out front with Tamiflu®<\/font><\/strong>, a drug essentially inert as a life-saver sold to governments by the barge load to save us from a flu epidemic. The story of the Cochrane quest to bring this drug’s worth to light is one of the century’s better scientific achievements [as well as a passable good sleuthing story]. So Roche’s rapid response<\/a> to the BMJ is more than just a day late and a dollar short<\/em>: <\/div>\n
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Roche Strikes Back at Study That Criticized Tamiflu Stockpiling <\/a><\/div>\n
Pharmalot WSJ<\/font><\/strong><\/div>\n
By Ed Silverman<\/div>\n
July 1, 2014<\/div>\n

Three months after a study concluded the widely used Tamiflu®<\/font><\/strong> treatment was not proven to reduce the spread of the flu or its complications, Roche has struck back by calling the analysis “seriously flawed” and warns the conclusions could lead to public health risks by confusing patients and physicians. In a letter<\/a> to the British Medical Journal, which published the study, the drug maker claims the authors made “basic errors” in assessing effectiveness data, “over-interpreted” the “limited” safety data that was evaluated and “wholly ignored” other types of data in reaching their conclusion.<\/p>\n

The study authors “have drawn many conclusions that would not be supported by a methodologically robust and comprehensive analysis of all relevant [Tamiflu®<\/font><\/strong>] data,” Roche scientists wrote. “Equally important, they have not exhibited the diligence necessary when working with large clinical trial datasets and extensive regulatory documents.”<\/p>\n

The missive was made in response to a study<\/a> by the Cochrane Collaboration, a non-profit, global network of health care academics. They concluded that Tamiflu®<\/font><\/strong> was no more effective than aspirin, and one of its authors said governments that stockpiled the drug had thrown money “down the drain.” The study, however, did not question the ability of Tamiflu®<\/font><\/strong> to treat flu symptoms.<\/p>\n

One of the Cochrane researchers wrote us that the authors stand by their conclusions. “Their response was disappointing window dressing designed for those who do not know the story,” Tom Jefferson, a study co-author, wrote us. He adds that a complete rebuttal will soon be provided in BMJ.<\/p>\n

Tamiflu®<\/font><\/strong> was approved by the FDA in 1999 and became a big seller several years ago as governments moved to stockpile the treatment in the wake of the H1N1 swine flu pandemic. This prompted the Cochrane researchers to assess the effectiveness. They analyzed results from 46 of 107 trials pertaining to both Tamiflu®<\/font><\/strong> and Relenza<\/font><\/strong>®<\/font><\/strong>, a less widely used flu drug sold by GlaxoSmithKline.<\/p>\n

But their study was released only after they battled, sometimes publicly, with Roche over access to Tamiflu data, because most of the trial information was unpublished. The episode, which played out in the pages of BMJ as the researchers often chronicled their efforts to convince Roche to release data, became a linchpin in the wider debate over access to clinical trial data harbored by drug makers.<\/p>\n

As a result, the European Parliament recently passed a law requiring drug makers to publish all clinical trials related to a drug, but only those approved since January 2014. Both Roche and Glaxo now say they are committed to publishing all clinical study reports on all their drugs, although some Cochrane researchers have also squabbled with Glaxo about data for its Paxil antidepressant.<\/div>\n<\/blockquote>\n
If you don’t know the whole story, here are a couple of catch-me-ups…<\/em> <\/div>\n