The most widely used drug in the world prescribed to fight the flu may prove ineffective for many this year, researchers say.
Tamiflu, the mainstay of flu treatment in the US, now may not work to prevent the flu if you've been exposed to someone who already has the flu (such as a sick coworker) or if there is a flu outbreak in your community or in reducing secondary complications such as pneumonia, according to a report published online January 18 in the British Medical Journal (BMJ).
“The Cochrane researchers set out to test Roche’s claim that Tamiflu prevented complications and reduced the number of people needing hospital treatment,”read a BMJ press release. “But their investigation was hampered by Roche’s refusal to provide all of its trial data for analysis.”
Every year, about 25 to 50 million Americans suffer from the flu, WebMD News reports. Symptoms come on rapidly which often result in absences from work and school.
If these symptoms are caught early, usually within first 24-48 hours, doctors can prescribe Tamiflu to treat the stuffy nose, cough, sore throat, fever/chills, aches, tiredness; making them less severe and shortens the recovery time so that people feel better faster.
But the flu can have serious complications ranging from ear and sinus infections to life-threatening pneumonia that may require hospitalization.
ABC news reports that the flu virus usually causes about 36,000 deaths in the United States each year. Pneumonia resulting from flu is usually the fatal complication.
Rome-based physician and epidemiologist Tom Jefferson, MD, along with colleagues at the Cochrane Collaboration pored over nearly 30,000 pages of clinical studies to examine the company’s claims only to be stonewalled.
Tara Iannuccillo, a Roche spokesperson denies Cochrane's allegations, saying that Roche stands behind the “robustness and integrity of our data supporting the efficacy and safety of Tamiflu.
“Roche provided the Cochrane group with access to 3,200 pages of very detailed information, enabling their questions to be answered.”
But their questions weren't answered. They were just beginning. Indeed, Roche did send them 3,195 pages of information covering 10 treatment trials of Tamiflu, but the table of contents suggested that there was more to the story.
"What we're seeing is largely Chapter One and Chapter Two of reports that usually have four or five chapters," Peter Doshi from Johns Hopkins University and the BMJ article's lead author told Medpage Today.
Added Dr. Doshi: “We are no longer sure that oseltamivir (Tamiflu) offers a therapeutic and public health policy advantage over cheap, over the counter drugs such as aspirin.”
"The authors have been unable to obtain the full set of clinical study reports or obtain verification of data from the manufacturer of oseltamivir (Roche) despite five requests between June 2010 and February 2011," Cochrane Collaboration researchers report.
Roche, based in Switzerland, added some $3.4 billion to the company's bottom line in 2009 alone, according to Deborah Cohen, investigations editor of BMJ; much of it spurred by retail sales and the stockpiling of the drug by governments and corporations.
Since 2005, federal and state governments in the United States have spent more than $1.5 billion to stockpile Tamiflu and another antiflu drug, Relenza which has to be inhaled,the New York Time reports.
Fiona Godlee, MD, Editor-in-Chief of BMJ writes that the decisions to stockpile the drug and made it widely available have been based on the flawed evidence.
Scientists at the Cochrane Collaboration recommend that until more is known about the Tamiflu from clinical studies in preventing complications of the flu " health professionals, patients and other decision makers need to reflect on the findings of this review before making any decision about the use of the drug."