A billion-dollar pill useless? Does Roche Pharma hide evidence?
Oseltamivir is the name of this pill- even if you don´t know it, your government will have bought it for millions of dollars. Oseltamivir, better known under its trade name Tamiflu is sold by its Producer Roche Pharma (respectively by Genentech, a member of Roche Group) to treat the flu. It became a „blockbuster“ (a drug sold very often) as it was recommened by the World Health Organisation and then bought by the governments to treat H5N1 (known as „bird flu“) in 2005 and H1N1 (known as „Influenza A“ or „swine flu“) in 2009. Governments spent eight billion dollars on it.
But Tamiflu is of questionable benefit, as the fear of the „bird flu“- pandemic was proved to be unnecessary. 258 people died, and with a lethality rate of 0,1 percent, the Influenza A was no mass-killer either. Tamiflu can be stored up to seven years, which means that the health agencies will soon have to dispose millions of Tamiflu pills that were never needed.
It is very interesting that Tamiflu became such a best-seller because Tamiflu was considered to have a low benefit already when it was approved (USA: 1999, Europe:2002). At that time , studies found out that Tamiflu could shorten the disease by 1,3 days if it was taken for five days. Even tough it may also alliviate the course of disease, this is not easy to measure. In 2000, the FDA (Food and Drug Administration) criticized Roche for its marketing claims. Roche had sold the drug stating it could prevent bacterial pneumonia, one of the most frequent causes of death after an Influenza. In Japan, two teenagers killed themselves after taking Oseltamivr. According to FDA data there were twelve such deaths after the intake of Tamiflu.
The next problem is an increasing resistence to Tamiflu. The European Centre for Disease Prevention and Control said in 2008 that the number of resistent virus types had increased by 14 percent. In 2008/2009 (in the US) the incredible number of 98,5 percent of Influenza-A-viruses were resistent against Oseltamivir.
However, an analysis of ten studies by Lauremt Kaiser (University hospital Geneva) from 2003 seemed to show the advantages of Tamiflu. The study was supported by Roche, it was partially done by Roche, and the data was „analysed“ by Roche employees. The analysis became known when both the WHO and the US Dept. for Health and Human Services relied on it. And the Cochrane Collaboration, an organization of doctors and scientists did it, too. But following a tip by a japanese pediatrician, the Cochrane Collaboration investigated and-surprise!- found out only two of the ten studies had been published in full. And just analysing these studies, the Collaboration could not find any evidence that Tamiflu would moderate the course of disease. Also the advantages of taking the pill as prevention was questionable.
What did Roche do? It refused to publish the eight other studies and the raw data. Well, it actually told the scientists to sign a secrecy contract, and even the existence of this contract was confidential.
Three men, professors named Monto, Nicholson and Hayden, were behind the WHO curtains of the 2004 Tamiflu recommendation, were paid by GlaxoSmithKline and Roche.
A tragic story- governments hoarding a drug, paying billions, and now they are just to throw it away. Patients getting a drug that probably only saved them 1,3 days (or,according to newer studies, only 21 hours), but that had serious side-effects that, according to newer studies, occurred more often. „Experts“ paid by the companies, and companies hiding data. Especially because the EMA (European Medicines Agency) still does not change its asessment of Oseltamivir. And the FDA recently decided to lower the age limit for Tamiflu (from one year down to two weeks (something which the EMA already did a long time ago).
Deutsches Ärzteblatt (german medicine journal), 25th January 2012, page 121 (available at http://www.aerzteblatt.de/archiv/134207/Tamiflu-Eine-unendliche-Geschichte-um-Datentransparenz , includes original texts)
Die Welt (german newspaper) 18th January 2012 „Tamiflu hat schwerere Nebenwirkungen als gedacht“