Tamiflu according to researchers without effectiveness

Study: influenza drug Tamiflu almost without effect

04/10/2014

The flu medicine Tamiflu (active substance oseltamivir) makes almost no contribution to the flu protection, so the devastating judgment of a meta-study of the Cochrane Collaboration. This is reported in relation to the current study results „British Medical Journal“ (BMJ) that, apparently based on enormous greed of the pharmaceutical companies, based on modest clinical data, the drug was massively pushed into the market.

The Cochrane Collaboration scientists are more cautious in their conclusions, but come to the clear conclusion that the protective effect of Tamiflu is extremely low. In addition, the drug has no significant effect on lost working days or the likelihood of in-patient hospitalization. The patients hardly benefited from the intake. „However, there is no doubt that Roche (manufacturer of the vaccine) and its shareholders are very susceptible to Oseltamivir (Tamiflu).“ benefited, so the critics of the authors in the „BMJ“.

Success thanks to fear of imminent pandemic
Tamiflu owes its success above all to the fear of an impending influenza pandemic (in particular the swine flu pathogen H1N1 was considered a potential candidate), which prompted numerous governments to invest billions of euros and to store hundreds of thousands of doses of the active substance, in case of emergency to be able to use. „From today's perspective, the H1N1 strain identified in 2009 has proven to be far less lethal than previously feared and much of the stored drug has never been used“, reports that „BMJ“. Already immediately after the approval of Tamiflu to the flu treatment the drug was heavily criticized from the side effects and the doubtful benefits from different sides. The new study by the Cochrane Collaboration shows that, at least in terms of benefits, the doubts were fully justified. However, the pharmaceutical company Roche has already stated that it does not recognize the researchers' findings.

Worthwhile business with Tamiflu
For Roche, the business with the active ingredient oseltamivir, which was introduced in 1999, was thoroughly rewarding. The „BMJ“ calls one „cumulative sales of over $ 18 billion.“ More than half of total revenue comes from governments and companies that have prepared for pandemic preparedness. In the US alone, $ 1.3 billion was spent on the purchase of the vaccine. „In the top year of 2009, Roche reported revenues of $ 3.6 billion from its oseltamivir business“, according to the information in the journal. The profit margins for the company were thereby - despite the partially reduced selling price - considerable. Not least because relatively few, expensive clinical trials have been conducted, and because marketing expenditures have been very limited, negotiating with a handful of policymakers rather than the usual large number of commercial agents, physicians and health institutions in each country.

Revision of national pandemic plans
The authors in the „British Medical Journal“ called for a new debate on the national guidelines to be adopted in the event of future pandemics. Because the drug has shortened the duration of the disease by a maximum of one day and has shown no effect on the risk of impending complications or the likelihood of hospitalization. However, patients would be at increased risk of side effects such as headaches, kidney problems, nausea and vomiting. Since there have been few adjustments to the guidelines since 2009, there is an urgent need for action. In Germany, the National Pandemic Plan from 2007 is currently being drafted. In addition to the Robert Koch Institute (RKI), the Paul-Ehrlich-Institut, the Federal Institute for Drugs and Medical Devices (BfArM) and the Federal Center for Health Education ( BZgA) were involved.

Storage of Tamiflu questionable
Accordingly, in this country, in view of the new findings, the question arises as to whether the pandemic plan would not have to be adjusted or whether a stockpiling of Tamiflu should continue to be provided for. However, the competent federal states have currently stored thousands of doses of the drug anyway and according to the „BMJ“ In fact, oseltamivir has proven to be extremely stable chemically, so that for many of the large remnants, the original five-year shelf life has been extended by at least two years. Accordingly, be „Significant new pandemic purchases are unlikely to be required before 2016, when the oseltamivir patent has expired in most countries and the drug can be offered cheaper by generic manufacturers.“

In the article of the „BMJ“ One of the lead authors of a Roche-funded study, which claimed that oseltamivir significantly reduces mortality and morbidity in patients treated for H1N1 influenza in the hospital, also speaks. Jonathan Nguyen, who also advised the British government on preparing for a pandemic, said he believes „Furthermore, neuraminidase inhibitors are a useful medication for patients with severe flu.“ Since the Cochrane Collaboration accepted only randomized, controlled trials, the considered data was inadequate. „We had to use the observation data“, Nguyen continues. (Fp)