Press Release, April 17, 2012
Coalition against BAYER Dangers (Germany)
Bayer Annual Stockholders' Meeting on April 27
Coalition introduces Countermotion on blood thinner Xarelto
Concerns regarding the safety of the anticoagulant Xarelto have not been dispelled. Trials carried out with the drug have resulted in a number of fatalities. Dubious practices are also being used to market the product. There are justified fears that a high-risk, over-expensive product with no additional therapeutic benefit is being forced onto the market. The BAYER Board of Management bears responsibility for this.
Christiane Schnura from the Coalition against Bayer Dangers: The numerous reports of vascular occlusion, bleeding, cardiovascular problems and liver damage make it inadvisable to use Xarelto on a wide scale for the prevention of stroke. Products that do not offer any advantage compared with older products should on principle not be given regulatory approval.
Advisers from the US Food and Drug Administration (FDA) recently came to the conclusion that Xarelto offers no additional therapeutic benefit compared with the anticoagulant warfarin, which has been in use for many years now. Xarelto is unable to prevent strokes any more frequently than the established, inexpensive products. Furthermore, no long-term studies exist on Xarelto's side effects. In the opinion of the FDA experts, the studies submitted by BAYER raise questions in particular about the risk of heart attacks and bleeding.
According to a statement by the FDA experts, the study (Rocket-AF) submitted by BAYER shows comparable efficacy between warfarin and Xarelto only because the patients treated with warfarin had not received an optimal dosage. In major orthopedic surgery, patients exhibited a high risk of thromboembolism. Moreover, Xarelto caused more bleeding than established products.
BAYER also wants to use the product as a general therapeutic drug to combat venous thrombosis. However, for this application, too, no evidence has yet been provided that Xarelto has any advantages over the drugs currently in use. The sole aim of the so-called Magellan study, says BAYER, was to demonstrate, for the over 3,400 participants in the study, that Xarelto "was not inferior" to the comparator drug. However, even BAYER says that the product did not display "any consistently positive risk-benefit profile."
BAYER is also currently endeavoring to obtain approval for the follow-up therapy of acute coronary syndrome (ACS). The drug, in combination with another therapy, is said to prevent the renewed formation of blood clots in the coronary arteries. However, the trials also clearly revealed the risks of the drug, as trial subjects taking Xarelto suffered severe bleeding more frequently than those taking the current standard medication.
The approval process for Xarelto was difficult from the very beginning due to the many side effects and unclarified long-term effects. In India, at least four people taking part in the Xarelto trials have died. In each case, BAYER paid the surviving dependents a mere USD 5,250 as compensation. In the United States, therefore, Xarelto will be marketed with a warning that patients should not stop taking the drug without consulting a physician, as there is otherwise an increased risk of strokes occurring.
There are considerable price differences: The present standard drug warfarin costs 25 cents per tablet in the United States, compared with six dollars for Xarelto.
Criticism should also be levied against the marketing practices used for Xarelto. In Germany BAYER distributes unsolicited samples to general physicians on a considerable scale. This is a clear infringement of the German drugs law. The legislation requires that samples may only be sent on written request. BAYER bypasses the law by enclosing with the sample what looks to be a receipt note, but turns out to be a sample request.
The Bayer Board of Management bears responsibility for the irregularities described here. Its actions should therefore not be ratified.
=> countermotion on BAYER website
=> Use of Anti-Clotting Drug Should Not Be Expanded to Prevent Strokes
=> Deadly Xarelto studies in India