Tag: warfarin

Food for Thought: Boehringer Ingelheim Puts Pradaxa Cards on the Table

When German pharma company Boehringer Ingelheim on November 12 said that 260 cases of fatal bleeding have been linked to its new stroke prevention pill Pradaxa, the figures were taken up by many media as evidence that Pradaxa dabigatran, which was launched in Europe in September this year, was a dangerous drug.

In a courageous move, Boehringer Ingelheim yesterday released detailed data from the drug safety database, data that are usually submitted to regulatory agencies only.

Now that the figures are out, several media have taken up the issue again to put it into perspective. Hartmut Wewetzer in Der Tagesspiegel writes that every drug inhibiting blood coagulation poses the risk of bleeding. Wewetzer cites Christoph Bode, a heart specialist from University Clinic Freiburg, as saying that Pradaxa is lowering the risk of fatal bleeding in the brain to 25%, which is a superior value compared to vitamin K antagonists such as Marcumar and Warfarin, the therapeutic standard of previous decades.

Wewetzer also features Boehringer’s calculation that – based on current data – Pradaxa each year can prevent 3,490 of 4,500 stroke cases among 100,000 patients with atrial fibrillation, but may cause 230 cases of fatal bleeding. In comparison, Warfarin is causing 330 deaths. Based on the sum total treatment duration of Pradaxa, which amounts to 410,000 patient years since market authorization, Pradaxa is causing 63 fatal cases among 100,000 patients and year, much less than the figures to be expected from the clinical study data.

Martina Lenzen-Schulte in Frankfurter Allgemeine Zeitung (FAZ) states that the figures reported do not constitute a scandal: “For one, it is in the nature of things that application of blood thinners can cause severe and sometimes fatal bleedings. And the bigger the number of patients treated, the more such complications are to be seen. … Second, it has to be asked whether the incidence of fatal bleedings following dabigatran administration is within the expected limits and – more importantly – whether conventional anticoagulants would have performed better.”

In her article “Deadly Speculations” Lenzen-Schulte also makes clear that competitors are often keen to scandalize side effects of novel drugs and mentions Bayer’s cholesterol-lowering drug cerivastatin as an example. Cerivastatin was withdrawn from the market by Bayer in 2001 following reports of fatal rhabdomyolysis. These cases mostly were due to combination with fibrate drugs – despite warnings on the label.

“It amounts to incapacitation, if one believes that patients always have to be dictated what it best for them”, she writes. “It would be better to put one’s cards on the table and let the patient decide what he wants and what not.”

Boehringer Ingelheim certainly has been quick to do just this, so that patients now can make an informed decision.

Food for Thought: Weekly Wrap-Up

Electronic waste is proliferating at an incredible speed: In 2007, an estimated 40 million computers became obsolete world-wide and the rapid turnover of cell phones, printers, cameras etc. comes on top. A US-solution to the problem is introduced by William Pentland in Forbes this week: EcoATM, a California-based startup, provides self-serve electronic recycling stations, or “ecoATM kiosks” at shopping malls, supermarkets and other high-traffic areas. Consumers can insert cell phones they want to get rid off and immediately get a quote based on the value of the device in secondary markets. The business model is about to be expanded to additional portable devices.

Rainer Floehl in Frankfurter Allgemeine Zeitung (FAZ) explains that to date, leukemia diagnostics does not take important informative parameters into account. A study in about 1,400 patients with acute myeloid leukemia (AML) led to the development of a risk scale which was subsequently tested in a further 800 patients. The scale comprises factors like patient age, chromosomal changes and body temperature as well as concentration of thrombocytes, hemoglobin fibrinogen and lactate dehydrogenase enzyme. The new scale will allow to stratify patients for aggressive chemotherapy or milder forms of treatment, thereby reducing unnecessary, severe side effects.

Alexander Picker, David Jackson and Stephan Brock in Die ZEIT respond to an article by Martina Keller in the same paper published in January, which dismissed the majority of novel cancer drugs as providing only marginal benefit to the patients while being grossly overpriced and full of severe side-effects. The authors, biologists and managers of Life Biosystems AG (Heidelberg, Germany), a company developing decision support systems for oncologists, point out that judgements like this – frequently found in today’s media – do not take into account the progress which is currently being made with personalized cancer therapies. They state that the diagnostic and analytic advances in this field still have to reach clinics and patients as well as regulatory agencies and insurers.

Malcolm Ritter in Die Welt reports about progress in personalized prostate cancer therapy. To date, a lot of men receive over-therapy such as chemo- and radiotherapy because doctors cannot tell apart aggressive from slowly growing, more benign forms. The article introduces a test developed by Ronald DePinho of Dana Farber Cancer Institute which identifies aggressive forms.

Alexander Wehr in Die Welt reports about a paradigm shift in preventing stroke by using novel anti-coagulants such as apixaban, dabigatran, edoxaban and rivaroxaban instead of warfarin or aspirin. In the same paper, Maria Braun features a study conducted by the University of Toronto showing that bilinguality has a surprisingly high protective effect against Alzheimer’s disease.

Finally, Amy Wallace in the New York Times introduces a start-up still seeking investors that has taught parasitic wasps new tricks. The founders discovered that wasps can be drilled to sniff any volatile substance, even if it is not occurring in the wasps’ natural habitat, and that they are even better in detecting odor traces than dogs. First product of the newly founded company is a device for detecting bedbugs, but the founders think of other applications as well – from sniffing explosives to detecting drugs or cadavers. The company is seeking a modest $200,000 to get the prototype on the market.