Tag: stroke

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 Cerivastatin was withdrawn from the market by Bayer in 2001 following reports of fatal rhabdomyolysis.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

Dieter Durand and Susanne Kutter in Wirtschaftswoche feature a disputation between Alzheimer-researcher Konrad Beyreuther and author Cornelia Stolze, who has written a book claiming Alzheimer’s disease does not exist as an exactly defined disease.

While Beyreuther maintains the disease is real and can be clinically separated from other forms of dementia, he concedes that current medications are useless and that diagnosis often is inadequate. Stolze in her book “Vergiss Alzheimer” (“Forget About Alzheimer’s”) states that patients with signs of dementia often are labeled as Alzheimer’s disease patients although they are not, that they receive useless medications, that the real causes of their respective dementias, such as diabetes, depression, stroke, or dehydration, are overlooked and not treated, and that medical doctors make money with unreliable early diagnostic tests. A review of the book is to follow soon – please regularly check the akampioneer.

Joachim Müller-Jung in Frankfurter Allgemeine Zeitung (FAZ) comments on a proposal by several US stem cell researchers in the “Cell Stem Cell” journal. The manifesto calls for establishing a market for human donor egg cells so that scientists can use these cells for cloning experiments. While the purpose is not cloning humans but generating pluripotent human stem cells, Müller-Jung warns that the push will once again put the “cloning humans” debate on the table – a discussion he thinks is needed like a hole in the head. He states there are plenty of experiments already demonstrating that sooner or later it will be possible to generate pluripotent human stem cells for regenerative medicine by reprogramming human body cells.

Martina Lenzen-Schulte, also in FAZ, features the first attempts to use the mirror neuron concept for clinical purposes, e.g. for the rehabilitation of stroke patients to support regain of movement control.

Hildegard Kaulen in FAZ reminds her readers that a substantial part of the research crowned by nobel prizes never received third-party funds. She expresses sympathy with the proposal put forward in “Nature” by Stanford University’s John Ioannidis to either allocate research grants by lottery, by dividing up the money so that each applicant receives the same amount, or simply by handing out money to outstanding scientists with the only specification to use it for research. He criticizes that it has never been investigated which method to allocate research grants is the best and that the current practice consumes too much valuable time that should be spent more creatively on research.

Die Welt reports in a feature by dpa on material scientists of the Technical University Dresden who use wood for pipes that are as strong and resilient as pipes made from concrete. Wood is cut to rectangular blocks, which are heated to 140°C and compressed. Subsequently, all air – which amounts to up to two third of the wood’s volume –  is removed. The resulting panels are then bonded and formed by applying steam. The team led by Peer Haller of the university’s Institute for Steel and Wood Construction calculates that a post carrying 50 tons of weight needs 155 kg of steel but only 28 kg of wood treated with the new procedure.

Katrin Blawat in Süddeutsche Zeitung (SZ) reports that Umckaloabo, an alcoholic extract of Pelargonium sidoides roots, is under investigation by Germany’s Federal Institute for Drugs and Medical Devices (BfArM). The medication, which is sold as OTC in Germany for the treatment of acute bronchitis (with annual sales of about € 40 million), is suspected to cause inflammation of the liver, with six cases reported in 2011.

The New York Times (NYT) this week deals in-depth with the recommendation of the United States Preventive Services Task Force that men no longer should have an annual prostate-specific antigen (PSA) test. Gardiner Harris interviewed the experts involved in reviewing PSA testing, citing Dr. Roger Chou, an associate professor of medicine at the University of Oregon, as saying “the idea that knowing you have a cancer isn’t always a good thing is a very difficult concept for many people.” Chou states that the vast majority of men who have prostate cancer will never be bothered by it. Urologists however view the issue differently, stating the task force chose to focus on the wrong studies and it was wrong to throw PSA testing away.

Last not least, in preparation of the coming common cold season, Ulrike Gebhard in Neue Zürcher Zeitung (NZZ) explains that men suffer from the common cold more often than women. Reason is – according to researchers from Belgian Gent University – that women often carry extra portions of genes from the toll-like receptor (TLR) gene family. As a result, they produce more of the so-called miRNA molecules that support the body in fending off viral infections. The downside of women’s more powerful immune system is increased susceptibility to autoimmune diseases and a more violent reaction to certain vaccines.

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.

Food for Thought: Weekly Wrap-Up

MacGregor Campbell reports in the New Scientist that DNA can stretch to nearly twice its length without breaking and explains how this feature can lead to the development of new drugs to fight cancer. Ferris Jabr in the same magazine reports about the first discovery of a virus infecting nematode Caenorhabdis elegans, a workhorse of developmental biology. The discovery will now enable biologists to study virus-host interactions in this model organism.

The Economist introduces a technology developed by Planar Energy (Orlando, Florida) which turns rechargeable batteries into thin, solid devices by printing lithium-ion batteries onto sheets of metal or plastic. The magazine quotes the company by saying the cells will be more reliable than conventional lithium-ion cells, will be able to store two to three times more energy in the same weight and will last for tens of thousands of recharging cycles. They could also be made for a third of the cost. The trick is done by using a ceramic electrolyte which can be printed and appears solid while it allows free passage to lithium ions.

Matthew Herper in Forbes reports on PerkinElmer’s entry into the DNA sequencing market by creating a service business. Researchers can send in DNA for sequencing by PerkinElmer and subsequently access and analyze the genetic data in a computer cloud. Focus will be on human exam sequencing. Matthew also features a video interview with Mischa Angrist, author of “Here is a Human Being: At the dawn of personal genomics” about what it means to look at one’s own sequence data and whether these data should be private or be available for science.

Also in Forbes, Robert Langreth introduces research by William DeGrado, of the University of Pennsylvania trying to breath new life in peptide drugs to fight infectious diseases. DeGrado uses supercomputer simulation to create antibiotics that mimic natural ones but are far simpler to produce and more stable. The first drug designed by DeGrado, PMX-30063 by PolyMedix to treat staphylococcus skin infections is now in clinical trials.

The New York Times also deals with infectious diseases. Sindya N. Bhanoo outlines efforts of researchers from seven countries to analyze how a single strain of Streptococcus pneumoniae bacteria has morphed over 30 years and spread across the world, as a result of evolutionary pressure by antibiotics and vaccines. Within three decades, the strain turned over about 75% of its genome by recombination and mutation. The study appeared in Science.

German papers feature two stories on drugs that surprisingly show efficacy in indications they have not been developed for: Cinthia Briseno in Der Spiegel reports on a study featured in Science on cancer drug Taxol paclitaxel which is able to stimulate the growth of nerve fibers that have been cut in two. The researchers are now planning clinical studies in paraplegics. Nicola von Lutterotti in Frankfurter Allgemeine Zeitung reports a Lancet Neurology study on Prozac fluxetin which is able support the recovery from palsy in stroke patients.