Tag: Martina Lenzen-Schulte

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 Cerivastatin was withdrawn from the market by Bayer in 2001 following reports of fatal rhabdomyolysis.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

Solar cells can become cheap bulk ware, even for developing countries, writes Manfred Lindinger in Frankfurter Allgemeine Zeitung (FAZ). He introduces a technology for printing a sheet of zinc oxide, a polymer containing fullerenes and an electrode made from polymers on paper. The technology developed at Technical University Chemnitz can use ordinary printing machines and paper, and the resulting solar paper can be bended and folded. However, the efficiency is still very poor (1.3% at 5 V compared to 10 or more with conventional ones). Life span will amount to a few months. For other approaches to make cheaper solar cells, see this post.

Martina Lenzen-Schulte, also in FAZ, explains how measle viruses leave cells to enter the airway. Today it is known that they do not proliferate in the outer epithelium cells but in lymph nodes. The way back is facilitated by the membrane protein nectin-4, which acts as a transporter carrying the virus through epithelial cells. Lenzen-Schulte also reports that the effect may explain why cancer cells, which often overexpress nectin-4, are vulnerable to measle and other viruses. This might pave a way to develop new oncolytic viruses.

Ernst-Ludwig Winnacker, the nestor of the German biotechnology industry, makes the case for green biotechnology in the weekly Die Zeit. Winnacker criticizes the concept of coexistence that tries to avoid a blending of genetically modified and conventionally bred plants by defining a minimum distance between cultivated areas. In Germany, a farmer cultivating GMOs is liable for every case of cross-breeding, a provision that effectively prohibits GMO cultivation as there is a zero threshold for “contamination”. Winnacker also criticizes the strategy of patenting genetically modified plants instead of protecting them with the traditional plant variety rights that allow for exemptions for the further use of GMOs by breeders and farmers. Green biotechnology, he writes, has – at least in Europe – become the scapegoat for everything that is wrong with modern agriculture, from monoculture to declining biodiversity to the death of bees, although Europe is almost free from GM plants. As 25 years of research into the risk of green biotechnology have not been able to reveal any real danger, Winnacker proposes to amend the German law on genetic engineering and to simply omit the measures restricting the cultivation of GMOs.

Diabetics may soon be able to measure blood sugar without pricking, reports Der Spiegel. A new technology developed by researchers of John’s Hopkins University enables measuring of blood sugar in tear fluid.

In Wirtschaftswoche, Matthias Hohensee introduces US-based 23andme company which offers genetic testing at a rate of $99 plus a flat fee of $9 per month for access to the data. The company, which was criticized for exaggerating the benefits of personal genetic testing, also changed its business model and is now offering its records comprising the data of 125,000 people for research purposes, e.g. to find out why certain hereditary diseases display incomplete penetrance in different carriers of the respective genes.

Theres Lüthi in Neue Zürcher Zeitung (NZZ) reports on clinical studies by Roche and Novartis in people suffering from Down’s or fragile X syndrome in an attempt to improve cognitive abilities.

Alyson Krueger in Forbes reports on a talk on synthetic biology given by Andrew Hessel of Singularity University during the Technonomy 2011 conference. Hessel describes synthetic biology as computer-assisted genetic design that goes from an idea to printing DNA to ultimately booting DNA and forecasts it will render the task of engineering life as straightforward as programming software, or creating a vaccine as simple as Tweeting.

Alex Knapp, also in Forbes, describes a “cyborg yeast” designed by researchers from the University of California at San Francisco and ETH Zurich, Switzerland. In the yeast, the expression of a certain gene can be switched on and off by different shades of red light. The technique may lead to advances in the production of proteins by yeast cultures.

The Economist reports on the first computational pathologist which can can distinguish between grades of breast-cancer cells to provide a more accurate prognosis than a human pathologist can manage.

And finally, scientists found a single gene which can make you appear kinder, reports Catherine de Lange in New Scientist. In experiments conducted at the University of Toronto, people with the so-called GG version of the oxytocin receptor gene were judged to be kinder than those with GA or AA versions. Those with GG variations used significantly more non-verbal empathetic gestures in their storytelling such as smiling and nodding which made them appear kinder.

 

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

Joining the recent denunciation of personalized medicine in Süddeutsche Zeitung (SZ), Der Spiegel this week follows suit. Markus Grill and Veronika Hackenbroch cite Dr. Baerbel Huesing, Coordinator of Business Unit Biotechnology and Life Sciences of Fraunhofer ISI, as saying that the concept of personalized medicine is a “battle cry” of public relations: “Whoever invented it needs to be congratulated.” She added: “It is not a paradigm change. There is not that much in it. However, it is very well suited to justify to Jane Doe the enormous investments made in genomics – similar to the teflon-coated frying pan which was used as an excuse for manned space research.” As an example, Grill and Hackenbroch cite a study from 2009 in colon cancer patients, stating that adding Erbitux to the treatment scheme of patients selected by a concomitant Qiagen test resulted in a survival improvement of 4 months: “Is this a medical breakthrough? Is this what  progress looks like, bought by spending billions?” Instead, Grill and Hackenbroch recommend spending money on better care at home and better palliative treatment. The article ends with a quote from Wolf-Dieter Ludwig, head of the clinic for hematology, oncology and tumor immunology at Robert-Roessle-Klinik in Berlin: “Up to date, the concept of personalized medicine is an empty promise in the first place.”

Harro Albrecht and Sven Stockrahm in Die Zeit feature the suspicion expressed by medical doctors and competent authorities in the EU that the flu vaccine Pandemrix might cause narcolepsy, in particular in children and young adults. Already, EMEA issued a recommendation to use Pandemrix in children and adults under 20 in exceptional cases only. While there were only two reported cases of narcolepsy among children in the US, there were more than 300 in the EU, with 70% of those cases coming from Scandinavia. Narcolepsy is an autoimmune disease, predominantly in humans with a certain genetic modification, and the authors feature the theory that the adjuvant used in the vaccine might have induced the disease in these patients. However, the genetic variant known does not have a bigger frequency in Scandinavia.

Sven Stockrahm, also in Die Zeit, features miniature, flexible electronic devices that stick to the skin by physical means. They can be hid by a tattoo motif and are able to measure and transmit physiological data for medical purposes. One company developing these devices is mc10 Inc. in Cambridge, Mass.

Martina Lenzen-Schulte in Frankfurter Allgemeine Zeitung (FAZ) gives an overview on the arrival of maggot therapy as a means to clean wounds, stating it has become standard therapy in many German clinics already. Maggots not only remove dead tissue and eschar, they also kill bacteria. Therefore, they are increasingly being used in infections with bacteria carrying multiple resistance to antibiotics. However, maggot therapy is not yet approved in Germany (in contrast to the US).

Sebastian Matthes in Wirtschaftswoche interviews Jackie Fenn, analyst at Gartner and co-author of Gartner’s Hype Cycle Report. Fenn forecasts computers with the ability to understand spoken questions and to put out spoken answers as well as printing of organs and arteries.

Roland Fischer in Neue Zürcher Zeitung (NZZ) looks back at 50 years of the influential Science Citation Index SCI. Originally founded to make the identification of relevant scientific papers easier, it soon became a tool for sociologists of science and led to the birth of scientometry as a new discipline. However, SCI also was used to take quantity for quality, measuring quality of science as number of citations, and it is a well-known episode that in the UK funding of clinical research was cut because preclinical research generates more citations. While this controversy is still ongoing, the taking of quantity for quality is already spilling over into search engines, Fischer describes.

Alex Knapp in Forbes describes a novel approach to broad spectrum antivirals. It is based on a bi-specific drug: one arm binds to double-stranded RNA which is specific for viruses. Once bound, a second arm triggers a mechanism that leads to the destruction of the cell it is in. The experimental drug named DRACO has been successful at eliminating cells infected by 15 different viruses from the common cold to polio in vitro and in vivo (mice).

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