Tag: Erbitux

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).

Company News: Micromet’s BiTE Antibodies Overcome Cancer Cell Resistance

In several clinical trials, antibody company Micromet has demonstrated outstanding efficacy and safety of its bispecific BiTE antibodies which come with two binding sites: one for a cancer target and a second one for a T cell. As a result, T cells are recruited and guided directly to the tumor cell, initiating cancer cell death in a serial fashion.

In this week’s PNAS, researchers of the company demonstrate that the BiTE antibodies also can overcome the notorious resistance against conventional monoclonal antibodies arising in many cancer patients.

The researchers converted the anti-EGFR antibodies cetuximab (Erbitux) and panitumumab (Vectibix) into BiTE antibodies by adding the binding site for T cells. In animal models, these BiTE antibodies then showed a remarkably high potency (in the sub-picomolar range) against cancer cells with KRAS and BRAF-mutations which made them resistant to the original monoclonal antibodies.

According to the authors, “the present study shows that conversion of EGFR-specific monoclonal antibodies cetuximab and panitumumab into T cell-engaging BiTE antibodies is technically feasible and that the BiTE technology can overcome resistance of KRAS- and BRAF- mutated CRC lines to the therapeutically used parental antibodies. The simplest explanation for the latter is that T cell-engaging BiTE antibodies do not rely on inhibition of EGFR signaling but use the receptor tyrosine kinase as mere surface anchor for attachment of cytotoxic T cells. This function of BiTE antibodies is not expected to be affected by mutations of downstream components of the EGFR pathway that obviate the cancer cell’s dependence on the EGFR surface receptor for delivery of growth-promoting signaling.”

If this holds up in clinical trials, it is not only good news for patients with resistance to conventional cancer antibodies already on the market, but it will also provide an opportunity for a whole range of new cooperations with pharma companies for product enhancement and life cycle management.

Food for Thought: Simply Obscene

In a recent article (“Simply Obscene”) the influential German news magazine “Der Spiegel” (20/2010, May 17, 2010) stated the pharma industry was using “with the unscrupulousness of a stock jobber” a loophole in Germany’s highly regulated health care system to charge extremely high prices for basically useless cancer medications. In particular, the article featured Yondelis by Pharma Mar, Nexavar by Bayer, Hycamtin and Tyverb by GlaxoSmithKline, Erbitux by Merck KGaA, Sutent by Pfizer, Iressa by AstraZeneca, Avastin, Xeloda, Mab-Thera and Herceptin by Roche and Alimta by Lilly as examples for cancer drugs providing only marginal survival benefits at enormous costs and stated this was “lawful looting of the health care system”.  The only exception according to the authors of the article was Novartis’ Gleevec.

This week, the Competence Network Malignant Lymphomas published an open “letter to the editor”  (only available in German) stating that in the case of lymphoma therapy the authors of the article had done “obviously sloppy work”: “Therapy costs of lymphocyte-specific antibody Rituximab [MabThera] amount to €24,000, not €134,000 per year. Several independent studies have demonstrated that overall survival in both follicular and diffuse large B cell lymphoma is prolonged on average by several years (!), in fact without substantial side effects.” Der Spiegel had stated extension of survival in these two indications was “not proven”.

The letter also said that administrative costs for studies to optimize therapies had increased by a a factor of 10 in the last couple of years due to legal requirements.

The article of Spiegel magazine is available online in German, however without the tables featuring treatment costs and extension of survival for the drugs mentioned.