Tag: cancer

Food for Thought: Weekly Wrap-Up

Rationing medicine already is clinical reality in Germany, reports this week’s Frankfurter Allgemeine Zeitung (FAZ). Christina Hucklenbroich features a representative survey among the members of the German Society for Hematology and Oncology (DGHO) about therapeutic decisions in treating cancer patients. According to the survey, 59% of the responding 345 oncologists said that they abstain from treatment options if they think the therapeutic benefit is too small as compared to the cost of treatment. However, 19% responded they even refrain from therapeutic options for cost reasons even if the treatments provide an additional, considerable benefit to the patients.

Michael Feld also in FAZ reports on a study by Pricewaterhouse Coopers and the Darmstadt Economics Research Institute Wifor that Germany will be lacking 56,000 physicians and 140,000 nursing staff by 2020, a situation that will hit the eldery most. The author, a practicing physician, states that the situation is not only caused by lack of money but also by disappearing values like charity, social responsibility and a sense of honor.

Focus magazine this week features a study from the University of Michigan giving rise to concerns that taking dietary supplements and OTC medications to stimulate the immune system can be counterproductive in patients with autoimmune diseases. The study demonstrates in animals that a strong immune response to common cold viruses can exacerbate inflammations and even lead to asthma attacks while the infection with a weaker immune system proceeds without complications.

Die Welt reports about clinical results on a new test for the early detection of Alzheimer’s disease (AD) communicated by the University of Leipzig. The test is based on radiolabeled Florbetaben which is injected into the blood stream. The substance binds to beta-amyloid peptides in the brain, and binding can be assessed using PET imaging. Thereby, AD can be diagnosed up to 15 years before onset of the disease. The paper does not mention, however, that the (preliminary) results are from an international multi-center Phase III trial sponsored by Bayer Schering Pharma that was designed to evaluate the efficacy and safety of florbetaben (BAY 94-9172) developed by the company. PET images are compared to corresponding histo-pathological specimens. Details will be published in the next issue of Lancet Neurology.

Christian Meier, Aitziber Romero and Dino Trescher in Sueddeutsche Zeitung (SZ) maintain that industry is trying to block attempts to regulate nanotechnology products. While the EU Commission prefers to define nanotechnology products by counting the number of particles smaller than 100 nanometers, industry wants a definition by determining the fraction of the particles contributing to the mass of the product. The authors, which claim that nanotech products bear all sorts of unforeseen health and environmental hazards, say that this is an attempt by industry to reduce the number of products defined as being nanotechnology.

The Economist makes a case in how food poisoning by EHEC, salmonella and other dangerous bacteria can be effectively prevented: radiating food. Irony is that it was Germany, the country currently suffering from the worst and most deadly EHEC epidemic ever, that vetoed a proposal by the European Commission to allow radiation for a greater range of food and at higher doses, e.g. for sprouts which caused this year’s epidemic, in 2000. However, the author doubts the epidemic will change the German government’s attitude for fear to upset Germany’s influential Green movement.

Last not least, comics are becoming increasingly popular among biotech companies and researchers. Silver Spring, MD based biotech company United Therapeutics chose to publish its annual report as a comic book, while researchers from the Department of Neurosurgery of Heinrich-Heine-University Düsseldorf published a retrospective study on traumatic brain injuries in comics, analyzing more than 700 head injuries in the Asterix comic books: “Although over half of patients had an initially severe impairment of consciousness after TBI, no permanent deficit could be found. Roman nationality, hypoglossal paresis, lost helmet, and ingestion of the magic potion were significantly correlated with severe initial impairment of consciousness (p ≤ 0.05).”

 

Food for Thought: Future Reimbursement of Novel Cancer Drugs in Germany

Germany’s new law regulating the reimbursement of drugs, the so-called Arzneimittelmarktneuordnungsgesetz – AMNOG, requires companies planning to introduce a novel drug to the German market to provide a value dossier, if they want reimbursement of the full price for the first year of marketing (See the akampioneer, “Germany’s New Reimbursement Law“). This value dossier not only needs to demonstrate efficacy and safety, but also has to provide evidence that the drug is more advantageous to existing treatments in terms of patient-relevant endpoints such as morbidity, mortality and quality of life.

This is difficult to prove as many novel cancer drugs are approved on the basis of surrogate endpoints such as slowing or stopping cancer growth (objective response rate ORR, time to tumor progression TTP, time to treatment failure TTF or progression-free survival PFS).

Late last month, Germany‘s Institute for Quality and Efficiency in Health Care (IQWiG) has published details on how it is going to evaluate the patient benefit in these cases. IQWiG usually is evaluating drugs on behalf of the so-called Gemeinsamer Bundesausschuss G-BA (Federal Committee), a decision body within Germany´s statutory healthcare system.

In cancer, IQWiG plans to primarily address „the question as to whether a therapy can prolong the life of affected patients. In addition, a new therapy should alleviate symptoms, prevent complications, and improve quality of life.“ If surrogate endpoints have been used for approval, IQWiG will only accept them as evidence for patient benefit, if the validity of these endpoints for demonstrating patient benefit can be proven by correlation-based approaches based on randomized controlled trials.

In a 160 page „rapid report“ (available in German only) IQWiG details its approach to search available literature for studies on the correlation between surrogate and patient-relevant endpoints. In addition, it describes how it is performing a meta-analysis of these studies for assessing the strength of the correlation (three levels) and the reliability of the validation studies (four levels) to reach an overall conclusion about the validity of the surrogate endpoint for a decision whether the new drug is providing patient benefit.

While the institute so far has only differentiated between „proof“ of surrogate endpoint validity and „indication“ of validity (meaning medium reliability), it proposes to introduce a third category called „hint“ for the fulfillment of certain minimal requirements for the available studies. This category will be applied in cases where the validity of a surrogate endpoint is unclear – a situation IQWiG expects to be quite common. In these cases, IQWiG states, „it can also be taken into account how strong the effect of a treatment turns out to be“. IQWiG would then seek to find a threshold value for the surrogate marker and evaluate whether the new treatment exceeds this value, e.g. whether it decelerates tumor growth for longer than a specified period of time.

Last not least, IQWiG appeals to drug makers and study groups to make accessible their analyses on the validity of surrogate endpoints and the specification of threshold values, e.g. in special registries.

A short English summary of IQWiG‘s basic assumptions on how to recognize at an early stage whether a new cancer therapy prolongs life can be found here. IQWiGs proposals for the early benefit assessment of cancer drugs can be read, also in English, here.

Food for Thought: Weekly Wrap-Up

In Germany, science pages were dominated by Japan’s nuclear disaster. Apart from topics such as radioactivity as a threat to human health and the environment, Christiane Hucklenbroich in Frankfurter Allgemeine Zeitung (FAZ) deals with an upcoming new definition of autism. Instead of seeing autism as a defined disease category, physicians have come to the conclusion that one should rather use the term “autism spectrum”, comprising several aspects of autism. The medical community also has started focusing on co-morbidity aspects as well as autism-like symptoms in other psychiatric diseases.

Susanne Kutter in Wirtschaftswoche summarizes latest advances in stem cell medicine. Among others, she features a clinical trial conducted at the University of Rostock in which the heart muscle of patients suffering from an infarction is injected with adult stem cells to initiate regeneration of muscle. The trial includes more than 150 patients and will be finished end of 2012. A method already successful has been established in India, where more than 700 people with blindness caused by Vitamin A deficiency regained eyesight after injection of stem cells into the cornea.

Roni Caryn Rabin in The New York Times reports on a Lancet study that pooled data from 58 studies involving more than 220,000 people with a mean age of 58 to find out whether the idea that obese people with an apple shape (carrying the overweight predominantly in the belly) are more at risk for heart disease than overweight people with a pear shape. The answer is: they are not. Overweight matters, but shape does not.

Ferris Jabr in New Scientist introduces a small implantable device developed by researchers from the  Massachusetts Institute of Technology (MIT) that can track tumor growth in the body of cancer patients. The device contains magnetic nanoparticles covered with monoclonal antibodies able to bind cancer-related molecules, e.g. human chorionic gonadotrophin (hCG), a hormone released by testicular and ovarian cancers. The first generation had read-out by MRI scans that detect formation of clusters within the device due to binding of the molecules. However, the researchers now improved detection so that readout can now be done by a hand-held device. The principle can also be adapted to monitor other changes in the body, e.g. silent heart attacks.

For blood transfusion, medical doctors need to carefully choose the right blood group from 29 possible combinations of the AB0, Rhesus, the MNS and other systems. This challenge sometimes needs to complications and logistic problems. The Economist reports on a successful approach by researchers from the University of Montreal to disguise the antigenic proteins from red blood cells. The trick is done by first dressing the fatty surface membrane of the cells and then attaching another cover so that the immune system does not pay attention to the cells. The cover is fully permeable by oxygen and carbon dioxide.

David Whelan in Forbes calls for a psychological study of people investing in biotech stocks, in particular those writing rude comments on articles featuring the ups and downs of stocks. He claims the phenomenon is only seen with articles on biotech stocks.

And finally, David M. Ewalt in Forbes reports about errors in Craig Venter’s first synthetic life form in which Venter inserted DNA composed on a computer. The DNA included quotes from James Joyce and Richard Feynman, however Craig used the Joyce quote without written permission from Joyce’s estate and misquoted Feynman by obtaining the quote from the internet. Craig said he was now going back to the organism to correct the error.

Food for Thought: Weekly Wrap-Up

Joachim Müller-Jung in Frankfurter Allgemeines Zeitung (FAZ) this week deals with the ethic implications of non-invasive prenatal diagnosis, describing that a huge number of tests based on fetal DNA entering the mother’s blood stream is ready to enter the market. His recommendation is to start an immediate discussion about which tests should be applied and which ones should not.

Ulrich Bahnsen in Die ZEIT interviews Norbert Donner-Banzhoff, Professor at the University of Marburg’s Department of General Practice, Preventive and Rehabilitative Medicine. Donner-Banzhoff conducted a study published in the Canadian Medical Association Journal CMAJ investigating the influence of pharmaceutical advertising on the drug recommendations made in articles in 11 German journals that focus on medical education. Donner-Banzhoff and his team come to the conclusion that journals financed by advertisement from the pharma industry and given away for free almost exclusively recommended the use of specified drugs, whereas journals financed entirely with subscription fees tended to recommend against the use of the same drugs. In the interview, Donner-Banzhoff suggests that a lot of articles published in the free journals have been written by ghost writers and/or members of the pharmaceutical industry.

Matthew Herper in Forbes this week deals with the latest setback in developing drugs to treat Alzheimer’s Disease (AD). He features the failure of Eli Lilly’s semagacest in a Phase III trial in more than 2,600 patients with mild-to-moderate AD. According to an interim analysis, patients receiving the drug, a gamma secretase blocker, worsened to a statistically significant greater degree than those treated with placebo. In addition, the drug was associated with an increased risk of skin cancer. Herper concludes that there is something fundamentally wrong with current hypotheses on the onset of AD and that the failure of the drug may set AD drug development back by many years (see also akampioneer’s recent comment on Probiodrug’s AD hypothesis).

While William Pentland, also in Forbes, reports a potential biofuel breakthrough in producing isobutanol directly from cellulose by using a microbe thriving in decaying grass, Josh Wolfe, co-founder and managing partner of Lux Capital Management, in Forbes states it is time to realize that investing in biofuels may be foolish. He states that while it is hyped as biotech 2.0, there is in fact a fundamental difference to biotech 1.0 which is often overlooked. While biotech 1.0 drugs and molecules can be protected by IP, biofuels cannot. In addition, the marginal cost of producing IP-protected molecules is really low once you did the discovery and first synthesis work (as compared to your margins) – so you can make big profits. Biofuel molecules however have to compete from the onset with the generic fuels already on the market. Biofuel is a commodity, he states, and instead of going back to an agrarian-based economy we should focus on materials and processing based on high energy density, such as uranium.

Donald G. McNeil jr in The New York Times reports on a panel of independent experts from 24 countries that reviewed the handling of the swine flu by the World Health Organization (WHO) in 2009. The draft report – “posted in an obscure corner of the W.H.O.’s Web site” – criticizes the WHO’s “needlessly complex” definition of a pandemic, its inability to deploy 78 million doses donated by rich nations for use in poor ones and its “clumsy communications”.

Colin Barras in New Scientist writes about the origin of cancer and features recent contributions by astrobiologists. While many researchers think that cancer is triggered by a malfunction of the genes trying to control replication which needs to be limited in multicellular organisms, some astrobiologists think a tumor is switching back to some forms of basic cellular cooperation found in the earliest ancestors of multicellular organisms. The distinction is far from being academic: if cancer is some sort of “living fossil” revived it would have only a limited set of survival strategies. In contrast, contemporary medicine regards a tumor as independently evolving cells with nearly unlimited evolutionary potential to escape treatment strategies. The hypothesis explains the co-ordinated survival strategies of cancer, such as angiogenesis and metastasis, and will be further tested soon by genetic profiling.

 

1 … 3 4 5