News

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: In the Health Care Sector, Who Should Choose Which Treatment Is Best?

The healthcare sector is under scrutiny in major developed countries across the globe. Some nations, like the UK and Germany, have already developed strict guidelines to determine the effectiveness of therapeutics and medical technologies, which must undergo comprehensive cost-benefit analyses as a pre-requisite for reimbursement. You can read more information about European regulations, especially German efforts, in our previous articles about the German Drug Reimbursemend Law AMNOG.

While cost-cutting is not as important in the U.S. healthcare system (yet), the emphasis on so-called comparative effectiveness research (CER), which is to assess the most effective treatment options for a patient,  has become undisputed.

An article in Knowledge@Wharton examines the pros and cons of CER efforts worldwide, stating that  “while not specifically designed to address health care costs, CER could ultimately lead to changes in the ways people seek medical treatment, the development of innovative remedies and other trends within the industry that could impact costs.”

Wharton healthcare management professor Scott E. Harrington takes an even more critical view: “The fear is that significant government involvement in CER will give rise to some form of restrictions on access to care [or to] particular treatments based on research studies and bureaucratic decision-making,” he says. “It might not be tied to what people want to have and what they are willing to pay for.”

On the other hand, if properly applied in both the state-funded and private healthcare sector, CER may incentivize biopharmaceutical and medical device companies to invest even more money into first-in-class or best-in-class innovative treatments by granting special patent protection and market access.

Knowledge @Wharton: In the Health Care Sector, Who Should Choose Which Treatment Is Best?, March 2011

Food for Thought: Weekly Wrap-Up

In Frankfurter Allgemeine Zeitung (FAZ), Manfred Lindinger reports on progress in designing intelligent materials. Physicists of Technical University Hamburg-Harburg succeeded in designing gold- and platinum-based materials that can be switched between hard and brittle or soft and elastic, just by applying different voltages. The trick is done by etching pores and channels into the material which subsequently are filled with perchloric acid.

Martina Lenzen-Schulte, also in FAZ, deals with the surprising finding that a screening test for ovarian cancer increases the number cases detected but at the same time does not improve survival. The test based on the CA-125 tumor marker was investigated in the PLCO longitudinal analysis comprising more than 75,000 women aged between 55 and 74 years, who were diagnosed as cancer-free at the beginning of the study. Half of them was tested once a year with the CA-125 test. While more women were diagnosed with ovarian cancer in the CA-125 test group, the outcome did not improve – in part, because the test did not detect the cancer early enough. Moreover, it resulted in a high number of false positives, and these patients were put at unnecessary risk of bleeding, infections, colon injuries and blood loss due to attempts to confirm the diagnosis via biopsies.

In Forbes, Matthew Herper features an interview with David Urdal, the now retiring CSO of Dendreon, who pioneered Provenge, the prostate cancer vaccine approved by the FDA last year as the first anti-cancer vaccine ever. Urdal in detail explains why the company did not specify overall survival as primary endpoint but choose to follow every patient for three years instead. While the FDA first ok’ed the approach and the FDA advisory committee recommended approval in 2007, the FDA did not approve it: in the committee, cell therapists were in favor of Provenge while the oncologists had doubts. The drug was approved only after another study, the famous IMPACT study, had been finished. Urdal maintains that this turned out to be very positive for Provenge: the study revealed new insights about progression in asymptomatic patients and demonstrated that the method to measure disease progression just by counting the time to the next progression event was inadequate. Urdal states that the FDA may have been right to reject Provenge in the first place: “I think if you follow the sentiments within the clinical community I think there was a sense of, okay, if it’s approved I’d probably prescribe it, but geez, it’s a small study, overall survival wasn’t the primary endpoint, there wasn’t a sense of enthusiasm for it, and I think in the end of course the IMPACT study results came back and this completely vindicated the results from the earlier trials.”

William Pentland, also in Forbes, introduces a new battery architecture invented by the Massachusetts Institute of Technology MIT. The semi-solid flow cell basically runs on “sludge”, combining the structure of so-called flow batteries, where the electrolytes are replaced from outside once they are consumed with the favorable energy potential of lithium-ion batteries. Pentland says the new design may have the potential of a game-changer, in particular in combination with electric cars and smart grids.

Todd Woody, also in Forbes, describes buildings that clean up after itself via panels coated with titanium dioxide particles that serve as photocatalysts. Once illuminated by the sun, the particles start destroying dirt on the panel’s surface and, as a side effect, can also clear the surrounding air from nitrogen oxide. The company selling the panels claims they can cut a building’s maintenance costs by a third to half.

The Economist this week makes a case for using personalized medicine approaches in clinical trials earlier. In most cases, the Economist writes, oncologists “base their treatment on where in the body a tumour has sprung up, rather than on which molecular aberrations have caused it”, adding that the same is true for recruiting volunteers for clinical trials, in particular Phase I.

Drawing conclusions from this year’s ASCO (American Society of Clinical Oncology) meeting, the Economist argues it may be much better to match the genetic profiles of patients to the drug being tested, rather than looking for the organs affected. The magazine introduces a study  by Apostolia-Maria Tsimberidou of the University of Texas’s MD Anderson Cancer Centre, in which the author selected volunteers with late-stage cancer across various organs whose tumors were caused by a single, known mutation. 175 volunteers were administered a targeted therapy in a low-dose, Phase I setting while 116 received traditional therapy. In the targeted therapy group, 29% responded, while in the untargeted therapy group there were only 5% responders.

Mark Brown in Wired reports on Harvard University researchers who created the first living laser, a human embryonic kidney cell that was genetically engineered to produce a visible laser beam. The cell producing green fluorescent protein was put between two mirrors and when the team ran pulses of blue light through the cell, it began to emit green light. When bouncing between the mirrors, certain wavelengths were preferentially amplified until a visible laser beam was created for a few nanoseconds. The cell was left unharmed. At present, researchers foresee applications in cell biology research.

Last not least, Herbert Renz-Polster in Der Spiegel this week answers crucial questions on why  kids like jelly babies buth not salad and Brussels sprouts and how they can be made to eat healthy. The answer: it’s the evolution stupid! It is more advisable to eat fat in order to survive the next famine, to eat hastily (who knows when the next rival appears) and it is also wise to avoid eating the unknown (maybe it’s poison). The simple advice: be patient, keep offering the healthy stuff and play while having a meal. That way, kids even learn to like seal fat, whale blubber and roasted locusts.

Company News: Study Demonstrates Micromet’s Blinatumomab Produces High Single-Agent Activity in Patients with Relapsed Acute Lymphoblastic Leukemia

75% of patients achieved a complete remission, with no evidence of remaining leukemic cells in blood or bone marrow
– Data add to a growing body of clinical evidence demonstrating blinatumomab’s potential to be used across the course of the disease

Data to be presented tomorrow at the 16th Annual Meeting of the European Hematology Association (EHA) in London, UK, show that Micromet’s blinatumomab produced a high complete remission rate in adult patients with acute lymphoblastic leukemia (ALL) who had relapsed following treatment with standard therapy. 1 Blinatumomab is the most advanced of a new class of agents called BiTE® antibodies, designed to harness the body’s T cells to kill cancer cells.

Interim results from this phase 2 single-arm trial showed that 75% of patients (9 of 12) achieved a complete remission (CR) or CR with partial recovery of blood counts (CRh*) following treatment with blinatumomab.  All nine responding patients achieved a complete molecular response, or had no evidence of leukemic cells in their bone marrow, a key prognostic factor for patient survival.  Notably, four patients with genetic abnormalities typically associated with poorer outcomes all achieved a CR or CRh*.

Current treatment for Philadelphia negative relapsed/refractory ALL consists of combinations of toxic chemotherapy drugs that in the majority of cases fail to drive the disease into remission.  In more than 30 years, no new drug has been approved for use in this setting, leaving physicians with few options to improve long-term patient outcomes other than variations in the dose and schedule of old drugs with limited efficacy.  With current approaches, complete remission rates range from 17-45%. 2-6 Standard chemotherapy is associated with a mortality rate of up to 23%. 7 The average five-year survival rate for adult ALL patients after first relapse is 7%. 5

 

Click here to read the abstract

 

References:

  1. Topp, M.S. et. al. Haematologica. 2011; abstract no. 844
  2. Kantarjian H, et al. Cancer. 2010;116:5568–5574.
  3. Advani AS, et al. Br J Haematol. 2010;151(5):430.
  4. Oriol A, et al. Haematologica. 2010;98(4):589-596.
  5. Fielding  A, et al. Blood. 2007;109(3):944-950.
  6. O’Brien S, et al. Cancer. 2008;113:3186–3191.
  7. Bassan R, et al. J Clin Oncol. 2011;29(5):532-543.

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