February 12, 2014
After more than 50 years, a dispute over Downs syndrome discovery
(Science) – It would have been a personal triumph for Marthe Gautier, an 88-year-old pediatric cardiologist and scientist living in Paris. On 31 January, during a meeting in Bordeaux, Gautier was to receive a medal for her role in the discovery of the cause of Down syndrome in the late 1950s. In a speech, she planned to tell an audience of younger French geneticists her story about the discovery—and how she felt the credit she deserved went to a male colleague, Jérôme Lejeune.
February 11, 2014
NIH makes wary return to India
(Nature) – Allayed by pledges that India’s strict new rules for clinical trials will be eased, a few principal investigators funded by the US National Institutes of Health (NIH) are cautiously restarting studies there. Clarifications on the rules by the Drug Controller General of India (DCGI), and a promise to soften others, have allowed a small number of researchers to return to their work. But for most others, the damage has already been done. Trial operators — both academic and industrial — have left India for other countries. Some researchers say that India’s clinical trials industry, which boomed over the past decade, may now be grinding to a halt.
Medicine gets up close and personal
(Nature) – Leroy Hood, president of the Institute for Systems Biology (ISB) in Seattle, Washington, likes to talk about what he calls P4 medicine: health care that is predictive, preventive, personalized and participatory. Medicine today is a string of infrequent interventions prompted mainly by symptoms of illness. Hood argues instead for continuous management of health, making full use of whole-genome sequencing and biomarkers to correct disease before it gains a foothold.
February 10, 2014
Genome editing goes hi-fi: Technique in stem cells to boost scientists’ ability to study genetic disease
(Phys.org) – Sometimes biology is cruel. Sometimes simply a one-letter change in the human genetic code is the difference between health and a deadly disease. But even though doctors and scientists have long studied disorders caused by these tiny changes, replicating them to study in human stem cells has proven challenging. But now, scientists at the Gladstone Institutes have found a way to efficiently edit the human genome one letter at a time—not only boosting researchers’ ability to model human disease, but also paving the way for therapies that cure disease by fixing these so-called ‘bugs’ in a patient’s genetic code.
Many promising embryonic stem cell therapies ensnared in legal loopholes
(Popular Science) – Universities usually do research on U.S. National Institutes of Health-registered embryonic stem cells. However, the NIH’s rules don’t match up with rules from the U.S. Food and Drug Administration, which would have to approve any embryonic stem cell-based therapy for use the U.S. So these university-created treatments technically aren’t allowed to move past the research stage.
February 6, 2014
A New Edition of Journal of the Royal Society of Medicine is Available
Journal of the Royal Society of Medicine (Volume 107, No. 2, February 2014) is now available online by subscription only.
- “Why don’t doctors worry about being under-prepared?” by Kamran Abbasi
- “‘Is it normal?’ A simple question that often lacks an easy answer” by Selaine Niedel and Martin McKee
- “Opt-out organ donation: on evidence and public policy” by Brian H Willis and Muireann Quigley
- “Gender, ethnicity and graduate status, and junior doctors’ self-reported preparedness for clinical practice: national questionnaire surveys” by Elena Svirko, et al.
- “Public consent for neonatal studies: putting values and virtues back into the practice of medicine” by Hazel Thornton
A New Edition of International Journal for Quality in Health Care is Available
International Journal for Quality in Health Care (Volume 26, No. 1, February 2014) is now available online by subscription only.
- “Bridging the ivory towers and the swampy lowlands; increasing the impact of health services research on quality improvement” by Martin N. Marshall
- “How can we recognize continuous quality improvement?” by Lisa Rubenstein, et al.
- “How many diagnosis fields are needed to capture safety events in administrative data? Findings and recommendations from the WHO ICD-11 Topic Advisory Group on Quality and Safety” by Saskia E. Drösler, et al.
- “The relationship between hospital patients’ ratings of quality of care and communication” by Anita C. Keller, et al.
- “What impedes and what facilitates a quality improvement project for older hospitalized patients?” by Roelie Ijkema, et al.
- “Association of healthcare expenditures with aggressive versus palliative care for cancer patients at the end of life: a cross-sectional study using claims data in Japan” by Toshitaka Morishima, et al.
A New Edition of Clinical Trials is Available
Clinical Trials (Volume 11 , No. 1, February 2014) is now available online by subscription only.
- “Bumps and bridges on the road to responsible sharing of clinical trial data” by Jesse A Berlin, et al.
- “Survey of consent practices in cluster randomized trials: Improvements are needed in ethical conduct and reporting” by Monica Taljaard, et al.
- “Understanding and retention of trial-related information among participants in a clinical trial after completing the informed consent process” by Fernanda Mexas, et al.
- “Satisfying the needs of Japanese cancer patients: A comparative study of detailed and standard informed consent documents” by Keiko Sato, et al.
- “Expectations and experiences of investigators and parents involved in a clinical trial for Duchenne/Becker muscular dystrophy” by Holly L Peay, et al.
- “Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE): A pragmatic trial of complex treatment for a complex disorder” by Andrew A Nierenberg, et al.
Partnership to develop drug against bioethreats, infections
(UPI) – The U.S. government is working with industry to develop a drug against bioterrorism threats and to treat antibiotic-resistant infections, health officials say. Robin Robinson, director of the Biomedical Advanced Research and Development Authority in the U.S. Department of Health and Human Services, said the authority will support the development of Carbavance under a five-year, cost-sharing agreement with Rempex Pharmaceuticals Inc., a wholly owned subsidiary of The Medicines Co. in San Diego.
Study of drug for blood clots caused a stir, records show
(New York Times) – The makers of the blood-thinning drug Pradaxa were so worried that an internal research paper would damage drug sales that some employees not only pressured the author to revise it, but suggested it should be quashed altogether, according to newly unsealed legal documents. The documents were made public last week by a federal judge in Illinois who is overseeing thousands of lawsuits filed by patients and their families, who say that Pradaxa’s manufacturer, the German company Boehringer Ingelheim, failed to properly warn them about the risks of taking the drug.
February 5, 2014
Biomedicine: The changing face of primate research
(Nature) – The problems continue even as the EU is pushing for the translation of basic research into therapies — a transition that often requires the testing of experimental therapies in primates. And opportunities for translational research are growing thanks to recent technological breakthroughs. However, restrictions on primate experiments could hinder their development.
February 4, 2014
In stunning win for open science, Johnson & Johnson decides to release its clinical trial data to researchers
(Forbes) – Drug companies tend to be secretive, to say the least, about studies of their medicines. For years, negative trials would not even be published. Except for the U.S. Food and Drug Administration, nobody got to look at the raw information behind those studies. The medical data behind important drugs, devices, and other products was kept shrouded. Today, Johnson & Johnson is taking a major step toward changing that, not only for drugs like the blood thinner Xarelto or prostate cancer pill Zytiga but also for the artificial hips and knees made for its orthopedics division or even consumer products.
January 31, 2014
Spanish HIV researcher faces €210,000 fine over unauthorizied clinical trial
(Science) – A Spanish HIV/AIDS researcher is facing a hefty fine for violating clinical trial regulations. A court of appeals has upheld most of a lower court’s verdict against Vicente Soriano, a physician at the Hospital Carlos III here and a well-known clinical researcher with hundreds of publications to his name.
Richard Smith: Medical research – still a scandal
(BMJ) – Twenty years ago this week the statistician Doug Altman published an editorial in the BMJ arguing that much medical research was of poor quality and misleading. In his editorial entitled, “The Scandal of Poor Medical Research,” Altman wrote that much research was “seriously flawed through the use of inappropriate designs, unrepresentative samples, small samples, incorrect methods of analysis, and faulty interpretation.” Twenty years later I fear that things are not better but worse.
A New Edition of The Journal of Law, Medicine & Ethics is Available
The Journal of Law, Medicine & Ethics (Volume 41, No. 4, Winter 2013) is now available online by subscription only.
- “Is Inclusive Education a Human Right?” by John-Stewart Gordon
- “Disability and Capability: Exploring the Usefulness of Martha Nussbaum’s Capabilities Approach for the UN Disability Rights Convention” by Caroline Harnacke
- “Human Rights, Civil Rights: Prescribing Disability Discrimination Prevention in Packaging Essential Health Benefits” by Anita Silvers and Leslie Francis
- “Disability, ‘Being Unhealthy,’ and Rights to Health” by Jerome Bickenbach
- “Subversive Subjects: Rule-Breaking and Deception in Clinical Trials” by Rebecca Dresser
- “Another Look at the Legal and Ethical Consequences of Pharmacological Memory Dampening: The Case of Sexual Assault” by Jennifer A. Chandler, et al.
- “Adherence to the Request Criterion in Jurisdictions Where Assisted Dying Is Lawful? A Review of the Criteria and Evidence in the Netherlands, Belgium, Oregon, and Switzerland” by Penney Lewis and Isra Black
- “Predictive Genetic Testing of Children and the Role of the Best Interest Standard” by Lainie Friedman Ross
January 28, 2014
Human stem cells predict efficacy of Alzheimer drugs
Researchers from the University of Bonn use reprogrammed patient neurons for drug testing. Why do certain Alzheimer medications work in animal models but not in clinical trials in humans? A research team from the University of Bonn and the biomedical enterprise LIFE & BRAIN GmbH has been able to show that results of established test methods with animal models and cell lines used up until now can hardly be translated to the processes in the human brain. Drug testing should therefore be conducted with human nerve cells, conclude the scientists. The results are published by Cell Press in the journal “Stem Cell Reports”. (Health Canal)
A genetic “Minority Report”: How corporate DNA testing could put us at risk
There is another aspect of 23andMe’s business, one which has received less attention from the media (with the exception of an excellent writeup in Scientific American by Charles Seife), but which is, in actuality, both equally troubling and equally fascinating. The company also houses a sizable research wing. 23andMe intends to aggregate the genetic information it receives and correlate that information with self-supplied data from customers about their biological traits – for instance, whether they clasp their hands with left thumb over right or vice versa; whether black coffee tastes bitter to them; or, more seriously, whether they have Parkinson’s disease. (Salon)
Antibiotics in animals tied to risk of human infection
In the documents, some of which were reviewed by The New York Times, scientists from the F.D.A. studied 30 penicillin and tetracycline additives in animal feed. They found that 18 of them posed a high risk of exposing humans to antibiotic-resistant bacteria through food. Resistant bacteria make it difficult and sometimes impossible to treat infections with ordinary antibiotics. The scientists did not have enough data to judge the other 12 drugs. (New York Times)
Researchers defend Japanese Alzheimer’s study
The scientist at the center of allegations of data manipulation in a large Alzheimer’s study is staunchly defending the integrity of the data, though he acknowledges shortcomings in managing the project. n its 10 January morning edition, the Asahi Shimbun, one of Japan’s leading newspapers, claimed that researchers involved in the ongoing $31 million Japanese Alzheimer’s Disease Neuroimaging Initiative (J-ADNI) changed certain details of memory tests long after data were collected and that some participants were improperly included in the study. (Science)
January 23, 2014
Education: Embed social awareness in science curricula
As a social scientist who is also trained as an engineer, I am puzzled by how often public-welfare and social-justice issues are viewed as irrelevant or tangential to ‘real’ technical work in science, technology, engineering and mathematics (STEM) professions. I carried out a study, the results of which suggest that university education exacerbates this culture of disengagement. Between 2003 and 2008, I surveyed a total of more than 300 engineering students in four US universities — a large state college, an elite technical college, a small engineering-only university and a small private liberal-arts college. Following students from their first year to 18 months after their graduation, I found that, on average, they left their degrees less interested in public welfare than when they began. (Nature)
‘Junk?’ Not so fast
Ever since the Human Genome Project decoded the genome, the prevailing scientific view has been that only the 2 percent that makes proteins — the building blocks of cells — was important. The rest was deemed not functional, or “junk.” But from his days in graduate school, through his postdoctoral fellowship, and now as a Harvard Stem Cell scientist, John Rinn has been digging through the genome, challenging that prevailing belief. Now, Rinn and his Harvard Stem Cell Institute colleagues, including neurobiologist Paola Arlotta, have carried out an elegant and important experiment in which they have demonstrated that much of what had been dismissed in fact plays as vital a role as protein-coding genes. (Harvard Gazette)