Tag: Ethics

Women earn nearly one-third less than men within a year of completing a PhD in a science, technology, engineering or mathematics (STEM) field, suggests an analysis of roughly 1,200 US graduates.

Much of the pay gap, the study found, came down to a tendency for women to graduate in less-lucrative academic fields — such as biology and chemistry, which are known to lead to lower post-PhD earnings than comparatively industry-friendly fields, such as engineering and mathematics.

But after controlling for differences in academic field, the researchers found that women still lagged men by 11% in first-year earnings. That difference, they say, was explained entirely by the finding that married women with children earned less than men. Married men with children, on the other hand, saw no disadvantage in earnings.

Many studies have reported similar gender pay gaps and have identified similar contributing factors — but few have systematically broken down the relative contributions of different variables, says Bruce Weinberg, an economist at the Ohio State University in Columbus who led the study, published in the May issue of American Economic Review. “I was quite surprised that we could explain the wage gap using just field of study and family structure,” he says.

An unmarried, childless woman earned — on average — the same annual salary after receiving her doctorate as a man with a PhD in the same field, the researchers found. The study examined the employment and earnings of 867 men and 370 women who graduated between 2007 and 2010 from 4 different universities.

Weinberg says that the data cannot identify or tease apart factors that might explain why married women with children earn less — among the possibilities, whether employers assign different responsibilities and salaries to these women, or whether the women spend less time or energy on their careers. But, he says, “our data suggest that these positions, as they are currently structured and operate, are not fully family-friendly for women”.

The findings support earlier research that suggests that parental and household responsibilities often affect women disproportionately, particularly in environments without adequate work–life and family policies, says Heather Metcalf, director of research and analysis for the US Association for Women in Science (AWIS) in Alexandria, Virginia.

The analysis is part of the UMETRICS project, based at the University of Michigan in Ann Arbor, which links anonymized census data on employment and income to student information from a consortium of universities, mainly in the midwestern United States.

Mary Ann Mason, a law professor at the University of California, Berkeley, says that the work is a “good, careful study”, albeit limited in that it cannot yet provide information on what happened in later postdoc years. Research by Mason and others suggests that women who have young children within 5–10 years after earning their PhDs are less likely to have tenure-track jobs or to hold tenured faculty positions than men or women without children, for instance.

An important missing piece, says economist Shulamit Kahn at Boston University in Massachusetts, is whether the women and men in the study worked equal numbers of hours. Kahn’s research suggests that, outside of academia, female scientists tend to work slightly fewer hours than do their male counterparts. (That paper did not examine scientists’ family status).

Weinberg says that the team is working to expand and extend the project, first by securing participation from more universities. He hopes, eventually, to be able to track doctoral recipients over the first 5–10 years of their post-PhD careers.

Nature doi:10.1038/nature.2016.19950

http://www.nature.com/news/index.html  Nature

http://www.nature.com/news/why-women-earn-less-just-two-factors-explain-post-phd-pay-gap-1.19950 Original web page at Nature

In the wake of the first ever report that scientists have edited the genomes of human embryos, experts cannot agree on whether the work was ethical. They also disagree over how close the methods are to being an option for treating disease. The work in question was led by Junjiu Huang, a gene-function researcher at Sun Yat-sen University in Guangzhou, China. His team used a technique called CRISPR/Cas9 to cut and replace DNA in non-viable embryos that could not result in a live birth because they were created from eggs that had been fertilized by two sperm. They published a paper in Protein & Cell, which was reported by Nature’s news team on 22 April, confirming rumours that had been circulating for months that scientists were applying such gene-editing techniques to human embryos.

In March, the rumours prompted calls for a moratorium on such research: work in human embryos is contentious because, in principle, any genetic changes will be passed to future generations, a scenario known as germline modification. Some feel that Huang’s group has already crossed an ethical line. “No researcher has the moral warrant to flout the globally widespread policy agreement against altering the human germline,” Marcy Darnovsky, executive director of the non-profit Centre for Genetics and Society in Berkeley, California, wrote in a statement. But whether the experiments carried out by Huang count as germline modification is not straightforward, because the embryos could not have led to a live birth. “It’s no worse than what happens in IVF all the time, which is that non-viable embryos are discarded,” says John Harris, a bioethicist at the University of Manchester, UK. “I don’t see any justification for a moratorium on research,” he adds. Huang says that he chose non-viable embryos to avoid ethical concerns.

Others say that modifying germline cells could be acceptable if it is solely for the purposes of research. George Daley, a stem-cell biologist at Harvard Medical School in Boston, Massachusetts, points out that using CRISPR/Cas9 and other gene-editing tools in human embryos, eggs and sperm could answer plenty of basic scientific questions that have nothing to do with clinical applications. Moreover, a moratorium may be an unrealistic goal. Modifying human embryos is legal in China and in many US states, although the US National Institutes of Health (NIH) forbids the use of federal funds for such research. Asked whether Huang’s study would have been allowed under its rules, the NIH says that it “would likely conclude it could not fund such research” and is watching the technology to see whether its rules need to be modified.

Another point of contention is that Huang’s and colleagues’ gene editing had a low success rate. The CRISPR/Cas9 system was supposed to cut and replace only a gene responsible for a blood disorder. But his team reported that the genome had acquired mutations in many other places too — which could introduce further health problems in a viable embryo. Furthermore, the technique failed entirely in most of the embryos they experimented on. Edward Lanphier, president of Sangamo BioSciences in Richmond, California, who co-authored a 19 March Comment piece in Nature calling for a halt on such research, says that these technical challenges point to the immaturity of the field and thus support arguments for a moratorium on all human germline-modification research. “I think the paper itself actually provides all of the data that we kind of pointed to,” he says. But George Church, a geneticist at Harvard Medical School, disagrees that the technology is that immature. He says that many of the problems with the latest work, such as the off-target mutations in DNA, could have been avoided or lessened had the researchers used the most up-to-date CRISPR/Cas9 methods.

Even if there are side effects, it may still be ethical to allow the technique to become available in clinics, says Harris. To justify banning gene editing for safety reasons, he says, one would not only need to have a reason to think that it will be harmful, but also that this harm would be worse than the genetic disease itself. “It’s not as if the alternative is safe,” he says. “People with genetic diseases are going to go on reproducing.” He likens the concerns to avoiding a surgery because of fear of complications. Hank Greely, a bioethicist at Stanford University in California, notes that there will be different degrees of safety concerns. A situation in which embryos have difficulty implanting and developing in the uterus, for instance, might engender different ethical questions from one in which there is a significant chance that a modification would result in a disability. Greely is not surprised by the disagreements. “I do think it points out and increases the urgency towards getting a conversation going about this,” he says. “A consensus is probably too much for hope for.”

Nature doi:10.1038/nature.2015.17410

http://www.nature.com/news/index.html  Nature

http://www.nature.com/news/ethics-of-embryo-editing-paper-divides-scientists-1.17410

Original web page at Nature

Members of the US National Academy of Sciences have long enjoyed a privileged path to publication in the body’s prominent house journal. Meet the scientists who use it most heavily. The building for the National Academy of Sciences was completed in 1924 as a “home of science in America”. The academy’s house journal was established a decade earlier, in part, as a home for members’ papers. In April, the US National Academy of Sciences elected 105 new members to its ranks. Academy membership is one the most prestigious honours for a scientist, and it comes with a tangible perk: members can submit up to four papers per year to the body’s high-profile journal, the venerable Proceedings of the National Academy of Sciences (PNAS), through the ‘contributed’ publication track. This unusual process allows authors to choose who will review their paper and how to respond to those reviewers’ comments. For many academy members, this privileged path is central to the appeal of PNAS. But to some scientists, it gives the journal the appearance of an old boys’ club. “Sound anachronistic? It is,” wrote biochemist Steve Caplan of the University of Nebraska, Omaha, in a 2011 blogpost that suggested the contributed track could be used as a “dumping ground” for some papers. Editors at the journal have strived to dispel that perception. With PNAS currently celebrating its centenary, the news team at Nature decided to examine the contributed track, both to assess its scientific impact and to see which members use it most heavily and why. After analysing a decade’s worth of PNAS papers, we found that only a small number of scientists have used the track at close to the maximum allowable rate. The group includes some of the biggest names in science, and six are past or current members of the journal’s editorial board. These scientists say that the main motivator for using the contributed track is an intense frustration with the peer-review process at other high-profile journals, which they argue has become excessive and laborious.

Our analysis also suggests that the efforts by PNAS to prevent abuse of the contributed track and to boost the quality of papers published by this route are bearing fruit. Although contributed PNAS papers attract fewer citations than those handled through the journal’s standard review process, the gap has narrowed in recent years. “We have worked really hard at this,” says Alan Fersht, a biophysicist at the University of Cambridge, UK, one of PNAS’s associate editors and a heavy user of the contributed track. An inside track to publication for academy members rests deep in PNAS’s DNA. The journal was established in 1914 with the explicit goal of publishing members’ “more important contributions to research” in addition to “work that appears to a member to be of particular importance”. That remit led to the creation of two publishing tracks: contributed and ‘communicated’ papers (manuscripts sent by non-members to colleagues in the academy, who would shepherd them through review). These two tracks were the only ways to get a paper into PNAS until 1995, when biochemist Nicholas Cozzarelli of the University of California, Berkeley, took over as editor-in-chief and introduced ‘direct submissions’, which are handled more like papers at other journals. Direct submissions must pass an initial screen by a member of the editorial board, after which they are assigned to an independent editor — either an academy member or a guest editor — who organizes peer review. Starting in 1972, the journal placed limits on the number of contributed papers that an academy member could submit, and the current annual cap of four was imposed in 1996. Then in 2010, PNAS abolished the communicated track, which was already declining in popularity. Today, more than three-quarters of the papers published in the journal are direct submissions. These papers are much less likely to be accepted than those contributed by academy members. Only 18% of direct submissions were published in 2013, whereas more than 98% of contributed papers were published, according to figures on the journal’s website. (The one caveat is that PNAS has no data on how many papers intended for the contributed track receive negative reviews and never get submitted.)

Despite the impressive acceptance rate for contributed papers, the data collected show that many eligible scientists choose not to submit papers through this track. Of the more than 3,100 academy members who could have used the contributed track between 2004 and 2013, fewer than 1,400 scientists did so. (This might in part reflect where researchers from different fields prefer to publish their work; the academy draws its members from all disciplines, including researchers from fields such as astronomy and mathematics, who rarely send their papers to PNAS.) Most members who used the contributed track did so sparingly: the majority published on average fewer than one contributed paper per year. Only a small group consistently used the track at close to the allowable maximum: from 2004 to 2013, 13 scientists each contributed more than 30 of their own papers. This roster includes some of the best-known people in contemporary science.

http://www.nature.com/news/index.html  Nature

July 22, 2014

http://www.nature.com/news/scientific-publishing-the-inside-track-1.15424  Original web page at Nature

US bioethics commission weighs in on debate over how scientists and companies should handle inadvertent discoveries in diagnostic tests. Doctors, researchers and companies should expect to find information they were not looking for in genetic analyses, imaging scans and other tests, concludes a report from the US Presidential Commission for the Study of Bioethical Issues. Moreover, medics and investigators should discuss with patients and research volunteers how these potentially serious findings will be handled before the tests are carried out. The advice given by the report echoes previous recommendations in specific fields. Still, researchers say it is a useful summary of basic overarching principles for grappling with ‘incidental findings’ that occur when a test ordered for one purpose uncovers information about another, unrelated health risk. “They get to the heart of what needs to be done, and there is a need to codify this,” says James Evans, a geneticist at the University of North Carolina in Chapel Hill, of the panel’s recommendations. Although incidental findings have always occurred in medicine and research, the rise of more omniscient tests that can reveal large amounts of information about a person’s risk factors have posed urgent ethical questions about how to deal with such data. Amy Gutmann, who leads the presidential commission, says new technology and other factors “make the likelihood of discovering incidental findings in the clinic, in research and in the commercial direct-to-consumer context a growing certainty”.

“This is an issue that affects everybody,” adds Gutmann, who is also president of the University of Pennsylvania in Philadelphia. Guidelines issued by the American College of Medical Genetics and Genomics (ACMG) in March recommended that doctors who order genetic sequencing for their patients for any reason should also specifically look for unrelated mutations in dozens of named genes, and should tell patients about medical risks associated with these genes. The new report endorses the idea of professional societies developing such guidance, but also says that patients should not have to learn of incidental findings if they do not want to — an important point for those bioethicists who disagreed with the ACMG’s recommendation that doctors could override patient consent in some circumstances. “It is absolutely critical that they endorsed the notion that patients and research participants have a far-reaching right to choose not to get results,” said Ellen Wright Clayton, a paediatrician and lawyer at the Center for Biomedical Ethics and Society at Vanderbilt University in Nashville, Tennessee. The report also says that researchers do not have a duty to seek out health-related findings in people who enrol in their research studies, because that could prove too costly and because researchers may not be adequately trained to find and interpret such results. Yet the analysis concludes that researchers should plan for how they will handle incidental findings — both those that can be anticipated and those that are unexpected — that do arise.

And it advises federal agencies to “continue to evaluate regulatory oversight” of direct-to-consumer testing companies, seemingly supporting actions such as that taken last month by the US Food and Drug Administration, which sent a warning letter to genetic-testing company 23andMe in Mountain View, California. The agency said that 23andMe has not provided information showing that its service is safe and effective. But by attempting to provide advice for such a wide range of settings, the presidential commission may have missed an opportunity to provide more detailed and helpful guidance, says ethicist Alex John London at Carnegie Mellon University in Pittsburgh, Pennsylvania. “Although there are many valuable recommendations in the report, it is not clear to me that such a highly general treatment will significantly advance the state of the debate,” he says. For instance, the report says that researchers may exclude research participants who don’t want to receive incidental findings from their studies, but also that there may be circumstances in which they should override a research participant’s preference not to receive such findings. “If there are cases where the researcher’s duty to look after the welfare of participants is so strong that it overrides the participant’s decision not to learn about incidental findings, then what we need are policies that provide some guidance about how to identify such cases and then to disclose such policies to participants before testing,” London says.

Nature
January 7, 2014

Original web page at Nature

Psychologists find deep connection between scientific method and morality. Public opinion towards science has made headlines over the past several years for a variety of reasons — mostly negative. High profile cases of academic dishonesty and disputes over funding have left many questioning the integrity and societal value of basic science, while accusations of politically motivated research fly from left and right. There is little doubt that science is value-laden. Allegiances to theories and ideologies can skew the kinds of hypotheses tested and the methods used to test them. These, however, are errors in the application of the method, not the method itself. In other words, it’s possible that public opinion towards science more generally might be relatively unaffected by the misdeeds and biases of individual scientists. In fact, given the undeniable benefits scientific progress yielded, associations with the process of scientific inquiry may be quite positive. Researchers at the University of California Santa Barbara set out to test this possibility. They hypothesized that there is a deep-seated perception of science as a moral pursuit — its emphasis on truth-seeking, impartiality and rationality privileges collective well-being above all else. Their new study, published in the journal PLOSOne, argues that the association between science and morality is so ingrained that merely thinking about it can trigger more moral behavior.

The researchers conducted four separate studies to test this. The first sought to establish a simple correlation between the degree to which individuals believed in science and their likelihood of enforcing moral norms when presented with a hypothetical violation. Participants read a vignette of a date-rape and were asked to rate the “wrongness” of the offense before answering a questionnaire measuring their belief in science. Indeed, those reporting greater belief in science condemned the act more harshly. Of course, a simple correlation is susceptible to multiple alternative explanations. To rule out these possibilities, Studies 2-4 used experimental manipulations to test whether inducing thoughts about science could influence both reported, as well as actual, moral behavior. All made use of a technique called “priming” in which participants are exposed to words relevant to a particular category in order to increase its cognitive accessibility. In other words, showing you words like “logical,” “hypothesis,” “laboratory” and “theory” should make you think about science and any effect the presentation of these words has on subsequent behavior can be attributed to the associations you have with that category.

Participants first completed a word scramble task during which they either had to unscramble some of these science-related words or words that had nothing to do with science. They then either read the date-rape vignette and answered the same questions regarding the severity of that transgression (Study 2), reported the degree to which they intended to perform a variety of altruistic actions over the next month (Study 3), or engaged in a behavioral economics task known as the dictator game (Study 4). In the dictator game the participant is given a sum of money (in this case $5) and told to divide that sum however they please between themselves and an anonymous other participant. The amount that participants give to the other is taken to be an index of their altruistic motivation. Across all these different measures, the researchers found consistent results. Simply being primed with science-related thoughts increased a) adherence to moral norms, b) real-life future altruistic intentions, and c) altruistic behavior towards an anonymous other. The conceptual association between science and morality appears strong. Though this finding replicates across different measures and methods, there’s one variable that might limit the generalizability of the effect. There is some evidence suggesting that attitudes towards science vary across political parties with conservatives having become decreasingly trustworthy of science over the past several decades. Though the researchers did include measures of religiosity in their studies, which did not affect the relationship between science and morality, ideally they would have also controlled for political affiliation. It’s not a stretch to imagine that undergraduate students at the University of Santa Barbara disproportionately represent liberals. If so, the relationship between science and morality found here might be stronger in self-described liberals.

That said, there’s also reason to believe that the general public, liberal or conservative, can draw a distinction between the scientific process and its practitioners. In the same way that people might mistrust politicians but still see nobility in the general organizing principles of our political structure, we could hold charitable views of science independent of how it might be conducted. These results might seem encouraging, particularly to fans of science. But one possible cost of assigning moral weight to science is the degree to which it distorts the way we respond to research conclusions. When faced with a finding that contradicts a cherished belief (e.g. a new study suggesting that humans have, or have not, contributed to global warming), we are more likely to question the integrity of the practitioner. If science is fundamentally moral, then how could it have arrived at such an offensive conclusion? Blame the messenger. How can we correct this thought process? A greater emphasis on, and better understanding of, the method might do the trick. It’s significantly harder to deny the import of challenging findings when you have the tools necessary to evaluate the process by which scientists arrived at their results. That new study on global warming is tougher to dismiss when you know (and care enough to check) that the methods used are sound, regardless of what you think the authors’ motivations might be. In the absence of such knowledge, the virtue assigned to “science” might also be a motivational force for ideological distortion, the precise opposite of impartial truth-seeking.

Nature
September 17, 2013

Original web page at Nature

Unconscious biases may drive researchers to overestimate their findings. US behavioural researchers have been handed a dubious distinction — they are more likely than their colleagues in other parts of the world to exaggerate findings, according to a study published today. The research highlights the importance of unconscious biases that might affect research integrity, says Brian Martinson, a social scientist at the HealthPartners Institute for Education and Research in Minneapolis, Minnesota, who was not involved with the study. “The take-home here is that the ‘bad guy/good guy’ narrative — the idea that we only need to worry about the monsters out there who are making up data — is naive,” Martinson says. The study, published in Proceedings of the National Academy of Sciences, was conducted by John Ioannidis, a physician at Stanford University in California, and Daniele Fanelli, an evolutionary biologist at the University of Edinburgh, UK. The pair examined 82 meta-analyses in genetics and psychiatry that collectively combined results from 1,174 individual studies. The researchers compared meta-analyses of studies based on non-behavioural parameters, such as physiological measurements, to those based on behavioural parameters, such as progression of dementia or depression.

The researchers then determined how well the strength of an observed result or effect reported in a given study agreed with that of the meta-analysis in which the study was included. They found that, worldwide, behavioural studies were more likely than non-behavioural studies to report ‘extreme effects’ — findings that deviated from the overall effects reported by the meta-analyses. And US-based behavioural researchers were more likely than behavioural researchers elsewhere to report extreme effects that deviated in favour of their starting hypotheses. “We might call this a ‘US effect,’” Fanelli says. “Researchers in the United States tend to report, on average, slightly stronger results than researchers based elsewhere.” This ‘US effect’ did not occur in non-behavioral research, and studies with both behavioural and non-behavioural components exhibited slightly less of the effect than purely behavioural research. Fanelli and Ioannidis interpret this finding to mean that US researchers are more likely to report strong effects, and that this tendency is more likely to show up in behavioural research, because researchers in these fields have more flexibility to make different methodological choices that produce more diverse results.

The study looked at a larger volume of research than has been examined in previous studies on bias in behavioural research, says Brian Nosek, a psychologist at the University of Virginia in Charlottesville. However, he and other researchers say that this study shows only a correlation, so it does not prove that being a behavioural researcher or working in the United States causes the more extreme results. Behavioural studies may report more extreme outcomes because they examine more diverse conditions, researchers argue. “One cannot straightforwardly conclude that the predictors are causes of the outcomes,” Nosek says. “To do an experimental test, we would need random assignment to biological or behavioural research and to US or non-US locations.” Fanelli says that the new paper shows that behavioral research outcomes are more variable than in another fields – genetics — which has tighter methodological standards. A key question raised by this study, Fanelli says, is why such differences lead more often towards favourable extreme results in the United States. “Whatever methodological choices are made, those made by researchers in the United States tend to yield subtly stronger supports for whatever hypothesis they test,” Fanelli says.

Fanelli and Ioannidis do not explain why that might be. They found that the ‘small-study effect’, in which overall results are biased towards positive, extreme findings because negative findings from small studies are not published, did not explain their results. “It has to be because of methodological choices made before the study is submitted,” Fanelli says, possibly under pressure from the ‘publish or perish’ mentality that takes hold when career progress depends on high-profile publications. Zubin Master, a bioethicist at Albany Medical College in New York, finds this explanation credible. “The current economic climate may further add to the pressure on researchers to publish in high-profile journals in order to enhance their chances of securing research funds,” he says. But how to verify that possibility is a bigger question. “The value of this study is not to say that this phenomenon is hugely worse in the United States, or in this field of science compared to that one,” Martinson says. “But the fact that you can show it raises the question of what it means.”

Nature
September 17, 2013

Original web page at Nature

Scientists raise serious concerns about a patent that forms the basis of a controversial stem-cell therapy. Davide Vannoni, a psychologist turned medical entrepreneur, has polarized Italian society in the past year with a bid to get his special brand of stem-cell therapy authorized. He has gained fervent public support with his claims to cure fatal illnesses — and equally fervent opposition from many scientists who say that his treatment is unproven. Now those scientists want the Italian government to pull out of a €3-million (US$3.9-million) clinical trial of the therapy that it promised to support in May, after bowing to patient pressure. They allege that Vannoni’s method of preparing stem cells is based on flawed data. And Nature’s own investigation suggests that images used in the 2010 patent application, on which Vannoni says his method is based, are duplicated from previous, unrelated papers. The trial is “a waste of money and gives false hope to desperate families”, says Paolo Bianco, a stem-cell researcher at the University of Rome and one of the scientists who says that Vannoni’s 2010 application to the US patent office does not stand up to scrutiny.

“I am not surprised to learn this,” says Luca Pani, director-general of the Italian Medicines Agency (AIFA), which suspended operations at the Brescia-based laboratories of Vannoni’s Stamina Foundation in May 2012, after inspectors concluded that the labs would not be able to guarantee contamination-free preparations of stem cells. Inspectors were not shown systematic methodologies or protocols. “We saw such chaos there, I knew that a formal method wouldn’t exist,” he says. But questions raised over the patent that underpins the methodology needed for the trial could be political dynamite. Well over 100 people with conditions ranging from Parkinson’s to motor neuron disease to coma — nearly half of them children — have already signed up to participate in the government-sponsored trial, despite there being no published evidence that the therapy could be effective. The Stamina Foundation has been given permission to treat more than 80 people on compassionate grounds since 2007, and Vannoni — who has not published follow-up data on patients — says that hundreds more were lined up waiting for treatment when the lab’s operations were suspended. Supporters held angry demonstrations up and down Italy earlier this year. The therapy involves extracting cells from patients’ bone marrow, manipulating them in vitro, and then injecting them back into the same patients. Vannoni has repeatedly avoided revealing details of his method beyond those available in his patent application, which he has referred to as complete.

Nature has independently confirmed that a key micrograph in that patent application, depicting two nerve cells that had apparently differentiated from bone-marrow stromal cells, is not original. Elena Schegelskaya, a molecular biologist at the Kharkov National Medical University, and a co-author of the 2003 paper, told Nature that the micrograph under scrutiny had originated with her team. Like Vannoni’s patent, Schegelskaya’s paper looked at coaxing bone-marrow cells to differentiate into nerve cells. But whereas Vannoni’s patent says that the transformation involved incubating cultured bone-marrow cells for two hours in an 18-micromolar solution of retinoic acid dissolved in ethanol, Schegelskaya’s paper uses a retinoic acid solution with only one-tenth of that concentration, and incubates the cells for several days. So the identical figures represent very different experimental conditions.

Schegelskaya also points out that a monochrome micrograph in the patent, is identical to a colour micrograph that she had published in the Ukrainian Neurosurgical Journal in 2006. Bone-marrow cells can differentiate into only bone, skin or cartilage cells. The idea that they can be forced to turn into other cell types is the basis of the claimed therapeutic potential in Vannoni’s patent. “In fact no-one has ever been able to convincingly show that bone-marrow cells can be converted into nerve cells,” says Elena Cattaneo, a stem-cell researcher who studies Huntington’s disease at the University of Milan, Italy. Vannoni, along with other proponents of bone-marrow stromal-cell therapy, says that the cells in his treatment may work by homing in on any damaged tissue and reducing inflammation or promoting blood-vessel growth there. Last year, the US Patent Office issued a ‘pre-final’ rejection of Vannoni’s patent — one that allows re-submission, although Vannoni has not yet resubmitted. The rejection noted that the application included insufficient details on methodology, that differentiation was unlikely to occur during the very short incubation time described, and that the appearance of nerve-like cells in the culture is likely to “reflect cytotoxic changes”.

The government-sponsored Italian clinical trial was intended to begin on 1 July, but is now being delayed because Vannoni has three times postponed commitments to reveal his method to the government-appointed committee that will prepare the trial’s details. That committee includes representatives from AIFA, the Italian health ministry and various scientific experts. It is led by the Superior Health Institute in Rome, Italy’s leading biomedical-research body. The institute’s president, Fabrizio Oleari, declined to comment. Nature made repeated attempts to contact Vannoni by e-mail and telephone for comment, since last Wednesday, 26 June, but received no response. The Stamina Foundation did not respond to emails. Irving Weissman, director of the Stanford Institute for Stem Cell Biology and Regenerative Medicine in California, says that the Italian government would be unwise to support a trial with so little evidence of efficacy.

Nature
23 July, 2013

Original web page at Nature

The increasing production and use of antibiotics, about half of which is used in animal production, is mirrored by the growing number of antibiotic resistance genes, or ARGs, effectively reducing antibiotics’ ability to fend off diseases — in animals and humans. A study in the current issue of the Proceedings of the National Academy of Sciences shows that China — the world’s largest producer and consumer of antibiotics — and many other countries don’t monitor the powerful medicine’s usage or impact on the environment. On Chinese commercial pig farms, researchers found 149 unique ARGs, some at levels 192 to 28,000 times higher than the control samples, said James Tiedje, Michigan State University Distinguished Professor of microbiology and molecular genetics and of plant, soil and microbial sciences, and one of the co-authors. “Our research took place in China, but it reflects what’s happening in many places around the world,” said Tiedje, part of the research team led by Yong-Guan Zhu of the Chinese Academy of Sciences. “The World Organization for Animal Health and the U.S. Food and Drug Administration have been advocating for improved regulation of veterinary antibiotic use because those genes don’t stay local.”

Antibiotics in China are weakly regulated, and the country uses four times more antibiotics for veterinary use than in the United States. Since the medicine is poorly absorbed by animals, much of it ends up in manure — an estimated 700 million tons annually from China alone. This is traditionally spread as fertilizer, sold as compost or ends up downstream in rivers or groundwater, taking ARGs with them. Along with hitching rides in fertilizer, ARGs also are spread via international trade, immigration and recreational travel. Daily exposure to antibiotics, such as those in animal feed, allows microbes carrying ARGs to thrive. In some cases, these antibiotic resistant genes become highly mobile, meaning they can be transferred to other bacteria that can cause illness in humans. This is a big concern because the infections they cause can’t be treated with antibiotics. ARGs can reach the general population through food crops, drinking water and interactions with farm workers. Because of this undesirable cycle, ARGs pose a potential global risk to human health and should be classified as pollutants, said Tiedje, an MSU AgBioResearch scientist. “It is urgent that we protect the effectiveness of our current antibiotics because discovering new ones is extremely difficult,” Zhu said. “Multidrug resistance is a global problem and must be addressed in a comprehensive manner, and one area that needs to be addressed is more judicious use and management of wastes that contain ARGs.”

Science Daily
March 5, 2013

Original web page at Science Daily

By offering unproven therapies, a Texas biotechnology firm has sparked a bitter debate about how stem cells should be regulated. Ann McFarlane is losing faith. In the first half of 2012, the Houston resident received four infusions of adult stem cells grown from her own fat. McFarlane has multiple sclerosis (MS), and had heard that others with the inflammatory disease had experienced improvements in mobility and balance after treatment. The infusions — which have cost her about US$32,000 so far — didn’t help, but she knew that there were no guarantees. It is McFarlane’s experience with Celltex Therapeutics, the company that administered the cells, that bothers her. She was told that she had been enrolled in a study to test the cells’ efficacy, but received almost no information about it. And although it wasn’t exactly a secret that the treatment had not been approved by the US Food and Drug Administration (FDA), Celltex, based in Houston, Texas, assured its clients that it was within its rights to provide it. But Celltex was forced to halt treatments in October, and in November a legal battle broke out over who owned the cells still being stored by the company. For weeks, McFarlane was uncertain whether her cells were being grown and stored properly. Although Celltex has told its customers that it has settled the dispute, McFarlane has her doubts. “I am not confident that the cells are viable and safe,” she says. “I probably will not feel comfortable using these cells.”

For the past decade, people such as McFarlane have searched far and wide for clinics offering to deliver on the promise of adult stem cells. Unlike embryonic stem cells, their use does not require the controversial destruction of an embryo. Yet although adult stem cells are claimed to ameliorate a wide range of disorders, they have not yet been shown to do so conclusively in clinical trials in the United States. Relying on customer testimonies and company promises, patients have travelled to clinics in places such as China, Costa Rica, Mexico and Japan to receive them from unregulated, often unaccredited, laboratories, driving a boom in stem-cell tourism. According to Leigh Turner, a bioethicist at the University of Minnesota in Minneapolis, at least ten clinics offer treatments in the United States. Turner and others have questioned the quality of the cells that these firms provide, and several outlets have been forced to stop providing treatments. CellTex has been one of the most visible. Established in 2011, it offered therapies for conditions as varied as arthritis, back pain, MS and Parkinson’s disease. It produced its cells in a 1,400-square-metre, state-of-the-art facility in Sugar Land, Texas, that was registered with the FDA, and — the company claimed — had strict quality control. Although the company flouted federal regulations, which deem such cell therapies to be biological drugs, it adhered to state rules, which had recently been tailored to bolster the stem-cell industry. But even with the support of Texas governor Rick Perry — Celltex’s first patient — the company had to stop offering treatments in the United States.

Nature
March 5, 2013

Original web page at Nature

The full clinical study reports of drugs that have been authorized for use in patients should be made publicly available in order to allow independent re-analysis of the benefits and risks of such drugs, according to leading international experts who base their assertions on their experience with Tamiflu (oseltamivir). Tamiflu is classed by the World Health Organization as an essential drug and many countries have stockpiled the anti-influenza drug at great expense to taxpayers. But a recent Cochrane review on Tamiflu has shown that even more than ten thousand pages of regulatory evidence were not sufficient to clarify major discrepancies regarding the effects and mode of action of the drug. Writing in this week’s PLoS Medicine, Peter Doshi from Johns Hopkins University School of Medicine in Baltimore, USA, Tom Jefferson from the Cochrane Collaboration in Rome, Italy, and Chris Del Mar from Bond University in the Gold Coast, Australia say that there are strong ethical arguments for ensuring that all clinical study reports are publicly accessible. In the course of trying to get hold of the regulatory evidence, the authors received several explanations from Roche as to why it would not share its data. By publishing that correspondence and comment, the authors assert that experiments on humans should be made available, all the more so given the international public health nature of the drug.

They argue: “It is the public who take and pay for approved drugs, and therefore the public should have access to complete information about those drugs. We should also not lose sight of the fact that clinical trials are experiments conducted on humans that carry an assumption of contributing to medical knowledge. Non-disclosure of complete trial results undermines the philanthropy of human participants and sets back the pursuit of knowledge.” However, according to the authors, industry and regulators have historically treated clinical study reports as confidential documents, impeding additional scrutiny by independent researchers. Using the example of Tamiflu, in which drug companies, drug regulators, and public health bodies such as the World Health Organization and the Center for Disease Control have made discrepant claims about its clinical effects, the authors argue that critical analysis by an independent group such as a Cochrane review group is essential. By recounting the details of an extended correspondence with Tamiflu’s manufacturer Roche, the authors argue that the company provided no convincing reasons to refuse providing access to clinical study reports.

The authors challenge industry to either provide open access to clinical study reports or publically defend their current position of randomized controlled trial data secrecy. They say: “we hope the debate may soon shift from one of whether to release regulatory data to the specifics of doing so. But until these policies go into effect — and perhaps even after they do — most drugs on the market will remain those approved in an era in which regulators protected industry’s data.” In a Perspective article accompanying a new analysis by Peter Doshi and colleagues in PLoS Medicine that recommended full clinical study reports of authorized drugs be made publicly available in order to allow independent re-analysis of the benefits and risks of such drugs, four drug regulators (representing the European Medicines Agency, the French Agence Française de Sécurité Sanitaire des Produits de Santé, the UK’s Medicines and Healthcare products Regulatory Agency, and the Medicines Evaluation Board in The Netherlands) respond. The four regulators say: “We consider it neither desirable nor realistic to maintain the status quo of limited availability of regulatory trials data,” and suggest what they call a “three pronged approach,” which includes establishing rules of engagement to follow the principle of maximum transparency whilst respecting the need to guarantee data privacy and to avert the potential for misuse. The regulators say: “We welcome debate on these issues, and remain confident that satisfactory solutions can be found to make complete trial data available in a way that will be in the best interest of public health.” However, they also lay out arguments for why trial data should not be open for all: personal data protection; non-financial competing interests; and the risks of competition. They conclude: “We welcome debate on these issues, and remain confident that satisfactory solutions can be found to make complete trial data available in a way that will be in the best interest of public health.”

Science Daily
May 1, 2012

Original web page at Science Daily