by Heidi Ledford, Nature, September 3, 2015
After years of uncertainty, the US government has revived an effort to update regulations that govern human-subjects research. The revision would be the most significant change to the rules since they were introduced in 1991. On 2 September, the US Department of Health and Human Services (HHS) announced a proposal to address concerns that have emerged since the regulations — known collectively as the ‘Common Rule’ — took effect more than two decades ago. (http://tinyurl.com/oeftvb9)
Some of the proposed changes to the Common Rule address the need for patient consent to use biomaterials for research purposes as newer technologies no longer make anonymizing biospecimens feasible. The changes would also address institutional review standards for collaborative research over multiple institutions. As of this writing the comment period on the proposed changes has been extended into January.
by Kelley Vlahos and Fox News Team, Fox News, September 17, 2015
Aggressive state efforts to ban the use of fetal tissue in research are alarming some scientists who say such measures will set back efforts to cure the world’s deadliest diseases, including cancer, diabetes and Alzheimer’s. But lawmakers in states like California and Wisconsin, which are deliberating whether to make their state laws even tougher than federal restrictions, say ending the practice of harvesting organs from aborted fetuses is a moral and ethical imperative. (http://tinyurl.com/hfcrogm)
by Rob Stein, NPR, September 29, 2015
Research involving fetal tissue has come under renewed public scrutiny recently because of a series of videos involving the Planned Parenthood Federation of America. The president of the organization, Cecile Richards, is slated to testify before a House committee Tuesday, even as some members of Congress try to cut off funding for Planned Parenthood, and some states try to restrict research involving fetal tissue. (http://tinyurl.com/hrxj29r)
The merits of fetal tissue research and whether it should be used in government-funded projects came to the forefront of political debate this past fall. Some states support restrictions while others fear that this will stymie research. This debate was prompted by a series of undercover videos revealing that Planned Parenthood, which receives government subsidies, also receives compensation for organs that some claim amounts to “selling organs” from aborted fetuses used for research purposes.
by Julie Beck, The Atlantic, September 22, 2015
The drug company Turing Pharmaceuticals is under fire after a New York Times article published Sunday detailing how it raised the price of a toxoplasmosis drug by more than 5,000 percent after acquiring the drug in August. One tablet of Daraprim used to cost $13.50; now, after its acquisition by Turing, it costs $750 per tablet. (http://tinyurl.com/p5mtlcn)
Rising drug prices have captured the news headlines lately. Turing Pharmaceuticals increased the price of Daraprim, a drug that treats taxoplasmosis, tounprecedented levels, resulting in a congressional investigation. However, drugs like Sovaldi, used to treat Hepatitis C and costs $84,000 for a full course of treatment, have also made the headlines leading to broader claims of industry abuse (http://tinyurl.com/q788kkc). Whether it is abuses by the industry or companies legitimately trying to recoup costs, high drug prices mean that insurance companies must limit who gets coverage for a drug. In the case of Sovaldi, for example, only people with liver failure qualify for coverage.
by Patrick McGreevy, Los Angeles Times, October 5, 2015
Caught between conflicting moral arguments, Gov. Jerry Brown, a former Jesuit seminary student, on Monday signed a measure allowing physicians to prescribe lethal doses of drugs to terminally ill patients who want to hasten their deaths. Approving the bill, whose opponents included the Catholic Church, appeared to be a gut-wrenching decision for the 77-year-old governor, who as a young man studied to enter the priesthood. (http://tinyurl.com/op8pfcs)
After failing in committee the first time the bill came before the California legislature, the End of Life Option Act passed the California legislature during a special session. Governor Brown eventually signed the bill that would allow physicians to prescribe a lethal dose of drugs to someone with a terminal illness. California joins Oregon, Vermont, and Washington with legislation that legalizes physician-assisted suicide.
The Economist, October 17, 2015
Until now, though, two technical problems have stood in the way of routinely transplanting animal organs into people. One is that the recipient’s immune system must be persuaded to tolerate a big chunk of foreign tissue. The other is that swapping tissues between species risks swapping diseases, too. This second problem may soon be addressed, if George Church of the Harvard Medical School has his way. (http://tinyurl.com/p3m2j2x)
The waning field of xenotransplantation has been revitalized thanks to the gene editing technology of CRISPR/Cas9. Researchers are investigating if they can rid pigs of viral DNA using gene editing, bringing them one step closer to harvesting organs from pigs that could be used for transplantation in humans. Studies with baboons have shown some promise with one baboon living for over one hundred days with a transplanted kidney from a genetically modified pig.
by Mitch Leslie, Science, October 26, 2015
Researchers who hope to use stem cells—the unspecialized cells that produce all of our tissues—to treat diseases face a dilemma. Stem cells from embryos (ES cells) could provide a wealth of new cells but spark ethical objections. Stem cells produced from adult cells (so-called induced pluripotent stem [iPS] cells) avoid the ethical difficulties, but some scientists have questioned whether they are as powerful as ES cells. A new study suggests that the two types of stem cells are equivalent and may help soothe worries about the capabilities of iPS cells. (http://tinyurl.com/psa6ck4)
Currently there are clinical trials for both ESCs and iPSCs, and scientists have been using adult stem cells to treat diseases for years. While iPSCs seemed to be a way to avoid the morally contentious destruction of embryos, some scientists questioned whether they were truly alternatives to the so-called “gold standard” of ESCs. This study, while not highly publicized, helps allay these concerns. As it turns out, the genetic differences between ESCs and iPSCs have more to do with genetic differences between the donors rather than differences in cell type.
by AFP, Australian Broadcasting Corporation, October 28, 2015
India’s government says it plans to ban surrogate services for foreigners wanting babies, a move likely to hit hard the booming and lucrative industry. Ranks of childless foreign couples have flocked to the country in recent years looking for a low-cost, legal and simple route to parenthood. (http://tinyurl.com/o2zbxgu)
In a setback to foreign nationals planning surrogacy in India, the union home ministry has instructed Indian missions and foreigners regional registration offices (FRRO) not to grant visa to couples intending to visit India for surrogacy. The move comes with health ministry also banning commercial surrogacy in India. (http://tinyurl.com/gl6rgye)
India had been the go-to destination for international commercial surrogacy, due to its few restrictions and lax laws. The health ministry recently moved to ban commercial surrogacy for people who are not from India and for unmarried couples, leaving many international couples and their unborn children in legal limbo. Thailand also recently banned commercial surrogacy and, in September, the Supreme Court of Nepal issued an order to stop commercial surrogacy services. More recently the European Parliament condemned surrogacy for exploiting vulnerable women.
by Steven Jiang and Susannah Cullinane, CNN, October 30, 2015
China will allow two children for every couple, the state-run Xinhua news agency reported Thursday, a move that would effectively dismantle the remnants of the country’s one-child policy that had been eased in recent years. ‘To promote a balanced growth of population, China will continue to uphold the basic national policy of population control and improve its strategy on population development,’ Xinhua reported, citing a communique issued by the ruling Communist Party. (http://tinyurl.com/naes27h)
In an effort to counteract undesired effects of its social policy, China is lifting its one-child policy, but still maintaining control over how many children a couple can have. In some parts of China, the government resorted to coercive measures to ensure that couples comply with the one-child policy. However, thirty years of this policy has resulted in an imbalanced sex ratio and an aging population without the resources to care for them.
by Ian Sample, The Guardian, November 28, 2015
Once an idea explored only in fiction, the prospect is now a real one. The inexorable rise of gene editing has put the technology in labs across the globe. The first experiments on human embryos have been done, in a bid to correct faulty genes that cause disease. To thrash out an answer, or at least find common ground, an international group of experts will descend on Washington DC next week for a three day summit. Convened with some urgency by the US, UK and Chinese national academies, the meeting is billed as a “global discussion.” (http://tinyurl.com/ou3fbnr)
Gene editing technology made a huge leap when scientists showed the abilities of the CRISPR/Cas9 system. Unlike prior gene editing technology, this one is able to make multiple, directed point mutations. Furor over the announcement that scientists in China genetically edited a human embryo prompted scientists to meet for a global summit on regulating this technology. The summit did not ban editing human embryos and germ cells outright, but called for more research and restrictions. They did ban editing embryos that would be used for establishing a pregnancy (http://tinyurl.com/jsg68wo).