Top Bioethics News Stories - Winter 2016

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“Boom in Unproven Cell Therapies Intensifies Regulatory Debate”

by Heidi Ledford, Nature, September 7, 2016

By the time Albini, an ophthalmologist at the University of Miami in Florida, had treated two more women who had been blinded by the same procedure, he knew that there was a systemic problem. Two of the women had been lured by a posting in a clinical-trial registry—even though there was no real trial to speak of—and none of the injections had been administered by a physician. (  

Scientists are pressuring the FDA to review and shut down clinics providing unproven stem cell treatments. Many stem cell clinics are popping up in the U.S with a recent study indicating the existence of more than 500 such clinics. Current FDA guidelines are unclear as to whether the clinic is required to meet their rules for testing a procedure prior to use, namely because of wording that says the procedure can involve “minimal manipulation” of cells without FDA oversight. However, this ambiguity is being exploited by clinics that are not properly informing patients of the risks involved.

“Belgium Minor First to Be Granted Euthanasia”

BBC, September 17, 2016

A terminally ill 17-year-old has become the first minor to be helped to die in Belgium since age restrictions on euthanasia requests were removed two years ago, officials say. The head of the federal euthanasia commission said the teenager was ‘suffering unbearable physical pain.’ Belgium is the only country that allows minors of any age to choose euthanasia. (

“Dutch Law Would Allow Assisted Suicide for Healthy Older People”

by Dan Bilefsky and Christopher F. Schuetze, New York Times, October 13, 2016

In the Netherlands, a country vaunted for its liberalism, a proposal to legalize assisted suicide for older people who are generally healthy but feel they have led a full life has stirred up an ethical storm in some quarters. (

Both Belgium and the Netherlands have become the global standard for legalized euthanasia. Since their respective laws were adopted in 2003 and 2002, the scope of criteria and conditions that qualify for euthanasia has continued to broaden. Now it is legal in Belgium to euthanize minors, and a new law in the Netherlands that will be drafted by the end of 2017 would allow healthy older people who have “completed life” to qualify for assisted suicide.

“Titanic Clash over CRISPR Patent Turns Ugly”

by Heidi Ledford, Nature, September 21, 2016

Much of the focus is on the teams centred [sic] at Berkeley and the Broad Institute, whose ‘foundational’ patents cover a wide swathe of CRISPR–Cas9 applications. Although Berkeley’s team filed for a patent first, the Broad opted for an expedited review process, and its patents were granted earlier. The Berkeley team then asked the USPTO to declare a ‘patent interference’, launching a complicated process to establish who first came up with the invention. (

There is a quite a bit of money at stake for whomever owns the patent rights to CRISPR-Cas9. The intellectual property conflict pits UC Berkeley and the Broad Institute of MIT and Harvard and will likely continue aggressively for months or even years. While these types of cases usually settle, the potential financial implications at stake along with the involvement of various commercial entities suggest that this dispute will likely continue until it is resolved in court.

In other CRISPR news, Stanford University announced plans to conduct human trials using CRISPR-Cas9 to correct sickle cell anemia ( This will be done by removing the person’s stem cells, editing them, and then returning the cells to the patient. And, in September, Swedish scientist, Fredrik Lanner, became the first known scientist to genetically edit a healthy human embryo using CRISPR (

“Exclusive: World’s First Baby Born with New ‘3 Parent’ Technique”

by Jessica Hamzelou, New Scientist, September 27, 2016

The controversial technique, which allows parents with rare genetic mutations to have healthy babies, has only been legally approved in the UK. But the birth of the child, whose Jordanian parents were treated by a US-based team in Mexico, should fast-forward progress around the world, say embryologists. (

In Mexico, the first baby was born using a technique that ensures a mother’s faulty mitochondria are not passed down to her children. In this case, the couple did not want to destroy two embryos, so they underwent a technique called spindle nuclear transfer rather than pronuclear transfer which involves removing the nucleus from two embryos. In spindle nuclear transfer, the nucleus of the donor’s egg is removed and replaced with the nucleus of the mother’s egg. Then IVF is carried out with the father’s sperm. In November, despite the continued moral questions and technical concerns about potential harm that have been raised with this technique, a UK panel stated that the technique was safe enough for patients under special circumstances.

“FDA Approves First ‘Artificial Pancreas’ for Diabetes Treatment”

by Rebecca Robbins, STAT News, September 28, 2016

The Food and Drug Administration on Wednesday approved the first so-called artificial pancreas, an out-of-body device expected to lift the burden for some diabetics on the daily grind they must go through to keep their blood sugar levels stable. It will be available next spring for patients with type 1 diabetes who are over age 14. (

A new device that received less press than it merited was the federal government’s approval for an artificial pancreas for Type I diabetes patients. The device will automatically monitor and deliver insulin as needed to the patient serving as a mechanical pancreas. While the development of the device appears to be quite promising, concerns have been raised whether the device will be prohibitively expensive for some patients and thus impact access.

“Drug Overdose Deaths Drive Increase in Number of Organ Donations: One Family’s Story of Hope from Despair”

ABC News, September 29, 2016

In recent years, so many people have died as a result of the nation’s opioid epidemic that it has caused the number of organ donations from fatal overdose victims to skyrocket—an unexpected consequence that highlights the nation’s agonizing opioid crisis. In 1994, only 29 donors in the U.S. had died of drug overdoses. Last year, that number climbed to 848 . . . (  

As the number of people who die from drug overdose continues to rise, several media outlets reported that there are now more organs available for transplants. In one statistic, Maryland, which has seen an incredible increase in overdose deaths over the last several years, attributed 6% of their organs to overdose deaths in 2010. It is estimated that in 2016, as much as 25% of their organs were from overdose deaths.

“The Need to Replace EipPens Regularly Adds to Concerns about Cost”

by Carmen Heredia Rodriguez, Kaiser Health News, September 30, 2016

As controversy about the pricing of EpiPens reverberates from Capitol Hill to school districts across the country, one recurring complaint from consumers is that the high cost is magnified because the drug expires quickly, forcing users to regularly bear the cost of replacing the medicine that saves lives in the event of a severe allergic reaction. (

Following Martin Shkreli’s unashamed price hike of a common anti-parasite medicine, other companies have followed suit, purchasing a drug company and increasing the price of a necessary drug. Mylan owns the patent on the EpiPen’s auto injector. Since acquiring the patent, the company has steadily increased the price to $600 for two injectors. The injections were $100 for two injectors just a few years ago. The CEO of Mylan has offered to make a generic version for half the price; however, the company is currently caught up in a class-action lawsuit.

“‘Like Doctors in a War’: Inside Venezuela’s Healthcare Crisis”

by Jonathan Watts, The Guardian, October 19, 2016

Despite its immense oil wealth, the country is in the midst of devastating economic, social and health crises. It has the world’s steepest economic decline, the second highest murder rate and the sharpest-rising inflation (forecast to reach 2,200% by the end of next year, according to the International Monetary Fund). These problems all converge in the nation’s hospitals, where doctors report rising levels of mortality thanks to a dire shortage of medical supplies, shutdowns of operating theatres, staff declines and violent crime, including gunshots during surgery and mugging in corridors. (

Venezuela’s economic crisis has led to a medical crisis. Patients are no longer able to get their basic needs met, and Venezuela’s mortality rate is rapidly increasing. Medical facilities are completely deteriorated, and doctors cannot complain for fear of punishment by the government. Unrest regarding these conditions have led to some reports that gangs have gunned down doctors in the midst of surgery.

“Assisted Suicide Is Now Legal in Colorado”

by Angela Chen, The Verge, November 8, 2016

Colorado becomes the sixth state to have a so-called ‘right-to-die law,’ joining Washington, Oregon, California, Vermont, and Montana. . . . The measure allows Colorado residents over 18 to request assistance to die if they are ill and have less than six months to live. (

“D.C. Council Approves ‘Death with Dignity’ Bill for Terminally Ill Patients”

by Josh Sanburn, TIME, November 15, 2016

The D.C. Council overwhelmingly approved a “Death With Dignity” bill Tuesday that allows terminally ill patients the ability to obtain medication to end their own lives. (

Laws that legalize physician-assisted suicide, often referred to as “right-to-die,” “aid-in-dying,” or “death with dignity” laws have gained ground in the United States with Colorado becoming the most recent state to legalize assisted suicide, and the mayor of Washington, DC signing a similar bill into law in December.

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