Sunday, January 22, 2017

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Donald Trump was a different sort of candidate and he gave a different sort of inaugural speech. It was short, sharp, divisive and isolationist, the kind of remarks that often precede a massive swamp-draining project. But in one respect it was similar to speeches by other presidents: bioethics was not a major theme.

He did say that "We stand at the birth of a new millennium, ready to unlock the mysteries of space, to free the earth from the miseries of disease" -- which sounds vaguely promising for scientific and medical research.

His twice-repeated invocation of the Almightly suggests that he might follow a Christian line on controversial issues like contraception, abortion and assisted suicide. 

But who knows? Mr Trump is a bit like that quintessentially American poet Walt Whitman -- "Do I contradict myself? Very well then I contradict myself, (I am large, I contain multitudes.)" No one really knows what he has in mind about a range of topics. Buckle up. It's going to be a bumpy ride.

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Michael Cook
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This week in BioEdge

2017-01-16 11:58 PM
Stem cells 1: ‘Be patient,” says Nobel laureate Shinya Yamanaka
by | Jan 21, 2017
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tags: shinya yamanaka, stem cells

Shinya Yamanaka / New York Times    

Japanese researcher Shinya Yamanaka won the Nobel Prize in Medicine in 2012 for discovering that mature cells can revert to stem cells. These “induced pluripotent stem cells” can, theoretically, become any cell in the body. This was greeted not only as an immense technical breakthrough, but an ethical one, as scientists’ interest in embryonic stem cells for potential cures swiftly declined after his ground-breaking research.

In an interview with the New York Times, he has answered some questions about the future of stem cell research.

For a layman, the surprising thing about Dr Yamanaka’s view of the field is his scepticism about “personalised medicine”. It was once confidently predicted that a person’s iPS cells could be used to create whatever cells are needed to cure him. Not so, he says. Even iPS cells are potentially cancer-causing and have to be tested carefully. Instead of using iPS cells developed from each patient, he envisages using 10 thoroughly safety-tested stem cell lines -- which could treat all patients in Japan (or 20 in the US).

Here are some excerpts from the interview:

Was the promise of stem cells overstated?     

In some ways, yes, it is overstated. For example, target diseases for cell therapy are limited. There are about 10: Parkinson’s, retinal and corneal diseases, heart and liver failure, diabetes and only a few more — spinal cord injury, joint disorders and some blood disorders. But maybe that’s all.

The number of human diseases is enormous. I don’t know how many. We can help just a small portion of patients by stem cell therapy.

Why so few?   

We have more than 200 types of cells in our body. But the diseases I described are caused by loss of function of just one type of cell. Parkinson’s disease is caused by failure of very specialized brain cells that produce dopamineHeart failure is caused by loss of function of cardiac heart cell.

So, that’s the key. We can make that one type of cell from stem cells in a large amount, and by transplanting those cells, we should be able to rescue the patient. But many other diseases are caused by multiple types of cell failures, and we cannot treat them with stem cell therapy.

What are your biggest concerns about the future of stem cell treatments?

I think the science has moved too far ahead of talk of ethical issues. When we succeeded in making iPS cells, we thought, wow, we can now overcome ethical issues of using embryos to make stem cell lines.

But soon after, we realized we are making new ethical issues. We can make a human kidney or human pancreas in pigs if human iPS cells are injected into the embryo. But how much can we do those things?

It is very controversial. These treatments may help thousands of people. So getting an ethical consensus is extremely important.

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Stem cells 2: Was California sold a stem cell pup?
by | Jan 21, 2017
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tags: california, cirm, stem cells

The California Institute for Regenerative Medicine was created in 2004 after voters overwhelmingly supported a US$3 bond issue to pay for stem cell cures. President George W. Bush had just restricted federal funding for human embryonic stem cells and the state set itself up to be the biggest and best stem cell institute in the world. The total cost to taxpayers would eventually be $6 billion, including interest. Was it worth it?

According to an article in the online journal STAT, the answer is probably No.

Back in 2004, the CIRM was “shamelessly oversold” to voters.

Desperate patients, Nobel laureates, and A-list celebrities such as Michael J. Fox — the Hollywood star and Parkinson’s sufferer — predicted “cures” that would “save millions of lives.”

“There are more Americans than … we can count who are sick now, or are going to be sick in the future, whose lives will be saved by Prop 71,” patient advocate Joan Samuelson said in another ad. The sponsors of the measure also predicted that CIRM-generated cures would drastically reduce health care spending. No one made specific promises for the 10-year timeframe initially planned for CIRM’s work, but miracles seemed just around the corner.

Instead, the CIRM can only boast of two completed clinical trials since it began. Most of the $2.2 billion it has distributed so far has been spend on buildings and basic research, not on cures. The new CEO of the CIRM, C. Randal Mills, now calls initial hopes “naïve”.

“You can support embryonic stem cell research, which we do and did, and still be pretty appalled by what was going down,” says Marcy Darnovsky, head of the Berkeley-based Center for Genetics and Society. “The airwaves were swamped with guys in white coats who were identified with their academic affiliation even though they were principals of private companies (some of which later got CIRM grants), and basically saying, ‘We’re going to have cures by Christmas.’”

Under its current funding plan, the CIRM’s money will run out by 2020. With its remaining $692 million, Mills hopes to fund another 50 clinical trials, 10 of which were announced last year. Only 17 trials were funded in the organisation’s first year. 

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Using patents to restrict harmful applications of CRISPR
by | Jan 21, 2017
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tags: crispr, patents

The new CRISPR gene-editing technology is an incredible tool, but it could be used for ethically-troubling procedures like human eugenics, modification of human germline cells, genetically-modified crops, gene drives to wipe out species and on and on and on. How can its uses be restricted?

Writing in Nature Biotechnology, several academics from Baylor College of Medicine in Houston and New York Law School, suggest that ethical licencing by patent holders is a necessary complement to government legislation.

The Broad Institute, in Boston, owns the foundational patents for the CRISPR process. It recently licensed the technology to chemical giant Monsanto with three provisos: (1) not to conduct gene drives, (2) not create sterile “terminator” seeds which farmers would be forced to buy new every year, and (3) not to conduct research to commercialize tobacco products which would add to the public health burden of smoking.

Two years ago, it also licensed CRISPR to Editas Medicine provided that Editas did not use it to to modify human germ cells or embryos or to modify animal cells for the creation or commercialization of organs suitable for transplantation into humans.

“Innovators should follow the Broad Institute’s lead and adopt the practice of using patent licenses to restrict socially harmful applications of their technologies. To be clear, we do not mean to suggest that licensing bans are preferable to, or should be used to the exclusion of, policymaking or professional standards setting. Rather, we believe that the promotion of private efforts as a complement to public efforts is worthy of serious consideration,” says Baylor ethicist Christi Guerrini. 

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Catholic healthcare in Colorado may clash with new assisted suicide law
by | Jan 21, 2017
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tags: assisted suicide, catholic church, colorado

The US state of Colorado has legalized assisted suicide, but its large Catholic hospital system is refusing to cooperate, according to STAT.  

The state’s largest healthcare company, Centura Health, which operates 15 hospitals and more than 100 physician practices and clinics, will “opt out” of offering aid in dying. Centura is jointly operated by Catholic Health Initiatives and Adventist Health System, associated with the Seventh Day Adventist Church, which also opposed assisted suicide.

The second-largest, SCL Health, says that patients who request assisted suicide will be given the option of transferring to another healthcare facility. SCL Health runs seven hospitals and dozens of clinics.

The Colorado law specifies that healthcare systems may not prohibit their doctors from discussing end-of-life options with their patients or from writing prescriptions for lethal medications which can be consumed elsewhere. The policies of Centura and SCL may be testing this provision, a representative of Compassion & Choices, the assisted suicide lobby group, told STAT. C&C is thinking of a legal challenge to their policies.

Other healthcare systems in Colorado will offer the option of assisted suicide, so patients in urban areas will still be able to access it. But in rural areas, sometimes the Catholic system is the only one available. 

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Duterte vows to roll out contraceptive plan in Philippines
by | Jan 21, 2017
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tags: contraception, philippines, rodrigo duterte

The President of the Philippines, Rodrigo Duterte, has vowed to ensure that there is “zero unmet demand” for contraception in his country by 2018.

Although contraception is technically legal, implementation has been held up in the courts with its opponents claiming that it is abortifacient. The Duterte government feels that unless it is freely available, the Philippines, a country of more than 100 million, will be unable to meet its poverty reduction target. This is to bring poverty levels down from 25% to to 13% by the end of Duterte's six-year term in 2022.

Government officials say that they will roll out the plan in the next six months. Local government officials will do house-to-house visits to identify women who need family planning. The Department of Education has also been told to implement a "gender sensitive and rights-based" sexuality education in schools.

The Philippines is 86% Catholic and President Duterte is well aware that the bishops are adamantly opposed to his “anti-life” plans. His administration counters that it is “pro-life, pro-women, pro-children, and pro-economic development."

Four years ago, under President Noynoy Aquino, a Responsible Parenthood and Reproductive Health Law was enacted, which permitted contraception – although abortion for any reason remains illegal. However, the law immediately was challenged in the courts. In 2015 a temporary restraining order was issued against implants, the most popular method, which still has not been lifted. Furthermore, Congress cut the budget of the contraception program to the bone. 

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First British man to give birth
by | Jan 21, 2017
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tags: sperm donation, transgender

In one of most head-scratching stories so far this year, a British woman who began living as a man three years ago at the age of 17, has stopped her transition process to become a male because she wants to have a child.

After the National Health Service refused to freeze her eggs, Hayden Cross, 20, of Gloucester, who is currently unemployed, joined a Facebook group where she found a sperm donor. She is now four months pregnant although she has no idea who the father of her child is. As she told The Sun:

“I don’t know who the bloke was. To be honest I can’t remember anything about him. He wouldn’t even tell me his name. He didn’t want any contact. He said he was just doing it to help people. It was the first attempt and it worked. I was really lucky.”

She has told the media that she will be the “greatest dad”.

After the birth, Cross plans to have her breasts and ovaries removed and to continue transition to become a male. But she feels frustrated that her plans to transition have necessarily been put on hold. She told The Sun:

“It makes me angry that I’ve been put through this. Carrying a baby is meant to be a happy time, but in my body it feels wrong. I just couldn’t face being years down the line and still waiting to transition so that I can have a kid. I wanted the kid now so that I can have the transition before I get old. I want to enjoy being the way I was meant to be.”

In the media, Cross is being billed as the first British man to give birth. 

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A doctor at the centre of the capital punishment debate
by | Jan 21, 2017
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tags: capital punishment, georgia

Emergency physician Carlo Musso is the President of CorrectHealth, a Georgia-based company with 400 employees which provides medical care for prisons. Although her personally opposes capital punishment, he believes that he should participate in executions to provide “end of life comfort measures”. “Instead of a carcinoma, that individual’s dying of a court order,” he says.

In this short video from the New York Times, he explains why he persists, despite vehement objections from lobby groups and medical professional bodies.

Since 1976, 69 prisoners have been executed in Georgia. In 2016, nine were executed, the most recent on December 6. 

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Michael Cook
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