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March
22
  2:16:23 PM

Bill Gates criticised over health initiatives

Billionaire philanthropist Bill Gates, the co-founder of Microsoft, has made many enemies in his healthcare policy campaigns. Gates was heckled by protesters from the Foreskin Awareness Project (FAP) in Vancouver on Thursday, just before he delivered a talk at a TED conference. The protesters were criticising circumcision programs in Africa funded by the the Bill and Melinda Gates Foundation. It donates millions of dollars each year to male circumcision programs in 14 countries, because of the procedure appears to reduce heterosexual HIV infections. FAP says that Gates is “Foreskin Enemy #1”.

FAP founder Glen Callender questions the merits of circumcision in preventing HIV, and is concerned about the aggression of ‘circumcision drives’ in African nations: “Soon it will be obvious that circumcision gave these men false confidence, not effective protection,” he said.

Elsewhere, conservative Bioethicist Wesley Smith attacked Gates for his recent remarks on “death panels” and “rationing medical advances”.  In an interview with Rolling Stone magazine, Gates had mentioned the need for caution when providing healthcare to the elderly:

“innovation can actually be your enemy in health care if you are not careful. If you accelerate certain things but aren't careful about whether you want to make those innovations available to everyone, then you're intensifying the cost in such a way that you'll overwhelm all the resources.”

Smith wrote in response, “Yes, we have to find ways to control medical costs. [But] not through invidious discrimination depriving people of non-elective or necessary care, while payment for coverage of life-style enhancers continues to increase.”

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March
22
  1:57:43 PM

“Mitochondrial transfer” is a misnomer: Stuart Newman

Both in the US and the UK, government authorities are considering the legalisation of so-called “three-parent embryos”. The US Food and Drug Administration held hearings in late February and the UK Department of Health has published draft guidelines which are currently open for comment by the public.

However, a leading US scientist has delivered a broadside at the scientific ignorance and spin involved in discussion of the proposals. Professor Stuart Newman, of New York Medical College, makes the obvious point that what is being proposed is nuclear transplantation, not mitochondrial transplantation.

He believes that the technique is being used as a stalking horse for genetically engineered children: “once the transfer of an entire haploid (i.e., one-parent's) set of chromosomes into a woman's egg is considered acceptable, transfer of a smaller number of chromosomes or genes will be a much easier sell.”

Professor Newman says that proponents of the technique, which is being described as a way of helping women with defective mitochondria to have healthy children, are underselling the importance of the egg. In a column in the Huffington Post, he writes:

“The egg is essential because in addition to its mitochondria it contains hundreds of different protein and RNA molecules it incorporates during its formation in the egg producer's ovary. This information directs the use, or ‘expression,’ of the transferred genes at the early stages of the embryo's development. From the standpoint of the woman who contributes this one non-redundant ingredient, the extent of genetic engineering of her egg in MST is massive….

“To use the emotive term ‘mother’ only for the donor of the maternal set of chromosomes downplays the unique biological role of the egg and of the woman who contributes it. It has the further effect of endorsing the false assertion of MST's advocates that the procedure comes down to the transfer of a few (ie, the mitochondrial) genes. What is actually being transferred are 20,000 or so genes provided by the chromosome donor.” 

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March
22
  1:52:21 PM

“Mitochondrial transfer” is dangerous: Maureen Condic

Some women are carriers of a genetic disease because of defective mitochondria. Replace hers with healthy mitochondria donated by a another woman. Result: a healthy child. Problem solved. What’s to worry about?

But in a ferocious blast in the on-line journal Public Discourse, University of Utah stem cell scientist Maureen Condic contends that there are significant ethical and medical problems with so-called “three-parent embryos”

Supporters of the technique frame it as if it were as simple as popping some extra RAM into a laptop to make it run faster. But Dr Condic looks at it differently. She analyses the three methods of “therapy” and concludes that they are all “macabre form[s] of eugenic cloning, in which a human being with a medical condition is killed and his or her parts are used to create a new human being with an improved biological state.”

She also disputes the ethics of the “extra RAM” approach:

“The embryo produced by this procedure is not just the original child of the parents, moved to a new cytoplasmic ‘environment’. This would only be true if a human being were nothing more than his or her DNA, which is clearly not the case. While our unique DNA clearly determines many aspects of our individual characteristics, we are also greatly influenced by the specific, non-genetic composition of the egg that produced us.”

There are also serious concerns about the health of the resulting embryo.

“All three [methods of ‘mitochondrial transfer’] are highly likely to be unsafe for the resulting children, even the ones that are not deliberately destroyed and are not damaged by the procedure itself. Mitochondrial heteroplasmy, or the persistence of some mitochondria from both the mother and the donor egg, is a significant risk to any children produced by these techniques. In general, heteroplasmy is not a good thing, and in this case, it could also cause reappearance of the disease in the offspring of any woman produced by the “three-parent” approach, due to mitochondrial ‘founder effects’ in oogenesis. Even a few ‘bad’ mitochondria can become the dominant type in any one egg, causing the mitochondrial disease to recur in any child produced from that egg.”

Finally, the technique could create another serious inheritable problem:

“We know that in nature, mtDNA and nuclear DNA ‘co-evolve’ to work with each other in an efficient manner. In some species, incompatibility between the mitochondrial and nuclear genome significantly compromises the health of the individual. All of the proposed methods of ‘treating’ mitochondrial disease introduce a permanent and unnatural mismatch between the nuclear and the mitochondrial genome that will be inherited by all subsequent generations.”

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March
22
  1:45:00 PM

US must debate “mitochondrial transfer”: Thomas H. Murray

 

The president emeritus of the Hastings Centre for Bioethics has written a forceful opinion editorial in Science calling for “a nationwide conversation about current and emerging reproductive technologies”. Thomas H. Murray believes that reproductive health law in the US is badly underdeveloped and that serious issues are being ignored. His article focused mainly on the question of mitochondrial manipulation, but also looked at IVF embryo selection on the basis of sex and other traits.

Sex selection of embryos for non-medical purposes is prohibited in 36 countries, but not in the United States. There is no federal prohibition on reproductive human cloning. And the Food and Drug Administration is yet to decide whether it will authorize clinical trials of mitochondrial manipulation technologies. 

“Discussion of the ethics of mitochondrial manipulation cannot be postponed indefinitely”, Murray wrote. “This is a task for the US Presidential Commission for the Study of Bioethical Issues to pursue, given that its mission is to ensure that scientific research, health care delivery, and technological innovation are conducted in a socially and ethically responsible manner.”

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March
14
  7:29:08 PM

Are totipotent cells really embryos?

Major developments in stem cell science tend to revive scruples about whether the new pluripotent cell is or could become an embryo. This happened with embryonic stem cells, with Yamanaka’s induced pluripotent stem (iPS) cells, and now with stimulus-triggered acquisition of pluripotency (STAP) cells. Unhappily, a cloud hangs over STAP cells because it appears that the original paper in Nature was peppered with mistakes. But the question remains: if scientists create cells which can develop into any cell in the body (and into the placenta as well), are they not what we would otherwise call embryos?

Maureen Condic, of the University of Utah, a redoubtable opponent of human embryonic stem cell research, debunks this idea in the journal Stem Cells and Development: stem cells, she insists, are not embryos.

The problem begins with terminology, she says. The National Institutes of Health defines “totipotent” in two different ways: “capable of developing into a complete organism” or “differentiating into any of its cells or tissues”. The first kind of totipotency is an embryo; the second is a stem cell.

The difference between these two definitions is not trivial. Producing a mature organism requires the ability to both generate all the cells of the body and to organize them in a specific temporal and spatial sequence, that is, to undergo a coordinated process of development. Totipotency in this strict sense is demonstrated by the ability of an isolated cell to produce a fertile, adult individual. Consequently, a cell that is totipotent is also a one-cell embryo; that is, a cell that is capable of generating a globally coordinated developmental sequence.

Only the fate of an organism which is capable of developing into an adult is ethically controversial.

Rather, ethical consideration is given to human embryos based on the status they already possess; that is, their unique and fully operative ability to function as a human organism. Therefore, ethical controversy regarding totipotent human cells only concerns cells that are totipotent in the strict, organismal sense; that is, a cell that is a human embryo.

 

Condic suggests that the term “totipotent” should be confined to organisms, ie, embryos. She coins the term “plenipotent” for cells which are capable of developing into all cells in the body.

What accounts for the difference? Condic explains that research shows that factors in the cytoplasm of the egg are necesssary for the existence of true totipotency. “At this time, the only known totipotent cytoplasm is produced by an oocyte and contributed to the embryo at fertilization. The fact that oocytes produce the cytoplasmic factors that are required for an embryo to be totipotent is the reason oocytes are used for cloning.” Without these factors, a “plenipotent” cell can never become an embryo.

Language matters. If people do not grasp the difference, they can create artificial controversies “over areas of research that are ethically unproblematic”, Condic writes.

Note: the article in Stem Cells and Development is behind a pay wall. Dr Condic has summarised her paper in Public Discourse, which is readily available.

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March
14
  3:12:09 PM

US Office of Research Integrity shackled by bureaucracy

Quis custodiet ipsos custodes? Who is watching the watchdogs, asked Juvenal about the bureaucracy of Rome. Now the question is: who is doing the watchdogs’ paperwork? The head of the US agency for investigating scientific misconduct has just resigned after two years of struggle with a “remarkably dysfunctional” Federal bureaucracy.

This is another small shortcoming in the checks and balances of the scientific method. If, because of bureaucratic incompetence, rogues are slipping through nets meant to sift out fraud and misconduct, how sure can we be of scientists’ claims?

David Wright, director of the Office of Research Integrity (ORI) for the past two years, was scathing in his letter of resignation, which was published in ScienceInsider. He claims that he had to spend 65% of his time navigating the bureaucracy. “What I was able to do in a day or two as an academic administrator takes weeks or months in the federal government,” he wrote. His own bailiwick, the Office for Research Integrity, had to report to the Department of Health and Human Services, a “secretive, autocratic and unaccountable” organisation. He concludes, “I’m offended as an American taxpayer that the federal bureaucracy—at least the part I’ve labored in—is so profoundly dysfunctional.”

The Office of Research Integrity runs education programs and oversees misconduct investigations. Every year, it issues about a dozen findings of fabrication, falsification, or plagiarism by scientists funded by the Federal Government. It was a target of harsh criticism recently from Iowa Senator Charles Grassley. He asked why the ORI had failed to recoup millions of dollars of research grants given to an AIDS researcher, Dong-Pyou Han, who faked data to demonstrate that a vaccine for HIV was effective.  

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March
14
  11:55:24 AM

Compassionate use on trial

In a story that has garnered worldwide attention, drug company Chimerix has given a seven-year-old American boy access to an experimental drug that could save his life. Josh Hardy of Fredericksburg, Viriginia, contracted an adenovirus following chemotherapy treatment for leukaemia. The virus was thought to be incurable, but the new drug Brincidofovir has shown some success against it.

Initially, the drug’s provider Chimerix said it would not grant use of the drug as it might slow down its approval process. However, following a massive social media campaign by Hardy’s parents, the drug company has changed its mind.

Bioethicist Arthur Caplan has questioned this. He cautioned against decisions based on emotion and public pressure:

“this is no way to handle requests from desperate patients, parents or families to try to save themselves or their loved ones from imminent death by giving them access to unproven, experimental drugs. We need an equitable compassionate use policy for everyone in this country.”

Caplan suggested that a myopic campaign directed at one small company misses the issue:

“If you want to help Josh and others like him, don’t just point a finger at a tiny biotech company…Josh needs a shot at his drug, but he also needs a nation that has a program with the financial and regulatory resources to systematically respond to those facing his horrible situation.” There is a need for broad health reform, including “a national compassionate use fund to pay for experimental drugs for all”. 
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March
13
  9:42:28 PM

The resurrection of the “technically dead”

Lorna Baillie with daughter and husband

The family of a 51-year-old British woman is suing the government for £5 billion after she was wrongly declared dead. Following her massive heart attack two years ago, the doctors of Lorna Baillie told her family she was “technically dead” and they switched off her life support system. However, once this had been done Baillie continued to breathe.  It was only after 45 minutes that her family persuaded the doctors to reconnect life-support.

Ballie’s family claim that this deprivation caused major brain damage. Lorna has recovered the ability to walk and talk, but has been left in a permanent child-like state, with little long-term memory.

“She now has to have constant two-on-one care for the rest of her life”, said Baillie’s eldest daughter, Leanne, 33. "That's why we are suing, we have to be able to get care for her so we can bring her home.”

Dr David Farquharson of Edinburgh’s NHS trust said the health board was not able to comment on the case as a result of legal proceedings.

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March
13
  3:08:32 PM

Assisted suicide is too dangerous in times of economic crisis, says disabled UK peer

Moves to legalise assisted suicide in Britain are a threat to the disabled during a time of economic hardship, says Baroness Campbell of Surbiton, a disabled peer. She told the London Telegraph that it was “a dangerous time” to consider to consider changes to legislation when people on welfare were being described as scroungers who are a burden on society.

Relaxing the law on assisted suicide would amount to an open invitation for relatives or carers to pressure people with disabilities to do away with their lives, she said.

The British House of Lords is currently debating the guidelines on prosecuting people who help loved ones to commit suicide. Baroness Campbell, who has suffered from a serious degenerative illness since childhood, is strongly opposed to altering the guidelines to mitigate penalties if the deceased had suffered from a disability.  

“Terminally ill and disabled people are in a worse position today than was the case five years ago. National economic instability means that public support services are under more pressure than ever. That has hardened public attitudes towards progressive illnesses, old age and disability.

"Words such as ‘burden’, ‘scrounger’ and ‘demographic time bomb’ come to mind, and hate crime figures in relation to vulnerable people have increased dramatically.

“This is a dangerous time to consider facilitating assistance with suicide for those who most need our help and support. “It is not only dangerous for those who may see suicide as their only option, but can be tempting for those who would benefit from their absence.”

She also commented on recent changes in the law in Belgium which will permit the euthanasia of children.

“Belgium has recently extended its law on euthanasia to include terminally ill and disabled children. That is not a future I want for our children or the most vulnerable, and this House has made it clear that it shares that view.”

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March
13
  2:33:06 PM

Doubts mount about new stem cell paper

A mouse embryo formed with Stimulus-Triggered Acquisition of Pluripotency (STAP) cells

 The world’s leading science journal, Nature, may end up with egg on its face as complaints mount about a recent paper on a radical new method of creating pluripotent stem cells.

One of the co-authors, Japanese stem cell scientist Teruhiko Wakayama, has called for the paper to be retracted after problems surfaced with the images and allegations of plagiarism. He now says that he is not sure that the cells given to him were really created by the technique. “I have lost faith in the paper,” he told Japanese media. “Overall there are now just too many uncertainties about it. I think we have to wait for some confirmation.” 

The original paper about "stimulus-triggered acquisition of pluripotency" (STAP) cells was published in Nature on January 30. A team led by Haruko Obokata of the RIKEN Center for Developmental Biology in Kobe, Japan, claimed that it had developed a way to reprogram cells to an embryonic state by bathing them in an acidic solution. The idea was so simple, yet so radical, that other scientists reacted with both amazement and scepticism. At the moment, the second emotion is dominant. 

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