BioEdge 273 -- Wednesday, 7 November 2007

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BioEdge 273: Is informed consent irrelevant on the battlefield?

THIS WEEK


bullet 
Is informed consent possible on the battlefield?
      US Army doctors have different rules
bullet 
Scientists need humility, says Harvard prof
      ... in the face of uncertainty and ignorance
bullet 
"Every month holds a miracle" -- and cash
      Menstrual blood may have useful stem cells
bullet 
MIT stem cell scientist urges closer ties with Iran
      Few restrictions there on embryonic research
bullet 
Chinese neurosurgeons cash in on mental illness
      Brain surgery leaves many worse off
bullet 
Mighty mice ready for Tour de France
      Genetically engineered mice can run for hours
bullet 
A peep into the future of science
      Leading scientists given crystal balls
bullet 
Living in ignorance of trial results
      Patients not told results of failed products
bullet 
Head and shoulders above other genome sequences
      Dandruff fungus decoded
bullet 
Lung patients denied intensive care in UK
      Doctors too pessimistic
bullet 
Thou shalt not bear false witness
      A British doctor who lied

Is informed consent possible on the battlefield?

from USA Today Bioethics is never far from the war in Iraq. This time, the centre of controversy is Colonel John Holcomb, the head of the US Army's Institute of Surgical Research, based on the campus of the Brooke Army Medical Center, in San Antonio, Texas. Col Holcomb is a highly respected and innovative trauma surgeon who has reorganised the way that the Army treats casualties. But his enthusiastic acceptance of unproven treatments for severely wounded soldiers has raised eyebrows.

Under his supervision, Army surgeons are using a controversial drug called Factor VII, which promotes clotting in cases of severe bleeding. He also strongly backs the use of experimental treatments on severely injured patients who cannot give informed consent. He contends that ethical problems pale in comparison to the toll that traumatic injuries take on civilians and soldiers every day. "You have a drug that you know is safe from the prospective randomised controlled clinical trials," Colonel Holcomb told the New York Times. "And you have to make a decision. It's not something you can decide to talk about. It's really yes or no. You have a lot of people bleeding to death in Iraq."

Despite his energy and good will, Col Holcomb's critics say that he is using drugs and treatments which other trials have already shown to be of dubious benefit. An experimental blood substitute called PolyHeme, which recently failed a clinical trial in trauma patients, is being used in Iraq on wounded soldiers who cannot give informed consent. However, points out one of his defenders, Dr John Hess, of the University of Maryland, civilian haematologists rarely see injuries as severe as those soldiers receive in battle, so they may not understand the circumstances. Colonel Holcomb would never encourage the use of Factor VII if he thought it was endangering soldiers. "He feels deeply concerned about the soldiers, he goes over there, he takes care of them," Dr Hess says. "If you were hurt, he's the guy you'd want taking care of you." ~ New York Times, Nov 6   

Scientists need humility, says Harvard prof

In an essay in the leading journal Nature, a Harvard professor of science and technology has called upon scientists to be more humble. In the face of the complexity and uncertainty of real-life problems, says Sheila Jasanoff, scientists need to acknowledge that they cannot provide all the answers and need to pay more attention to ethics:

"Science fixes our attention on the knowable, leading to an over- dependence on fact-finding. Even when scientists recognise the limits of their own inquiries, as they often do, the policy world, implicitly encouraged by scientists, asks for more research. For most complex problems, the pursuit of perfect knowledge is asymptotic. Uncertainty, ignorance and indeterminacy are always present...

"This call for humility is a plea for policy-makers to cultivate, and for universities to teach, modes of knowing that are often pushed aside in expanding scientific understanding and technological capacity. It is a request for research on what people value and why they value it. It is a prescription to supplement science with the analysis of those aspects of the human condition that science cannot easily illuminate. It is a call for policy analysts and policy- makers to re-engage with the moral foundations for acting in the face of inevitable scientific uncertainty." ~ Nature, Nov 1   

"Every month holds a miracle" -- and cash

from C'elle website Although umbilical cord blood is a rich source of stem cells, debate rages over whether parents who store it in commercial stem cell banks are being taken for a ride. But this has not stopped a Florida stem cell bank from taking the even more audacious step of freezing and storing stem cells from menstrual blood. With an estimated 100 million American women experiencing menstrual cycles, Cryo-Cell is dreaming of a huge market. The new product is coyly called C'elle and its slogan is "every month holds a miracle".

Cryo-Cell has launched its product without citing any peer-reviewed research to support its claim that menstrual flow "contains millions of stem cells that have many properties and characteristics similar to those of both bone marrow and embryonic stem cells". On the other hand, it cites several doctors who rhapsodise over its "compelling promise to transform regenerative medicine in the coming years". The service is not cheap: a single collection costs US$499 in the first year, with $99 annual storage fees thereafter. The company makes no promises about whether cures will ever result from its service. ~ www.celle.com   

MIT stem cell scientist urges closer ties with Iran

Renowned MIT stem cell scientist Rudi Jaenisch believes that more scientific cooperation could lead to more understanding and less fanaticism and intolerance in the relationship between the US and Iran. He recently travelled to Teheran and found that Iranian stem cell scientists are well funded and work under very permissive regulations. The only real restriction appears to be a ban on human reproductive cloning. Ayatollah Ali Khamenei, the country's spiritual leader and highest authority, even paid a visit recently to a brand new stem cell undertaking, the Royan Institute, to express his support.

Dr Jaenisch laments that Iranian scientists work under conditions which would be unbearable in the US. But these are caused not by the ethics of the Islamic regime, but by American trade restrictions which make it impossible to obtain technology which is essential for research. ~ Nature Reports Stem Cells, Oct 25   

Chinese neurosurgeons cash in on mental illness

Chinese neurosurgeons are treating mental illness with brain surgery, a practice which has practically disappeared in the West. According to the Wall Street Journal, doctors do thousands of the procedures to make money for themselves or for their hospitals. Furthermore, because of the lack of mental health facilities, it can be the only treatment available. The WSJ chronicles the stories of Chinese families who spent their life savings on operations promoted with glossy brochures and glowing promises -- from which their children emerged crippled and worse off psychologically.

Since 2004, Wang Yifang, of the No. 454 People's Liberation Army Hospital in Nanjing, has drilled into the skulls of nearly 1,000 patients and burnt small areas of brain tissue. "It's completely off the charts. If he had done 10, it would be highly controversial," says Michael Schulder, president of the American Society for Stereotactic and Functional Neurosurgery.

Chinese doctors make as much as nine tenths of their income through bonuses tied to business they generate, according to Henk Bekedam, who until recently was the World Health Organisation's chief representative in China. This gives them a huge incentive to promote even risky neurosurgery.

Dr Wang says that the procedure is needed. "There are so many mental-disease patients," he says. "In many of the mental-disease hospitals, 30% to 50% of the patients cannot be treated by medicine. And these patients have caused a great burden to their families and society."

According to families interviewed by the WSJ, elementary precautions appear to be ignored. Pre-surgical tests are minimal; post-surgical follow-up is almost non-existent. Informed consent is dubious. ~ Wall Street Journal, Nov 2   

Mighty mice ready for Tour de France

Encouraging news for transhumanists who want to extend human lifespans to Methuselah levels: scientists at Case Western Reserve University in Cleveland, Ohio, have genetically engineered mice which can run for hours without stopping. They can also reproduce at the age of 2.5 years, while normal mice stop reproducing at 1 year. They are metabolically similar to Lance Armstrong biking up the Pyrenees; they utilise mainly fatty acids for energy and produce very little lactic acid," said Richard W. Hanson, the lead author of an article in the Journal of Biological Chemistry.

The "mighty mice" are seven times more active in their home cages than other mice and are markedly more aggressive -- not necessarily a good prognostic for humans. "We humans have exactly the same gene. But this is not something that you'd do to a human," says Dr Hanson. "It's completely wrong. We do not think that this mouse model is an appropriate model for human gene therapy. It is currently not possible to introduce genes into the skeletal muscles of humans and it would not be ethical to even try." ~ Guardian, Nov 2   

A peep into the future of science

Sir Isaac Newton once marvelled at "the great ocean of truth [which] lay all undiscovered before me", but modern scientists will soon turn the ocean into a shallow pond, according to theoretical physicist Michio Kaku, of the City College of New York. He is the host of a new BBC series in which scientists peer into the future.

His own feeling is that "We have unlocked the secrets of matter. We have unravelled the molecule of life, DNA. And we have created a form of artificial intelligence, the computer. We are making the historic transition from the age of scientific discovery to the age of scientific mastery in which we will be able to manipulate and mould nature almost to our wishes."

Nearly all of the predictions have some bioethical relevance, but here are two which are good talking points:

Control over human evolution, by Joel Garreau, author of Radical Evolution: "For the first time, our technologies are not so much aimed outward at modifying our environment in the fashion of agriculture or space travel; increasingly, technologies are aimed inward, at modifying our minds, our memories, our metabolisms, our personalities and our kids. And this is not in some distant, science-fiction future -- this is now. What's shocking about this is that if you can do all that, you're talking about humans becoming the first species to take control of their own evolution."

An end to ageing, by Prof Leonard Hayflick, University of California, San Francisco: "Our conscious recognition of the finitude of our lives is key to how we live. Virtually every aspect of our lives is governed by our sense of self and our sense of when we will age, and, of course, when we will die. One really has to think seriously about tampering with the ageing process and what its implications might be." ~ London Telegraph, Oct 23   

Living in ignorance of trial results

Thousands of patients who took place in clinical trials may never learn whether the drugs or devices were faulty, the New York Times says. Although the US Congress recently required manufacturers to disclose results of approved products, it did not require disclosure of non-approved products. Hence, people with implanted medical devices such as shunts or breast implants could be at risk.

For everyone involved in the research, "there is a tremendous incentive to go on, to forget about the old and move on to the new," said Drummond Rennie, a deputy editor at the Journal of the American Medical Association.

Although researchers conducting clinical studies are not required to disclose test results to participants, they are supposed to alert them to emerging product dangers. They are also supposed to follow the health of participants. But this often is neglected.

Industry successfully lobbied Congress against disclosure of the results of trials which failed. The manufacturers argued that releasing data about them would confuse patients and would give away valuable information to competitors about devices under development that might succeed later on. ~ New York Times, Oct 30   

Head and shoulders above other genome sequences

Just a bit of flaky news for genetics buffs: Proctor & Gamble has sequenced the complete genome for a fungus that causes dandruff. In an article in the Proceedings of the National Academy of Sciences, P&G scientists say that their work could help fight dandruff and a range of other skin conditions. In the course of their research they also managed to grow 10 litres of the fungus, Malassezia globosa -- enough to give 10 million people a very bad hair day. ~ Reuters, Nov 6   

Lung patients denied intensive care in UK

Patients with chronic lung disease are being denied intensive care treatment because doctors are too pessimistic about their chances, research suggests. A British Medical Journal study of 800 patients who had been admitted to intensive care to help them breathe has found survival rates were higher than doctors predicted. The implication is that patients might not be admitted, even though they would benefit from the treatment.

The syndrome under study, chronic obstructive pulmonary disease, which includes chronic bronchitis and emphysema, causes 30,000 deaths a year in the UK.

When patients have a COPD attack, they can benefit from intubation -- where a tube is put into their airway to help them breathe -- but they have to be admitted to intensive care so they can be sedated for the procedure. However, doctors may be unwilling to admit patients who have a poor prognosis.

Often, however, the survival rate is higher than pessimistic doctors believe. Some 62% of patients who were intubated were alive six months later, although doctors had forecast that less than half would survive that long. In the worst cases, the forecast was 10% survival at six months but 40% of patients lived this long. ~ BBC, Nov 2   

Thou shalt not bear false witness

Most medical ethics issues are brain teasers, but occasionally they are just no brainers. Take this case brought before the UK's medical registration board, the General Medical Council. Dr Alan Howlett, a general practitioner from Devon, was suspended for 10 months because he failed to disclose that he had been named a beneficiary in the will of an elderly woman in his care.

He lied on the form which authorised her cremation and stated that he had no pecuniary interest in her death. Furthermore, he failed to honour an agreement with his partners to disclose any such bequests. A remorseful Dr Howlett was told that "the offence for which you were cautioned is one which is particularly serious in professional terms". ~ BMJ, Nov 3   

  

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Australasian Bioethics Information
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