Presumed consent may be illegal

A Catholic bioethicist in Britain is warning scientiststhere that they may be breaking human rights laws if they take advantage of new legislation in the UK governing reproduction and medical research.

The controversial new British bill gives researchers the power to use genetic material such as skin or blood to create human and human-animal hybrid embryos. Researchers can take the needed tissue from people lacking the mental capacity to give consent, from seriously ill children whose parents give permission, or anyone who has already donated samples for medical research but cannot be contacted.

David Jones, director of the Centre for Bioethics and Emerging Technologies at St Mary's University College, says the act -- passed last month -- could be open to legal challenge on the grounds that what happens to individuals' cells is a private matter covered by the country's Human Rights Act.

"I am sure that when people give general consent to use tissue samples they don't think that they are going to be used to create human embryos."

The presumed consent clauses are justified by the British ggovernment as being of "scientific necessity," which Jones said "shows how open to challenge the legislation is."

Jones's comments are also an indication that opponents of the new law will not be relaxing their fight just because the llegislation has now been passed.

Stephen Minger, director of the stem-cell biology laboratory at King's College London, defended the law.

"You can't use (a person's material) if you are aware you would in some way be violating their personal beliefs about how their cells should be used."

Vatican to rule on human cloning, stem cell research

The Vatican will update Catholic Church teachings on bioethics in two weeks with the planned release of a new document looking at human cloning and stem cell research in Rome.

The document, prepared by the Congregation for the Doctrine of the Faith, will be released during a bioethics conference at the Vatican on Dec. 12.

It is expected to examine issues not explicitly considered by two previous church documents: "Donum Vitae" ("The Gift of Life") in 1987 and Pope John Paul II's encyclical "Evangelium Vitae" ("The Gospel of Life") in 1995.

Pope Benedict XVI, prefect of the Congregation for the Doctrine before becoming pontiff, told the grouplast January that new ethical problems needing their attention included the freezing of human embryos, the selective reduction of embryos, pre-implant diagnosis, research on embryonic stem cells and attempts at human cloning.

"The two fundamental criteria for moral discernment in this field are unconditional respect for the human being as a person from the moment of conception to natural death, (and) respect for the originality of the transmission of human life through the acts proper to spouses."

Stem cell researchers pin hopes on Obama

Stem cell researchers in the United States, hobbled for years by President George Bush's ban on federal funding for embryonic stem cell research, are looking forward to Barack Obama taking office in January.

And outside the U.S., researchers are using his election to push their own governments for more funding.

Mary Hendrix, a stem-cell scientist at Northwestern University in Chicago, said Obama needs to give a clear signal to the scientific community early in his administration that he will jump start research in the U.S.

"The biopharmaceutical industry has been skittish about making investment in this kind of research. An executive order would give the signal that it's acceptable."

Obama promised during the campaign to issue such an order.

James Thomson, a stem-cell scientist at the University of Wisconsin who created the first human embryonic-stem-cell line in 1998, however, said money will also have to accompany any such order -- but expects that sort of action to take time.

"To make stem-cell science take off, it needs something equivalent to Nixon's war on cancer. ... But because of today's economic realities, it's not going to happen for at least a couple of years." 

Opponents of embryonic research vow to continue fighting such work, saying it involves the destruction of life.

Obama has already named several pro-stem cell bioethicists to his transition team.

Meanwhile, researchers in Britain are warning their government that Obama's election could hurt them. With U.S. scientists held back by Bush's ban, scientists in other countries have been able to surpass the work of their American colleagues.

Chris Mason, professor of regenerative medicine at University College London, said an infusion of cash is needed to solidify the advances made by British scientists. 

“The UK, through its firm commitment of public money to stem cell research, remains at the cutting edge of the science. Now is the time to translate this valuable knowledge into real benefits for patients. This will require additional funding for translation [into the clinic] and manufacture, plus strong commitment to these advanced therapies."

The current credit crunch has made it difficult for researchers to raise private capital, making government funding all the more important, Mason, a member of the UK Stem Cell Network steering committee, said.

Drug researchers claim intimidation from Glaxo

Two researchers have come forward to say they felt intimidated from coming forward when they started to notice health problems with a one-time top-selling drug made by GlaxoSmithKline.

Dr. Mary Money, an internist in Hagerstown, Md., told the company in 2007 of repeated instances of congestive heart failure and dangerous fluid retention in patients taking Avandia, a diabetes medication. Both she and Stephen Lippman, a doctor she worked with on the research, said in interviews that the company failed to take their concerns seriously.

"I felt intimidated; I know she felt intimidated. We both at the time, and still do, think that they were essentially trying to stonewall us and really impede a resolution of the issue."

Money said she felt vindicated last year when Steven Nissen of the Cleveland Clinic published research in the New England Journal of Medicine saying that Avandia could increase the risk of heart attack 43 per cent.

Nissen says GlaxoSmithKline had always treated him respectfully, even when it disagreed with him. Nissen has consulted for several drug companies, including GlaxoSmithKline.

Lippman, however, said there is a problem that needs addressing

"The problem with [the] drug system is that if people on the front line feel that they're going to get humiliated for bringing up questions, they're not going to report things and they are not going to be the canary in the coal mine."

GlaxoSmithKline issued a statement defending itself.

"GSK does not condone any actions that would interfere with an individual's ability to discuss, report or publish adverse events related to any GSK product. As a corporation, we actively train all employees on ethical business practices and compliance with the Rx&D Code of Conduct."

Republican Senator Charles Grassley of Iowa is expected in the next few weeks to release results of an investigation into GlaxoSmithKline's handling of Avandia.

University of Manitoba medical ethicist Arthur Schafer says drug companies attempt to silence doctors and critics in Canada as well, using both threats and offers of research grants for hospitals and universities and lucrative consulting contracts for doctors.

"Threats of lawsuits or threats to go to your employer or actually going to your employer to get you fired or disciplined or silenced in some way are unusual. They happen, but usually for the drug companies, the carrot is more effective than the stick."

The FDA is looking into Avandia and several other drugs linked to heart problems.

Medical ethics in the Obama White House

A few hintsare beginning to emerge about how a Barack Obama administration will approach some of the touchy bioethical issues of our times, particularly stem cell research, thanks to recent appointments to his transition team.

University of Wisconsin bioethicist Alta Charoand University of Pennsylvania bioethicist Jonathan Moreno have both been asked to advise the incoming US president as he prepares to take office in January.

Both are prominent proponents of stem cell research, and have called for an end to George Bush's ban on federal funding for embryonic stem cell research. While stem cell researchers have applauded the appointments, opponents see it as a warning of fights to come.

Richard Doerflinger, director of the Secretariat for Pro-Life Activities for Catholic bishops in the US, says the church will resist any change in policy.

"The question is, does the Bush policy get replaced with the law of the jungle? We are very concerned about it as a moral issue."

Supporters, however, including Robert Klein of the California Institute of Regenerative Medicine, are counting the daysuntil Obama takes office.

"Today there's trial ready for humans sitting at the FDA that the Bush administration blocked. 45 days from now, when there's a change in administration. I expect that trial to move forward."

Medical tourism declines

Reports out if India -- a leader in medical tourism -- say that bookings for non life-threatening surgeries are down due to the worldwide economic slowdown.

Brokers who arrange the surgeries -- and the required flights, transfers and hotel rooms -- say inquiries from patients are down significantly from last year at this time. Dr Mikdad Ukaye, part owner of Vasai-based Royal Medical Tours, said patients are worried they may not be able to afford the surgery, and expects about a 50 per cent drop in business in the coming year.

“Earlier, we received least 2-3 calls per day from clients abroad, but this year it has come down to barely 1 or 2 calls in a week. ... They are reluctant to even transfer the deposit amount thinking what if they change their plans at the last moment.”

India has been a leader in medical tourism, offering surgeries at a fraction of U.S. prices -- and up to half the cost of some other destinations.

Until now, most reports and studies have predicted fast growth for the sector, with a growing number of U.S health insurance companies offering medical tourism packages as a way to keep rates down.

Singapore's Health Minister Khaw Boon Wan said last week that slower growth in the city-state's large medical tourism industry was due to a lack of capacity.

"I don't think it's because of demand, or we are losing competitiveness, but capacity is constrained...Both public and private hospitals are short of capacity...I think it's a situation of where demand has been curtailed because we don't have enough capacity to respond."

Singapore hopes to attract over 1 million international patients a year by 2012, nearly three times the current number.

Assisted suicide an "escape" few take: report

A report out of Oregon, which approved physician assisted suicide for terminally ill patients 11 years ago, says few patients actually use the option -- but like that it's there.

"Over the past 11 years in Oregon, 341 people have used the law, and the lethal medication provided by their doctors, to die."

That works out to about 1 in 1,000 deaths, according to the Oregon Health Division. The rate of talking about assisted suicide, however, is much higher. About 1 in 50 dying patients discuss assisted suicide with their doctors, according to the state, and one in six with their families.

"All this suggests that people just want to know that the escape is there if they need it, but very few decide that they do. It is powerful evidence that palliative care has come a long, long way since the Oregon measure took effect 11 years ago."

The report says palliative care -- health care for the terminally ill -- has done such a good job of making people's final days comfortable, that few patients want to end their lives early.

The Oregon Health Department is required maintain statistics on the law's uptake. The numbers provide an interesting glimpse into who uses such a law, and how. Over the past 11 years, 82 per cent of patients requesting assisted suicide had some form of cancer, and 93 per cent died at home. Top reasons for wanted assisted suicide were a loss of autonomy, a loss of dignity and an inability to still do things they always enjoyed.

Earlier this month, voters in neighbouring Washington state voted to approve a similar assisted suicide law for their state.

Medical ethics in an Obama White House

Medical ethicists in the United States are beginning to take stock of what a Barack Obama administration will mean to the medical community -- particularly as it relates to ethical questions.

Without doubt, the White House of George W. Bush has been very conservative when it comes to medical ethics.

But with the election of a more liberal Democrat, as well as the results of several state resolutions that were also on the ballot Nov. 4, American ethicists expect to see a loosening of attitudes.

Writing for MSNBC.com, Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, writes that "the 2008 election will be remembered not only for Obama becoming the first African-American president, but also for its impact on core bioethical topics that have long dominated American domestic politics."

"Divisive issues such as abortion bans failed to gain traction on state ballot initiatives, while newer bioethical concerns that are likely to dominate American politics for years to come, including physician-assisted suicide, emerged. The past eight years of the Bush White House have seen stem cell research and the status of embryos at the centre of the moral values debate. Obama’s election has brought the fight over embryonic stem cell research in the U.S. to an end."

On November 4, Michigan became the tenth state to approve embryonic stem cell research. The Bush White House has refused to fund such work, hampering research in the U.S. Calling the stem cell debate a "stalking horse" of the abortion debate (since objections to the use of embryonic stem cells are based on the same right to life arguments), Caplan points to Nov. 4 vote results in Colorado.

"The voters of Colorado were given the chance to put that view into law with the proposed Amendment 48. The so-called “Personhood Amendment” sought to define fertilized eggs as human beings, extending them constitutional rights. Coloradoans defeated this amendment by a margin of three to one."

Caplan later adds:

"Like it or not -- and I am well aware that many are not ready to let go of these issues -- the nation may be starting to move past the endless battles over stem cells, embryos and abortion."

Also, in Washington state, voters approved a resolution to allow physician-assisted suicide.

Bernard Lo, a professor of medicine and medical ethics director at the University of California San Francisco, for instance, has some advice for the new president, saying he should replace Bush's President's Council on Bioethics when its mandate expires next year.

A National Bioethics Advisory Council can help the American public and the new administration understand the ethical issues and choices that new biomedical advances present and think through the appropriate policy responses. Now is the time to consider this new national Council because the charter for the current President's Council on Bioethics expires next year and the incoming president will have the opportunity to form a new advisory body. The new Council can identify policy options, explain their pros and cons, and make recommendations to policymakers.

That would be a very different body from the current President's Council, which advises only the president and has been used by the White House to find ways to implement pre-determined policy -- such as a recent instruction from Bush to find a way around a California court decision that a doctor cannot refuse in vitro fertilization to a lesbian couple because of his personal religious beliefs.

The President's Council meets this week.

More than Obama

Besides helping elect Barack Obama as the first black president of the United States, voters in Washington state also voted yesterday to make their state the second in the country to allow physician-assisted suicide.

Under the resolution, terminally ill people can get lethal prescriptions to hasten their deaths. Late Tuesday night, the "death with dignity" measure was leading with 58 per cent of the vote to 42 per cent. Patients would have to ask their doctors for a prescription giving them enough medication to kill themselves.

Neighbouring Oregon has had a similar measure for more than a decade.

"We feel like the voters of Washington have agreed to give terminally ill and their families the dignity that they've asked for," said Anne Martens, a spokeswoman for the Yes campaign.

Opponent Chris Carlson said, "It appears that the voters of the state of Washington have, unfortunately, started down a path that I believe with historical hindsight they'll come to regret."

Washington was one of the states carried by Obama in the presidential election.

Sex selection in Turkey

Parents who want to pick the sex of their babies need only to travel to Turkey and pay for in-vitro fertilization there, an undercover BBC report has found.

As in Canada, sex selection is illegal in Britain is illegal, unless for medical reasons. For instance, if your family has a genetic disorder affecting only males, you can chose to have a girl.

Ironically, similar rules apply in Turkey, and yet the Jinemed Center, a fertility clinic in Istanbul, has proven a popular destination for patients wanting to pick the gender of their baby.

BBC reporter Colette McBeth took her husband and a hidden camera to a meeting with representatives from the centre and made it clear they wanted to have a girl. A video of the meeting shows the couple discussing with the representative ways to get around the law by pretending a heriditary desorder runs in their family.

The Turkish government is now investigating the centre, but the incident shows the ease with which medical tourism allows people to flout health laws in their own country.