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President Obama Establishes New Bioethics Commission

President Barack Obama has created a new Presidential Commission for the Study of Bioethical Issues and appointed Amy Gutmann, president of the University of Pennsylvania, to serve as chair and James W. Wagner, president of Emory University, to serve as vice chair. The committee will ultimately be composed of 13 members, it is unclear when the other 11 will be named. This new commission will replace the council that advised the Bush administration, which President Obama disbanded earlier this year.

The President’s Commission for the Study of Bioethical Issues will advise the President on bioethical issues that may emerge from advances in biomedicine and related areas of science and technology. The Commission will work with the goal of identifying and promoting policies and practices that ensure scientific research, healthcare delivery, and technological innovation are conducted in an ethically responsible manner.

Dr. Amy Gutmann, in addition to being president of UPenn, is also the Christopher H. Browne distinguished professor of political science in the school of arts and sciences and holds secondary appointments in communications, education, and philosophy. She was previously provost at Princeton University, where she was the founding director of the University Center for Human Values—a multidisciplinary center that fosters greater research and discourse on ethics and human values.

At Emory, Dr. Wagner has championed the role of ethics in the mission of the university by enhancing the prominence of Emory’s university-wide Center for Ethics and including ethical engagement as one of the six pillars of the University’s strategic vision.

Info: http://www.genengnews.com/news/bnitem.aspx?name=69500059

November 30th 2009 Posted to US, Biomedical Ethics, Fall 2009

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With Help, Conductor and Wife Ended Lives

July 15, 2009

By JOHN F. BURNS

LONDON — The controversy over the ethical and legal issues surrounding assisted suicide for the terminally ill was thrown into stark relief on Tuesday with the announcement that one of Britain’s most distinguished orchestra conductors, Sir Edward Downes, had flown to Switzerland last week with his wife and joined her in drinking a lethal cocktail of barbiturates provided by an assisted-suicide clinic.

Although friends who spoke to the British news media said Sir Edward was not known to have been terminally ill, they said he wanted to die with his ailing wife, who had been his partner for more than half a century.

The couple’s children said in an interview with The London Evening Standard that on Tuesday of last week they accompanied their father, 85, and their mother, Joan, 74, on the flight to Zurich, where the Swiss group Dignitas helped arrange the suicides. On Friday, the children said, they watched, weeping, as their parents drank “a small quantity of clear liquid” before lying down on adjacent beds, holding hands.

“Within a couple of minutes they were asleep, and died within 10 minutes,” Caractacus Downes, the couple’s 41-year-old son, said in the interview after his return to Britain. “They wanted to be next to each other when they died.” He added, “It is a very civilized way to end your life, and I don’t understand why the legal position in this country doesn’t allow it.”

Sir Edward, who was described in a statement issued earlier on Tuesday by Mr. Downes and his sister, Boudicca, 39, as “almost blind and increasingly deaf,” was principal conductor of the BBC Philharmonic Orchestra from 1980 to 1991. He was also a conductor of the Royal Opera House at Covent Garden in London, where he led 950 performances over more than 50 years.

Lady Downes, who British newspapers said was in the final stages of terminal cancer, was a former ballet dancer, choreographer and television producer who devoted her later years to working as her husband’s assistant.

“After 54 happy years together, they decided to end their own lives rather than continue to struggle with serious health problems,” the Downes children said in their statement.

British families who have used the Zurich clinic in the past have said that Dignitas charges about $6,570 for each assisted suicide.

Scotland Yard said in a statement on Tuesday that it had been informed on Monday “that a man and a woman” from London had died in Switzerland, and that it was “looking into the circumstances.” The information that prompted the police inquiry appeared to have been given voluntarily by the Downes family, which, Caractacus Downes said, “didn’t want to be untruthful about what had happened.”

“Even if they arrest us and send us to prison, it would have made no difference because it is what our parents wanted,” he said.

Attempting suicide has not been a criminal offense in Britain since 1961, but assisting others to kill themselves is. But since the Zurich clinic run by Dignitas was established in 1998 under Swiss laws that allow clinics to provide lethal drugs, British authorities have effectively turned a blind eye to Britons who go there to die.

None of the family members and friends who have accompanied the 117 people living in Britain who have traveled to the Zurich clinic for help in ending their lives have been charged with an offense. Legal experts said it was unlikely that that would change in the Downes case.

But British news reports about the Downeses’ suicides noted one factor that appeared to set the case apart from others involving the Dignitas clinic: Sir Edward appeared not to have been terminally ill. There have been at least three other cases similar to the Downeses’, in which a spouse who was not terminally ill chose to die with the other.

Sir Edward was known for his support for British composers and his passion for Prokofiev and Verdi. After studying at the Royal College of Music in London, he joined the Royal Opera House in 1952. His first assignment was prompting the soprano Maria Callas. He traveled widely as a conductor and became music director of the Australian Opera in the 1970s.

Friends of Sir Edward said that his decision to die with his wife did not surprise them. “Ted was completely rational,” said Richard Wigley, the general manager of the BBC Philharmonic. “So I can well imagine him, being so rational, saying, ‘It’s been great, so let’s end our lives together.’ ”

Jonathan Groves, Sir Edward’s manager, called their decision “typically brave and courageous.”

But even among those who support decriminalizing assisted suicide, Sir Edward’s death raised troubling questions. Sarah Wootton, chief executive of Dignity in Dying, said in a BBC interview that the growing numbers of Britons going abroad to die, and the manner of their deaths, made it more urgent to amend Britain’s laws. There are “no safeguards, no brakes on the process at all,” she said.

The British Medical Association voted this month against legalizing assisted suicide, or lifting the threat of prosecution from “friends and relatives who accompany loved ones to die abroad.” Last week, the House of Lords defeated a bill that would have allowed people, subject to safeguards, to travel abroad to help people choosing to die.

Source: www.nyt.com

July 16th 2009 Posted to Euthanasia, Europe, Spring 2009

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Bioethicists Call For Heightened Oversight of Genetic Ancestry Testing

July 02, 2009

Newsletter: GenomeWeb Daily News

NEW YORK (GenomeWeb News) – More guidance and oversight are needed to make sure that genetic ancestry tests are carried out ethically and accurately, according to a policy paper appearing online today in Science.

A team of bioethics and anthropology researchers from Stanford University, the University of California at Berkeley, the University of Texas at Austin, New York University, and the University of Wisconsin argued that a sound public policy should be developed around existing genetic ancestry testing recommendations — such as those issued by the American Society for Human Genetics at its annual meeting last fall.

“The ASHG statement identifies key issues surrounding the science of ancestry estimation and represents an important first step,” lead author Sandra Soo-Jin Lee, a researcher at the Stanford Center for Biomedical Ethics, and her co-authors noted. “However, an effective public policy for the growing market of genetic ancestry tests must build on the ASHG’s recommendations and must generate specific mechanisms and approaches.”

Genetic ancestry is increasingly entering research and recreational realms. For instance, Lee and her colleagues noted that such tests are currently being used for everything from biomedical and forensics research to genealogical studies and immigration control.

Some direct-to-consumer genetic testing companies are relying on genetic ancestry information, too, not only to help interpret the risk posed by specific genetic variants, but in some cases to offer consumers a glimpse at their ancestry and family history.

“Despite the proliferation of companies providing genetic ancestry information, DTC genetic ancestry tests fall into an unregulated no-man’s land, with little oversight and few industry guidelines to ensure the quality, validity, and interpretation of information sold,” Lee and her co-authors wrote.

In their policy paper, the researchers focused on issues related to the responsibility and accountability of those collecting samples and doing genetic tests, the need to come up with standard ways to assess genetic ancestry data, and the role of government agencies, if any, in developing DTC genetic ancestry test guidelines.

The team highlighted ethical issues that can spring from DNA sample collection and reuse, using the Havasupai Tribe as an example. In that case, researchers from Arizona State University and elsewhere came under fire for allegedly using samples collected for diabetes research for additional studies of schizophrenia, human migration, and inbreeding. The tribe’s lawsuit against the Arizona Board of Regents was dismissed in 2007 but re-instated by an appeals court last November.
“It is a scientific imperative that we enact enforceable policies that determine what constitute responsible and accountable collection and secondary use of DNA samples,” Lee and her colleagues argued.

They noted that previously collected genetic samples aren’t considered human subjects research by the US Department of Health and Human Services’ Office for Human Research Protections, leaving a gray area with respect to informed consent and other requirements.

The team also touched on the need to develop common terms for sharing genetic ancestry information between academic researchers, research subjects, industry representatives, consumers, and others.

Finally, the researchers contend that specific systems should be put in place to enforce genetic ancestry guidelines. For their part, the authors called on agencies such as the Federal Trade Commission, the US Food and Drug Administration, and the US Centers of Disease Control and Prevention to increase oversight and regulation of ancestry testing.
“New regulations … will help shape how practitioners are able to communicate genetic ancestry testing results to consumers,” the authors concluded. “Political will and leadership toward addressing fundamental differences in perspectives may ultimately determine whether a gold standard for genetic ancestry testing can be achieved.”

source: http://www.genomeweb.com/dxpgx/bioethicists-call-heightened-oversight-genetic-ancestry-testing?emc=el&m=435036&l=6&v=7fc0c79c02

July 06th 2009 Posted to Genetics & Religion, US, Spring 2009

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Obama Plans to Replace Bush’s Bioethics Panel

June 18, 2009

By NICHOLAS WADE

Members of the President’s Council on Bioethics were told by the White House last week that their services were no longer needed and were asked to cancel a planned meeting, a council staff member said Wednesday.

The council was disbanded because it was designed by the Bush administration to be “a philosophically leaning advisory group” that favored discussion over developing a shared consensus, said Reid Cherlin, a White House press officer.

President Obama will appoint a new bioethics commission, one with a new mandate and that “offers practical policy options,” Mr. Cherlin said.

The council was appointed by President George W. Bush in November 2001, in the wake of his decision to let government-financed scientists begin research with human stem cells, but only with existing cell cultures.

Mr. Bush’s council was first led by Leon Kass of the University of Chicago and, since 2005, by Edmund Pellegrino of Georgetown University.

Under Dr. Kass in particular, the council was sometimes accused of being more ideological than its predecessors, but several bioethicists said that was not entirely fair.

“The other view is that all presidential commissions are structured in the context of a particular administration,” said Dr. Ruth Faden, a bioethicist at John Hopkins University.

Bioethics commissions, mostly at the presidential level, have been in existence since 1974. Composed mostly of biologists and ethicists, they have served to familiarize the public with new advances and have developed guidance on contentious issues like genetic engineering, human cloning and research on humans.

Under Dr. Kass the council produced reports with a somewhat philosophical bent on issues like the screening of newborns and how to determine death. Several bioethicists said Wednesday that a new commission could also focus on giving more practical guidance.

“If we wish to enhance the quality of health care, we will need gobs of quality-improvement studies,” said Thomas H. Murray, president of the Hastings Center, a bioethics research organization.

Dr. Alta Charo, an ethicist at the University of Wisconsin, said that much of the Bush council’s work “seemed more like a public debating society” and that a new commission should focus on helping the government form ethically defensible policy.

A commission of this kind, Dr. Charo said, “lets the president react judiciously to rapid and often startling changes in the scientific landscape.”

www.nyt.com

June 18th 2009 Posted to News, US, Spring 2009

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Some Stem Cell Research Limits Lifted

April 18, 2009
By GARDINER HARRIS

WASHINGTON — The Obama administration announced Friday that it planned to lift some but not all federal financing restrictions on human embryonic stem cell research, drawing criticism both from abortion opponents and from scientists who had expected a more liberal policy.

Guidelines proposed by the National Institutes of Health to carry out an order made last month by President Obama would allow research with federal financing only on stem cells derived from surplus embryos at fertility clinics. The money would still be prohibited for stem cell lines created solely for research purposes and for embryos created through a technique known as therapeutic cloning.

During the campaign last year, Mr. Obama said he supported “therapeutic cloning of stem cells,” a policy his administration rejected Friday. A White House spokesman, Reid Cherlin, said the president “directed N.I.H. to formulate the best method for moving forward with stem cell research, both ethically and scientifically,” in an independent process.

Many scientists praised the new guidelines as an expected compromise.

“I think it’s a big step forward,” said Richard O. Hynes, a cancer researcher at the Massachusetts Institute of Technology, “although there are aspects of stem cell research that will still be outside federal funding.”

Others called the proposed rules a sellout.

“I’m disappointed,” said Dr. Irving Weissman, the director of the Stem Cell Biology and Regenerative Medicine Institute at Stanford. Dr. Weissman accused the health institutes of “putting this ideological barrier in the way” of treating disease.

Abortion opponents predicted that the administration would soon embrace less restrictive stem cell policies.

“This is clearly part of an incremental strategy to desensitize the public to the concept of killing human embryos for research purposes,” said Douglas Johnson of the National Right to Life Committee.

The acting director of the health institutes, Dr. Raynard S. Kington, said that in writing the guidelines, officials had taken into account ethical considerations and “broad public support” for the use of discarded embryos from fertility clinics.

“As science changes,” Dr. Kington said, “we will take note of that and, when appropriate, reconsider the guidelines.”

Sitting on more than $10 billion in stimulus money, health institute officials have been eager to expand financing for stem cell research. Under restrictions put in place by President George W. Bush, just 21 stem cell lines have been eligible for federal financing. But researchers using private money have created more than 700 stem cell lines, some with specific diseases or mutations, many of which may now be eligible for federal financing.

Some scientists said new rules requiring that donors be informed of all options could render too many new cell lines ineligible. And the rules could make ineligible for future federal financing even some cell lines approved by Mr. Bush.

Dr. George Q. Daley, the director of the stem cell transplantation program at Children’s Hospital Boston, said his team had used private financing to create 15 stem cell lines from poor-quality embryos that clinicians had told couples they should discard. Not all couples may have been told that they could donate the weakened embryos to other couples, a requirement under the new guidelines.

“My major concern,” Dr. Daley said, “is grandfathering all those medically important lines” made under less stringent consent policies, including some approved by Mr. Bush.

The announcement on Friday is likely to kick off a rush of applications from scientists eager for federal support for stem cell research. The health institutes has approved 20 such proposals for financing, although the projects have been delayed until the stem cell guideline is finalized.

In fiscal year 2008, the health institutes financed 260 research projects, at a cost of $88 million, that involved stem cell lines approved by Mr. Bush.

“In a relatively short period of time, we’re likely to greatly increase the number of stem cell lines eligible for federal funding,” Dr. Kington said. “Ultimately, this will have a significant impact on human health and disease.”

The new guidelines will be published next week in the Federal Register, and the health institutes then will accept comments for 30 days. The rules are to be final by July 7.

Some in Congress have promised to introduce legislation that would allow financing of more stem cell lines. Representative Diana DeGette, Democrat of Colorado, said in a statement that the proposed legislation would “promote all forms of ethical stem cell research.” A statement from Representative Michael N. Castle, Republican of Delaware, said there was “opportunity for more expansive guidelines.”

Staff members for both lawmakers said they could not describe details of the legislation or whether it would seek to legalize federal financing of research using embryos created by therapeutic cloning.

Mr. Johnson of the National Right to Life Committee said the DeGette and Castle legislation would almost certainly undermine the few restrictions left in place by Mr. Obama.

Many scientists believe that the development of matched organs for transplantation would be possible only with therapeutic cloning or somatic cell nuclear transfer, a process by which genetic material from a patient is placed in the nucleus of an egg to produce embryonic stem cells that are an identical genetic match.

“You can’t even apply for funding now if you have a cell line derived by somatic cell nuclear transfer that faithfully reproduces, say, juvenile diabetes,” Dr. Weissman said.

But Dr. Kington said this cell transfer process had never been successfully carried out in human cells. And other scientists have suggested that if scientists create 1,000 or more genetically distinct stem cell lines, organs could be grown that would be a close enough genetic match to avoid rejection by patients’ immune systems.

Source: www.nyt.com

April 18th 2009 Posted to Stem Cells, Biomedical Ethics, Spring 2009

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Men on a slippery slide in future hermaphrodite world

Julia Medew
July 11, 2008

ARE men the new endangered species? According to a Melbourne bio-ethicist, they’re way up there with pandas and polar bears.

In a speech titled Should human beings have sex?, Dr Robert Sparrow yesterday told the Australian Medical Students Association convention that females could soon rule the world as hermaphrodites without any biological use for men.

With the help of some frozen sperm at first, females could procreate on their own until stem-cell technology meant bone marrow and other human tissue could be converted into sperm, the senior lecturer at Monash University’s Centre for Human Bioethics said.

To reach this post-sex world, Dr Sparrow said parents wanting the best for their children should start choosing baby girls through IVF because they live longer and have more opportunities in life.

“There are significant restrictions on the opportunities available to men around gestation, childbirth, and breastfeeding, which will be extremely difficult to overcome via social or technological mechanisms in the foreseeable future. Women also have longer life expectancies than men,” he said.

Dr Sparrow said his somewhat “tongue-in-cheek” argument was based on a line of thought about medical ethics that suggests medical technology should be used to serve the welfare of individuals and remove limitations on the opportunities available to them.

“I argue that, if these are our goals, we may do well to move towards a ‘post-sex’ humanity. Until we have the technology to produce genuine hermaphrodites, the most efficient way to do this is to use sex selection technology to ensure that only girl children are born. Girl babies therefore have a significantly more ‘open’ future than boy babies,” he said.

The argument, Dr Sparrow says, started developing in his mind after the professor of practical ethics at Oxford University, Julian Savulescu, suggested in 2005 that “designer babies” should be created by enhancing their DNA before birth.

When asked if people should act on his suggestion, Dr Sparrow said he didn’t expect many people would take up the challenge just yet.

“I don’t think we’re seriously looking at a world of only girl children just yet, but I do think that when philosophers start talking about using medical technology to achieve things that aren’t about health, so increasing people’s IQ or life expectancy for example, you have to ask why we shouldn’t all be girls,” he said.

This story was found at: http://www.theage.com.au/national/men-on-a-slippery-slide-in-future-hermaphrodite-world-20080710-3d73.html

March 21st 2009 Posted to Ethics and Science, Biomedical Ethics, Spring 2009

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Obama Lifts Bush’s Strict Limits on Stem Cell Research

The New York Times
March 10, 2009
By SHERYL GAY STOLBERG

WASHINGTON — Pledging that his administration will “make scientific decisions based on facts, not ideology,” President Obama on Monday lifted the Bush administration’s strict limits on human embryonic stem cell research.

At a ceremony in the East Room of the White House, before an audience that included lawmakers, scientists and patients, several of them in wheelchairs, Mr. Obama announced that he was issuing an executive order intended to advance the research. He said he hoped Congress would follow with bipartisan legislation that would ease the existing restrictions even more.

The president acknowledged that studying stem cells extracted from human embryos, which are destroyed in the process, is deeply divisive.

“Many thoughtful and decent people are conflicted about, or strongly oppose, this research,” the president said. “I understand their concerns, and we must respect their point of view.”

But Mr. Obama went on to say that the majority of Americans “have come to a consensus that we should pursue this research; that the potential it offers is great, and with proper guidelines and strict oversight the perils can be avoided.”

In making his announcement, Mr. Obama drew a strict line against human cloning, an issue that over the years has become entangled with the debate over human embryonic stem cell research.

He said that he would ensure that his administration “never opens the door” to cloning for human reproduction, adding, “It is dangerous, profoundly wrong and has no place in our society or any society.”

Mr. Obama paired his executive order with another document, a presidential memorandum directing the head of the White House Office of Science and Technology Policy to “develop a strategy for restoring scientific integrity to government decision-making.”

Taken together, the two actions are the latest in a series of rebukes by Mr. Obama to his predecessor, former President George W. Bush.

Many Democrats criticized the Bush administration for politicizing science on a range of issues, from climate change to protecting endangered species to family planning.

Mr. Obama pledged during his campaign to chart a different course.

Already, abortion opponents are bracing for a battle over the stem-cell policy.

“The administration now steps onto a very steep, very slippery slope,” Douglas Johnson, legislative director for the National Right to Life Committee, said in anticipation of Mr. Obama’s action. “Many researchers will never be satisfied only with the so-called leftover embryos.”

One Republican lawmaker, Representative Christopher Smith of New Jersey, called Mr. Obama “the abortion president,” and organized an event Monday afternoon protesting the new policy. He invited some so-called snowflake children, those born after couples who underwent in-vitro fertilization released their remaining embryos for use by other couples, to attend.

“President Obama has chosen to turn back the clock,” Mr. Smith said in remarks prepared for the event, according to an advance text. “Human-embryo-destroying stem cell research is not only unethical, unworkable and unreliable, it is now demonstrably unnecessary.”

He was referring to progress that scientists have made using adult stem cells derived from nonembryonic sources, such as umbilical cord blood, bone marrow or skin.

Still, the president’s decision drew warm praise from a number of Democratic lawmakers. “Today, an extraordinary medical breakthrough was achieved with the stroke of a pen,” said Senator Edward M. Kennedy of Massachusetts. “With today’s executive order, President Obama has righted an immense wrong done to the hopes of millions of patients.”

The Bush administration, in a careful compromise eight years ago, allowed tax dollars to support studies on a small number of existing lines, or colonies, of stem cells that had already been derived from embryos, though not on creating new lines. That meant that a provision renewed by Congress every year since 1996, banning research in which embryos are destroyed, no longer stood as an absolute barrier to the stem cell work.

Mr. Obama’s new executive order will open the door wider, but not as wide as Congress would if it were to remove its legislative restrictions.

Because embryonic stem cells are capable of developing into any type of cell or tissue in the body, many scientists believe they hold the possibility for treatments and cures for ailments as varied as diabetes, Parkinson’s and heart disease. Some researchers say stem cells may someday be used to treat catastrophic injuries, such as spinal-cord damage.

The promise that these advances might help bring a cure for Alzheimer’s disease and other afflictions made Nancy Reagan an avid supporter of stem cell research. Her husband, the late president, suffered from Alzheimer’s.

Other prominent Republicans who opposed President Bush’s stance included Senator Gordon Smith of Oregon, who lost three family members to Parkinson’s, and Governor Arnold Schwarzenegger of California.

Limitations on federally funded research in American laboratories gave an indirect boost to such work abroad, particularly in Britain, where it received unabashed support.

“The current policy is eroding our national advantage on stem cell research,” Senator John Kerry, Democrat of Massachusetts, said during a congressional debate on the question in July 2006. “We’re tying our scientists’ hands. We’re holding back our doctors.”

http://video.nytimes.com/video/2009/03/09/us/politics/1194838463059/president-obama-on-stem-cell-research.html

March 10th 2009 Posted to Stem Cells, US, Biomedical Ethics, Spring 2009

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Pharmacogenetic-Based Prescribing Slow to Take Hold

February 16, 2009
Newsletter: GenomeWeb Daily News

CHICAGO (GenomeWeb News) – Despite mounting evidence that genetics can affect the way some individuals process drugs, identifying genetic variants associated with drug response is just the first step in a long road to implementing the information in the clinic, according to a speaker at the American Association for the Advancement of Science meeting in Chicago this weekend.

Speaking during the meeting, Deanna Kroetz, a biopharmaceutical sciences and pharmaceutical chemistry researcher at the University of California at San Francisco, noted that since 2004 there have been no less than nine drugs that have had label changes based on new genetic information. But such changes don’t always translate into changes in the way drugs are prescribed and dosed, she explained.

The first example Kroetz gave was 6-mercaptopurine or purinethol, a drug used to treat acute lymphoblastic leukemia. While most individuals can convert the drug to active metabolites using an enzyme called thiopurine methyltransferase, some individuals carry a deficient version of the enzyme. For these patients, 6-mercaptopurine treatment can lead to severe adverse drug reactions and an increased risk of infection.

Researchers first recognized variability in TPMT activity nearly 30 years ago. And since then, the genetics behind that activity were uncovered. Eventually, the US Food and Drug Administration recommended TPMT testing for purinethol, though such testing is not required. And most ALL patients aren’t tested for the risky TPMT variant. Kroetz said, even though a recent cost-effectiveness analysis indicates that such testing would be beneficial.

Kroetz also outlined the situation so far with respect to warfarin treatment. Warfarin, a much more widely prescribed drug, is an anticoagulant that must be carefully dosed to prevent under-dosing or over-dosing, which can lead to major bleeding events.

Several studies suggest variants in CYP2C9, the gene coding for cytochrome P450, and VKORC1, which codes for vitamin K1 2,3-epoxide reductase subunit 1, can influence an individual’s warfarin response. Together, CYP2C9 and VKORC1 account for roughly 55 percent of the variability in warfarin response, Kroetz said.
There is still heated debate among physicians over warfarin genetic testing, Kroetz said. A recent study concluded that warfarin genetic testing was not cost effective for initial warfarin dosing except for certain high-risk patients. As for purinethol, the FDA recommends but does not mandate that physicians perform genetic testing before prescribing warfarin.

On the other hand, Kroetz noted, physicians have been much quicker to adopt genetic testing to guide abacavir treatment. Individuals with specific forms in the HLA-B*5701 allele are hypersensitive to the HIV drug, which came on the market just over a decade ago. Last summer, the FDA recommended HLA-B*5701 genetic testing for abacavir treatment.

Kroetz speculated that the acceptance of genetic testing for abacavir may be due, at least in part, to the fact that physicians treating HIV patients regularly have to deal with rapidly changing drug regimes. That may make them more willing to use a new genetic test and follow new guidelines, she argued.

Even so, Kroetz said there are several factors that account for whether genetic associations lead to changes in the clinical application of a drug. Before a test is implemented, she added, research must be done to provide evidence that the genetic test is beneficial. FDA guidance, an appropriate cost-benefit analysis, willing and educated physicians, and other parameters also influence the translation of such research.

Despite the hurdles that must be overcome, Kroetz said increased research and discussion should ultimately facilitate a transition from pharmacogenetic research to clinical practice.

February 16th 2009 Posted to Ethics and Science, DNA Test & Personalized Medicine, Spring 2008, US

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Francis Collins Addresses State of Personalized Medicine

January 30, 2009

By Matt Jones

NEW YORK (GenomeWeb News) — In order for personalized medicine to progress as many US researchers want it to, it will require a more focused commitment from better informed federal agencies, smarter collaborations across public and private sectors, bigger studies and bolder science, and intelligent changes in the healthcare system overall, former Director of the National Human Genome Research Institute Francis Collins said this week.

Collins described himself as “an unemployed geneticist,” who just finished spending months “working night and day” with the White House transition team led by HHS Secretary Tom Daschle. He said he now feels free to discuss how federal research and academic research, business, and larger political forces commingle in the effort to tailor medicine for individuals.

Speaking to attendees — including biomedical researchers, biotech execs, and policy people — of a meeting in Washington, DC, organized by the Personalized Medicine Coalition, Collins said that he currently is writing a book for mainstream audiences that will talk about the promise of personalized medicine by profiling real-world cases.

“Pharmacogenomics, which from my perspective has been one of the most promising areas of personalized medicine, has also turned out to be extremely complicated, not that we shouldn’t have known that,” Collins said.

Collins pointed out as a pharmacogenomics success how studies of an AIDS drug led to a Food and Drug Administration guidance for a genetic test. It was “exciting to see the Abacavir example come forward this past year where hypersensitivity reactions are almost entirely predictable by a genetic test,” he said. “It was good to see that that was well demonstrated in a carefully controlled clinical trial… [and that] led to a clear change in the FDA labeling.”

Wafarin, however, has been a different story, in Collins’ mind. He said the data on the anticoagulant drug, which has serious adverse effects in some patients, is “starting to look a little tired.”

Although FDA has cleared tests for sensitivity to the drug, we still don’t have the right type of evidence “to enable a clear statement to providers about whether this kind of genetic testing ought to be done prospectively before trying to prescribe this drug with all of its complications.

“Because [warfarin] has become a poster child for the future of pharmacogenomics,” Collins said, “it’s appropriate to do this kind of rigorous analysis with prospective studies, but I’m not sure that we can afford to do that every time.”

If DNA testing keeps coming down in price, Collins suggested, it could turn out that the “very, very, rigorous” approach taken for warfarin “may be something we can’t afford and shouldn’t necessarily advocate as having to do every time.”

He also said that he is “delighted” that direct-to-consumer genetic testing services are being offered, even though the field “has become a favorite whipping boy for some of us.” He said it is good “that the public is having the chance to learn about their genomes if they think they want to know … and that companies are doing this in a responsible way. But, of course, there are some things on the web that are not responsible.”

In addition, Collins endorsed the call by the Secretary’s Advisory Committee on Genomics, Health and Society to create a public database of information that would give consumers “a place to go to seek objective information about the clinical validity and clinical utility of these tests.

“It’s disturbing to see that there hasn’t been much progress on that because it makes so much sense,” he said, adding that without “some objective way to evaluate” these gene tests there will be “some other entities on the scene that are a little less responsible.”

Collins is adamant in his call for more studies of gene and environment interactions, and he said he is concerned that not enough investment has gone into that area.

“If we’re serious about preventive medicine, and using personalized genomics to inform that, we’re not going to change the genome,” he said. “It’s the environment we’re going to want to change.”

In order to collect such data, Collins called for a massive study. “Wouldn’t it be nice if we invested in an organized US prospective cohort which was a snapshot of the population?”

Collins guessed that such a study would require “a genome project kind of budget,” and that it could cost around $300 million or $400 million a year and include at least half a million people and possibly a million.

“But we’re probably going to spend that amount anyway on a whole bunch of studies that are cobbled together to look at individual diseases, so why don’t we just do it right the first time and have this study which could be a stimulus for many spin-offs?” he asked.

The upshot of such spending would be a study that could become “the centerpiece of our efforts to try to figure out how to take genomic discoveries and implement them into public health.”

Collins also noted that for personalized medicine to become a usable reality healthcare providers will need help translating the new science into their offices and hospitals. For average family practitioners, he speculated, personalized medicine could become a “net negative.”

Healthcare providers now are “ill-prepared for what’s coming” he warned, and said more efforts and more funding needs to be put behind educational efforts.

In federal drug development research, Collins said he sees “a great deal of interest in being a more effective partner with the private sector.” He said that government could contribute more to the front end of drug development and to “de-risk” problems which may otherwise seem to industry “too much to take on.

“I think that’s something we’re going to be talking about in the course of the next couple of years … ways to make this interaction between government, academia, and the private sector more effective in the translational effort,” he said.

Looking forward to 2015, Collins said there are some milestones he expects to see achieved, chief among them he said he could nearly guarantee complete genome sequencing for $1,000 or under. He also expects that researchers will identify many more risks for heritable diseases and a growing number of targeted therapeutics.

Collins said he has “great hopes” for the new administration in Washington. He said that his experience on the transition team left him with the impression that “the vision, and the smarts, and the determination are all there” to push medicine and healthcare forward in many ways, including the adoption of electronic medical records.

While the economy is “a bit of a problem,” Collins admitted, he hopes research will receive proper investment.

“I think if we all work together on this we have a chance of doing what we’ve promised all along … we’re going to revolutionize medicine.”

February 02nd 2009 Posted to DNA Test & Personalized Medicine, US, Biomedical Ethics, Spring 2009

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FDA approves clinical trial of human embryonic stem cell therapy

Green light for US stem cell work

US regulators have cleared the way for the world’s first study on human embryonic stem cell therapy.

The US Food and Drug Administration have been considering the 21,000 page application for months.

The decision by the FDA to give the go-ahead comes at a symbolic moment, just days after the inauguration of President Barack Obama. Since 2001 there have been limits on federal funding for embryonic stem cell research.The decision of the FDA is independent of White House control, but the new president is widely expected to adopt a more pragmatic and science-oriented approach to stem cell research.

Under President Bush, federal funding had been limited to around 60 stem cell lines created from embryos destroyed prior to August 2001.

Scientists had warned that only 20 eligible cell lines remained useful for research and many of these were problematic. Researchers had told the BBC that the restrictions had slowed down their work.

Controversy

Geron Corp, the company behind the research, plans to initiate a clinical trial in a handful of patients paralysed due to spinal cord injury. Interest in use of embryonic stem cells is due to their ability to turn into any of the body’s 200 cell types.

Using embryos donated through IVF treatment scientists have coaxed the stem cells inside into many types of tissue. One embryo can provide a limitless supply because the cell lines can be grown indefinitely.

But the use of human embryonic stem cells in research is controversial with some campaigners saying it is unethical.

Geron, a biotech company based in “silicon valley” south of San Francisco, has spent $170m on developing a stem cell treatment for spinal cord injury. The research will use cells coaxed to become nerve cells which are injected into the spinal cord.

In animal trials of the treatment, paralysed rats regained some movement.

Company chief Dr Tom Okarma said: “What stem cells promise for a heart attack or spinal cord injury or diabetes is that you go to the hospital, you receive these cells and you go home with a repaired organ, that has been repaired by new heart cells or new new nerve cells or new islet cells that have been made from embryonic stem cells.”

The cells being used in the trial are derived from the H1 human embryonic stem cell line, which was created before 9 August 2001 and thus eligible for federal research funding. However, Geron received no federal funding for the studies leading up to the clinical trial or to support the trial itself.

‘Pivotal decision’

Professor Chris Mason, an expert in regenerative medicine at University College London, described the FSA decision as “historic” and a “pivotal milestone in the development of embryonic stem cell therapies.

He said: “The knowledge that will be gained in this first clinical trial deploying embryonic stem cell derived material will accelerate the development of all future stem cell therapies.”

Professor Pete Coffey, director of the London Project to cure blindness, said: “It’s great news for the field.

“This strengthens our recent call for regulators in the UK to help provide a clear process for researchers to take this forward.

“It’s also exciting for me because it brings our own moves towards clinical trials with embryonic stem cells for age-related macular degeneration a step forward.”

Professor Robin Lovell-Badge, of the MRC National Institute for Medical Research, said it often took 15 to 20 years to develop a therapy.

“It takes a long time and much work to derive processes that will efficiently and reproducibly give an appropriate cell type for grafting and many animal experiments to test efficacy and safety.

“An appropriate set of patients have to be identified for the first tests and clinicians willing to participate in trials.

“And the regulatory hurdle is, understandably, a huge one - in this case it required 21,000 pages of documents.”

He added that for those patients desperate for treatment, and for their families, the news showed the research is moving in the right direction. But Josephine Quintavalle, director of Comment on Reproductive Ethics (Core), which opposes embryonic stem cell therapies, dismissed the research as “highly speculative”.

“The work is at a highly experimental stage and there’s still a question mark over the capacity of these cells to form tumours,” she said.

“What worries me is that patients will really believe this is going to cure their spinal injury.”

She pointed out that other research teams in Australia and Portugal were developing spinal therapies using adult stem cells.

“We’ve never changed our point of view, which is that embryonic stem cell treatments cannot ever be justified,” she said.

BBC NEWS
http://news.bbc.co.uk/go/pr/fr/-/2/hi/health/7847450.stm

January 26th 2009 Posted to Stem Cells, US, Biomedical Ethics, Spring 2009

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