Personalized medicine — the ability to predict how patients will react to certain medications based on their genetic profiles — will lead to changes in clinical trials and the business model for the pharmaceutical industry, as well as the FDA approval process for new treatments, agency commissioner Andrew von Eschenbach said on Friday during a speech to business students at St. Joseph’s University, the Philadelphia Inquirer reports. (Medical News Today)

Now it turns out that genes, per se, are simply too feeble to accept responsibility for much of anything. By the traditional definition, genes are those lineups of DNA letters that serve as instructions for piecing together the body’s proteins, and, I’m sorry, but the closer we look, the less instructive they seem, less a “blueprint for life” than one of those disappointing two-page Basic Setup booklets that comes with your computer, tells you where to plug it in and then directs you to a Web site for more information. (New York Times)

The US President’s Council of Advisors on Science and Technology (PCAST) has released a report on personalised medicine containing recommendations on the governmental and private sector action needed in order to realise the benefits of personalised healthcare. The report, Priorities for Personalised Medicine is from a study on personalised healthcare that began in January 2007, in order to assess eight major policy areas including: technology/tools, regulation, reimbursement, information technology, intellectual property, privacy, education and economics. Although personalised healthcare can encompass a wide range of technologies such as imaging technologies as well as genomic diagnostics and therapeutics, it was decided to focus the report and its recommendations in three main areas (technology/tools, regulation and reimbursement) in relation to genomic-based molecular diagnostics, as these were felt to be the most pressing area for policy action. (PHG Foundation)

In a genetics first, researchers report that they have decoded the complete DNA sequence of a person with acute myelogenous leukemia. (Washington Post)

When scientists opened up the human genome, they expected to find the genetic components of common traits and diseases. But they were nowhere to be seen. Brendan Maher shines a light on six places where the missing loot could be stashed away. (Nature News)

The Center for Genetic Medicine at Northwestern University presented Dr. Drew Endy of Stanford University as part of its annual Silverstein Lecture Series Monday night (10-27-08). Endy, voted by Esquire magazine as one of the 75 most influential people of the 21^st century, gave the audience a small taste of what the future holds for bioengineering. One of Endy’s main goals is to turn bioengineering into an accessible field by creating tools which can help scientists design and implement projects more easily and quickly.

Dr. Endy spent part of his lecture giving the audience a glimpse of what currently is being done in the field of bioengineering. Japanese scientists have already manipulated DNA at the scale of 8 million base pairs, almost the size of the yeast genome. Bacteria have been engineered already with the environmental input and logic capabilities to enable them to attack cancer cells specifically. Still other bioengineers are creating yeast organisms that manufacture drugs for malaria.

The heart of the talk, however, was the unveiling of an ambitious plan to make bioengineering a simpler, fabrication enterprise like that of civil engineering or software programming. Endy and his team are currently stocking an open, online database, called the Registry of Standard Biological Parts, with components that researchers can use to assemble their own biological machines. The different biological parts are created by scientists who change the DNA coding of a cell so that it will produce a desired biological product, such as a protein used in a cell’s cytoskeleton. The technical specifications, including the genetic code, are then filed away in the Registry’s database.

The Registry, filled with what are known as BioBricks, is the foundation for Endy’s vision of making bioengineering an easier process. Researchers already are planning a bioengineering programming architecture that would allow engineers to build biological machines without having to know all the ins and outs of the genetic code itself. Some would work on the more basic parts that would be held in the registry, others would create devices that make use of these parts, and others would work on the macro level creating entire biological systems made out of these devices. Dr. Endy and his colleagues are convinced that bioengineering can be done in a manner akin to software design, thus providing the means for creating a number of biological machines on a large scale.

After the lecture, several graduate students discussed the presentation and came to the conclusion that Dr. Endy’s discussion of safety only glossed over the hazards that could develop as a result of such bioengineering projects. His concluding remarks brought up concerns of the use of such technologies in areas such as military weaponry, yet he offered no substantive solutions. An audience member’s question about high schoolers or undergraduates working with such sophisticated biological tools led only to a discussion of a list of safety guidelines that students are to discuss with supervising professors. These comments appear to be a strong indication that significant ethical work remains to be done alongside these scientific developments. It is very likely that Endy and his team consult with others who can help provide ethical parameters for such work, but his open-ended questions at the conclusion of his lecture led the audience to believe that many ethical issues have been left unaddressed.

Such bioengineering does in fact threaten to create problems in areas ranging from the environment to warfare.  Because such research involves the very substance of life, special care must be taken when considering the ethics of such projects. Basic guidelines on how to prevent biological components from harming individuals are helpful; but as we are able to build more powerful, living machines, we will need to reflect more on the question of what it means to be human, upon the nature of human life, and how technological advances in the area of bioengineering should interact with them.

Scientists say that they have taken a step closer to recreating extinct animals like the mammoth, after successfully cloning living mice from donor animals that had been frozen. (Times Online)

Scientists around the globe may soon be studying tiny bits of George Church. The Harvard Medical School professor of genetics will be one of the first people to have stem-cell lines created from his skin cells propagated and distributed worldwide–along with a record of the cells’ donor’s identity and genetic and medical quirks. (Technology Review)

The price of gene sequencing is falling fast and Helicos BioSciences is poised to push it down even further — perhaps below the $1,000 mark. (Wired)

Journal of Applied Philosophy (Volume 25, Issue 24, November) 2008 is now available by subscription only.

Articles Include:

• “The Metaphysical Status of the Embryo: Some Arguments Revisited” by David S. Oderberg, 263-276
• “Recognizing Humanity” by John Haldane, 301-313

Book Reviews Include:

• “Choosing Between Possible Lives: Law and Ethics of Prenatal and Preimplantation Genetic Diagnosis by R. Scott” by John McMillan, 355-357

A growing number of British couples are undergoing procedures at clinics overseas to determine the gender of their babies. However, as the BBC’s Colette McBeth reports, this service is often offered illegally. (BBC)

>A colleague just sent me this article. Last year, when I was in London, attending the annual ISMAAR conference on Mild Approaches to Assisted Reproduction, I heard Teresa Woodruff from Northwestern speak on her research in this area.

This article in today’s London Telegraph states, “Scientists have grown eggs from tissue taken from five-year-old girls meaning future childhood cancer sufferers could go on to have children of their own.” Sounds wonderful and promising for these little girls, should they ever be at risk of lost fertility from cancer treatments.

What were their results? “They worked with 19 patients between the ages of five and 20. On average they were able to retrieve an average of nine eggs per patient and 34 per cent of them were successfully matured.”

Critically though, this technology can be used by women who just want to delay childbearing. Also, concerns over germ line manipulation taking place in ovarian tissue for screening in or screening out genetic traits for future children.

Curious, Dr. Woodruff spoke on this technique and its use for preserving endangered and threatened species.

New DNA tests to screen fetuses for a wider array of genetic abnormalities early in pregnancy are raising some hopes as well as concerns that the “flood of murky, misleading results” could lead to more abortions and “needlessly alarm” many people, the Washington Post reports. According to the Post, the tests — called comparative genomic hybridization — use gene chips, or “microarrays,” to search for deletions or additions of genetic material that can lead to less common, but often more severe, syndromes that are commonly missed by standard genetic analysis. (Medical News Today)

Prospective parents will be able to screen embryos for almost any known genetic disease using a revolutionary “universal test” developed by British scientists, The Times has learnt. ( Times Online )

The ban in Australia on producing embryos that fuse human DNA and empty animal eggs will remain, despite a British vote legalising the inter-species creations for stem cell research. (The Australian)

Doctors have started using powerful new DNA tests to screen fetuses for a wider range of genetic abnormalities, spotting more problem pregnancies early but stirring fears that the results will increase abortions as well as confuse and needlessly alarm many couples. (Washington Post)

A gene mapping test could tell parents-to-be if embryos are affected by almost any inherited disease, UK scientists have claimed.

The team from London’s Bridge Centre say the £1,500 test could detect any of the 15,000 inherited diseases in weeks. (BBC)

British plans to allow scientists to use hybrid animal-human embryos for stem cell research won final approval from lawmakers Wednesday in a sweeping overhaul of sensitive science laws. The House of Commons also clarified laws that allow the screening of embryos to produce babies with suitable bone marrow or other material for transplant to sick siblings. (Contra Costa Times)

Ever since the Health Insurance Portability and Accountability Act (HIPAA) of 1996 was passed, we have become accustomed to far more forms and red tape than ever before in hospitals and physicians’ offices. With the institution of the Privacy Rule, our Protected Health Information is strictly guarded in new ways by healthcare professionals and hospital systems — with good intentions. This law was designed to protect a patient’s privacy in ways no hospital gown ever could. For similar reasons, but hopefully with less resultant red tape, Congress passed the Genetic Information Nondiscrimination Act (GINA) earlier this year. Neither an individual’s medical history nor his/her genetic information is to be publicly revealed.

What, then, are we to make of the “Personal Genome Project”? This project is seeking 100,000 individuals who will agree to have their personal genomes made publicly available via the Internet. Their website states,

We believe individuals from the general public have a vital role to play in making
personal genomes useful. We are recruiting volunteers who are willing to share their
genome sequence and many types of personal information with the research
community and the general public, so that together we will be better able to advance
our understanding of genetic and environmental contributions to human traits and to
improve our ability to diagnose, treat, and prevent illness.

To date, the Personal Genome Project has enrolled ten luminaries, including Misha Angrist, Keith Batchelder, George Church, Esther Dyson, Rosalynn Gill, John Halamka, Stan Lapidus, Kirk Maxey, Steven Pinker, and James Sherley. Portions of their genomes are to be revealed this week on the PGP website. Information once revealed, even if subsequently taken down from a public website, remains known by someone, somewhere. If one of these ten has a gene associated with the development of Alzheimer’s Disease, how will that person or those who know him or her react? If such information were subsequently taken down from a public website, would the knowledge disappear? Not likely.

How we treat information, particularly genetic information, is a very important issue. It is becoming increasingly vital to develop appropriate safeguards and procedures for managing such specific and identifiable data. From the New York Times this week:

Over the last three years, more than a half-million people who participated in over 100
publicly financed genetic studies on traits like schizophrenia and drug addiction were
promised that their anonymity would be protected. But last month, after a paper in a
scientific journal described how an individual’s profile could be identified even when it
was aggregated with hundreds of others, the National Institutes of Health abruptly
restricted access to the data. ( “Taking a Peek at the Experts’ Genetic Secrets” by
Amy Harmon)

Where are the limits for privacy with respect to our DNA? Where are we going? What is happening in the arena of storing and/or disclosing our genetic data? Do we have a blueprint for our biobanks? We need more than a hospital gown to protect our privacy.

Creating a therapy derived from the genetic information of a person’s cancer is working to change today’s standard medical approach — and may help bring on a cure. (Los Angeles Times)

An intrepid group of volunteers will be granted a glimpse at their genomes today as part of the first release of data from the Personal Genome Project (PGP). (Technology Review)