Wednesday, July 30, 2008

Dangers but no regulations in biotechnology and nanotechnology

The public remains oblivious to the public health and safety dangers in biotechnology. And the scientific community intends to keep it that way to avoid responsibility and regulation.

And now, as with biotechnology, nanotechnology with serious inherent dangers to worker safety and dangers to the public health in contaminating our air and water remains unregulated.

We continue to move forward developing 21st century state of the art technologies at the public’s expense, both in terms of public funding and at serious risks to their health. And at the same time new emerging disease and idiopathic illnesses increase, but are persistently being ignored. The public remains ignorant, abandoned and left in the dark.

Science is out of control regarding public health and safety.

Monday, July 21, 2008

New Emerging Disease---Trouble Inevitable

Flu pandemic may kill 50m worldwide22 Jul 2008, 0000 hrs IST,ANI
WASHINGTON: The world is at the risk of an "inevitable" disease pandemic, which could kill 50 million people and wreak massive disruption around the globe, the British government has warned. In a report, the House of Lords Intergovernmental Organisations Committee said that new infectious diseases are emerging and being given the opportunity to spread because of changes in ways of life. The committee called for urgent improvements to international surveillance so that action can be taken against outbreaks of infectious disease before they develop into pandemics. Describing the World Health Organisation as "dysfunctional", the committee said that it should be organised to cope with the threat. Ministers warned that there was "no agreed vision or clarity over roles" among the international bodies working in the field. The committee heard evidence that while there had not been a pandemic since 1968, another one was inevitable. They were told by ministers: "Estimates are that the next pandemic will kill between two million and 50 million people worldwide and between 50,000 and 75,000 in the UK. Socio-economic disruption will be massive." The committee said that with three quarters of newly emerging human infections originating from animals, more stringent ways of detecting diseases are needed. "The last 100 years have seen great advances in public health and disease control through the world, but globalization and changes in lifestyles are giving rise to new infections and providing opportunities for them to spread rapidly," the Telegraph quoted Clive Soley, the chairman of the committee, as saying. "We are particularly concerned about the link with animal health," he added. Peers joined ministers calling for urgent action to build up early warning systems across the third world that can identify and neutralise outbreaks of potentially deadly new strains of disease before they are swept across the globe by modern travel. They asked the government to consider urgently how it funds aid projects in developing countries so the funds can also help UK's defences against a pandemic. While the last two pandemics in the 1950s and 1960s were triggered by mild strains of influenza, future ones could be far more serious, particularly if linked to the H5N1 strain of bird flu a type that has already jumped species from birds to humans. According to the report, bird flu "at some point in the near future" could become capable of "human to human transmission".

Saturday, July 19, 2008

Stem Cells and Executive Order 13435

Recasting the Federal Debate on Stem Cells

Bush Administration Revisits ESC Stance by Encouraging Funding for Pluripotent SCs

GEN JULY 2008 page 8-9
Joseph R. Sollee

Stem cells are one of the most promising areas of R&D in biotechnology today but also one of the most politically divisive. Scientists believe that stem cells offer the potential to cure or mitigate a host of pervasive and debilitating diseases and conditions such as multiple sclerosis, Parkinson’s, Alzheimer’s, and diabetes. They also believe that stem cells can be used to repair or replace damaged tissues or cells caused by injuries to organs, limbs, and the spinal cord.

Yet despite these potential benefits, research on stem cells in the U.S. has suffered in recent years. This is due to religious, moral, and political concerns that have in particular affected studies associated with the harvesting and use of embryonic stem cells (ESCs).

In April, federal funding of stem cell research took a major step forward with the announcement that the DOD is “embarking on the next generation of research that is going to redefine the face of Army medicine” with the creation of the Armed Forces Institute of Regenerative Medicine (AFIRM). This federally funded institution will focus on the development of clinical treatments for battlefield trauma and severe injuries utilizing stem cells and other tissue-regeneration technologies.

The stem cell community has applauded the government’s commitment of significant resources through AFIRM and the breakthroughs that it is expected to bring to the clinic in the near term. With initial funding in excess of $250 million, AFIRM will work in consortium with academic centers, led by Wake Forest Institute for Regenerative Medicine and the University of Pittsburgh’s McGowan Institute for Regenerative Medicine.

Many scientists and stem cell advocates are skeptical of the AFIRM announcement, however, viewing it as further evidence of President Bush’s policy to steer funding away from human ESC research and toward somatic stem cell technologies. Given AFIRM’s stated focus on technologies that are close to the clinic, it is expected that AFIRM-sponsored investigations will be directed primarily toward therapies and technologies utilizing somatic stem cells, as these are more advanced than human ESC technologies.

Within the stem cell community, the Bush Administration’s seven-year ban on human ESC funding is a controversial issue that has created deep and perhaps permanent divisions, pitting scientists engaged in somatic stem cell research against ESC investigators.

Despite a growing and increasingly broad spectrum of public support to lift this moratorium, the Bush Administration has held firm on its policy. This past summer, when President Bush issued his second veto of a Congressional bill providing expanded federal funding for human ESC (hESC) research, many stem cell advocates decided that the only remaining course was to wait out the Bush presidency in hopes of a more supportive future administration.

Regardless of one’s position on the Bush Administration’s hESC policy, resolution of the issue is not as simple as merely ending the ban on federal funding. Any future administration that intends to lift the funding ban will need to interpret and address the myriad of existing rules and regulations that would apply to ESC research. The basis for federal legislation and policy applicable to current ESC research dates back to the mid-1970s (more than 25 years prior to the first successful isolation of a human ESC), when Congress limited federal funding of research on human fetuses following the Supreme Court’s Roe v. Wade decision.

In addition, since 1995 Congress has appended a rider (known as the Dickey-Wicker Amendment) to each NIH appropriations bill prohibiting the use of federal funds for the creation of human embryos for research or for any research in which human embryos are destroyed, discarded, or subject to a greater than minimal risk of injury or death.

Executive Order 13435

Executive order 13435, issued by President Bush in June 2007, may provide important insight into the future of stem cell policy if the federal funding moratorium is lifted. This order has largely been overlooked since it was issued concurrently with the President’s veto of the ESC Congressional bill. Though many characterized the order as a symbolic measure intended to blunt the inevitable criticism arising from the veto, closer scrutiny yields several potentially important steps taken by the Bush Administration in favor of expanded stem cell research.

The operative provisions of the order represent a shift in focus away from the source of the stem cells toward the key attributes of the stem cells in question, such as pluripotency. Additionally, the order directs the NIH to rename the “Human Embryonic Stem Cell Registry” as the “Human Pluripotent Stem Cell Registry” to appropriately capture human pluripotent stem cells (PSCs) that may be created or derived from sources other than embryos. The order contains a broad description of types of PSCs that will be considered as pluripotent for the purposes of the Administration’s policy, including cells that are capable of producing all (pluripotent) or almost all (multipotent) cell types in the developing body.

The order directs HHS and NIH to ensure that all types of ethically produced human PSC lines will be included in the NIH stem cell registry and be eligible for federal funding. In addition to nonembryonic sources of PSCs like amniotic fluid, cord blood, and dedifferentiated somatic stem cells, the order directs HHS to support research on sources of PSCs that “take into account techniques outlined by the President’s Council on Bioethics (PCOB).” The PCOB’s 2005 White Paper considered several potential methods for deriving PSCs from embryos (See Insert).

The order recognizes that “the Nation should move forward vigorously with medical research” and directs the HHS and the NIH to conduct, promote, and intensify research in the derivation of human PSCs (hPSCs) from a variety of alternate sources. Though no specific funding commitment was attached to the order, it directed HHS to issue a funding implementation plan.

In summary, although the Bush Administration hasn’t abandoned its position on the inviolability of nascent human life, the policies enumerated in the executive order are based in part on the same scientific framework employed by advocates of broader stem cell research funding. The Administration may have come to the realization that for certain of the alternate sources of human PSCs supported by President Bush to be acceptable, its stem cell policy must recognize the complexities of early human life. The Administration’s willingness to recast the debate at the scientific level may, in the long run, be the most important aspect of the executive order.

Alternative Sources of PSCs

The President’s Council on Bioethics (May 2005) White Paper identified four

alternate techniques for deriving PSCs:

1. Organismically Dead Embryos: by extracting cells from embryos already dead

2. Preimplantation Genetic Diagnosis: by nonharmful biopsy of living embryos

3. Altered Nuclear Transfer: by extracting cells from artificially created nonembro

nic but embryo-like cellular systems (engineered to lack the essential

elements of embryogenesis but still capable of some cell division and growth)

4. Somatic Stem Cells: by dedifferentiation of somatic cells back to pluripotency

Joseph R. Sollee is an attorney in the life sciences practice at Kennedy Covington. He currently serves as general counsel for Oncomethylome Sciences. Web: www. Email:

Thursday, July 10, 2008

Embryonic Stem Cell Debate Remains Polarized


The embryonic stem cell debate still remains polarized. Political agendas have enabled a misinformed public to cling to political ideologies instead of understanding the actual scientific and bioethical issues related to embryonic stem cell technologies.

As a scientist who has worked on embryonic stem cell technologies, I have become surprised and appalled at how the scientific community has used their political machinery to push these technologies forward without educating the public on how these advances can impact our culture and society, both positively and negatively. Not only that, I have actually witnessed some top level scientists using words advocating the application of eugenics with such technologies. Historically speaking, we should all be familiar of how eugenics has led to terrible consequences and human suffering. Yet the scientific community moves forward believing that they alone know how to apply eugenics using scientific tools and measurements.

In the past, I have ignored the religious right because of their seemingly inflexible stand regarding embryonic stem cell science. But now, the scientific community who no longer represents the public as a whole and who also has garnered their political agenda to obtain funding at any expense, has brought me to look upon their opposition as not fanatical, but as a much needed counter-balance.

The public remains ignorant of the cultural, societal and health implications from stem cell research, human cloning and related practices. Public opinion is politically driven by those with special interests instead of scientific and bioethical analysis. Until bioethicists begin proper studies to educate the public regarding these critical issues, unfortunately, it will remain that way.

The consequences of implementing human embryonic stem cell technologies, in the end, may not be what the public expected and not what they were led to believe.

Wednesday, July 9, 2008

Iran and Biological Warfare

Biological warfare research laboratories are presently being operated throughout the international communities. Pinpointing Iran as a culprit, while ignoring the ever burgeoning biological warfare infrastructure being created worldwide, is not a useful or appropriate perspective. In fact, pointing a finger solely at Iran will only promote and justify more biological warfare research by encouraging fear.

This does not mean, however, that we should ignore the problem.

We currently are in an international biological arms race. It is a threat to everyone and every country. Our ability to create sophisticated and dangerous infectious agents that could debilitate or kill millions is a fact and a realistic danger.

The challenge we face is that infectious genetically engineered agents used for research to help humanity can unfortunately alternatively be used and developed as biological warfare agents as well. "Defense" laboratories, "animal disease" laboratories and "embryonic stem cell" laboratories are presently engaged in dangerous biological research in academic, private and government laboratories all around the world. As of today, no effective regulations or oversight governing these dangerous biological laboratories are in place in the United States. Self-regulation is the practicing model where secrecy and privacy supersede biotech worker’s rights and public health and safety rights. Laboratories can “appear” to be doing legitimate research when in fact they could be also engaging in biological warfare manufacturing and research. This can happen as easily in the United States as it can Iran, as it can in Europe, Australia, Russia, India and China.

We desperately need international laws and international treaties governing this type of research and denouncing biological warfare. For the sake of humanity, we need to stop the biological arms race on all fronts, and not just in Iran. We need leaders and peacemakers to step up to the plate and start addressing this problem now.