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Still in the Red
Posted by Osagie K. Obasogie on May 4th, 2007
| Nitromed - makers of BiDil, the first FDA approved race based medicine - released its first quarter results for 2007, and it looks like their boat is still slowly sinking. While sales improved to $3.6 million (up $1.3 million compared to the same time last year), they spent $13 million in operating costs, making their net loss for the quarter $10.1 million. BiDil is still NitroMed's only product on the market; Keith Knight's comic below might partially explain the drug's sluggish sales.
(Click on image for better resolution)
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| File Under: Trust Us, We're Scientists
Posted by Jesse Reynolds on May 1st, 2007
| From the Chronicle of Higher Education:
A federal advisory board proposed on Thursday ways for scientists and universities to minimize the risk that terrorists would use research findings about disease-causing microbes to mount biological-warfare attacks. The panel would give individual scientists much of the responsibility to police their conduct and decide how much sensitive information they publish....
Several of the panel's members are themselves biological scientists doing research relevant to biosecurity, and so some outsiders have worried that the board would lean toward self-regulation, not additional government controls.....
Raising another set of questions, the draft suggests few specific ways to ensure researcher's compliance. One is that institutions require their scientists to annually certify that they regularly and carefully monitor their own studies. The draft also calls for mandatory training of researchers about the code once it is finalized, but does not spell out who should receive that training or how.
The draft does recommend that the federal government check to make sure that scientists and universities are properly policing themselves, but again does not say how. It suggests that the government could make proper self-regulation and oversight a condition of its research grants.
What is more, the document does not specify criteria that researchers could use to decide which sensitive details of their work to publish and which to withhold for security reasons. The draft does recommend, however, that researchers conduct public-education efforts -- through newspaper opinion pieces, for example -- to assure the public that they have carefully considered security issues before publishing findings of dual-use research and to lay out the potential for misuse of their results.
Of course, such voluntary guidelines are unlikely to be followed, at least in the private sector. A recent survey by the Sunshine Project found that 18 or the 20 largest biotech companies are not complying with voluntary NIH guidelines for genetic engineering.
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| UK's HFEA Lowers the Bar, Again
Posted by Jesse Reynolds on April 30th, 2007
| The Human Fertilization and Embryology Authority - Britain's regulatory body for reproductive and genetic technologies - has just given the green light for IVF embryos to be screened for the "breast cancer genes". Two couples, whose families have histories of breast cancer, will be permitted to use pre-implantation genetic diagnosis (PGD) to screen out embryos carrying the BRCA1 and BRCA2 gene mutations before going forward with assisted reproduction.
This is part of the HFEA's recent lowering of the bar in expanding PGD's use. Initially, the HFEA approved PGD only in limited circumstances: (1) when genes are certain to lead to disease, not merely probable (2) when the disease is early onset and (3) when it is almost always fatal. Remarkably, the HFEA changed course last year, stating it would consider PGD for hereditary cancers on a case-by-case basis. The mutations that have now been approved for PGD are associated with a 60% of female children eventually developing breast cancer - much lower than the HFEA's original standards.
But besides this dropping bar, this also highlights two roles played by government in promoting what some call a "new eugenics."
Many defenders of using today's biotechnologies to improve the human gene pool accurately cite a key difference with 20th century eugenics: decisions now ultimately lie with individuals, not the state. Yet here with the HFEA's loosening its PGD rules, we are witnessing a widely-respected government agency approving the deselection of genes that have about a fifty-fifty chance of causing disease, which only the females could develop, not to mention the growing number of therapies to treat people with these conditions.
Moreover, the ability to detect breast cancer genes was developed with public funds at the University of Utah, a public university. While no coercive laws mandate the deselection of certain embryos, saying that government is not involved here in weeding out undesirable embryos is like saying the government had not role in the recent deaths from Vioxx. Government action is not merely limited to writing laws, but also funding certain types of research and regulating (or failing to) certain areas of commercial activity such as assisted reproduction.
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| 200 and Counting for the Innocence Project
Posted by Osagie K. Obasogie on April 27th, 2007
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The Innocence Project, a public interest litigation shop dedicated to using DNA evidence to free wrongly convicted prisoners, recently reached a remarkable milestone: its 200th exoneration. This application of human biotechnology is certainly an unqualified good; falsely convicted inmates in 31 states - 14 of whom were on death row - have been reunited with their families. And in 43 cases the real assailant was found.
Barry Scheck, the Project's co-founder, zealously supports using DNA forensics in criminal justice, noting that "we have a technology (DNA) that is a truth machine." Scheck's passion is admirable; we should all celebrate the Innocence Project's success and hope for more. But we must also be careful to distinguish the positive use of DNA technologies - in this case for exoneration purposes - from applications that support DNA databanks and dragnets, which trounce basic civil liberties by treating us all like felons under constant government surveillance. It may be tempting to use these 200 stories to justify broadening the use of DNA forensics in criminal justice. Yet we must remain vigilant to ensure that the key used to unlock these former prisoners' shackles isn't used to unjustly lock away others.
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