Author Posts Archive: Michael Rugnetta


03-16-10 | Legislation Introduced to Codify Stem Cell Rules

Last week, Rep. Diana DeGette (D-CO) introduced a bill that would codify the bedrock bioethical safeguards for federally-funded human embryonic stem cell research. These provisions reflect the guidelines that have been in effect at the National Institutes of Health since last July and also align with the guidelines that the Center for American Progress recommended [...]

03-03-10 | Commissioner Enhances FDA’s Commitment to Personalized Medicine

Incorporating personalized medicine into the U.S. health care system is a process rife with complexities, but last week, FDA Commissioner Margaret Hamburg outlined some initiatives aimed at surmounting a few of the primary challenges. At the Sixth Annual Keynote Luncheon Address on the State of Personalized Medicine for the Personalized Medicine Coalition, she explained plans [...]

02-26-10 | Perfecting Policy on Stem Cells

The National Institutes of Health has a smart and ethical stem cell policy in place, but that doesn’t mean that the agency can’t improve upon the policy once it is put into practice. A new regulatory notice published this week proposes a rules adjustment that would slightly expand the definition of human embryonic stem cells [...]

02-05-10 | They’re Not Perfect Cells, But They’re Model Cells

In his final column for Science Progress, Rick Weiss responded to critics of stem cell research who argue that injections of stem cells will never serve as treatments for certain chronic diseases. True enough, Weiss wrote, injections of stem cells are unlikely to serve as a treatment for conditions like Alzheimer’s: Alzheimer’s, after all, affects such [...]

02-02-10 | Genomic Medicine on the March

On Thursday, the Secretary’s Advisory Committee for Genetics, Health, and Society at the Department of Health and Human Services will meet to discuss a set of reports on the future of genomic medicine. The meeting will cover a range of important issues such as the impact of affordable whole-genome sequencing; comparative effectiveness research; genetics education [...]

01-07-10 | Science Education Progress

Yesterday, President Obama led some much needed pomp and circumstance over STEM education. In a speech at the White House, he emphasized the critical importance of an aggressive commitment to improving our nation’s education in science, technology, engineering and mathematics, the so-called STEM fields. “Make no mistake,” he said, “Our future is on the line. [...]

12-18-09 | More Cells are Good, More Diverse Cells are Better

Eleven of the Bush-era human embryonic stem cell lines are of European origin. Of the 40 lines newly approved by the National Institutes of Health, at least 22 are of European origin. Five of the Bush lines are from two gamete donors, and six of the new Harvard University lines are from three donors. A team [...]

12-17-09 | More Stem Cells Lines Approved, Process Proves Smart

The National Institutes of Health have added 27 more human embryonic stem cell lines to the 13 approved two weeks ago. These new lines come from Harvard University and have some interesting stipulations attached to them that illustrate the diligence and ethical seriousness that the NIH has brought to the approval process. Harvard submitted 28 lines [...]

12-03-09 | Line Up for the New Lines

Yesterday, the National Institutes of Health approved 13 new embryonic stem cell lines according to the rigorous ethical guidelines that went into effect July 7th. The lines will now be eligible for use in federally funded research. The 15-point rules include requirements that cells must be derived with private funds from embryos created solely for [...]

11-25-09 | Your Commission, Should You Choose to Accept It (And We Do!)

Yesterday President Obama issued an Executive Order establishing the Presidential Commission for the Study of Bioethical Issues. The Commission’s Chair will be Amy Gutmann, President of the University of Pennsylvania and a political theorist. Its Vice Chair will be James W. Wagner, President of Emory University and an engineer. Over her career, Dr. Gutmann has [...]

11-20-09 | Genetic Testing 101

With new opportunities come questions about how to interpret the avalanche of genetic information and how to protect it from improper use.

11-19-09 | United States Takes a Step Towards Isotope Independence

Earlier this month, the House passed a bill that will protect as many as 50,000 nuclear medical procedures a day in the United States. That’s how many procedures rely on nuclear isotopes produced by foreign reactors. The United States has been at risk of experiencing a shortage of these isotopes since the Chalk River Reactor [...]

10-02-09 | Collins Reports to Colbert

Joking that he is eager to grow a pair of crab claws, Stephen Colbert asked National Institutes of Health Director Francis Collins last night what’s taking so long with stem cell research. In response to the Colbert Report host, Collins presented a smart example of how we need to make sure that we get stem [...]

09-14-09 | Paving the Way for Personalized Medicine

There are promising developments heralding the arrival of personalized medicine, a new medical field where the results of genetic tests or other biomarker assessments are used to tailor drugs and treatments to individual patients.

07-27-09 | Chinese Research Teams Build Mice from Reprogrammed Cells, Raising New Bioethical Questions

It turns out that induced pluripotent stem cells are more similar to embryonic stem cells than previously thought—at least in mice. Although iPS cells are not completely identical to embryonic stem cells, two teams of Chinese scientists have been able to demonstrate that reprogrammed cells introduced into an early-stage embryo, or blastocyst, can grow into [...]

05-14-09 | Roundup: ACLU Sues Over Breast Cancer Gene Patents

The American Civil Liberties Union filed suit Tuesday against the U.S. Patent and Trademark Office, Myriad Genetics, and the University of Utah, arguing that patents for the BRCA1 and BRCA2 genes are invalid. Mutations in the two genes are responsible for a large number of hereditary forms of breast and ovarian cancer. Myriad holds a [...]

05-13-09 | Getting Sober on Stem Cells

Stem cell research might need to be the tortoise to gene therapy’s hare. In the most recent issue of Science, James M. Wilson of the University of Pennsylvania, cautions stem cell research advocates to avoid the hype surrounding much work in the field (sub’s required). Wilson understands first-hand the pitfalls of proceeding too quickly with [...]

05-12-09 | Centers for Medicare and Medicaid Services Say More Research on Warfarin Tests Necessary

Warfarin is a widely-used drug that prevents blood clots during surgery. Two million patients a year take it, but doctors must calibrate dosing carefully to prevent bleeding complications from the blood thinner. Fortunately, the Food and Drug Administration last year approved a genetic test can help physicians prevent adverse responses. The test, which costs up [...]

04-27-09 | Intelligent Solutions

A raft of scientific evidence in recent years, along with a recent book, demonstrates that environment has a very strong impact on an individual’s brain development. The work effectively rebuts most of the lingering arguments over the controversial Bell Curve hypothesis.

04-17-09 | Ethics Triumph

The new rules on embryonic stem cell research weigh ethical considerations and sound science. Now that’s progressive.

04-10-09 | New Transparency for Genomic Data

The National Human Genome Research Institute recently posted a searchable database and spreadsheet of genome-wide association studies, or GWAS. The catalog includes data on 1309 single nucleotide polymorphisms, called SNPs, from articles in 296 publications. The table explains what traits were studied in each paper, the sample size, the relevant genes, and the statistical significance. [...]

03-18-09 | New Stem Cell Policy Founded on Ethics and Expertise

Predictably, President Obama has run into some political pushback on last week’s Executive Order. The complaints have arisen primarily over two issues, neither of which is substantial and both of which deserve to be countered.

03-17-09 | iPS Takes Another Step

Although we are still celebrating President Obama’s executive order on stem cell research, it’s important to remember that the policy change was proceeded by new research involving the creation of virus-free induced pluripotent cells. The discovery came courtesy of Rudolf Jaenisch’s team at the Whitehead institute. Publishing their research in the journal Cell, the group described [...]

03-10-09 | Getting Down to Business on Stem Cell Research Ethics

Stem cell policy just caught up with research, and SP contributor and CAP Research Assistant Michael Rugnetta outlines how to move forward with dicussions on how to to conduct ethical research involving human embryonic stem cells at the Huffington Post. From his op-ed: What the Department of Health and Human Services should do is take the extra step [...]

03-02-09 | Whither Personalized Medicine? Warfarin Study May Help with the Answer

The National Institutes of Health announced in late February that it will soon begin a clinical trial that will prescribe the anticoagulant drug warfarin based on genetic data collected by an international consortium that the NIH spearheaded. The decision and certainly the outcome could have enormous implications for personalized medicine, a new medical field where [...]

02-06-09 | FDA Embraces Personalized Medicine

Food and Drug Administration Acting Director Frank Torti announced Monday in a podcast the creation of a new position in the Office of Chief Scientist: the Senior Genomics Advisor. Dr. Liz Mansfield, a scientist who has worked on scientific policy at both the FDA and in the private sector, will be the first to fill [...]

02-04-09 | Senate Multiplies Biomed Stimulus

The Senate is doubling down on the House proposal to support biomedical research and innovation with the recovery and reinvestment package—and then some. The Senate version of the stimulus bill originally provided $3.5 billion in funds for the National Institutes of Health (similar to the House version), but an amendment (SA 178), cosponsored by Sens. [...]

11-21-08 | Neuroethics Comes of Age

MRI image of a brainOriginally, the Neuroethics Society expected 50—maybe 80—people to show up for its First Annual Meeting. But over 200 neuroethics devotees assembled last week at the American Academy for the Advancement of Science in Washington, D.C. This is just the beginning, as neuroscience experts are moving to educate more policymakers on the implications of advances in the field.

11-05-08 | Victory for Stem Cells in Michigan

Yesterday, Michigan voters amended the state constitution to allow Michigan’s scientists to derive human embryonic stem cells without fear of criminal prosecution. The amendment will allow fertility patients to donate excess embryos from IVF clinics, a practice which up until now was illegal in Michigan.

10-24-08 | Pro-Life, Pro-Cloning?

“Saving” embryos from destruction through the Human Cloning Ban Act, as conservatives suggest, would neither save them or the women carrying them to term.

10-15-08 | Bluegrass Brain Surgery

Banjo during brain surgeryDeep brain stimulation is an experimental technique in which electrodes are implanted into the thalamus to correct the effects of neurodegenration or brain injury. Scientists have used the process to treat essential tremor since 1997 and Parkinson’s disease since 2002. The Neurophilosophy blog reports that doctors have recently used the technique to monitor brain surgery in real time—and in tempo. Neurosurgeons had their patient, the legendary bluegrass musician Eddie Adcock, play his banjo while he was undergoing deep brain stimulation.

10-02-08 | Michigan’s Modest Ballot Proposal Gains Media Support

Today, the Detroit Free Press and the Detroit News both endorsed a new policy that will be on the ballot this November in Michigan, and, if passed, will allow stem cell research. Michigan has the most restrictive anti-stem cell research laws in the nation, a tragedy which is compounded by the fact that Michigan has one of the most productive biotech R&D infrastructures of any state.

09-26-08 | Induced Progress

Stem cell mediaWhen James Thomson’s and Shinya Yamanaka’s research teams published their ground-breaking papers last year on induced pluripotent stem cells, or iPS cells, one of the major hurdles to clinical application was the propensity of the cells to cause cancer. Now, scientists from Harvard University have successfully introduced the pluripotency-inducing genes into mouse somatic cells by way of adenoviruses, which are less harmful than retroviruses.

09-16-08 | Genetic Privacy in Practice

DNA under magnifying glassAt the beginning of the month, NIH pulled pooled GWAS data from its website and began encouraging other institutions to follow suit, because a team of scientists have figured out just how to identify a single person’s DNA from a sample of hundreds.

09-16-08 | A New Way to Bank

Major innovations in the United States are often driven by collaborative research. Regenerative medicine is no different, and the federal government can help coordination.

08-20-08 | MO Woes

human embryonic stem cellsThe anti-science forces in Missouri don’t know when to call it quits. This week a state judge decided to hear a lawsuit from the Missouri Roundtable for Life that seeks to block $21 million of state funds from going to the state’s Life Sciences Research Board. The suit may tackle the definitions of reproductive and therapeutic cloning.

07-02-08 | British Diligence on Genetic Privacy for Life Insurance Policyholders

The Association of British Insurers has extended a moratorium banning the use of genetic testing results in setting life insurance premiums.

06-06-08 | The Interpretation of Genes

chromosomesWhat do researchers and clinicians actually need to understand about a gene in order to diagnose and treat patients? Play-by-play from a lively discussion on the state of genetics at the World Science Festival.

05-02-08 | GINA Passes House and is Ready for Signing

The Genetic Information Non-discrimination Act (H.R. 493) moved another step closer to becoming law yesterday. Although the House passed the bill last year, a reconciled version had go through again, as the Senate added an amendment when it passed the bill last week.

04-24-08 | Neuroethics 101

New technologies enable scientists to understand, alter, and enhance our brains. These raise a host of policy-relevant questions about privacy, social and political coercion, access to technology and therapy.

04-24-08 | GINA Passes!

The Senate just passed the Genetic Information Non-discrimination Act (H.R. 493) by a vote of 95-0 after two hours of debate consisting of mostly well-deserved self-congratulations. Senator Enzi (R-WY), a cosponsor of the bill, raised a very good point, saying about GINA that “If the publicity doesn’t go out on it, the people don’t know about it….we are interested in people knowing what this bill does that will help them and that will encourage them to use the genome.”

04-22-08 | Senate May Consider GINA As Early As Tomorrow

The Senate is closing in on a deal for the Genetic Information Non-Discrimination Act (HR 493), and a vote might come as early as Wednesday. According to Congress Daily, Senate Majority Leader Reid will “hotline” the bill to determine if any Senator objects to the legislation.

01-23-08 | NSF Looks At STEM Education In Practice

Elementary school girls at a microscopeThe NSF has been making measurable headway in its efforts to improve STEM education from Kindergarten to Grad School and beyond, but it still has a long way to go. On Jan. 15th and 16th the NSF held a conference in DC entitled “Science Education and Workforce Development: Key Challenges for Innovation in the States,” focusing on progress an challenges in the overlapping fields.

01-10-08 | Snap Observations: January 10, 2008

Army helmet sensorsNew helmet sensors will improve army body armor; the disorganization of state stem cell initiatives; acute stress spikes after 9/11; think tanks for developing nations.

01-04-08 | New Studies Highlight the Public Health Risks of Inequities In Health Care Coverage

Doctor with child patientHealth coverage inequalities limit patient access to the free drugs pharmaceutical companies distribute, accelerate the illnesses of elderly patients, and limit access to preventative cancer screenings.

12-20-07 | National Academies Explore Interdisciplinary Research

NAS logoThe National Research Council of the National Academies convened a symposium Wednesday to explore approaches among “Future Directions in Research at the Intersection of the Physical and Life Sciences.” The intersections up for discussion ranged across the research spectrum: from synthetic biology to geoengineering to bioterrorism.

12-18-07 | Genes, Depression, and Policy

Genetics and Public Policy Center logoHealthcare professionals helping patients with mental health problems have an increasing array of treatment and prevention tools at their disposal. But on the horizon is a preventative tool that poses challenging public policy questions about ethics and privacy: personal genomic sequencing.

12-11-07 | Expanding the R&D Tax Credit

Presenting at a policy summit last Wednesday, Dr. Robert Atkinson, president of the Information Technology and Innovation Foundation, offered recommendations for tax policies that offer “enterprise-focused” tax credits for Research & Development.

12-04-07 | Mapping the Terrain of the Nano Frontier

Nano crystalsAdvances in nanotechnology may yield myriad powerful technical applications. But to grapple with the gap between research and regulation, the Center on Nanotechnology and Society held its 2nd Annual Conference on Nanopolicy this past Friday.

12-04-07 | Snap Observations: China Cleans House at Drug Approval Agency

The efforts of China’s State Food and Drug Administration to crack down on drug and medical device companies seems to be improving the industry’s reputation and will hopefully make for a safer marketplace.

12-03-07 | Stem Cell News Roundup: Dec 3, 2007

Stem-cell-derived motor neuron“A new way to trick skin cells into acting like embryos changes both everything and nothing at all.” Alan I. Leshner and James A. Thomson on the new advances in stem cell research, and other news and commentary from the mainstream press.

11-20-07 | Stem Progress

Cell logoResearchers working independently in Japan and the U.S. published papers this week announcing the creation of non-embryonic pluripotent stem cells. The method side-steps the ethical concerns over the destruction of embryos and could open the doors for federal funding of research on stem cells and the medical breakthroughs they promise.

11-19-07 | Politics on the Brain

Human brainA recent New York Times Op-Ed on brain response to political keywords has drawn criticism from the neuroscience community for its incomplete findings and its false air of scientific certainty.

11-08-07 | Laying the Groundwork for the Era of Synthetic Genomics

Synthetic Genomics: Options for Governance reportThe J. Craig Venter Institute, along with researchers at MIT and the Center for Strategic and International Studies, recently released a report entitled “Synthetic Genomics | Options for Governance.” But are there larger unanswered questions about the societal impacts of creating synthetic life?

11-08-07 | Science Regress

Vitruvian ManFear of science is still alive and well. This past Tuesday at the Heritage Foundation, John West of the pro-Intelligent Design Discovery Institute gave a lecture entitled, “The Abolition of Man? How Politics and Culture Have Been Dehumanized in the Name of Science.”

11-02-07 | Embryonic Stem Cell Research Heads for FDA Approval

FDA logoTwo companies are about to become the first Embryonic Stem Cell biotech firms to draft FDA applications for human testing. For some time, ESC-research opponents have complained that human trials have involved therapies utilizing adult stem cells, but none have utilized embryonic stem cells.

11-01-07 | How To Make Nanotechnology Bigger

Nanocrystals magnified under an electron microscopeNanotechnology is fertile new field with a host of unexplored risks, so how should the government go about cultivating it? This was the major question at yesterday’s hearing on the National Nanotechnology Initiative.

10-31-07 | Vint Cerf Leaves Post At ICANN

ICANN logoVint Cerf leaves his post as Chairman of the Internet Corporation of Assigned Names and Numbers this Friday. ICANN has drawn criticism in the past for U.S. control of the Internet, but new changes will expand and internationalize possibilities for domain names.

10-29-07 | Snap Observations: Principled Uncertainty, A Glut of Engineers?, Science and the University

Science and the University bookAndrew A. Rosenberg on how “emphasizing what we don’t know often drowns out what we do know.” Also, a new Urban Institute study claims that the U.S. has more than enough scientists and engineers.

10-29-07 | Science and Technology on Capitol Hill This Week

U.S. Capitol buildingThis week boasts a slew of congressional hearings on science and technology policy issues including: renewable energy, gene patenting, aviation safety, nanotechnology safety, and drug-resistant TB.

10-25-07 | American Society for Reproductive Medicine Says Eggs Are Best Fresh, Not Frozen

Human ovumOnly in rare cases should women freeze their eggs in order to save them for fertilization at a later date, according to the American Society for Reproductive Medicine.

10-23-07 | Missouri Matters: The State of Stem Cells

Protesters against the 2006 stem cell initiativeCures Without Cloning, a Missouri group that opposes embryonic stem cell research, is trying to overturn the results of last year’s ballot initiative that protected stem cell research in the state. The CAP Bioethics Initiative posted an update last week. Here’s a roundup of the latest.

10-19-07 | Snap Observations: NASA Puts Kibosh on Kistler, Comcast’s Bandwidth Bias, Watson Suspended

Rocketplane KistlerMSNBC’s Cosmic Log reports that NASA has disowned Rocketplane Kistler, the private company that, along with SpaceX, was the co-winner of NASA’s rocket competition in August of 2006. The effort was part of NASA’s Commercial Orbital Transportation System program. COTS was designed to encourage private companies to devise low-cost ways of resupplying the international space station.

10-18-07 | Dispatches from the Many Fronts of the Stem Cell Wars

Stem cells in a lab at the University of GeorgiaNo new stem cell funding will be included in the Labor-HHS-Education appropriations bill (S.1710). Senator Tom Harkin (D-IA) promptly offered an amendment removing language that he and Senator Arlen Specter (D-PA) had previously inserted to expand funding for stem cell research. There was no vote, only a removal.

10-16-07 | Do Androids Dream of Electric Spouses?

Woman shaking hands with robotRobot sex is only five years away, robot marriage a mere 45 years, and the first state to legalize it will be Massachusetts. Those are the predictions of David Levy, a researcher at the University of Maastricht who successfully defended his thesis, “Intimate Relationships with Artificial Partners,” on October 11 and made international headlines.

10-11-07 | Going Off-Label to Get On the Wagon

AlcoholThe University of Virginia is being accused of encouraging doctors to prescribe Johnson & Johnson’s anti-seizure and migraine drug Topamax “off-label” to treat alcoholism. But is the medicine safe for treating alcoholics without FDA approval?

10-10-07 | Nature NeuroPod: Neuroscience Meets Military Technology

Jonathan Moreno tells Nature podcast host Kerri Smith about what happens when neuroscience meets warfare. Be prepared for soldiers who don’t need sleep and detainees who can be chemically induced to trust their captors.

10-09-07 | But Is It Life?

The Guardian reported this past weekend that J. Craig Venter will soon announce that he has created artificial life. But even his spokesperson is saying that’s not the whole story.
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