Month Archives: October 2009

Next Year” for Embryonic Stem Cells?

by David Prentice

October 31, 2009

Geron now says that it hopes its embryonic stem cell experiment on spinal cord injury patients might begin in the 3rd quarter of 2010. The original FDA approval to test the cells in patients was given in January 2009 and Geron claimed it would begin in the summer of 2009, but before a single desperate patient had been injected with the potentially-dangerous cells, the FDA placed a hold on the Geron experiment due to safety concerns.

Meanwhile, the obsession with embryonic stem cells has obscured the real hope for patients—ADULT STEM CELLS. Peer-reviewed evidence of adult stem cell success for spinal cord injury patients has already been published by groups in Portugal, in Australia, in Ecuador, and in Brazil.

Of course, Geron’s latest announcement achieved its primary goal—Geron stock rose as much as 12%.

The Geron Prophecies

30 October 2009

Geron expects the data from this study to enable re-initiation of the clinical trial in the third quarter of 2010.

27 January 2009

Geron says that it expects to begin enrolment early this summer at up to seven US medical centres.

20 October 2008

A clinical trial that would test the use of embryonic stem cells to treat spinal cord injury could begin within three months.

17 October 2008

But the FDA is nearing the end of its review process and may lift the hold and allow clinical trials to commence within the next three months, Okarma told The Scientist.

15 May 2008

The Geron Corporation announced Wednesday that its plans to begin the first clinical trial using embryonic stem cells had been delayed by federal regulators. While companies typically do not announce when they submit an application to begin a trial for an investigational new drug, the F.D.A.s action means Geron must have submitted its application in the last 30 days, Mr. Benjamin said.

12 February 2008

The first experiments using human embryonic stem cells in human subjects could begin within a few months, the chief executive of biotech Geron said Monday. At the annual BIO CEO conference in New York, Dr. Thomas Okarma said Geron plans to start embryonic stem-cell studies in humans with spinal cord injuries toward the end of the second quarter. Okarma said the tests would involve up to 40 human patients, while all prior tests involved rats.

13 November 2007

Gerons development plan for the product calls for the filing of an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration and, pending the agencys review, initiation of human clinical trials in 2008.

31 October 2007

Geron, based in Menlo Park, Calif., has been using rats in its experiments of a potential treatment for spinal cord injuries. Geron has already met with the FDA and will submit its plans for human testing to the agency by the end of this year, according to Sion.

20 July 2007

Geron Corporation in Menlo Park, California, expects to start clinical trials of a therapy for spinal cord injury early in 2008, according to spokesperson David Schull.”

9 May 2007

The first clinical trial of embryonic stem cells is on track to start early next year on patients with spinal cord injury. Geron, the California-based biotechnology company, will carry out the study on accident victims in six trauma centres across the US.”

4 August 2006

One company, in particular, Menlo Park, CA-based Geron, is taking the lead in developing experimental embryonic stem cell therapies and hopes to begin human trials next year.

27 July 2006

The company will apply for approval to start US clinical trials in 2007, using glial cells derived from human embryonic stem cells to treat spinal injuries.

17 June 2006

I’m confident that we will be in the clinic next year with the first human ESC-derived product,” said Tom Okarma, chief executive of Geron, at a conference in London last week.

29 March 2006

Tom Okarma: We will complete our IND-enabling studies, which are now in process and still on track, and file our IND during the fourth quarter of this year, assuming the preclinical data continue to go well. That starts a 30-day review clock by the FDA, who then has 30 days to either accept our IND and allow us to proceed or, at that point, they have questions that we must answer before we can begin. We are on track for that. So, assuming they bless the IND, we would hope to be in the clinic in the first quarter of (2007).

7 November 2005

[R]esearchers at Geron of Menlo Park want to take the next step — in people. They hope to get federal permission to inject those cells into damaged spinal cords. The procedure — which Geron intends to do next year — would be the first human tests of a treatment derived from human embryonic stem cells, the highly versatile body cells that can be coaxed into becoming almost any tissue in the body.”

9 September 2005

Geron plans to begin clinical trials on acute spinal cord injury treatment in early 2006, according to chief executive officer Tom Okarma.”

19 April 2005

Thomas Okarma, Geron’s CEO, is even less convinced that larger animals are necessary before testing Keirstead’s technique in humans. During an interview at the conference, he said he believes the clinical trial could begin in mid-2006.

5 February 2005

Next year [Hans Keirstead] and his corporate partner, Geron, plan to try treating people who have recent spinal cord injuries, in what would almost certainly be the first human trial of any therapy derived from such cells.

1 December 2004

According to Geron CEO Thomas Okarma, the company is aiming to file an investigational new drug application with the U.S. Food and Drug Administration (FDA) requesting permission to begin clinical trials using glial cells derived from embryonic stem cells to repair damaged spinal cords in 2005 or early 2006.

22 February 2004

The company believes it will be cleared to start the first stem-cell therapy in human tests next year, possibly for spinal-cord injury.”

18 March 2002

Keirstead…would ask university officials to seek the U.S. Food and Drug Administration’s approval to test the human embryonic stem cells on human patients with spinal cord injuries. Initially, Keirstead said he might be ready to take this step in about a year.

Adult Stem Cells for the Arts

by David Prentice

October 31, 2009

Tony Iommi, the guitarist for Black Sabbath, is getting adult stem cell treatment for cartilage damage. More than 40 years of guitar riffs have taken their toll.

I’ve had this problem with my hand and I’ve had this stem-cell treatment on it. The cartilage (was worn out between) the joints, and the joints (were) rubbing on the joints. It was bone to bone and it was getting a bit painful.”

Professor Peter Buckle of the Robens Centre for Health Ergonomics at the University of Surrey notes that strain injuries are common for rockers. “Guitarists need to pace themselves more,” he said. The adult stem cell treatment apparently works by restoring defective muscles and helping to regenerate cartilage growth. Given the success of adult stem cells, worried fans shouldn’t be paranoid.

Maybe There Is Hope: Most Americans Still Think Viewing Porn is Immoral

by Cathy Ruse

October 30, 2009

A recent survey of 1,000 adults by Harris Interactive found that 76% of Americans disagree with the proposition that viewing hardcore adult pornography on the Internet is morally acceptable and 74% disagree that it is harmless entertainment. The survey was commissioned by Morality in Media in connection with the White Ribbon Against Pornography week this week.

There is a perception held by many that hardcore adult pornography has become acceptable in American society. But the perception is false, according to Robert Peters, President of Morality in Media. This is evidence that, what primarily fuels the market is sexual addiction, not casual viewing, said Peters in a press release. For full survey results and more information about WRAP week, contact Bob Peters at Morality in Media.

Suffering Suffrage

by Robert Morrison

October 30, 2009

Last year, I voted. I joined the 125,225,900 other Americans (at least, I hope they were all Americans) who voted for President. It was the 40th anniversary of my first vote in a Presidential election. My vote is worth, correspondingly, less now than it was worth then. In 1968, I was one of only 72,054,692 citizens who exercised the suffrage—that old-fashioned word for the right to vote.

Now, I take my vote very seriously. I have never missed once voting in an election in which I was eligible. Im still not sure if I was eligible to vote in Connecticut by absentee ballot in 1984, since we moved to Maryland just one month before election day. I was afraid of missing the voter registration deadline in the Free State (Maryland), so I thought I should take no chances and cast my absentee ballot early in the Constitution State (Connecticut).

If that gets me in trouble, so be it. I was determined to vote for Ronald Reagans re-election. I was also under consideration for a post in the Reagan administration and it would not have served to have missed voting for the Gipper one last time.

Weekly Standard editor Bill Kristol also voted in that 1984 election. A student at Harvards Kennedy School, he cast one of the Ivy Leagues precious few ballots for the Great Communicator. (Good thing the ballots are secret.) Kristol also voted for House Speaker Tip ONeills opponent in that election. The morning after, when Reagans Electoral Vote total looked like an elephant stampede, Kristol asked his wife how many votes the Republican running against the powerful Democrat ONeill had gotten. There was a Communist running against ONeill, but no Republican candidate, Mrs. Kristol informed her stunned hubby.

Bill Kristol was then a candidate for a top slot at Bill Bennetts Department of Education. Kristol was telling the story around Washington to general merriment: Oh my, he exclaimed, I voted inadvertently for a Communist!

When Kristol showed up at the Office of Presidential Personnel, he told the story to an unsmiling Director, Becky Norton Dunlop. Mr. Kristol, she sternly advised the Harvard man, we in the Reagan administration do not think its funny to vote for Communists. Amen to that. Bill Kristol and his excellent magazine have more than made up for that one youthful indiscretion.

Ive just returned from a three-day family vacation in Virginia. The Old Dominion most thoughtfully schedules her gubernatorial elections for one year after the Presidential contests.

It provides a wonderful fix for political junkies like me. I was able to combine dandling my grandson with hunting for votes in the crisp fall air. This year, Virginia and New Jersey are joined by New Yorks 23rd Congressional District as the centers of attention for political trend watchers. These three contests are thought to be bellwethers for next years crucial congressional races.

These three contests are also important because they could provide a boost—or a brake—to President Obamas ambitious legislative agenda. Members of Congress who may be straddling the fence, wondering whether to back ObamaCare or not, will be analyzing next Tuesdays results with the keenest interest.

My Virginia experience of pitching in for my candidates was a joy. The Williamsburg campaign office was efficiently run and brightly lighted. I was welcomed and made to feel right at home. Volunteer telephone callers were busily going through their lists, carefully marking down their responses. In forty-three years, Ive walked precincts, attended rallies, and called in phone banks in New York, Minnesota, Michigan, Washington state, Pennsylvania, Connecticut, and Louisiana. Ive only rarely had anyone be rude to me. Most of the time, Americans when you show them the courtesy of asking for their vote, are the friendliest people you could meet.

Because this was near Colonial Williamsburg, you could expect to see red-white-and-blue throughout the campaign headquarters. It reminded me of that less happy time, back in 1972, when George McGovern ran against Richard Nixon. One of the young McGovernites came into the headquarters where I was the candidate for state legislature. He spied a big American flag on the wall. Whats that doing there, he demanded to know. Im a candidate for office. This is the United States. What would you prefer, a Vietcong Flag, I replied testily.

There was one incongruous sight at the Williamsburg campaign headquarters, however. The faux parchment copy of the Declaration of Independence was proudly on display—but in the bathroom. I thought maybe even that made a point. If we dont take our right of suffrage seriously—and vote—we may find all our inalienable rights, along with our precious independence, flushed away!

But It Was Just a Fetus … Wasn’t It?

by Rob Schwarzwalder

October 28, 2009

Today in Utah, a 21 year-old man was sentenced to five years in prison for, according to the Associated Press, “beating a pregnant (17 year-old) girl to try to cause a miscarriage” after she paid him $150 to do so.

The girl was seven months pregnant. Aaron Harrison, the criminal convicted of assaulting her, beat her stomach and, bizarrely, even bit her on the neck to induce a miscarriage. And although Harrison had pled guilty to “second-degree felony attempted murder, which is punishable by up to 15 years in prison .. District Judge A. Lynn Payne instead sentenced him under Utah’s anti-abortion statute, saying a charge of third-degree ‘attempted killing of an unborn child’ better fit the facts of the case.”

I don’t think words can describe the kind of depraved conduct you entered into in trying to take the life of a child,” Judge Payne said to Harrison from the bench.

The mother of the baby, born healthy in August, is now seeking custody of the child she tried to have killed.

Judge Payne’s words ring like a bell: “The life of a child.” At seven months, the child is almost fully developed; it’s eyelids are opening and closing at this stage, with its brain functioning and its heart beating. All that really needs to happen prior birth is weight increase.

The potency of medical knowledge has pushed proponents of abortion on demand out of the realms of reason and science. The humanness and personhood of the unborn child are indisputable by any measurable, objective standard.

It was President Obama who said, during his one-on-one with Rick Warren last summer, that determining when human life begins is “above my paygrade.” Perhaps the President could read Judge Payne’s remarks and the facts of this wrenching case and let us know if his current salary is sufficient for him to decide.

In the Know…

by Krystle Gabele

October 28, 2009

Here’s some articles that might be of interest.

White Ribbon Against Pornography Week

by Cathy Ruse

October 28, 2009

According to Bob Peters of Morality in Media, our nation is facing a moral crisis, including, among other things, teen promiscuity, sexually transmitted diseases (including AIDS), abortion, illegitimacy, divorce, sexual abuse of children, rape, trafficking in women and children, on-the-job sexual harassment and lost worker productivity. And what is fueling this crisis is the spread of hardcore pornography, on the Internet and elsewhere.

Thats why one week every October we observe White Ribbon Against Pornography week, where people display white ribbons and inform their public officials about the harms of pornography and the need to enforce our obscenity laws.

The 22nd annual WRAP week runs Sunday, October 25 through Sunday, November 1st, and its chief promoter is Morality in Media. (Resources for individuals and groups can be found at www.moralityinmedia.org under WRAP Campaign and include information about ordering white ribbons, sample letters to Attorney General Holder and state prosecutors, and sample prayers and sermons.

If you think about it, someone is going to define the culture. The Porn Industry and their friends at the ACLU seek an America where there are no legal limits on pornography no limit to how graphic it may be, no limit to the people it can exploit for profit, including children.

And theyre winning, not because what theyre doing is legal, but because theyre getting away with it. But the Supreme Court has ruled that obscenity laws can be enforced against hardcore pornography when a jury finds the material appeals to the prurient interest, is patently offensive, and lacks serious value.

So it doesnt matter what the Porn Industry or the ACLU thinks. All that matters is what a jury thinks, and that means ultimately its up to the American people to decide whats illegal or not.

But the people become disenfranchised when obscenity laws are not vigorously enforced.

Our voice is the jury verdict. Without obscenity prosecutions there are no juries, and no juries mean no verdicts, and no verdicts mean the people have no voice. And that leaves the Porn Industry to set the standards for the culture.

An important way to attack the moral crisis is so simple its deceptive: enforcement of our already-existing obscenity laws.

We call on President Obama and Attorney General Holder give us back our voice, and to vigorously enforce this nations obscenity laws.

Something Has Gone Terribly Wrong

by Chris Gacek

October 25, 2009

Jeffrey Kuhner is one of the best conservative writers going these days. His column appears on Sundays in the Washington Times. He has a way of getting to the heart of a topic, and two Sundays ago he addressed President Obamas jihad against Fox News Channel (see Whos Partisan Now, 10/18/09, p. B1):

For decades, the Washington press corps has presented itself as the guardian of political order and institutional stability. They are the real news experts whose experience and rational judgment are necessary to preserve fairness and objectivity. The rise of Fox News and the New Media - Internet news sites, such as the Drudge Report, World Net Daily and Newsmax, along with talk radio - has ripped away that shallow, smug and self-satisfied journalistic veneer.

The emergence of Fox News is a sign many Americans no longer trust the political and media class. It is part of a larger populist revolt that is slowly reshaping our society. The American people crave government accountability and political transparency. Moreover, many in the heartland rightly sense that something has gone terribly wrong. They are slowly losing their country to globalist progressives who no longer share any attachment to traditional America. (my emphasis)

Right, and we recently got an Exhibit A of things gone terribly wrong.

Heres a headline from a Financial Times story: [Securities and Exchange Commission] hires Goldman [Sachs] alumnus to head enforcement division. Fox, hen house. Say no more. But there is more. First paragraph of updated story: The Securities and Exchange Commission has hired a 29-year-old Goldman Sachs alumnus as managing executive of its enforcement division. Is this a joke? I guess no high school students were available. Well, he has an MBA from New York University. I am so glad the SEC is serious about enforcement.

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