FDA approves first human embryonic stem cell safety trial (3 days after Pres. Bush left)

Scientific American ^ | 1-23-09 | Jordan Lite

[STARWISE]

Federal regulators have green-lighted the first trial of an embryonic stem-cell treatment in humans.

The U.S. Food and Drug Administration (FDA) gave the go-ahead for Geron Corporation to start a phase I safety trial of its therapy GRNOPC1 for spinal cord injuries, the Menlo Park, Calif.–based company announced today.

It first sought permission for the trial four years ago and spent much of the last year trying to satisfy the FDA’s concerns about it.

"This marks the beginning of what is potentially a new chapter in medical therapeutics—one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of healthy replacement cells,” Thomas Okarma, Geron's president and CEO, said in a statement today.

The trial will involve up to 10 patients and will test whether it is safe to inject nerve cells from embryos into the site of their injuries, according to Geron. A study published in 2005 in the Journal of Neuroscience found that giving rats the injections seven days after a spinal cord injury improved their motor function.

Wise Young, director of The W. M. Keck Center for Collaborative Neuroscience at Rutgers University, hailed the FDA’s decision, but says his expectations are tempered.

“It’s a big deal—it’s a long time in coming. There’s a lot of hope riding on this,” Young tells ScientificAmerican.com. But he cautions that people should not expect "a miraculous result" from this initial trial.

"I do believe cellular therapy will have a beneficial effect," he says, "but it’s very important to understand that we’re just starting. We have a long road to go.”

Geron and FDA officials told The Wall Street Journal that it was a coincidence that the announcement came just three days after George Bush left the White House. Bush restricted federal funding of embryonic stem cell research.

"The FDA looks to the science on these types of issues, and we approve [such applications] based on a showing of safety," FDA spokesperson Karen Riley told the Journal. “Political considerations have no role in this process."

Pres. Obama said during his campaign that he would lift the ban on federal funding of research on embryonic stem-cell lines produced after August 9, 2001. But he told CNN on January 18 that he may ask Congress to undo it.

Lawmakers passed legislation three times during the Bush administration that would have erased the limit and allowed research on stem cells from embryos at fertility clinics (with donors' consent) that would otherwise be discarded; Bush vetoed them all.

"I like the idea of the American people's representatives expressing their views on an issue like this," Obama told CNN.

That may not be a bad thing, Young says. “If he were to reverse this on his own, it takes Congress off the hook.

It’s much more important that Congress makes sure this doesn’t happen again,” he says. “What is worrisome is that if Obama did just reverse the rule, stem cells would be a political football in Congress to trade for something else.

It’s really important from the viewpoint of the advocacy community that legislation is passed so other presidents don’t come in and say, ‘I will forbid this.’”

[ohioWfan]

Here's a question for those in the medical/scientific community.....

How many universities and med schools require courses in the ethics and morality of research and medical practice? Is the subject even brought up to these young 'skulls full of mush' that what they are doing may be wrong?

Or is there no right or wrong in the mind of a 'scientist?'

(Rhetorical question......of course some scientists consider ethics in the equation, but is it just their own personal values, or ar they actually guided into making ethical choices in leftist academia?)

[ohioWfan]

Amen, Kitty Mittens! AMEN!

[ga medic]

“Pretty enough picture for you abortion-loving slime?”

Stem cells have nothing to do with abortion. Your insult doesn’t make any sense.

[benjibrowder]

I was referring to where embryonic stem cells were coming from.

[ohioWfan]

However, when it comes to the huge number of embryos produced, stored and discarded in the fertility industry they are silent.

It appears that not everyone is silent on the subject, ga medic.

All of these parents are part of a rescue group for these tiny human beings.

The pro-life community is very broad and very all-encompassing in its efforts to save the lives of the unborn (as well as heal the scars of those who have allowed their own child to die, and provide for the care of those mothers who choose life).

Perhaps it's just because embryonic stem cell research has been championed by the political left as a weapon against our strong pro-life President Bush that more attention was drawn to that aspect of the pro-life movement.

We are not silent.

[STARWISE]

Bush vetoes embryonic stem-cell bill
POSTED: 9:51 a.m. EDT, September 25, 2006

President Bush used his veto power Wednesday for the first time since taking office 5 1/2 years ago, saying that an embryonic stem-cell research bill “crossed a moral boundary.”

The bill, which the Senate passed Tuesday, 63-37, would have loosened the restrictions on federal funding for stem-cell research.

House Republican leaders tried Wednesday evening to override the veto, but that vote was 235 to 193, short of the necessary two-thirds majority.

“This bill would support the taking of innocent human life in the hope of finding medical benefits for others,” Bush said Wednesday afternoon.

“It crosses a moral boundary that our decent society needs to respect. So I vetoed it.”

Attending the White House event were a group of families with children who were born from “adopted” frozen embryos that had been left unused at fertility clinics.

“These boys and girls are not spare parts,” he said of the children in the audience. “They remind us of what is lost when embryos are destroyed in the name of research. They remind us that we all begin our lives as a small collection of cells.”

The measure, which the House of Representatives passed in May 2005, allows couples who have had embryos frozen for fertility treatments to donate them to researchers rather than let them be destroyed.

Bush said, “If this bill were to become law, American taxpayers would, for the first time in our history, be compelled to fund the deliberate destruction of human embryos, and I’m not going to allow it.”

In August 2001, Bush announced that his administration would allow federal funding only for research on about 60 stem-cell lines that existed at the time. Researchers have since found that many of those lines are contaminated and unusable for research.

*snip*

Opponents argue that other alternatives, such as adult stem cells, are available. Two companion bills — one to promote alternative means of developing stem-cell lines from sources such as placental blood and another to ban the commercial production of human fetal tissue, also known as “fetal farming” — passed the Senate in 100-0 votes.

On Tuesday evening, the House approved the “fetal farming” bill 425-0 but didn’t pass the measure promoting alternative stem-cell sources when backers failed to achieve the two-thirds majority that House rules required. The vote on the alternative-sources bill was 273-154.

Bush signed the “fetal farming” legislation and urged Congress to fund alternative research.

~~~

Pres. Bush maintained the moral high ground. Leadership matters.

[STARWISE]

Link to above

http://www.cnn.com/2006/POLITICS/07/19/stemcells.veto/index.html

[Amelia]

Question: Would Pres. Bush’s FDA have done this ?

I suspect so.

Pres. Bush did not ban research on human embryos, he only limited the federal funding that could be used on such research.

Remember, actually some research was still being done on human embryos using federal funding during the Bush years.

[STARWISE]

I totally disagree.

[sarah p]

As a biomedical researcher at a large university, I think that I am qualified to answer this question.

Some universities may teach courses on ethics in science, but it is hardly core curriculum. However, there are many ethic rules that prevent unchecked research. To conduct any scientific research using animals and especially human subjects, the investigator must abide by these rules. Also, when one applies for any federal funding for their research they must submit a person statement on how they will conduct ethical research.

Scientific research is a highly bureaucratic process, which keeps little to no unchecked research from occuring. Panels of scientists review the research aims and proposed experiments when someone applies for a research grant. The scientist usually has to actually do the work that they proposed if they hope to have their grant funding to continue. Also, any published results from federally funded work must be made available to the public.

Most scientists that I have met conduct ethical research and the system makes it very difficult for anyone to do much unchecked research. Those in academia are driven by publishing their work, so it does not make sense for them to do any work that they can not publish.

So while academia does not have many ethical crusades, the system is set up to promote ethical research.

By the way, since I am conservative scientist, I am vastly outnumbered by liberals. Don’t even get me started on that topic!

[Amelia]

I was referring to where embryonic stem cells were coming from.

Most of the embryonic stem cells don't come from aborted babies.

A couple of years ago, there were reported to be at least 400,000 discarded embryos in storage, left over from in-vitro fertilization attempts. The number is likely higher now.

[<1/1,000,000th%]

Hwang Mi-Soon already had this done with adult stem cells 4 years ago.

[sarah p]

“Most of the embryonic stem cells don’t come from aborted babies.”

Well I guess that depends on what your definition of what an aborted baby is. If that embryo were in a uterus and it was removed to die, then that is an abortion. Does that mean that a living embryo that has not been in a uterus that is killed is not an abortion?

I define abortion as aborting the human baby embryo’s path of development to a newborn infant by purposefully ending its life. I don’t believe that the physical location of the living embryo defines whether it can be called an abortion when it is killed.

[maryz]

E.g., why did we research optical storage, when magnetic showed such promise?

Gee, I don't know -- which one was considered morally reprehensible by large numbers of people and, incidentally, in no instance did any good, but caused tumors in numerous cases?

[Gene Eric]

>> If embryos were being created to be destroyed, that’s a different question

Why should that make a difference? Wouldn’t it be better science to grow the embryos known or expected to have certain DNA characteristics?

I agree with your desire to cure the injured, but I’m not convinced embryonic stem cell research is the exclusive solution for certain injuries or diseases. On the other hand, I am certain that segments of science are willing to experiment with human life at its earliest stages for ambitious and opportunistic reasons. Using human embryos in medicine also justifies the farming of human life for the ‘greater good’.

To accuse those against embryonic stem cell research to be anti-science misrepresents the concerns expressed for human life. What you describe as knee-jerk reaction, is passion for the decency and respect of new life, human life.

[ga medic]

It still has nothing to do with abortion. Do you know where embryonic stem cells come from?

[ga medic]

You didn’t answer my question. Why would GWB allow research which destroys embryos, and then prevent the treatment developed from being used to help people? If he had intended to prevent any embryonic stem cells from being used, he would have said so. He says that he didn’t want to compel taxpayers to fund the destruction of embryos.

This research occurred while he was president, and went through the vast majority of the FDA approval process while he was president. Allowing research to continue destroying these innocent lives, while intending to prevent the treatments developed from ever being used would be grossly irresponsible.

[Gondring]

You just made that up. Now that the contamination problem is known, it's NOT inevitable over practical timescale. Even "production levels" are fine with this line...

The cells are derived from the H1 human embryonic stem cell line, which was created before August 9, 2001. Studies using this line qualify for U.S. federal research funding, although no federal funding was received for the development of the product or to support the clinical trial.

Geron's H1 hESC master cell bank is fully qualified for human use and was shown to be karyotypically normal and free of measurable contaminants of human or animal origin. Production of GRNOPC1 from undifferentiated hESCs in the master cell bank uses qualified reagents and a standardized protocol developed at Geron over the past three years. Each manufacturing run of GRNOPC1 is subjected to standardized quality control testing to ensure viability, sterility and appropriate cellular composition before release for clinical use. GRNOPC1 product that has passed all such specifications and has been released is available for the approved clinical trial. The current production scale can supply product needs through pivotal clinical trials. The existing master cell bank could potentially supply sufficient starting material for GRNOPC1 to commercially supply the U.S. acute spinal cord injury market for more than 20 years.

[Gondring]

According to the Catholic definition, God kills off more than half of humans before they are born.

[TChris]

According to the Catholic definition, God kills off more than half of humans before they are born.

Are Catholics fatalists? Do they believe that everything that happens is because God made it happen?

I seriously doubt that.