Plame-Gate: Flame-Out

Filed in PoliticsTags: Media Bias, Republicans, War on Terror

I told you so.

Christopher Hitchens lays it out.

Plame-Gate, Part I: The Joe Wilson Niger Affair:

I have now presented thousands of words of evidence and argument to the effect that, yes, the Saddam Hussein regime did send an important Iraqi nuclear diplomat to Niger in early 1999. And I have not so far received any rebuttal from any source on this crucial point of contention.

Plame-Gate, Part II: The "Outing" of Valerie Plame:

But there was always another layer to the Joseph Wilson fantasy. Easy enough as it was to prove that he had completely missed the West African evidence that was staring him in the face, there remained the charge that his nonreport on a real threat had led to a government-sponsored vendetta against him and his wife, Valerie Plame.

In his July 12 column in the Washington Post, Robert Novak had already partly exposed this paranoid myth by stating plainly that nobody had leaked anything, or outed anyone, to him. On the contrary, it was he who approached sources within the administration and the CIA and not the other way around. But now we have the final word on who did disclose the name and occupation of Valerie Plame, and it turns out to be someone whose opposition to the Bush policy in Iraq has—like Robert Novak's—long been a byword in Washington. It is particularly satisfying that this admission comes from two of the journalists—Michael Isikoff and David Corn—who did the most to get the story wrong in the first place and the most to keep it going long beyond the span of its natural life.

And the conclusion:

The answer to that question (of whether the Intelligence Identities Protection Act had been broken), as Patrick Fitzgerald has since determined, is "no." But there were plenty of senior people who had known that all along. And can one imagine anybody with a stronger motive to change the subject from CIA incompetence and to present a widely discredited agency as, instead, a victim, than Tenet himself? The man who kept the knowledge of the Minnesota flight schools to himself and who was facing every kind of investigation and obloquy finally saw a chance to change the subject. If there is any "irony" in the absurd and expensive and pointless brouhaha that followed, it is that he was abetted in this by so many who consider themselves "radical."

Checkmate.

(Hat tip: Lucianne)

More Re-Definition of Terminology

Filed in Politics, Science, Social IssuesTags: Clone The Truth, Cloning, Missouri, Sanctity of Life, Stem Cells

First, they tried to re-define "embryonic" as "early". Next, they tried to re-define "cloning" as "implantation". Now, they're trying to re-define "cure".

Adult stem cells have thus far produced at least 72 human treatments. It appears that one of the latest tactics of the pro-Amendment 2 Coalition is to refute that fact (emphasis added):

Winship says there have been no proven cures found with embryonic stem cell research and said adult stem cells are a proven - and ethical - alternative.

"The reality is, it’s still zero" cures "for embryonic stem cells," she said.

Farrow said embryonic stem cell opponents would do anything to derail the initiative, including overstating the potency of adult stem cells.

"You’ll hear our opponents say that there are between 65 to 100 adult stem cell cures. That’s simply not true," Farrow said.

"The truth is there are only nine adult stem cell cures, and we believe that research needs to go forward," she said. "But adult stem cells have been researched for over 50 years. The first earlier embryonic stem cell research didn’t start until 1998. We haven’t even had a full decade of research with embryonic stem cells."

What on earth could possibly explain such disparity? Apparently, the Coalition, in an attempt to level the playing field in their favor, have begun applying a "FDA-approved" qualification (emphasis added):

Dr. William Neaves is with the Stowers Institute Medical Research. "This is a contest between society and disease, not between adult stem cells and early stem cells," says Neaves.

Researchers say embryonic stem cells hold infinitely more potential than adult stem cells for curing disease. They say the claim about dozens of treatments already developed from adult stem cells is not true. "At best, only nine of those diseases have, after 50 years of research with adult stems cells, FDA-approved therapies that are available to patients," says Neaves.

The Coalition is obviously hedging on the belief that the general public have no real understanding of what FDA approval is, what it means, or how it happens. I will try to give a brief overview.

FDA is divided into various "centers". I work for a pharmaceutical company that manufactures, packages, and sells drugs. We are under the direction of FDA's CDER: the Center for Drug Evaluation and Research. Medical devices - pacemakers or defibrilators, for example - are under the direction of CDRH: the Center for Devices and Radiological Health. Stem cell treatments are under yet another center - CBER: the Center for Biologics Evaluation and Research.

In order for a drug, device, vaccine, or other treatment (hereafter, treatment) to get FDA approval, a rigorous and intensive process is required. The sponsor (company requesting approval) must complete a submission application including all the data supporting the approval request. For a new treatment, the submission would include data from three phases (Phase I, Phase II, Phase III) of clinical studies. These clinicals are the heart of the company's justification for requesting approval. Phase I clinicals are very small (less than 100 participants) studies, generally using healthy humans, to determine physiological interaction of a treatment with humans. Phase II clinicals follow successful of Phase I, and are controlled, small-scale (a few hundred participants) studies using people who have the condition for which the treatment is indicated, used to determine preliminary data with respect to the effectiveness of the treatment, and any side effects associated with the treatment. Phase III clinicals follow successful completion of Phase II, and are controlled (or uncontrolled), large-scale (a few hundred to thousands of participants) studies used to determine the effectiveness of the treatment for the general population, and to ascertain the overall risk-benefit relationship of the treatment.

Based on these data, in addition to other aspects of the submission (stability data for a drug, for example), FDA will approve or reject the application. Once FDA has approved an application, the sponsor can legally market and sell the treatment in the US.

As with many other treatments, due to the nature of the conditions for which stem cell treatments are intended, such treatments are not always well-suited for typical clinical trials. FDA is aware of and working to reconcile the difficulty of translating stem-cell treatments into clinical trials.

Note, however, that other mechanisms exist, prior to or in lieu of FDA final approval, for treatments to be used (legally and effectively). Two such mechanisms are the Treatment Investigational New Drug (Treatment IND) approval, in which "FDA will permit an investigational drug to be used under a treatment IND if there is preliminary evidence of drug efficacy and the drug is intended to treat a serious or life-threatening disease, or if there is no comparable alternative drug or therapy available to treat that stage of the disease in the intended patient population", and the parallel track policy, in which "patients with AIDS whose condition prevents them from participating in controlled clinical trials can receive investigational drugs shown in preliminary studies to be promising."

Some treatments - such as prenatal drugs - may never proceed through all clinical phases and final approval, but may be given to patients as investigational treatments for non-approved indications as long as the patient gives informed consent (which is also required for participation in clinical studies). Such is the case for Treatment INDs discussed above.

The bottom line is this: all treatments administered in the US must have FDA approval, whether in the form of a final New Drug Approval (NDA), or as an Investiational New Drug approval (IND). So, of the more than 72 treatments currently in use, every single one in use in the US has FDA approval of one form or another.

That said, much stem cell research and advancement takes place outside the borders of the US and outside the control of FDA. Any treatments derived from such research would not be subject to FDA approval; therefore, any implication regarding such approval is

This argument is not unique to the Missouri Amendment battle. In this 07/06 letter to Science, Do No Harm refutes the argument for the straw man that it is, and also points out that some 1170 clinical trials involving stem cells currently exist, including some 565 trials currently active and seeking participants - while not one single clinical trial is underway for embryonic stem cell treatments. Moreover, the letter points out that there are currently no peer-reviewed references to embryonic stem cell-derived human treatments. The above-referenced list of 72 human treatments derived from adult stem cells, which Do No Harm maintains, includes only those treatments for which peer-reviewed scientific publication of their effectiveness exists.

Yet again, the Coalition can only offer mistruths and deception.

Christians Against Human Cloning Rally

Filed in Politics, Religion, Science, Social IssuesTags: Christianity, Cloning, Missouri, Saint Louis, Sanctity of Life, Stem Cells

Last night, I attended the Christians Against Human Cloning Rally, held at Life Christian Church and sponsored by Vision America/Missourians for Truth. Speakers included Shao-Chun Chang (professor of medicine at Washington University in St. Louis), Charles Drury (Hotel Developer), Archbishop Raymond Burke, Rich Bott (executive vice president, Bott Radio Network), Rick Scarborough (President, Vision America), Phyllis Schlafly (Founder and President, Eagle Forum), and Alan Keyes.

Some notable quotes:

"It is wrong to create human life for the purpose of destroying that life."

-- Archbishop Raymond Burke

"The most fundamental premise of our nation is not that we have rights, but that our rights come from God."

-- Dr. Alan Keyes

(Pictures will be available soon.)

UPDATE: See the Flickr photoset for the rally.

CAHC Rally 001

Christians Against Human Cloning Rally, Life Christian Church, Saint Louis, 28 August 2006
Photo © Chip Bennett, all rights reserved.

The Post-Dispatch covered the rally. Below are some excerpts from the article.

(St. Loius Archbiship Raymond) Burke, head of the St. Louis Roman Catholic archdiocese, joined other regional and national religious conservatives - from Eagle Forum founder Phyllis Schlafly to commentator Alan Keyes - who addressed hundreds who packed the sanctuary at the Life Christian Church, 13001 Gravois Road in south St. Louis County.

"Hundreds"? My estimation was more like 2,000. I was in the balcony, and couldn't see the entire floor seating area. The Cape Girardeau rally had 300, and gauging by the photo, we had as many in the balcony seating, alone.

(I just called the church to inquire about estimated attendance. Though I didn't get an actual number, I was informed that the rally was believed to be essentially a "full house", and the church sanctuary/auditorium holds between 3,000 and 4,000 people. I know the balcony wasn't entirely full, but the floor seating was.)

Back to the article:

In a telephone interview, (chairman of the Missouri Coalition for Lifesaving Cures Donn) Rubin contended that it was the opponents who were spreading untruths. Otherwise, he said, the Cures Coalition wouldn't have support from more than 100 groups, including research centers, health care groups and patient groups.

We'll see the most fundamental of your untruths, a couple paragraphs below. And it's about time I parsed your "factsheet" as well, since every single point listed is a mistruth at best, or a bald-faced lie at worst.

Critics, said Rubin, are "inventing wild claims to distract the public from what we're really voting on - the right of Missourians to obtain the same medical treatments available in other states."

The "medical treatments" canard is nothing but a "wild [claim] to distract the public from what we're really voting on." Missouri's access to medical treatments available in other states has never been in question, and likely will never be in question. In the far-off (and, in all reality, unlikely) event that a human treatment derived from embryonic stem cells ever becomes available, the location of the research into that treatment will not determine the location of the application of such a treatment. The availability of such a treatment will depend only upon the availability of access to the stem cell line from which such treatment was developed.

At the rally, opponents emphasized that much of the debate centers on a procedure known as somatic cell nuclear transfer, or therapeutic cloning.

Under that procedure, the nucleus of an unfertilized human egg is replaced with the nucleus of another human cell. Opponents say it is a form of human cloning and cite the use of the procedure to clone Dolly the sheep. The Lifesaving Cures Coalition says the procedure is not cloning and cites the proposed amendment's specific ban against implanting such an egg in a womb.

And here it is: the number one, most fundamental, outright, bald-faced lie of the Coalition. By definition Somatic Cell Nuclear Transfer (SCNT) is cloning; cloning is SCNT. The two terms are interchangeable.

In genetics, somatic cell nuclear transfer (SCNT) is a technique for cloning.

...

This technique is currently the basis for cloning animals, such as the famous Dolly the sheep, and could theoretically be used to clone humans. Scientists at the Harvard Stem Cell Institute are currently researching a technique to use somatic cell nuclear transfer to produce embryonic stem cells.

For human cells, no other method exists as a viable means of cloning.

Even your own supporters recognize and admit this truth. From your own website:

Let us freely admit that the procedure used to produce human stem cells for research is cloning, but not in any way part of a process for creating human babies. The distinction should be clear.

The distinction is clear, but it is also irrelevant. Your Coalition is promoting Amendment 2, specifically stating that the amendment "bans human cloning" - yet, you never reveal that the amendment uses a conjured definition of "cloning" not recognized anywhere else, nor do you point out that the amendment actually prohibits the banning of human cloning - that is, cloning according to the proper usage of the term.

So, which side is it, again, using distractions and spreading untruths?

Back to the article:

Scarborough said the number of Missouri rallies would depend on how much money can be raised to pay for them. So far, each rally has cost close to $20,000. That includes Keyes' speaking fee of $2,500.

The Lifesaving Cures' leaders point to the payments as evidence that Keyes and Scarborough may have financial motives. Scarborough said he was offended by such talk, and added that Keyes' payment was a fraction of his usual speaking fee.

Let's compare rallies, shall we?

How much do you want to wager that the Coalition Rally held at the Capitol Plaza Hotel in Jefferson City, with its Hollywood glitz, busloads of "hundreds" (er, make that, about 150) attendees from across the state, red-carpet treatment of speakers, and applause cues cost more than the Christians Against Human Cloning rallies? To wit (emphasis added):

From their state-of-the-art audio/visual equipment to the busloads of backers brought to town from across the state, it was clear supporters of an effort to amend Missouri's constitution to protect embryonic stem cell research spared no expense at a Monday morning campaign kickoff rally.

With an audience of nearly 150 proponents at the Capitol Plaza Hotel prompted to applaud on cue and a podium of speakers from the political to the poignant, the rally in favor of the Missouri Stem Cell Research and Cures Initiative had the look and feel of a television talk show.

Are you going to imply, with a straight face, that all of the Coalition's speakers are speaking without compensation? Further, what of the over ten million dollars in Coalition support from the Stowers Institute? Would you actually lead to believe that this investment is made without an expectation of a return? Follow the money, indeed!

See also: LifeNews coverage.

OYB August 29

Filed in ReligionTags: Christianity, Devotions, One Year Bible

Today´s reading:
OT: Job 31-33
NT: II Corinthians 3:1-18
Ps: Psalm 43
Pr: Proverbs 22:8-9

Today´s notable verse:

7 I thought, 'Age should speak;
advanced years should teach wisdom.'
8 But it is the spirit in a man,
the breath of the Almighty, that gives him understanding.
9 It is not only the old who are wise,
not only the aged who understand what is right.

Job 32:7-9 (NIV)

Now the Lord is the Spirit, and where the Spirit of the Lord is, there is freedom.

II Corinthians 3:17 (NIV)

The One Year Bible Blog´s comments for today.