Little Red Ribbon-Hood: July 2006: Archives
The Food and Drug Administration has announced that it is ready to consider over-the-counter sales of Barr Laboratories morning-after pill...a move that surprised many observers given the protracted delays that have raised concerns that the agency is allowing politics to guide medical decisions.
Despite the announcement, there is reason for skepticism since President Bush's nominee to head the Agency; Dr. Andrew von Eschenbach is scheduled to appear for confirmation hearings. Two Senators, including Hillary Clinton, have vowed to block the nomination until the agency makes a decision on over-the-counter sales. Read the full article here.
Barr’s application for over-the-counter approval of Plan B has been pending before the F.D.A. for three years and has sparked considerable discord within the agency. It has also become a proxy fight in the debate between foes and supporters of abortion rights.
In December 2003, an F.D.A. advisory committee voted 23 to 4 to approve Barr’s application with no age restrictions. Six months later, however, a top agency official rejected the application, citing concerns that the pill would be available to young teenagers.
Internal F.D.A. documents show that agency officials suggested to Barr that it rewrite its application to allow over-the-counter sales to adult women while still requiring younger teenagers to get a prescription. Barr did that, but in January 2005, the statutory deadline for an F.D.A. decision passed without a decision.
In a letter to Barr today, Dr. von Eschenbach indicated the F.D.A. would not approve Plan B for over-the-counter sale for girls under 18. “We believe that the appropriate age for OTC access is 18," he wrote.
While the F.D.A. has insisted that its decisions to reject or delay the Plan B application were the result of scientific or regulatory concerns, a Congressional investigation found last year that top agency officials decided at one point to reject the application before its staff’s scientific review was even complete.
Senator Clinton and Senator Murray issued a joint statement that accused the agency of making the announcement as a further effort to stall the approval of the pill. They indicated they would still block the nomination until such time as a decision was finalized.
Thought Theater previously reported on the controversy surrounding the agency and the approval of the pill for over-the-counter sales here.
Daniel DiRito | July 31, 2006 | 1:16 PM |
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A recent poll indicates that voters in South Dakota are not in favor of the recently enacted ban on abortions that many feel could become a key component of efforts to overturn Roe v. Wade. The full article can be found here.
The statewide survey of 800 registered voters found 47 percent opposed the strict ban, while 39 percent favored it. The remaining 14 percent were undecided. The poll had a margin of sampling error of plus or minus 3.5 percentage points.
The Legislature voted overwhelmingly earlier this year to make abortion illegal in all cases -- including rape and incest -- unless the procedure was necessary to save the woman's life. It was to become law on July 1, but opponents gathered enough signatures to delay it and to let voters decide in November whether the ban should take effect.
If voters reject the abortion ban at the ballot box, they would effectively repeal it.
The poll also indicated that voters were more favorable to a ban on abortions if the law would provide for exceptions in cases that involve rape or incest. Should the current measure be rejected in November, a new bill would likely be submitted to the legislature with exceptions for rape and incest in order to make it less likely to be rejected by voters in the future.
Daniel DiRito | July 31, 2006 | 12:52 PM |
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The Vatican issued a condemnation of Monday's approval by the European Union to continue funding stem cell research. The Associated Press has the full article here.
VATICAN CITY -- A Vatican newspaper on Tuesday condemned a decision by the European Union to continue funding embryonic human stem cell research, calling it the result of "a twisted sense of progress."
The 25-nation bloc agreed Monday in Brussels to keep up the funding through 2013, but only under new rules that prevent human cloning and destroying embryos.
Critics of the agreement have argued that the EU was splitting hairs in order to get the funding approved with minimal objection. The Times of Malta explains the subtle distinction as follows:
The German delegation accepted the final draft where a statement was included stating that the EU will not finance the destruction of human embryos.
But, at a press conference later, the Commissioner for Science and Research, Janez Potocknik, said that although the EU will not be funding such research itself, the destruction of the embryo was an inevitable phase in the process. It is simply that the EU will not be involved in that phase.
Asked specifically whether this was not a "fudged" solution, given that such research will ultimately involve the destruction of embryos, the commissioner said smilingly: "I don't know what you want me to say".
Clearly the wording did not satisfy the Vatican's position on stem cell research. The approval will provide the funds to conduct the research on the cells once they have been harvested from IVF clinic embryos scheduled for disposal but will not fund the actual destruction of the embryos. Nonetheless, the approval is an important commitment to pursuing the promising research. The Vatican spokesman made the following comments.
Monsignor Elio Sgreccia, a top Vatican official on bioethical questions, described the EU decision as "grave" and said it authorizes "the use of human beings, on the basis of 'I kill you to get advantages for others.'"
"The macabre product of a twisted sense of progress," the newspaper's headline said.
Daniel DiRito | July 25, 2006 | 4:44 PM |
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On Meet the Press this past Sunday, Josh Bolton, White House Chief of Staff, struggled to answer the questions about the President's position on stem cell research. Bolton was obviously uncomfortable when attempting to finesse Bush's position, as previously stated by Press Secretary Tony Snow, that the destruction of frozen embryos is "Murder". In 2004, just before the presidential election George and Laura Bush were interviewed by Larry King. In that interview, Bush stated the following with regard to stem cell research and the use of human embryos.
G. BUSH: That's the big debate, Larry, and this country has got to be very careful on destroying life to save life. And it's a debate that needs to move forward in a very careful way. And I listen very carefully to ethicists who impressed me about being cautious and respecting human life, I guess, is the best way to put it. And that's one issue, embryonic stem cell.
G. BUSH: These are embryos that represent life and the fundamental question, as a society, is: Does society continue to take life, destroy life?
The following video is from Bolton's appearance on Meet the Press.
The Washington Post has a good article on the retraction offered by Tony Snow on Monday here. It was clear from the Bolton appearance that the White House would be unable to rationally explain the position taken with regard to the embryos which are the focal point in the debate. Note that Russert backed Bolton into a corner on why the President hasn't banned in-vitro fertilization clinics if he in fact believes that the destruction of an embryo is in fact "murder".
White House press secretary Tony Snow said yesterday that he "overstated the president's position" during a briefing last week but said Bush rejected the bill because "he does have objections with spending federal money on something that is morally objectionable to many Americans."
The shifting terminology underscored the sensitivity of the issue, especially heading into midterm elections. Many antiabortion conservatives strongly oppose stem cell research involving the destruction of embryos, viewing it as killing human beings. But polls show that most Americans see such research as a potential key to treating Alzheimer's disease, Parkinson's disease, spinal cord injuries and other afflictions.
Supporters of the research said the shift reflects White House concerns that it is alienating mainstream Republicans. "What Tony Snow was doing was calling them all murderers, and that doesn't do much for close midterm elections," said Michael Manganiello, former president of the Coalition for the Advancement of Medical Research.
In another segment of the interview, Russert challenged the Karl Rove assertion that adult stem cells have "far more promise" that embryonic stem cells. Russert's challenge highlights the distortions being offered by those on the right with regards to stem cell research. The reality is that adult stem cells have been the focus of research for a far longer period of time and while some of that research has been developed into treatments, it remains far more limited in its potential than embryonic stem cell research.
The often unspoken issue that underscores much of this embryonic stem cell debate is once again abortion. Those opposed to abortion see the easing of restrictions on embryonic stem cell research undermining their belief and assertion that human life begins at conception. If embryonic stem cell research were to be fully funded by the government, it would make it increasingly difficult to hold the strict definitional distinction that anti-abortion activists seek to advance.
The rationale of their argument seeks to define conception as the point at which human life begins which could then be argued to afford the embryo the same rights to protection as all other citizens. Clearly, they do seek to define the destruction of an embryo as murder which they see as the ultimate means to achieving the goal of making abortions illegal and overturning Roe v. Wade.
I find it interesting that the President felt that he needed to clarify his position. It points out that there is some realization that the majority of Americans do not agree that the use of frozen embryos, which are otherwise apt to be destroyed, is the same as murder. Further, it points out that he is concerned with how the issue will impact Republican candidates in the November election. Note the following statement from Tony Perkins of the Family Research Council, a religious right advocacy group.
Tony Perkins, president of the Family Research Council, a group that opposes embryonic stem cell research, said he does not see much significance in the White House revision. "I'm not troubled by that at all," he said. "The president's actions speak louder than words."
The remark clearly points out that those who seek to make abortion illegal have a clear understanding of the basic legal arguments. The Bush veto holds open the legal line that opponents of abortion feel is essential to their efforts to overturn Roe v. Wade and make all abortion illegal.
A cynic might even conclude that the entire situation, in which Snow made the assertion of murder only to follow it up with a retraction, may have actually been a fully orchestrated strategy. It has all the characteristics of a Karl Rove manipulation. It looks similar to President Bush's seemingly back and forth triangulation with regard to same-sex marriage in the lead up to the 2004 presidential election. He offered both a call for an amendment to the constitution to define marriage as between a man and a woman but then also suggested in an interview with Larry King that he had no problem with individual states providing same-sex couples with many of the same benefits and protections that come with marriage.
I've previously argued that the Rove strategy is to offer carefully tailored messages to the various voting constituencies in order to develop a majority coalition of voters. This stem cell issue looks like more of the same.
Daniel DiRito | July 25, 2006 | 7:54 AM |
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Daniel DiRito | July 20, 2006 | 9:19 PM |
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Today George Bush vetoed the stem cell bill that had been passed by overwhelming majorities in the House and the Senate. Tony Snow, the White House Press Secretary, when explaining the Bush position stated "The simple answer is he thinks murder is wrong." As I've thought about Snow's message, it seems obvious to me that it was crafted to appeal to those on the religious right who are vehemently opposed to abortion. It is another clear example of the Rove strategy...which is to deliver a carefully crafted message to each constituency in order to solidify their support and motivate them for the upcoming election.
I decided to offer an equally simplistic demonstration that clearly points out the absurdity of the Bush position as well as the fact that it frankly does nothing to prevent "murder" and can actually be construed to facilitate euthanasia or murder. Here's the argument in pictures:
The above image of an eight cell embryo is the predecessor of a viable blastocyst. It must successfully mature within the fallopian tube...exit the tube into the uterus...and successfully attach to the uterine wall while continuing to mature.
In order for a woman to test positive for a pregnancy, the blastocyst must successfully attach to the uterine wall and trigger the ongoing production of progesterone which is necessary to prevent the shedding process. If this fails to happen the blastocyst will be flushed from the uterus and no pregnancy will be recorded through testing. Essentially, this means that those who oppose embryonic stem cell research expect scientists to preserve more embryos (which are not yet even viable blastocysts) than nature is able to preserve.
In fact, one could argue that abortions occur naturally all the time. Allowing scientists to use some portion of the existing embryos that are scheduled to be destroyed would potentially provide for saving more lives than are naturally destroyed by the human body...assuming one even believes that an embryo is a human life as opposed to a group of cells that have some potential to develop into a blastocyst that has some chance of attaching to the uterine wall and becoming a verifiable pregnancy.
Clearly the rhetoric is far from accurate and not based upon any legitimate rationale. Further, in the zeal of those who seek to ban abortions, based upon their rigid religious interpretations, they are willing to forego the ability to save existing human lives. They prefer to prevent viable research from moving forward by blocking the essential government funding that could help those in obvious need. They do this even though nature destroys more embryos and blastocysts than would ever be needed to provide the stem cell lines that would allow for the important research to advance.
In the end, the arguments put forth by the President and those groups who contend that they are preserving the sanctity of life can just as easily be equated with "murder". The hypocrisy is abundantly evident. While they assert that science is callous and careless in its pursuits and in respecting human life, it is actually science and scientists that have saving life as their defining principle. Those who oppose them are simply lost in the ideology of fanatical religious extremism. I don't believe in an after life, but as far as I'm concerned those who seek to stall these efforts to save life can take their religious babble and their righteous pontifications and go straight to hell.
Daniel DiRito | July 19, 2006 | 9:10 AM |
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The Gates Foundation announced that it was contributing 287 million dollars towards efforts to develop an AIDS vaccine. Scientists have been seeking a vaccine for some 25 years with little success. Currently, there are more vaccine candidates in the pipeline than have ever before. Nonetheless, experts caution that the virus is very clever and it is possible that none of the current vaccines will produce the desired results. Read the full article here.
The package of grants - 16 in all spread among more than 165 researchers in 19 countries, including Canada _ represents the largest single investment for HIV/AIDS by the philanthropic organization created by Microsoft co-founder Bill Gates and his wife Melinda.
"There still remain many unanswered scientific questions, and, in addition, resources haven't always been allocated in the most strategic way, which means there is also a greater need for collaborations amongst investigators.''
To that end, the foundation has earmarked about two-thirds of its grants to create 11 large-scale consortia that will pursue innovative ideas for designing an effective HIV vaccine. The five remaining grants will fund central laboratories and other facilities to ensure that research results from one scientific team can be compared in a standardized fashion with those from other teams.
The aim of this collaborative network is to quickly identify the most promising candidate vaccines and pursue their testing and development, Hellmann said. All the researchers accepted grants on the understanding that any successful vaccine would be made available cheaply and quickly to HIV-ravaged developing countries.
The collaborative notion represents a radical shift in the world of science, where researchers typically jealously guard their results until publication or presentation to their peers.
The donation stands in stark contrast to today's veto, by President Bush, of a bill passed by the House and the Senate to expand stem cell research. Fortunately, there are people like Bill and Melinda Gates and Warren Buffett who have made important commitments to furthering scientific research. Until such time as the President recants or is replaced by his successor, the U.S. may lag other nations in the effort to move forward with stem cell research.
Daniel DiRito | July 19, 2006 | 9:03 AM |
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With the Congress set to debate and vote on measures to expand government funding for stem cell research, those opposed to further funding have been offering false information to bolster their argument. If you listen to those who have been interviewed or have engaged in the discussions about stem cell research, those opposed to the use of embryonic stem cells repeat the oft heard argument that adult stem cells are already being used to treat some 65 diseases and offer far more tangible promise than embryonic stem cells. A group of prominent scientists has responded to these claims in the journal Science. Read the full article here.
As the week drew to a close, commentators opposed to the research, such as William Kristol, editor of the conservative Weekly Standard, released fiery commentaries urging senators to reject the bill. And several scientific and medical groups, including the American Society for Reproductive Medicine, released countervailing warnings that patients and their families would suffer if the bill failed.
The letter to the journal focused on David A. Prentice, a scientist with the conservative Family Research Council. Prentice has been an adviser to Sen. Sam Brownback (R-Kan.) -- a leader in the charge to maintain tight restrictions on the research -- and an "expert source" often cited by opponents of embryonic stem cell research.
Prentice has repeatedly claimed that adult stem cells, which can be retrieved harmlessly from adults, have at least as much medical potential as embryonic cells. He often carries a binder filled with references to scientific papers that he says prove the value of adult stem cells as treatments for at least 65 diseases.
In the letter to Science, however, three researchers went through Prentice's footnoted documentation and concluded that most of his examples are wrong.
For example, they wrote, a study cited by Prentice as evidence that adult stem cells can help patients with testicular cancer is in fact a study that evaluates methods of isolating adult stem cells.
Similarly, a published report that Prentice cites as evidence that adult stem cells can help patients with non-Hodgkin's lymphoma does not address the medical value of those cells but rather describes the best way to isolate cells from lymphoma patients and grow them in laboratory dishes, the letter said.
Much like with homosexuality, those on the religious right have a propensity to co-opt the services of a few like minded individuals with expert credentials to assist them in providing what appears to be authoritative information to support their positions. Paul Cameron, the primary "scientific" tool of the anti-gay movement, has been condemned by most psychological and sociological associations and yet he remains the source of most of the data that is offered to oppose gays. I find it ironic that these "Christians" have no hesitation to promote false or flawed scientific and statistical information in their efforts to "promote" a values driven society. Mr. Prentice is apparently becoming the Paul Cameron of stem cell opponents.
All told, the scientists concluded, there are only nine diseases that have been proved to respond to treatment with adult stem cells.
"By promoting the falsehood that adult stem cell treatments are already in general use for 65 diseases and injuries, Prentice and those who repeat his claims mislead laypeople and cruelly deceive patients," the scientists wrote.
Prentice, in a brief voice message left for a reporter as he embarked on a trip yesterday, said, "I appreciate them pointing out some of the things . . . that need to be changed and updated." But he accused the letter writers of "mental gymnastics" by focusing narrowly on proven therapies, as opposed to the large number of diseases for which the value of adult stem cells is now being tested.
As with many who promote the agenda of the right, Mr. Prentice doesn't restrain his remarks to those he left on the voice message. He and others opposed to funding expanded stem cell research simply repeat the mantra that seeks to make people believe that adult stem cells not only offer the same promise as embryonic stem cells but have actually been shown to be effective in fighting numerous diseases. Clearly, those who can separate their scientific endeavors from their religious fervor do not agree and that disagreement is fully based upon science absent the bias that permeates most "scientific" arguments put forth by the religious right. Note that the article also points out that a number of journalists who embrace the positions of the President and his evangelical supporters have joined in the effort to spin this false data.
Both bills are expected to pass easily and to be taken up and passed by the House on Wednesday and Thursday, congressional aides said. At that point, President Bush would be free to follow up on his oft-repeated promise to veto the bill that would loosen his rules.
That could come as early as Thursday, the aides said, and would constitute the first veto of Bush's presidency.
Daniel DiRito | July 15, 2006 | 8:45 AM |
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For the first time in the history of HIV, the Food and Drug Administration has approved a single pill therapy for the treatment of the disease that is expected to be made make available for use in the U.S. within approximately a week.
The pill, a combination of three different drugs is called Atripla and it is the result of a collaboration of two pharmaceutical companies, Gillead Inc. and Bristol-Meyers Squibb Company. The three drugs were previously the FDA's recommended first line treatment regimen. Read the full article here.
Atripla, which contains Bristol-Myers Squibb Co.'s drug Sustiva and Gilead Inc.'s medicines Viread and Emtriva, is the latest step in making it easier for AIDS patients to keep the human immunodeficiency virus or HIV in check -- a process that once included dozens of daily pills.
Atripla will cost $1,150.88 for a 30-day supply and will be available within seven business days, the drugmakers said.
In June, the FDA approved another three-in-one AIDS pill for use in poor countries under a global relief plan. That product contains generic versions of older HIV drugs, and the combination is not sold in the United States.
Daniel DiRito | July 12, 2006 | 7:24 PM |
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President Bush has not vetoed a single bill since he began his presidency. Yesterday, Karl Rove indicated the President would use his veto power to kill any bill to expand funding for embryonic stem-cell research. The move, on the heels of ever increasing evidence of the potential for medical advances as a result of stem-cell research, seems to be more about signaling his far right constituency than about preventing the destruction of embryos.
In reality, large numbers of embryos are destroyed as a result of in vitro fertilization efforts whereby embryos are frozen for future use yet are often subsequently discarded. Proponents of expanded funding for the development of additional stem-cell lines have argued that including these embryos would merely be utilizing already available sources as opposed to creating new embryos specifically for use in stem-cell research. Read the full article here.
President Bush will likely cast the first veto of his presidency if the Senate, as expected, passes legislation to expand federal funding of embryonic stem-cell research, White House aide Karl Rove said Monday in Denver.
"The president is emphatic about this," said Rove - Bush's top political adviser and architect of his 2000 and 2004 campaigns - in a meeting with The Denver Post editorial board.
The U.S. House of Representatives voted 238-194 last year to pass the legislation, co-sponsored by Rep. Diana DeGette, D-Colo., and Rep. Mike Castle, R-Del. If the Senate approves the bill, it will go to the president's desk.
Senate Majority Leader Bill Frist, R-Tenn., who backs the bill, has said he will try to bring it up for a Senate vote soon.
"I'm appalled that Bush would use the first veto of his presidency to veto a bill that could help 110 million people and their families," DeGette said Monday of Rove's remarks.
Colorado Springs-based Focus on the Family is among many conservative and anti- abortion groups opposed to the measure.
Daniel DiRito | July 11, 2006 | 7:47 AM |
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UCLA has taken a large step towards demonstrating the ability to use genetic manipulation to create t-cells which are an essential component of the immune system. The results are a further indication of the potential offered by the continuation of controversial stem cell research and may provide a promising means to combat HIV and other immune system ailments. Read the full article here.
Scientists at the University of California, Los Angeles, reported this week that they coaxed stem cells into becoming T-cells, a crucial part of the immune system. If T-cells could be manufactured, doctors would have a powerful new weapon against AIDS and other diseases at their disposal, the investigators said.
But the research "is not ready for prime time," cautioned study co-author Dr. Jerome Zack, a UCLA professor of medicine, microbiology, immunology and molecular genetics. It will take several years just to prepare for testing in humans, and even that process will take a while, he said.
Still, "the potential is huge," Zack said. "We have to see if it lives up to that potential."
In the new research, Zack and colleagues tested what happened when blood-forming stem cells were injected into a human thymus that had been implanted into a mouse.
The findings of the federally funded study were released in this week's issue of the Proceedings of the National Academy of Sciences.
The thymus, part of the human immune system, converted the stem cells into T-cells.
In another positive sign, the research suggests that scientists can piggyback a gene onto stem cells, delivering it to a diseased organ.
That ability would allow a treatment to not only create new immune cells but also target a diseased part of the body with gene therapy, Zack explained.
Potentially, the stem-cell therapy could fight any disease that robs the immune system of its ability to function properly.
"The caveat in all of these types of studies is that it is still an early laboratory study, and does not mean that this is a treatment," he said. The public should "realize that such treatments may be years away."
President Bush has opposed expanded funding for the development of additional stem cell lines that were in existence before he approved his limited research initiative. The Bush position has drawn criticism from many within the scientific community as well as from high profile individuals like Nancy Reagan and the late Christopher Reeve. The Senate is expected to bring the issue up for further debate this year. If the Senate were to vote to expand stem cell research, they would need 67 votes in order to overturn an expected Bush veto.
Daniel DiRito | July 9, 2006 | 9:06 AM |
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