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	<title>Science Progress &#187; Lisa Ikemoto</title>
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		<title>Scientific Integrity Makes a Comeback</title>
		<link>http://scienceprogress.org/2009/03/scientific-integrity-makes-a-comeback/</link>
		<comments>http://scienceprogress.org/2009/03/scientific-integrity-makes-a-comeback/#comments</comments>
		<pubDate>Tue, 24 Mar 2009 21:23:15 +0000</pubDate>
		<dc:creator>Lisa Ikemoto</dc:creator>
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		<guid isPermaLink="false">http://www.scienceprogress.org/?p=2235</guid>
		<description><![CDATA[A federal court ruled Monday that an FDA decision to limit access to emergency contraception was based on politics and ignored scientific advice. The move highlights the importance of Obama administration directives to protect scientific integrity in the policymaking process.]]></description>
			<content:encoded><![CDATA[<p>On Monday a federal court <a href="http://reproductiverights.org/sites/crr.civicactions.net/files/documents/Decision_FDA%202009.pdf">ruled</a> that Food and Drug Administration decisions to prohibit access to the emergency contraceptive Plan B to women below age 18 “were arbitrary and capricious because they were not the result of reasoned and good faith agency decision-making.” In short, the court determined that the FDA “repeatedly and unreasonably delayed issuing a decision on Plan B,” and then bypassed scientific review and issued a Not-Approvable letter, imposing the age restriction, for political reasons.</p>
<p>There are two reasons to celebrate this decision. The FDA’s own scientific review shows Plan B to be a safe and effective contraceptive for women, including young women. Thus, the decision is a victory for women’s health and liberty. In addition, this decision is perfectly timed to highlight the point of two actions that President Obama took earlier this month. On March 9, the president issued an <a href="http://www.whitehouse.gov/the_press_office/Removing-Barriers-to-Responsible-Scientific-Research-Involving-Human-Stem-Cells/">Executive Order</a> that lifts the Bush administration’s restrictions on funding for human stem cell research. He also issued a <a href="http://www.whitehouse.gov/the_press_office/Memorandum-for-the-Heads-of-Executive-Departments-and-Agencies-3-9-09/">Memorandum on Scientific Integrity</a>. The memorandum grants the director of the Office of Science and Technology Policy responsibility for ensuring the highest level of integrity in the federal executive departments and agencies, and instructs him to propose a plan based on a set of principles. The principles are not novel. The first two state:</p>
<blockquote><p>(a) The selection and retention of candidates for science and technology positions in the executive branch should be based on the candidate’s knowledge, credentials, experience, and integrity;<br />
(b) Each agency should have appropriate rules and procedures to ensure the integrity of the scientific process within the agency;</p></blockquote>
<p>In fact, the court’s decision is based on the findings that the FDA has violated its own standards, which substantially reflect these principles. The court’s decision shows the extent to which the previous administration had set them aside.</p>
<p>The court’s opinion should also raise a red flag for the Obama administration. One of the major actors in delaying Plan B approval and imposing the age restriction was <a href="http://www.surgeongeneral.gov/about/biographies/biosg.html">Steven Galson</a>, M.D., M.P.H. Galson is presently the acting Surgeon General and Acting Assistant Secretary for Health. In 2003 through 2005, the critical time period for the FDA’s actions on Plan B, Galson was the director of the Center for Drug Evaluation and Research at the FDA. The court’s findings of fact state: “the pressure coming from the White House appears to have been transmitted down by the Commissioner’s office in such a way as to significantly affect Dr. Galson’s position” on Plan B. One of Galson’s subordinates testified, “Dr. Galson . . . told me that he didn’t have a choice, and . . . that he wasn’t sure that he would be allowed to remain as Center Director if he didn’t agree with the [Not-Approvable] Action.” In other words, Galson caved to political pressure.</p>
<p>The pressure—in this case on his career—was significant. But consider the action of one his colleagues. Dr. Susan Wood was then Assistant Commissioner for Women’s Health and Director of the FDA Office of Women’s Health. In September 2005, she <a href="http://www.defendingscience.org/upload/Wood_WomensHealthFDA.pdf">resigned her position in protest</a> over the FDA’s actions on Plan B. Galson saved his job, but abrogated scientific integrity, sacrificed women’s health, and violated the law in the process. It appears that he was and continues to be well rewarded.</p>
<p>In its holding, the court remanded to the FDA “for reconsideration of whether to approve Plan B for over-the-counter status without age or point-of-sale restrictions.” The FDA’s scientific process has already recommended over-the-counter distribution of Plan B to young women. Now is it time to honor those recommendations, and perhaps to do a little housecleaning, as well.</p>
<p><a href="http://www.law.ucdavis.edu/faculty/Ikemoto/"><em>Lisa C. Ikemoto</em></a><em> is a professor at the University of California Davis School of Law.</em></p>
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		<title>The Human Life Amendment Redux</title>
		<link>http://scienceprogress.org/2007/11/the-human-life-amendment-redux/</link>
		<comments>http://scienceprogress.org/2007/11/the-human-life-amendment-redux/#comments</comments>
		<pubDate>Mon, 19 Nov 2007 19:26:58 +0000</pubDate>
		<dc:creator>Lisa Ikemoto</dc:creator>
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		<guid isPermaLink="false">http://www.scienceprogress.org/2007/11/the-human-life-amendment-redux/</guid>
		<description><![CDATA[A new proposal to grant embryos legal rights could disrupt more than just access to abortion: it threatens women’s rights and demonizes medical technology.]]></description>
			<content:encoded><![CDATA[<p>On November 13, the Colorado Supreme Court <a href="http://www.scienceprogress.org/wp-content/uploads/2007/11/Colo_SC_11-13-07_Court_Order[1].pdf">approved</a> language for a <a href="http://www.scienceprogress.org/wp-content/uploads/2007/11/board_title_setting_board_36[1].pdf">proposed ballot initiative</a> that, if passed, would amend the Colorado constitution to define “person” to “include any human being from the moment of fertilization” for purposes of the state’s constitutional provisions “relating to inalienable rights, equality of justice, and due process of law.”</p>
<p>The Court’s decision allows the initiative’s supporters to go forward in their attempt to collect the 76,000 signatures necessary to place the initiative on the ballot.   The initiative might surprise those too young to remember the immediate aftermath of <em>Roe v. Wade</em>.  But for baby boomers, the proposed ballot initiative is a redux of the first campaign to pass a human life amendment.</p>
<p class="pullquote">Professor Alan Brownstein suggests that defining fertilized eggs as “persons” under state law could expand the official state population count.</p>
<p>The first campaign started in 1973 in direct response to the U.S. Supreme Court’s decision in <em>Roe v. Wade</em>.  Over a ten year period, several proposals were made.  Only one made it to a Senate vote.  In 1983, the Senate considered the Hatch-Eagleton Human Life Amendment, which in its amended form stated, “A right to abortion is not secured by this Constitution.” The proposal received only 49 yes votes, and thus failed to receive the necessary two-thirds vote required for passage.  That essentially ended the first campaign. But efforts to implement human life amendments by initiative or legislation are now underway in several other states, including Georgia, Michigan, Montana, Oregon and South Carolina. Legislation granting legal rights to embryos is <a href="http://www.scienceprogress.org/2007/10/sex-lies-and-embryos/">already on the books is Louisiana</a>.</p>
<p>The current iteration of the human life amendment does not explicitly refer to abortion.  Critics of the Colorado Supreme Court’s action point to that omission as <a href="http://www.knowledgemessenger.com/b/KMTasks/View.aspx?app=ProChoiceColorado&amp;id=53">misleading</a>.  It is clear that human life amendment supporters have abortion on their minds.  As an organization, the National Committee for a Human Life Amendment is closely intertwined with the National Conference of Catholic Bishops.  Its website presents an <a href="http://www.nchla.org/about.asp">issues list</a> that is long and familiar: the Abortion Non-Discrimination Act, Assisted Suicide, Embryo/Fetal Tissue Research, the Hyde Amendment, Stem Cell Research, RU-486, Terri Schiavo, and the United Nations Population Fund.  Obviously, the familiarity of the issues reflects the influence that religious conservatives have had in science, medicine and health care.  Similarly, the scope of the list reflects the vortex-like quality that pro-life politics have acquired.</p>
<p class="pullquote">In this iteration of the debate, technology becomes the strawperson that erases the human lives at stake.</p>
<p>The list also suggests the legal implications of implementing a human life amendment.  As critics have been quick to point out, if passed, the Colorado initiative would provide a legal base for challenging access to abortion, contraceptives that prevent a fertilized egg from implanting, in vitro fertilization, and human embryonic stem cell research.  There may be less obvious consequences as well.  My colleague, Professor <a href="http://www.law.ucdavis.edu/faculty/brownstein.shtml">Alan Brownstein</a>, suggests that defining fertilized eggs as “persons” under state law could expand the official state population count.  That has implications for political districting, government funding, and so on.</p>
<p>The recent campaign is not, of course, identical to the first.  The abortion debate itself has undergone the greatest change.  The dominant debate has become substantially polarized, and to a great extent, simplified.  In the 1970s, it was individual autonomy and women’s status versus potential life and (patriarchal) family integrity.  Since then, religious conservatives have succeeded in positioning the “unborn child” as a political presence in the debate, one that obscures the significance of women’s experience and women’s status to the issue.</p>
<p>Justice Kennedy’s opinion in <em>Gonzales v. Carhart</em> earlier this year made the erasure of women painfully clear.  The word “woman” appeared very seldom in his opinion for the Court.  Most of the references occur within Kennedy’s summary of the 9th Circuit’s decision (which the Court overturned) and of the Court’s own decision in Casey.   But “fetus” and “baby” were everywhere.  The “woman” that finally appeared in the Court’s opinion is only a strawperson for Kennedy’s admittedly unsubstantiated claim of the harm that abortion causes women.  Justice Ginsberg’s dissent roared back with a reminder of what’s been missing from the public debate, as well as from the legal analysis.  The human life amendment sets up the “unborn child” against a procedure or technology use, whether that be abortion, contraception, in vitro fertilization, or stem cell research.   In this iteration of the debate, technology becomes the strawperson that erases the human lives at stake.</p>
<p><em><a href="http://www.law.ucdavis.edu/faculty/ikemoto.shtml">Lisa Ikemoto</a> is a Professor at King Hall, U.C. Davis School of Law.</em></p>
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