William Saunders, Senior Vice President of Legal Affairs and Senior Counsel, featured in the National Catholic Bioethics Quarterly in which he gives a “Washington Insider” report of bioethical issues from our nation’s capital.
Bioethics
William Saunders in the National Catholic Bioethics Quarterly
Saturday, May 11th, 2013Court: U.S. can fund embryo research, as long as researchers kill the embryos first
Monday, August 27th, 2012The U.S. Court of Appeals for the District of Columbia Circuit issued an opinion late last week in Sherley v. Sebelius allowing the Obama administration to continue funding destructive embryo research.
At issue was President Obama’s March 9, 2009 executive order directing the National Institutes of Health (NIH) to issue new stem cell guidelines to include the funding of research on stem cell lines derived from human embryos.
The plaintiffs in the case—researchers who perform ethical adult stem cell research—argued that the funding violates the Dickey-Wicker Amendment (renewed annually since 1996). Specifically, the Dickey-Wicker Amendment expressly prohibits NIH from funding research in which human embryos “are destroyed, discarded, or knowingly subjected to risk of injury or death.” The researchers argued that because performing research on stem cell lines from human embryos means that human embryos must first be destroyed to obtain the stem cell lines, funding research on stem cell lines violates the Dickey-Wicker Amendment.
Unfortunately, the Court rejected this logical argument. On its face the Court’s decision is technical in nature; the Court simply states that it had already concluded in a previous appeal that funding research on stem cell lines from destroyed human embryos does not violate the Dickey-Wicker Amendment.
But the reasoning used in that previous appeal was flawed. The Court made the atrocious distinction that research on stem cell lines does not actually kill or harm embryos because the stem cell lines are no longer embryos. Of course, that is because the embryos have already been destroyed in order to obtain the stem cell lines. The Court stated, “Dickey-Wicker permits federal funding of research projects that utilize already-derived [embryonic stem cells]—which are not themselves embryos—because no ‘human embryos or embryos are destroyed’ in such projects” (emphasis in original).
In other words, the government will fund any research using human embryos, as long as the researchers kill or harm the embryos before getting the money. This is a clear distortion of the intent and spirit of the Dickey-Wicker Amendment.
The plaintiff researchers also argued that NIH violated the federal Administrative Procedure Act (APA). Section 553 of the APA requires government agencies to provide the public with notice of a proposed rulemaking, an opportunity to comment, and a concise general statement of the rule’s basis and purposes after considering the relevant comments.
When NIH opened comment on its proposed funding guidelines, the plaintiff researchers and many other individuals and organizations—including AUL—filed comments demonstrating that funding research on embryonic stem cell lines violates Dickey-Wicker and is unnecessary in light of the significant breakthroughs in adult stem cell research.
The plaintiff researchers filed comments advocating that the government not fund research on embryonic stem cell lines. But the Court declared that the plaintiffs’ comments “did not address any factor relevant to implementing” Obama’s executive order, and thus NIH did not have to respond to them and the APA was not violated.
As such, explaining that there are better, more ethical, and more successful avenues of research was deemed irrelevant information. The government does not have to consider such “irrelevant” things as whether there are more promising forms of research when deciding which research to fund. This makes no sense from either an economic or medical perspective—and it is not at all comforting that such information does not factor into budgetary decision-making.
This means that funds are diverted away from adult stem cell research—which has yielded successful treatments and cures of over 70 diseases and conditions—and toward embryonic stem cell research, which has never helped a single human patient. In fact, in 2011, Geron—the company that received the first government approval for human clinical trials using human embryo stem cells—announced it is discontinuing “further stem cell work.”
Of course, this seems to be a theme with the current administration. Disregard the sanctity of human life. Ignore the pro-life community. And just throw American’s money away.
Embryo research yields no results—or money
Tuesday, November 15th, 2011USA Today is reporting today that Geron—the company that received the first government approval for human clinical trials using human embryo stem cells—is discontinuing “further stem cell work.”
This decision hardly comes as a surprise. There simply is no money in research that yields no results.
Geron says that the decision came “after a strategic review of the costs… timelines and clinical, manufacturing and regulatory complexities associated with the company’s research and clinical-stage assets.” Reportedly, Geron has been trying to find financial partners, “and people have said, ‘Show us later-stage results.’”
Clearly, investors don’t want to put money into research that will not pay off. There are no “later-stage results” showing any real-life positive uses of embryonic stem cells.
USA Today editorializes that Geron’s decision is “a move with stark implications for a field offering hope of future medications for conditions with inadequate or no current treatments.”
We can hope it is the bell toll for unethical and unproductive embryo stem cell research. But it will not have a devastating impact on the field of “stem cell research” as a whole.
As AUL has stated repeatedly, stem cells from human embryos have never successfully treated human patients. On the other hand, treatments from adult stem cells (which do not result in the destruction of human life) have yielded treatments or cures for over 70 conditions.
Apparently, Geron’s investors (or potential investors) understand this basic fact. Investing in a failed research strategy does not pay—either financially or medically. Unfortunately, the Obama Administration lacks this basic understanding, as it continues to push for government funding of embryo research to the detriment of research rendering true medical advances.
Yoest on Stem Cell Appeal
Tuesday, August 31st, 2010YOEST NOTES KNEE-JERK SUPPORT OF EMBRYO-DESTRUCTIVE RESEARCH COSTING TAXPAYERS MILLIONS WHILE DESTROYING LIVES
WASHINGTON, D.C. – (8/31/10) – AUL President and CEO Dr. Charmaine Yoest called the decision by the Department of Justice to appeal an injunction of federal funding for embryonic stem cell research “not surprising, but not the biggest story here.”
“Adult stem cell research has yielded incredible, life-giving results for people with many diseases and disabilities, while the stem cell lines created by destroying unborn children has provided little hope for those suffering,” Yoest noted. “Media reports indicate that more than $100 million in federal funds has been wasted on embryonic stem cell research in the last year alone. With our tax dollars, we should be investing in the adult stem cell research that works now and holds the greatest long-term promise for all Americans.”
Federal District Court Judge Royce Lamberth issued the injunction against the government’s use of tax dollars for embryonic stem cell research based on a reading of the Dickey-Wicker amendment. That 1996 law prohibits federal funding for research in which a human embryo or embryos are destroyed and was the foundation for legal challenge when Obama signed his 2009 order which allowed embryos to be destroyed in research paid for with tax dollars.
Yoest on Stem Cell Ruling
Monday, August 23rd, 2010COURT STRIKES DOWN OBAMA ADMINISTRATION STEM CELL POLICY
Washington, D.C. – (8/23/10) – Today, a U.S. District Court halted the Obama Administration’s illegal and unethical policy of funding research that necessarily entails the destruction of human embryos. Judge Royce Lamberth issued a preliminary injunction against the Administration’s policy in the case Sherley v. Sebelius.
“Since 1996, Congress has been clear that no federal funds are to be used in research that destroys, or even harms, embryos,” said Dr. Charmaine Yoest, President and CEO of Americans United for Life. “The Obama Administration has attempted to skirt the law by arguing that they are only funding research after the embryos are destroyed. Today’s sensible ruling reconfirms what we already knew, that Administration policy is in violation of the law.”
On March 9, 2009, President Obama, by executive order, directed the National Institutes of Health (NIH) to issue new stem cell guidelines to include the funding of human embryonic stem cell research.
Since 1996, the Dickey-Wicker Amendment has expressly banned NIH from funding research in which human embryos “are destroyed, discarded, or knowingly subjected to risk of injury or death.”[1] The amendment has been renewed every year by Congress.
Attorneys defending the Obama Administration’s policy argued that since the federal government is only funding research on stem cells after being extracted from the embryos, and not the actual destruction of the embryos, the NIH guidelines are not violating the law.
However, that interpretation would require a strained reading of the Dickey-Wicker amendment. The Obama Administration policy of funding human embryonic stem cell research incentivizes the destruction of human embryos. Further, it is common sense that destroying embryos and using them in research are part of a common project.
Judge Lamberth held the policy violated the clear language of the law:
“The Dickey-Wicker Amendment unambiguously prohibits the use of federal funds for all research in which a human embryo is destroyed. It is not limited to prohibit federal funding of only the ‘piece of research’ in which an embryo is destroyed. … Despite defendants’ attempt to separate the derivation of [embryonic stem cells] from research on [embryonic stem cells], the two cannot be separated. Derivation of [embryonic stem cells] from an embryo is an integral step in conducting [embryonic stem cell] research.”
Since the Obama Administration policy violates the law, Judge Lamberth issued a preliminary injunction to stop funding of human embryonic stem cell research.
[1] Public Law 104-99, sec. 128, U.S. Statutes at Large 110 (January 26, 1996): 34, http://history.nih.gov/research/downloads/PL104.99.pdf.
Court Finds Obama Administration Stem Cell Policy Illegal
Monday, August 23rd, 2010AUL’s news release on this decision can be found here.
Today, a U.S. District Court halted the Obama Administration’s illegal and unethical policy of funding research that necessarily entails the destruction of human embryos. Judge Royce Lamberth issued a preliminary injunction against the Administration’s policy in the case Sherley v. Sebelius.
On March 9 2009, President Obama, by executive order, directed the National Institutes of Health (NIH) to issue new stem cell guidelines to include the funding of human embryonic stem cell research.
Since 1996, the Dickey-Wicker Amendment has expressly banned NIH from funding research in which human embryos “are destroyed, discarded, or knowingly subjected to risk of injury or death.”[1] The amendment has been renewed every year by Congress.
Attorneys defending the Obama Administration’s policy argued that since the federal government is only funding research on stem cells after being extracted from the embryos, and not the actual destruction of the embryos, the NIH guidelines are not violating the law.
However, that interpretation would require a strained reading of the Dickey-Wicker amendment. The Obama Administration policy of funding human embryonic stem cell research incentivizes the destruction of human embryos. Further, it is common sense that destroying embryos and using them in research are part of a common project.
Judge Lamberth held the policy violated the clear language of the law. “The Dickey-Wicker Amendment unambiguously prohibits the use of federal funds for all research in which a human embryo is destroyed. It is not limited to prohibit federal funding of only the ‘piece of research’ in which an embryo is destroyed. … Despite defendants’ attempt to separate the derivation of [embryonic stem cells] from research on [embryonic stem cells], the two cannot be separated. Derivation of [embryonic stem cells] from an embryo is an integral step in conducting [embryonic stem cell] research.”
Since the Obama Administration policy violates the law, Judge Lamberth issued a preliminary injunction to stop funding of human embryonic stem cell research.
[1]Public Law 104-99, sec. 128, U.S. Statutes at Large 110 (January 26, 1996): 34, http://history.nih.gov/research/downloads/PL104.99.pdf.
Western Australia Legislature Backing Adult Stem Cells
Friday, May 30th, 2008Science Alert Australia & New Zealand reports that Western Australia’s Upper House has rejected human embryonic stem cell research and human cloning.
Dr. Millet, director of Curtin University of Technology’s Centre for Applied Ethics and Philosophy explains why.
“The whole debate has changed, and it’s changed dramatically since the Yamanaka discovery because, while both his method and therapeutic cloning technologies have their problems, the advantage of the Yamanaka method is that you get 100 per cent of the donor’s own DNA and, of course, collecting skin cells involves minimum invasiveness and trauma. Most importantly, it is far less morally problematic than creating an embryo with the sole purpose of destroying it.”
He goes on to make the pragmatic public policy case in addition to the scientific and ethical case above:
“One of the arguments against therapeutic cloning is that the research has a low likelihood of a short- to medium-term outcome,” Dr Millett says. “So we have to ask ourselves, what is the opportunity cost of funding this research? By spending millions on embryonic stem cell research, what other important science is missing out? Are there better things to spend our money on?
What will the result be? Again, Dr. Millet:
“This could be the turning point for stem cell science here. It is entirely feasible that the (Upper House) decision could lead to [Western Australia] becoming one of the world centres of research into alternatives to embryonic stem cell research.”
Well said.
What US state will take a similar leadership position on adult stem cell research and attempt to establish itself as a “world center of research into alternatives to embryonic stem cell research?”
The Genetic Information Nondiscrimination Act (GINA): A Proposed Answer to Genetic Discrimination
Wednesday, May 21st, 2008On Wednesday, May 21, 2008, President Bush signed the Genetic Information Nondiscrimination Act (GINA). GINA prohibits employers and health insurers from discriminating against persons on the basis of their genetic information. The measure passed by a vote of 414-1 in the House and 95-0 in the Senate before making its way to the President’s desk.
The almost-unanimous Congressional support is indicative of the public support—or public fear—behind the measure. A 2007 survey indicated that 93 percent of Americans oppose employer or insurer access to their genetic test results. Another survey indicated that 92 percent fear harmful use of their genetic test results by employers or insurers. GINA is an attempt to put such public fear to rest.
The Ethical Concerns Surrounding Genetic Testing
Genetic testing is currently available for 1200 diseases, and tests for hundreds of others are currently being developed. But as with other areas of biotechnological success, ethical issues have arisen with the advancement of genetic testing. For example, can health insurance companies use the results of genetic testing in granting or denying coverage? Or can employers screen the genetic information of potential employees before making hiring or promotion decisions?
Denying health insurance coverage on the basis of genetic disease is not new. In the 1970s, some insurance companies denied coverage or charged higher premiums to African Americans who carried the sickle cell anemia gene. More recently, young children have been denied health insurance because they carried a recessive genetic disease. In another example, a newborn was denied coverage after a prenatal genetic test indicated that the baby would be born with a genetic disorder. On the employment front, workers for Burlington Northern Sante Fe Railroad were tested for genetic predisposition to carpel tunnel syndrome.
State prohibitions of such genetic discrimination vary. Forty states and the District of Columbia prohibit discrimination in health insurance policies based upon genetic testing, but the extent of the protection differs. For example, only seven states specifically prohibit health insurers from requiring testing, while other states allow health insurers to consider the results of genetic testing only if the patients voluntarily submit favorable test results. On the other hand, 14 states encourage genetic testing or allow discrimination in certain types of insurance policies. Seven states have no provisions prohibiting insurance discrimination on the basis of genetic testing results.
Genetic discrimination and the patchwork of state laws have prompted concerned Americans to call for more uniform regulation of genetic testing, and many analysts believe that GINA is the answer.
The Potential Impact of GINA
Some analysts believe that the passage of GINA ensures that Americans no longer have to choose between genetic privacy and good medical care. Patients can proceed with genetic testing without fearing that the results can be used against them in the healthcare or employment setting.
It is also believed that GINA will help ensure the progress of genetic testing and research. Scientists have reported a difficulty in engaging large numbers of patients in genetic studies because patients fear that the information obtained may be used against them by an insurer or an employer. Analysts have seen this effect as an impediment to genetic research and clinical practice. Under GINA, it is proposed, researchers can affirm their patients that their genetic information is protected against misuse.
Thus, it is believed that the passage of GINA will help the progression of “personalized medicine,” where patients are treated according to their specific genetic make-up.
Whether GINA will properly address these concerns and open up a new realm of healing remains to be seen. But for now, the President—and a unified Congress—is banking upon it.
