What's New
President's
Council on Bioethics: Human Cloning and Human Dignity: An Ethical Inquiry,
July 2002
State Cloning Legislation
(pdf format)
Gene Therapy Carried Away By The Excitement Of
New Technologies?
ISLAT Director Testifies Before French National Assembly
Reproductive Technology Meets the Courts
GENE THERAPY: CARRIED AWAY BY THE EXCITEMENT OF NEW TECHNOLOGIES?
Proponents of gene therapy exalt its potential to one day cure diseases
such as cystic fibrosis, breast cancer and muscular dystrophy. However,
in the fervent pursuit to “fix” the genetic misspellings in a person’s
DNA, researches may have become overzealous at the expense of the very
patients they seek to help. One might ask, are researchers becoming more
concerned with patents than with patients, or as Forbes Magazine suggests,
has “the pursuit of truth has been corrupted by the pursuit of royalties?”1
Concerned with this trend, the US government halted several human research
trials. All eight of the University of Pennsylvania Institute for Gene
Therapy’s trials were suspended by the FDA on Friday, January 21 after
a three month investigation spurred by the death of 18 year old Jesse
Gelsinger.2 The FDA cited 18 violations of
government rules including extremely flawed consent forms which failed
to warn that participation could result in injury or death as well as
the fact that earlier studies in monkeys resulted in death.3
The FDA further alleged failure to report serious side effects in other
patients and evidence that Jesse Gelsinger, because his liver was not
functioning well enough before therapy was initiated should have been
deemed ineligible to participate in the experiment.4
As a result of these violations, the Institute was ordered to cease all
gene therapy studies except for situations which would further jeopardize
a patient’s health.
Adding to the concern for patient’s safety is the recent discovery that
three cancer patients died while enrolled in gene therapy treatments at
Boston’s Beth Israel Hospital.5 But what may
be more alarming is that their deaths went unreported since last summer,
despite federal rules which require immediate reporting.6
The National Institutes of Health admits that of 691 serious side effects
experienced by patients in gene therapy experiments using adenovirus,
only 39 were reported immediately.7 That translates
into a nearly 95% failure rate. And this type of gene therapy protocol
represents only 25-30% of the total number of gene therapy trials taking
place in the United States.8
Though Jesse Gelsinger’s father, Paul originally supported the Institute
and its director, Dr. James Wilson after his son’s death, in the wake
of the FDA’s allegations that the gene therapy treatment Jesse received
was not designed to benefit the 18 year old, but to test the safety of
a gene therapy treatment for newborns, he has now sought legal counsel.9
Mr. Gelsinger also claims that he and his son were misled by researchers
at Penn into believing the worst that could happen to Jesse if he chose
to participate in their gene therapy trial were flu-like symptoms for
a week.10
The fever pitch pursuing genetic therapies has also been heightened by
the co-mingling of science and business. Dr. Wilson not only chairs the
department of molecular and cellular engineering at the University of
Pennsylvania Medical Center, but also founded a biotech company called
Genovo in 1992.11 Dr. Wilson’s lab at Penn
receives approximately $2.8 million from Genovo and the university itself
is a shareholder and stands to share in royalties from any new gene therapies
Wilson’s team licenses to Genovo. But Dr. Wilson is not alone: The National
Science Foundation estimates that corporations invested almost $2 billion
to fund academic labs in 1997.12
Concerned with the apparent lack of oversight and potential conflicts
of interest, U.S. Senator Bill Frist, M.D. (R-Tenn.), who chairs the subcommittee
of the Health, Education, Labor and Pension Committee’s on public health,
held a hearing, “Gene Therapy: Is There Oversight for Patient Safety?”
on February 2, 2000.13 At this hearing, Paul
Geslinger testified that, “When lives are at stake, when my son’s life
was at stake, money and fame should take a back seat. The concern should
be not on getting to finish line first, but making sure no unnecessary
risks are taken, no lives filled with potential and promise are lost forever,
no fathers lose their sons.”
____________________
1. Zina Moukheiber, “Science for Sale”, Forbes,
May 17, 1999.
2. “FDA Halts UPenn Trials, Cites 18 Violations,”
American Health Line, Jan. 24, 2000; See also, FDA Report,
January 21, 2000. Also under scrutiny for flaws in its oversight system
for human research studies, the University of Alabama-Birmingham’s medical
center was ordered by the Office of Protection from Research Risks (OPRR)
to shut down more than 25% of its research involving human subjects.
3. Sheryl Gay Stolberg, “Gene Therapy Ordered
Halted at University,” New York Times, Jan. 22, 2000.
4. Id.
5. Elizabeth Kaledin, reporting, “Government May
Have Been Kept in the Dark About the True Extent of Death Among Gene Therapy
Patients,” CBS News Transcripts, Feb. 1, 2000.
6. Deborah Nelson and Rick Weiss, “Deaths in Gene
Test Went Unreported,” Washington Post, Feb. 1, 2000.
7. Sheryl Gay Stolberg, “Agency Failed to Monitor
Patients in Gene Research,” New York Times, Feb. 2, 2000.
8. Deborah Nelson and Rick Weiss, “Victim’s Dad
Faults Gene Therapy Team,” Washington Post, Feb. 3, 2000.
9. Sheryl Gay Stolberg, “Youth’s Death Shakes New
Field of Gene Experiments on Humans,” New York Times, Jan. 27,
2000.
10. Jim Moret and Elizabeth Cohen, “Lawmakers
Taking Long, Hard Look at Gene Therapy,” CNN The World Today, Feb.
2, 2000, transcript no. 00020205v23. See also, Paul Gelsinger,
Prepared Testimony before the Senate Health, Education, Labor and Pensions
Committee Subcommittee on Public Health, Federal News Service,
Feb. 2, 2000.
11. Deborah Nelson and Rick Weiss, “Hasty Decisions
in the Race to a Cure?” Washington Post, Nov. 21, 1999.
12. Zina Moukheiber, “Science For Sale,” Forbes,
May 17, 2000.
13. Bill Frist, Senator, “Gene Therapy: Is there
Oversight for Patient Safety?” Congressional Press Releases, Jan 31, 2000.
_________________________________________________________
ISLAT DIRECTOR TESTIFIES BEFORE FRENCH NATIONAL ASSEMBLY
On November 26, 1999, ISLAT director Lori Andrews testified in the French
National Assembly at a hearing addressed to the revision of the French
national bioethics law. She testified alongside Ian Wilmut, who cloned
Dolly the sheep, and John Gearhart, who developed a procedure for harvesting
stem cells from aborted fetuses. Gordon Dunstan, a British theologian
who also testified made a compelling statement about how social values
should not be set aside in a rush to attempt to develop medical treatments.
"A hardening of the heart," he said, "would be worse for
us than a hardening of the arteries."
Related Links
Text of Lori Andrews Testimony
_______________________________________________
REPRODUCTIVE TECHNOLOGY MEETS THE COURTS
On September 29, 1999, Cook County Circuit Court Judge Gerald
C. Bender ordered a preliminary injunction enjoining Margaret Hale, the
estranged wife of Dr. Todd Ginestra, from taking any action toward the
transfer and implantation of two embryos in herself or or any other woman.
This case is one of first impression in Illinois and has the potential
to impact the rights of individuals who are going through a divorce to
be or not to be parents. Ginestra's complaint attempting to prevent
his wife from creating children with the embryos alleged a contractual
right arising from consent forms the couple signed and a constitutional
right to decide whether or not to procreate. Because the court found
that Ginestra had raised a fair question of a contractual right, it did
not address the constitutional issue. However, the court found that
if it did not grant the preliminary injunction, Ginestra would suffer
irreparable harm due to the impact of unwanted fatherhood -- both financial
and psychological.
Hale, a 35-year-old registered nurse at Lutheran General
Hospital in Park Ridge, Illinois, and Ginestra, a 32-year-old plastic
surgery resident at the University of Illinois at Chicago Medical Center,
originally created five viable embryos at Highland Park Hospital's IVF
Center in February 1999. Because of the couple's concern regarding
the possibility of multiple births, only three of the embryos were used
for implantation which did not result in a pregnancy. The two remaining
embryos were cryopreserved.
Cryopreservation was at the heart of the couple's dispute.
Ginestra claims that because he and his wife wrote on the consent form,
"Don't want freezing at this time," the couple did not agree
to preserve any remaining embryos. Hale, however, contends that
although they agreed not to make any decisions regarding cryopreservation
at the time the forms were signed, the couple later agreed to cryopreservation
of any remaining embryos.
Also at issue was the characterization of preserving the
status quo until a final hearing on the merits. Ginestra
alleged that to maintain the status quo meant keeping the embryos
cryopreserved while Hale argued that prior to the issuance of the temporary
restraining order, the status quo was that she was preparing to implant
the embryos. Hale testified that her husband was aware of the fact
that she had begun the drug protocols to effectuate a transfer of the
remaining embryos before he filed for divorce and before he sought a temporary
restraining order. Based on the testimony of both parties and a
nurse from the IVF clinic at Highland Park Hospital, the court found that
the parties agreed, after executing the informed consent documents, to
cryopreserve any remaining embryos and that as such, this was the best
way to maintain the status quo of the parties.
Although the order also prevents Highland Park Hospital
from transferring or implanting the two embryos, the hospital has stated
that it has a policy that would not allow such an action without the written
consent of both parties.
Related Links
Text of Preliminary
Injunction
Please send questions or comments to Tracy Green, tgreen@kentlaw.edu.
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