Fwd: [SSRI-Research] Du Pont Cardiologists implanted experimental stent - 14 Babies without Informed

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Mon, 12 Apr 2004 15:16:47 -0000

[sSRI-Research] Du Pont Cardiologists implanted experimental stent - 14

Babies without Informed

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Du Pont Cardiologists implanted experimental stent in 14 Babies

without Informed Consent-Phila Inquirer

 

Promoting openness and full disclosure

http://www.ahrp.org

 

FYI

 

The Philadelphia Inquirer reports that cardiologists at Du Pont

Hospital for Children in Delaware, implanted an experimental device

in 14 babies without approval of the FDA, without approval of the

hospital's ethics review board, and without the permission of

parents.

 

" For the first time, the hospital placed clear blame on its cardiac

center's director, surgeon William I. Norwood, and chief

cardiologist, John D. Murphy. The doctors " were involved in the

decisions to place unapproved medical devices in patients without

prior notification to, and approved by our " Institutional Review

Board, the hospital said in a response included in the report. "

 

There is no law to protect babies / children that is comparable to

the Animal Welfare Act of 1966 which sets forth specific protections

such as: minimizing pain and forbidding unnecessary duplication of an

experiment involving warm-blooded animals and maintaining accurate

records of the acquisition and disposal of animal subjects. Under the

Animal Welfare Act penalties are imposed on violators. No such

protections exist in human research. The absence of a law--as

opposed to administrative regulations--encourages adventurous medical

cowboys to test experimental medicines and devices on vulnerable

patients, including babies.

 

As has recently been demonstrated--in the Fred Hutchinson Cancer

Center trial and the investigation of the multi-site government

funded experiment conducted on critically ill patients with lung

injury (ARDS)--vulnerable patients are at risk of being subjected,

without their informed consent, to medical experiments that increase

the risk of death.

See: http://www.ahrp.org/ARDSpages/ARDSindex.html

 

Negligence is well defined in tort law and the Seattle jury had no

difficulty finding The Hutch negligent in the death of one patient-

subject due to a mix up in the hospital's laboratory. But in the

absence of a law clarifying what constitutes informed consent, the

jury did not rule in favor of 4 family plaintiffs who sued the Hutch

on the grounds that their relatives' right to informed consent had

been violated--even though jury members acknowledged that informed

consent at the Hutch had been " really shoddy. "

 

The absence of a law to specifically address informed consent to

medical research encourages some physician-researchers who seek

subjects for their experimental treatments, not to disclose fully the

risks or the alternatives to patients. The absence of a law puts

vulnerable patients at increased risk of harm with few legal remedies

to compensate them (or their surviving

families) when harm has been done.

See: Seattle Times Friday, April 09, 2004

http://seattletimes.nwsource.com/html/localnews/2001899403_hutchverdic

t09m.h

tml

 

The Delaware case is most unusual because Du Pont Hospital has

acknowledged the culpability of the doctors on their staff.

 

 

Contact: Vera Hassner Sharav

Tel: 212-595-8974

e-mail: veracare

~~~~~~~~~~~~~~~~~~~

 

http://www.philly.com/mld/inquirer/news/front/8371296.htm?1c

Philadelphia Inquirer

Babies' doctors broke rules in use of stent, Del. says

 

By Karl Stark and Susan FitzGerald

 

Wed, Apr. 07, 2004

 

Heart doctors at Alfred I. du Pont Hospital for Children implanted an

experimental device in 14 babies without obtaining full consent from

their parents, a report by Delaware health officials said yesterday.

 

Doctors also did not get the necessary approval from the U.S. Food

and Drug Administration and from a hospital committee charged with

protecting patients from unproven treatments, investigators said.

 

The report, which the Wilmington hospital acknowledged yesterday as

accurate, said 14 babies with a congenital heart defect had received

an experimental stent at du Pont. State investigators initially were

unable to find four signed parental consent forms, the state report

said, and no parents knew that the doctors were performing procedures

without hospital approval. The device has not yet received FDA

approval.

 

" It's an obvious violation of the regulations, " said Mary Peterson,

director of the state Office of Health Facilities, Licensing and

Certification. " Unfortunately, you can't have full, informed consent

if the parents were not aware that the hospital had not approved this

study. "

 

For the first time, the hospital placed clear blame on its cardiac

center's director, surgeon William I. Norwood, and chief

cardiologist, John D. Murphy. The doctors " were involved in the

decisions to place unapproved medical devices in patients without

prior notification to, and approved by our " Institutional Review

Board, the hospital said in a response included in the report.

 

Kevin E. Charles, chief of Health Systems Protection in Delaware,

said the venerable hospital could lose its license. But he

acknowledged that was unlikely because du Pont was cooperating and

making changes.

 

Norwood and Murphy left Feb. 19 as part of an " administrative

overhaul, " the hospital said yesterday. And the hospital said it

would form a new department for Human Subject Protection to help its

staff adhere to research regulations.

 

The doctors' lawyer did not return phone calls yesterday.

 

Misfiled consent forms

 

Neither the state nor the hospital would say whether any babies had

been injured because of the experimental care.

 

One couple have said their son suffered complications after getting

the stent, which had to be surgically removed at another hospital.

 

The state's report also noted that the Institutional Review Board's

leader said he did not learn of the experimental procedure until

early December when FDA inspectors showed up unannounced at du Pont

in response to a family's complaint.

 

The FDA declined yesterday to comment on its probe.

 

In addition, the report said four parental consent forms were not

found during the inspection. Then, state inspectors said, they

received a call Feb. 26 from a hospital attorney, saying three of the

documents had been found in a drawer in the cardiac catheterization

lab. Two were not properly executed, Peterson said. The fourth has

not been found.

 

The state cited du Pont for failing to properly file those records.

 

The experimental care at du Pont became public in February when

hospital officials said they had halted a cardiac procedure involving

the use of a covered stent amid an investigation by the FDA and

Delaware regulators.

 

Treating heart defects

 

Covered stents, tubes designed to redirect blood flow, are being

tried to treat congenital heart defects, particularly one called

hypoplastic left heart syndrome, in which the heart's main pumping

chamber is underdeveloped. The condition was always fatal until the

early 1980s when Norwood developed a treatment that requires three

surgeries to reroute blood flow. The procedure is now standard.

 

Murphy was among a small group of doctors that had recently been

testing whether the final surgery could be replaced by opening a

blood vessel and using a thin catheter to maneuver a stent into place.

 

Some families at du Pont were offered this less-invasive procedure -

but without a full explanation, Delaware officials said.

 

Last month, The Inquirer reported on a sworn statement that Judith

Guinan of Vineland, N.J., gave to the FDA. Guinan said she and her

husband, Kevin, did not know beforehand that the covered stent used

on their daughter Molly's heart defect was experimental. They said

they learned that when a hospital doctor called a year later in late

2003, asking them to sign and backdate a consent form.

 

Judith Guinan said she could not recall seeing the consent form.

 

The state report indicated that the Guinans' consent form, one of

those found in the drawer, was signed by a parent. Lawyers for the

Guinans have disputed that.

 

Philadelphia lawyer Andrew J. Stern, whose firm represents the

Guinans, would not comment again yesterday on the forms.

 

" At least A.I. du Pont has admitted that its doctors were involved in

inexcusable behavior, " Stern said.

 

The state said yesterday that the unapproved stent was used for 11

months, from June 20, 2002, to May 5, 2003, without the hospital's

permission.

 

Peterson said her state agency did not learn of the situation until

Jan. 20 when a parent alerted her. State investigators went to du

Pont on Jan. 22 and investigated there until Feb. 11.

 

In the next 60 days, state inspectors will visit du Pont unannounced

and conduct a full survey. If it is in compliance, the hospital will

be monitored for at least three months, Peterson said.

 

The hospital said yesterday that it had already begun making changes.

 

Du Pont cardiologists have personally notified the parents of

children who got the covered stents. Doctors will create a registry

for the babies to monitor their health.

 

 

Contact staff writer Karl Stark at 215-854-5363 or

kstark.

 

 

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