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From: TSS ()
Subject: Re: CJD TISSUE DONATIONS FROM OUR LOVED ONES UP FOR SALE TO HIGHEST BIDDERS
Date: July 1, 2006 at 3:56 pm PST

In Reply to: CJD TISSUE DONATIONS FROM OUR LOVED ONES UP FOR SALE TO HIGHEST BIDDERS posted by TSS on June 14, 2006 at 6:40 am:

Science 23 June 2006:
Vol. 312. no. 5781, p. 1733
DOI: 10.1126/science.312.5781.1733

News of the Week

U.S. BIOETHICS:

House Panel Finds Fault With How NIH Handles Tissue Samples

Jocelyn Kaiser

A congressional finding that a drug company paid a National Institutes of
Health (NIH) scientist for spinal fluid samples has raised a larger
question: What happens to NIH's archived patient samples? NIH's efforts to
improve practices within its intramural program come as U.S. medical centers
are trying to tighten controls over such materials.

At a 2-day hearing last week, Joe Barton (R-TX), chair of the House Energy
and Commerce Committee, complained about the "lack of a centralized database
[for patient samples] and a lack of oversight at NIH that could, and
probably does, leave NIH laborator[ies] vulnerable to the risks of theft and
abuse." NIH officials testified they have already begun to improve their
procedures.

But outside scientists agree with NIH that the agency needs time to organize
its millions of stored specimens. "People have their samples everywhere,"
with details recorded on everything from paper notepads to computers, says
Mark Sobel, a former NIH researcher who is now executive officer of the
American Society for Investigative Pathology. Creating a central registry of
NIH's holdings, he predicts, "is going to be a massive undertaking."

Barton's ethics investigation is an extension of an earlier one questioning
large payments from drug companies to senior NIH scientists. That led NIH to
ban industry consulting by its intramural scientists last August (Science, 2
September 2005, p. 1469). Last week's hearing focused on Alzheimer's disease
researcher Trey Sunderland of the National Institute of Mental Health (NIMH)
and his dealings with drug giant Pfizer.

The committee pursued a complaint from Susan Molchan, a former clinical
researcher in Sunderland's lab, that Sunderland wouldn't provide her with
some of her old spinal fluid samples. Staffers eventually learned that
Sunderland had sent Pfizer about 3200 spinal fluid samples and 388 plasma
samples he and others had collected since the early 1980s, including some
from Molchan, along with clinical data, from Alzheimer's patients and
controls. The company used them to study so-called biomarkers, proteins that
might serve as indicators for the neurodegenerative disease.

Pfizer had signed a Material Transfer Agreement with NIMH for the samples in
April 1998. Around the same time, Sunderland signed a consulting agreement
with Pfizer that eventually paid him $285,000. A 26-page bipartisan report
released last week by the Commerce Committee's oversight and investigations
subcommittee found "reasonable grounds to believe" that Pfizer made the
payments in exchange for the samples. Neither this agreement nor others with
Pfizer, for which Sunderland was paid more than $300,000 over several years,
were reported to NIH.

Figure 1 Exhibit A. Concerns that NIH researcher Trey Sunderland (with
former co-worker Karen Putnam at a congressional hearing) was paid for
patient tissue samples have triggered a call for a central NIH database.

CREDIT: CHRISTINE MCCARTY
At the hearing, NIH officials said the transfer and consulting agreements
would not have been approved because they improperly mixed official duties
with consulting. "You could have both collaboration and consulting [but not]
with the same agent," said NIMH Director Thomas Insel. Insel said Sunderland
instead should have organized a cooperative agreement with the company for
which he would not have been paid.

Sunderland and a co-worker, Karen Putnam, invoked their constitutional right
to decline to answer questions before the committee. Sunderland has said
that his staff simply failed to complete the proper paperwork, and his
attorney Robert Muse says that "there is no truth to the allegation that Dr.
Sunderland received a penny from Pfizer for the samples." NIH investigators
earlier found that Sunderland had committed serious misconduct, and Insel
suggested to the U.S. Public Health Service Commissioned Corps that he be
terminated. The corps has put his retirement on hold, however, and the
Department of Health and Human Services Inspector General's office and the
Department of Justice are still investigating.

The committee's report also questions whether Sunderland had obtained proper
informed consent from some patients for the Pfizer study. NIH officials told
the subcommittee that they have tightened rules on the sharing of human
tissues, including adding a requirement that investigators describe future
plans for samples to an Institutional Review Board (IRB). In the mid-1990s,
the policy was "very general," Insel said.

Indeed, a decade ago, researchers themselves often decided the fate of
leftover samples, says bioethicist Mark Rothstein of the University of
Louisville in Kentucky. Since bioethics council and other U.S. and
international advisory bodies have called for better controls on the use of
stored human tissue (Science, 18 December 1998, p. 2165). Reviews of old
collections have revealed that informed consent forms are often missing,
leaving IRBs to decide whether samples can be used, Rothstein says: "It's
been a revelation."

But NIH officials say they need more time to figure out whether a central
database of tissue specimens would make sense for the intramural program.
The agency is looking at combining a new campuswide database of clinical
trials with sample barcoding systems, says NIH Deputy Director for
Intramural Research Michael Gottesman. And although extramural researchers
have also traditionally tracked their samples individually, NIH's largest
institute, the National Cancer Institute, is encouraging cancer centers to
tally their tumor specimens in databases so sharing will be easier.

Insel warned that moving toward a central system too quickly could add
"speed bumps" to the scientific process. Legislators haven't said if they
plan to require a central database.


http://www.sciencemag.org/


TSS




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