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From: TSS ()
Subject: Re: NIH says it will preserve CJD brains
Date: June 21, 2005 at 9:54 am PST

FOR IMMEDIATE RELEASE CONTACT: Press Office
Tuesday, June 21, 2005 202-225-5735

NIH Lacks Uniform Protection of Research Samples, Committee Leaders Say

Few Safeguards in Place Despite Enormous Potential Value

WASHINGTON - The research and handling of human tissue samples at the National Institutes of Health (NIH) appears to be largely ungoverned and there is almost no accountability for damaged or lost samples, according to leaders of the House Energy and Commerce Committee.

In a letter to NIH Director Elias Zerhouni, M.D., lawmakers said they were "extremely concerned" by "a fairly loose, ad-hoc approach" to the samples, which could hold significant potential for research to combat any number of illnesses or disease. The members of Congress are seeking extensive information detailing the scope of the samples and an estimate of those lost each year at NIH labs.

Committee Chairman Joe Barton, R-Texas, has said he will introduce legislation to reauthorize the NIH and hopes for House passage this year. The last reauthorization of NIH occurred in 1993.

The full text of the letter, signed by Chairman Barton, ranking member John Dingell, D-Mich., Oversight and Investigations Subcommittee Chairman Ed Whitfield, R-Ky., and subcommittee ranking member Bart Stupak, D-Mich., follows:

June 20, 2005

Dear Dr. Zerhouni:

The Committee on Energy and Commerce is investigating the adequacy of the National Institutes of Health (NIH) policies for maintaining research samples of human tissue.


Our interest in the NIH's maintaining of human tissue samples arises from concerns raised by a scientist at NIH ("NIH scientist"). She contacted the Committee staff about the problems she encountered in locating spinal fluid samples she and her colleagues had collected from over 30 patients with Alzheimer's disease.

The NIH scientist had previously worked at the National Institute of Mental Health (NIMH) with the Geriatric Psychiatry Group. She left the NIMH in 1997, and returned to NIH at another institute/center in August 2001. Prior to leaving the NIMH in 1997, she was the principal investigator on drug studies in which she and other colleagues collected spinal fluid from over 30 Alzheimer's patients. Approximately 20 ccs of spinal fluid were collected with each spinal tap. The NIH scientist left the NIMH before conducting these studies and did not use the spinal fluid samples. According to the NIH scientist, these spinal fluid samples were stored in appropriately backed-up freezers when she left NIMH in 1997.

Sometime in mid-2004, the NIH scientist, now at another NIH institute/center, asked her former supervisor at NIMH for these patient samples for a study she wanted to conduct. After several months, the former supervisor in January 2005 reported to the NIH scientist that his group would be able to produce 10 subjects total (before and after taps) with only 0.5 cc available for most of the subjects. The former supervisor and the NIMH have been unable to account for what happened to the rest of the spinal fluid samples.

The Committee staff has learned from NIH officials that the NIH has no uniform, centralized, and mandatory authority regulating the handling of human tissue samples. Some NIH laboratories keep a written record on the maintenance of these samples, but other NIH laboratories do not. Although there are explicit regulations defined in 42 C.F.R. 72.6 detailing the handling for hazardous biological materials and select agents, there is no explicit policy for the handling and accounting of human tissue samples. In addition, there is no formal inventory control or tracking system at NIH. If a freezer or other storage facility malfunctions and the human tissue samples become unusable, NIH laboratories are not required to account for the disposition of these samples. There is reason to believe that there are cases where NIH loses human tissue samples but has no record of what has been lost. Moreover, the lack of accountability leaves NIH wholly vulnerable to theft and diversion of valuable human tissue samples.

We are extremely concerned over what was described to Committee staff by NIH officials of a fairly loose, ad-hoc approach to controlling human tissue samples. These samples were collected under informed consent from human subjects who agreed to provide their tissue because they were told that the sample would be used for a particular purpose in the study, perhaps even used to look at the effects from a particular drug. Some of these samples are extraordinarily precious from a research standpoint because some patients who donated samples had a rare disease. For example, we note that the National Institute of Allergy and Infectious Diseases obtained blood samples from SARS patients as part of its immunological research of SARS and coronaviruses. In addition, NIH intramural researchers sometimes rely on obtaining human tissue samples from sources outside NIH for their laboratory work, or even in their work for Cooperative Research and Development Agreements with third parties.

NIH has an obligation to the human subjects and the outside scientific community to require an appropriate tracking system or protocol for all laboratories involved with collection and maintenance of human tissue samples. NIH officials acknowledged to Committee staff the importance of maintaining human research samples because for all published work, scientists are expected to provide access to other researchers to the human tissue samples for the purpose of reproducing the results reached in the scientist's reported study.

In light of the concerns about the current handling by NIH of human tissue samples, pursuant to Rules X and XI of the U.S. House of Representatives, please provide the following by no later than Tuesday, July 5, 2005:

1. The current total number of human tissue samples maintained at NIH, with a breakdown for each Institute or Center. The current total number of laboratories at NIH that maintain human tissue samples and the current total number of laboratories that have a tracking system accounting in place for the human tissue samples.

2. All records dated on or since January 1, 2002, in possession of NIH, including communications within each Institute/Center and each laboratory, relating to any distinct direction, instruction, or policy relating to the handling of human tissue samples.

3. All records dated on or since January 1, 2002, in possession of the NIH Office of Intramural Research or the NIH Office of Management Assessment relating to any closed investigation of an allegation relating to the handling or accounting of human tissue samples. Please also state whether there are any open investigations and, if so, which institutes or centers are under investigation.

4. The current total amount of expenditures for FY2005 by NIH for maintaining and repairing freezers or other storage facilities containing human tissue samples.

5. An estimate of the total number of human tissue samples lost each year at NIH laboratories, and an estimate of the number of human tissue samples lost each year at NIH laboratories because of freezer or storage facility malfunctions.

6. A description of any measures NIH is taking to reduce the number of research freezer or other storage facility malfunctions or breakdowns.

7. List the names of the ten rarest diseases for which NIH has human tissue samples, the name of the Institute and laboratory that has possession of these samples, and the specific measures currently being taken to track these samples.

8. All records relating to the CSF samples collected by the NIH scientist and others in a NIMH study on lithium in early Alzheimer's disease patients. Patient identifiers may be redacted.

Additionally, please provide the following:

9. Since January 1, 1995, has any official at NIH authorized the use of human tissue samples in possession of NIH to be used by any NIH employee in support of an outside activity?

10. Since January 1, 1995, has any official at NIH ever used human tissue samples that were in possession of NIH in connection with any of his or her outside activities?

Please note that, for the purpose of responding to these requests, the terms "records" and "relating" should be interpreted in accordance with the attachment to this letter. In addition, we are requesting that following production of the records to the Committee, you make available NIH employees for Committee staff interviews as requested by Committee staff.

# # #


http://energycommerce.house.gov/108/News/06212005_1562.htm


Greetings,

>>>The research and handling of human tissue samples at the
National Institutes of Health (NIH) appears to be largely ungoverned and
there is almost no accountability for damaged or lost samples, according to
leaders of the House Energy and Commerce Committee.<<<

SO, the loved ones to CJD human TSE deaths that went to the pain of submitting these samples for answers and science, are now to wonder if they even used them at all, and if they were just thrown out like some old used garbage. IF we would have known that, we would have rathered burried them with the deceased, in tact. This
is all very disgusting and very disturbing...TSS


>>>7. List the names of the ten rarest diseases for which NIH has human tissue samples, the name of the Institute and laboratory that has possession of these samples, and the specific measures currently being taken to track these samples.<<<


RATHER interesting, but it would seem that human prion disease should be at the top of the list...


TSS


----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Sent: Tuesday, May 31, 2005 5:15 PM
Subject: NIH says it will preserve CJD brains


##################### Bovine Spongiform Encephalopathy #####################

NIH says it will preserve CJD brains
By STEVE MITCHELL

WASHINGTON, May 31 (UPI) -- The National Institutes of Health apparently has reversed its position on the fate of an invaluable collection of brains from people afflicted with a condition similar to mad cow disease, saying in a letter to a U.S. senator it will not destroy the collection.

An NIH official had told United Press International previously that the brain collection, which consists of samples from hundreds of people who died from the brain-wasting illness called Creutzfeldt Jakob disease, could be discarded if another entity does not claim them.

That sparked an outcry from patient-advocacy groups, consumer watchdogs and scientists, and the agency now appears to have backed away from that course.

"All the brains and other tissues with potential to help scientists learn about CJD are, and will continue to be, conserved," Story Landis, director of the National Institute of Neurological Disorders and Stroke, which oversees the brain collection, wrote in a May 10 letter to Sen. John Cornyn, R-Texas.

Cornyn had inquired about the status of the collection in April.

Last March, Eugene Major, acting director of the basic neuroscience program at the NIH, told UPI the useful portions of the collection had been doled out to scientists and the remaining samples had "very little remaining value" and could be destroyed.

Landis could not be reached for comment Tuesday. NINDS spokesman Paul Girolami told UPI he had been unable to locate her.

Scientists think the collection, which dates back to 1963, is invaluable for research on CJD and similar diseases and could even provide insight into treatments. There is no cure for CJD and patients typically die within a year after symptoms begin.

"Absolutely, the collection is worth keeping," Bruce Johnson, a former NIH scientist who said he had been told the collection would be destroyed in two years if no one took the samples from the agency, told UPI.

The Memorial Institute for Neurodegenerative Diseases Inc., a non-profit organization consisting of more than 40 researchers from several countries, offered to take the collection off of NIH's hands more than a year ago and so far has not heard anything from the agency, Harry Peery, MIND's executive director, told UPI.

CJD belongs to a group of incurable and fatal diseases collectively known as transmissible spongiform encephalopathies, or TSEs, that includes mad cow disease in cows, chronic wasting disease in deer and elk, and scrapie in sheep.

Variant CJD, or vCJD, is a relatively new TSE, which people can contract from consuming beef products infected with the mad cow pathogen.

Despite Landis' assurance the collection will be preserved, some family members of the patients who donated their brains to the NIH are still skeptical. This is because the wording Landis used in the letter leaves open the possibility that some brain samples are being destroyed.

"The tissues that are discarded are those that have either decayed to an extent that renders them no longer appropriate for research or those for which we do not have sufficient identification," Landis wrote.

"Which ones" are being destroyed? asked Terry Singeltary, who is involved with several CJD patient groups.

"With a system like this, they could destroy whatever and whenever they wanted, for whatever reason they wanted," Singeltary, whose mother died of CJD in 1997, told UPI.

"It's a perfect excuse to discard some suspicious tissue resembling vCJD or some atypical TSE related to animal TSEs in the USA," he added.

Although the collection includes samples from CJD patients as young as 16 that could make them candidates for possible vCJD, the brains have never been screened for evidence of the disease. The only confirmed vCJD case in the United States occurred in a Florida woman who is thought to have contracted the disease in England.

Johnson said he along with renowned CJD expert Paul Brown were in the process of sorting through the samples to match them up with patient identification documents until they both retired. Some of the samples may prove impossible to identify, he said, but he and Brown are the only ones familiar enough with the collection to organize it and neither has been asked back by the agency to aid in the identification process.

Steve Mitchell is UPI's Medical Correspondent. E-mail: sciencemail@upi.com

Copyright 2005 by United Press International. All Rights Reserved.


http://washingtontimes.com/upi-breaking/20050531-050800-6771r.htm


http://www.sciencedaily.com/upi/index.php?feed=Science&article=UPI-1-20050531-17245200-bc-us-cjdbrains.xml


=====================


JOHN CORNYN
TEXAS
UNITED STATES SENATE
WASHINGTON, DC 20510-4305
April 26,2005
Mr. Terry SingeltaryP.O. Box 42Bacliff, Texas 77518
Dear Mr. Singeltary:
In response to your recent request for my assistance, I have contacted the National Institutes ofHealth. I will write you again as soon as I receive a reply.
I appreciate having the opportunity to represent you in the United States Senate and to be ofservice in this matter.
Sincerely,

JOHN CORNYN
United States Senator
JC:djl


===============

JOHN CORNYN
TEXAS
UNITED STATES SENATE
WASHINGTON, DC 20510-4305
May 18,2005
Mr. Terry SingeltaryP.O. Box 42Bacliff, Texas 77518
Dear Mr. Singeltary:
Enclosed is the reply I received from the Department of Health and Human Services in
response to my earlier inquiry on your behalf. I hope this will be useful to you.
I appreciate having the opportunity to represent you in the United States Senate.
Thank you for taking time to contact me.
Sincerely,

JOHN CORNYN
United States Senate
JC:djl
Enclosure

DEPARTMENT OF HEALTH & HUMAN SERVICES
National Institutes of HealthNational Institute of NeurologicalDisorders and Stroke
NINDS
Building 31, Room 8A52
31 Center Dr., MSC 2540
Bethesda, Maryland 20892-2540
Phone: 301-496-9746
Fax: 301-496-0296
Email: sll22c@nih.gov


May 10, 2005


The Honorable John CornynUnited States SenatorOccidental Tower5005 LBJ Freeway, Suite 1150Dallas, Texas 75244-6199


Dear Senator Cornyn:


Your letter to the National Institutes of Health (NIH) forwarding correspondence from Mr. Terry
S. Singeltary, Sr., has been forwarded to me for reply. Mr. Singeltary is concerned about thepreservation of Creutzfeldt-Jakob disease (CJD) brain samples that have been maintained by theNational Institute of Neurological Disorders and Stroke (NINDS) Intramural Research programfor many years.
I am sorry to learn that Mr. Singeltary's mother died of CJD and can certainly understand hisdesire that any tissues that could help investigators unravel the puzzle of this deadly disease arepreserved. I hope he will be pleased to learn that all the brains and other tissues with potential tohelp scientists learn about CJD are, and will continue to be, conserved. (The tissues that arediscarded are those that have either decayed to an extent that renders them no longer appropriatefor research or those for which we do not have sufficient identification.)
The purpose of gathering these brains and tissues is to help scientists learn about CJD. To that
end, some of the NINDS-held samples are distributed to investigators who can demonstrate thatthey have a compelling research or public health need for such materials. For example, sampleshave been transferred to NIH grantee Dr. Pierluigi Gambetti, who heads the National PrionDiseases Pathology Surveillance Center at Case Western Reserve University in Ohio and workswith the Centers for Disease Control and Prevention to monitor all cases of CJD in the UnitedStates. Dr. Gambetti studies the tissues to learn about the formation, physical and chemicalproperties, and pathogenic mechanisms of prion proteins, which are believed to be involved inthe cause of CJD. Samples have also been transferred to Dr. David Asher, at the U.S. Food andDrug Administration, for use in assessing a potential diagnostic test for CJD.


Page 2 - The Honorable John Cornyn


in closing, we know that donating organs and tissue from loved ones is a very difficult andpersonal choice that must often be made at the most stressful of times. We at the NINDS aregrateful to those stalwart family members who make this choice in the selfless hope that it willhelp others afflicted with CJD. We also know the invaluable contribution such donations maketo the advancement of medical science, and we are dedicated to the preservation of all of thetissue samples that can help in our efforts to overcome CJD.


I hope this information is helpful to you in responding to Mr. Singeltary.
Sincerely,

Story C. Landis, Ph.D.
Director, National Institute ofNeurological Disorders and Stroke
==================================

TSS

a.. see re-NIH to destroy brain samples and tissues

TSS

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