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From: TSS ()
Subject: Extra scrutiny on cadaver harvesters FDA task force recommends more stringent controls over body parts
Date: June 13, 2007 at 8:45 am PST

June 12, 2007, 10:42PM

Extra scrutiny on cadaver harvesters

FDA task force recommends more stringent controls over body parts


By SETH BORENSTEIN and MARILYNN MARCHIONE
Associated Press

WASHINGTON — Federal regulators say they have dramatically boosted inspections of companies that harvest cadaver body parts for transplant, acknowledging weaknesses in government oversight of the multibillion-dollar human tissue industry that last year was rocked by scandal.

The U.S. Food and Drug Administration said the inspections turned up no serious problems. But an internal task force report urges agency officials to set up a method for tracking body parts from cadaver to transplant patient — a system that currently doesn't go that far.

The targeted companies remove bones, tendons, cartilage, heart valves and other non-organ parts from corpses. These tissues are used in roughly 1 million medical procedures in the United States each year, many of them for routine knee and back surgeries.

If improperly screened and processed, these tissues can cause serious infections, including HIV or hepatitis, or even death in transplant recipients. Fears about the lax regulation of the industry arose after scandals involving two companies and the recall of thousands of tissues, many of which were already transplanted.

A three-month investigation by The Associated Press last year detailed many gaps in oversight by the FDA.

The task force recommends steps to address some of those problems, but operators of accredited tissue banks and others familiar with the industry say the report doesn't go far enough to clean up the problem.


Extended tracking system
The FDA says it is reviewing the recommendations, which include:

• A tracking system that ends with the recipient of the transplanted tissue. Currently, the tracking requirement ends with the doctor or hospital that does the transplant. As a result, it has been difficult to warn patients who may have received improperly processed cadaver parts. The agency says it must review the legality of enforcing such a requirement.

"They have the legal authority, they just need the backbone to do it," said former FDA attorney Areta Kupchyk, an expert in the tissue industry. She was among several critics of the task force report, which was written by FDA employees.

• Requiring companies that use tissue parts to audit their suppliers regularly. In an interview the FDA's Dr. Jesse Goodman said his agency has reiterated to doctors and tissue banks that they are responsible for making sure that their suppliers comply with the law and are safe.

• Hiring a microbiologist to resolve scientific questions about tissue safety — such as what sterilization or treatment processes are best.

Experts in the field criticized the task force for not urging more, such as:

• Tightening standards for who can run a tissue bank, or require licensing or background checks. Under current regulations, even convicted felons could start such a business and would only have to register their intent with the FDA.

• Requiring inspections at the time a tissue handler first starts in the business.

• Limiting or banning retrieval of tissue at funeral homes. Many in the industry have urged such limits because unsterile retrieval can increase the chances of germs being passed to recipients.

In the meantime, Goodman, director of the FDA's Center for Biologics Evaluation and Research, said the agency has inspected all 153 companies that remove tissue from cadavers. He said future inspections would include some of the more than 2,000 companies that prepare the tissue for use by doctors.

In recent years, the FDA has never inspected more than a few hundred of these businesses on an annual basis.

Goodman, in an interview with The Associated Press, said only minor problems were turned up from the agency's inspections and overall, "the finding there was generally reassuring."

Dr. Celia Witten, who oversees FDA's cellular tissue and gene therapies office, said: "Today's report finds no significant industrywide problem in the recovery of human tissues"


Stolen bodies alleged
However, some in the industry disagree. And weaknesses came to light through recent scandals, the biggest involving Biomedical Tissue Services of New Jersey. The company's operator faces trial along with a former New York funeral home director on charges that they stole bodies and unlawfully dissected them. Among the corpses that had body parts removed was Alistair Cooke, the 90-year-old former host of PBS' Masterpiece Theater, who died of cancer.

Seven funeral home directors have already pleaded guilty and tens of thousands of body parts removed by BTS were recalled. About 10,000 people are believed to have received tissues from the company.

One victim of the BTS scandal, Alicia Dawes, who received a bone implant from that company, said she wanted a ban on tissue recovery at funeral homes and some kind of background check on companies that harvest cadaver tissue.

"There is just too much money in body parts for profit," said Dawes, of Medford, Ore. "You're going to find the same thing happening over and over."

Dawes has not become ill from the bone that was implanted in her neck, but she has been told to be tested for the AIDS virus and hepatitis, like thousands of other patients who received BTS body parts.

"If this is the end of it, they've missed some opportunities" to improve tissue safety, Robert Rigney, head of the American Association of Tissue Banks, said of the task force report.

He said the task force consulted once by phone with the association, which requires members to follow tougher standards than the FDA's. All of the scandals and problems with tissue so far have involved companies not accredited through the tissue bank group association, but the FDA has not required accreditation or similar standards, he noted.


http://www.chron.com/disp/story.mpl/business/4884958.html

Cadaver corneal transplants -- without family permission
Houston, Texas channel 11 news 28 Nov 99
Reported by Terry S. Singeltary Sr.son of CJD victim

"It was a story about how the Lions eye bank were harvesting corneas from victims in the Morgue, without their consent. Under Texas law, this appears to be legal (remember Texas has the Veggie liable law). Even if Family says no, this appears to happen, from what the news story said.
They said the only way to prevent this, is to fill out a form, stating not to have this done. So if you don't fill out the form, they can do this. How many people don't know about the form?

This is not only disgusting and appalling, it could be highly infectious. Without proper background checking of the donors, on their physical history, checking on past dementia, and/or family history, some of these unfortunate victims, could be passing a human TSE.

Response Jill Spitler Clevelland Eye Bank:

"No, we are not stealing.........Yes, you do have such a law in the state of Texas, but not all your state Eye Banks utilize the law. The Eye Bank that you're speaking of is only one of 43 certified Eye Bank throughout the USA.

And there are measure taken per the Medical Standards of the Eye Bank Association of America, the certifying body for eye banks and per FDA regulations to address those concerns that you speak of.

I would suggest that those interested/concern with transplant contact their local agencies. The Eye Bank Association of America has a web. site . Further if anyone has problems contacting or finding out about their local organization(s), call me or e-mail me I would be glad to help. My e-mail address is jill@clevelandeyebank.org"

Terry Singeltary responds:

"Explain this to the family in Houston who went to their loved ones funeral, only to find out that the loved one that was in the casket, had their corneas removed without their permission, without the consent of the victim or it's family. They would not have known it, only for the funny look the victim had. So, they questioned, only to find out, the corneas, had in fact, been removed without consent.

I call that stealing, regardless what the law states. This type of legal grave robbing is not a logical thing to do without knowing any type of background of the victims medical past, which really will not prove anything due to the incubation period. Eye tissue being potentially a highly infective source, there are risks here.

Should they not at least know of the potential ramifications of TSE's (the person receiving the corneas)?

Should there not be some sort of screening?

Should there be some sort of moral issue here? If this is the case, and in fact, they can come take your corneas, without your consent, then what will they start taking next, without your consent?

Lets look at a hypothetical situation: What would happen if my Mom (DOD 12-14-97 hvCJD) would have gotten into a car wreck and died, before the symptoms of CJD appeared. Not much money, so there was no autopsy. What would have happened to that recipient of those infecting corneas?"

Comment (webmaster): Actual transmission of CJD by means of corneal transplant may or may not be rare. The incidence of infectivity in older people could be fairly high; this is not to be confused with the lower incidence of symptomatic (clinical) CJD. It is very unlikely that familial CJD would have been diagnosed in earlier generations; however, without interviewing the family even known kindreds would not be excluded.

In blood donation, a much stricter policy is followed, even though corneal transplant may be far more dangerous (being a direct link to the brain and not going through purification steps).

Since highly sensitive tests for pre-clinical CJD are now available, it would make sense to screen corneas for CJD, just as they are screened for AIDS, hepatitus, and a host of other conditions.


http://mad-cow.org/~tom/dec99_news.html#bbb


Sept. 15, 2000, 11:39PM

Slain woman's family sues over
missing eyes

By BILL MURPHY
Copyright 2000 Houston Chronicle

The family of a woman who was stabbed to death last year has
filed a lawsuit accusing the Lions Eye Bank of Houston of
removing the woman's eyes without permission and inserting
plastic discs in their place.

Daisy Diaz's relatives were horrified when they saw her body
and noticed her eyes were missing, said their lawyer, Duncan
Neblett III.

"They're a Catholic family," Neblett said. "They have strong
beliefs about the body and burial. They were really upset by
this."

Dorey Zidrow, the eye bank's spokeswoman, said she could
not specifically discuss the Diaz case because it was in litigation.
But Zidrow said a state law allows doctors to remove corneas
-- the dime-sized lens near the eye's surface -- from a corpse
without the family's permission.

The eye bank's usual procedure calls for removing the corneas,
Zidrow said, but not the entire eyes.

"There are an awful lot of people who benefit from this program
in the state of Texas," she said.

Diaz, 25, was stabbed to death in her apartment in the 400
block of Thornton in October. Her brother-in-law, 30-year-old
Raudel Quiroz, is charged in the killing but has not been caught.

Neblett said authorities have told him Quiroz may have returned
to his native Guatemala.

Neither Diaz nor her family had given permission to donate any
of her organs, Neblett said.

Although state law allows corneas to be removed from corpses
without first gaining the family's permission, they cannot be
removed over the family's stated objection.

The eye bank is located at, and staffed by, the Baylor College
of Medicine, and receives part of its funding from the Lions
Club.

The Diaz lawsuit is the second such suit to be filed against the
eye bank in recent years.

The family of Levi Perry Jr., a Houston teacher shot to death in
MacGregor Park in 1994, also alleged in their suit that Perry's
eyes were removed. The family was awarded $345,000 from
the eye bank in April 1999.

http://www.chron.com/cs/CDA/story.hts/metropolitan/669555

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

THE LEGALITY OF STEALING ORGAN/TISSUE...

TEXAS STATUTES

Sec. 693.012. Removal of Corneal Tissue Permitted Under Certain
Circumstances.

On a request from an authorized official of an eye bank for corneal
tissue, a justice of the peace or medical examiner may permit the
removal of corneal tissue if:

(1) the decedent from whom the tissue is to be removed died under
circumstances requiring an inquest by the justice of the peace or
medical examiner;

(2) no objection by a person listed in Section 693.013 is known by the
justice of the peace or medical examiner; and

(3) the removal of the corneal tissue will not interfere with the
subsequent course of an investigation or autopsy or alter the decedent's
postmortem facial appearance.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Note: This information includes legislation enacted through the 75th
Congress. The 76th session of the Texas Legislature has concluded. The
State of Texas has not yet made the new codes available to the public.
Until they do, search the bill text for any changes or amendments.

Search 1999 Legislation for: 693.012
--------------------------------------------------------
TEXAS STATUTES
Sec. 693.003. Consent Required in Certain Circumstances.

(a) A medical examiner or a person acting on the authority of a medical
examiner may not remove a visceral organ unless the medical examiner
or person obtains the consent of a person listed in Section 693.004.

(b) If a person listed in Section 693.004 is known and available within
four hours after death is pronounced, a medical examiner or a person
acting on the authority of a medical examiner may not remove a
nonvisceral organ or tissue unless the medical examiner or person
obtains that person's consent.

(c) If a person listed in Section 693.004 cannot be identified and
contacted within four hours after death is pronounced and the medical
examiner determines that no reasonable likelihood exists that a person
can be identified and contacted during the four-hour period, the medical
examiner may permit the removal of a nonvisceral organ or tissue.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Note: This information includes legislation enacted through the 75th
Congress. The 76th session of the Texas Legislature has concluded. The
State of Texas has not yet made the new codes available to the public.
Until they do, search the bill text for any changes or amendments.

Search 1999 Legislation for: 693.003
--------------------------------------------------------
PLEASE NOTE; the bottom would only pertain to those who know of the
law. if you don't know about it, you cannot dispute, so in four hours,
they can legally remove body organs, as long as they don't disfigure.
and who is to know the difference? makes me wonder of some of my dead
relatives, and if they were burried with their eye's and or any of their
organs. This is very disturbing, if not for moral reasons, but for the
risk of dangerous pathogens (human TSE's, etc.) to be transmitted. only
time will tell, but i am very disturbed.
these laws are not morally correct. They should be re-written as to they
cannot so easily take your organs, with no one knowing. The Family or
Victim, must consent. There should be some kind of research
on donor/family medical history...TSS
--------------------------------------------------------

Sec. 693.013. Persons Who May Object to Removal.

The following persons may object to the removal of corneal tissue:

(1) the decedent's spouse;

(2) the decedent's adult children, if there is no spouse;

(3) the decedent's parents, if there is no spouse or adult child; or

(4) the decedent's brothers or sisters, if there is no spouse, adult
child, or parent.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Note: This information includes legislation enacted through the 75th
Congress. The 76th session of the Texas Legislature has concluded. The
State of Texas has not yet made the new codes available to the public.
Until they do, search the bill text for any changes or amendments.

Search 1999 Legislation for: 693.013
-------------------------------------------------------
to cover one's butt....

Sec. 693.014. Immunity From Damages in Civil Action.

(a) In a civil action brought by a person listed in Section 693.013 who
did not object before the removal of corneal tissue, a medical examiner,
justice of the peace, or eye bank official is not liable for damages on
a theory of civil recovery based on a contention that the person's
consent was required before the corneal tissue could be removed.

(b) Chapter 104, Civil Practice and Remedies Code, applies to a justice
of the peace, medical examiner, and their personnel who remove, permit
removal, or deny removal of corneal tissue under this subchapter as if
the justice of the peace, medical examiner, and their personnel were
state officers or employees.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Note: This information includes legislation enacted through the 75th
Congress. The 76th session of the Texas Legislature has concluded. The
State of Texas has not yet made the new codes available to the public.
Until they do, search the bill text for any changes or amendments.

Search 1999 Legislation for: 693.014

[[[as you can see, they knew it was wrong when they wrote the laws. or
they would not have covered the rear-ends so well...TSS]]]
---------------------------------------------------------
thanks again,
kind regards,
Terry S. Singeltary Sr.

############ http://mailhost.rz.uni-karlsruhe.de/warc/bse-l.html ############

----- Original Message -----
From: "Terry S. Singeltary Sr."
To:
Sent: Wednesday, May 31, 2006 4:13 PM
Subject: Brief Report: Investigation into Recalled Human Tissue for
Transplantation --- United States, 2005--2006


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

MMWR Brief Report: Investigation into Recalled Human Tissue for
Transplantation --- United States, 2005--2006
Posted: 5/30/2006


Brief Report: Investigation into Recalled Human Tissue for
Transplantation --- United States, 2005--2006

On September 29, 2005, a human tissue-processing company discovered
inaccuracies in donor records forwarded from a tissue-recovery firm and
notified the Food and Drug Administration (FDA). An FDA investigation
determined that the recovery firm, Biomedical Tissue Services, Ltd. (BTS)
(Fort Lee, New Jersey), recovered tissues from human donors who might not
have met donor eligibility requirements and who were not screened properly
for certain infectious diseases. In October 2005, BTS and the five
processors* that had received the tissues, working with FDA, issued a recall
for all tissues recovered by BTS. The continuing FDA investigation
determined that information for some donors (e.g., cause, place, or time of
death) was not consistent with death certificate data obtained from the
states where the deaths occurred. The investigation also determined that BTS
had failed to recover tissues in a manner that would prevent contamination
or cross-contamination and failed to control environmental conditions
adequately during tissue recovery. These failures were violations of the
Current Good Tissue Practice Rules? (effective May 25, 2005), which require
manufacturers to recover, process, store, label, package, and distribute
human cells, tissue, and cellular and tissue-based products (HCT/Ps) to
prevent introduction, transmission, or spread of communicable diseases. In
January 2006, FDA ordered BTS to cease manufacturing and to retain all
HCT/Ps.

The tissues recovered by BTS had been sent to five processors, who
distributed them through one or more sub-distributors or directly to
clinicians and health-care facilities. CDC learned that, during June
2002--October 2005, approximately 25,000 BTS-recovered tissue products were
distributed to all 50 states and internationally. Most of these tissue
allografts were bone or demineralized bone matrix; others included skin and
soft tissue (e.g., tendons or fascia lata). Before distribution, tissues
were disinfected by tissue processors to reduce or eliminate contamination
with bacteria, fungi, or viruses.

During September--October 2005, the five tissue processors recalled all
products that had been produced from BTS tissues. Each of the processors and
related distributors issued letters to consignees (i.e., health-care
facilities or clinicians) to notify them of the recall and request return of
unused products. The letters included a recommendation by FDA and CDC that
transplant recipients be notified of the recall and offered access to
testing for the communicable diseases for which donor screening is required:
human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C
virus (HCV), and syphilis.

In March 2006, FDA determined that, in some instances, blood samples
submitted for disease screening had not come from the persons from whom the
linked tissues had been obtained. This finding cast doubt on the blood
sample--screening status of the tissue donors, and FDA and CDC issued an
update§ that strongly recommended health-care providers offer patients
access to or referral for testing for HIV, HBV, HCV, and syphilis. CDC
recommendations¶ for testing persons who received BTS tissues call for
patients whose tissue implants have been in place >6 months to be offered
the following tests: HIV antibody, antibody to hepatitis B core antigen,
antibody to hepatitis C virus, a non-treponemal syphilis test (i.e., rapid
plasma reagin [RPR] or Venereal Disease Research Laboratory [VDRL]), and a
treponemal syphilis test (i.e., Treponema pallidum particle agglutination
[TP-PA] or any enzyme-linked immunosorbent assay [ELISA] test). Patients
whose tissue implants have been in place <6 months can be offered the same
tests; however, they also should be retested 6 months after the tissue was
implanted. If all of these tests yield negative results, the likelihood that
one of the diseases was contracted from an implanted BTS tissue is small; no
further follow-up testing is recommended. Patients who have a positive
result for any of these tests should undergo confirmatory or supplemental
testing. Positive test results in recipients of BTS tissue should be
reported to local or state health departments, the tissue distributor, FDA's
MedWatch program (http://www.fda.gov/medwatch), or CDC at telephone
800-893-0485.

FDA and CDC are continuing to investigate reports of BTS tissue recipients
who have undergone screening and tested positive for one of the four tested
diseases. Some positive results would be expected in any U.S. population
tested; the prevalence of current or past infection with HIV, HCV, and HBV
is approximately 0.5% (2), 1.8% (3), and 4.9% (4), respectively.
Transmission of infection via tissue allografts is rare, but transmission of
HIV (5) and HCV (6) to tissue recipients has been documented previously.
However, the relationship between implanted BTS tissue and positive test
results reported to FDA and CDC is difficult to ascertain because of
inaccurate BTS donor records and, in some cases, the absence of properly
linked donor blood samples.

Allograft recipients who are concerned that they might have received tissue
recovered by BTS should contact the health-care providers who performed
their implants. Clinicians with specific questions about the recovery
history of tissues they have used in implants should contact the health-care
facility or the distributor that provided the tissues. State or local health
departments can determine 1) where BTS-recovered tissues were sent and 2)
whether they were implanted by contacting the tissue processors and working
with local hospitals and health-care facilities. Tissue processors and
distributors maintain information they receive regarding tissue providers
and health-care facilities in each state that received products associated
with recalls. However, because information regarding the tissue recipient
might not be available to tissue processors and distributors, state or local
health departments might need to provide patient follow-up by contacting the
health-care facilities where implantation occurred.

Reported by: M Malarkey, R Solomon, MD, C Witten, MD, PhD, E Bloom, PhD, M
Wells, MPH, M Braun, MD, R Wise, MD, C Zinderman, MD, Center for Biologics
Evaluation and Research, Food and Drug Administration. DB Jernigan, MD, MJ
Kuehnert, MD, A Srinivasan, MD, Div of Healthcare Quality Promotion,
National Center for Preparedness, Detection, and Control of Infectious
Diseases (proposed); S Wang, MD, EIS Officer, CDC.

References

American Association of Tissue Banks. 2003 Annual Tissue Bank Survey.
McLean, VA: American Association of Tissue Banks; 2003.
CDC. HIV/AIDS surveillance report: Cases of HIV infection and AIDS in the
United States, 2004. Atlanta, GA: US Department of Health and Human
Services, CDC; 2005. Available at
http://www.cdc.gov/hiv/topics/surveillance/resources/reports/2004report/defa
ult.htm.
Alter MJ, Kruszon-Moran D, Nainan OV, et al. The prevalence of hepatitis C
virus infection in the United States, 1988 through 1994. N Engl J Med
1999;341:556--62.
McQuillan GM, Coleman PJ, Kruszon-Moran D, Moyer LA, Lambert SB, Margolis
HS. Prevalence of hepatitis B virus infection in the United States: the
National Health and Nutrition Examination Surveys, 1976 through 1994. Am J
Public Health 1999;89:14--8.
CDC. Transmission of HIV through bone transplantation: case report and
public health recommendations. MMWR 1988;37:597--9.
Tugwell BD, Patel PR, Williams IT. Transmission of hepatitis C virus to
several organ and tissue recipients from an antibody-negative donor. Ann
Intern Med 2005;143:648--54.

* Regeneration Technologies, Inc. (Alachua, Florida); LifeCell Corporation
(Branchburg, New Jersey); Tutogen Medical, Inc. (Alachua, Florida); Central
Texas Regional Blood and Tissue Center (Austin, Texas); and Lost Mountain
Tissue Bank, Inc. (Kennesaw, Georgia).

? Available at http://www.fda.gov/bbs/topics/news/2004/new01137.html.

§ Available at http://www.fda.gov/cber/safety/bts030206.htm.

¶ Available at http://www.cdc.gov/ncidod/dhqp/tissuetransplantsfaq.html.

Use of trade names and commercial sources is for identification only and
does not imply endorsement by the U.S. Department of Health and Human
Services.


----------------------------------------------------------------------------
----
References to non-CDC sites on the Internet are provided as a service to
MMWR readers and do not constitute or imply endorsement of these
organizations or their programs by CDC or the U.S. Department of Health and
Human Services. CDC is not responsible for the content of pages found at
these sites. URL addresses listed in MMWR were current as of the date of
publication.


Disclaimer All MMWR HTML versions of articles are electronic conversions
from ASCII text into HTML. This conversion may have resulted in character
translation or format errors in the HTML version. Users should not rely on
this HTML document, but are referred to the electronic PDF version and/or
the original MMWR paper copy for the official text, figures, and tables. An
original paper copy of this issue can be obtained from the Superintendent of
Documents, U.S. Government Printing Office (GPO), Washington, DC 20402-9371;
telephone: (202) 512-1800. Contact GPO for current prices.

**Questions or messages regarding errors in formatting should be addressed
to mmwrq@cdc.gov.


Date last reviewed: 5/25/2006


http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5520a6.htm


Body snatchers tied to allograft firms?
Alleged New York-area ring investigated for selling parts to corpse tissue
harvesters.
October 7, 2005: 2:54 PM EDT
By Aaron Smith, CNN/Money staff writer


NEW YORK (CNN/Money) - A Brooklyn funeral home and a New Jersey company that
harvests body parts from corpses are being investigated for their alleged
roles in a body snatching ring that sold parts to companies specializing in
medical grafts, sources close to the investigation said Friday.

The Brooklyn district attorney's office declined to comment on the
investigation. But sources close to the investigation acknowledged that it
has been going on for about one and a half years, focusing on Michael
Mastromarino of Biomedical Tissue Services Ltd. of Fort Lee, N.J., who
allegedly harvested body parts illegally from the Daniel George funeral home
in Brooklyn.

The firms that bought the allegedly black-market tissue have not been
accused of any wrongdoing. Human tissue is usually obtained from non-profit
tissue banks. In the U.S., it's illegal to buy and sell human tissue.

Wendy Crites-Wacker, spokeswoman for Regeneration Technologies (down $0.66
to $7.28, Research), a company in Alachua, Fla., said her company has
severed all ties with Biomedical Tissue Services, their former source for
some of the body parts used to make medical grafts, or allografts.

"We had previously terminated the relationship with Biomedical Tissue
Services and we are cooperating with the appropriate authorities on this
issue," said Crites-Wacker, who declined to say when the termination took
place.

Crites-Wacker also said that her company's BioCleanse process, in which
bones and tendons are sterilized through a melange of chemicals, temperature
and pressure, ensures that its products are safe.

Two other allograft companies have been identified as customers of
Biomedical Tissue Services: LifeCell Corp. (down $2.82 to $17.33, Research),
of Branchburg, N.J. and Tutogen Medical Inc. (down $0.15 to $4.06, Research)
of West Paterson, N.J.

LifeCell Corp. had issued a Friday statement saying it had voluntarily
recalled some human tissue products after questions were raised about
Biomedical Tissue Services.

"Specifically, the company recalled all lots of product that were produced
using tissue from Biomedical Tissue Services (BTS)," LifeCell said in a
release.

LifeCell, which markets products made from human tissues that are used in
surgical procedures, said it recalled certain AlloDerm, Repliform and
GraftJacket products on Sept. 30.

LifeCell's stock price slid about 5 percent this morning, and a Piper
Jaffray analyst attributed the slump to a New York Daily News story that
first reported on the investigation.

"We believe this morning's weakness in LifeCell's shares is related to a
news article that alleges LifeCell inadvertently received tissue from an
illegal body-snatching ring," said Raj Denhoy of Piper Jaffray, in a written
report.

LifeCell said in the statement all other tissues supplied by Biomedical
Tissue Services remain "on hold until the discrepancies in the donor
documentation can be resolved."

Denhoy said that LifeCell did not appear to do anything illegal and that
"LifeCell itself was the victim of fraud," referring to allegations that
Biomedical Tissue Services forged death certificates and family consent
forms.

Denhoy said that LifeCell receives tissue from 30 sources, "so the loss of
one will likely not impact the underlying business," though increased
regulatory scrutiny could drive down the stock price.

"While LifeCell and the other tissue companies appear to have done nothing
wrong, this event could increase regulatory and media scrutiny of the
business," said Denhoy, who rates the company market perform. "We recently
downgraded LifeCell shares on competitive concerns and today's revelations
may pressure the stock further."

Eric Franz, the attorney representing funeral home owners Debora Johnson and
Robert Nelms, said his clients "did not participate in any criminal conduct
whatsoever."

Attempts to reach Mastromarino and his company Biomedical Tissue Services
were unsuccessful. The Daily News reported that Mastromarino declined to
comment.

Regeneration Technologies produces heart valves, bone and tendon implants
and bone paste, which is used to plug holes. LifeCell specializes in
AlloDerm, a "dermal matrix" made from human skin that is used in grafts.
Tutogen focuses on bone and dental implants.

--from staff and wire reports


http://money.cnn.com/2005/10/07/news/midcaps/corpse/?section=money_latest


Order to Cease Manufacturing and to Retain HCT/Ps


January 31, 2006

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Michael Mastromarino, D.D.S.
CEO & Executive Director of Operations
Biomedical Tissue Services, Ltd.
2125 Center Avenue, Suite 300
Fort Lee, NJ 07024-5874

Dear Dr. Mastromarino:

snip...see full text ;


http://www.fda.gov/cber/compl/bts013106.htm

TSE i.e. CJD and the legal stealing of tainted tissue

http://www.rense.com/general62/don.htm

http://disc.server.com/discussion.cgi?disc=7498;article=2820;title=CJD%20Voice%20Discussion%20Group

THE LEGAL TRADING AND SELLING OF BODY PARTS AND TSEs i.e. THE BODY SNATCHERS


http://disc.server.com/discussion.cgi?disc=167318;article=2864;title=CJD%20WATCH

http://disc.server.com/discussion.cgi?disc=7498;article=2818;title=CJD%20Voice%20Discussion%20Group

http://lists.iatp.org/listarchive/archive.cfm?id=119823

http://mad-cow.org/~tom/dec99_news.html#bbb


NIH Researcher Pleads Guilty to Improperly Taking Fees
SELLING TO HIGHEST BIDDER

http://lists.ifas.ufl.edu/cgi-bin/wa.exe?A2=ind0612&L=sanet-mg&T=0&O=D&P=12771


http://blogs.nature.com/news/blog/2006/06/cjdrelated_disease_can_incubat.html


Position Statement vCJD and Dentistry SEAC June 2007


Conclusions
14. Preliminary research findings suggest that the potential risk of
transmission of vCJD via dental procedures may be greater than previously
anticipated. Although this research is incomplete, uses an animal model
exposed to relatively high doses of infectivity, and there are no data from
infectivity studies on human oral tissues, these findings suggest an
increased possibility that vCJD may be relatively efficiently transmitted
via a range of dental procedures........

http://www.seac.gov.uk/statements/state-vcjd-dentrstry.htm


(DH) Precautionary advice given to dentists on vCJD
Thu Apr 19, 2007 11:11
70.110.92.6


http://neurotalk.psychcentral.com/showthread.php?p=89728


Human Tissue Task Force - 2007 Report
Posted: 6/12/2007

http://www.fda.gov/cber/tissue/httf07report.htm


TSS






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