A TOUGH LITTLE NEURO-INVADER
April 10, 2001
Scientific American
http://www.sciam.com/2001/0501issue/0501scicit1.html
Malformed prions are thought to cause TSEs. But not all the evidence
supports
this so-called protein-only theory. A few researchers believe some kind of
mini
virus might be involved, but there has been no evidence of nucleic acids in
infectious prions. In any case, the malformed prions aren ecessary to
produce
TSE, and getting rid of them is difficult, because the prions Withstand
typical
Cooking temperatures Are impervious to radiation (one argument against
viral involvement) Resist proteases, enzymes that break down protein
Sterilizing instruments against abnormal prions can be tricky. Autoclaving
at
134 degrees Celsius inactivates them, but paradoxically,a utoclaving at
138 degrees C does not. A prior soak in sodium hydroxide is recommended.
ORTHO-CLINICAL DIAGNOSTICS COLLABORATES WITH CAPRION
PHARMACEUTICALS ON
BLOOD-SCREEN TEST AND DIAGNOSTIC FOR HUMAN STRAIN OF 'MAD COW
DISEASE'
April 5, 2001
From a press release
RARITAN, NEW JERSEY and MONTREAL, QUEBEC-- Ortho-Clinical Diagnostics has
Taken an Option to License Caprion's Prion Technologies Including Unique
Monoclonal Antibodies for the Detection of the Agents for Creutzfeldt-Jacob
Disease
Ortho-Clinical Diagnostics Inc., a Johnson & Johnson company (OCD),a nd
Caprion Pharmaceuticals Inc. (Caprion) announced today that they
would begin a research collaboration to develop a human blood test forn ew
variant Creutzfeldt-Jacob Disease (vCJD).
OCD has taken an option to license Caprion's prion technologies including
Caprion's unique monoclonal antibodies for the detection of the agent
behind vCJD, the human equivalent of Mad Cow Disease, for human in vitro
diagnostic applications.
vCJD is a fatal neurodegenerative condition which has taken the lives ofa t
least 90 people in the UK and Europe. There is currently no cure for
the condition, which is believed to be caused by the ingestion of meatf rom
cows infected with the disease. Both Canada and the United States
have banned blood donations by individuals who lived in the UK during the
height of the Mad Cow Disease epidemic.
"This agreement illustrates the commitment of Ortho-Clinical Diagnosticst o
the safety of the world's blood supply and to seeking technology
partners, such as Caprion, that are operating at the leading edge of
technology and advancing diagnostic medicine," stated Gerard Vaillant,
Chairman of OCD.
"This collaboration and our previously announced agreement with our
veterinary partners, IDEXX Laboratories, is a vote of confidence in our
core proteomics technologies by two of the leading global developers of
diagnostic products," said Lloyd Segal, President and CEO of Caprion.
"With the support of OCD and with our existing collaborators at IDEXX, we
believe that we are extremely well positioned to provide the
technology that will enable these premier companies to deliver the products
that make the routine screening and diagnosis of infected humans
and cattle possible."
Ortho-Clinical Diagnostics, a Johnson & Johnson company, is a leading
provider of high-value diagnostic products for the global health care
community and is committed to developing the most advanced tests for early
detection and diagnosis of disease. The Company has a wide
variety of products and services for blood screening and typing, clinical
chemistry and immunodiagnostics that help health care organizations
provide better patient care.
www.caprion.com.
CONSUMER BRIEFING ON BOVINE SPONGIFORM ENCEPHALOPATHY (BSE)
AND
TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES (TSE)
April 3, 2001
Federal Register (Volume 66, Number 64)
[Page 17719]
[DOCID:fr03ap01-64]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of meeting.
The Food and Drug Administration (FDA) is announcing the following consumer
meeting: Consumer Briefing on Bovine Spongiform Encephalopathy (BSE) and
Transmissible Spongiform Encephalopathies (TSE). This briefing is the first
in a series of consumer briefings on the consumer protection priorities
discussed by the agency and consumers at the December 13, 2000, Consumer
Roundtable on Consumer Protection Priorities meeting. These consumer
briefings enable the agency and consumers to sustain a dialogue on FDA
priorities of high consumer interest in the spirit of openness,
transparency, and participation. This consumer briefing will provide an
update on FDA's efforts to ensure the safety of products that may contain or
are manufactured with bovine-derived ingredients.
Date and Time: The briefing will be held on April 16, 2001, 1 p.m. to 4:30
p.m. Registration will open at 12 noon.
Location: The briefing will be held at Holiday Inn Capitol, Columbia II,5 50
C St., SW., Washington, DC.
Contact: Karen R. Mahoney, Office of Consumer Affairs (HFE-88), Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4393,
FAX 301-827-2866, e-mail: Kmahoney@oc.fda.gov.
Registration: Preregistration is required as space is very limited. Send
registration information (including name, title, organization/firm name,
address,hone, fax number and e-mail) to the contact person by April 13,
2001. Preregistered consumer attendees will be given first priority for
seating.
If you need any special accommodations due to disability, please contact
Karen R. Mahoney (address above) by April 13, 2001.
Transcripts: Transcripts of the meeting may be requested in writing fromt he
Freedom of Information Office (HFI-35), Food and Drug Administration, 5600
Fishers Lane, rm. 12A-16, Rockville, MD 20857, approximately 15 workingd ays
after the meeting at a cost of 10 cents a page.
BSE UPDATE
April 4, 2001
A ProMED-mail post
Switzerland Reports 3 More Cases BSE
HAMBURG: The Swiss Federal Veterinary Agency said Wednesday 3 more caseso f
Bovine Spongiform Encephalopathy (BSE), or mad cow disease, have been found
in Switzerland. This brings the number of confirmed cases to 8 in 2001.O ne
case was in the Zug canton (local government area), one in the Bern canton
and one in Schwyz. In 2000, Switzerland had 33 BSE cases.
Switzerland imposed a ban on feeding meat and bone meal (MBM) to cattlei n
May 1996.
BRUSSELS: The European Commission said on Monday its scientific advisers
believe certain east European countries including Poland, the Czech
Republic, and Hungary are likely to have mad cow disease in their cattle
herds. The opinion, issued by the scientists on a range of non-European
Union countries, forms part of the Commission's assessment of mad cow, or
bovine spongiform encephalopathy (BSE), risk among countries seeking to
export beef to the EU.
Albania, Cyprus, Estonia, the Slovak Republic, Poland, the Czech Republic,
Hungary, Lithuania, and Switzerland were classed "category III," meaning
"likely to present a BSE risk, even if not confirmed, or presenting a low
level of confirmed BSE risk." All those countries not in "category I" --
BSE highly unlikely -- have to remove potentially dangerous cattle tissues
such as spinal cords at the slaughterhouse from meat they intend to export
to the EU. The Commission said the countries in category III had imported
significant numbers of live cattle and meat and bonemeal from EU countries
where BSE has been confirmed. "Therefore it is regarded likely that their
cattle herds were exposed to potentially BSE-contaminated feed and
subsequently infected," the Commission said in a statement. Switzerland
remains the only country outside the EU to have confirmed the presence of
native cases of mad cow disease.
The category II country list, where a BSE risk is deemed to be unlikelyb ut
is not excluded, contains the United States, Canada, India, Pakistan, and
Colombia. Category I countries include Argentina, Australia, Brazil, Norway,
and New Zealand.
[UK] Ministers are considering banning hundreds of medicines after the
makers failed to prove they do not risk infecting patients with the human
form of Mad Cow Disease. The Health Department says 800 drugs breach
European Union rules on medicine safety. Many use animal material such as
cattle serum. Companies were warned as long ago as 1989 not to use serum
from cattle that could have been exposed to the risk of infection by BSE.
Ministers will not reveal which drugs are involved in the new scare but
insist all vaccines and inoculations in Britain, including the controversial
measles, mumps, and rubella jab, have passed tests.
A deadline expired this month for drug firms to prove products are freef rom
CJD.
No information was given to ministers on almost 1000 pharmaceutical
products. It is understood this remains the case for some 800 medicines.
The Medicines Control Agency has been told to make risk assessments ofa ll
products whose makers failed to submit scientific proof that they were
BSE-free. Asked about the possibility of medicines being banned, a senior
Health Department source said: "We won't hesitate to act to protect public
health if advised to do so."
Despite some drug companies effectively breaking the law, the Health
Department refused to say if they will be prosecuted.
[Byline: Patrick O'Flynn, Political Editor]
[On 30 Mar 2001 the UK Minister of Health was asked in Parliament about
bovine products used in producing various vaccines, specifically in relation
to vaccines given to British troops in the Gulf:
<http://www.publications.parliament.uk/pa/ld199697/ldhansrd/pdvn/lds01/text/
10330w02.htm#10330w02_sbhd1>