Hello, ermite-ga!
After many hours of research in numerous public and proprietary
databases, I have to say that the transmission of animal diseases
(primarily BSE) to humans through animal-derived pulmonary surfactants
is still theoretical. However, the prospect is worrisome enough that
research is accelerating to find better synthetic forms to replace
animal-derived products.
I have found no scientifically-based research studies linking human
disease derived from animal-based surfactants. If such cases did
exist, I am sure that my searches would have been inundated with
"scare stories" from special interest groups as well as from
legitimate scientific sources. Such transmission would undoubtedly put
an immediate stop to the use of animal-derived surfactants in most
countries around the world.
I have provided some references that allude to the "potential" for
animal-to-human disease transmission from pulmonary surfactants, but
have found no evidence of existing cases. I have also provided several
references to the newest synthetic surfactant up for FDA approval,
since the articles also include some mention of the theoretical risk
for transmission of animal disease in the natural products.
==
From "Pulmonary surfactant: functions, abnormalities and therapeutic
options," by Ilka Frerking, Andreas Guntehr, Werner Seeger and Ulrich
Pison. Intensive Care Med. (2001) 27: 1699-1717.
http://www.dea-cardiopneumo.org/doc_telechargement/biblio_r/Jarreau_Pulm%20Surf_IntensCareMed2001.pdf
..synthetic surfactants such as ALEC and Exosurf have been promoted as
being more uniform in composition and safer, as there is no
transmission risk of diseases such as bovine spongiform encephalopathy
(BSE) or the potential of allergic sensitisation to animal SP-B or
SP-C."
==
From "Exogenous surfactant therapy: newer developments." Thierry
Lacaze-Masmonteil. Service de Pédiatrie et Réanimation Néonatale,
Hopital Antoine-Béclère, Assistance Publique/Hopitaux de Paris 92141,
Clamart, France. Seminars in Neonatology (2003) 8, 433-440
http://www.simponline.it/archivio/exogenous_surfactant_therapy.html
"If adverse immunological reactions have not been recognized among
preterm infants treated with natural surfactant extracts, concerns
still remain for the administration of animal-derived proteins in more
immunocompromised populations, such as children or adults with acute
lung injury. This complication could be avoided with the use of
synthetic surfactants containing phospholipids and chemically or
genetically engineered homologous peptides.38 Treatment with such
preparations, available in unlimited amounts in contrast to
animal-derived surfactants,
** would also completely eliminate the already very low and
hypothetical risks of transmission of viral or unconventional
infectious agents.
It is therefore not surprising that the development of a new
generation of surfactants is presently the subject of intensive
research."
==
From EBSCO Database: (Two articles from Suresh)
====================
Title: Lung surfactants for neonatal respiratory distress syndrome:
animal-derived or synthetic agents?," Suresh GK; Soll RF. Source:
Paediatric drugs [Paediatr Drugs] 2002; 4 (8), pp. 485-92.
The abstract mentions the theoretical possiblility of transmission of
infectious agents and immunogenicity, stating that natural surfactants
are still preferred over synthetic products.
=
"Exogenous surfactant therapy in newborn infants." Suresh GK; Soll RF
Annals of the Academy of Medicine, Singapore [Ann Acad Med Singapore]
2003 May; 32 (3), pp. 335-45
Again mentions the advantages of natural surfactants over synthetic,
but mentions that the search for newer surfactants is underway.
===
(Dated but interesting)
"Guidelines for good practice in the management of neonatal
respiratory distress syndrome. Report of the second working group of
the British Association of Perinatal Medicine." Guideline produced in
November 1998, Not valid beyond 2002
http://www.bapm.org/documents/publications/rds.pdf
"Administration of materials containing foreign animal proteins has
also led to concerns of immunogenicigty but as yet there is no
evidence of a significant immunological disturbance. There is a
theoretical risk of prion transmission although Survanta is prepared
from New Zealand cattle, where BSE has not been identified; porcine
products have not been associated with any transmitted prion disease."
THE PUSH FOR APPROVAL OF A NEW SYNTHETIC SURFACTANT - SURFAXIN
===============================================================
The reference to the "potential" for disease transmission from
animal-derived surfactants is mentioned in the press release promoting
the superiority of the new drug, Surfaxin, that has recently been
submitted for FDA approval.
From "Discovery Laboratories Files New Drug Application with the FDA
to Market Surfaxin for the Prevention of Respiratory Distress Syndrome
in Premature Infants." Drugs.com
April 2004. http://www.drugs.com/nda_surfaxin_040414.html
"Surfaxin - an engineered surfactant with the potential to address RDS
worldwide. Surfactants are substances that are produced naturally in
the lungs and are essential to the lungs' ability to absorb oxygen and
to maintain proper airflow through the respiratory system. Premature
babies are born with a lack of natural surfactant in their lungs.
Without surfactant, the air sacs in the lungs collapse and are unable
to absorb sufficient oxygen resulting in RDS. The current standard of
care for treating these patients is Surfactant Replacement Therapy
using animal-derived surfactants. Animal-derived products are prepared
using a chemical extraction process from cow and pig lung washes or
from the mincing of these animal lungs. Because of the inherent
limitations of animal-derived products, the manufacture of large
quantities of high quality product can be problematic and their use is
largely limited to North America and Western Europe.
Discovery's Surfaxin is an engineered version of natural human lung
surfactant and contains a peptide, sinapultide, that is designed to
closely mimic the essential human lung surfactant protein B (SP-B)."
******
"Surfaxin, unlike the animal products, can be produced in virtually
unlimited quantities, in consistent pharmaceutical grade quality, and
** has no risk of potential transmission of animal-associated
diseases."
*******
Another reference to possible infectious transmission is included in
the following quote from Thomas E. Wiswell, M.D., a Professor of
Pediatrics, Division of Neonatology, SUNY at Stony Brook, a leading
neonatologist and member of Discovery's Scientific Advisory Board:
From "Discovery Laboratories (DSCO) Announces Results Of Its
Supportive Phase 3 Clinical Trial Of Surfaxin For Respiratory Distress
Syndrome In Premature Infants." Biospace. June 4, 2004.
http://www.biospace.com/ccis/news_story.cfm?StoryID=12889220&full=1
"I am optimistic about Surfaxin. Surfaxin mimics the most active
protein found in human surfactant (the essential surfactant protein,
SP-B) and, in contrast to the animal-derived products, Surfaxin has
the potential to be produced in virtually unlimited quantities, at
lower costs, and *** without infectious or antigenic consequences."
===
Direct reference to the possibility for transmission of Bovine
Spongiform Encephalopathy is made in the following statement about
Surfaxin:
From SARS: Assessment, Outlook, and Lessons Learned." Subcommittee on
Oversight and Investigations. Dr. Robert J. Capetola Ph.D. President &
Chief Executive Officer - Discovery Laboratories, Inc. May 7, 2003
http://energycommerce.house.gov/108/Hearings/05072003hearing917/Capetola1444.htm
"In addition, we believe that our engineered humanized surfactants
might possess other pharmaceutical benefits not currently found with
the animal surfactants such as longer shelf-life, reduced number of
administrations to the patient?s lungs,
* and elimination of the risk of animal-borne diseases including the
brain-wasting bovine spongiform encephalopathy (commonly called
"mad-cow disease"). Our humanized surfactant technology was invented
at the world-renowned Scripps Research Institute and was further
developed and licensed to us by Johnson & Johnson."
From the CDC
=============
The Center for Disease Control makes no mention of pulmonary
surfactant transmission of BSE on their fact sheet:
"Questions and Answers Regarding Bovine Spongiform Encephalopathy
(BSE) and Creutzfeldt-Jakob Disease (CJD)
http://www.cdc.gov/ncidod/diseases/cjd/bse_cjd_qa.htm
** They do, however, mention the relation of infected animal tissue in
Creutzfeldt-Jakob Disease
From "Questions and Answers Regarding Creutzfeldt-Jakob Disease
Infection-Control Practices. CDC.
http://www.cdc.gov/ncidod/diseases/cjd/cjd_inf_ctrl_qa.htm
"Have there been any reports of iatrogenic transmission of CJD?"
"Yes, iatrogenic transmission of the CJD agent has been reported in
over 250 patients worldwide. These cases have been linked to the use
of contaminated human growth hormone, dura mater and corneal
grafts..."
POTENTIAL TRANSMISSION OF ANIMAL DISEASE BY VACCINE AND NUTRITIONAL SUPPLEMENTS
===============================================================================
TSE and Rabies vaccine:
See "7.6 Could vaccines prepared from animal brain tissue pose a risk
of transmission of Transmissible Spongiform Encephalopathies to
humans?" World Health Organization Consultation on Public Health and
Animal TSE's. (2000)
http://www.who.int/emc-documents/tse/docs/whocdscsraph20002.pdf
==
Read:
Date: September 06, 2001 RE: Mad Cow Disease Suspected in
Pharmaceuticals and Supplements Petersen M, Winter G. 5 Drug Makers
Use Material With Possible Mad-Cow Link. The New York Times. February
8, 2001:C1 - 5. Anon. Medicine Capsules Found to Be Safe. (Reuters).
USA Today. July 2, 2001.
http://herbalgram.org/naturemade/herbclip/pdfs/032410-201.pdf
==
Supplements which contain animal extracts are considered a threat now
that mad cow disease has entered the United States
From "Nonfood use of cow parts faces review," by Dorsey Griffith.
Sacramento Bee. January 13, 2004.
http://www.sacbee.com/content/business/agriculture/story/8092123p-9024490c.html
"Now that the United States has mad cow disease, federal regulators
are reconsidering long-held policies aimed at prohibiting importation
of products or ingredients with bovine tissue or blood from countries
with documented cases of the illness. The products include vaccines,
nutritional supplements and cosmetics, all of which can contain
ingredients derived from cows."
"Bovine ingredients can be found in several nonmeat products. Many
immunizations are grown in blood from calves. Some supplements contain
bovine brain or myelin -- the sheath surrounding a cow's spinal cord."
"The FDA has long been aware of the potential -- however remote -- of
BSE being transmitted via nonmeat products. In the early 1990s, when
many immunizations were made with bovine serum imported from countries
where BSE existed, the agency alerted vaccine manufacturers."
"Fetal calf blood is used to create the cultures in which viruses and
bacteria are grown for vaccine development."
"We said, 'Keep the vaccine because the benefit of having vaccine so
far outweighed any theoretical risk,' " Lumpkin said. "On the other
hand, we said, 'If you can do it from serum from a BSE-negative
country, do it by all means.'"
"Dean Cliver, a University of California, Davis, expert in BSE and
food safety and a former member of the FDA's advisory committee on
transmissible spongiform encephalopathies, noted the potential problem
now facing U.S. regulators and vaccine companies."
"The FDA took the position that any foreign bovine serum was
undesirable because of the risks," Cliver said. "Now that we are a BSE
country, 'foreign' doesn't apply anymore."
(Read more about the difficulty in regulating supplements....
==
Also read "Some pills contain dried cow parts," by Heath Foster.
Seatlle Post-Intelligencer. December 31, 2003
http://www.organicconsumers.org/madcow/parts123103.cfm
==
Again....the potential for animal-borne disease transmitted to humans
through pulmonary surfactants appears to be theoretical. Although it
is entirely possible that a case has occurred which has never been
diagnosed or reported, I have no doubt that if the public got wind of
such an event, there would be an immediate outcry.
The push to develop synthetic surfactants which are both readily
available to the world population and considered just as good as
natural extracts is partially due to the "potential" for disease
transmission. Economics and need, however, seem to be the biggest
drivers behind the development of the synthetic surfactants, as
opposed to the remote possibility of contracting an animal-borne
disease.
Since none of the databases I searched turned up any actual cases of
transmitted disease, I certainly hope that my research has served to
meet your goal of getting "the strait dope", as you put it!
Best regards!
umiat
Google Search Strategy
animal-derived pulmonary surfactants and disease transmission
disease transmission from animal-derived surfactants
dangers from animal derived pulmonary surfactants
dangers from animal surfactants
pulmonary surfactants from animal extracts
prion transmission to humans +surfactants
disease transmission from pulmonary surfactants from animal extracts
Lung surfactants AND transmission of BSE
Lung surfactants AND BSE
BSE transmission from pulmonary surfactants "animal extracts"
Also searched several proprietary databases, including EBSCO, Medline,
Proquest, etc. |
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