Global effort exposes bid to dismantle Indian lab animal welfare regulations

From ANIMAL PEOPLE, April 2004:

NEW DELHI–An apparent covert attempt to
erase regulatory protection of rats, mice, and
birds in Indian laboratories, in the name of
harmonizing Indian regulations with international
standards, was flushed into the open and at
least briefly delayed on March 19 when an
appalled insider leaked the strategic blueprint
to ANIMAL PEOPLE through a chain of street dog
rescuers.
The document was received on a Friday afternoon.
ANIMAL PEOPLE immediately forwarded
copies to regulatory experts throughout the
world, including several in India, soliciting
comment.
The Indian experts promptly recognized
that the proposed “harmonization” was more a move
to dismantle the entire Indian laboratory animal
welfare assurance structure.
Working through the weekend to provide
informed reinforcement were Humane Farm Animal
Care founder Adele Douglass, who led the effort
to obtain the 1990 addition of dog and cat source
tracking requirements to the U.S. Animal Welfare
Act; Aesop Project founder Linda Howard; Animal
Welfare Institute president Cathy Liss; and
International Society for the Protection of
Exotic Animal Kind & Livestock founder Marc
Jurnove, whose case in 1998 established the
right of private citizens to sue the USDA to
obtain Animal Welfare Act enforcement.
By Monday morning cabinet-level e-mails
forwarded from New Delhi indicated that the
status of the strategic blueprint had been
downgraded to “internal brainstorming,” and
there seemed to be a strong likelihood that no
action would be taken until after the current
Indian national election campaign, and perhaps
not then, depending on the strength and
direction of ongoing global response.

The document leaked to ANIMAL PEOPLE was
entitled Harmonization of CPCSEA Norms in India
With International Norms & Amendment of Breeding
Rules With Regard to Import of Animals for
Experimentation. The author was microbiologist
S.C. Adlakha, Ph.D., who was identified as an
animal health consultant for the Animal Welfare
Division, Government of India.
The CPCSEA, chartered in 1964 and
reconstituted in 1996 after nearly 20 years of
inactivity, is the Indian national advisory body
on animal use in laboratories. It was purged of
prominent animal advocates in mid-2003, a year
after the combination of opposition from the
pharmaceutical industry and pro ponents of
religious animal sacrifice brought the ouster of
People for Animals founder Maneka Gandhi from her
position of five years as minister of state for
animal welfare.
The first two sentences of the Adlakha
paper stated, “USDA regulations exclude rats,
mice, birds, and farm animals used in
agricultural research. We can also exclude these
animals, as well as clinical trials on sick
animals brought to the clinics of veterinary
colleges, from our regulations.”
Later Adlakha noted that,
“Inter-national standards are very high, and we
are not able to modernize animal housing within a
limited time frameŠMost institutions use small
animals, which require less stringent but
adequate provisions at affordable cost.”
Exempting rats, mice, birds, and farm
animals from the CPCSEA guidelines for animal
care would in effect exempt most Indian
laboratories from having to meet either the
existing CPCSEA standards or the standards of
other nations.
Adlakha advised establishing a laboratory
accreditation program modeled after that of the
U.S.-based Association for the Assessment &
Accreditation of Laboratory Care International.
This would provide the appearance of supervision
of animal welfare without guaranteeing the level
of public accountability that the CPCSEA was
constituted to provide.
“Since the United Kingdom lab animal
regulations cover rats and mice,” and since the
European Union is believed to be leaning in that
direction, “it could be argued that global
harmonization of standards will require the U.S.
to improve our standards and cover rats and
mice,” responded Humane Farm Animal Care founder
Adele Douglass.
“All laboratories should be accredited,”
Douglass continued. “Adlakha mentioned several
times the need to use contract laboratories.
They must be accredited as well. In the U.S.,
if laboratories are not AAALAC-accredited, they
will get no funding from the National Institutes
of Health.”
Aesop Project founder Linda Howard
pointed out that the present exclusion of rats,
mice, and birds from the U.S. Animal Welfare Act
was done by an act of Congress, solicited by the
biomedical research industry, against the views
of many regulators.
“In 2000,” Howard recounted, “the USDA
settled a lawsuit [brought by a subsidiary of the
American Anti-Vivisection Society] by agreeing to
begin the rulemaking process to protect rats,
mice, and birds under the Animal Welfare Act.
The American Association for Laboratory Animal
Science stated that they were ‘convinced that all
vertebrate animals used in research, education,
and testing should be afforded protection under
the AWA.'”
Indicating that Adlakha did not intend
that his paper should get the quick and broad
distribution among Indian animal defenders that
it did, he wrote that “We should avoid animal
activists with religious leanings who oppose all
animal experimentation and bring a bad name to
the CPCSEA.”
This was an apparent direct reference to
Brahmins, Jains, and others who observe faiths
with strong teachings about being kind to animals.
Adlakha outlined his apparent primary
concern under the subheading Ethics in Animal
Experimentation.
“We are nearing the January 2005 deadline
when the World Trade Organization patent regime
will become operative in India,” Adlakha said,
“and Indian pharmaceutical companies will have to
compete with multinational corporations in new
drug discovery research to establish a global
position.”
Therefore, Adlakha wrote, “routine
diagnostic and testing” should be excluded from
the categories of experimentation that require
review by institutional animal use ethics
committees.

Exemptions

Further, Adlakha said, “Use of animals
for the production of serums and vaccines is an
important component of health care. As these are
not experiments they should be outside the
purview of the CPCSEA.”
The Indian pharmaceutical industry began
their concerted effort to oust Maneka Gandhi from
the animal welfare ministry and purge the CPCSEA
after Mrs. Gandhi in January 2002 won a series of
rulings from the Supreme Court of India enabling
her to close the King Institute, at Guindy,
Chennai; Haffkine Bio-Pharmaceuticals, of Pune;
Vin Bioproducts, of Hyderabad; the Central
Research Institute, of Kasauli; and Bengal
Chemicals, of Kolkata.
The King Institute and Haffkine
Bio-Pharmaceuticals produced snakebite antivenin
by injecting snake venom into horses and mules.
If properly done, the procedure should
not harm the equines, whose capacity for
resisting the effects of snake venom is many
times that of a human. But 77 horses died at the
King Institute and 84 at Haffkine
Bio-Pharmaceuticals during 2000, allegedly from
overbleeding, underfeeding, and general neglect.
ANIMAL PEOPLE personally verified the
poor care standards at the King Institute, where
the supervising veterinarian insisted that the
horses could eat moldy hay because they have four
stomachs, like a cow, and did not know that
horses’ hooves need to be trimmed.
Haffkine Bio-Pharmaceuticals and the
Central Research Institute were also makers of
anti-rabies vaccines cultivated in the brains of
live sheep, using a process invented by Louis
Pasteur in 1875. Use of the Pasteur vaccine,
instead of newer vaccines cultivated in egg
yolks, has been discouraged by the World Health
Organization for more than 30 years. Not as
effective or safe to handle as the newer
vaccines, the Pasteur vaccine can have
paralytic side effects, and was already
considered obsolete when the Haffkine plant was
built in 1975.

Animal sourcing

Adlakha emphasized broad relaxation of
regulations pertaining to lab animal acquisition.
“Research institutes engaged in
experiments on animals may be requested to
increase their breeding facilities to meet the
requirements of animals for experimentation,”
Adlaka suggested.
Noting that two “large-scale breeding
facilities are being developed in Mumbai for
primates,” Adlakha opined that “The Indian
Veterinary Research Institute has tremendous
potential of being developed as a major supplier
of experimental animals, both small and large.
“There are no breeders for small animals
like frogs, fish, chicks, etc., and all large
animals [such as] cats, dogs, goats, horses,
monkeys, etc.,” Adlakha went on. “Hence it is
impossible to obtain such animals from registered
breedersŠMongrel dogs and cats are usedŠProvision
should be made for limited trapping of such
animals in approved numbers by registered vendors
from approved locations.”
This would in effect introduce to India
an equivalent of the “Class B dealer” system that
was codified as the U.S. status quo by the
Laboratory Animal Welfare Act of 1966, and
incorporated into the present Animal Welfare Act
in 1971.
Long defended as necessary by U.S.
biomedical researchers, the Class B dealer
system is now almost abandoned, chiefly because
researchers themselves came to recognize the
unreliability of experiments done on animals of
uncertain genetic and veterinary history. U.S.
laboratory use of dogs has fallen by two-thirds
since 1979; use of cats has fallen 70% since
1974. While more than 300 Class B dealers sold
random source dogs and cats to laboratories 20
years ago, fewer than 25 continue to supply labs.
Most of the remaining market is for
educational use, but educational exercises using
live animals are also in steep decline.
A 2002 survey by University of California
at San Diego professor of neuroscience and
pathology Lawrence Hansen found that since 1985
the use of live mammals in teaching physiology
had dropped by more than two-thirds, in teaching
surgery had dropped by more than half, and in
teaching pharmacology had fallen by 90%.
On February 27, 2004, the University of
Virginia medical school became the latest of many
to discontinue using dogs in teaching emergency
surgical technique.
Claimed Adlakha, “The non-availability
of large animals, especially monkeys and cats,
is becoming a big stumbling block for some
crucial research work, for which these are the
only experimental modelsŠIt is suggested that for
a period of 10 years, trapping of a fixed number
of monkeys from defined localities should be
allowed to registered suppliers for laboratories
identified by CPCSEA.”
“No one knows the history or health issues of those monkeys,” said Douglas
s.
“This recommendation is not good science.”
India until 25 years ago led the world in
capturing monkeys from the wild and selling them
to laboratories–but that was long before
scientists were fully aware of the many viruses
endemic among nonhuman primates that are
seriously harmful to humans. The HIV virus, for
example, is widely believed to have infected
humans from green vervets, who were either eaten
or used in vaccine research in central Africa,
depending on whose theory one accepts, between
40 and 50 years ago.
In 1977, appalled by the suffering of
rhesus macaques in labs, as documented by the
Blue Cross of India and the International Primate
Protection League, then-Indian prime minister
Morarji Desai banned the export of nonhuman
primates.
Capturing wild primates for laboratory use within
India has continued, but was officially
discouraged during the past 15 years while Maneka
Gandhi served different governments as minister
of forests, the environment, and animal welfare.

Market share

Adlakha warned that without the
regulatory changes he recommended, there might
be a “possibility of pharmaceutical companies
relocating their drug discovery activities
outside the country.”
“This is the same stuff the research
community in the U.S. said 15 years ago about the
changes we wanted,” Douglass observed.
Since the 1990 Animal Welfare Act
amendments that Douglass won took effect, the
U.S. share of the global pharmaceutical market
has increased from 34.7% to 51%.
“Basically, the Adlakha paper says to me that the
Indian pharmaceutical industry wishes to
‘harmonize with international norms’ only when
they can find regulations which would allow them
to decrease standards,” concluded Howard.
“Note: I did not see any reference to the
regulations of any country except the U.S.,
which is not the standard for ‘international
norms.'”
Adlakha further called for an effort to
“Educate the CPCSEA nominees and animal activists
about the importance of animal experiments”; for
limiting CPCSEA membership to “qualified
veterinary scientists, with someŠrecord of
caring for experimental animals and also
promoting scientific research”; for promoting
“research on development of experimental animals
including transgenic animals, and also
alternatives to animal experimentation”; and for
establishing “a centralized National Experimental
Animals Breeding and Supply Center.”

Growth prospects

While Adlakha pushed to relax Indian lab
animal regulation on behalf of the pharmaceutical
industry, scientific opinion is divided as to
whether most branches of animal testing really
are likely to expand.
The European Union in January 2003 approved a
phase-out of the sale of new cosmetic products
which have been tested on animals, to take
effect by 2009.
While that will eliminate an entire
category of animal testing, the EU Registration,
Evaluation, & Authorization of Chemicals program
could potentially require Britain to perform
tests on as many as 6.5 million animals, British
rural affairs minister Alun Michael told
Conservative member of the Parliamentary Select
Committee for Science & Technology Bob Spink on
March 5, 2004.
The EU testing program, called REACH,
parallels the High Production Volume testing
program underway in the U.S., and as in the U.S.
it is possible that much of the required
information can be extrapolated from previous
test data. In addition, some data may be shared
between the REACH and HPV programs.
Sequencing the 30,000 genes that form the
human genome, completed in 2001, has stimulated
experimentation on mice who have been modified to
carry human genes, and nonhuman primates,
especially monkeys.
Swiss lab animal use increased 5.6% in
2001, the first rise since 1983, according to
the Federal Veterinary Office. 446,654 animals
were used in all, more than 90% of them rats and
mice. About 75% were used by private industry.
British lab animal use rose to 2.73
million in 2003, from 2.62 million in 2002–but
the 2002 million were the fewest used in any year
on record, half has many as the highs reached
more than 30 years ago. In both 2002 and 2003,
between 84% and 85% were rats, mice, and other
rodents. About 15% were fish and birds. Below
1% were dogs, cats, horses, and nonhuman
primates.
About 28% of the rats and mice were genetically modified.
Use of rats and mice by the University of Iowa
increased during the 2001-2002 academic year from
16,400 to nearly 100,000, according to the
university office of animal resources. The
combined numbers of cats, dogs, and monkeys
fell from 2,293 to 210.
Massey University in New Zealand used
263,684 animals in 2002. Animal ethics committee
chair Hugh Blair predicted in February 2004 that
the total might soon quadruple.
Anticipating similar growth in mouse
research, Ohio State University in July 2003
announced plans for a $30 million expansion of
animal care facilities, chiefly to accommodate
more mice. OSU animal research chief William
Yonushonis told reporters that the university
currently uses 75,000 animals per year, 92% of
them mice.
Where animal lab expansions have
encountered resistance in the U.S. and Britain,
the work is often jobbed out to other nations.
Intensive protest, for example, on January 27
caused Cambridge University to cancel the planned
construction of a nonhuman primate research lab,
after the projected cost soared 50% in six years
of study. Medical Research Council chief
executive Colin Blakemore, the most prominent
defender of animal research in Britain,
immediately pledged that the work to have been
done at Cambridge would go on “elsewhere in the
world.”
Charles River Laboratories, however,
seems to be betting that animal research is not
the direction of the future. Headquartered in
Wilmington, Massachusetts, Charles River is
still believed to be the largest supplier of
animals to laboratories in the world, and the
Charles River lab animal division is still
reporting annual sales increases–but it has also
expanded promotion of non-animal testing
technology. Circa 1996, sales of lab animals
reportedly accounted for 80% of Charles River
income. By 2001, sales of non-animal tests
accounted for 60%, according to a company
profile authored in 2002 by Boston Globe staff
writer Naomi Aoki.