The leader of the clinical team stated, "Liposomes do not appear to cause inflammation but the effects of long-term repeat dosing have not yet been evaluated...There is a long way to go before the encouraging start is translated into realistic treatment. It is not yet clear which cell type within the lungs should be targeted and it may be that the sub-mucosal glands are at least as important as the epithelium.  Furthermore, the duration of statement of the inserted gene is not known and this is essential information for working out dosage schedules. Finally, the safety of gene therapy needs to be established both for single and multiple applications before Phase III clinical trials can begin"(101Britain`s first clinical trials of CF gene therapy with liposomes were announced in September 1993(102) - pre-dating the first meeting of the Gene Therapy Advisory Committee in November 1993(103).

Gene therapy or gene transfer research in humans, in  Britain, requires approval from the UK Gene Therapy Advisory Committee. For researchers, funding agencies,research charities, local ethical committees, and medical schools, guidelines were issued by the British Department of Health(104). `SCRIP` related (in an article of September 1994) that in an application for use of gene therapy, researchers should include the following points:

*   "the justification for, and scientific validity of, the proposed research"

*   "assessments of the risks of harm and, when the research has a therapeutic purpose,     potential benefits and their `relative weight`"

*  "the degree to which the safety of subjects and third parties is taken into account in the research design"

*  "criteria used to recruit and select subjects"

*  "the means of informing potential subjects (and children`s parents/guardians) and of seeking appropriate consent"(104).

The Gene Therapy Advisory Committee had approved, in principle, (by September 1994) an application for gene therapy research preliminary trial in 15 CF patients(105).

In 1995, `New Scientist` pointed out, "Genetic treatments for cystic fibrosis, a fatal inherited lung disease, have scarcely benefitted patients". The article went on to explain, "liposomes are not very efficient at transferring genes into the nuclei of cells. It takes 1000 vesicles to deliver a single gene"(106).

DRUG TREATMENT
Attempts have been made at developing treatments for the symptoms or complications of cystic fibrosis. Mainly, these have focussed on treating infections, keeping lungs free of sputum, improving airflow, and adequate calories and nutrition(107).

Pulmozyme
As far back as the 1950s, clinicians knew that the thick mucus of human CF sufferers was rich in DNA and that the DNA had a thick consistency(108). CF patients were being treated with natural DNAase (an enzyme which breaks down DNA) derived from the pancreas of cattle, but the treatment caused allergic reactions in patients(109).

In 1990, researchers from Genetech announced that they believed that the thick mucus in human CF patients was a result of large amounts of free DNA released by the white blood cells that accumulate in the lungs to fight infections. One of the researchers conducted a search of the medical literature and read of the clinical findings of the 1950s. From this, he reasoned that the thick mucus might be due to excess DNA and that a DNAase might thin it(110).

Although natural DNAase had previously been derived from bovine pancreas(111), no-one had produced genetically-engineered DNAase before, so the Genetech researcher set out to do just that. He collected a sputum sample from a colleague with CF, and divided the sample into two - mixing one half with recombinant DNAase, and the other half with a saline solution.  Both mixtures were placed in a water bath at body temperature, and the test-tubes inverted. Within minutes, the sputum reacted to the DNAase and liquified, but sodium in saline solution remained thick and unchanged(112).

In 1990, `SCRIP` reported, "The company plans to start to test DNAase in aerosol form initially in young adults with cystic fibrosis to determine the safety and appropriate dosing regimens, studies in children will follow"(113).

In 1993, the `Lancet` announced, "A US Food and Drug Administration advisory panel has unanimously recommended approval of Polymozyme, an aerosolised recombinant human DNAase, for the treatment of cystic fibrosis. In test-tube studies, DNAase has been shown to improve the visco-elasticity of the mucus secretions of cystic fibrosis"(114).

Pulmozyme received full FDA approval in 1993(115) and it is interesting to note that neither `SCRIP` nor `Lancet` made any mention of experiments with the treatment being conducted in any of the supposed CF animal "models" - instead both journals cite the in vitro test-tube studies.

In 1994, Genetech (assisted by the US Cystic Fibrosis Foundation) performed clinical trials which showed the treatment to be beneficial in bringing about a slight improvement in lung function but a dramatic reduction in lung infections(116).

Over the years of clinical use with the treatment, it is not surprising that this initial clinical finding should be reiterated by the US Cystic Fibrosis Foundation - which states on its website, "Pulmonzyme reduced the number of respiratory infections and
improved lung function"(117).

Any animal expermentation which was conducted with the treatment would have been irrelevant. The development, and initial findings, were dependent on in vitro studies with human DNAase. It was the initial clinical trials which demonstrated beneficial effects to the lungs of human cf patients.

POSTSCRIPT
Take the DNA of two people from any two parts of the world. They would differ by approximately one letter in every 1,000-2,000 in their genetic code. Now consider that each of these individuals has about 3.2bn letters making up their complete genetic
sequence, and consider also that most variation between humans occurs when single letters change in that code. This means there will be about 1.6m-3.2m places where genetic codes differ.

Many of these differences, are considered, neutral: not all differences in DNA being the consequence of an evolutionary adaptation (all mutations occur by chance but have nonetheless grown within our populations, also by chance). Some estimates suggest less than 1 per cent of all DNA sequence differences will be associated with a functional difference.

Bearing that in mind, this still leaves thousands and thousands of significant genetic differences between individuals. In addition, it is estimated that well over 90 per cent of human genes exist in more than one form in the human population. Some genes are known toexist in as many as 60 different forms.

So, not only is there enormous genetic variation between individuals, but that variation exists across nearly all of our genes.

The idea of 99.9 per cent similarity, then, is a kind of deceit(118).

Now apply this scientific knowledge to any species of non-human animal, extrapolate the information and consider what relevance that data will have in application to humans = nothing.

Species differences, inter-species differences, intra-species differences, inter-breed differences, intra-breed differences; right at the fundamental genetic and chromosomal level.

With the advent of modern technology and increasing knowledge, we now know that the differences between humans and animals that exist on the cellular level outweigh the similarities on the superficial level.  Disease occurs on the cellular level. Humans suffer from diseases that have uniquely human manifestations.  The only people calling for more animal experimentation, in light of the knowledge that has come from the human genome project, are those who will profit financially from more animal experimentation.  Consider the source(119).                                          continued
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TREATMENT
"We have treated hundreds of these patients and the procedure is being done around the country and is approved by the FDA. We found that by putting a little saline solution into the Heimlich Micro-Trach, it forces a cough that expels secretions and also loosens the mucus. It seemed logical - logical is the operative factor - that if we used this method in cystic fibrosis (CF), it would clear out the secretions that kill CF patients.

"Ninety-eight percent of CF children die because of the thick secretions in the lungs, causing infections and destroying the lungs. They die mostly in childhood or adolescence. Some now get to over age twenty. So if you put the Micro-Trach into the CF patient and they squirt a little saline solution through it, it obviously loosens the secretions, which they cough up.