Since no one has posted on this thread for a long time,
I thought I would put this in. I remember that you had
written about the vaccine for cows a time or two. I wondered
if you would give an opinion on my idea.
Nabi Business Plan
I am going to suggest a fundamental shift in Nabi's plan for vaccines. In brief, instead of concentrating on producing a vaccine for humans, I am suggesting that they
concentrate on producing a vaccine for cows. I am not an expert in vaccine production or animal husbandry, so what follows is JMHO.
One reason for this shift in policy is the market for bovine vaccine is much larger than for human vaccine since the incidence of staph infection in cows is
much larger than in humans. More important, I will show that dairy farmers will want to use the vaccine because it will increase their profit, in a fairly linear manner, from each
cow that receives the vaccine. In fact, the vaccine trial that I am going to propose will
have as one end point, the dollars and cents value of the milk produced. I expect that
the milk production of the cows that receive the vaccine will be be significantly larger
than for those who do not receive the vaccine.
Finally, I think that Nabi might reasonably expect the NIH to help support the cost for this trial, since a successful result would mean much less use of antibiotics by dairy farmers, therefore less development of antibiotic resistant strains that can affect
both humans and animals.
First, here is an abstract which illustrates the widespread nature of staph infections.
Milk samples were collected from 108,312 dairy cows during 1601 farm visits made between January 1991 and June 1995. The herd visits were made by personnel from the Central Laboratory of the Quality Milk Promotion Services at Cornell University (Ithaca, NY) to farms located in central New York and northern Pennsylvania.
Dairy Herd Improvement Association records were available for 32,978 cows in 327 herds. Intramammary infections, as defined by positive milk cultures, were present in 48.5% of all cows and in 36.3% of cows in herds enrolled in
the Dairy Herd Improvement Association. Over 75% of the intramammary infections were caused by Streptococcus agalactiae, Streptococcus spp. other than Strep. agalactiae, Staphylococcus aureus, and coagulase-negative staphylococci.
The major technical factors which cause the disease are poor milking hygiene, milking machine faults, faulty milking management, teat injuries and teat sores. Mastitis can be peracute, acute, sub-acute, and sub- clinical.
Because of the widespread of the organisms that cause mastitis, eradicating the disease is impossible.
However, with good hygiene and management, mastitis can be kept well under control. Flies may
spread the disease from teat to teat. Therefore, fly control may be required.
Here is a link to a report which discusses manifestations and costs of the disease.
ext.nodak.edu
Clinical Mastitis -- visible signs of mastitis which include:
Mild signs flakes or clots in the milk, may have slight swelling of infected quarter.
Severe signs secretion abnormal, hot, swollen quarter or udder; cow may have a fever, rapid pulse, loss of appetite, dehydration and depression; death may occur.
Sub-clinical Mastitis -- no visible signs of the disease:
Somatic cell count (SCC) of the milk will be elevated.
Bacteriological culturing of milk will detect bacteria in the milk.
Causes the greatest financial loss to dairy farmers through lowered milk production.
For every clinical case of mastitis, there will be 15 to 40 sub-clinical cases.
Finally, here is an analysis of the cost elements on a per cow annual basis. This was provided in the
same document that yielded the Mastitis description and represents costs in 1996. For example,
milk at $12.07 per hundred weight. The organization that produced the report is the National Mastitis Council.
Reduced Production $121.00
Discarded Milk $10.45
Replacement Cost $41.73
Extra Labor $1.14 .
Treatment $7.36
Veterinary Services $2.72
Total $184.40
From a Nabi investor point of view, a big question is:
How much will it cost to produce and deliver a dose of vaccine to a cow? I have no
direct knowledge but I think the people at Nabi can make a good estimate.
The next question then is:
How well does the vaccine work in reducing the cost of mastititis in a herd of cows?
Does vaccination of a herd produce a net profit for the farmer compared with not doing it?
No one knows the answer to these questions, and obtaining the answer is the purpose
of my proposed "Phase III" vaccine trial. I think that samples of a few thousand cows,
one group vaccinated and one group unvaccinated could be compared over a years time.
I see no reason for blinding, there are no subjective measures.
I admit I am biased, but from what I have read about the human vaccine, and because
scientific people have been very impressed by how well the human drug works I think
that will significantly reduce the incidence of mastitis in vaccinated cows.
Since the incidence of infection of sub-clinical masititis can approach 50% in a herd,
any significant reduction will have a big economic benefit.
There are about 9.5 million dairy cows in the U.S. , so mastitis is costing about 1.8
billion in this country alone. The total cost in the rest of the world is probably greater
than that. I would think bovine staph could be a billion dollar drug.
Norman |
