I would NOT like to advise anyone, what stock to buy or not to buy. Each person should make their own decision. I would like to confine myself to science part of a product, and when appropriate, my interpretation of facts.
(1) I read with interest the claim that Biopure bovine Hb will be stable at room temp. I do have problem digesting that. I would like to know more about the validity of that claim and scientific data to back the claim. Recombinant Hb solution produced by Somatogen will be stable in refrigerated state for one YEAR. This is possible because, 6 weeks life of stored blood is due to metabloic reactions in RBCs, involving various enzymes. Since Hb solution will not have such metabloic enzymes, stability should be enhanced. They stated that they are working on lyophilized version for stability at room temp.
(2) I still believe that once genetically engineered product is available, very few people would want animal/bovine products. Even products which have been in use for years, get jettisioned quickly. It happened to Insulin, growth factor, Hepatitis vaccine. It is not only a question of blood borne infection, but idea of prefering synthetic or genetically engineered product over animal/bovine product.
(3) I must respectfully disagree with your contention that bovine products will not face supply constraint. How can one get millions of grams of Hb from birds? Which type and how many millions of birds can yeild such an industrial quantity of Hb?
The time to demonstrate to FDA "safe and effective" for Human use is very demanding and lengthy, for everyone. Biopure is just starting to take the initial steps. If it is hard and cumbersome to conduct trials of Human or Genetically engineered product, bovine product will have even tougher time. First, they will have to prove that Human beings can tolerate the product without developing allergic reactions/ antibodies. Even if everything went picture perfect, it will be 5-7 years before the product can come to market.
The fact that someone got financing is different and in no way implies that their product will work scientifically. All companies working on Hb substitutes had venture capital funding and financing. NO One has commercial product yet. How many Silicon valley companies and how many biotech companies have gone caput, after venture capital funding. REALITY IS THAT MOST BIG MONEY PEOPLE DO NOT HAVE DEEP SCIENTIFIC BACKGROUND TO UNDERSTAND THE VERY COMPLICATED SCIENCE INVOLVED AND THE NATURE OF THE PRODUCTS. In 1995, everyone thought that there was no end to demand for technology products, billions of Dollars were poured like crazy into tech stocks. Are we little more sober today?
BHARAT H. BARAI MD
HEMATOLOGIST |
