reprinted from the Yahoo message board.
In an official "Dear Doctor" letter, the FDA today warned doctors of the increased risks of using albumin
and PPF (plasma protein fraction) and "urged treating physicians to exercise discretion in the use of
albumin and PPF". The FDA issued this warning after reviewing the recent articles in the British Medical
Journal (BMJ) which reported a 6% increase in mortality associated with the administration of albumin
and/or PPF.
"It is FDA's current view that the cited studies warrant serious consideration. FDA encourages additional
controlled trials on the use of albumin and PPF and is committed to working with the product
manufacturers to determine whether the label indications for albumin and PPF should be revised. Until the
results of further, well-focused studies are available, the FDA urges treating physicians to exercise
discretion in use of albumin and PPF based on their own assesment of these data."
At present, there are three choices available to doctors to treat hypovolemia (shock) and other indications
for plasma volume expansion: crystalloids (salt water and Ringer's lactate), generic hetastarch in saline
(Hespan), and albumin. Crystalloids cause edema, a life threatening condition. Hespan causes coaguation
problems when used in amounts above about one liter. And now, albumin has been shown to cause
increased mortality.
The only other possible solution close to reaching the market to treat hypovolemia caused by trauma or
surgery is BioTime's Hextend, which has been shown to be safe and effective in Phase III clinical trials.
Hextend also demonstrated superior coagulation performance and required use of less blood products
(including PPF) in these trials in comparison to Hespan. These results were reported in a poster paper
presented last January at the Anesthesiology conference in San Juan, Puerto Rico.
I expect a peer-reviewed paper describing in detail the results of the Phase III trials to be published in a
scientific journal before the end of the year. Some of the data in this paper (not shown in the poster paper)
demonstrating superiority of Hextend was examnined by me at BioTime and may be shown to BTIM
shareholders if they visit the company.
Paul Segall stated in a past press release that he expected the marketability of Hextend to be decided by the
end of the year.
Hexted is, of course, presently being evaluated by the FDA for marketability in the US.
September should be a very interesting month for BioTime shareholders.
--Mark A. Voelker, PhD
(Speaking for myself as a BTIM shareholder since 1995.
I am not nor have ever been an employee of BioTime.)
mesaone's website can be viewed at:
inch.com
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