Problems in Developing Artificial Blood

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Artificial blood is a potentially important product for people who need blood transfusions because it carries less risk of contamination than donated blood. Artificial blood might also serve as a supplement to donated human blood, and it could be used in the event of emergencies or shortages of specific blood types. However, like new drugs that are developed, blood substitutes must pass stringent clinical trials.

Various companies have attempted to develop artificial blood. Some blood substitutes are produced through recombinant DNA techniques, in which the gene for the oxygen-carrying compound in the blood, called hemoglobin, is inserted into bacteria, and those bacteria then produce hemoglobin. In another case, a type of artificial blood called HemAssist was engineered to be produced from outdated human blood.

HemAssist was developed by Baxter International and was the first type of artificial blood to go into phase III trials—that is, to be tested in humans. The phase III trials were conducted in Europe on 117 emergency room patients who had traumatic injuries caused by stabbings, gunshots, or accidents. The trial results showed that more patients in the HemAssist group died than in the group receiving donated blood. This was a blow to Baxter International, which decided to shut down the clinical trials. (An additional setback had occurred during previous trials when a slight elevation in blood pressure appeared to be a side effect of HemAssist.) The company closed its $110 million plant in Switzerland and is faced with the loss of its $500 million investment in the research and development of HemAssist.

Most recently, Baxter has approached Alliance Pharmaceutical Corporation of San Diego for an exclusive license to sell and distribute Alliance’s new blood substitute, Oxygent, in the United States, Canada, and Europe. Oxygent is a synthetic, milky-white, fluorocarbon-based chemical that is much more efficient at oxygen transfer than hemoglobin. Phase III clinical trials with surgical patients are ongoing, but so far the results are promising, with fewer patients requiring blood transfusions. However, coronary artery bypass grafting studies were temporarily stopped when some patients had strokes.

Questions

  1. At what point do you think a pharmaceutical company should stop testing a drug because of its adverse effects?
  2. If companies spend a great deal of money on research and development and then cannot market their product, how do you think they make up that loss?
  3. A law called the Orphan Drug Act makes money available for drug companies to develop drugs for rare diseases. Without such an act, companies would not even try to develop such drugs. Could it be argued that this act covers a product such as Oxygent? Give three reasons why or why not.
  4. What incentive is there for Baxter to continue to develop a blood substitute when the company has already tried and failed with HemAssist at great financial loss?

Assignment

Research the types of safeguards that are in place for a patient who participates in a phase III clinical trial. Since HemAssist was withdrawn, what are the options of the patients who participated in the phase III trial?

References

Alliance Pharmaceutical Corporation. http:///www.allp.com/

Baxter Healthcare. http://www.baxter.com/

Blood Bulletin. 2004. 7(1):1–3. Retrieved from: http://www.americasblood.org/download/bulletin_v7_n1.pdf

Blood Substitutes. http://www.emedicine.com/med/topic3198.htm


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