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Artificial Blood

Bioethics Case Studies

For many years, Baxter International has worked on developing a type of artificial blood, called HemAssist. Artificial blood is a potentially important product. Donated blood carries the risk of HIV and hepatitis, and, though the risk is getting smaller, many people still worry about a contaminated blood supply.

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, which then produce hemoglobin. HemAssist, on the other hand, was engineered to be produced from outdated human blood.

Although other companies are working on types of artificial blood, Baxter was the first to go into Phase III (human) trials. The blood works as a supplement to donated human blood, and it was thought the blood could be used in emergencies or in cases of shortages of specific blood types.

The Phase III trials were conducted on 117 patients in emergency rooms in Europe. The patients had traumatic injuries, caused by stabbings, gunshots, and accidents. The trials showed that more patients died in the HemAssist group than in the group receiving donated blood. This was a blow to Baxter.

Earlier, the U.S. Army had almost decided to use HemAssist for injuries in the Gulf War, but backed out because of a side effect, a slight elevation in blood pressure, which showed up in previous trials.

After these setbacks, the company is closing a $110 million plant in Switzerland. Facing a loss of $500 million investment in research and development, it has still not decided whether to discontinue its trials of HemAssist.

Questions

  1. Should Baxter withdraw the drug?
  2. If companies spend a great deal of money on research and development and then cannot market their product, why should they continue to work on new products?
  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 HemAssist? Give three arguments.
  4. If Baxter doesn't withdraw HemAssist, what else might it do? Suggest three things.
  5. If the drug is withdrawn, what can the patients do who were in the Phase III trial?

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