Drug, Tysabri, That Was Tested

¶ … drug, Tysabri, that was tested for its effectiveness in treating the symptoms of multiple sclerosis. According to the case documentation, Anita Smith from Colorado died of a rare disease allegedly directly related to her participation in the trial, using Tysabri in combination with another drug, Avonex. Furthermore, according to an initial MRI of the deceased woman's brain, she did not suffer from multiple sclerosis at the time when she was enrolled in the trial. The result is that her husband, Walter Smith, sued the Cambridge biotechnology company and Elan Corp. For wrongful death.

The outcome of the suit and further investigations was that the drug was removed from the market, and trials were terminated. According to investigation results, only one other death was recorded in clinical trials, while other patients recovered. However, two deaths were regarded as sufficiently serious to remove the drug from the market altogether. It is interesting to note that the initial marketing of the drug's approval was hastened in order to make it available to patients with multiple sclerosis.

Currently the drug is to be re-entered into the market, but Walter Smith will be arguing for restrictions in its use.

2. Issues and points of conflict: The main issue in the case is the rapidity with which Tysabri was entered into the market in the first place, and also its potential return to the market after the death of two patients. It is argued on the one hand that the drug does have some positive effects on patients suffering from severe symptoms of multiple sclerosis. On the other hand, others claim that the effects are not sufficiently significant to justify the risk of death.

According to Smith, sufficient warning and entering the correct persons with the correct symptoms into clinical trials will provide some safeguards against a fate similar to that of his wife.

Another issue raised by Annette Langer-Gould and Lawrence Steinman in an article focused on the issue is the danger of testing drugs with unknown side-effects on patients. According to these authors, the fatal tragedy could easily have been avoided by taking more time for more focused and carefully planned clinical trials. According to this view, it was unethical to test Tysabri in the way it has been done, and furthermore irresponsible to enter it into the market before all side-effects were ascertained.

3. Interested parties: The interested parties in this case include Walter Smith, Anita's widower, as well as Cambridge biotechnology and Elan Corp. From Smith's point-of-view, the companies are at fault for causing harm to his wife, and potential harm to many others using the drug. His current assertions regarding the reentry of the drug into the market appear to be well thought out and mature, focusing on the future benefit of patients rather than on his own need for revenge.

From the point-of-view of the companies, the drug is developed to help those suffering from multiple sclerosis, and as such should be made available to patients. However, they also have a financial interest, having invested funding into projects to develop and test the drug.