Archives | (April 2003) Printer Friendly
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A NEW PLAYER BUT OLD PROBLEMS

At this point, Dr. William Bensinger, a researcher working on stem cell transplants became interested in PTX. Two of his four patients had died as a result of high-dose chemotherapy, and he hoped that this new “magic bullet” might be the “rescue drug” that would solve his problem. He was told that PTX didn’t seem to work, but that there was hope that in combination with Cipro and prednisone it would.

That’s all he needed to hear. He submitted a proposal to the Center’s IRB to use PTX as a “rescue drug.” There was, however, one detail he left out: the fact that PTX didn’t seem to work, and might even be harmful.

Even as Bensinger was beginning his research using PTX and Cipro, CTI, the company founded by Dr. Bianco, its initial advocate, was in the process of abandoning it.

There were a number of reasons why Bianco had thrown in the towel on the combination drug. First, the FDA had serious questions about the way it worked. Bianco and his colleagues had postulated that the two drugs interacted to change the way the body processed other drugs. Citing the fact that individual body chemistries varied, the FDA felt there was no way to guarantee it would work in the same way in everyone who took it. Secondly, the FDA was also concerned that giving Cipro to patients might cause them to develop a resistance to antibiotics – a potentially fatal problem for immuno-compromised transplant patients. Also, different companies owned the drugs, and it was unlikely that they would approve of the combination.

With all these problems, CTI decided to strike out in a different direction and create a drug that was actually the compound created when PTX and Cipro interacted in the body. With two prominent Hutch officials on the CTI board, it is difficult to believe that Bensinger was unaware of the compound’s failure. Still, he persisted. But the CTI decision to abandon their original line of research was about to create a new and ultimately deadly problem in Bensinger’s experiment.

Because many patients who have high-dose chemotherapy suffer from terrible nausea and vomiting, it was critical that the so-called “rescue drug” could be administered in an intravenous form. The only trouble was that the intravenous form of PTX was not approved by the FDA for use in the United States. While still working at the Center, Bianco had gotten special permission from the FDA to use the IV form of PTX for clinical research. When he left The Hutch to form CTI, the permission to use IV PTX went with him. Therefore, researchers at The Hutch had to obtain their IV PTX through Bianco. When CTI decided to go in a different direction, Bianco no longer had a need for the intravenous form of the drug and gave up his special rights – The Hutch no longer had access to a supply.

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