Gene therapy not the cause of arthritis patient death

Medpage Today published on July 08, 2009 reported a 32 year old women death who participated in the gene trial therapy for rheumatic arthritis. The patient died after 22 days of treatment. This incident has put a halt to all the clinical tests that was going on related to gene therapy. Actually the researchers were testing a drug named experimentally as tgACC94. This drug is based on the recombinant adeno-associated virus (AAV) derived vector. It carries the tumor necrosis factor receptor (TNF-receptor) gene to block the inflammation.

After investigation the researchers say that the death of the patient is not because of the gene therapy treatment for rheumatic arthritis. It is because of the wide spread histoplasmosis. Histoplasmosis is a normal fungal infection but in this case it has gone deadly as the result of immunosuppressant therapy. The patient was under immunosuppressant therapy for few years she was under the medication of adaimumab, methotrexate and prednisone. These drugs have only increased the risk of histoplasma fungus, said the researchers. They also add that the combination of histoplasmosis and retroperitoneal hematoma has only led to patients death. It is a well known thing that the risk is more when a patient affected by histoplasmosis takes TNF antagonists. The important explanation the researchers say is that she was already infected by the histoplasmosis fungus when she was receiving her second dosage of tgAAC94 as a part of her gene therapy. After the second dosage she was suffering with large number of symptoms like fever, vomiting, abdominal pain etc. The symptoms started getting worse day by day and she was hospitalized. Finally she was suffering from large abdominal hematoma, liver damage and kidney failure. After three weeks of suffering from all these symptoms from the day the second dosage for gene therapy was given she died on 24^th July. Some people say, the death can be avoided if the researchers had taken enough care of the patient at the beginning itself when she started showing some negative symptoms. If she would have brought under complete monitoring at that time itself definitely her death would have been avoided.

Elizabeth L.Hohman, MD, of partners human research committee in Boston, wrote in an editorial that this incident has taught a number of lessons to the researchers, mainly making them to concentrate about the endemic infections in the area where the patients are residing. This incident has cautioned all the researchers around the globe. This has made them to take a keen note of all the endemic diseases that are in the prevailing in patient areas who all are receiving TNF antagonist drugs. And also in addition to that the researchers have come to know about the importance of a proper complete monitoring system of the patients who fall ill when they are under such researchers. Because of this negative result in gene therapy people will come to a thought that acceptance of a gene therapy approach for non genetic diseases such as arthritis is marginal and the serious adverse effect of the treatment could even destroy the entire activity.