Monday, March 2, 2009

At the next consultation, Dr. Ramon explained the format of the trial to us and introduced Inma, a nurse who had been appointed to take care of my wife throughout the trial


At one point during our discussion the secretary to Dr. Ramon expressed concern at the fact we didn't speak Spanish (it is safe to say we speak enough Spanish to survive). He then explained to us that there might be a problem if the auditor wanted to question us (although I do not know who the auditor is or what they audit).

Dr. Ramon said that we would be reimbursed for any expenses during the trial and I asked if that included the cost of medication as well. He said it did not and also that my wife would need to take CellCept, which is made by the trial sponsor, Roche, instead of Myfortic, which is made by another company. When I asked why she would have to take 3g of the Roche drug, CellCept, when she had been taking only 2g of Myfortic, Dr. Ramon said it was to do with the way the different drugs were assimilated in the body. When we asked why Roche could not also supply its own tablets, Dr. Ramon said that existing prescription medicines that were not part of the clinical trial would not be paid for by the sponsor. However, we had already purchased several hundred generic Myfortic tablets from India. Dr. Ramon was aware that my wife was taking these (he had calculated that it was actually cheaper than if we had been receiving Social Security) so when I complained at the prospect of having to buy more of the new drug he asked how many we had and said we could change to Cellcept once she had used all the Myfortic.

My wife was also to be screened for the trial, which involved extraction of blood and urine for testing. Over one year later we received a bill from the hospital for my wife's treatment during the period of the trial, which included these tests. One of the tests was called an Anti-Nuclear Antibody (ANA) and cost a whopping $1200. Three of these were conducted over the period of the trial even though my wife had already been diagnosed as having Lupus Nephritis Type 4 through a kidney biopsy. The same test in India costs $6. That's right, six dollars, not six hundred or sixty dollars.