A stunning diagnosis and STI 571

Ravi Godey – Vishakapatanam, October 2006

After a long gap I re-read the “Together we Share and Learn” Booklet. Although I couldn't make it to the Friends of Max meeting in Mumbai last year, Viji mailed a copy to me. The personal accounts are very inspirational and here am I jabbing away at the keyboard with two fingers to give you my version.

For us the CML journey was literally a dizzy beginning. After a few episodes of giddiness in Dec 1996, since I am my own chauffer, on the insistence of family members, I went to a general physician who ordered a whole battery of tests including CBC, X-rays, and ECG etc. Not too happy with having to go through all the tests, I postponed it for a couple of days. On the third day, on the way back from a wedding, my wife and I stopped by a diagnostic center. It must have been a funny sight in a diagnostic center…me in formal clothes, my wife in a Kanjeevaram sari and a big gold necklace. Ignoring the raised eyebrows we managed to convince the technician that I was the 'Patient', although I didn't quite look or feel that way…at least not as yet.

Two days later, I was sitting in Tata Memorial Hospital registered as patient No XXXX waiting to meet Dr Tapan Saikia. The shock of being told that I had CML did sink in at one level and yet seemed so unreal. This couldn't be happening to us. As it is, we were running around hospitals all over the country for our only child who undergone several surgeries for the congenital problems she was born with. We then made a very conscious decision not to tell anyone apart from immediate family of my condition since we thought the commiserative words and platitudes would undermine all attempts at leading a 'normal' life. Anyway, we stayed in Mumbai for the next ten days, started treatment under the expert care of Dr.Saikia who put me on Hydrea. I went through some more tests including the barbaric Bone Marrow Aspiration which confirmed 100% Ph + cells.

January 1997 was the first year we didn't celebrate our daughters' birthday. Life continued. There were good days when we could at least pretend that all was well, and then there were days when I actually felt like a patient with terrible muscle camps, nausea, weakness and other associated symptoms which were draining both physically and mentally. To counter raising WBC counts despite relatively high doses of Hydrea, Interferon injections were added to the daily regimen. Since our daughter was not told of my condition, we would tell her to go out of the room on some pretext and administer the injection. Most days she would come back in and say “ I can smell spirit” and my wife would fob her off by saying it was the smell of nail polish remover. We had to change the story after a few times to “ Daddy has a stomach pain so he needs injections”. The most traumatic phase for me was the loss of hair. My friends attributed the sudden loss with the excess shopping they thought my wife did during our trip to Dubai.

By 1999, a combination of Interferon, Hydrea and Cyterabin were not successful in keeping WBC counts under control. The doctors were talking about a very promising new drug that was controlling CML very effectively. This new drug was under clinical studies, not yet available in India or in any drug store or Hospital abroad. So how was one to avail the benefits of this new wonder drug?? The ONLY way was to get enrolled as a patient in the Clinical trial.

Thank God for the Internet. Most trial centers were not willing to enroll an international patient since a clinical trial patient had to report back to the hospital where he is enrolled EVERY three months without fail to report on his progress / condition. Four months of extensive searches on the World Wide Web, scores of emails, lots of phone calls to doctors and hospitals abroad and weeks and days of disappointing news when each hospital said “Sorry”. Persistence pays…finally at 2.41 am… 4 months, 3 weeks and three days after the search for a clinical trial that would accept an International patient started, I was reading an email that asked us to report at Stanford Hospital, California, USA in about 7 weeks from then.

The first person we informed about being accepted as a Clinical trial patient was of course Dr Saikia who was more than just a doctor to us. Since distance was a major constraint between doctor and patient, the telephone was our savior. We called him at all hours with all kinds of doubts, worries, medical problems and he very patiently answered our questions and allayed our fears. Once I was actually accepted at Stanford, we had doubts about the safety of clinical trials…since it is essentially a trial on humans. Dr Saikia convinced us that the results so far were encouraging and safe.

We began the usual hectic preparations that go with travel abroad. Our first application for an US Visa was rejected since we didn't take any proof that we had a daughter whom we would be leaving behind here in India. Armed with a birth certificate, school records and photographs our second visit to the US embassy proved fruitful and we were granted a visa. On October 9th 2000, I was part of a Clinical Trial for STI 571 (as Gleevec was known before being given FDA approval) at Stanford Hospital.

There came a day before we left for Stanford, when my daughter who is a voracious reader and as a matter of habit reads any printed material, read a copy of an email from Stanford and wanted to know what CML was. Although I long dreaded this inevitable day, we explained to her that though cancer was part of our lives now, we are putting up a good fight and we will emerge winners. So very sweetly she said with all the wisdom that only a child could have “ so you actually don't have stomach pain”.

The first thing that struck me at Stanford was the almost empty look in every department. Finally on 10th Oct 2000 I was formally accepted into the clinical trial and given my first bottle of the miracle drug “ STI 571”. Except for the first few days when I had nausea in the morning (my wife fondly diagnosing it as morning sickness) I had no problem. I had to report back at Stanford on 9th Nov 2000 since this was my first prescription of STI 571. We used the intervening weeks between our appointments at Stanford to do a bit of sightseeing. It was such a relief not having to carry our Interferon vials (and find a fridge to store it), syringes and needles even when travelling.

For the next six months all was hunky dory till Stanford dropped the bombshell that Clinical trials were ending in the USA since STI 571 had been given FDA approval and christened GLIVIC. After March 2001 we would have to buy the medicine. Frantic calls and emails to Stanford Hospital gave us the same reply. The Novartis website had a new program called GIPAP which was applicable only to US residents. We then started a new search for an alternative to the clinical trial at Stanford. We contacted Novartis offices in Switzerland and the USA who put us on to their office in New Jersey which actually looks after Clinical trials . I would like to mention the extensive support and helpful attitude of the staff at Novartis, New Jersey especially Ms. Julie Koehler who went beyond the call of duty in keeping our spirit and hope together in the months that we were looking for a way to get Gleevec either at no cost (like the GIPAP
members in the US) or at an affordable cost that we would be able to sustain for a long duration. Finally after more than a month of discussions, we were told we could apply for a transfer to any center in the world still conducting the Clinical trial on STI 571.

Friends unknowingly sometimes lift your spirits with their comments. Every party or social gathering would inevitable start or end with my “glowing complexion” and improved skin colour. On one hand we were desperately looking o a way to continue STI 571, while our friends were wanting to know how I was getting so fair…What is some foreign sunscreen? or home made ubtan ? or what ?…..my wife usually made a huge joke of the whole thing by saying “ two teaspoons of Fair and Lovely in a glass of milk early in the morning”. =The whole rigmarole of getting accepted as an international patient at a Clinical trial centre started. We had the option of Singapore, Hong Kong and Melbourne ( Australia). Talks with Singapore had reached a stage when we were sure of being accepted when news came that the trials had ended in Singapore and Hong Kong. When God closes some doors he opens some others. The one he opened this time had “HOPE” written on it and we went right in. Keeping our fingers crossed we applied to Melbourne and thankfully with the kind cooperation of Dr Jeff Szer I was part of the clinical trial at the Royal Melbourne Hospital. So I was  off to Melbourne. My friends were wondering why I was taking so many holidays abroad. !!!!

Six months later the story repeated itself. Clinical trials had closed worldwide. Back to the Novartis angels in New Jersey. Ms. Julie came to the rescue again. She assured me that Novartis would do everything they could as a result of which one fine day we got news from Novartis India that they were arranging Glivec for me free of cost. A few months later GIPAP India was in place and the wonderful Viji Venkatesh became a part of our lives. Vijiji has been our pillar of strength and support and constant encouragement. It is amazing how she remembers to ask those little details about each member and his /her family even months after the last meeting with her proving that each person is special to her as she is to us. I would also like to thank every one at TMF India who works behind the scenes every single day to ensure that each member of GIPAP gets their re-approvals without any delays every single time.

Thank you Dr.Saikia (whom I do not disturb much these days), Thank you Vijiji. Thanks NOVARTIS .
Thanks GIPAP. Thanks MAX FOUNDATION. Thanks TMF India.