Experiences with Chemotherapy

In my intense battle with a very aggressive form of chronic lymphocytic leukemia (CLL), I believe acupuncture has made a critical difference in helping me not only to survive, but to actually thrive as my good health has gradually returned to me. I was part of a clinical trial that world-wide had shown tremendous promise in putting difficult forms of leukemia like mine into remission. Thirteen of us began this trial. At it’s end, I was the sole survivor. The side effects of the drugs I took were excruciating in the extreme. I finally understood that something had to change when my liver counts became dangerously elevated. I found a caring, gifted acupuncturist, who is the very definition of a healer. Within a couple of months, the differences in my overall condition were dramatic. My liver counts began to descend to more normal levels, and my blood counts began to rise. My white, immune boosting cells increased, as did my red cells, especially my platelets. I was able to eat more and sleep better. I continued with my wonderful acupuncturist as I went through the challenging steps of a bone-marrow transplant. Working together, acupuncture and traditional medicine achieved a complementary balance that eventually gave me the precious gift of remission.

I noticed that the foundhealth website has not mentioned the current drug shortage problem. I would like to share my experience hoping that if this topic is given more exposure it will save lives.

I have been battling Leiomyosarcoma while on Doxil for over four years. Incredibly, with only two days notice before my next scheduled chemotherapy, I was advised that Doxil would not be available to me at any time in the near future. This effectively amounts to a death sentence for me, without any reasonable time to find an alternative viable therapy.

Prior to being treated with Doxil, my tumors were increasing in size and number while on other chemo drugs. While on Doxil, I have seen significant and continuous reduction in tumor size. During the past two years, the days between my Doxil cycles have been significantly increased and my Doxil dosage has been significantly reduced to help moderate toxicity side effects. I am now at the minimum dosage intensity. With my current dosage at a minimum and the time between treatments lengthened, any interruption in treatment could be fatal. In addition, it has been documented by Janssen that discontinuing Doxil treatments after prolonged use, may potentially cause fatal cardiac side effects.

On August 5th Janssen, a division of J&J, sent out a letter requesting that healthcare providers register their patients for the Doxil CARES program. I have since obtained a copy of that letter and there was no sense of urgency indicated in it. Prior to this letter, Healthcare providers were told that only new patients would be affected.

On August 24th, I was told, by my oncologist's office, that an application was being filed on my behalf, as part of the Doxil CARES program, and that it was just procedural. It was the first time I was ever informed of such a program. It was reinforced to me that I should not be concerned because my September 1st. scheduled chemotherapy treatment was not affected. On August 30th, I was called by my oncologist and told that my appointment was being postponed because there was no Doxil available for me. I was also told that I was on an indefinite waitlist and that they have not received any shipments of Doxil since August 9th.

My application was submitted 19 days later than the announcement date. I was never been given a chance to advocate on my own behalf since I was totally uninformed about the process. Although I wish that my application was filed sooner, I believe my healthcare provider acted in good faith because they assumed that this was just a bureaucratic procedure and they were also not properly informed about the crisis.

After speaking to many representatives of J&J, I learned that the current production allotment of Doxil was allocated by the end of the day that the program was announced. Any additional Doxil CARES applications were put on a wait list. They informed me that the criterion for distributing Doxil is only on a first come-first serve basis without exceptions for medical urgency or necessity. It essentially became a race to the fax machine by oncologists all over the country. I have since learned that there are over 2000 patients on this waitlist. When I requested to know where my name is on the waitlist, I was informed that this information was not being released. In other words, patients scheduled for a treatment on August 5th may have Doxil on reserve if their Oncologist filed their paperwork while patients scheduled at a much later date on a more critical timeline are being denied treatment.

I also have learned that many distributors and hospitals throughout the country have ample supply of Doxil because there were "tipped off" about the pending crisis. A J&J representative also acknowledged that they expected hoarding by healthcare providers. Unfortunately, these other healthcare providers are unwilling or unable to "share" their Doxil with other healthcare providers that do not have and any Doxil inventory. They also will not accept new patients for treatments because they claim that it is not in accordance with the Doxil CARES program rules. In my case, I was told that there is available Doxil with ten miles of my home but I have been declared ineligible to receive the drug at those facilities because I would be considered a “new patient”.

I have also inquired about a compassionate drug use waiver with my local Congressional office. I was told that Doxil does not qualify for compassionate use since it is an approved drug even though it is unavailable in the USA. One alternative was to purchase the drug out of the country, smuggle it back into the USA and then find someone to administer it to me while risking the potential for a contaminated or counterfeit drug.

I consider myself to be among a fortunate group of perhaps 10% of diagnosed Leiomyosarcoma patients who have survived five years or more and I am probably among a smaller group of patients that have been taking Doxil for more than four years. One would think that as a long time patient on Doxil with such good results that Janssen would be interested in my outcome especially since I am taking the minimum dosage intensity and I am at high risk for serious side effects, if I were to discontinue using Doxil. One would think that I would be among the last patients to be deprived of the drug.

However, this issue is bigger than just its impact on me. This is a national if not an international crisis. There are many, many cancer patients affected by this tragedy that may not be as resourceful as me and have nowhere to turn. I have read some internet postings that have been heartbreaking. In my opinion, this is a form of attempted murder and now that there have been reported deaths in some cases, a form of murder.

I am questioning the specific reasons for the shortage. What role did the government play? What is the manner and method of this decision-making regarding who receives the drug? Who made the decision to withdraw the medication, was it the government, the manufacturer or was it the hospital? What criteria were utilized in the decision-making process? Were financial considerations involved?

Once I resolve the necessary steps to secure my next treatment, I plan to make it my personal mission to help increase awareness about this tragedy. I hope you can help, too.

Dan Schiavello

I think for some people this might be the right course of action. I was diagnosed with SLL - small lymphocytic lymphoma, stage 4 - found when I went in for an MRI for pain in my lower back and they saw the enlarged lymph nodes - about 5 years ago. This disease hadn't affected my life style much until this winter when fluid started accumulating in my chest and abdomen. After many tests on the fluid which never produced any answers as to what was causing this fluid, my oncologist decided it might be the lymphoma. After a 6 month regimen of Bendamustine + Rituxan , my cancer was not reduced by the amount my oncologist (or I) was hoping. My life has been pretty much on hold with the side effects of lack of energy and appetite. Now he's suggesting a daily chemo - Ibrutinib pills. Not sure I'm willing to do this. I'm looking to get a second opinion to see if there might be newer, less toxic treatments out there which might help.