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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 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

In 2000, Dan Schiavello formed a company called Minerva Health Technologies, named after Minerva, the Roman goddess of wisdom and medicine. The company was formed to develop and implement Medical Quality Improvement Systems and improve individualized Health Risk Assessment models using advanced statistical analyses.

Unfortunately, in 2001, Dan, was diagnosed with Cancer. Then in 2006 he learned it had metastasized to his lungs. That news was devastating to his family and him!

Throughout the years since, he has had to bring, fax or mail ALL of his medical and personal records to one doctor after another. That task alone was a daunting and time-consuming job that zapped his patience and his energy! Because of this experience, his company, Minerva Health technologies Inc., designed a new software product you should all know about. It’s called Minerva Health Manager – a system that allows you to store all of your health information onto a portable flash drive as small as a house key.

Dan was once hospitalized for several months due to a medical emergency. After being admitted, he came very close to having a drug administered to him that could have killed him. When he was asked for his health information, he couldn’t even remember his birth date let alone communicate clearly! But, fortunately, he had his prototype of Minerva Health Manager! He literally had all of his health information – the equivalent of every file from every doctor he had ever visited since his diagnosis – tucked away in his wallet, on his portable Minerva Health Flash Drive.

His doctor reviewed his Minerva Health Flash Drive and a potential life-threatening situation was averted. It revealed that he was allergic to an antibiotic about to be administered. The injection could have killed him. This inspired him to continue the development of Minerva Health Manager, and make it commercially available to everyone.

Minerva can store as much or as little health and medical information as you choose. For your family, you enter or scan in the data for every file from every doctor or facility you have ever visited. Minerva allows you to easily create accurate health records that include emergency contacts, diagnosis, medications, procedures, diagnostic images, medical alerts, trends in vital signs and lab results, living wills and much more. You can also enter all health records for your entire family and synchronize your personal health records with healthcare providers and other family members. All health records are securely saved on your computer – NOT on the Internet – and it is HIPAA compliant.

Health and medical information can also be exported, easily and quickly, to a unique, portable Minerva Health Flash Drive available as a USTA wristband or slimline model. Because it can be read from any computer with a USB port – it makes it easily accessible by first responders in an emergency situation, as well as healthcare providers during regular office visits. Everyone in your family, including children, can carry this potentially life-saving device at all times; including when we you are travelling, away at camp/school/college and participating in sports. It can help minimize medical errors, enhance communication between healthcare providers and patients, and save lives.

You can learn more about Minerva Health Manager by visiting www.MyMinerva.com. There is even a three minute video tour of the product and a free trial version.