Tuesday, November 10, 2009

Sent a Letter to Dr. Margaret Hamburg, Commissioner of Food and Drugs.Melanoma..Jim Breitfeller

Sent a Letter to Dr. Margaret Hamburg, Commissioner of Food and Drugs.

Dr. Margaret Hamburg,

I am a melanoma patient/survivor/researcher, who has been stabilized by the use of Ipilimumab (Anti-CTLA-4 Blockage). BMS/Medarex stopped compassionate care use due to a shortage they say. It has been over a year (9/12/2008) since Melanoma patients that need the drug as a last resort of survival, have been left out of Clinical Trials which seems to me to be unethical. I know for a fact that it only takes 3 months to make and certify a batch of this monoclonal antibody. In fact, I contacted your shortage team a number of times. This drug never showed up on the shortage list and as a matter of fact, Bristol-Meyer Squibb has made a number of batches. They continued to start up new clinical trials, while leaving the most vulnerable to fall though the cracks of our Heath System.

I asked you to please show some compassion and look into this matter. I hope it doesn’t fall on deaf ears.

Take Care,

Jimmy B

-----Original Message-----
From: dbreitfe [mailto:dbreitfe@rochester.rr.com]
Sent: Friday, August 14, 2009 11:35 AM
Subject: RE: Anti-CTLA-4 blockage shortage.... Medarex and BMS

It has been almost a year that they said they have a production problem. I don’t think so.

Where is the compassionate use????????????????

Please investigate!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

There is no Shortage!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! It is Greed!!!!!!!!!!!!!!!!!!!!!!! And Monopoly. It all comes down to money and the string of Pearls

Medarex 1999


Medarex (Annandale, NJ) recently announced that Centocor has paid $4 million in milestone fees for its use of the HuMab-Mouse technology. Separately, the company announced a new licensing agreement for the HuMab technology with Immunex Corp. Centocor holds exclusive commercial licenses to develop HuMab antibodies on four licensed targets.

“sing the HuMab-Mouse technology, Centocor researchers have obtained a number of product candidates, including an anti-IL-2 antibody of exceptionally high affinity. Immunex has obtained the right to use HuMab-Mouse for an unlimited number of targets for up to 10 years. Medarex will receive technology access fees, and cold receive research payments, license fees, milestone payments, and royalties on any commercial sales. HuMab-Mouse is a transgenic mouse system that creates high affinity, fully human antibodies. According Medarex, scientist can produce these antibodies in a matter of months. The agreement with Immunex is the tenth corporate partnership for Medarex involving its HuMab-Mouse system. Other partners include Bristol-Myers Squibb, Novartis Pharma AG, and Schering AG”

Where is the shortage if they can make product in a matter of months.

Sounds very fishy to me


Posted by Jim Breitfeller at 08:38 on Fri, Oct 02, 2009 [Show other posts by Jim Breitfeller]

In Reply to: Re: A new clinical trial has been launched using patients' own immune systems by I know this is bothering you..... posted at 08:32 on Fri, Oct 02, 2009

Bristol-Meyer Squbibb is unethical in my opinion.

I go my dose of Ipilimumab. It saved my life.

I am fighting for all the others that are too sick to fight.

Posted by Tim--MRF at 02:47 on Mon, Sep 28, 2009 [Show other posts by Tim--MRF]

In Reply to: Bristol-Meyer Squibb has a lot to Explain!! Ipilimumab compassionate use by Jim Breitfeller posted at 08:03 on Mon, Sep 28, 2009


I have had the opportunity to meet with several people at BMS who are involved in ipi and can tell you that they share your frustration. The official word is that when they applied for compassionate use approval they underestimated the demand they would face. That plus the fact that people were surviving longer on the drug placed an unanticipated strain on capacity, resulting in suspending the compassionate use program. They have a new batch of ipi available, but are holding off on compassionate use until they are absolutely sure they have enough to fulfill the requirements of the clinical trials. I have heard that the trials are largely enrolled and that many trials have waiting lists. I have sent a note to the people I met at BMS and asked them two questions you raise: Why did the new batch take so long? And, when do they expect compassionate use to be re-opened? The word I had earlier was the first quarter of 2010. I will post again when and if I get a reply.

I have tried to encourage them to provide regular updates on status--people definitely want to know what is going on.


Best to all

On June 11, 2007, BMS agreed to plead guilty and pay a $1 million criminal fine for misleading the government about the Plavix patent deal. BMS paid the maximum fine permitted by statute for committing two violations under the federal False Statements Act."

They mislead Government officials so why would they tell us the Patients, the truth about the shortage?

April 25 2008

Medarex and Bristol-Myers Squibb Joint Statement on Submission Status of Ipilimumab

PRINCETON, N.J., April 25 2008 /PRNewswire-FirstCall/ -- Medarex, Inc.

(Nasdaq: MEDX) and Bristol-Myers Squibb Company (NYSE: BMY) today announced that, after meeting with the U.S. Food and Drug Administration (FDA), the companies will delay the Biologics License Application (BLA) submission for ipilimumab, an investigational immunotherapy for patients with advanced metastatic melanoma. The FDA has requested additional overall survival (OS)data to further demonstrate the benefit of ipilimumab. Revised timelines are under development, but a BLA for ipilimumab will not be submitted to the FDA in 2008.

As far as my research to date(10-22-2009), BMS/Medarex has not file a BLA with the FDA.

On September 12 2008 they closed the compassionate use for Ipilimumab

Your email was forwarded to us by CBER (this IND resides in the Center for Drugs Evaluation and Research). We have contacted BMS to check into the availability of ipilimumab and here is the information that BMS provided to us.

“Toensure treatment is not interrupted for patients currently receiving ipilimumab and to provide ongoing supply to the registrational program, Bristol-Myers Squibb and Medarex have suspended enrollment of new patients into the compassionate use program, single patient exemptions and initiation of some non-registrational trials effective September 12, 2008.

Bristol-Myers Squibb and Medarex are working to manage the supply issue and may be able to re-open compassionate use in the future.

The companies are committed to providing uninterrupted treatment to patients who initiate therapy with ipilimumab. Therefore, if and when the compassionate use program reopens, it will be at such time when continuous and unconstrained supply is available."

Please let us know if you have any questions.


CDER Drug Shortage Team

It Takes about a month to make a batch of monoclonal antibodies. By the time the batch is tested and packaged and approved, let us allow another two months. So in a year you should be able to make 3 to 4 batches.

Melanoma Treatment Information - Updated 09.10.09

Ipilimumab which ASCO reported some promising results had been widely available in compassionate use trials across the county until a shortage halted the studies. Bristol Myers Squibb, is now manufacturing the drug again and there are a few small “pharmacokinetic” trials to prove the agent is the same as the previous one used in trials. Most of these trials already have waiting lists, but it may be worth checking out. Screening started August 4th and you can find the locations on www.clinicaltrials.gov.



Well come to find out that BMS/Medarex is opening up new clinical trials with Ipilimumab and continue to keep the compassionate use trial closed. How ethical is that?

When big pharma is involved in clinical development, it usually means large-scale clinical trials with patients and multiple sites.

Here are the trials:

Study of Ipilimumab and Dasatinib Combination Therapy in Patients With Chronic or Accelerated Chronic Myeloid Leukemia

Start Date: August 2009

Estimated Study Completion Date: Feb 2011

Estimated Enrollment: 30

ClinicalTrials.gov Identifier: NCT00732186

Ipilimumab +/- Vaccine Therapy in Treating Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer

Start Date: February 2009

Estimated Study Completion Date: Feb 2013

Estimated Enrollment: 30

ClinicalTrials.gov Identifier: NCT00836407

Bevacizumab Plus Ipilimumab in Patients With Unresectable Stage III or IV Melanoma

Start Date: February 2009

Estimated Study Completion Date: Feb 2011

Estimated Enrollment: 33

ClinicalTrials.gov Identifier: NCT00790010

Laboratory-Treated T Cells With or Without Ipilimumab in Treating Patients With Metastatic Melanoma

Start Date: February 2009

Estimated Study Completion Date: Feb 2011

Estimated Enrollment: 30

ClinicalTrials.gov Identifier: NCT00871481

Study of Immunotherapy to Treat Advanced Prostate Cancer

Start Date: May 2009

Estimated Study Completion Date: December 2012

Estimated Enrollment: 800

ClinicalTrials.gov Identifier: NCT00861614

Further study details as provided by Bristol-Myers Squibb:

These are all trials that were started after the halting of the compassionate Use. Bristol-Meyer Squibb thinks we the Melanoma Patients are expendable so they continued there quest to seek out new uses for the Drug.

Get a bigger bang for the buck.

They already know it will work well with Melanoma so why not find other uses.

Base on my calculation, 923 late stage Melanoma Patients were denied the drug while Bristol–Meyer Squibb continued to apply and start up new trials.

Bristol-Meyer Squibb Quote:

“What sets us apart? We believe it's our commitment to patients with serious diseases, our focus on finding innovative medicines that combat those diseases, and our dedication to extending and enhancing human life.”

All Lip Service!!!!!!

“Jim, thank you so much for your efforts. My father passed away this past March. He was also scheduled to start the ipi trial last year and found out the Saturday before he was to go in that the compassionate use trial was suspended. He developed 3 mets in his brain by Thanksgiving. The ipi trials with brain mets were closed to new patients by then. I've spent countless hours and days frustrated and angry, unable to express or figure out what you have with BMS and wanting to take some sort of action. I also sent letters, made phone calls, etc. One day, someone will be able to stop these drug companies from playing with our lives. Please keep me posted in your findings.”

Update on Ipilimumab

Ipilimumab is not back yet. Patients are not being encouraged to wait for Ipilimumab to become available for now. The only Ipilimumab melanoma trials currently enrolling new patients in the US are the brain metastases trial (CA-184042) and the phase 3 adjuvant trial (CA-184029) because the supply for those trials was protected in advance. Bristol Myers Squibb is working diligently to overcome the drug shortage, but can’t guarantee a time that it will return to the compassionate use setting

Source: Melanoma International Foundation: https://www.z2systems.com/np/clients/mif/news.jsp?news=376

Response from BMS as of 10-21-2009

“Regarding compassionate use, as you are aware, the rate of enrollment in the compassionate use program for ipilimumab was greater than anticipated with 30 to 40 percent of patients continuing on therapy beyond the initial induction schedule. This demand depleted drug supply at a faster rate than anticipated. Bristol-Myers Squibb had to suspend enrollment of new patients into the compassionate use program and single patient exemptions to ensure treatment is not interrupted for patients currently receiving ipilimumab and to provide supply for ongoing clinical studies.

We are working through the manufacturing and testing process, and continue to carefully manage the supply to enable the potential re-opening of compassionate use at the earliest possible time and when continuous supply is available.

Bristol-Myers Squibb remains committed to the development of ipilimumab and to addressing the great unmet medical need for patients with metastatic melanoma.”

As you can read, BMS is not even acknowledging that they even produced other batches.

We the Patients deserve better, We are the ones who are taking all the risk. We should have some control in this process.

We the Patients have had to hear it from second hand sources like the Melanoma International Foundation and Melanoma Research Foundation. I don’t believe that their ad advertisers (The Ogilvy Group Inc) can repair the public’s trust in this company.

This Month will be the anniversary of the discovery of Anti-CTLA-4 antibodies, celebrating ten years in the making of the drug. This is way to long for a drug to come to market. It usually takes 8.7 years for monoclonal antibodies. So what gives?

How Drugs are Developed and Approved by the FDA


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Greetings to One and All

This Blog is dedicated My Brother Kenny B. who passed away in the late 1970's with Cancer before the Internet.

It was he, who showed me How to live and give back. He was wise beyond his years.

Kenny B

Jimmy and Dee

Carepage: Jimmybreitfeller
Jimmy Breitfeller

My Profile as of 2009

My photo
Last July (2005)I was riding my bicycle to work at the Eastman Kodak Research Labs about 3 miles from home. I was wearing a knapsack to carry my things to and from the labs. I started noticing an ache on my back. So I decide to go to the dermatologist. To make the long story short, it was cancer. I knew from my research that I would be needing adjuvant therapy. So I started communicating with Sloan Kettering, University of Pittsburgh Cancer Center, and a couple of others including the Wilmot Cancer Center at Strong. I realized that by telling my story, I might help someone else out there in a similar situation. So to all who are linked by diagnosis or by relation to someone with melanoma, I wish you well. Stay positive, read as much as you can (information helps to eliminate the fear associated with the unknown), and live for today, as no one can predict what tomorrow may bring. Jimmy B. posted 12/15/08


The information contained within this Blog is not meant to replace the examination or advice of your Oncologist or Medical Team. The educational material that is covered here or Linked to, does not cover every detail of each disorder discussed.

Only your physician/Oncologist can make medical decisions and treatment plans that are appropriate for you. But, An Educated Consumer is a Smart consumer.

As Dr. Casey Culberson Said:

"The BEST melanoma patient is an ACTIVE PARTICIPANT in his or her treatment

Melanoma and the “Magic Bullet” (Monoclonal Antibodies)

Just to let you know I posted the first draft of the Melanoma and the “Magic Bullet” (Monoclonal Antibodies). on Melanoma Missionary In the Shared File Section. you can download it for 19.95 (Only kidding) it is Free for the taking.

It is 33 pages long and may help you in your quest for the Yellow Brick Broad. Just to let you know it is only the first draft. Revisions are sure to come. I wanted to get it to the people that need it the most, the Melanoma Patients.


So, where does Interluekin-2 (IL-2) come into play? According to Byung-Scok et al and recent reports, IL-2 is not needed for developmental CD4+ CD25+ Treg cells in the thymus but does play an important role in the maintenance and function in the peripheral.18 Peripheral is defines as secondary system outside the bone marrow and thymus. It entails the site of antigen, immune system interaction. IL-2 is required for the peripheral generation of Tregs based Abbas’s and colleagues research.19

IL-2 prevents the spontaneous apoptosis of the CD4+ CD25+ Treg cells. It has been reported that patients with multiple advance-stage tumors have elevated levels of Tregs within the tumor microenviroment.20 Interluekin-2 is the survival factor for CD4+ CD25+ Treg cells.21 If the addition of IL-2 is on or before the maximum propagation of the CD4+ T cells, the Tregs population can increase 5-fold in a 96 hour period based on certain growth mediums.

By controlling the addition of the endogenous IL-2, one has a knob to turn and can lead to the control of the expansion of the Tregs. When you combined this control with the anti-CTLA-4 blockage, you can shift the balance of the immune response.

Now here is the catch. The maintenance and function of the CD8+ T-cells require CD4+ cells which secrete IL-2. So we don’t want to deplete the CD4+ cells, we want to control the expansion of the Tregs which are a subset of the CD4+ cells. It has been postulated by some researchers that the Anti-CTLA-4 blockage also suppresses the Treg function in a different mechanism. By using IL-2 as the rate limiting factor, we can suppress the CD4+ CD25+ Treg cell expansion by controlling the concentration and timing of the Inerluekin-2 at the tumor microenvironment.

The Interluekin-2 plays another role in this Melanoma Maze. In a study by Janas et al, Il-2 increases the expressions of the perforin and granzyme A, B and C genes in the CD8+ T-cells. This increase expression causes the CD8+ T-cells to mature into Cytoxic T Lymphocytes (CTLs). The exogenous IL-2 is required for the granzyme proteins. As stated previously, CTLs have cytoplasmic granules that contain the proteins perforin and granzymes. A dozen or more perforin molecules insert themselves into the plasma membrane of target cells forming a pore that enables granzymes to enter the cell. Once in the tumor cell, these enzymes are able to breakup (lyse) the cell and destroy it. This is the beginning of the end for the cancer cells. The tumors begin to shrink and the rest is history,

On the other hand, prolong therapy with Il-2 can result in causing apoptotic death of the tumor- specific CD8+ T-cells.23

Clearly in a clinical setting, timing, dose, and exposure to these drugs play a major roll in the immunotherapy, and can have dramatic effects on the outcome.

All it takes is that one magic bullet to start the immune reaction..


Melanoma And The Magic Bullet (Monoclonal Antibodies)

Public Service Announcement

A call for Melanoma Patients by Dr. Steven A Rosenberg

"We continue to see a high rate of clinical responses in our cell transfer immunotherapy treatments for patients with metastatic melanoma", Dr. Rosenberg said.

"We are actively seeking patients for these trials and any note of that on a patient-directed web site would be appreciated."

If you would like to apply for his trials, here is the website and information.

Dr. Rosenberg's information

Dr. Rosenberg's Clinical Trials

For the Warriors

The Melanoma Research Alliance has partnered with Bruce Springsteen, the E Street Band, and the Federici family to alleviate suffering and death from melanoma. Please view Bruce Springsteen’s public service announcement inspired by Danny Federici. Danny was the E Street Band’s organist and keyboard player. He died on April 17, 2008 at Memorial Sloan-Kettering Cancer Center in New York City after a three year battle with melanoma.


Source Fastcures blog

Join the Relay for Life!!!


Dear Family and Friends,

I’ve decided to take a stand and fight back against cancer by participating in the American Cancer Society Relay For Life® event right here in my community! Please support me in this important cause by making a secure, tax-deductible donation online using the link below.

To donate on line now, click here to visit my personal page.
Jimmy B AKA Melanoma_Missionary

Relay For Life® is a life-changing event that brings together more than 3.5 million people worldwide to:

CELEBRATE the lives of those who have battled cancer. The strength of survivors inspires others to continue to fight.

REMEMBER loved ones lost to the disease. At Relay, people who have walked alongside people battling cancer can grieve and find healing.

FIGHT BACK. We Relay because we have been touched by cancer and desperately want to put an end to the disease.

Whatever you can give will help - it all adds up! I greatly appreciate your support and will keep you posted on my progress.

Keep the Fire Burning!!!



Jimmy Breitfeller
Turn off Music before you "Click to Play"
Signs of Melanoma Carcinoma Skin Cancer

How Skin Cancer Develops by "About.com : Dermatology"

Call for Patients with Unresectable Liver Metastases Due to Melanoma

Delcath Systems Granted Orphan-Drug Designations for Cutaneous and Ocular Melanoma

Delcath is actively enrolling patients in a Phase III clinical trial testing its proprietary drug delivery system, known as Percutaneous Hepatic Perfusion (“PHP”), with melphalan for the treatment of ocular and cutaneous melanoma metastatic to the liver.

This NCI-led trial is enrolling patients at leading cancer centers throughout the United States. Commenting on these orphan-drug designations, Richard L. Taney, President and CEO of Delcath, stated, “These favorable designations are important steps in our efforts to secure Delcath’s commercial position upon conclusion of our pivotal Phase III trial for metastatic melanoma. We remain steadfast in our commitment to become the leader in the regional treatment of liver cancers and we continue to enroll patients in this study, and advance our technology and the promise that it offers to patients with these deadly forms of melanoma and other cancers of the liver, all with limited treatment options.”

Orphan drug designation, when granted by the FDA’s Office of Orphan Products Development, allows for up to seven years of market exclusivity upon FDA approval, as well as clinical study incentives, study design assistance, waivers of certain FDA user fees, and potential tax credits.

Current Trial Centers

Phase I Study of Hepatic Arterial Melphalan Infusion and Hepatic Venous Hemofiltration Using
Percutaneously Placed Catheters in Patients With Unresectable Hepatic Malignancies

James F. Pingpank, Jr., MD, FACS
Associate Professor of Surgery
Division of Surgical Oncology
Suite 406, UPMC Cancer Pavillion
5150 Centre Avenue
Pittsburgh, PA 15232
412-692-2852 (Office)
412-692-2520 (Fax)

Blog Archive

Call For Melanoma Patients!!!!

Call For Melanoma Patients!!!!

Dr. Rosenberg Has a New Clinical Trial.

Our latest treatment has a 72% objective response rate with 36% complete responses.

We are currently recruiting patients for our latest trial.

Is there some way to post this “Call for Patients” on the web site?

Steve Rosenberg

Dr. Rosenberg's Clinical Trials

(For a copy of the research paper.. see My Shared files)

The news headlines shown above for Melanoma / Skin Cancer are provided courtesy of Medical News Today.