Wednesday, July 28, 2010

Commentary.. Is this What Melanoma Patients are going to foresee in the future with Ipilimumab from BMS?Melanoma..Jim Breitfeller

Commentary.. Is this What Melanoma Patients are going to foresee in the future with Ipilimumab from BMS?

As one can see GREED has been taken to the next level. I am astounded that BMS will not Help, when their help is needed. Where are their ETHICS?????

In a letter to BMS’ CEO Lamberto Andreotti dated July 9, 2010, Controller Chiang states:

"California’s AIDS Drug Assistance Program (ADAP), like ADAPs across the nation, is in jeopardy as California’s budget continues to suffer the ravages of the recent recession. As available state general fund dollars continue to shrink, demand on the program has grown faster than normal (another byproduct of the recession) and the cost of drugs has been increasing.
"This is an unsustainable situation. California has no interest in depriving people with HIV/AIDS of drugs that keep them alive, so the only available recourse is to rein in the growing drugs costs. On balance, it seems that all parties should do their part to ease the pain this recession has inflicted on ADAP."

In order to help alleviate the crisis, other major AIDS drug manufacturers have agreed to significant reductions in the pricing of their lifesaving AIDS medications to ADAPs, including Merck and Company, Johnson & Johnson’s Tibotec Therapeutics, Gilead Sciences Inc., Viiv Healthcare and Abbott Labs. But not BMS. Meanwhile, twelve states have instituted waiting lists. And the number of people waiting to access medicines continues to balloon. In Florida, the waiting list is increasing at a rate of 250 to 300 people per month.

Adds Chiang: “Ultimately, modest changes from drug companies are all that is needed to help ensure ADAPs can continue to serve the people who need them. It is time for BMS to step up and join the other pharmaceutical companies that have found ways to reduce the cost of drugs to California and its ADAP program.”

“AHF would like to thank Controller Chiang for expressing his concerns over the pricing of BMS’ Reyataz and for urging the drug giant to do its part to ensure that patients in need of lifesaving AIDS medicines are being served,” said Michael Weinstein, AIDS Healthcare Foundation President. “AHF believes there is simply no justification for BMS to price Reyataz $3,000 to $5,400 more than other first-line AIDS drugs. The price of this drug is putting an unbearable strain on taxpayer funded, cash strapped State AIDS Drug Assistance Programs in California and around the country, ultimately limiting access to lifesaving HIV/AIDS treatment to those most in need.”

To read the letter sent by Controller Chiang to BMS, click HERE

Background on the Pricing and Impact of BMS’ Reyataz

Since it was first approved by the FDA in 2003, BMS has increased the price of Reyataz by over 25%. Today, the Average Wholesale Price (AWP) of Reyataz (atazanavir) stands at $13,046 per-year. AHF officials note Reyataz must be taken with at least two other HIV/AIDS drugs as part of an effective antiretroviral treatment regimen.

AHF has seen firsthand the impact of high priced AIDS drug like Reyataz. In California, for example, since 2000 the number of new ADAP clients has only increased by 50%, but AIDS drug spending has increased by 165%. The price of Reyataz and other drugs is a major contributing factor to this increase.

Across the country, states have been forced to make cuts to ADAP services and enrollment because of high cost AIDS drugs like Reyataz. States can no longer afford to provide treatment to many of their current ADAP clients, and as costs increase more people will be put at risk of losing access to services. Ultimately, this means that the more people who go on high-priced drugs like Reyataz, the fewer who can receive lifesaving services.

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and services to more than 139,000 individuals in 23 countries worldwide in the US, Africa, Latin America/Caribbean the Asia/Pacific region and Eastern Europe.


As I see it, The Melanoma Patients could be next in line.

Q2 Conference Call July 2010 from Bristol Myer Squibb


We'll go next to Seamus Fernandez with Leerink Swann.
Seamus Fernandez - Leerink Swann LLC

Just a couple of questions on ipilimumab actually. Can you just discuss the kind of strategy that you might be evaluating relative to -- assuming that the frontline study is successful, the strategies in terms of pricing that you're thinking about relative to the differential in the 3-milligram per kilogram dosing versus the 10-milligram per kilogram dosing that you have for second-line versus first-line and how you can deal with that commercially? And then secondly, could you just, Elliott, clarify for us the maintenance paradigm in the IPI 024, the frontline study, versus the retreatment paradigm in the 020 study? I think there might be a little bit of confusion out there. I think it would help to clarify that.

Lamberto Andreotti

Than means I would start, and I will ask Beatrice to follow. Obviously, pricing of IPI is natural very important to us. We have initiated that review of the different options we have. And for obvious reasons, we will not disclose much in terms of prices until we are closer to the market. There is a -- this is really a different situation from what we experienced in the past with other oncology products because of the emerging profile of these products. So we don't want to exclude any possible new approaches to pricing, and we will discuss more about this when we launch. But Beatrice, why don't you speak a little bit more about the opportunity that we see for IPI?

Beatrice Cazala

As you know, this is a working science and new, so we don't really have a comparator into most standard of care because many investigational agent are used in that segment. So it creates a new set of challenges for us on pricing, I think if you outline some of them with a three and a 10, you will find interesting and new approach to solve that. The number of case is 30,000 to 40,000 annually in the U.S. and EU, and 60,000 worldwide. And we also know from, and Elliott will comment more about the schedule and dilution, but we also know in the surrounding setting that most of the patient will be treated with a number of dose and that would be it. So it creates an interesting situation for pricing and we're, clearly, today working very hard on nonstop therapy pricing in our overall share to be determining the optimal pricing for the products and to satisfy the multiple stakeholders and the access around markets when we introduce it. So interesting challenges, not on insufferable secondhand setting with a definite, it's a definite market. As you know, some of our patients also know it's a semi-treatment in most patients. So those are along the line of what we are working on today.

Elliott Sigal

So with regard to the maintenance schedules or the terminology of induction, re-induction and maintenance, in 020, there was no maintenance per se. There was induction and based on physician evaluation, a possible re-induction. The induction is an infusion, in this case, the three milligram dose, every three weeks for four complete doses. Now if a patient did respond, and these are patients that are pre-treated for which there's no approved drug and it is a fatal disease. If they did show some benefit after that induction and then later, seem to deteriorate, they could be reinduced. The 024 was a different trial, there is an approved drug DTIC and we ran ipilimumab on top of that backbone. To see if we could improve against the standard care and first-line metastatic melanoma and the protocol for that was at 10 milligrams. It was the same four doses in the induction every three weeks, and then there was a maintenance every three months.


Bristol Myer Slogan:

"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."

So we can deplete your life savings for the good of the company and line our pockets!!!!

“It is not the strongest of the species that survives, nor the most intelligent, but the one most responsive to change.”

~Charles Darwin~

Take Care,
Jimmy B

1 comment:

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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 " : 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.