Friday, February 5, 2010

Keeping the lid sealed on Medical Science to ensure its translation into Medical Practice..Melanoma..Jim Breitfeller

“To keep the lid sealed on this corruption of medical science—and to ensure its translation into medical practice—there is a complex web of corporate influence that includes disempowered regulatory agencies, commercially sponsored medical education, brilliant advertising, expensive public relations campaigns, and manipulation of free media coverage. And last, but not least, are the financial ties between many of the most trusted medical experts and the medical industry. These relationships bear a remarkable resemblance to the conflicts of interest the Securities and Exchange Commission recently brought to a halt after learning that securities analysts were receiving bonuses for writing reports that drove up stock prices with the intent of bringing in more investment banking business.”

Quoted from:
Overdosed America by John Abramson MD, page 9


Is it one Big Infomercial? Commercial Support of this Educational Meeting?

Financial ties between many of the most trusted medical experts and the medical industry.

And Bristol Myer Squibb can’t open Compassionate Drug use to the Critically Ill Patients.

Who is watching the Hen House? What happen to the code of ethics?

Not an official event of the ASCO Annual Meeting. Not sponsored or endorsed by ASCO or The ASCO Cancer Foundation.
In accordance with the Accreditation Council for Continuing Medical Education (ACCME) Standards for Commercial Support, all educational programs sponsored by the Oncology Learning Center (OLC) demonstrate fair balance, complete independence from any commercial supporters, objectivity, and scientific rigor. All faculty, authors, editors, OLC staff and planning committee members participating in an educational activity who are in control of content or in communication with faculty are required to disclose any relevant financial interest or other relationships with the manufacturer(s) of any commercial product(s) and/or provider(s) of commercial services that are discussed in an OLC educational activity. All disclosures will be made available to all activity participants prior to the conduct of its educational activity. In addition, all conflicts of interest will be resolved prior to the conduct of its educational activity.


This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The Oncology Learning Center does not recommend the use of any agent outside of the labeled indications.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the Oncology Learning Center. Please refer to the official prescribing information for each product for discussion of approved indicated, contraindications, and warnings.


Participants of OLC's educational activities have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development and practices. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient's conditions and possible contraindications on dangers in use, review of any applicable manufacturer's product information, and comparison with recommendations of other authorities.
In a related Story
FBI: Syracuse man downloaded Bristol-Myers Squibb's process for making cutting-edge cancer drug
By Douglass Dowty / The Post-Standard
February 04, 2010, 5:47PM

"When you marry the devil's daughter don't be surprised when your father-in-law comes to visit."

Syracuse, NY -- Among the trade secrets a Syracuse man took from Bristol-Myers Squibb were steps to produce a multi-million dollar drug under development to treat a deadly form of cancer, FBI agents said.
Shalin Jhaveri, 29, was arrested Tuesday after a two-month investigation by the company and the FBI. He was living in an apartment on East Water Street in Hanover Square.
Jhaveri was in a management training program at Bristol’s East Syracuse facility, which develops cutting edge drugs known as biologics, federal authorities said. While there, he downloaded confidential procedures for biologics that he e-mailed to a potential business partner in his native India, prosecutors said.

Jhaveri’s ultimate goal was to start his own biopharmaceutical company, Cherish Bio Services, in India, according to court documents. His business partner was a potential investor who FBI agents recorded talking to Jhaveri on Jan. 25, court documents show.
During that conversation, Jhaveri told the partner he had set up a Gmail account and sent procedures for making “Anti-Human CD137 Monoclonal Antibody,” a biologics drug for patients with malignant melanoma. The rare skin cancer has no proven cure in its advanced stages.

Human CD137 (4-1BB) is expressed on activated T cells within 24-48 hours of activation.

That’s why the drug is a potential blockbuster for Bristol that could bring in $1 billion a year if it reaches mass production, said a stock analyst who monitors Bristol’s products. Right now, the drug is in early stages of clinical testing.

“It’s a big deal,” said Les Funtleyder, a health care strategist with Miller Tabak & Co. “If it were to succeed, it could be a blockbuster.”
He said biologics use animal cells to create pharmaceuticals, which cost a lot of money to produce and test. He estimated that Bristol could have spent up to $500 million developing this drug, BMS-663513, and others like it.

“It’s not easy to do,” he said. “It takes a lot of time and money.”
Bristol officials, who declined comment for this story, began tracking Jhaveri’s actions in December after finding documents on his work laptop that included an application to the government of India to start his own biopharmaceutical company, court records show. Computer specialists found Jhaveri had downloaded 45 gigabytes of information onto an external drive.

Soon afterward, authorities recorded a phone conversation Jhaveri had with the business partner from India. Their correspondence led to a meeting in Syracuse at the Renaissance Hotel on Tuesday, according to court documents.

There, Jhaveri showed the partner virtually all the “Standard Operating Procedure” documents kept at the East Syracuse facility, court records state. These included the trade secrets for the melanoma drug, among many others. All together, Jhaveri had 1,327 standard operating procedures, all of which were confidential, court records state.

An FBI agent confronted Jhaveri, who admitted to sending the confidential drug information and taking the standard operating procedures without authorization, court documents state.

Jhaveri, who holds a Ph.D. and was a former graduate research assistant at Cornell University, is currently in federal custody without bail. A detention hearing is scheduled for Monday in Syracuse.


As you can see, Bristol Meyer Squibb is infiltrated with corruption.

Take Care,

Jimmy B

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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.