Bristol Meyer Squibb, Where do you draw the Line in the Sand?Melanoma ..Jim Breitfeller

Bristol Meyer Squibb, Where do you draw the Line in the Sand?



“What I found over the next two and a half years of "researching the research" is a scandal in medical science that is at least the equivalent of any of the recent corporate scandals that have shaken Americans' confidence in the integrity of the corporate and financial worlds. Rigging medical studies, misrepresenting research results published in even the most influential medical journals, and withholding the findings of whole studies that don't come out in a sponsor's favor have all become the accepted norm in commercially sponsored medical research. 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


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?

Where do you draw the Line in the Sand?

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:



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


Estimated Enrollment:30
Study Start Date:February 2009
Estimated Primary Completion Date:
February 2013 (Final data collection date for primary outcome measure)ClinicalTrials.gov Identifier:NCT00836407

A Phase I Study of Repetitive Dosing of Anti-CTLA-4 Antibody (MDX-010) in Combination With GM-CSF in Patients With Metastatic, Androgen-Independent Prostate Cancer


Estimated Enrollment:36
Study Start Date:November 2009
Estimated Primary Completion Date:
November 2013 (Final data collection date for primary outcome measure)



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 as the STRING OF PEARLS.

.And the FDA has turned a blind Eye and gave it its unoffical approval to allow this to happen.
Where are the comsumers being protected. Without the patients, Bristol Meyer would have no trials. Very STRANGE BEDFELLOWS TO SAY THE LEAST.



Take Care,

Jimmy B

I thought you would like to Know this. BMS..Melanoma..Jim Breitfeller

IPILIMUMAB TUMOR PLANNING(Job Number: 1000235)

Description

This candidate will be a member of the Ipilimumab Global Marketing team. Major responsibilities will include - Leadership of the prostate cancer program oPositioning work o Label Optimization (Collaboration with the clinical, medical and regulatory team to ensure commercial success) o Patient Insight work o Tumor Strategy Group Member (Opportunity to provide input to franchise strategy: Future market Map, Scenario Planning, CI readiness) Leadership of the pancreatic program o Label Optimization (Collaboration with the clinical, medical and regulatory team to ensure commercial success) o Preparation for key DP discussions o Choices 1-5 o Collaboration with franchise GI tumor lead Management of innovative virtual insight exchange program for all indications Key commercial member to the future tumor planning for the brand o Lead commercial tumor deep dives for assessment of attractiveness Management of the Competitive Intelligence Plan for non-Melanoma indications Collaboration with advertising agency, medical education agency and interactive agency to drive performance of projects Collaboration with SPDA on Forecasting for LCM opportunities. This position will work closely with the melanoma team to insure integration of learnings is rapidly applied and appropriate market development is being identified.

Qualifications

2 plus years of Global Marketing and operational Marketing experience at the D7 level. MBA or equivalent. Understanding of the oncology marketplace and demonstrated ability to learn about different tumor types (preferable). Experience in communication and leadership of teams across various functions. Ability and desire to analyze clinical data. Strong interpersonal skills and ability to motivate and build alignment across matrix teams. Demonstrated ability to effectively and efficiently drive performance within a matrix organization. Analytical thinking and innovative approach to problem solving. Experience in strategic thinking and executing against plans. Ability to demonstrate expertise in marketing analytics and market, customer & competitive insight

Job Function: Marketing
Primary Location: NA-US-NJ-Princeton

It is not about the patient, it is about how they can leverage this drug in the marketplace

The results were so startling that researchers decided to release details of the two cases before the drug trial – in which the patients took part – was complete. Doctors said their progress had exceeded all expectations. The men were treated at the Mayo Clinic in Minnesota in the US, one of the top medical centres in the world.

Dr Eugene Kwon, the urologist who was in charge of their treatment, compared the results to the first pilot breaking the sound barrier.

"This is one of the Holy Grails of prostate cancer research. We have been looking for this for years," he said.

Ipilimumab is one of a class of drugs called monoclonal antibodies, which stimulate the body's own immune system to fight disease. The experimental treatment is being developed by Bristol-Myers Squibb and Medarex, a US biotech company. The drug is being trialled on malignant melanoma, the most serious form of skin cancer, Hodgkin's disease, lung cancer and prostate cancer. Studies are most advanced in melanoma, where it has been shown to prolong survival in patients with advanced forms of the disease. In the Mayo Clinic study of prostate cancer, researchers say that standard hormone treatment ignited the immune response, and adding ipilimumab was like "pouring gasoline on the pilot light".

Take Care,

Jimmy B

Bristol-Meyer Squibb, Tight Lips Sink Ships..Melanoma..Jim Breitfeller

Bristol-Meyer Squibb, Tight lips sink Ships

Bristol-Meyer Squibb can donate to the Disaster Relief in Haiti, But can’t donate to the citizens in the United States that need it the most, the Melanoma Cancer Patients that are fighting for survival and don’t qualify for BMS’s Trials. These are the cancer patients that are falling through the Healthcare system cracks. Jumping on the band wagon to get some extra PR is not the way to try to bolster their image. I believe in helping Haiti, but also Charity should start at home. Are they doing to for Humanitarian reasons or is it a just a big brand recognition scheme? I believe it is for the PR.


What really happened with the Compassionate Drug care use for Melanoma Patients? They said as of 9-12-2008 that they had to stop the use because they were having trouble manufacturing it. I believe it was all a cover up. As of 9-12-2008 they have opened quite a few new Clinical Trials with Ipilimumab. Then they pointed to a new process. There is one problem I see here. It only takes 3 months to grow the antibodies. They already had the master seed vials from Medarex. It is a Batch fermentation process or a continuous feed process. At the most it should take 4 to 5 months with testing and Good GMP.


So about 18 months have elapsed since the stoppage and we still have no Compassionate Drug use. That means at least 3 to 4 batches were made. We confirmed at least one or two batches based on information from some Melanoma non-profit organizations.


Bristol-Meyer Squibb, Show Us the Patients, the Master Production Batch Record (MPBR) or Production Batch Record (PBR) for Ipilimumab



Bristol-Meyer Squibb, If there was truly a Shortage/problem in the production of Ipilimumab, the it would show up in the Master Production Batch Record (MPBR) or Production Batch Record (PBR).


They won’t respond because there was not incident. The reason they shut it down in my opinion was, they were loosing money giving it away. It was not in the plan “Sting of Pearls”, and since it was going to take longer to get it FDA approved, they wanted to stop the outflow of revenue.


As of 1-29-2010, I am still getting lip service from Bristol Meyer Squibb.


“In light of the previous demand, Bristol-Myers Squibb is committed to ensuring that a continuous supply of ipilimumab is available prior to the re-opening of compassionate use so there are no treatment interruptions for patients who initiate therapy. As you probably know, the manufacturing cycle time and testing of a biologic such as ipilimumab is more complex than what is traditionally seen with small-molecule synthetic chemical pills. For example, host cells need to be grown, the purification process requires several steps before the active pharmaceutical ingredient can be formulated and the complexities associated with the manufacturing process limit the amount of drug supply that can be produced at one time. For more information on the manufacturing of biologics, please visit the Biotechnology Industry Organization's website at: http://www.bio.org/healthcare/pmp/factsheet1.asp.


It doesn’t take a year and half to produce. It all comes down to power and Greed



It is taking way to long for this drug to come to market. It was discovered over 10 years ago by Dr. Jim Allison at USC.




Bristol Meyer Squibb Has not even filed for a BLA yet. Biological License Application
So we could be another year or two before they go infront of the FDA. Many Melanoma Patients will die in the meantime. It will be blood on the the Hands of Bristol-Meyer Squibb. Greed has over taken compassion.

Just look at the graphic they put up at one of their financial meeting. They know what they have.
They realize what they are holding in their Drug Pipeline.

Take Care,

Jimmy B

Bristol-Meyer Squibb the New Dr. Kevorkian of the Decade?Melanoma..Jim Breitfeller

Is Bristol-Meyer Squibb the New Dr. Kevorkian of the Decade?

• Mislead the public/Government about the Ipilimumab Shortage
• Stopped the compassionate drug use on 9/12/2008
• Continued to create/open clinical trials with Ipilimumab
• Increased their stock dividend as of February 2010
• Continuously turn away Melanoma patients that did not qualify for their trials

As a Melanoma Patient and a survivor, I believe BMS is the New Dr. Kevorkian.
They are killing cancer patients that have no other alternative and Anti-CTLA-4 blockage was their last hope.
“Scientists have discovered that an important mechanism for down regulation is mediated by a molecule called CTLA-4. The T cells are initially activated by other immune cells, called dendritic cells, that display the foreign, or cancerous, antigens to the T cells and instruct them to be active. After this initial activation, CTLA-4 appears on the surface of the T cells, and when CTLA-4 interacts with the dendritic cells, the next set of signals are to turn the response down, or even off. CTLA-4 is part of a regulatory mechanism that normally protects the body from immune overreactions, but when it is expressed in the presence of mutant cancer cells the result is tumor evasion of the immune response. Ipilimumab is an antibody that blocks CTLA-4, releasing this safety brake, and allowing the immune response to have a stronger anti-tumor effect.”

Source: Oregon Health and Science University

With Bristol-Meyer Squibb not allowing compassionate drug use, they are invoking a death sentence on the cancer patient. Since Pfizer pulled out of this therapy due to the fact they wanted the drug as a monotherapy when the scientific data suggests that a combination of this drug would have better results. So BMS now has a monopoly on this drug and will be able to charge a great deal for it even though it is made in thousands of units per batch. When will the FDA coming in and do what is ethical for the country?


We cannot let a deceitful and greedy company control our destiny.


“In our daily life, we encounter people/companies who are deceitful, intent only on satisfying their own needs. There is so much anger, distrust, greed, and pettiness that we are losing our capacity to work well together to do what is ethically right.”
Jimmy B


Take Care,

Jimmy B

Bristol-Meyer Squibb.."When you marry the devil's daughter don't be surprised when your father-in-law comes to visit."Melanoma.. Jim Breitfeller

Monday, May 18, 2009
Quote of the week - and It's only Monday morning!

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

Corey Nahman writes:

A Celebrity Patient's Backing Turns Sour for Drug Company … wasn't the truth, he says now. Within weeks of taking Abilify, Mr. Behrman says he felt stiffness and agitation in his legs. He says Abilify clouded his thinking. He now says the drug made him feel worse than any treatment he has tried…[Wall Street Journal]

Editor's Note: Sequence of events: (A) Bristol hires author/bipolar patient to tell the world how great Abilify is, pays him $10K per day in speaking fees and he tells everyone it is the best thing since sliced bread.(B) His contract is over and he demands $7.5 million to renew; BMS tells him to shove it.(C) Now he's going around saying that he lied all along and Abilify hade him feel like crap.

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

This happened in 2009. BMS still has not changes it's way of doing business. It is all about the bottom-line and how to make a profit.

Now think about the Ipilimumab Shortage. Go to the Clininal Trial website and see all the trials started after the shortage/ stoppage of the the compassionate drug use (Ipilimumab).

This is not rocket science

We been had!!!!
Mislead!!!!!

Patients have died due to the fact they did not have access to Ipilimumab.

BMS only cares about the bottom-line. What about what is ethically right?

They are the Tiger Woods of the pharma companies.We should boycott them.








Take Care,

Jimmy B

2009 Sustainability Reporting of the World's Largest Pharmaceutical Companies (BMS)..What about Ethics??? Melanoma ..Jim Breitfeller

Dr. Morhardt,

While reading the Scores

2009 Sustainability Reporting of the World's Largest

Pharmaceutical Companies

A benchmarking tool for online sustainability reporting

Roberts Environmental Center

Source: http://www.roberts.cmc.edu/PSI/PDF/Pharmaceuticals2009.pdf

I have some comments:

While base on your environmental standards Bristol-Meyers Squibb is worthy of an A+, their Ethical conduct should be also taken into account. As a patient of stage IV Melanoma Cancer, I saw firsthand what BMS is all about. It is greed and the bottom line and the “string of Pearls”. They chose to close the compassionate drug use (Ipilimumab). They told the public and the Government that they were having trouble producing the drug, but proceeded to startup new Clinical trials with the drug after they stopped compassionate drug use. How ethical is that? They even went as far to respond to a patient’s family with this response;” Jimmy, remember what the BMS "doctor" told me "Mrs. Lawrence, you will get the drug for your husband when we can charge for it."



BMS is only looking out for their bottom-line and to hell with patients.

So with this information, BMS in my opinion is only worth a C- to a D+, not an A+.

You can’t just use what they say on their website. You need to do real research. The information on their website is skewed in the drug companies favor.



Best regards,



Jim Breitfeller Patient/Survivor/Researcher of Stage IV Melanoma



http://melanomamissionary.blogspot.com/



Take Care,

Jimmy B

In this Holiday Season there is a Scrooge (Bristol Meyer Squibb) among us!! Melanoma..Jim Breitfeller

In this Holiday Season there is a Scrooge among us. It is the Bristol-Meyer Squibb. In September of 2008 they stopped compassionate drug use (Ipilimumab) because they claimed that they were having trouble producing it. It has come to light that their major intension was to stop giving it away until they could get paid for it. The Shortage was a Magic act. Now it’s there and now it’s not.

To make matters worse, The FDA was contacted and never really looked into the Shortage. Did they turn blind eye or are they short staffed?

I have reason to believe Bristol-Meyer Squibb is the poster boy for Scrooge this Holiday Season In their Company Documents they say:

“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.”
Bristol-Meyer Squibb is committed to their bottom line. They are the Scrooge of the pharmaceutical Industry in my opinion. They all do it, just not as publicly as Bristol-Meyer Squibb.


The company should be investigated on their ethics.


1. They mislead Government officials, the truth about the shortage?
2. They added new Clinical Trials after they stopped Compassionate Drug Use
3. They mislead the general public (The Melanoma Patients)
4. They went so far to amend their Compassionate use protocol to read “the study will be closed to enrollment upon market availability and then need to switch to commercial supply.”
5. Jimmy, remember what the BMS "doctor" told me "Mrs., you will get the drug for your husband when we can charge for it."

This all comes down to Ethics. Doing what is right.

I say to Bristol-Meyer Squibb

“BAH HUM BUG!!!!!”



Please sign the E-Petition at Melanoma Missionary
Your Life may depend on it



Take Care,

Jimmy B

Bristol-Meyer Squibb and Responsibility..Melanoma ..Jim Breitfeller

Bristol-Meyer Squibb and Responsibility

“We take our responsibilities in the world seriously and always strive to do what is right. We do this for our customers, for our employees, for the environment, for our families and friends, and, for the communities in which we operate.”

~Bristol-Meyer Squibb ~


“To offset the approaching patent “cliff,” as the industry calls it, Bristol decided in 2007 on a twin strategy of cost-cutting and strategic acquisitions. The company reported productivity savings of $1.2 billion in 2008, largely through staff cuts and the shuttering of manufacturing plants. It plans further cuts and savings totaling $1.3 billion by 2012.”

This included shuttering down the Compassionate Care Use of Ipilimumab on 8-12-2008. I believe there was no shortage. They took the opportunity to save on the bottom line instead of saving some Melanoma Patients. They seem not care about the patients as much as their bottom line. They say the take their responsibilities in the world seriously.
PROVE IT. Return the compassionate drug to the patients that need it the most. By doing so, Bristol Meyer Squibb will get more back than just money for the bottom-line. They will get back their loyal consumers. This not about money, this about doing what is right and ethical.

I urge Bristol-Meyer Squibb to do what is right and not just give us lip service.

Please take the time to sign the E-Petition this Holiday Season. We won’t stop until the injustice has been righted. As a consumer of BMS products we can make a difference




Take Care,

Jimmy B

Bristol Myers Squibb to pay 515 million to Settle Fraud Charges 2007 Melanoma..Jim Breitfeller

Shortage of Ipilimumab, I don't think so. I think it was staged to save and revert the drug to other Clinial trials. That is my opionion. Go to Clinical Trials. In the search field, type, Ipilimumab, Melanoma, protrate cancer, breast cancer,colon cancer, liver cancer. Then see when the trials that are recruiting and start date.

If it is after 8-12-2008, then the clinical trials was started with Ipilimumab after they took away compassionate drug use for the Melanoma Patients and is unethical to say the least.



Drugs giant Bristol-Meyers Squibb and a former subsidiary have been hauled over the coals and forced to pay more than half a billion dollars to settle settle federal and state investigations for promoting an anti-psychotic drug, Ablify, for uses that were not approved by the US Food and Drug Administration and providing illegal inducements to doctors and other health care providers.

The inducements included consulting fees and all expenses paid trips to resorts to attend conferences. There were also allegations that Bristol-Myers Squibb was behind the submission of false or fraudulent claims to medicaid, Medicare and other federal health programs.

Bristol Myers Squibb_pinged_515_million_to_settle_fraud_charges





Take Care,

Jimmy B

If you believe what Bristol-Meyer Squibb is telling us about the shortage watch This.Melanoma..Jim Breitfeller

Ex Drug Rep -- Manipulating Doctors

If they can manipulate Doctors, just think what they can do to the patients.

Watch the last two minutes.




Take Care,

Jimmy B

E Petition For BMS's Compassionate Investigational Drug Access.Melanoma..Jim Breitfeller

E Petition For BMS's Compassionate Investigational Drug Access

“You Can’t Start a Fire Without a Spark!!”

It is time to rally the Melanoma Patients and take back the Clinical Trials.

Bristol-Meyer Squibb halted the compassionate Drugs stating a drug shortage. There is evidence out there that the shorage was over months ago. They left the Melanoma Patients falling through the cracks of the Health Care System. We need change NOW!!!!!

Please sign the E Petition at Melanoma Missionary

Take Care,

Jimmy B

Bristol-Meyer Squibb, Show Us the Patients, the Master Production Batch Record (MPBR) or Production Batch Record (PBR) for Ipilimumab

Bristol-Meyer Squibb, If there was truly a Shortage/problem in the production of Ipilimumab, the it would show up in the Master Production Batch Record (MPBR) or Production Batch Record (PBR)

“A master production batch records (MPBR) is a detailed, step-by-step description of the entire production process for a specific drug. It is the document wherein the chemical and biological processes of drug manufacturing (developed during the phase of research and process development of the drug) are merged with the regulatory requirements of the FDA. A good batch record ensures the fundamentals of cGMP compliance while providing a practical set of instructions for the manufacturing technician or operator. The MPBR explains exactly how the product is produced, indicating specific types and quantities of components and raw materials, processing parameters, in-process quality controls, environmental controls, etc. To support the requirements of the production batch record (PBR) which is also known as the batch production and control record, the MPBR contains fill-in-the-blank spaces throughout the text to facilitate the documentation of events for each individual batch. In fact the PBR is an exact copy of an approved MPBR. A PBR is issued for each batch of product produced in the facility. A batch, by the way, is defined in the Code of Federal Regulations, Title 21 210.3: "Batch means a specific quantity of a drug or other material that is intended to have a uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacturing." For a cell-culture derived protein product, a batch begins with inoculation and then proceeds through harvest and purification (sometimes the final purification steps may have a separate batch record). There would be separate batch records for media preparation, equipment preparation (cleaning, assembly, sterilization, etc.), and scale-up for innoculum preparation. There would also be separate batch records for final product formulation, filtration, filling, lyophilization, sealing, inspection, and labeling. PBRs must be followed during production events, and the information and signature blocks must be completed as production proceeds. Production and QC personnel write the MPBR.”

This Document would be the proof that there was or wasn’t a shortage/problem.

We would also like a copy of the production log book ledger dating back to 7-1-2008.



Facts About Current Good Manufacturing Practices (cGMPs)http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm169105.htm#

fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing


Take Care,

Jimmy B

This is why I am so upset.Melanoma..Jim Breitfeller

COPosted by Tim--MRF at 02:47 on Mon, Sep 28, 2009 [Show other posts by Tim--MRF](Melanoma Research Foundation)

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

Jim:

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.

Tim

So why is the compassionate Use not first inline to get it?


It comes down to greed.They are looking after their bottom line but they preach:

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!!!!!

THEY DID NOT EVEN HAVE THE DECENCY TO LET THE PATIENTS KNOW

Bristol-Meyer Squibb, LET YOUR TRUE COLORS COME SHINING THROUGH!!!!!!!

WHAT A BOONDOGGLE

THIS SHOULD BE REOPORTED TO THE FDA..CDER Drug Shortage Team

Take Care,

Jimmy B

A new clinical trial has been launched using patients' own immune systems to fight prostate cancer cells.Melanoma ..Jim Breitfeller

A new clinical trial has been launched using patients' own immune systems to fight prostate cancer cells. Patients with advanced hormone refractory prostate cancer who have failed to respond to chemotherapy may qualify for this unique clinical trial.

Canton, Ohio (PRWEB) October 2, 2009 -- A new clinical trial has been launched using patients' own immune systems to fight prostate cancer cells. Patients with advanced hormone refractory prostate cancer who have failed to respond to chemotherapy currently have no viable options available. There is an experimental agent which is a monoclonal antibody that attacks the T-lymphocytes. Those lymphocytes' function is to weaken the immune system. By reducing the number of T-lymphocytes, the patient's immune system is augmented and strenthened producing antibodies that would potentially attack cancer cells.

A nationwide, placebo-controlled, clinical trial was recently launched where patients with prostate cancer who have received chemotherapy before will be treated with this monoclonal antibody. Preliminary previous trials using this compound in patients with melanoma and other cancers have produced encouraging results that made investigators conduct this large, clinical trial for prostate cancer patients.

Researchers involved in this innovative and relatively safe treatment (including Gabrail Cancer Center, Canton, Ohio) are trying to find out if this agent will produce an additional weapon to fight prostate cancer especially since there are no alternative therapies available. Log on to www.GabrailCancerCenter.com or call (330) 492-3345, for more information

source:http://www.prweb.com/releases/2009/10/prweb2971344.htm

Bristol-Meyer Squibb closed the compassionate drug use of Ipilimumab so it could open NEW CLINICAL TRIALS FOR OTHER CANCERS!

Do you see the Disparity in that?

This so unethical it makes me SICK.

Bristol-Meyer Squibb should reopen the Compassionate Use NOW!!!!!!!

The FDA should also look into the supposedly shortage that Bristol-Meyer Squibb CREATED so it could open NEW CLINICAL TRIALS OF OTHER CANCERS.

Take Care,

Jimmy B

Food for Thought...Howard H. Pien..Melanoma..Jim Breitfeller

Howard H. Pien, M.B.A.
Mr. Howard H. Pien , 51
Chairman, Chief Exec. Officer and Pres

Annual Salary $ 1.46M

CEO of Medarex



They make the CTLA-4 antibodies

"Mr. Pien is the Chairman of our Board and our President and Chief Executive Officer. Prior to joining us in June 2007, Mr. Pien was the Chairman and Chief Executive Officer and a Director of Chiron Corporation, a biopharmaceutical company involved in three healthcare markets: blood testing, vaccines, and biopharmaceuticals, from April 2003 until Chiron's merger with Novartis in April 2006. From April 2006 to June 2007, Mr. Pien performed consulting services. He joined Chiron from GlaxoSmithKline, where he held roles in commercial operations and general management, including positions as the head of the international business. Mr. Pien previously held key positions in SmithKline Beecham's pharmaceuticals business in the United States, the United Kingdom, and North Asia, culminating in his tenure as President, Pharmaceuticals-North America and head of the worldwide pharmaceutical and vaccines businesses. Prior to joining SmithKline Beecham, he worked for six years for Abbott Laboratories and five years for Merck & Co., in positions of sales, market research, licensing and product management. Mr. Pien is a Massachusetts Institute of Technology graduate and received an M.B.A. from Carnegie-Mellon University. Mr. Pien currently serves as a director of ViroPharma Incorporated and Vanda Pharmaceuticals, Inc., each a publicly traded biotechnology company."

Source:Yahoo Finance

2004 shorage and contamination of the FLU Vaccine

http://archives.energycommerce.house.gov/press/108ltr161.pdf


Contamination of Vaccines


Do you see a pattern emerging?



Take Care,

Jimmy B