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
To: 'CDER DRUG SHORTAGES'
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
http://findarticles.com/p/articles/mi_m0DED/is_7_19/ai_53992410/
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
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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
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
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.
Sincerely,
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.
Source:https://www.z2systems.com/np/clients/mif/news.jsp?news=381
https://www.z2systems.com/np/clients/mif/news.jsp?news=381
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
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/default.htm#
