Dying man fights to get experimental drug from Bristol-Myers Squibb..Melanoma ..Jim Breitfeller

Emily Jackson Staff Reporter Darcy Doherty’s last chance at life lies in an experimental drug. The yet-to-be-approved treatment is the only option left for the 48-year-old father of three with metastatic melanoma, believes his oncologist Dr. David Hogg, an attending physician at Princess Margaret Hospital. But maker Bristol-Myers Squibb (BMS) refuses to give Doherty the drug, saying it’s not yet safe for use outside the clinical trial, which Doherty was excluded from because of new cancer growth in his brain. That reason is simply not good enough for Doherty’s family and friends. If he will certainly die without the drug, why not let him try it? “They have an ethical responsibility to try to save a life,” his wife Rebecca Cumming said as she handed out “Help Save Darcy” stickers at the Ride to Conquer Cancer Sunday. “I think they’re afraid it will be harder to get the drug to market if the drug brings harm to patients like Darcy.” About 30 family friends were at the fundraiser to promote a change.org petition pressuring BMS to give Doherty access to the drug by Father’s Day. Wait much longer, Cumming said, and it will be too late. More than 171,000 have signed the plea. “We love our dad very much and we want a lot more time with him,” Doherty’s emotional 13-year-old son Ganden said in a video. A cancerous mole was first removed from Doherty’s back in 2003. By 2007 the cancer spread to his brain. He survived because of a then-experimental drug. His doctor said immune system off-switch blocker BMS-936558, which has had success in phase one of testing, could have similar benefits. BMS is aware of the petition, but did not budge on its decision. The company empathizes with patients who have limited treatment options, said spokeswoman Sonia Choi in a statement Sunday. Compassionate use requests are carefully reviewed using information from a patient’s physician, she said. To get access, the benefits must outweigh the risks. “At this time, there are not enough data on BMS-936558 to allow its use outside of a clinical trial.” Choi could not provide a timeframe on when more data might become available. The trial’s final stages are set for later this year or early 2013. “In the long term, the best way to ensure the broadest access for patients is to successfully register a medicine with health authorities through the conduct of well-controlled clinical trials.” “There’s no obligation on the drug companies to provide compassionate relief,” said Bernard Dickens, professor emeritus of health law and policy at the University of Toronto. BMS “can’t invest money in handing out unproven products if they’re not going to get data for study purposes.” But if the drug wasn’t safe enough to test on humans, it would not go to stage-two testing, argued advocate Frank Burroughs, founder of American organization the Abigail Alliance for Better Access to Developmental Drugs. For now, Doherty tires quickly. Sitting in his wheelchair at the fundraiser, the former big-bank financial services managing director called the petition an “amazing show of the human spirit.” He thinks it’s “kind of crazy” that he can’t get the drug. “It doesn’t hurt to give a guy a chance.” Source:http://www.thestar.com/news/article/1209218--dying-man-fights-to-get-experimental-drug-bristol-myers-squibb-won-t-give-him We have seen this type of action numerous times with BMS.They did this with Yervoy in the early days, closing compationate use. They appear to have no compassion or ethics, Just Greed!!!! to make a buck. I believe Bristol Myer Squibb is doing a disservice to the Cancer Community especially the Melanoma Patients.





"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."

There is no commitment to patients with stage IV Melanoma.

They have dollars Signs in the eyes and don't give a cr%& about the patients.

This is what Big Pharma has become. (Greed)

Take Care,

“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
 

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-Myers Squibb.. The Company..Melanoma ..Jim Breitfeller

Bristol-Myers Squibb

And what does Bristol-Myers Squibb 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.”

What sets us apart? …We are Greedy!!!!!!!!

Generics and Job-Cutting Costs Lower Drug Makers’ Profits
By BLOOMBERG NEWS
The drug maker AstraZeneca, the Bristol-Myers Squibb Company and Bayer reported declines in first-quarter profit on generic competition and costs from cutting jobs.
April 25, 2008

Drug Executive Is Indicted on Secret Deal
By STEPHANIE SAUL
A former Bristol-Myers Squibb executive was charged with making false statements to the F.T.C. about a pact made with a Canadian maker of generic drugs.
April 24, 2008

3 Drug Makers Are Convicted in Reimbursement Overcharges
By BLOOMBERG NEWS
AstraZeneca, Bristol-Myers Squibb and Schering-Plough must pay damages for overcharging on certain drugs.
June 22, 2007

Drug Maker Ending 2 Years of Probation
A two-year probation for Bristol-Myers Squibb ends Thursday, freeing the company from federal supervision after a major accounting scandal and other misconduct.
June 15, 2007




Drug Maker Fined in Plavix Case
By STEPHANIE SAUL
Drug maker Bristol-Myers Squibb pleaded guilty to making false statements to a federal agency in a case involving its blockbuster drug, Plavix.
June 12, 2007

Cancer Drug Representatives Spelled Out the Way to Profit
By ALEX BERENSON
Big pharmaceutical companies sometimes calculated to the penny the profits that doctors could make from their cancer drugs and shared those estimates with doctors.
June 12, 2007

Bristol-Myers to Pay Fine
The company will pay a $1 million criminal fine for lying to the government about a patent deal on its blood-thinning drug Plavix.
May 31, 2007

And there is more at the site below.

Source:http://topics.nytimes.com/top/news/business/companies/bristol_myers_squibb_company/index.html?offset=20&s=newest

Bristol-Myers Squibb.. The Company


Does anyone see a trend emerging?


Take Care,

Jimmy B

It is Time to Have Our Voices Heard!!! Melanoma ..Jim..Breitfeller

Please go to Melanoma Missionary and write to your congress Person.

We need to get this movement started.

Dear Congressperson,
I am writing this letter to ask for your help. As a constituent in your district, we need you to act, vote and rally for this cause. The Health Care System is failing us. The Drug (Ipilimumab (MDX-010) is a fully human, monoclonal antibody that overcomes CTLA-4-mediated T-cell suppression to enhance the immune response against tumors) has been fast tracked by the FDA has not been available for compassionate use for almost a year now. The company Bristol Meyers Squibb says they are having trouble making it. We are questioning their ethics. We believe that they are holding back and inflating the demand or does it have to do with the FDA approval process. This seems to be corporate greed at its finest.

"Unfortunately, they also have some bad habits. For example, there were two anti-trust suits filed against them, for monopolizing the market in order to delay, or stop, the generic versions of the anti-cancer drug Taxol, and the anti-anxiety drug Buspar. The company was able to do this through manipulation of loopholes in the Hatch-Waxman Act. Under this act, brand name manufacturers list un-expired patents with the FDA in a listing, or compendium, known as the ?Orange Book?. This listing offers a reward of an automatic 30-month stay against certain potential generic entrants who have been sued for product infringement."

Source:http://www.academon.com/lib/essay/bristol-myers-squibb-company.html

Right now they have the monopoly on this monoclonal Antibody.

Compassionate Use Trial for Unresectable Melanoma With Ipilimumab (IMEXA)This study has been suspended.

First Received: June 29, 2007 Last Updated: June 17, 2009 Sponsored by: Bristol-Myers SquibbInformation provided by: Bristol-Myers SquibbClinicalTrials.gov Identifier: NCT00495066

We are asking for a Congressional Investigation into this matter.

As you know 64,000 will be diagnosed with this terrible disease, and about 8400 will die this year alone in the U.S.
One in three will be touched by cancer in their lifetime, you may be the next.

Please don’t let it fall on deaf ears. Our life depends on your help.
Sincerely,

=========================================================
Here is what Bristol Meyer Squibb says about themselves:

"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."

What sets them apart is:
Corruption at the Top!!!!!

"You remember the case: Andrew Bodnar, former Senior EVP at Bristol, pleaded guilty to a single count of lying to the FTC to hide a secret deal with Canadian generics maker Apotex. Bristol had promised Apotex that it wouldn't interfere with future generic sales, provided the copycat drugmaker agreed to postpone launching its version of Plavix. The FTC objected to that deal as, in effect, a pay-for-delay agreement. Bodnar excised that provision from Bristol's agreement with Apotex--but he made an oral promise to the generics maker, the government said. Bodnar denied it; he was charged with the crime."

Source:http://www.fiercepharma.com/story/ex-bms-exec-sentenced-write-plavix-book/2009-06-09


Take Care,

Jimmy B