|Jerome Bettis and Jen on the set of The Jerome Bettis Show|
Some of you may have been paying attention to the news lately and heard that the FDA is revoking “Avastin” from the market. This is one of the drugs that I am taking and is not very good news although I found an article dated December 28, 2010 that the manufacturer, Genentech, is requesting a hearing with the FDA before anything takes effect. The next 5 paragraphs are completely plagiarized. I cut and paste a couple of articles together instead of reinventing the wheel.
The U.S. Food and Drug Administration did something highly unusual on Dec. 16: It revoked its previously granted approval for using a drug called Avastin to treat late-stage metastatic breast cancer. Avastin reduces blood flow to tumors. This allows it to halt the spread of breast cancer in some patients. In one clinical trial, 52 percent of Avastin users saw their tumors stop growing or spreading to other parts of their bodies. In most other breast cancer patients, Avastin acts as a pause button, sparing women from deteriorating further – at least temporarily. On average, Avastin can extend patients' lives by four to five months. However, some "super-responders" react especially well and enjoy unexpected years of additional life. (This is my plan)
The FDA has started the process of removing the breast cancer indication for bevacizumab (Avastin, by Genentech), saying the drug is too toxic and confers no survival benefit for women with HER2-negative metastatic breast cancer (MBC). The drug has been shown to improve progression-free survival (PFS).
The FDA’s decision was based on four clinical trials: E2100, AVADO, and RIBBON-1, which studied bevacizumab in the first-line treatment of MBC, and AVF 2119g, which studied it as second-line treatment in this setting. “Today’s announcement is the first step in a process and will not have immediate impact on use of Avastin to treat breast cancer or the drug’s availability,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a press briefing. “For patients, this means no disruption in treatment. Their access to Avastin will not be affected.” She added that oncologists currently treating patients with bevacizumab should use their judgment in deciding whether to continue with the drug or explore other treatment options.
Dr. Woodcock emphasized that the FDA’s decision did not take into account the cost of bevacizumab, which is estimated at about $100,000 per year per patient. “Reimbursement is a decision that is made by insurance providers which often use different criteria from those used by the FDA when we determine that a drug is safe and effective for marketing,” she said. “At this time, the CMS [Centers Medicare & Medicaid Services] will not be making any changes to its reimbursement policy for Avastin and is waiting until the resolution of this process before deciding whether to make any changes.”
Meanwhile, as the FDA was announcing its decision, the European Medicines Agency (EMA) declared that bevacizumab in combination with paclitaxel remained a valuable treatment option for women with MBC, claiming that the benefits of the combination outweighed the risks. (I’m not taking paclitaxel at this time)
What does this mean for me? Well everything is still up in the air as you can see. Dr. Bowers is keeping a close watch on the situation and will make whatever recommendation is necessary at that time. As of now, I received a dose of Avastin on December 20th and will continue to do so until I hear differently. J
Onto good news now. The bucket list is coming along very nicely. I’ve crossed off 3 items in the last 2 months and they were a blast!
|Nancie and Jen with winning cards.|
In between games there were lots of prizes to win too. If my memory serves me correctly, Nancie’s gang and JR and I walked out of there with a City of Carver baseball hat, City of Carver sweat shirt, 3 gift certificates for bars down the street, around $60 in cash, a pack of steaks, a ham and 5 turkeys. We rocked at Bingo; I don’t want to talk about it. After Turkey Bingo we did a little more bar hopping with Nancie and Terry. What a fun night! Thank you Nancie, Terry and the City of Carver!
|Gravy Lessons at Open Arms of Minnesota|
On November 24th I went over to their new building to learn how to make gravy. I was met by their executive chef Nick Collins who got me prepped with an apron and hairnet, no one looks good in these by the way, and after a thorough hand washing I went to the biggest kitchen I’ve ever been in. It was there that I met Austin, who is the greatest gravy making instructor in the world. I learned so much that day! It was better than watching Food Network and I had a great time getting to know Austin and learning how to make gravy. I’m the gravy master. Bonus, I brought some home for our Thanksgiving dinner the next day. It was delicious. Thank you Nick, Austin and Open Arms of Minnesota!
|The Bus and Jen in the Owners Suite of Jerome Bettis Grill 36|
Last but definitely not least, Bucket List #37 should be Bucket List #36, and I call myself a Steeler fan. Have a beer with Jerome Bettis. I swear you cannot make this one up. As it turns out several of you reached out to Jerome Bettis for this one, thank you very much. But, his people responded to our friend Jeff Wille in Colorado. That must have been some letter you wrote Jeff, I cannot thank you enough for setting this one up.
As it turns out Jerome Bettis is in Pittsburgh every weekend of a home game to tape “The Jerome Bettis Show” at one of the local TV stations, WPXI, and after the show he visits his bar, “The Jerome Bettis Grille 36”. So we flew out to Pittsburgh the weekend of December 10th to meet the Bus. How cool is that?
|Jen on the set of The Jerome Bettis Show|
When we went into the studio we were told to sit in specific seats to get the best view of the show and I was one of the first brought up to get my picture taken with Jerome. He’s HUGE! After Jerome had his picture taken with the remaining audience members we were taken to the green room to hang with him for about 30 minutes while he changed into street clothes and signed a bunch of things. The rest of the audience went to a conference room to wait for him. We’re so cool.
|Gifts from The Bus and the staff of Jerome Bettis Grill 36|
|Beers with the Bus........Check!|
To everyone who has helped me, thank you from the bottom of my heart. I look forward to crossing off a whole lot more with you all in 2011! I hope this note finds you all well and that you had a blessed Holiday Season and a safe and Happy New Year!
Love to you all,