Thursday, March 22, 2012
Sunday, March 18, 2012
Peritoneal Cancer Diagnosis Journey Phase XIV
Phase XIV
Had my MUGA Scan appointment. Uneventful which is always a good thing. It took longer this go around as the Radiologist had 2 University Students so he was explaining everything to them. The one student got to start the IV in me for the test. He did a really good job, didn’t feel the needle stick. It’s funny I don’t remember tests taking as long as they do. So while the test was doing its thing I closed my eyes and pictured being on a golf course on a sunny day with a light warm breeze… Next to the ocean… Of course my ball does not go into the ocean or any sand trap… <Laughing> Yeah, anyone that has golfed with me know that’s not true… My drives were amazing and my short game flawless, it’s fun to dream <smiling>. The radiologist touched my arm mid way through the test and asked if I was okay. I said sure, I’m imaging I’m on a golf course, he smiled and said just checking you are okay… So I went back to my awesome golf game…
When the test was done off I went with my day, huh after my imaginary golf game, maybe it is time for a warm vacation somewhere, maybe exotic… Have to get with Lynn and see what comes to mind…
I was on facebook “Teal Warriors” the other day and one of them posted this USA Today article addressing the Doxil shortage:
The FDA has approved the temporary import of Lipodox from a drug manufacturer in India that the FDA has inspected their plant. I am so thrilled that the FDA has taken such a strong stance against this shortage and the pharmaceutical industry. I hope it is a message of sorts to them… Get their act together… Did you know that Janssen has an extended patent on Doxil…? So they are the only company that can manufacture this drug in the USA. With that they have let this happen with full knowledge of the ramifications’ (no one else in the US can help). There is no way they could not have known that if their 3rd party manufacturer didn’t get the problems fixed that this drug would disappear from the US market. A drug that is critical to recurrent ovarian cancer patients… Because of legislation that has been approved on president Obama’s watch the FDA now requires at least 6 months notice from drug companies if they suspect a potential shortage. It really is sad that the government must tell business (Drug companies) to act responsibly in the healthcare market. Isn’t there some kind of inherent obligations or maybe ethical is a better word, to take care in ensuring needed items are safe and available. The FDA can and has the authority to find comparable drugs to fill the pharmaceuticals monopoly on a drug and authorize its temporary import of it.
You can read the latest letter from Jansen dated 2/23/12
Okay, I am really not a fan at all of Janssen… And quickly becoming very upset with Johnson and Johnson, Janssen’s parent company. Janssen continues to say “we at Janssen are committed to returning Doxil to the market for patients needing Doxil” but they cannot say when that maybe, except LATE 2012 at the EARLIEST and my other favorite is “lipodox is not an equivalent drug to Doxil”. Mind you the FDA has said in a FAQ:
Q2. Is Lipodox the same as Doxil, or a generic of Doxil?
A2. Lipodox is a drug with the same active ingredient, dosage, strength, and route of administration as the FDA-approved drug Doxil, and Lipodox is manufactured in a facility that has been inspected by FDA and found to be in compliance with current good manufacturing practices. Lipodox has not been approved by FDA, and therefore, FDA cannot consider it a “generic” of Doxil. The agency has exercised enforcement discretion for the importation of Lipodox during this critical shortage of Doxil. Here is the address to the FDA question and answers on the Lipodox.
I did find the Dear Healthcare Professional letter mentioned above and it is from the distributor of Lipodox.
I find it ironic that Janssen and the FDA keep pounding the drum that this is not a generic version of Doxil. The distributor says the following in the above letter “Lipodox 50TM 50mg/25ms (2mg/mL) single use vials contain the same active ingredients, doxorubicin hydrocloride, in the same concentration as Doxil® doxorubicin HCL Liposome injections (janssen Products, LP: 2mg/mL-20mg/10mL and 50mg/25mL) marketed in the United States”. Sigh… Who do you believe, the drug manufacturer that allowed Doxil to leave the market for a year or more holding and extended patent to not allow anyone else to enter the market? Or a company that is willing to step in with what appears to be a comparable product? If it has the same active ingredient in the same strength how is that not comparable? So, what else could be different? What other active and inactive ingredients separate them? That would be an interesting comparison… huh maybe my next research, reading the dreaded informational packet of both drugs of what makes up these two drugs… ZZZZZZZZZZZZ… <laughingly>
My take is the FDA cannot call it a generic, and it has not been approved for the US market, why? Because Janssen has an extended patent to be the only manufacturer in the US… This is so self-serving and they (Janssen) are squarely responsible for this drug shortage that they saw coming. They knew of the manufacturing difficulties of their 3rd party manufacturing plant and were not aggressive enough to remedy fully knowing that no one else in the US makes it. If they didn’t know of the problems, then that borders neglect from where I am sitting. Which I’m feeling very neglected by the drug industry being right in the middle of this Doxil nightmare, as are thousands of patients in the US.
I am definitely a lucky person and really am SO grateful to be receiving treatment and it has been a bit concerning each month wondering when my Doxil treatments will be gone… My heartaches for the thousands of women experiencing recurrence and having to have more toxic drugs and deal with many more side affects. With the news of Lipodox, it gives me, I think, a much welcome breath of relief that I can continue on the treatment regimen as my doctor feels is working and not be force off because a drug is not available… I will have to ask my oncologist his thoughts on this drug (Lipodox).
Below under My Blog List is one that really has a lot of great information on the Doxil and drug shortages.
I would encourage a read…
Had my doctors’ appointment on 3/6. Mixed report is how I would describe it… My MUGA Scan is at 64%... WOO HOO basically no change. My CA 125 # crept up to 2342. Really…. Grrrrr sigh. All my other blood numbers are great. Spot on… Just this damn CA #. Lots of thinking going on in the room… I am to schedule another CAT scan to check what is going on inside. I feel good, so I am thinking I am good… We are continuing with the Cisplatin/Doxil/Avastin infusion. My one blood result was not back yet so we are starting with Doxil… I fell asleep, as my appointment was bright and early, 7am. So after my pre-drugs off to dream land I went… lol When I awoke the doxil was done and I had the Cisplatin going in. When that was about done I asked about the Avastin. Guess I slept through that one, < smile>… Good I’m thinking… We are passing on the chest x-ray this month as I scheduled my CAT scan of chest, abdomen, and pelvis for 3/19… One of my blood work up days… The up side is I will only have to get stuck just once and it will be via my mediport for both my blood work and CAT scan…
My treatment is uneventful… and the next couple of days I will feel good, before my crash day/sleep day-weekend. Lately I have been doing good on Friday working from home most of the day and it seems Saturday I nap on and off. Sunday I start puttering around. This go around I seem to feel it a bit more, probably just the cumulative affect of being on Chemo for over a year now. By the following weekend I am back doing my usual puttering… That is so great and I am as I said very lucky… A remission would be so very awesome, and I will get there only a matter of time…
Over St. Patrick’s Day weekend we are having Lynn’s sister Christine’s 60th Birthday Party at one of our favorite restaurants’ Curly’s in Lackawanna. All of Lynn’s siblings will be there and nieces and nephews. The only one missing is Will… He will be there in spirit… And most fun is Jesse and Kyle and the baby boys are staying overnight at our house, yippee, dancing around to the music in my head… Hey that is better than voices… Oh what fun the weekend will be… The baby boys are so cute and have amazing personalities, can’t wait to see them… We certainly can see why they are amazing, their parents are amazing young adults and wonderful parents… It is so much fun to see…
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