holy crap. I’ve been on cellcept for lupus since fall 06. I’m on a lupus chat group and now it seems like they’re giving *everyone* with lupus cellcept, even those with no major organ involvement, which I think is irresponsible. first of all, much as I hate the crap, prednisone works much faster and has a longer track record. Second of all, again, I do not like the drug but it works, Prednisone is like $4 a month and cellcept is $800. EIGHT HUNDRED. I know, because even though I had prescription coverage last year, i still paid $5000 out of pocket for drugs. About 95% of that was for cellcept.
I can only say the drug reps must be doing a helluva a job schmoozing up the doctors and convincing them to prescribe this expensive, unproven drug to every lupus patient (and there are millions of us, so what a racket!) Someone’s getting a new Beemer and a vacation in Rio. And someone else is getting an early grave (PML).
>>>>
FDA issues a Communication About an Ongoing Safety Review of CellCept and Myfortic
ROCKVILLE, Md., April 10, 2008–FDA is investigating a potential association between the use of CellCept (mycophenolate mofetil) and Myfortic (mycophenolic acid), medicines used to prevent organ rejection, and the development of progressive multifocal leukoencephalopathy (PML), a life-threatening disease.
PML is a rare disorder that affects the central nervous system. When it occurs, it is usually in patients with immune systems suppressed by disease or medicines. It happens when the polyomavirus, also known as the JC virus, is activated. The JC virus is found in most adults but does not usually cause symptoms. Scientists do not know exactly how the JC virus is activated. Once activated, the JC virus attacks the cells that make myelin, the protective coating around nerve cells. Signs and symptoms of PML can include localized neurologic signs and symptoms including vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and weakness in the legs. Many patients who develop PML die. Patients who survive may have permanent disability due to irreversible nerve damage. More information on PML can be found at the National Institutes of Health website.
CellCept is approved to prevent heart, liver, and kidney transplant rejection and Myfortic is approved to prevent kidney transplant rejection. Mycophenolate mofetil, the drug ingredient in CellCept, is metabolized by the body to mycophenolic acid, the drug ingredient in Myfortic. Both CellCept and Myfortic are used with other drugs to suppress the immune system.
On November 8, 2007, Roche, the maker of CellCept, submitted an evaluation of its PML cases in patients who have received CellCept in addition to other immunosuppressive medicines. Roche also submitted recommendations to the FDA for including information about PML in the CellCept prescribing information. On March 14, 2008, Roche informed the FDA of the Dear Health Care Professional letter it issued in Europe on February 18, 2008.
Roche is aware of cases of PML in transplant recipients and patients with systemic lupus erythematosus (SLE), an autoimmune disorder that is sometimes treated with CellCept; however, CellCept and Myfortic are not approved for treating SLE or similar autoimmune disorders.
FDA is reviewing data submitted by Roche, including postmarketing reports it has received of PML in patients who took CellCept or Myfortic, and the proposed revisions to the CellCept prescribing information. FDA has asked Novartis, the maker of Myfortic, for data on PML cases and to revise the Myfortic prescribing information to include the same information about PML included in the CellCept prescribing information.
FDA anticipates it may take about 2 months to complete its review of the postmarketing reports and the proposed revised prescribing information for CellCept and Myfortic about PML. As soon as FDA completes the review, FDA will communicate the conclusions and recommendations to the public. Until further information is available, patients and healthcare professionals should be aware of the possibility of PML, such as localized neurologic signs and symptoms in the setting of a suppressed immune system, including during therapy with CellCept and Myfortic. Decreasing total immunosuppression may improve the outcome of patients who develop PML.
This communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs.
>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>
Yes, it's killing people, but more importantly (the cha-ching):
>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>
....More than 500,000 patients worldwide have used CellCept, which brought in more than $2 billion Swiss francs ($1.99 billion U.S. dollars) in 2007, according to the company....
Sales of a multiple sclerosis drug, Biogen Idec Inc’s and Elan Corp Plc’s Tysabri, were suspended in 2005 amid three reports of PML.
The drug returned to the market in 2006 with limits, when the FDA decided patients were willing to accept the risk in light of the drug’s benefits.
The agency said it has also asked Novartis for related data and called on the drugmaker to update its prescribing information on Myfortic’s label. The drugmaker does not provide specific sales figures for Myfortic because it is not one of its top 20 products.
In a statement, Novartis said while it “is not aware of any instances of PML in patients using Myfortic, we will comply with the class label change requested by FDA.”
Shares of Novartis were off 3.9 percent, or $1.90, at $47.27 in afternoon trading on the New York Stock Exchange; earlier they closed down 2.8 percent in Switzerland. Shares of Roche closed down nearly 1 percent on the Swiss exchange. (Reporting by Susan Heavey; editing by Gerald E. McCormick and Dave Zimmerman)
Tuesday, April 15, 2008
Friday, April 11, 2008
hoo boy people can be judgmental
wow. so i was reading a blog by an woman who calls herself "possummama." SHe has lupu and happens to be an atheist. SOmeone who calls themself "savedinchrist" chimed in with all kind of "Christian" hate. savedinchrist is a real piece of work. and i gotta say, while I don't understand atheism, I have had atheist friends, and they were far more interesting to talk to (and far less judgmental) than S-I-C (a perfect acronym for someone who can't spell).
Why do people lash out at others the way SIC does?
I can tell you. I have been there. i am a CHristian, and left the fundamentalist church I was in when they all but threw me out because I developed lupus and could not be healed by faith. they kept telling me things like I must have sin in my life and that's why I'm sick, or my faith was failing and that's why I wasn't healed. or i was doing god's work so the devil was attacking me. (uh, pick one they can't all be true).
And what about St Paul who suffered some sort of chronic illness (A "thorn in the side") and asked ot be healed but was not? does this mean he was not a "good enough" person?
the reason people act this way is simple: self-centered fear. they figure if they live their life "perfectly" (by always being at church and trying to recruit everyone else to be exactly like them) then nothing bad will happen to them. they can convince themselves that you have lupus because you're an atheist.
I am not an atheist and I and at least 1 million other americans have lupus. we have an autoimmune epidemic going on, which i believe is caused by pollution of our environment and crap being put in our food supply, much of which we dont' even know about.
i believe we can acheieve better health and wholeness through some form ofspiritual practice, whether it be meditating, yoga, gardening, journalling, as well as seeking out alterntive medicine. yes i do believe prayer can work. but if you are not a believer, there are other things that can work.
and thinking you're goign to win anyone over to your way of thinking by attacking them is just dumb.
"Christian" means "little Christ"
SIC, do you really think you are acting like Christ? what would jesus do?
would he only help those who already believed?
clearly not (read the gospels).
would he blame people for their illnesses? no.
would he give someone a meal and a blanket or just say "be ye warmed and filled" (also in the bible)
would he say to someone whose exposure to the sun makes them very ill (and this is real, I have lupus too) "you spent a minute in the sun taking a picutre, so you're a sham"
thinkin about it. where's the love that was showered on you, SIC, that was so generously poured out on you when Christ died on the cross, just as much for your sins as anyone else's?
and don't think you are without sin just because you believe. You are only forgiven, not perfect.
Why do people lash out at others the way SIC does?
I can tell you. I have been there. i am a CHristian, and left the fundamentalist church I was in when they all but threw me out because I developed lupus and could not be healed by faith. they kept telling me things like I must have sin in my life and that's why I'm sick, or my faith was failing and that's why I wasn't healed. or i was doing god's work so the devil was attacking me. (uh, pick one they can't all be true).
And what about St Paul who suffered some sort of chronic illness (A "thorn in the side") and asked ot be healed but was not? does this mean he was not a "good enough" person?
the reason people act this way is simple: self-centered fear. they figure if they live their life "perfectly" (by always being at church and trying to recruit everyone else to be exactly like them) then nothing bad will happen to them. they can convince themselves that you have lupus because you're an atheist.
I am not an atheist and I and at least 1 million other americans have lupus. we have an autoimmune epidemic going on, which i believe is caused by pollution of our environment and crap being put in our food supply, much of which we dont' even know about.
i believe we can acheieve better health and wholeness through some form ofspiritual practice, whether it be meditating, yoga, gardening, journalling, as well as seeking out alterntive medicine. yes i do believe prayer can work. but if you are not a believer, there are other things that can work.
and thinking you're goign to win anyone over to your way of thinking by attacking them is just dumb.
"Christian" means "little Christ"
SIC, do you really think you are acting like Christ? what would jesus do?
would he only help those who already believed?
clearly not (read the gospels).
would he blame people for their illnesses? no.
would he give someone a meal and a blanket or just say "be ye warmed and filled" (also in the bible)
would he say to someone whose exposure to the sun makes them very ill (and this is real, I have lupus too) "you spent a minute in the sun taking a picutre, so you're a sham"
thinkin about it. where's the love that was showered on you, SIC, that was so generously poured out on you when Christ died on the cross, just as much for your sins as anyone else's?
and don't think you are without sin just because you believe. You are only forgiven, not perfect.
Saturday, April 5, 2008
Top 10 Ways You Know you Are at a Palliative Care Conference
10 ways you know you are at a palliative care
conference
10) the conference opens not with HEY EVERYBODY
WELCOME TO OUR 2007 SYMPOSIUM WOOOOOOOH! but "ok
everyone let's get started."
9) most of the powerpoints include slides of scenery
or dogs or both.
8) at no point has anyone said "After my presentation
I'll be signing autographs in the bookstore."
7) You learn at least one new way to administer a
narcotic
6) All the website addresses are forward slash bunch
of letters slash tilda letters underscore forward
slash tilda letter letter dot gov dot html
5) You're in Alaska
4) instead of free beer, free beads
3) evening activities do not involve drunkenness and
nudity (as far as I know)
2) one panelist uses the word "rectally" 27 times and
"suppository" 29 times and no one even blinks.
1) the room is filled with loving respectful people
who make a difference by giving of themselves
I'm grateful for the folks in healthcare who see how bad it is and try to make things different, but i am sad that the system makes it so difficult for them to do so, or that they forget to stop and care for themselves, that there is a high burnout rate. It's nice to know someone "inside" the system "gets it."
conference
10) the conference opens not with HEY EVERYBODY
WELCOME TO OUR 2007 SYMPOSIUM WOOOOOOOH! but "ok
everyone let's get started."
9) most of the powerpoints include slides of scenery
or dogs or both.
8) at no point has anyone said "After my presentation
I'll be signing autographs in the bookstore."
7) You learn at least one new way to administer a
narcotic
6) All the website addresses are forward slash bunch
of letters slash tilda letters underscore forward
slash tilda letter letter dot gov dot html
5) You're in Alaska
4) instead of free beer, free beads
3) evening activities do not involve drunkenness and
nudity (as far as I know)
2) one panelist uses the word "rectally" 27 times and
"suppository" 29 times and no one even blinks.
1) the room is filled with loving respectful people
who make a difference by giving of themselves
I'm grateful for the folks in healthcare who see how bad it is and try to make things different, but i am sad that the system makes it so difficult for them to do so, or that they forget to stop and care for themselves, that there is a high burnout rate. It's nice to know someone "inside" the system "gets it."
Friday, April 4, 2008
i hate the needles. it doesn't matter how many times i get my blood taken, or an IV put in, or chelation or chemo, i never get used to it.
I have this theory now that a little controlled bloodletting under these conditions may actually be good for me. one of the many theories i've read recently about what may exacerbate or trigger lupus is the overabundance of dead cells, and our not being able to clear them. so our immune system goes nuts attacking them. these cells are killed off at a faster than normal rate by things such as harsh sunburns, toxins, pollutants and in particular aspartame (nutrasweet, there goes the diet coke, people!)
so when i get my blood taken i think "there's a chance for my body to make some fresh new blood"
it doesn't make the needle hurt any less but it does make me feel better about having to go through it.
And then when i fall off the wagon and start drinking diet coke again, which seems to happen when i travel, the universe takes care of me by send in me an e mail article from one of the health newsletters i receive about "excitotoxins" (a.k.a. neurotoxins) and how they cause *cell death.* For some reason, the term "cell death" really speaks to me right now, so I say "OK" and i throw the remaining diet coke down the drain and get back to drinking something from nature, like tea or water.
Funny how when you talk about toxins a lot of people still laugh and think you're some kind of paranoid nut. Because they've bought into the idea that Drs buy into, which is that all disease is caused by germs/ viruses or genetics. that kind of thinking abdicates all personal responsibility for our own actions, including diet, exercise, stress management, personal relationships, life balance, getting enough rest, eating real food and drinking plenty of clean water, not chain smoking (which BTW causes COPD more than it does lung cancer, and only a fraction of folks with lung cancer are smokers), not holding a cell phone to our head all day long (now linked to brain tumors), and maintaining a social and a spiritual life.
If you read the pamphlets from your pharmacist when you pick up your drugs you'll see language about toxins and toxicity. In fact, many people get liver toxicity from TYLENOL, which for some reason is the drug of choice in hospitals for pain. Even though I have taken 12 tylenol in the course of a few hours and got no pain relief whatsoever.
Toxins. They are real. They are in our food, air, water, soil, relationships, and especially our pharmaceuticals. We can eliminate them through various means. Our 5 eliminative organs are : kidney colon liver lungs and spleen. Which is why some detox programs include coffee enemas or colonics (Colon), water fasting (kidney), poutices (liver/ spleen), and deep breathing (lungs). When I was in kidney failure and had pleurisy (limited lung capacity), I detoxed using enemas and baths, which involed organs (colon adn skin) that as far as I knew were not in danger of failing. I also now use foot detox pads.
for whatever reason, people with SLE are not supposed to use saunas; nor are people with high blood pressure. Saunas or very popular in some countries,a dn a wonderful refreshing way to detox.
A word about high-fiber diets- switching too suddenly to high-fiber can be tough on your colon, and even cause little tears, which can leak toxins into your body. So work with a health professional if you can, in order to decide which detox path is right for you.
I have this theory now that a little controlled bloodletting under these conditions may actually be good for me. one of the many theories i've read recently about what may exacerbate or trigger lupus is the overabundance of dead cells, and our not being able to clear them. so our immune system goes nuts attacking them. these cells are killed off at a faster than normal rate by things such as harsh sunburns, toxins, pollutants and in particular aspartame (nutrasweet, there goes the diet coke, people!)
so when i get my blood taken i think "there's a chance for my body to make some fresh new blood"
it doesn't make the needle hurt any less but it does make me feel better about having to go through it.
And then when i fall off the wagon and start drinking diet coke again, which seems to happen when i travel, the universe takes care of me by send in me an e mail article from one of the health newsletters i receive about "excitotoxins" (a.k.a. neurotoxins) and how they cause *cell death.* For some reason, the term "cell death" really speaks to me right now, so I say "OK" and i throw the remaining diet coke down the drain and get back to drinking something from nature, like tea or water.
Funny how when you talk about toxins a lot of people still laugh and think you're some kind of paranoid nut. Because they've bought into the idea that Drs buy into, which is that all disease is caused by germs/ viruses or genetics. that kind of thinking abdicates all personal responsibility for our own actions, including diet, exercise, stress management, personal relationships, life balance, getting enough rest, eating real food and drinking plenty of clean water, not chain smoking (which BTW causes COPD more than it does lung cancer, and only a fraction of folks with lung cancer are smokers), not holding a cell phone to our head all day long (now linked to brain tumors), and maintaining a social and a spiritual life.
If you read the pamphlets from your pharmacist when you pick up your drugs you'll see language about toxins and toxicity. In fact, many people get liver toxicity from TYLENOL, which for some reason is the drug of choice in hospitals for pain. Even though I have taken 12 tylenol in the course of a few hours and got no pain relief whatsoever.
Toxins. They are real. They are in our food, air, water, soil, relationships, and especially our pharmaceuticals. We can eliminate them through various means. Our 5 eliminative organs are : kidney colon liver lungs and spleen. Which is why some detox programs include coffee enemas or colonics (Colon), water fasting (kidney), poutices (liver/ spleen), and deep breathing (lungs). When I was in kidney failure and had pleurisy (limited lung capacity), I detoxed using enemas and baths, which involed organs (colon adn skin) that as far as I knew were not in danger of failing. I also now use foot detox pads.
for whatever reason, people with SLE are not supposed to use saunas; nor are people with high blood pressure. Saunas or very popular in some countries,a dn a wonderful refreshing way to detox.
A word about high-fiber diets- switching too suddenly to high-fiber can be tough on your colon, and even cause little tears, which can leak toxins into your body. So work with a health professional if you can, in order to decide which detox path is right for you.
Wednesday, March 26, 2008
great lupus advice- from an MD even!
Andrew Weil is very open-minded for a doctor.
This is some fantastic advice on dealing with lupus, whether your own or your loved one's.
http://www.drweil.com/drw/u/id/QAA74996
He must have gone through some serious soul-searching to reclaim his humanity after surviving medical school. Amazing stuff.
Read it!
http://www.drweil.com/drw/u/id/QAA74996
This is some fantastic advice on dealing with lupus, whether your own or your loved one's.
http://www.drweil.com/drw/u/id/QAA74996
He must have gone through some serious soul-searching to reclaim his humanity after surviving medical school. Amazing stuff.
Read it!
http://www.drweil.com/drw/u/id/QAA74996
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