Wednesday, April 15, 2009

Savella.™ The Wonder Drug That Works The Wonder Of Emptying Your Wallet For Little Apparent Gain.

I'm excited about the upcoming release of Savella™ (milnacipran), the new drug from Forest Laboratories and Cypress Bioscience to combat the suddenly oh-so-fashionable plague of fibromyalgia. I'm not excited because Savella offers the prospect of relief mind you, but for precisely the opposite reason. Something tells me this med is gonna warrant the unveiling of the hottest sales reps ever in order to convince much of anyone to actually write a prescription for it, and hot sales reps are cause for excitement in the happy pill room. If you saw the customers I have to look at all day long you'd know why. From The Rx Consultant, which for some reason gets mailed to me every month. I have never once to my knowledge asked for a copy of The Rx Consultant.  Maybe I subscribed when I was drunk or something. That would be depressing. Getting drunk and subscribing to trade journals. At any rate:

In the 15 week trial, response rates were about 19% in both milnacipran groups and 12% in the placebo group. At the 15 week point in the longer study, response rates with milnacipran (both doses) and placebo were about 15% and 9%, respectively....At 27 weeks, however, there was no significant difference between milnacipran and placebo.

Now I know what the fibromyalgics amongst you are saying; Wow! A 7% chance this stuff will work better than a placebo! And a whole 6 months before there's no difference from placebo at all! Tell me more!*

Happily:

The most common adverse effects of milnacipran, compared to placebo, have been nausea (37% vs. 20%) ... constipation (16% vs. 4%),  hot flush (12% vs. 2%)....

So.......lets recap. You ask your doctor if Savella™ is right for you, and if he decides it is, he'll hand you a prescription for something that's over twice as likely to make you feel like puking than it is to give you any relief. About 25% of people in the clinical trials of Savella™ dropped out because they couldn't handle the side effects by the way.

Oh, and it blew some people's livers out too. No word yet on how much Savella™ will cost, but I mean really, can you put a price on the value this type of thing adds to the practice of medicine? Hell, I wish I had fibromyalgia now so I could get me some of this action.  Actually, I think I do, since the most common way to diagnose fibromyalgia is for the patient to announce they have it, yes, I definitely do. 

On second thought never mind, I'll just look forward to seeing the sales reps. 

*You and I both know this is wrong. Most of the fibromyalgics among us are probably saying things like, "Bring me some ho-ho's!!" or "My dog ate my Vicodin!!," but for the sake of this post I'm pretending like fibromyalgia is a real condition. 



34 comments:

Anonymous said...

Again, with the making me laugh.

Frank, CPhT said...

The only Fibromyalgic I know tends to lean more towards microwave popcorn then Ho-hos.... And She'll be damned if the dog gets anywhere near the vicodin... That's what the toilet is for.

And I say, Bring on the hot drug reps... Too bad I work third shift and don't get to see their hotness. :(

Scritches.com said...

I don't have fibromyalgia or know anyone who does, but what if it IS a real condition/disease? Didn't people used to say the same kind of thing about sun allergies or chemical sensitivities?

I'm just saying, is all.

Jessica said...

I am shocked the FDA approved this crap. I am also shocked that fibromyalgeurs reported "significant improvement" on it. I wonder if they knew it didn't have narcotics in it.

Gourmandish said...

I'm sure the layperson will be bombarded with TV ads for it too.

Sexy broads notwithstanding, I can't imagine why anyone would prescribe this stuff, except maybe to make their local Vicodin addict go away and stop bugging them. And even then, it probably wouldn't work.

Leave it to the FDA to approve a fake drug for a fake condition.

Anonymous said...

I think, Fibromyalgia is probably a real condition to 5%-20% of the people who actually claim it. People use it as an excuse to become fat/lazy/whiny/junkie.

snarkie said...

Drugmonkey, you have been my hero for probably the last year and a half. I've loved your blog, been a faithful reader and now...well, maybe I misjudged you. I am a CPhT, have been for more then 10 years. I am almost 54 yrs old and I have been diagnosed with fibromyalgia by my very competent family Dr. The only medication I take is Lyrica and I thought at one point it wasn't helping so I quit taking it only to realize it had been helping all along. I don't take narcotics and I work 40 hours every week, on my feet for sometimes 10 hours a day. No one at work does anything for me. I'm not stupid or lazy or addicted to anything. But I AM always in pain! Frankly, I don't care what you call it, I have chronic unexplained pain. Everyday. Whether you believe it or not. Yes, I can understand that you see the same kinds of people I do, people that think drugs are the answer to every little ache or pain or problem, but please don't judge everyone by those that abuse everything from drugs to alcohol to the system, I'm not like them

Anonymous said...

Acording to my doctor I had fibromyalgia. I stopped taking Prozac and it went away....hmmmm his advice was that I increase my dose. After 2 years SSRI free I have never felt better. Good thing this wonder drug wasn't available then or I'd be constipated, nauseous and havig more hot flashes than I currently am having due to the peri menopause that my doctor says I don't have based on a blood test that is useless for diagnostic purposes. Are all doctors idiots or just the rural ones I am stuck with??

Anonymous said...

Fibromyalgia isn't a fake condition just because many lazy people fake it. I am an RN,working 40-plus hours with fibro. When I see people collecting disability for fibro I just want to slap them silly and tell 'em to buck up.

Anonymous said...

Your poll is crazy drugmonkey. Yeah, all the rest of them stink but Benicar smells great.

asd said...

Meh. You "fibromalgics" have not convinced me. I still think its a fake disease even though some docs gave it a name. I will still take your money for the drugs though. Thanks.

Anonymous said...

dude, you need to make CHEMET one of the options on that poll. Many people don't know it, but those who have taken one whiff will remember. I don't have any in the store now, but I used to. Always fun to get the intern to take a big deep inhalation of it!!!

snarkie said...

asd...I hope you wake up tomorrow morning with fibromyalgia, it would serve you right. Did you even read my post? Why would I say I have a fake disease?

Anonymous said...

Working whilst standing on one's feet for forty hours a week will cause "chronic unexplained pain" - but that's the explanation. Nurses and Pharmacy employees (only ones that chimed in so far) are stressed and on their feet all day. Not sitting down coupled with cleaning up shit all day (literal and figurative) will do that. If one does that, has a poor diet, doesn't work out, has children or combine all of these things, you have a fake disease, or "fibromyalgia." Look, I am in chronic pain all day because I stand in basically the same place for extended periods of time with my neck lurched to one side on hold with some asshole named "Steve" in India saying "tank you fur patiently waiting...steel loooking....the patient wheel haf to contact their benefeets core-didator or pay out ofe po-ket." I don't claim to have a "disease," just a day to day pain in the ass (and mid-back, calves, neck and in between the shoulder blades). Other than that, you can wish in one hand and fill the other with malnacipran and see which empties your pockets first. Best of luck with the vague aches and or pains, yo. Fibromyalgia is just a nice way for one's doctor to say you're fat and need to get laid without saying it.

seth said...

all i can really say is, haaaaaaaa!

thank whoever, i have no ailments besides a achy breaky back. i could really use a few nuprin...

DKLA said...

Well it depends if they make through the veritable gauntlet of diagnoses ("point to where it hurts") and meds (*pfft*).

If they give me the usual "vicodin/oxycontin seems to help", then the auto-reply is "studies have shown that exercise and counseling (CBT) helped." I do the about face, roll my eyes, then write down a warning on the person's record or just let the attending MD know.

I know doctors/nurses don't want to deal with this crap (late night, no coffee, etc.), but it happens more often than not. I usually hear more of the "bad back" excuse in the ER and see them walk out to their car without difficulty.

Anonymous said...

Is there anything the FDA won't approve as long as there's money to be made?

Nope, guess not.

Anonymous said...

I swear to god, you can turn around and the FDA has either approved or is going to approve some useless drug for a faked condition or they're approving the enantiomer or different salt of some drug that is about to go generic. All I can think of is Pristiq (desvenlafaxine), why do people immediately assume if its brand, it must work better. Somone wants to shell out the money for a private drug plan that covers it and wants to shell out the huge copays, fine. I get pissed when I see that going out to people who's healthcare is getting paid for on the public dime (ie medicaid).

eulogos said...

There are more things in heaven and earth, Horatio, than are dreamt of in your philosophy.

As a Disability analyst-person who does Social Security Disability claims- I understand your frustration with some people who have fibromyalgia in their list of diagnoses. The ones that have a long list of diagnoses, a long list of doctors, and a long list of meds.. whose families do everything for them because they can't possibly do anything.

But I am also a person whose doctor diagnosed her with fibromyalgia. I had been in achy pain all over every day for a about 4 years. I went on with my daily life which included taking care of many children, going to nursing school, and working part time. But there were a few days I didn't want to move at all. I thought I had arthritis. The doctor saw me rubbing the muscles near the joints, tested the fibromyalgia tender points, and told me that was what I had. I protested that I did not want THAT trendy diagnosis. She just smiled. She prescribed a small dose of amitriptyline at bedtime to give me deeper sleep. A very inexpensive medication. The lowest dose they make is 10 mg, but that glues me to the bed for about 10 hours, so I take half pills, and even that little amount makes a big difference for me. If I don't take it for a while, and don't sleep enough, the nagging achy pain comes back.

Anyway, I think fibromyalgia is real. That doesn't mean everyone has it who has that diagnosis. It also doesn't mean that everyone who has it is a pleasant or admirable person. I think there may be a connection between a history of abuse or overwhelming stress at some point in one's life, and fibromyalgia, kind of a muscle memory of pain, and some people with that kind of experience will also have personality disorders and so on. But not necessarily.

It is always wise to remember that one does not know everything. Since that is true, do you really want to be the kind of idiot who laughed at people in pain and told them their condition is not real...if you just happen to be wrong?
Susan Peterson

Anonymous said...

I used to be one of those people that thought fibromyalgia was all in the head until I was rear-ended 4 years ago and was told I had it, after months of pain and not being able to move,and felling things like ants all over me burning and stinging. Fibromyalgia is very real. It is very painful and it screws up any normal life I was to have. Just because I have fibromyalgia don't mean that I sit around eating hoho's and taking pills. I actually get up every morning and depend on my new medications to help me make it through another day. That is another day of working, taking care of my family, going and tolerating the ballgames at my daughters school,being mom,and wife. People don't believe it is real because they can't see nothing phyisicaly wrong with you, its just like back pain.. you can't see people hurting but yet if it ever happened to you,then you would understand. I really hope that you never have to deal with fibromyalgia and then have your friends or people in general say that its all in your head or there is nothing wrong with you.

Anonymous said...

Okay...Just recovering from mastectomy and cancer treatments from Hell...

Have bi-lateral frozen shoulder...and can't walk without pain...

My doc....says its Fibromyalgia...and the Savella really helped...almost like a miracle... in my legs..for a little while....No help at all with the shoulder problem.....Now In 2nd month of pill paks...It seems like my body is fighting it..Legs getting worse again...and I'm throwing up all the time .. Stopped taking it..to talk to doc..about maybe trying something that doesn't make me so sick...

Oh...
And all you rude folks that want to be cruel to those of us who get a fibromyalgia diagnosis.....Go Pick on Someone else...I'm not a druggy..just trying to get better from breast cancer ...Okay?

Anonymous said...

I usually lambaste "Keyboard Commando's" - you know, people who sit at the computer and type shit they have absolutely NO idea about. I started to read your blog with some interest then I took offense because you obviously do NOT know what you are talking about. I am probably one of the most active guys you will ever meet. Former US Military, have climbed mountains. Was a lineman for a telephone company for years. Avid outdoorsman, deer hunter, fisherman, Gold prospector. My wife and I own property in rural South Carolina where I grow a huge garden. I had some goats ..but still have chickens, basically a small farm. Besides bulged disks from a car wreck, I was diagnosed by 3 MD's with Fibromyalgia. It was a 6 month process and a massive battery of test to exclude quite a few things. You don’t just SAY you have this disease - it dont work like that. Maybe at one time, but not anymore. If you have insurance then of course they can do the muscle tests which tell alot. Are there people who fake Fibromyalgia - Absolutely. Are some misdiagnosed - Absolutely. But, is it a REAL Disease? Absolutely. I cannot even hardly describe some of the days I go through. If you knew even a small part of who I am and the kind of man I am, it would astound you. Its real and its hard to put into words the way the disease affects your life.

I feel sorrier for women who have it because they seem to hurt even more than many of us men do. Maybe its just the way God made us, but that’s the way it seems. But imagine someone like me who can drag a buck 1/2 mile up and down hills back to my truck (yes it hurts my back) ...but sometimes be sitting in my chair with muscle pain that hits so fast and so bad so bad I cannot even hardly move. Some days every single muscle in my entire body feels like I have swam the English Channel - when I've just gotten out of bed...and it will stay that way for days. People say "Yea, but you get the good drugs!" BULLSHIT. I take heavy stuff - but all it does it take the top edge off the pain so you can "HOPEFULLY" make it through the day. You do this day after day, after day. This is your life you make the best of it. You don’t whine about it, you go on. I don’t sit in my F'king chair fat and lazy... I work 50 hours a week and I STILL do all the other stuff that I do. Oh, and I make our own Bread, Butter, Jelly & Cheese in my spare time.. besides tending the garden and putting up the vegetables we grow with my wife. So I would say that one should be careful when making blanket statements about something one knows actually knows very LITTLE about.

Savella – I just started taking it. I read the literature, I got online and read all the junk about it. Ill try it, I’m watching for any problems. I’m on the sample package right now, I haven’t filled the script yet – but so far it has SEEMED to help some. If it does and it there are no side effects – its better than upping the narcotics wouldn’t you say?

Junkie said...

Can you snort it???

Anonymous said...

I told my Doc after 5 years of being diagnosed with this stupid disease to give me the RA backt that she had first diagnosed. Your attitude is exactly why. I'm not sure it is a disease. i think it's a symptom of something else and since doctors don't want to admit they don't know what it is that's wrong that's the diagnosis everyone gets.
I know it hurts like a bitch.
I know it knocks the shit out of me.
I know I have something that every lazyass shit who wants SSI claims to have. But that does't make it fake. That just means they need to develop a test for it so you, my monkey, can highmindedly tell them there fakers to git back to work.
As far as Savella goes - it SUCKS!!! Been on it 3 weeks and I'm tired of the bad sideffects such as tachycardia, insomnia and wild hyperactivity. However, I really like the side effects of weight loss, grandious thoughts and did I mention the hyperactivity? I cleaned out a closet the other day and detailed my car.
I'll be going off it but here's a question: can you cut those suckers in half? Because the pain is way less and I like the speedy effect but the heart thumping is so distracting.
By the way, thanks for the empathy. I'll keep telling my pharm I have
RA

Anonymous said...

To all you doubters, better watch out. I thought the condition was just lazy people complaining as well. As fate would have it I got hit hard with Fibromyalgia. I can tell you it is not a made up condition. Ii am sure there are some that are diagnosed that do not have the condition but it is real.

I hurt all the time. It is like having the flu everyday, all day without the fever and stomach problems. The fatigue is overwhelming. I also have osteoarthritis in my knees, hands and spine. I am only 49 and I feel like I'm 99.

I work 40-80 hrs a week, owning my own business. I can't just stay in bed all day and whine but that does not mean I feel terrible and have no quality of life.

There may be those that have a more severe case than I do and can't function through the pain and fatigue. The mental fog makes me wonder if I am losing my mind sometimes.

Please don't dismiss this just because it does not seem to make sense to most of you. I was one of you and got hit between the eyes.

If there is a drug that has some hope of working, sign me up.

Anonymous said...

The comment above is right on. Fibro is exactly like having the flu...only everyday...and it never goes away. It's horrible. I'm a 47 year old man...former all state athlete in great shape and was hit with this stuff about 4 years ago after a bad bout with the flu. Nothing makes me more angry than hearing about people who claim this disease in order to get disability or a dope fix. Losers. It makes the real sufferers look folish and weak. You CAN'T be weak and deal with this stuff...no way. As for the Pharm rep drug pusher babes, I'm very critical myself of the idiocy and screwball marketing tactics of the drug pusher companies, But please, don't confuse that nonsense with this very real disorder.

Unknown said...

I have had fibro for over 25 years. I don't give a rats ass if you think it's real or not. I work every day but can do very little else. Getting laundry done, groceries,etc take up my 2 off days a week. I rarely am able to do fun stuff I would like to do. I am hoping Savella works so I can stop taking narcotic pain meds. They used to think MS patients were a bunch of fakers until they found out the mylan sheath was coming off of their nerves. Just because science doesn't know why I hurt from head to toe and am totally exhausted doesn't mean I am a faker. Grow up.

Anonymous said...

And professionals thought CFS was made up too, and all in people's heads.

Now they are coming close to identifying the proteins in spinal fluid.

And one day you are going to eat your words.

trinlayk said...

for 15 years I was being told "you are depressed" and antidepressants thrown at me... or "you're a single mom with a young child, of COURSE you are tired-all-the-time..." and "take vitamins"....

about 10 years ago, after I ended up in the ER with an abscessed appendix that I'd been walking around with FOR YEARS (and no Dx)... I had the worst flare up ever.

about 7 years ago, after FINALLY a doctor running some tests(thyroid, Lyme disease, etc ... ) I got this crap diagnosis. (Fibromyalgia apparently means, "you hurt all the time and feel exhausted even after a full night's sleep but fuck if we know what it is....")


still, up until about 5 years ago I worked 40+ hr work weeks, raised my child alone AND took care of elderly relatives. I kept a garden and grew fruits and vegetables for my family in our yard.

I've just now gone about 3 weeks without being able to brush my damn hair properly. I have about 1 day a week where I wake up exhausted often with something like a migraine as well.

That "Oy I'm coming down with something" ache people get with the flu, that's a GOOD day with the fibromyalgia.

No narcotics, they don't do crap for this anyway. Physical therapy, gabapentin, heat packs and simply waiting out the flare seems to be the only way for me to manage it.

Anti-derpessants helped with coping, sort of.... counseling wasn't really helping at all...
Weirdly it was originally the psyc professional who said "I don't think this is a psyc issue."

I lose weeks or months of productivity every time I have a flare up. I NORMALLY have to decide if I'm going to get groceries, or do laundry on a particular day.

Given the choice, I'd be working full time again. But while I've been able to sometimes get a remission for up to 3 months at at time, each flare up seems worse than the last one.

On the hyperactivity, OH man! exactly, the days where I wake up feeling like "Damn! I think I can actually GET SOMETHING DONE today... " I probably start triggering the NEXT flare up, because I'll try to catch up on everything I hadn't managed to get done that's waiting to get finished.

Some day, there's going to be a nice tidy lab test for this... (though I'm betting there's probably more than one illness or disorder going on).

Just because there are people out there faking it, doesn't mean everyone is.

I'd rather be productive again.

(People on disability seem to get around HALF of what they were making before they couldn't work anymore. Would you take that much of a pay cut to stay home if you didn't have to? I sure wouldn't!)

trinlayk said...

secondarily, I find I'm aggravated that the TV talk is ONLY about the muscle pain... no mention of the digestive issues that seem to be a part of it (I haven't been able to eat corn products for a couple years now... and cheese is a "careful! not too much" food now.)

Or the fatigue or the headaches/migraines, lack of decent sleep. (oh yay! 3 whole uninterrupted hours of sleep!) muscle weakness, fogged/muddled thought processes (even when there are no narcotics being used)...

If only it were JUST muscle pain, I think what messes up my productivity, social life, family life so much is the fatigue... I could cope with the pain if I didn't have all the other crap to deal with on top of it.

Anonymous said...

I absolutely do not get hyperactivity. I don't cry, as often, but I feel I could whoop some ass if someone pushed it. Im going to titrate myself off. The best thing is when the Dr. gave me 3 starter packs, all expired 13 months ago... I guess there aren't many hot reps in this oxy/ meth town.

Doc M said...

Drugmonkey, I enjoy and appreciate your blog.

But I hope the above comments make you realize you're dead wrong on fibromyalgia. Sure, there are fakers and hypochondriacs.

But in my studied opinion as an MD and as a friend to a couple of CFIDS patients I'm sure this is a disease as real as it is hellish.

I believe 'fibromyalgia' is part of an autoimmune clusterfluck which involves deterioration of the myelin sheaths of the nerves. Diseases can be related and what at first presents as fibro may even morph into multiple sclerosis.

CFIDS is the disease to wish on one's worst enemy. It can progress to a diability with no end in sight not even death.

Anonymous said...

My wife has 'fibromyalgia' and I would do ANYTHING to get relief for her....

Anonymous said...

Thank you. I have severe fibromyalgia. I go to work everyday don't ask for anything. By the end of the day I wish I was dead because the pain is so bad. No one should judge because one day that could be you then wishing you had someone to believe you. People that abuse drugs stuck. The people that are suffering have to pay the price because of them