WebMd: new Enbrel/mtx study | Arthritis Information

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The new study shows good results, but read carefully perhaps, just perhaps, how they got them?
http://www.webmd.com/rheumatoid-arthritis/news/20080715/drug-combo-fights-rheumatoid-arthritis
Suzanne2008-07-16 10:59:35Oh, Good God!

 
Enbrel is marketed in the U.S. by the drug companies Amgen and Wyeth. Wyeth funded and designed the study, collected the data, and helped analyze the data, according to The Lancet.
 
And it doesn't help that WebMD is a 'sponsored' site.  They are just awful!
 
Pip
From the article:

"During that time, half of the patients taking Enbrel and methotrexate had their rheumatoid arthritis go into remission, compared to 28% of those taking methotrexate alone. And rheumatoid arthritis at least didn't worsen on X-ray in 80% of the Enbrel-plus-methotrexate group, compared to 59% of those only taking methotrexate.

Side effects were similar in both groups, according to the researchers, who included Paul Emery, MD, a professor at the University of Leeds in England.

Enbrel is marketed in the U.S. by the drug companies Amgen and Wyeth. Wyeth funded and designed the study, collected the data, and helped analyze the data, according to The Lancet.

An editorial published with the study points out that methotrexate injections might have been more effective than oral methotrexate."


At least didn't worsen?  Okay.  In 80% Enbrel/mtx vs. 59% oral mtx.  If the statistical range is +/- 5%, this could be 75% vs. 64%.  Not huge to me, when you consider the cost and risk.  And what if it was injectible mtx?  Anybody know the percentages for 'at least didn't worsen' between oral and inj. mtx?  Inj. mtx is said to have less side effects, too, so that would have helped that part of the study, too, I guess.

Good post Suzanne.  You seem to find the good ones!!!!!! THanks.
 
Jan
Well, when I was taking mtx alone it didn't do nearly enough as far as controlling my pain and inflammation.  When enbrel was added their was a profound difference overnight (literally).  I'm thankful everyday that those greedy, lying, bastards over at wyeth & amgen got to my RD.    :)  [QUOTE=Linncn]Well, when I was taking mtx alone it didn't do nearly enough as far as controlling my pain and inflammation.  When enbrel was added their was a profound difference overnight (literally).  I'm thankful everyday that those greedy, lying, bastards over at wyeth & amgen got to my RD.    :)  [/QUOTE]
 
 
Me too, only I'm grateful to Genentech, Inc and Biogen Idec......
Yes, Lincoln has used the right wording, Enbrel made a profound differance for me also..We are lucky to have the variety of meds that weren't available to our older relatives...Hope everyone can find the right meds/combo...Don't give up the hope!!!I wouldn't discount a clinical study simply because the drug manufacturer was involved.  Granted there have been occurrences in the past, as in Merck/vioxx, where complete findings of studies were not revealed, and that has shaken the public's trust in such studies, but I believe as a result, there is now greater transparency.  All clinical studies are suppose to be posted  in their entirety, online, for scrutiny, by  other professional medical researchers and the public.
 
While I am critical of pharma's powerful influence in hindering health care reform, protecting the industrys interests over the interest of those in need of affordable prescription medications, and of their marketing practices, especially direct to consumer advertising, I do not hold the entire industry up to suspicion.  For me, enbrel and mtx has controlled RA, had these drugs been available back in 1977, perhaps I wouldn't have the joint damage I've experienced.  If I had known about AP therapy back in 77, perhaps I would have given that a try.  But given my personal situation and circumstances, I went on my first biologic  in 2002, I am aware of the risks, and I am grateful for the choice.
 
    
I'm with Linncn, thank you for being my thieving, lying bastard company as my life is a million times better.

Joy,

Granted, we have more choices - but that's the first time I'd ever seen that in a report.  I don't like the fact the company did the analyzing.  What exactly did the researchers do?  Lend his name, perhaps? 
 
Hugs,
 
Pip
When I first started researching Humira I read that one of the scientists got involved because her grandma had RA.  Fortunately the evil drug company employed her.  We thank them for Humira every day.  All medicines are technically "toxins", including whatever they use in Microdose Therapy. The risk of a serious side effect from a biologic is about the same as turning blue from minocycline.   [QUOTE=Joe M]When I first started researching Humira I read that one of the scientists got involved because her grandma had RA.  Fortunately the evil drug company employed her.  We thank them for Humira every day.  All medicines are technically "toxins", including whatever they use in Microdose Therapy. [/QUOTE]

When I worked at a big pharma (and later went on to do consulting at several big pharmas), I was amazed at the dedication of the scientists.  Many of them practically lived in their tiny cinderblock offices and labs.  They worked insane hours not because they were told to, but because they were hell-bent on finding treatments for whatever disease they were targeting.  Vacations were spent at meetings.  Hell, even I've gone to an American Chemical Society meeting as my vacation (and yep, I paid for the whole thing myself).  Sure, there are some slackers out there, but by and large, the scientists at big pharma are very dedicated and driven individuals.  There is such a HUGE difference between walking the halls in the lab buildings vs. walking the halls up in Mahogany Row.  The lab buildings are like a college chem/bio building.  Many of the scientists have personal reasons for targeting their disease/condition of choice - perhaps they lost a father to heart disease, or have a sister with RA, or lost a friend to cancer back in high school.

I can't speak for the marketing side of the house... we always thought they were a big bag of idiots with expensive clothes and lots of cool trinkets.

And I'll never give up my foam rubber Viagra (discovered, by the way, while trying to find a cardiovascular drug... profits from Viagra help fund other less profitable ventures)!!!The problem with Pharma is that the scientists are no longer running the show.  The bean counters and the sales force is.  I read an article a while back about the 'change' when the first Pharma CEO wasn't a scientist and was instead a marketing bigwig and how that changed the world of medicine.
 
I like the scientists - lets put them in charge!
 
Pip
[QUOTE=Pip!]The problem with Pharma is that the scientists are no longer running the show.  The bean counters and the sales force is.  I read an article a while back about the 'change' when the first Pharma CEO wasn't a scientist and was instead a marketing bigwig and how that changed the world of medicine. It sure does!
 
Keep going Joe!
 
OK, you have to post that capsacin shirt!
[QUOTE=Pip!]It sure does! Fab!  Have you been to Wootshirt?
 
http://shirt.woot.com/
 
Pip
[QUOTE=Pip!]Fab!  Have you been to Wootshirt? Suzanne and Pip,
 
How can you and the few other APers constantly try to convince everyone that all studies concerning drugs other than your AP drugs are tainted by money? Aren't yous at least a little bit embarressed to keep preaching that when yours roadback AP study is the most tainted misleading study that can ever be. Why don't yous try to explain why a marketing study is passed off as credible scientific fact? This is from the front page from roadback:
 
See complete Harris Poll results.
 
This is how the study was conducted. This is the APers way of doing medical studies and yet the APers still have the audacity to question other scientific studies. Maybe you APers shoud contact the Amgen people and tell them that they need to hire marketing firms like the Harris Group so that their studies would be more credible. Here is how the Harris marketing group conducted their study with phone calls and e-mails to people given in a list from roadback. This is the way the "study" was conducted, very scientific, well, maybe not.

Methodology

Harris Interactive® conducted the online survey on behalf of the Road Back Foundation between October 3 and 21, 2005, among 452 respondents with rheumatic conditions. Eligible respondents, defined as adults aged 18 and over who have been diagnosed with rheumatoid arthritis or scleroderma and who have been on an antibiotic regimen for at least one month, completed a longer survey.  Respondents either volunteered to take a survey included as a link on the Road Back Foundation website or other websites that provided information about rheumatoid arthritis and scleroderma, or were sent an invitation via email to participate in the survey. The email list was provided by the Road Back Foundation.  Data were not weighted and therefore are only representative of those who were surveyed.  This online sample is not a probability sample.

About Harris Interactive®

Harris Interactive Inc. (www.harrisinteractive.com), based in Rochester, New York, is the 13th largest and the fastest-growing market research firm in the world, most widely known for The Harris Poll® and for its pioneering leadership in the online market research industry. Long recognized by its clients for delivering insights that enable confident business decisions, the company blends the science of innovative research with the art of strategic consulting to deliver knowledge that leads to measurable and enduring value.  Harris Interactive serves clients worldwide through its United States, Europe (www.harrisinteractive.com/europe) and Asia offices, its wholly-owned subsidiary Novatris in Paris, France (www.novatris.com), and through an independent global network of affiliate market research companies.

This is the APers truth in advertising and yet they have the audacity to question real scientific studies. They try to pass off this fake study as a real scientific study. Respondants didn't even have to prove their disease and no medical data was considered. Yeah, trust the APers.
 
LEV
Thank you Larry. Finally some facts, not to mention their own constant marketing campaign which twists the facts too.http://www.rheumatology.org/publications/hotline/archive/0195minocycline.asp?aud=mem

AP'ers have the MIRA study to back them up.  It was double-blind and showed effectiveness in mild-moderate RA.  I agree the Harris thing was nothing but a poll. 
By the way Lev, isn't your Dylan quote wrong?   Joe M and All,
 
All of the studies are ancient. The mira report that you posted is from 1995 and this was the conclusions:
 

A similar study has been reported by Kloppenburg et al (Arthritis & Rheumatism 37:629-636, 1994). Although this Dutch study was of shorter duration (26 weeks), it included patients with more severe disease than in the MIRA trial. Again, the drug was well-tolerated, but the improvement in clinical parameters was modest.

The precise mechanisms whereby minocycline may be efficacious in RA 2re unclear. Apart from the potential anti-microbial effects of this medication and the interest in Mycoplasma as a causative or contributing agent for the development of RA, minocycline has been demonstrated to be an inhibitor of metalloproteinases, including collagenases and gelatinases. Conceivably, reduction in enzymatic activity induced by minocycline might exert a beneficial effect. Other potential mechanisms of action might include inhibition of phospholipase A2, suppression of neutrophil function, and reduction in T cell proliferation.

Although these results are clearly of interest, enthusiasm for minocycline in the treatment of RA must be tempered. The patients in the MIRA trial appeared to have moderately severe disease, and many had required remittive therapy prior to inclusion in the trial. Modest responses were noted for some, but not all, parameters. Both minocycline- and placebo-treated patients showed improvement in joint swelling and tenderness, although statistically significant changes were observed in the comparison of agents. Many patients received either NSAIDs or low-dose corticosteroids during the study which may have influenced disease activity. Furthermore, the duration of response after discontinuation of treatment is unclear. Finally, longer treatment periods and comparison with disease-modifying drugs will be necessary.

Additional trials are required before minocycline can be favorably compared with, or used instead of, current second-line agents in RA.

I wouldn't be proud of this study either. Where is some new study or evidence of the effectiveness of AP therapy?
 
LEV
Don't disagree with anything you reported.  Here's one from 1999.  Considering the relatively benign side effects, if I got a mild case it would be the first thing I tried.  My wife tried it, didn't work so well, so now its Humira and it was life-changing.

http://cat.inist.fr/?aModele=afficheN&cpsidt=1916979

I don't think this should be an AP vs biologic thang, its a matter of consumers trusting info/research findings.  The possibility of a conflict of interest is always there, thus a need for full disclosure and transparency, so the watchdog groups/consumers can evaluate such studies.  A responsible, ethically minded company should be willing to do that, it would be good for business wouldn't it to have consumer confidence and trust in your product.
Sorry, wasn't making it into a AP vs biologic thing... I think both have their place. [QUOTE=Joe M]Sorry, wasn't making it into a AP vs biologic thing... I think both have their place. [/QUOTE]

I don't think anybody thought you were.  Welcome to AI, you'll figure it out so enough.  Most people here do think both have their place, including me.
Joe, That really wasn't directed at you.  The discussion started in an ap vs biologic vein before you joined in.  These threads can go off in all kinds of directions, thats okay, I justed wanted to make the point a big issue is the consumer's trust, and how a company's transparency practices can instill that.   As for AP, I think I would have given it a try at first onset of RA. 
 
Hope you and yours are doing well.  Happy to hear your wife has had good results with humira, I did that a while, those shots stung though.  I'm now on enbrel and methotrexate, its keeping me moving. 
 
Thanks, so did Humira stop working for you?  I'm hoping it keeps working for my wife until they come up with something better, and there are all kinds of things in the pipeline but they are years away. Joe,
 
Humira worked okay, I didn't have any side effects.  My doc had originally wanted me to go onto enbrel, but I live alone and couldn't prepare an enbrel syringe (back then premixed, preloaded enbrel wasn't available) Soooooo, I went on remicade - outpatient infusions.  My doc wasn't satisfied w/results from remicade, so since humira was a shot every 2 weeks, I switched to that and my sister would drive up to administer it.  Well humira still wasn't controlling the RA to my doc's satisfaction.  During this time though I was dealing w/big time stress, my mom began showing signs of dementia, so I took over power of attorney for her and dealt w/her financial and medical matters.  She then had a series of strokes, along with the emotional stress of seeing my mom decline, I had to deal w/nursing home (they almost killed her by giving her whole pills when she couldn't swallow and dropped her on the floor), hospice, and sisters constantly bickering.  It was a very hard time, and the RA worsened, sooooooooo, my doc switched me to enbrel -- he felt I could benefit from its dose frequency -- 2 25mg shots a week.  And that, along w/methotrexate, has helped control RA pain and inflammation.  I have to add though, I've had RA 31 yrs now, so my experience is just that, my experience, this disease and these drugs all affect us differently.
 
I agree w/your viewpoint, taking a drug to control the RA now, preventing joint damage now, and hoping for a better drug or treatment down the road.  Doing something, AP or biologics, stress reduction techniques, pool therapy, fish or flaxseed oil, vit d, to better manage and control the RA.
 
 
 
    
Joie, (pronounced Joey or Joy?)

Thanks for relating your story.  Michelle has had RA about 5-6 years now.  We spent the first few months in denial, then tried some alternative stuff, then MTX/sulfasalizine combo, then AP and finally Humira.  The doc gave her a large tapering dose of pred when she started the humira because she was in a huge flare, so we were sure it was the pred and not the humira that was making her feel so good.  But the pain didn't return when the pred was gone. We couldn't believe it.   Keeping our fingers crossed (now that she can cross them) every day.

Sorry to hear about your rough times, but I do have a question.  I am just entering the same situation with my mother.  Her mental decline has been rather rapid over the past year or so. I am an only child so siblings are not an issue, and I have a signed power of attorney.  How do you know when its the right time?  She lives in a semi-assisted care complex now, and gets by OK because everything is right there for her.  But she has problems with knowing what day it is, remembering close relatives names including ours, etc.  I have asked her about it, and she said that when I think it is time to "put her in a home" that I should do it.  I am very reluctant about it.  Any advice you have for me would be appreciated.

Thanks again,
Joe
I think/hope your wife will have good results w/the humira.  Nowadays, I think many RA docs believe in aggressive treatment early on, like starting biologics sooner rather than later.  Probably someone else can speak to this, since I'm such an old-timer. 
 
When I was diagnosed in 1977, I think I was on 15 tabs of trilisate and naprosyn.  Went on and off gold shots.  Added plaquenil, dropped that, added methotrexate in 1986, started biologics around 2002.  My RA wasn't managed well, I'd go to work w/swollen, inflamed knees which lead to joint damage.  I think the outcome for someone newly diagnosed will be much better these days with the drug treatments available.  The patients in my RA docs waiting room don't seem as bad off these days.
 
Joe, I think I'll start a new thread, "taking care of our parents," that way others with similar experiences can offer their advice.
 
My name?  Is actually Joy.  It was already taken here, so I chose Joie, which is sorta a phonetic spelling of how some family members say my name -- Jo-ee, somehow they stretch it to 2 syllables.
 
[QUOTE=Joie] Joe M,
 
The only person that thought that this thread was about APvsBiologics is maybe Joi. I'm sure that everyone else read this thread as it is, a thread concerning credibility. The biologic and ap studies just happened to be the two being compared. I don't think that anyone claims that ap is not a medical path for minor ra, even my UofM Rheumatologist stated that he prescribes minocin for those with minor ra. He said that it is comparable to plaquinal but with fewer cases of side effects. He said that it is not effective for moderate to severe ra compared to dmards and biologics.
 
This is from the American College of Rheumatology recomendatons June 2008:

Hydroxychloroquine or minocycline. Hydroxychloroquine

monotherapy was recommended for patients without

poor prognostic features, with low disease activity,

and with disease duration 24 months. Minocycline

monotherapy was recommended for patients without poor

prognostic features, with low disease activity, and with

short disease duration (level C* evidence) (52–59).

 
Oh and Joe M, I was under the assumption that Mr. Dylan had misquoted me. Of course I could be mistaken.
 
LEV

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