STELARA (Be careful) It may work, but is killing me

DISCLAIMER: ( I only ever had "light,.,,,mild Psoriasis" less than 10% at its worst. Why they approved me for this study, who knows (they really were more interested in my Psoriatic Arthritis but it was not helped by Stelara. This CRISIS occurred to me not while I was on Stelara but immediately after I stopped taking it. I was also on a much higher dose and frequency than they allow now. I might have been a ONE IN A MILLION. It may work for many others, just be careful, I am dieing from it.)

Johnson and Johnson's drug STELARA has destroyed my immune system beyond repair. They ignore my requests for help, I volunteered for taking part in the clinical trial of STELARA and once it killed my immune system and began destroying my entire body......I pleaded for help and have been ignored. I have a petition online:
http://www.change.org/petitions/johnson-johnson-follow-your-credo-to-fix-ou r-mistakes#supporters

Please sign it and then read the whole story about what took place. PLEASE do not take this drug if you want to live. PLEASE think about what you are putting into your body. A biological mix of things that have only been tested for a few years and I wonder why the cases of Psoriasis in America have doubled over the last 10 years. Ever since these biologic drugs came onto the market. Your immune system is too important to allow it destroyed.

After you view my body and the condition I am in, then look at how I used to be ......before I took STELARA. I am interested in talking to anyone who has had a similar experience, anyone who has questions, anyone who would like to pray for me, anyone who has some ideas on how I can get Johnson to help me, anyone who knows a really good lawfirm, anyone who just needs to talk.

Aloha and Mahalo for taking the time to join my discussion group.
www.helpfortony.org

Edited August 16, 2013 at 10:00 pm

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80 replies. Join the discussion

Hear that buzzing ? Might be a drone.Psoriasis has bee aronud since Adam was a pup. Act accordingly.
Now.
What else are you taking besides that nonsense ?
Don't be upset. It's just business.

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Aloha, JULIAinFLA.....

Thanks for your validity of the petition. It is working for our needs. Take the time to review the 36 pages of the photo journal where you can see the progression of the effects from stelara. I never needed to take detailed pictures of my body before I had this reaction, but luckily we started taking detailed pics as soon as the first signs appeared. It is too bad that Johnson and Johnson did not take any photos either, but the medical records are what provide the proof needed to susbstantiate my claim, You need not sign any petition but Thank you so much for your interest, the time and support. Please allow your anger at being sick to go, god bless you.

Aloha Itchimess.....

Thank you so much for your reply, Yes we all know the story of this disease. However, take a look at the increase in USA actual diagnoses of Psoriasis and or Psoriatic Arthritis and it as doubled in less than ten years (since the first of the biologics) were made available. BUT, I must be wrong. thanks for your history . Being that my situation occurred during a drug trial, I was not allowed to be on anything other than Stelara (the tested my blood twice a month to ensure this). Aloha and Bzzzzzzz...God Bless.

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Oh yes Tony
NOW I found a link to more pics....hope others notice it

OMG something must be done for you. I hope you recover soon,,,it is possible
Sometimes we see no way out of impossible situations but where their is life there is hope

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This is pretty shocking stuff to see, and absolutely some of the worst-case psoriasis I've seen in quite awhile.

I'm willingly participating in a study where Stelara (Ustekinumab) is the control drug. (used as the standard by which to measure the capability of the experimental drug) In reading through the study, I wasn't too concerned about the possibility of getting Stelara, as I would be on it for one year (if I ended up starting out of the Stelara drug variable at the start the study). At the end of the 1st 12 or 52 weeks, I'd be switched to the experimental drug.

What I understood about Stelara was that it was used as the 'control drug' because it is one of the most effective treatments out there for psoriasis at the current time. In my case, many parts of my body were already looking like Tony's "After" photos.

 photo tony_zps2a36fe0a.jpg

In the past couple years, I have been very interested in the possibility of taking Stelara, and when it first became available, I didn't hesitate to ask my doctor if I might be a good candidate.

At the time I first requested it, the doctor I spoke to said it might be "a little too early in the game" to start Stelara, as he and others wanted to see how Stelera would do "in the field." His explanation was that with Stelara, the length of time that it holds down a person's immune system was much longer than other biologics. He explained that his concern was that if a patient came down with a severe respiratory infection, they might be hospitalized for a short period of time if they were on Humira or Enbrel, but that with Stelara, months of hospitalization would pose astronomical expenses to a patient. So, since it was still relatively new, Stelara was not a viable option for me in 2010.

As a footnote to that scenario, I think that I was also fairly determined to get Stelara at the time because of all of the good things I was hearing about it. I realize that my doctor also tended to pad things in some of his explanations to me, and that he may have steered me away from it because I didn't have adequate coverage to receive it, or possibly because it wasn't a drug that he was being compensated for to dispense it. There are always layers of considerations in today's health coverage, and I know that a patient's coverage can also often determine which drugs a doctor will prescribe.

In 2010, I did want to correspond with as many people that I could who were starting Stelara, and I was able to keep in touch with a few Inspire members who were receiving it. For the persons I spoke to, the news was all good. No noticeable side effects and dramatic improvement / clearing with their psoriasis. I still have one former Inspire buddy in London who I believe is still on Stelara (He started in 2010) and last time I spoke with him, he was still doing very well with the drug. (psoriasis-free)

It's tragic, though, when somebody potentially does experience bad side effects on a drug trial - or after taking a drug. Tony's situation is horrendous, and it's good that there are a large number of people petitioning and lobbying on his behalf to get some kind of monetary compensation to cover his expenses, and, hopefully get his health restored. If there is liability on the drug manufacturer's part, I hope that they are required to provide some form of resolution.

Many years back, I participated in a clinical trial for Dovonex (Calcipotriol), a synthetic-type topical steroid cream derived from Vitamin D. In the clinical trial, there were 3 dosages... low, medium and high concentrations of the active ingredient. I only did one or two applications of the drug on my calves, covering two spots about the size of a quarter. That small amount of the cream (likely the high concentration) caused my entire body to break out from head to toe in small, painful water blisters.

The horrendously painful blisters happened on the first day of an incredible sweepstakes vacation I'd won to Washington, D.C. I spent 4 straight days in agony laying naked in my room in front of my air conditioner on the floor at the Washington Hilton. Needless to say, I knew my body didn't agree with that medication. There were no lingering effects, and I simply shed several layers of blistered skin. My psoriasis didn't improve or worsen. I wished that the Dovonex people could have compensated me for the missed vacation, but I didn't pursue any legal action. (that never even occurred to me..) I was in a clinical trial, and was unfortunately one of the 'bad reactions.' The drug was eventually approved, and I think it's still widely prescribed today.

There's always a risk factor with clinical trials, and, in some cases, people suffer agonizing symptoms and even die. In cases where many people suffer adverse results, the tested drug doesn't make it to the marketplace. I want to believe that great care is usually taken to assure a participant's health and well-being throughout most clinical trials, although I'm sure there are glaring exceptions. In the study I'm participating in, there was a litany of tests conducted before I was approved for participation, and my blood and urine and vitals are monitored frequently. I try to be optimistic about the research I'm participating in. I am seeing good results so far, and hope things continue to improve - while hoping that there isn't a Raptiva-type factor somewhere down the road.

My heart goes out to Tony and his family -- and I hope that things turn around for him soon. I think the headline verbage "the new killer drug" is a little extreme, but I understand the emotion. I'm sure there are many people who would also write that Stelara was their lifesaver drug. We all have a different genetic make-up, and there is rarely a uniformity in response for everyone. Hopefully, whatever went wrong in Tony's case can be uncovered, so that others won't have the same experience in the future.

Three Cheers to all of us fellow 'lab rats' out here in the world --- hopefully making it better for psoriasis people in generations to come!

 photo mice2_zpsd6ae9a6a.jpg

peace and healing,

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Aloha friends,

I wanted to thank you for bringing up really important information about my situation. I added a disclaimer at the very top of my discussion to try and isolate some of those concerns. I also changed the title of my discussion to (reduce) the fear factor. You are correct, being in this much pain, in bed for 5 years with no help.....can have an emotional effect on a person's overall outlook. I am trying really hard to keep things positive, regardless of my issues. I know others suffer much greater crisis in life than what I am going through. Mahalo (thank you) and keep up the great dialogue. You guys know better than anyone else what it is like to live with such a (downplayed) disease of the immune system.

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Tony was the trial for PsO or for PsA? What phase was it? When did it start, when did it finish? What dosage were you on? Were you still being seen by clinicians when your really bad symptoms appeared?

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LiveLongAndProsper

Thank you for your reply, Here are the facts:
1. double blind (CNTO1275) third phase 5 year study on Psoriasis NOT Psoriatic Arthritis. (the study ended very early as it was FDA approved)
2. started late 2006 and ended it late 2007
3. on the highest dose in the study.
4. the minute I stopped the trial they cut all communication with me. And it has been that way for 5 years
5. they seemed to care more about my arthritis than they ever did with my psoriasis through my time in the study. Never even took one picture of my skin, I was just a test rat.

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Aloha Tony!
I just left 5 years of quality life in Kailua, where you from brah?
My Rheumy was the best in all O'ahu, Mohamed Abuyouseff at straub none and joint center on South King. If you're a HMSA Quest patient, you can get in to see him without a referral! He knows his shit! Does a 45 minute initial exam, thorough labs right next to his office, and doesn't mess around with BS that isn't going to help you! Quality of life is his key function, and reducing flares/pain his mission.

I'm very glad you shared this info with us. I'm on the list for stelara trials, and after being on Humira and Embrel and still hospitalized with extensive pustular flares, I was hoping stelara would help. Now I'm taking a step back!

Mahalo for the post, friend request if you want to stay in touch!

Hardin O'hana (my wife and son are Hawaiian from the Han Family that runs Apothalistic Faith Church on TV- big Jesus is coming soon tower on H201)

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Your situation is the very reason they have clinical trials of new drugs--to find out the efficiacy and safety of new drugs. That you have suffered as you have is certainly sad and I do personally feel that you should be compensated for the results. However, I was in the psoriasis test group for CNTO-1275 and I was compensated for my participation and although I do not have papers handy since it goes back 8 years now, I believe we signed a release disclaiming action against the company and acknowledging that we were taking stated risks. That, notwithstanding, I still think that you should be due compensation.

A few other points, however. First it was Centocor, Inc. that did the development and supervised the clinical trials, not the parent company Johnson & Johnson and it might be the former that you request compensation from, not the later.

Second, from your description of them focusing on your PsA rather than your P, you may be confusing the clinical trial that you were in. At the date you have given they were indeed starting Phase 3 of the P clinical trials but they were actually also in Phase 2 of a CNTO-1275 clincial trial for PsA and it is my impression that this was the one that you were in, not the same trial that I was in and it being Phase 2 rather than Phase 3 does make a difference. Please recheck your information against this:
http://clinicaltrials.gov/ct2/show/NCT00267956 It is vital that you have the right clinical trial if you take this further or the courts would throw this out.

I am surprised that they did not discover impending problems during your regular follow ups while in the test and even more surprised that they did not grab your case to further attempt to determine what went wrong in your particular case as part of the developing alerts to possible side effects. You explained that you developed this right after the end of your trial but I must have missed how long you were on it. You stated that it was of no help to you and one possibility was that you were on a placebo and had the placebo effect until it was ended and in that case they might argue that what is now Stelara had no responsibility for your result because you never actually got the real medicine. You said you were at a higher dose than would be allowed today but I am curious as to how you would know that since this was a double blind clinical trial and even your doctor did not know what you got.

You are right that your case might be one in a million as due to our genetic makeup and different triggers, we react differently to new meds. This rarity, in my opinion, should even boost your claim request since it would cost the company very little in comparison to the total cost fo the trials to compensate you and the few others that may have experienced the same problem. When I signed up for the trial, I was under the impression that if something did go wrong, they would provide medical assistance to correct it although i knew the risks I was taking.

I am sorry that your situation evolved as it did and, indeed. do pursue compensation. I do feel bad because I am one of those that was completely cleared of both PsA and P and I remained in remission for 6 months after I ended my trial and the basic reason I am not on Stelara today (I am on Remicade) is because it was not available commercially for almost a year after the trial, awaiting FDA approval and when P started coming back while awaiting approval, I gave up and moved to Remicade and have remained clear the past 7 plus years on that.

At the very least, your posting is a reminder that, no matter how small, there are risks involved in participating in a clinical trial and it is important that as soon as something starts to go amiss, action is taken before it gets worse and worse. If in a clinical trial, the administrator should be initiating this but if you are on a biologic, you need to initiate action yourself with your dermy or rheumy.

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The biggest problem I see is you seem to be asking the impossible. I really doubt they can fix him. One thing you need a lawyer for at this point is to clarify what, exactly, it is that you want. They may be more than happy to settle, but they're not willing to make some open ended commitment, like find a cure. They'll do things with definite boundaries, like invest some amount into research as to what went wrong here. They have no problem cutting you a check one time, but they will have a real problem cutting you some unknown number of checks for some unknown amounts. You have to set some definite bounds on their liability. If you're reasonable in that may say sure, no problem. If they think you're excess and have no chance of a judgment for that amount they will fight you. If your requests are modest enough they may cut you check just to get you to sign papers.

When it comes to some grand conspiracy to keep people from finding out a settlements is the easiest way. Part of most settlements is you aren't allowed to talk about it. So just buy your silence is the easiest thing to do. What they're doing certainly isn't any way to keep a secret. Far more likely it's benign neglect or bureaucratic malaise. You got lost in the red tape. You didn't talk to the right people or didn't talk to them in the right manner. That's what a lawyer does for you. They figure out the right person to talk to and correct manner to do so to actually get results. You don't have a file a lawsuit with a court, but you most definitely do a lawyer. You're just spinning your wheels without a lawyer. That's corporate America. It would be refreshing if they did this crap out of malicious intent. You could fight them then. When it's just inertia it just rolling a rock up a hill to watch it roll back down again. It isn't that gravity hates you it's that gravity doesn't think. You aren't dealing with a human being, you're dealing with a corporation.

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I'm sorry to hear about the pain you are experiencing. You are an inspiration for continuing to fight.

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Hey there lelawprof!

I'm sure glad you're here in this Inspire Psoriasis-Talk community! You have such a wealth of experience and knowledge from your history with psoriasis/ psa. I always appreciate your input and helpful advice. Glad to know that Remicade has worked for you for such a long period of time also. It's nice to know that if you ever start to relapse with Remicade that Stelara might be a silver bullet somewhere down the road. It's strange... I had an incredibly negative, terrible experience in a clinical trial, but all these years later, I'm right back in one (IL-17 Brodalumab) and thrilled that it's making a difference.

As I was going through the pages of Tony's online case history, I couldn't help but wish that he could be in this same trial I'm in, just to watch all that inflammation go away. But, given all that he's been through, a new clinical trial probably sounds like the last thing he'd want to do. It looks like some of the latest wave of drugs (Il-17/23,etc) are coming on board in India and elsewhere, so once these newer applications get through the FDA hurdles in the U.S., Tony will have some options to get back to healthy skin.

Thanks, again, for being here!

peace and healing,

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Tony, I will never complain about my P and PA again! I am so sorry to see your condition, I hurt for you! Have you reported this to the FDA? I would def. contact an Atty! From what I understand most biologics suppress the immune system to some degree and that's why you have to be careful around sick people/kids. I had trouble while on Enbrel, I ended up seeing an infectious disease specialist because of a skin infection that was taking over, she had a fit that I was taking Enbrel and told me to discontinue it immediately. I didn't want to because it helped so much with the P & PA, I had complete skin clearance while on it! I did get off of it pronto! I would stay out of the Sun also, too much weakens the immune system from my understanding. I've been plagued with P & PA for over 36 years! I will keep you in my prayers and hope you find some relief soon! God Bless!

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What a horrific situation.

Have you tried contacting the National Psoriasis Foundation to see if they could be some assistance to you?

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I'm scared to death after reading about Tony . I had been on humira for 3 years with great results, until it just quit working around this time last year . Within 3 months, my body was 95% covered in plaque, gutte, and pustular psoriasis . my dermatologist recommended stelara, and it took some time to be approved for their assistance program ( I had resigned from my job as an RN due to my condition and all the pain, burning, and itching . I also felt like pins were pricking my skin . I couldn't wear anything except underwear and a very loose t shirt due to the fabric touching the lesions, causing pain . ) I finally was approved, and had my first shot of stelara this past march . after my 2nd shot, I was about 85 % clear, and am now about 90% clear . I know the stelara won't work forever because our immune systems have ways of " figuring out " how to work around whatever medication we may be taking . I feel like I have walked into a situation that is going to be just like Tony's once the stelara becomes ineffective . it's a vicious cycle . I began the biologics out of desperation, and now I have put myself in a situation that may very well wind up being the literal death of me . I've tried every treatment/medication on the market as I have dealt with psoriasis since I was 13 years old ( I'm now 45 ) . When the stelara quits working, I'm out of luck . There are no further treatments . Tony, bless you . I hope against hope that you can receive help somehow . Psoriasis is a curse, and I will never believe otherwise .

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Here's my 2 cents

Here some answers in this link & other meds. Just google info u need.
http://www.stelarainfo.mobi/

Here are some links to answer some of UR questions about the LY2439821.....Interlukin, IL-17 .....same drugs ...........
Different names depending on Parm Company doing clinical trials. See other names from link below. Research all side effects
Online.
Below link to Tony:
http://www.change.org/petitions/johnson-johnson-follow-your-credo-to-fix-ou r-mistakes#supporters

http://clinicaltrials.gov/show/NCT01107457. Google ge any 5 or 5 names of IL-12- 17 different names same or similar drug.

Dr, Mercola talks about the dangers of shutting down the already compromise immune system.
http://articles.mercola.com/sites/articles/archive/2012/01/03/flu-shot-incr ease-flu.aspx

Chotti

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Chotti, your 2 cents isn't helping much in this particular situation. These are not the same drugs, different names/companies. Stelara targets IL-12 and IL-23 and the others you refer to target IL-17, very different targets although all with the same goal. Aspirin and Tylenol both have a goal of treating a headache but they don't work the same way.

To make matters even more confusing, there are 3 clinical trials targeting IL-17 but they are NOT the same drugs and each will have its own patent and to get that you must distinguish it from another. Just as Enbril and Humira both target TNF when one does not work for a specific genetic makeup/trigger combination, the other might. If one of the new IL-17 drugs does not work, another might but this is all off topic as Stelara works differently from these currently being tested drugs. You are also mixing discussion of vaccines to prevent diseases with treatments for them with your third link.

Your link to the Stelara side effects is very relevant here for those contemplating taking Stelara and for their doctors to know what to look for and test for before prescribing it. That listing is possible only because of people like Tony joined the clinical trials over 8 years ago and the manufacturer was able to discover what can happen even if there is only a one in a hundred thousand chance that it does. Tony has provided a very valuable contribution to Stelara research and might prevent others in the future of experiencing the same effect and being able to be treated for it. The issue here is having discovered this possible side effect, what are they doing to help Tony recover from this discovery and why haven't they responded to his needs and covered his medical treatments and lost income because of their delay.

We read about big Pharma taking in billions of dollars and that is because millions of people are successfully benefitting from these drugs and continue to buy them year after year although unfortunately a few people are actually harmed because some chemical or component in the drug triggers their predisposition to a disease. We must be grateful to people like Tony who are aware they are taking risks by signing up for a clinical trial and are helping us just as we must be grateful for those who serve on active duty in the armed forces and if something happens to them, we should take care of them.

And we must understand also, that taking a drug in a clinical trial where the side effects are at that point unknown and taking a drug where side effects are already known and published are two VERY different things.

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Your concern is: I feel like I have walked into a situation that is going to be just like Tony's once the stelara becomes ineffective

Tony's situation was because another health problem was discovered while he was on the trial, his medication was abruptly put to a stop, it was not that it became ineffective for him. I had a similar situation--while on the clinical trial it was discovered that I had Prostate Cancer and FDA rules do not permit someone who develops another medical problem during a trial to continue.

Perhaps Tony's case would help if they had done further research to determine if the abruptly stopping this med had a causative effect. In my case I was not able to get further injections but I did continue in the clinical trial to the end and they continued to do blood work and evaluation as originally scheduled. I do not remember if that was recommended or just suggested to me as an option but I did get follow up and wish that Tony had also.

I did not have the problem that Tony did though as the Psoriasis did not return for at least 6 months after which i switched to Remicade to fix what had started to reappear and then kept me in remission.

I would suggest that if you come to a point where it is ineffective you ask about being weaned off of it. This principle does apply to some drugs and might with Stelara as a safety measure.

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thank you so much , lelawprof . that's encouraging to hear . Now that you mention it, the humira that I was on WAS abruptly stopped - tapering off was never mentioned by my dermatologist . I will definitely bring it up to her should the need arise to go off the stelera .

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I've been fortunate to have a very skilled nurse in my family for the past 8 years, and here's one particular phrase that I've learned from her that I've since learned is SO necessary on SO MANY medications: "TITRATE DOWN"

This often applies to persons on anti-depressants. It definitely applies to patients on methotrexate. It applies to patients on Coumadin (warfarin).

The list goes on and on. I am NOT a medical professional, but you'll find that titrating down is often standard procedure with a good majority of drugs that are prescribed for everything from High Blood Pressure to ADHD... it is important that a patient is titrated down off of drugs that have residual levels in the person's bloodstream.

I'm making some very broad, generalized statements here -- and again, I'm NOT a doctor -- but every year a LOT of patients go through severe health issues either because they decided to stop taking a drug without consulting their doctor -- or their doctor or pharmacist neglected to 'wean' them down from their initial or long-term dosage level, oftentimes unaware that a patient is still filling prescriptions.

Much of it has to do with the body's/brain's/blood's adaptation. Once a set protocol is in place, the body usually regulates and adapts to it, an any abrupt changes can be upsetting/traumatic. Methotrexate is a good example of a drug that is rarely stopped 'cold turkey' anymore. The dose is generally reduced gradually, over weeks... sometimes months.

Unfortunately, when a person loses employment, medical coverage, or has other circumstances that prevent access to a medication, some people simply 'quit' and think that their body will just adapt accordingly. Depending on the medication, sudden cessation can cause some very serious consequences.

Stelara is still a relatively new weapon in the psoriasis arsenal, and while I'm not familiar with the prescription protocols for it, perhaps it is another medication which requires a 'cooling down' TITRATION period where the drug dosage is gradually reduced/withdrawn over a period of time.

As medicine evolves more and more into genetically modified applications, the concept of gradually withdrawing from a dose will probably be very common for the newer meds as well. With the newer drugs that have a 'shelf life' after their injected, I don't know if it's necessary to titrate down over time with reduced injections, or if 'cold turkey' simply causes the drug to diminish by itself at an acceptable rate.

With Tony being barraged by so many anti-biotics and other drugs even prior to Stelara, it might be hard to establish a solid causal relationship when it comes to a court case. I'm not a lawyer either. (don't even know if I have 2 cents or common sense worth...) But speculation and having doctors conclude that Tony's condition was 'likely' caused by the Stelara (or the cessation of it) might be heard in a clinic conversation, but difficult to get in a documented deposition. If Tony's friends and family and supporters are going to move forward, it really seems like you'd need an established law firm to do it.

That said, I hope that the major focus, at this moment, is getting Tony's health back first, and doing whatever is necessary to get him back on his feet. (literally).

peace & healing

(and a Ronald Reagan quote for Chotti.... 10/28/1980 "There you go again....") :-)

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