About The FDA TNF Cancer Study | Arthritis Information
I think that it is important for everyone to understand that this is a study that is going to happen. It hasn't happened. As much as the same few members are trying to make it sound like the study has happened and the TNF blockers are cancer causing, the study hasn't happened. To those few members let me say this, before you wet your panties in glee at the prospect of being able to say that the TNF blockers are cancer causing, the TNF blockers are being investigated for thirty cases of cancer in 10 years. You hopeful members may be very surprised and disappointed that the study may find that 30 cases in 10 years may very well be in line with the averages of normals, immune diseases and etcs. It surprises me that those few members actually believe that the truth will come out from the FDA. Aren't these hopeful members the same members that claim that big pharm pays off the FDA? So for those wearing your depends in gleeful anticipation, you may be very disapointed with the outcome. Don't worry though, you can just claim the study to be innaccurate because of big pharm pay-off of the FDA.
LEV
[QUOTE=levlarry] To those few members let me say this,
before you wet your panties in glee at the prospect of being able to say that the TNF blockers are cancer causing, the TNF blockers are being investigated for thirty cases of cancer in 10 years. [/QUOTE]
They have pills for that now. But I hear they cause dementia or loss of cognitive function, or something like that.
Amgen And Wyeth Statement On The FDA Early Communication About Tumor Necrosis Factor (TNF) Blockers:
Amgen And Wyeth Statement
Amgen and Wyeth are committed to the safety of patients and have consistently updated the product labeling for Enbrel® (etanercept) over the past decade. The companies maintain ongoing safety surveillance programs worldwide to analyze and evaluate safety reports, including reports of malignancies, from controlled and open-label clinical trials and patient registries, as well as reports received from healthcare professionals and patients. Amgen provided the FDA with information from both companies' adverse events databases and is continuing to work with the Agency to evaluate the overall risk benefit of ENBREL in pediatric patients.
The FDA has conducted an analysis of safety information provided by the manufacturers from all TNF blockers as well as that collected from its own adverse events reporting system (MedWatch). Based on it's preliminary review, the FDA has decided to conduct further analyses to evaluate the risks and benefits of TNF blockers in pediatric patients. The Early Communication mechanism has been used by the FDA on numerous occasions during the past year to inform the public about its ongoing safety reviews of drugs. The Agency's posting of this Early Communication means that FDA is considering the information but has not yet reached a conclusion.
Amgen and Wyeth support the ongoing FDA review of safety information for TNF blockers and remain committed to providing FDA with any additional information needed. According to the FDA Early Communication, "FDA has been aware of the possible association between the use of TNF blockers and the development of cancers. The prescribing information for all four TNF blockers warns about the possible risk of cancer." The FDA Early Communication also states, "At the current time, the FDA believes that the potential benefits of the use of TNF blockers outweigh the potential risks in certain children and young adults having one of the diseases for which the TNF blockers are approved to treat. Until the evaluation is completed, healthcare providers, parents, and caregivers should be aware of the possible risk of lymphoma and other cancers in children and young adults when deciding how to best treat these patients." Amgen and Wyeth agree, and as always, physicians and patients, or their caregivers, should carefully evaluate the benefits and risks of ENBREL before initiating therapy.
http://www.medicalnewstoday.com/articles/110206.php
Here is an informative article on the RA/Lymphoma "connection".
K.
PS to LEV: In that jingle jangle morning I'll come followin' you.
What has this to do with the subject matter at hand?
Absolutely nothin'.
Katalina2008-06-06 08:26:08What about the MS connection ??Wyeth is the company that refused to fund Dr. Trentham's Minocin study with children because they make Enbrel at $l,300/mo.
Jan
I started typing in the other thread about cancers and Biologics but then deleted it. The cancers referred to are common cancers in childhood.
I didn't read all that's been posted about the study so forgive me.....In 10 years 30 children were reported to have been dx'ed with lymphoma. How many children were actually prescribed the medications to begin with? It had to be a lot in 10 years were talking about thousands if not hundreds of thousands right? Does the study say?
Like Lev mentioned it sounds like to me that might just be about average. It doesn't sound that high to me. Unfortunately lymphoma and non-hodgkin's lymphoma are not that uncommon in children and young adults.
From the article Lynn posted:
"Common side effects in adult clinical trials were injection site reaction, infection and headache.
In a medical study of patients with JIA, infection, headache, abdominal
pain, vomiting, and nausea occurred more frequently than in adults. The
kinds of infections reported were generally mild and similar to those
usually seen in children. Other serious adverse reactions were
reported, including serious infection and depression/personality
disorder."
I think this shows how children are affected differently. Depression/personality disorder is news to me, too. I'm unsure of the difference in a 'clinical trial' and 'medical study', but I do know the trials in children have been very small.
It doesn't sound that high, until you consider what might be unreported. The two people I know who had adverse cardiac events on Vioxx and Bextra were not reported - at the time, doctors did not know there was a link.
Also from the same article, in Amgen's Forward-Looking Statement:
"Only the FDA can determine whether the products are safe and effective
for these uses. Healthcare professionals should refer to and rely upon
the FDA-approved labeling for the products, and not the information
discussed in this news release."
Katalina,
The link you posted is such a good read. I think that it opens our eyes to just some of the other diseases that we with ra are at higher risk for and that's whether or not any drugs are used. We are more likely to be affected by other immune diseases such as lymphoma and ms. MS seems to have some of the very same markers as ra. Heart disease, strokes, lung problems and etc. Also Katalina, I really don't think that my "signature" line really has anything to do with the subject at hand or at foot and probably has absolutely nothing to do with the price of dry beans in Alaska either, it's just my signature line and is in the signature line of every one of my posts. I hope that clears that mystery up.
I think it is so sorry that a few people look for the ugly and are so quick to joyfully share every story with a possible (no matter how slight) ugly effect. If all medicines with "rare" possibly fatal side effects were banned, where would we be? Who in this world believes that one can alter the human life structure with out effect?
Why do a few of you believe that Wyeth owes roadback anything? What did roadback do with the money that Wyeth gave them previously? I'll bet yous didn't even say thanks, just kept taking shots at them as if they are the enemy. Did roadbak use the money that Wyeth gave them to pay the Harris people to produce that phoney-baloney study or use it to spread ugly things against Wyeth and Enbrel as the roadback members do here. Isn't the director of roadback a bigshot with some prestigious university? Wouldn't you think that if roadback's claims were so believable that even his university would fund the study? If there is such a conspiracy against ap therapy and yous have such proof, why don't yous just call 20/20 or some other news agency. If you can prove what you spew, certainly any of the large news agencies would love to have the story, or so you would think.
LEV
A risk if you do. A risk if you do not. A risk for every medicine. A risk for every chioce you make with this disease it is all a gamble. Never a way to know if you made the right chioce or the wrong chioce. We are all in it together. Prayers and good luck to each and all.
[QUOTE=Lovie]I started typing in the other thread about cancers and Biologics but then deleted it. The cancers referred to are common cancers in childhood.
I didn't read all that's been posted about the study so forgive me.....In 10 years 30 children were reported to have been dx'ed with lymphoma. How many children were actually prescribed the medications to begin with? It had to be a lot in 10 years were talking about thousands if not hundreds of thousands right? Does the study say?
I am sure that all of these medicines you gave your daughter had side effects. How awful this is to hear about a child going through all of this. No not all children have these problems. And i certainly do not suggest that you put her back on any of the medicines. However in the fairness of science. I have always been consider the sickly person in my family. In a strangly sick sort of way. I got this reputation as a child. I always got the bad side effects and or allergies to medicines even as a young child. I always had wierd illnesses. Just plenty of unanswered problems and illnesses. So arggha it can go both ways. I am totally against the taking of NSAID's for RA or JRA. All of this medicine will mess up our stomaches regardless of what we take. Well that has been my experience. My stomache of course was fried before i could get anyone to give me medicines. So I certainly do not want to make it worse. Well i don't even want to talk about my stomache and esophogus. Scary just plain scary.
For me sqamas cells and inflamation damage ect. I had that with just plain old lack of treatment. It is a horrible disease. Sometimes people get so sick they have no chioce than to treat with drugs that they know can harm them. I am at that piont. I often wonder if i had been treated sooner if i would be in better shape than i am now. I tend to think i would be. But i guess i will never know. So yes the drugs are brutal to our bodies. And yes the disease is brutal to our bodies.
Just to say i have no spit no tears. My spine is swollen as our my joints. The back of my head hurts so bad it is scary. My pain meds are not even working and they are strong. Like i said esophogus and stomache are fried. I am tired. No doubt with a zero reading of tears on an eye test can you imagine what shape my internal organs are in right now. My skin is not right in so many ways. Even my muscles are being attacked. So what have i got to loose. There are no easy answers. The disease is real and really awful. It does plenty of damage in plenty of strange ways.
Milly, I'm so sorry you having such hard time now, and I was relieved to see your post that today is a little better. I hope the new meds will help you be able to rest today, so tomorrow will bring even more improvement.
I know all meds have side effects, and many we would happily take for a good outcome.
The reason for my post was to share why I thought thirty cases could mean more than it sounds like it does. Because of the way the system is. I don't think it means much for adults, or there would be a stronger warning for them by now, but for children I think it is something to seriously consider.
Suzanne2008-06-08 08:17:08
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