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clinical review of Schering's application for PEG-Intron to The Center of Biologics Evaluation and Research (CBER)

Following is the actual clinical review of Schering's application for PEG-Intron to The Center of Biologics Evaluation and Research (CBER), the division of the FDA that regulates these types of drugs. In other words, it is the highest authority's (CBER) review of PEG-Intron, as studied by the very people who most wanted it to be approved (Schering). It reads like an admission, an admission that the drug is neither safe nor effective, but "hey, it's all we've got". It may shock you. It may only confirm what you already know.

§ PEG-Intron is the Same Drug as Interferon Only Worse
§ PEG-Intron is NOT Safe
§ PEG-Intron is NOT Effective

You need only read one paragraph into the study to learn that PEG-Intron is the same drug as Interferon, only modified to stay in your system longer  (Thereby killing you more consistently) ."PEG-lntronTM, peg-interferon alfa-2b, is a covalent conjugate of recombinant interferon alfa-2b with monomethoxy polyethylene glycol product. The biological activity of peg-interferon alfa-2b is derived from its interferon alfa-2b moiety."

compared to interferon alfa-2b treatment.Time to response to treatment and time to relapse were  not superior with peg-interferon alfa-2b treatment compared to interferon alfa-2b treatment. Health-Related Quality of Life Scores were not improved in any of the interferon treatment groups either during or after treatment."

After reading 43 pages of evidence, in Schering's own words, that PEG-Intron is not effective and not safe.


Dr. Russell Blaylock, a board-certified neurosurgeon and author of the books Health and Nutrition Secrets That Can Save your Life and Natural Strategies for Cancer Patients, contributed this outstanding article about interferons, which are used widely for the treatment of multiple sclerosis (MS), hepatitis, cancer and more. If you, or someone you know, are taking these drugs, this article will help you decide if the benefits outweigh the many risks.

By Russell L. Blaylock, M.D.
http://www.russellblaylockmd.com/

How Interferon Ruins Your Brain:

The mechanism of this injury to the brain appears to involve the brain's special immune cell called the microglia. Normally, these cells remain dormant in the brain. That is, they are sleeping. Microglia cells can be activated by numerous factors, including mercury, aluminum, iron, overvaccination, and brain trauma, strokes, infections (viruses, bacteria, rickettsia) and cytokines such as interferons.

Once activated, microglia can move about the brain secreting very toxic compounds, which include two excitotoxins (glutamate and quinolinic acid). These excitotoxins dramatically increase free radical generation in the brain as well as oxidation of lipids (called lipid peroxidation). These radicals damage synaptic connections, interfere with neurotransmitters and can even kill neurons. In addition, these activated microglia generate other toxic compounds such as prostaglandins (PGE2), which increase brain inflammation.

If the microglia activation is short lived, the damage to the brain is minimal and recovery takes place. Yet, should the activation continue, which would occur with high-dose and long-term use of interferons, the damage could be substantial and irreversible.
19 Responses
Avatar universal
Interferon or something has apparently ruined your brain. I've been on every interferon there is for 10 years now. High dosage Roferon,Infergen,Intron with Riba,Peg and Riba,peg intron and riba in trials and now Peg maintainence. It has kept me alive against long odds  and will keep me alive until there is a new drug to knock out this bug. Then I'll do another 6 months or a year of Peg and Riba. I thank God for interferon and give thanks with every shot I do.
Avatar universal
Tx has kept you alive for 10 years?  How do you come to that conclusion?  No one can predict the course of the virus.  You may indeed have gained some benefit from Tx but then again it may have caused other types of problems.  

                                                                                                                                       Ron
137025 tn?1217768341
I can understand the feeling that one should be grateful for IFN.  I have moved from stage 2 to stage 3 with some significant symptoms and if teleprevir is not approved, I will do IFN and be glad I am able to.  Probably some sort of maintenance which is very specific in that it will give my liver time to heal and give me time to wait for something better.  

So I am very glad for IFN also.  I advanced the one stage in 5 years and I am only 55 years old.  My time line sucks pretty bad.  I do not drink, eat well, do a lot of gardening, and do the milk thistle/herb thing.  There is nothing left for me but IFN.  Yes, there are significant sides and some linger, but liver death is so final, I gotta go with the IFN every time and be thankful to my gods that it is available.
Avatar universal
Iam not sure if I can buy the notion that treating without SVR somehow gives your liver a rest and a chance to heal.  If in fact viral load has no impact on liver condition then lowering your viral load from lets say 3 mil to 100k should make make no difference. It could be the viral load you kill off are not the ones causing the problems. This is just me thinking out loud.  I find myself doing that alot lately.

                                                                                                                                           Ron
Avatar universal
Hi Willow, hang in there, better drugs are coming. Just do whatever you need to do to be there when the day comes. Had a friend that passed away in Oregon State University Hospital from liver failure and it hits you hard.May he rest in peace. Hate to see anyone else go and it ticks me off to see someone pumping some quack and running down the only available treatment when they haven't even done it.  I've had problems with INF but it was made quite clear to me 10 years ago that if we couldn't knock down the virus then a transplant would be the only other option. Lots of people on that list and not enough organs. I've had the best doctors in the world and believe what they say.I have survived other life threatening situations and I will survive this. Just another challenge and it's a pass/fail test. There was a Peg maintanence trial that found it worked well at arresting the virus but if you can go 2 years then go for the knockout then do it.
137025 tn?1217768341
They are doing a very long term study at the University of Washington on maintenance and the results so far have been very good.  My doc is one of those involved and while he couldn't tell me a lot because they were still blinded, he did tell me that the study was extended because the results of maintenance were great at 12 post maintenance, now they are studying 24 months.

He offered me maintenance now, but said that he has enough faith in teleprevir to ask me to wait until the winter of 2009.  If teleprevir is not approved by then, we will go with about 48 weeks of maintenance.  One of the big drawbacks is maintenance is not FDA approved, hence the trials in Seattle, so right now, my insurance will not pay.  Even with my progression, Doc Scott figured I could wait till 2009 just fine, so I'm in a waiting mode, with IFN as a back up.

What IFN does has not so much to do with vl, but with inflammation.  It stops the cell death for a while, thus less necrosis, less scar tissue, happier liver.  I still have great portal tissue for an old lady, so I can wait.  But if teleprevir doesn't work, well, hello IFN.  Believe me, given the choice between 24 weeks of a combo tx with an 80% of SVR and 48 weeks of low dose maintenance, well, pass me the teleprevir and call me SVR.  

xhrles, sorry to hear about your loss.  I lost my ex from liver failure, my god, what a horrific thing.  We were married 17 years, then divorced because the fool would not quit drinking.  I do not know if I caught Hep from him, does not matter, but I do know that I have a decent liver left and we lost him and the one difference was his drinking.  I was with him when he left us, no one else would make the trip, I had to go for our kids and I am darn glad I did.  That was in 2002 and at that time, the docs weren't even sure what the hell was going on.  Now, in retrospect, it all makes a sad kind of sense.

I don't know where your head is, but mine is not anywhere near thinking a transplant is a viable option for me.  I want to keep my own organs inside me and will do just about anything to make that so.  It always amazes me the number of folks who casually say, "well, has anyone talked about a transplant" as if it were buying a new pair of shoes.  We have folks who post here with transplants and I am always in awe of them, they seem like they are thriving and doing well.  Somewhere, I just have this great, terrifying fear that I could not do that well.  So I live from year to year and hope for teleprevir and feel comforted that I can do maintenance and hang around for a long long time.

Perhaps long enough to see teleprevir succeed and the yahoo doubters to go away.  Cross your fingers!

Willows
Avatar universal
Yours is by far the most interesting battle against this Virus I have heard.  I have never heard of anyone doing Interferon for 10 years.  If my memory serves me right 10 years ago Interferon was all there was and the odds of it working was under 10%.  The notion of knocking down the virus is kinda strange to me.  What is your Geno type?  What was your viral load 10 years ago?  What was your liver condition then compared to ten years later?  I don't want to sound to personal its just I am always trying to expand my knowledge.

                                                                                                                                   Ron
Avatar universal
think the maintaince trial was called HALT-C. Not sure if it is ongoing but heard it had good results which is consistent with what my doc told me long ago. he said he couldn't cure me but the INF would keep me alive until they could and I believe it has. It makes the pain in my side go away and I feel better, 2 more years,100 and some shots. think the Vertex drug is a good one and will be approved as soon as they can. expect Schering to be close behind with their PI drug. They have used PI's for HIV for years so they are not a complete unknown. Agree with you that toughing it out until an effective treatment is available is the way go. My doc used the "T" word last year and we had a talk.I'll do whatever I have to do to get better and if it comes to that then we'll see but doubt it will.They are testing the teleprevir now and are quite encouraged. Please accept my regrets about the loss of your ex.Never really cut the tie when you have children together.
Avatar universal
Not more Blaylock again - gee whiz, if these guys would just come up with something new it would be very refreshing but it appears as if this is all they can find. BORING!!!! Mike
137025 tn?1217768341
it is the HALT-C trials and they are ongoing at the U of W.  The trial was just extended about 8 months ago for another 18 months and I'm hoping for some good news.  Maintenance seems to be another good tool to add to the bag when trying to blast the **** out of the virus.  I have read much about protease inhibitors and understand their use with HIV, it seems to me that finding the right one will be the thing it takes for Hep C.  Or perhaps a combo of protease and polymerease.  Again, I have my fingers crossed.

And yes, you never cut the ties when there are children.  This is okay with me, my ex and I got along great, but only as long as we kept the conversation to the needs of our kids.  I always told him...."we were lousy mates, but great parents" and our kids are indeed okay.  The experience of losing him and all it's mysteries, has probably shaped me more than any other experience.  Well, to try tx for 30 weeks and experience breakthru when I was doing so well has also made me a bit cranky, but it was his death that brought it home to me that we were not playing around here.  But it also left me feeling like I had a huge amount of control over the quality of my life...quit drinking, etc.  Like you, I will do whatever it takes.  Right now, it takes losing 30 lbs and boy, I'm having a hard time with it.  But I like the feeling of achieving goals, so I will be fine.  You take care too.
Avatar universal
I know who you are.  Stop spamming us!
Avatar universal
You can find just about any article that you want to support the viewpoint that you want to express.  I, myself, had a much better viral load response with the Peg-Intron than I ever did with the Pegasys or with the Infergen.  I would even consider doing a twice a week dosage of Peg-Intron + Ribavirin + Telaprevir and maybe even a (polymerase inhibitor thrown into the mix for good measure) combination, if it became available to me.  Just because I know that nothing else has worked and I know that I can tolerate Peg-Intron.  

Susan
96938 tn?1189803458
'Following is the actual clinical review of Schering's application for PEG-Intron to The Center of Biologics Evaluation and Research (CBER)'

OK, I give up where is the clinical review that follows?.  I looked all over area 51 and the Grassy Knoll and couldn't find the 'clinical review' anywhere.  Maybe if I take the aluminum foil off all the windows in the house I could find it in the garden, next to Bigfoot's left foot impression in the mulch.  Nah, the CIA covered the tracks when they removed the monitoring devices from my electric outlets.   I'll check the hidden cameras, later (they're watching me right now).
96938 tn?1189803458
Guess I should have posted that last comment in the 'Does alcoholism allow HCV to become an active infection???'  On second thought, applicable to both.  Maybe I'll just copy it to there too.  By the way, I know for a fact  he was not in it alone.
137025 tn?1217768341
Naaa...your comment was just as appropriate in response to the original post and actually, extremely funny!   Call me naive, but I am very very afraid of people who post that "stuff" here and think we will believe it..."How interferon ruins your brain"????   Holy moly, I have a ruined brain.  Jeez, I think I will get the tin foil off my windows too.

These guys make me crazy!  Can't someone find them a real job?  I have enough grief in my life, makes me sort of ballistic, I've got an empty milk thistle bottle in my hand, I'm armed and dangerous, looking for quacks.  No, not the ducks, they would be a welcome change!  Thanks for the giggle, I was getting waaay to serious here.  Have a good one.
96938 tn?1189803458
If you can recall the scene and the song from 'West Side Story'.  In the song 'Gee, Officer Krupke' the gang sings:

It's just his neurosis that oughta be curbed.
He's psychologic'ly disturbed!

and....

We are sick, we are sick,
We are sick, sick, sick,
Like we're sociologically sick!
Avatar universal
LOL
Avatar universal
is your handle shorthand for factotum? as in an all round waterboy for Baylock? cui bono?= who benefits? or, follow the money.......
Avatar universal
your response is priceless and your brain appears in absolute tip top shape,at least the humor section,or 'the comics'..methinks some folks are off their meds,or mixing the martini's a tad strong..hope your trx is going aok? nothing like laughing your way to Better Health.....
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