I'm a new member, I have a 94 year old grandmother with Alzheimer's. My mother called me to tell me a Dr. was on the news and had a big breakthrough for Alzheimer's treatment. I went to the the Kcal9 news website and found the video and listened to the story. The claims that were being made were: The Dr. is using an anit-inflamatory drug "etanersept" and injecting this drug through the spine, the interviewer says that they bypass blood barriers and lower the level of chemical that causes Alzheimer's. The Dr. states that in Alzheimer's, it has this amazing rapid effect with in a few minutes, because it allows nerve cells and brain cells to communicate. He went on to say: because of the rapid delivery through this new method we see these effects within minutes of their administration. The interviewer then states at the end of this news piece that this is not an experimental procedure and is going thru the FDA as we speak. They give the Dr's name as Dr. Edward Tobinick and tell you to go to their website for more info, which of course I did and next to his name is UCLA's Institute for Neurological Research. So now I guess I should get to the point, if this is such a major breakthrough, why isn't it in all the news? Has anyone else heard of this treatment? I think sometimes the news media can get it wrong, so is that possibly what happened here? I am very hopeful for a cure, or anything that will stop the progression of this thieving disease, but before I tell my 95 year old, completely sane Grandfather that there is HOPE for his wife of 76 years, I want to find out from other's if they've heard of this treatment, and what can it do. Please give me your insight.

dinky --

To my knowledge, there are no clinical trials for this treatment. It is very expensive ($42,000 per year) and requires weekly injections into the spinal cord in the neck. Such an injection is dangerous. Also, enbrel can have serious side effects even when used as directed; no one knows what can happen when injected into the spine. Some people swear they seen improvement in their LOs, others don't. Because of the cost, the weekly injections, and the potential dangers, I think it is very unlikely this will ever get into clinical trials.

The drug is a large protein, which cannot cross the blood-membrane barrier, and so it never gets into the brain. It binds another protein, TNF-alpha, that is associated with AD, but only in the spinal fluid. This lowers the amount of active TNF-alpha, which is what can sometimes help the patient.

A number of companies are exploring the potential use of small molecules which can also bind and inactivate TNF-alpha. These would be able to penetrate the brain where most of the protein is found, and are expected to be much more effective. They can also be administered orally, as a pill. One of these is thalidomide.

Use the "find" button in the purple bar at the top of the page, and enter enbrel or etanercept (same thing), to see what people have to say about etanercept. Enter thalidomide to find a thread "Thalidomide: an alternate anti-TNF-alpha therapy".

Hi Dinky,

I happened to be at Dr. Tobinick's office the day the News Crew was coming! The news flash didn't do it justice. As JAB said, please read the Thread under Medications/Tratments, Enbrel for Alzheimer's.

JAB - I haven't heard about the thalidomide...I'm going to start that research now. Thanks.

"JAB" raises some concerns about etanercept (trade name "Enbrel"). But as a researcher myself, I must point out that s/he got a few things wrong. First and foremost, Dr. Tobinick's injections do not go into the spinal cord. They are made into the connective tissue between the bones of the vertebrae; the object is to hit some specialized veins that comprise the "cerebrospinal venous system" (CVS), aka "Batson's paravertebral plexus." Studies in rats have shown that large molecules normally excluded by the blood-brain barrier (BBB) can get into the brain from this CVS. Moreover, being a large protein does not necessarily exclude a molecule from passing the BBB; there are several large proteins that cross the BBB from the normal vascular system, TNF-alpha itself being one of them. Because etanercept contains the "tail" of an antibody, it may trick the body into thinking it's an antibody and thus get transported across the BBB actively. Also, TNF-alpha is not associated with AD "only in the spinal fluid"; indeed, there is no such thing as "spinal fluid" (and TNF elevations have been documented in the brain tissue itself). Finally, it should be emphasized that cost is not a determinant of whether something becomes the subject of a clinical trial.

Thanks Shinbarker. You seem very educated in this. I bring my Mom in tomorrow...she has had miraculous results. Do you know anything about the intranasal procedure that has been suggested? I looked up the "intended" study, and am not sure if they are taking the same medication and spraying it into the nose -- with a dosage measured device like my Flonase??? What do you think of this method?

Thanks, Felicia

Call for Alzheimer's Association to ADD AGENDA ITEMs!

These Agenda additions will better serve our membership:

1) Dr. Tobinick to report on the use of Enbrel and the Perisinal treatment for AD.
2) Panel Discussions: Off-Label Drug Use and Patient Care.
Two Panel Groups Represented:
a) AD Patients and Caregivers.
b) FDA, Medical Community, and Drug Companies.

ICAD
The Alzheimer's Association International Conference on Alzheimer's Disease (ICAD) brings together the top dementia researchers every two years to engage in a multidisciplinary international exchange of ideas.
When: July 26-31, 2008
Where: McCormick Place, Chicago, Ill.

Dementia Care Conference
This annual event for dementia care professionals features the latest developments in Alzheimer care and support.
When: August 24-27, 2008
Where: Hyatt Regency, Garden Grove, Calif.

In the interest of helping members through Education, the addition of these Agenda Items is requested. We all need to stay current with progress and replace controversy with knowledge.

Robert Lee

Hi everyone,
I'm a new contributor to this forum but not a new reader.
I have read this thread, Dr T's, enbrel papers, and talked to Dr T a number of times. I have been preparing for having my Dad treated and fuly anticipated jumping on this forum immediately once treated.
Today was the day. We have been preparing and waiting for this day for a long time. That is if you can consider 3 months all that long in the grand scheme of things.
I have to admit that the expectations probably got out of control no matter how much I read and prepared myself for little or no affect. You see, it seems that all o fhte success stories seem to be the same, almost immediate recognition of some progress. Well, that didn't happen for my Dad or us.
My Dad went to see Dr K in Florida. After a round of tests he was given the injection. After the injection they ran similar tests with no apparent improvement. You can imagine the dissapointment we all felt when there did not seem to be a single sign of progress. I know this is early. We still plan on going for additional treatments to see if there will be any difference.
I guess, I really joined today to look for any signs of encouragement as the dissapointment was great. does anyone know of a patient that did not show some signs of improvement almost immediately and then show significant improvements in later visits?
I am so glad that the treatment has paid off for a couple of you on this forum. I wish the public "good news" stories were plentiful.
I'm still praying for that tiny little miracle to shine through my fathers eyes.

AlCal;

Sorry things didn't turn out like you wanted. I can only imagine your disappointment. Prayerfully, the next injection(s) will present the desired results we all will be looking for.

I'll keep you in my prayers.

Blessings!

AlCal---Saw your posting on our other Enbrel thread and responded there expressing my regret at the treatment's lack of positive results for your father. Bob Lee did the same and requested further information about his age, stage, end test scores. Please consider providing that information. It may help to identify poor candidates for treatment and save others money.

I'm posting on this thread to let you know that you are not alone. If you visit a thread located at http://www.alzforum.org/new/detail.asp?id=1738#{A7FFF99A-260E-4AB0-9DEB-4AA549DE9357 and scroll to a comment posted 04/13 you will learn that your father is not the only individual that experienced a lack of results.

Hi AlCal, (I'm posting this on both threads)

I hope you give this a little more time. And I pray that you see results. I went back to my first post of the first time my Mom went in, because I too remembered being a bit disappointed. She showed a little improvement in a test at the office which was a little encouraging, but not the miracle I was hoping for. Here is my last paragraph of that post:
March 7, 2008: "Well, my overall thoughts are good, but I have to admit a little disappointed. I don't think I EXPECTED a big huge change, but I think I was HOPING for it. But as we all know, any improvement is a good thing, and I will be going again next week, and probably for the next few months to give it the complete try. Also, as far as we can tell, there is NO ADVERSE REACTION to the medication. She says she feels good today. I will give more info about how she's doing as the week goes on".

The next day, I posted a little more improvement. To look at everyone's posts, just click on our names on the board and it let's you see them all in one spot.

Anyway, I am not by any means saying that you are wrong and that this will work. I'm just trying to give you some encouragement that hopefully you will see more as the week goes on. Like it's been said, so far the percentages are 90% effective and I don't know the reasons for the other 10%. I will pray that you are not in that 10%...but not everything works for everybody. Give it some time and try to keep your hopes up. It's hard. Everytime Mom has a bad day, my emotions go crazy, even now. But, when I look at the "before" videos, it brings me back to earth.

I'm hoping and praying for you, Felicia

here is link i found. http://www.mailonsunday.co.uk/pages/live/articles/health/healthmain.html?in_article_id=558849&in_page_id=1774

Hi Joey,

Thanks for the link. I just made a couple of comments there. I hope they don't boycott me like a lot of other boards and articles have done. It seems I have been blacklisted for telling people about my Mom! Also, under the comments, I found our "friend" Dr. Cummings from UCLA kindly suggest to people that this is a "false hope" and that we should join clinical trials.

Felicia

I hope AlCal doesn't mind, but he has posted a couple of updates on his Dad on the Medications and Treatments/Enbrel for Alzheimer's thread, page 15. He has now seen improvement and is a bit more hopeful. Praise God!

Amgen Statement on Alzheimer's Case Study
A number of news reports recently have been published regarding an experimental treatment for Alzheimer's disease by using Enbrel® (etanercept), a potent anti-inflammatory agent. This off-label, unapproved treatment, administered by Dr. Edward Tobinick, is not supported nor endorsed by Amgen.

Amgen's mission is to serve patients by aggressively pursuing research to help fight grievous illnesses. We fully recognize that Alzheimer's disease is a relentless neurological disease for which there is currently no cure. Our hearts truly go out to brave patients and families who are dealing with this disease. Amgen will continue to review data on the use of ENBREL and other anti-inflammatory agents for the treatment of Alzheimer’s disease.

While Amgen and others have long recognized the potential role of inflammation in neurological conditions, we have carefully examined these reports and believe that there is insufficient and unsubstantiated scientific data to support the use of ENBREL as a means of treating Alzheimer's disease. For example:

We are not aware of any data to suggest that ENBREL reaches either the cerebrospinal fluid or the central nervous system in sufficient concentrations to inhibit the action of TNF when administered by Dr. Tobinick's method.
In addition, we find the rapidity of response reported by Dr. Tobinick to be implausible when considering the time required for resolution of an active inflammatory response and the potential impact that this could have on cognition.
Furthermore, we are not aware of any placebo-controlled data for Dr. Tobinick’s method. Thus, it is not possible to determine whether the clinical benefit that Dr. Tobinick reports is due to treatment with ENBREL.
Dr. Tobinick's case studies have not been presented at an appropriate medical or scientific meeting, nor have they been published in a rigorous peer-reviewed medical journal. Anecdotes are not sufficient scientific evidence to support treatment of Alzheimer's disease with ENBREL, and Amgen does not support this or any off-label use of ENBREL.

Additional Information:
The Alzheimer's Association has additional information regarding Alzheimer's research and patient/family support groups, as well as a statement regarding these reports.

For more information about the approved indications for ENBREL, including important safety information, please visit www.enbrel.com.

"Dr. Tobinick's case studies have not been presented at an appropriate medical or scientific meeting, nor have they been published in a rigorous peer-reviewed medical journal. Anecdotes are not sufficient scientific evidence to support treatment of Alzheimer's disease with ENBREL, and Amgen does not support this or any off-label use of ENBREL."



Hmmm. I wonder how the conference in Little Rock was? Dr. Tolbinick and others were there. I'm sure Dr. T spoke on his treatment of Alz with Enbrel. I wonder if Amgen officials have seen the you tube videos of Rose, Linda, and Biblecat's Dad? I wouldn't consider them "anecdotes"

Hmmm.

Hi Maac,

Yes, this is just making me sick. Dr. Cummings from UCLA goes out to the BBC and tells people that this is a false hope, when I invited him to see my Mom and observe how she was doing. GER from the other thread says that Amgen is aggressively pursuing research, yet refuses to look at something that has had a ninety percent success rate. And, since Jan at least, many articles have come out in Prestigiuos Medical Journals, but the no-sayers keep forgetting to update their info.

Mom is going to go out shopping with me today. She now likes to look at things, instead of just following me around in a confused state. The experts are still hung up on the fact that there was no double-blind study. Well, Dr. Tobinick addressed that in his initial study...and of course he was hoping for the funding to do it...it never happened. Amgen was busy with a new drug that will make them more money because the patent will be in force, and the Enbrel patent will be gone before a clinical trial can be finished and generic drugs will be made. Double-blind studies don't make that much sense when you're talking about Alzheimer's. You are dooming the person on the placebo to a life of confusion, and then death. Their minds aren't capable of "fixing themselves". I DO believe that attitude can carry a lot of weight in disease, like Cancer. But not Alzheimer's, any strain on my Mom's mind, and she gets worse.

Felicia

You know I catch myself saying the meds Mom has taken have not helped her any, but then like I said I stop and think, and I realize, I have NO clue what her condition would be todaY, if she had never taken anything at all. She could possibly not know any of us who knows! When I get really upset, which is often lately after returning home from Moma's, and I notidcd my hubby starting with this, "You need to stop it, they are making great advances in working on cures and so on." I just get even madder and act uglier when he does that, because like I tell him, stop trying to build up false hope. They may cure it someday, but not in time to return my Mother to me. I know I act horrible at times, and he truly is patient, more so with Moma then me ha! He's VERY good with her, but here lately he just makes me sick. ha! Guess that is one of the symptoms of the care givers. Thanks for listening. She

April 16, 2008
Amgen Statement on Alzheimer's Case Study

Amgen Statement on Alzheimer's Case Study
A number of news reports recently have been published regarding an experimental treatment for Alzheimer's disease by using Enbrel® (etanercept), a potent anti-inflammatory agent. This off-label, unapproved treatment, administered by Dr. Edward Tobinick, is not supported nor endorsed by Amgen.

Amgen's mission is to serve patients by aggressively pursuing research to help fight grievous illnesses. We fully recognize that Alzheimer's disease is a relentless neurological disease for which there is currently no cure. Our hearts truly go out to brave patients and families who are dealing with this disease. Amgen will continue to review data on the use of ENBREL and other anti-inflammatory agents for the treatment of Alzheimer’s disease.

While Amgen and others have long recognized the potential role of inflammation in neurological conditions, we have carefully examined these reports and believe that there is insufficient and unsubstantiated scientific data to support the use of ENBREL as a means of treating Alzheimer's disease. For example:

We are not aware of any data to suggest that ENBREL reaches either the cerebrospinal fluid or the central nervous system in sufficient concentrations to inhibit the action of TNF when administered by Dr. Tobinick's method.
In addition, we find the rapidity of response reported by Dr. Tobinick to be implausible when considering the time required for resolution of an active inflammatory response and the potential impact that this could have on cognition.
Furthermore, we are not aware of any placebo-controlled data for Dr. Tobinick’s method. Thus, it is not possible to determine whether the clinical benefit that Dr. Tobinick reports is due to treatment with ENBREL.
Dr. Tobinick's case studies have not been presented at an appropriate medical or scientific meeting, nor have they been published in a rigorous peer-reviewed medical journal. Anecdotes are not sufficient scientific evidence to support treatment of Alzheimer's disease with ENBREL, and Amgen does not support this or any off-label use of ENBREL.

Additional Information:
The Alzheimer's Association has additional information regarding Alzheimer's research and patient/family support groups, as well as a statement regarding these reports.

For more information about the approved indications for ENBREL, including important safety information, please visit www.enbrel.com.

http://www.dailymail.co.uk/pages/live/articles/news/news.html?in_article_id=562254&in_page_id=1770

Daily Mail (UK)

False claims of doctor who 'can reverse' Alzheimer's
By BARNEY CALMAN - More by this author »

Last updated at 23:54pm on 26th April 2008

Comments

A doctor who claimed to be able to reverse the effects of Alzheimer's with an arthritis drug was disciplined last year by US health chiefs for claiming the same drug could halt back pain.

Sensational footage of Dr Edward Tobinick injecting a dementia patient who subsequently appeared to recognise his wife for the first time in five years was shown in Britain earlier this month.

It gave new hope to the 700,000 UK dementia sufferers and their families.

Scroll down for more...


Denials: Dr Edward Tobinick, right, with a patient at his California practice
But this newspaper has learned Dr Tobinick, 56, has previously made unfounded claims that the same drug, etanercept, could cure chronic back and neck pain.
He also has a financial interest in the success of the drug because he owns shares in its manufacturer, Amgen.

Last year Dr Tobinick was disciplined by the Medical Board of California (MBC) after he failed to provide scientific evidence that etanercept was a 'breakthrough' treatment for back pain.

He was found guilty of unprofessional conduct and placed on probation for a year. He was banned from practising for 60 days - but the order was suspended for the period of his probation.

Last year researchers conclusively proved that etanercept was not an effective treatment for back pain, although Dr Tobinick contests their methods.

In 2001, he was involved in another row when he threatened legal action against a website that challenged claims he made about his patented laser hair removal treatment.

Dr Tobinick claims he teaches at the prestigious University Of California Los Angeles (UCLA) and is a member of its clinical faculty.

But a UCLA spokesman said Dr Tobinick merely rented an office in a private building also used by the university's medical centre.

He added that his work was not supported by the university and that any teaching he did was on a voluntary, unpaid basis.

Dr Greg Cole, assistant director of the UCLA Alzheimer's Disease Centre, called Dr Tobinick's Alzheimer's work "suspicious" and said it did not meet clinical trial standards. He added that most doctors were "very sceptical" of his claims.

Etanercept is part of a group of medicines which work by "switching off" a chemical that causes inflammation in the body. It is routinely used to treat rheumatic problems and severe psoriasis.

Dr Tobinick says he has given weekly injections to 50 dementia patients, many of whom have shown continuing improvement in problems such as forgetfulness and confusion.

The drug is injected into the neck near the spinal column and the patient is tilted, supposedly to encourage the drug to seep into the brain.

An Amgen spokeswoman said: "We have carefully examined this study and believe there is insufficient scientific data to support the use of a TNF inhibitor as a means of treating Alzheimer's disease."

Alzheimer's experts in the US have also described Dr Tobinick's findings as "implausible".

When approached by The Mail on Sunday, he said: "Pilot studies are the initial scientific evidence that support further investigation of a new treatment approach. Our results support the initialisation of further large-scale clinical studies.

"This is how all new treatment approaches begin. I feel the disciplinary action was unfair. There is not a single study that shows my treatment methods do not work.

"My breakthrough ideas have been attacked by the scientific community for almost a decade. This is what happens when you are the first in the world to invent a new treatment. It has happened to every medical pioneer throughout history.

"My ideas are legitimate and valid - all of this just points to the fact that my work is ahead of its time."

Additional reporting by Peter Sheridan

GER,

I appealed to your kinder side, to which you did not respnd, so I guess you don't have one.
Again, you are spinnig your wheels...Until you can prove to me/us that Enbrel DOES NOT help in reversing symptoms of AD, you are wasting everyone's time, including your own. We proved to you Enbrel does indeed work, now you prove to us it doesn't. Show us your studies! My guess is you will not respond once again.

(Repeated from the Enbrel Thread - Felicia...man GER, you are getting harder to keep up with, but I can do it!)

Thanks Ger, I was waiting for someone to find this and post it. I kind of thought it would be you...you proved yourself a Elan paid bad guy again! (See Bob, they ARE interested!)

I wrote a comment to the article this afternoon, funny, it still says Zero comments. Then, I noticed that their fine print said that not only can they delete your message, they can edit it! I wonder how many words they are going to delete to make my message say what they want. I don't have a million dollars to give them for advertising, so I don't think they care about my opinion.


Can you all believe it? Dr. Tobinick had told me about this interview they had this week. He was very happy about it, but told me not to say anything to anybody...now I know why. Well, apparently the news leaked out, and Amgen/Wyeth and/or Elan got a hold of the paper and paid them off. Good financial move for the paper, devastating move for millions of people afflicted with Alzheimer's.

They used Leo's picture...how do you think it makes Leo and Arminee feel to have been put in this article as part of the "Big Lie" by Dr. Tobinick! If it was a picture of my Mom under that title, I would sue!

Most of us here know that this treatment works. The interviewer that day spoke with Dr. T and his staff, and saw 4 patients and interviewed all of them. I believe that one was a new patient that showed improvement that day. I'm not sure about that but I think that's what Dr. T said. Either way, it was 4 patients and their families or caregivers that gave praise to Dr. Tobinick and his treatment. The editor called Dr. T on Friday, and "grilled" him on things like his probation, the lack of a double-blind study, the fact that Amgen didn't back the treatment, and many other things. Then they told him they weren't going to run the story, either at all or as first intended.

Read it over again, they didn't say a single word about the patients or that it's effectiveness is at 90%. They titled it with an outright lie! Do you still not believe there is someone behind all this? Why are they after Dr. T if he's no threat to them. Maybe this BAP drug isn't going as well as they had hoped. We all have been hoping for it, especially if it works, but why else would they be so concerned about Dr. Tobinick and his 50 patients?

Oh, and by the way, what I have been trying to say and nobody has even mentioned...THE PATENT ISN'T VALID IN THE U.K. or anywhere outside the United States. So, the theory of the Patent stopping this doesn't work in this case.

He was set up for failure. The article blew up the "disciplinary" actions and made him look like a liar. UCLA uses Dr. T when they want to look good, and "disowns" him when they are afraid of something. See this UCLA news article: http://www.newsroom.ucla.edu/portal/ucla/ucla-headlines-jan-11-2008-43001.aspx
UCLA Newsroom
UCLA Headlines Jan. 11, 2008
By Office of Media Relations| 1/11/2008 2:58:24 PM
IN THE NEWS:
------------------
New Drug May Help Combat Alzheimer’s
Research by Dr. Edward Tobinick, ASSISTANT CLINICAL PROFESSOR OF MEDICINE AT THE DAVID GEFFEN SCHOOL OF MEDICINE AT UCLA, on a new drug that may help reverse some of the early symptoms of Alzheimer’s disease was featured Thursday by FOX News, BBC News, Bloomberg, the Times Online (U.K.), the Daily Telegraph (U.K.) and Asian News International and Wednesday by United Press International. Tobinick was quoted in the Bloomberg article.
---------------------
Interesting that they used this title in their own article in Jan 2008 -- his position has not changed since then. I'm sure there's more examples but that's all I have time for tonight.

I'm going to sleep. Again, thanks GER for bringing this outright lie to our attention.

Felicia

(I am posting this everywhere GER has posted the Amgen statement. I will be sending this letter to Amgen, in response to their recent statement regarding Enbrel, which GER has posted all around this forum. I wrote to them once, and they sent me a "pasted" statement about how there's not sufficient data, etc. I am also posting this where I feel it relevant in other forums where we have been speaking about Enbrel for Alzheimer's)


A caregiver’s response to Amgen:

Dear Sirs,

My Mom has had Alzheimer’s for 3 – 5
years (at first we thought it was “just” dementia) and I have watched her deteriorate progressively, despite the best available medical care from her neurologist and GP; not from afar, but up close, since I had my
parents move in with me 4 years ago because
of her increasing disability and because
it was getting too hard on my Dad. You may consider my Mom a case report, but she is a wonderful human being; and her improvement after being treated with the medication you own, etanercept, in a unique new way (perispinal)) developed by
Dr. Edward Tobinick, has been wonderful
and marvelous to behold. She is now able
to do things she could not or would not do before this new treatment; her normal activities of daily living are enriched and significantly better, which to me is the
best part. These observations are not just
my own, they are those of all of my family members, including my children, boys aged 19, 17 and 10. They don’t usually notice things like this, but they couldn’t help but notice Grandma’s smile and comments that had disappeared only two months earlier.

We are not alone. Our same experiences have been reported by multiple other families, in watching the daily activities of their own family members improve after beginning treatment by Dr. Tobinick.

How cruel your recent “Amgen Statement of Alzheimer’s Case Study” is. You call the
rapid effects all of our families have
observed in our loved ones “implausible”
–how dare you impugn our personal
observations, when you have never even
made the effort to see for yourself. You refuse to recognize the human benefit
which the drug that you own is having. You call us all “case studies”, we are people,
who are sharing our personal experiences
with the world.

How can you claim to be “aggressively
pursuing research to help fight grievous illnesses” when you refuse to support or initiate further study of your own drug for Alzheimer’s disease despite multiple
positive published studies and an
established scientific rationale.
Why have you ignored the fact that
multiple prestigious neurologists and scientists have recognized the promise
of Dr. Tobinick’s work with the drug
which you own? Those recognizing the
promise of this new approach to treatment include the Dana Alliance for Brain
Initiatives (see their 2007 Progress
Report on Brain Research at http://www.dana.org/news/publications/
detail.aspx?id=6620&p=4, the prestigious neurology journal Nature Clinical Practice Neurology (see their April 2008 issue at http://www.nature.com/ncpneuro/journal/
v4/n4/full/ncpneuro0763.html): and scientists from the National Institute of Health (see reference 1 below)

1.http://www.ncbi.nlm.nih.gov/pubmed/17908040?ordinalpos=3&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum

and Northwestern (see reference 2).

2.Van Eldik LJ, et. al. Glia proinflammatory cytokine upregulation as a therapeutic target for neurodegenerative diseases: function-based and target-based discovery approaches.
And recently, the Alzheimer’s Society in
the UK has called for clinical trials to
begin studying perispinal etanercept for Alzheimer’s disease.

Why do you mischaracterize the off-label treatment as experimental? The off-label
use of etanercept for the treatment of Alzheimer’s disease, as utilized to treat
my mother, is both legal and not experimental
- it involves the use of a medication the FDA has approved for treating humans, albeit for different indications. Off-label use in this way is legal, and off-label use is commonly utilized by physicians, particularly for illnesses, such as Alzheimer’s, where the existing FDA approved medications are inadequate.

Why do you mischaracterize Dr. Tobinick’s published work? His studies have all been published in peer-reviewed scientific journals, including respected journals such as Current Alzheimer Research. Why did you mischaracterize the 15 patient pilot study published by Dr. Tobinick, two-board certified neurologists, and a board-certified rheumatologist as “anecdotal evidence” or as a “case report? Why do you mischaracterize
Dr. Tobinick’s scientific presentations? He has presented his work at the 7th
International Alzheimer’s Drug Discovery Foundation Conference; at the Days of
Molecular Medicine Conference at the
Karolinska Institutet; and an abstract
of his work was at the last ICAD Conference
in Madrid (http://www.sciencedirect.com/
science?_ob=ArticleURL&_udi=B7W6D-4KBG8NV-1G9&_user=4423&_rdoc=1&_fmt=&_orig=search
&_sort=d&view=c&_acct=C000059605&_version=1
&_urlVersion=0&_userid=4423&md5=
8f7d00c668ed3af41c72ecc1209b58c2),
which is known as the largest Alzheimer’s conference in the world!

Amgen’s refusal to investigate the potential
of its own drug will be recognized as the personal failures of Kevin Sharer, its
current CEO; and of Roger Perlmutter, its current scientific director. Why does Amgen management continue to mischaracterize and distort the facts?

An “aggressive pursuit of research” would be the sponsorship of a large and proper double-blind, placebo-controlled trial of etanercept for the treatment of Alzheimer’s disease,
by independent researchers trained by Dr. Tobinick in the perispinal administration method which he invented and has continued
to use so successfully for my Mom and now
many others. To do anything less will just delay the acceptance of this extraordinary
new advance in scientific discovery, and
cost lives. Amgen cannot continue to hide behind its blatantly false “scientific” rationale. With over 3 billion dollars of
2007 revenue from etanercept sales, how can
you justify not investigating the clue which Dr. Tobinick has handed to you? The 5 million patients with Alzheimer’s disease and their families, all without a truly effective treatment, will not soon forget your
failure to investigate, and, by so doing,
your prolongation of their (and my) agony.
How can your shareholders let Amgen management continue this perversity of science? Should they have an unshakeable belief that Roger Perlmutter is always right? Or is it just possible that Mr. Perlmutter’s failure to support clinical trials of perispinal etanercept for Alzheimer’s will be seen, alongside the Amgen fiasco of anemia drugs,
as another in a series of broad and
serious miscalculations by the current
Amgen management?

Felicia

Posted May 01, 2008 02:02 PM Hide Post
US FDA: Amgen, Wyeth's Enbrel drug to carry warning
Thu May 1, 2008 2:40pm EDT May 1 (Reuters) - The U.S. Food and Drug Administration said on Thursday that Amgen Inc (AMGN.O: Quote, Profile, Research) and Wyeth's (WYE.N: Quote, Profile, Research) Enbrel arthritis drug will carry a warning about the risk of serious infections that can lead to hospitalization or death.

The companies had announced the new warning -- a so-called black box -- in March. Enbrel's label now warns patients and doctors about tuberculosis, bacterial sepsis and other infections in patients taking the drug.

The same dangers were previously printed in bold-face type in Enbrel's package insert label.

"Patients who develop an infection should be evaluated for appropriate antimicrobial treatment and, in patients who develop a serious infection, Enbrel should be discontinued," the FDA said in a statement on its Web site.

Amgen and Wyeth both market the drug in North America. (Reporting by Susan Heavey, editing by Dave Zimmerman)

One Amgen Center Drive P.O. Box 8299
Thousand Oaks, CA 91320-1799 Philadelphia, PA 19101-8299
IMPORTANT DRUG WARNING
SUBJECT: Tuberculosis and Infections with Enbrel® (etanercept)
March 14, 2008
Dear Health Care Professional:
Amgen Inc. and Wyeth Pharmaceuticals have added a BOXED WARNING to the ENBREL US Prescribing Information (US PI) to further strengthen and clarify information regarding the risk of infections, including tuberculosis (TB) in patients taking ENBREL; namely the new recommendation to screen for latent tuberculosis infection before beginning Enbrel. The complete BOXED WARNING is as follows:
WARNING
RISK OF INFECTIONS
Infections, including serious infections leading to hospitalization or death, have been observed in patients treated with ENBREL® (see WARNINGS and ADVERSE REACTIONS). Infections have included bacterial sepsis and tuberculosis. Patients should be educated about the symptoms of infection and closely monitored for signs and symptoms of infection during and after treatment with ENBREL®. Patients who develop an infection should be evaluated for appropriate antimicrobial treatment and, in patients who develop a serious infection, ENBREL® should be discontinued.
Tuberculosis (frequently disseminated or extrapulmonary at clinical presentation) has been observed in patients receiving TNF-blocking agents, including ENBREL®. Tuberculosis may be due to reactivation of latent tuberculosis infection or to new infection. Data from clinical trials and preclinical studies suggest that the risk of reactivation of latent tuberculosis infection is lower with ENBREL® than with TNF-blocking monoclonal antibodies. Nonetheless, postmarketing cases of tuberculosis reactivation have been reported for TNF blockers, including ENBREL®. Patients should be evaluated for tuberculosis risk factors and be tested for latent tuberculosis infection prior to initiating ENBREL® and during treatment. Treatment of latent tuberculosis infection should be initiated prior to therapy with ENBREL®. Treatment of latent tuberculosis in patients with a reactive tuberculin test reduces the risk of tuberculosis reactivation in patients receiving TNF blockers. Some patients who tested negative for latent tuberculosis prior to receiving ENBREL® have developed active tuberculosis. Physicians should monitor patients receiving ENBREL® for signs and symptoms of active tuberculosis, including patients who tested negative for latent tuberculosis infection.
The ADVERSE REACTIONS: Infections section of the US PI has also been updated to include the following information: “In global clinical studies of 20,070 patients (28,308 patient-years of therapy), tuberculosis was observed in approximately 0.01% of patients. In 15,438 patients (23,524 patient-years of therapy) from clinical studies in the US and Canada, tuberculosis was observed in approximately 0.007% of patients. These studies include reports of pulmonary and extra-pulmonary tuberculosis (see WARNINGS).”
The ENBREL Patient Package Insert (PPI) is being converted to a Medication Guide. The Medication Guide is designed to provide important patient safety information and increase the awareness about the proper use of ENBREL. The Medication Guide will be distributed when a prescription for ENBREL is dispensed in the US.
A copy of the revised US PI is enclosed. Following approval by the FDA the Medication Guide will be available on Enbrel.com. We encourage you to review the full prescribing information and discuss the safety information with your patients.
To report adverse patient experiences or request further safety information on ENBREL, please contact Amgen’s Medical Information Connection™ at 1-800-77-AMGEN. Alternatively, adverse events may be reported to FDA’s MedWatch reporting system:
•
by phone (1-800-FDA-1088), by facsimile (1-800-FDA-0178),
•
online (https://www.accessdata.fda.gov/scripts/medwatch/) or
•
mailed, using the MedWatch for FDA 3500 postage paid form, to the FDA Medical Products Reporting Program, 5600 Fishers Lane, Rockville, MD 20852-9787
Sincerely,
Sean E. Harper, MD Bruce Freundlich, M.D.
Senior Vice President, Global Development Multi-Therapeutic Area Head
and Chief Medical Officer Inflammation/Musculo-
Amgen, Inc. Skeletal Diseases
Global Medical Affairs
Wyeth

"GER,

I appealed to your kinder side, to which you did not respond, so I guess you don't have one.
Again, you are spinnig your wheels...Until you can prove to me/us that Enbrel DOES NOT help in reversing symptoms of AD, you are wasting everyone's time, including your own. We proved to you Enbrel does indeed work, now you prove to us it doesn't. Show us your studies! My guess is you will not respond once again." It sounds like more people just need [url=http://www.123world.com/states/california.php]California Vacations[/url]

Ger doesn't waste my time.

[QUOTE]Originally posted by Felicia:
(I am posting this everywhere GER has posted the Amgen statement. I will be sending this letter to Amgen, in response to their recent statement regarding Enbrel, which GER has posted all around this forum. I wrote to them once, and they sent me a "pasted" statement about how there's not sufficient data, etc. I am also posting this where I feel it relevant in other forums where we have been speaking about Enbrel for Alzheimer's)


A caregiver’s response to Amgen:

Dear Sirs,

My Mom has had Alzheimer’s for 3 – 5
years (at first we thought it was “just” dementia) and I have watched her deteriorate progressively, despite the best available medical care from her neurologist and GP; not from afar, but up close, since I had my
parents move in with me 4 years ago because
of her increasing disability and because
it was getting too hard on my Dad. You may consider my Mom a case report, but she is a wonderful human being; and her improvement after being treated with the medication you own, etanercept, in a unique new way (perispinal)) developed by
Dr. Edward Tobinick, has been wonderful
and marvelous to behold. She is now able
to do things she could not or would not do before this new treatment; her normal activities of daily living are enriched and significantly better, which to me is the
best part. These observations are not just
my own, they are those of all of my family members, including my children, boys aged 19, 17 and 10. They don’t usually notice things like this, but they couldn’t help but notice Grandma’s smile and comments that had disappeared only two months earlier.

We are not alone. Our same experiences have been reported by multiple other families, in watching the daily activities of their own family members improve after beginning treatment by Dr. Tobinick.

How cruel your recent “Amgen Statement of Alzheimer’s Case Study” is. You call the
rapid effects all of our families have
observed in our loved ones “implausible”
–how dare you impugn our personal
observations, when you have never even
made the effort to see for yourself. You refuse to recognize the human benefit
which the drug that you own is having. You call us all “case studies”, we are people,
who are sharing our personal experiences
with the world.

How can you claim to be “aggressively
pursuing research to help fight grievous illnesses” when you refuse to support or initiate further study of your own drug for Alzheimer’s disease despite multiple
positive published studies and an
established scientific rationale.
Why have you ignored the fact that
multiple prestigious neurologists and scientists have recognized the promise
of Dr. Tobinick’s work with the drug
which you own? Those recognizing the
promise of this new approach to treatment include the Dana Alliance for Brain
Initiatives (see their 2007 Progress
Report on Brain Research at http://www.dana.org/news/publications/
detail.aspx?id=6620&p=4, the prestigious neurology journal Nature Clinical Practice Neurology (see their April 2008 issue at http://www.nature.com/ncpneuro/journal/
v4/n4/full/ncpneuro0763.html): and scientists from the National Institute of Health (see reference 1 below)

1.http://www.ncbi.nlm.nih.gov/pubmed/17908040?ordinalpos=3&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum

and Northwestern (see reference 2).

2.Van Eldik LJ, et. al. Glia proinflammatory cytokine upregulation as a therapeutic target for neurodegenerative diseases: function-based and target-based discovery approaches.
And recently, the Alzheimer’s Society in
the UK has called for clinical trials to
begin studying perispinal etanercept for Alzheimer’s disease.

Why do you mischaracterize the off-label treatment as experimental? The off-label
use of etanercept for the treatment of Alzheimer’s disease, as utilized to treat
my mother, is both legal and not experimental
- it involves the use of a medication the FDA has approved for treating humans, albeit for different indications. Off-label use in this way is legal, and off-label use is commonly utilized by physicians, particularly for illnesses, such as Alzheimer’s, where the existing FDA approved medications are inadequate.

Why do you mischaracterize Dr. Tobinick’s published work? His studies have all been published in peer-reviewed scientific journals, including respected journals such as Current Alzheimer Research. Why did you mischaracterize the 15 patient pilot study published by Dr. Tobinick, two-board certified neurologists, and a board-certified rheumatologist as “anecdotal evidence” or as a “case report? Why do you mischaracterize
Dr. Tobinick’s scientific presentations? He has presented his work at the 7th
International Alzheimer’s Drug Discovery Foundation Conference; at the Days of
Molecular Medicine Conference at the
Karolinska Institutet; and an abstract
of his work was at the last ICAD Conference
in Madrid (http://www.sciencedirect.com/
science?_ob=ArticleURL&_udi=B7W6D-4KBG8NV-1G9&_user=4423&_rdoc=1&_fmt=&_orig=search
&_sort=d&view=c&_acct=C000059605&_version=1
&_urlVersion=0&_userid=4423&md5=
8f7d00c668ed3af41c72ecc1209b58c2),
which is known as the largest Alzheimer’s conference in the world!

Amgen’s refusal to investigate the potential
of its own drug will be recognized as the personal failures of Kevin Sharer, its
current CEO; and of Roger Perlmutter, its current scientific director. Why does Amgen management continue to mischaracterize and distort the facts?

An “aggressive pursuit of research” would be the sponsorship of a large and proper double-blind, placebo-controlled trial of etanercept for the treatment of Alzheimer’s disease,
by independent researchers trained by Dr. Tobinick in the perispinal administration method which he invented and has continued
to use so successfully for my Mom and now
many others. To do anything less will just delay the acceptance of this extraordinary
new advance in scientific discovery, and
cost lives. Amgen cannot continue to hide behind its blatantly false “scientific” rationale. With over 3 billion dollars of
2007 revenue from etanercept sales, how can
you justify not investigating the clue which Dr. Tobinick has handed to you? The 5 million patients with Alzheimer’s disease and their families, all without a truly effective treatment, will not soon forget your
failure to investigate, and, by so doing,
your prolongation of their (and my) agony.
How can your shareholders let Amgen management continue this perversity of science? Should they have an unshakeable belief that Roger Perlmutter is always right? Or is it just possible that Mr. Perlmutter’s failure to support clinical trials of perispinal etanercept for Alzheimer’s will be seen, alongside the Amgen fiasco of anemia drugs,
as another in a series of broad and
serious miscalculations by the current
Amgen management?

Felicia[/QUOTE



Well folks. I just called a Doctor here in Florida that is at the villages of this treatment of Enbrel. It was $7000 up front with out even starting at reatment. Most people with this disease are on a fixed income.
Even if the drug cost them $200.00 We would not mind paying $250.00. To speak to the doctor T in California who started all this it is $500 just to talk. This is shameful. They know we are desperate but we can not afford $7000. I have faith in the good Lord of whatis ment to be will be. If this drugis all that they say and can do all that it claims, I am sure the maker Amgen will start doing some studies. The response when I called them and said my mom is on afix income. " this treatment is not for everybody." What does that tell you about their motives.
Olgamae
Orlando Fl

That's sad Olgamae.

Many people have researched this and are doing it on their own by reading the patent and having their own doctors administer the injection. The patent is available on the nrimed.com website. Bob Lee has a video on youtube showing how he does it for his wife at:

http://www.youtube.com/watch?v...feature=channel_page

He also has other videos showing her progress during the year.

There is a long discussion on this in the Medications and Treatments thread in this forum - The thread is called Enbrel for Alzheimer's.

I'm trying to find a doctor to prescribe the medication and give the treatment but am having no luck.

Moonie