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