Tuesday, January 15, 2008

Miracle Cure For Alzheimer's Disease?

Speaking of ethics, from the Bureau of Irresponsible Press Releases comes this headline:
Reversal Of Alzheimer's Symptoms Within Minutes In Human Study

ScienceDaily (Jan. 9, 2008)
— An extraordinary new scientific study, which for the first time documents marked improvement in Alzheimer’s disease within minutes of administration of a therapeutic molecule, has just been published in the Journal of Neuroinflammation.
Have any of the credulous commentators raving about this finding actually read the journal article in question? It's Open Access, so it's freely available to all when you click on a link in the Science Daily piece. Even a cursory perusal will indicate that the manuscript could not have been reviewed by anyone who follows the scientific method.
... The study focuses on one of these cytokines, tumor necrosis factor-alpha (TNF), a critical component of the brain’s immune system. Normally, TNF finely regulates the transmission of neural impulses in the brain. The authors hypothesized that elevated levels of TNF in Alzheimer’s disease interfere with this regulation. To reduce elevated TNF, the authors gave patients an injection of an anti-TNF therapeutic called etanercept [aka Enbrel, used to treat rheumatoid arthritis]. ...

The new study documents a dramatic and unprecedented therapeutic effect in an Alzheimer’s patient: improvement within minutes following delivery of perispinal etanercept, which is etanercept given by injection in the spine. Etanercept (trade name Enbrel) binds and inactivates excess TNF. Etanercept is FDA approved to treat a number of immune-mediated disorders and is used off label in the study.
Although suppressing inflammation with an anti-TNF agent may indeed be a promising treatment (e.g., Ryu & McLarnon, 2007), I think one must test its efficacy against a placebo. And what mechanism of action would mediate cognitive improvement within minutes, in a disease with complex pathology that takes years and years to develop?

The actual article (Tobinick & Gross, 2008) reads like physician's notes, not a research study or clinical trial. Here's the extent of their "immediate effect" (with absolutely no placebo condition, of course):
Ten minutes after dosing the patient was reexamined. He was noticeably calmer, less frustrated, and more attentive. He was able to correctly identify the state as California, and he identified the year as 2006. His responses to questioning seemed less effortful and more rapid, with less latency. He left for author HG's office for further testing.
See also Etanercept Improves Alzheimer's Disease In Minutes for a critical discussion of this single-case study -- including the lack of a formal research protocol, the lack of any patient selection criteria (the gentleman in question may not be a typical dementia patient), the fact that the authors patented an off-label treatment [how can they do that? was it for the perispinal route of adminstration?], and links to a video interview with family members, for starters.

References

Ryu JK, McLarnon JG. (2007). Thalidomide inhibition of perturbed vasculature and glial-derived tumor necrosis factor-alpha in an animal model of inflamed Alzheimer's disease brain. Neurobiol Dis. Sep 15; [Epub ahead of print].

Tobinick EL, Gross H. (2008). Rapid cognitive improvement in Alzheimer's disease following perispinal etanercept administration. J Neuroinflammation Jan 9;5(1):2 [Epub ahead of print].

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15 Comments:

At January 19, 2008 1:13 PM, Blogger Dave Jensen said...

Good comments -- I agree completely and nailed these guys on my blog as well. Read about it in Sham vs. Wham, thanks.

 
At January 19, 2008 1:18 PM, Blogger Dave Jensen said...

Another editorial on this topic is located at Sham vs. Wham.

 
At July 01, 2008 11:32 AM, Blogger Felicia said...

You say it needs a Controlled Double Blind study -- Exactly! That's what Dr. Tobinick has been trying to get for the last 4 years! Nobody did it, so he just kept on treating his patients. Talk about a scam, it's people like you that cause thoughts of scams, with your closed minds and thoughtless comments. Do you care for someone with AD? Do you even know how significant even a SMALL sustained improvement is? No you don't. Did you investigate the treatment and find out that it is real? No, you were quick to label it as a scan, which irresponsibly turned people away from something that can help their Loved Ones stabilize, and at least live a decent life. Think before you write, that's all I can say. Research before you turn people against something that works. My Mom has now been having the treatment for 4 months, and improved a little bit in the beginning, and is now stabilized. She can eat, drink, talk, walk and live the rest of her years with a little dignity, albeit confused a lot of the time...but smiling and laughing when she wasn't before. Recently, they have finally done some of your all important studies, and they are finding that this treatment has real potential for this horrific disease. You are not alone in your thoughts, the experts on AD didn't believe it either, but everyone keeps saying it needs investigating yet nobody did it. Why?? Don't know, but I do know Clinical Trials cost in the Hundreds of Millions of dollars. So is it about money, oh yes, no doubt there. I stress, do your homework before bagging on something, and I promise you that this is an amazing treatment.

Felicia McColl
famc17@yahoo.com

 
At July 01, 2008 2:14 PM, Blogger The Neurocritic said...

I'm not going to explain the power of the placebo effect here. You can read a short review article about it in Functional Neurology (free with registration), Brain mechanisms underlying the placebo effect in neurological disorders.

An article at the Alzheimer Research Forum states:

Controls could include injecting placebo, i.e., sterile saline, in the exact same way that etanercept is injected. This would test whether any response is due to the drug or to something else about the procedure. One reason why this is important is that patients with probable Alzheimer disease have been noted to have strong placebo effects, as occurs in other diseases. “I never fail to be dismayed at the magnitude of placebo effects in Alzheimer disease; they are remarkably large,” said Ben Barres, a professor of neurobiology and leader in glial cell research at Stanford University...

Finally the Alzheimer's Association provides a cautionary note:

...we are concerned that, in their strong desire for more effective therapies, people with Alzheimer’s and their families may place undue value on this new finding based on the dramatic language used in its description and the apparent immediate effect. Special care needs to be taken when investigating and discussing drugs already on the market in order that they are not prescribed nor made available inappropriately based on preliminary findings and/or news media coverage.

This possible treatment strategy is very preliminary. This newly published case study is of one subject. In addition, one of the lead investigators has stock in the company that produces the drug and has a number of patent positions in the area. All of this strengthens the need for independent confirmation to establish this finding.

Alzheimer's disease is a terrible thing for patients and their families, of course I realize that. Time is of the essence in developing new and effective therapies through controlled clinical trials. Many many AD patients do not have the luxury of time, unfortunately.

 
At July 03, 2008 12:35 PM, Anonymous Felicia said...

Hi again,

Did I forget to mention the "placebo effect"? Yes I did, but don't think it hasn't been investigated or researched by me and many other caregivers. First off, AD patients definitely do have good days and bad days. If a good day happens to coincide with a day they had treatment, it can construed as real or a placebo effect or just a good day. What I'm talking about here is "sustained" improvement with the Enbrel Treatment. Several of Dr. T's patients have been receiving the treatment for over 3 years and have maintained (not progressed in the disease). My Mom has been receiving the treatment for 4 months now, and is maintaining. I don't care what the "experts" say they know about placebo effect, unless they are the caregiver for someone they love and care about, they don't truly know the differences. I put up a youtube video along with a couple of other people...NOT encouraged or endorsed by Dr. T, but by other caregivers. Most people are amazed, a couple don't think there's much there. For those of us that are caregivers, we know the significance of little improvements. Since Mom's treatment, she has NEVER slipped back to where she was before the injections. Bob Lee's wife, Linda Lee (on youtube) was, and is, in the severe stage at only 51 years old. She was completely mute and couldn't hold attention for more than a few seconds at a time. Bob Lee just laughs when people say it's a placebo effect...she wasn't aware of anything and her mind isn't strong enough to have such control. She is better now, just a little, but she was recently able to tell him she loved him as he told us on a post on a message board!
Most trials have a restriction on how severe their "subjects" can be...a recent study called for an MMSE (mini mental status exam)of 15 or higher. My Mom was at a 7, Linda Lee was at a ZERO! People this low don't have placebo effects, in my opinion and many other caregivers opinions. Sometimes the experts are wrong, or just haven't seen everything yet.
Please see the videos on youtube:
http://youtube.com/user/famc17,
http://youtube.com/user/tumates
And, please see the message board full of true pros and cons written by actual caregivers:
http://alzheimers.infopop.cc/eve/forums/a/tpc/f/762104261/m/4081064272/p/33
It's a lot to take in, we started in Jan 08 and are now on page 33!

Thanks for listening, Felicia

 
At September 17, 2009 12:22 AM, Blogger Belen said...

Felicia,

My mum has Alzheimer, and have been finding info about the work at the INR, however, I don´t think there might be a chance that we could afford the treatment (even more as we live in Spain). Is there any chance that you could give us an idea of the price of the treatment or the price of the training for a doctor so the treatment could be done locally?
The results seem pretty amaizing, and when a loved one is in that situation, you really want to do all that you can for them...
Please, please let us know
Thanks
Maria

 
At September 17, 2009 12:25 AM, Blogger Belen said...

Dear Felicia,

My mum has Alzheimer, and i have been reading about the treatment at INR in Los Angeles, which seems to show some amaizing results. However, I think this treatment might be very expensive and I am not sure we will be able to afford it.
is there any chances that you could tell us how much this treatment could cost? or how much it will cost to get a doctor trained to be able to get the treatment locally (we live in Europe)?
Please, please, let us know
Thanks a lot
Belen

 
At September 17, 2009 12:31 AM, Blogger The Neurocritic said...

Belen,

You might want to contact Felicia directly, her e-mail address is famc17@yahoo.com

You might also be able to leave a comment on her YouTube videos, links listed above.

 
At October 22, 2009 11:55 AM, Blogger Belen said...

Thanks, Neurocritic, I will.
I agree with all the doubts about Dr. Tobinick´s work, and also about his morals... it is sad that someone could have some help for so many people in the world, and wouldn´t be prepared to make it easily available....
However, if there is a dim light at the end of the tunnel I want to try to reach it!

 
At November 19, 2009 10:32 PM, Anonymous Anonymous said...

I wish I could take my dad with Alzheimer's to get this treatment, but like most people I can't afford this. What I can't believe is how much this treatment costs: $800.00 per week, and you have to get this every week for the rest of your life. That's over 38 thousand dollars a year! Who can afford this except the wealthy and those like Felicia who can't afford it but sacrifice? Even Felicia says in one of her videos that her family will probably be living out of her van in the future due to this astronomical expense.

What does this say about this doctor that he charges so much? This is just another sign of how bad our healthcare system is, where doctors are more interested in profits than in lowering their prices to help more people. We need to take the profit out of healthcare, and this doctor needs to lower his prices if he really cares about helping people, which he probably doesn't or he wouldn't charge so much to begin with.

 
At May 10, 2010 9:44 PM, Anonymous Anonymous said...

It is unbelievable that someone can be so greedy when there is so much they can do to help people in crisis. I'm sure you could raise funds and get donations and still make money helping families get their lives back.

 
At November 16, 2010 8:48 PM, Blogger Janet said...

You are so wrong. But I must admit before I left Virginia to come to California to try the Perispinal Etanercept I was sure it had to be a scam also. Up to the last moment I was not sure what I was going to do. I sat in the hallway outside of Dr. Tobinick's office and I asked people as they came out if they were there for the Perispinal Etanercept and some said yes. I asked them how long they had been taking the injections and how they felt about the results. Everyone unequivocably raved about the results so I decided to go ahead and risk it. I absolutely could not believe my own eyes. The change that took place in my husband within minutes of receiving the first injection were absolutely astonishing. Prior to the injection he was enraged. He could not pick out clothes to wear nor dress himself alone. He could not be left alone for a minute for fear of what he might do next. Shortly before coming to California he filled the dishwasher with Dawn and turned our home into a white winter wonderland except that it was disastrous. As soon as we arrived in our hotel room he started taking the labels off our prescription bottles. The morning of the first treatment on our way to the Dr. he said he was going to divorce me and shove me into the railroad tracks and watch the train run over me. This is from a man who has always been so kind and gentle. He has never had a mean thought in his head before Alzheimers. He has Alzheimer's with Lewy Body disease and some Frontal Temporal damage. He is 77 years old. He had always been a very social being. Before the treatments he had reached the point he barely spoke except one word responses to questions which he usually didn't understand anyway. He had lost most of the expression on his face. His eyes sometimes would look at me as if he wasn't actually seeing me. We have been married 50 years and were very much still on our honeymoon until this horrible disease came into our lives. We hardly ever quarreled and when we did it never amounted to much. With his progression of Alzheimer's he was always angry at me because I was always reminding him to do something he did not want to do such as get dressed, brush teeth, eat, drink, go to bathroom etc. You owe it to yourself and to your readers to go in person to Dr. Tobinick's office and meet the patients whose lives he restores. Only then will you be a true believer.

 
At November 16, 2010 9:15 PM, Blogger Janet said...

You are so wrong. But I must admit before I left Virginia to come to California to try the Perispinal Etanercept I was sure it had to be a scam also. Up to the last moment I was not sure what I was going to do. I sat in the hallway outside of Dr. Tobinick's office and I asked people as they came out if they were there for the Perispinal Etanercept and some said yes. I asked them how long they had been taking the injections and how they felt about the results. Everyone unequivocably raved about the results so I decided to go ahead and risk it. I absolutely could not believe my own eyes. The change that took place in my husband within minutes of receiving the first injection were absolutely astonishing. Prior to the injection he was enraged. He could not pick out clothes to wear nor dress himself alone. He could not be left alone for a minute for fear of what he might do next. Shortly before coming to California he filled the dishwasher with Dawn and turned our home into a white winter wonderland except that it was disastrous. As soon as we arrived in our hotel room he started taking the labels off our prescription bottles. The morning of the first treatment on our way to the Dr. he said he was going to divorce me and shove me into the railroad tracks and watch the train run over me. This is from a man who has always been so kind and gentle. He has never had a mean thought in his head before Alzheimers. He has Alzheimer's with Lewy Body disease and some Frontal Temporal damage. He is 77 years old. He had always been a very social being. Before the treatments he had reached the point he barely spoke except one word responses to questions which he usually didn't understand anyway. He had lost most of the expression on his face. His eyes sometimes would look at me as if he wasn't actually seeing me. We have been married 50 years and were very much still on our honeymoon until this horrible disease came into our lives. We hardly ever quarreled and when we did it never amounted to much. With his progression of Alzheimer's he was always angry at me because I was always reminding him to do something he did not want to do such as get dressed, brush teeth, eat, drink, go to bathroom etc. Several people have eluded to the cost. Yes it is expensive but no where near as expensive as the $800.00 a week they quote here. As for treatment every week that all depends on the individual. My husband gets treatment every two weeks. One man with Lewy Body disease comes from Kenya and gets treatment once a year. Dr. Tobinick trains doctors from all over the world. There was one from Australia one day when we were there. He is begging for doctors to come there to get the training so it can be available to everyone locally. You should not listen to people who do not know what they are talking about. As for the placebo effect. That is obsurd in the case of a person with Alzheimer's. They are not capable of imagining healing. My husband has had the FDDNP PET scan done by Dr. Gary Small at the Semel Institute which is extremely accurate in diagnosing exactly what type of dementia it is. He has had the Spinal Tap for diagnosing dementia. He has had a recent MRI since we have been here He has been examined by the very best Doctors at UCLA and they have come up with an exact diagnosis based on many facts. He definitely has Alzheimer's not maybe. If it is a placebo effect which had brought him to this point in his healing then so be it. I will gladly accept his healing from whatever source God sends it. You owe it to yourself and to your readers to go in person to Dr. Tobinick's office and meet the patients whose lives he restores. Only then will you be a true believer and qualified to make judgements then report them.

 
At November 22, 2011 1:57 PM, Blogger Yery said...

Good Afternoon,

Does anyone have any idea the price on the treatment? I read on one of the comments that it is $800 a week and the patient has to have it done once a week for the rest of their lives... is this true...?

Thank you
Yery

 
At November 22, 2011 8:10 PM, Blogger Janet Beaudet said...

No that isn’t true. It isn’t that expensive. It truly is a miracle. My husband went from not recognizing me at times, not know where he was within 1 mile from home, being violently threatening to a time about 6 months prior to the treatments. While he was taking the shots he was wonderful. The only problem was eventually we could no longer afford them. I had spent many thousands of dollars on the PET SCAN that Dr. Gary Small does at the University of CA which gives 100% accurate diagnosis as to whether it is Alzheimer’s, and the spinal tap for Alzheimer’s and the conventional PET scan which is only about 60% accurate. I also took him to Dr. Mario Mendez who is a world renowned specialist on Lewy Body disease and other dementia related problems and to Dr. Yvette Bordelon who is a highly specialized Neurologist in Supranuclear Palsy and other dementias. He was tested exhaustively & had MRI s & Cat Scans. We lived in a hotel for 3 months, ate all our meals out, had a rental car and other transportation costs. Some days we paid $300.00 for the taxi to take us and wait for us for the day while my husband was treated. When we came home we flew to Florida to Dr. Richardson in Vero Beach Florida weekly and every other week as needed until Dr. Tobinick set his office up in Boca Raton, again paying for hotels, meals, as much as $300.00 for taxis. The combination of all the above is why we could no longer afford the shots. Had the shots been available locally & had we not spent so much money on airfare, hotels, meals, (we live in Virginia) then we would not have run out of money so soon. Dr. Tobinick now is in Boca Raton Florida treating stroke patients. We were in California when he began doing this. We have seen people in the waiting room unable to move, get the shot and start dancing around. He seldom spent less than 4 hours with us on any visit. He interviewed me carefully each time to see what had happened since the last shot. I had to fill out a questionnaire about my husband each time. The shots are not just randomly given every week. Each patient differs. One of his Clients is an Ambassador in South Africa and only has to come once a year. That is why Dr. Tobinick told us to stay for 3 months so he could evaluate my husband to determine what dosage & what frequency to use. Our local Neurologist who is supposed to be the best in the city said “It’s not Alzheimer’s, I don’t know what it is”. Dr. Tobinick accurately diagnosed my husband from the first day when he did the all day evaluation of him. After we had all the tests run and PET scans, and Lumbar puncture, and evaluations from world renowned specialist they all concluded exactly what Dr. Tobinick said the first day. If you are skeptical as I was do what I did. I went and sat in the hallway outside of his office and talked to patients when they came out and asked them if they were there for the Enbrell shots and everyone had the same response. They all agreed it was well worth the money. One man was 93 years old and had been receiving them for 5 years and was doing better now than 5 years ago. Everyone was blown away by the miraculous results. Once we stopped my husband declined rapidly. His last shot was August 21, 2011. At that time He could carry on a conversation, tell a joke, walk, was fully continent, knew and understood that it was our anniversary. Now he cannot finish a sentence, is totally incontinent at night and frequently in the day, does not remember what he did that same day, falls, has difficulty walking and has to have a transport chair and generally has declined unbelievably. Dr. Tobinick is a very caring person who isn’t getting rich on any of this. He is just sincerely trying to help people because his is that kind of person. His prices are no higher than any other specialists but because it is not covered by insurance it seems high when you have to pay out of pocket. God Bless You and guide you to do the right thing.
Sincerely,
Janet Beaudet

 

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