Enbrel, Alzheimer’s And A Controversial Doctor
203 CommentsBy Ed Silverman // July 1st, 2008 // 3:11 pm
Earlier this year, Amgen went out of its way to disavow a widely publicized case study that suggested Enbrel, which is only approved for treating rheumatoid arthritis and psoriasis, may be useful in combating Alzheimer’s disease.
In fact, the biotech issued successive press releases due to the single-patient case study, which was published last January by a Los Angeles physician in The Journal of Neuroinflammation and that suggested “rapid cognitive improvement” occurred in an 81-year-old patient, beginning only two hours after Enbrel was administered. The case report then noted his improvement lasted during a seven-week follow-up program that included weekly injections.
Not surprisingly, the case report generated significant media coverage (CNN and BBC) and Internet chatter, which in turn prompted some people to call Amgen directly to inquire about obtaining and using Enbrel. As a result, Amgen found itself in a dilemma – the beleaguered biotech would have happily welcomed increased sales, but the suggestion that Amgen may be somehow involved in promoting off-label use has serious regulatory implications.
And so a statement issued in January was followed by a longer and more emphatic statement this past April, in which Amgen declared it did not “support or endorse” the use of Enbrel for treating Alzheimer’s. Moreover, Amgen argued there is “insufficient and unsubstantiated scientific data to support” using Enbrel for this purpose.
While noting the “potential role” inflammation may play in Alzheimer’s, Amgen called the results “implausible,” given the speed at which improvement reportedly occurred in the single patient. The biotech also questioned the lack of “placebo-controlled data,” and noted the physician’s research was never published in a peer-reviewed medical journal. “Anecdotes,” Amgen charged, “are not sufficient scientific evidence.”
Despite the harsh words, the conundrum remains. The physician who published the case study, Ed Tobinick, continues to court the media, noting that he previously co-authored a proof-of-concept study involving 15 patients and reached the same conclusion. Meanwhile, video testimonials in which people praise his treatment have been popping up on YouTube (see below). A video can be seen on Google in which Tobinick discusses the “enormous promise” Enbrel holds. And more recently, he published in Medscape yet another case study in which a 78-year-old woman with primary progressive aphasia, a form of dementia, showed improvement 20 minutes after Enbrel was administered.
The claims have stirred controversy among neurologists and the larger Alzheimer’s universe populated by people with family members who suffer from the disease. On one hand, there is widespread acknowledgement that targeting TNF, a protein that causes inflammation, has scientific validity in combating Alzheimer’s. And, in general, case reports can also be useful in triggering further research into drug development.
But some neurologists say the methodology gives them pause. “For me, that study has gotten way too much press,” says Cynthia Lemere, associate professor of neurology at Brigham and Women’s Hospital in Boston. “None of his methods are being tested scientifically or rigorously. You have to remember that the fact someone wants something to work so badly can produce a huge placebo effect. Maybe there is some potential for this drug to work in Alzheimer’s or have some benefit in some people. But he’s making it seem like it’s a magic bullet without doing what the rest of us do.”
In a brief telephone interview, Tobinick calls the case report approach “a time-honored form of medical reporting.” He then explained that “what prompted this was the ability of the doctor to do a scientific observation never seen before. It was a fortuitious occurrence. It wasn’t really planned.
“The patient was examined by a neurologist the day before treatment and he was able to finish the consultatation that day. Then, he asked the patient to return the next day. The neurologist, by the way, was also one of the co-authors of the 2006 study. This is the way things happen in evidence-based medicine. You make the observations and report them…It’s quite unprecedented and scientifically worthy of discussion…This provided new insights into brain function and Alzheimer’s disease.”
Tobinick and his report have raised questions for other reasons, though. For one, he sits on the editorial board of the Journal of Neuroinflammation, whose editor, Sue Griffin, also offered a supportive editorial last January accompanying his case report. (”I was amazed,” she wrote). Griffin didn’t respond to messages. UPDATE: Griffin has now called us and maintains Tobinick wasn’t on the board at the time the paper was published in January, although we did notice his name in February. UPDATE: On August 4, we noted that Tobinick claims, on his web site, that he joined the editorial board in 2007. We asked Griffin for clarification.
As to the use of Enbrel to treat Alzheimer’s, she told us this: “From my point of view, a drug like that…could be helpful and this is one that has been tried. I think there is potential it may help. What I think a trial could do is let us know whether or not it works for a lot of people or only a few people, and how long it would stay effective if treatment continued.”
Tobinick also lists a UCLA e-mail address on his case report, suggesting an affiliation with UCLA. However, a UCLA spokeswoman tells us that he is only a voluntary clinical professor with UCLA’s Division of Dermatology and his practice is located in a building called UCLA Medical Plaza, which is not owned by the university. And in 2002, she adds, UCLA officials held a meeting where concerns were discussed that ads run by Tobinick - who was promoting the use of Enbrel for treating disc pain - could have been misinterpreted and led readers to believe he was affiliated with the university.
Meanwhile, Tobinick identifies himself as heading the Institute for Neurological Research. However, a spokeswoman for the Association of American Medical Colleges tells us that Tobinick is not board certified as a neurologist, although he is certified as an internist and dermatologist. A decade ago, he was actively involved in laser hair removal and his Institute of Laser Medicine is in the same building as the Institute for Neurological Research, as noted in an article on the Alzheimer’s forum.
Another issue that troubles some neurologists is that Tobinick holds several patents for administering Enbrel for neurologic conditions. As a practical matter, this means he can charge other doctors a licensing fee for using his particular method to inject Enbrel into the neck, an approach that some also question as a potential stumbling block since the drug is a large molecule and crossing the brain barrier poses a hurdle.
“I’m not going to tell you this drug and his procedure, which he has patented, doesn’t work. Sometimes, people come up with something that works despite conventional belief,” says Greg Cole, a professor of medicine and neurology at UCLA, where he is also the associate director of the UCLA Alzheimer’s Center.
“But you’d like to see somebody who doesn’t have a vested interest do a placebo-controlled trial. None of his trials have done that. My understanding is that some people don’t respond, but he doesn’t publicize these. Meanwhile, people are beating a path to his door. I’d like to see somebody who doesn’t have a conflict of interest doing this.”
When asked about further research with federal backing, Tobinick says he approached the National Institutes of Health, but without success. “I’ve had a long series of discussions with various people at the NIH and we’ve been unable to get anyone at the NIH to start testing…It’s not a single reason. Sometimes, they don’t even give a reason.” When asked for names of NIH staff with whom he met, Tobinick was unable to offer any.
As far as conducting research with Amgen, Tobinick – who holds Amgen stock and in past years has been a fixture at Amgen shareholder meetings – crticized the biotech for ignoring him. He then cited the rejection as another in a series of mistakes for which Amgen management has been widely criticzed by its investors and employees.
“Companies make mistakes,” Tobinick told us. “Certainly, there are scientists in the company who have made a lot of mistakes and a lot of people are unhappy with the direction of the company and what their scientists have done. And clearly, in my mind, this is another of their mistakes.”
As for patient costs, his office says a 30-minute in-person or telephone consultation typically runs $700, but declined to provide estimates for full treatments, other than to say insurance may not cover the treatments. Tobinick himself refused to comment. He also declined to discuss licensing arrangements with other physicians who may want to administer Enbrel.
“I’ve only agreed to talk about the science,” he maintained in our brief discussion, a stipulation we actually did not agree to before chatting. “There’s a lot of unjustified skepticism and improper attacks on me and my ideas,” he continued, before hanging up.
Tobinick has generated controversy before, though. In 2000, he was awarded patents for a method of administering Enbrel for disc-related back and neck pain, another unapproved use. And from 2000 to 2002, he advertised this method, which he called DiscCure and promoted as a “breakthrough” and an “innovative approach,” according to a complaint filed in 2006 by the Medical Board of California. At the time of the infraction, the complaint noted, there were no peer-reviewed scientific studies to provide evidence that Enbrel was effective for disc pain.
He was subsequently charged with unprofessional conduct and placed on probation, which ended earlier this year. Although in 2004, Tobinick did co-author a case-study report of 143 patients who were given Enbrel for back pain and concluded the medication “can lead to significant clinical improvement in selected patients with chronic, treatment-refractory disc-related pain…(and) may be useful for both acute and chronic disc-related pain.” As the Alzheimer’s forum article noted, however, a recent study in Anesthesiology debunked this theory.
[UPDATE: We should note that Tobinick actually authored the paper but added a colleague's name because she had connections to the journal publisher, according to a separate complaint filed in 2005 by the MBC against his colleague, Susan Davoodifar, who worked for Tobinick and helped him administer and obtain Enbrel for treating back pain. The complaint has very interesting detail, such as how Tobinick allgedly obtained Enbrel after supplies grew tight by registering 47 people, including family members, as patients with an Amgen enrollment program. The complaint against Davoodifar was resolved this year.]
The September 2006 MBC complaint against Tobinick also noted a “circumstance in mitigation,” referring to the fact that Tobinick had since published results of other uses for Enbrel but did not advertise them. There was no reference to the video testimonials on YouTube, some of which appear to have been filmed in Tobinick’s offices (check out the first one below), or his own video on Google, because these began to appear since the complaint was resolved. We wanted to ask Tobinick about the videos, but he hung up before we had the chance.
Nathan
Great reporting Ed. You were incredibly thorough. I heard of this case, but didn’t really understand the controversy behind it. This guys seems like a real entrepreneur. While I admire people with entrepreneurial spirit, it seems that sometimes they think more highly of their ideas than sound reason would suggest.
Dan
FYI: Check out Enbrel on Wikipedia. I found the story behind this bipharmaceutical quite interesting.
Ed Silverman
Hi Nathan,
Thanks for the kind words. It’s a complicated story that can take any number of turns and took me awhile to research it myself. I should note that the piece on the Alzheimer’s Research forum was quite helpful, which is why I sited it and provided the link.
Cheers
ed
Justice in MI
Closes a kind of circle for me. A few years ago, I used to visit a forum for people with “spine issues” (I have one bad back). A couple of obvious marketeers kept appearing touting (in the language quoted above) the miracles of Enbrel for such ills.
I have never seen such aggressive tactics, at least in that sort of context. They eventually got kicked off the site (no doubt moving on to a different one).
Salut.
Ger
Ed, I must congratulate you for your obvious tenacity in unravelling the many sides of Dr. Edward Lewis Tobinick (Dermatologist). I publically call upon the Medical Board of California to investigate the practices in the field of Alzheimer’s claims and treatement of Alzheimer’s patients by Dr. Edward Tobinick (Dermatologist), and his creation, The Institute for Neurological Research.
I challenge all the testimonial videos created by Dr. Tobinick at his INR clinic. I do not believe that they are authentic. These testimonial videos have generated worldwide media hype with the fallout in many cases of Doctor/Patient relationships over the Doctor’s rightfull unwillingness to entertain Dr. Tobinick’s extraordinary claims of near instantaineous benefit in the off-label use of Etanercept (Enbrel). Dr. Tobinick should be answerable for all this consternation within the Alzheimer’s community, all based on a Dermatologist’s infatuation with Etanercept (Enbrel), an anti inflammatory drug. So, let’s tick off the Tobinick Claims:
http://www.tobinick.com/bio.pdf
Disc-relate pain
Alzheimer’s disease
painful solid tumor metastasis to bone
I ask you to look at these disc testimonial videos made a few years ago, with the thought, “is this real, or could this be unreal” There are three videos at link.
Dr. Tobinick creations; Disc testimonial videos
http://www.discpainbreakthrough.com/video.html
Now, have a look at the Alzheimer’s Testimonial videos. The first features a man who cannot recognise a watch, then after injection of Etanercept (Enbrel) it is portrayed that he recognises his wife for the first time in two years. Is it me, but does the wife not have a certain family resemblance to Dr. Tobinick, maybe just me. The claims in this testimonial video have generated worldwide TV and press interest. I challenge the reality of another example of these testimonial videos, this time, for Alzheimer’s http://www.msnbc.msn.com/id/21134540/vp/24074869#24074869
This link to two more testimonial videos, featuring so called family members.
http://www.nrimed.com/AD.videos.html
This link brings us up to date with Dr. Tobinick’s latest claims in Primary Progressive Aphasia, with an accompanying video.
I ask you, the general public, do you agree with me, that the “Daughter” is behaving like a ventriliquist and it is her voice you hear, that if you look closely toward the end, you can spot a gumshield of sorts moving in her mouth as she laughs in a lighter moment. The person featured as a PPA patient may in this case be true. I say that with the benefit of the amount of research I have done on the available Tobinick created testimonial videos.
http://www.nrimed.com/PPA.WMV.htm
This present situation cannot be allowed to continue. I ask you all to do further research into Dr. Tobinick and his practices in the past and now with these extraordinary claims of near instantanious benefit with the patented “Tobinick Method” as an Alzheimer’s disease therapy.
Ger
Note to Sue Griffin
On the testimonial video as File 1 in the Tobinick paper which you edit and wrote an accompanying commentary on your experience at the clinic of Dr. Tobinick, Institute for Neurological Research. Have you ever considered the possibility that you were “Set Up”, that what you saw and heard were people acting out their roles. Sue Griffin, that is your voice near the end saying, “I was thinking, I might try this”. Sue, 24 hours from your initial call is a lot of time to get things organised. For those who wish to see testimonial video, it is to be found within the article or at File 1 link: http://www.jneuroinflammation.com/content/5/1/2
How about this for Editorial Success
http://www.jneuroinflammation.com/mostviewedalltime
Top 10 most accessed articles for last 30 days / past year / all time
1.
Accesses
57108
Case report
Rapid cognitive improvement in Alzheimer’s disease following perispinal etanercept administration
Edward L Tobinick, Hyman Gross
Journal of Neuroinflammation 2008, 5:2 (9 January 2008)
[Abstract] [Full Text] [PDF] [PubMed] [Related articles] [F1000 Biology]
2.
Accesses
27362 Commentary
Perispinal etanercept: Potential as an Alzheimer therapeutic
W Sue T Griffin
Journal of Neuroinflammation 2008, 5:3 (10 January 2008)
[Abstract] [Full Text] [PDF] [PubMed] [Related articles]
Ger
Further Note to Sue Griffin.
Why did you take the unconventional step of using the Press Office of the University of Arksansas for Medical Science (UAMS) to inform the world’s press about the Tobinick paper release in the electronic Journal of Neuroinflammation, which you, Sue Griffin are Editor in chief. I put it to you that you used this facility to add credence to the Tobinick paper, coming from the press room at UAMS. Who came up with this strategy, could it have been Dr. Tobinick.
http://www.newswise.com/articles/view/536734/
Source: University of Arkansas for Medical Sciences Released: Wed 09-Jan-2008, 09:00 ET
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Reversal of Alzheimer’s Symptoms Within Minutes
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Medical News Keywords
ALZHEIMER’S, TUMOR NECROSIS FACTOR-ALPHA(TNF), TNF-ALPHA, CYTOKINES, PERISPINAL ETANERCEPT, EDWARD TOBINICK, SUE GRIFFIN, UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES, UNIVERSITY OF CALIFORNIA LOS ANGELES, UCLA, DONALD W. REYNOLDS INSTITUTE ON AGING, UAMS,
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Description
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.
Newswise — 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.
This new study highlights the importance of certain soluble proteins, called cytokines, in Alzheimer’s disease. 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. Excess TNF-alpha has been documented in the cerebrospinal fluid of patients with Alzheimer’s.
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.
The use of anti-TNF therapeutics as a new treatment choice for many diseases, such as rheumatoid arthritis and potentially even Alzheimer’s, was recently chosen as one of the top 10 health stories of 2007 by the Harvard Health Letter.
Similarly, the Neurotechnology Industry Organization has recently selected new treatment targets revealed by neuroimmunology (such as excess TNF) as one of the top 10 Neuroscience Trends of 2007. And the Dana Alliance for Brain Initiatives has chosen the pilot study using perispinal etanercept for Alzheimer’s for inclusion and discussion in their 2007 Progress Report on Brain Research.
The lead author of the study, Edward Tobinick M.D., is an assistant clinical professor of medicine at the University of California, Los Angeles and director of the Institute for Neurological Research, a private medical group in Los Angeles. Hyman Gross, M.D., clinical professor of neurology at the University of Southern California, was co-author.
The study is accompanied by an extensive commentary by Sue Griffin, Ph.D., director of research at the Donald W. Reynolds Institute on Aging at the University of Arkansas for Medical Sciences (UAMS) in Little Rock and at the Geriatric Research and Clinical Center at the VA Hospital in Little Rock, who along with Robert Mrak, M.D., chairman of pathology at University of Toledo Medical School, are editors-in-chief of the Journal of Neuroinflammation.
Griffin and Mrak are pioneers in the field of neuroinflammation. Griffin published a landmark study in 1989 describing the association of cytokine overexpression in the brain and Alzheimer’s disease. Her research helped pave the way for the findings of the present study. Griffin has recently been selected for membership in the Dana Alliance for Brain Initiatives, a nonprofit organization of more than 200 leading neuroscientists, including ten Nobel laureates.
“It is unprecedented that we can see cognitive and behavioral improvement in a patient with established dementia within minutes of therapeutic intervention,” said Griffin. “It is imperative that the medical and scientific communities immediately undertake to further investigate and characterize the physiologic mechanisms involved. This gives all of us in Alzheimer’s research a tremendous new clue about new avenues of research, which is so exciting and so needed in the field of Alzheimer’s. Even though this report predominantly discusses a single patient, it is of significant scientific interest because of the potential insight it may give into the processes involved in the brain dysfunction of Alzheimer’s.”
While the article discusses one patient, many other patients with mild to severe
Alzheimer’s received the treatment and all have shown sustained and marked
improvement.
The new study, entitled “Rapid cognitive improvement in Alzheimer’s disease following perispinal etanercept administration,” and the accompanying commentary, entitled “Perispinal etanercept: Potential as an Alzheimer’s therapeutic,” are available on the Web site of the Journal of Neuroinflammation, at http://www.jneuroinflammation.com.
Author Hyman Gross, M.D., has no competing interests. Author Edward Tobinick, M.D. owns stock in Amgen, the manufacturer of etanercept, and has multiple issued and pending patents assigned to TACT IP LLC that describe the parenteral and perispinal use of etanercept for the treatment of Alzheimer’s disease and other neurological disorders, including, but not limited to, U.S. patents 6015557, 6177077, 6419934, 6419944, 6537549, 6982089, 7214658 and Australian patent 758523.
UAMS is the state’s only comprehensive academic health center, with five colleges, a graduate school, a medical center, six centers of excellence and a statewide network of regional centers. UAMS has 2,538 students and 733 medical residents. Its centers of excellence include the Winthrop P. Rockefeller Cancer Institute, the Jackson T. Stephens Spine & Neurosciences Institute, the Myeloma Institute for Research and Therapy, the Harvey & Bernice Jones Eye Institute, the Psychiatric Research Institute and the Donald W. Reynolds Institute on Aging. It is one of the state’s largest public employers with about 9,600 employees, including nearly 1,000 physicians who provide medical care to patients at UAMS, Arkansas Children’s Hospital, the VA Medical Center and UAMS’ Area Health Education Centers throughout the state. UAMS and its affiliates have an economic impact in Arkansas of $5 billion a year. Visit http://www.uams.edu.
Bill
Take a look at this for a rapid response:
http://www.abstractsonline.com/viewer/viewAbstract.asp?CKey={EE8D30B4-A2F3-4BF5-9B7C-032B2C10CC4C}&MKey={CFC5F7C6-CB6A-40C4-BC87-B30C9E64B1CC}&AKey={50E1744A-0C52-45B2-BF85-2A798BF24E02}&SKey={BD1757D5-7976-493C-841B-F29B2D3484D8}
Bob Lee
The lady in the second video is my wife, Linda Lee.
We have never met Dr. Tobinick, and I feel his business model has vampire roots.
We have a relationship with a local Neurologist who duplicated the procedure. It is a quite simple injection between the vertebrea C6 and C7 in the interspinous space to a depth of 1/2″ TO 3/4″ and takes just a few seconds, with the following 10 minutes Linda is in a reclining head-low position. That’s it. I cannot believe he has “licensed” doctors charging $1,100 a week for such a simple procedure.
The bottom line: Linda has seen some improvement, and has more focus and some of her “attitude” has returned. Occasionally there has been some speech, but rarely.
Linda, at 51 was in a very advanced Alzheimers stage and fully aphasic, incontinent, and needed assistance with all ADLs. She still does, bt there is a noticable difference in her personality with less of the “flattness” of AD being replaced by a ready smile and a twinkle in her eyes.
So, instead of a turnip, she is much more of a tomato.
Is it worth it?
We are continuing… she seems to be maintaining and this may buy us some time for dimebon or BAP or something else.
The AD will probably win in the end, but when you are in the middle of the situation you try to hold off the advance in as many ways as you can.
I do believe that for AD patients where conventional therapy has not stopped the decline, finding a “straight” doctor to try a series of 4 weekly Enbrel injections is a valid risk to take. (Enbrel is sold in (4) 25 mg. dose kits: a 4 week regiment.) From my experience and others posting results on the board, this should be enough to see some results or not.
If the results are evident, continued off-label usage is legal and may offer benefit. We pay about $760 a month at Walmart for 4 doses.
If you do not see results by the end of the first 4 doses, you probable never will. If you see a return of some functionality, it will be obvious to the caregivers in many ways.
So, since Enbrel is already well tolerated by about a million RA patients, and a month to try it will show results or it won’t, this is not a bad bet.
After all, Alzheimers is progressive and fatal, so far. This has worked for some.
Just stay away from the vampires.
Bob Lee
tumates@gmail.com
Justice in MI
Well conveyed, Bob. God speed to you both.
Felicia McColl
To all, I started this ealier today when there were only two comments. Ger is someone who works for a Pharma Company with a drug in direct competition with Enbrel for AD. I haven’t read his comments yet, but I hope my comment answers some of his debate. Bob Lee is my “virtual friend”, and even though he doesn’t care for Dr. T’s tactics, he does know the validity of this treatment, and I praise him for hanging in there even though Linda is so far advanced…but at least she can say “she loves him again”, which I’m sure is worth the world to him right now.
My name is Felicia McColl, and I am not affiliated in any way with Dr. Tobinick or his clinic. My Mom has been receiving this treatment for 4 months now, and after a small immediate, yes immediate improvement, continued to improve for the first few treatments and is now truly maintaining, even though she is already in the moderate stage of Alzheimer’s.
In your article, you are trying to attack Dr. Tobinick, who has treated, successfully, a considerable number of patients that I am personally aware of, including my Mom. Your article is full of mistakes, and I will address them and show you where you made your errors.
First off, Dr. Tobinick does not “court” the media. They now come to him, and he proudly talks about his patients and the treatment. The media took it on themselves to say “Reverses Alzheimer’s In Minutes”, to catch the public eye. Of course, they caught my eye that way too, and I’m glad they did. The media focused on one patient, but the study was based on 15 patients, the one they focused on being part of that study…not a different study. All patients, 100%, showed sustained improvement over 6 months. The efficacy and safety was easily shown in this preliminary study.
What Amgen charged as “Anecdotes”, and “not sufficient scientific evidence”, is why we needed a Double-blind Clinical Trial sponsored by them. Clinical trials of this sort cost in the hundreds of millions of dollars, Dr. Tobinick does not have that kind of money, Amgen does. They chose not to do the study, it apparently wasn’t in their best financial interest.
I was one of those who wrote to Amgen, offering them to do their own study on my Mom, all I received from them was a “form” letter stating their stand on the treatment. They never even investigated this, which is why it never received the recognition it deserved. I later sent them an even stronger letter, and received no response whatsoever. You state that Amgen said the research was never published in a peer reviewed journal…wrong again:
JNI, Current Alzheimer Research, and Medscape General Medicine are all peer-reviewed:
Tobinick E. Perispinal etanercept for treatment of Alzheimer’s disease. Curr Alzheimer Res 2007 Dec; 4(5):550-2.
Tobinick EL, Gross H. Rapid cognitive improvement in Alzheimer’s disease following perispinal etanercept administration. J Neuroinflammation 2008 Jan 9; 5(1):2.
Tobinick E, Gross H, Weinberger A, et al. TNF-alpha Modulation for Treatment of Alzheimer’s Disease: A 6-Month Pilot Study. MedGenMed 2006; 8(2):25.
Also, his work has been presented at appropriate medical and scientific meetings:
Dr. Tobinick’s presentation at the 7th International Alzheimer’s Drug Discovery Conference: http://www.bentham.org/car/contabs/editorial%204-5/ CAR%204-5%20-%20Editorial.doc.pdf
Dr. Tobinick’s presentation at the Best Practices in the Continuum of Care: Advances in Alzheimer’s Disease Management, speaking at this conference also were speakers from UCSF, Northwestern University, and Samuel Gandy, MD, Scientific Chair of the Alzheimer’s Association, along with Dr. Tobinick: see:
http://www.agec.org/programs/conferences/BP_Alzheimers/schedule.asp
About the youtube videos. Dr. Tobinick had nothing to do with putting them up on youtube himself, and he did not ask us to do it. In fact, he didn’t even know about the one I put up till he saw it himself on youtube. On an Alzheimer’s Message Board (http://alzheimers.infopop.cc/eve/forums?a=tpc&s=387101241&f=762104261&m=4081064272&r=3951059013#3951059013), we caregivers were talking about this since the media coverage in Jan 2008. Bob Lee first put up a before video of his wife, hoping that he would be able to get her the treatment. He then asked me to please put up some videos of Mom. I had taken shots of her before the treatment, anticipating and hoping for some improvement. Bob asked if Dr. T took any videos, saying that we should be allowed to have access to them. Dr. T gave Leo’s wife a copy of the videos done at his office. He has one of my Mom too. He did not initiate any of these youtube videos.
In another paragraph, you quote “some neurologists”. They say he’s doing it different then the rest of them do! Well, that is because he couldn’t get anyone to take notice doing it “their way”, and he did not want to quit, he knew this was too important.
Dr. Tobinick does head the INR, it is his clinic. When I called, they never said they were affiliated with UCLA, just that they are in the Medical Building. In early January, the University proudly listed him as an employee in their paper, since he is a volunteer professor. He also NEVER said he was a neurologist, some media people said that carelessly in their reporting. And, as you stated in your article, Greg Cole from UCLA now does not deny it “may” work. Earlier this year, some UCLA associates flat out said it was “false hope”…they can no longer say that.
The other issues you bring up are Dr. Tobinick’s patents. Patents do NOT stop trials. There is no reason Dr. T shouldn’t have a patent to protect his interests on this treatment. It’s up to him whether he wants to charge doctors or not for the training, but with all the controversy, and with all the time, money and energy he’s invested in his research, he deserves some monetary benefits.
You say Dr. Tobinick was “unable” to offer names of who he spoke to at the NIH. You know he’s not going to “bad mouth” anyone in particular when he is hoping for their approval. By the way, the NIA/NIH has just come out with a study where in their conclusion they verified what Dr. Tobinick had said about TNF years ago, and gave him credit - no longer “implausible” as Amgen stated:
http://www.abstractsonline.com/viewer/viewAbstract.asp?CKey={EE8D30B4-A2F3-4BF5-9B7C-032B2C10CC4C}&MKey={CFC5F7C6-CB6A-40C4-BC87-B30C9E64B1CC}&AKey={50E1744A-0C52-45B2-BF85-2A798BF24E02}&SKey={BD1757D5-7976-493C-841B-F29B2D3484D8}
Conclusions:
Our findings reveal rapid, nSmase-mediated, effects of TNF on the function of two types of glutamate receptors that regulate hippocampal synaptic plasticity, and provide a potential explanation for the recently reported rapid improvement in cognitive function of AD patients treated with a TNF inhibitor (Tobnick and Gross, J Neuroinflammation 2008 Jan 9;5:2).
Disclosures: Y. Wang, None.
This is going to be presented at ICAD 2008:
Presentation Number: P4-266
Poster Board Number: P4-266
Presentation Time: 7/30/2008 12:30:00 PM
Title: Modification of synaptic plasticity by TNF and sphingomyelinase: Implications for cognitive impairment in AD
Category: Molecular Mechanisms of Neurodegeneration Synpatic disruption
Author(s): Yue Wang, NIA/NIH, Baltimore, MD, USA. Contact e-mail: wangyu@grc.nia.nih.gov
In yet another paragraph, you state that a study in Anesthesiology debunked his treatment for refractory disc-related pain. The Anesthesiology study consisted of using 1/100th of the dose of etanercept that Dr. Tobinick used in his treatment, and, they did it “Intradiscal”, which is completely different from “extrathecal” which Dr. Tobinick’s treatment calls for. They are not even comparable! Also, Dr. Tobinick was never put on probation, all charges were dropped or suspended, and his back-pain treatment helped over 3000 people. Oh yeah, and at EULAR 2008, a study came up with this conclusion:
OP-0261 THE EFFICACY AND SAFETY OF CAUDAL EPIDURAL INJECTION WITH THE TNF-ALPHA ANTAGONIST, ETANERCEPT, IN PATIENTS WITH DISC-HERNIATION-INDUCED SCIATICA. RESULTS OF A RANDOMIZED, CONTROLLED , 1-MONTH FOLLOW-UP STUDY.
Conclusion: The results of this randomized study support that caudal epidural injection of ETN(Etanercept) for lumbar ridiculer pain in patients with disc herniation-induced sciatica is efficacy and safety, is potential to be quick recovery from the pain.
I hope I covered everything. Dr. Tobinick may have not done things in the conventional manner, but that is only because he was met by such controversy and refused to stop, for the sake of his patients, who Amgen call Anectodal Evidence, aka: my Beautiful Mom! This is NOT a placebo effect — some patients have maintained for over 3 years with weekly injections…my Mom, 4 months and counting!
Sincerely, Felicia McColl
famc17 [ ] yahoo.com
Cherie
Since January I’ve read thousands of news articles and blog entries about Dr. Tobinick’s use of Enbrel as a tool in fighting Alzheimer’s. Countless people have questioned his results but no one has run a study in neutral territory. Is this some type of a joke?
Does the scientific community have a combined IQ of about 50? We’re not talking about a procedure that requires the intelligence of a rocket scientist…This is something that an RN could accomplish.
Could the hold up be that Amgen afraid that a study (and/or clinical trial) will yield additional health warnings for Enbrel?
How about some tangible effort instead of useless words????
Ger
Bob Lee is right, this testimonial video is not a creation of Dr. Tobinick. I presume it appeared here as the video is based on “Linda” who is being treated by an unknown doctor in the off-label use of Etanercept (Enbrel) for Alzheimer’s disese. I would ask people to separate the “Linda” video from all the other testimonial videos, which are the creation of Dr. Tobinick (Dermatologist),at his clinic at Institute for Neurological Research
Felicia McColl
I have a video up too, which was not done at Dr. Tobinick’s office. Just go to youtube and search Enbrel for Alzheimer’s. The video of Leo was done at his office, like he does with many of his patients. He was obligated to furnish Leo with the video at their request. Dr. Tobinick had nothing to do with us putting up our videos, showing our excitement about this treatment. Bob Lee started it before he even was able to get the treatment for Linda, hoping and anticipating the results. He encouraged me to put one up of my Mom, knowing I had taken videos of her before the treatment too.
Dr. T has now trained over 10 doctors across the country, and one in England. We’re moving along, hoping for approval so insurance will help pay for the treatments and make it available to everyone. A study has just been completed by the NIA/NIH where they have concluded that this is indeed plausible! This is going to be presented at the ICAD 2008, Presentation Number: P4-266:
Conclusions: Our findings reveal rapid, nSmase-mediated, effects of TNF on the function of two types of glutamate receptors that regulate hippocampal synaptic plasticity, and provide a potential explanation for the recently reported rapid improvement in cognitive function of AD patients treated with a TNF inhibitor (Tobnick and Gross, J Neuroinflammation 2008 Jan 9;5:2).
Disclosures: Y. Wang, None.
Felicia
Ger
Dr. Edward Tobinick (Dermatologist)was the principal author of these papers making extraordinary claims in the off-label use of Etanercept (Enbrel) as a therapeutic in Alzheimer’s disease. The full data of this 6-month pilot studies in 2006, have never been disclosed for public scrutiny. All we have is this electronic online journal from MedGenMed. Where’s the real data Dr.Tobinick, have you any real data from this 6-month study, Dr. Tobinick. A patient died on this trial, why was there no autopsy. Did you report this SAE to the FDA or appropriate regulatory body. To all, I say, what you read in papers authored by Dr. Tobinick, such as the two provided here are works without any scientific analysis. Dr. Edward Tobinick (Dermatologist) has no credibility. Dr. Edward Tobinick’s papers do not stand up to proper scrutiny.
Read the comments by Paul Aisen in Alzfourum
This is only a part of the fallout caused by Dr. Edward Tobinick (Dermatologist)
To make matters worse, those who do take the initiative to find out about medical research can find themselves misguided, said Paul Aisen, who directs the Alzheimer’s Disease Cooperative Study (ADCS) at the University of California, San Diego. “I think too many people have the idea that scientists make a discovery, the media covers it, and then people rush out to get the treatment. That’s not the process,” he told this reporter, citing a recent case report touting apparent therapeutic effects of an FDA-approved arthritis drug in a single California patient with probable AD (Tobinick and Gross, 2008). Upon publication in the January 9 Journal of Neuroinflammation, the presumed anti-AD effects of the drug (etanercept), a tumor necrosis factor α blocker marketed under the name Enbrel, were hyped by the media, Aisen said (see ARF related news story). “Every clinician I know in the field was inundated with questions that wasted time, interfered with patient-doctor relationships, and were quite damaging,” Aisen said. “People were flying out to California to get that treatment.”
I say, enough is enough. The Alzheimer’s Research community have a policy of allowing researchers to submit hypothesis for consideration. They will have gone through the conventional routes in labs clincal trils etc. What we have here is a Dermatologist with no experience in Neuroscience, coming out with extraordinay claims of rapid improvement in his patened “Tobinick Method”. The generosity or innocence of the Alzheimer research community was fertile ground for an outsider (Dermatologist), to come in from the blue, breaking every known convention, ends up attracting worldwided TV, Press coverage, and finds his papers being quoted in respected Journals, and given a certain amount of status on the basis, that their may be something in the Dr. Tobinick claims. Dr. Tobinick has found himself presenting at Alzheimer’s conference amongst some of the genuine best there is in Alzheimer’s research. How long more will the leadership in the Alzhemer’s Community allow this to continue. What does it take for people to wake up and deal with this problem.
I call on the leadership in Alzheimers and The Medical Board of California to act immediately to put a halt to this charade, and to protect the Alzheimer’s patients from further exploitation.
Here are the two papers on Alzheimer’s, author, Dr. Edward Lewis Tobinick (Dermatologist)
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1785182
MedGenMed. 2006; 8(2): 25.
Published online 2006 April 26. PMCID: PMC1785182
copyright ©2006 Medscape
TNF-alpha Modulation for Treatment of Alzheimer’s Disease: A 6-Month Pilot Study
Edward Tobinick, MD, Assistant Clinical Professor of Medicine, Hyman Gross, MD, Clinical Professor of Neurology, Alan Weinberger, MD, Associate Clinical Professor of Medicine/Rheumatology, and Hart Cohen, MD, FRCPC, Associate Clinical Professor of Medicine/Neurology
Edward Tobinick, University of California, Los Angeles. Email: etmd@ucla.edu.
http://www.jneuroinflammation.com/content/5/1/2
Rapid cognitive improvement in Alzheimer’s disease following perispinal etanercept administration
Edward L Tobinick1,2 and Hyman Gross1,2
1Department of Medicine, Institute for Neurological Research, a private medical group, inc., Los Angeles, USA
2Department of Neurology, USC School of Medicine, Los Angeles, USA
author email corresponding author email
Journal of Neuroinflammation 2008, 5:2doi:10.1186/1742-2094-5-2
The electronic version of this article is the complete one and can be found online at: http://www.jneuroinflammation.com/content/5/1/2
Received: 29 November 2007
Accepted: 9 January 2008
Published: 9 January 2008
scs
Congratulations on your article. As a retired health care professional with a husband who has AD, I am eager for any intervention that will slow or reverse the symptoms of Alzheimers.
I also believe that the Enbrel claims are encouraging but require further academic scrutiny. Until that is accomplished, what can we do to ensure that vulnerable patients and families are protected from losing their life savings. The costs associated with the “Enbrel off label franchise” are reprehensible. Calling them vampires is too nice.
Ger have you contacted the California Medical Board?
Whatever we can do to get the message out to protect families is our moral obligation.
AMountainClimber
The only difference between the Pros and Cons in this issue is Actual Experience (pejoratively labeled ‘anecdotal’) vs. Conventional Training.
I suppose acupuncture was similarly debunked at one time in Western Medicine.
In any event, the debunkers in this case are those who have NEVER WITNESSED OR EXPERIENCED the almost immediate positive effects of perispinal enbrel injections for Alzheimer’s victims. They are so certain that their training confers all knowledge, that they have been drained of the curiosity or possibility that there still might be inexplicable phenomena.
I have actual experience. My wonderful husband has regained cognition and skills that had been lost prior to the injections. I can’t explain it — but it doesn’t matter that I can’t explain it. I can say, however, that it works.
Ger
KCAL9 TV http://cbs2.com/video/ featured two presentations around March 2008. The majority of the content was the creation of Dr. Tobinick. The rest were small inserts made by KCAL9 TV and it’s presenter Kaj. These presentations featured “Elmer” portrayed as a veteran world war ii pilot, with his flight cap on. In these presentations, a caption comes up: Dr Edward Tobinick, Neurologist. In the presentations we also find Kaj the journalist refer to Dr. Tobinick, Neurologist. At the end, the presenter Kaj informs us that Dr Tobinick’s drug is not an experimental drug, that it is through the FDA as we speak. All these statements are wrong. Dr. Tobinick is a dermatologist, not a neurologist. So, who got it wrong, the caption writer, then the journalist Kaj, or did Dr. Tobinick supply the wrong information. The two KCAL9 TV Alzheimer presentations featuring “Elmer” have been withdrawn after my concerns were drawn to one of it’s editors.
Ger
I challenge authenticity in all the testimonial videos created at Dr. Edward Tobinick’s (dermatologist) clinic, Institute for Neurological Research. They are shameless in their exploitation of one of the most vulnerable people in our society, the Alzheimer’s community. In the original article by Ed Silverman, the first video is a creation from Dr. Tobinick’s clinic. The second you tube featuring “Linda” is not by Tobinick. I have posted links to other Tobinick testimonial videos, in earlier comments
Ger
Felicia states in earlier comment: To all, I started this ealier today when there were only two comments. Ger is someone who works for a Pharma Company with a drug in direct competition with Enbrel for AD. I haven’t read his comments yet, but I hope my comment answers some of his debate.
Let me be quite clear. I do not work for a pharma company. You don’t appear to be very good on facts. Dr. Tobinick does not “court” publicity. So the worldwide publicity he received with the release of his extraordinary claims in the off-label use of Etanercept (Enbrel) in Alzheimer’s disease, helped by Sue Griffin at her place of employment the Universtiy of Arkansas press room with worldwide coverage. Then to boost the paper we find testimonial videos created by Tobinick popping up on TV stations around the world. Not bad for a person who does not “court” publicity. And may I say, on this front, Felicia, you never fail to be the mouthpiece for all things Tobinick. Dr. Edward Lewis Tobinick, Dermatologist, ABRACADABRA man.
Ger
Drug Repositioning Summit: Finding New Routes to Success
October 6-7, 2008
Hyatt Harborside
Boston, Massachusetts
http://www.healthtech.com/rjv/overview.aspx?c=525
Drug Repositioning Summit - Day 1
Monday, October 6, 2008
Drug Repositioning Summit
KEYNOTE PRESENTATIONS:
Repurposing of Enbrel for Alzheimer’s Disease
Edward Tobinick, M.D., Assistant Clinical Professor of Medicine at the University of California, Los Angeles and Director of the Institute for Neurological Research
Keynote Presentation
1:35 Repurposing of Enbrel for Alzheimer’s Disease
Edward Tobinick, M.D., Assistant Clinical Professor of Medicine, University of California, Los Angeles and Director, Institute for Neurological Research
Etanercept, a biologic anti-TNF fusion protein, received FDA-approval at the end of 1998 for the treatment of rheumatoid arthritis, and was subsequently FDA-approved for the treatment of psoriasis, ankylosing spondylitis, and additional forms of arthritis. In 2006, at a time when the amyloid hypothesis dominated the thinking of the Alzheimer community, a pilot study, using a novel form of administration of etanercept, suggested an entirely new field of use for this class of anti-TNF agents. The pilot study documented sustained clinical improvement through six months in 15 patients with probable Alzheimer’s disease ranging in severity from mild to severe, utilizing a novel form of perispinal administration of etanercept. In 2008, there are further reports of rapid improvement, beginning within minutes, in patients with severe dementia treated with perispinal etanercept. As the inventor of this repurposed use of etanercept, I will review how this paradigm shift occurred.
[ and you thought I was kidding ]
Felicia McColl
Hi Ger,
Thanks again for putting up the work that Dr. T has been doing, and for courting publicity with it here in this blog!
Also, you never denied the Pharma fact before, so I stand corrected! I’m glad you don’t work for them…but you still have never told us exactly what your interest is in all of this.
Oh, did you check out the Message Board today? Another successful Enbrel treatment has come up…it’s like magic! And my Mom says “Hi” as she walked out the door today with my Dad as chipper and happy as ever…Thank God for Enbrel!
Felicia
Felicia McColl
Oh NO! I just saw that a lot of my posts came up –DUPLICATES!! SORRY!! They wouldn’t go through last night, and I kept trying…now they’re all over the place!
Oooops! I publicly give permission for the Blog Administrator to delete the duplicates, Sorry!
Felicia
Ger
Ed, just catching up with the update. This is fascinating reading. This is what real journalism is all about, a service to the public. Congratulations.
Now, So, Dr. Edward Tobinick (dermatologist) was the single author of the disc pain study of 143 persons, and addes on Davoodifar as co-author. I am not surprised.
Then we come to this link featured in story:
“The complaint has some very interesting reading.”
It is full of the cunning exploits of ABRACADABRA MAN - Dr. Edward Tobinick (dermatologist). I urge you all to read the full document contained at this link. It is astonishing. Here is an extract from Medical Board of California document:
Near end of 2000, Tobinick learned that because prescription of Enbrel could not meet demand, current Enbrel users were required to register with the “Enbrel Enrollment Program” in order to have their prescriptions filled; and, further, that prospective Enbrel users were required to add their names to the “Prospective Patient List” in order to obtain Enbrel if and when the medication became available. Tobinick then registered or caused to be registered 47 individuals, including his brother, other members of his family, and himself, who were not patients, in the Enbrel Enrollment Program as current patients being treated with Enbrel and, further, listed INR’s address as the delivery site for the Enbrel prescriptions. Most, if not all, of the individuals whose names were registered or caused to be registered by Tobinick were not current users of Enbrel and almost none suffered from rhematoid arthritis or other diseaseor medical condition for which Enbrel was an approved treatment.
Monthly, between January and November 2002, Tobinic ordered, through Campus Pharmacy, located in the same building as INR, eight vials of Enbrel in the name of each of the 47 individuals he falsely and fraudulently registered with the Enbrel Enrollment Program as current Enbrel users. However, during an audit of Tobinick’s facilities conducted by Medical Board of California investigators in November 2002, Tobinick falsely reported that he obtained his supply of Enbrel from local pharmacies which had overstocked the drug.
By registering, and obtaining supplies of Enbrel in the names of individuals who were not then current Enbrel users or sufferers from rheumatoid arthritis or other diseases or medical condition for which Enbrel was an approved treatment who were obtaining relief with Enbrel and for whom Enbrel had been appropriately prescribed. On or about and during September and October 2002, Tobinick obtained 712 vials of Enbrel, enough medication to treat seven patients with rheumatoid arthritis for and entire year, from a single pharmacy.
Ed, once again, great story, great links. I urge the leaders in the Alzeimer community along with the Medical Board of California to investigate the Alzheimer’s claims and practices of Dr Edward Tobinick, and to take the appropriate action to protect the Alzheimer’s community from any further exploitation.
Bob Lee
Ger;
You certainly spend a lot of time trying to convince people that Enbrel is just an impossible treatment for AD.
The fact of the matter is that for some people it is working in noticable ways.
It made a differance in Linda, and I know of many others where improvement was significant.
Instead of trying to debunk the reports of well meaning people with firsthand experience, why don’t you spend some time researching why it works for some AD patients.
That said, I am in complete disagreement with the mode of business Dr. Tobinick employs.
Since the procedure is a simple injection, people do not need to be involved with his practice to try Enbrel for Alzheimers.
Several private unaffiliated doctors are now performing the interspinous injections for their patients and as the results dictate, more will follow.
When a patient compares risk with inevitable decline towards severe AD, there is every incentive to use more aggressive treatment.
Bob Lee
Bob Lee
I just spoke with Sabrina from NY. She is a caregiver to her 81 yo Mom with AD. She just posted her Mom’s response after the first Enbrel injection given by her private doctor who is not affiliated with Dr. T.
Quote from Alzheimers Assn. Forum:
______________________________________________
Hello everybody,
My name is Sabrina and my mother 81 years old and has alzhemeir’s last 7 years. She rapidly declined last 2 years, she didn’t recognize me or identify any objects.I have been sole caregiver last 5 years because of that I had to quit my job.Because she would needed me 24 hours. I have been following this forum long time. My mother was calling me her mother, or sister,sometimes her student. By the way she was a retired teacher. She also design dresses when she was young. Every object for my mom was a dress.
My biggest inspiration was Bob&Linda Lee.
I spoke to our private doctor he agreed to do the enbrel shots for my mom after I showed him Linda’s and Felicia’s videos. I am also very grateful to Bob Lee to help me to get my doctor convinced to give the injections. first enbrel injection was june 30, so since then my doctor and myself was amazed my mother remembered me as her daughter, se remembered long time friends and her brothers and she became very happy. She has changed without telling me she goes to bathroom,i was shocked. she still makes mistakes sometimes says wrong words but she started talking more sensible. She became more aware and curios of her environment. She used to not interested in anything except she would want her dresses but she would even think that her blanket was a dress. I am so grateful to Bob Lee for his help and inspiration to direct me right way and also our doctor helping agreed to do the injections.I am very thankful to them both. God bless them. My mother’s improvement was like miracle for me and our doctor. our doctor was doing this injection so he wasnot certain of the outcome but injection was easy he said ‘this is simple’ but holding my mother’s head down wasn’t successful. my mother was very angry to me because she wouldn’t wanted to stay her head down. She was biting my hands and arm. Raising her head. I still have bruises on my arms and hands.But it was all worth it to see My angel mother’s improvements..I am very excited about the next injection.
god bless you all….
Sabrina
____________________________________________
Dr. Wang from NIH has recently confirmed a scientific basis for the rapidity of the reported Enbrel response. The link to this was posted above by Bill on 7/1.
In spite of the shady past of Dr. T, and the sky is falling predictions of Ger, AD patients are seeing an improvement with Enbrel.
My recommendation is to avoid Dr. T and his hyper-expensive treatment and find a trusted local doctor for a short 4 dose test on your AD patient. It will be obvious what your next steps will be based on your specific results.
Last year 40% of ALL prescriptions were for off-label use. I wonder why.
Ger
Do you see anything similiar with these extraordinary claims by Dr. Tobinick in the off-label use of Etanercept, it was for treatment-refactory pain due to bone metastasis. The date: August 2003
1: Clin Ther. 2003 Aug;25(8):2279-88. Links
Targeted etanercept for treatment-refractory pain due to bone metastasis: two case reports.Tobinick EL.
Institute for Neurological Research, Los Angeles, California 90095, USA. etmd@ucla.edu
BACKGROUND: Parallel bodies of research suggest both a central role for osteoclasts in tumor-induced destruction of bone and the ability of biologic tumor necrosis factor-alpha (TNF-alpha) antagonists to attenuate the osteoclast-mediated bone destruction that accompanies a variety of nonmalignant disorders. Additional studies have implicated TNF-alpha in the promotion of osteoclast-mediated malignant osteolysis and the pathogenesis of neuropathic pain. TNF-alpha antagonists have the potential to interfere in both processes. OBJECTIVE: This article reviews the cases of 2 patients with treatment-refractory pain due to cancer metastases to bone who were given targeted injections of the biologic anti-TNF agent etanercept based on its potential to interfere directly with both malignant activation of osteoclasts and neuropathic pain. METHODS: One patient had a diagnosis of non-small cell lung cancer and the other had a diagnosis of breast cancer. Both presented with treatment-refractory pain due to bone metastases. The 2 patients received etanercept 25 mg by targeted SC injection in anatomic proximity to the site of spinal metastasis for relief of their treatment-refractory pain. RESULTS: Both patients experienced rapid, substantial, and sustained relief of chronic refractory pain at the treatment site after targeted administration of etanercept. Symptomatic improvement was correlated with objective measures of improvement, including weight gain in 1 patient and decreased uptake of radioactive tracer at the targeted site on positron emission tomography in the other. CONCLUSIONS: Etanercept delivered by targeted SC injection may be of clinical benefit in selected patients with treatment-refractory pain caused by bone metastases. Clinical trials are needed to define the potential benefit of biologic TNF-alpha antagonists in the treatment and prevention of malignant osteolysis.
PMID: 14512134 [PubMed - indexed for MEDLINE]
Ger
What about these extraordinary claims by Dr. Tobinick in the off-label use of Etanercept (Enbrel), this time it was for discogenic neck pain. Date: April 2003
1: Clin Ther. 2003 Apr;25(4):1211-8. Links
Targeted etanercept for discogenic neck pain: uncontrolled, open-label results in two adults.Tobinick EL.
Institute Research Associates, A Medical Group, Inc., Los Angeles, California 90095, USA. etmd@ucla.edu
BACKGROUND: Etanercept, a recombinant biologic anti-tumor necrosis factor (TNF)-alpha therapeutic, is approved for the treatment of certain autoimmune arthritides by subcutaneous (SC) injection. TNF-alpha has been suggested to play a central role in neuropathic pain and neuronal damage associated with intervertebral disc herniation. Directed local administration of etanercept, in anatomic proximity to the site of disc and neuronal abnormality, may result in an enhanced therapeutic response. OBJECTIVE: This study reviews findings from 2 patients with chronic, severe, discogenic cervical pain who were treated with a targeted cervical injection of etanercept with the objective of obtaining relief from their treatment-resistant pain. METHODS: In this uncontrolled, open-label study, the case histories of 2 patients (1 woman and 1 man) presenting with a history of chronic neck pain refractory to various treatments are reviewed. Both patients were treated with etanercept 25 mg by SC injection to the cervical region (case 1) or the posterior neck overlying the spine (case 2). RESULTS: Both patients experienced almost complete pain relief as assessed subjectively. In case 1, the Oswestry score decreased from 58 before treatment to 6 one day following treatment. In addition, 1 day after treatment the patient reported a subjective assessment of 98% pain improvement, 100% sensory improvement, and 100% weakness improvement. She has remained asymptomatic for >1 year. In case 2, the Oswestry score decreased from 44 before treatment to 4 two months after treatment. The patient reported 100% pain relief and 90% sensory improvement 1 day after treatment. At 8-month follow-up, pain improvement continued to be 100% and sensory improvements was 75%. CONCLUSIONS: Etanercept, delivered by targeted SC injection, may be of benefit for selected patients with resistant pain associated with cervical disc disease. Further study of this new treatment modality is warranted.
PMID: 12809967 [PubMed - indexed for MEDLINE]
Ger
This time we have the paper which is attributed to Dr Tobinick and Dr. Davoodifar. We all know now, that this paper was written solely by Dr. Tobinick
1: Swiss Med Wkly. 2003 Mar 22;133(11-12):170-7. Links
Perispinal TNF-alpha inhibition for discogenic pain.Tobinick EL, Britschgi-Davoodifar S.
Institute for Neurological Research, Los Angeles, California, USA. etmd@ucla.edu
OBJECTIVE: To examine the potential of etanercept, a biological inhibitor of tumour necrosis factor-alpha (TNF), delivered by perispinal administration, for the treatment of pain associated with intervertebral disc disease. METHODS: Charts from 20 selected patients treated at our private clinic by perispinal delivery of etanercept 25 mg for severe, chronic, treatment-resistant discogenic pain were reviewed. Therapeutic benefit was assessed clinically and was documented by changes in a validated pain instrument, the Oswestry Disability Index. The patients were treated off-label with etanercept as part of our usual practice of medicine. Five detailed case reports are presented, including three additional patients. RESULTS: Rapid, substantial and sustained clinical pain reduction was documented in this selected group of patients. The cohort of 20 patients had a mean age of 56.5 and mean duration of pain of 116 months. Nine of the patients had undergone previous spinal surgery; 17 had received an epidural steroid injection or injections (mean 3.2). This group of patients received a mean of 1.8 doses (range 1-5, median 1.0) of etanercept during the observation period. The mean length of follow-up was 230 days. Clinical improvement was confirmed by a decrease in the calculated Oswestry Disability Index from a mean of 54.85 +/- 12.5 at baseline, improving to 17.2 +/- 15.3 (p <0.003) at 24 days and ending at 9.8 +/- 13 (p <0.003) at 230 days. CONCLUSIONS: TNF inhibition by etanercept delivered by perispinal administration may offer clinical benefit for patients with chronic, treatment-resistant discogenic pain. Further study of this new treatment modality is warranted.
PMID: 12715286 [PubMed - indexed for MEDLINE]
Ger
Wikipeida profile of Dr. Edward Tobinick.
How many patients over the years have been treated for these various conditions. In the meantime, the leaders in research are prepared to find Dr. Tobinick’s extraordinary claims as “interesting”, but will require clinical trials. To The Medical Board of California and the relevant medical research bodies; Is it not time to call this man’s bluff. Ger
****************************************
Edward Tobinick
From Wikipedia, the free encyclopedia
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Edward Lewis Tobinick is an American physician currently in full-time private practice in Los Angeles, California and he is an Assistant Clinical Professor of Medicine at the David Geffen School of Medicine at UCLA.[1] Dr. Tobinick is co-author of the recent case report documenting rapid clinical improvement in a patient with Alzheimer’s disease following perispinal administration of etanercept[2] which has been received with considerable interest[3][4].
Tobinick has been issued patents for methods of perispinal administration, of certain recombinant DNA-derived (biologic) therapeutics including the TNF receptor fusion protein etanercept, for the treatment of certain neurologic disorders with widespread unmet medical need, including Alzheimer’s disease; pain due to cancer metastasis to bone; severe, intractable, intervertebral disc-related pain and radiculopathy (including sciatica); and myasthenia gravis.[5] In addition, he originated the concept of the potential utility of etanercept, alone or in combination with oseltamivir for treatment of influenza (U.S. patent 6,419,934, filed September 5, 2000 [1]). For these novel treatment methods he has been issued multiple U.S. patents, including 6,015,557 (Tumor necrosis factor antagonists for the treatment of neurological disorders) [2]; 6,177,077 [3]; 6,419,934 [4]; and 6,982,089 [5]. In general, his concepts represent emerging therapeutic strategies supported by small pilot studies and expert reviews. (see 2007 Citations, below). [6]
Tobinick earned his M.D. from the UC San Diego School of Medicine in 1977.
Jim Witte
Cynthia Lemere, associate professor of neurology: “None of his methods are being tested scientifically or rigorously .. Maybe there is some potential for this drug to work in Alzheimer’s or have some benefit in some people.”
Well Ms. Lemere, *you’re* a medical professional, why don’t you do the placebo-controlled study you just outlined? Good god - I read about stuff in the wacky world of alternative “evidence-based” autism treatment (the “evidence” being recovering kids - but that doesn’t count!) and I see the same thing..
Chelation is controversial, although parents claim that it can work. because it’s controversial, it can’t possibly work, and thus we’re note going to do studies on it. Because we don’t do studies on it, it remains controversial, and there is no chance to show whether it “possibly works” or not. What part of Catch-22 don’t these idiots understand??!!
Same thing with B6/Magnesium treatment, HBOT, Low Dose Naltrexone, etc etc etc.
I pray for the future of the human species.. Especially since we’re going to be giving statins to 6 year olds.. What happens when they get a “sudden muscle weakness” in gym class in 3rd grade? I really hope the Co-Q10 depletion doesn’t interfere with pubertal growth of muscles. Or that such grown doesn’t demand too much energy which the mitochondria can’t provide because Co-Q10 is in the electron transport chain.. Continual, low level muscle weakness.. On the upside, it might mean the kids will be having less sex! (No sense in actually *teaching* kids how to have sex responsibly. Or to NOT have sex responsibly - sometimes (most at that age) not having it is the most responsible thing of all. But we never give them the chance.. No trust..)
Ger
Jim Witte, I put it back to you, why should a “real” Neurology expert be asked to accept at face value the claims of Dr. Edward Tobinick, a dermatologist, who in recent years was peddling the off-label use of Etanercept for disc related pain, making extraordinary claims on paper and using testimonial videos created of instant benefits, the same Dr. Tobinick who has just finished a year’s probation served on him by his license holder, The Medical Board of California. I think you owe Cynthia Lemere an apology. Ger
Researcher Bio
Cynthia A. Lemere, Ph.D. Associate Professor of Neurology at Harvard Medical School and an Associate Neuroscientist at Brigham & Women’s Hospital in the Center for Neurologic Diseases (CND). She has been an active participant in the research field of Alzheimer’s disease (AD) for more than sixteen years. Dr. Lemere received her B.A. from Mount Holyoke College, her M.S. in Neurobiology from State University of New York at Albany, and her Ph.D. in Pathology from Boston University School of Medicine. Her thesis research, conducted in the laboratory of Dr. Dennis Selkoe at the CND, focused on mechanisms of ß-amyloid generation and deposition in Alzheimer’s disease and models thereof, particularly in Down syndrome. During her years as Postdoctoral Fellow and Instructor at the CND, her research focused on the role of inflammation in Alzheimer’s disease. In particular, these studies involved examining brain tissue from APP transgenic mice, a transgenic or genetically-engineered mouse model of AD, and Down syndrome to examine the temporal accrual of amyloid-associated inflammatory proteins, such as complement protein, in relation to Aß deposition, gliosis and neuritic changes. In addition, she collaborated with scientists in Medellin, Colombia, to confirm in vivo that which was already known in vitro, that mutations in the presenilin 1 gene lead to overproduction of Aß42.
In 1997, she founded an independent laboratory at the CND and continued her research on the role of inflammation in AD by examining strategies for reducing amyloid ß-protein (Aß) protein, cerebral deposits of which are a key feature of AD, and its resultant inflammation in the AD brain. Her results showed that chronic nasal immunization with Aß peptide in APP transgenic mice led to anti-Aß antibody production and a lowering of the Aß burden in the brain. Dr. Lemere and her colleagues have optimized various treatment protocols in non-transgenic mice and then employed them to lower cerebral Aß levels in APP transgenic mice. In addition to pursuing the mechanism of these effects, much of her laboratory’s work focuses on the humoral and cellular immune responses to Aß immunization in APP tg mice and in non-human primates. Recently, her lab completed a 10 month Aß immunization trial in Caribbean vervet monkeys and found a lowering of Aß protein in both CSF and brain.
Other projects in her laboratory have involved examining the temporal appearance of both intraneuronal Aß and P25 (the regulatory subunit for cdk5) in Down syndrome brain, characterization of a-synuclein following traumatic brain injury and characterization of sonic hedgehog in aged human control and AD brain.
Cherie
Ger—I believe that we caregivers are owed an apology by Amgen (I believe that they are the only ones that can apply to the FDA for a clinical trial) and the medical community associated with Alzheimer’s research for their inaction in checking out the value of Enbrel as a tool in fighting Alzheimer’s. If you are correct in your opinion that Dr Tobinick’s results are false…It should be easy and relatively inexpensive to prove it useless.
Until more evidence is amassed…I suggest that people heed the advice of Bob Lee from his post that you appear to have buried by your technical mumbo-jumbo:
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“My recommendation is to avoid Dr. T and his hyper-expensive treatment and find a trusted local doctor for a short 4 dose test on your AD patient. It will be obvious what your next steps will be based on your specific results.
Last year 40% of ALL prescriptions were for off-label use. I wonder why.
———————————————–
Ger
Dictionary: Anecdotal, refers to evidence based on reports of specific individual cases rather than controlled clinical trials
Cherie, I refer you to the Amgen statement on this matter. Apr. 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 http://www.enbrel.com.
****************************************
Anecdotal refers to evidence based on reports of specific individual cases rather than controlled clinical trials. All the anectotes come from Dr. Edward Tobinick, dermatologist and his clinic, with the implicit or complicit support of Sue Griffin, editor in chief Journal of Neuroinflammation who published Dr. Tobinick’s claims with an accompanying commentary of exhuberant support for the Tobinick claims, the same Sue Griffin, who, thru her work affiliations at UAMS, took the inappropriate steps in facilitating the maximum worldwide exposure on the release of the Tobinick claims, by using the press offices of the University of Arksansas for Medical Sciences and the UAMS logo as a header for authenticity. UAMS, had nothing to do with the Tobinick claims, so should not have been associated in any shape or form. This lies squarely at the desk of Sue Griffin, who abused her position as a faculty member of UAMS.
http://www.newswise.com/articles/view/536734/
A little bit of a historical note on Dr Edward Tobinick (dermatologist)
Photolysis HR threatens legal action
On 6 December 2001, a lawyer for Photolysis HR sent me a letter threatening legal action for making comments critical of certain promotional claims on their website.
December 6, 2001
BY LETTER AND EMAIL
Ms. Andrea James
P.O. Box 13217
Chicago , IL 60613
PERSONAL AND CONFIDENTIAL
NOT FOR PUBLICATION
Re: Our File: IRA 9.0-001
Charge of Defamation, Slander and Libel
Dear Ms. James:
We are counsel to Institute Research Associates, A Medical Group, Inc., and the Institute of Laser Medicine. This correspondence relates to information present on http://www.hairfacts.com (hereafter “your web site” or “your web pages”), which has just come to our client’s attention. None of the content of this communication should be construed to limit any of the rights of my client to pursue any and all legal remedies for any damages directly or indirectly caused by your improper actions, including Attorney’s fees, compensatory damages, punitive damages, and Court costs. This communication constitutes notice of the improper and illegal content of your web site, and your failure to act immediately to remedy the defects discussed below shall be considered to be evidence of your negligence and intent to harm my client’s interests.
On the web pages present on your web site you have made false, incorrect, and inaccurate statements regarding the Institute of Laser Medicine, PHOTOLYSIS HR®, and Edward Tobinick, M.D.. These false, inaccurate, and misleading statements have caused damage to the professional reputation of my clients, and the continued presence of these statements on your web site will produce further damages. Additionally, these false, inaccurate, and misleading statements have damaged the medical practices of my clients, and their continued presence on your web site will produce further damages.
On your web site you have acknowledged that your web site has “authoritative tone”. This is correct, and makes the false and misleading statements present on your web site even more damaging. Additionally, you have acknowledged that your web site is linked to other more authoritative web sites.
Your mistakes, enumerated elsewhere in this communication, are not excused by your acknowledgment on your web site that: “It contains opinions, sweeping generalizations, and at least one mistake. The author is not a medical doctor, and makes no claim or warranty as to the suitability of the information in this document for application to any particular individual. You, the reader, take sole responsibility for interpretation and application of this information.” In fact, the foregoing constitutes an admission on your part that your web site has mistakes.
You are aware of and have listed four (4) of the United States Patents that have been awarded to Dr. Tobinick in the laser hair removal field. These patents grant Dr. Tobinick the exclusive right to use these patented and unique methods to treat patients, which he has licensed exclusively to the Institute of Laser Medicine. In view of this it is clear that statements that you refer to as “hype” such as “available exclusively at the Institute of Laser Medicine” and “There is not a comparable facility anywhere else in the world” are in fact completely accurate. Thus, your characterization of these and other statements of my clients as “hype” (hyperbole), is false, inaccurate, misleading, and damaging. Further, you have investigated these patents and you therefore are aware of their content which is contrary to the false statements you have made on your web site. Thus, your statements are intentionally false and malicious, and must be removed immediately.
Additionally your web pages include quotations attributed to my client’s web sites which are not currently present on the web sites. Some of these statements were taken from old material, written in 1997, which was long ago updated. Please review the current web sites of my clients and correct these many mistakes.
Your characterization of Dr. Tobinick as a physician/salesman is also false, inaccurate, misleading, and damaging to his reputation and the reputation of his medical practices. Dr. Tobinick is a Professor of Medicine, a physician who has won praise and award for his medical teaching. He is a respected and well known co-author of a highly regarded medical textbook; a medical researcher; a Fellow of the American Academy of Dermatology, a Fellow of the American Society for Laser Medicine and Surgery, and is Board-Certified in two different specialties. Since this information is available on my client’s web sites and through other readily accessible public sources, you must have been aware of my client’s true qualifications. Therefore, your characterization of my client is intentionally false and malicious, and must be removed immediately.
PHOTOLYSIS HR is a registered trademark which refers to the patented and unique methods and techniques used by the Institute of Laser Medicine for laser and pulsed light removal of unwanted hair. The patented and unique techniques of PHOTOLYSIS HR do indeed offer unparalleled clinical advantages. Institute Research Associates, A Medical Group, Inc., stands behind each and every statement made on the web sites of the Institute of Laser Medicine. These statements are true and correct, and there is absolutely no basis for your false assertion that these statements constitute “hype.” In view of your knowledge of the four (4) patents granted covering the PHOTOLYSIS HR techniques, your characterization of PHOTOLYSIS HR is intentionally false and malicious and must be removed immediately.
The statements on your web site are not correct, are not substantiated, and you have no qualifications for making such assertions. You are not a medical doctor, and you have no training in our client’s patented laser techniques. There is no evidence that you are trained in optics, or thermodynamics, or laser physics. The Institute of Laser Medicine has an unmatched record of safety, and has conducted over 30,000 laser treatments. Thus, you have no medical or scientific training to support your false assertions and your false unsubstantiated accusations of “hype.”
In view of the above, we must demand the immediate removal of all false, incorrect and misleading statements regarding methods covered by PHOTOLYSIS HR, Institute of Laser Medicine, Dr. Tobinick, and all other associated entities that are present on your web site, http://www.hairfacts.com, or any other web pages which you have authored or control. We also demand immediate acknowledgment that you have complied with this demand, including the date and time when this was accomplished.
Further, we note that you are generating revenue from your web site, and you are illegally damaging my client’s business and reputation to generate such revenues. Thus, your motives and practices are questionable at best.
Lastly, in order to reach a satisfactory settlement without litigation, the following information will be necessary:
The date when this information was placed on your web site;
The number of visitors whom you estimate have viewed this information, and your method for calculating same;
Your professional qualifications in science or medicine, if any;
Your affiliation with any medical or electrolysis practice which is in competition with the Institute of Laser Medicine;
Dates of your visits to the Institute of Laser Medicine, if any;
Your source of reliable medical information concerning the Institute of Laser Medicine, if any;
Your willingness to issue a retraction regarding the false information on your web site; and,
Your willingness or unwillingness to enter into settlement discussions regarding your ability to compensate the Institute of Laser Medicine for the above damages and legal fees incurred as a result of your illegal actions.
Failure to promptly reply to this communication will leave my clients with no alternative other than to file suit in Federal Court for injunctive relief to remove the web site, compensatory damages, punitive damages, attorney’s fees, and Court costs. The lawsuit will include claims for intentional and malicious defamation, disparagement, slander, slander per se, and libel per se, among other claims.
Yours truly,
EZRA SUTTON
ES/kn
Below is my response:
December 10, 2001
Mr. Ezra Sutton
Ezra Sutton, P.A.
Plaza 9
900 Route 9
Woodbridge, NJ 07095
VIA CERTIFIED MAIL
Mr. Sutton:
I am in receipt of your letter dated December 6, 2001. In it, you take issue with certain statements on my website hairfacts.com about your client Institute Research Associates, A Medical Group, Inc./Institute of Laser Medicine (hereafter ILM). You characterize some of my statements as “improper and illegal,” as well as as “false,” “incorrect,” “inaccurate,” “misleading,” “damaging,” “intentionally false,” “malicious,” “not correct,” and “not substantiated,” among other things. You also threaten me with a SLAPP suit unless I meet several demands.
I strive to present factual data on hairfacts. I will address complaints specified in your letter in the order presented. If after reading my response, you feel I failed to address a specific complaint, please provide a list of any statements which you feel match your characterizations listed above. Please accompany each disputed statement with your corrections, and I will address them as warranted.
ILM makes numerous claims which I characterize as “hype” and which legally constitute puffery, or exaggerated advertising, blustering, and boasting upon which no reasonable buyer would rely. It’s not illegal to make these kinds of overblown claims. Puffery that ILM is the “finest facility” offering “unparalleled quality” can’t really be challenged legally. However, claims such as “overwhelming first choice” and “there is not a comparable facility anywhere else in the world” might require substantiation if challenged. I would like to see the data that substantiates claims that Photolysis HR® offers “unparalleled clinical advantages” and that “the skin itself is unaffected.” I suspect these last two move beyond puffery into actionable claims.
Obviously, Dr. Tobinick is a physician and a salesman as I state. He has an M.D. and is clearly involved in the promotion and sale of treatment with his trademarked Photolysis HR® procedure. I’m certain Dr. Tobinick receives considerable revenue from Photolysis HR® treatments sold by himself and employees of ILM.
Although the trademarked Photolysis HR® procedure is indeed “available exclusively at the Institute of Laser Medicine,” multiple-pulse hair removal using light is widely available. As mentioned previously, I am not aware of any comparative published clinical data demonstrating Photolysis HR® has greater safety or efficacy over other methods of multiple-pulsed hair removal using light.
The only ILM quotation appearing on my site that sems to have been removed from the ILM site is that Photolysis HR® has the “ability to treat hair of all colors.” This false and misleading statement appeared on the ILM site at the time I wrote my analysis in October 2001. I will note on my site that this fraudulent claim was removed from the ILM site in November 2001. I will also note that ILM has removed the comparison chart in which it appeared and has replaced the original contents of that page with other promotional material.
Although I am under no obligation to do so, I am voluntarily answering your list of nine questions. The information was placed on my web site in October 2001 in response to a reader inquiry. At the time of this writing, the number of visitors to my ILM analysis page was 666, based on the counter on that page. I have no financial connection with any medical or electrolysis practice which is in competition with ILM. My expert qualifications are in the field of advertising, and I have limited my comments to ILM’s advertising practices. In light of your threats, I will be adding further comments on ILM’s promotional claims of efficacy and use of misleading “before and after” photos. I have not visited ILM. My sources of information are the claims made on ILM promotional websites. I am willing to issue a retraction if warranted, and I am willing to settle any dispute in court if necessary.
Since I have answered your nine questions, I’ve made a list of four questions I would like ILM to supply me or add to their promotional site, so consumers are less likely to be misled:
1. The manufacturer(s) and model(s) of the IPL hair removal device(s) used by ILM
2. The manufacturer(s) and model(s) of the laser hair removal device(s) used by ILM
3. Published clinical data substantiating that Photolysis HR® is safer and more effective than other types of multiple-pulse light-based hair removal treatments.
4. Specific data omitted from misleading labeling on “before and after” photos:
Patient sex, age, Fitzpatrick skin type, hair color in area treated, device make and model used, fluence(s) used
Name of practitioner who performed treatment
Date of first treatment, final treatment, and total number of treatments.
Amount of permanent hair reduction one year after final treatment: client estimate and physician estimate
Photo of treated area one year after final treatment
Statement whether results shown in each photo is typical
I hope I have responded to all of your concerns, and I look forward to ILM’s response to my four questions.
Sincerely,
Andrea James
hairfacts.com
Cherie
Ger—Back again. Brevity has never been your strong point….but…You are out-doing yourself here. Can’t figure out what you are trying to accomplish or what is in it for you.
I’ve come to the conclusion that your goal here is to bury facts, and the opinions of others.
Research continually is showing that Enbrel has potential as a tool in fighting Alzheimer’s. Yue Wang (one of a group of scientists at the NIA/NIH (National Institute on Aging/National Institutes of Health) did a study to find out if Etanercept could be of value as a treatment for A/D and came to the following conclusion:
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“Our findings reveal rapid, nSmase-mediated, effects of TNF on the function of two types of glutamate receptors that regulate hippocampal synaptic plasticity, and provide a potential explanation for the recently reported rapid improvement in cognitive function of AD patients treated with a TNF inhibitor (Tobnick and Gross, J Neuroinflammation 2008 Jan 9;5:2).”
ICAD 2008 Presentation Number P4-266
The full abstract is available at:
http://www.abstractsonline.com/viewer/viewAbstract.asp?CKey={EE8D30B4-A2F3-4BF5-9B7C-032B2C10CC4C}&MKey={CFC5F7C6-CB6A-40C4-BC87-B30C9E64B1CC}&AKey={50E1744A-0C52-45B2-BF85-2A798BF24E02}&SKey={BD1757D5-7976-493C-841B-F29B2D3484D8}
———————————–
In my opinion Dr. Tobinick is a person who was in the right place at the right time (there are probably not a whole lot of individuals with both RA and AD) and was smart enough to recognize that something unusual was taking place. It is unfortunate that since 1999 he appears to have spent more time and money obtaining procedural patents and attempting to establish a network to extract exorbitant amounts of money from individuals with AD and their loved ones than he has substantiating his claims. Rumor has is that the New York City in network doctor is charging an up-front fee of $9,000 and $1,000 per weekly injection.
Time is running out for my loved one. Within the next 12 months I will take the following advice of Bill Lee and hit the streets in search of an out of network physician.
—————
“My recommendation is to avoid Dr. T and his hyper-expensive treatment and find a trusted local doctor for a short 4 dose test on your AD patient. It will be obvious what your next steps will be based on your specific results.
Last year 40% of ALL prescriptions were for off-label use. I wonder why.”
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There will be no worry about a placebo effect…My partner feels that he has a little memory problem and I’ll make up a reason for the injection. If he can remember what he had for dinner after the dishes have been cleared and playing pool at the club 10 minutes after the game, I guess that we’ll join the ever growing group of individuals being dismissed as examples of anecdotal evidence.
If any of you care to visit us we can be found on the Alzheimer’s Association forum.
Ger
Cherie, you state; In my opinion Dr. Tobinick is a person who was in the right place at the right time (there are probably not a whole lot of individuals with both RA and AD) and was smart enough to recognize that something unusual was taking place.
All materials to be presented at the Alzheimer’s Association 2008 International Conference on Alzheimer’s Disease (ICAD 2008) are embargoed for publication and broadcast until the date and time of presentation at ICAD 2008, unless the Alzheimer’s Association provides written notice of change of date/time in advance.
Cherie, Dr. Tobinick, dermatologist, was smart enough in past years, this time it was oncology. You can fool some people some of the time, but you can’t fool all the people, all of the time.
************************************
Tobinick Files Oncology: Clin Ther 2003 Aug
Targeted anti-TNF modulation for treatment-refractory pain due to bone metastasis
Title Targeted etanercept for treatment-refractory pain due to bone metastasis: two case reports.
Author(s) Tobinick EL
Institution Institute for Neurological Research, a private medical group, inc. Los Angeles, California 90095, USA.
Source Clin Ther 2003 Aug; 25(8) :2279-88.
MeSH Aged
Anti-Inflammatory Agents, Non-Steroidal
Bone Neoplasms
Humans
Immunoglobulin G
Injections, Subcutaneous
Male
Middle Aged
Pain, Intractable
Receptors, Tumor Necrosis Factor
Treatment Outcome
Tumor Necrosis Factor-alpha
Abstract BACKGROUND: Parallel bodies of research suggest both a central role for osteoclasts in tumor-induced destruction of bone and the ability of biologic tumor necrosis factor-alpha (TNF-alpha) antagonists to attenuate the osteoclast-mediated bone destruction that accompanies a variety of nonmalignant disorders. Additional studies have implicated TNF-alpha in the promotion of osteoclast-mediated malignant osteolysis and the pathogenesis of neuropathic pain. TNF-alpha antagonists have the potential to interfere in both processes.
OBJECTIVE: This article reviews the cases of 2 patients with treatment-refractory pain due to cancer metastases to bone who were given targeted injections of the biologic anti-TNF agent etanercept based on its potential to interfere directly with both malignant activation of osteoclasts and neuropathic pain.
METHODS: One patient had a diagnosis of non-small cell lung cancer and the other had a diagnosis of breast cancer. Both presented with treatment-refractory pain due to bone metastases. The 2 patients received etanercept 25 mg by targeted SC injection in anatomic proximity to the site of spinal metastasis for relief of their treatment-refractory pain.
RESULTS: Both patients experienced rapid, substantial, and sustained relief of chronic refractory pain at the treatment site after targeted administration of etanercept. Symptomatic improvement was correlated with objective measures of improvement, including weight gain in 1 patient and decreased uptake of radioactive tracer at the targeted site on positron emission tomography in the other.
CONCLUSIONS: Etanercept delivered by targeted SC injection may be of clinical benefit in selected patients with treatment-refractory pain caused by bone metastases. Clinical trials are needed to define the potential benefit of biologic TNF-alpha antagonists in the treatment and prevention of malignant osteolysis.
Language eng
Pub Type(s) Case Reports
Journal Article
PubMed ID 14512134
(Note: Perispinal etanercept for back pain and sciatica is an off-label use which was developed at the Institute for Neurological Research® (INR®), a private medical group, inc. in Los Angeles. This use is neither sponsored by nor endorsed by UCLA. Rather, it is a patented method which is licensed solely to the INR®. The relevant patents include, but are not limited to, U.S. patents 6,015,557; 6,177,077; 6,419,934; 6,419,944; 6,537,549; and 6,982,089, all issued to Edward Tobinick, MD).
Ger
The Tobinick Dermatologist Files:
Discogenic Neck Pain, April 2003
Extraordinary claims yet again……Ger
You have to see this disc pain testimonial, of a so called patient treated with the off-label use of Etanercept (Enbrel) under by Dr. Tobinick dermatologist at his clinic. The testimonial videos are the creation of Dr. Edward Tobinick at his clinic. A healty skeptism at all times is advised when watching these testimonial videos of treatments, so called patients, so called carers and family members. I regard all the testimonial videos created by Dr. Edward Tobinick at his clinic as duplicitious. Try not to laugh at the clock: http://www.discpainbreakthrough.com/real.video1.html
Targeted anti-TNF modulation for discogenic neck pain
Title Targeted etanercept for discogenic neck pain: uncontrolled, open-label results in two adults.
Author(s) Tobinick EL
Institution Institute Research Associates, A Medical Group, Inc., Los Angeles, California 90095, USA.
Source Clin Ther 2003 Apr; 25(4) :1211-8.
MeSH Anti-Inflammatory Agents, Non-Steroidal
Cervical Vertebrae
Female
Humans
Immunoglobulin G
Injections, Subcutaneous
Intervertebral Disk Displacement
Male
Middle Aged
Neck Pain
Receptors, Tumor Necrosis Factor
Recombinant Proteins
Abstract BACKGROUND: Etanercept, a recombinant biologic anti-tumor necrosis factor (TNF)-alpha therapeutic, is approved for the treatment of certain autoimmune arthritides by subcutaneous (SC) injection. TNF-alpha has been suggested to play a central role in neuropathic pain and neuronal damage associated with intervertebral disc herniation. Directed local administration of etanercept, in anatomic proximity to the site of disc and neuronal abnormality, may result in an enhanced therapeutic response.
OBJECTIVE: This study reviews findings from 2 patients with chronic, severe, discogenic cervical pain who were treated with a targeted cervical injection of etanercept with the objective of obtaining relief from their treatment-resistant pain.
METHODS: In this uncontrolled, open-label study, the case histories of 2 patients (1 woman and 1 man) presenting with a history of chronic neck pain refractory to various treatments are reviewed. Both patients were treated with etanercept 25 mg by SC injection to the cervical region (case 1) or the posterior neck overlying the spine (case 2).
RESULTS: Both patients experienced almost complete pain relief as assessed subjectively. In case 1, the Oswestry score decreased from 58 before treatment to 6 one day following treatment. In addition, 1 day after treatment the patient reported a subjective assessment of 98% pain improvement, 100% sensory improvement, and 100% weakness improvement. She has remained asymptomatic for >1 year. In case 2, the Oswestry score decreased from 44 before treatment to 4 two months after treatment. The patient reported 100% pain relief and 90% sensory improvement 1 day after treatment. At 8-month follow-up, pain improvement continued to be 100% and sensory improvements was 75%.
CONCLUSIONS: Etanercept, delivered by targeted SC injection, may be of benefit for selected patients with resistant pain associated with cervical disc disease. Further study of this new treatment modality is warranted.
Language eng
Pub Type(s) Case Reports
Journal Article
PubMed ID 12809967
(Note: Perispina