You be the judge. Tell me if I am right or wrong to have written the following letter to the two researchers behind a huge press release that went out today. I don't think it does anyone any good to have sensational headlines attached to press releases like this. Here's my letter to Dr's Tobinick and Gross:
As an Alzheimer's caregiver for a loved one, I must tell you that sensationalized press releases of the kind that went out today ("Reversal of Alzheimer's Symptoms Within Minutes") are not only damaging to families, but they are unethical.
You have allowed the University of Arkansas to publish something that reads as if a cure for the disease is right around the corner. There should have been a statement in that press release that describes the "real world" effect and timing of your work. The headline should have been cranked down significantly from the sensational and misleading one that was used.
This, gentlemen, appears to be a sham. While your work is real and quite meaningful, you have allowed it to be packaged and sold in a manner that doesn't do credit to your science.
David Jensen
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Headline: Reversal of Alzheimers Symptoms Within Minutes
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 www.uams.edu.
I believe that it is important to ask "Is this appropriate?" when sending a press release out to the media as the example above. I can only assume that the motivation for this release came from the University of Arkansas, which may have been looking for some kind of publicity. Others may see a more sinister connection between the lead author and the commercial company which licenses his work.
Either way, I believe the way it was packaged was inappropriate and unclear, both of which put this wonderful science into the "sham" category for many readers. I have called and written the UAMS and given them the opportunity to respond here.
Dave
15 comments:
Dave, I think this letter is spot-on. There is a thin line between hope and hype, and the way this whole study is framed is irresponsible and misleading, and, as you point out, grossly unfair to those of us directly or indirectly affected by dementia. Thought you might like to know about a book that I've co-authored with Dr Peter Whitehouse, a neurologist at Case western Reserve University called "The Myth of Alzheimer's: What you aren't being told about today's most dreaded diagnosis" (St Martin's Press). We critique the over-exaggerations that are all-too-common in the field, and try to offer a truer source of hope for readers (focusing on prevention and caregiving). Here is a link to a press release from CWRU http://blog.case.edu/case-news/2008/01/09/alzheimersbook. If you'd like to check out our website, it's www.themythofalzheimers.com, and my email is dgeorge2844@gmail.com.
Again, thanks for your candid response to the latest "research breakthrough"
take care Dave,
Danny
Dave: Danny is correct. That thin line, that single letter between HOPE & HYPE has predictable consequences when misued. When that line is irresponsibly crossed, as it certainly seems to have been here, important such terms as "breakthrough" or "groundbreaking" become meaningless.
With recent evidence-based findings confirming that hope does, in fact, spring "internal", it's a shame or even wrong to cavalierly offer these words of hype to those listening so intently for any sounds of immediate hope.
Please keep up your good work.
Roger
P.S. for Danny: Your book has been the discussion point for the past two evenings. Looking fwd to reading.
I am furious about this situation. It appears that there is indeed a treatment that provides excellent results for at least some people. I have already written Dr. Tobinick who has patented this process and asked him how things would be if the first physician who did an appendectomy had "patented" the process. My mother has Alzheimer's and my father died from it - I do not need to describe the suffering to you. I am about to move my mother to assisted living, and it is going to be an enormous stress - I miss being able to talk to her very much.
It appears that these doctors have manipulated catheters and timing in such a way as to deliver etarnacept to the venous system of the brain and let it sit there for awhile. I cannot remember any other such methodology being patented. Now specific devices to deliver medication more conveniently have been patented, but the skill of placing a catheter or the place to put it? None of this makes sense.
How can UCLA permit such nonscientific "advertising?" If there is real science behind this methodology, and if the methodology works well for some, then keeping it secret and allowing it to be done only in a special clinic in Los Angeles on a (surely very expensive) weekly schedule should be criminalized.
As a physician who read this article, not realizing how corrupt the whole process was in this case, I was enthused and naive enough to write the authors and ask if they thought a neuroradiologist or an interventional radiologist might be the best person to attempt the procedure. I figured the methodology was published - although this would be considered experiemental, off label uses of medications are entirely legal, and I believed such an injection by any qualified physician would be entirely legal - I still believe so - of course my response was from a PR person telling me how I could call the information number for the clinic and, of course, that the treatment was unfortunately available only in Los Angeles.
You are right to complain, not only about the wild headlines, but about the entire commercialization of cures for deadly diseases. Regarding the reply to your post by Evelyn, I disagree. We CAN and MUST do something about it. Allowing medical treatments by physicians to be patented and thus withheld from large numbers of people who need them is anathema. We must let doctors who do this know what we think of them. We must demand the availability of every legal and useful treatment to every patient when that treatment may be lifesaving (as this one could be - saving the thinking process is saving life!) We must demand that our representatives STOP the blatant and overwhelming commercialization of medicine. The ownership of gene sequences has gotten incredibly out of hand, for example.
So yes, say something, and by all means DO SOMETHING. In particular, write to these selfish and heartless physicians in Los Angeles and to the dean of UCLA and let them know that we believe their process, their patents, their "sham" science (as you so rightly call it, Dave)- that we believe the whole concept and practice to be unethical, cruel, illegal, and deserving of the disdain of their colleagues. We should also encourage other physicians who find treatments that will help their patients to ignore these patents and to take chances to make sure that treatments are available to those who need them.
I totally agree with your analysis, the press releases were terribly irresponsible. I wrote about that and the actual journal article in my neuroscience blog: Miracle Cure for Alzheimer's Disease?
Dave, The whole Kaboodle is a sham. There is presently (but not for long) a void in meaningfull therapies for Alzheimer's disease patients. This continues to be fertile ground for sham therapies. I invite you all to read the full article, don't forget to watch the testimonial film of nearest and dearest, badly spliced together, then again everything about this stinks. http://www.jneuroinflammation.com/content/5/1/2#+B22.
Full marks go to Alzforum.org for exposing these shamateurs for what they are, pure carpetbaggers
Snug, hate to burst your enthusiasm for Alzforum, but I posted my exposé nearly a week before they did. They took their clue from an unlisted "blogger" and didn't even show my name or allow me to post a comment afterwards,
Dave
Dave, I bow to your record. Thanks for the opportunity vent my feelings towards these charlatans.
Dave, reading your letter to the authors Tobinick and Gross, gives these Bozo's gravitas they do not deserve. I invite you to research Tobinick's Insitute for Neurological Research http://www.nrimed.com/index1.html
Please review the history of disease treatments with Etanercept, under what he terms are self patented methods. There is nothing ethical in their practices, but exploitation of the vulnerable who may have run out of FDA licenced indications for their condition, and out of any other alternatives, turn to these kind of people, who mask themselves with integrity thru the obvious sub standard of certain Medical Journals and their peer reviewers. They should be held up to the greatest scrutiny and blackballed from Neurological practice, research, submission of further papers for consideration in Medical Journals. Dave, I would appreciate your review of Tobinick's Institute, also the role of Sue Griffin, editor in chief of Journal of Neuroinflamation, where this paper appears and the link that this same Sue Griffin, happens to be on the staff of University of Arkansas, where you so rightly remarked on the initial release of the PR which made such fantastic claims, and would expect to surface from the usual sources, not a University. Sue Griffin's accompanying commentary in the issue of Journal of Neuroinflamation as well as her comments in the paper are hysterical. Dave, I invite you to research Tobinick & cabal and see can you surprise me with more on Tobinick the dermatologist.s
Dave, read your post in Alzforum. This story is not over!
I am very interested in the results of Dr. Tobinick, as my wife Linda has EOAD and is severely affected at 51, with speech all but gone, but physically trim and healthy. We want to try this too, as we have little to lose at this late stage. I am less interested in his business methods than the possibility that he stumbled onto something that will help.
The INR website as well as several articles reference Dr. Tobinick teaching others to use his patented techniques. I have no information about any others performing this technique. We live in the Northeast between Boston and Providence with excellent medical facilities in our region. It would be much less disruptive for Linda to have treatment available in the region. To go to Dr. Tobinick’s INR clinic for treatment involves moving to LA for many weeks of treatment, a costly and confusing situation for an Alzheimer’s patient.I have been following AlzheimersWeekly Forum with a caregiver who just started his Mom with Dr. Tobinick’s Enbrel therapy, and the Alzheimer’s Association Forum with a caregiver’s Dad starting with the same therapy. Both took them to LA for treatment. It will be more than interesting to see the first hand postings on these forums. I suggest that your investigation of this technique include finding patients with demonstrated results.
If Dr. Tobinick and Amgen make a potful of money as a result, I don't care if Linda could just speak again.
For Bob Lee . . .
Bob, I would like to be in touch with you personally. As an Alzheimer's caregiver myself, I can tell you that it is very important to stay as upbeat as possible even in such circumstances. I'd like to reach you -- one product I am aware of may be a great help to you and I can arrange for the company to send you some without cost. Bob, please write me directly.
Dave Jensen
As the daughter of an 83 year old woman with moderate+/severe Alzheimers, I was initially so excited about the potential benefits of perispinal Enbrel, such that I was ready to take her to L.A. for the treatment. I just moved her from an assisted living facility to one for Alzheimer's patients -- the best that is available -- which isn't much at all, really. Thus, I'm ready to pounce on anything possibly helpful. So, why not give this a try? We don't have time for "double-blind" clinical trials, etc.
Peggy, this article is about medical ethics, not about the value of this one man's work. As I said in my letter to this doctor, his work can be very meaningful but allowing it to be packaged in this way (with the press release being written like some kind of used car sales promotion) is just disgusting. Yes, I know how you feel, my 84 year old Mom-in-Law is a wonderful person who we'd love to have talk to us again. But if the dietary supplement business tried this -- writing PR with headlines like this -- the FDA would close the company down. It should be the same with doctors. This work is not yet ready for prime time, and they've made it appear to be a "miracle cure."
My father took my mother to see Dr. Tobinick on 3/18/08. It was $800 for the first visit (no treatment). If she were to be treated it will be $4,600 (its $6,200 if you are out of state) to join the program and get an MRI. Then $800/week for an injection for as long as she lives. That is more than $40,000/year!
This seems like a treatment for the wealthy. If this is so good why not release to other doctors and make even more money?
My concern is that this doctor is preying on seniors who are desperate for a cure and who will try anything.
Harold Monroe - hmonroe-at-onebox.com
In regard to cost:
First visit $600.00
Second visit was $2800.00, but has just been increased to $3800.00
Weekly visit might still be $800.00
Business is very good.
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