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Author Topic: Dr. Edward Tobinick and off-label use at law  (Read 6402 times)


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Dr. Edward Tobinick and off-label use at law
« on: July 23, 2014, 05:20:34 PM »

The background:

Enbrel for Stroke and Alzheimer’s
Posted by Steven Novella on May 8, 2013 (30 Comments)

A recent article in the LA times,0,1373554.htmlstory tells of a husband’s quest to find a treatment for his wife’s Alzheimer’s disease. This is a narrative that journalists know and love—the brave patient or loved-one who won’t accept the nihilism of the medical establishment, who finds a maverick doctor willing to buck the system.

The article itself at least was not gushing, it tended toward a neutral tone, but such articles do tend to instill in the public a very counterproductive attitude toward science and medicine. I would have preferred an exposé of a dubious clinic exploiting desperate patients by peddling false hope. That is a narrative in which journalists rarely engage.

The story revolves around Dr. Edward Tobinick and his practice of perispinal etanercept (Enbrel) for a long and apparently growing list of conditions. Enbrel is an FDA-approved drug for the treatment of severe rheumatoid arthritis. It works by inhibiting tumor necrosis factor (TNF), which is a group of cytokines that are part of the immune system and cause cell death. Enbrel, therefore, can be a powerful anti-inflammatory drug. Tobinick is using Enbrel for many off-label indications, one of which is Alzheimer’s disease (the focus of the LA Times story).

The Dubious Health Clinic

Before I go into the details of Tobinick’s claims, let’s review the typical features of what we commonly call the “quack clinic” or the dubious health clinic. I wrote about this in 2009 , and listed the following features:

    The clinic often has an impressive name, such as “The Institute Of,” but lacks any formal affiliation with an established institution, like a university or hospital, and was founded and may even continue to be operated by one person.
    The clinic claims to treat or cure one or more diseases that is currently believed to be incurable. Their claims sound too good to be true.
    There is only one clinic in the world that can perform their special procedure or that uses their proprietary treatment. Sometimes the treatment offered is new and experimental.
    The clinic claims to cure a variety of diseases, all with different causes and pathophysiology, with a single treatment – the “one cure for all diseases” approach.
    The clinic is often located in a country with little or no regulation.
    The clinic claims that it is the victim of repression. Typically they will say that either Big Pharma, the medical establishment, the insurance industry – or some other convenient villain—is trying to suppress their revolutionary treatment. Alternatively, the “medical establishment” is simply closed-minded to their paradigm-shifting ideas.
    Testimonials are used to promote the treatments offered by the clinic, but they have not published appropriate research in legitimate peer-reviewed journals.
    When challenged by professional organizations, the clinic defends itself by appealing to politicians, using the testimonies of previous patients who believe they have been helped by the clinic and the accusation of a conspiracy of those trying to protect their monopoly.

The Institute of Neurological Recovery

Now let’s take a look at Tobinick’s clinic. It has an impressive name—a one-man institute. The website proclaims:

    The Institute of Neurological Recovery (INR®) is pleased to provide this introduction to its pioneering medical concepts, research, and treatment programs. INR designates a group of separate medical practices that utilize innovative, patented, off-label medical treatments developed by Edward Tobinick M.D. These treatment methods are designed to target a number of neuroinflammatory conditions with unmet medical need.

Many of the features of a dubious clinic are right there—the impressive name, claim to treat many conditions with one treatment, emphasis on how innovative the treatments are. The website also claims that his treatments are patented.

This is an interesting side issue, worthy of its own post. There has been a surge in the US in recent years in medical procedure patents. However, the first (and I think only) infringement lawsuit lost its case. Medical procedure patents are generally opposed by medical organizations as counterproductive profiteering and are banned in 80 countries. They are still legal in the US but there has been a number of legislative effort recently to limit or ban them.

The patented procedure (even if not enforced) seems like just another way to market the uniqueness of the treatments offered by the dubious clinic.

The list of conditions for which Tobinick claims or even has patented use of Enbrel include Alzheimer’s, stroke, traumatic brain injury, Parkinson’s disease, carpal tunnel syndrome, brain tumor, spinal cord injury, and back pain. That quite impressive for a doctor who isn’t even a neurologist. Tobinick is an internist who, prior to curing a long list of neurological diseases, specialized in laser hair removal.

The LA Times reports:

    But his claims about the back treatment led to an investigation by the California Medical Board, which placed him on probation for unprofessional conduct and made him take classes in prescribing practices and ethics.

Tobinick has since moved his clinic to Florida, which is a very quack-friendly state.  Its “health care freedom” law effectively shields dubious practitioners from pesky medical boards.
Plausibility and Evidence

When considering just the notion that Enbrel, a TNF inhibitor, might have a broad range of applications, this is entirely plausible. It is common for immunosuppressive drugs to gain an FDA approved indication for one specific condition, such as transplant rejection or rheumatoid arthritis, and then to be used off-label for many other autoimmune conditions.

This is very tricky, however, as the immune system is complex. There are different components to the immune system, and different aspects of immunity are involved in different auto-immune conditions. Therefore there is no one immunosuppressant drug or treatment for all auto-immune conditions.

When a new immune suppressing drug comes on the market it is common for it to be tried in a variety of conditions—but practice then follows evidence. Initially we might see some case reports, followed by a case series. If the drug shows promise, then a double-blind placebo-controlled trial would ultimately determine its effectiveness.

This is definitely a gray area of off-label use. How much evidence is necessary to justify an off-label use of a drug—and how far off label? Sometimes the popularity of a new off-label use of a drug gets ahead of the evidence. In most cases, however, eventually the research is done and practice conforms to the evidence.

The claims of Tobinick, however, are not in the gray area—they are leaps and bounds ahead of the evidence. Further, the conditions he claims to treat are not clearly immune-mediated diseases. It’s one thing to use an immune-suppressing drug to treat a disease that is known to be caused by immune activity, and probably the kind of immune activity suppressed by the drug.

Tobinick, however, is claiming that a wide range of neurological conditions not known to be immune mediated are treated by a specific immunosuppressant.

On his website he cites many studies, but none of them establish the effectiveness of Enbrel for any of the conditions he is treating. Most of them are simply identifying that TNF is increased in the condition. This is very weak evidence, however, as markers of immune activity are frequently increased in diseases that are not caused by immune activity. The immune system is very reactive—it reacts to disease with inflammation (often what we refer to as the cleanup crew). The inflammation is not causing the disease, it is simply the body’s reaction to it.

Tobinick has also started to publish case series —little more than retrospective case series reporting on his own patients.  This is weak evidence even when coming from an established researcher within their own area of expertise. It is all but worthless coming from clinic like Tobinick’s.

This is where his lack of expertise is especially relevant. Such arguments are often portrayed as elitist, as if a mere internist cannot have a valuable insight into how to treat neurological disease. But medicine and research are complex and there are many pitfalls. Unless you have expertise dealing with strokes or dementia, including how to properly research these conditions, you are likely to fall for these pitfalls.

For example, in his recent case series he writes:

    Significant improvement was noted irrespective of the length of time before treatment was initiated; there was evidence of a strong treatment effect even in the subgroup of patients treated more than 10 years after stroke and TBI.

This, if anything, is evidence that the observed treatment effect is mere placebo. It is very implausible that stroke or TBI deficits will be equally responsive to an anti-inflammatory treatment (or any treatment) regardless of time since the stroke or trauma.

Stroke researchers are also very familiar with what is known as the “cheerleader effect.” Take any patient with chronic deficits, give them any intervention and then encourage them to function better, and they will function better. This can result simply from trying harder, or even just the incidental physical therapy benefit of engaging in a treatment and being evaluated.

Unless all these factors are controlled for with proper blinding, no conclusions about the treatment effect are possible. Tobinick is providing the kind of evidence that is guaranteed to be positive, but not the kind of evidence that would determine if his treatments are effective or not.

If you strip away the gratuitous narrative in the LA Times story and just look at the facts presented, a very different narrative emerges. Ken Chiate brought his wife to Tobinick’s clinic for 165 injections of Enbrel over four years, at a cost of $800 each (that’s $132,000). During that time there were questionable subjective effects from the treatment, typical of placebo-only effects. Meanwhile his wife continued to relentlessly progress, as is typical of the disease, until she finally died in 2011.

According to the article, the treatments gave Chiate a sense of purpose and of hope—a false hope, it turned out. He still clings to the idea that Enbrel may be an effective treatment for Alzheimer’s disease—even though Tobinick himself has apparently moved on to treating stroke.

In my opinion, the story documents exploitation of a well-meaning and desperate husband at the hands of a dubious practitioner, practicing at the fringes of medical ethics and evidence, making bold claims without adequate justification. The story also documents the utter failure of the regulatory system to prevent (or even properly react to) such exploitation. Florida in particular appears to be a haven for such activity.


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Posted in: Health Fraud, Medical Ethics, Politics and Regulation
Leave a Comment (30) ↓
30 thoughts on “Enbrel for Stroke and Alzheimer’s”

    windriven says:   
    May 8, 2013 at 11:58 am   

    And let’s not forget that etanercept (who comes up with these names???) is not entirely benign.

    FDA placed a black box warning on etanercept as far back as 2008 due to a number of serious infections associated with the drug. FDA cautions that as immunosuppressants, TNF blockers may increase risk of various cancers, listeria, legionella, histoplasmosis, coccidioidomycosis, blastomycosis, aspergillosis, candidiasis, and other opportunistic infections.
    nickmPT says:   
    May 8, 2013 at 2:36 pm   

    I have a question regarding medical school. It seems that there are a decent number of these MD quack-types, how much critical thought/scientific appraisal is taught in med school beyond rote memorization? (I can understand that all schools are different, but there are accreditation standards…)

    And, perhaps it is just hearing more of the small number of negatives of the profession, while most are practicing scientifically.
    windriven says:   
    May 8, 2013 at 3:32 pm   


    “[H]ow much critical thought/scientific appraisal is taught in med school?”

    This is a particular irritation for me. But I don’t think that it is fair to blame medical school. Inculcation of the scientific method is a process that should begin early and one hopes would be complete by the time a baccalaureate degree is earned. Medical school is not the place to teach English composition, differential calculus or the rudiments of how science works; it is a place to teach the practice of medicine.

    That said, it is unconscionable and unethical for medical schools to embrace and even teach unscientific mumbo-jumbo through sCAM curricula and sCAM “Integrative Medicine” facilities. It is no different than teaching so-called intelligent design. Bullcrap is bullcrap whether the cowpie flops at some fundamentalist school in Lubbock or the halls of Yale Medical School.
    nickmPT says:   
    May 8, 2013 at 4:45 pm   


    I agree, I just think of the degree inflation and how many students are coming out of high school and/or undergrad with very little appraisal of critical thinking (including possible pre-med, pre-PT type students). Teaching to the test has also been a pitfall as well.

    Perhaps, I am just lamenting at the overall lack of critical thought at all levels of education which then allows this crap to flourish (I suppose manure is good for crop growth, eh?).
    windriven says:   
    May 8, 2013 at 5:28 pm   


    You would be appalled at some of the resumes that I receive from graduates of presumably good programs. Some can’t write a coherent paragraph and I wouldn’t guess for a moment that they could summarize the scientific method in a couple of sentences.

    I agree that grade and degree inflation are out of control. And I deeply share your lament of the near absence of critical thinking skills demanded throughout the educational process.
    Sawyer says:   
    May 8, 2013 at 6:00 pm   


    Not unique to med school either. I have a Bachelor’s and a Master’s in Mechanical Engineering from a top-tier US university. While engineering programs may do a better job than med school at teaching students how to apply existing knowledge to new challenges, they put very little time into covering the scientific method, logical fallacies, pseudoscience, or the history of scientific discovery. I really don’t know how you would squeeze all this stuff into an already dense curriculum, so maybe suggesting to students that they should spend time looking at supplemental sources like SBM is the only viable option.
    nickmPT says:   
    May 8, 2013 at 6:44 pm   


    I could understand that in a professional program the goal is applying the existing knowledge to a trade. Ultimately, teaching of critical thought needs to start far sooner, i.e. grade school.

    I was having a discussion with my great aunt last night. She told of a math teacher (pre-highschool) her children had. He did not care about the kids getting the right answer, he cared more about their thought process. He also did not want the parents to help with the homework as he wanted the children to struggle and challenge their minds. Finally, he sat down with each child and worked through the problem with them, recognizing where there frame of reference was and guiding them towards less wrong trains of thought. This takes patience, compassion, and hard-work. It breeds motivation, curiosity, and intelligence.

    As long as our education system is built on the goal of getting the correct answer rather than how to get there this kind of thing will be perpetuated and society will suffer.
    wertys says:   
    May 8, 2013 at 8:44 pm   

    Some Australian doctors at a new University research institute tried to bring this therapy to Australia. The story is told in this link

    It seems they weren’t aware of the need for ethics approval for unregistered use of drugs which is disappointing for the huge number of patients and donors who were left hanging…
    woody2 says:   
    May 8, 2013 at 8:46 pm   

    Thank you for tackling Tobinick’s shenanigans. I felt he deserved the SBM Quack Takedown several years ago when he started pushing perispinal etanercept for Alzheimer’s disease. I had no idea how many injections he was giving patients. I am surprised that there have not been procedural complications – perispinal injections are not without risk even if you don’t factor in the potential adverse effects of etanercept.
    Zuppy says:   
    May 9, 2013 at 2:52 pm   

    Dr. Edward Tobnick, Dermatologist has created near 100 ‘testimonial videos’.


    I invite you to view the video and discuss!

    Rapid Relief for Orthopedic Surgeon with severe pain

    nrimed·102 videos
    Subscribe 816

    Uploaded on 25 Nov 2009

    Please see
    The Institute of Neurological Recovery Los Angeles and Newport Beach, California and Boca Raton, Florida.
    Zuppy says:   
    May 9, 2013 at 2:59 pm   

    more informantion on Dr. Edward Tobinick created video: RAPID RELIEF FOR ORTHOPEDIC SURGEON WITH SEVERE PAIN

    Uploaded on 25 Nov 2009

    Please see
    The Institute of Neurological Recovery Los Angeles and Newport Beach, California and Boca Raton, Florida.

    Orthopedic Surgeon responds within minutes to a single dose of perispinal etanercept for severe pain. Copyright 2010 INR®, all rights reserved. Perispinal etanercept is a patented treatment developed and invented at the Institute of Neurological Recovery, a private medical group, inc. in Los Angeles. This video was shot in July 2009. More complete information at See also Tobinick, E., Perispinal etanercept for neuroinflammatory disorders Drug Discovery Today 2009 Feb;14(3-4):168-77.
    windriven says:   
    May 9, 2013 at 3:08 pm   


    “I invite you to view the video and discuss!”

    Cool! I wonder if Tobnick learned that schtick from Benny Hinn?

    I especially liked the part where he asked the shill, I mean patient, whether he thought his relief might be from the placebo effect.
    windriven says:   
    May 9, 2013 at 3:14 pm   


    “The Institute of Neurological Recovery Los Angeles and Newport Beach, California and Boca Raton, Florida.”

    INR in Boca Raton. Mouth of the Rat. One couldn’t make this stuff up!
    windriven says:   
    May 9, 2013 at 3:27 pm   


    I did find one interesting citation on the IRP site:

    “Randomized, double-blind, placebo-controlled, dose-response, and preclinical safety study of transforaminal epidural etanercept for the treatment of sciatica.”

    Cohen SP, Bogduk N, Dragovich A, Buckenmaier CC 3rd, Griffith S, Kurihara C, Raymond J, Richter PJ, Williams N, Yaksh TL. Anesthesiology. 2009 May;110(5):1116-26.PMID:19387178.

    Anesthesiology is a first rate journal and Steven Cohen, MD is a well known pain researcher and a full professor at Johns Hopkins.
    windriven says:   
    May 9, 2013 at 3:28 pm   

    Forgot to add that the Cohen study I mentioned above is a small study (n=24).
    WilliamLawrenceUtridge says:   
    May 9, 2013 at 3:32 pm   


    What’s your point? That anyone can claim anything on the internet and there is no quality control? That testimonials are worthless? The importance of clinical trials in creating evidence that can be relied upon, because it’s too easy to create fake testimonials or cherry-pick only those who believe they are improving? That testimonials are indistinguishable from advertising, and about as trustworthy?

    Certainly those are valid points I can agree with.
    Zuppy says:   
    May 9, 2013 at 3:33 pm   

    Oops, sorry, I added in the line “I invite you to view and discuss”

    I wanted the readership to view Tobinick’s video and comment!
    windriven says:   
    May 9, 2013 at 3:38 pm   

    Curiously, in a later study* Cohen et al found epidural etanercept inferior to epidural steroids for lumboscral radiculopathy. This was also a small study (n=84)

    *Ann Intern Med. 2012 Apr 17;156(8):551-9. doi: 10.1059/0003-4819-156-8-201204170-00002.
    windriven says:   
    May 9, 2013 at 3:39 pm   


    I believe that Zuppy was offering this video for ridicule.
    Zuppy says:   
    May 9, 2013 at 4:03 pm   

    windriven is correct!
    Chris says:   
    May 9, 2013 at 4:20 pm   


        INR in Boca Raton. Mouth of the Rat. One couldn’t make this stuff up!

    Actually raton (with an accent over the “o”) is mouse, so it is mouse mouth, a rat is “rata. In Venezuela* the Mighty Mouse cartoon I watched was called “Super Raton.” Anyway I read somewhere it is a Spanish colloquial description of a type of inlet with jagged rocks that nibble on ropes like micey teeth. It is a bit more creative than the description of a bay on Whidbey Island: Useless Bay.

    * And I wish I spoke Spanish better than I do. I rebelled against linguist father and took more math. Which, in retrospect, was better since engineering paid lots better than either of parents’ liberal art degrees.
    windriven says:   
    May 9, 2013 at 4:40 pm   


    Yo no quiero rata o raton! :-)

    How’s that for Spanglish? I know what it means but my Spanish isn’t good enough to say that I don’t care if it is a rat or a mouse. I even ran a plant in Reynosa for a while. So I have no excuse for my abysmal Spanish.

    Math, physics, all good. I took German in high school (it still charges back when I spend a few weeks in Germany) and managed to take no language classes at all in college.

    Interesting that you went with an engineering degree coming from a liberal arts household. I’d bet that isn’t all that common – especially for a female going to U in the 70′s (I hope I remember that correctly).
    Zuppy says:   
    May 9, 2013 at 6:17 pm   

    I must compliment Steven Novella on this review of the Los Angeles Times story. Excellent commentary, which cannily captures the claims and practices of one Dr. Edward Tobinick, a person ticks all the boxes as a dubious person, who presently runs three dubious clinics, where dermatology clinics double as neurological clinics……with the same dermatology doctors and staff, led by dermatologist Dr. Edward Tobinick. There is not one neurology trained doctor or staff at Tobinick’s clinics. At these dubious clinics, an Alzheimer’s or Stroke patient on initial consultation and administration of the off-label drug Enbrel (etanercept) can expect to pay circa $5000 on the day. A single dose of Enbrel cost circa $200. Steven’s commentary goes some way to shine a spotlight on one Dr. Edward Lewis Tobinick, dermatologist.
    Zuppy says:   
    May 9, 2013 at 6:47 pm   

    You want Institutes………Dr. Edward Tobinick, dermatologist gots Institutes.

    Tobinick’s dermatolgy practice is called: Institute of Laser Medicine

    also home of Institute of Neurological Recovery

    which was previously called Institute of Neurological Research.

    INSTITUTE OF NEUROLOGICAL RECOVERY – A New Breakthrough for Stroke and Traumatic Brain Injury (TBI)

    2300 Glades Road, Suite 305E
    Boca Raton, FL 33431

    361 Hospital Road, Suite 428
    Newport Beach, CA 92663

    100 UCLA Medical Plaza
    Suites 205-210
    Los Angeles, CA 90095

    (310) 824-6199
    Chris says:   
    May 9, 2013 at 6:53 pm   

    windriven, not being a liberal arts major was a goal of both myself and my brother. Part of it was seeing frustration in our parents. Though the fortunate part of being an Army brat was that moving around I was always the new kid, so I learned to ignore comments from certain people.
    Xplodyncow says:   
    May 10, 2013 at 12:29 am   

        etanercept (who comes up with these names???)

    I might be wrong about this, but I believe it’s R&D that devises the generic name, and the syllables reflect the type of compound. For example (writes this non-scientist), drugs with a particular action on some specific part of the immune system all end in “-cept” (e.g., etanercept, abatacept) or “-mab” (e.g., adalimumab, certolizumab, golimumab, infliximab, rituximab, tocilizumab). Brand names, however, seem to be random combinations of letters invented by marketers.
    Zuppy says:   
    May 10, 2013 at 3:40 pm   

    Los Angeles Daily News 1987

    Warning: Fry Now, Pay Later Melanoma Is Caused By A Serious Sunburn From Childhood
    By JENNIFER LOWE, Los Angeles Daily News
    Posted: May 20, 1987

    “You can’t have people in not stay out of the sun,” said Dr. Edward L. Tobinick, a Beverly Hills dermatologist and medical director of the Skin Cancer Institute, a private skin-care clinic.
    Narad says:   
    May 10, 2013 at 8:44 pm   

        INR in Boca Raton. Mouth of the Rat. One couldn’t make this stuff up!

    Tobinick also has a house in Highland Beach. I recall that Florida’s homestead exemption, which shields one’s house from creditors, was cited as a reason for Boca long being Spam Central. It was also popular for pump-and-dump boiler rooms and, before that, swamp peddlers.
    norrisL says:   
    May 11, 2013 at 5:11 am   

    As a 49 year old sufferer of early onset of dementia, this crap gets me really wound up, especially when I see that he had tried to do trials here in Australia. Grrrrrrrrrrr (angry noise)
    Pingback: NeuroLogica Blog » Transcranial Magnetic Stimulation for Autism

Comments are closed.

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« Last Edit: July 24, 2014, 12:46:39 PM by Omegafant »


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Another Lawsuit To Suppress Legitimate Criticism
« Reply #1 on: July 23, 2014, 05:25:46 PM »

Another Lawsuit To Suppress Legitimate Criticism – This Time SBM
Posted by Steven Novella on July 23, 2014


I suppose it was inevitable. In fact, I’m a bit surprised it took this long. SGU Productions, the Society for Science-based medicine, and I are being sued for an article that I wrote in May of 2013 on Science-Based Medicine . My SBM piece, which was inspired by an article in the LA Times, gave this summary:

    The story revolves around Dr. Edward Tobinick and his practice of perispinal etanercept (Enbrel) for a long and apparently growing list of conditions. Enbrel is an FDA-approved drug for the treatment of severe rheumatoid arthritis. It works by inhibiting tumor necrosis factor (TNF), which is a group of cytokines that are part of the immune system and cause cell death. Enbrel, therefore, can be a powerful anti-inflammatory drug. Tobinick is using Enbrel for many off-label indications, one of which is Alzheimer’s disease (the focus of the LA Times story).

The claims and practice of Dr. Tobinick have many of the red flags of a dubious medical practice, of the sort that we discuss regularly on SBM. It seems that Dr. Tobinick does not appreciate public criticism of his claims and practice, and he wants me to remove the post from SBM. In my opinion he is using legal thuggery in an attempt to intimidate me and silence my free speech because he finds its content inconvenient.

Of course, we have no intention of removing the post as we feel it is critical to the public’s interest. This is what we do at SBM – provide an objective analysis of questionable or controversial medical claims so that consumers can make more informed decisions, and to advance the state of science in medicine.

We also feel it is critical not to cave to this type of intimidation. If we do, we might as well close up shop (which I suspect the Tobinicks of the world would find agreeable). Defending against even a frivolous lawsuit can be quite expensive, but we feel it is necessary for us to fight as hard as we can to defend our rights and the work that we do here at SBM.

An interesting wrinkle of this suit is that Tobinick is claiming that my blog post is an “advertisement.” This is a legal maneuver as the threshold for forcing someone to remove an advertisement is much lower than the threshold for suppressing their free speech. I can only assume that he and his attorneys are not bothered by the fact that blog posts on SBM are blatantly not advertisements.

In the case of the Enbrel article he had to make the absurd claim that the post (which does not mention my own practice) was an advertisement for my neurology practice at Yale, designed to attack a “competitor.” He would have us believe that Yale neurology in Connecticut is concerned about a distant clinic. Further, Yale Neurology is an academic practice. Our problem is too many referrals and long wait times, not competitors. To see how desperate the claim is, he argued that because I use Botox, which can be used to treat symptoms following stroke, that his treatments for stroke represent a competitor. However, I don’t use Botox to treat stroke patients. I mostly use it to treat migraines, as I am a headache specialist.

Perhaps he feels that my 18-year career promoting science, critical thinking, and science-based medicine is just a cover so I can occasionally attack distant tangential “competitors.”

In any case, the fight is on. Here is a review of the salient points of my criticism of Tobinick:

Tobinick is not a neurologist, and yet he feels it is appropriate for him to treat multiple neurological conditions with an experimental treatment. It is generally considered unethical for physicians to practice outside of their area of competence and expertise. He is trained in internal medicine and dermatology and is certified in those specialties. He has never completed a neurology residency nor is he board certified in neurology.

Despite his lack of formal training and certification, he feels he has ushered in a “paradigm shift” in the treatment of Alzheimer’s disease – a disease that has proved challenging for actual neurologists for decades.

His treatment of choice is perispinal etanercept (Enbrel), which basically is an immunosuppressant drug. He is using this treatment for not only Alzheimer’s disease, but neurological deficits following stroke, traumatic brain injury, and pain resulting from vertebral discs. He therefore claims that the neurological deficits in these various conditions result from active inflammation (specifically tumor necrosis factor – TNF) and by inhibiting TNF “rapid improvement” in neurological function is possible.

These claims are highly implausible, and in my opinion reflect his lack of training and expertise as a neurologist. Strokes cause ischemic damage to the brain – brain cells in severe stroke die. Inflammation following stroke is incidental, not causative. Yet Tobinick claims that 10 years following a stroke, long after any neurological recovery would have occurred, patients can improve by inhibiting TNF.

He makes the same claim for Alzheimer’s disease, despite the fact that this is a neurodegenerative disease resulting in loss and destruction of brain cells. An anti-inflammatory drug is not going to bring back dead brain cells, yet he claims “rapid improvement” is possible.

The simplest explanation for the apparent response to his treatments is simply placebo effects. Stroke neurologists, for example, are acutely aware of the so-called “cheerleader” effect. Take a patient with chronic deficits, get them off the couch, give them any treatment and tell them it will make them better, and they will likely demonstrate increased functionality simply because they are making an effort they had not made for a while.

The only way to really know if the treatment itself is having any neurological benefit is with careful double-blind placebo-controlled clinical trials. Tobinick, however, has not produced such evidence. He has a long list of publications – all case series, observational studies, pilot studies, case reports, and reviews. I could not find a single double-blind placebo-controlled trial establishing the efficacy of his treatment for any of the conditions I listed above. (There are small studies for disc herniation showing conflicting results.)

At best his treatment should be considered experimental. I think the plausibility of the effects he is claiming is extremely low. It’s possible that an anti-TNF effect may be of some use, but given the type of evidence we have it is likely we are seeing mostly (if not completely) placebo effects.

Despite the preliminary nature of his evidence, the “paradigm shift” such claims would represent, and his lack of formal training in neurology, Tobinick has obtained a number of use patents for his treatments. Use patents for medical procedures are still legal in the US, although they have been banned in many other countries, and many consider them unethical. The AMA has this to say:

    The intentional withholding of new medical knowledge, skills, and techniques from colleagues for reasons of personal gain is detrimental to the medical profession and to society and is to be condemned.

The case highlighted in the LA Times story involved Ken Chiate, who brought his wife who was suffering from Alzheimer’s disease to Tobinick’s clinic for 165 injections of Enbrel over four years, at a cost of $800 each (that’s $132,000). During that time there were questionable subjective effects from the treatment, typical of placebo-only effects. Meanwhile his wife’s condition continued to relentlessly progress, as is typical of the disease, until she finally died in 2011.

I am not the only one to have concerns about Tobinick’s practices. The Medical Board of California filed an accusation in 2004, amended in 2005 and 2006, stating:

        From about 2000 to 2002, Tobinick, owned and operated a medical practice under the name “Institute for Neurological Research” in Los Angeles and Newport Beach.
        During those years, Tobinick promoted and advertised a new off-label use for an FDA-approved drug, etanercept (Enbrel). He referred to his drug as DiskCure® [sic] and advertised it as “a new and innovative approach for back or neck pain without surgery,” and as a “breakthrough” in the treatment of disc-related back and neck pain.
        Enbrel is a genetically engineered protein and immune response modifier approved by the FDA for treating several types of arthritis but not for back pain. Tobinick’s treatment involved injecting it near the spine.
        Until May 2002, there had been no published, peer-reviewed, scientific studies showing the effectiveness of the treatment for back pain in humans. Nor had there been an approved, pending, or investigational drug application for this use of etanercept.
        Tobinick’s advertisements for DiskCure constituted unprofessional conduct under the California Business and Professions Code.
        Tobinick had also failed to obtain a fictitious name permit for the Institute for Neurological Research as required by law.

Tobinick agreed to serve one year on probation during which he was required to complete courses in ethics and prescribing practices and have his practice monitored by another physician or complete a professional enhancement program.

But now he is not only up to his old tricks, but he has greatly expanded the scope of his Enbrel claims and practice. He has his own “Institute for Neurological Recovery” in which he shows videos of select patients to promote his patented treatments.

This is all, unfortunately, a far too common pattern, one with which we at SBM are very familiar. There is definitely a need here to provide critical analysis of such extraordinary medical claims. That means, also unfortunately, that we will occasionally need to spend our time and resources defending our right to do so.


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Tags: Alzheimer's disease, Edward Tobinick, Enbrel, tumor necrosis factor

Posted in: Announcements, Legal
Leave a Comment (39) ↓
39 thoughts on “Another Lawsuit To Suppress Legitimate Criticism – This Time SBM”

    Bob Blaskiewicz (@rjblaskiewicz) says:   
    July 23, 2014 at 7:47 am   

    Where do we send our checks?
        Jeff Clegg says:   
        July 23, 2014 at 9:57 am   

        That was my first response too. Opening up the virtual wallet now…
        BobbyGvegas says:   
        July 23, 2014 at 10:54 am   

        My first thought.
    Steven Novella says:   
    July 23, 2014 at 7:52 am   

    Thanks for the offer, Bob. We certainly would welcome support. You can donate to SBM at the button above, or to SGU Productions (

    Just tag the donation with “legal defense fund.”

    Or if you want to send a physical check, e-mail me directly and I will send you an address.
    Randy Goldberg MD MPH FACP says:   
    July 23, 2014 at 7:58 am   

    This is called a SLAPP lawsuit (strategic lawsuit against public participation), and is explicitly against the law in 28 states and DC, including California. California, in fact, permits an accelerated anti-SLAPP motion. If he has filed his suit in California, I urge you to retain counsel and file a CCP 425.16 motion forthwith. If you win, he has to pay reasonable attorney’s fees.
        David Gorski says:   
        July 23, 2014 at 8:03 am   

        It’s Florida.
            Peter S says:   
            July 23, 2014 at 8:17 am   

            From a quick search, Florida’s anti-SLAPP statute appears to apply only to governmental plaintiffs.
    Peter S says:   
    July 23, 2014 at 8:04 am   

    It seems a stretch, to say the least, to have brought this claim under the Lanham Act.
        Peter S says:   
        July 23, 2014 at 8:13 am   

        To clarify, the Lanham Act applies to commercial advertising or promotion. This site hardly seems that.
    Unity says:   
    July 23, 2014 at 8:33 am   

    Time to contact Ken White and get him to send up the Popehat signal –
        David Gorski says:   
        July 23, 2014 at 8:35 am   

        He already knows. We contacted him. He helped Steve locate a Florida lawyer specializing in such cases, for which we are grateful.
    Pingback: Legal thuggery directed at Steve Novella and Science-Based Medicine – Respectful Insolence
    Stefan Harders says:   
    July 23, 2014 at 8:54 am   

    This is one of the times I’m glad to practise and publish in Europe. That guy, Tobenick, sounds exactly like another one of those assholes doing experiments on severely ill patients for money, thereby displaying a severe lack of empathy, and I’m free to say so without the risk of a pending lawsuit. Fight on!
    Frederick says:   
    July 23, 2014 at 11:14 am   

    WOW, That guy’s record is not really good and he think suing will help him?

    Maybe a judge will reject his complaint, it is frivolous after all. The whole Advertisement angle is ridiculous. Your article is not a smear campaign either. You demand better evidence, which he does not have. I really hope you get a good judge that will see that it is ridiculous and That it is a slapp. Here In Quebec we now have a anti slapp law now ( loi anti poursuite bâillons we call it). The fact that he patented he “use” is quite weird, he want to be sure nobody else use that, Or test it. It is a sign i guess that it is dubious.

    Extraordinary claims demands extraordinary evidence. In which language can we right that so he understand? he does not only need a double blinded placebo, but also a independently replicated experiment after his own. Than if it work, he’ll be famous. What wrong about that?

    Anyway Let us know how the case is going. I’m already a Member of the SGU, My budget is limited, But I will certainly help SM as much as I can. Lucky for SBM there’s a Super good Lawyer on the staff!

    But being Sued by a guy like him kind is evidence that you are doing you job right.
    Bonne chance!
        Frederick says:   
        July 23, 2014 at 11:16 am   

        I want to had, As I express in another comment, I really don’t like cranks who make money out of patient with neurological disorder. So kick his ass.
        Mike says:   
        July 23, 2014 at 2:35 pm   

        A common tactic among quacks (e.g. Burzynski) is to use their patents as evidence for efficacy, but a patent office review typically only looks for novelty and non-obviousness, and not whether the invention described in the patent application works. It is probably easier to get a patent on a treatment that doesn’t work because it’s easy to come up with quackery that it novel and non-obvious.

        Still, receiving a patent says little to nothing about whether or not a treatment is effective, so no, just knowing that Tobinick has patents is not evidence that his treatments are dubious.
    Nell on Wheels says:   
    July 23, 2014 at 11:17 am   

    Related article from 2008: Breakthrough or False Hope? Etanercept Case Report Draws Scrutiny

        Most media reports presented the work as a “UCLA study.” Tobinick lists a UCLA e-mail address on the manuscript, and the private medical group where he works full-time is located in a building at UCLA’s medical plaza. According to the UCLA media office, Tobinick is a voluntary assistant clinical professor with UCLA’s Division of Dermatology. The office stated that his etanercept study did not go through the UCLA IRB. Greg Cole, associate director of the UCLA Alzheimer Disease Center (ADC), said that the center had nothing to do with Tobinick’s etanercept work.
        Amgen, the maker of etanercept, distanced itself from the study… “This study was not supported nor endorsed by Amgen. While Amgen and others have long recognized the potential for TNF inhibitors to have an effect on neurological conditions, we have carefully examined this study and believe that at this time there is insufficient scientific data to support the use of a TNF inhibitor as a means of treating Alzheimer’s disease.”

    goodnightirene says:   
    July 23, 2014 at 11:24 am   

    I’ve already donated to Dr Barrett’s fund, a case which seems to never be resolved, and is just as absurd in its obvious intent to get revenge for being exposed as a questionable practice or practitioner. Nevertheless, I will contribute what I can.
    Ed Whitney says:   
    July 23, 2014 at 11:42 am   

    Actually, etanercept has been tested in randomized trials for lumbar herniated disc and spinal stenosis; there is uncertainty about its benefits but at least some decent scientific work is being done in this area. Freeman and Ohtori reported a therapeutic effect but Cohen did not; however, Cohen used a smaller dose (4 mg) than the other authors used. This is all recent work and does not justify Tobinick’s using it in 2002. But it is not in the same league as trying it out for Alzheimer dementia.

    Ohtori S, Miyage M, et al. Epidural Administration of Spinal Nerves With the Tumor Necrosis Factor-Alpha Inhibitor, Etanercept, Compared With Dexamethasone for Treatment of Sciatica in Patients With Lumbar Spinal Stenosis. Spine 2012 ; 37 : 439 – 444

    Cohen SP, White RL, et al. Epidural Steroids, Etanercept, or Saline in Subacute Sciatica A Multicenter, Randomized Trial. Ann Intern Med. 2012;156:551-559

    Freeman BJC, Ludbrook GL, et al. Randomized, Double-blind, Placebo-Controlled, Trial of Transforaminal Epidural Etanercept for the Treatment of Symptomatic Lumbar Disc Herniation. Spine 2013;38:1986–1994
    Steven Novella says:   
    July 23, 2014 at 12:24 pm   

    Ed – these are small studies (less than 50 participants) with conflicting results, so hardly sufficient to establish efficacy, but I added a small addition to clarify.
    NotADoc says:   
    July 23, 2014 at 12:24 pm   

    Dr. Novella, you should take offense at his allegation that you are engaged in advertising at SBM. As a frequent reader, I knew you were in neurology, but didn’t know you were at Yale or that you specialized in headaches until reading this post. If you were indeed trying to advertise, I sincerely hope you would be a little bit better at it.

    Good luck deflecting this. Hope you’re rid of this guy quickly.
    daedalus2u says:   
    July 23, 2014 at 12:56 pm   

    You might want to look at this paper

    It shows clinically significant effects in Parkinson’s due to a placebo treatment.

    They knew it was a placebo effect because it was done in a double-blind placebo controlled trial.

    The Etanercept results may or may not be placebo, because there has been no trial measuring them against placebo. I suspect that the very prompt acute effects may be due to the effects of Etanercept reducing inflammation, but that reduction in inflammation is only acute. It does not lead to resolution of whatever is causing the inflammation.

    My hypothesis is that while Etanercept may acutely and temporarily improve things like Alzheimer’s by acutely reducing inflammation, it would very likely accelerate progression because physiology will respond and upregulate inflammation to compensate for the perturbation of Etanercept.

    Each dose likely “ratchets” the state of neuroinflammation a little bit higher. If there are periodic MRIs, you could probably see the progression accelerate.

    Since they have sued you, in discovery you should be able to get the records of the patients used for the case studies and so determine if they are likely placebo responses or not
    R.w.Foster says:   
    July 23, 2014 at 1:25 pm   

    May I reblog your original article? The one that knucklehead wants pulled down? Naturally, you’ll be sourced, Dr. Novella. Unless you happen to lose, then I suppose we could credit it to Dr. Scratcheenseiff…
    Paul Ingraham says:   
    July 23, 2014 at 1:38 pm   

    Bravo! Fantastic. I doubt Tobinick has a clue just how much of a Streisand Effect he’s in for. If he thought Google’s search results were unkind to him before, he hasn’t seen anything yet!

    I love the toughness and ethical clarity of this response. Having endured my own legal incident a few years ago (after provoking the wrath of chiropractors), I know how surreal and stressful these kinds of threats can be. A firm decision to fight for the right to criticize is a perfect demonstration of why I’m proud and humbled to be involved with I’ll be doing my bit to help get that Streisand effect going. And munching my popcorn…
        Windriven says:   
        July 23, 2014 at 2:37 pm   

        His Wikipedia entry could use some editing :-)
    smh says:   
    July 23, 2014 at 1:43 pm   

    You are familiar with anti-SLAPP laws? He hasn’t got a chance. Make sure your lawyer is not a complete idiot.
        smh says:   
        July 23, 2014 at 1:48 pm   

        Don’t forget to sue for attorney’s fees.
    Mikael Nylén says:   
    July 23, 2014 at 1:51 pm   

    This is an outrage!
    I’m already donating to the SGU every month as a damned dirty ape, but I’ll make sure to send a bit more your way this month, every little bit helps!

    thetentman says:   
    July 23, 2014 at 1:57 pm   

    Good luck with the lawsuit. Nobody on Yelp likes him either.
        Windriven says:   
        July 23, 2014 at 3:12 pm   

        Neither do his reviewers at Healthgrades where he earned 2.9/5, below the national averages on every measure (except wait time where he was at the national average).

        We all know the problems with these subjective reviews. But it is striking that there are quite a number of internists close by with similar numbers of reviews and much higher marks.

        It would seem like the doctor is quite the entrepreneur, dabbling in hair removal and neurological research. I guess the two are related. There is hair on most heads. And there’s a lot of neurological stuff inside most heads. So … yeah, I can see that.
    CrankyEpi says:   
    July 23, 2014 at 3:00 pm   

    I realize this is off the main topic and rather trivial, but I feel you (Dr. Novella) are being overly kind by saying that “at best his [Dr. Tobinick's] treatment should be considered experimental.” Outside of the usual scientific connotation of the word “experimental,” I would think of a patient who has a bad disease and who has responded poorly or not at all to all other standard, science-based treatments. Not that the patient would be expected to be cured or respond really well, but rather that you don’t see at least the minimally acceptable improvement from standard treatments in this patient that you would see in others. So in an effort to help the patient, who may have certain peculiarities about his case, the physician might try an unusual treatment (“experimental”) and carefully observe whether the patient responds. I am describing a relatively rare scenario. Without this connotation I worry that non-science based people will interpret “experimental” to mean “let’s try it!” without qualifiers.

    Okay, I did not read the LA Times article but it does not sound like this is Dr. Tobinick’s approach.
    Doug Attig says:   
    July 23, 2014 at 3:02 pm   

    Attorneys who take cases like this should be disbarred, IMO.
        Peter S says:   
        July 23, 2014 at 3:34 pm   

        It will be interesting to me to see their argument how they have satisfied the “commercial advertising or promotion” element of a Lanham Act claim. I fail to see it.
    Peter Kaplan says:   
    July 23, 2014 at 3:41 pm   

    Might I suggest crowdsourcing the cost of defending against the lawsuit? Adam Carolla and other podcasters are using this strategy to finance a defense against patent trolls who are suing them for bogus patent infringement. As of 7/23, they are closing in on half a million dollars (
    Keith Eric Grant says:   
    July 23, 2014 at 3:49 pm   

    SMH mentioned Anti-SLAPP laws above. California has one of the stronger ones: California Anti_SLAPP Law

    Anti-SLAPP laws are designed to provide a remedy against “Strategic Lawsuits Against Public Protection” (SLAPPs), often lawsuits with little merit but designed to intimidate and silence. See Public Participation Project
        Windriven says:   
        July 23, 2014 at 4:17 pm   

        One suspects that Tobinick filed in FL rather than CA because of less restrictive SLAPP laws in FL.
    Mike says:   
    July 23, 2014 at 4:22 pm   

    I wish you the best of luck in getting this lawsuit dismissed. Since neither you nor Dr. Tobinick are Florida residents, it would seem that he did some forum shopping to find a state without an anti-SLAPP law.

    However, as a former patent practitioner, I strongly disagree with your statements about the patent system, which is a completely separate topic from this quack’s actions.

    You write:

        Use patents for medical procedures are still legal in the US, although they have been banned in many other countries, and many consider them unethical.

    This argument sounds very similar to a Non-GMO Project statement on GMOs:

        Most developed nations do not consider GMOs to be safe. In more than 60 countries around the world, including Australia, Japan, and all of the countries in the European Union, there are significant restrictions or outright bans on the production and sale of GMOs.

    The basis for the U.S. patent system is enshrined in article 1, section 8 of the Constitution, which states:

        The Congress shall have power … To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries;

    The modern patent system institutes a quid pro quo, whereby an inventor is required to publicly disclose how to make and/or use the invention in return for receiving a 20 year monopoly on practicing that invention. Because the patents are published online, a patent by definition cannot constitute “intentional withholding of new medical knowledge, skills, and techniques from colleagues.”

    According to U.S. statute, a patentable invention must be novel and non-obvious at the time of the invention. Thus there is (at least in theory) a high bar to obtaining a patent, and a patent should not preclude people from using existing techniques. Patents are especially important in the pharmaceutical industry, where it can cost $1 billion to create the first pill, and a penny to create the second pill. Patents are an important tool for incentivizing drug and medical device development because they can help recover the large research and development costs. Thus, “use” patents are pursued in pharmaceutical and medical device patents all the time.

    The WMA makes several distinctions between physicians and companies where that do not apply. For example, aren’t uses of medical devices and drugs considered medical procedures? The WMA seems to acknowledge the importance of patents but states that physicians are special because they “already have incentives [e.g. professional reputation] to innovate and improve their skills.” Well, under the same logic, physicians should never charge for care because any such charges might stop patients from getting the medical care they need and not charging would improve physicians’ professional reputations. Similarly, medical schools should not charge for teaching doctors, and doctors should not charge for training other doctors. Why are not all medical school teaching materials and lectures freely available online?

    Basically, the WMA seems to just be coming up with reasons why doctors shouldn’t have to pay for development of novel medical techniques, while making excuses for why it’s ok to pay for (and not steal) pharmaceuticals and medical devices. The WMA also seems to dramatically understate the costs involved in developing new medical procedures.

    Furthermore, even if one thought the use of patents on medical procedures to make money was unethical, merely holding a patent on a medical procedure and not enforcing the patent (as Elon Musk recently pledged to do for Tesla’s patents) costs the public nothing, so can not be considered unethical.

    Is it possible to unethically assert a patent? Perhaps, by refusing to allow anyone to practice a life saving invention at any price or at a price considered to be too high, but such discussions are not because medical procedure patents are, by themselves, unethical. The WMA statement also discusses possibly problematic conflict of interests, but, again, this problem is irrelevant to whether medical procedure patents themselves are ethical or not. This debate is really about the costs of healthcare in general. Of course the costs of medical care are an important topic to debate, but a particular type of patent should not be singled out as unethical over any other cost involved in providing healthcare in the 21st century.
    KillCurve says:   
    July 23, 2014 at 4:26 pm   

    What a slimeball! So thrilled to see you fight!
    Kiiri says:   
    July 23, 2014 at 4:41 pm   

    You are right Dr. Novella, it was only a matter of time before someone thought to sue. Best of luck and keep fighting the good fight. Will be looking into making a contribution to the defense.


  • Jr. Member
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Enbrel provider charged again with improper advertising
« Reply #2 on: June 02, 2015, 03:59:16 PM »

Consumer Health Digest #15-21
May 31, 2015

Enbrel provider charged again with improper advertising

The Medical Board of California has charged Edward L. Tobinick, M.D. with advertising improperly that his clinic offers "revolutionary" and "breakthrough" treatment that can enable patients with strokes, Alzheimer's disease, and other chronic neurological conditions to improve rapidly—often within a few minutes—after receiving his injections. Tobinick, who operates the Institute of Neurological Recovery (INR)
,with offices in Boca Raton, Florida and Los Angeles, California, has for many years offered to treat spine-related pain and various neurological conditions with Enbrel (etanercept), a drug that is FDA-approved for other purposes. He and several other authors have published many papers supporting his off-label use, but his work remains controversial. The accusation document
states that the ads "contained misrepresentation of facts, were likely to mislead or deceive, created false or unjustified expectations, and/or make scientific claims that cannot be substantiated by reliable, peer reviewed, published scientific studies." In 2006, he settled previous allegations
related his marketing of Enbrel by agreeing to serve a year on probation. Last year, Tobinick filed a suit against Steven Novella, M.D. for criticizing his advertising claims


Justia › Dockets & Filings › Eleventh Circuit › Florida › Florida Southern District Court › Edward Lewis Tobinick, MD et al v. Novella et al
Edward Lewis Tobinick, MD et al v. Novella et al

Plaintiff:    Edward Lewis Tobinick, MD, The Institute of Neurological Recovery, INR PLLC and Edward Tobinick
Defendant:    Steven Novella, Yale University, Society for Science-Based Medicine, Inc. and SGU Productions, LLC
Case Number:    9:2014cv80781
Filed:    June 9, 2014
Court:    Florida Southern District Court
Office:    West Palm Beach Office
County:    Broward
Presiding Judge:    William J. Zloch
Nature of Suit:    Other Statutory Actions
Cause of Action:    15:1125
Jury Demanded By:    None
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Available Case Documents

The following documents for this case are available for you to view or download:

Date Filed   #   Document Text

December 30, 2014    115    Opinion or Order of the Court ORDER denying 95 Motion for Reconsideration. Signed by Judge Robin L. Rosenberg on 12/30/2014. (cgn)

January 23, 2015    117    Opinion or Order of the Court ORDER granting in part and denying in part 65 Motion to Dismiss. Signed by Judge Robin L. Rosenberg on 1/23/2015. (cgn)

March 16, 2015    157    Opinion or Order of the Court ORDER granting in part 74 Converted Motion for Summary Judgment. The Clerk of Court is Directed to Terminate the Society for Science-Based Medicine, Inc. from the Instant Suit. Signed by Judge Robin L. Rosenberg on 3/16/2015. (jua)

April 2, 2015    172    Opinion or Order of the Court MEMORANDUM OPINION AND ORDER on 6 Plaintiff's MOTION for Preliminary Injunction and Temporary Relief and Incorporated Memorandum of Law filed by Edward Lewis Tobinick, MD, Edward Tobinick, INR PLLC. The Motion is DENIED. Signed by Judge Robin L. Rosenberg on 4/2/2015. (cgn)
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