Another Lawsuit To Suppress Legitimate Criticism

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Another Lawsuit To Suppress Legitimate Criticism


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TG-1 * Transgallaxys Forum 1

Topic: Dr. Edward Tobinick and off-label use at law
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uggulin
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Posts: 2

Dr. Edward Tobinick and off-label use at law
� on: July 23, 2014, 09:20:34 PM �
The background:

http://www.sciencebasedmedicine.org/enbrel-for-stroke-and-alzheimers/

[*quote*]
Enbrel for Stroke and Alzheimer�s
Posted by Steven Novella on May 8, 2013 (30 Comments)

A recent article in the LA times
http://www.latimes.com/la-me-chiate-20130505-dto,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 expos� 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
http://www.sciencebasedmedicine.org/index.php/quack-clinics/ , 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
http://corporate.findlaw.com/intellectual-property/patents-on-medical-procedures-and-the-physician-profiteer.html
lost its case. Medical procedure patents are generally opposed by
medical organizations
http://www.wma.net/en/30publications/10policies/m30/ 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
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(05)64490-X/fulltext
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
http://www.ncbi.nlm.nih.gov/pubmed/23100196 �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.
Conclusion

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

@nickmPT

�[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

@windriven

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

@nickmPT

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

@nickmPT

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

@Sawyer

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

http://www.smh.com.au/national/health/patients-left-in-limbo-as-alzheimers-trial-awaits-ethical-approval-20120817-24dwa.html

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�.

The title is � RAPID RELIEF FOR ORTHOPEDIC SURGEON WITH SEVERE PAIN

I invite you to view the video and discuss!

Rapid Relief for Orthopedic Surgeon with severe pain

http://www.youtube.com/watch?v=qFsPIAMLSjU

nrimed�102 videos
Subscribe 816
5,182

Uploaded on 25 Nov 2009

Please see http://www.painbreakthrough.com.
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 http://www.painbreakthrough.com.
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 http://www.painbreakthrough.com. 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

@Zuppy

�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

@Zuppy

�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

Hmmm�

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

@Zuppy:

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(:551-9. doi:
10.1059/0003-4819-156-8-201204170-00002.
windriven says:
May 9, 2013 at 3:39 pm

@WLU

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

windriven:

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

@Chris

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 http://www.universitylaser.com/

also home of Institute of Neurological Recovery
http://www.instituteofneurologicalrecovery.com/

which was previously called Institute of Neurological Research.
http://www.nrimed.com/

INSTITUTE OF NEUROLOGICAL RECOVERY � A New Breakthrough for Stroke
and Traumatic Brain Injury (TBI)
http://www.strokebreakthrough.com/

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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uggulin
Newbie

Posts: 2

Another Lawsuit To Suppress Legitimate Criticism
� Reply #1 on: July 23, 2014, 09:25:46 PM �
http://www.sciencebasedmedicine.org/another-lawsuit-to-suppress-legitimate-criticism-this-time-sbm/

[*quote*]
Another Lawsuit To Suppress Legitimate Criticism � This Time SBM
Posted by Steven Novella on July 23, 2014 (39 Comments)

Gavel-court-legal-law-lawsuit

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
http://dockets.justia.com/docket/florida/flsdce/9:2014cv80781/443251 for
an article that I wrote in May of 2013 on Science-Based Medicine
http://www.sciencebasedmedicine.org/enbrel-for-stroke-and-alzheimers/ .
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
http://www.strokebreakthrough.com/wp-content/uploads/CV.ET_.Sept2010.final2_.pdf
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:
http://www.wma.net/en/30publications/10policies/m30/

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:
http://www.casewatch.org/board/med/tobinick/accusation.shtml

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.




by Taboola
Sponsored Content
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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?
Reply
Jeff Clegg says:
July 23, 2014 at 9:57 am

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

My first thought.
Reply
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
(http://www.theskepticsguide.org/support).

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.
Reply
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.
Reply
David Gorski says:
July 23, 2014 at 8:03 am

It�s Florida.
Reply
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.
Reply
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.
Reply
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.
Reply
Unity says:
July 23, 2014 at 8:33 am

Time to contact Ken White and get him to send up the Popehat signal
� http://www.popehat.com
Reply
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.
Reply
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!
Reply
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 b�illons 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!
Reply
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.
Reply
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.
Reply
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.�

Reply
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.
Reply
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
Reply
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.
Reply
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.
Reply
daedalus2u says:
July 23, 2014 at 12:56 pm

You might want to look at this paper

http://www.jci.org/articles/view/75073

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
Reply
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�
Reply
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
ScienceBasedMedicine.org. I�ll be doing my bit to help get that
Streisand effect going. And munching my popcorn�
Reply
Windriven says:
July 23, 2014 at 2:37 pm

His Wikipedia entry could use some editing :-)
Reply
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.

http://en.wikipedia.org/wiki/Strategic_lawsuit_against_public_participation
Reply
smh says:
July 23, 2014 at 1:48 pm

Don�t forget to sue for attorney�s fees.
Reply
Mikael Nyl�n 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!

/Mikael
Reply
thetentman says:
July 23, 2014 at 1:57 pm

Good luck with the lawsuit. Nobody on Yelp likes him either.

http://www.yelp.com/biz/tobinick-edward-md-los-angeles
Reply
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.
Reply
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.
Reply
Doug Attig says:
July 23, 2014 at 3:02 pm

Attorneys who take cases like this should be disbarred, IMO.
Reply
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.
Reply
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 (https://fundanything.com/patenttroll?locale=en).
Reply
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
Reply
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.
Reply
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.
Reply
KillCurve says:
July 23, 2014 at 4:26 pm

What a slimeball! So thrilled to see you fight!
Reply
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.
Reply
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