05/06/2019    Jeff Bean, DPM

Laser Treatment Reported Ineffective for Onychomycosis Related to Diabetes (Adam Landsman, DPM, PhD)

I have seen successful clearing of mycotic
toenails with laser treatment most of the time.
However, it almost never works as mono-therapy.
It must be combined with consistent use of
effective topical medications, frequent thorough
debridement, consistent shoe disinfection, and
treatment of the skin with a topical antifungal
cream. If you are missing any of these
components, you are simply “shoveling in a fungal
snowstorm.” It’s like giving antibiotics but not
climbing out of the septic tank with your open
wound.

But wait, there’s more. The condition will almost
always recur without long term prevention,
including shoe disinfection, topical medication a
few times a week, treating any tinea pedis as
soon as it appears, treating any underlying
conditions (ie., hyperhidrosis), and returning to
twice daily treatment (and perhaps another laser
treatment) whenever an area of onychomycosis
first re-appears. I tell each patient that
treatment WILL NOT WORK if they do not do ALL of
these things. I have been doing this for 7 or 8
years with a very high success rate. We track
those patients we can still find, and have had
85% or higher success rate among the compliant
and committed patients each year.

Does the right wavelength of laser kill
dermatophytes? Yes it does. Does it kill them
all (and their spores)? Get real, no way. Can it
cure or even cosmetically clear moderate
onychomycosis by itself? Almost never. Will it
work on extreme toenails? No, there is too much
nail unit and matrix deformity to expect a crazy
nail to normalize even if every organism were
eliminated. Can it be the foundation of a very
effective multi-faceted treatment program that
will clear the toenails most of the time?
Absolutely, but only for the motivated patients.
Is the clearing permanent? ONLY if your patient
sticks with the preventative maintenance program.

I think oral terbinafine would also have a >85%
success rate if all the other pieces were in
place. Fungus is everywhere. Those who are
susceptible to it WILL be infected eventually.
Those who cure it WILL be re-infected without
prophylaxis. There is NO single therapy that is a
lasting cure. However, there are protocols that
work VERY well if the you cover all the bases and
the patient is motivated to stick with it. It’s
not even time-consuming or expensive for them (as
long as you are not greedy with your pricing).
They just have to remember to stick with it. Many
women and a few men really will do this
successfully if you teach it comprehensively.

The argument that any single treatment does not
reliably cure onychomycosis is undeniably true.
These studies are asking an important question,
but not the entire question. Does any single
treatment cure all plantar fasciitis or
rheumatoid arthritis, or most other chronic
conditions? No way! I urge everyone who treats
this stubborn problem to look at the bigger
picture, develop a protocol, treat it thoroughly
from every necessary angle, and you (and the
motivated patient) will usually achieve a lasting
difference.

Jeff Bean, DPM, Carson City, NV

Other messages in this thread:

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05/10/2019    Bryan C. Markinson, DPM

Laser Treatment Reported Ineffective for Onychomycosis Related to Diabetes (Adam Landsman, DPM, PhD)

When the laser technology achieved very anemic
approval for "temporary clearing of nails," as
did all lasers marketed for onychomycosis, it
seemed as if every five minutes in NYC a DPM was
advertising on the radio about it. Unfortunately,
the overwhelming majority of the ads gave the
listener the impression that laser was a quick
"zap" cure that was permanent, without actually
saying so. Most ads pushed the limit excessively
and unethically to give that impression without
running afoul of the law. Some state boards
actually took action against this advertising.

Soon enough, the Internet was full of patient
postings that laser treatment for onychomycosis
was a sham. How unfortunate to ruin a potentially
efficacious adjunctive treatment based on
overzealous marketing and no science whatsoever
accept a declaration of FDA approval or
clearance. Patients showed up regularly in my
office with histories of the lasers being applied
to nails that were never properly worked up or
laboratory confirmed, further creating undeserved
impressions that the lasers in use were not
efficacious.

Around that time, the principals of two laser
companies met with me to discuss opportunities
to be a key opinion leader in behalf of the
companies. I was certainly interested in working
with one of them (the other had delays in getting
FDA clearance) with one significant condition,
and that was that they reign in their users of
the laser from their marketing tactics that were
successful, but clearly unethical and potentially
damaging to the technology, and the podiatry
profession. I had similar discussions with
several of the laser companies getting into the
market.

Universally, the principals of the companies
rejected my concerns and stated that they have no
control over what the doctors do once they buy
the machine, and made no attempt to even consider
my points for obvious reasons. Several sales
representatives for the various companies
addressed my concerns of lack of laboratory
confirmation before use of the laser as not
"major" because the procedure was largely
cosmetic.

Still to this day, the true potential for these
technologies go unknown due to lack of good
studies in peer reviewed literature, though
podiatrists all over the country have their
"protocols" which they tout as very successful
but refuse to publish. Interestingly, and
expectedly, the dermatology profession has never
been impressed and has not at all embraced it for
treatment of onychomycosis. So although Dr.
Landsman's protestations that laser technology
has gotten a bad rap is a position I agree with,
he and others may have done more to reduce the
root causes of this, which largely can be laid at
the feet (no pun intended) to no one else but
ourselves.

Bryan C. Markinson, DPM, NY, NY

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05/09/2019    Allen Jacobs, DPM

Laser Treatment Reported Ineffective for Onychomycosis Related to Diabetes (Adam Landsman, DPM, PhD)

Mark Twain stares that “facts are stubborn
things. But statistics are pliable”.
Let us look at facts.

Fact: Current “ approved lasers for onychonycosis
“ have been cleared through the 510k process, not
by virtue of prof of efficacy.

Fact: Treatments which affect the appearance of a
nail do not imply resolution of fungal infection;
Fact: We do not know if special populations (eg:
diabetics, immunocompromised, chemotherapy)
respond differently;

Fact: The FDA recommended labeling states the
following; “ indicated for adjunctive use in the
temporary increase in clear nail in patients with
onychomycosis. This device should be used with
manual debridement and/or topical antifungal
products.”

Fact: The FDA further notes; “WARNING: these
devices should be used with caution in patients
with diabetes, peripheral vascular disease, or
immune-suppression, or any other medical state
which warrants definitive antifungal therapy“
(note: it is not potential physical harm from the
laser, it is the denial of needed treatment which
is the issue );

Fact: The FDA is clear that “this device has not
demonstrated effectiveness in the treatment of
onychomycosis. It is cleared only for improvement
in nail appearance “

Fact: Published studies are frequently of small
sample size, often lack a control group,
demonstrate limited efficacy, and often do not
require either clinical or mycological cure as
end points

Fact: Of those studies published, the average
mycological cure rate is 11%, clinical cure rate
13%, and “ clinical improvement ranging from 36%
to 67%; these do not meet criteria for medical
improvement

As Mark Twain so aptly stated; “statistics are
like garbage. You better know what you’re going
to do with it before you collect it.”

Allen Jacobs, DPM, St. Louis, MO

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05/06/2019    Allen Jacobs, DPM

Laser Treatment Reported Ineffective for Onychomycosis Related to Diabetes (Adam Landsman, DPM, PhD)

As do many in our profession, I hold Dr. Adam
Landsman with the highest regard. His commentary
is well taken and deserves consideration. Dr.
Landsman, however, fails to inform the readers of
his research and consulting relationship with
laser manufacturers from which relations he was
rightfully paid. This is the very type of
potential bias and conflict of interest which
concerns me. Dr. Landsman’s published works on
the subject of laser management of onychomycosis
are worthy of review and consideration. His
insight and conclusions are always of import to
our profession.

Dr. Landsman dutifully notes that lasers are
cited as ineffective for the treatment of
onychomycosis because the condition is
“incurable“. Why then suggest that lasers effect
a cure? In point of fact, FDA published
guidelines call for interdiction of advertising
which suggests that lasers are effective for
treating onychomycosis. That is exactly by point.
Switch and bait advertising such as “FDA
approved“ refer to safety, not efficacy.

For as many years as I can recall (and those
years are increasingly difficult to recall),
Warren Joseph has called for active treatment of
this disorder, not just palliation. I should
like to modify his call in the following manner;
EFFECTIVE active management and control.

It is my firm belief that our profession, as
American and British dermatology associations,
should establish recommended protocols for the
EVALUATION and TREATMENT of onychomycosis.
Establishment of standards of care, absent
corporate bias and absent conflict of interest,
provides preferred clinical guidelines which both
benefits patients and Podiatric physicians. The
relative free for all “anybody with a checkbook
can purchase lecture time “at a CME meeting must
be discontinued.

I can guarantee that if I were to give an
“unrestricted educational grant “of $30,000 to a
meeting, you’d hear me lecturing on moonlight
curing onychomycosis. And I can equally guarantee
you that if I pay speakers $2,000, I’d have no
shortage of thought leaders climbing over each
other to give those lectures with corporate
approved slides. And finally, if I offer free
steak dinner and drinks, I’d fill the room for
those speakers.

Never forget: it is the first mission of
corporations to sell product and make money. It
is your first mission and ONLY mission (legally a
duty) to provide appropriate medical to those
seeking your guidance. Those receiving corporate
money for CME activities are serving two masters,
one of which may not be that of patient best
interest.

Allen Jacobs, DPM, St. Louis, MO

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05/06/2019    Jeff Bean, DPM

Laser Treatment Reported Ineffective for Onychomycosis Related to Diabetes (Adam Landsman, DPM, PhD)

I have seen successful clearing of mycotic
toenails with laser treatment most of the time.
However, it almost never works as mono-therapy.
It must be combined with consistent use of
effective topical medications, frequent thorough
debridement, consistent shoe disinfection, and
treatment of the skin with a topical antifungal
cream. If you are missing any of these
components, you are simply “shoveling in a fungal
snowstorm.” It’s like giving antibiotics but not
climbing out of the septic tank with your open
wound.

But wait, there’s more. The condition will almost
always recur without long term prevention,
including shoe disinfection, topical medication a
few times a week, treating any tinea pedis as
soon as it appears, treating any underlying
conditions (ie., hyperhidrosis), and returning to
twice daily treatment (and perhaps another laser
treatment) whenever an area of onychomycosis
first re-appears. I tell each patient that
treatment WILL NOT WORK if they do not do ALL of
these things. I have been doing this for 7 or 8
years with a very high success rate. We track
those patients we can still find, and have had
85% or higher success rate among the compliant
and committed patients each year.

Does the right wavelength of laser kill
dermatophytes? Yes it does. Does it kill them
all (and their spores)? Get real, no way. Can it
cure or even cosmetically clear moderate
onychomycosis by itself? Almost never. Will it
work on extreme toenails? No, there is too much
nail unit and matrix deformity to expect a crazy
nail to normalize even if every organism were
eliminated. Can it be the foundation of a very
effective multi-faceted treatment program that
will clear the toenails most of the time?
Absolutely, but only for the motivated patients.
Is the clearing permanent? ONLY if your patient
sticks with the preventative maintenance program.

I think oral terbinafine would also have a >85%
success rate if all the other pieces were in
place. Fungus is everywhere. Those who are
susceptible to it WILL be infected eventually.
Those who cure it WILL be re-infected without
prophylaxis. There is NO single therapy that is a
lasting cure. However, there are protocols that
work VERY well if the you cover all the bases and
the patient is motivated to stick with it. It’s
not even time-consuming or expensive for them (as
long as you are not greedy with your pricing).
They just have to remember to stick with it. Many
women and a few men really will do this
successfully if you teach it comprehensively.

The argument that any single treatment does not
reliably cure onychomycosis is undeniably true.
These studies are asking an important question,
but not the entire question. Does any single
treatment cure all plantar fasciitis or
rheumatoid arthritis, or most other chronic
conditions? No way! I urge everyone who treats
this stubborn problem to look at the bigger
picture, develop a protocol, treat it thoroughly
from every necessary angle, and you (and the
motivated patient) will usually achieve a lasting
difference.

Jeff Bean, DPM, Carson City, NV

---

05/05/2019    Richard Silverstein, DPM

RE: Laser Treatment Reported Ineffective for Onychomycosis Related to Diabetes (Adam Landsman, DPM, PhD)

I whole heartedly agree that we must be very
careful when treating onychomycosis with lasers.
If there is an active tinea infection it must be
treated along with the onychomycosis, if optimal
results are desired. Culture results
demonstrating the presence of a fungal infection
is always an appropriate step prior to initiating
therapy.

Why is it we must be on guard especially in our
diabetic and vascularly compromised patients? I
presume it is to prevent a burn from the heat
build-up of a thermal laser. Our diabetics who
may have neuropathy may not be able to tell us
that something hurts when heat is generated
within the nail plate or nail bed. We also don’t
want to cause a burn in patients whose
circulation is less than adequate to heal a
thermal injury.

This is the crux of my issue when the term
“laser” is tossed about. Not all lasers produce
heat. If the FDA is using this term, it should
responsibly be preceded by “thermal" or "non-
thermal". There is absolutely no contraindication
in diabetics or PAD patients to use an automated,
non-thermal, FDA cleared laser for onychomycosis
(The Lunula Laser).

In the thousands of patients that have been
treated with the only low level, non-thermal
laser (510 K cleared by the FDA) with a
wavelength of 405 nm and 635 nm there has never
been any adverse event reported.

In fact, due to the nature of the mechanism of
action of low level lasers, photobiomodulation,
there is a sustained hyperemic effect which
stimulates the bodies immune system to help fight
the fungal infection. This has been confirmed
with ultrasound.

One size never fits all when tailoring a
treatment protocol for a patient. Some do not
want to be placed on medication no matter how
safe it is. Others want to try everything at
once: creams, pills and non-thermal laser
included. And yet others come in asking for non-
thermal laser therapy, specifically. Our job is
to provide the relevant information so an
educated decision can be made by the patient.

Disclosure: I am a consultant for the Erchonia
Laser Corporation

Richard Silverstein, DPM, Havre de Grace, MD