©2005-2020 Unimax Supply Co Inc. NY, NY

Quoted in Where's the Evidence
Drummond Rennie, editor of the
Journal of the American Medical Association.

“There seems to be
no study too fragmented,
no hypothesis too trivial,
no literature citation too biased,
or too egotistical,
no design too warped,
no methodology too bungled,
no presentation of results too inaccurate,
and too contradictory,
no analysis too self-serving,
no argument too circular,
no conclusion too trifling,
or too unjustified and
no grammar and syntax too offensive
for a paper to end up in print."
p27

 

By Westley Wood May be sourced provided citation.
Sunday, April 03, 2005

Toxic Tattoo Ink Examination, of a Medical News Today Article


As I understand The Toxic Tattoo Ink Argument, it does not stand up to scrutiny.

The danger for tattoo is that false arguments will be used by the
Laser Tattoo Removal specialties, Cosmetic and Pharma Companies to hijack FDA into forcing tattooists to use only inks that are laser removable - and colorants only available to FDA licensed facilities of production. (Dr. R. Rox Anderson)
Below is an examination of this article illustrating how unscientific so-called "scientific" reporting can be.
By Westley Wood (Original Text indented in black)

The article will refer to Dr. Anderson as well.
Medical News Today (MNT) Article is about the
"scientific" paper presented to the American Chemical Society.
Chemicals in tattoo inks need closer scrutiny
, 14 Mar 2005
Source:
http://www.medicalnewstoday.com/medicalnews.php?newsid=21202

The first sentence:

As tattoos have grown in popularity,
so have complaints of adverse side effects
associated with both their application and removal.


The statement quoted is a lie.

-A mere claim we dispute and will argue that the safety of the
inks currently used confirms, proves, that tattoo
inks are safe and effective by 100s of millions of tattoos
by tens of thousands of tattoo artists for the
last 30 years. Facts that we can testify about.


Consider that the MNT statement to be true we would have to know

--a) the number of complaints relative to
--b) the number of tattoos at a point in time
--c) both before and
--d) after the date of popularity.

the disappointment is from doctors and laser technicians not getting the results they want using laser technology: Clients are not getting the results promised.

Tattooists are sympathetic to the anguish experienced leading to removal. It has nothing to do with the application of the tattoo. This is not the place for examining the cultural, psychological role of tattooists in the process. 

The purpose of the study is stated openly: to help justify regulation of tattoo ink: if the presence of certain chemicals is detected then tattoo ink should be regulated, i.e. prohibited ingredients - the one's that cannot be easily removed with lasers.


As a tattoo ink supplier for 35 years, the second in line to hear adverse-effect-reporting we state that reports of any kind are rare. The few cluster of cases we hear are from pre-bacterial contaminated non-sterile ink or mixing non-sterile diluents into ink.  Any argument based on under-reporting is not considered valid unless a study is done to support the theory. No study has been done.

As it is, laser removal works but should be recognized as un-reliable and may be causing harm. Don't be surprised. Studies of the health effects of laser removal are conspicuously missing. If anything, the FDA should take a long hard look at the laser's damaging effects on the body and what new chemicals are being created by the transforming effects of the laser. Medically trained laser specialists claim they don't know. Therefore they don't comment.

The goal is to have the FDA remove tattoo inks from the market that are not adequately removable by Anderson's lasers.

Quote from Dr. R. Rox Anderson,The Archives of Dermatology: 2001

Like it or not, we are charged with caring for the nation's skin problems, including self-inflicted ones. Unless something changes, we are going to disappoint the thousands of persons getting tattoos, who eventually show up at a dermatologist's practice to get them removed..
...If the most stubborn-to-remove tattoo inks can be identified, we might predict which patients will do poorly, and perhaps these inks can be taken off the market.
But, what else can be done?
This editorial will address the following topics:
(1) improving the clearance of tattoo ink particles after laser treatment,
(2) optimizing the laser–tattoo ink interaction
(3) eliminating difficult-to-remove, antigenic and/or toxic tattoo inks from the market and
(4) designing new tattoo inks.
Archives of Dermatology,
Regarding Tattoos: Is That Sunlight, or an Oncoming Train at the End of tR. Rox Anderson, MD, Vol. 137 No. 2, February 2001

Anderson's report goes on to explain that option 1 and 2 either don't work, can't be done, or are unlikely to be achievable. Option 3 is his answer because he created (4) Infinite Ink, more easily removable with lasers, but it failed in the market place. We know because we bought into the idea of having an option available for consumers. Tattooists need to see 10 year old tattoos after ten years. Infinite Ink is an unknown requiring a significant usage over time to try. Tattooists are the last people in the world to experiment on customers.

The answer is (3): removal of inks that cannot be removed by lasers. .
From Anderson's article: "Regarding Tattoos" the process is described.

What and where are the tattoo ink particles?

Tattoos consist of phagocytosed submicrometer ink particles trapped in the
lysosomes of phagocytic dermal cells, mostly fibroblasts, macrophages, and mast
cells.

What happens during laser removal?

When extremely intense (100 million W/cm2), brief (billionths of a second) light pulses are absorbed by these intracellular ink particles, they reach extreme temperatures (at least 300°C). The particles fracture, undergo chemical changes, violently boil water in the cell cytoplasm, rupture the cells, and release laser-altered ink into the dermis.

Some of this free ink is eliminated by lymphatic and transepidermal transport, but most of it is rephagocytosed by somatic dermal cells within a few days.

The cells again trap remaining smaller ink particles that have not been removed.

This rephagocytosis accounts for the "residual" tattoo after each laser treatment; we found that essentially all of the residual tattoo ink particles were ultrastructurally altered by a single, previous laser treatment.
Each successive laser treatment alters the structure and therefore the properties of pigments. All the ink particles are reduced in size and altered chemically by a first laser session but within a few days the body responds by healing cells migrating back into the area and re-phagotize the particles still there. The body works too fast to repair itself for laser success. Cells enter the area quickly and start trapping the particles. Each laser session now has to blast the replacement cells which have re-phagocytosed the ultrastructurally changed ink particles again and again until eventually all the ink is gone.

Here is a notice, Dec. 2017  from an ink manufacturer:

Due to the increasing usage of laser removal tattoo treatments, we have begun to review our raw materials and colors in the overall digestion process. The total digestion method indicates that the following tattoo inks may cause the release of heavy metals above the legal limit in case of laser removal. In the extraction process our colors do not exceed the legal limit.

 The following is from The Archives of Dermatology: 2001
Like it or not, we are charged with caring for the nation's skin problems,
including self-inflicted ones. Unless something changes, we are going
to disappoint the millions of persons getting tattoos, who eventually
show up at a dermatologist's practice to get them removed.

Dermatologists consider tattoos self-inflicted skin problems.


...If the most stubborn-to-remove tattoo inks can be identified, we might predict which patients will do poorly, and perhaps these inks can be taken off the market. [Emphasis added.]
But, what else can be done?
This editorial will address the following topics:
(1) improving the clearance of tattoo ink particles after laser treatment,
(2) optimizing the laser–tattoo ink interaction,
(3) eliminating difficult-to-remove, antigenic and/or toxic tattoo inks from the market,and
(4) designing new tattoo inks.
Archives of Dermatology,
Regarding Tattoos: Is That Sunlight, or an Oncoming Train at the End of the Tunnel? R. Rox Anderson, MD, Vol. 137 No. 2, February 2001


Anderson's report goes on to explain that option 1 and 2 either don't work, can't be done, or are unlikely to be achievable. Option 3 and 4 are the answer. In short, the  detection of the presence of toxic chemicals is to be championed by laser doctors to push for the forced removal of inks that cannot be removed (so that lasers will work). Because lasers don't work good enough is the problem.

From this same article: "Regarding Tattoos"
the process is described.

What and where are the tattoo ink particles?

Tattoos consist of phagocytosed submicrometer ink particles trapped in the
lysosomes of phagocytic dermal cells, mostly fibroblasts, macrophages, and mast
cells.

What happens during laser removal?

When extremely intense (100 million W/cm2), brief (billionths of a second) light pulses are absorbed by these intracellular ink particles, they reach extreme temperatures (at least 300°C). The particles fracture, undergo chemical changes, violently boil water in the cell cytoplasm, rupture the cells, and release laser-altered ink into the dermis.

Does this sound scary?

Some of this free ink is eliminated by lymphatic and transepidermal transport, but most of it is rephagocytosed by somatic dermal cells within a few days.

The cells again trap remaining smaller ink particles that have not been removed.

This rephagocytosis accounts for the "residual" tattoo after each laser treatment; we found that essentially all of the residual tattoo ink particles were ultrastructurally altered by a single, previous laser treatment.

All the ink particles are reduced in size by a first laser session but within a few days the cells migrate back into the area and rephagotize the particles still there. The body works too slowly for laser success. Cells enter the area again and start trapping the particles. Each laser session now has to blast all the new cells, again and again. The army keeps marching forward and the laser keeps cutting them down until eventually all the ink is gone. It occurs to me to ask if this is safe and "good" for the body.

Lymphatic transport seems to account for most of the ink removed, although ink is sometimes shed in a scale-crust after each treatment.

What happens to those particles? Where do they go? What is known? What actually happens chemically?

Although it is clear that chemical reactions occur during laser treatment, we know almost nothing about them.

Did we read that correctly?? We know almost nothing...?

But I don't believe it. I suspect that laser manufacturers have studied this and are keeping their findings to themselves. It's a sure thing they are not sharing.

For carbon tattoos, the chemistry may be "good." Homemade tattoos made of carbon
(india ink, graphite, ash) are easy to remove. Perhaps the reason for this is
simply that carbon can burn.


And how good is burned carbon in the body? To the Doctor "good" is not defined by body chemistry and client safety but by the ink "disappearing" beneath the surface. Out of sight out of mind.

For other tattoos, the laser-induced chemistry may be "bad." Cosmetic tattoos containing red iron oxide (FE2O3) and titanium dioxide turn black on Q-switched laser
treatment.
The word "cosmetic" reveals their "permanent cosmetic" orientation and that is their money-making market segment but they have to regulate tattoo ink to get their way.

Or maybe the know that lasers break down tattoo ink into toxic chemicals. Which it does.

Which leads to the call for action and battle plan -- change tattoo.

The inks that darken could easily be identified and potentially removed from the market...This is a good idea. (They say)

Many, if not most tattooists are professionals who genuinely care about the well-being and long-term satisfaction of their clients. These tattooists would gladly stop using problematic inks.

 

Problematic inks? The inks are not the problem. The lasers are the problem and can't be fixed so the ink needs to be changed to insure the profitability of doctors wedded to their lasers.

Notice the manipulation -- tattooists called "Professionals who genuinely care" who would "gladly stop" using their inks. Wait to you hear what he really thinks about tattoo professionals.

In the first half of the last century some inks contained chemicals that produced adverse effects and these chemcials were abandoned - the same process by which medicine has advanced. So why this double standard because some types of inks were used a century ago.
Implicit to the meaning of a tattoo is its irrevocable and permanenece. Part of the attraction (a horrible concept to some).


Remove-ability is not the problem seeking an answer. The problem is laser technicians who want 100% success.

The Food and Drug Administration, which does not approve any tattoo inks, should
be willing to remove some from commerce if there were good data and a formal
request to justify such action.


Kind of schocking to see such a blunt intention to use the FDA to change tattoo because these doctors can't get their lasers to remove all pigments.

It is unlikely the FDA will regulate tattoo inks without real scientific justfication. They are certainly not going to be fooled by chemistry students claiming epidemiologic expertise and insight.
For example, cinnabar (mercuric sulfide), an antigenic red ink that contains mercury, was removed from the US market long ago.

This is a tricky deception - these inks were not "removed" at all, but abandoned by tattooists.
It wasn't the FDA or any other body that stepped in and saved tattoo clients, but the tattooists that stopped using inks that caused client problems.


Tattooers are the most knowledgeable observers of tattoo and any adverse reactions. Tattooers are the first to see, the first to understand and the first to
act in the best interest of the greatest satisfaction for tattoo clients. This author distorts the record by omission leaving the reader to believe the FDA acted to do that and they need now to do more.
Because tattooing extends into prehistory and will extend far into the future, it simply makes sense for us to figure out how to "do it right."


Do it Right?
What did he say ? ?
So for thousands of years humanity has got it all wrong.
Anderson's
"Doing it Right" is to make it removeable by his lasers.
Who can take this seriously?
 

In view of the care we take for testing and prescribing drugs, how should we feel about the fact that 1 in 20 Americans will be injected with unknown impure substances by people with little or no medical training?


Have you ever read such loaded language of manipulation:
drugs, injected, unknown, impure, substances by people--

--2 sentences ago he called tattooists professionals, now tattooists are untrained "people" with little or no training in medicine. Where did medical training pop up?


It would seem medical training according to the doctor must be a prerequiste to being a tattooist. Of course, ... he's the doctor. People shouldn't be allowed to.
Ten years ago or more doctors were advocating permanent cosmetic tattooing be done by licensed doctors only, and yes, nurses under their supervision.

There are several schemes that could be used to design easily removable tattoos.

A market segment would want laser removable inks. This would be a good contrbution for tattoo. But an additional option is a far cry from banning permanent inks for the sake of laser technicians. New inks would be welcome to expand the world being touched by tattoo - now everyone can have the experience. Would removable inks mean minors would be getting tattooed?

The program is to use toxic arguments to reformulate ink.


Why should laser removal be advocated when nobody knows or even cares to know how these lasers are effecting the body?

Answer: because doctors want to make money too?

This effort itself is proof that the laser industry has failed as a reliable predictable option for tattoo removal and seem unable improve their product.

This emperor is naked.

The Medical News Article continues:

A new study, done by chemistry students at Northern Arizona University, looked at the chemical composition of a variety of tattoo inks to better understand their potential health risks.
The study was not looking at the chemical composition of inks at all but testing to find the presence of "toxic" elements.

It was not and does not contribute to any understanding of potential health risks – that's epidemiology -- not what chemistry students do in a lab exercise looking for specific compounds or elements in a liquid.

Totally surprising that this should appear in writing in a medical news paper and
before the American Chemical Society.
The findings, presented today at the 229th national meeting of the American Chemical Society, the world's largest scientific society, suggest that closer regulation of the tattoo industry may be warranted, according to the researchers.


This is known as a fallacy in logic: the conclusion does not follow from the evidence. Though the presence of a toxic chemicals may be detected, that is not evidence that harm is of any magnitude that FDA regulation is required or that there is any harm done. Hundreds of millions of people the world over get tattooed without adverse side effects.
Chemistry students need courses in logic and scientific method. They probably don't get any.

Although inks used in tattoos are subject to regulation by the U.S. Food and Drug Administration as cosmetics and color additives, the agency has not traditionally regulated them, letting the task fall to local jurisdictions, according to a fact sheet issued by the FDA Office of Cosmetics and Colors cfsan.fda.gov/~dms/cos-204.html. This effectively gives a tattoo artist license to inject whatever he or she deems appropriate under the skin, according to the researchers.


The author intentionally leaves out the reason why the FDA does not regulate tattoo inks:
there is not evidence of harm other than isolated anecdotal cases.

"Tattoos are no longer limited to the rough and rowdy," says Haley Finley-Jones, an undergraduate chemistry student and lead author of the study. "With the growing popularity of tattoos among young people, it is vital that we develop a better understanding of this form of self expression.


We don't have to comment on this statement because it is philospohical-psychlogical without an understandable meaning.

The new research - a joint effort between Finley-Jones and Leslie Wagner as part of an undergraduate research project directed by Jani Ingram, a professor of chemistry at NAU - has two main goals: to characterize the diversity of tattoo inks, and to determine if any inks pose health threats in the form of heavy metals or other potentially dangerous chemicals.


The first goal is a good exercise and reasonable. To determine health threats by means of a lab analysis drawing epidemiologic conclusions about health is absurd.
The second goal is improper and not achievable - by any scientific process.

To be toxic, chemicals require dose amounts, per kg, per exposure and by cumulative exposure.


Toxic to human health is relative. Doseage, weight of the subject, how many exposures and the ability of the body to handle the toxic substances determine health. The goal is incorrect and would not follow from any analytical chemical analysis. Students as well as their professors need serious remedial training about good scientifc methodology.

Overall, the study covers 17 inks from five different manufacturers.
"We chose to study five different brands of black ink as it is the most common
color used in tattoos," Finley-Jones says.
The researchers also are testing three different brands of red, blue, yellow and white ink. Tattoo artists frequently mix inks to achieve the desired color, so the researchers selected their samples based on the most likely base colors.

Because there have been no previous studies, they are using analytical techniques that can test for a wide variety of chemical components, rather than looking for a specific group of compounds.


Not only wrong but may be considered deceitful at worst, incompetent at best because they claim to have searched the records and found nothing. Another failing.

In fact, Spaulding's inks were the subject of a published study – that they must have known about. They did not contact this ink manufacturer, asking if any studies were done on the inks.

Surprise! we already did chemical analyses of our tattoo inks which we would have gladly shared - if we had been asked. But their study was probably considered "cool" and undoubtedly encourage by their professor as subjects the kids were interested in.

Unfortunately the predetermined goals and method of presentation harms the tattoo industry by
false unfounded allegations with an attempt to generate fear in the general public. The distortion and unwarranted conclusions about the safety of tattoo inks needs an apology and should be withdrawn. The students deserve an F.

This study should be publicly discredited. The professor should be talked to.

At this point in the study, we have determined that the inks do in fact vary in composition from manufacturer to manufacturer and from color to color," Wagner says. The researchers also have found some indication of the presence of metals, and are in the process of running more tests to verify the identity of the metals.


The presence of toxic metals isn't even demonstrated and the conclusions are published before the evidence is confirmed.

A number of potential health problems might be stemming from the lack of oversight, according to the researchers. There have been a variety of claims that tattoo inks cause adverse effects in people, including allergic reactions to ink components, a burning sensation during the course of MRIs, and the migration of inks to different tissues in the body, such as the lungs.
The dreaded "dire" consequences finally appear. These statements can't be taken seriously.

How is it possible to think the statement makes sense -- that "potential" health probelms could have been prevented by the FDA ridding ink of even detectable levels of certain chemicals. There is no evidence that these "adverse" reactions are caused by these chemicals' presence.

The Institute of Health wrote book after book decrying the lack of evidence based public health policies and here we see a perfect example of how students are being prepared.

This sentence isn't even grammatically possible to be meaningful.

There is no evidence – not one piece - that links so called "adverse" effects with any ingredient - the exact composition of which still remains unconfirmed, unchecked.

And the "researchers" go even further suggesting that the cause is the lack of oversight (by the FDA).

If they read FDA statements they would have learned what allergic reactions are and that clusters of cases would be required to determine if there was sufficient evidence for a study.

"Burning" sensations during MRI is made-up, folk tales without documentation or evidence.

Migration to different tissues in the body is known for anything taken into the body and is not evidence of harm. Tattoo ink going into the lungs is a real mystery. In all my years this has never been heard of, not even from pathologists.

It is unclear, however, what the specific causes of these reactions might be, and the only way to gain better understanding is to know what chemicals make up the inks, the researchers say. Finley-Jones and Wagner expect that the variation found in their testing and the potential presence of toxic metals will encourage regulators to begin monitoring the tattoo ink industry more closely.
The researchers admit the don't know but then make sweeping pronouncements anyway.
We already know what is in the ink. This study is useful but not new, and now sensationalized.
Saying that knowing the specific composition of inks might help understand the reasons for adverse reactions is again an error.

The list of three adverse reactions: 1) allergy, 2) burning MRI sensations and 3) ink going into other "tissue" are not problems at all.

Even if a study were conducted about someone's allergic reaction (an isolated case) the results still may never be known. It would be an extravagant waste of taxpayer money pursuing this. It is only theoretical that inks containing iron oxides are pulled - and no record we can find of any reported adverse effect. And inventing a migration problem is just that, an invention. The authors want to encourage the FDA to monitor tattoo inks. What a huge waste of valuable resources that could be used for real health problems
There are other problems with unknown compositions of tattoo inks. For example, surgery to remove tattoos is becoming more widespread, and not knowing the composition makes the procedure more difficult. "Once the components of a tattoo ink have been identified, doctors removing the inks can use their knowledge of the chemical characteristics of the components to select a treatment that will be most effective and, hopefully, the least painful for the patient," Wagner says.


They mean laser surgery. And yes there are problems with laser surgery.

The American Chemical Society is a nonprofit organization, chartered by the U.S. Congress, witha multidisciplinary membership of more than 159,000 chemists and chemical engineers. It publishes numerous scientific journals and databases, convenes major research conferences and provides educational, science policy and career programs in chemistry. Its main offices are in Washington, D.C., and Columbus, Ohio.

- Jason Gorss

Haley Finley-Jones and Leslie D. Wagner are undergraduate chemistry students at NorthernArizona University in Flagstaff, Ariz.

Jani C. Ingram, Ph.D., is a professor of chemistry in the Department of Chemistry and Biochemistry at Northern Arizona University in Flagstaff, Ariz.

ANYL 248 In the flesh: Chemical characterization of tattoo inks

Haley Finley-Jones1, Leslie D. Wagner2, and Jani C. Ingram2. (1) Department of Chemistry andBiochemistry, Northern Arizona University, P. O. Box 5698, Flagstaff, AZ 86011, Fax: 928-5238111, hjf2@dana.ucc.nau.edu, (2) Chemistry and Biochemistry, Northern Arizona University

The intentions of this study are to determine the composition of tattoo inks as currently they are not regulated. While the components of topically applied make-up must be approved by the FDA, a tattoo artist has the license to use whatever he deems appropriate for injection into the skin. The hypothesis this study seeks to prove is that there is a great variety in chemical compositions for tattoo inks on the market. It is expected that the variation of results will be useful in support of regulating the tattoo
ink industry. To determine the actual variation of inks on the market, we will test several inks in a variety of colors. In this study we will employ a stepwise analytical approach to determine the chemical components of the ink samples. The results from metals analysis by ICP-MS and functional group screening by SIMS will be discussed.

Briefly explain in lay language what you have done, why it is significant and what are its implications (particularly to the general public)

Tattoos are no longer limited to the rough and rowdy. With the danger of dirty needles deteriorating, new potential risks are coming to the surface. The intent of this study is to determine the chemical composition of tattoo inks. It is widely unknown that tattoo ink manufacturing is not regulated by the FDA. Because of this, there are a number of potential health problems that might arise. There are other problems with unknown composition as well. For example, tattoo removal is becoming more prevalent and not knowing the composition makes it all the more difficult. In our research we have obtained a selection of inks varying in color and manufacturer. We are analyzing these inks using a variety of different techniques and methods. For health purposes, we are analyzing for heavy metals and other potentially dangerous chemicals. We are also trying to determine just how varied the components are. With the growing popularity of tattoos among young people, it is vital that we develop a better understanding of this form of self expression.

How new is this work and how does it differ from that of others who may be doing similar research?

This is the first scientific study done on the composition of tattoo inks. In literature searches, we were unable to find any similar research that had been published in a peer-edited journal.


They carefully word this so that they don't exactly hide but don't reveal they must know of the Garric Law Groups Toxic Tattoo Ink suit action from 2003 naming Spalding-Rodgers as well as ourselves, Unimax Supply Co. and others, based on toxic chemicals in our inks as violating California Proposition 65. This case is pending because the people of California in a referendum overturned the law that allowed private individuals to sue others if there are no victims.

It would be reasonable to think that this is where they got the idea to examine tattoo inks.

They did not contact us to ask if we had any information or chemical analyses of inks – which we do, and what aspects of the we consider important or what steps are we taking to assure the safety of inks. We were not contacted to see if we could help.

If they did a literature search they would have found a previous study examining Spalding-Rogers ink. It is not reasonable to think they did not find this information

I don't believe for a second that they had no information, starting with a blank slate. This is not reasonable to believe.

Quoted in Where's the Evidence
Drummond Rennie, editor of the Journal of the American Medical Association.
“There seems to be
no study too fragmented,
no hypothesis too trivial,
no literature citation too biased,
or too egotistical,
no design too warped,
no methodology too bungled,
no presentation of results too inaccurate,
and too contradictory,
no analysis too self-serving,
no argument too circular,
no conclusion too trifling,
or too unjustified and
no grammar and syntax too offensive
for a paper to end up in print." p27



Haley Finley-Jones
Department of Chemistry and Biochemistry
Northern Arizona University
P. O. Box 5698
Flagstaff, AZ 86011
Phone Number: 928-523-7877
Fax Number: 928-523-8111
Publishable Email: hjf2@dana.ucc.nau.edu

Contact: Michael Bernstein
619-525-6402, in San Diego
March 12-16, 2005
202-872-4445 (Washington, D.C.)
American Chemical Society
http://www.acs.org

This analysis made and posted by Westley Wood solely responsible for the contents.