To CITnews/Dr. Cole, about donor regeneration

Accepted abbreviated phrases exist. For example, another exists in the medical industry. When a patient is ready for surgery and a technician requests the doctor’s presence, the tech will pass a note to the doctor who may be in another room or on the phone etc. The note will say “Green in 2” That is the short version of; “the patient in surgery room 2 is ready for the doctor’s presence.”
Now if it were a patient using Licht’s reasoning, in the surgery room who overheard a technician pass the abbreviated phrase, “Tell the doctor we’re green in room 2”, there may be a danger of that patient latching on to another definition of the word “Green”. This patient might protest… I don’t want greenhorn trainees working on me, I paid good money and I demand experienced technicians.

Technically, the FDA uses a definition of the word “approved” that is considered “obsolete” in Webster’s dictionary:
ap·provedap·prov·ing
transitive verb
obsolete : prove, attest
According to the CDC, tobacco is responsible for approximately 5 million deaths worldwide annually.
“Approved” or “Approval” is used by the FDA as their official term for their safety and efficacy vindication process.
The FDA, an organization that exists to protect the public from harmful and ineffective products runs into trouble with the “approval” word because they approve the sale of tobacco products. That said, tobacco products have never gone through the FDA’s official Approval testing process and declared safe for public consumption.
There are numerous examples where the word “approval” has been used in the same context I am being criticized for with reference to the FDA giving the green light to a company, allowing sale of a product. That context is one of the common dictionary definitions meaning “consent or agree to”. The following are examples where others have used the word approve or approved without making reference to the FDA’s offficial process they have named the “Approval process”:

New York Times Article
In First, F.D.A. Rejects Tobacco Products
“Kenneth E. Warner, a public health professor at the University of Michigan in Ann Arbor, said the ruling might be an indication of the agency’s thinking on menthol. Newport cigarettes are traditionally menthol flavored, but the two types the agency approved did not contain the menthol additive. The agency is expected to rule on whether to ban menthol, but the timing is not known.”

Redorbit
First New Cigarettes Receive FDA Approval For Sale In The US
Furthermore, the FDA revealed 136 substantial equivalence applications had been withdrawn at the request of the applicants. According to Bloomberg, the agency had initially received 500 requests for approval from tobacco companies.
http://www.redorbit.com/news/health/1112883698/fda-approves-new-tobacco-products-from-lorillard-062613/

ABCNEWS
Congress Readies Bill to Give FDA Tobacco Oversight
However, the bills would not require FDA approval of tobacco products already on the market; only new products would need FDA approval before they could be sold to consumers. In addition, the FDA would not have the authority to increase the legal age for buying cigarettes or restrict where cigarettes are sold.

Consumerist
FDA Okays Two New Cigarettes Because They Are Just As Harmful As What’s Already Available
While the FDA is patting itself on the back over the SE process, the agency is also taking every opportunity to point out that approval of a new cigarette does not mean it’s any less harmful than what’s already available to smokers, nor does FDA’s go-ahead mean smoking is a good idea. In fact, tobacco companies are forbidden from saying their products are “FDA approved.”

Medical News Today
FDA Approves Two New Tobacco Products And Denies Four Others
Although the new products have some different characteristics to the predicate products, the FDA said that they do not pose any different questions of public health.
Products that raise questions of public health that are not substantially equivalent (NSE) will be denied approval to enter the market.
The four products that the agency didn’t approve lacked evidence to suggest that they did not raise different questions of public health.

Law Firm
After Decades, Is the FDA Ready to Crackdown on Tobacco Use?
“The Food and Drug Administration (FDA) recently announced it has rejected the approval of four proposed tobacco products while authorizing the marketing of two new ones.”
http://www.searcylaw.com/blog/after-decades-is-the-fda-ready-to-crackdown-on-tobacco-use/

NPR
Cigarette Makers Frustrated As Product Approvals Stall
“A clerk prices cigarettes at Discount Smoke Shop in Ballwin, Mo. The Food and Drug Administration, which must approve all new tobacco products or any changes to existing brands, has not cleared any products since assuming that responsibility in 2009.”

The above examples show that the word approval or approved is commonly used as an abbreviated version of, cleared for sale. This is not illegal or a deceptive misrepresentation you imply.

I was originally accused of using the word “approved” with regards to the FDA because it instills some kind of false endorsement of a product. When one considers the FDA approves the sale of tobacco, responsible for approx. 5 million deaths per year, that puts FDA approval in an entirely different light.

Speaking of jokes… After reading your posts, our associate who works with the FDA reminded me of the “joke” made in a film:
Leslie Neilson
Mimi Du Jour: Is this some kind of bust?
Lt. Frank Drebin (Nielsen): Yes, maam, its very impressive, but we need to ask you a few questions.

CITNews works at Dr. Cole’s office

Cole Hair Transplant
1045 Powers Place
Alpharetta, Georgia 30009
Phone 678-566-1011
I am not a doctor and the content of my posts are my opinions, not medical advice
email CITNews at chuck@forhair.com

licht, you made your point and there is no need to get personal. i think CITnews is very informative and participated in this nonsense more then any other’s clinic representative will ever do (except Jotronic :slight_smile: )
point is, Acell is a great solution and shows great promise, it is been used by many respected doctors and clinics and everyone knows that if Dr. Cole is using it then it’s perfectly safe. Dr. Cole choose very carefully what treatments are good for his patients and he is honest about the use and the success rate of Acell.
We need to give patients the confidence and not scare them from something that might benefit them.
so, bottom line:

  1. ACell is approved by the FDA for sale to physicians in the United States
  2. Dr. Cole, his patients and other highly respectable physicians report that Acell has regenerative properties
    Answer: That is safe enough for the patients to consider it.
    Is Acell FDA approved for regenerative properties? i don’t know, i guess not
    Answer:Who cares

licht, it’s all politics with the FDA!
here is a list of FDA approved products that have been withdrawn from the market because of risks to the patients:

This debate is good IMO but it can obfuscate what’s really important to patients… Effectiveness and safety. The FDA approves the sale of tobacco which is responsible for around 5 million deaths annually according to the CDC in Atlanta, GA.
I can’t find a single death that has been attributed to the use of ACell. In fact there is an article appearing on the FDA’s website that speaks highly of cell-based therapies:

“Cell-based therapies show great promise for repairing, replacing, restoring, or regenerating damaged cells, tissues and organs. Researchers are working to develop cell-based treatments that are both effective and safe.”

Next the paper goes on to describe the role extracellular matrix (ACell is an extracellular matrix product) plays in tissue regeneration:

“Scientific Overview
Our research program uses animal models and cell cultures to study how cells multiply and differentiate (mature into specialized cells with limited, specific functions). We also study the effects on cells of their microenvironment, both inside and outside of the body. The microenvironment is the immediate area around cells. Parts of the microenvironment include other cell types, and other tissues and growth factors that have a localized effect on how the cells grow, divide, or migrate. Part of the microenvironment is the extracellular matrix made up of a carbohydrate-protein gel. The extracellular matrix helps to support the cell and cushion it from physical stress; it also serves as a means through which cells communicate with each other by releasing signaling molecules.”

The communication among cells, as well as the time and conditions in which cells grow exert significant influence on stem or progenitor cell proliferation and differentiation. Progenitor cells are stem cells that have differentiated enough to be committed to becoming a certain general type of cell, and will eventually differentiate into a specific cell."

Now compare a positive review of extracellular matrix to what the FDA says about tobacco, which it has given consent to sell (approved for sale):

Youth & Tobacco
Each day in the United States 3,600 kids under 18 years of age smoke their first cigarette, and an estimated 900 kids become daily cigarette smokers. Many of these kids will become addicted before they are old enough to understand the risks and will ultimately die too young of tobacco-related diseases. FDA is working to protect the health of America’s children and ultimately reduce the burden of illness and death caused by tobacco use.
http://www.fda.gov/TobaccoProducts/ProtectingKidsfromTobacco/default.htm

Now when talking about the dangers of strip surgery, let’s let patients speak for themselves:

Posted In Sly bald guys forum
Thoughts of suicide after Hair Transplant
« on: September 12, 2009, 05:13:02 PM »
Hey guys, I had a Transplant done when I was still a kid(19) by a despicable piece of human excrement dr xxxxxxxx. I was in panic mode about losing my hair and I never even got the chance to go sly(which suits me well) Now I have severe anxiety/depression issues and even suicidal thoughts because I am so consumed with regret. My question for anyone who wishes to help is What do you think about a shaved head with a strip scar? How bad do you think it looks?

Posted in Balding Blog
Suicidal Thoughts After Hair Transplant

March 27 2006, 3:36 pm PT | Posted in: Hair Transplantation
I am devastingly depressed from my strip procedure…I made a very very bad mistake by doing a “fill in” procedure when I was 27 (something I regret more than anything) not realizing I would eventually get 2 other procedures of over 1000 grafts later and have a scar that I can not cut my hair short or shave my head… I am having suicidal thoughts and wish I never did this at all…Id give anything to have no scars and just shave my head like I should have done. I was too young, uneducated and stupid at the time I made the decision for the first procedure. Now my friends with less hair than I have, Im jealous of. Is there anyway to cover up this strip scar with FUE? DOes the donor area have to be shaved to do this? Will it cover it enough to cut my hair short again? Should I wait for potential hair multiplication someday? Your opinion and expertise is appreciated. Im overwhelmed here…please help

I stand by my statement:
ACell was approved by the FDA as a regenerative medical product
I’m the one who stated this. Now let me provide my intended meaning:
ACell was approved or given consent (which is a dictionary, recognized definition of the word approved) for sale and marketing as a regenerative product.
A company has to have their marketing cleared or approved by the FDA before they can say such things. Scientific documents on the FDA’s website support the role of extracellular matrix in the healing and regenerative process. ACell is an extracellular matrix product. The FDA classifies ACell as a device. Does an FDA classification category restrain what a product can do in the real world? Of course not!!! Products do what they do and FDA classification plays no role in that whatsoever.

Licht… Try focusing on criticizing things that have the potential for harm, like tobacco and strip surgeries.

CITNews works at Dr. Cole’s office

Cole Hair Transplant
1045 Powers Place
Alpharetta, Georgia 30009
Phone 678-566-1011
I am not a doctor and the content of my posts are my opinions, not medical advice
email CITNews at chuck@forhair.com

hey chuck sent you an email just wondering if you got it thanks

[quote][postedby]Originally Posted by forhair[/postedby]
licht, you made your point and there is no need to get personal. i think CITnews is very informative and participated in this nonsense more then any other’s clinic representative will ever do (except Jotronic :slight_smile: )
[/quote]

I’m really not intending to be getting personal here. I would have liked to have thought I had made my point, but continued posts by CITnews makes it very clear that obviously I haven’t.

CITnews may very well be an informative poster generally, but in this case, he is both wrong and engaging in purposeful misdirection of what is ultimately a very simply issue (that of ACell’s FDA status). You have to admit that his frivolous attitude towards the matter is unbecoming of somebody who is supposed to be representing a well-respected clinic.

To further that, he’s now engaging in ad hominem arguments, such as the utterly bizarre implication that we who care about the accuracy of claims by clinic reps about the products they are representing are part of some “pro-strip agenda”. It’s both insulting and completely unfounded. I’ve never made a pro-strip comment in my life.

We all agree with this, that ACell may have potential and may be worth trying. This is no excuse to mislead about ACell’s status however, and that is what this issue is about.

Nobody is trying to “scare patients” away from trying it. The whole issue could have been solved if, instead of backing himself into a corner, CITnews simply said “Oh, sorry, I made a mistake. ACell is not approved as a regenerative product, but we believe it is helpful to our patients because [dot dot dot]”

Nobody is questioning that ACell is allowed to sell its products to doctors. It is not, however, FDA approved for an indication as a regenerative medical product.

That’s fine. If Dr. Cole or any other physician feels that ACell has regenerative properties relevant to hair restoration, wonderful. They are free to report so, regardless of the FDA’s indications. That is, however, not the issue at hand. Nobody is challenging that. Once again, it is NOT right to mislead about the product’s FDA status.

The answer to that question, as I think we’ve made very clear, is an outright, absolute no. If you don’t care, that’s no problem. Nobody is attacking ACell because it is not FDA approved as a regenerative medical product. A representative of your clinic is being taken to task for wrongly suggesting (continuously) that it is.

I am very aware that the FDA is a less than perfect organization. That is, however, neither here nor there. If you or other members of your clinic question the meaningfulness of FDA status, fine. There is no excuse, however, for misleading about the FDA status of a product you are using.

CITNews, not once have I, or (I think) anybody else on this thread “criticized” ACell. You seem to have totally misinterpreted the problem here, which might explain the random quotations from ACell’s website, etc, which have nothing to do with the issue at all.

The issue is YOUR statement, which was incorrect (yet which you have inexplicably stood by) that ACell is approved by the FDA as a regenerative medical product. This is a statement which is demonstrably wrong.

If you think ACell is efficacious, then feel free to say so. You can do so without misleading about its FDA status.

If you think strip surgery is dangerous, then feel free to say so. I’m not even sure why strip surgery was ever brought up, except to deflect attention from the issue at hand, and vaguely and totally falsely imply that people here are criticizing your statements because they are “strip shills” or something bizarre like that.

However, if you outright mislead about a product’s FDA status, any product’s FDA status, then you can expect to be taken to task for that.

I can overlook all the FDA technicalities if the stuff works, but unfortunately most of what I have seen are questionable. There might be one or two photos that I found somewhat convincing but we are talking about photos showing a couple follicles here and there, can’t really trust that wholeheartedly.

CITNews,

I made my initial post to point out that your description of Acell is inaccurate and I showed the proof. Every link I’ve included goes straight to the FDA website. In response, you’ve made 19 posts to defend yourself with multiple websites and quotes from everyone that doesn’t matter. You then included references to how this is a pro-strip agenda effort. What better way to deflect your inability to accept that you made a mistake than to turn this into an FUE vs. strip debate?

From the FDA website…
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194460.htm

510K Clearance -

This is what Acell did. I’ve already shown that the stated intended use as provided by Acell is:

NO WHERE does it say ANYTHING about regeneration. Here’s the link:

Approval -

To acquire approval of a device through a PMA application, the PMA applicant must provide reasonable assurance of the device’s safety and effectiveness.[/quote]

Therefore, when you to say that “ACell was approved by the FDA as a regenerative medical product” you are specifically saying that Acell is a class III medical device that has received much higher scrutiny than that required for class II devices (510K clearance) with not only proof of safety (which is not required of a 510K clearance) but also EFFICACY as defined by the requirements for a class III device. Acell is not a class III medical device thus it never received evaluation for safety or efficacy which means it was never APPROVED as a regenerative product much less approved for anything else.

The statement, “ACell was approved by the FDA as a regenerative medical product”, tells the patient or consumer that, by definition of “approval” per the FDA guidelines, Acell was put through an examination process, which never occurred and that it was officially tested for safety and effectiveness as a regenerative product, which it was not. That is why to make the statement that you made can give the patient a false expectation with regards to what may or may not happen through the application of Acell. Your own tests show SOME successes, not definite much less consistent successes.

This does not mean that Acell has zero benefit. This does not mean that Acell does not have regenerative properties. This does not mean that more advances will not come of it’s use in hair restoration. This does not mean that strip is better than FUE. This means that you made a mistake.

[quote]CITNews,

I made my initial post to point out that your description of Acell is inaccurate and I showed the proof. Every link I’ve included goes straight to the FDA website. In response, you’ve made 19 posts to defend yourself with multiple websites and quotes from everyone that doesn’t matter. You then included references to how this is a pro-strip agenda effort. What better way to deflect your inability to accept that you made a mistake than to turn this into an FUE vs. strip debate?

From the FDA website…
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194460.htm

510K Clearance -

To acquire clearance to market a device using the 510(k) pathway, the submitter of the 510(k) must show that the medical device is “substantially equivalent” to a device that is already legally marketed for the same use.

[postedby]Originally Posted by jotronic[/postedby]

This is what Acell did. I’ve already shown that the stated intended use as provided by Acell is:
intended for the management of topical wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic Moh’s vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post- surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.

[postedby]Originally Posted by jotronic[/postedby]

NO WHERE does it say ANYTHING about regeneration. Here’s the link:

Approval -

To acquire approval of a device through a PMA application, the PMA applicant must provide reasonable assurance of the device’s safety and effectiveness.

[postedby]Originally Posted by jotronic[/postedby]

Therefore, when you to say that “ACell was approved by the FDA as a regenerative medical product” you are specifically saying that Acell is a class III medical device that has received much higher scrutiny than that required for class II devices (510K clearance) with not only proof of safety (which is not required of a 510K clearance) but also EFFICACY as defined by the requirements for a class III device. Acell is not a class III medical device thus it never received evaluation for safety or efficacy which means it was never APPROVED as a regenerative product much less approved for anything else.

The statement, “ACell was approved by the FDA as a regenerative medical product”, tells the patient or consumer that, by definition of “approval” per the FDA guidelines, Acell was put through an examination process, which never occurred and that it was officially tested for safety and effectiveness as a regenerative product, which it was not. That is why to make the statement that you made can give the patient a false expectation with regards to what may or may not happen through the application of Acell. Your own tests show SOME successes, not definite much less consistent successes.

This does not mean that Acell has zero benefit. This does not mean that Acell does not have regenerative properties. This does not mean that more advances will not come of it’s use in hair restoration. This does not mean that strip is better than FUE. This means that you made a mistake.[/quote]

The purpose of the FDA is to clear a company’s products for sale. Products viewed by the FDA as having the possibility of being either dangerous or inefffective are run through what the FDA terms as its FDA “Approval” process.
The FDA does not “clear” or approve words, sentences or language US citizens are allowed to use. Case in point where Kenneth E. Warner, a public health professor at the University of Michigan in Ann Arbor used “approved” in the context I used.

New York Times Article
In First, F.D.A. Rejects Tobacco Products

Kenneth E. Warner, a public health professor at the University of Michigan in Ann Arbor, said the ruling might be an indication of the agency’s thinking on menthol. Newport cigarettes are traditionally menthol flavored, but the two types the agency approved did not contain the menthol additive. The agency is expected to rule on whether to ban menthol, but the timing is not known.

Again, the purpose of the FDA is to clear a company’s products for sale. Products viewed by the FDA as having the possibility of being either dangerous or ineffective are run through what the terms as its FDA “Approval” process.
The FDA does not “clear” or approve words US citizens are allowed to use. Case in point where Kenneth E. Warner, a public health professor at the University of Michigan used “approved” in the context I used.

Do Licht and Jotronic plan to send critical letters of disapproval to authorities like Kenneth E. Warner for using the word “approved” in the dictionary definition sense as I did? If anything criticism should be directed to the FDA for using a definition of the word “approved” considered “obsolete” in the dictionary in the naming of it’s offficial safety and efffectiveness clearing for sale process.

I have demonstrated in earlier posts how the naming of the FDA’s clearing for sale process as an “approval” process has caused the FDA grief.
People have reasoned, how does an organization whose mission is to protect the public from harmful and/or ineffective products justify clearing a product for sale (tobacco) that the CDC claims kills 5 million people annually worldwide?
This is due to an unfortunate public perception in some cases where FDA approved is viewed ad FDA endorsed. That is not the case at all. The FDA specifically ruled that tobacco companies can not state on their packaging that a brand of tobacco product is FDA approved. This indicates to me that the FDA is aware the public perception of their term approved can suggest endorse.

There is no FDA ruling stating US citizens are not allowed to use dictionary definitions of words.
A baseball team can’t win the Super Bowl.

A product deemed sufficiently safe and effective is classified by the FDA as a product that does not need to prove that it is neither dangerous or ineffective by going through the official vindication process the FDA calls its Approval process. What the FDA calls its Approval process is technically a vindication process, NOT an endorsement process as the public may perceive in errror.

Now Jotronic, if you wish to get personal and imply that I’m misrepresenting Dr. Cole’s clinic by making wrong statements, I think the time has come to examine statements you’ve made in forums, including this one:

Previously in this thread Jotronic stated:
“That said, I’m not saying Acell works one way or the other but the language should be corrected because it is grossly inaccurate.”
Compare the above to the remarks Jotronic made in another forum:
“Wow, Camp Cole coming out swinging and for no reason at all. Let’s get something straight. When I say that there is no such thing as an illusion of coverage, I’m talking about what we see with out eyes. Having enough hair transplanted to cover the scalp with a moderate and conservative hair style is not an illusion. My own coverage is not an illusion because my hair covers my scalp. I do not grow it super long to cover it either. It is clean, short on the back and sides, and a few inches long on top. I have enough hair to allow for real coverage. I do not have enough hair for real density. Seems to me that our definitions are complete polar opposites.
I’m not sure what nerve I touched on but it seems to be one that you feel warrants a flurry of insults and bold faced lies. That’s fine, I’m used to it. The one thing I’ve learned over the years is that when one hasn’t anything tangible to say they tend to throw what they can against the barn door to see what sticks.
Didi,
LOL! I think if we split FU’s we could sell that quite easily as stem cell multiplication. We will mix in PRP, Acell, RU then stick a 9 volt battery in and let it sit overnight. If we’re lucky, we may even get 70% regeneration!!! Whaddyathink?
Monger out!
And I stand by my statement. Remember, it is a range of grafts, 6000 being on the low end of average with “average” meaning average donor density and average donor laxity. I’ve seen guys that can’t get past 5000 and of course I’ve seen guys that get way more than 8000. It is difficult to nail down but it is what it is, an average if not a loose one.”

OK Jotronic, lets examine your quoted statement above where you wrote:
“My own coverage is not an illusion because my hair covers my scalp.”
If that is the case Jotronic, why did you have have Scalp Micropigmentation Performed on the top of your head a short time after making that statement? People whose hair covers their scalp have no need for Scalp Micropigmentation. I ask that forum readers have a look at the video and judge for themselves whether or not your hair covers you scalp as you claim. That’s a wrong statement as far as I’m concerned.
Here Jotronic, you contradict your statement made in this thread:
“That said, I’m not saying Acell works one way or the other but the language should be corrected because it is grossly inaccurate.”
Now compare what Jotronic said here to what he stated in another forum:
“LOL! I think if we split FU’s we could sell that quite easily as stem cell multiplication. We will mix in PRP, Acell, RU then stick a 9 volt battery in and let it sit overnight. If we’re lucky, we may even get 70% regeneration!!! Whaddyathink?”

When one denigrates something, that is not indicative of a neutral position.

The bottom line is, strip surgeons are tired of having patients and potential patients asking about ACell, which has little effectiveness in the field of strip surgery. If you want I can call a patient who I recommended to your clinic for a scar revision and get a quote from him regarding the opinion your clinic has related to the use of ACell. So don’t tell us that you or the clinic you represent takes a neutral stance on the effectiveness of ACell.
Strip surgery is like an injured and dying animal. As they say an injured animal poses a greater danger of being on the offensive and attacking. This is the reason I’m being singled out and attempts are made to discredit me. Strip surgery has already been discredited because of the dangers of a widened scar and its negative psychological impact on patients even to the point of suicidal thoughts.

CITNews works at Dr. Cole’s office

Cole Hair Transplant
1045 Powers Place
Alpharetta, Georgia 30009
Phone 678-566-1011
I am not a doctor and the content of my posts are my opinions, not medical advice
email CITNews at chuck@forhair.com

This would be comedy if the issue weren’t so serious.

This discussion has nothing to do with tobacco (how bizarre it was even brought up) and absolutely nothing to do with strip or FUE. It’s only very obliquely related even to the potential of ACell.

The only thing it has to do with is the fact that you were flat-out wrong when you said that ACell is FDA approved as a regenerative medical product.

That deception is one that matters, as it misleads the public about what standards the product has been tested to in that area. Ironically, if FDA approval didn’t matter, you wouldn’t have mislead about it in the first place.

I’m sorry CITNews, but no amount of irrelevant verbiage and no number of equally irrelevant links will serve to deflect the issue. You will not get away with it.

[quote][postedby]Originally Posted by licht[/postedby]
This would be comedy if the issue weren’t so serious.

This discussion has nothing to do with tobacco (how bizarre it was even brought up) and absolutely nothing to do with strip or FUE. It’s only very obliquely related even to the potential of ACell.

The only thing it has to do with is the fact that you were flat-out wrong when you said that ACell is FDA approved as a regenerative medical product.

That deception is one that matters, as it misleads the public about what standards the product has been tested to in that area. Ironically, if FDA approval didn’t matter, you wouldn’t have mislead about it in the first place.

I’m sorry CITNews, but no amount of irrelevant verbiage and no number of equally irrelevant links will serve to deflect the issue. You will not get away with it.[/quote]

Licht:

Why not examine the comment Jotronic made in another forum. You don’t have an agenda, right?

Jotronic wrote:
“My own coverage is not an illusion because my hair covers my scalp.”

Now have a look at the a still frame from the video featuring Jotronic having SMP. Tell me, Licht, can you see his scalp? Is Jotronic’s scalp concealed by hair as he claims? What are your thoughts on that?

CITNews works at Dr. Cole’s office

Cole Hair Transplant
1045 Powers Place
Alpharetta, Georgia 30009
Phone 678-566-1011
I am not a doctor and the content of my posts are my opinions, not medical advice
email CITNews at chuck@forhair.com

The reason is very simple. It has absolutely nothing to do with this topic. Just as tobacco, strip versus FUE, and whatever other manner of misdirection you choose to throw at this thread have absolutely nothing to do with the issue.

Are you somehow justifying your deception by suggesting that others deceive too? Sorry, but that just isn’t going to fly.

Once again, unable to respond, you lower the conversation again by suggesting that I have some sort of “agenda”. Sorry, but I don’t. You were wrong about ACell’s FDA status, and you continue to mislead about it. You won’t get away with it by trying to put up a smokescreen.

[quote][postedby]Originally Posted by licht[/postedby]
This would be comedy if the issue weren’t so serious.

Ironically, if FDA approval didn’t matter, you wouldn’t have mislead about it in the first place.
[/quote]

You pretend to be a mind reader and claim to know why I make statements. I made that statement to encourage patients and prospective patients to loosen their focus on treatments still in the experimental, developmental, or testing phase. For example, Histogen and Aderans are not cleared for sale by the FDA. I believe it is of more value for patients and potential patients to place focus and hope in products that have already been cleared for sale by the FDA. Not because “FDA approved” is some form of endorsement, but rather because ACell, which has been cleared for sale can be used by doctors in the real world where it is being proven very effective when used in conjunction with minimal depth FUE.

CITNews works for Dr. Cole’s clinic

Cole Hair Transplant
1045 Powers Place
Alpharetta, Georgia 30009
Phone 678-566-1011
FREE CONSULTATION
email CITNews at chuck@forhair.com

[quote]
[postedby]Originally Posted by CITNews[/postedby]

Licht:

Why not examine the comment Jotronic made in another forum. You don’t have an agenda, right?

[postedby]Originally Posted by licht[/postedby]

The reason is very simple. It has absolutely nothing to do with this topic.[/quote]

Technically, what you refer to as this topic is in fact the topic of your agenda and is not related in the slightest to the original topic of this thread which is a request for verification of Dr. Cole’s ACell studies.

CITNews works for Dr. Cole’s clinic

Cole Hair Transplant
1045 Powers Place
Alpharetta, Georgia 30009
Phone 678-566-1011
FREE CONSULTATION
email CITNews at chuck@forhair.com

I’m really not sure how this possibly justifies deception.

The FDA has not approved ACell as a regenerative medical product. The statement is simply wrong. The FDA has not made any stance whatsoever on ACell’s efficacy as a regenerative product, never mind as an adjunct to a hair restoration procedure.

The ethical implications of misleading about a product’s FDA status in order to place patients’ “focus” (as you put it) on a product your clinic is using should be painfully obvious.

To make it very clear, I have not once made any issue with the idea of experimenting with ACell in conjunction with hair transplantation. I don’t believe anybody on this thread is. The issue is with your deceptive statements about ACell.

Anyway, I take it that even if you don’t see how serious this issue is, you at least admit that your initial statement regarding ACell’s FDA approval status as a regenerative medical product was incorrect?

[quote]

The purpose of the FDA is to clear a company’s products for sale. Products viewed by the FDA as having the possibility of being either dangerous or inefffective are run through what the FDA terms as its FDA “Approval” process.
The FDA does not “clear” or approve words, sentences or language US citizens are allowed to use. Case in point where Kenneth E. Warner, a public health professor at the University of Michigan in Ann Arbor used “approved” in the context I used.

New York Times Article
In First, F.D.A. Rejects Tobacco Products

Kenneth E. Warner, a public health professor at the University of Michigan in Ann Arbor, said the ruling might be an indication of the agency’s thinking on menthol. Newport cigarettes are traditionally menthol flavored, but the two types the agency approved did not contain the menthol additive. The agency is expected to rule on whether to ban menthol, but the timing is not known.

Again, the purpose of the FDA is to clear a company’s products for sale. Products viewed by the FDA as having the possibility of being either dangerous or ineffective are run through what the terms as its FDA “Approval” process.
The FDA does not “clear” or approve words US citizens are allowed to use. Case in point where Kenneth E. Warner, a public health professor at the University of Michigan used “approved” in the context I used.

Do Licht and Jotronic plan to send critical letters of disapproval to authorities like Kenneth E. Warner for using the word “approved” in the dictionary definition sense as I did? If anything criticism should be directed to the FDA for using a definition of the word “approved” considered “obsolete” in the dictionary in the naming of it’s offficial safety and efffectiveness clearing for sale process.

I have demonstrated in earlier posts how the naming of the FDA’s clearing for sale process as an “approval” process has caused the FDA grief.
People have reasoned, how does an organization whose mission is to protect the public from harmful and/or ineffective products justify clearing a product for sale (tobacco) that the CDC claims kills 5 million people annually worldwide?
This is due to an unfortunate public perception in some cases where FDA approved is viewed ad FDA endorsed. That is not the case at all. The FDA specifically ruled that tobacco companies can not state on their packaging that a brand of tobacco product is FDA approved. This indicates to me that the FDA is aware the public perception of their term approved can suggest endorse.

There is no FDA ruling stating US citizens are not allowed to use dictionary definitions of words.
A baseball team can’t win the Super Bowl.

A product deemed sufficiently safe and effective is classified by the FDA as a product that does not need to prove that it is neither dangerous or ineffective by going through the official vindication process the FDA calls its Approval process. What the FDA calls its Approval process is technically a vindication process, NOT an endorsement process as the public may perceive in errror.

Now Jotronic, if you wish to get personal and imply that I’m misrepresenting Dr. Cole’s clinic by making wrong statements, I think the time has come to examine statements you’ve made in forums, including this one:

Previously in this thread Jotronic stated:
“That said, I’m not saying Acell works one way or the other but the language should be corrected because it is grossly inaccurate.”
Compare the above to the remarks Jotronic made in another forum:
“Wow, Camp Cole coming out swinging and for no reason at all. Let’s get something straight. When I say that there is no such thing as an illusion of coverage, I’m talking about what we see with out eyes. Having enough hair transplanted to cover the scalp with a moderate and conservative hair style is not an illusion. My own coverage is not an illusion because my hair covers my scalp. I do not grow it super long to cover it either. It is clean, short on the back and sides, and a few inches long on top. I have enough hair to allow for real coverage. I do not have enough hair for real density. Seems to me that our definitions are complete polar opposites.
I’m not sure what nerve I touched on but it seems to be one that you feel warrants a flurry of insults and bold faced lies. That’s fine, I’m used to it. The one thing I’ve learned over the years is that when one hasn’t anything tangible to say they tend to throw what they can against the barn door to see what sticks.
Didi,
LOL! I think if we split FU’s we could sell that quite easily as stem cell multiplication. We will mix in PRP, Acell, RU then stick a 9 volt battery in and let it sit overnight. If we’re lucky, we may even get 70% regeneration!!! Whaddyathink?
Monger out!
And I stand by my statement. Remember, it is a range of grafts, 6000 being on the low end of average with “average” meaning average donor density and average donor laxity. I’ve seen guys that can’t get past 5000 and of course I’ve seen guys that get way more than 8000. It is difficult to nail down but it is what it is, an average if not a loose one.”

OK Jotronic, lets examine your quoted statement above where you wrote:
“My own coverage is not an illusion because my hair covers my scalp.”
If that is the case Jotronic, why did you have have Scalp Micropigmentation Performed on the top of your head a short time after making that statement? People whose hair covers their scalp have no need for Scalp Micropigmentation. I ask that forum readers have a look at the video and judge for themselves whether or not your hair covers you scalp as you claim. That’s a wrong statement as far as I’m concerned.
Here Jotronic, you contradict your statement made in this thread:
“That said, I’m not saying Acell works one way or the other but the language should be corrected because it is grossly inaccurate.”
Now compare what Jotronic said here to what he stated in another forum:
“LOL! I think if we split FU’s we could sell that quite easily as stem cell multiplication. We will mix in PRP, Acell, RU then stick a 9 volt battery in and let it sit overnight. If we’re lucky, we may even get 70% regeneration!!! Whaddyathink?”

When one denigrates something, that is not indicative of a neutral position.

The bottom line is, strip surgeons are tired of having patients and potential patients asking about ACell, which has little effectiveness in the field of strip surgery. If you want I can call a patient who I recommended to your clinic for a scar revision and get a quote from him regarding the opinion your clinic has related to the use of ACell. So don’t tell us that you or the clinic you represent takes a neutral stance on the effectiveness of ACell.
Strip surgery is like an injured and dying animal. As they say an injured animal poses a greater danger of being on the offensive and attacking. This is the reason I’m being singled out and attempts are made to discredit me. Strip surgery has already been discredited because of the dangers of a widened scar and its negative psychological impact on patients even to the point of suicidal thoughts.

CITNews works at Dr. Cole’s office

Cole Hair Transplant
1045 Powers Place
Alpharetta, Georgia 30009
Phone 678-566-1011
I am not a doctor and the content of my posts are my opinions, not medical advice
email CITNews at chuck@forhair.com[/quote]

CITNews,

I read your last post to me and then I had to read it again. It has become obvious to me that you are going to continue to deflect the issue with irrelevance. Tobacco? Really? Coverage vs. density? SMP? None of this has the slightest thing to do with your statement that “Acell is FDA approved as a regenerative medical product.”. If you wish to start discussions about these non-issues then feel free to start new threads. I can and will respond to each one but not here, not in this thread. This thread is about how you have made a statement that is incorrect, nothing more and nothing less.

I’m sincerely sorry you think that this is personal because it’s not. I don’t know you, I’ve never seen your face and I think your name is Chuck. And I certainly never said you were misleading anyone, not on purpose. I said I believe the WAY that you worded your statement could be misleading, not that you were INTENDING to be misleading. There is a big difference. There is no reason for me to be personal because I don’t need to be to get my point across. Getting personal is easy. Debating with facts and staying on point, well, it appears that that is not so easy.

This thread was redirected by you and Licht into a debate related to my suitability to represent a hair restoration clinic based upon you and Licht’s insistence that words exclusively be interpreted according to your selective definitions. I responded to these attacks.

Now it’s my turn to redirect this thread. You had your turn at redirection, now its mine, after all, as they say, turnaround is fair play.

Explain why Jotronic made the following statement:
“My own coverage is not an illusion because my hair covers my scalp.”

What is so serious about this claim is that it gives prospective patients the false impression that hair transplants can provide a Norwood 6 with a full head of hair.

Now look at the screeen shot from the video featuring Jotronic having scalp micro pigmentation. The screen shot represents Jotronics head before scalp micro pigmentation.

Care to comment Jotronic? Failure to comment could be construed as a complete absence of credible defense of the statement you made.

CITNews works for Dr. Cole’s clinic

Cole Hair Transplant
1045 Powers Place
Alpharetta, Georgia 30009
Phone 678-566-1011
FREE CONSULTATION
email CITNews at chuck@forhair.com

CITNews,

You seem angry. I apologize for any part I had in that. I am not sure how you came to the conclusion that I called your abilities at representing your clinic into question. I certainly have not as you do a fine job of it. Had anyone asked I would have said so. Disagreeing with each other is not synonymous with questioning one’s ability to perform their job.

However, I’ll remind you that I said I’d be happy to answer your questions about my SMP if you simply start another thread but I will not do so here. Again, it has no relevance to the issue. You stated that Acell is FDA approved as a regenerative medical product and I said that you are wrong. I did not say you were lying. I did not say that you were misleading people with any malintent. I said you were wrong, mistaken, incorrect. There is a big difference.

[quote][postedby]Originally Posted by jotronic[/postedby]
CITNews,

You seem angry. I apologize for any part I had in that.[/quote]

No apology necessary. I am not angry in the least. I view this as a good debate which may inspire others to look more deeply into the meanings of words and the importance of honesty in representation.

Your accusation of me being “wrong, mistaken, incorrect” is based upon the false notion that words can only be interpreted according to your limited definitions. The dictionary is the authority here, not you.

Licht brought forth a valid point of discussion regarding the integrity of statements made by clinic reps. This is within the context of this discussion so please answer my question. How can you state “My own coverage is not an illusion because my hair covers my scalp” when the photo clearly indicates that your hair does not cover your scalp?

CITNews works for Dr. Cole’s clinic

Cole Hair Transplant
1045 Powers Place
Alpharetta, Georgia 30009
Phone 678-566-1011
FREE CONSULTATION
email CITNews at chuck@forhair.com

Ok, I’ll play.

[quote]Explain why Jotronic made the following statement:
“My own coverage is not an illusion because my hair covers my scalp.”

What is so serious about this claim is that it gives prospective patients the false impression that hair transplants can provide a Norwood 6 with a full head of hair.

Now look at the screeen shot from the video featuring Jotronic having scalp micro pigmentation. The screen shot represents Jotronics head before scalp micro pigmentation.

Care to comment Jotronic? Failure to comment could be construed as a complete absence of credible defense of the statement you made.[/quote]

And so everyone knows, the above quote is from another forum, not Hairsite.

The problem with your quote from me is that it is incomplete. You left out the rest of my statement. What I said was…

You said that my statement gives prospective patients the false impression that a NW6 can get a full head of hair through hair transplantation but you ignored the rest of my statement that talks about the lack of “real density”. Coverage is coverage, whether it be thin coverage or thick coverage it is still coverage. With better coverage the illusion of density increases. My density NOWHERE near matches my coverage. I’ve not only always SAID my crown is thin I’ve always SHOWN that my crown is thin.

There are more photos of me on the internet than anyone else with regards to hair restoration, going back over twelve years and many videos as well. I was the first guy to start this whole “blog about your results” thing and no one is more exposed. I can usually back up what I say. For instance, here is my crown progression that has been public and easily found on the web, on my website, the forums, etc.

Before 1st Sx for 2406 grafts placed in the front only.

After, no grafts in crown.

After 2nd Sx, 2425 grafts, some in crown, rest in front and temple points.

After 3rd Sx, 2488 grafts, more in crown, more in front and temple points.

And here is a very telling photo taken right before my 4th Sx for 1399 grafts, of which about 900 were placed in my lower crown. The text on the image explains everything.

Here is the result six months later, outdoors.

It is obvious that I do NOT have a full head of hair and certainly not high density but I do have really good coverage. There are also dozens and dozens of posts of me telling patients that a full head of hair is not possible especially for advanced Norwoods.

So your partial quote of me, out of context, is an effort to corral me into the same box that you’re in. I explained my position in detail and there are dozens and dozens of my own photos online, with my hair in multiple styles and at varying lengths ranging from buzz cuts to several inch mop styles. I voluntarily show my hair at it’s worst and I obviously show it at it’s best. The only issue is, at most, contextual but only because you quoted a snippet, not the entire statement. My ACTIONS and my history contradict your misinterpretation of my statement.

You however made a specific statement contrary to the FDA. There is not an interpretation issue but maybe it’s a reading comprehension issue. To recap:

You said “Acell is FDA approved for regenerative medicine”.

We both agree that Acell is a class II medical device.

We both agree that since it is a class II device it is cleared, not approved, since only class III devices are actually approved. This is not an issue of definition because both words are used with clear meaning to differentiate from each other.

You say that it is recognized by the FDA with clearance or approval as a regenerative medical device when Acell’s application, and the FDA’s notification of clearance BOTH clearly state the intended use and neither state that it is for being a regenerative medical device. You can’t point to Acell’s website because it is not the FDA. You can’t point to Dr. Shapiro’s website because it is not the FDA. We have to go by the FDA website and it’s content specifically with regards to Acell and the language used when the FDA OK’d it’s use. There are two forms that matter; the application by Acell and the notification for 510K clearance to sell their product.

You say that it is because our definitions are different and you quoted Webster’s dictionary for the definition of “approval”. I agree that there are multiple definitions but because FDA did not use the word “regenerative” or “regeneration” to begin with the question of multiple definitions becomes moot.