I learn from the best
[quote][postedby]Originally Posted by NeverAgain[/postedby]
I learn from the best
[/quote]
Lol!
[quote][postedby]Originally Posted by CITNews[/postedby]
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 Lichtās insistence that words exclusively be interpreted according to your selective definitions. I responded to these attacks.
[/quote]
Selective definitions? We are using the FDAās own definition of the term. I think there is some sort of selective comprehension block happening on your end.
Weāre not trying to play semantic games with you. Most common words in the English language can have different implications in different contexts. When people use the term āapprovedā in the context of the FDA, it has a very specific definition, one which weāve explained over and over on this thread. When a statement regarding āapprovalā in the sense of the FDA comes from a representative of a medical clinic using the product in question, it is absolutely imperative that the word be used properly.
FDA approval is an official status that a drug or device can attain for a particular indication. Approval is explicitly granted by the FDA, and a product that has not been granted that approval cannot be termed FDA approved for that indication. A representative of a clinic that provides medical services misleading the public about the FDA approval status of those medical services is very serious. That you cannot see that is astonishing.
I could understand it at the beginning when I thought you had made a simple, honest mistake, that could easily have been retracted. In truth, I still think it was an honest mistake. I donāt doubt that you thought that ACell had FDA approval as a regenerative medical product. I would be very surprised if you, or anybody else here, still does, but who knows. What is unacceptable, however, is the continued obfuscation and misdirection since your mistake was brought to light.
This is not, by the way, about anything as broad as your overall āsuitability to represent a hair restoration clinicā. Thatās between you and your employer, and you may well be an excellent representative in almost all respects. That doesnāt change that you are totally in the wrong here.
Anyway, now weāve been through all this, perhaps I can leave with a simple, final question. Please answer it simply, and without misdirection or changes of topic.
Do you, as a representative of Dr. Coleās clinic, claim that ACellās product is FDA approved as a regenerative medical product?
Licht:
Let me remind you, this thread was started by cal and his question was addressed to me, not you or Jotronic. When cal started this thread he titled it "to CITnews/Dr. Cole, about donor regeneration . . .
I have already answered the questions you asked in my previous posts. Iām not going to repeat myself. You have glossed over what I have written so far and you misrepresent my meaning here in this thread in ways similar to methods used by bias news media outlets. Bias news media outlets have an agenda.
If you were paying attention, the topic of this discusssion thread has now focused upon something that you stated is very important to you. That is, the accuracy of statements made by clinicās representatives. So answer the question⦠Do you believe Jotronicās statement he made in another thread is accurate?
The following is my original statement made in a debate with Jotronic in another forum :
āOn average a patient has between 5000 and 7000 follicular units available for transplant to the top. When this person was a teenager, he may have had 25,000 follicular units on top. Replacing all of that hair is simply not possible, so any great result that a Norwood 6 gets from hair transplant surgery represents an illusion of coverage. In other words, itās not going to look like a teenage head of hair in certain lighting and styling situations.ā
Jotronic responded with the statement:
āMy own coverage is not an illusion because my hair covers my scalpā .
Look at the photo. Does Jotronics hair cover his scalp?
There are other issues here worthy of discussion. Jotronic previously stated that his position on ACell is as follows:
āI never once referenced the efficacy of Acell one way or the other.ā
Yet here in an exchange of words with Dr. Cole Jotronic denigrates the use of ACell:
āLOL! I think if we split FUās 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 weāre lucky, we may even get 70% regeneration!!! Whaddyathink?ā
One who denigrates something can not claim they have a neutral position toward something.
You say in you signature that H&W never uses flash photography. Iām not referencing that statement one way or the other but, flash photography is not the only method by which a before photo can be made to look worse. I have a college degree in optics and taught a college course in digital creative. Several of H&Wās before photos have a peculiar yellowish cast. How did they get that way? If I were to take one of our photos and apply the āExposureā filter in PhotoShop, it would have a yellowish cast and the balding areas would appear much more pronounced. I am certainly not accusing you or H&W of doctoring photos in PhotoShop in order to make your ābeforeā photos look worse. Iām simply asking why many of your before and even after photos have a pronounced yellowish cast? Posting before photos that have a yellowish cast can create doubt in the minds of prospective patients who have a trained eye.
Example:
Minimal depth FUE as of this writing is the future of hair transplant surgery. Extracellular matrix products such as ACell only make matters worse for strip clinics. Acell is a very expensive product (our cost). ACell is not a big money maker by any stretch in Dr. Coleās practice. We come close to breaking even. I promote ACell because I have seen itās effectiveness and regenerative results first hand. I insist on having it administered during and after my personal surgeries. I believe in the product and promote its use because of its benefit to patients. At the very least ACell improves hypopigmentation of extraction sites. At best ACell properly administered, results in follicle regereration and extraction sites, once healed that I can not even locate under the best lighting and magnification.
So in essence, Iām being criticized for promoting a product that has proven beneficial. On the other hand promoting strip surgery is basically the promotion of an outdated technique that carries with it the danger of a widened scar and often severe psychological impact even to the point of suicidal thoughts.
CITNews works at Dr. Coleās 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
So you wonāt answer this one very simple question?
Do you, as a representative of Dr. Coleās clinic, claim that ACellās product is FDA approved as a regenerative medical product?
Chuck,
When I said I wasnāt referencing the efficacy of Acell, I was referring to the context in this thread. Meaning, I was not injecting my opinion of Acell, for better or for worse, into my statement about how you said āACell was approved by the FDA as a regenerative medical product.ā when clearly it was not. You again quote only a snippet of my statement when the rest of the statement keeps everything in context in relation to this thread.
This is the entire statement for contextual clarityā¦
I have no problem sharing my opinion of Acell if anyone wants to know it. Donāt forget to include PRP and RU, oh, and 9 volt batteries for that matter, too:)
Hang on, youāre casting doubt on our before photos by saying that potentiallyy by applying the exposure filter in Photoshop the resulting yellowish appearance would make the balding areas more pronounced but then you go on to say that some of the after photos have this too? If the yellowish appearance could potentially make the balding areas more pronounced why would the same yellowish appearance be applied to the AFTER photos??? Did you read this out loud to yourself before you posted? This doesnāt make any sense. If the yellowish appearance makes the before pics look worse, as you imply, would it not stand to reason that the same application would make the after pics look worse as well? For someone that supposedly has a degree in optics and taught a college course called ādigital creativeā (creative what?) you seem to have a hard time recognizing simple white balance issues. Do you really want to get into discussing each otherās galleries? Really?
Of course, the best way to overcome white balance issues and supposed āexposure filterā issues is to just shoot a lot of HD video of patients so there is nothing else left to guess. Oh yeah, we do that.
Oh, and this photoā¦
It was taken twelve years ago with a 2.1mp Fuji Finepix before I had my first procedure with Dr. Wong. It is one of the first photos I ever took of my hair and it was a very difficult time for me. This is the first time anyone has ever made this type of accusation or slight of hand reference with one of my old photos and quite frankly it makes you look desperate if not a bit mean spirited. I think Iām done playing your games.
Back to the issueā¦
So the only thing preventing actual follicle generation is if Acell is applied properly? It has nothing to do with Acell itself? Sorry, I found this statement to be interesting to say the least.
No, you are not being criticised for promoting a product that has proven benefit. The criticism is that you made a statement that is false, simple as that. You saidā¦
āACell was approved by the FDA as a regenerative medical product.ā when in FACT it was not. Instead of accepting this you decide to play games and start throwing out questions about matters that have nothing to do with your incorrect statement including questioning the authenticity of one of my own photos that is over twelve years old.
Itās time for this merry-go-round to end. I advise you to stay on point else the downward spiral of this thread will only get much worse.
We all make mistakes. It is not easy navigating through all the FDA technicalities in a changing environment.
Dr. Cole has run a very well respected clinic over the years. Itās best to acknowledge the problem and make the necessary corrections. Nobody will fault Dr. Coleās clinic for this as long as the necessary corrections are made promptly.
We are all learning as we go along.
[quote][postedby]Originally Posted by HairSite[/postedby]
We all make mistakes. It is not easy navigating through all the FDA technicalities in a changing environment.
Dr. Cole has run a very well respected clinic over the years. Itās best to acknowledge the problem and make the necessary corrections. Nobody will fault Dr. Coleās clinic for this as long as the necessary corrections are made promptly.
We are all learning as we go along.[/quote]
Well said. This was about a statement that was made in error and of course the subsequent argument that ensued. Nothing more.
The whole point of the criticism by Licht and Jotronic was to claim that I was taking advantage of an FDA status in order to sell a product to patients.
Let me repeat, I donāt make a commission on ACell sales and Dr. Coleās clinic does not make enough profit on ACellās use to run the clinic for one week. I recommend ACell because I have seen itās benefits to patients first hand.
Does a product that has gone through the FDA approval process really have a marketing advantage? I donāt think so. You decide.
I experienced another example today, illustrating the word āApprovedā used in the same context the FDA uses approval when referring to itās official āApprovalā process:
My wife is an art teacher and today she bought some canvasses for an upcoming art class. When she slid her credit card through at the checkout, the little credit card authorization screen flashed the word āApprovedā. When the credit card was Approved for the canvas purchase, do Licht and Jotronic believe that āApprovedā indicates the credit card company thinks purchasing art canvass is a virtuous and honorable act? I certainly hope they donāt believe that. If they do, theyāre seriously living in a fantasy world. The credit card company used the authorization service to determine whether or not our credit card was good or bad. Similarly, the FDA uses its approval process to clear a product for sale that is classified as having the potential of being either dangerous or ineffective, or both.
Jotronic:
In response to your inquiry regarding yellow images; if someone were doing it intentionally, which Iām not claiming you or your clinic are, why not mix it up a bit? If all of the before photos are yellowed, that could raise more suspicion than making some of the after images yellowed as well. Patient results photos taken at certain angles are not affected by an image exposure ramp up. I can make an image of the top of a patientās head appear yellow without making the hair density appear thinner. That could be accomplished by using the colorize feature in the āHue Saturationā panel. I could also make a photo appear to show less hair density by using the āExposureā filter. Both filters can give a similar yellowish tint to an image. It takes a trained eye to discern between the two. Kind of like a bank teller who can detect a counterfeit bill simply by feel. None of our clinicās photos I have taken and posted have a yellowish exposure cast.
I agree with Hairsite. Itās time to wrap this up. I have already stated my position and stand by it. My position is available for those who wish to actually read what I stated and make up their own mind. I will not discuss this further as per Hairsiteās request. I trust that Hairsite will not permit further attacks on my credibility or the clinic I represent.
I am at retirement age and do not need to work. My house is paid off and I could retire. I work at Dr. Coleās office because it is absolutely fascinating work. I get to meet patients from all over the world and see menās lives transformed. I personally think very highly of Dr. Cole and believe he is doing a great service to the hairloss community by offering state of the art hair restoration services. Dr. Cole can be tough to work for at times because he is a perfectionist. He cares very deeply about his patients and does a great deal of free work for patients who canāt afford to get fixed up. I would estimate, Dr. Cole personally gave me approximately $40,000 worth of probono work. Actually, Dr. Cole picked up the tab. He had to pay for medical supplies and employees on the time clock. Dr. Coleās goal was getting a result on someone who was disfigured by another clinic, not making money off me. I am very proud of Dr. Cole for being awarded the Golden Follicle Award at the 2013 ISHRS workshop in San Francisco. Itās like a relief for me to see him finally get the recognition he has deserved for years.
I see at least two strip scar repair patients per week. Widened strip scars have the potential to literally ruin lives. To me a strip surgery clinic is comparable to a computer builder who refuses to acknowledge new technology. Imagine a computer company selling computers in 2013 with the obsolete Windows 3.1 operating system. Their customers might return complaining that Adobe Master Collection, for example will not install on their computer. Rather than update the technology they offer, they instead denigrate Adobe Master Collection. This is similar to how strip clinics denigrate the use of ACell. Thatās a fair illustration of what strip clinics are doing in 2013. Thatās a fair illustration of what Jotronic and Licht are attempting to do here. They sell an obsolete procedure and bad-mouth progress that in effect gives better results for patients. That is seriously wrong.
CITNews works at Dr. Coleās 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][postedby]Originally Posted by CITNews[/postedby]
The whole point of the criticism by Licht and Jotronic was to claim that I was taking advantage of an FDA status in order to sell a product to patients.
[/quote]
No it wasnāt. The point of the criticism was to indicate and demonstrate that your statement was incorrect, and that it is a mistake that matters. People on this board, including potential patients, were being give incorrect information about ACellās regulatory status.
This is swerving way off topic here. How is credit card approval at all the same context as the FDAās approval status? In fact, this example illustrates very well how the term āapprovalā means different things in different contexts, and so indicates how the context is important.
The term āapprovedā in the context of the FDA has very different implications to the term āapprovedā in the context of a credit card. The term āapprovalā in terms of the FDA means that the productās efficacy has been demonstrated to the FDAās satisfaction. The term āapprovalā in terms of a credit card means you have enough credit on your account to cover the cost of the item.
This really proves the opposite of what you are saying. Just as random dictionary definitions of āapprovalā donāt have any specific relevance to credit card approval, random dictionary definitions donāt have anything to do with FDA approval. In both cases, the term means something official in their own contexts, and to misuse the term semantically would be deceptive.
[quote]I agree with Hairsite. Itās time to wrap this up. I have already stated my position and stand by it. My position is available for those who wish to actually read what I stated and make up their own mind. I will not discuss this further as per Hairsiteās request. I trust that Hairsite will not permit further attacks on my credibility or the clinic I represent.
[/quote]
Actually, Hairsite didnāt say it was time to wrap this up (although it might be). He said āitās best to acknowledge the problem and make the necessary corrections.ā. I.e., the best course of action is simply to acknowledge your mistake, and move on.
To that end, letās wrap this up once and for all. I once again put to you the very simple question, which you have so far avoided answering.
Do you, as a representative of Dr. Coleās clinic, claim that ACellās product is FDA approved as a regenerative medical product?
I think at this point we will have to interpret silence as indicating that you no longer make that claim, and thatās not a problem at all. We all make mistakes.
[quote][postedby]Originally Posted by CITNews[/postedby]
Thatās a fair illustration of what Jotronic and Licht are attempting to do here. They sell an obsolete procedure and bad-mouth progress that in effect gives better results for patients. That is seriously wrong.
[/quote]
This statement is just disgusting.
Are you suggesting that I sell strip procedures? Are you suggesting that I am in any way affiliated with a strip clinic, or in fact, any clinic at all?
Do you have any proof of this whatsoever? Or is making things up (I donāt use a stronger word only out of politeness) the best you can do when you back yourself into a corner after making a mistake.
I have absolutely no interest in promoting strip or any other hair restoration technique and absolutely no affiliation with any clinic or product. I am only interested in ensuring that people who read this board, who like me suffer from hair loss, are not mislead or given false information. That you would suggest otherwise, simply because I havenāt let you get away with misleading about your product, is disgusting and in horrible taste.
Secondly, neither jotronic and I are ābad-mouthingā anything. Nobody is criticizing ACell, or its use in hair-restoration surgery. We are simply pointing out that you were wrong and that it is not FDA approved as a regenerative medical product.
You have been unable to give the slightest ounce of rational proof that the truth is in anyway otherwise. The fact that you resort to bizarre ad-hominem attacks and outright false statements about those who disagree with you is simply further evidence that you are wrong.
So anyway, enough with the slander and the ad-hominem attacks. Answer the simple question I asked, multiple times, in the above posts, that you have so far refused to answer.
[quote][postedby]Originally Posted by scarred5[/postedby]
hey chuck sent you an email just wondering if you got it thanks[/quote]
scarred5:
I have been taking vacation days and have been out of the office. I will be back in on Monday 12/09/13. I havenāt been getting my emails while away, so I will read yours and reply Monday morning.
CITNews works at Dr. Coleās 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
thanks so much
This thread took a detour.
Per calās original question:
to CITnews/Dr. Cole, about donor regeneration . . . (Hair Transplant)
When Iām back in the office, I will propose to Dr. Cole that we build a Website specifically designed for posting up to date information on regenerative medicine and Dr. Coleās extracellular matrix studies. When/if Histogen is given consent by the FDA so that it becomes legally available for physicians to purchase, you can be certain Dr. Cole will put Histogen through his approval process, not to be confused with the official FDA Approval process.
CITNews works for Dr. Coleās 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]
Thatās a fair illustration of what Jotronic and Licht are attempting to do here. They sell an obsolete procedure and bad-mouth progress that in effect gives better results for patients. That is seriously wrong.
[postedby]Originally Posted by licht[/postedby]
So anyway, enough with the slander and the ad-hominem attacks. Answer the simple question I asked, multiple times, in the above posts, that you have so far refused to answer.[/quote]
I believe Hairsite would prefer we all give it a rest. You, Licht persist and as a self proclaimed expert in the use of words, you should practice what you preach.
Look it up Licht⦠āSlanderā, which is what you accuse me of, quoted above, is the act of speaking something false about a person. I have never met Jotronic and have never spoken to him in person. By your use of the word āslanderā, you imply that I met Jotronic and made untrue statements to his face. That never happened. Libel, on the other hand refers to the printed word. To qualify as Libel, a statement has to be both harmful and untrue. What blows away a legal case is a statement made as an opinion. There is no law against expressing oneās opinions.
Do I plan on going on a Licht rampage day after day, pressing you to admit you made a mistake using the word slander improperly and even inappropriately? No, because I know what you meant even though you didnāt use an even remotely accurate word to express your thoughts.
CITNews works at Dr. Coleās 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
Letās not belabor this further. The important thing is that nobody is here to intentionally mislead the public. We all make mistakes, we acknowledge the problem, remedy the situation, and move on. I trust that we are all in agreement in this respect, and thatās all that matters.
Very often if we let our ego do the talking, it turns into something bigger than it really is.
So yes, letās call this a wrap!
Hairsite, check out the very important email I sent you.
[quote][postedby]Originally Posted by CITNews[/postedby]
[postedby]Originally Posted by CITNews[/postedby]
Look it up Licht⦠āSlanderā, which is what you accuse me of, quoted above, is the act of speaking something false about a person.
[/quote]
You are right. While your statements were an unquestionably fallacious ad-hominem attack, I incorrectly used the word āslanderā in this sentence. That wasnāt so hard, was it, to acknowledge a mistake? Had you also done that at the beginning, we would have gotten here a lot faster, and with a lot less absurdity.
As to where we ended up, now that we have seen that you opt to answer the simple question posed to you, that even you now recognize that ACell is not FDA approved for the indication you claimed, and we can indeed lay the matter to rest.
CIT clarified the context of his statement, and licht clarified the context of his interpretation of CITās statement. Moving onā¦
-
What percentage of strip patients end up with visible scars that could be seen when wearing a standard crew cut?
-
Has Acell been tested on fresh strip wounds in order to reduce the disfiguring scars that sometimes result from strip surgery?
[quote][postedby]Originally Posted by James Bond[/postedby]
CIT clarified the context of his statement, and licht clarified the context of his interpretation of CITās statement. Moving onā¦
- What percentage of strip patients end up with visible scars that could be seen when wearing a standard crew cut?[/quote]
I probably see the worst of strip scars working at Dr. Coleās office. The best strip scar Iāve ever seen was about 1mm wide. A narrow scar like that doesnāt show up with longer hair, but shave the head and it jumps right out at you. Bad FUE looks worse on a shaved head than a 1mm strip scar, IMO. A 5mm+ wide strip scar on a shaved head looks worse than moderately bad FUE shaved down.
If it were me and I were considering strip, I would take a scientific approach. I would have a HairCheck done, I would have photos of my relatives on my mother and dadās side available to a competent hair restoration doctor and I would get a Hairmes area measurement. A great strip doctor like Dr. Wong would be the best person to ask about scalp laxity issues. Itās very important that your donor has a wide enough area of consistent hair direction and hair caliber. I have seen some thin strip scars with different hair directions and caliber āmarriedā and it looks like hell with a short haircut. I donāt recommend more than one strip procedure, so make it as large a session as is safely possible. Next go FUE with either Dr. Cole or Dr. Mwamba in Belgium. Make sure the doctor can use at least a .85 punch. An optimal hair configuration for FUE consists of hair that grows parallel rather than angled in relation to each other within a follicular unit. This configuration often enables a pristine donor area because the doctor can more safely remove a partial follicular unit.
Here is a page on the ACell Website that touches on hair transplant scars.
ACell is cleared for sale by the FDA in the US as a āMedical Deviceā. Strange classification. Dr. Cole asked me to call ACell to see if itās available for purchase in Canada. The ACell contact person on the phone said that ACell is only approved for sale in the US. I kid you not.
Possibly because extracellular matrix was once thought to be only a āscaffoldā. Kind of like the reinforcing framing on a home or structure. Now research indicates that native extracellular matrix has many other functions in the body besides being a reinforcing framework. Extracellular matrix serves as a cell communication medium, just to mention one. Currently science does not fully understand all of the biological activities related to extracellular matrix. As research continues and new discoveries are made, the effectiveness of ACell (extracellular matrix) in conjunction with minimal depth FUE will certainly be enhanced. Of course ACellās promise will become virtually meaningless should something better come our way, but as it stands, ACell or extracellular matrix is out front.
The content of my posts are my own opinions and are not medical advice.