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Stating the obvious

topccat29

topccat29

29 year HT veteran
The quote below was recently made by Rassman. Here is what I don €™t understand €¦ €¦ €¦.. many posters who have been around long enough state the obvious well before those that actually work in the industry helping to promote it. For instance if someone is achieving hair regeneration where are the pictures and the restorations and these posters were doing this more than 10 years ago. It €™s common sense or should be that many interested in only making money look at balding men as desperate and easy marks and one can pretty much sell them or tell them anything regardless of if it €™s non existent donor regeneration or tattooing someone €™s head and they will buy into it.

All the loud mouths and drum bangers disappear and you are the one to deal with the giant Acell scar on the back of your head or the blue tinted scalp or whatever else they are promoting because they don €™t have the skill to excel with what actually works so they are always trying to work some other angle................I got something new it's going to revolutionize the industry.

Patients do not need anyone stating the obvious years after the damage is done. They need someone making those statements before the damage is done.

If you don €™t have the necessary skills just move into another line of work and spare many young men the devastation of half assed work and half assed options. If you want to experiment, there have been many doctors in history who experimented on themselves, Salk, Goldberger, etc €¦ €¦ €¦ €¦maybe start a trend in HT and try it on yourself first and let €™s assess the long term results before offering to young men.


€œWe also used ACell in many years ago in graft growth and even possible replication in recipient area. We submitted and applied for research approval with the medical board and conducted studies with Dr. Bernstein in New York. In the end, it didn €™t work. The claims were false. To date, no one was able to replicate the claims of hair regeneration. Simply put, it was a publicity hype for the hair transplant world €

€œACell did not really have a reduction in the overall scar width and it does not make the scar any smaller in our observation. In one or two cases, the patient (who had prior non-ACell surgeries) thought it made the scarring worse. €
 
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topccat29

topccat29

29 year HT veteran
One doctor made these claims listed below in 2011. The point being people tend to forget all the buzz that is generated by many in this industry in order to have young guys sign up for something for which there is no proof or the longer term results are unknown and in some cases devastating. They just hope that no one is around to point out what they are doing is wrong and that it €™s just the guys that don €™t know much that they are speaking to because they are the easy bait.


Debate helps to dig down deeper in order to get at the truth and truth can only benefit the patient €¦ €¦ €¦ €¦ask lots of questions and do not believe anything until you know for absolute certain or you are close enough to feel comfortable with what you are believing is true.


One thing that I have learned and it applies to everything. The more information you have the better decision you will make and do not trust an expert €¦ €¦ €¦ €¦ €¦ €¦.become your own expert. Never make a decision under duress €¦ €¦ €¦ €¦.if you are desperate do nothing.

1. Acell is helping with regrowing skin and hair when extracting a donor strip so that some of it grows back....

2. In 2 years with Acell and bone marrow stem cells it will be all over...

3. PRP and acell is creating new hairs around the transplanted hairs when doing a traditional strip. We're creating completely new hairs.....

4. My PRP is reversing miniturisation so much that you can see it in these before and afters. (Different hair length, hairstyle and lighting).....

5. I'm having success with my auto-cloning.....
 
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topccat29

topccat29

29 year HT veteran
These guys that have been harmed by testing of products on their head which resulted in severe damage are entitled to monetary compensation that is in the $10M range. All one needs to do is investigate similar type cases where doctors used drugs/devices for unapproved uses, growing plucked hair and promoting a drug or device along with it would fall under the same category in my opinion. You cannot simply do and say whatever you want to patients as a doctor.............it doesn't work that way.

February 1, 2010
F.D.A. Aims at Doctors' Drug Pitches
By NATASHA SINGER

In the rarefied world of fashion magazines, beauty editors have often relied on a coterie of prominent dermatologists and plastic surgeons to keep them current on advances in cosmetic medicine. This symbiotic relationship has benefited magazines eager for beauty scoops and doctors seeking visibility - and patients.

But now the Food and Drug Administration has cracked down on one of the most widely quoted cosmetic doctors, sending shudders through the ranks of opinion leaders in fashion publishing and vanity medicine.

The F.D.A. recently sent a warning letter to Dr. Leslie Baumann, a well-known dermatologist and clinical researcher in Miami Beach, citing the doctor for expressing premature enthusiasm in the media about Dysport, an injectable antiwrinkle drug the agency had not yet approved.

Dr. Baumann's comments in the media in 2007 violated restrictions on drug promotion, according to the letter; the agency asked Dr. Baumann to explain how she intended to prevent similar violations in the future.

Under the Obama administration, the F.D.A. has stepped up scrutiny of drug advertising, dispatching many warning letters about misleading commercials and online marketing efforts. But this is believed to be the first time the agency has warned an individual investigator - a medical researcher who oversees a clinical trial - for apparently promoting an unapproved drug.

Dr. Baumann is far from the only cosmetic doctor to have jumped the gun. Some talk show hosts and beauty editors (including this reporter in her previous job at W magazine) have often turned to clinical investigators for news of the latest cosmetic medical treatments.

Now, some industry experts say the F.D.A. warning may curb the media enthusiasm of certain cosmetic doctors who until now have provided scoops about coming medical products - or have talked up the latest unapproved cosmetic uses for drugs and devices that the agency had approved only for other purposes.

"It's a wake-up call," said Nancy Behrman, owner of Behrman Communications, a public relations firm in Manhattan. Her firm has represented cosmetic medical companies as well as doctors. "The whole business has spiraled out of control, and we need to step back and slow it down."

Federal rules bar drug makers and investigators on their clinical trials from promoting a drug before the agency has approved the product. Dr. Baumann violated the restrictions, the F.D.A. letter said, because she was an investigator on a clinical trial for Dysport and promoted it well before the drug's approval in April.

"Early data shows it may last longer and kick in faster than Botox," Dr. Baumann told the fashion magazine Allure in 2007. She made similar comments that same year to Elle magazine and during an appearance on the "Today" show on NBC in January 2009.

In response to a query from a reporter, Dr. Baumann said in a statement that she had discussed the F.D.A.'s concerns with members of the agency's staff in a conference call last week and that the agency now considered the matter closed. Medicis Pharmaceutical, which markets Dysport in the United States as treatment for furrows between the eyebrows, was not involved in Dr. Baumann's comments to the press, the F.D.A. letter said.

Thomas W. Abrams, director of the agency's Division of Drug Marketing, Advertising and Communications, said that investigators were free to have scientific conversations about investigational drugs with their peers and with journalists. But an investigator should not promote any unapproved prescription drug - or an unapproved use of an already approved drug - as being safe or effective if the agency has not yet deemed it to be so, he said.

"You can't promote a prescription drug before it is approved, whether they are diabetes drugs or heart drugs or for cosmetic uses," Mr. Abrams said.

The federal restrictions are meant to keep drug makers and their clinical investigators from conveying misleading or unduly favorable first impressions about a drug to health care providers or the public, Mr. Abrams said.

Similar restrictions prohibit companies and investigators from promoting an unapproved medical device or the unapproved use of an approved device, the agency said.

Some magazine editors said they hoped the warning letter would not have a chilling effect on investigators, the people who have hands-on experience with experimental drugs and devices.

"There is real value in a doctor involved in a clinical trial because they know about the products in a way that other doctors are only getting by hearsay," said Linda Wells, the editor in chief of Allure.

Allure has been particularly reliant on Dr. Baumann's expertise. The monthly magazine quoted her in 10 articles last year and mentioned her in another, according to a Nexis search.

Dr. Baumann, a former professor of dermatology at the University of Miami medical school who recently opened a dermatology research center in Miami Beach, says she has been a clinical investigator or consultant for about 40 makers of drugs, devices or cosmetics.

"I understand that as a clinical investigator for many different drugs, I am held to a higher standard than ordinary treating physicians," Dr. Baumann wrote in a statement sent in response to a reporter's query.

Medicis, meanwhile, said in a statement responding to a reporter's question last week that the company "respects and observes the F.D.A.'s prohibitions on pre-approval promotion, which are designed to protect the integrity of the F.D.A.'s product approval process and to further patient safety."

In the wake of the agency's warning letter, some often quoted cosmetic doctors like Dr. Fredric S. Brandt, a dermatologist in Manhattan and Coral Gables, Fla., are wondering what they can and cannot say. Dr. Brandt is an investigator and consultant for Medicis; Allergan, the maker of Botox; and Ortho-Neutrogena, as well as an investigator for a dozen other makers of dermatology products.

For many years, Dr. Brandt has held an annual event for beauty editors at the Four Seasons Hotel in Manhattan. At those gatherings, he has recapped cutting-edge developments that he learned about at professional medical society meetings, and he has delivered his own reviews about unapproved products for which he was an investigator.

Dr. Brandt was also the featured guest at a Medicis dinner for beauty editors, held at Le Bernardin in Manhattan two years ago. The invitation to the event promised a discussion on "innovative products on the horizon." These turned out to include Dysport, a product for which Dr. Brandt was an investigator.

In a phone interview last week, Dr. Brandt said he would continue to talk to journalists about products in the pipeline. But he might limit his future comments to scientific facts and published studies.

"We have been talking about new products in the pipeline for years, and I think there is nothing wrong with that," Dr. Brandt said. "But we are going to have to keep our opinions to ourselves."

Medicis declined to comment about the dinner at Le Bernardin.(This reporter attended the event. The New York Times paid for my filet mignon; dinner, with tip, came to $115.54. )

Ms. Wells of Allure said that it was important for her magazine to report on advances in cosmetic medicine, informing readers when products were still under F.D.A. review. Should the new warning letter muzzle clinical investigators, Allure has other resources, she said.

"We hear about products approved in Europe, Canada or South Africa a year before they are approved in the U.S.," Ms. Wells said. "We will figure out other ways to report the story."

But Didi Gluck, the executive beauty director at Shape magazine, said she typically waits for federal approval before she publishes information about a cosmetic medical product.

"If it's still in clinical trials, then it's of no benefit to the readers anyway, so wait until it is safe for them," Ms. Gluck said. "That's what a responsible reporter should do."
 
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topccat29

topccat29

29 year HT veteran
You see these guys that have been damaged by products for which there was no approval and were marketed on online formats. They are entitled to damages in the $10M range and up. The reason being is not because they have suffered that amount of damage but because it keeps honest people doing what they are doing and puts dishonest people out of business while protecting the public. But that is only the beginning the fines outside of personal judgments are usually 10 times that amount.

Were you led to believe it grew hair or did something for which it was not approved? Did you suffer damage in the process? How did you come to believe this in the first place? All valid questions.

 
topccat29

topccat29

29 year HT veteran
You see when a product company removes every trace of hair related promotional material from it's literature very quickly it €™s telling you something.

But the only problem is patients have been damaged from the marketing of that unapproved use in various ways. That €™s not going away and that is in fact why the law is on the books and the penalties are so severe. Then you still have those out there that don €™t know they are breaking the law €¦ €¦ €¦ €¦.it certainly does say something about how much they really know.


I mean how does one not understand this very simple law. You cannot market drugs or medical devices for something they have not been approved for.................like hair regeneration or bringing plucked hairs to life.


If you do not understand what the term marketing means then maybe you should learn it.

 
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topccat29

topccat29

29 year HT veteran
For those that have had Acell used on them and it did not turn out well cafepharma is a good site to take a look at as many employees/ex-employees have much to say regarding off label use that some might find useful. How truthful those employees/ex-employees are is unknown to me but it does make one wonder why take the time to post this type of information.

Why do I no longer see anything hair related on the Acell site? Why are some clinics now promoting a completely different product as the next big thing? If someone knows please post the answer for me.
 
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topccat29

topccat29

29 year HT veteran
Understand something that just bears repeating over and over, many of these guys behind the scenes are laughing at you. So slow down and learn what many of them are really about because it €™s not about helping you and you can only learn if you spend the time, wait, and watch. It €™s not what people say it is what they do. Why has Acell removed anything hair related from their site? Why has one clinic that has been consistently vocal on hair regeneration now suddenly switched to some other magic substance and they are doing the same promoting but now they are a bit careful with their wording? What happened to the amazing plucked hair?

The fact is if you promote something for which it has not been approved you go to jail for a long time and you receive huge fines because you are breaking Federal laws. Even simply being a conduit can implicate someone and the I didn €™t know defense doesn €™t work. All the disclaimers in the world are not worth the paper they are written on some times and those that break laws to make a buck showing little concern for the consumer are hardly concerned about the conduit. That is why it is so important to find people that are concerned about the people around them because if they are not concerned about those people they certainly will not be concerned about you. And those guys on the bottom they always sacrifice the guys on the top to save themselves. This is why when you associate with dishonest people it can really come back to haunt you.

I love these first 2 quotes from the HT industry with the second one being a bit more careful with the wording by using the words appear and may. Now compare that with the quotes from the cafepharma forum (paraphrased) granted these are supposedly disgruntled employees but that is usually when the truth starts to come out but it could also very well be some type of competitor making those statements but that would be a real stretch for another company to write those words. The statements could very well be false but when you start adding up the other pieces of the puzzle is does make one start to think. When I write about big food processors just trying to figure how to put some cheap toxic crap together, make it taste good and then program you to buy it €¦ €¦ €¦ €¦ €¦ €¦ €¦it €™s not made up €¦ €¦ €¦ €¦ €¦..that is exactly how it works. They make fools of people and that is why you should not buy their crap.

Those guys on the bottom here are all potential whistleblowers looking at a potentially huge pay day. When you read how they were not happy with the $100K or so that tells you something, It €™s like the guy that wants to share the tattoo love with you €¦ €¦ €¦ €¦..I mean are you kidding me. A good majority working in this business are not honest people €¦ €¦ €¦.not all but a good majority. And providing information that keeps others out of harm €™s way is positive. Don €™t be swayed or caught up in too much fluff €¦ €¦ €¦ €¦ €¦look for real information that benefits you in the decision making process and not much of the nonsense that is posted to forums to just generate traffic. Sure go ahead and read it as it will tell you who is full of crap and who is not €¦ €¦ €¦ €¦ €¦ €¦..all part of the research process.

I do like the way these guys write about the product they were selling. Would they write this way in their professional capacity €¦ €¦ €¦ €¦ €¦no €¦ €¦ €¦ €¦.but this is how people write when they are being real including often times poor grammar, spelling etc €¦ €¦ €¦ €¦as it becomes more about the message and just telling it like it is and not worry about sentence structure. You see those reps on the bottom they don €™t talk to you the way they are writing on the bottom there but if you spend enough time you might pick up on something when they put on their professional happy face that might give them away and that is something you need to actively look for when researching hair transplantation. I €™m always amazed at prospective patients that have doctors who have sued or threatened to sue their own patients. It €™s like how do you not know this €¦ €¦ €¦ €¦ €¦ €¦ €¦.exactly what kind of research did you do and how much time did you spend and it €™s not up to me to tell them.

HT Industry
€œWe've made amazing breakthroughs using MatriStem as a hair cloning tool,We've been able to multiply the number of hair follicles growing in the recipient area, and as an added benefit are seeing faster hair growth. This new hair cloning technique also makes hair transplantation surgery less invasive.


€œWe are excited about the results of our preliminary studies, € €œBy combining the MatriStem with existing follicle components, it appears that we are able to achieve true hair regeneration. Further research will help us to refine this process to make it a consistent, reproducible technique. It may be especially well suited for those who have run out of traditional hair for transplantation. €

Cafepharma

Training? Oh yeah where I was taught how to mix powder into an injectable. Where I was told put this shit on everything. Is that the training your talking about? The one where we learned to sell it to grow cartilage? Or are you talking about bladder matters? You know I could go on and on, so like I said before, get real.

I don't know if the people in charge are really dumb and don't understand indications or just really shady and actually think that they will get away with this $#!+. Either way, it's not a valid excuse. The bad guys will not win this one, so I hope they enjoy the dirty money while it lasts, because another med device company will not touch you.

I totally agree with the last comment. I like the fact that the FDA is on to them. I was lied to again, wow big surprise. First about how much reps were making and now about off label uses. I just never thought a company would be so open about promoting off label use so I thought it had to be OK. My manager still gives me shit about not adding more powder to each case even though it is clearly off label. I am labeled a Goody Two Shoes because I won't knowingly break Federal Law. Can't wait to get out of here.


Not sure if the link is allowed but it is of interest and sponsored by whistleblowers against fraud so it €™s not a competing site €¦ €¦ €¦ €¦..will give it a try.

http://www.cafepharma.com/boards/showthread.php?t=475886
 
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topccat29

topccat29

29 year HT veteran
These types of threads regardless of what others might think are necessary and can help patients make better decisions. Of course not everyone will get a chance to view the information.

This patient below posted onto another forum just the other day. I have pasted the highlights because it's information prospective patients need. Then they can make their own decision.

I will give you my lay persons opinion on this and it's just a guess. Scar tissue seems to be similar to a bone break in many ways. As the bone heals it actually becomes denser in the area of the break. Scar tissue hopefully small seems to be the glue that keeps the wound from expanding further. Sure you might have nice smooth skin in the area without that glue but then is stretches into a giant bald spot in some cases.


This would not have been so tragic if he had just ripped me off for a couple thousand dollars and ejected my scalp with that ACell BS, but no, he had to actually do invasive surgery. I don €™t know why. And then charge me 15K for it. He took a perfectly good Dr Wong scar, which is pretty much like having no scar at all, if you ask me, and now look. See what he did? This was a classic con job. He charged me for a botched surgery and to take more pills. He must have known that his treatment doesn €™t do what he claims. He said my Dr Wong scar would actually turn out better with his ACell treatment - he should have left it alone! He said that new donor hairs would grow in its place, that it would regenerate itself. It didn €™t!
 
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topccat29

topccat29

29 year HT veteran
What I truly don €™t understand about this issue is that the doctors/clinics don €™t know that this is marketing fraud €¦ €¦ €¦ €¦ €¦. making claims for something in which it has not been approved. I have seen the hair regeneration pitch made numerous times and it €™s completely illegal marketing fraud.

I also do not understand the patients not being smart enough to know that this is an FTC issue and not a matter of damages from cosmetic surgery. The FTC pursues these types of cases vigorously at no cost to the plaintiff and the awards are always astronomical as a means to protect the public.
 
SADbutTRUE

SADbutTRUE

Valued member
very informative read topccat, many new readers that are researching hairtransplants need to pick your brain ,because hes see and been through it all...a veteran of the forums and the hairtransplant industry.
 
topccat29

topccat29

29 year HT veteran
SBT thanks for the comment. It becomes hard to pass on information sometimes without making it look negative but it €™s information none the less. Exactly what many others are searching for when coming to the forums. Yes results are always good to see but there is so much more to making an informed choice and I believe this all matters. I wish i had the same opportunity to see the this type of information years ago. It has been a good life lesson giving me a better understanding in how information is manipulated in so many areas outside of ht. Those areas have much more importance in one's life and that is kind of scary.


When one has all the information and not just some of it they can take full responsibility for their decisions and not look for someone to blame. The hair transplantation industry should welcome the many that come forward with a different view.


Thanks again it €™s appreciated and I hope you are doing well.

 
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topccat29

topccat29

29 year HT veteran
The main take away point here for those researching is you better get it right the first time because if you don €™t there is not much many feel they can do about. Sure they might think they can but then they realize when they start putting some thought into it that their options are limited. Even those that are not looking to do something about it including myself 30 years ago. One then becomes a little too desperate to just fix it and from my own experience and from watching this over the years the desperation often digs a deeper hole unless one gets lucky and the right information falls into their lap.

This guy that has a giant scar that just posted will rant a bit. He posts the doctor €™s name as a warning for others and starts to feel better until he gets that letter in the mail you know the cease and desist letter. He can €™t really sue for damages himself as it €™s cosmetic surgery and scars are a risk of the procedure. Keep in mind he does not understand the FTC issue so he just goes away.

I heard an interesting quote this morning, it €™s not fraud until you get caught and there is great deal of truth to that statement. I looked at a few websites that show a before scar and after Acell no scar and only hair. Completely illegal to promote something for which it was not approved stating hair regeneration............... the law is specific.

I like the example of the guy selling Enzyte the over the counter erection pill. Long story short he was raking it in and although the customers were victims of fraud in several ways this guy was actually laughing because he knew no one would spend too much time or any time at all complaining that they got ripped off on some erection pills they purchased €¦ €¦ €¦ €¦.lol €¦ €¦ €¦ €¦ €¦one does really have to laugh because it is very true. Many couldn €™t even stop the credit card charges as they would be put into a position of explaining to their credit card company over the phone what has happened €¦ €¦ €¦..lol €¦ €¦ €¦hey the guy keeps charging my card for erection pills..............lol....

Bet every once in a while someone comes along that doesn €™t care too much. In the above case that happened and the guy running the company was found guilty and the judgment was $500M and 20 years in prison.

All it took was one guy that didn €™t care to organize all the guys filled with shame and many just plain selfish and do something about it. Same thing will happen in HT in my opinion, it €™s very ripe as there are too many bad players.

And to repeat the main point here €¦ €¦ €¦ €¦ €¦ €¦you better hope you get it right the first time. There are good doctor/clinics out there but they are in the minority and seem to have very little power within the industry itself.

 
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