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New article (March 2014)


#1

http://www.upenn.edu/pennnews/current/2014-03-13/research/penn-dermatologist-makes-breakthrough-battle-against-hair-loss


#2

“I think we can probably make that happen in 10 years”

So we have gone from ‘within 5 years’ to ‘probably within 10 years’ - that’s “progress” in the hair loss industry :no:


#3

Good article, I actually think this is encouraging news, 10 years is assuming that the trials are done in countries like the US where there are strict regulations, well we are no longer banking on the US to come up with the goods anymore, are we? There is a good chance it may happen sooner if the trials are done elsewhere.


#4

can you name me a single breakthrough treatment in history, which bypassed western regulations by being offered in third world countries?

its absolutely ludicrous to think that such international, high tech, bleeding edge research is going to be delivered to us by pakistan or the likes.

Also how do you know that he is assuming 10 years are including human trials… seems like you are merely speculating…

[quote][postedby]Originally Posted by helpmeout[/postedby]
Good article, I actually think this is encouraging news, 10 years is assuming that the trials are done in countries like the US where there are strict regulations, well we are no longer banking on the US to come up with the goods anymore, are we? There is a good chance it may happen sooner if the trials are done elsewhere.[/quote]


#5

[quote][postedby]Originally Posted by hairman2[/postedby]can you name me a single breakthrough treatment in history, which bypassed western regulations by being offered in third world countries?

its absolutely ludicrous to think that such international, high tech, bleeding edge research is going to be delivered to us by pakistan or the likes.

Also how do you know that he is assuming 10 years are including human trials… seems like you are merely speculating…

[postedby]Originally Posted by helpmeout[/postedby]
Good article, I actually think this is encouraging news, 10 years is assuming that the trials are done in countries like the US where there are strict regulations, well we are no longer banking on the US to come up with the goods anymore, are we? There is a good chance it may happen sooner if the trials are done elsewhere.

[/quote]

I don’t know if there are any, but that doesn’t mean that it can’t happen in the future. Are you saying that because all medical breakthroughs were invented by developed countries in the past and that’s the way it has to be for the future too?

Yeah, I am speculating, isn’t that what most posters here are doing anyway?


#6

“can you name me a single breakthrough treatment in history, which bypassed western regulations by being offered in third world countries?”

How about Helsinki formula

or Spanish Fly


#7

[quote]can you name me a single breakthrough treatment in history, which bypassed western regulations by being offered in third world countries?

[/quote]

Acupuncture. It was invented by the Chinese and definitely bypassed western regulations, nowadays also adopted by the western world as a legitimate treatment.


#8

are you seriously comparing an ancient tradition of sticking fine needles in people to high tech multi-million dollar international research with financial interest and western patents.

Acupuncture was originally performed in asia in the first place and not based on modern western research for which clinical trials were moved to developing countries for the sake of bringing it to market early.

Sorry but they both dont really have the slightest thing in common. There are a couple of thousand cancer treatments in clinical trials, I dont think a single one has been performed in developing countries for the sake of bypassing national legislation.

People involved in this kind of research arent doing it out of kindness they are doing it so that they can make a ton of money by bringing it to market in developed nations so that they can charge an arm and a leg for it. It simply is not realistic to believe that hair loss treatments are going to be any different.

[quote]can you name me a single breakthrough treatment in history, which bypassed western regulations by being offered in third world countries?

[postedby]Originally Posted by abcxyz[/postedby]

Acupuncture. It was invented by the Chinese and definitely bypassed western regulations, nowadays also adopted by the western world as a legitimate treatment.[/quote]


#9

You said “IN HISTORY”, so that’s fair game if I quoted a treatment from thousands years ago :stuck_out_tongue:


#10

What about Nigam? That’s exactly what he is trying to do in order to bypass FDA or European regulations, there are guys from Europe who went to him already for treatment that would not be possible in their home countries.


#11

I think FDA trials alone take about 10 years, so when he says that they “can make it happen in the next 10 years” that almost certainly doesn’t include FDA trials. That’ll be 20 years before it’s on the market then…


#12

I agree that it’s not very likely that they’re gonna try to launch this somewhere where they can bypass Western regulations.
But on the other hand, the financial incentive is quite considerable… (Whoever finds a hairloss cure basically has a license to print money…)


#13

[quote][postedby]Originally Posted by News[/postedby]
I agree that it’s not very likely that they’re gonna try to launch this somewhere where they can bypass Western regulations.
But on the other hand, the financial incentive is quite considerable… (Whoever finds a hairloss cure basically has a license to print money…)[/quote]

Maybe Xu and his team have no intention to bypass FDA but what about some researchers in India or China copying the concept and developing it on their own? Does Xu and his team have a patent on how to multiply epithelial cells? If not, can another researcher in India or China experiment with what Xu is doing?


#14

so the spanish fly was based on western research which then brought the fly to market in developing nations to bypass FDA regulation? Interesting. This has nothing to do with my question but nice try.

As for the helsinki formula, it was developed in helsinki, I hope you understand that helsinki is not based in a developing country.

Also, for both i wld say neither of them were in any way a breakthrough treatment.

I think people here need to be more realistic and not get carried away by wishful thinking. If a treatment becomes available it will in all likelihood go down the exact same route that all other regulated treatments have taken in modern history. It will go through regular and rigorous clinical trials.

[quote][postedby]Originally Posted by alecbaldone[/postedby]
“can you name me a single breakthrough treatment in history, which bypassed western regulations by being offered in third world countries?”

How about Helsinki formula

or Spanish Fly[/quote]


#15

[quote]can you name me a single breakthrough treatment in history, which bypassed western regulations by being offered in third world countries?

its absolutely ludicrous to think that such international, high tech, bleeding edge research is going to be delivered to us by pakistan or the likes.

Also how do you know that he is assuming 10 years are including human trials… seems like you are merely speculating…[/quote]

Hairman, your view is simplistic. No one is talking about going to Pakistan. There are countries outside of the Western world which are still considered by many like you to be “Third World” but are rapidly developing (like India), and then there are countries like Singapore which is where HISTOGEN went to do its trials. Cutting-edge cell based treatments for hair loss are being researched at the top university in Taiwan… Taiwan is not a Western country. Nobody said “Third World”. The distinction is not necessarily “First World” vs. “Third World” anymore, the distinctions are “West” vs. “East”, “North” vs. “South”, and “traditional markets” vs. “emerging markets”.

What about all the medical tourism that occurs where Western people from Europe and North America go to countries like Costa Rica, Brazil, Cyprus, Dubai, etc. for the most sophisticated types of medical procedures, including cosmetic surgery? Do you label these countries “Third World” and say everything that goes on in these places is crap?


#16

The trials which Histogen is conducting in Singapore which are in full compliance with FDA regulations. They have emphasized this on numerous occassions. They are NOT bypassing US Regulations as has been proposed as a supposedly viable option for big pharma in order to release a product early. This simply doesnt happen and is not going to happen for hair loss either. Its quite ludicrous to think that it might.

Medical tourism is also an entirely different issue. People go abroad for financial reasons (cheaper healthcare at a comparable level of quality), not because they are receiving some kind of revolutionary new treatments which have not passed regulations in their home countries. But this is exactly what is being suggested here. I think that is rather naive.

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

Hairman, your view is simplistic. No one is talking about going to Pakistan. There are countries outside of the Western world which are still considered by many like you to be “Third World” but are rapidly developing (like India), and then there are countries like Singapore which is where HISTOGEN went to do its trials. Cutting-edge cell based treatments for hair loss are being researched at the top university in Taiwan… Taiwan is not a Western country. Nobody said “Third World”. The distinction is not necessarily “First World” vs. “Third World” anymore, the distinctions are “West” vs. “East”, “North” vs. “South”, and “traditional markets” vs. “emerging markets”.

What about all the medical tourism that occurs where Western people from Europe and North America go to countries like Costa Rica, Brazil, Cyprus, Dubai, etc. for the most sophisticated types of medical procedures, including cosmetic surgery? Do you label these countries “Third World” and say everything that goes on in these places is crap?[/quote]


#17

Hairman, back to my point, even if you are right that it had never happened before in history but that doesn’t mean that it can’t happen in the future. Are there any international laws that say all new inventions must go through western regulations first? What bugs me about your theory is that because that’s what happened in the past, then it has to be the same for the future. That kind of thinking doesn’t sit well with me.


#18

No helpmeout, that is not what I am saying. I am not saying that because it has never happend that it is impossible. What I am saying is that there is a reason why it just doesnt happen.

The scientists and firms that are involved in Research and Development aren’t exactly fools. I understand that people might think its a viable option to because the earlier they can bring a product to market the earlier they can earn money. The thing is however that if they really want to turn their research into profit they wld most likely sell their patents to big pharma and not open some back ally clinics and start charging a couple of thousand euros per patient. They wld sell it for a multi-million dollar figure to a western company.

These companies in return plan their market strategies 10-20 years in advance and have their products in the pipeline of FDA approval knowing that they wont be gaining returns any time soon, but that the potential of their product is to earn them billions of dollars in the hair loss industry.

The idea is simply not realistic, no matter how much hair loss sufferers wish it to be true.

[quote][postedby]Originally Posted by helpmeout[/postedby]
Hairman, back to my point, even if you are right that it had never happened before in history but that doesn’t mean that it can’t happen in the future. Are there any international laws that say all new inventions must go through western regulations first? What bugs me about your theory is that because that’s what happened in the past, then it has to be the same for the future. That kind of thinking doesn’t sit well with me.[/quote]


#19

Interesting discussion, out of curiosity, I did a google search and came across 30 Significant Medical Achievements and Their Country of Origin,

Some interesting inventions/discoveries and their country of origin:

Contact lenses invented by Leonardo Da Vinci (Italy), really?

Asprin invented by the Germans, yeah that I know.

Clinical trials: Austin Bradford Hill (UK) - hmm, someone could claim that they invented the concept of clinical trials?

What surprised me is that US was only involved in 8 out of the 30 medical breakthroughs, I thought US would have more of an involvement.

BTW, I think Hairman made a good point, he didn’t say it can’t be done, it’s just doesn’t make sense for the researcher to bypass FDA.


#20

"they must figure out how to maintain and multiply human dermal papillae cells, a finding that has so far evaded them."
Multiplying papillae is the issue, not the FDA; however, we Americans are sick of the power the FDA has incumbered. Taking 10 to 15 years and a billion dollars to get something that would benefits millions of people is ludicrous. Currently there are very promising drugs that have not been approved but in clinical trials have save the lives of people with leukemia. It is time for change!