sweet technology

[Baby Astronaut]

http://news.yahoo.com/s/ap/20090211/ap_on_sc/sci_cotton_candy_research

 

Cotton candy has delighted children for a century. Now it may have found a new role: helping scientists grow replacement tissues for people. The flossy stuff may be just right for creating networks of blood vessels within laboratory-grown bone, skin, muscle or fat for breast reconstruction

[Phi for All]

Please remember to give your opinion in your OP to set the tone for discussion, otherwise you're just reporting the news, which we don't need *you* for. It's your angle on the story we want.

 

 

 

This is so cool, but the cynical side of me is thinking about the pharm that's out there right now trying to spin gold by spinning something more expensive so they can spin it as preferable to the medical industry. I hope they stick to the cotton candy.

[Baby Astronaut]

Phi, my opinion is right in the title (sweet: double meaning).

 

Was rushing to my job so didn't have time to elaborate, and figured I'd do so later (i.e. now). Also, I'm sure a lot of people didn't get this news. We're all busy.

 

I could see the pharm doing what you say, but I'm not certain they always have the last word on the process. Question is, who's to prevent the competition from using an inexpensive alternative (not candy though, but similar to it)?

 

Unless, a higher-up in the FDA is paid by medical corps to deny the green light to anything cheaper? Dunno how that process really works, so I can only speculate -- is it an open process, or all closed doors?

[GDG]

Well, if you're going to implant something in the human body, you need FDA approval first. If it is something inert, you'll have to show that it is safe and non-toxic in humans, and you'll have to implant a sufficient number in a bunch of volunteers and monitor each one carefully for a period of time. Depending on how long you propose the implant is supposed to last, you'll need to prove that it is safe for that amount of time -- i.e., this can take years.

 

If your implant is supposed to have some therapeutic value (not just inert), you also have to prove that it is effective for that, using a statistically significant number of volunteers. It is not uncommon for clinical trials to require thousands of patients, and hundreds of doctors and researchers. The trials required to get a drug approved frequently run US$800 million to over US$1 billion -- regardless of whether or not the trials are successful! This is the main reason that non-generic drugs are expensive, and that generic drugs are cheap (generic drugs do not require clinical trials: just proof that they work like the original drug that they've copied).

 

AFAIK, the FDA does not consider pricing when it approves or rejects a new drug. Its remit is to determine whether or not the drug is safe and effective. As for pharma companies, most prefer to keep their cost of goods down where possible: they won't use gold filaments if they can do the job with cellulose -- there has to be a real advantage other than "costing more."

 

Grant

[Baby Astronaut]

AFAIK, the FDA does not consider pricing when it approves or rejects a new drug. Its remit is to determine whether or not the drug is safe and effective. As for pharma companies, most prefer to keep their cost of goods down where possible: they won't use gold filaments if they can do the job with cellulose -- there has to be a real advantage other than "costing more."

That makes sense, Grant. Where do you obtain your info from? I'd like to research more if possible.

[GDG]

That makes sense, Grant. Where do you obtain your info from? I'd like to research more if possible.

 

Mainly from working for pharmaceutical and biotech companies for the past 25 years. The FD&C "Pink Sheet" is also a good source of news about the industry.