The FDA's role is to do testsing on various products and devices for the public's safety and use. It must qualify in the USA (if place invented to mass market) before going on to sales elsewhere/internationally.

"The Kefauver-Harris Amendments of 1962, which were inspired by the thalidomide tragedy in Europe (and the FDA's vigilance that prevented the drug's marketing in the United States), strengthened the rules for drug safety and required manufacturers to prove their drugs' effectiveness.

The Medical Device Amendments of 1976 followed a U.S. Senate finding that faulty medical devices had caused 10,000 injuries, including 731 deaths. The law applied safety and effectiveness safeguards to new devices.

Today, the FDA regulates $1 trillion worth of products a year. It ensures the safety of all food except for meat, poultry and some egg products; ensures the safety and effectiveness of all drugs, biological products (including blood, vaccines and tissues for transplantation), medical devices, and animal drugs and feed; and makes sure that cosmetics and medical and consumer products that emit radiation do no harm."

Below is a link to the site's homepage.

http://www.fda.gov/RegulatoryInformation/L...ion/default.htm

I'm not quite sure what the question or whatever was.

I don't think it was so much a question,, as an answer to so many posters detrimental remarks about one of the most important administrations in the country,, possibly the world.

The FDA may be slow,,, but if that's what it takes to be sure someone isn't allowed to do harm out of greed,, It's fine by me.
ed

That's a good point Ed, Mac, but if they use their power to help the giant pharmaceutical conglomerates to make more money by depriving the public of viable health care products then it's doing us a disservice. A buddy of mine had a very aggressive prostate cancer. Radiation therapy would have cost him 100,000 bucks just to get started. His doc suggested some kind of chryo-something-or-other where they go in and freeze something or other. Only problem was that it wasn't approved by the FDA. His same doc did the procedure, in the Bahamas, for 25 grand and the guy's just fine now.

Pharm companys make a lot off other people's misery and they want to continue doing so. I'm all for regulation of what may or may not be a cure for what ails me but if something is being withheld from me just because it will cause them to make less money then that is a crime.

The FDA's role is to do testsing on various products and devices for the public's safety and use. It must qualify in the USA (if place invented to mass market) before going on to sales elsewhere/internationally

Did you mean "if place introduced to mass market" or "invented to mass market" McCann. I know the NZ government (and as E-dog pointed with his friend having a lump cryogenically removed) doesn't require FDA approval, but it does help because I do know they are a reputable and highly respected organisation but they have no legal mandate here. It's just a pity cigarettes weren't classed as a drug until recently or a lot less people would have died of lung (tobacco) cancer.

When the reason it/medical device hasn't been approved for is "due to monetary" reasons/motives, I feel safe to say that our knowledge (or lack thereof) is due to our assumptions.

I do not know why the links aren't working, but it is what was directly within my webpage address bar. Several reasons possibly are maybe because I cut and paste it incorrectly, I don't know the correct way to cut and paste (so much for my "mastery" lol), or the portion that states to email the according person if the webpage isn't found (due to some other problem) may have/need to be done. Eitherway the info can/will be found if one decided to look it up.

Now regarding the idea of certain procedures not being done as opposed to others, that I cannot speak about because a procedure is much different than a product.

This link should allow one to see/find information about the varied definitions (what a medical advice is).
www.fda.gov/MedicalDevices/ResourcesforYou/Consumers/ucm142619.htm

If incorrect address or not able to view then I have an excerpt added of a medical device definition as written by the FDA page.

"A medical device is:

"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar article that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease." Medical devices can be anything from thermometers to artificial hearts to at- home pregnancy test kits.

(source: Federal Food, Drug and Cosmetic Act, Section 201)"

E,, timing is the biggest problem with the stuff the FDA does. If that same procedure had killed your friend,, you might think it wasn't all that good. If it is ineffective or harmful in 5 out of 10 cases,, should it be used,,, how about 8 out of 10,, or 2 out of ten?

Somebody needs to make that decision,,, that's why we have them. But to find this stuff out takes time,, if you want it done right. There's the rub,,, some people are protected from worthless/harmful procedures,,, some can't get the good ones in time.

How does anyone fix that? Speeding up the approval process has been an ongoing effort almost since it started.

Happy to hear your friend got successfully treated.
ed

I second E-Dog's post!

If you want to get into a harmful numbers question, you are going to find that the FDA has approved plenty of harmful shit in their pursuit of helping big pharma execs to make those huge bonuses.

Yes, somebody needs to make the decisions, but plenty of those FDA decisions have been awfully suspicious at best. They haven't tried to speed up the approval process on anything really successful in DECADES.

Don't believe me?

How about procedures that are effective in the positive in 8 out of 10 cases, and ineffective (not negative or positive) in 2 of 10? (I'll start with what I know a bit about.) Like the adult autologous repair cell treatments for SCI. Granted, they're not getting people walking out right after surgery (which would be a ridiculous expectation), but they are helping in bowel/bladder function, sensation, and even hand function (for quads). That treatment was available a decade ago in other countries, but the clinical trials didn't even start here until this year. Interestingly enough, the FDA has deemed the adult autologous cells as "drugs" that will be regulated and sold by pharmaceutical companies. All that's done with the cells prior to injection is culturing. Culturing is done daily for tons of tests in the local doctors' offices. No extra drug company purchase necessary.

It's the same with olfactory mucosa autografts, which were effective in the positive for 6 of 7 (1 was some positive, some slightly negative effect) in Dr. Lima's study. The procedure has been available in Lisbon since late '03-early'04, but they haven't even tried it here, partly because of the FDA's "intervention." Hell, they haven't even tried the chondroitinase here. (That's the protein used to promote neuron regeneration and scar tissue removal.) They're finally starting to in the UK, but with rats. It's been used in humans for several years in other countries.

Then, how about the harmful stuff they've approved? Like some of the birth control meds that have a chance of causing life-threatening blood clots? They're still FDA approved. How about the anti-depressants? FDA approved anti-depressants are the topic of some debate. Partly due to the FDA not making sure they are prescribed according to guidelines, but partly because the antidepressant market is HUGE. I used to take Zoloft. I can tell you firsthand that it's not the drug I want to be taking. Zoloft is actually the reason I hate taking pills. It caused the worst hangover I've ever had for the entire time I took it. I hadn't had a drink in months, hadn't done a drug for 3 months, and still the Zoloft made me feel so hungover I couldn't function. I'm talking about the migraine-level headache, the blurred vision, the inability to keep food down. It was horrible. Even the low dose the doc put me on at the first caused this stuff. I'm aware that every body reacts differently to some things, but the scrip info didn't even mention anything about migraine headache and extreme nausea being possible side effects.

Or ADD drugs. Ritalin? I think most of us have a little bit of an idea about the Ritalin issues, but for those that don't--Ritalin has caused about the same number of problems as solutions (maybe more problems). Again, partly due to the FDA not doing their watchdog duties, but due in bigger part to it basically being speed (Yeah, that's a real good thing to give kids. Tell them not to do drugs, but feed them speed. WTF is going on here?!). Adderall? Same concept-"Let's feed little Johnny some speed. That oughtta be good for him."
How about radiation and chemotherapy? I've never actually had them, and won't have them as long as I have a say in the matter. I'd rather they just give me the morphine. I've seen too much of what chemo and radiation do to the body. For many, the chemo and radiation cause worse effects than the cancers they're supposed to treat. What, with all the vomiting, inability to eat, hellish pain, confusion, hair loss, skin problems, etc; chemo and radiation are some of the most barbaric things we've used on people since freaking crucifixion. But still, they're FDA approved (Unlike crucifixion, which could be a really good crime deterrent.).

Viagra is one used by some on here. I could point out the possible side effects of it, but I'm sure everyone got warned of all those possible side effects by their doctors. Maybe... I know my doc forgot to warn me of a few things with Caverject. Good thing I read that manual they gave me at the pharmacy.

Point being, there are plenty of drugs/treatments that are FDA approved that have "side" effects that are no better than the conditions they're used to treat. Some are worse. I could pick up my wife's Nursing Drug Guide and pick you out tons of them. So, where are all the "safe drugs" that the FDA and pharma companies claim are being made? Isn't that what the FDA is supposed to be making sure they all are? At least reasonably safe? Who really decides what's "reasonably" safe? The FDA, or the pharma execs? Why are there so many approved treatments/drugs that are harmful?

There are also some new and wonderful treatments/drugs that the FDA just refuses to help make available (even for trials), regardless of the proven safety and effectiveness. It's like they're just putting up as many obstacles as possible for some things, like (again, back to ones that apply to many of us here) olfactory mucosa transplantation and autologous repair cell injections. What has the FDA done to help get proven safe and effective treatments/drugs approved and stop the BS treatments/drugs? Nothing really. If they did, they wouldn't be getting their pockets lined by big pharma, which is what seems more every day to be the case.

Again, don't get me wrong. I'm for having competing pharma companies that help us out, provide lots of jobs, etc, but the FDA shouldn't be working for them. The FDA should work for US. They were established to work for our best medical interests, not the best interests of the pockets of the pharma execs or themselves either.

Truth of the matter is that the FDA also allows some products to remain on the market even though the company may have things that they need fix/correct (read about the approval process and stages by the FDA and products). Many times these companies are given a certain amount of time in which to correct the product (warning letter etc) before it is pulled. Maybe that’s why some countries don’t even bother making the product available for sale to the public.

Some products are “hot” for a while then are no longer heard of (exist on the market) in that name anymore (big companies cash-out scheme/scam).

How much does the FDA stand to make from allowing these companies to have their product on the market? Especially, if the FDA does annual checking/testing on these products to ensure they maintain it’s approved quality standards?

There it is again. That key word if. If the FDA did what they're supposed to, we wouldn't have the BS that we now have. I think it's fairly apparent that the FDA is just as much a part of the healthcare problem in this country as any of the insurance companies.

What I'm saying is not "They don't test this stuff enough times," as the annual tests are just that and nothing more. What I'm saying is that some of the pharma companies have some of the FDA in their pockets--You know...payoffs, bribes, stocks; call it whatever you want, it's still the same in the end. Somebody (if not lots of somebodies) in the FDA is making money on certain products/treatments getting/staying approved, and certain ones staying off the market as long as possible. If that wasn't the case, we would have successful things like autologous cell implantation for heart problems, eye problems, and SCI here like some of those other countries that nobody here seems to want to admit are decades ahead of us. The FDA's roadblocks have set us back by at least 10yrs.

You talk as if the FDA takes steps to keep harmful products from being kept on the market. I know they say they do, but really? Obviously they don't take the same steps for every harmful product out there. Again, I ask "What about chemo/radiation, and all those others I mentioned earlier?" We've had the same treatment for cancer for over 20yrs. Where are the products of those 2 decades of research we've funded through taxes, fundraisers, donations, etc? Ritalin--isn't it still on the market? I know adderall is. I have a little nephew that used to take it until his mom realized that it was what was making the insomnia and lack of appetite worse for him. That shit's as bad as any street crank you can buy in the ghetto. WTF makes people think it's a good idea to give that stuff to kids? And why the hell is that crap still on the market?

Now to the bigger question here. I'm sure somebody's thinking I'm nuts and can't possibly have any reasoning behind what I'm saying, but think about this for a minute--What happens when stem cell treatments replace a whole bunch of drugs? Right, it's not good for pharma companies. So, now think about the FDA classifying a person's own cells as drugs that will be regulated and sold as such by pharma companies. That's basically telling me that my cells belong to pharma companies. That's absurd!! (Sounds like a team effort between big pharma and the FDA to me.) But if I want to have some cultured (by a doctor in a lab, not at Pfizer or GSK) and reintroduced, even if I'm the one who cultures them and I reintroduce them into myself, then I have to have them sent to a pharma company, packaged, and then have to purchase them back. Hmm...The timing and convenience seem a bit odd to me.

And the process sounds pretty wasteful, too.

Particularly considering how easy it is to culture autologous repair cells with chondroitinase (among other proteins used). It can be done by just about anyone familiar with practically any specimen culturing, which includes a whole lot of lab techs in hospitals and doctors' offices around the world. So what's the problem with having it all done in the same place, without having to ship the cells off to some pharma lab, have them packed, and then order and pay for them (After just paying for their removal!!), then wait for them to come back, then have the injection? The only problem I can see is that the pharma companies wouldn't be involved and wouldn't be making money. The safety and effectiveness of the autologous cells (and olfactory mucosa neurons) have already been proven in plenty of places, and I'm sure that plenty of American doctor's will (if they haven't already) be able to personally report the same findings in those respects. But then again, safety and effectiveness are part of the problem. If those safe, effective treatments don't make the pharma companies money... Well, we can't have those treatments. To even think that we could leave out Pfizer, GSK, etc is simply preposterous. At least to the FDA.