Question about the FDA

[Dynaflow]

 
 I just wonder on the drug ad's we see these days telling us that we really need they're product so that we can feel normal what is the acceptable side effect of deaths for a product to still be ok'd by the FDA for sale in the U.S.? I've seen several products that actually say (rather quickly) 'And in some cases Death' when referring to side effects of the medication. Whats acceptable, 1 in 100? 1 in 1000? Seems to high to me if there's any deaths from a product, but people be different mechanically from one to another I know its impossible to account for all possible problems that could happen or the number of drug interactions that could happen depending on what the person is prescribed. Anyone else think that was NOT a good idea to allow drug manufacturers to advertise on TV btw?

Regards,

Dyna

[FYL]

Don't watch teevee, boycott all advertised products, don't use any drugs unless prescribed at an hospital, eat real food, don't drink mixed junk, smoke cigars, hit the stage, play rough, live hard and be merry.

[Bassmanster]

A legitimate alternative IMO:  Harvard M.D. and researcher who looks at both western and natural medicine,

http://www.drweil.com/

[bnwitt]

I followed Weil for awhile.  You might want to do some research on his beliefs and writings though:

http://www.quackwatch.com/11Ind/weil.html

In general, this is a pretty good site for getting some non-hype opinions about every new health craze:

http://www.quackwatch.com/index.html

[tubesornothing]

anecdotal versus scientific evidence... where have I head this before?

(sounds like the "capacitor tone" debate is going to start up, but in the form of medicine)

oh oh...

[stingray_65]

finding a Dr you trust is more than difficult

had one Dr that I truely trusted, but she moved out to NY.

She actually fixed a crick in my neck by fixing a corn on my foot!

I would have ate a cat turd if she told me I would feel better.

I would never trust any corperation to tell me what i want or need.
only a person that I've developed a relation with.

what the heck are you doin watchin comercials for any how? LOL

all they are good for is to misguide you. If you want it, get it, if you didn't know it existed, you couldn't know you want one. comercials are the seed of the devil that spawns  $20 SS amps :)

[PRR]

> Seems to high to me if there's any deaths from a product

Music kills people. Infection.  Electrocution. Airplane crash. Terminal VD. Enhanced depression.

Death happens. You want to live forever?

[Bassmanster]

What he said. ^^

[rafe]

  Is that the origin of the Lully-bye ??

[bnwitt]

Well good health is pretty basic.  If you eat right, exercise, bed and rise early and minimize the ingestion of unnecessary foreign substances, you may extend your life a little before you die from whatever you are genetically predisposed to croak from.   Of course that is living like a monk your whole life for a few extra days I think.  But, there is nothing wrong with wanting a few extra days and if you can take the regimen, more power to ya.  Life is good.

[Shrapnel]

Remember health supps don't need FDA approval, just disclaimers. Pharms need FDA approval. Snake Oil exists at all levels, and the ambulance chasers who love to go after any of 'em.

Good Physical health, good hygiene, good diet (but then again... what IS good? too many conflicting reports now days,) good mental health. (That includes forgiving the clown who cut you off and forced you to take a different route, or the joker with the flare gun who burnt the place to the ground.) Today's out of control emotions don't help mental health.

[P Batty]

There are a few independent sources on health that are worth reading. Check out Stephan Guyenet for some research-based information on diabetes, saturated fats and other modern maladies:

http://wholehealthsource.blogspot.com/

[Dynaflow]

 Thanks for all the responses.. I guess people aren't all that concerned with the big drug companies peddling that crap on TV. Fair enough. It ain't about living forever, good grief outside of missing the grand kids and my family I've had a good run and if the pit boss wants me to cash my chips in at any time I'm ready.


Regards,

Dyna

[bnwitt]

Dyna,
The FDA doesn't give a rat's patuity about individual life.  Only excessive deaths which make the news worry them. Because then the jig can be up on the under the table profit they make everyday with their little "Approved" stamps.  

I remember giving cases of Chevas to inspector's from the Agriculture department in order to get them to pass the cleanliness of ship holds for the loading of wheat going to Russia back in the Carter era.  As an honest boy it took me a little while to get the hint.  Nudge, nudge, wink wink.   Now I know how the government works.

Bottom line, don't take any drug or substance that you haven't thoroughly researched and that hasn't been well tested on your fellow citizens/guinea pigs.  I haven't even thought about getting the H1N1 vaccine yet

[Shrapnel]

I haven't even thought about getting the H1N1 vaccine yet

The SAD thing is just about everyone who takes that THINKS they are immediately protected. The bad news is Flu season will be over by the time full immunity takes effect for the blokes who are just now taking it.

Personally I think there's a bunch of hype and fear being spread over it just because it is "new" AND the media likes the results of fear mongering (plus the control it gives governments and pharm companies)

[Bassmanster]

"I guess people aren't all that concerned with the big drug companies peddling that crap on TV."

Probably most of us view it as having its fair share (more than its fair share in this case) of horsecrap, same as everything else.  Along with the high prices, the battle btw the drug companies and insurance, the subsidizing of R & D by the US and not other nations with price controls, the complicity of the FDA and the pressure on doctors to do this or that, the whole thing is insane.  But the skepticism feels normal; I feel skeptical and cynical about many things.  So, the upshot for me is that whatever the doctor wants to do, I can second guess him or her and do my own research because this is a free country.  Also, I have my own doctorate (in engineering) and I don't see an MD as someone with godlike powers.

I also think that science is wonderful, necessary and pretty darn rigorous, but often of limited scope.  To get information about aspects of reality that lie outside the scientific method, we need to use other, softer methods.  I personally don't see anything wrong with that.

YMMV

From the posts above, I agree most strongly with the mental health aspect of holistic health.   Stress kills (research backs this up more and more) and I think we can impose stress upon ourselves even when external stressors are not that bad.

[Boots Deville]

There was a story on NPR a couple months back - "Selling Sickness: How Drug Ads Changed Health Care" that gives a little history on these ads and their impact:

http://www.npr.org/templates/story/story.php?storyId=113675737

-John

[FYL]

You want to live forever?

"Eternity is very long, especially towards the end", Woody Allen

[madison]

Gosh all these new types of flu......

Stress is the leading killer afaic.
Drug corps put crap on tv that make us unnessarly stress out and worry.(vicious circle).
I don't watch tv.

My biggest concern is when (now?) drug corps have the the lobby potential$ in Govt to force us to take their medicine.

Eat well, work hard, and for goodness sakes......... do what makes you happy, without hurting others in the process.

[bigsbybender]

I got immunized from H1N1 the old fashioned way :sad4:  I was laid out for about a week.

[Frankenamp]

Gosh all these new types of flu......
...

My biggest concern is when (now?) drug corps have the the lobby potential$ in Govt to force us to take their medicine.

Eat well, work hard, and for goodness sakes......... do what makes you happy, without hurting others in the process.

Case in point: every normal-acting boy is now labeled with ADD & ADHD and dozed up with Ritilin (methamphetamine) or some other drug. Now we are reaping the whirlwind of a spectacular rise in crank-addiction and other speed-freak problems...  But hey, whadda I know? I just had a smattering of university courses in about ever other 'ology* there are, just no degree. (*only one was in Psychopharmacology)

[thermion]

Imagine you are the CFO at a big pharma - you just spent a billion $$$ developing the next treatment for ___. To get profit flowing off of the patent ASAP, the second your drug passes phase 3 clinical trials (small-scale safety and efficacy) you get it advertised publicly. It's the new way to sell pharma - get the patients to start deciding on their own that YOUR drug is just what they need so they will ask their doctor for it by name. Modern drug marketing is scary and marginally deceptive stuff. Largely, modern drug development is not. To relieve themselves (pharma) of possible blowback from not disclosing any and all side-effects encountered by anyone at any point during clinical trials, they have that insane language in the ad copy (ex. rectal bleeding from an allergy med...). SOMEbody in the trial had that happen, maybe one person, and maybe their grotto would have bled out even if they hadn't gotten the test article, but they admit it loud and clear up front to minimize liability on the back end.
This is a post Vioxx world and pharma does not want a class action lawsuit 15 years into the clinic that could bankrupt the company. I am talking about long-term off target effects that don't show up until someone has taken the drug daily for 10 years. Chronic damage to some major organ has occured that nobody could have foreseen but the family wants heads to roll. Especially if 500 other patients on the same drug saw the same effect in roughly the same time frame. Clear, easily understood disclaimers help with all of this. These long-term effects are sometimes studied as a trial but it is voluntary phase 4 testing (large scale safety and efficacy) paid for the the manufacturer. As you can guess, sometimes this isn't done.
Back to the original post - it's all about biomedical stats and ultimately p-values. The phase 3 clinical trial data is in and the statisticians start crunching numbers. If there is a clear correlation (low p-value) of death or some other gnarly outcome vs. being in the test article group and not the placebo group (you have data from both groups to compare), the drug does not receive approval. Also rare outcomes don't pop up until very large groups are tested (ie you need a very large group of test subjects to see a 1 in 100,000 effect). Again, this would come up in the voluntary P4 testing if it was done.

My biggest concern is when (now?) drug corps have the the lobby potential$ in Govt to force us to take their medicine

Lobbying is not required. The CDC can determine that an illness is a grave threat to public safety and mandate through FEMA disaster response that the public be treated should a treatment exist (even if it's not so great and has lots of side effects since these could be minor compared to the actual illness). You refuse, you go to quarantine at gunpoint. The drug manufacturer then gets mega-rich mega-quick since they just sold millions of doses to the gov't.

[EL34]

Many Americans seem to be convinced that they need all these drugs that you see in these comercials

I can't believe how mant tv commercials the drug companies put on tv.

The silly part is that the drug companies sell this crap because people allow doctors to prescribe it and they take the crap

Americans in general have no concept of how their bodies work or how to maintain them.

Being overweight and not doing enough excersise is the fast lane to disease.

The % of obese americans climbs every year.
It's really sad to read some of the latest figures on obesity and how many overweight people do not even think they are obese.

The report finds that adult obesity rates now surpass 25 percent in 31 states and exceed 20 percent in 49 states and Washington, D.C. In 1991, no state had an adult obesity rate above 20 percent. In 1980, the national average for adult obesity was only 15 percent. Today, two-thirds of American adults are either obese or overweight. Sixteen states experienced an increase in the rate of adult obesity for the second year in a row, and 11 states experienced an increase for the third straight year when compared with past reports.

http://www.medicalnewstoday.com/articles/156367.php

People eat way too much brown colored crap food and do not excersise.

It's all very sad, gets worse every year and affects my health insurance rates.

Why on earth do I have to pay for the ignorance of all these people that eat a crap diet, are overweight, abuse their bodies, get sick and want drugs to save them?

Don't get me started. 

[GroundhogKen]

Agreed Doug,

I can't believe how many people take anti-depressants where I work .  I work at a great place, if you need psycho-candy here, you're in sad shape.  The same people that take the meds are also overweight and have diabetes.  They also complain a lot and make fun of me for eating oatmeal for lunch.  I'm hardly in shape for Olympic competition, but at least I exercise and I don't require a motorized shopping cart to make my way through the grocery store.

If I watch the evening network news there is 10 minutes of broadcast and 20 minutes of drug advertisements.

Restless Leg Syndrome!!!   What the f_ck is that.  Come on you fat losers--if your legs are restless, take them for a walk.  Don't suppress the urge with a pill.


However, I do like those Lunesta commercials.  I never have trouble sleeping, but if taking a pill will make me see green and purple luminescent butterflies, I might just try it.


Ken

[thermion]

However, I do like those Lunesta commercials

you mean non-narcotic Lunesta? I thought narcotics made people sleepy...

evening network news there is 10 minutes of broadcast and 20 minutes of drug advertisements

obviously there is some major demographic targeting at work here. my legs start feeling restless just watching those ads, screaming at me to run outside and profess to the world VIVA VIAGRA!

[EL34]

It is not going to change, it is only going to get worse until it all comes to a head

People somehow seem to ignore their bodies every day and every year the % of overweight americans goes up.
They believe modern medicine will provide a pill that replaces excersise and burns body fat.

I am no angel either
I do drink beer and I do tend to have one or two more than I should and that's probably not real good for me
I don't take any drugs, except an aspirin now and than and maybe one of those PM type pain relievers

I rarely eat red meat, but I do love butter. Me and Paula Dean would get along fine
But, I do get some serious biking excersise a couple times a week because it's fun for me and it's a social thing with my buddies
I get a fair amount of hiking excersise also.

I can feel a huge difference if the weather keeps me from my riding and I don't get any good excersise for a few days.
It's amazing how good excersise makes you feel.
I believe excersise and diet are the cure for most things that affect modern society

And if you act right now, I will throw in some Lipozene
http://www.lipozene.com/indexa.php?source_in=LPGOG3&gclid=CJ7xwKri4J4CFR5inAodSCOYKA