Is the FDA Being Too Lenient?
 

http://www.npr.org/templates/story/s...toryId=4236757

This issue of Celebrex brings up a long-standing debate: Whether or not the Food and Drug Association is too lenient and/or lax about banning drugs that have potentially harmful symptons that could be hazardous to your health. The FDA has always had a close relationship with the drug companies. Many critics claim that this relationship stands in the way of the FDA's abillity to protect the consumers...

What do you think about this? Where do you think the line should be drawn?

Really depends if you're one of those people who believes that the FDA only allows drugs that will make a profit into the marketplace, or if you are one of hte people who believe that their (the FDA and Drug Co.'s) close relationship is just so that the process of approving a drug can be hastened.

I personally believe the latter, and as such, I don't think their being too lenient. I think a few corners may ahve been cut, but mostly it's just that they didn't know the threat was a big as it is. One of the Ingredients (forgot name, and frankly don't care) was known to increase the risk of heartattacks and other cardiovascular problems, but Celebrexx, Vioxx, and other drugs that used this ingredient added other compounds to try and counteract the increased risk. Apparently Celebrexx did a better job then Vioxx at this, but they still haven't completely coutneracted the increased risk. The FDA thought that they had done a good job, so that the risk of heart attack was greatly minimized, and the drug was ready for mass use since the benefits outweighed the risks. Turns out they were wrong and it still has a pretty big risk. I know they are supposed to protect the people from this sort of thing, but htey made a mistake, so sue 'em. Well, don't actualyl sue them, medical-based lawsuits are out of control, but I digress.

No, I don't think they're being too lenient.

Really? I've always had the impression that the FDA were like Nazis when it came to drugs; and that it was the lobbyists in Washington that the drug companies were in bed with.

It seems to vary from topic to topic. They seem to go crazy with tiny insignificant health codes but care less about things just like Celebrex. They don't want to go over the line and have their approval go down by dealing with drugs that are already controversial.

Vioxx was good.... It was the only thing to cure me when I had these horrible throat inflamations. You know, right at the back of the throat, so it hurts when you swallow.... I popped one in, and the swelling went down immediatly(sp), for the whole day.

But, I digress... Yes, they are too lax on some things. Ever heard of rGBH? (the capitalizations may be screwed up) It's this hormone used to increase the amount of milk produced by cows. The thing can give you cancer, and yet the FDA aproved it... (Yes, it can transfer to humans)

Then, in other drugs, they are nazis. I'll provide an example soon. Either an edit or a new post. Sorry. This Celebrexx stuff is a good example, though.

Nazi is a very good description, what with the FDA being the only organization in the history of our government (to my knowledge) to burn the books of someone they didn't like.

http://en.wikipedia.org/wiki/Wilhelm_Reich

Oh, and don't forget about the whole "accidentally adding a compound that is 50% mercury to MMR shots given to infants and watching autism rates increase exponentially and then getting the government to write laws preventing any future compensatory lawsuits" stunt.

http://www.kansascity.com/mld/kansas...0409744.htm?1c
http://www.thimerosal-litigation.com/

Hm, and then there's the FDA not requiring the labeling of certain products banned in the EU and Canada, like genetically modified foods and milk with bovine growth hormone.

http://www.greenpeaceusa.org/multime...1/544226/0/331

Oh yes, and deliberately hiding experimental data about potentially harmful new drugs.

http://www.washingtonpost.com/wp-dyn...2004Sep23.html

And while simultaneously allowing potentially hazardous drugs from multibillion-dollar pharmeceutical corporations on the market with flawed or downright fraudulent testing, attempting to supress the distribution of cheap, natural alternatives

http://www.rmhiherbal.org/a/f.ahr6.fda.html

Don't forget about about RU-486, which has already killed 3 Americans (more overseas, but I'm not sure of the number). It has yet to be pulled from the market (and likely won't be for years).

Compared to how much RU-486 is used, the fatality rate is EXTREMELY low.

I had the exact statistics down somewhere, but I forget where I put it. If I come across it again, I'll be sure to post it up.

No drug is 100% safe, not RU486, not Tylenol.

Last time I checked, Tylenol didn't cause serious bacterial infection (without the symptoms common to most infections).

If you seriously think that ANY drug that can be fatal (without an allergic reaction, which is someone you can't really protect against) should be on the market, then you should rethink some aspects of your philosophy.
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Your talking about 3 deaths (which mind you, any needless death is a tragedy) out of the probably thousands of women who take RU-486 as emergency contraception a year.

"A much underutilized means of reducing unintended pregnancy is the use of emergency contraceptive pills (ECP). The two major types of emergency contraceptive pills currently available, Preven[TM] and Plan B[TM], received Federal Drug Administration approval in 1998 and 1999 respectively (Federal Register, 1999). Emergency contraceptive pills, often mistakenly called the "morning-after pill" can be at least 75% effective if taken within 72 hours of unprotected intercourse (Trussel, Rodriguez, & Ellerston, 1999). Establishing absolute effectiveness rates is impossible as there is no way to establish whether or not conception has actually occurred at the time of taking ECP. However, ECP's potential for reducing the rate of unintended pregnancy and ultimately abortion is very strong. The National Abortion and Reproduction Rights Action League (NARAL) estimates that emergency contraception could reduce the number of unintended pregnancies and abortions by one-half each year (NARAL, 2001). For college-aged women of 18-24 years, that would equate to potentially preventing almost one million pregnancies and over 600,000 abortions annually (Henshaw, 1992; Alan Guttmacher Institute, 2000b)."
http://www.findarticles.com/p/articl...7/ai_112720416

Medication like this is labeled as "emergency contraception" for a reason, it's not made to be taken on a consistant basis. A lot of the reasons people may have increased side-effects because of it may be various: from improper usage to allergic reaction. Without knowing the specifics for each case, there is no way to tell what the situation was per case.

Think about this, with everything as utterly un-partison in the current political climate, do you honestly think that if this pill wasn't concidered safe, it would still be on the market?