Strict FDA - Good or Bad?

[yurano]

Insight: Evidence grows for narcolepsy link to GSK swine flu shot

STOCKHOLM (Reuters) - Emelie is plagued by hallucinations and nightmares. When she wakes up, she's often paralyzed, unable to breathe properly or call for help. During the day she can barely stay awake, and often misses school or having fun with friends. She is only 14, but at times she has wondered if her life is worth living.

Emelie is one of around 800 children in Sweden and elsewhere in Europe who developed narcolepsy, an incurable sleep disorder, after being immunized with the Pandemrix H1N1 swine flu vaccine made by British drugmaker GlaxoSmithKline in 2009.

...

In total, the GSK shot was given to more than 30 million people in 47 countries during the 2009-2010 H1N1 swine flu pandemic. Because it contains an adjuvant, or booster, it was not used in the United States because drug regulators there are wary of adjuvanted vaccines.

...

The FDA is frequently criticized for being too strict but it seems like American kids dodged a bullet this time.

Should the FDA be more or less strict?

[Tomec]

Personally I think it really depends on the product whether they should be more strict or not. Like I'm all for the very strict drugs and stuff, that's def a bullet dodge there. (Although the actual % is pretty low it sounds like... 800 children out of 30mil people?) However I'm not too sure they should be sticking their noses in certain FOOD things.

Like in Cali there was some prop (not sure if it passed or not) that was supposed to require farmers to label products if they were like cross species mutated or something. Ummm... what? Why? Cause some health nut said "you should be natural man!" I mean it's not like they are doing some spiderman style thing using radiation to modify DNA or something. Just taking the best strains of plants and putting them together, something gardeners have been doing for hundreds of years!

[Butler to Baby Sloths]

Like in Cali there was some prop (not sure if it passed or not) that was supposed to require farmers to label products if they were like cross species mutated or something. Ummm... what? Why? Cause some health nut said "you should be natural man!" I mean it's not like they are doing some spiderman style thing using radiation to modify DNA or something. Just taking the best strains of plants and putting them together, something gardeners have been doing for hundreds of years!

That wasn't designed to stop GMO crops being sold, but to allow the customer to differentiate between nonGMO and GMO if they wanted to.

[Mihalik]

Personally I think it really depends on the product whether they should be more strict or not. Like I'm all for the very strict drugs and stuff, that's def a bullet dodge there. (Although the actual % is pretty low it sounds like... 800 children out of 30mil people?) However I'm not too sure they should be sticking their noses in certain FOOD things.

Like in Cali there was some prop (not sure if it passed or not) that was supposed to require farmers to label products if they were like cross species mutated or something. Ummm... what? Why? Cause some health nut said "you should be natural man!" I mean it's not like they are doing some spiderman style thing using radiation to modify DNA or something. Just taking the best strains of plants and putting them together, something gardeners have been doing for hundreds of years!

Well that is just one side of the thing. The real issue is that genetically modified crops tend to cross breed with the natural genetic stock eventually damaging the original stock beyond repair. Now this is an rather large problem in case you have an issue with the genetically modified crop. If you no longer have the original source it is very difficult to fix the problem you created. So you have to further engineer the product, potentially reaching a point where due to the genetic engineering the crop completly stops resembling the original product, thus you lose biodiversity and endanger your own food chain.

The public really tends not to know much about genetic engineering.

Don't missunderstand me. I am not at all against it. But I do know for a fact that we need better checks and balances around it and need to keep a very close eye on it, or else we could be risking further problems down the line.

As a general rule the least the general public knows about something the more likely they will dismiss the potential dangers and that in the US governament phobia world means they will also oppose governament oversight.

What I don't get how is stem cell research is against the bible and is playing God, but genetic engineering of crops or livestock is not? Stem cell research is less intrusive on the genetic code (God's blueprint so to say) then Genetic engineering. Rather stupid don't you think?

This very relevant to this topic.

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



This sort of breaks down all the issues around mass distribution of Crop genetic engineering.

I repeat I am not against genetic engineering. I think it can be beneficial and it is needed. What I do think that something that can potential cause so much damage needs proper oversight.

[Osyrus]

Insight: Evidence grows for narcolepsy link to GSK swine flu shot



The FDA is frequently criticized for being too strict but it seems like American kids dodged a bullet this time.

Should the FDA be more or less strict?

Yes. I worked in shipping.

You should see what happens to your food before it gets here. For the love of everything wash it please.

THB I wish we should stop taking in food from a lot of other countries. They have NONE of our standards of cleanliness.


Do you realize all pallets have to be heat treat for bugs to get into certain countries? Why because a pallet had a bug and ate an entire forest.

[Spectral]

Whoever wrote that story didn't really get what the regulator he spoke to was saying - the FDA isn't wary of adjuvanted vaccines, they're wary of vaccines with relatively untested adjuvants. As a general rule, the only vaccines without adjuvants are live attenuated viruses, which have their own concerns.

I don't think the FDA is presently too strict or not strict enough; there's some gaps in the regulatory process I'd like to see fixed (negative data reporting from companies is the biggest) and the FDA's hands are tied on certain matters, but I think the overall tone is fine.

[Deadvolcanoes]

Should the FDA be more or less strict?

In regards to your first article, I have a pretty difficult time believing the H1N1 vaccine caused narcolepsy. I'm open to investigating further, but it's a very unscientific article, and doesn't make the case for causation. Narcolepsy is very strongly linked to genetic predispositions:

Specifically, there appeared to be a strong link between narcoleptic individuals and certain genetic conditions. One factor that seemed to predispose an individual to narcolepsy involved an area of Chromosome 6 known as the HLA complex. -Wiki

In regards to the FDA, I dont think it's a matter of them being "strict." It's a matter of them conducting the proper scientific experiments, and basing their decisions off the results.

[Wildtree]

The FDA is frequently criticized for being too strict but it seems like American kids dodged a bullet this time.

Should the FDA be more or less strict?

I do not know what the deal is with the FDA... To me they make no sense whatsoever.
On the one hand they have restrictions, which can only make you shake your head. Let's give a prime example.. Surprise Eggs. A German candy product. On the market, for I don't know how long. 40 years maybe? I don't know..

It's an egg made of chocolate, filled with a plastic egg which contains a little toy. The egg is so popular, there's a whole community out there with collectors of said toys. Yet, it's prohibited in the USA for some years now. The FDA thinks that it can harm kids.. They could just eat the entire egg including the toy content /facepalm.

At the same token, just last night during a tv show, there was again an add about some sleeping pills..
They names all the side effects for the product.. Hell, any sane person would never take those pills. Why would I take a medicine that can drive me into suicide?
So, we discussed that, and compared. Our conclusion was, how very little we can and do trust into what ever prescription we get from a doctor here in the USA.
Back home in Germany, we did, and we do trust in the doctor, and we know that what ever he prescribes will not harm us. The medicine on the market is rather safe, or otherwise wouldn't be on the market. The health department wouldn't allow it. Plus, our doctors don't make money of what they prescribe to their patients.
US doctors do. They almost need to rely on that kind of upsale. The FDA does nothing in that regard.
Another example. How can it be, that some drugs are classified enhancement drugs in Europe, yet they are freely available in the USA?
Bodybuilders from Europe order products in the USA to enhance their body, since they cannot buy the products in Europe...
To me something sounds extremely fishy. Almost as if the FDA is very cozy in bed with all different kinds of industries.
The World's pharmacy manufacturers are able to sell products in the USA, which aren't allowed in Europe, or at least not allowed in the same consistency as they are in the US version of the drug...

So, should the FDA be less or more strict? I say, the FDA needs to start making sense.

[Dezerte]

It does kind of poke holes in the "FDA conspiracy".

[Kujako]

Wait... you saying that the FDA has some sort of power? Thought they "fixed" that already based on the amount of snake oil I see for sale these days.

[oblivionx]

FDA has a long history of effectiveness, Undoubtedly the most effective of entities like it.

While I don't think that in itself is proof of anything, track record being good is a point in itself.

[Kasierith]

It is pretty fine where it is, if someone would go through and restructure it just to clear out residual red tape and reformat it. It has shown time and time again that adopting as strict a stance as possible can save lives.

I would, however, like to see another attempt made to bring the wildly out of control "alternative medicine" products under supervision.

[yurano]

In regards to your first article, I have a pretty difficult time believing the H1N1 vaccine caused narcolepsy. I'm open to investigating further, but it's a very unscientific article, and doesn't make the case for causation. Narcolepsy is very strongly linked to genetic predispositions.

If you've watched Bourne Ultimatum, there was this whole deal about 'viraling' off their meds. While Bourne Ultimatum is fiction, there are certain viruses that can be used alter genetic material. If the H1N1 vaccine used retroviruses then genetic alteration causing narcolepsy is possible. However, retroviruses are heavily controlled and only used in research and gene therapy so I doubt genetic alteration is the mechanism. While unlikely, this example shows that vaccines (sometimes 'attenuated' viruses) can alter your genetic material.

One factor that seemed to predispose an individual to narcolepsy involved an area of Chromosome 6 known as the HLA complex.

Use of the word 'predispose' suggests that even if you have the 'genetic defect' you might not develop narcolepsy. How is this possible? Well, gene expression is based off of a variety of factors (molecules within the cell). Just because you have a certain gene doesn't mean it will be expressed. It could be that the H1N1 vaccine somehow indirectly induces the expression of 'narcolepsy genes' in those that are predisposed for narcolepsy.

At the same token, just last night during a tv show, there was again an add about some sleeping pills..
They names all the side effects for the product.. Hell, any sane person would never take those pills. Why would I take a medicine that can drive me into suicide?

Most drugs have really random side effects. The reason said drug passed the FDA is that such occurrences are rare and you can negate the symptoms by stopping the drug (tested and proven in FDA trials).

In contrast, narcolepsy 'caused' by the H1N1 vaccine is permanent. Choking is also pretty permanent. The FDA doesn't act in 'mysterious ways'. Most likely there was a toy where children choked on years ago. As a result, there was a public outcry which changed the FDA's stance on such products.

I would, however, like to see another attempt made to bring the wildly out of control "alternative medicine" products under supervision.

This is probably a good idea but a lot of people will complain. FDA approval is an expensive endeavor.

[semaphore]

This is probably a good idea but a lot of people will complain. FDA approval is an expensive endeavor.

People will complain about anything. Not really a good reason to not regulate these nonfunctional alternatives to real medicine.

[Deleted]

Have they still got a ban on imported Haggis?

I always found the thought of Haggis being smuggled over the Canadian border hilarious.

[Deleted]

Have they still got a ban on imported Haggis?
I always found the thought of Haggis being smuggled over the Canadian border hilarious.

Sounds like a great idea for a national lampoons movie. "National Lampoons Presents .... The Great Haggis Chase"
could have a Hockey team that say "Eh?" a lot, a Maple Syrup covered moose chasing a group of Canadian Mounties, The Niagara falls, Staring Jim Carrey, Dan Akroyd and Carrie-Ann Moss.

Basic story line would involve Jim Carrey as a Mountie chasing Dan Akroyd and Carrie-Ann Moss through Canada who are smuggling a consignment of Haggis in the back of a Maple syrup truck. Dan Akroyds Character picks up Carrie-Ann Moss (Trinity from the matrix) who is hitchhiking, unbeknown to him though she has a mental illness which makes her slip into delusions where she believes is stuck in a computer simulated world.



On Topic, Its good that they are strict, as long as they not stupid with it.

[Adam Jensen]

I'd rather not eat food that capitalist corporations are allowed to load with bad chemicals just so they can save money.

Sure, the FDA can go overboard like any other agency, but on the whole, I think they're necessary.

[Sunseeker]

Each product should be analyzed carefully, and I think that on the whole, the FDA does a good job, so I'm all for the FDA being strict and firm before allowing products to be sold for human consumption.

[Spectral]

Wait... you saying that the FDA has some sort of power? Thought they "fixed" that already based on the amount of snake oil I see for sale these days.

Unfortunately, the FDA has narrow regulatory powers, there's not much than be done about homeopathy as long as they use certain phrasing on labels.

---------- Post added 2013-01-23 at 08:44 PM ----------

I would, however, like to see another attempt made to bring the wildly out of control "alternative medicine" products under supervision.

The hard part is they'll just sell the same useless shit with ever more amorphous claims. It's pretty hard to regulate, really.

[Sunseeker]

Unfortunately, the FDA has narrow regulatory powers, there's not much than be done about homeopathy as long as they use certain phrasing on labels.

Indeed, I used to work on creating labels for a company, specifically, the verbage. There's so much you can indirectly imply and associate with your product without actually claiming your product does those things.