How ridiculous is the FDA?

[barcafan]

http://www.nytimes.com/2010/03/31/busin ... s.html?hpw

With the government’s blessing, a drug giant is about to expand the market for its blockbuster cholesterol medication Crestor to a new category of customers: as a preventive measure for millions of people who do not have cholesterol problems.

There is also debate over the blood test being used to identify the new statin candidates. Instead of looking for bad cholesterol, the test measures the degree of inflammation in the body, but there is no consensus in the medical community that inflammation is a direct cause of cardiovascular problems.

The Food and Drug Administration approved the new criteria last month for Crestor, which is made by AstraZeneca and is the nation’s second best-selling statin, behind Lipitor by Pfizer. AstraZeneca plans soon to begin a new marketing and advertising campaign for Crestor, based on the new F.D.A.-approved criteria.

Under those criteria, an estimated 6.5 million people in this country who have no cholesterol problems and no sign of heart problems will be deemed candidates for statins. That is in addition to the 80 million who already meet the current cholesterol-based guidelines — about half of whom now take statins.

The new Crestor label says it may be prescribed for apparently healthy people if they are older — men 50 and over and women 60 and over — and have one risk factor like smoking or high blood pressure, in addition to elevated inflammation in the body.

 

[HughJass]

"medication for the well"


And no doubt the medical establishment will help propagate the drug companies message. F*ck you, medical establishment.

 

[cuebald]

Meh. The big corps can do what they like in this country. And have.

 

[somone uk]

heart disease is Britain's biggest killer, whether or not that is a result of cholesterol is a different matter
however
1) if you are prescribed to take statins, you are not legally obliged to take them

2)

Statins are among the safest drugs and one of the most studied medicines available today.

http://www.bhf.org.uk/living_with_a_hea ... atins.aspx

 

[Aplunk1]

What's the problem here? I think it's good that people will have the option for preventative care. Sure, there are potential side effects, but the sheer obesity rate in this country calls for desperate measures.

 

[HughJass]

statin drugs have to be the biggest con ever. There is a table on the pfizer website showing Liptor at 1% effectiveness (on the link below)

like somone said, cholesterol isn't the issue and never has been:

A thirty-year study published in 1987 provides evidence that elevated cholesterol in people over the age of 50 does not increase the risk of heart attack. Cholesterol levels of people free of coronary heart disease (CHD) and cancer were measured; the study found that there was no increase in death rate in those with high cholesterol. Research on the effects of cholesterol levels and age shows that high cholesterol levels in people over the age of 75 are protective, not harmful. A separate study published in the European Heart Journal (1997) found that the risk of cardiac death was the same in groups of people with low or normal cholesterol levels as those with high cholesterol.

...Cholesterol is the most abundant organic molecule in the brain which contains almost a quarter of the unesterified cholesterol present in the entire body. In 2001, in groundbreaking research and with media fanfare, cholesterol was identified as the synaptogenic factor that is responsible for the development of synapses, the connections in the brain. The glial cells of the central nervous system that perform the housekeeping functions in the brain produce their own cholesterol for the specific purpose of providing nerve cells with the vital component required for synapse function. Cholesterol is also required for the function of serotonin receptors in the brain
http://drpeterdingle.blogspot.com/

Doctor's are confused on this issue and are going to cause more harm as a result.

 

[Hammy070]

Doesn't Niacin in high doses reduce LDL and increase HDL?

Not really lucrative though for the likes of big pharma.

The specifics of these statins effectiveness are unknown to me.

But the concept of preventative medicine is surely better than treatment.

All healthy people at one point have died. Therefore they were never healthy.

I am of the school that death is a disease like any other, and as long as one is dying, one is unhealthy. With everything else, this makes sense...for me, it applies to life too.

 

[Hammy070]

I prefer mechanical, engineering approaches. I'm studying biomedical engineering.

I think drugs and biochemistry are going to be replaced with things we can readily understand. Like...chimneysweepers. Except tiny ones...that swim inside arteries, sweeping away stuff that causes us bad times! :thumbdown2:

That approach is definitive, saves us having to learn about synapses, metabolic pathways, cell processes etc. Just do it the kickin' *** American way.

[youtube:1lcmdxch]http://www.youtube.com/watch?v=6riY-103vbc[/youtube:1lcmdxch]

 

[barcafan]

What's the problem here? I think it's good that people will have the option for preventative care. Sure, there are potential side effects, but the sheer obesity rate in this country calls for desperate measures.

It's a huge issue. For one, these people have NO CHOLESTEROL problems, that'd be like telling somebody with a full head of hair to take propecia 'just in case'. Or a non diabetic to take insulin.

Another point is that Cholesterol is NOT the direct cause of cardiac problems, it's been proven already. Getting your damn blood sugar down to a non diabetic state is exponentially more important than squashing cholesterol (Which actually creates most if not all of the sex hormones)

How long before the government controls every damn aspect of our lives? Because this is what its all coming to anyway

This is all just a huge scam, and millions of sheeple will fall for it.

 

[barcafan]

Doesn't Niacin in high doses reduce LDL and increase HDL?

Not really lucrative though for the likes of big pharma.

The specifics of these statins effectiveness are unknown to me.

But the concept of preventative medicine is surely better than treatment.

All healthy people at one point have died. Therefore they were never healthy.

I am of the school that death is a disease like any other, and as long as one is dying, one is unhealthy. With everything else, this makes sense...for me, it applies to life too.

I'm a huge proponent of preventative medicine -- This isn't even close to being it.

 

[somone uk]

well i could say the FDA probs took a bribe and brought society another what i like to call a stupidity tax

they are usually plain deceptive but normally if you question sociaty a bit you do become immune to them, this isn't the first stupidity tax and it won't be the last (like This, This, This and This )

 

[dougfunny]

The clinical trial on which the F.D.A. approved the new Crestor use was a global study of nearly 18,000 people. It looked only at patients who had low cholesterol and an elevated level of inflammation in the body as measured by a test called high-sensitivity C-reactive protein, or CRP.

Sounds good to me. Also these are not "healthy" people. They have to have at least one risk factor such as hypertension or smoking.

 

[Petchsky]

FDA is joke!

My problem with the preventative medicine, for the worried well, especially concerning cholesterol and blood pressure, is that there are foods, fruits, minerals...diet changes that can more effectively lower cholesterol and blood pressure than any of these pharmaceutical drugs, but these are not primarily discussed in GP surgeries/hospitals and people are then not aware unless they take their own health in to their hands and inform themselves.

The pharmaceutical industry is a beast, and one of the biggest earning industry in the world, and very powerful. I think that one day it will tumble like the tobacco industry and be scaled down, it's influence lessoned, and taken to task over the decades of scientific fraud, and malpractice.