Are drug companies using bogus studies to push statins?

On the whole, I love drug companies.  They have created many wonderful drugs that have eased human suffering.  But they are companies, like any other business, which means their aim is to increase sales as much as possible.  So caveat emptor!

These thoughts came to my mind when I read about two new studies that claim to validate the wider use of statins in the general population:

Two studies published Tuesday lend support to controversial new cholesterol guidelines that could vastly increase the number of Americans advised to take cholesterol-lowering drugs called statins.

study published last year estimated that 56 million American adults, or almost half those age 40 to 75, would be advised to take statins under the new guidelines, compared with 43.2 million, or 37.5 percent, under the old ones. In actuality, about one in four adults of that age now take statins, according to the Centers for Disease Control and Prevention.

The guidelines were contested almost as soon as they were announced. Critics said that the online calculator greatly overstated a patient’s risk of developing a heart problem and that new guidelines would lead millions of additional people to take statins, exposing them to potential side effects such as muscle pain or damage with little to gain.

One of the new studies looked at 2,435 people who were not taking statins... Among the people eligible for statins under the old guidelines, 6.9 percent had a heart attack or stroke or died from coronary disease over the ensuing nine years. Among those eligible for statins under the new guidelines, the figure was 6.3 percent, almost as high.

Guess what's missing from these statistics: how many people would have been saved by taking statins!  It's not enough to know whether a certain population gets heart attacks or not.  You need to find out if that group actually had fewer heart attacks or strokes by taking statins, and you do it by having two groups, one who takes the drug, and another, called a control group, who doesn't.  It's called double-blind studies.

But that's not what happened here.  The drug companies simply said, These people had heart attacks!  They should have been taking statins!  The study itself was not very useful; the interpretation was definitely questionable, but the Times led with a deceptive headline trumpeting the wider need of statins.

The other study found that treating patients who have a 7.5 percent risk of heart attack or stroke over the next decade — the threshold for statin use under the new guidelines — was cost-effective, even though more people would be treated.

What does that mean?  I went to the actual study and read the abstract, and I still can't figure it out!  But I am sure that people don't want to take a drug because it is "cost effective"; they want to take it because it will prevent a heart attack or save their lives.  This shift toward "cost effectiveness" looks like a dodge to get away from the core subject that should be studied: does the drug actually save lives?

If statins were harmless, we wouldn't be having this discussion.  But there are  risks to taking them.  Muscle pain is most common and can be unpleasant.  Liver damage, which is a lot more serious, can occur, too, as well as other side-effects.  So people shouldn't be taking statins unless there is solid proof they are needed, and neither of these two studies proved that.   It's a little discomforting that the media would portray things otherwise.

This article was produced by NewsMachete.com, the conservative news site.

On the whole, I love drug companies.  They have created many wonderful drugs that have eased human suffering.  But they are companies, like any other business, which means their aim is to increase sales as much as possible.  So caveat emptor!

These thoughts came to my mind when I read about two new studies that claim to validate the wider use of statins in the general population:

Two studies published Tuesday lend support to controversial new cholesterol guidelines that could vastly increase the number of Americans advised to take cholesterol-lowering drugs called statins.

study published last year estimated that 56 million American adults, or almost half those age 40 to 75, would be advised to take statins under the new guidelines, compared with 43.2 million, or 37.5 percent, under the old ones. In actuality, about one in four adults of that age now take statins, according to the Centers for Disease Control and Prevention.

The guidelines were contested almost as soon as they were announced. Critics said that the online calculator greatly overstated a patient’s risk of developing a heart problem and that new guidelines would lead millions of additional people to take statins, exposing them to potential side effects such as muscle pain or damage with little to gain.

One of the new studies looked at 2,435 people who were not taking statins... Among the people eligible for statins under the old guidelines, 6.9 percent had a heart attack or stroke or died from coronary disease over the ensuing nine years. Among those eligible for statins under the new guidelines, the figure was 6.3 percent, almost as high.

Guess what's missing from these statistics: how many people would have been saved by taking statins!  It's not enough to know whether a certain population gets heart attacks or not.  You need to find out if that group actually had fewer heart attacks or strokes by taking statins, and you do it by having two groups, one who takes the drug, and another, called a control group, who doesn't.  It's called double-blind studies.

But that's not what happened here.  The drug companies simply said, These people had heart attacks!  They should have been taking statins!  The study itself was not very useful; the interpretation was definitely questionable, but the Times led with a deceptive headline trumpeting the wider need of statins.

The other study found that treating patients who have a 7.5 percent risk of heart attack or stroke over the next decade — the threshold for statin use under the new guidelines — was cost-effective, even though more people would be treated.

What does that mean?  I went to the actual study and read the abstract, and I still can't figure it out!  But I am sure that people don't want to take a drug because it is "cost effective"; they want to take it because it will prevent a heart attack or save their lives.  This shift toward "cost effectiveness" looks like a dodge to get away from the core subject that should be studied: does the drug actually save lives?

If statins were harmless, we wouldn't be having this discussion.  But there are  risks to taking them.  Muscle pain is most common and can be unpleasant.  Liver damage, which is a lot more serious, can occur, too, as well as other side-effects.  So people shouldn't be taking statins unless there is solid proof they are needed, and neither of these two studies proved that.   It's a little discomforting that the media would portray things otherwise.

This article was produced by NewsMachete.com, the conservative news site.