The Risks of an Expanded Use of Crestor
The article I chose is about the controversy surrounding the new FDA approved use of Crestor as a preventative medication for people with low risks of heart attacks and strokes. Although statins like Crestor have been proven to be effective in saving lives, critics question if taking Crestor as a preventative measure is necessary, or even safe, for healthy people. New evidence shows that statins may increase the chances of developing Type 2 diabetes by 9 percent. Additionally, the blood test used to identify new statin candidates is controversial. This test looks for high levels of inflammation in the body, and doctors disagree whether this is actually related to cardiovascular problems.
Under the new FDA criteria, an additional 6.5 million people will be approved for Crestor, with 80 million people already taking it for cholesterol problems. The new criteria require that the patient be at least 50 if male and at least 60 if female, have high inflammation levels, and possess one other risk factor. The side effects can include muscle aches and high liver enzyme levels, which doctors have previously said are outweighed by Crestor’s ability to lower cholesterol. However, regardless of the new possible link to Type 2 diabetes, the FDA is approving the drug, which “showed a small, but measurable reduction of strokes, heart attacks, and other ‘cardiovascular events’ among people taking the statin, compared with patients taking the placebo.”
The trial the FDA looked at to approve this new use of Crestor only used patients with low cholesterol levels and high inflammation as measured by a CRP (C-reactive Protein) test. Dr. Paul M. Rider, the inventor of the test, was the one who convinced Crestor’s maker AstraZeneca to pay for the statin study. He also receives royalties from CRP tests. As the study found reductions in heart attacks, strokes, and angioplasty bypass surgery, the study was stopped after 1.9 years instead of the original five. However, critics still say that doctors and patients may have been misled because the patients in the study were already healthy.
By analyzing the statistics, it was found that Crestor only prevented heart attacks in 2 out of 1,000 in this group of people. This means that 500 people would need to be treated in order to prevent one heart attack, making AstraZeneca $638,000 in the meantime. Additionally, though statistically significant, it is not clinically significant. The bottom line is that, though the FDA has ruled that the benefits are worth the cost, there are still plenty of critics who disagree.
I liked this article because it showed some interesting points about the medical industry. The first is that there is plenty of disagreement within the medical community. As the article presented, there are many arguments for and against the use of Crestor as a preventative medicine. Additionally, it shows that even FDA approved medications come with risks. One needs to weigh both the costs and the benefits before one decides to start taking a particular medication. Finally, the article hinted at the fact that money played a part into the study that was done and in the future effects of the FDA’s decision. It shows that business, unfortunately, plays a role in even medicine.
http://www.nytimes.com/2010/03/31/business/31statins.html?pagewanted=2&ref=health
-- Nicole Wanlass, VTPP 435-502
Under the new FDA criteria, an additional 6.5 million people will be approved for Crestor, with 80 million people already taking it for cholesterol problems. The new criteria require that the patient be at least 50 if male and at least 60 if female, have high inflammation levels, and possess one other risk factor. The side effects can include muscle aches and high liver enzyme levels, which doctors have previously said are outweighed by Crestor’s ability to lower cholesterol. However, regardless of the new possible link to Type 2 diabetes, the FDA is approving the drug, which “showed a small, but measurable reduction of strokes, heart attacks, and other ‘cardiovascular events’ among people taking the statin, compared with patients taking the placebo.”
The trial the FDA looked at to approve this new use of Crestor only used patients with low cholesterol levels and high inflammation as measured by a CRP (C-reactive Protein) test. Dr. Paul M. Rider, the inventor of the test, was the one who convinced Crestor’s maker AstraZeneca to pay for the statin study. He also receives royalties from CRP tests. As the study found reductions in heart attacks, strokes, and angioplasty bypass surgery, the study was stopped after 1.9 years instead of the original five. However, critics still say that doctors and patients may have been misled because the patients in the study were already healthy.
By analyzing the statistics, it was found that Crestor only prevented heart attacks in 2 out of 1,000 in this group of people. This means that 500 people would need to be treated in order to prevent one heart attack, making AstraZeneca $638,000 in the meantime. Additionally, though statistically significant, it is not clinically significant. The bottom line is that, though the FDA has ruled that the benefits are worth the cost, there are still plenty of critics who disagree.
I liked this article because it showed some interesting points about the medical industry. The first is that there is plenty of disagreement within the medical community. As the article presented, there are many arguments for and against the use of Crestor as a preventative medicine. Additionally, it shows that even FDA approved medications come with risks. One needs to weigh both the costs and the benefits before one decides to start taking a particular medication. Finally, the article hinted at the fact that money played a part into the study that was done and in the future effects of the FDA’s decision. It shows that business, unfortunately, plays a role in even medicine.
http://www.nytimes.com/2010/03/31/business/31statins.html?pagewanted=2&ref=health
-- Nicole Wanlass, VTPP 435-502
posted by Pamplemousse at 11:44 AM
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