AstraZeneca won approval Monday to promote its cholesterol fighting drug Crestor for preventing heart disease in a vast new market of people with healthy cholesterol but other heart risks.
Crestor won approval from the Food and Drug Administration for reducing the risk of heart attacks, strokes, bypass operations and artery-clearing procedures in people with high levels of C-reactive protein in addition to at least one other risk factor. That clears the way for the drug for millions of people who are not typically prescribed cholesterol drugs now.
C-reactive protein, or C.R.P., is a sign of inflammation associated with heart disease. Patients should be men at least 50 years old or women at least 60, the F.D.A. said.
The approval was based on data from a nearly 18,000-patient study, called Jupiter, financed by AstraZeneca.
The study tested Crestor versus a placebo in middle-age people with healthy cholesterol, but high levels of C.R.P. The rate of major cardiovascular problems was 1.6 percent for patients treated with Crestor compared with 2.8 percent with a placebo, the F.D.A. said.
An F.D.A. advisory panel that reviewed the Jupiter results in December backed wider use but voiced concern that doctors might use Crestor too broadly in patients with low risk. F.D.A. reviewers had told the panel up to 6.5 million Americans meet the criteria used in the Jupiter study.
On Monday, the F.D.A. said doctors “must interpret the results of the Jupiter trial with caution.”
For example, there was no evidence Crestor helped patients with high C.R.P. but no traditional risk factors like high blood pressure, low HDL or “good” cholesterol, smoking or a family history of early heart disease, the F.D.A. said.
Wider approval for Crestor is likely to increase sales of the drug, but industry analysts say the size of the opportunity is uncertain because of the impending arrival of cheaper generic versions of the rival Lipitor from Pfizer in late 2011.
Dr. Court’s Comments
Well it is apparent that the pharmaceutical industry can see the writing on the wall. More and more research is showing that simply lowering cholesterol numbers is not enough to reduce heart disease. That, however, is not going to stop them from continuing to find new ways to market their billion dollar statins.
This new research is just about as ridiculous as it gets. It opens up a whole new market for Crestor of 6.5 million people. Imagine if you had a business and you could add 6.5 million new customers. Sounds like a pretty good idea doesn’t it?
This study is ridiculous for three reasons:
1. The study was funded by the maker of the drug. There is no way the numbers are impartial. I was required to do a research study before graduating from school and therefor was required to analyze the study results. It was clear to me that you could make the numbers say just about anything you wanted depending on what formula and limitations you put on certain variables.
2. C-reactive protein, or CRP, can be lowered easily through proper diet. There is no need for a drug that has side effects to be used. I routinely measure this in my patients before and after a program of sound diet and supplements and it is always lower. The side effects of my program include weight loss, increased energy, better sleep, less aches and pain and the list goes on and on.
3. The FDA strongly advises doctors to look at the results before they start prescribing this drug because it works only on a very small percentage of people. This might be the biggest understatement of the year. Unfortunately, most doctors will not look at this study closely and will recommend this drug for anyone with a risk of heart disease when it has shown to have no benefit. This is precisely what AstraZeneca is counting on. Drugs are prescribed because the risk benefit ratio is favorable. If there no potential for benefit, as will be the case for many people that get this drug prescribed, then all there is is risk. This is a poor scenario for millions of unknowing Americans.
The bottom line is that these studies are done simply in the interest of opening up a new market for a drug that may be peaking in the amount of people who can take it. The numbers are manipulated and twisted so they can show some benefit, when in reality there probably is only risk. While CRP is a danger to people who have high levels of it, it is totally controllable by diet and supplementation.