Whoa, missed this piece of big news last month about Statins.
Apparently the FDA has recognized the risk of cognitive impairment with Statin use. Statins, known more by their trade names of Zocor, Crestol and Lipitor, are cholesterol reducing medications given in hopes to reduce serum cholesterol and therefore potentially reduce the risk of heart disease. How does this work? In a nutshell statins inhibit a liver enzyme that is responsible for cholesterol production. However, there are many side effects of Statin use including the risk of developing diabetes.
The interesting part of this article was a statement from the FDA Deputy Director of Safety Dr. Amy G. Egan:
But federal officials and some medical experts said the new alerts should not scare people away from statins. “The value of statins in preventing heart disease has been clearly established,” said Dr. Amy G. Egan, deputy director for safety in the F.D.A.’s division of metabolism and endocrinology products. “Their benefit is indisputable, but they need to be taken with care and knowledge of their side effects.”
When phrases such as “clearly established” and “benefit is indisputable” it conveys a sense of established reality to the public along the lines of “the earth is round.” However, Statin use has been controversial and perhaps more alarming – the studies used to support statin themselves. An example of these controversies can be found in the review Cholesterol Lowering, Cardiovascular Diseases, and the Rosuvastatin-JUPITER Controversy by Lorgeril et al from the Archives of Internal Medicine. http://archinte.ama-assn.org/cgi/content/abstract/170/12/1032
This review points out many flaws in the JUPITER (Justification for the Use of Statins in Primary Prevention) trial which showed rosuvastatin (Crestor) being effective in reducing heart disease complications in primary prevention. Some of the interesting comments by Lorgeril et al are:
“…the results have undoubtedly propelled many healthy persons without elevated cholesterol levels onto long-term statin treatment, the clinical relevance of the JUPITER trial remains in question.”
While this shouldn’t make you reject the use of statins, it should at least make one more interested in looking at additional literature on their efficacy opposite to the FDA’s statements.
Lorgeril et al also point out the study ending prematurely without specifying what the established criteria for a stoppage were. Studies often have stoppage rules that are strictly defined in order to protect subjects or to maintain validity. There might also be potential manipulation of variables that are unexplained:
“Although it is quite unusual that the burden of calculating cardiovascular mortality is placed on the readers, all methods used, however, lead to the same conclusion: there is no significant difference in cardiovascular mortality between the 2 groups in the JUPITER trial.”
Another important point Lorgeril et al point out is the population used is not reflective of populations outside Japanese and Mediterranean populations. Looking at previous studies on rosuvastatin, it also appears the study cherry picked statistics and results that favored them in the literature:
“…the JUPITER data set appears biased. Three other trials1, 3, 5 involving rosuvastatin therapy in high-risk patients did not show any protection. The authors of the JUPITER study fail to comment on these negative trials but go on to report…analyses that appear to support the efficacy (and safety) of rosuvastatin therapy.35–38“
Conflict of interests also plagued the study with 9 out of 14 authors being financed by the sponsor. Additionally, the sponsor was the one who collected and monitored all the RAW data. However, despite these controversies, this does not stop panels from advising the FDA to make changes to clinical practice such as what occurred in December 2009:
By the way, after checking out that piece on Crestor, take a look at this photo still from one of their ads. Notice something?
While inconsistencies in the literature should not cause people to drop their Statins overnight, it certainly warrants more research than being accepted as “indisputable” evidence.