Cholesterol, Statins and the book Overdosed America
Jacob Schor, ND
August 30, 2007
In July 2004, an official government committee published a set of guidelines on cholesterol levels regarding when and how people should be treated. The new guidelines suggested people should take cholesterol lowering drugs for cholesterol levels far lower than was thought reasonable in the past. Cholesterol levels over 200 are now supposed to be treated using prescription drugs[i]
Patients ask me about this all the time. Typically, they have gone for a yearly exam or been to the 9Health Fair. Seeing cholesterol levels over 200, their MDs hand them prescriptions for Lipitor or similar drugs. Something about this does not feel right; they know it and they want our opinions.
We like to assume in this day and age that published peer reviewed scientific literature is true. To question the recommendations based on these data is medical sacrilege. As a result, it is difficult to know how to answer patients who do not believe that they need drugs.
I have often wondered whether greed might be swaying some of this information. These are expensive drugs that manufacturers hope a great many people will take for a long time. When billions of dollars are at stake, one has to wonder if everyone is still honest.
Some practitioners and writers question the validity of these recommendations and whether the data and the studies are reliable. [ii] An article related to these questions was published August 6, 2007 in the Los Angeles Times. According to this article, when the National Cholesterol Education Program revised the clinical guidelines for diagnosing and treating high cholesterol in adults in July 2004, 8 million Americans became new candidates for cholesterol-lowering drugs. A prior revision in 2001 had added 23 million people to the list of ‘drug deficient' people. It turns out that most of the doctors on the committees that made these guidelines worked for companies that make these drugs. These ‘new guidelines' turned Lipitor and the other statin drugs, into the world's bestselling prescription medications.
We had the pleasure of hearing Dr. John Abramson lecture at this year's American Association of Naturopathic Physicians annual conference last week. Dr. Abramson trains family practice medical doctors at Harvard and lectures and writes extensively on these and similar problems in our medical system. His lecture fascinated me. I did not just buy his book after hearing him speak, I have just ordered a case of them for the office.
More information about Dr. Abramson's book, Overdosed America : the broken promise of American medicine can be found at his website:
The lecture we heard was based on an article Abramson wrote for the Lancet published this January: “Are Lipid Lowering guidelines evidenced based?”
According to Abramson of the 36 million Americans who current guidelines say should take these drugs, most do not have coronary heart disease; they are only at risk of getting it. The guidelines cite seven randomized trials in support of using statin therapy in women and nine randomized trials in support of using statin therapy in people over 65 as justification. Yet when examined closely, not one of the studies actually provide evidence to justify the recommendations.
Statins do provide protection for adults between 30 and 80 years old who already have occlusive vascular disease and this use is not controversial. The controversy has to do with which people without disease should take the drugs. This is important because currently, 75% of the people taking statins fit into this category; they have no evidence of disease.
Abramson and company pooled data from all eight randomized trials that compared statins with placebo for primary prevention. This was hard to do because these trials were not about prevention, they were about treating people who already had heart disease.
Taking stating did not reduce total mortality, which one would think would be the bottom line. Two trials reported total significant adverse events (SAEs) and statin use did not decrease them. Statins did reduce the frequency of cardiovascular events, but not by much. You have to treat 67 people with statins for 5 years to prevent one such event. This benefit was limited to only high-risk men between 30 and 69 years old. Statins did not reduce total coronary heart disease events in the 10,990 women in the studies. Of the 3,239 men and women older than 69 years, statins did not reduce total cardiovascular events.
To quote the study, “Our analysis suggests that lipid-lowering statins should not be prescribed for true primary prevention in women of any age or for men older than 69 years. High-risk men aged 30 to 69 years should be advised that about 50 patients need to be treated for 5 years to prevent one event.” [iii]
This is a very different story from what usually heard. All that is definitely known is that high cholesterol is bad for men younger than 70 and could be treated. However, do not expect dramatic results. For women, there is no evidence that statins will prevent heart disease.
Statins are not innocent drugs. They can cause rhabdomyolysis, a condition that destroys muscle tissue. Many people complain about milder versions of this condition when they complain of leg pain. Newer and of greater concern are studies which link the decrease of low density lipoproteins that results from statin use with increased risk for cancer. [iv] Few people when given a choice between dying of a heart attack and dying of cancer chose the later disease.
This information is forcing us to rethink our standard of care that, to date, has mirrored the government recommendations.
Abramson's books are on order. They'll be here soon.
[i] Posted 7/12/2004 4:36 PM Updated 7/13/2004 12:41 AM
Cholesterol guidelines get stricter
By Rita Rubin, USA TODAY
From funding to findings: When drug companies conduct research on new pharmaceuticals, outcomes may be affected -- greatly
By Melissa Healy, Los Angeles Times Staff Writer
August 6, 2007
[iii] Lancet. 2007 Jan 20;369(9557):168-9.
Are lipid-lowering guidelines evidence-based?
Abramson J, Wright JM.
Harvard Medical School , Cambridge , Massachusetts , USA .
[iv] J Am Coll Cardiol. 2007 Jul 31;50(5):409-18. Epub 2007 Jul 16.
Effect of the magnitude of lipid lowering on risk of elevated liver enzymes, rhabdomyolysis, and cancer: insights from large randomized statin trials.
Alsheikh-Ali AA, Maddukuri PV, Han H, Karas RH.
Molecular Cardiology Research Institute and Division of Cardiology, Department of Medicine, Tufts-New England Medical Center and Tufts University School of Medicine, Boston, Massachusetts 02111, USA.
OBJECTIVES: We sought to assess the relationship between the magnitude of low-density lipoprotein cholesterol (LDL-C) lowering and rates of elevated liver enzymes, rhabdomyolysis, and cancer. BACKGROUND: Although it is often assumed that statin-associated adverse events are proportional to LDL-C reduction, that assumption has not been validated. METHODS: Adverse events reported in large prospective randomized statin trials were evaluated. The relationship between LDL-C reduction and rates of elevated liver enzymes, rhabdomyolysis, and cancer per 100,000 person-years was assessed using weighted univariate regression. RESULTS: In 23 statin treatment arms with 309,506 person-years of follow-up, there was no significant relationship between percent LDL-C lowering and rates of elevated liver enzymes (R2 <0.001, p = 0.91) or rhabdomyolysis (R2 = 0.05, p = 0.16). Similar results were obtained when absolute LDL-C reduction or achieved LDL-C levels were considered. In contrast, for any 10% LDL-C reduction, rates of elevated liver enzymes increased significantly with higher statin doses. Additional analyses demonstrated a significant inverse association between cancer incidence and achieved LDL-C levels (R2 = 0.43, p = 0.009), whereas no such association was demonstrated with percent LDL-C reduction (R2 = 0.09, p = 0.92) or absolute LDL-C reduction (R2 = 0.05, p = 0.23). CONCLUSIONS: Risk of statin-associated elevated liver enzymes or rhabdomyolysis is not related to the magnitude of LDL-C lowering. However, the risk of cancer is significantly associated with lower achieved LDL-C levels. These findings suggest that drug- and dose-specific effects are more important determinants of liver and muscle toxicity than magnitude of LDL-C lowering. Furthermore, the cardiovascular benefits of low achieved levels of LDL-C may in part be offset by an increased risk of cancer.
PMID: 17662392 [PubMed - indexed for MEDLINE]