Cholesterol Reducing Drugs; Statins: The Case Has Not Been Made

This is an article summary about Cholesterol Reducing Drugs know as Statins.     

                        A Closer Look

                        Written by Dan Murphy, D.C., D.A.B.C.O.
                        TAC, Research Review , Volume 30, Issue 8
                        Published:
  

                        KEY POINTS FROM DAN MURPHY
                        1. Because statin drug therapy is likely to continue for
                        many years, or for a lifetime, the official written
                        position of the National Cholesterol Education Program
                        of the National Institutes of Health state, "the
                        decision to add drug therapy to the regimen should be
                        made only after vigorous efforts at dietary treatment
                        have not proven sufficient." "Vigorous" dietary efforts
                        are defined as a minimum of six months of intensive
                        dietary counseling before starting statin drug therapy.
                        2. Statin drug trials are not preceded by vigorous
                        dietary efforts because to do so would help people and
                        render statin drug therapy less effective in reducing
                        deaths from coronary heart disease (CHD) and other
                        causes of mortality.
                        3. In performing a clinical trial of a drug, "all-cause
                        mortality" is the only endpoint measure not prone to
                        diagnostic variance and is, therefore, not popular with
                        the drug company studies. Most statin drug trials do not
                        even look at all-cause mortality because of the
                        probability that taking the drugs does not alter
                        all-cause mortality.
                        4. Drug company study designers search for endpoints
                        that are most apt to yield a positive result. "This
                        would not be the scientific approach but would make
                        sense if the aim was to make the study appear highly
                        successful."
                        5. "If a drug or other intervention neither extends life
                        nor improves its overall quality, then it is of no
                        value."
                        6. "There is no rigorous reporting of all-cause
                        morbidity, nor of measurement of changes in overall
                        quality of life, in any of the [statin drug] studies."
                        7. Statin drug trials show absolute differences of less
                        than 1 percent to a maximum of 3.3 percent in all-cause
                        mortality between the control and treatment groups.
                        "These are not impressive results."
                        8. However, drug companies make statin drug results look
                        impressive "by expressing the results as relative
                        difference rather than as absolute difference." In a
                        statin drug trial of patients with existing CHD, the
                        difference in deaths between the statin group and the
                        placebo group was 3.1 percent (14.1 percent of the
                        placebo group died and 11 percent of the statin group).
                        The benefit of such results can appear to be magnified
                        by expressing them as relative differences, which would
                        be 11/14.1 = 22 percent: "The statin drug lowered the
                        risk of death by 22 percent (11 is 22 percent lower than
                        14.1)."
                        9. The small differences favoring statin drugs in
                        published studies "have been magnified by the manner of
                        presentation of results, most notably by the use of
                        relative differences between statins and placebo groups
                        rather than absolute differences."
                        10. Another serious problem is that the study does not
                        state the number needed to treat (NNT) for one patient
                        to benefit, which is over 100 in primary prevention
                        trials. This means that more than 100 patients would
                        have to take the drugs for one patient to actually
                        receive any benefit.
                        11. In a study where 100 patients take statins drugs,
                        two will have a fatal heart attack. In 100 patients
                        taking a placebo, three will have a fatal heart attack.
                        The absolute risk reduction of a fatal heart attach is 1
                        percent. Yet the drug company spins the pathetic results
                        by dividing 2/3 and publish the relative risk, which is
                        a 33 percent reduction of a fatal heart attack. This is
                        dishonest. These authors claim an honest disclosure
                        would be to state "if you take statins then, in seven
                        years’ time, there is a one chance in about 120 that
                        your death will have been prevented."
                        12. Using current available number needed to treat (NNT)
                        data and assuming the cost of a year of statin drugs is
                        $500, the cost of postponing one death by using statin
                        drugs is $85,500 for patients with the highest risk, to
                        more than $300,000 for those with the lowest risk.
                        13. "It is arguable that statins are cost-effective for
                        the small minority of people at especially high risk of
                        CHD."
                        14. "Lowering the threshold to make much larger numbers
                        of people eligible for drug therapy has the effect of
                        making statins an extremely expensive means of
                        preventing heart disease. The case for statin drugs,
                        especially for primary prevention, has not been made."

       Key Points are taken from an article that appeared in the
       Journal of the Royal Society of Medicine
       October 2004; Vol 97, Number 10, pp. 461-464
       by Andrew Thompson, Ph.D, and Norman J. Temple, Ph.D.
                      
       Dr. Dan Murphy graduated magna cum laude from Western
                        States Chiropractic College in 1978. He received
                        Diplomat status in Chiropractic Orthopedics in 1986.
                        Since 1982, Dr. Murphy has served part-time as
                        undergraduate faculty at Life Chiropractic College West,
                        currently teaching classes to seniors in the management
                        of spinal disorders. He has taught more than 2000
                        postgraduate continuing education seminars. Dr. Murphy
                        is a contributing author to both editions of the book
                        Motor Vehicle Collision Injuries and to the book
                        Pediatric Chiropractic. Hundreds of detailed Article
                        Reviews, pertinent to chiropractors and their patients,
                        are available at Dr. Murphy’s web page,
                        www.danmurphydc.com