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SUBJECTS
Hyperlipidemia Clinical Trials Agenda LDL 248 Cholesterol VA Schedul
4903 -
4903 - ..
4904 - Summary/Objective
4905 -
490501 - Follow up ref SDS 7 0000. ref SDS 6 0000.
490502 -
490503 -
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490506 -
490508 - ..
4906 -
4907 -
4908 - Progress
4910 - ..
491001 - New Directions Reducing Risks CAD
491002 -
491003 - Follow up ref SDS 7 0J5N.
491004 -
491005 - Scheduled to meet with VA on 131121 to review clinical trials for
491006 - lowering cholesterol, and particularly LDL 249 to below 70, planned in
491007 - meeting at VA in Martinez with Doctor Egan on 131017 1000. ref SDS 5
491008 - 8B3M VA Progress Notes show referral made. ref SDS 5 EU9F
491009 -
491011 - ..
491012 - Op Ed in New York Times today says...
491013 -
491014 - 1. Don't Give More Patients Statins
491015 - By JOHN D. ABRAMSON and RITA F. REDBERG
491016 - Published: November 13, 2013 208 Comments
491018 - ..
491019 - 2. ON Tuesday, the American Heart Association and the American
491020 - College of Cardiology issued new cholesterol guidelines that
491021 - essentially declared, in one fell swoop, that millions of
491022 - healthy Americans should immediately start taking pills -
491023 - namely statins - for undefined health "benefits."
491025 - ..
491026 - 3. This announcement is not a result of a sudden epidemic of heart
491027 - disease, nor is it based on new data showing the benefits of
491028 - lower cholesterol. Instead, it is a consequence of simply
491029 - expanding the definition of who should take the drugs - a
491030 - decision that will benefit the pharmaceutical industry more
491031 - than anyone else.
491033 - ..
491034 - 4. The new guidelines, among other things, now recommend statins
491035 - for people with a lower risk of heart disease (a 7.5 percent
491036 - risk over the next 10 years, compared with the previous
491037 - guidelines 10 to 20 percent risk), and for people with a risk
491038 - of stroke. In addition, they eliminate the earlier criteria
491039 - that a patient's "bad cholesterol," or LDL, be at or above a
491040 - certain level. Although statins are no longer recommended for
491041 - the small group of patients who were on the drugs only to lower
491042 - their bad cholesterol, eliminating the LDL criteria will mean a
491043 - vast increase in prescriptions over all. According to our
491044 - calculations, it will increase the number of healthy people for
491045 - whom statins are recommended by nearly 70 percent.
491047 - ..
491048 - 5. This may sound like good news for patients, and it would be -
491049 - if statins actually offered meaningful protection from our No.
491050 - 1 killer, heart disease; if they helped people live longer or
491051 - better; and if they had minimal adverse side effects. However,
491052 - none of these are the case.
491054 - ..
491055 - This appears conflicting with reporting on the new guidelines, which
491056 - seem to justify increasing use of statins, precisely because they
491057 - "clearly" result in people living longer, seemingly indicated in
491058 - reporting a few days ago on 131112 1422, ref SDS 7 HV61
491060 - ..
491061 - NYT article continues...
491062 -
491063 - 6. Statins are effective for people with known heart disease. But
491064 - for people who have less than a 20 percent risk of getting
491065 - heart disease in the next 10 years, statins not only fail to
491066 - reduce the risk of death, but also fail even to reduce the risk
491067 - of serious illness - as shown in a recent BMJ article
491068 - co-written by one of us. That article shows that, based on the
491069 - same data the new guidelines rely on, 140 people in this risk
491070 - group would need to be treated with statins in order to prevent
491071 - a single heart attack or stroke, without any overall reduction
491072 - in death or serious illness.
491074 - ..
491075 - 7. At the same time, 18 percent or more of this group would
491076 - experience side effects, including muscle pain or weakness,
491077 - decreased cognitive function, increased risk of diabetes
491078 - (especially for women), cataracts or sexual dysfunction.
491080 - ..
491081 - 8. Perhaps more dangerous, statins provide false reassurances that
491082 - may discourage patients from taking the steps that actually
491083 - reduce cardiovascular disease. According to the World Health
491084 - Organization, 80 percent of cardiovascular disease is caused by
491085 - smoking, lack of exercise, an unhealthy diet, and other
491086 - lifestyle factors. Statins give the illusion of protection to
491087 - many people, who would be much better served, for example, by
491088 - simply walking an extra 10 minutes per day.
491090 - ..
491091 - 9. Aside from these concerns, we have more reasons to be wary
491092 - about the data behind this expansion of drug therapy.
491094 - ..
491095 - 10. When the last guidelines were issued by the National Heart,
491096 - Lung, and Blood Institute in 2001, they nearly tripled the
491097 - number of Americans for whom cholesterol-lowering drug therapy
491098 - was recommended - from 13 million to 36 million. These
491099 - guidelines were reportedly based strictly on results from
491100 - clinical trials. But this was contradicted by the data
491101 - described in the document itself.
491103 - ..
491104 - 11. For example, even though the guidelines recommended that women
491105 - between the ages of 45 and 75 at increased risk of heart
491106 - disease and with relatively high LDL levels take statins, the
491107 - fine print in the 284-page document admitted, "Clinical trials
491108 - of LDL lowering generally are lacking for this risk category."
491109 - The general lack of evidence for LDL level targets is why they
491110 - have been dropped from the current guidelines. In fact,
491111 - committee members noted that cholesterol lowered by drugs may
491112 - not have the same effect as cholesterol lowered by nondrug
491113 - methods, such as diet, exercise and being lucky enough to have
491114 - good genes.
491116 - ..
491117 - 12. The process by which these latest guidelines were developed
491118 - gives rise to further skepticism. The group that wrote the
491119 - recommendations was not sufficiently free of conflicts of
491120 - interest; several of the experts on the panel have recent or
491121 - current financial ties to drug makers. In addition, both the
491122 - American Heart Association and the American College of
491123 - Cardiology, while nonprofit entities, are heavily supported by
491124 - drug companies.
491126 - ..
491127 - 13. The American people deserve to have important medical
491128 - guidelines developed by doctors and scientists on whom they can
491129 - confidently rely to make judgments free from influence,
491130 - conscious or unconscious, by the industries that stand to gain
491131 - or lose.
491133 - ..
491134 - 14. We believe that the new guidelines are not adequately supported
491135 - by objective data, and that statins should not be recommended
491136 - for this vastly expanded class of healthy Americans. Instead
491137 - of converting millions of people into statin customers, we
491138 - should be focusing on the real factors that undeniably reduce
491139 - the risk of heart disease: healthy diets, exercise and avoiding
491140 - smoking. Patients should be skeptical about the guidelines,
491141 - and have a meaningful dialogue with their doctors about
491142 - statins, including what the evidence does and does not show,
491143 - before deciding what is best for them.
491145 - ..
491146 - 15. John D Abramson, a lecturer at Harvard Medical School and the
491147 - author of Overdosed America: The Broken Promise of American
491148 - Medicine,, serves as an expert in litigation involving the
491149 - pharmaceutical industry. Rita F Redberg is a cardiologist at
491150 - the University of California, San Francisco Medical Center and
491151 - the editor of JAMA Internal Medicine.
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