6/27/17

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“We provide truthful information without emotion or influence from the medical establishment, pharmaceutical industry, national organizations, special interest groups or government agencies.”  Charles B Simone, M.MS., M.D.

LOW LDL DOES NOT PROTECT, BUT BIG PHARMA AND HARVARD SAY YES

Lawrenceville, NJ (Dr Simone) – I have written that the LDL cholesterol contributed only modestly to overall risk prediction (Lancet 2014) because people who had the most reduction in inflammation, not LDL, had the least recurrent vascular events (http://www.simonesuperenergy.com/do-you-know-your-ldl-hdl-triglycerides-are-they-important/).  And that’s why US guidelines issued by a committee of a mere 15 people no longer advocate treatment to specific LDL targets, but instead suggest using high dose statin for high risk patients.  

However, Big Pharma developed antibodies to decrease LDL to very low levels to determine if that made a difference.  Amgen, the maker of evolocumab (Repatha) funded the research, paid EVERY author on the paper, led by Harvard researchers, and the findings were published in the prestigious New England Journal of Medicine May 4, 2017 (N Engl J Med 2017; 376:1713-1722May 4, 2017DOI: 10.1056/NEJMoa1615664).

Does this scenario look familiar? SUGAR INDUSTRY SECRETLY PAID FOR FAVORABLE HARVARD RESEARCH (http://www.simonesuperenergy.com/sugar-industry-secretly-paid-for-favorable-harvard-research/)

Salient points of this LDL study:

1) 27,564 patients – the larger the number, the easier it is for statisticians to bias the findings.

2) Primary end point was 9.8% for the treatment group and 11.3% for the control group.  These numbers don’t look very different.  This included: cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization (Hazard Ratio = 0.85).

3) More deaths in the treatment group (cardiovascular deaths and deaths from any cause – Table 2).

4) The authors failed to mention that ‘serious adverse events’ cover all serious cardiovascular and non-cardiovascular disease. They double-counted the cardiovascular events, first as part of the primary outcome and later among the ‘serious adverse events’. As a result, it is suggested that the risk of unintended serious events is equal in both groups. In reality, the increased risk of serious adverse non-cardiovascular events is negated by the reduced risk of serious adverse cardiovascular events.

5) Cost = $14,300 per patient per year

 

Hazard Ratio Defined:

If the Hazard Ratio = 2, then the treatment causes twice as much harm.

If the Hazard Ratio = 10, then the treatment causes ten times as much harm.

If the Hazard Ratio = 1, there is no benefit from the treatment.

If the Hazard Ratio = 1.2, then the treatment causes 20% more harm.

If the Hazard Ratio = 0.80, then there is a 20% benefit from the treatment.

 

BOTTOM LINE: If you take the drug, evolocumab (Repatha), your LDL will go down but you won’t live any longer.  Wall Street wasn’t impressed, but some physicians will prescribe lots of it.

IT’S ALL ABOUT INFLAMMATION AND OXIDATION.    Lipids are markers of foods that increase inflammation and oxidation.  So if you take prescription medications or herbals to lower your lipids but continue eating high fat, high sugar, low fiber foods, you will continue to cause inflammation and oxidation in your body.  Other controllable risk factors like smoking, alcohol, etc, also increase inflammation and oxidation. (INFLAMMATION AND OXIDATION – WHAT YOU CAN DO  http://www.simonesuperenergy.com/inflammation-and-oxidation-what-you-can-do/ ). You should consider taking antioxidants in the correct doses, correct chemical forms, and correct ratios of one to another.  Also take anti-inflammatory agents.

 

Disclosure Statements of Each Author Reveals that they are all on Amgen’s payroll

http://www.nejm.org/doi/suppl/10.1056/NEJMoa1615664/suppl_file/nejmoa1615664_disclosures.pdf 

Dr. Sabatine reports grants from Abbott Laboratories, grants and personal fees from Amgen, grants and personal fees from AstraZeneca, grants from Critical Diagnostics, grants from Daiichi-Sankyo, grants from Eisai, grants from GlaxoSmithKline, grants and personal fees from Intarcia, grants and personal fees from Merck, grants from Roche Diagnostics, grants from Takeda, grants from Gilead, personal fees from CVS Caremark, grants from Poxel, personal fees from Alnylam, grants from Novartis, grants and personal fees from MedImmune, personal fees from Ionis, grants from Janssen Research Development, grants from Genzyme, personal fees from Cubist, personal fees from Esperion, personal fees from Medicines Company, personal fees from MyoKardia, personal fees from Zeus Scientific, grants from Pfizer , outside the submitted work.

Dr. Robert Giugliano and I have personally met twice in the last several years. He reports grants and personal fees from Amgen during the conduct of the study, as well as grants and other support from Amgen and personal fees from Amarin, American College of Cardiology, AngelMed, Beckman-Coulter, Boehringer-Ingelheim, Bristol-Myers-Squibb, CVS Caremark, GlaxoSmithKline, Janssen, Lexicon, Portola, Pfizer, Regeneron, Sanofi-Aventis, St. Jude Medical, and Stealth Peptides outside the submitted work.

Dr. Keech reports grants and personal fees from Abbott and Mylan and personal fees from Amgen, Astra-Zeneca, and Pfizer outside the submitted work.

Dr. Honarpour is an employee of Amgen, Inc.

Dr. Wiviott reports grants and personal fees from AstraZeneca, grants and personal fees from Bristol Myers Squibb, grants from Eisai, grants and personal fees from Arena, grants from Merck, personal fees from Aegerion, personal fees from Angelmed, personal fees from Janssen, personal fees from Xoma, personal fees from ICON Clinical, personal fees from Boston Clinical Research Institute, grants and personal fees from Eli Lilly/Daiichi Sankyo, grants from Sanofi-Aventis, other from Merck, personal fees from Boehringer Ingelheim, grants and personal fees from Amgen, outside the submitted work

Dr. Murphy reports grants from Abbott Laboratories, grants from Amgen, grants from AstraZeneca, grants from Critical Diagnostics, grants from Daiichi-Sankyo, grants from Eisai, grants from GlaxoSmithKline, grants from Intarcia, grants and personal fees from Merck, grants from Roche Diagnostics, grants from Takeda, grants from Gilead, grants from Poxel, grants from Novartis, grants from MedImmune, grants from Janssen Research Development, grants from Genzyme, personal fees from Amarin, outside the submitted work.

Dr. Kuder reports grants from Abbott Laboratories, grants from Amgen, grants from AstraZeneca, grants from Critical Diagnostics, grants from Daiichi-Sankyo, grants from Eisai, grants from GlaxoSmithKline, grants from Intarcia, grants from Merck, grants from Roche Diagnostics, grants from Takeda, grants from Gilead, grants from Poxel, grants from Novartis, grants from MedImmune, grants from Janssen Research Development, grants from Genzyme, grants from Pfizer, outside the submitted work.

Dr. Wang reports personal fees from Amgen, Inc. during the conduct of the study, as well as personal fees from Amgen, Inc. outside the submitted work.

Dr. Liu is a full-time employee of Amgen Inc., as a statistician

Dr. Wasserman reports other support from Amgen, Inc. during the conduct of the study, as well as other support from Amgen, Inc. outside the submitted work; in addition, Dr. Wasserman has patent applications pending.

Dr. Sever reports grants and personal fees from Amgen, Inc. during the conduct of the study, as well as grants and personal fees from Pfizer outside the submitted work.

Dr. Pedersen reports grants and personal fees from Amgen during the conduct of the study, as well as personal fees from Amgen, Sanofi, Merck, Boehringer Ingelheim, and The Medicines Company outside the submitted work.

(c) 2017 Charles B. Simone, M.MS., M.D.