The following post is based on paper 474 in my new book Statins Toxic Side Effects: Evidence From 500 Scientific Papers. In 2013 new statin guidelines were issued by the American College of Cardiology and the American Heart Association (formerly called the Adult Treatment Panel). These guidelines mean that 56 million Americans are eligible for statins which is nearly half of the U.S. population between the ages of 40 and 75. Your doctor may tell you statins are lifesavers, but an analysis of some statin trials by Professor Jesper Hallas revealed that, at best, statins may delay death by four days. My closer analysis of the Professor Hallas trials found that between 50% to 80% of the population were screened out of the studies, so the results of the trials are only applicable to, at most, 50% of the population. If all types of people were included in the trials, just like they are in real world statin prescribing, there could be a huge increase in toxic side effects with a concomitant rise in death rates. If all these screened out people had been included in the trials then the results could possibly, just possibly, have generated the hypothesis that statins shorten lifespan. Bearing in mind the above analysis of the Professor Hallas trials, it will be interesting to look at the evidence cited by the 2013 American College of Cardiology and the American Heart Association guidelines. It will be very revealing to see the results of the evidence, and very, very revealing to see who the American College of Cardiology and the American Heart Association members are who issued the guidelines, and their relationships with the pharmaceutical companies that sell cholesterol lowering drugs. The evidence cited in the 2013 American College of Cardiology and the American Heart Association guidelines. The American College of Cardiology and the American Heart Association evidence was heavily based on the following randomised controlled trials: · TNT: Treating to New Targets trial (high dose atorvastatin v moderate dose atorvastatin). · IDEAL: Incremental Decrease in Endpoints Through Aggressive Lipid lowering trial (high dose atorvastatin v moderate dose simvastatin).
· PROVE-IT and A to Z. The Pravastatin or Atorvastatin Evaluation and Infection Therapy trial and Aggrastat to Zocor trial (Intensive statin therapy v moderate statin therapy).
· ACCORD. Action to Control Cardiovascular Risk in Diabetes trial (simvastatin plus fenofibrate or simvastatin plus placebo).
· SEARCH. Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine trial (high dose simvastatin v moderate dose simvastatin).
· SPARCL. Stroke Prevention by Aggressive Reduction in Cholesterol Levels trial (atorvastatin v placebo). · HATS. HDL-Atherosclerosis Treatment Study (simvastatin plus niacin v placebo)
· MIRACL. Myocardial Ischemia Reduction with Acute Cholesterol Lowering trial (atorvastatin v placebo).
· CORONA. Controlled Rosuvastatin Multinational Trial in Heart Failure trial (rosuvastatin v placebo).
· WOSCOPS. West of Scotland Coronary Prevention Study (pravastatin v placebo).
· 4S. Scandinavian Simvastatin Survival Study (simvastatin v placebo).
· CARE. Cholesterol and Recurrent Events Trial (pravastatin v placebo).
· AFCAPS/TEXCAPS. Air Force/Texas Coronary Atherosclerosis Prevention Study (lovastatin v placebo).
· LIPID. Long-Term Intervention with Pravastatin in Ischaemic Disease Trial (pravastatin v placebo).
· GISSI-P. Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto Miocardico-Prevenzione trial (low cholesterol v high cholesterol).
· LIPS. Lescol Intervention Prevention Study (fluvastatin v placebo).
· HPS. Heart Protection Study (simvastatin v placebo).
· PROSPER. PROspective study of pravastatin in the elderly at risk (pravastatin v placebo).
· ALLHAT-LLT. Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (pravastatin v usual care).
· ASCOT-LLA. Anglo-Scandinavian Cardiac Outcomes Trial—Lipid Lowering Arm (atorvastatin v placebo).
· ALERT. Assessment of LEscol in Renal Transplantation study (fluvastatin v placebo).
· CARDS. Collaborative Atorvastatin Diabetes Study (atorvastatin v placebo).
· ALLIANCE. Aggressive Lipid-Lowering Initiation Abates New Cardiac Events (atorvastatin v usual care).
· ASPEN. Atorvastatin Study for Prevention of Coronary Heart Disease Endpoints in Non-Insulin-Dependent Diabetes Mellitus (atorvastatin v placebo).
· MEGA. Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese (pravastatin plus diet v diet).
· JUPITER. Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin trial (rosuvastatin v placebo).
· GISSI-HF. Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto Miocardico-Heart Failure trial (rosuvastatin v placebo).
· AURORA. A Study to Evaluate the Use of Rosuvastatin in Subjects on Regular Hemodialysis: An Assessment of Survival and Cardiovascular Events study (rosuvastatin v placebo).
· 4D. Deutsche Diabetes Dialyse Studie (atorvastatin v placebo).
· GREACE. The GREek Atorvastatin and Coronary-heart-disease Evaluation study (atorvastatin v usual care).
· MUSASHI-AMI. MUlticenter Study for Aggressive Lipid Lowering Strategy by HMG-CoA Reductase Inhibitors in Patients with AMI (statins v no statins).
· SEAS. Simvastatin and Ezetimibe in Aortic Stenosis study (simvastatin and ezetimibe v placebo).
· SHARP. Study of Heart and Renal Protection (simvastatin and ezetimibe v placebo).
The results of the evidence cited in the 2013 American College of Cardiology and the American Heart Association guidelines.
Below is a table showing the percentage of people still alive at the end of the trials.
Trial Name | Number in Trial | % of people alive at the end of the trial in treatment group | % of people alive at the end of the trial in control group |
TNT | 10,001 | 94.31 | 94.36 |
IDEAL | 8,888 | 91.75 | 91.59 |
PROVE-IT & A to Z | 8,658 | 96.37 | 95.31 |
ACCORD | 5,518 | 92.65 | 91.97 |
SEARCH | 12,064 | 84.01 | 83.92 |
SPARCL | 4,731 | 90.86 | 91.08 |
HATS | 80 | 97.61 | 97.36 |
MIRACL | 3,086 | 95.83 | 95.60 |
CORONA | 5,011 | 71.04 | 69.60 |
WOSCOPS | 6,595 | 96.78 | 95.90 |
4S | 4,444 | 89.96 | 85.80 |
CARE | 4,159 | 91.35 | 90.56 |
AFCAPS/TEXCAPS | 6,605 | 97.57 | 97.66 |
LIPID | 9,014 | 88.96 | 85.93 |
GISSI-P | 4,253 | 86.32 | 92.21 |
LIPS | 1,677 | 92.29 | 89.91 |
HPS | 20,536 | 87.10 | 85.40 |
PROSPER | 5,804 | 89.69 | 89.49 |
ALLHAT-LLT | 10,355 | 85.10 | 84.70 |
ASCOT | 10,305 | 96.42 | 95.87 |
ALERT | 2,012 | 86.38 | 86.88 |
CARDS | 2,838 | 95.70 | 94.20 |
ALLIANCE | 2,442 | 90.05 | 89.63 |
ASPEN | 2,410 | 94.20 | 94.30 |
MEGA | 7,832 | 98.57 | 98.00 |
JUPITER | 17,802 | 97.77 | 97.22 |
GISSI-HF | 4,574 | 71.24 | 71.86 |
AURORA | 2,773 | 54.21 | 52.31 |
4D | 1,255 | 52.01 | 49.68 |
GREACE | 1,600 | 97.12 | 95.00 |
MUSASHI-AMI | 486 | 99.17 | 99.59 |
SEAS | 1,873 | 88.87 | 89.23 |
SHARP | 9,270 | 94.98 | 95.07 |
Neil Stone | Financial relationship with Abbott, AstraZeneca, Merck, Pfizer, Sanofi-Aventis, and Schering-Plough, and has served as a consultant to Abbott, AstraZeneca, Merck, Pfizer, Reliant, Schering-Plough |
Jennifer Robinson | Research grants from Aegerion, Amarin, Amgen, AstraZeneca, Esperion, Genentech/Hoffman, LaRoche, GlaxoSmithKline, Merck, Sanofi-Aventis/Regeneron |
Alice Lichtenstein | Research grant from Merck, Sharp & Dohme |
Noel Bairey Merz | Received lecture honoraria from Pfizer, Merck, and Kos; she has served as a consultant for Pfizer, Bayer, and EHC (Merck); she has received unrestricted institutional grants for Continuing Medical Education from Pfizer, Procter & Gamble, Novartis, Wyeth, AstraZeneca, and Bristol-Myers Squibb Medical Imaging; she has received a research grant from Merck; she has stock in Boston Scientific, IVAX, Eli Lilly, Medtronic, Johnson & Johnson, SCIPIE Insurance, ATS Medical, and Biosite. |
Conrad Blum | None |
Robert Eckel | Consultant for Merck, Pfizer, Abbott, Amylin, Eli Lilly, Esperion, Foodminds, Johnson & Johnson, Novo Nordisk, Vivus. Research grants from GlaxoSmithKline and Sanofi-aventis/Regeneron |
Anne Goldberg | Consultant for Abbott, Roche, ISIS/Genzyme, Sanofi-Aventis, Unilever, Merck. Research grants from Abbott, Aegerion, Amarin, Amgen, Genentech/Roche, GlaxoSmithKline, ISIS/Genzyme, Merck, Novartis, Reliant, Sanofi-Aventis/Regeneron, Sanofi-Aventis |
David Gordon | NHLBI employee |
Daniel Levy | Participated in CME activity supported by an independent educational grant from Merck & Co., Inc. |
Donald Lloyd-Jones | AstraZeneca, Schering-Plough |
Patrick McBride | Grants and/or research support from Pfizer, Merck, Parke-Davis, and AstraZeneca; has served as a consultant for Kos Pharmaceuticals, Abbott, and Merck; and has received honoraria from Abbott, Bristol-Myers Squibb, Novartis, Merck, Kos Pharmaceuticals, Parke-Davis, Pfizer, and DuPont |
J. Sanford Schwartz | Has served as a consultant for and/or conducted research funded by Bristol-Myers Squibb, AstraZeneca, Merck, Johnson & Johnson-Merck, and Pfizer. |
Susan Shero | NHLBI employee |
Sidney Smith | Received institutional research support from Merck; he has stock in Medtronic and Johnson & Johnson. Consultant for or on the speakers’ bureaus of Bayer Corp., Eli Lilly and Co., GlaxoSmithKline Pharmaceuticals, Pfizer Labs, and Sanofi-Aventis; and has served as a member of the Data Safety Monitoring Board of AstraZeneca Pharmaceuticals. |
Karol Watson | Consultant for Abbott, AstraZeneca, Genzyme, GlaxoSmithKline, Kos, Medtronic, Merck, Novartis, Pfizer |
Peter Wilson | Consultant for Merck, XZK. Research grants from Merck and Liposcience |
Out of the 16 members of the panel, 13 members have had or have financial relationships with pharmaceutical companies who market cholesterol lowering drugs, two members were employees at the NHLBI (who set up the ATP panel) and one had no obvious ties.
Impact of the recommendations
Professor Michael J. Pencina from the Duke Clinical Research Institute analysed the recommendations from ACC/AHA 2013 and concluded: “As compared with the ATP-III guidelines, the new guidelines would increase the number of U.S. adults receiving or eligible for statin therapy from 43.2 million (37.5%) to 56.0 million (48.6%). Most of this increase in numbers (10.4 million of 12.8 million) would occur among adults without cardiovascular disease. Among adults between the ages of 60 and 75 years without cardiovascular disease who are not receiving statin therapy, the percentage who would be eligible for such therapy would increase from 30.4% to 87.4% among men and from 21.2% to 53.6% among women. This effect would be driven largely by an increased number of adults who would be classified solely on the basis of their 10-year risk of a cardiovascular event”.
Summary of ACC/AHA 2013
The members of ACC/AHA 2013 recommended a large increase in statin use. This advice was given using evidence from statin trials in which the participants had been carefully selected. Despite this, the results of the trials revealed no difference in death rates. Over 90% of the panel members have at some time developed financial relationships with pharmaceutical companies who market cholesterol lowering drugs, or were employed by the organisation that set up the panel.
The first set of cholesterol lowering guidelines were issued in 1988 (the 2013 guidelines were the fifth set). Before the first set of guidelines were issued, about 261,000 people in the USA were receiving cholesterol lowering drugs. After the last set of guidelines were given in 2013, 56 million Americans are now eligible to receive statin drugs – a 214-fold increase.
So the American public are en masse taking statin drugs that possibly shorten their lifespan whilst at the same time causing them a plethora of debilitating toxic side effects.
Links to other studies:
