The drug industry has obviously realized that more and more people have become critical to cholesterol-lowering treatment, This is probably the reason why several large and complicated multi-authored reviews paid and in some cases performed by the drug industry have been published recently. It may also explain why a new report about the FOURIER trial has been published by Amgen, the producer of the drug investigated. If you have read my newsletter from March 2017 you will know that both cardiovascular and total mortality increased in that trial, although not with statistical significance, and this was probably the reason why the trial was stopped already after 2.2 years.
Using complicated statistical methods the 19 authors of the new FOURIER report ended up with the following conclusion:
There was a monotonic relationship between achieved LDL cholesterol and major cardiovascular outcomes down to LDL-cholesterol concentrations of less than 0·2 mmol/L. Conversely, there were no safety concerns with very low LDL-cholesterol concentrations over a median of 2·2 years. These data support further LDL-cholesterol lowering in patients with cardiovascular disease to well below current recommendations.
And here comes the declaration of the authors´ interests:
RPG reports grants and personal fees from Amgen, during the conduct of the study; grants and personal fees from Amgen, Daiichi-Sankyo, and Merck; and personal fees from Amarin, American College of Cardiology, Angel Med, Beckman-Coulter, Boehringer Ingelheim, Bristol-Myers Squibb, CVS Caremark, GlaxoSmithKline, Janssen, Lexicon, Portola, Pfizer, Regeneron, Sanofi-Aventis, St Jude, and Stealth Peptides, outside from the submitted work. TRP reports grants and personal fees from Amgen, during the conduct of the study; and personal fees from Amgen, Sanofi, Merck, Boehringer-Ingelheim, and The Medicines Company, outside the submitted work. GMDF reports grants and personal fees from Amgen, during the conduct of the study; grants and personal fees from Amgen and MSD; grants from Boton Scientific; and personal fees from LivaNova and Sima Tau, outside the submitted work. ZAG reports personal fees from Amgen and Sanofi, during the conduct of the study. RC reports grants from Pfizer–International Atherosclerosis Society; and personal fees from MSD, Bayer, Amgen, Boehringer Ingeslheim, Sanofi, AstraZeneca, NovoNordisk, Servier, and Kowa, outside the submitted work. IG-B reports personal fees and non-financial support from Amgen and Sanofi; and personal fees from Eli Lilly, Regeneron, and Aegereon, outside the submitted work. JL-M reports personal fees and non-financial support from Amgen and Sanofi; personal fees from MSD and Laboratorios Dr Esteve, outside the submitted work. FM reports grants, personal fees, and non-financial support from Amgen, MSD, Sanofi, AstraZeneca, and Pfizer, during the conduct of the study. BRO reports personal fees from Amgen, during the conduct of the study; participation on a data safety monitoring board for Accera; and grants from Long Term Care Group, Merck, Eli Lilly, TauRx, Janssen, Biogen, Avid, and Hoffman-La Roche, outside the submitted work. EK reports grants from Amgen during the conduct of the study; and grants from Amgen and AstraZeneca, outside the submitted work. ALP is an employee of and holds stocks in Amgen. RS is an employee of Amgen and, as such, has received salary, bonus, stock or stock options, health insurance, and benefits; and is identified as an inventor on at least one pending patent application owned by Amgen relating to evolocumab. SMW is an employee of Amgen; and has a patent for evolocumab issued to Amgen. ACK reports grants and personal fees from Abbott, and Mylan; and personal fees from Amgen, AstraZeneca, and Pfizer, outside the submitted work. PSS reports grants and personal fees from Amgen, during the conduct of the study; grants and personal fees from Pfizer, outside the submitted work; and that he is the recipient of a National Institute for Health Research Senior Investigator Award and receives support from the Biomedical Research Centre Award to Imperial College Healthcare NHS Trust. MSS reports grants from Abbott Laboratories, Clinical Diagnostics, Daiichi-Sankyo, Gilead, GlaxoSmithKline, Roche Diagnostics, Takeda, Novartis, Poxel, Eisai, Genzyme, and Pfizer; grants and personal fees from Amgen, AstraZeneca, Intarcia, Merck, Janssen Research Development, The Medicines Company, and MedImmune; and personal fees from Alnylam, CVS Caremark, Lonis, Cubist, Esperion, and MyoKardia, outside the submitted work. J-GP, KT, and FS declare no competing interests.
With this background is it possible that these authors have given the reader true information about the benefits and side effects of this drug? My question is relevant, because according to Wikipedia AMGEN was accused in 2012 for illegal marketing. Federal prosecutors accused the company of pursuing profits while putting patients at risk. Amgen paid $762 million after pleading guilty to criminal charges of improper promotion and sale of misbranded drugs.
And Amgen is not alone. In his book Deadly Medicines and Organised Crime Peter Gøtsche, who is professor at the University of Copenhagen and head of Nordic Cochrane, has told the reader about the many fines the major drug companies have received. On Wikipedia you can find a list of the largest pharmaceutical settlements.
A relevant question is, why the drug companies are allowed to continue with their criminal behavior. And how come that the responsible directors haven´t been arrested?
Fortunately more and more researchers have understood that the drug industry is criminal and that the cholesterol campaign is the greatest medical scandals in modern time. Unfortunately most people do not read medical papers, because they are too complicated, even for most doctors. However, if you for instance search Youtube with the word “statin”, you will get access to dozens of videos performed by independent researchers, doctors, journalists or well informed lay people, who can tell you more about this issue. The most recent and informative one is probably this one by Dr. Sam Eggertsen (52 min.). If you understand the Scandinavian languages, you can also go to an interview with me (100 min.).