Statin wars: have we been misled about the evidence?

Asks Dr. Maryanne Demasi in her latest publication in the British Medical Journal of Sports Medicine (BJSM). (As the article appears to no longer be open access but Dr. Demasi permitted the sharing of it, please find the article attached Statin wars- have we been misled about the) Her review of the years of research, all paid for by the pharmaceutical companies, and the many scientists conducting biased research, is hardly new. We all have read or heard about the “Heart Health Hypothesis” that damaged the health of several generations.

However, what most of us didn’t know is that the scientists, who conducted the original research about statins, made a deal with the pharmaceutical companies to never reveal their data!

“Much has been made about the fact that the raw data from statin trials are only available to a single group of researchers—the CTT Collaboration—and they have agreed to keep the data in confidence and will not share anonymised data with independent researchers. This is one of the most contemptible breaches in transparency”

writes Dr. Demasi but I think it is much more than breach of transparency; it is against all scientific publishing responsibilities. There is not a journal that doesn’t require the data of all research to be available to be downloaded and further analyzed. In my view this is criminal.

Dr. Demasi continues:

“When asked in 2013, the CTT [Cholesterol Treatment Trialists by Oxford University] confirmed that it would not allow other scientists to access the raw statin data to conduct an independent analysis. They wrote: ‘The CTT secretariat has agreement with the principal investigators of the trials and, in those instances where trial data were provided directly by the drug manufacturers, with the companies themselves, that individual trial data will not be released to third parties. Such an agreement was necessary in order that analyses of the totality of the available trial data could be conducted by the CTT Collaboration: without such an agreement the trial data could not have been brought together for systematic analysis… Not even the Cochrane Collaboration had access to the patient-level data when conducting its review of statins in low-risk people, and its conclusions ultimately influenced the prescribing guidelines’”. (emphasis mine)

How is it possible that research of such significance affecting millions of people each day, often causing major damage to their health, is not verifiable or replicable by independent researchers and yet it is publishable? And how did the world end up following the guidelines of such hidden data results put forth by obvious financial interest?

Do we have any data at all that is not funded by the pharmaceutical companies? We do, though minimal (here, here as a couple of examples). Who wants to fund a fight against big pharma?

Britain’s Chief Medical Officer, Dame Sally Davies, wrote to the Academy of Medical Sciences:

“Only one major non-industry-funded study on statins has been done (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)), which showed pravastatin had no significant benefit in reducing either all-cause mortality or coronary heart disease in primary prevention.” (emphasis mine)

Furthermore, Dr. Demasi continues,

“If the public demands that scientists declare their conflicts of interest in order to restore confidence, then so should medical journals. Former Editor in Chief of The New England Journal of Medicine, Dr Marcia Angell, famously said, ‘It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.’”

Damn right! If it is impossible for an academician to publish any findings without ethical board approval (even for a survey) that may take over a year and making all data available free of charge for all who wish to analyze that data, then so must those who were funded by pharmaceuticals. Either that, or they should not be able to advocate the use of statins for anything. After all, they say that there is evidence but where is the data proving that? Given the lack of any evidence of statins benefits confirmed by an independent research authority of the now hidden data, nothing can be said about statins.

It is a quite simple logical statement:

Hidden data ==> Hidden result ==> Cannot recommend drugs in the blind

I highly recommend you read the whole article written by Dr. Demasi—it is a total eye opener. The article can be downloaded if you have subscription here. If you have no subscription, with the permission of Dr. Demasi, the link to the article is in the introduction above. You may want to reconsider taking any statins; particularly if you are a woman!

Comments are always welcome,

Angela