Tag Archives: Mathieu & Ravaud- Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials


In the study published today in JAMA  “Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials” ( RCTs) by experts from France, Canada and Oxford,

the end result was that, “in 323 included trials ( in cardiology, rheumatology, and gastroenterology) indexed in 2008 in the 10 general medical journals and specialty journals with the highest impact factors, the influence of  multiple discrepancies could be assessed in only about 7%; and in these 23 RCTs,  statistically significant results were favored ie biased in 82.6% (19 of 23)”.

This highlights the overwhelming spin by vested interests, the gross deceit of many RCTs. The reason is obvious- favourable results (by publishing only favourable trials or selective facts) can profit many eg the sponsor, the authors and their employer, and the journal.

Nowhere was this better illustrated than in the two primary publications of the landmark Women’s Health Initiative in 2002 and  2004, which misguided  trial and reports – also published in JAMA  (about Wyeth’s commercial therapy- equine estrogen and synthetic progestin, not about physiological human hormone replacement)  are still causing grievous chaos and premature deaths in  senior  women in first-world communities.

The evil that men – or biased RCT reports-  do lives after them- the good is oft interred with their bones: eg  despite the International and British Menopause Societies patiently pointing out since 2002   the invaluable findings but also the  gross errors and dangerous deductions in that uniquely costly and big and important RCT , all HRT hormone replacement therapy  was hysterically and dangerously labeled eg   “a thalidomide disaster” by no less than the president of the German Medicines Authority, and hence by many others, including being embargoed by the naive European Medicines Authority at the time.

But any experienced practicing clinician (and even well-read patient)  ie one in touch with both patients and the scientific literature and endocrinology – ie someone not influenced by the FDA-Wyeth marketing machine- had only to read the initial  1998 design paper of the WHI, let alone the 2002 and 2004 main reports,  to see the gross biases of the $billion Premarin/Provera promotion, first for and then against the moneyspinning drugs – which had long been, and were confirmed by the WHI results to be, appropriate (if not ideal) and major longterm prevention  when used appropriately in suitable women soon after menopause..

Certainly that catastrophe (the bad planning, then the inappropriate early closure of the HRT arms due to bad statistics,  then  misapplication of the WHI results) did Wyeth, the FDA,  the American Menopause Society, and women  worldwide incalculable harm; but it had both intended and  unintended outcomes:

it confirmed the one-third reduction at least for the first 10 years  in all  major illness and deaths even from breast cancer with appropriately used Premarin or  PremPro;

but because of the resultant scandalous  trumpeted USA and European  bias against all HRT, it gave gigantic boost to prescriptions and sales of even more risky and inappropriate $trillion substitutes eg phytoestrogens (including potentially lethal black cohosh);  statins;  bisphosphonates; SERMs;   psychotropes etc – none of which have been proven to reduce all-cause mortality as does appropriate HT like Prem/Pro, or metformin. .