More scaremongering about irrelevant data:
Once again the BBC yesterday published an alarmist report without scientific validity.
But uniquely big size , and cost (~$1 billion for a complex study involving 161 800 postmenopausal women) do not guarantee validity, as Drs Prentice and Anderson stress in their excellent major 21page recent overview of the landmark Womens’ Health Initiative WHI. The source, the latest WHI report from the notoriously disease-industry- biased New England Journal of Medicine NEJM, covered an impressive 58000 postmenopausal women, ~300 000 PMW years on HT, up to 30 years of postmenopausal statistics on and off megadose oral hormone therapy OHT- not physiological hormone replacement HRT .
Once again this BBC, and the source NEJM 15page, report – as is repeated BBC and NEJM style – in carefully focusing solely on the overblown scare of breast cancer BRCA when other (preventable with appropriate parenteral HRT) diseases will kill and disable >15 times more– omit cardinal facts, omissions which (apart from crucial statistical errors) immediately discredited the early WHI HT reports from mid-2002 :
1.like the original 2002 WHI HT report, it fails to give the results by age-group: in both studies the majority of women were well over 60years at screening;
2. it fails to disclose mortality data by all-cause and by common disease and age-group- eg in the estrogen-only arm of the 2004 WHI report, both breast cancer and all-cause major morbidity and mortality was significantly reduced in the women who were under 60yrs at enrollment;
3. it fails to acknowledge that using oral xenohormones OHT especially synthetic medroxyprogesterone MPA has for over 50years consistently been shown to be less safe than estrogen alone and especially than physiological replacement with balanced human parenteral estrogen, progesterone and testosterone. We and others stopped using potent xeno-OHT (equine estrogen, synthetic progestin) in the early 1990s because both the literature since the 1950s, and our experience, and longterm preventative endocrinological (not symptom-relief-based) practice, overwhelmingly argued against anything but physiological replacement of human hormones;
4. the 2004 estrogen-only arm report of WHI confirmed previous studies and experience that use of even oral estrogen OHT appropriately in healthy young women for up to 10 years reduces all-cause major disease and breast cancer morbidity and mortality; it is almost 30 years since Brian Henderson ea (1980 onwards) showed that the incidence of breast cancer rises steadily after >12years of OHT with equine CEE;
5. oral synthetic progestins especially MPA are a major breast cancer (and cardiovascular, and osteoporosis) risk factors, with Horwitz ea in New York recently confirming that it is progestin, not estrogen, that initiates growth in otherwise dormant breast cancer cells; and
6. There never was evidence from either observational studies, practice or eg the US Nurses’ Health Study, or the Heart and Estrogen Study HERS or PEPI, to justify the bizarre WHI protocol to inappropriately randomize women well over 60years, the majority HT-naive and overweight (BMI>25kg/sqm), with predictable latent if not obvious hypertension-vascular disease, to start the OHT with two already long-discredited xenohormones. This was borne out by the small Oulu 2006 randomized controlled trial (Heikinnen ea) which confirmed that European OHT (lower-dose oral human estradiol plus more modern safer progestin than MPA), in younger fit PMW abolished any serious adverse disease events let alone deaths for a mean of 10years.
7. The dietary arm of the WHI showed the miniscule mortality rate of breast cancer today: the women who got breast cancer under observation (0.45% per year) had a deathrate from breast cancer of only 0.02% per year ie (unlike the death rate from all other cancers), fewer than 1 in 20 of breast cancer sufferers die each year of the breast cancer. This 0.45% breast cancer incidence (which rarely cripples those who survive) contrasts with the 2/3 lower hip fracture rate off HT of 0.15% per year- which kills 20% of victims, and cripples three-quarters of the survivors- whereas appropriate early and permanent balanced HRT (testosterone and estrogen) combined with the basket of a dozen natural vitamin-mineral supplements virtually abolishes osteoporotic hip fracture. In western women, by contrast with the average <4% of annual deaths that are from breast cancer, over 50% of postmenopausal deaths are from vascular diseases – which like osteoporotic fractures and breast cancer are largely preventable with natural supplements.
8. and even appropriate OHT may reduce the mortality from breast cancer and all causes by a third:
a Medline review up to 2002 of OHT after breast cancer showed no adverse effect on recurrence and mortality;
a study from Australia in a cohort of 4022 postmenopausal women diagnosed with breast cancer between 1993 and 2000 showed 36% lower breast cancer mortality and 31% lower all-cause mortlaity in HRT ever-users;
and a 2008 study of PMW with BRCA shows “Tumor prognostic factors were better and survival rates higher for both CEE and combination HT users of any duration. Use greater than 10 years correlated with node-negative disease, mammographically detected tumors, and 100% survival. CEE supported minimal proliferation; MPA induced cell death; CEE+MPA results were similar to E alone. CONCLUSIONS: HT users, regardless of type or duration of HRT use, continued to have higher survival rates. In vitro results supported the clinical finding that outcomes for users of E and E+MPA were similar. ”
Funded research studies, and risky HT, and for-profit incentives, are potent stimuli to mass screening interventions. The very low rate of breast cancer deaths after breast cancer is arguably due to the gross and (in those without risk factors eg family history, obesity) unwarranted over-diagnosis of silent breast cancer by screening mammography of the well, who (like asymptomatic men with silent prostate cancer) would often have died old of other causes without the cancer ever causing symptoms. This was clearly shown in the recent Canadian mammography screening trials.
These crucial facts have been endlessly presented at the world authority congresses of eg the International IMS and British BMS Menopause Societies since 2002, so much so that even leading Americans (as in this new NEJM paper) have finally stopped calling unphysiological oral hormone therapy (OHT-which uses doses effectively 10 to 100 times stronger) physiological human sex steroid replacement- SHRT. Medical HRT obviously in simple English encompasses all hormone replacement, so SHRT distinguishes sex or steroid HRT from the dozen other HRT acronyms.
The crucial differences between (risky) OHT and appropriate safe physiological parenteral SHRT have yet again been summed up in a new paper from the IMS (Genazzani ea 2008). All these issues and references have been posted on the IMS and BMS websites, and analyzed the past year in this column. But the American Disease Industry – led by Big Pharma like Wyeth, and it’s front the (USA) FDA and the (European) EMA, does not give up in it’s profit-dominated campaign against the proven effective old and natural supplements (eg appropriate human hormones) – it’s War Against Patients, it’s cancer scaremongering; why should it give up, since only disease pays! Prevention Does Not pay!