Tag Archives: WHI



for appointments for consultations,   or non-xray procedures by registered practitioners :  Sure Touch breast prescreening on  Saturday mornings next on  7 February 2015  by Sister Zeneath Ismail – cash R650 (then R450 if followup scan desired within 3 months);   -QUS  ultrasound quantitative bone density  cash R450 -tariff item 3612-  anytime;  Unlike radiologists’  and thermography reports (which describe only  the imaging finding), the rates quoted include relevant breast or bone consultation and management planning  by specialist nurse & physician.

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: ABSTRACT:  since last review in  this column 5 years ago, what progress has there been with ovarian cancer OvCa? On Pubmed there are 81000 references,  45500 reviews on OvCa

5 Oct 2014:  Ovarian Cancer Often Arises from Precursor Endometriosis    Frontline Medical News, 2014 Sep 29, B Jancin

   29 Sept 2014  The good news is that if ovariectomy is not done at hysterectomy, then at least salpingectomy should be done- it does not cause earlier menopause.  And the modern fashion for progesterone cream as baseline hormone balancing in this age of estrogen dominance, the feminization of nature,  also adds major protection for heart, bone, memory, mood,  and against cancer, without the risks of estrogen.

Before this month’s update,  the latest, an Australian cancer review  Mette ea 2013, shows that cigarette smoking increases the risk of OvCa by 30% to 60%.

The latest   review 2013 Modugno ea at Univ Pittsburgh/Mayo Clinic  Hormone response in ovarian cancer: time to reconsider as a clinical target?   said “Ovarian cancer is the sixth most common cancer worldwide among women in developed countries and the most lethal of all gynecologic malignancies. There is a critical need for the introduction of targeted therapies to improve outcome. Epidemiological evidence suggests a critical role for steroid hormones in ovarian tumorigenesis. There is also increasing evidence from in vitro studies that estrogen, progestin, and androgen regulate proliferation and invasion of epithelial ovarian cancer cells. Limited clinical trials have shown modest response rates; however, they have consistently identified a small subset of patients that respond very well to endocrine therapy with few side effects. We propose that it is timely to perform additional well-designed trials that should include biomarkers of response.The most consistently reported reproductive and hormonally related factors found to protect against EOC are use of oral contraceptives (OCs), increasing parity, and having a tubal ligation. In contrast, increasing age and nulliparity have been consistently shown to increase EOC risk. 

    Recent studies, including the prospective Women’s Health Initiative (WHI) (Anderson et al. 2003) and the Million Women Study (Beral et al. 2007), report an increase in risk for both estrogen-only (ET) and estrogen–progestin (EPT) formulations, although the risk associated with EPT was lower than that of ET. A recent meta-analysis of 14 published studies found risk increases 22% per 5 years of ET use compared with only 10% per 5 years of EPT use, suggesting that risk differs by regimen (Pearce et al. 2009).               Exogenous androgens may be associated with EOC. One case–control study found that use of Danazol, a synthetic androgen commonly used in the treatment of endometriosis, significantly increased EOC risk (Cottreau et al. 2003), although this finding has not been replicated (Olsen et al. 2008). Ever use of testosterone (tablets, patches, troches, or cream) has been associated with a threefold increase in EOC (Olsen et al. 2008).             

     Reproductive disorders and other reproductive factors :  Factors affecting childbearing have also been shown to be associated with EOC. In most studies, infertility has been associated with an increased risk, which may be greatest among women who fail to conceive (Vlahos et al. 2010). In general, infertility treatment does not appear to increase EOC risk, although the subset of treated women who remain nulliparous may be at an increased risk (Vlahos et al. 2010).

         Endometriosis, defined as the presence and growth of endometrial tissue outside the uterine cavity, has also been associated with EOC. A recent pooled analysis of 13 case–control studies showed a threefold increase in the incidence of clear cell EOC and a twofold increase in endometrioid EOC among women with a self-reported history of endometriosis (Pearce et al. 2012).

    An increased risk of EOC was reported by one case–control study (Schildkraut et al. 1996) among women with polycystic ovary syndrome (PCOS), a condition associated with menstrual dysfunction, infertility, obesity, the metabolic syndrome, hyperandrogenism, and insulin resistance. However, the finding was based on a small number of cases (n=7) and the association was limited to nonusers of OCs and thin women. Further case–control and prospective studies have failed to confirm this relationship (Pierpoint et al. 1998, Olsen et al. 2008, Brinton et al. 2010).

   Tubal ligation has been consistently shown to be associated with reduction in EOC risk (Cibula et al. 2011). This protection appears similar in magnitude to OC use and child bearing (about 30%) and is protective in high-risk women (i.e. BRCA1/2 carriers) as well. Hysterectomy has also been shown to reduce EOC risk, although the magnitude of the association is not as great nor as consistent as that reported for tubal ligation (Riman et al. 2004). Finally, reproductive factors associated with other hormonally linked cancers, such as age at first menarche, age at menopause, and length of reproductive years, have not been consistently associated with EOC (Riman et al. 2004).

    Estrogens and androgens –  The evidence linking these  to EOC are mixed. The majority of women who develop ovarian cancer are postmenopausal at the time of diagnosis. In postmenopausal women, the major source of circulating estrogen is from the peripheral conversion (in skin and adipose tissue) of androstenedione by the enzyme aromatase.

    Progesterone and progestins- Epidemiological data suggest that progestins and progesterone may have a protective role against EOC. Importantly, there is some evidence that progesterone might synergize with chemotherapeutic drugs to induce apoptosis.

Now this month  comes exciting news about  a  Paradigm Shift: Prophylactic Salpingectomy for Ovarian Cancer Risk Reduction   Frontline Medical News, 2014 Sep 24, B Jancin     :   Removing the fallopian tubes at the time of pelvic surgeries as a potential means of reducing ovarian cancer risk appears to be a movement that’s picking up steam in clinical practice.
       A recent survey of 234 U.S. gynecologists showed prophylactic bilateral salpingectomy is catching on when performed in conjunction with hysterectomy, but far less so for tubal sterilization, Dr. Austin Findley observed at the annual Minimally Invasive Surgery Week.                                                                       A total of 54% of respondents indicated they routinely perform salpingectomy at the time of hysterectomy in an effort to reduce the risk of ovarian cancer as well as to avoid the need for reoperations. However, only 7% of the gynecologic surgeons said they perform salpingectomy for tubal sterilization, even though 58% of respondents stated they believe the procedure is the most effective form of tubal sterilization (J. Minim. Invasive Gynecol. 2013;20:517-21).
  “In my experience at various hospitals, I think these numbers are a pretty accurate reflection of what folks are doing,” commented Dr. Findley of Wright State University in Dayton, Ohio.
     The prophylactic salpingectomy movement is an outgrowth of the tubal hypothesis of ovarian cancer.
    “There is now increasing and dramatic evidence to suggest that most ovarian cancers actually originate in the distal fallopian tubes. I think this is a concept most people are unaware of or are just becoming accustomed to. The tubal hypothesis represents a major paradigm shift in the way we think about ovarian cancers. The previous belief that excessive ovulation is a cause of ovarian cancer is no longer regarded as accurate,” he explained at the meeting presented by the Society of Laparoscopic Surgeons and affiliated societies.
      Ovarian cancer is the No. 1 cause of mortality from gynecologic malignancy, accounting for more than 14,000 deaths per year, according to National Cancer Institute data. The lifetime risk of the malignancy is 1.3%, with the average age at diagnosis being 63 years.
       Only 10%-15% of ovarian cancers occur in women at high risk for the malignancy because they carry a BRCA mutation or other predisposing gene. The vast majority of ovarian cancer deaths are caused by high-grade serous tumors that have been shown to be strongly associated with precursor lesions in the distal fallopian tubes of women at low risk for the malignancy.
            There is no proven-effective screening program or risk-reduction method for these low-risk women. However, with 600,000 hysterectomies and 700,000 tubal sterilizations being performed annually in the United States, prophylactic salpingectomy has been advocated as an attractive opportunity to potentially reduce ovarian cancer risk. Other common pelvic surgeries in which it might be used for this purpose include excision of endometriosis and laparoscopy for pelvic pain. It also has recently been shown to be feasible and safe post partum at cesarean or vaginal delivery (Obstet. Gynecol. 2014 [doi: 10.1097/01.AOG.0000447427.80479.ae]).
   But the key word here is “potentially.” It must be emphasized that at present the ovarian cancer prevention benefit of prophylactic salpingectomy remains hypothetical; in theory, the procedure should reduce ovarian cancer risk, but there is not yet persuasive evidence that it actually does, Dr. Findley emphasized at the meeting, presented by the Society of Laparoendoscopic Surgeons and affiliated societies.
            In contrast, one well-established ancillary benefit of prophylactic salpingectomy is that it eliminates the need for future reoperation for salpingectomy. This was demonstrated in a large Danish cohort study including close to 10,000 women undergoing hysterectomy and a similar number undergoing sterilization procedures. Among the nearly two-thirds of hysterectomy patients who had both fallopian tubes retained, there was a 2.13-fold increased likelihood of subsequent salpingectomy, compared with nonhysterectomized women.
        Similarly, Danish women who underwent a sterilization procedure with retention of the fallopian tubes – typically tubal ligation with clips – were 2.42 times more likely to undergo subsequent salpingectomy, most often because of the development of hydrosalpinx, infection, ectopic pregnancy, or other complications (BMJ Open 2013;3 [doi:10.1136/bmjopen-2013-002845]).
     The most commonly cited potential risk of prophylactic salpingectomy – decreased ovarian function – now appears to be a nonissue. This was demonstrated in a recent retrospective Italian study (Gynecol. Oncol. 2013;129:448-51) as well as in a pilot randomized controlled trial conducted by Dr. Findley and his coworkers (Fertil. Steril. 2013;100:1704-8), which appears to have answered many skeptics’ concerns. Indeed, Dr. Findley’s coinvestigator Dr. Matthew Siedhoff said he has recently been approached by researchers interested in collaborating in a larger confirmatory randomized trial, but all parties eventually agreed it was a no-go.
    “It’s a little hard to demonstrate equipoise for a larger randomized controlled trial. We’re beyond that now, given that prophylactic salpingectomy really doesn’t seem to make a difference as far as ovarian function,” according to Dr. Siedhoff, director of the division of advanced laparoscopy and pelvic pain at the University of North Carolina, Chapel Hill.
         Another oft-expressed reservation about salpingectomy as a means of reducing ovarian cancer risk in women seeking sterilization is that salpingectomy’s irreversibility may lead to “tubal regret” on the part of patients who later change their mind about further pregnancies. However, Dr. Findley cited a recent editorial whose authors criticized colleagues who made that claim. The editorialists argued that the tubal regret concern indicates surgeons weren’t really listening to their patients’ true desires during the informed consent conversation.
     “We should not have started thinking about salpingectomy for female sterilization only once a decrease in ovarian cancer risk became part of the equation,” they declared (Obstet. Gynecol. 2014;124:596-9).
           Dr. Findley noted that Canadian gynecologists are leading the way forward regarding prophylactic salpingectomy as a potential method of ovarian cancer prevention. The Society of Gynecologic Oncology of Canada in a 2011 policy statement recommended patient/physician discussion of the risks and benefits of bilateral salpingectomy for patients undergoing hysterectomy or requesting permanent sterilization. The Society of Gynecologic Oncology followed suit with a similar clinical practice statement in late 2013.
        Additionally, the Canadian group declared that a national ovarian cancer prevention study focused on fallopian tube removal should be a top priority.
    Gynecologic oncologists in British Columbia recently reported the eye-catching results of a province-wide educational initiative targeting gynecologists and their patients. In 2010, all British Columbia gynecologists had to attend a course on the role of the fallopian tubes in the development of ovarian cancer, during which they were advised to consider performing bilateral salpingectomy for ovarian cancer risk reduction.
              Surgical practice changed dramatically in British Columbia in response. In 2009 – the year prior to the physician education initiative – salpingectomy was utilized in just 0.3% of permanent sterilization procedures. In 2010, it was 11.4%. By 2011, it was 33.3%.
           Similarly, only 7% of hysterectomies performed in British Columbia in 2009 were accompanied by bilateral salpingectomy. This figure climbed to 23% in 2010 and jumped further to 35% in 2011. Meanwhile the rate of hysterectomy with bilateral salpingo-oophorectomy remained steady over time at 44% (Am. J. Obstet. Gynecol. 2014;210:471.e1-11).
     This project was conducted in collaboration with the B.C. Cancer Agency, which maintains comprehensive province-wide registries. Over time, it will be possible to demonstrate whether prophylactic salpingectomy is indeed associated with a reduction in the incidence of ovarian cancer. “I think this study demonstrated that there’s a lack of awareness on this issue, but also [that there’s] potential effectiveness of introducing an educational initiative like this in changing our practice patterns. As we start talking more about this issue amongst our colleagues and our patients, we’re more likely to see a practice pattern shift in the United States as well,” Dr. Findley commented.

17 July 2009     A new cancer study of  over 7 million women years is another major coffin for unopposed estrogen ET, for progestin Pg, and for oral  sex hormone therapy SHT.

Danish  Universities prospectively document  the incidence of ovarian cancer OvCa in a million postmenopausal women PMW  from 1995 through 2005.  Compared to non-users, use of HT increased OvCa (mean age 62yrs) by about 40%   for up to 2 years after stopping Ht, ie increased the absolute incidence  of clinically diagnosed OvCa from ~ 0.04 to ~0.052% ie per 100 patient yrs.

Transdermal TD ET alone  increased risk by 13%; vaginal ET by 23%;                                            Oral ET alone increased  risk by  34%; oral E+ progestin Pg by  48%;          TDE+Pg by 67%.

Thus the relative incidence of OvCa rose about 33% by 7 years on HT, to 48% if HT continued beyond 7years.

In 2004 Glud ea reported an increase risk of 31% for OvCa in Danish women on OHT use – total ET dose of ~5gm ie for about  for 15yrs – at a time when the standard premarin  dose was 0.625mg/d (equivalent to l mg E2)  if not double that .

For perspective,  the relative incidence of cancers in similar mostly 1st world European women from the  the USA SEER data for 2006 age over 50  years  are: BrCa 0.33%,  uterus 0.07%, ovary o.03%(ie very similar to the baseline Danish figure of 0.04% above), colon 0.15%,and cervix 0.01%. The new (Norwegian)  analysis in the latest BMJ suggests that screening mammography may result in overdiagnosis of BrCa by up to 50% (the other 50% may arguably never have been clinically significant-diagnosed- during life) , so the provocative could argue that the relative incidence of clinically significant BrCa to OvCa is more like eg BrCa 0.2 to ovary 0.03 ie just below 10:1. But OvCa is notoriously about 70% fatal within a few years, so  the absolute  mortality rate – at age 60-64yrs-  from  the same SEER  source and period are as relevant: BrCa 0.063%, uterus 0.011%, ovary 0.033%, colon 0.03% & cervix 0.005%. ie new OvCa may be only 1/10th as common as newBrCa, but BrCa  kills only twice  as many PMW as OvCa.

And finally the 2007  survey by  Rossing ea of  Menopausal Hormone Therapy and Risk of Epithelial Ovarian Cancer in women in Washington State 2002-2005 showed that  ET -mostly premarin (but not ET + progestin- MPA medroxyprogesterone provera) – especially in  low-parity  younger slim women increased OvCa compared to non-users, and that this risk  was highest- up to 90%-  in  users of OET  for more than 6 years.

By comparison – BREAST CANCER BrCa and HT: Hoover ea  1976  are the first on Pubmed to report doubling in  risk of breast cancer  BrCA after 15yrs on premarin in USA ie at least 5gm cumulative dose.

In Denmark by 1994 Ravn ea reported that if there was a risk of BrCa from OHT, it was small, and only after prolonged use of estrogen (15-20 years).  But by 2004 -2005 Tjønneland ea , Stahlberg ea  and Ewertz ea  found increased risk for BrCa  of 61 to 112%  associated with current use of HT.  Stahlberg ea already in 2003 concluded from recent studies from both the USA and Europe that the combined treatment regimens with estrogen and progestin increase the risk of BrCa  beyond the risk of unopposed estrogen.

In Norway, a recent Tromso study suggested that the dominant HT therapy used in Norway was oral estradiol E2 plus the progestin norethisterone acetate. . An earlier Tromso study in only 35000 PMW was too small- it showed that use of such OHT for >5yrs trebled the incidence of breast cancer BRCa, but did not influence that of OvCa.

Apart from smokers’ lung cancer, the commonest cancer in older women- BrCa- clinically affects perhaps 5% of PMW  lifelong – but  with prompt therapy after clinical presentation kills as few as 5% of sufferers- and with appropriate OHT (premarin +- provera)  for up to 8years in the Women’s Health Initiative both the incidence of and mortality from BrCa, and all-cause mortality,  were reduced by about one-third. Hence appropriate HT saves many from both BrCa and from premature death and disability from the commonest degenerative diseases- vascular, dementing and fracturing. 75% of women who develop BrCa  die with it –  not from it but from far more prevalent degenerative diseases after an  otherwise normal lifespan. But the Danish evidence is that combined OHT will increase OvCa by >50%.

Ovarian Ca kills 70% of victims, and is it so rare compared to BrCa? .

Hence with the perhaps 2/3  lower incidence of OvCa, it is a relatively trivial problem for women overall- except for the 4  in  10 000 women  who develop it, who have <50% 5year survival, ie 3 out of 4  of whom it will kill within a few years- compared to <25% of breast cancer victims who will be killed by the BrCa.

However, it becomes clear that these hormone-dependent cancers are both  duration-  and total-dose HT related; but even more important, that unopposed OET is a risk if persisted more than about 12 yrs; and even if used in far lower dose parenterally, the risk of OvCa is far higher if combined with the European fashion of androgenic synthetic progestins Pg – even parenterally; whereas the American MPA for up to 8years at least apparently if anything mitigates the OvCa risk of ET..

By contrast this column has repeatedly reviewed evidence that balancing physiological ERT with physiological testosterone replacement TRT eliminates the risk  for BRCA and endometrial cancer of unopposed ERT +- PRT in PMW.  Intuitively this should also apply to ovarian cancer.

Hence the message strengthens that PMW should not be exposed for  any length of time at any stage to the much higher oro-hepatic HT doses (needed for symptom control) or OET+- Pg; but as in all other endocrine replacement for permanent  multisystem prevention – let alone sexual function-  patients with gonadal deficiency should have physiological sexhormone balance restored  ie with balanced parenteral  human androgen, estrogen and progesterone replacement.

It is common cause that (reproductive cycles and pregnancy aside) all the physiological  prime sex hormones-DHEAdehydroepiandrosterone, P4, T, E2, E3 – are as important as all other human hormones, essential life long  for optimal health; and that estrogen dominance (due to inadequate  androgen and progesterone levels) is deleterious. Hence most PMW require both physiological progesterone and androgen replacement- sometimes to balance excessively high endogenous estrogens, usually to accompany necessary ERT for full balance.



who says Large doses of fish oil don’t prevent heart attack or stroke?

update 8 August 2013 the  OregonUniversity Linus Pauling Institute website still promotes the numerous benefits of fishoil.

update 2 August 2013    the Topol- Rowen- Peskin rejection of need for  fish oil EPA+DHA was  not supported by the recently NEJM-published  R&P 5 year trial in Italy, which compared  modified ie patented ethylester marine essential fatty acids with olive oil.

This R&P  trial was thus not a trial of fish oil (concentrate or otherwise), nor placebo-controlled, since olive oil is hardly a placebo- in the 13.4year Spanish EPIC trial  published last year , olive oil dramatically reduced all-cause mortality by 1/4 and CVD mortality by 44%. The full 2013 NEJM R&P paper is inexcusably silent in omitting this cardinal fact that it was no ways placebo-controlled- placebo means an inert comparator.

Thus  it can only be concluded from the Italian R&P trial that addition of patented processed EthylEster EFAs for only 5 years  gives no more benefit than the already major protection of olive oil and  mediterranean lifestyle alone. Contrary to Topol-Rowen-Peskin, this  R&P trial says nothing about the longterm benefits of vigorous fish oil intake in a high-risk population eg in USA/ other populations (especially smokers)  not  on a mediterranean/ Asian  high-fish intake.

the 2010 Nordic study ( Dyerberg  ea  Copenhagen University- who first reported in 1978 the association between marine omega3 PUFA and health in Eskimos) http://www.nordicnaturals.com/images/pdfs/tgstudy.pdf details the better bio-availability of natural ie triglyceride- bound fish oil- EPA+DHA compared to that in processed ethylester low-triglyceride omega3 products-   as used in the R&P and GISSI trials of patented commercial designer products. .

2 June 2013 Its some 4 years since this healthsite started promoting marine oil for optimal development and health.

    what say you to the latest hype about the  predictable negative result of the Italian N-3  Cardiovascular Risk and Prevention trial  R&P from the NEJM? ie that omega3 oil was no better than olive oil.
the major problem is that the R&P trial didnt use  natural clean FISH OIL, nor    in primary prevention.
Nowhere does it say it used fish oil- it says N-3 ie omega3, and in patients with multiple vascular disease. Nor does the original 2010 R&P plannng paper  state that in fact  it used  a patent formula of  chemically changed ethyl esters in tertiary  prevention,

like the GISSI trial used apparently patent branded altered  Om3  after heart attacks – it wasnt  natural clean fish oil..
the GISSI abstracts 1999 and 2008 also dont mention fish oil.
 So  it wasnt natural   fish oil  like I use and promote- clean codliver oil or clean om3  concentrate from clean factories in northern Europe and now even from Cape Town..  The R&P abstract paper cleverly doesnt mention  the brand Omega3  name- but Pfizer funded the trial…
Its the “top” journals  likely up to their  old tricks, publishing probable infomercials paid for in this case by Pfizer and mates,  without making that clear.
I cant see if these Italian trials used Lovza/Omacor or whatever  Big Pharma  chemically altered snakeoils.
But looking at the extensive debate already around Dr Topol’s condemnation of real fishoil  supplement,   many commentators  fell into the same trap- they didnt notice that  R&P didnt use fish oil, but about 850mg/day  ethyl esters of omega3.

Synthetic patent designer drugs dont do what the natural  food/supplement/human biophysiologic product  does.

   Ethyl esters eg ethinylestradiol, and xenohormones eg Premarin,  are  dangerously different from  estradiol.  Look at the controversy, the danger in using  altered natural products eg:
slowrelease niacin instead of natural niacin.
or  neurontin/lyrica or benzos  instead of natural  GABA to bind to the GABA receptors.                                                                                  or  anabolic steroids eg methyltestost instead of testosterone.         or methylprogesterone Provera instead of progesterone.                 or margarine instead of butter !.                                                             or  methanol  –   dangerously different from  ethanol;                        or synthetic substitutes for natural digoxin…      

or the Women’s Health Initiative- which through gross misrepresentation stopped many women from using beneficial physiological human HRT for 10 years, despite the bad design of the WHI that used  long-proven risky xenohormones (premarin, provera) at dangerous older age, while in the first 6 years it enormously benefitted women in the first decade after menopause.. .

It’s  dis-ingenouos of Messrs Rowen,  Topol  and Peskin  not to state this, that the R&P TRIAL  DIDNT USE FISH OIL..
Dr Rowen and Mr Peskin are heavily promoting their own PEO Parent Essential Oil  Brand of Omega6 plant oils. The evidence is that such combination is excellent benefit- but I see no science, no reason not to balance it with clean fish oil since this is now so deficient in general diet.
But surely Prof Topol is doing patients a huge disservice in backing the R&P trial in dumping fish oil  -when that trial didnt use fish oil, and makes no conclusion about fish ol?

I await the full  copy of the R&P study – which the NEJM mysteriously doesnt  make available on line as they usually do with any seriously important  new  study.. .

No-one doubts that good plant oils , good mixed diet have benefit.
there is no doubt that a few gms of fish oil a day have huge  benefit.
Its the balance that matters- and the avoidance of  smoking, sloth, adiposity, refined sugars and cooked animal fats that matters.
so I see no reason to change from taking/ recommending   daily  a tsp (or 4)   of codliver oil (ie about 800 – 3000mg EPA+DHA) ,
and olives/ mixed nut/plant/olive oils on salads/pasta etc ,
     and a tsp of DMSO, and  2 tsp coconut oil/day.
   A recent Australian paper analyses usefully the growing problem of dwindling resources and  the inestimable health importance   of marine  oil – but does not mention viable  marine  om3   synthesis. Like a cure for HIV-AIDS,  the latter  is an elusive  improbability.  .  There is still no objective independent eg  Cochrane review of  prescription omega-3-acid ethyl esters (P-OM3), despite Omacor being on the market for over 20 years .  Why is this?
      Wikipedia specifically notes that  Lovaza/Omacor  has not been shown to lower the rates of all cause mortality and cardiovascular mortality, or the combination of mortality and non-fatal cardiovascular events.[3]It is .. fishoil that has been  chemically altered”…  and the USA FDA still hasnt licensed such derivatives for anything but severe hypertriglyceridemia.   And the US Supreme Court banned patenting of any natural marine oil extract.  Whereas in stark contrast, unpatentable  natural marine omega3  EPA+ DHA–   clean  marine  oil- lowers all  major morbidity  from conception,  and all-cause mortality.

what say you?…




18 months ago a warning was published about   the risk of Negligence  Damages for  Prescribing Bisphosphonates- Fosomaxes- for common osteoporosis. 

 A year later an updated review of the evidence rebutted    the attempt by an Australian group (Phillip Sambrook  MD, BS, LLB, FRACP  ea )  to promote routine use of bisphosphonates, blame the news media for wrongly sensationalizing these largely unnecessary drugs’ rare but lethal  adverse effects. 

 Now three other eminent Australian professors, of   Oral and Maxillofacial Surgery and  Endocrinology  (Paul Sambrook, Chris Nordin and Alastair Goss) publish a further rebuttal  of Phillip Sambrook ea for serious errors in underestimating by at least twentyfold both the incidence and the seriousness of bisphosphonate risks.

 In  a USA case for damages against Merck,  for irreversible  osteonecrosis- resulting in jaw amputation-  following Fosamax, a patient was last year awarded $1.5million . This American class action is about over 1500 Fosamax cases against Merck.  So far two related case against Merck  have been  dismissed. But all such cases are on appeal. The robust American tort system may yet hammer Merck. .

 As recently as october 2010 Merck staunchly defends Fosamax’s safety for osteoporosis.

The FDA has recently added a warning about Fosamax-related thigh fractures.

But no evidence has ever been published that the catastrophic risk of bisphosphonates- however rare-  is justified for routine osteoporosis when

1.In common osteoporosis, Bisphosphonates have no multisystemic benefits  except for halving fracture risk, and

2.Appropriate combination of natural supplements- as this column has repeatedly revewed -approximately halve all risks ie of both osteoporosis fractures and all other common major diseases of aging, and thus chronic disability and deaths, without any significant risks.

Curent Authority statements eg from the Mayo Clinic simply fail to say this- why risk bisphosphonates?  New reports  in November-December of dozens of osteonecrosis cases on bisphosphonates  have just appeared on Pubmed  from Italy, Germany, Romania and Spain.

In fact a major international study has just beeen published showing the obvious, that survival in the elderly is strongly linked to gait speed and mobility. It is common cause that such integrated function is dependent on optimal joint, neuromuscular and cardiovascular integration- to which (- unlike the score of natural human micronutrient supplements that deplete with age-) bisphosphonates and strontium contribute nothing except bone density.

Fosamax lobbyists studiously avoid the plain  truth that it is not osteoporosis; but frailty – falls –  that is the chief cause of major elderly fractures- and that bisphosphonates and strontium may make bones appear denser.

Its too early to judge strontium ranelate (which also has rare but catastrophic risk- the DRESS syndrome); but fosamaxes in some cases  make bones more brittle; without in the slightest combating senescence frailty ie muscle, mobility, vascular, cancerous, arthritic, immune, mood, cognitive and neurological deterioration (unlike the multinutrient microsupplements – vitamins, minerals and biologicals like fish oil, chondroglucosamine, sex hormones which together halve all chronic major degenerative diseases and premature mortality) ..

August 15, 2010 Regulators like the FDA  and WHO the world health organization and  their worldwide equivalents are notorious for bowing to their chief funders- Big Pharma- in registering new designer drugs on the flimsiest evidence, often despite vociferous objection from some honest assessor at the Regulator; then waiting till there is an uproar of complaints over the drug before they belatedly demand more evidence of cost-benefit from the manufacturer, and admit that key adverse data were  suppressed from the outset- as happenened and is still happening most notoriously  in the case of aspartamate Canderal.

And what was obvious from the word go,   that  in the case of last year’s swine flu vaccines and the spurious pandemic declaration, the Regulators/WHO expert committees were  heavily loaded with biased specialists paid by  vaccine  manufacturers.

But why are the fosamaxes and other  bisphosphonates  still allowed to be prescribed  for osteoporosis? When the first report of long bone fracture associated with them first appeared on Pubmed 16 years ago (Guanabens 1994) and they are unnecessary -indeed contra-indicated – for osteoporosis.   Not for nothing does a  recent ABC Good Morning America broadcast   ask: “Fosamax: Is Long Term Use of Bone Strengthening Drug Linked to Fractures”?  

This review is in fact an update on The Fraud of Modern Medicines.

 A recent review from Oxford    lists the myriad adverse effects of bisphosphonates. They say “All four  currently approved nitrogen-containing bisphosphonates have a favorable tolerability and safety profile.” But why don’t they discuss the reality which is that although all these adverse effects  may be infrequent, why risk such serious  complications  such as 30% incidence of oesophagogastric symptoms?; oesophageal stenosis and cancer?, toxiderma, atrial fibrillation, eye, muscle bone joint pain?; or incapacity from jaw and teeth loss or  longbone fracture related to bisphosphonates for osteopororis?,  when bisphosphonates  are clinically unnecessary and unjustified for osteoporosis.

 Why dont they state the truth, that there are no head to head trials against the basket of proven natural supplements, comparing fracture and global benefits versus risks of bisphosphonates ? Most reviews eg Wikipedia say bisphosphonates are “ the leading prescription for osteoporosis”; but this is simply for the same reasons that statins are for lipidemia, angiotensin blockers for hypertension and sulphonylureas/ glitazones are for type 2 diabetes, and aspartame is for artificial sweetening- because drug companies market such hoped-for $billion rainchecks overwhelmingly, and fund no comparative trials against the gold standard old supplement basket that makes most hazardous modern drugs like statins, glitazones and bisphosphonates mostly redundant.

Filleul ea from Univ Mona, Belgium have just reviewed the world literature from 2003-2009, finding 2400 cases of BIOJ bisphosphonate induced osteonecrosis of the jaw. of these about 215 were not cancer cases. Such cases very rarely occur without cancer. So why risk them?

 So why does an Australian team bewail decreased use of the fosamaxes? Impact of adverse news media on prescriptions for osteoporosis:effect on fractures and mortality. Their statistical modelling is perhaps no more than promotion of bisphosphonates since it ignores the high number of adverse effects that bisphosphonates cause long term; and the major reduction in allcause disability and premature mortality that balanced appropriate supplements ( instead of bisphosphonates ) produce. Why would the lead author of so many papers- Professor Phillip Sambrook – promote bisphosphonate as the prime pharmacological prevention, and only calcium and vitamin D as the supplementary prevention of osteoporosis fractures?  when the evidence so strongly favours safe multisupplements including appropriate lowdose hormone balance as preventative against all major chronic diseases? Can a new-drug proponent who sits on the medical advisory boards of and has received speaker fees from Amgen, Merck Sharp & Dohme, Novartis, Sanofi-Aventis and Servier. be considered objective ? Their critique of the media for publicizing the potential disaster from bisphosphonates is hollow when they fail to mention the numerous potential risks, and the numerous benefits instead from supplements.

Geusens, Sambrook ea in 2008 published  a major review on Drug Insight: choosing a drug treatment strategy for women with osteoporosis-an evidence–based clinical perspective.. ‘The most important clinical determinant in the clinical choice of drug therapy for fracture prevention is a woman’s fracture risk; second is the evidence for fracture prevention in terms of spectrum, size and speed of effect. Other determinants include the potential extraskeletal benefits and safety concerns of the drugs.” But they again studiously avoid considering supplements (vitamins plus minerals plus appropriate hormone combination) as one of the drug regimes, especially as osteoporosis is simply one of the co-morbidities of aging, and far less of a risk for premature death and disability than stroke, cardiovascular, cancer, diabetes, frailty, dementia, arthritic disease and premature death – all of which can along with fractures be avoided and mitigated by the basket of supplements. So their review is surely biased in excluding all but new designer patent drugs while excluding the best and safe anabolics. .

 It is well proven from observational studies that longterm use of appropriate natural supplements reduce all-cause mortality by at least a third:              In the Womens’ Health Initiative WHI, appropriate hormone replacement HRT reduced all-cause mortality i.e. deaths from vascular disease, cancer and  fractures by 1/3 as well.    In the UKPDS the plant extract metformin reduced all-cause mortality also by 1/3. Understandably, metformin halves the incidence of new diabetes by reducing insulin resistance,  hence it also reduces fracture risk let alone cancer and vascular disease risk .   

 Incontestable data shows that epidemic deficiency  of vitamin D ,  vitamin C, magnesium, vitamin B especially B6,   vitamin K,    fish oil,    and prime hormone dysregulation  (thyroid, insulin,  cortisol vs androgens and estrogens)   in first-world aging populations are associated with increased mortality from all degenerative diseases especially fracturing, cardiovascular and cancer. It also showed that  vigorous supplements of balanced vitamins,  minerals (especially B,C,D,K, and Ca, Mg, Zn, Bo, Mn, Se, Cr), fish oil,  and human sex (co)hormones (testosterone, progesterone, estradiol, metformin) drastically reduce all morbidity and especially fractures  even  (perhaps especially )  in the well-off over nourished..  

  In contrast to bisphosphonates- which are aimed solely at reducing fracture in the at-risk elderly and thus reduce all-cause mortality by perhaps 10%-  these supplements in appropriate doses and balanced combination  reduce all-cause aging disease and preventable premature mortality by at least 50%, without any adverse risks. .  

Neville-Webbe ea (2010)  note that bisphosphonates have anti-cancer potential. So use it for terminal cancer fracture pain. Why use it for anticancer potential in those with just osteoporosis when the basket of supplements (including approriate HRT, vigorous dose vitamin D and if approriate metformin) gives safe  global protection against all the major aging diseases?

 Just the reduction in excess diet omega6 oils will mean that only 10% of the current necessary omega3 daily allowance (3.5gm) will be essential.  

 In 2007 a leading team from the International menopause Society  Genazzani ea  warned that “Recent controversies with hormone replacement therapy (HRT) have caused much concern in women and their health-care providers. As a result, the number of HRT users in USA has fallen dramatically. Consequently, the potential HRT-induced reduction in fracture risk is lost so that, in the next few years, we can expect an excess of 43,008 fractures per year in women aged 65 – 69 years. In addition, the recent evidence on the merits of early initiation of HRT on cardiovascular disease risk and neurocognitive function and the effect of type and combination of hormones on breast cancer risk now require an urgent review by the regulatory authorities of their recommendations about HRT.”

 Now – 8 years after the  debacle the WHI caused – the Endocrine Society has at last come out with a Position Statement admitting the grave consequences from the hysterical misinterpretation of the early release of the Womens Health initiative results in 2002-2004, especially in rising fracture and colon cancer rates from avoidance of appropriate HRT in menopausal women across midlife. . Let alone, as Genazzani ea said above and we discussed at international, UK and European menopause meetings in 2003-2006, the potential loss of benefit against breast cancer, heart, stroke, depressive, diabetic and neurocognitive problems.

 In conclusion: A major intervention is required from governments, world authorities  to reduce all-cause morbidity and mortality : by drastically curtailing the marketing and prescription of rarely essential prescription designer drugs like bisphosphonates, and strontium ranelate for osteoporosis;  by insisting on increasing universal intake of proven natural multisupplements that are increasingly deficient in the food chain for the poor,  for infants, youngsters and the multiplying  aging- in the latter, including appropiate HRT;  and by forcing the processed food industry to stop stuffing foods and drinks with not just salt  and aspartame but also fructose, sucrose, various growh hormones, and omega6 oils.

But neither Big Pharma manufacturers, governments, so-called independent regulators, nor university and private practice leaders or retail pharmacists will do so, promote evidence-based supplements over risky new drugs- there is too much money at stake from lost taxes. research funding, lower under-patent snake-oil sales and far less major disease and hospital admissions.

So it is up to patients and honest healthcare providers to insist that evidence-based supplements – not trading practice based on huge marketting and snakeoil preaching for profiteering – be prescribed for prevention/ managing the major diseases of aging including osteoporosis.


 5 June 2010. neil.burman@gmail.com 

Part 1: Transdermal better than oral estrogen for replacement: the importance of appropriate HRT.

part 2: Information warfare, Big Pharma, Appropriate HRT and the Doctrine of Deception.


The  health bite today from the BBC  correctly highlights one of the many critical reasons why appropriate routine Hormone Replacement HRT should be taken permanently  by any route  – but preferably transdermally, not as tablets.  In the appropriate low human dose HRT reduces the natural risk of stroke- and of the far more common chronic major diseases that cripple and kill – ie heart disease, cancer, fractures, dementia..

  But the Menopause Societies (South African, British  and  International) ie BMS , SAMS ,   IMS , and  the BMJ must promptly issue strong statements to the media condemning the BBC again for its typical misleading  elementary misreporting- in this instance  as regards progestins..  

 Transdermal and oral hormone replacement therapy and the risk of stroke: The source report –  this week’s BMJ –   describes HRT use in UK over about 6.7years among postmenopausal stroke victims mean age 70years (50 to 79) compared to matched controls without strokes. But the inexcusable error in the BBC report is that it twice mentions progesterone as being quoted in the BMJ study- which is nonsense.  The  BMJ report never mentions progesterone,  it repeatedly says progestogen -ie synthetics progestins since these were and are deliberately and wrongly routinely prescribed (instead of progesterone) for HRT due to manufacturer-led market disinformation.

  Progesterone is the original natural progestogen- but no major drug company promotes it, so it has been rarely used except by thinking women who prefer to use prime ie human – bioequivalent- hormones!  

In the adjusted risk statistics, lowdose transdermal estradiol TD replacement  0.025 to 0.05mg a day lowered stroke risk by 19%; whereas the average gynecologist’s  arbitrary  patent pharmacological oral  dose (20 to 40fold higher than the TD dose)  of  about 0.625 conjugated estrogens CE equivalent to 1 to 2 mg estradiol OET ) a day increased stroke risk by 35% . Thus, in contrast to lowdose estradiol  TD which reduced the natural stroke rate, OET  and highdose  estrogen TD  increased the stroke rate by 50% – 90%.  

COMPARISON WITH USA WOMENS’ HEALTH INITIATIVE WHI:  the WHI  showed that on premarin 0.625mg/d the absolute  risk of stroke in USA women age 50 to 79years was about 0.3% ie 3 cases per 1000 women per year -but about 45% higher in depressed women on antidepressants. And  depression is even  more common after midlife, especially without HRT. This cohort from the volunteer WHI trial  was a mean of 63years at enrolment ie 7years younger than the British real-life cohort; and since the risk of stroke approximately doubles with every 10 years of aging, the basic risk in the British study women may have been about 5 cases per 1000 per year or 33 per 1000patients over the duration of the British stroke and HRT study. ie annually 4 cases per 1000 on lowdose estrogen TD versus 6 cases per 1000 on OET 

Despite vast evidence  that physiological replacement doses of the human hormone progesterone (the original progestogen in humans) has endless benefits for older adults, doctors, government clinics and committees overwhelminglly still are lead by the marketing hype of drug companies (and the regulators  lobbyists and governments they fund) to use  drugs designed for profit  eg xenohormone progestens that they wish  were and falsely claim are as good as the original one that our bodies produce.

Truthful information  on HRT for women is widely and easily available from even Wiki    and the real authorities like the British and International Menopause Societies, and any university department of gynecology. .   Thus today’s BBC report reflects the BBC’s willful  neglect  of the most basic check of its facts before publishing health bites. In this case, it misleads women that  conventional combined oral HRT (in fact containing the synthetic progestin that most drug companies and doctors encourage women to take) is beneficial in somewhat lowering the risk of stroke  (never mind womb cancer) – whereas such synthetic progestins. progestogens   especially in oral HRT have numerous sinister other adverse effects  eg breast cancer and heart disease,  compared to the numerous proven benefits of  lowdose human progesterone. .

KEEPS: THE DEFINITIVE HEAD-TO-HEAD TRIAL OF APPROPRIATE HRT: ORAL vs NON-ORAL ERT WITH OR WITHOUT PROGESTERONE.: The small but definitive 5year KEEPS double blind randomized controlled trial RCT is now more than half way through and due to report in 2012, comparing the alternative regimes in women in the early menopause (10years younger and less overweight than in WHI) . “ KEEPS is a multicenter trial that will evaluate the effectiveness of 0.45mg of conjugated equine estrogens CEE Wyeth Premarin, a weekly estradiol TD Climara patch delivering 0.05mg estradiol a day -( both in combination with cyclic oral, micronized progesterone (Prometrium Solvay) 200mg for 12 days each month), and placebo”.

Recent information from KEEPS is that it is proceeding smoothly, with no significant differences so far between the three arms- no increase in serious adverse events has yet been seen by the Independent Monitoring Committee in the still unblinded results.  

 Wyeth (now Pfizer since 2009) is not crossfunding KEEPS, although they may be hoping that  their premarin in lower dose will prove to be as safe as or better than estrogen TD in the medium term.. But given the ~70year experience with oral HT mainly premarin 0.625mg/d promoting breast cancer increase (although not mortality) after >12-15years of use , it is remotely unlikely that even ¼ of the long-standard premarin oral dose will prove anywhere as safe and effective as parenteral balanced human hormones for permanent protection in aging women.  One hopes it is, to vindicate the insistence of so many doctors on still prescribing OHT for  even just the first 10 years of menopause,  despite so much damning evidence to the contrary (see this entire website of reviews).

SO WHY PRESCRIBE, RECOMMEND HRT PILLS FOR POSTMENOPAUSAL WOMEN? when hard evidence is that non-oral  balanced human HRT (appropriate estrogen, progesterone and testosterone) is far superior in both benefits and zero risks for women? Whereas it is common cause that conventional oral HT ie about 0.625mg CE or equivalent started at menopause increases the  early risk of dangerous deep vein thrombosis DVT; and  begins to increase the risk of breast cancer to above that of untreated women after a cumulative dose of about 2 – 3 gms oral estrogen – after 10 – 15years ie by prime post retirement midlife in the midsixties. It is only some compensation that other cancers, fractures, ischaemic heart disease, dementia and (breast cancer- and all-cause) mortality, are reduced by appropriate m0dest doses of such OET combined with appropriate progestin; but such regime increases the risk of DVT, gallstones and fatness frailty- increasing body fat with increasing muscle wasting due to collagen loss which also promotes increase in the natural tendency to fractures and urinary incontinence by the midsixties.

Promoters of oral estrogen, bisphosphonates, SERMS,  and strontium cleverly ignore the hard fact that by far the greater risk for aging fractures is not bone density but muskuloskeletal ie failing bone and muscle strength and global co-ordination – which bisphosphonates do nothing to promote, while estrogen and strontium nad SERMS  may promote bone strength but not crucial muscle strength, and SERMS double the laready very high rate of stress urunary incontinence. .

  American major authorities do anything to promote their own commercial interests.  so they have long given their drug regulator the FDA – which is unashamedly paid for by big pharma- unbridled licence to make nonsensical claims and draconian laws. And because drug companies fund the FDA and the lobbyists and legislators in USA to promote their  products, (in a $trillion disease industry – some 8% of American GDP) they have the vast profits to in turn influence medicines regulators and legislators throughout the world to follow their profitable lead.

So  only the FDA and regulators  decide what foods are good for people, what supplements (of microfood stuffs) people may take, and licence designer synthetics for human prescription after trials of only a few months in a few hundred subjects – but insist  that old proven nutritional remedies may not even be claimed to have any health, preventative and therapeutic benefits unless they have undergone massively costly controlled trials that Big Pharma will never fund.

 Their hypocritical deadly nonsense is then to use draconian measures to stop suppliers from making any health claims for even supplements that are well known to be gold standards for prevention and treatment eg fish oil and the scores of other highly effective and safe biologicals- minerals, vitamins, human (eg glucosamine, chondroitin, n-acetylcysteine, coQ10, arginine, carnitine, carnosine), and plant products- that are (co)-hormones, antioxidants, true anabolics, nitric oxide promotors, anti-inflammatories, antidepressants, memory and vision promotors, neurotropics, insulin sensitizers, antiatheroma, hypolipidemic , antimicrobial etc. .  

In fact they now proclaim that citizens may not even buy supplements, foodstuffs  or even legally prescribed compounded hormone creams made from legal components (as are all other prescriptions made by manufacturing pharmacists practicing alone or in Big Pharma), unless the FDA has proclaimed them safe, because “they have not been proven safe”.

 This despite the facts that most  enduringly successful prescription drugs  (eg reserpine, metformin, digoxin, the synthetic progestins) are derived from/ based on successful evolution of and human experience  with the parent supplement eg vitamin, mineral and other biologicals  (eg non-oral progesterone, estradiol, testosterone)  over thousands of years,   and millions of patient years experience  in the past >100years of scientific discovery. 

The Disease Industry- FDA-Big Pharma – organized medicine international network- proclaims that no claims may be made for the benefits of supplements (the vehicles, parents  of most prescription drugs in use) unless they have been tested in rigorous trials to the same standards as designer drugs are recently tested.  

Yet the FDA and regulators allow the marketing of generics- chemical identicals but often far from identical pharmacology and therapeutic action- without clinical trials. Where is the logic for the vendetta against supplement creams  like individually compounded bioidentical hormones that produce measurable physiological levels and appropriate relief?

 This despite the fact that millions of patients have been and continue to be  damaged (iatrogenesis that results in vast numbers of hospital admissions and deaths annually) the past 50 years by drugs promoted by the FDA at the pushing of Big Pharma, based on far too short poor and often fraudulent reports which the drug industry ruthlessly manipulates.

  This led to the disasterous use of stilbestrol in pregnancy from the 1940s to the 1970s;         to the disasterous registration and extensive liberal prescription – in many cases even promotion over-the-counter- of practolol, thalidomide,  chloromycetin and other antibiotics;     potentially fatal unnecessary patent anti-inflammatories  up to the Cox2   inhibitors (eg Vioxx, celebrex) as painkillers;  barbiturates benzos and antidepressants;   lately sulphonylureas and glitazones as firstline drugs for type 2 diabetes instead of the gold standard metformin; new antihypertensive drugs as firstline therapy instead of the goldstandard lowdose amiloretic plus reserpine; appetite-weight suppressants instead of metformin;  bisphosphonates for osteoporosis instead of the goldstandard combined dozen vigorous vitamins minerals and sex hormones that halve all major diseases; and statins for uncomplicated mild to moderate cholesterolemia  instead of goldstandard combined minerals vitamins  metformin and HRT.

  And the simple fact that drug companies  will no longer risk funding head to head trial of one of their profitable drugs against gold standard old drugs or supplements of proven great all-disease medicinal value; since prevention does not pay- only disease pays.

The cost of protectionism for the lucrative Big Pharma industry – for the sake of trade and taxes – is vast  as witnessed by governments sponsoring eg statin , H1N1 flu vaccines , modern antidepressants, bisphosphonates and nonsteroidal anti-inflammatories, and when each of these products of unproven benefit in mass use nets the manufacturers  obscene multibillion dollar profits- in the case of vaccines, with 100%  indemnity guaranteed them at taxpayers’ ie the consumers’  expense!

The lesson from the new UK  study of oral versus estrogen TD is that appropriate ie balanced physiological-dose  human sex hormones are the logical 1st-choice prevention and treatment for postmenopausal women (and their peer mates) – not the multirisk wannabe synthetic substitutes that  Big Pharma keep hammering on the public- new psychotropes, NSAIDs, Cox2 antagonists, statins, bisphosphonates which lack the multisystem benefits of physiological balance of evolution-evolved natural micronutrients ie nutriceuticals.

Part : 2. DOCTRINE OF CENSORSHIP and DECEIPT;   vs DOCTRINE OF TRUTH/… see next review above this.


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. .


This column last considered bisphosphonates BPN in February. This  reviews some new papers published since.

ADVANCED  CANCER with bone spread:  Recent major (Cochrane)  reviews confirm that BPNs may be  valuable in   advanced prostate and  breast cancer ,  for reducing skeletal events and maybe pain, although they   do not clearly  influence disease progression or patient survival.

OSTEOPOROSIS: It is now almost 5 years since the balloon went up on the unnecessary major risks of BPN for osteoporosis.  So anyone who was prescribed these dangerous drugs since then for osteoporosis, without the rare special  indications, and who develops BNP-related complications  (or osteoporosis-related fractures) has a strong case for heavy damages against the prescriber, the dispensing pharmacy  and regulator eg the State clinic or medical plan who/which advised/ allowed use of the drug for that condition. .

Bisphosphonates were invented over a century ago but developed over the last 40years  for clinical treatment of metabolic bone diseases,  with the first human trials reported about 35 years ago (Heaney 1976). Why have they been exhaustively tested and now routinely used for prevention and treatment of aging osteoporosis, despite their considerable cost especially risks, and lack of global benefit?

Obviously because as patented designer drugs they are profitable to the Disease Industry – despite the fact that their biggest section on Wiki is about their rare but major adverse effects- to quote Wiki :

  • Oral BPN can cause upset stomach, inflammation and erosions of the esophagus,
  • Intravenous BPN can give fever and flu-like symptoms after the first infusion. The  slightly increased risk for electrolyte disturbances is not enough to warrant regular monitoring.
  • BPN have been associated with osteonecrosis of the jaw – the mandible twice as frequently affected as the maxilla- and most cases occurring following high-dose intravenous administration  for cancer patients. Some 60% of cases are preceded by a dental surgical procedure (that involve the bone).
  • severe bone, joint, or musculoskeletal pain has been reported.
  • BPN  use ( zoledronate and alendronate) is  a risk factor for atrial fibrillation in women. The inflammatory response to BPN or fluctuations in calcium blood levels have been suggested as possible mechanisms..
  • Matrix metalloproteinase 2 may be a candidate gene for BPN-associated ONJ since it is the only gene known to be associated with bone abnormalities and atrial fibrillation, both of which are side effects of BPN.
  • Long-term BPN  use resulting in severe or over suppression of bone turnover especially at the  femur sub-trochanteric region.  Micro-cracks in the bone maybe  unable to heal and eventually unite and propagate, resulting in atypical fractures, which  tend to heal poorly and often require some form of bone stimulation eg bone grafting.

NO COMPELLING INDICATIONS FOR BPN IN OSTEOPOROSIS: the Wiki entries for BPN  and osteoporosis are cleverly written by BPN promoters / marketeers – they fails to justify  why BPNs are “the most popular first-line drug”… and the overwhelming evidence that favours combined natural supplements: eg that in the Womens Health Initiative, appropriate hormone replacement HRT ie started soon after menopause is safe up to 10 years of use, halved fracture rate and colon cancer, and lowered all other chronic major degenerative diseases AND breast cancer AND  premature deaths by a third.  BPNs have risks but no  benefits other than fracture reduction- ie for osteoporosis, no compelling indications  and the legal eagles are hungry.. .

BPN-ASSOCIATED OSTEONECROSIS IN LONG BONES: Guanabens from Spain first described long bone fractures related to BPN in 1994,  and more such cases (iatrogenic Toulouse-Lautrec disease) are reported now from the UK.

ATRIAL FIBRILLATION:   Denmark reports some 30% increase in potentially crippling atrial fibrillation in patients with fractures treated with BPN  – whereas it is common cause that appropriate supplements drastically reduce arrhythmia eg fish oil halves sudden death.

Italy now reports increase in hypocalcemia and raised serum creatinine ie kidney impairment after BPN  for cancer . . Sweden reports no benefit of 2 years’ BPN   on knee prosthesis migration. The incidence of metabolic bone disease and all other system complications in intensive care is notorious – and a   Princeton report gives no justification for BPN use in ICU when all the safe natural supplements are essential and ensure better protection globally..

Canadian study shows that ” managed intervention” after osteoporotic hip fracture prevented  4 new hip fractures and gained 4 quality life-years –   but the available abstract omits what the interventions were, and whether survival was increased.

And while all rational evidence-based appropriate prevention and treatment of osteoporosis – the permanent baker’s dozen of safe natural supplements- reduce all-cause chronic degenerative disease and mortality by at least a third, without any risks, – BPNs  have increasingly recorded risks both short term and long term, with no extraskeletal benefits, despite reducing the fracture risk (spine -Cummings 2002; hip Nguyen 2006) by up to a half.

OSTEONECROSIS OF THE JAW ONJ:   first reported in 2003,   only 26 cases of ONJ  on oral BPN could be found  reported worldwide up to Sept 2006  in a  2007 University Pennsylvania study . Only  15 % were men, and the majority involved the mandible.    Now Israel alone reports another 100 cases of BNP- related jaw osteonecrosis – fossy jaw  – and 16% were on oral BPN. The incidence of OJN is  speculated to be between 5% and 11% in cancer patients treated with BPN.

A world-wide  panel produced the  2008  Canadian Consensus Practice Guidelines for BNP Associated Osteonecrosis of the Jaw, but did not estimate  the incidence of ONJ.   It concludes  that “High-dose intravenous BNP have been identified as a risk factor for ONJ in the oncology patient population. Low-dose BNP use in patients with osteoporosis or other metabolic bone disease has not been causally linked to the development of ONJ”  “BPNs have become a cornerstone in the management of skeletal complications of malignancy as well as osteoporosis and metabolic bone disease, as these agents offer tremendous benefit to those with malignancy or metabolic bone diseaseDue to limited and misleading public information regarding ONJ, many patients have discontinued  BPN treatment, resulting in inadequate care of the underlying skeletal condition.”

But the Canadian Consensus paper fails to clarify in what way BPN offers “tremendous benefit” to those with osteoporosis? The  consensus of the majority of practitioners who do not recommend BPN for osteoporosis is that evidence still shows that appropriate HRT with other standard supplements is  the best prevention and treatment not just of osteoporosis but of all the common major degenerative diseases of aging. (The International Menopause Society). This eternal truth and aim- the wellbeing of seniors- is the imperative, not the wishful thinking of Big Pharma to replace natural supplements with designer magic bullets for each disease.

By far the most comprehensive and objective review is  the American Association of Oral and Maxillofacial Surgeons   Position Paper January 2009 Update on Bisphosphonate-Related Osteonecrosis of the Jaw BRONJ: Indications and benefits of BPN therapy:

Intravenous (IV) BPN are primarily used and effective in treatment and management of cancer-related conditions including hypercalcemia of malignancy, bone metastases such as breast, prostate and lung cancer, and multiple myeloma- for which the clinical efficacy of IV BPN  is well established.

BPN have not been shown to improve cancer-specific survival, but they have had a significant positive effect on the quality of life for patients with advanced cancer involving the skeleton.

Oral BPN: By far the most prevalent and common indication is osteoporosis and  osteopenia. They are also used for a variety of less common conditions such as Paget’s disease of bone, and osteogenesis imperfecta of childhood.

INCIDENCE OF BRONJ: Based on case series, case-controlled and cohort studies, estimates of the cumulative incidence of BRONJ range from 0.8%-12%.

ORAL  BPN BRONJ: Surveillance data from Australia estimated the incidence of BRONJ for patients treated weekly with alendronate as 0.01-0.04%. In a survey study of over 13, 000 Kaiser-Permanente members, the prevalence of BRONJ in patients receiving long-term oral BPN therapy was reported at 0.06% (1:1,700).

Demographic and systemic factors:  In the original Position Paper, age, race, and cancer diagnosis with or without osteoporosis were reported as risk factors for BRONJ. Seven studies report increasing age as consistently associated with BRONJ. Sex was not statistically associated with BRONJ.  Other systemic factors or conditions, i.e., renal dialysis, low hemoglobin, obesity, and diabetes, were variably reported to increase the risk for BRONJ. Malignancy type was not statistically associated with an increased risk for BRONJ.

Genetic factors: Sarasquete et al, demonstrated that genetic perturbations, i.e. single nucleotide polymorphisms (SNPs), in the cytochrome P450-2C gene (CYP2C8) gene were associated with an increased risk for BRONJ among multiple myeloma patients treated with IV BPN.

Preventative factors  The AAOMS Taskforce on BRONJ recommended that patients undergo dental evaluations and receive necessary treatment prior to initiating IV BPN therapy.  In addition, given the long-term biologic activity of IV BPN one may hypothesize that different dosing regimens may be equally effective and decrease the risk for BRONJ.

Using a retrospective cohort study design, Coso et al, evaluated the BRONJ and skeletal-related events  e.g. pathologic fracture in multiple myeloma patients using different dosing schedules for zoledronate. These findings suggest that alternative dosing schedules that reduce IV BPN exposure have comparable outcomes in terms of preventing SREs and a decreased risk of BRONJ.

The effectiveness of hyperbaric oxygen therapy as an adjunct to non-surgical and surgical treatment is under investigation at two institutions where a randomized controlled trial is underway. Preliminary results have shown some improvement in wound healing and long-term pain scores, but its use as the sole treatment modality for BRONJ cannot be supported at this time.

Yet despite the fact that osteoporosis and fractures are closely related to and occur along with the major causes of aging disability and premature death – 20% of osteoporotic hip fracture victims die within a year- BPNs have not been shown to reduce any let alone all the other aging diseases let alone premature deaths. The closest a study came to assess the issue was a Singapore analysis of the  30year old clodronate used for up to 2-3 years after breast cancer  – which drug showed no influence on overall survival.

This failure of global benefit of BPNs – which are  in fact never indicated except rarely eg as palliation in preterminal cancer bone lesions – raises the question of criminal negligence when doctors prescribe and medical schemes and Regulators allow BPN use for osteoporosis. Why are BPNs allowed and prescribed when they have no global benefit but numerous serious risks; and when conventional lowcost natural supplements combined do nothing but global good.   eg essential fish oil, essential vigorous-dose blend of vitamins-minerals-biologicals-herbs, essential appropriate HRT , and essential galega-metformin in the overweight let alone obese each lower all-cause chronic morbidity  and death by a third to a half.

It is no defence that adverse effects are rare when  they are  sometimes deadly, and never worth the risk of these drugs since there is rarely overwhelming need to prescribe such drugs- for which there are safe  natural and far more effective alternatives.

CASE REPORTS: In 2007 we saw a well-built  physically active woman of 61years, whose bone density had fallen some 9% on regular DEXA screening  since menopause despite the usual calcium-vitamin D supplement. In 2008  she  decided to delay HRT because of  strong family history of breast cancer. A year later at followup DEXA  on just fish oil plus a modest dose of the standard HealthSpan For-Bone  supplement blend (calmag zinc boron manganese; proline; and vits B6-9-12 – C- D3 & K2), her DXA BMD has risen 2% (2.5% at the spine, 1.5% at the hip).

A small slim 61year old bookkeeper presented a year ago on just calcium &  vitamin D, her 2007 DEXA spinal density 0.99 having fallen 1% from  2005 ie T -1.6  but her hip down 6.3% from 0.792 to 0.764 ie T-2.  Since then, on the Bone Blend and a little estrogen-progesterone-testosterone cream daily, her spine has stayed constant but her hip BMD has risen 2.4% to 0.783.

A new review from Toulouse France has the last word: “Postmenopausal osteoporosis is a chronic disease which justifies long-term treatment.  Efficacious available modern  fracture-reducing drugs raise the question of the best treatment strategy in postmenopausal women .    In this regard, HRT, which allows a more global approach to the menopause-induced consequences of hormone deficiency than the sole prevention of osteoporosis,  should be privileged… Use of BPN or strontium ranelate should be thus (at best) be reserved for a more advanced age, when the prevention of hip fracture becomes mandatory“. .

Yet, because it is profitable, the fashion grows to treat the elderly with grossly expensive designer oral strontium, or designer injections of BNP or hormone analogues (of calcitonin or parathormone) – despite the fact that these experimental agents have no extra-skeletal benefits (ie improving cardiovascular, muscle, immune, brain function),  have never been tested in longterm studies  for at least 6-10 years to test their safety as has eg HRT in the Nurses’ and WHI studies.

But millions of years of bipedal evolution, and numerous studies over the past century, show that all that is required to  maintain maximum mobility, mind and mood to enjoy life is lifelong supplements as listed above, appropriate to youth, parents, the middle-aged and seniors.. including healthy seniors’ sexuality. It is  too late postponing  prevention  till wished-for healthy advanced age- which most do not reach due to early demise, or irreversible crippledom from largely avoidable fractures, strokes, heart failure, arthritis, or dementia.

The Israelis’ maxillofacial team lament that “Solutions for decreasing morbidity and poor outcome of ONJ remain elusive.” The answer is painfully obvious: avoid iatrogenic ONJ by avoiding  BPN -even orally- except for advanced cancer with bone metastases, but back up lower dose  BPN  with all the  anabolic supplements.

A risk of “only” 7 in 10 000 may reassure a patient being offered BPN for  osteoporosis- but if she decides to sue for damages for prescription of totally unnecessary hazardous therapy, the prescriber doesnt have a leg to stand on when the gold standard is appropriate titrated supplements (including HRT)  without risks since  they reduce all risk by at least one-third.

As  wise Chinese taught 2600 years ago, Society, Authorities, Regulators, health professionals have a sacred obligation to above all else prevent avoidable premature death and crippledom with the freely available and low-cost well-proven natural supplements. These must prevail despite the best efforts of Big Business, Big Pharma and their academic and political lobbyists (Governments, Regulators) worldwide to ignore if not outright suppress safe effective old natural  supplements  (as the FDA and EU are doing) in favour of Diseases and Modern Drugs that Pay – but do not reduce all-cause  disease and mortality .