Tag Archives: sibutramine

WIKIPEDIA IS INVALUABLE, BUT BEWARE IMPORTANT BIAS IN IT’S CHRONIC DISEASE ARTICLES PART 1:

Wikipedia is now the top and invaluable reference source for the public.

Wikipedia entries are commendably frequently updated; but this does not mean that the entries are both up to date, objective and unbiased, since they are constantly being altered by conflicting outside editors.

We suggest amendments in  Wiki  health entries where appropriate as follows.

It will obviously have most effect if the recommendations to Wiki are based on consensus by the relevant international leaders- eg the International Society for Aging Males ISSAM, the International Menopause Society IMS, the International Pediatric Association, and so on; NOT by drug companies and their product promoters including individual disease associations (which by definition do not take a holistic multisystemic  view) or private and academic national groups whom/which drug companies sponsor/influence- including the problem of ghost writing! Many entries on Wiki appear to suffer from this problem of vested interests.

INTRODUCTION: EBM:

The Wiki article on EBM  Evidence-based_management ie  Evidence-Based Medicine hits the nail on the head. Medical diagnosis and treatment need to be evidence- based- but as the heretical pioneers Shaughnessy and Slawson stress, this must be POEM- patient-orientated evidence that matters. However, for the Drug Industry and their state arm  the USA FDA, the chronic major degenerative diseases are the biggest money-spinners since they arguably need lifelong drugs. Hence the Disease Industry  has invented epidemics of chronic diseases that were regarded as inevitable or self-induced until drug companies came up with designer drugs for each new  disease to medicalize – eg  epidemics of erectile dysfunction, mild to moderate hyperlipidemia, anxiety, mild-to-moderate depression, mild PMS and menopause syndromes, smoking, alcoholism,  and so on. Then  they and the FDA  generated trials and procedures  testing these patients with new “diseases”, and convinced the public that despite clinically insignificant benefits in trials often lasting well under a year, tested against only placebo,  the drugs could be registered  for chronic use even though there were long- proven natural remedies that did as well or better. They (their well-paid researchers, statisticians and often professional spin writers) then produce and pay for publication of  drug  trial reports claimed to be favourable, even though the evidence is weak or in fact adverse. . And the FDA is at least consistent- it still allows American chronic drugs to be thus launched with  only short trials, without head-to-head comparison against proven remedies – but blocks dubious foreign drugs like rimonabant..

Hence in our lifetime we have seen the rise and spectacular  fall – fatal for many patients- of many trumpeted medicines – of  stilbestrol, anabolic steroids, practolol, thalidomide, ticrynafen, barbiturates, antidepressants, fenformin, Vioxx, benzbromarone, troglitazone, cerivastatin, antiarrhythmics, phenfen, and antiplatelet drugs. And the Bush Administration recently forced through legislation immunizing the drug industry against claims for  damages from failed drugs! Mostly me-too drugs whose sole need and purpose was to create profit for industry for a few years before complications force their disappearance. This indeed is the FDA – Drug Industry’s  60  year commercial War Against Humanity (Elaine Feuer)  and compassion, Al Gore’s The Assault on Reason, Naomi Klein’s Disaster Capitalism, Ivan Illich’s Medical Nemesis.

The FDA-Disease Industry (and medical schemes)  then calls this sham  process  EBM, and denies the same recognition to long proven  optimal remedies  eg parenteral human HRT because there is no need, and no sponsor, to do long-term trials on natural remedies long-proven in clinical practice studies. The only “designer” drug – metformin- which is in fact a simple tagged plant extract-  that has ever been subjected to a 20 year trial  was effectively kept  off the USA market until the  trial was nearing completion in the mid-1990s – ie metformin in the UKPDS, which proved to be the only designer drug ever that almost  halves both all mortality and all chronic major degenerative diseases including type 2 diabetes. And still the FDA demanded a 10-000 patient one-year trial  – COSMIC- to prove the safety of metformin- after all, it was a Scottish invention and long-proven European drug, thus not to be trusted because it was not invented in USA. As if the Americans were not of recent European origin.

Similarly, the FDA (and the British)  embargoed/derided  lithium- the gold standard drug against bipolar disease- until 1970, forcing Mogens Schou to do an unethical double-blind withdrawal trial on stabilized patients to prove it’s efficacy – 100% of whom relapsed within 6 months on placebo, and restabilized back on Lithium. .

Hence all drug study and trial reports, especially for  registered drugs – however prestigious the journal and origin- have to be examined carefully to see if they were done without bias/spin to paint the new drug in a rosy light. The Womens’ Health Initiative most certainly was not unbiased despite the close to $1billion cost – it scandalously failed to test Wyeth’s two xenohormones against the gold standard, human estradiol and progesterone. Similarly, the statins for mild-to-moderate hypercholesterolemia  have never been tested head to head against the only drugs that reduce all-cause morbidity and mortality by 1/3 to 1/2- metformin, fish oil, appropriate balanced human hormone replacement, and a blend of effective safe doses of all the beneficial minerals, vitamins and biologicals including some herbs.

Similarly, the Viagra trials were fraudulent- they excluded men with frank hypogonadism (since Viagra will not work without testosterone priming). But Pfizer  and the FDA also colluded to refuse to disclose, publish the testosterone levels of men enrolled in the Viagra trials- when it has been known since the early 1980s that there is a dose-response correlation between erectile function up to a plateau above a serum testosterone of about 4.5ng/ml 16nmol/L -.1982 Salmimies ea. It turns out from other Viagra trials that the serum testosterone of trialists was around 13.5nmol/L.. So most of the men using Viagra/Cialis  did not/do not  need 2 Viagra tabs a week costing hundreds of dollars a month (as the NHS was conned into providing), but a conservative shot of depot testosterone perhaps 160mg every fortnight at a cost of below $5/month- with far more multisystem benefit, and none of the deadly risks (sudden death or stroke or blindness) of Viagra.

The Wiki article on erectile dysfunction dismisses testosterone deficiency as being a rarer cause of erectile dysfunction, but fails to mention the obvious, that partial androgen deficiency ie a serum testosterone below the mid-range -ie average- often responds to adequate depot injection trial of testosterone to elevate the blood level into the mid range of healthy young men (not just the range of elderly men, as is so often done).

Such is the power of fraudulent drug company deceit in collaboration with Regulators.

It is hollow hypocrisy that the UK has now introduced a regulator of alternative practitioners- but neither the USA, UK nor  other governments  have ordered their Medicines Regulators  to drastically restrict many of the scheduled drugs discussed below (and a few risky complementaries like black cohosh and kava) when there are far safer proven  alternatives. Manufacturers and Regulators themselves are certainly not going to do this- not when their  raison d’etre is well-paid screening and registering as many new drugs as possible, not policing old drugs.

PART 1: THERAPY OF COMMON MULTISYSTEMIC DEGENERATIVE DISEASES OF AGING:

1.1 Hypercholesterolemia and statins

1.2 Osteoporosis and Bisphosphonates

1.3 Hypertension and antihypertensives

1.4 Diabetes type 2, Obesity, metformin and other weight-reducing drugs.

1.5 Pain, arthritis and NSAIDs.

1.6 Fish Oil

1.7 MULTIPLE DESIGNER DRUG INTERACTIONS

PART 2: SEX HORMONES see next publication.

1.1 Under hypercholesterolemia wiki says “statins are the most commonly used and effective forms of medication for the treatment of high cholesterol”. But the wiki entries on statins, cardiovascular disease and hypercholesterolemia, and Pubmed, give no evidence to justify statins’ heavily marketed primary use in mild-to-moderate hypercholesterolemia and diabetes, no reference that shows they are as good and safe as the old proven combination of natural evidence-based remedies – vitamins, minerals and biologicals (including appropriate eg non-prescription fish oil, carnitine, CoQ10, arginine, ribose, carnosine,  galega officinalis- metformin, and appropriate sex hormone replacement).

It is metformin and appropriate HRT, not statins, that reduces both cardiovascular and all-cause deaths by at least a third, and meformin that halves the incidence of new diabetes when used preventatively in the adipose with insulin resistance etc. It is metformin, not statins, that merit marketing over the counter:  in sensible use imetformin is totally safe, unlike unregulated poisons like cigarettes, alcohol and  sugar.

None of the vast statin trials show that statins do any good other than lowering CVD risk by a third. So it is a blatant dangerous lie to state as Wiki does that “statins are the most effective medication for treatment of high cholesterol”- this claim certainly does not apply to the universal common mild to moderate hypercholesterolemia MMHC. Familial or secondary severe hypercholesterolemia justifying statins is generally rare; and  the indolent overweight/ diabetics with MMHC have enough problems with diabetic cardiovascular disease, neuromyopathy,  and osteoporosis without the added risk (fatigue; myalgia; hepatorenal; depressive; sexual; skin; respiratory impairment; and cancer associated with severe hypolipidemia) of statins, when metformin and the other antioxidant insulin-sensitizing supplements like appropriate HRT are safe and far more effective across the board – and do not deplete and antagonize  crucial and very expensive CoQ10 as statins do..

1.2 Under bisphosphonates, wiki says “In osteoporosis, alendronate and risedronate are the most popular first-line drugs. If these are ineffective or the patient develops digestive tract problems, intravenous pamidronate may be used. Alternatively, strontium ranelate or teriparatide are used for refractory disease, and the SERM raloxifene is occasionally administered in postmenopausal women instead of bisphosphonates”.

But popular does not mean most effective or safe. Wiki quotes no sources to prove that bisphosphonates- now with a notoriously long list of complications – or the designer drugs mentioned are anywhere near as good and safe for osteoporosis and all diseases of aging as the baker’s dozen of appropriate human HRT, vitamins and minerals. The popularity of bisphosphonates, premarin, statins and SERMs is obviously based simply on heavy marketing.

1.3 ANTIHYPERTENSIVES: the Wiki entries for hypertension, antihypertensives and reserpine are in total conflict – for the obvious main reason that the main entries are written by those sponsored by new-drug companies. On the other hand, Wiki says correctly under Reserpine: “it is one of the few antihypertensive medications that have been shown in randomized controlled trials to reduce mortality… In some countries reserpine is still available as part of combination drugs for the treatment of hypertension, in most cases they contain also a diuretic.”  see Pubmed  for at least a dozen such landmark studies.  It was confirmed as recently as the SHEP(1995) and ALLHAT (2007) trials that combinations containing reserpine are the best for resistant hypertension. And numerous trials up to the 1990s showed that lowdose reserpine plus a lowdose diuretic is as good as any more modern drug for mild-to-moderate hypertension. And trials show that lowdose thiazide diuretic plus a potassium-sparing diuretic eg amiloretic is better than a thiazide alone, and such combination was the only drug regime  associated with halving of dementia in the Cache County study.

It has been established for decades, and we see in hypertension practice every day, that the best results, with zero adverse effects, are with low dose of reserpine eg starting with ½ a reserpine tablet (ie 0.125mg/day) and half an amiloretic tablet (ie 27.5mg/day); usually reducing to ¼ of each tablet daily after a week. In many cases the dose can be reduced to 3 times a week because amiloretic has a gentle action over 24hours, but reserpine over weeks- so (unlike with modern drugs) forgetting the occasional dose does not matter. It’s cardioprotective, bone-protective and antianxiety benefits persist, with neutral effect or benefit on the metabolic and allergic and oedema  problems that abound with modern regimes.

But under Antihypertensives and Hypertension, this optimal regime is barely mentioned to be condemned – because it is old-fashioned, and the most effective therapy for mild to moderate hypertension. But it costs as little as $0.50 a month in eg South Africa, 1/300th of the price of an inferior designer combination like Prexum Plus. So it was removed from state codes in eg UK, Europe and South Africa precisely because it is too cheap and too good, it drastically reduces revenues from modern drugs. This despite the fact that this optimal combination has not been tested as first-line therapy against any modern drug- trials up to the 1990s showed that it was too good, so no drug company dare allow head-to-head trials again. And Regulators and involved politicians simply ignore these hard facts since their massive incomes depend on promoting modern, not old, drugs.

1.4 Antidiabetic and anti-obesity drugs: Wiki correctly says “Metformin is usually the first-line medication used for treatment of type-2 diabetes.” In practice, it is always the first line drug in a new type 2 diabetic since such patients invariably have excessive visceral girth and body fat if not rising BMI (above about 23kg/sqm except in a gymnast/athlete). But Wiki then perpetuates a disinformation myth: “Initial metformin dosing is 500 mg twice daily but can be increased up to 1000 mg twice daily”. This is nonsense, the reason why so many patients drop out of metformin trials and treatment, since perhaps half of us ( especially smaller people) are genetically slow metabolizers of metformin. . Metformin must simply be started at very low dose eg ¼ tablet (125mg/day), and adjusted upwards every day or two to tolerance- avoiding more than reduction in appetite and loosening of stools… with this simple approach, whether for diabetes control or, far more important, for obesity-diabetes and polycystic ovary syndrome prevention , the average tolerated dose is about 2.5 to 3gm a day in split dose (except with the new sustained release tablet). .

Wiki then says “metformin is also available in combination with other oral diabetic medications.”- but this is also dangerous marketing hype, such fixed combinations are to be avoided at all costs  since combination of metformin with any other antidiabetic drug both brings the disastrous risk of hypoglycemia, and neutralizes some of the benefits of  optimal dose metformin combined with optimised diet and lifestyle.  This is the heart of the reason not to delay metformin till diabetes- neurovascular- pancreatic disease is established, by when sometimes irreparable damage – glycation – is common, with irreversible eg kidney, nerve, eye or heart damage.

Wiki correctly states that the French drug  rimonabant was soon abandoned, and never released in the USA. And under Obesity Wiki indicates the adverse effects and lack of longterm safety-efficacy data that confirm why orlistat and sibutramine have no place in overweight-obesity-diabetes prevention and treatment when metformin is by far the best proven. .

1.5 NSAIDS NONSTEROIDAL ANTI-INFLAMMATORY DRUGS: The Wiki entry is pretty good except that it ignores the obvious – not only are these drugs poor analgesics, little better than the old paracetamol Tylenol, but they also have major risks- not just gastrointestinal bleeding but also heart and kidney failure, dermatoses and sudden death. Wiki discreetly omits to mention that there are many cheap proven old supplement NSAIDs  that in combination do better without risk (eg MSM methylsulphonomethane; vitamins (B3, B5, C, D); curcumin; cat’s claw, boswelia, bromelain, arnica, fish oil) than the problems of aspirin and the other myriad patent NSAIDS; and that, trauma aside, NSAIDS do nothing for the cause ie the underlying disease.

And there is no evidence whatsoever to support the for-profit rationale for promoting use of the NSAIDS- that they (even ibuprofen) are any better or safer short-term or long-term than judicious appropriate use of paracetamol+-codeine, or natural supplements eg judicious appropriate steroids- whether corticosteroid, secosteroid (vitamin D3) or sex steroid SHRT eg estrogen and testosterone. Detailed referenced reviews the past year on each of these topics are published below.

1.6 FISH OIL: Coyly, the only NSAID that Wiki lists under “other” is omega 3 – which actually reduces all major degenerative diseases and mortality by 20 to 50%…

But Wiki certainly gives full credit to the myriad health  benefits- and lack of adverse effects- of fish oil -EPA+DHA – in appropriate dose.

1.7 MULTIPLE DESIGNER DRUG INTERACTIONS: The older we are, the more likely we are to suffer from multiple chronic diseases, the more likely we are to be recommended different drugs for each disease- especially if we shop around consulting a doctor per disease. In particular, the use of multiple designer and synthetic drugs that interfere with normal metabolism is high risk- and becomes higher in older people who are prone to combined degenerative diseases like osteoporosis, muscle frailty, vascular disease, diabetes, anxiety, depression, arthritis and infections.

Eg there are on Pubmed since 1992 at least 6 reports on serious bisphosphonate – induced dermatoses, and 9 on statin dermatoses. . Statins are notorious for causing insidious myositis- especially with antibiotics; and there are reports of myositis-arthitis with bisphosphonates.   Statins can cause interstitial pneumonitis, fatigue and  weakness; bisphosphonates can contribute to lung problems via reflux, antihypertensive drugs via bronchial irritation. NSAIDs cause gastritis, oedema, hypertension, heart failure. the modern antidiabetics and antihypertensives  can aggravate heart failure. Yet doctors who advise against any HRT and other medicinal supplements frequently prescribe statin, bisphosphonate, NSAIDs, modern antidiabetics, antihypertensives  and periodic antibiotics together. This is criminal, since these drugs are mostly  unnecessary in either mild-to-moderate lipidemia, or osteoporosis, or arthritis, or hypertension, or  type 2 diabetes.

In conclusion, especially as specialists  (except for the old-fashioned increasingly rare general practitioner and the specialist in general internal medicine) tend to be increasingly specialized in one niche organ system or area of medicine ( but not in comprehensive and preventative care) , it is obvious that for serious illness, the patient is advised to study personally the latest illness advances  remedies and problems. But for researching health matters, the public is advised to use the websites of international multidisciplinary expert associations eg ISSAM- the International Society for Aging Males; IMS- the International Menopause Society; and  Medline- Pubmed;

rather than those which are prone to commercial or academic  bias (by local vested/ financial  eg drug/ equipment company/institutional interests) like Wikipedi,   universities, patient support associations,  the FDA/NIH, other National Health Services,  private practice  and craft groups,  or patient’s or lay associations’ reports and advice; especially the mass media which are especially open to marketing hype and sensationalism, and which with publication deadlines and bias to sensationalism, bad or lurid  news,  seldom succeed in tracking down objective unbiased expert opinions.Like Only Disease Pays, Only Bad News Pays.

And once disinformation is published, the media  (unlike Wikipedia) rarely bother to give equal time to  or opportunity for correction of misinformation- eg withdrawing bad information from websites. Which is not to say that old ideas should be deleted from the internet- they should just give the date of last update, and indicate if they are outdated.
Wikipedia health articles should be depended on only if they are certified by international multidisciplinary consensus bodies (of specialists and family practitioners)  like ISSAM and IMS.; or if material facts are referenced to a verifiable expert source. For the reasons stated, neither trials, reviews, metanalyses or “expert opinions” – even on Pubmed- are necessarily reliable evidence.

Detailed reviews of all these topics have been published the past year below on this column.

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SLIMMING DRUGS CANCELLED.

Evidence-based  reviews hereunder   have  warned since April ie for 6 months of the obvious  fraud of  modern touted designer appetite-weight suppressants (which among other adverse effects often cause depression if not suicide)
.
The Sanofi-Aventis drug  rimonabant was turned down in USA in Feb 2006,  June 2007 and again April 2008, based on lack of efficacy and safety.
 
The question remains: why prescribe new designer drugs  especially for overweight and type 2 diabetes with diet-resistant overweight, without a long trial record of both safety and efficacy,
when metformin and it’s parent herb galega officinalis  titrated simply to tolerance has been the proven gold standard for centuries,  losing on average 6% of weight (up to 20kg in 2yrs) and halving the incidence of new diabetes, while  in diabetics it almost halves the death rate and most major chronic degenerative  diseases of aging.
 
Based on the clear published evidence  (of risk, and lack of long term benefit from rimonabant, and abundant evidence of the superiority of metformin)  on which rimonabant was never  licenced in USA ,  patients who were prescribed rimonabant in 2008 have a prima facie case for damages against both European Regulators, the NHS  and doctors there who prescribed it.
 
and this month, for similar reasons, the Merck clone taranabant crashes out. 
 

The for-profit Disease Industry and the  researchers and Regulators they pay will  never stop trying to promote the profitable new over the proven  cheap old. So it’s up to consumers- the public- to seek out the evidence for themselves.

 Fenfluramine / Phen-Fen/ Ponderax crashed a decade ago after lethal complications  .

Orlistat (foul faecal problems) and  sibutramine(hypertension, nausea/vomiting, palpitation, and sweating) have major potential adverse effects, and do not do as well as metformin for longterm reduction in all-cause mortality and major adverse outcomes.

now   Anti-obesity drug use suspended 23 Oct 2008 
The European Medicines Agency  is recommending doctors do not prescribe the anti-obesity drug rimonabant, also known as Acomplia – it says the risk of serious psychiatric problems and even suicide are too high.

 

Why accept  risky mediocre  new drugs  (sibutramine, orlistat) or risky bariatric surgery (40% complications in first 6 months) when only metformin simply adjusted to tolerance  has been shown for decades to reduce all-cause mortality by at least 1/3 to 1/2, and even reduce cancer incidence.

 Tesofensine  seems similar to sibutramine in it’s potential to increase bloodpressure, dry mouth, nausea, constipation, hard stools, diarrhoea, and insomnia. But the longest trial so far seems to be only  24 weeks.

 

Most importantly, it is medical negligence to wait for frank obesity,  instead of early prescribing metformin to tolerance  to prevent progression from mild overweight  to obesity, diabetes, vascular disease, depression and cancer.