Tag Archives: FDA

THE FDA GLITAZONE- ACTOS, AVANDIA- DISASTER CONTINUES.

neil.burman@gmail.com   

         The subservience of governments- led by Big Pharma’s protector  the FDA- to profit rather than patient interest is well shown in the ongoing protection of the glitazone antidiabetic drugs and their manufacturers GSK and Eli Lilly 

How much more clearly does the chairman of the  recent FDA Joint Committee have to state it, that these drugs have no distinctive role and should be banned, or reserved for last ditch trial of therapy under special regulator approval? 

It is revealing, as Dr Rosen says, that the USA Govt FDA (to this day in August)  still refuses to put patient benefit as the top priority- ie submissions for new drugs, and ongoing licencing of drugs, must depend primarily on  both evidence of need ie proven benefit of the new drugs at least equal to that of older or natural remedies, and more obviously on  low risk- ie low cost:benefit ratio compaed to proven drugs

How many of the FDA review committees who voted to retain Avandia  -other than Prof Capuzzi – had vested interests in the manufacturer (GSK)?

Where is the evidence to support anything but metformin titrated to tolerance,  and other natural insulin sensitizers which reverse weight gain, fractures, cancer and cardio/vascular diseases ( eg alphalipoic acid, carnitine, vitamins A to K,  lecithin, coQ10, ribose, fish oil, stevia, cinnamon, garlic, gymnema, coleus, fenugreek, curcumin, ginseng, melatonin, inositol, aloe, sutherlandia, cayenne,  acetylcysteine, and approriate chromium, magnesium, HRT etc),  as the only allowed and mandatory baseline drug therapy for type 2 diabetes? until this proves inadequate?

Never mind  glitazones  increasing the risk of dying from heart disease, at least 13 reports on Pubmed have appeared since 2005 on the link between rozglitazone and vision loss – more than doubling the risk of macular oedema. .

 With so many antidiabetic multiprotective natural remedies to choose from and simply combine against the now  chief self-inflicted degenerative killer , it is criminal to allow doctors to prescribe and pharmacists to dispense snakeoils like glitazones except as desperate last ditch.

Since these drugs’ manufacturers- GSK and Eli Lilly -are based respectively in UK and USA and are major money-spinners for those governemnts, naturally those governments will delay canning  these drugs for as long as possible. Its like banning smoking, or jailing and withdrawing drivers’/ gun  licences from those who drink and drive- permanently  

Who cares how many patients suffer and die when the ruthless manufacturers provide  handsome taxes, jobs, ‘research’ and advertising  money and lobbying fees?

At least in South Africa, the human rights Constitution and the Consumer Protection Act compel regulators and healthcare providers to ensure that such unnecessary and risky drugs are not routinely prescribed.  Yet a glance at Google shows that the South African media -who will do anything to avoid upsetting advertisors-  till today remain silent on the glitazone issue.

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SWINE FLU (?CONSPIRACY) UPDATE- PANDEMIC THAT NEVER WAS: WHAT A WINDFALL FOR THE UNITED $TATES OF EURO-AMERICA.

n d burman cape town

News on the 2009  swine flu pours in daily- see this column’s   last report only 4 days ago.

Roche’s response arrived a few days later.

Conspiracy theory: Definition: “A  theory seeking to explain a disputed case or matter as a plot by a secret group or alliance”

We all disdain  farfetched conspiracy theories, but some eventually prove true- especially in war, politics and Big Business.  The British Intelligence deception  of the Germans in WW2 over the Sicily landings with The Man Who Never Was was one of the cleverest successful conspiracies at least of WW2. Conspiracy was the downfall of Richard Nixon, but not of  Joseph’s murderous brothers in planning sell him off to slavers going down to Egypt and then telling Jacob that his favourite youngest son had been eaten by a lion; and not of George W Bush- the most successful rogue politician and ruthless warmonger of modern times despite his irrelevant defeat by Al Gore in 2000  in the democratic popular vote. The truth about the $multibillion Armsgate conspiracy (arms which South Africa never needed) between top ANC politicians and various European arms traders is still being suppressed, to protect present and past presidents, politicians and business moguls  in South Africa and Europe…

But since no evidence can be found on Google, Pubmed or the USA Government websites, it is a given  that neither the ”Authorities”  (the Government Health Agencies NIH-CDC-FDA,  the WHO and the European Union) can produce any evidence to justify the claimed pandemic state of 2009 swine flu or its major danger which justify a national state of emergency declaration– in effect, martial law. Truly following in George W Bush’s footsteps after 9/11. Why would Government conceal such public health evidence if there was any? ..

Nor can the same world  ”Authorities”  that regulate and recommend them nor the EuroAmerican  manufacturers  produce any randomized double-blind  controlled trial RCT evidence in humans to satisfy regulatory criteria  for registration and prescription  of  either the recommended (swine flu) antiviral drugs Tamoxifen or Relenza, or vaccines based on both the  hyperinflated but unproven imminent risk theory of this disease or the efficacy versus harm from these costly agents.

So as other sober voices ask, on what evidence  is the USA basing its claims of a dangerous pandemic,  and  its mandatory recommendations? – which are binding on those Authorities’ prudent health professionals as well as on its state employed patients.

The continuously updated USA surveillance report notes explicitly that “Several states have abandoned the counting of confirmed cases. This step is justified by the finding, that at this point of the year more than 98% of detected flu cases are caused by the novel flu. Other states have started to report the number of hospitalized cases instead of infected cases. The CDC discontinued reporting of individual confirmed and probable cases of novel H1N1 infection on July 24, 2009.”  So there are no statistics from the USA to show that morbidity and deaths from swine flu are increasing, let alone attributable primarily to the 2009 H1N1 virus.     In fact  evidence apparently  suggests the opposite since mid-October.

On October 9, 2009, Dr Gary Null & healthcare associates filed for a USA court injunction to stop the FDA distribution of   swine flu vaccines since these violate Federal Law “in its hasty approval of four swine flu vaccines by failing to scientifically determine either the safety or efficacy of the vaccines.”

Profit Driven Swine Flu Propaganda – Pump Up the Volume – is a series of Natural News articles since October 21 by Evelyn Pringle, health freedom writer exposing a conspiracy by rogue USA Government’s arms and Disease  Industry to extort the biggest profiteering in history from drugs and vaccines forced on  billions of people -who may (as in the  previous ’emergency” 1976 pandemic that never happened) derive far more illness than benefit from these unproven drugs.

Authorities – the FDA itself, no less- have hastily on 15 October racked up up this brutal campaign – now against Dr Andrew Weil – to suppress natural nutrition approaches that both work and are safe so as to favour their Disease Industries’ snakeoil profiteering. Under the mantle of no less than a Presidential State of Emergency declared this day October 24  over the nonexistent swine flu pandemic, they impose a ban on  disseminating knowledge- the benefits of proven naturally beneficial nutritionals  eg vitamin C; or astragalus – despite decades of evidence supporting it–  while at the same time stating blatantly ” The Secretary of Health and Human Services, under section 319 of the Public Health Service Act… has determined that a public health emergency exists nationwide involving the H1N1 Flu Virus that affects or has the significant potential to affect national security. Following this determination and in response to requests from the U.S. Centers for Disease Control and Prevention, FDA issued letters authorizing the emergency use of certain unapproved and uncleared products or unapproved or uncleared uses of approved or cleared products...” ie vaccines designed and hastily manufactured only this year, with no  efficacy trials to show reduction in serious illness and deaths and no longterm human safety record, containing known dangerous ingredients.


As if millennia of genocidal suppression of free choice and rights – the Martyrdom of Man – by those in power since recorded history began  was not enough. The greedy and ruthless learn well to manipulate power progressively to subvert justice and security  for all, as Churchill, Ivan Illich, JK Galbraith, Margaret Attwood, Tom Bower, Joe Stiglitz, Naomi Klein, Al Gore so eloquently wrote, and Kissinger’s Kindergarten (Bush father and son, Cheney, Rumsfeld, Wolfowitz) have so profitably  done  the past 35 years for themselves but not the nations including the USA that they sabotaged..

And today Dr Joe Mercola   reports on the CBS expose of massive US  CDC disinformation on their website  about the swine flu “epidemic” in the USA – which is reportedly contradicted by the individual US state health spokespeople.  Finland and Russia at least deproclaimed the pandemic, since nothing has been seen of the disaster predicted for the Southern hemisphere’ past winter – today being the official first day of Spring- , nor for North America in this  October fall month.

Just count  the untold $billions in profits for the USA via the companies who control the FDA – and for governments  around  the world who conspire with the disinformation  and largesse promoted by the  Disease-Industry controlled FDA and EU and  WHO.

It should be noted that Tamiflu is distributed by the Swiss-USA-based  giant Hoffman La Roche; Relenza marketed by UK-USA  giant GSK; and swine flu vaccines are now being mass produced by archaic methods (in hens’ eggs, animal cell cultures)  by GSK , Baxter international (USA) and Novartis (Switzerland-USA)  – containing amongst others the feared neurotoxins mercury-thiomersal, squalene (and- who-knows-even aluminium?)  to be injected, not taken orally when they are likely harmlessly excreted.  Co-incidentally, it was a USA Baxter heparin batch that was found to be contaminated, and in early 2009 a Baxter seasonal flu vaccine  vaccine batch destined for the Czech Republic that was found there to have contamination by a deadly H5N1 strain. Not to mention the US Merck’s intended universal flu vaccine. ; and Merck’s and GSK’s notoriously controversial anti-cervix cancer vaccines which have   been associated with much death and illness in young girls after it too was made mandatory in many regions, despite lack of evidence of benefit in longterm RCTs.

Furthermore, wiki reports thatIn January 2009 the  USA awarded Swiss-based Novartis a $486 million contract for construction of the first US plant to produce cell-based influenza vaccine – to be located in North Carolina, aiming to produce  150,000,000 doses of pandemic vaccine within six months of declaring a flu pandemic”.

How’s that for strategic prophetic planning, 2 months ahead of the California-Mexico swine flu outbreak? .Some call it disease-mongering.

What an ‘unexpected’  windfall  the coincidence  of the outbreak of the American-Mexican swine flu epidemic 6 months ago has been for USA –  UK – European-based Disease Industry mega-corporations – all of which have at least one foot in USA-  and thus governments.

Is the outbreak and ensuing $billiondollar industry a fortuitous windfall? As the saying goes, success is not built on luck but on wise  planning.

So the jury will inevitably favour conspiracy theory until the Authorities involved produce the scientific evidence to justify the swine flu “pandemic” proclamation and the multi $billion antiviral drug and mandatory vaccine campaign against the still-awaited swine flu holocaust.

Why does it take the mind  back  to the 2003 USA Bush gang’s  decision  (that made their allied corporations  $billions, and made USA  the world’s biggest aggressor and debtor) to occupy  and destroy Iraq based on USA- ‘Intelligence”-fabricated  evidence that Iraq was a nuclear threat? and the world’s worst Great Depression ever  the past year as a result of Bush- Blair regimes’ conspiracy with the criminal  banking and stockbroking industry?

THE FDA’S DOUBLE STANDARDS ABOUT SUPPLEMENTS

So the FDA complains about supplements: “products that have not been shown to be safe and effective for their labeled conditions of use”.
 
Thats why the FDA was able to block the still-best drugs – the andidiabetic supplement metformin- and the antidepressant supplement  lithium- for decades.
 
We must agree that the evidence of both safety and efficacy  for many supplements is lacking eg for black cohosh, kava kava for  menopause.
 
But where is the long-term evidence of “safe and effective” (let alone essential)  for pharma industry  synthetics eg non-steroidal anti-inflammatories, bisphosphonates; sulphonylureas, glitazones, ACEIs, ARBs, SSRIs, anti-platelet,  gabapentin, pregabalin, and  antiAlzheimers agents, ?
 
The FDA’s double standards ie USA self-interest are endemic not just to USA Administrations (read Gore Vidal, Elaine Feuer, Naomi Klein, Al Gore, Levine & Scott-Clark), but to all Govts, businesses,  most politicians and most  citizens worldwide of the past 40 years if not centuries. No neutral Courts support them.
 But these double standards are why religious and racial and gender  intolerance, fraud, war, genocides and poverty prevail, why mankind (ie greed)  is fast wiping out life on this planet- in our lifetime-, as eg Shute, Miller, Carson and Attwood’s novels so depressingly predict –  in our lifetime.

HORMONE THERAPY, HORMONE REPLACEMENT AND BREAST CANCER (Dr Burman)

This excellent Belgian/ INSERM  October 2007 review is explicitly about HORMONE THERAPY and breast cancer BRCA. and the risks of long-term (>15years) higher dose oral estrogenic THERAPY, and PROGESTIN,  and  ORAL androgen THERAPY,  for increasing the risk of BRCA  (but if anything reducing the risk of death from all causes including BRCA).

The review mentions  the safety of PROGESTERONE, but does not otherwise discuss either physiological human estrogen or androgen REPLACEMENT i.e. HRT.

           (Post) Menopause and Andropause (Androgen deficiency in men) are, like pituitary, hypothyroidism, adrenal, pancreas and parathyroid failure,  Hormone DEFICIENCY states, which have been uniformly treated for a century now with PHYSIOLOGICAL HORMONE REPLACEMENT i.e. HRT.

         For HORMONE DEFICIENCY STATES (excluding hormone resistance or other  eg collagen/allergic/ gynaecological diseases ),
We have always replaced approximately the normal daily hormone output by the most physiological route –
orally in the case of thyroid, cortisone   and melatonin, otherwise parenterally as with egg   SHR, insulin, HGH, vasopressin, erythropoeitin etc.

         Dozens of reputable clinics on all continents have used such physiological HRT including sex hormones (SHR) for hormone deficiency   for up to  40-60 years in many patients, and no-body of note  (in Canada, USA, UK, Europe, Australia, South America, South Africa, Asia) has ever  reported such physiological  systemic SHR to any pathology, let alone increased cancer.

           There is no paradox – disease is linked both to DEFICIENCY and to EXCESS of anything. As we have long discussed and Foidart ea repeat, Henderson ea since 1980 observed that the INCIDENCE (but not mortality) of breast cancer increases when HTs (oral estrogens)  are continued beyond about 15 years, ie exceeds about  5 grams of estradiol equivalent.

           It is common cause that  stilbestrol (DES)  (and Estinyl)  are vastly more potent than human estrogens, hence the marked increase in BRCA in the thousands of women given DES  for even just a few months of pregnancy in the  criminally infamous Chicago 1950 trial, let alone the increased breast and vaginal cancer in their daughters, and now problems in their granddaughters.

           That is why, on physiological  and safety grounds, we recommend only balanced human hormone replacement  HRT for chronic PREVENTION in hormone deficiency states.
We must keep asking ourselves: why treat postmenopause  hormone deficiency differently from men, when it has long been recognized that even men are best treated for gonadal deficiency with appropriate  physiological systemic  human testosterone?.
The commercially driven   North American tradition of convenient oral xenohormones (premarin, progestin) established by Wyeth et al by their buying the support of  the FDA, Masters, Wilson et al is no reason to go on forcing such xenotherapy on women, and blocking them (as the FDA is trying to do) from obtaining physiological HRT as is used for all other hormone deficiency states –  and sex hormone deficiency affects 100% of women from midlife. Unassailable evidence has been freely available for thirty years of the inferiority of xenohormones (including sex hormones) over physiological human hormones, but of course the New Drug Industry (apart fom Schering AG) and thus their front, the FDA, have done their  best to suppress this.

            This has little to do with PHARMACOLOGICAL THERAPY with eg corticosteroids for inflammatory disease, or HT (as traditional gynaecology uses)  for eg contraception or gynaecologic DISEASES.

               And this principle of physiological human hormone replacement HRT for all deficiency disease  does not gainsay that lower dose oral estrogen  HT eg appropriate estradiol 1mg/day for up to 10 years in the Oulu Trial (Heikkinen 2006) appears to greatly reduce all longterm disease, just as premarin in similar dose 0.625mg/day for up to 7 years reduced all diseases and mortality by 1/3  when started appropriately soon after menopause in the Womens’ Health Initiative, and the Nurses’ Study.  These studies do not disprove the Henderson  evidence  that  the threshold for promoting presentation of breast cancer  is a total cumulative  dose of about 5gm estradiol ie >3.4gm premarin.   It will take more than a  century   of systemic estraddiol at 50-70mcg/day use for a women to achieve such estrogen megadose  exposure.

              Given the evidence of uniform longterm preventative good from continuation of youthful  balanced  appropriate systemic estradiol-progesterone-testosterone  post menopause for up to and over 40 years in many women and men (eg Greenblatt; Greenblatt, Gambrell, Karpas; Schleyer-Saunders, Whitehead, Studd;; Nieschlag & Behre; Moller & Hansen;  Davis & Burger; Davey D  et al),  there is more physiological and observational data (in men, women and primates) to support the longterm use of appropriate balanced human SHR for multisystemic protection than there is for the use of oral xenoHT for even five years.

So we must at least give women the choice – of physiology-based evolutionary natural replacement, or (in Bill Masters’ words in 1957) convenience patent xenotherapy.  For the past century  (in fact millenia)  the evidence and thus Internists favour physiology. Random brain trephining, clitoridectomy, routine ulcer gastrectomy, hysterectomy, tonsillectomy, coronary artery stenting have come and gone. But appropriate hormone replacement- especially of sex hormones- will endure.

NDB  200711  Appropriate Hormone Replacement Group.