Tag Archives: pioglitazone

BANNING THE PRESCRIPTION OF THE GLITAZONE ANTIDIABETIC DRUGS

 neil.burman@gmail.com

This was a bad month for Actos (Takeda-Rly Lilly)  and Avandia (Glaxo), another good month for metformin.

As indicated in this week’s NEJM, the glitazone  class of drugs sold commercially as Avandia and Actos, has now belatedly  been suspended,  restricted or black boxed  by the European – EU and the  USA- FDA- regulators  (after shocking prevarication pandering to Big Pharma), because of  promoting  heart failure, let alone visual loss- macular oedema, osteoporosis fractures,  fatal hepatitis (troglitazone deaths), and adiposity –weight gain and  cancer.; with consequently and unsurprisingly no significant reduction in all-cause mortality ..

Regulators like our own MCC  must now surely suspend ie ban the current  glitazone drugs in view of the long-accumulating list of their serious adverse effects and related deaths.. There never was or is compelling clinical reason for their prescription any more than there is or was allowing eg  the soon- banned Mandrax, Ponderax, practolol, stilbestrol, cerivastatin or the original glitazone troglitazone Rezulin on the market.

The current glitazones have  been in use scarely a decade; and  are not necessary let alone essential since:

-metformin remains the best drug ever discovered against all major common degenerative diseases including type 2 diabetes and overweight, with zero serious adverse effects in the longest (20year) randomized controlled trial ever conducted,

– with 1/3 reduction in all mortality and major chronic degenerative disease, halving of heart attacks in type 2 diabetics due to metformin’s unique combination in titrated clinical use of antioxidant, anti-lipidemic, vasodilator antihypertensive, anticancer, anti-aging, appetite- and adiposity-controlling, anti-hepatitis, antimicrobial, insulin-sensitizing, pro-fertility and fibrinolytic benefits, protecting all organ systems;

and at least halving of new diabetes in major preventative trials in “prediabetics” on four continents; and provided the dose of metformin is simply started low- at most 250mg/day

– and provided the starter dose is titrated weekly up to comfortable safe tolerance and desired effect- as must naturally be done with all chronic drugs.

In contrast to the glitazones, the latest studies  October 2010 by Evans ea   from Tayside Scotland and by MacDonald ea in the UK as a whole, showed that compared to sulphonylurea and other antidiabetics, metformin alone or combined with sulphonylurea  in +-75year old diabetics with congestive heart failure lowered all-cause mortality by 41% after 1 years and by about 30% longterm – the same outcome as in the UKPDS trial 30year followup.

From France Mouchiroud ea Sept 2010  discuss why global lifespan has risen from about 46 to 65years accross the 20th century, and how metformin (as dietary restriction mimetic) shares with rapamycin and resveratrol the slowing-down of age-related diseases.  And Li ea Sept 2010  show in experimental stroke in rats how chronic prevention with metformin was neuroprotective  via nitric oxide.

A careful population study in USA by Wertz ea Sept 2010  could find no difference in the 4.15% incidence of heart attack, heartfailure or death in  rosglitazone or pioglitazone users aged 18years or older;   and a careful study by Kaiser Permanente  Sept 2010 of all published glitazone trials confirms Pubmed search, that  after ten years of massive marketing  trials and massive unjustified use, there is  still no evidence that  the glitazones reduce all-cause mortality as metformin does, nor statistically reduce the primary usual glitazone trial endpoint of major cardiovascular event or death. 

How can glitazones have such benefits of metformin  when glitazones  are not dietary restriction mimetics but actually increase adipocytes and thus obesity and hence  cancer?  

 Instead of protecting drug companies’ and their lobbyists’  interests,  will the Regulators everywhere, including the “experts” at the  Universities – medical schools-  now act against these  unnecessary, risky,  fattening antidiabetic glitazones to protect patients?

Or will the leading medical schools and governments  continue ruthlessly  to put their massive monetary support from Big Pharma ahead of  truth, evidence and patients’ interests?

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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.