Monthly Archives: August 2010

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.

SCREENING TO MANAGE/ DELAY THE DISEASES OF AGING – especially OSTEOPOROSIS FRACTURE RISK MEASUREMENT:

neil.burman@gmail.com, Cape Town, South Africa.

UPDATE 15 October  2010

Patients with relevant symptoms,  or  those with serious familial risk factors,  must be relevantly investigated.

Those who claim to be and appear well need only a few proven regular simple and relatively low-tech noninvasive screening steps – which unless applied  opportunistically should be scheduled periodically:

1. Systematic history-taking questionnaire and relevant interrogation & physical exam (including periodic whole body skin examination for melanoma);.

2. Electronic bloodpressure on arm (and  ankle if it is significantly raised on the arm) –  standardized certified (by eg world or national authorities)  electronic upper arm machines eliminate the major risks of mecury contamination and observer error and digital preference;

3. Body fat and lean mass measurement. Height change. Fitness measurement.

 4. Pap smear for the younger who have been sexually active.

5.  Relevant for-age hormone imbalance appraisal.

6. Mobile five minute Ultrasound Fracture Risk Measurement;

7.   Eye pressure and retinoscopy by a trained optometrist; and 

8   dental evaluation.

It is never too early and never too late to start prevention including appropriate screening, diet, exercise -lifestyle; and permanent appropriate supplements – vitamins, minerals, herbs and human biologicals; and occasionally lowdose proven old prescription medication  eg appropriate HRT or antihypertensive medication.

SERVICE TO THE COMMUNITY: MEASURING FRACTURE RISK BY ULTRASOUND : KEEPING THE YOUNG GROWING, THE AGING MOVING, AND ALL LEARNING!!

A new study from Perth University Australia promotes BMD screening for osteoporosis.  They conclude: “A major key to improving osteoporosis management is to actively identify all patients at risk and proactively engage and encourage them to seek assessment and management.” Precisely as with neglect of risk of glaucoma and hypertension, the University Pittsburgh similarly notes “Older adults demonstrate several beliefs that may be barriers to osteoporosis screening, including low belief in susceptibility to osteoporosis. These beliefs should be targeted with patient education to improve screening rates.”

Note the latest running update from UK universities below  (Aberdeen 2006 and Cambridge 2009) on the growing validation of regular ultrasound bone density measurement at 10year interval at all ages from toddlers upwards .

Major frailty fractures (hip/spine) are a major cause of disability and death amongst the aging – only 4 out of 5 survive at least a year after such injuries, and only 1 in 5 recovers completely from them. Prevention and better recovery requires effective and safe treatment of the underlying osteoporosis and the fractures. Screening and simple necessary supplements apply to children, women at all ages, and many men at risk- whether from frailty, alcohol, cortisone, cancer, malnutrition, chronic illness , unintended weight loss, laziness or longevity.

Thus screening applies to all. Marked height loss with a wedging spine – the ‘dowager’s hump’- indicates progressive fractures of the spine (ie of vertebrae, discs)., an indictment of negligent ignorance or neglect of simple preventative measures by the patient, relatives and carers. And medical schemes have to pay for fractures as Prescribed Medical Benefits.

The myth is that osteoporosis is a disease of bone. It is rarely a primary disease of bone (eg degenerative, metabolic, cancer) but like rickets mostly of the neglect of mineral and other deficiencies – neglect of exercise, sunlight, healthy alkaline (high-produce-low meat) diet, vitamins, minerals, protein, fish oil, and appropriate human hormones. Genetics plays a part, but only a small one.

Sunlight alone is not an adequate source of the crucial vitamin D except in those spending hours working outdoors in light clothing- and few people now drink therecommended four glasses of fresh milk a day, let alone (in this age of television, PCs, and abolition of compulsory school sport and phys-ed) exercise and sleep,  that used to build strong kids.

 Osteoporosis, hypertension and the other major aging diseases share so many common risk factors that neglect of easy permanent prevention is a tragedy. Early signs of  adiposity,  hypertension  and musculoskeletal frailty by simple regular tests are safe economic markers of the preventable diseases of premature aging: frailty, obesity, diabetes, heart-attack , heart/ kidney failure, stroke, memory loss/dementia, arthritis, fractures, cancer,blindness, disability and early death.

Obviously growth ie increasing height does not confirm strong bones but sometimes the opposite. The biggest risk marker for aging fractures (apart from obvious factors like physical laziness, immobility, early castration, thyroid, liver/kidney impairment, rheumatoid arthritis, type 1 diabetes, and excessive use of drugs (alcohol, furosemide, aluminium, betablockers, antireflux agents and anti-inflammatories  not least cortisone steroids),  is not osteoporosis but frailty and falls- which modern synthetic anti-osteoporosis drugs – the Fosamaxes, Proteos, Forteo, Livifem) do nothing to reverse. Naturally their heavy marketing fails to say this. Whereas, within reason at least, the higher the weight the stronger the muscles and bones get to carry the load – Wolff’s law (1892) . Hence by common sense, musculoskeletal strength is proportionate to BMI bodymass intake rather than to height.

The simple and safe economic multi-supplement that prevents and reverses osteoporosis also – with addition of a few other supplements – largely delays or prevents the other common diseases of aging – and can improve thin bones, poor circulation and much arthritis. Popular synthetic designer drugs like cholesterol-busters and warfarin may actually worsen frailty, fractures, cancer and vascular disease.

And while anti-osteoporosis drugs do make bones harder, they may increase vascular and cancer risks, cause terrible allergy and digestive problems, and worsen risk of fractures, jaw disintegration and teeth loss. Pictures on Google show this horror complication,  from a drug group which has no compelling indication since natural supplements ALWAYS prevent and reverse the osteoporosis. 

These designer drugs (despite earning $ billions) do nothing to prevent the other associated diseases of premature aging. In fact new research published this July suggests that drugs which slow down healthy bone turnover eg bisphosphonate may actually worsen the risk of diabetes .

The Wikipedia BMD description is balanced, and mostly about DXA.  “ DEXA is currently the most widely used, but ultrasound has been described as a more cost-effective approach to measure bone density” – usage depends on marketing rather than efficacy or necessity! “The USA National Osteoporosis Foundation recommends BMD testing for the following individuals:

All women aged 65 and older regardless;

 Younger postmenopausal women with one or more risk factors.

Postmenopausal women who present with fractures (to confirm the diagnosis and determine disease severity). Estrogen deficient women at clinical risk for osteoporosis. with vertebral abnormalities. Or history of eating disorders ;

 receiving, or planning to receive, long-term cortisone therapy.

 with primary hyperparathyroidism.

being monitored to assess response or efficacy of osteoporosis therapy.

 They omit chronic wasting illness like alcohol intake, cancer, HIV, bowel or kidney or heart or lung disease etc..

Of the Four Limitations of BMD the Wiki article discusses, two don’t apply to QUS in average women:  

 1. the size of the patient & overlying tissue dont apply to QUS at the heel (except when BMD is almost irrelevant- the grossly obese, or those with elephantiasis- massively swollen feet.)  

 4 DXA is a major error problem in elderly women- like the spry  82yr old I screened recently who has severe arthritic spine  and aortic  atheromatosis – ie   the overlying calcification in bone- and bloodvessels- give serious falsely high DXA readings that we have to ignore. The same applies at the hip.    It is especially in older patients- and in kids in whom one at all costs wants to avoid irradiation- that QUS is the only good method.

Their Limitation 2- “in some circumstances bone density is a poorer indicator of bone strength” is the major reason why bisphosphonates are so risky- they improve BMD ‘hardness’, but sometimes make bones more brittle. – hence osteonecrosis.

And of course a further advantage of the standardized modern fixed-double-head heel scanner is that it does not involve the performer- sonographer-  variability and repetitive-strain injury risk  – of the older hand-operated scanner probe.

Remember that it is not low bone density  that is the greatest risk factor for fracture, but frailty, falls, poor muscle strength and co-ordination. – which Fosamaxes, Proteos, Livifems and PTH injections certainly dont benefit. Giving just calcium with lowdose vitamin D does very little to reduce fractures but in fact worsens vascular calcification ie disease.

ULTRASOUND vs DUAL XRAY DEXA BONE RISK MEASUREMENT:

 Recent major reviews by Cambridge UK (Moayyeri A Khaw KT ea 2009)  and Aberdeen UK (Stewart, Kumar & Read 2006) Universities confirm (over 53 000 patient years) that the gold standard for monitoring fracture risk over 10 years is the portable quantitative ultrasound bone density machine QUS which measures fracture risk without xray, by ulstrasound scanning at the heelbone..

The just-published Screening for Osteoporosis: Update for the U.S. Preventive Services Task Force (Nelson ea 2010)  and trials from Taiwan (Lee 2010) and University Pittsburgh (Cauley 2010) and now from Southampton UK (Cook ea) come to the same conclusion – that QUS measurement is as effective for screening as DEXA for determining hip and spine fracture risk  in both men and women and children . As with height, weight, waist girth and bloodpressure, the younger (from childhood) these measurements – including heel bone density – are started, the earlier the risk of stroke, heart disease and fractures can be determined and simple steps taken to promote future health.

Cincinnati Childrens’ Hosptal   already in 2007 published reference curves for BMD in children, so we have standards for all ages. But it is increase in childrens’ Z scores with time that matters..   Conversely, waiting until diabetes, cancer or fracture occurs, or till the heart, brain, joints, vision or kidneys are severely damaged, is the height of folly, since supplements, modern drugs and surgery can then do precious little to restore and preserve health. Even in those suffering dementia, and the stroke-impaired, it is worth monitoring and managing bloodpressure and osteoporosis, since recurrence of strokes, avoidable fractures and bed-bound immobility bedsores create far higher cost and burden to manage.

McCue C.U.B.A. Clinical™ Contact Ultrasound Bone Analyzer says: “ Never before has assessing a patient’s risk of fracture been easier or more cost-effective than with the C.U.B.A. A dry ultrasound sonometer, the C.U.B.A. Clinical™ is designed to perform a heel measurement in less than a minute. The world’s first dry ultrasound system (no water bath). Patented internal electronic phantom for simple calibration. Lightweight (22 lbs.) and easy-to-operate. Does not produce ionizing radiation. Cost-effective assessment of risk of fracture.       Recent studies suggest that the VOS mode is better for crosscomparison with DXA XRAY screening; while the BUA mode may be better for serial comparison ie trend of change.

FRACTURE RISK MEASUREMENT IN SOUTH AFRICA:

Our experience in Cape Town the past two years is that the CUBA machine regularly recalibrated (like the DXA machines) with a standardized phantom is consistent and reliable with the limitations discussed in this review. . Normally only the left foot is done (the machine does an average of 3 to 4 readings in 2 minutes to get a satisfactory average), but we may do both feet IF there is any doubt that the feet may be different- obviously the ‘healthy” foot will be the better one for reflecting whole body bone density (as we calculate by averaging the hips and spine). The CUBA system can for practical purposes always be used as long as the patient can sit with one foot in the QUS footbox- ie a bedbound patient must be able to sit up (ideally in a chair rather than at the bedside) for 5 minutes – and sit fairly still for about 3 minute. This is far less demanding than lying on a trunk scanner. .

The law in South Africa is that  although medical schemes deny it daily to patients, all open medical (including ‘hospital’)  plans are compelled to pay the member’s benefits themselves (not from patients’ savings) for outpatient diagnosis and management of most major chronic diseases including menopause and fractures, ie under the Prescribed Minimum Benefit PMB regulations – provided the healthcare provider is registered eg doctor with the medical council HPCSA..

Osteoporosis itself is not one of the core 27 PMBs; it is however one of the 270 conditions covered as Diagnostic Treatment Pairs; but fracture is a prescribed medical benefit, and fracture risk measurement must therefore be payable as a necessary diagnostuic test. .

The State eg Groote Schuur Hospital GSH  provides free regular screening breast mammography for the ‘well’ – although this screening procedure in women without risk factors has been increasingly discredited for years as possibly increasing unnecessary biopsies, breast cancer, anxiety, and death risks for women; but GSH does not   provide DEXA bone density screening for referred patients on outside referral via  outpatient  referral. However,  Groote Schuur Hospital last year published a major local population study validating such ultrasound heel scanning against DEXA.

 Some schemes themselves pay for bone density screening; and osteoporosis, while others don’t yet acknowledge the importance of fracture risk measurement, and so reject claims. The medical aid tariff rate for ultrasound bone density (item 3612) is about one fifth of that of the xray DEXA scan. Obviously this tariff – like that for eg a mammogram- is for the procedure, and does not include the usual fee for a medical consultation. The scan report simply says whether it is normal or not, any change relative to previously; and thus when it next warrants repeat, and perhaps consultation with a doctor.

Affordable QUS osteoporosis  fracture risk measurement (CUBA system)  is available at the Peninsula Osteoporosis Screening and Natural Management Centre at Grove Building Medical Centre near Cavendish in Claremont.   (phone or fax 021 6717415)  for appointment (or phone 0836299160 for further information); the service is also available in Gauteng.      

    Members of indigent families are screened within reason, at nominal cost.