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Archive for the ‘DRUGS AND DISEASEMONGERING’ Category

Chances are, if you are an American woman over the age of 50, you have had your bone density tested. It is highly likely you’ve had a result that has alarmed you and prompted you to consider treatment options. You are not alone. Although a bone density diagnosis was never an accurate predictor of fracture, it is estimated that it has resulted in more than half the US female population over 65 years (and a good percentage of younger women) being treated with osteoporosis drugs – drugs that offer minimal benefit and pose serious harms.
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Now, in 2011, the field of osteoporosis diagnosis is even more of a minefield. Whether you are male or female, new US clinicians’ guidelines greatly increase your likelihood of being labelled at risk. You can go on-line (with or without your physician), fill in a free questionnaire, and presto! – determine your apparent risk of fracture in the next yen years, and whether you need to be treated. Created by the WHO, the Fracture Risk Assessment Tool (FRAX) is the latest of many multiple risk factor tools that have been developed over the years. But this has the added sophistication of easy on-line access. It has been sanctioned and adopted by the US National Osteoporosis Foundation (NOF) and other august bodies. It is currently on a calculator in Japan, a CD in Poland, and is also available as an iPhone or iPad app. The FRAX website has an average 60,000 hits daily.

Accurately determining fracture risk is a science still in it infancy. After all, who can ever really predict who is going to fall and break a hip? The questions in the FRAX calculator cover risk factors including age, gender, weight and height, a previous fracture, a parent with a hip fracture, current tobacco smoking, alcohol consumption, treatment with corticosteroids, long term use of corticosteroids, rheumatoid arthritis and secondary osteoporosis due to factors such as diabetes, thyroid conditions, early menopause and liver disease. Bone density of the neck of femur (hip bone) can be included or not.

On the face of it, it seems like a good move to include a range of factors. But The NOF guidelines based on the FRAX algorithm have drawn wide criticism from within the osteoporosis clinical community, as rather than excluding patients at low risk, they run the risk of casting an even wider net and diagnosing and treating much larger populations than those identified by a BMD diagnosis alone.

The NOF guidelines recommend screening all women over 50 years, and if this target is achieved it is estimated that at least 72% of U.S. white women age 65 years and 93% of those aged 75 year of age would be recommended for drug treatment. Application of the same guidelines to men has similarly estimated that a very large proportion of white men in the United States (At least 34% of US white men aged 65 years and older and 49% of those aged 75 years and older) would be recommended for drug treatment.

FRAX has never been tested on a large population over time, and its algorithm formula revealing how each risk is weighted for calculation has been kept secret. But you certainly don’t have to tick every box to qualify for treatment. Just being female, over 60, and of small build may be enough. And if you have broken your wrist, or one of your elderly parents fell and fractured a hip, you are a likely candidate.

And while the calculator includes tobacco and alcohol use, it doesn’t ask how long or how much a person has been smoking or drinking. The effect of cigarette smoking on bone health is also complicated. Long-term smoking does appear to reduce bone density, but the NIH statement on bone health and smoking observes: “It is hard to determine whether a decrease in bone density is due to smoking itself or to other risk factors common among smokers.”
The current evidence around the influence of alcohol on bone is inconclusive and contradictory. Moderate drinking does not seem to be a significant risk factor for bone loss and osteoporosis.

And the inclusion of a previous fracture as a risk factor is always contentious. How is it determined whether the reported fracture was a result of low impact (a sign of fragility), or the result of an impact under which any bone is likely to break? And the reported fracture could have occurred in bones not related to osteoporosis, such as fingers and toes. There is no discrimination around site.

Factors such as risk of falling, vitamin D levels, measurements of physical activity (particularly weight-bearing exercise) and whether a person’s diet is rich in bone building nutrients like calcium, magnesium, vitamin K etc. have not been included.

If the FRAX website is receiving 60,000 hits a day, we can conclude that the osteoporosis drug industry is in great heart. But when is the safety and the interest of the patient going to be the priority? Once in the diagnostic door it is very hard to find a way out.

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The WHI trial results of 2002 concluded that the risks of using HRT outweighed the benefits. But industry had too much to lose. Like the contraceptive pill, hormone replacement therapy was one of the biggest money spinners of all time and history had shown that healthy older women are a target group easily convinced.  So as the years have gone by the risks of cancer heart attack and stroke have been downplayed and the possible benefits to bone and menopause management enthusiastically revisited. Although many women have stopped using HRT, some have continued and others returned, reassured by their doctors that the risks are minimal.

But the damning evidence keeps coming…

Further analysis of the WHI trial has found that taking combined oestrogen plus progestin longer than 5-years nearly doubles subsequent breast cancer risk each year. [i]  And among current smokers using combined HRT there was an increased risk for death from non-small-cell lung cancer. It was reported that 1 in 100 current smokers experienced an avoidable death during the 8 years of the study. The death rate among women who had been most regular with their HRT during the trial was 53 percent higher in the hormone group than in the placebo group. [ii]

A Dutch study published in February 2009 found that women taking HRT for more than six months at a time are twice as likely to have a malignant melanoma. The investigation, one of the largest ever carried out on oestrogen use and malignant melanomas, found a sharp increase in risk.[iii]

A study published in the journal Cancer in March 2009 reports that breast cancer risk increases steadily during the first three years of hormone therapy and the combination of oestrogen and progesterone is the HRT regimen most likely to be the source of that danger.[iv]   In addition, women who used oestrogen for 10 years or longer had a 50 percent increase in risk of invasive lobular breast cancer.

 

A Nationwide Danish prospective cohort study published in the Journal of the American Medical Association in July 2009 concluded that regardless of the duration of use, the formulation oestrogen dose, regimen, progestin type, and route of administration, hormone therapy was associated with an increased risk for ovarian cancer. [v]

 

More dodgy science

Physicians rely on medical literature to keep abreast of safety profiles. A colleague’s name on a peer-reviewed article gives confidence when making prescribing decisions. But it has come to light that over several years Wyeth pharmaceuticals hired medical ghost-writers to create favourable articles about HRT that would later add the name of a reputable physician, giving the appearance that they were the writer. A New York Times article ‘Medical Papers by Ghostwriters Pushed Therapy’ of August 4th  documents the practice which is also known to be used by other pharmaceutical companies.  Earlier this year it came to light that Merck went so far as to create a fake medical journal called The Australasian Journal of Bone and Joint Medicine in order to promote Vioxx and Fosamax.  World osteoporosis authorities were named on the editorial board, giving great credibility to what was nothing but a marketing tool. Unsuspecting doctors receiving the literature would be hard pushed to see through the deception.

  (more…)

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A National Women’s Health Network article  Bone-Breaking Drugs? reports on the sudden increased incidence of unusual and serious fractures of the femur (thigh bone) in women taking Fosamax (alendronate) for more than four years.  A  Medline search revealing more than 50 reported cases suggests an epidemic of such fractures say the authors Adriane Fugh-Berman and Charlea T. Massion, as reported cases usually tend to be the tip of the iceberg.

 Reports of serious adverse reactions to bisphosphonate drugs continue to accumulate, indicating they may be doing far more harm than previously thought.  Jaw necrosis and other bone necrosis (bone death) is associated with bisphosphonate use and many dentists now won’t work on orthodontic problems in people on bisphosphonates  as even without osteonecrosis of the jaw,  there is an overall impairment of bone repair mechanisms. Earlier this year the FDA issued an alert regarding chronic and debilitating joint bone and muscle pain. And recently, after examining the evidence the FDA has not been able to confirm that the drugs cause irregular heart rhythms (atrial fibrilliation), but can’t rule it out, either. The FDA says it will do further studies of this issue, but in the meantime it has alerted women about the possible problem. 

A 2006 literature review published in Drug Safety concluded that the underreporting by US physicians of adverse drug reactions including serious and fatal adverse drug reactions is in excess of 90 percent.  Astonishing!  If you or someone in your family has experienced a serious reaction to a bisphosphonate drug or any medical product, you can now report directly to the US Food and Drug Administration MedWatch program by going to the MedWatch homepage clicking on “How to Report”, then “Reporting by Health Professionals” or “Reporting by Consumers”. Or you can report your adverse experience directly to the MedWatch Program by calling call 1-800-FDA-1088.

 

There are also consumer websites like  http://www.askapatient.com or http://www.topix.com/forum/drug/ where you can read others experiences, ask questions and discuss your concerns.

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We need to fully understand the benefits, side-effects and risks of a drug before embarking on treatment.  Prescription drug information from advertising or brochures employs the clever use of medical concepts that require interpretation. Advertisers rely on our ignorance of such matters and drugs are often made to seem more effective than they really are. Many of us might choose not to take a particular medication if we understood the very small absolute benefit on offer.  (more…)

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The biggest selling drugs of all time – anti-depressants — are only as effective as the placebos they were tested against. An analysis of data from 35 trials including some that had never seen the light of day, has shown that clinically the drugs Prozax, Paxil, Effexor and Serzone don’t work except in a subset of severely depressed patients. The pharmaceutical industry has been accused of withholding data that would have revealed the ineffectiveness of the medication long ago. Whether this shocking news will make a difference to prescribing patterns remains to be seen, but many are calling for the treatment of depression to include safer and effective modalities such as counseling.

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Barbara Quart’s excellent article  ‘Big Pharma is big dog at symposium’  (following this comment) observing the culture of excess and hype pervading the osteoporosis symposium in Washington DC in April is a salutory reminder that despite the efforts of many, nothing has changed. The powerful osteoporosis industry still promotes lies and misinformation, not just to the consumer, but to unwary or easily bought medics as well. Well known authorities who are specialist speakers by day, then drug company reps by night are the norm at these industry-sponsored events. We need more people like Barbara Quart and the one courageous solitary orthopedic surgeon at the symposium who voiced his concerns about the potential for a major medical disaster in future from the global experimentation occurring with the potent bisphosphonate drugs Fosamax and Actonel. (more…)

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Just when you would think the osteonecrosis of the jaw risks with injectable bisphosphonates would cause a re-think about the appropriateness of plying these potent drugs for osteoporosis prevention, the drum roll has started for once yearly injections of Zometa. (more…)

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