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WEBINAR

The Myth of Osteoporosis: blowing the whistle on the epidemic webinar was recorded Thursday Sept. 8, 2011. It can now be viewed on the CWHN website

 

 

An FDA Advisory Committee meeting on the bisphosphonate drugs was held in Adelphi, Maryland on September 9, 2011. The following is from a report by Cindy Pearson Executive Director of the National Women’s Health Network (NWHN), Washington DC:

“NWHN warned back in the 1990s when these drugs were brand new that they might cause more problems than they would prevent, but the FDA ignored our cautions and approved the drugs for ‘prevention’.

Now evidence is emerging to show that the problems we warned about are real.  Women who use these drugs for many years have unusually high rates of thigh fractures and death of the jaw bone.  Women who were perfectly healthy before they started taking drugs to prevent osteoporosis are now suffering from pain and disabilities that appear to be caused by these drugs.  Last week, several brave women testified at an FDA meeting about their experience with these drugs.  They joined with NWHN to ask the FDA to take these risks seriously and restrict the use of bisphosphonates to patients with full-blown osteoporosis.

Officials at the meeting said the FDA would “re-visit” the use of bisphosphonates for prevention.  That’s good news!  But it’s only a first step.  We need to make sure the FDA takes steps to restrict the use of these drugs as quickly as possible so more women won’t be exposed to unnecessary risks and harm.  The FDA listened to the women who were able to speak up at the meeting – now they need to hear your voice, too.”

Please write to FDA Commissioner Margaret Hamburg at margaret.hamburg@fda.hhs.gov and urge her to protect healthy women by not approving bisphosphonate use to prevent osteoporosis.

The just-published fully revised edition of my book ‘The Myth of Osteoporosis’ reveals that osteoporosis is an even more controversial condition in 2011 – still trumpeted by drug companies, front-line advocacy groups and clinicians as a silent but deadly disease that stands to destroy the lives of tens of millions of postmenopausal women – but with the market further expanded to include those with osteopenia or low bone density, resulting in untold numbers now taking potent osteoporosis drugs. The drugs offer minimal (if any) benefit amidst ever-increasing evidence for serious harm, but they continue to be widely prescribed while massive profits roll in for the companies that produce them. While alerting you about the misinformation and how to side-step it, the book is equally a manual on how to maintain healthy bones and avoid fracture later in life. It can be purchased from the publisher’s website, or from Amazon.com. The following two new articles give a glimpse of the information available in the new book.

These days even a diagnosis of mild bone loss (osteopenia) is likely to have you walking out your physician’s door with a prescription for a bisphosphonate drug – most likely Fosamax, Actonel or Boniva. As new clinical guidelines around who should be screened for osteoporosis are set to net most of the female US population over the age of 50, bisphosphonate prescriptions are soaring, as vast numbers of healthy individuals are exposed to their effects for better or worse.
When it was revealed in 2002 that the harms of hormone replacement therapy (HRT) outweighed the benefits, its demise was the moment bisphosphonate manufacturers had been waiting for. By 2006 Fosamax prescriptions totaled 22 million and annual sales of these drugs reached a staggering US$8.3 billion by 2009. Persuasive advertising, and exaggerated scenarios linking osteoporosis hip fractures to an untimely death easily convinced women to move from one questionable drug therapy to another.
But it now seems to be a case of history repeating itself. As the balance of benefit to harm weighs heavily towards serious damage from these drugs, bisphosphonates are well on the way to being shrugged off as another medical mistake of gargantuan proportions.
After decades of indiscriminate prescribing to mostly well individuals, the attitude of the experts who vehemently promoted the drugs is noticeably toned down. The accumulating evidence that bisphosphonates can cause severe adverse effects including spontaneous fractures of the femur (thigh bone), has the experts quietly recommending patients who have taken the drugs for five or more years take a ‘drug holiday’. In a November 2010 LA Times article Dr. Felicia Cosman, clinical director of the National Osteoporosis Foundation is quoted as saying: “it’s ironic that many of these cases of femur factures were in women with mild bone loss who probably should not have been on these drugs…We probably used too many bisphosphonates in too many women for too many years. “
And what about the benefits? Close scrutiny of the evidence indicates that these are drugs that probably don’t prevent fracture at all. Apart from a possible short-term reduction of vertebral height “fractures” determined by x-ray in a very small percentage of high-risk patients, hip fractures are NOT reduced, and may in fact be increased in bisphosphonate users. A large cohort study from Denmark of 16,000 women over 8 years found the incidence of hip fractures was higher in the women taking Fosamax. And a large US trial also found that wrist fractures were higher in the group taking Fosamax. In the long term there is an increased risk of ‘atypical’ (i.e. sudden and spontaneous and slow healing) fractures of the hip and thigh.
Given that the potential harms now include jaw osteonecrosis (bone death), pain affecting the bone, joints or muscles, atrial fibrillation, esophageal cancer and spontaneous fracture, some clinicians and researchers are calling for immediate suspension of the use of these drugs.
New drugs waiting in the wings like the FDA-approved drug Prolia look set to take over from the bisphosphonates. Prolia has huge potential for harm. And huge potential for profit – predicted to bring in US$2.1 billion by 2012. Sound familiar?
For more on this and all aspects of the osteoporosis industry and on maintaining bone health read my newly revised book The Myth of Osteoporosis.

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.

In recent times there has been a raft of major medical scandals involving false and misleading evidence around the safety and effectiveness of certain drugs – evidence that has undoubtedly led to tens of thousands of unnecessary deaths. Individuals who have dared reveal the truth have been discredited, bullied, and fired, and it has been rare for any individuals complicit in the deceptive science to be called to account.

But in an unprecedented case, the General Medical Council (GMC), the UK doctors’ registration body, is  investigating influential Dr Richard Eastell in early November over the ghostwriting of a study of the drug Actonel conducted by Sheffield University for Procter and Gamble Pharmaceuticals . This case may well be the first time that a professional regulator of doctors has had to deal in public with a highly regarded doctor over whether doctors can and should be involved in fronting manipulated research for industry. But whether it will involve that, and whether it will be honest, remains to be seen.

In 2005 Dr Aubrey Blumsohn publicly raised concerns about the osteoporosis drug Actonel, and the way in which Procter and Gamble had controlled a series of studies at his University, the University of Sheffield. Proctor and Gamble provided millions of pounds of funding for the University and senior academic and osteoporosis authority Dr Richard Eastell in turn signed off ghost written papers that he was unable to verify, allowing wrong information about their drug Actonel to be published. The two papers Blumsohn was supposed to “write” were never published except as meeting abstracts because he didn’t agree to it.  Read more:

Eastell continues to enjoy celebrity status in the osteoporosis field, his name  appearing on numerous industry pharmaceutical papers. But Dr Blumsohn’s career as an osteoporosis authority and his position at the university are over because he refused the use of his name and exposed the truth.

It may look as though justice is about to be done. But chances of the investigation pursuing the truth and restoring Dr Blumsohn¹s reputation are minimal. Eastell is a powerful academic with powerful friends, and the GMC will have its eye on the investment interests of the profession, and the usual business of research at medical schools desperate for cash and the personal wealth of the “key opinion leaders” who have led medicine and science along the path of prostitution.

The involvement of doctors in helping companies to manipulate the pharmaceutical literature is the most important problem in medicine right now. Medical professional regulators like the GMC have failed to deal with the problem in any way despite their claims to uphold the welfare and interests of patients.

If the GMC fails to deal with this justly, the widespread practice of ghostwriting and more importantly of blind academic fronting of company statistics will receive a huge boost from a government body that is supposed to protect patients. The huge implications it has for patients will continue, and more principled academics like Dr Blumsohn will suffer the same injustice if they are brave enough to let us, the pill taking public, know what happens behind closed doors. There will be few academics willing to raise problems in the future, and we will all be a little more unsafe.

Have your say – demand a full and fair investigation : write to the GMC at  email: practise@gmc-uk.org  website: http://www.gmc-uk.org/index.asp

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.

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