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

“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.

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.

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

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 4^th  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.

[ii] Chlebowski RT, Schwartz A, Wakelee H, et al. Non-small cell lung cancer and estrogen plus progestin use in postmenopausal women in the Women’s Health Initiative randomized clinical trial. Presented at the 2009 annual meeting of the American Society of Clinical Oncology, May 29-June 2, 2009, Orlando, FL. Abstract CRA1500.

[iii] Koomen ER, et al Estrogens, oral contraceptives and hormonal replacement therapy increase the incidence of cutaneous melanoma: a population-based case-control study. Annals of Oncology. 2009 Feb;20(2):358-64. Epub 2008 Aug 25

[iv] Calle EE, et al. Postmenopausal hormone use and breast cancer associations differ by hormone regimen and histologic subtype Cancer  2009; 115. http://www.medpagetoday.com/OBGYN/HRT/12709

[v] Mørch L.S., et al, Hormone Therapy and Ovarian Cancer JAMA. 2009;302(3):298-305

Not a happy new year so far for Merck pharmaceuticals with a swathe of damning reports on their osteoporosis drug Fosamax appearing on January 1^st:

·         Dr Diane Wysowski of the FDA reports an increased risk for cancer of the esophagus with Fosamax use in the New England Journal of Medicine;

·         The Journal of the American Dental Association publishes a study by Parish Sedghizadeh and his colleagues finding an alarming four percent of their dental patients taking Fosamax have osteonecrosis of the jaw;

·         A further NEJM article contradicts everything we have been told about the way bisphosphonates work in the body.  It now seems they increase rather than decrease osteoclast cell production and that these feral bone-absorbing cells are giant and detached. What this means nobody knows. Hardly stuff to inspire confidence in users!

If bisphosphonates offered significant fracture prevention it may be worthwhile debating the benefits and risks. But the majority of the millions of people who take these drugs do not stand to benefit AT ALL.  Meanwhile these are toxic compounds that stay in the body. Their mechanics of action are still not understood, and users remain guinea pigs in a massive experiment.

A diagnosis of osteoporosis on the basis of a bone density test alone is flawed and close to meaningless. The widespread prescribing of bisphosphonates based on a bone density diagnosis has the ‘worried well’ taking the drug in droves believing they are preventing a disease may never have.

The lengthening litany of side-effects: chronic and acute joint bone and muscle pain, sudden serious fractures of the femur, atrial fibrillation, osteonecrosis of the jaw, inflammatory eye disease, and now cancer of the esophagus should have even the most passive of Fosamax , Boniva, Didronel and Actonel users closely questioning their doctors.

Ninety-five percent of serotonin in the body is produced in the gut and only 5 percent in the brain. The discovery is linked to a gene called LRP5 which controls an enzyme that converts the amino acid tryptophan to serotonin in the gut. The new research indicates that high levels of gut serotonin inhibit bone growth, and lowered levels of serotonin make bone denser.

The serotonin link to bone strength was identified in children with a rare condition of very weak bones and in people with extremely dense jaw bones. These conditions were found to be due to mutations of the gene LRP5 which in turn either impaired or increased bone formation. The projection from the discovery is that a drug may be created that reduces serotonin production in the gut thereby stimulating bone growth.

As exciting as it sounds, the information may not alter what we know about age-related osteoporosis as the investigators found osteoporosis patients tend to have normal serotonin levels. And in the trial, animals with normal genes that were fed a tryptophan deficient diet didn’t grown denser bones. Time will tell whether this apparent ‘breakthrough’ will translate into a safe and effective new treatment.  Read more…