Feeds:
Posts
Comments

Archive for the ‘ARTICLES’ Category

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.

Advertisements

Read Full Post »

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

Read Full Post »

 

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

·         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.

Read Full Post »

A sensation was created in osteoporosis research circles recently (Nov 26 2008) when a report published in Cell revealed that serotonin made by the gut appears to control bone formation. Osteoporosis authorities expressed surprised at the development which the investigators hail as a breakthrough that could lead to a new and very different treatment. The preliminary research was conducted on mice that were engineered to have human genes.

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…

Read Full Post »

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…)

Read Full Post »

It is with great sadness that I write of the death on Feb 27 of Barbara Seaman. Barbara was a fearless and prolific writer on women’s issues, probably most famous for challenging the cavalier use of powerful hormones to prevent pregnancy, assist conception, manage menopause, and ‘prevent’ age-related disease. One of the early feminist/activists of the women’s movement in the US, she has been a friend to many and a foe of industry when it has sought profit over safety for women. I had the great privilege of meeting and interviewing her in Manhattan in 2006. She has been incredibly kind to me in the few years that I have known her – connecting me with people in her network, giving me articles for my website and always supporting my work. I will miss her very much. Her friend and co-founder of the National Women’s Health Network Phyllis Chesler has written a moving eulogy and others have added comments. Read also an article from the LA Times on March 2.

Read Full Post »

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.

(more…)

Read Full Post »

Older Posts »