Patient safety vs industry profit: will justice be done?

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

Efforts to rehabilitate HRT backfire

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 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.

 

Esophageal cancer, jaw bone necrosis, and giant floating osteoclasts!

 

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.

Bone Health Breakthrough?

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…

New Osteoporosis Documentary

The Osteoporosis Story: Broken Bones or Broken System  examines the historical 1992 redefining of osteoporosis, the multi-billion dollar drug and device industry that burgeoned in the wake of the new definition, and the untold numbers of adverse health events that occurred as a consequence.  The documentary covers the essentials on bone metabolism, details the serious limitations and risks of past and current osteoporosis drug therapies, and questions how ‘evidence-based’ medicine can favour profit before patient safety.  It includes women’s stories on the debilitating effects that bisphosphonate drugs like Fosamax have had on their lives; along with Swedish, Canadian, Georgetown, Harvard  and UCLA physicians’ views on the over-selling of the disease, and comments by leading medical authorities and health activists on the woeful state of much of the science behind the osteoporosis ‘epidemic’ and medicine in general. The Osteoporosis Story was written and directed by Ross Johnston and produced by JPL Productions Dunedin New Zealand.  It can be purchased on line at www.theosteoporosisstory.com

More bad news for bisphosphonates

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.

NEWS: Snapping thigh bones caused by bisphosphonates?

Hard on the heels of the FDA’s January 2008 alert about serious joint bone and muscle pain associated with the bisphosphonates, comes a worrying series of reports of spontaneous fracturing of the femur (thigh bone) in women who have taken Fosamax for several years.

There have long been concerns that the bisphosphonate action of suppressing bone turnover may cause bone to deteriorate in strength and become more brittle over time. It would seem that those fears are being realized and although still small, the number of spontaneous fractures is prompting an FDA investigation of the phenomenon. Reports from Singapore, Hong Kong and the US all have a similar story to tell: the thighbones of women patients on Fosamax for five years or more have simply snapped while they were walking or standing. Some individuals experienced hip and thigh pain leading up to the event, and others had no warning whatsoever. Biopsies after fracture have shown severely depressed bone formation.

Deciphering Drug Adverts

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. 

Barbara Seaman: In Memoriam

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.

Antidepressant drugs don’t work – official study

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.