July 21st, 2011 by DrWes in Opinion, Research
No Comments »
To ensure rational and responsible dissemination of this new
technology (transcatheter aortic valve replacement [TAVR]), government,
industry and medicine will need to work in harmony.”
– David R. Holmes, Jr., MD, FACC
President, American College of Cardiology
Today, Edwards Lifesciences’ will request pre-market approval of its SAPIEN Transcatheter Heart Valve from the FDA’s Circulatory Systems Devices Panel of the Medical Devices Advisory Committee. And for the first time, the groundwork for our complicated new era of health care rationing will be exposed.
To win an expensive technology on behalf of patients these days, there will have to be “harmony” between doctors and their professional organizations and government regulators. If not, patients lose.
At issue is a transformative technology – another milestone forwarding medical innovation on behalf of some of our oldest and sickest patients: those with critical aortic stenosis who are too sick to undergo open heart surgery. Aortic stenosis tends to be a disease of the elderly that carries at least a 2-year 50% mortality when accompanied by a weakened heart muscle. Yet thanks to the wonders of careful engineering and some daring researchers that paired their expertise and lessons learned from a variety of disciples (cardiothoracic and peripheral vascular surgery, cardiology, and even cardiac electrophysiology), technigues and technology have combined to offer a percutaneous option for aortic valve replacement.
Everyone involved in this research (and even those who have watched from afar) knows this therapy works. Most believe in the long run, it will prove to be a safer option than open heart surgery in these patients.
But that’s about where the harmony ends. Read more »
*This blog post was originally published at Dr. Wes*
July 21st, 2011 by GarySchwitzer in News, Research
No Comments »
Several newspapers in the UK reported this week that cancer rates have risen over the past two decades. That set into motion an analysis by the excellent “Behind the Headlines” service offered by the NHS Choices website. They found this in newspapers:
“Cancer rates in the middle-aged “have jumped by almost a fifth in a generation”, according to The Daily Telegraph, which says that the increase “is thought to be mainly due to better detection of cancers rather than people adopting more unhealthy lifestyles”. The Sun takes the alternate view, saying that doctors are “blaming the rise on obesity and home boozing”. The Daily Mail similarly suggests that lifestyle changes are to blame.”
You don’t have to live in the UK to learn from their analysis.
They wrote:
“One factor contributing to these increases is likely to be higher rates of detection due to the NHS breast cancer screening programme and the PSA test for prostate cancer. The raw data behind these stats also needs to be placed into context: these particular cancer diagnosis rates are drawn from the datasets for England from the Office of National Statistics and similar datasets from registries in Scotland, Northern Ireland and Wales. The ONS urges caution when interpreting its data, particularly when looking at trends across time, or differences across regions.
For example, Read more »
*This blog post was originally published at Gary Schwitzer's HealthNewsReview Blog*
July 21st, 2011 by Glenn Laffel, M.D., Ph.D. in News, Opinion
No Comments »
I thought I read the final chapter in the tale of Pfizer’s shady marketing practices for Neurontin years ago. Sadly, there’s at least one more chapter to go.
Recall that in 2008, leaked documents from a US District Court revealed that Pfizer had covered-up the results of a clinical trial which showed the drug didn’t work for chronic nerve pain, even as it promoted off-label use of the anti-seizure drug for that purpose. The next year, it was revealed that Parke-Davis (now a subsidiary of Pfizer) took advantage of lax disclosure policies by certain medical journals to publish 13 articles promoting off-label use of Neurontin that were ghostwritten and funded by the company without disclosing such arrangements.
Now, it has come to light that Parke Davis’ marketing department sponsored a Seeding Trial of Neurontin back in the day—that is, a trial portrayed deceptively as a patient study but whose real aim was to encourage prescribers to use the drug.
The trial was STEPS, the ‘Study of Neurontin: Titrate to Effect, Profile of Safety’ trial. More than 772 physician ‘investigators’ and 2800 patients participated in STEPS.
The stated objective of STEPS was to study the safety, efficacy and tolerability of Neurontin. However, after reviewing documents compiled for a pair of lawsuits against Pfizer and its subsidiaries, Joseph Ross and colleagues concluded that the actual objective was to increase prescribing rates by ‘investigators’ in the study. Neither the ‘investigators’ nor their patients were informed about the real purpose of STEPS.
The trial worked, from Parke-Davis’ point of view. Read more »
*This blog post was originally published at Pizaazz*
July 21st, 2011 by iMedicalApps in News
No Comments »
The recognition and management of cardiac arrhythmias is a must-have clinical skill for residents and physicians, and one that is often not well-taught at some institutions.
For example, deciding whether a patient is in a shockable rhythm, realizing what medications should or should not be given in a particular situation, or assessing the degree of atrioventricular block, can all be important considerations in patient care.
The Arrhythmias app, designed by Abe Balsamo, recently cracked the Top 10 list of most-downloaded medical apps in the app store. This app represents Mr. Balsamo’s first foray into the app world, though he has several other apps in development, according to his website AppsByAbe.com. The app’s growing popularity has been driven by its point-of-care abilities that appeal to healthcare professionals, especially emergency medical personnel.
Read below the jump to see how the Arrhythmias app can assist healthcare professionals with the recognition of different arrhythmias. Read more »
*This blog post was originally published at iMedicalApps*
July 20th, 2011 by Paul Auerbach, M.D. in Health Tips
No Comments »
Ear infections are the bane of childhood and can spoil many outdoor adventures. One of the most common infections of childhood, they provoke long nights of miserable children, sleepless parents, and unhappiness all around. They may be recurrent, and can also progress (rarely) to more serious medical problems, such as meningitis.
What Are Ear Infections?
Acute otitis (inflammation of the ear) media (“middle”) infection is caused by bacteria or viruses. When it occurs, there is redness and inflammation of the eardrum, frequently with a collection of blood, serum, or pus behind the drum. To know whether or not this has occurred, and to precisely determine the anatomic diagnosis and severity, one needs to see the eardrum, which is what the healthcare provider does with an otoscope.
With otitis media (middle ear infection), there is no drainage from the external ear canal (unless the eardrum ruptures, which is unusual in an adult and more common in a child) and the victim has a fever, sometimes with an accompanying sore throat. In many cases, the victim has a history of prior similar ear infections. Most often, otitis media occurs in children; when it occurs in an adult, it may be associated with a sinus infection or functional obstruction of the eustachian tube (the pressure-release mechanism from the middle ear into the throat).
It is interesting to note that children who chew Read more »
This post, One Of The Most Common Infections Of Childhood: Otitis Media, was originally published on
Healthine.com by Paul Auerbach, M.D..
