The Concern about Overdiagnosis

A clear insight about over diagnosis in less than 3 mns

Video published on 19 Nov 2016 by Show More Spine.

Paul Glasziou’s Interview by Alan Cassels at Preventing Overdiagnosis Conference 2016 in Barcelona, Spain.

Watch more videos about overdiagnosis on YouTube.

Doctors misunderstand what FDA drug approval really means

Shouldn’t physicians and consumers hear about the negative studies?

Most doctors do not fully understand the drug approval process for the US Food and Drug Administration (FDA) or the FDA’s “breakthrough” drug classification.

” Physicians tended to overestimate the minimum evidence of efficacy required of new drugs.

Similarly, many misinterpreted the term breakthrough—believing these drugs were supported by stronger evidence than required by the statute. “

write Aaron S. Kesselheim, MD, JD, MPH, from Brigham and Women’s Hospital in Boston, Massachusetts

Abstract

This survey study examines how well physicians understand the US Food and Drug Administration’s (FDA’s) statutory definition of a “breakthrough” therapy, and whether the term breakthrough affects their perceptions of a drug’s efficacy.

Physicians’ Knowledge About FDA Approval Standards and Perceptions of the “Breakthrough Therapy” Designation, JAMA. 2016; 315(14):1516-1518. , doi:10.1001/jama.2015.16984, April 12, 2016.

Before US patients can use new prescription drugs, the US Food and Drug Administration (FDA) reviews the clinical trial results to confirm that benefits outweigh harms for the indication. Approval may involve superiority to placebo, not to an active comparator or standard of care (although approval can be based on uncontrolled or historically controlled studies). Numerous pathways expedite drug development and approval for serious or life-threatening conditions. For example, since 2012, the FDA can designate a drug as a “breakthrough therapy” if preliminary clinical evidence—such as an improvement in a pharmacodynamic biomarker—suggests an advantage over existing options Through April 2015, the FDA designated 76 “breakthrough” drugs and the term is routinely used in press releases and prescribing resources.

Press releases
  • Inside the Sausage Factory of Drug Approval: Nuplazid (pimavanserin) coverage didn’t inspect closely enough, healthnewsreview, May 23, 2016.
  • Internists, Specialists Lack Knowledge About FDA Drug Approval Process, medscape, April 12, 2016.

Too much medicine in older people?

Deprescribing through shared decision making

Abstract

Too much medicine is an increasingly recognised problem, and one manifestation is inappropriate polypharmacy in older people. Polypharmacy is usually defined as taking more than five regular prescribed medicines. It can be appropriate (when potential benefits outweigh potential harms) but increases the risk of older people experiencing adverse drug reactions, impaired physical and cognitive function, and hospital admission. There is limited evidence to inform polypharmacy in older people, especially those with multimorbidity, cognitive impairment, or frailty. Systematic reviews of medication withdrawal trials (deprescribing) show that reducing specific classes of medicines may decrease adverse events and improve quality of life.

Jansen and colleagues explore the role of shared decision making in tackling inappropriate polypharmacy in older adults, BMJ 2016;353:i2893, 03 June 2016.

Two recent reviews of the literature on deprescribing stressed the importance of patient involvement and shared decision making. Patients and clinicians typically overestimate the benefits of treatments and underestimate their harms. When they engage in shared decision making they become better informed about potential outcomes and as a result patients tend to choose more conservative options (eg, fewer medicines), facilitating deprescribing. However, shared decision making in this context is not easy, and there is little guidance on how to do it.

Combating the Over-medication of Seniors, ottawalife, JUNE 7, 2016.

Image of 17 Pills for from food supplements to medications by Peter Prehn.

We draw together evidence from the psychology, communication, and decision making literature. For each step of the shared decision making process we describe the unique tasks required for deprescribing decisions; identify challenges for older adults, their companions, and clinicians; give practical advice on how challenges may be overcome; highlight where more work is needed; and identify priorities for future research.

The Cochrane Collaboration: Medicine’s Best-Kept Secret

By Alan Cassels, Foreward by Sir Iain Chalmers, 2015

The-Cochrane-Collaboration book cover omage
To celebrate its 20th anniversary, writer and professional medical skeptic Alan Cassels was selected to draw back the curtains on the Cochrane Collaboration. His extensive interviews of Cochranites allowed him to document their achievements, resulting in a book that its leadership ultimately refused to publish.

” In the complex, ever-evolving realm of modern medicine, how can you even begin to understand what’s hocus-pocus and what really works? Best-selling author and researcher Alan Cassels answers with a single word: Cochrane.

Though largely unknown to the public, the Cochrane Collaboration is made up of more than 30,000 medical researchers and consumer representatives from more than 100 countries – unbiased experts and investigators who parse the science of modern health care and delve deep into the evidence (or lack thereof) to determine what works and what doesn’t.

In this frank, factual and entertaining volume, Cassels draws from more than 160 interviews to shed light on this international cadre of medical truth-seekers whose rigorous work helps prevent medical misjudgement, reduce unnecessary suffering, preserve lives and circumvent the squandering of billions of dollars. “

More books from Alan Cassels

News drugs and marketing tactics of the pharmaceutical industry

How Big Pharma is Selling Sickness, Alan Cassels, 2012

Alan Cassels was the keynote speaker at the Victoria Seniors Meeting, Febr. 2012.

More information
  • A drug policy researcher for the University of Victoria, Alan Cassels is a known for having a knack for finding and describing the chasm between what the market says and what science does in modern healthcare. Over the past two decades Cassels has spent much of his research energy studying clinical research and the marketing tactics of the pharmaceutical industry, turning some of that research into journalism and books, including international best-sellers Selling Sickness: How the World’s Biggest Pharmaceutical Companies are Turning us All into Patients and The ABC’s of Disease Mongering: An Epidemic in 26 Letters.
  • Watch more pharma videos on @DES_Journal YouTube channel.

Medicating normalness: saying “know” to drugs

Are we over-medicating ourselves and our children?
Video with Alan Cassels 6/6

Are we over-medicating ourselves and our children? Drug policy researcher Alan Cassels discusses the drug industry; the methods and practices on how they operate and he questions whether or not we need to take as many prescription drugs as we are lead to believe for that ‘quick fix’ in our lives.

More information

Medicating normalness: saying “know” to drugs

Are we over-medicating ourselves and our children?
Video with Alan Cassels 5/6

Are we over-medicating ourselves and our children? Drug policy researcher Alan Cassels discusses the drug industry; the methods and practices on how they operate and he questions whether or not we need to take as many prescription drugs as we are lead to believe for that ‘quick fix’ in our lives.

More information

Medicating normalness: saying “know” to drugs

Are we over-medicating ourselves and our children?
Video with Alan Cassels 4/6

Are we over-medicating ourselves and our children? Drug policy researcher Alan Cassels discusses the drug industry; the methods and practices on how they operate and he questions whether or not we need to take as many prescription drugs as we are lead to believe for that ‘quick fix’ in our lives.

More information

Medicating normalness: saying “know” to drugs

Are we over-medicating ourselves and our children?
Video with Alan Cassels 3/6

Are we over-medicating ourselves and our children? Drug policy researcher Alan Cassels discusses the drug industry; the methods and practices on how they operate and he questions whether or not we need to take as many prescription drugs as we are lead to believe for that ‘quick fix’ in our lives.

More information

Medicating normalness: saying “know” to drugs

Are we over-medicating ourselves and our children?
Video with Alan Cassels 2/6

Are we over-medicating ourselves and our children? Drug policy researcher Alan Cassels discusses the drug industry; the methods and practices on how they operate and he questions whether or not we need to take as many prescription drugs as we are lead to believe for that ‘quick fix’ in our lives.

More information