First do no harm: Listen to Freakonomics Radio Episodes Bad Medicine

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How come up to 250,000 people a year die of medical errors and is the third leading cause of death in the USA (Makary & Daniel, 2016)?

Why are some drugs recalled after years of use because they did more harm than good?

How come arthroscopic surgery continues to be done for osteoarthritis of the knee even though it is no more beneficial than mock surgery (Moseley et al, 2002)?

How come women have more negative side effects from Ambien and other sleep aids than men?

Is it really true that the average new cancer drug costs about $100,000 for treatment and usually only extends the life of the selected study participants by about two months (Szabo, 2017; Fojo, Mailankody, & Lo, 2014)?

“It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of the New England Journal of Medicine”Dr. Marcia Angell, longtime Editor in Chief of the New England Medical Journal (Angell, 2009).

Medical discoveries have made remarkable improvements in our health.  The discovery of insulin in 1921 by Canadian physician Frederick Banting and medical student Charles H. Best allowed people with Type 1 Diabetes to live healthy productive lives (Rosenfeld, 2002).  Cataract lens replacement surgery is performed more than three million times per year and allows millions of people to see better even though a few patients have serious side negative side effects.  And, there appears to be new hope for cancer. The FDA on August 30, 2017, approved a new individualized cancer treatment that uses genetically engineered cells from a patient’s immune system to produce remissions in 83 percent of the children and young adults who have relapsed after undergoing standard treatment for B cell acute lymphoblastic leukemia. (FDA August 30, 2017). The one-time treatment for this breakthrough cancer drug for patients who respond costs $475,000 according to the manufacturer Novartis. Yet, it will be years before we know if there are long term negative side effects.

The cost of this treatment is much more than the average cost of $100,000 for newly developed and approved cancer drugs which at best extend the life of highly selected patients on the average by two months; however, when they used with more typical Medicare patients, these drugs often offer little or no  increased benefits (Szabo, 2017; Freakonomics Radio episode Bad Medicine, Part 2: (Drug) Trials and Tribulations).

As the health care industry is promising new screening, diagnostic and treatment approaches especially through direct-to-consumer advertising, they may not always be beneficial and, in some cases, may cause harm.  The only way to know if a diagnostic or treatment procedure is beneficial is to do long term follow-up; namely, did the treated patients live longer, have fewer complications and better quality of life than the non-treatment randomized control patients.  Just because a surrogate illness markers such as glucose level for type 2 Diabetes or blood pressure for essential hypertension decrease in response to treatment, it does not always mean that the patients will have fewer complications or live longer.

To have a better understanding of the complexity and harm that can occur from medical care, listen to the following three Freakonomics Radio episodes titled Bad Medicine.

Freakonomics Radio episode Bad Medicine, Part 1: The story of 98.6.  We tend to think of medicine as a science, but for most of human history it has been scientific-ish at best. In the first episode of a three-part series, we look at the grotesque mistakes produced by centuries of trial-and-error, and ask whether the new era of evidence-based medicine is the solution. http://freakonomics.com/podcast/bad-medicine-part-1-story-98-6/

Freakonomics Radio episode Bad Medicine, Part 2: (Drug) Trials and Tribulations. How do so many ineffective and even dangerous drugs make it to market? One reason is that clinical trials are often run on “dream patients” who aren’t representative of a larger population. On the other hand, sometimes the only thing worse than being excluded from a drug trial is being included. http://freakonomics.com/podcast/bad-medicine-part-2-drug-trials-and-tribulations/

Freakonomics Radio episode, Bad Medicine, Part 3: Death by Diagnosis.  By some estimates, medical error is the third-leading cause of death in the U.S. How can that be? And what’s to be done? Our third and final episode in this series offers some encouraging answers. http://freakonomics.com/podcast/bad-medicine-part-3-death-diagnosis/

References

Angell M. Drug companies and doctors: A story of corruption. January 15, 2009. The New York Review of Books 56. Available: http://www.nybooks.com/articles/archives/2009/jan/15/drug-companies-doctorsa-story-of-corruption/. Accessed 24, November, 2016.

FDA approval brings first gene therapy to the United States, August 30, 2017. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm574058.htm

Fojo, T., Mailankody, S., & Lo, A. (2014). Unintended consequences of expensive cancer therapeutics—the pursuit of marginal indications and a me-too mentality that stifles innovation and creativity: the John Conley Lecture. JAMA Otolaryngology–Head & Neck Surgery140(12), 1225-1236.

Makary, M. A., & Daniel, M. (2016). Medical error-the third leading cause of death in the US. BMJ: British Medical Journal (Online)353. Listen to his BMJ medical talk: https://soundcloud.com/bmjpodcasts/medical-errorthe-third-leading-cause-of-death-in-the-us

Moseley, J.B., et al, (2002). A controlled trial of arthroscopic surgery for osteoarthritis of the knee. New England Journal of Medicine. 347(2), 81-88.

Rosenfeld, L. (2002). Insulin: discovery and controversy. Clinical chemistry48(12), 2270-2288. http://clinchem.aaccjnls.org/content/48/12/2270

Szabo, L. (201, February 9). Dozens of new cancer drugs do little to improve survival. Kaiser Health News. Downloaded September 3, 2017.  https://www.usatoday.com/story/news/nation/2017/02/09/new-cancer-drugs-do-little-improve-survival/97712858/

 


Placebo, social compliance, belief and health

After taking the drug Rumyodin my fear of heights totally disappeared.

I totally stopped smoking.

I continue to be intrigued how mind and body affect each other as in many cases we are our own worst enemies.  Our beliefs are the result of family, friends, cultural and social hypnotic inductions and our lived experiences. We know we are not smart in math because we struggled in 4th grade and our parents said that we were just like aunt Cindy who also was poor in math. The limits of our experiences are often constraint by the limits of our beliefs.

Our covert belief constraints our performance.  Just looking at the math problems causes us to freeze—we already know we cannot do it.  This is no different from being psyched out in sports.  We look at the other athlete and we give up because we know/assume they are better than us. If we can free ourselves from our own limitations, who knows what is possible?  How can we be open and trusting that new options are possible instead of feeling fearful? What is needed to change your beliefs?  We are often unaware how much of our experience is shaped by covert suggestions, imitation and social compliance.

This process has been demonstrated with hypnosis and placebo treatment or medications. They may result in remarkable clinical outcome such as painless surgery without anesthesia, elimination of fear of heights, or resolving an asthmatic episodes. In many cases the outcomes may even be more dramatic if the information is made totally believable and fits our beliefs.  This is the art of medicine.  The intersection of mustering the patients’ belief to support the actual medical treatment.

The following two videos,  Fear and Faith and How to Hypnotise Simon Pegg, by the well-known British stage hypnotist and illusionist, Derren Brown.  He magically weaves together the external environment, language, role modeling, hope, trust and social compliance so that we experience a change in health and beliefs. The first video demonstrates the power of placebo to improve health and performance while the second video illustrates the power of language to change memory and desire.

Fear and Faith A great video showing the power of placebo It uses the cover of a drug trial to convince various members of the public to overcome their fears using “Rumyodin” (your mind) and demonstrates that the limits of experience are the limits of your belief.

How To Hypnotise Simon PeggIllustrates how subtle suggestions can make the person transform a past memory.


Evoking your healing potential: You are your placebo

Be careful what you think. You may get what you wish.

The power of the placebo and nocebo are remarkable and often overlooked in medicine. With a placebo, severe chest pain disappears with mock surgery, Parkinson’s tremors stop, knee pain is eliminated following mock arthroscopic knee surgery and even  of lymphosarcoma can be affected (Beecher, 1961; Benedeteti, 2007; Moseley et al, 2002; Kirkley et al., 2008; Klopfer, 1957; Moerman & Jonas, 2002). On the other hand, nocebo can increase pain, accelerate cancer growth, and cause death (Cannon, 1942; Klopfer, 1957; Benedeteti, 2007). These are demonstrations of the self-healing and non-healing potential intrinsic within each of us.

The placebo response (from Latin, “I shall please”) is the beneficial physiological or psychological effect that results from the administration of an otherwise ineffective or inert substance, procedure, instruction. and/or environment.  An example of placebo on neuron activity is demonstrated with  a patient who has Parkinson’s disease (see figure 1).

Fig 1.Figure 1. Recording the activity of single neurons from the brain of an awake patient suffering from Parkinson’s disease. Both the recording apparatus (a) and the electrode track (b) can be seen. In (c), the activity of a single neuron in the subthalamic nucleus can be seen before and after placebo administration (reproduced from: Benedeteti, F.(2007). The Placebo and Nocebo Effect: How the Therapist’s Words Act on the Patient’s Brain. Karger Gazette, 69)

The nocebo response (from Latin, “I will harm”) may evoke the non-healing process and reactivate symptom/disease producing process and experiences. The nocebo response can be evoked by ineffective or inert substances, procedures, instructions, and internal and external environments which by themselves have no known effects.

The placebo/nocebo response is modulated by our covert cultural, familial and personal beliefs, limitations and expectations. The placebo/nocebo effects are the actual demonstrations that the limits of our beliefs are the limits of our possibilities. This process is well described  in the recent published book, You are the Placebo: Making Your Mind Matter, by Chiropractor Joe Dispenza.

Fig 2Dr. Dispenza describes the classic studies of placebo, mental processes and possible mechanisms by which placebo effects occur and disappears and how our thoughts and expectancies create our reality.  The placebo transforms the inner beliefs and give the person the experience of improved health which transforms beliefs. In many cases we can experience improvement but are pulled back into our previous beliefs and self-images of illness by inner and outer cues which are associated with disease process.

The book describes of the covert conditioning process by which we return to our old self and may maintain illness. It is challenging to maintain new beliefs and act/think in new patterns. The internal mental chatter and doubts flood our awareness. Even the question, “How long will the improvement last?” re-evokes the associative mental conditioned disease patterns. If it is possible to interrupt and transform our thoughts moment by moment, minute by minute, hour by hour, day by day and not just for 15 minutes of practice, remarkable changes are sometimes possible. Every thought that triggers an association of the illness state needs to be interrupted and redirected. When patients somehow transform their thoughts, it may result in reversing and eliminating illnesses such as polyostotic fibrous dysphasia, Hashimot’sthyroiditis or chronic lympocytic thyroiditis, and secondary progressive multiple sclerosis.

I highly recommend this book for its outstanding description of placebo/nocebo and cognitive a model of the conditioning processes that underlie it. The book offers hope and inspiration for many patients who  accept “what is/was” and  are open to the present and future possibilities without judgement.

The book’s cases  show that it is possible to reverse chronic “incurable illnesses.” Patients and health care providers should read the book–it provides hope, empowerment, and possibility. It is an antidote to the feeling that there is nothing one can do except to live with the illness. Medicine needs to explore and study the unusual patient who has reversed the disease process and ask, “How can we understand this process and teach it to other patients.”

The major limitation of the book is the absence of data; namely, what percentage of the patients/participants who have practiced Dispenza’s techniques have actually benefited and transformed their illness? The book would be more useful if it included both successful and the many unsuccessful cases. This would help patients who do the practices and do not improve. These patients sometimes  blame themselves and failed at their self-healing—a process that increases depression and hopelessness. We need to realize that many factors affecting our health and illness are beyond our control.

Although I agree with Dr. Dspenza’s basic premise that our beliefs, acceptance of what is and being open to the present and future supports healing. This perspective is only part of the whole picture. Health and illness are multi-factorial and many factors are not within our control.

Read the book and skip chapter 8, The Quantum Mind.  This chapter attempts to describe the physics of the healing process using quantum physics.  As I did not understand quantum physics and quantum mind, I asked my colleague, James Johnston, PhD, who is an expert in quantum physics, to read it for accuracy. He confirmed my gut reaction when he said, “the quantum physics description of how energy changes is pseudo science, involving an incomplete understanding of quantum theory.”

Beecher, H.K. (1961). Surgery as Placebo. JAMA, 176(13), 1102-1107.

Benedeteti, F. (2007). The Placebo and Nocebo Effect: How the Therapist’s Words Act on the Patient’s Brain. Karger Gazette, 69.

Cannon, W. B. (1942). “Voodoo” death. American Anthropologist, 44(2), 169-181.

Dispenza, J. (2014). You are the Placebo: Making Your Mind Matter. Hay House, Inc.

Kirkley, A. et al,. (2008) A Randomized Trial of Arthroscopic Surgery for Osteoarthritis of the Knee. New England Journal of Medicine. 359:1097-1107

Klopfer, B. (1957). Psychological Variables in Human Cancer. Journal of Projective Techniques, 21, (4), 331–340.

Moerman, D.E., & Jonas, W.B. (2002). Deconstructing the Placebo Effect and Finding the Meaning Response. Annals of Internal Medicine. 136 (6), 471-476.

Moseley, J.B., et al, (2002). A controlled trial of arthroscopic surgery for osteoarthritis of the knee. New England Journal of Medicine. 347(2), 81-88.