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/
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.
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 Surgery, 140(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
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/
Medications can be beneficial and safe lives; however, some may not work as well as promised. In some cases, they may do more harm than good as illustrated by the following examples.
- There is weak or no evidence of effectiveness for the long term use of any opiod (morphine, fentanyl, oxycodone, methadone and hydrocodone) in the treatment of chronic pain (Perlin, 2015). As the Center for Disease Control and Prevention reports, “Since 1999, the amount of prescription painkillers prescribed and sold in the U.S. has nearly quadrupled, yet there has not been an overall change in the amount of pain that Americans report. Over prescribing leads to more abuse and more overdose deaths.” More than 16,000 people a year die from prescription drug overdose (CDC, 2016). For a superb discussion of the treatment of chronic pain, see the recently published book by Cindy Perlin, The truth about chronic pain treatments.
- Selective serotonin re-uptake inhibitor such as Paxil and Prozac (SSRI) are much less effective than promised by pharmaceutical companies. When independent researchers (not funded by pharmaceutical companies) re-analyzed the data from published and unpublished the studies, they found that the medication was no more effective than the placebo for the treatment of mild and moderate depression (Ioannidis, 2008; Le Noury et al, 2015). In addition, the SSRIs (paroxetine and Imipramine) in treatment of unipolar major depression in adolescence may cause significant harm which outweigh any possible benefits (Le Le Noury et al., 2015). On the other had, exercise appears as effective as antidepressants for reducing symptoms of mild to moderate depression (Cooney et al., 2013). Despite the questionable benefits of SSRI medications, pharmaceutic industry to posted $11.9 billion dollars in 2011 global sales (Perlin, 2015).
- Why are you prescribing the medication?
- What are the risks and negative side effects?
- Do the benefits outweigh the risks?
- How do I know when the medication is working?
- What will you do if the medication does not work?
- How many patients do you need to treat before one patient benefits?
- Can you recommend non-pharmaceutical options?
The important questions to ask are:
- How many patients need to be treated with the medication before one patient benefits?
- How many will experience negative side effects?
The data can be discouraging. As Daniel Levitin, neuroscientist at McGill University in Montreal and Dean at Minerva Schools in San Francisco, points out, it takes 300 people to take statins for one year before one heart attack, stroke or other serious event is prevented. However, 5% of all the people taken statins (the of drug of choice to lower cholesterol) will experience debilitating adverse effects such as severe muscle pain and gastrointestinal disorders. This means that you are 15 times more likely to suffer serious side effect than being helped by the drug. Nevertheless, the CDC reported that during 2011–2012, more than one-quarter (27.9%) of adults aged 40 and over used a prescription cholesterol-lowering medication (statins) (Gu, 2014).
Before making any medical decision when stressed, watch the superb 2015 TED London presentation by neuroscientist Daniel Levitin, How to think about making a decision under stress.
CDC Center for Disease Control and Prevention (2016). Injury prevention & control: Prescription drug overdose. http://www.cdc.gov/drugoverdose/
Cooney, G.M., Dwan, K., Greig, C.A., Lawlor, D.A, Rimer, J., Waugh, F.R., McMurdo, M., & Mead, G. E.(2013). Exercise for depression. Cochrane Database of Systematic Reviews 2013, Issue 9. Art. No.: CD004366. DOI: 10.1002/14651858.CD004366.pub6.The Cochrane Library. http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD004366.pub6/epdf
Goter, R. & Peper, E. (2011). Fighting cancer: A nontoxic approach to treatment. Berkeley, CA: Noreth Atlantic Books.http://www.amazon.com/Fighting-Cancer-Nontoxic-Approach-Treatment/dp/1583942483/ref=sr_1_2_twi_pap_2?ie=UTF8&qid=1452715134&sr=8-2&keywords=gorter+and+peper
Gu, Q., Paulose-Ram, R., Burt, V.L., & Kit, B.K. (2014).Prescription Cholesterol-Lowering Medication Use in Adults Aged 40 and Over: United States, 2003–2012. NCHS Data Brief No. 177. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention National Center for Health Statistics.http://www.cdc.gov/nchs/data/databriefs/db177.pdf
Ioannidis, J. P. (2008). Effectiveness of antidepressants: an evidence myth constructed from a thousand randomized trials?. Philosophy, Ethics, and Humanities in Medicine, 3(1), 14. http://peh-med.biomedcentral.com/articles/10.1186/1747-5341-3-14
Le Noury, J., Nardo, J. M., Healy, D., Jureidini, J., Raven, M., Tufanaru, C., & Abi-Jaoude, E. (2015). Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. http://www.bmj.com/content/351/bmj.h4320.full
Levitin, D. (2015). How to stay calm when you know you’ be stressed. TEDGlobal London Talk http://www.ted.com/talks/daniel_levitin_how_to_stay_calm_when_you_know_you_ll_be_stressed
Perlin, C. (2015). The truth about chronic pain treatments. Delmar, NY: Morning Light Books, LLC. http://www.amazon.com/gp/product/B0160UEQB2/ref=dp-kindle-redirect?ie=UTF8&btkr=1
Robin, E.D. (1984). Matters of life & death: Risks vs. benefits of medical care. New York: W.H. Freeman and Company. http://www.amazon.com/Matters-Life-Death-Benefits-Medical/dp/071671681X/ref=tmm_pap_swatch_0?_encoding=UTF8&qid=&sr=