The prevailing attitude “There’s a pill for that” comes from effective marketing!

The prevailing attitude “There’s a pill for that” comes from effective marketing!

The prevailing attitude “There’s a pill for that” comes from effective marketing!

The bispectral index monitor (BIS) illustrates

many of the principles of medical

reversal. Although rare, anesthesia awareness

(or intraoperative awareness) is debilitating

and is associated with post traumatic stress disorder

and anxiety.74 The BIS monitor was

developed to ensure that patients were

receiving adequate anesthesia by using a single

electroencephalographic lead to calculate a

the monitor’s use increased. By

July 2007, half of all operating rooms in the

United States had a BIS monitor.77 Then in

2008, a large, randomized trial comparing the

BIS monitor with a standardized sedation monitoring

strategy found no benefit for the device on

anesthesia awareness.78 Many reversals have

similar narratives

These reversals include arthroscopic surgery

for knee osteoarthritis,40 vertebroplasty for

osteoporotic fractures,17 endovascular repair

of infrarenal abdominal aortic aneurysms,43

stenting in patients with stable coronary artery

disease,1 amnioinfusion for women with meconium

staining,44 C-reactive protein testing,45

screening men with the prostate specific antigen

test,46 and routine revascularization or stress

testing before surgery

Antimicrobial treatment in

diabetic women with

asymptomatic bacteriuria

(Harding et al,48 2002)

In contrast to European societies, several groups49,50 in the United States recommended screening and treating

for asymptomatic bacteriuria in women with diabetes. This randomized trial found that although this practice

leads to more antibiotic use, it did not reduce complications or improve the time to symptomatic infection

Conventional adjuvant

chemotherapy with or

without high-dose

chemotherapy and

autologous stem-cell

transplantation in high-risk

breast cancer (Tallman

et al,51 2003)

Multiple studies have claimed that high-dose chemotherapy with stem cell transplantation improves disease-free

survival at 3 years to 65%-70%, an improvement of 20%-30% beyond standard adjuvant chemotherapy.52,53

High-dose chemotherapy and autologous stem cell transplantation became a common, costly, and

controversial practice for more than a decade. This trial randomized patients with primary breast cancer with

involvement of at least 10 ipsilateral axillary lymph nodes to standard adjuvant chemotherapy vs adjuvant

chemotherapy followed by high-dose chemotherapy and stem cell transplant. The study arm was found to

reduce risk of relapse, but no improvement in survival was found

Control of exposure to mite

allergen and allergen impermeable

bed covers for

adults with asthma

(Woodcock et al,54 2003)

The cost of impermeable bed covers is in the millions of dollars annually, whereas the cost of all preventive

interventions for asthma and allergic rhinitis is in the billions.55 US56 and European57 guidelines recommend

these covers be used among many patients with asthma. This double-blind, randomized, placebo-controlled

trial of >1100 patients found no benefit on any clinical or physiologic outcome for this practice

Methylprednisolone,

valacyclovir, or the

combination for vestibular

neuritis (Strupp et al,58

2004)

The cause of vestibular neuritis is presumed to be a viral infection,59 and yet it is unknown whether

corticosteroids, an antiviral medication, or a combination of both have any benefit in treating this disease. At

the time of this publication, physicians prescribed either or both. A prospective, randomized, double-blind, 2-by-2

factorial trial was performed assessing whether placebo, methylprednisolone, valacyclovir, or a combination of the 2

would improve symptoms. Only the corticosteroids, and not the antiviral, improved the recovery of patients with

vestibular neuritis

Mild intraoperative

hypothermia during surgery

for intracranial aneurysm

(Todd et al,60 2005)

Hypothermia was found to be helpful as a neurosurgical adjunct in 1955, especially for ischemic and traumatic insults.

At the time of this publication, the practice was used in nearly 50% of aneurysm surgeries.61 This large randomized

study, the Intraoperative Hypothermia for Aneurysm Surgery Trial (IHAST), found no improvement in neurologic

outcomes with hypothermia, while noting an increase in bacterial infections with the intervention

Optimal medical therapy with

or without PCI for stable

coronary disease (Boden

et al,35 2007)

Although treatment guidelines recommended an initial approach of intensive medical therapy, reduction of risk

factors, and lifestyle modification (optimal medical therapy) for patients with stable coronary artery disease,

percutaneous coronary intervention (PCI) was still a common initial treatment strategy for patients with stable

coronary artery disease at the time this study was performed.62,63 The authors found that PCI added to optimal

medical therapy did not reduce the risk of death, myocardial infarction, or other major cardiovascular events

In vitro fertilization with

preimplantation genetic

screening (Mastenbroek

et al,64 2007)

Because low pregnancy rates in women of advanced maternal age undergoing in vitro fertilization (IVF) may result

from chromosomal abnormalities, the use of preimplanation genetic screening had become increasingly more

common at the time of this study.65-67 However, this multicenter, double-blind randomized controlled trial

comparing IVF with and without preimplantation genetic screening found that screening significantly reduced

rates of ongoing pregnancies and live births after IVF in women of advanced maternal age

Effects of intensive glucose

lowering in type 2 diabetes

(Action to Control

Cardiovascular Risk in

Diabetes Study Group

et al,68 2008)

A target hemoglobin A1c of 7.0% or less as recommended for most patients with diabetes.69 The Action to Control

Cardiovascular Risk in Diabetes (ACCORD) trial found that target of <7 .0="" 3.5="" for="" increased="" p="" sustained="" years="">

mortality and did not significantly reduce major cardiovascular events compared with a more permissive goal

Revascularization versus

medical therapy for renal artery

stenosis (ASTRAL

Investigators et al,70 2009)

Renal artery stenosis is associated with hypertension and kidney disease, but it is unclear if the relationship is

causal. Despite this uncertainty, data from studies in the United States indicate that revascularization is

performed in 16% of patients with newly diagnosed atherosclerotic renovascular disease and hypertension.71

This large randomized trial of revascularization with medical management vs medical management alone found

substantial risks but no evidence of benefit from revascularization in this population

Gentamicin-collagen sponge

for infection prophylaxis in

colorectal surgery (Bennett-

Guerrero et al,72 2010)

The gentamicin-collagen sponge has been approved for use in numerous countries and used in millions of patients

worldwide since 1985. A single-center, randomized trial found a 70% decrease in surgical site infection with

implantation of the sponge.73 However, this large, multicenter, phase 3 trial found that the gentamicin-collagen

sponge paradoxically resulted in significantly more surgical site infections, was associated with more visits to the

emergency department or surgical office, and more frequently precipitated subsequent hospitalization for the

infection

evidence for vitamin E’s cardiovascular benefits from 1993 (refuted in 2005).

Also looked at articles citing evidence for b-carotene in cancer from 1981 (refuted in 1994-1996)

Also looked at articles citing evidence for estrogen in Alzheimer’s disease from 1996 (refuted 2004)

Table 1. Number (Percentage) of Reversal, Reaffirmation, and Inconclusive Articles by Year

Year	Reversal	Reaffirmation	Inconclusive
2001 (n=48)	14 (29.2)	20	14
2002 (n=26)	12 (46.2)	9	5
2003 (n=31)	12 (38.7)	12	7
2004 (n=33)	12 (36.4)	15	6
2005 (n=41)	19 (46.3)	14	8
2006 (n=20)	12 (60.0)	5	3
2007 (n=54)	18 (33.3)	17	19
2008 (n=32)	15 (46.9)	13	4
2009 (n=35)	16 (45.7)	16	3
2010 (n=43)	16 (37.2)	17	10
Total (N=363)	146 (40.2)	138 (38.0)	79 (21.7)

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The prevailing attitude “There’s a pill for that” comes from effective marketing!