To: [log in to unmask]
From: Ash Paul <[log in to unmask]>
Sent by: "Evidence based health (EBH)" <[log in to unmask]>
Date: 05/06/2011 03:37
Subject: Re: What proportion of our current treatments are 'evidence-based'?
Dear Penny,The recent Propublica investigative journalism article on the US Heart Rhythm Society completely supports your assertions.The CardioBrief Blog summarised the Propublica article on its website:
Heart Society’s Tip Sheets Fail To Mention Risksby Charles Ornstein and Tracy Weber ProPublica, May 5, 2011, 9:48 p.m.For patients researching solutions for scary, often debilitating irregular heartbeats, the information sheets on the Heart Rhythm Society website offer reassuring remedies.Implantable cardioverter defibrillators—devices that automatically deliver shocks to restore normal heart rhythms—are “99% effective,” one sheet says [1]. The sheet doesn’t mention that the devices may also deliver unnecessary and painful jolts [2], which can damage a patient’s quality of life.
Nor does the sheet say that sicker and older patients were underrepresented in clinical trials of the devices, even though they are more likely to have heart rhythm problems, according to cardiologists who reviewed the information sheet for ProPublica.“Even advertisements on TV run through the side effects real quick at the end of the ad,” said Dr. David Mann, an electrophysiologist inLouisville ,Ky. Another society tip sheet says [3] that cardiac ablation, in which catheters are used to destroy abnormal heart tissue, is “an effective treatment for many types of arrhythmias [4]. It is successful in 90 to 98 percent of cases, eliminating the need for open-heart surgery or long-term drug therapy.”
But it too lists no limitations or risks [5]—though they include blood clots, damage to the heart’s electrical system and even puncture of the heart.
Among the society’s biggest funders are makers of defibrillators and catheters used during cardiac ablation. Nearly half of the $16 million in annual revenues last year came from the device and drug industries, according to records on its website [6].
While there is no evidence of a quid pro quo, those who study conflicts of interest in medicine say industry money may subtly affect what groups say—or don’t—about the products made by their financial supporters.In a statement to ProPublica [7], society President Douglas Packer and President-elect Bruce Wilkoff said industry support does not influence educational offerings or the group’s positions on appropriate treatments.
“The risks and limitations of treatments are best conducted between a patient and his/her physician,” they said. A disclaimer on the group’s website also advises patients to consult a doctor.In an interview Thursday at the society’s annual meeting, Wilkoff defended the tip sheets. “Putting out a list (of side effects) doesn’t really inform,” he said. “It just produces anxiety.”By the way, I just love your logo line at the bottom of your email viz The plural of "anecdote" is not "data"
Regards,AshDr Ash Paul
Medical Director
NHS Bedfordshire21 Kimbolton RoadBedfordMK40 2AWTel no: 01234897224Email: [log in to unmask]
--- On Thu, 5/5/11, Penny S Reynolds/FS/VCU <[log in to unmask]> wrote:
From: Penny S Reynolds/FS/VCU <[log in to unmask]>
Subject: Re: What proportion of our current treatments are 'evidence-based'?
To: [log in to unmask]
Date: Thursday, 5 May, 2011, 14:54
Re comments by Ash on the off-label use of rFVIIa and why clinical practice has got so far ahead of the evidence so quickly:Although Big Pharma may contribute to such potentially dangerous clinical practices, it may be unfair to place the burden entirely on them. Clinicians are busy people; many simply lack the time to thoroughly read and digest the research literature. As a result, they rely on a sort of "little Jack Horner" approach to assessing the medical literature - they pick out the "plums" from opinion pieces in flagship journals (such as JAMA, NEJM), abstracts, and talks at meetings. That the information presented at these venues may be highly filtered often escapes attention. For example, one survey of 148 RCT presented at the American College of Cardiology meetings between 1999-2002 found that 61 (or 41%) differed in the efficacy estimate of the primary outcome from later published (and peer-reviewed) reports. Meetings are exciting to be at, lots of new ideas are fermenting and bubbling all over the place, and of course one never ever hears of a negative outcome for all the novel potential silver bullets that are reported on, do we. (A colleague and I have an informal pools where we try to anticipate the "molecule du jour" that will be reported each year at our favourite meetings. The MdJ is always touted as the next magic cure for shock one year, but somehow we never hear of that molecule again). In the talks on rFVIIa I have heard over the years, much was made of the miraculous saves for everyting from severe penetrating trauma to TBI, but deleterious outcomes and costs were almost never mentioned. Perhaps clinical meetings should follow the same reporting guidelines for investigational drugs or procedures (or new uses for them) as those advocated for journalistsPenny S Reynolds, PhD
Assistant Professor, Emergency Medicine Research
Department of Emergency Medicine & VCURES
600 East Broad St, Suite 630
Virginia Commonwealth University Medical Center
Richmond VA 23298
USA
Office: 804 628 1942
Lab: 804 828 4911
Mobile: 804 516 0862
FAX 804 628 0805
Pager: 804 373 0436 / 3427
The plural of "anecdote" is not "data"