FDA and ECT

I found this enjoyable blog this morning while I was checking my emails and perusing tweets.  The article that caught my eye was about a disconnect between hospital administrators and doctors.
My comment was that there is a serious disconnect between administrators and nurses too.
The blog title is apropos regarding a disconnect between health care providers and patients, and now clearly the FDA too over ECT.
When I started out in psych nursing in the late 60s I refused to participate in ECT and this caused a serious row.  I also received the only 'A' in my Abnormal Psych class for my term paper on " ECT as a Creator of Social Problems ".
It appears as if little has changed.
More of the pattern of sell out to Big Bus from the White House I'd say...

Human Factor in Medicine and Life.

Alliance for Human Research Protection
A Catalyst for Debate
www.ahrp.org

At the end of today's hearings, an FDA advisory panel will issue
recommendations about whether manufacturers of electroconvulsive devices
must put their devices to rigorous safety tests, or whether they should be
reclassified from Class III (high risk) to Class II (moderate risk).

Below are critical comments by Professor John Read (University of Auckland,
New Zealand) about FDA's Summary of Electroconvulsive devices.

Of note, although 103 deaths were reported to the FDA in individual
submissions, the FDA report devotes merely half a page to this issue.
Does that not demonstrate a disregard for the value of the lives of those
who are subjected to ECT--most often against their will ? 

http://www.ahrp.org/cms/content/view/762/9/ 


Contact: Vera Hassner Sharav
veracare@ahrp.org
212-595-8974


January 28, 2011: MEDIA RELEASE: 

FDA REPORT on ELECTROSHOCK UNDER-ESTIMATES MORTALITY AND MEMORY LOSS
Professor John Read (University of Auckland, New Zealand) has submitted to
the FDA a 'Commentary' of the FDA's 150 page 'Executive Summary' report -
released on the eve of its hearings about Electroshock Therapy (Jan 27-28).
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/M
edicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/UCM24
0933.pdf 

Effectiveness
The five page Commentary (available on request: j.read@auckland.ac.nz)
states, in relation to effectivness,'The FDA staff seem to have conducted a
comprehensive review of the available research. They reach broadly similar
conclusions to that of our own recent review', namely:
'Little evidence exists supporting the long-term effectiveness of ECT' (FDA
Report))

Suicide Prevention
The belief that ECT somehow prevents suicide has long been a central plank
of claims that it is effective made by ECT proponents. The Commentary notes
that the FDA reports no studies at all in support of this claim.  There are
none. There were, however, 43 individual submissions to the FDA citing
suicidality as an adverse effect (p 68).

Deaths
The FDA report devotes only half a page to this issue. 
A claim first made by the American Psychiatric Association (2001) is
repeated verbatim by the FDA: 'mortality rate of 1:10,000 patient, or
1:80,000 treatments'.
Our literature review (Read & Bentall, 2010) found numerous studies with
mortality rates far in excess of that claimed by the APA and reproduced,
rather uncritically, by the FDA. 
103 deaths were reported to the FDA in individual submissions "The FDA
report appears to have significantly underestimated the mortality rate of
ECT."

Memory Loss
The FDA report fails to include the best designed study to date assessing
autobiographical memory. Despite repeated claims, for 50 years, that ECT is
safe, the first large-scale prospective study of cognitive outcomes
following ECT did not occur until 2007. Prominent ECT advocate Harold
Sackeim, found that autobiographical memory was significantly worse than
pre-ECT levels six months later. At both times the degree of impairment was
significantly related to the number of shocks. [The Sackeim study was
formally submitted to the FDA, by JR, on Dec. 30, 2010, with the Read &
Bentall literature review - which is also uncited] A New Zealand Government
report, commissioned by the Ministry of Health concluded that "ECT may
permanently affect memory" (Ministry of Health, 2004) and bemoans the
"slowness in acceptance by some professional groups that such outcomes are
real and significant in people's lives".

Even the 2001 APA Report has acknowledged that "In some patients the
recovery from retrograde amnesia will be incomplete, and evidence has shown
that ECT can result in persistent or permanent memory loss".
The Commentary concludes: "The FDA report has grossly underestimated the
duration of the memory deficits caused by ECT".

'Subjective' Memory Loss
"The FDA report also repeats the claim that much of the memory loss is
related to the depression rather than to the ECT, using the term 'subjective
memory loss' employed by by ECT proponents to promote this hypothesis. Our
review points out that this oft-made claim has been repeatedly demonstrated
to be unsubstatantiated."

* Dr Read had previously submitted a 2010 research literature review,
co-authored with Professor Richard Bentall (University of Liverpool),
concluding that ECT had no benefits beyond the treatment period, did not
prevent suicide and caused long-lasting, sometimes permanent memory
dysfunction.
Read, J., Bentall, R. (2010). The effectiveness of electroconvulsive
therapy: A literature review. Epidemiologia e Psychiatria Sociale, 19,
333-347.

Posted in: ECT,FDA,memory loss