Fwd: Media Release: FDA ECT Summary Blind Spots

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Media Release: FDA ECT Summary Blind Spots

Date:

Fri, 28 Jan 2011 11:51:26 -0500

From:

veracare <veracare@...>

Infomail1ahrp (DOT) org <Infomail1@...>

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 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@...

212-595-8974

January 28, 2011: MEDIA RELEASE:

FDA REPORT on ELECTROSHOCK UNDER-ESTIMATES MORTALITY AND MEMORY LOSS

Professor 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@...)

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 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.

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