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E-Articles - Electroconvulsive Therapy - Updates from Harvard Medical School - What Are the Benefits and Dangers?
Memory loss attributed to electroconvulsive therapy (ECT) may to a large extent be associated with how the treatment is administered, according to a study of patients referred to one of seven hospitals in the New York me
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
tropolitan area for ECT.
"The team found that electrical waveform and electrode placement had marked cognitive effects. Sine wave stimulation resulted in pronounced slowing of reaction time, immediately and 6 months fol
"The team found that electrical waveform and electrode placement had marked cognitive effects. Sine wave stimulation resulted in pronounced slowing of reaction time, immediately and 6 months fol
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
owing ECT. Bilateral ECT resulted in more severe and persisting retrograde amnesia than right unilateral ECT."
The above paragraph is not easy to understand. The message is that if you are contemplating ECT for your dep
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ession, it is critical that the ECT clinician be highly skilled, experienced and up-to-date on the latest ECT techniques.
Dr. Harold Sackeim of New York State Psychiatric Institute commented that ECT is currently”the mo
Dr. Harold Sackeim of New York State Psychiatric Institute commented that ECT is currently”the mo
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
t effective short-term antidepressant and its adverse cognitive effects can be substantially reduced, if not eliminated, by adoption of advances in technique."
The results were reported in the February 2007 issue of Neu
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
opsychiatry.
ECT Effectiveness
In February of 2007, Harvard Medical School published a special report investigating the effectiveness of ECT and explaining its dangers. Here is a quick summary:
• ECT does not cause an
ECT Effectiveness
In February of 2007, Harvard Medical School published a special report investigating the effectiveness of ECT and explaining its dangers. Here is a quick summary:
• ECT does not cause an
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
damage visible on brain scans
• The most common complaint is short-term memory loss
• Memory retrograde( events that occurred before treatment) declined with each treatment
• Memory anterograde(ability
• The most common complaint is short-term memory loss
• Memory retrograde( events that occurred before treatment) declined with each treatment
• Memory anterograde(ability
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
to absorb new knowledge) declined with each treatment
• Memory usually returns to normal within a few weeks, but not for all patients and all respects
• Researchers have agreed that most patients suffer some
• Memory usually returns to normal within a few weeks, but not for all patients and all respects
• Researchers have agreed that most patients suffer some
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
permanent memory loss
In controlled studies, ECT had a response rate of about 70%, even though it usually isn't attempted until other treatments fail.
"Like other treatments for depression, ECT is no cure. About half o
In controlled studies, ECT had a response rate of about 70%, even though it usually isn't attempted until other treatments fail.
"Like other treatments for depression, ECT is no cure. About half o
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
the patients relapse within a year and require maintenance ECT treatments. The high relapse rates are not surprising given that most people who undergo ECT have particularly severe symptoms"
What are the dangers?
Here
What are the dangers?
Here
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
is a quick summary:
• ECT does not cause any damage visible on brain scans
• The most common complaint is short-term memory loss
• Memory retrograde( events that occurred before treatment) declined with each
• ECT does not cause any damage visible on brain scans
• The most common complaint is short-term memory loss
• Memory retrograde( events that occurred before treatment) declined with each
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
treatment
• Memory anterograde(ability to absorb new knowledge) declined with each treatment
• Memory usually returns to normal within a few weeks, but not for all patients and all respects
• Research
• Memory anterograde(ability to absorb new knowledge) declined with each treatment
• Memory usually returns to normal within a few weeks, but not for all patients and all respects
• Research
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
rs have agreed that most patients suffer some permanent memory loss.
According to the special 2007 Harvard Medical School report, the placement of the electrodes and the type of electric current make a big difference in
According to the special 2007 Harvard Medical School report, the placement of the electrodes and the type of electric current make a big difference in
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
improving patient outcomes and memory loss. Originally, electrodes were placed at the templates on opposite sides of the head( bilateral placement).
Two new innovations:
• Placement of both electrodes on the same side(
Two new innovations:
• Placement of both electrodes on the same side(
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
unilateral placement), usually the right
• A new ECT machine that produces brief intermittent pulses instead of continual electrical stimulation. This allows for an electrical dose that can be adjusted so that it
• A new ECT machine that produces brief intermittent pulses instead of continual electrical stimulation. This allows for an electrical dose that can be adjusted so that it
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
ust is strong enough to cause a seizure.
Researchers determined that these newer procedures greatly reduced the memory loss. There is still more extensive research required about these new ECT procedures.
If you are co
Researchers determined that these newer procedures greatly reduced the memory loss. There is still more extensive research required about these new ECT procedures.
If you are co
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
sidering ECT, I think that three things are critical:
1. Your psychiatrist should clearly identify you as a good candidate for ECT
2. The clinician that administers the ECT must be highly skilled with extensive e
1. Your psychiatrist should clearly identify you as a good candidate for ECT
2. The clinician that administers the ECT must be highly skilled with extensive e
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
perience in ECT
3. The anesthesiologist should be up-to-date on the latest strategies when administering the muscle relaxant and the anesthesiology
It should be noted that there is no relationship between the po
3. The anesthesiologist should be up-to-date on the latest strategies when administering the muscle relaxant and the anesthesiology
It should be noted that there is no relationship between the po
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
ential effectiveness of vagus nerve stimulation and lack of effectiveness with ECT. I had a series of fifteen unsuccessful ECT treatments in 1998. Thankfully, in April of 2001, I was implanted with the vagus nerve stimul
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
tor. The therapy completely changed my life, I still have the implant, I don't feel the stimulation, the remarkable response has been sustained (i.e. "Prozac poop out”) and there was no absolutely no cognitive impairment
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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