ALERT!! FDA Urged to Curb Bogus Energy Medicine Devices

[Guest guest]

This is of great concern to anyone involved in any way with any type of

electromedical device that is not FDA approved. You may recall the Seattle Times

series on the EPFX and Bill . Here is the next step. Note the long list of

energy devices to be banned. Device manufacturers and vendors may wish to be

especially careful about making claims for their devices.

FDA Urged to Curb Bogus " Energy Medicine " Devices

In January 2008, Washington Attorney General Rob McKenna and state Department of

Health Secretary Selecky sent the below letter asking the FDA to block the

sale and distribution of unproven and dangerous " energy medicine " devices. An

FDA official replied http://www.devicewatch.org/eav/fda_reply.pdf that the

agency has increased its surveillance of Internet promotion and advertising.

=====================================================

Rob McKenna

ATTORNEY GENERAL OF WASHINGTON

1125 Washington Street SE

PO Box 40100

Olympia WA 98504-0100

December 20, 2007

Ulatowski

Compliance Director

U.S. Food and Drug Administration

Center for Devices and Radiological Health

Room 244 Gaither Road

Rockville, land 20850

RE: " Energy Medicine " Medical Devices

Dear Mr. Ulatowski:

We were encouraged by your recently announced commitment to block the import of

the EPFX, and to investigate its manufacturer, distributors and operators. We

believe your response to the Seattle Times series that exposed the dangers of

the EPFX was appropriate and commendable.

While the Seattle Times series presented an in-depth look at the dangers of one

" energy medicine " device, it also alluded to the existence of dozens of other

devices that are equally dangerous. We encourage you to expand your import block

and investigation to those other devices.

In 2003, the state of Washington sued Pacific Health Center for, among other

things, its use of an " electrodermal testing " device, the Omega Accubase C-29a.

Investigations by our agencies and the Attorney General's Office lawsuit confirm

our belief that targeting a singular device does not deter or immobilize the

overall industry.

This particular " energy medicine " device was purported to determine the

presence of various conditions, including arthritis, immune deficiencies, high

cholesterol and hypertension. It was also purported to be able to determine the

proper remedy for these conditions. The Attorney General's Office lawsuit

claimed that the efficacy of the device - which had been used on more than 5,000

people who each paid approximately $500-had not been adequately substantiated.

The suit also claimed that the operators of the device were practicing medicine,

acupuncture and naturopathy without proper licensure. The State ultimately

dropped its substantiation claims voluntarily when the court decided that the

defendants were engaging in unlicensed practices. The defendants are no longer

doing business in Washington, but continue to operate from locations in Oregon

and Idaho.

In the course of investigating and litigating the case, we learned an enormous

amount about the " energy medicine " field. Our research of the device used by

Pacific Health Center uncovered an entire industry devoted to the sale,

distribution and use of various unproven devices. These devices were advertised

widely on the Internet, sold by several manufacturers, and used in clinics

across the country. We found no research that scientifically substantiated their

effectiveness, not even one study that relied on the double-blinded clinical

trials that are the scientific " gold standard " for proving the truth of medical

claims. And yet, they were and are used widely for a variety of purposes

including diagnosing and treating human and animal diseases, determining food

sensitivities and allergies, and finding tooth decay. The amount of money spent

by unwary consumers is enormous, and the risk that these consumers are foregoing

traditional treatment in favor of " snake oil " cures is frightening.

We request that the FDA consider not just the EPFX as the target of your

investigation, but to include all of the unproven and dangerous medical devices

that are currently being sold and used the U.S. market.

In a recent review of Internet websites touting these devices, the Attorney

General's Office was able to find the following numerous examples that are

indistinguishable in their ineffectuality from the EPFX: NES, E-Lybra, LSA

Biofeedback, QXCI/SCIO, Life System, CoRe, Oberon, Mars, Quantec, Metascan,

Etascan, SCENAR, ACUSEN, Interx: VEGA, Prognos, Biomeridian, Rife, Bicom,

BioPuslar, Mitosan Therapy, Bodyscan, Zappers, F-Scan, Q2, Syncrometer,

Magnagraph, Merid, NES, Acusense, Listen, EQ4, Orion, Explorer, Computron,

Elision, Interro, Interactive Query System, MORA, Matrix Physique System,

Propylene, Punts III and Vitel.

This list is not exhaustive, and there are even more devices on the market.

The sale and use of untested medical devices is a national problem. States can

chip away at it through actions under their consumer protection and medical

licensing statutes, but the FDA is the most effective regulator in this area.

We encourage you to ban the manufacture, distribution and use of these dangerous

devices, to step up enforcement against those who are taking consumers' money

and risking their health, and to generalize your approach to include more than

just one device. We pledge to work with you in this endeavor and are happy to

share our thoughts, research and the testimony of the experts we have consulted.

Sincerely,

ROB MCKENNA

Washington State Attorney General

MARY SELECKY

Secretary, Washington State Department of Health

[Guest guest]

Hi,

How do we get in touch with these people to stop this from happening? Oh, I

guess if these devices are no longer sold, we better get the rife videos on dvd

and start passing them out like crazy to ensure the ongoing research into

technology developed by Rife.

Josh

email: jkenn337@...

msn: kenn6498ku@...

skype: jkenn337

ALERT!! FDA Urged to Curb Bogus " Energy Medicine " Devices

This is of great concern to anyone involved in any way with any type of

electromedical device that is not FDA approved. You may recall the Seattle Times

series on the EPFX and Bill . Here is the next step. Note the long list of

energy devices to be banned. Device manufacturers and vendors may wish to be

especially careful about making claims for their devices.

FDA Urged to Curb Bogus " Energy Medicine " Devices

In January 2008, Washington Attorney General Rob McKenna and state Department

of Health Secretary Selecky sent the below letter asking the FDA to block

the sale and distribution of unproven and dangerous " energy medicine " devices.

An FDA official replied http://www.devicewatch.org/eav/fda_reply.pdf that the

agency has increased its surveillance of Internet promotion and advertising.

=====================================================

Rob McKenna

ATTORNEY GENERAL OF WASHINGTON

1125 Washington Street SE

PO Box 40100

Olympia WA 98504-0100

December 20, 2007

Ulatowski

Compliance Director

U.S. Food and Drug Administration

Center for Devices and Radiological Health

Room 244 Gaither Road

Rockville, land 20850

RE: " Energy Medicine " Medical Devices

Dear Mr. Ulatowski:

We were encouraged by your recently announced commitment to block the import

of the EPFX, and to investigate its manufacturer, distributors and operators. We

believe your response to the Seattle Times series that exposed the dangers of

the EPFX was appropriate and commendable.

While the Seattle Times series presented an in-depth look at the dangers of

one " energy medicine " device, it also alluded to the existence of dozens of

other devices that are equally dangerous. We encourage you to expand your import

block and investigation to those other devices.

In 2003, the state of Washington sued Pacific Health Center for, among other

things, its use of an " electrodermal testing " device, the Omega Accubase C-29a.

Investigations by our agencies and the Attorney General's Office lawsuit confirm

our belief that targeting a singular device does not deter or immobilize the

overall industry.

This particular " energy medicine " device was purported to determine the

presence of various conditions, including arthritis, immune deficiencies, high

cholesterol and hypertension. It was also purported to be able to determine the

proper remedy for these conditions. The Attorney General's Office lawsuit

claimed that the efficacy of the device - which had been used on more than 5,000

people who each paid approximately $500-had not been adequately substantiated.

The suit also claimed that the operators of the device were practicing medicine,

acupuncture and naturopathy without proper licensure. The State ultimately

dropped its substantiation claims voluntarily when the court decided that the

defendants were engaging in unlicensed practices. The defendants are no longer

doing business in Washington, but continue to operate from locations in Oregon

and Idaho.

In the course of investigating and litigating the case, we learned an enormous

amount about the " energy medicine " field. Our research of the device used by

Pacific Health Center uncovered an entire industry devoted to the sale,

distribution and use of various unproven devices. These devices were advertised

widely on the Internet, sold by several manufacturers, and used in clinics

across the country. We found no research that scientifically substantiated their

effectiveness, not even one study that relied on the double-blinded clinical

trials that are the scientific " gold standard " for proving the truth of medical

claims. And yet, they were and are used widely for a variety of purposes

including diagnosing and treating human and animal diseases, determining food

sensitivities and allergies, and finding tooth decay. The amount of money spent

by unwary consumers is enormous, and the risk that these consumers are foregoing

traditional treatment in favor of " snake oil " cures is frightening.

We request that the FDA consider not just the EPFX as the target of your

investigation, but to include all of the unproven and dangerous medical devices

that are currently being sold and used the U.S. market.

In a recent review of Internet websites touting these devices, the Attorney

General's Office was able to find the following numerous examples that are

indistinguishable in their ineffectuality from the EPFX: NES, E-Lybra, LSA

Biofeedback, QXCI/SCIO, Life System, CoRe, Oberon, Mars, Quantec, Metascan,

Etascan, SCENAR, ACUSEN, Interx: VEGA, Prognos, Biomeridian, Rife, Bicom,

BioPuslar, Mitosan Therapy, Bodyscan, Zappers, F-Scan, Q2, Syncrometer,

Magnagraph, Merid, NES, Acusense, Listen, EQ4, Orion, Explorer, Computron,

Elision, Interro, Interactive Query System, MORA, Matrix Physique System,

Propylene, Punts III and Vitel.

This list is not exhaustive, and there are even more devices on the market.

The sale and use of untested medical devices is a national problem. States can

chip away at it through actions under their consumer protection and medical

licensing statutes, but the FDA is the most effective regulator in this area. We

encourage you to ban the manufacture, distribution and use of these dangerous

devices, to step up enforcement against those who are taking consumers' money

and risking their health, and to generalize your approach to include more than

just one device. We pledge to work with you in this endeavor and are happy to

share our thoughts, research and the testimony of the experts we have consulted.

Sincerely,

ROB MCKENNA

Washington State Attorney General

MARY SELECKY

Secretary, Washington State Department of Health

[Guest guest]

WOW, thanks for sending, was wondering when this was going

to happen, only a matter of time.

I just love the " golden standard " referred to, now if they just

honestly applied that to drugs.

Jay

-------------- Original message --------------

This is of great concern to anyone involved in any way with any type of

electromedical device that is not FDA approved. You may recall the Seattle Times

series on the EPFX and Bill . Here is the next step. Note the long list of

energy devices to be banned. Device manufacturers and vendors may wish to be

especially careful about making claims for their devices.

FDA Urged to Curb Bogus " Energy Medicine " Devices

In January 2008, Washington Attorney General Rob McKenna and state Department of

Health Secretary Selecky sent the below letter asking the FDA to block the

sale and distribution of unproven and dangerous " energy medicine " devices. An

FDA official replied http://www.devicewatch.org/eav/fda_reply.pdf that the

agency has increased its surveillance of Internet promotion and advertising.

=====================================================

Rob McKenna

ATTORNEY GENERAL OF WASHINGTON

1125 Washington Street SE

PO Box 40100

Olympia WA 98504-0100

December 20, 2007

Ulatowski

Compliance Director

U.S. Food and Drug Administration

Center for Devices and Radiological Health

Room 244 Gaither Road

Rockville, land 20850

RE: " Energy Medicine " Medical Devices

Dear Mr. Ulatowski:

We were encouraged by your recently announced commitment to block the import of

the EPFX, and to investigate its manufacturer, distributors and operators. We

believe your response to the Seattle Times series that exposed the dangers of

the EPFX was appropriate and commendable.

While the Seattle Times series presented an in-depth look at the dangers of one

" energy medicine " device, it also alluded to the existence of dozens of other

devices that are equally dangerous. We encourage you to expand your import block

and investigation to those other devices.

In 2003, the state of Washington sued Pacific Health Center for, among other

things, its use of an " electrodermal testing " device, the Omega Accubase C-29a.

Investigations by our agencies and the Attorney General's Office lawsuit confirm

our belief that targeting a singular device does not deter or immobilize the

overall industry.

This particular " energy medicine " device was purported to determine the presence

of various conditions, including arthritis, immune deficiencies, high

cholesterol and hypertension. It was also purported to be able to determine the

proper remedy for these conditions. The Attorney General's Office lawsuit

claimed that the efficacy of the device - which had been used on more than 5,000

people who each paid approximately $500-had not been adequately substantiated.

The suit also claimed that the operators of the device were practicing medicine,

acupuncture and naturopathy without proper licensure. The State ultimately

dropped its substantiation claims voluntarily when the court decided that the

defendants were engaging in unlicensed practices. The defendants are no longer

doing business in Washington, but continue to operate from locations in Oregon

and Idaho.

In the course of investigating and litigating the case, we learned an enormous

amount about the " energy medicine " field. Our research of the device used by

Pacific Health Center uncovered an entire industry devoted to the sale,

distribution and use of various unproven devices. These devices were advertised

widely on the Internet, sold by several manufacturers, and used in clinics

across the country. We found no research that scientifically substantiated their

effectiveness, not even one study that relied on the double-blinded clinical

trials that are the scientific " gold standard " for proving the truth of medical

claims. And yet, they were and are used widely for a variety of purposes

including diagnosing and treating human and animal diseases, determining food

sensitivities and allergies, and finding tooth decay. The amount of money spent

by unwary consumers is enormous, and the risk that these consumers are foregoing

traditional treatment in favor of " snake oil " cures is frighten

ing.

We request that the FDA consider not just the EPFX as the target of your

investigation, but to include all of the unproven and dangerous medical devices

that are currently being sold and used the U.S. market.

In a recent review of Internet websites touting these devices, the Attorney

General's Office was able to find the following numerous examples that are

indistinguishable in their ineffectuality from the EPFX: NES, E-Lybra, LSA

Biofeedback, QXCI/SCIO, Life System, CoRe, Oberon, Mars, Quantec, Metascan,

Etascan, SCENAR, ACUSEN, Interx: VEGA, Prognos, Biomeridian, Rife, Bicom,

BioPuslar, Mitosan Therapy, Bodyscan, Zappers, F-Scan, Q2, Syncrometer,

Magnagraph, Merid, NES, Acusense, Listen, EQ4, Orion, Explorer, Computron,

Elision, Interro, Interactive Query System, MORA, Matrix Physique System,

Propylene, Punts III and Vitel.

This list is not exhaustive, and there are even more devices on the market.

The sale and use of untested medical devices is a national problem. States can

chip away at it through actions under their consumer protection and medical

licensing statutes, but the FDA is the most effective regulator in this area. We

encourage you to ban the manufacture, distribution and use of these dangerous

devices, to step up enforcement against those who are taking consumers' money

and risking their health, and to generalize your approach to include more than

just one device. We pledge to work with you in this endeavor and are happy to

share our thoughts, research and the testimony of the experts we have consulted.

Sincerely,

ROB MCKENNA

Washington State Attorney General

MARY SELECKY

Secretary, Washington State Department of Health

[Guest guest]

Hi,

maybe we should all email the FDA with a petition to stop this.

email: jkenn337@...

msn: kenn6498ku@...

skype: jkenn337

Re: ALERT!! FDA Urged to Curb Bogus " Energy Medicine " Devices

WOW, thanks for sending, was wondering when this was going

to happen, only a matter of time.

I just love the " golden standard " referred to, now if they just

honestly applied that to drugs.

Jay

-------------- Original message --------------

This is of great concern to anyone involved in any way with any type of

electromedical device that is not FDA approved. You may recall the Seattle Times

series on the EPFX and Bill . Here is the next step. Note the long list of

energy devices to be banned. Device manufacturers and vendors may wish to be

especially careful about making claims for their devices.

FDA Urged to Curb Bogus " Energy Medicine " Devices

In January 2008, Washington Attorney General Rob McKenna and state Department

of Health Secretary Selecky sent the below letter asking the FDA to block

the sale and distribution of unproven and dangerous " energy medicine " devices.

An FDA official replied http://www.devicewatch.org/eav/fda_reply.pdf that the

agency has increased its surveillance of Internet promotion and advertising.

=====================================================

Rob McKenna

ATTORNEY GENERAL OF WASHINGTON

1125 Washington Street SE

PO Box 40100

Olympia WA 98504-0100

December 20, 2007

Ulatowski

Compliance Director

U.S. Food and Drug Administration

Center for Devices and Radiological Health

Room 244 Gaither Road

Rockville, land 20850

RE: " Energy Medicine " Medical Devices

Dear Mr. Ulatowski:

We were encouraged by your recently announced commitment to block the import

of the EPFX, and to investigate its manufacturer, distributors and operators. We

believe your response to the Seattle Times series that exposed the dangers of

the EPFX was appropriate and commendable.

While the Seattle Times series presented an in-depth look at the dangers of

one " energy medicine " device, it also alluded to the existence of dozens of

other devices that are equally dangerous. We encourage you to expand your import

block and investigation to those other devices.

In 2003, the state of Washington sued Pacific Health Center for, among other

things, its use of an " electrodermal testing " device, the Omega Accubase C-29a.

Investigations by our agencies and the Attorney General's Office lawsuit confirm

our belief that targeting a singular device does not deter or immobilize the

overall industry.

This particular " energy medicine " device was purported to determine the

presence of various conditions, including arthritis, immune deficiencies, high

cholesterol and hypertension. It was also purported to be able to determine the

proper remedy for these conditions. The Attorney General's Office lawsuit

claimed that the efficacy of the device - which had been used on more than 5,000

people who each paid approximately $500-had not been adequately substantiated.

The suit also claimed that the operators of the device were practicing medicine,

acupuncture and naturopathy without proper licensure. The State ultimately

dropped its substantiation claims voluntarily when the court decided that the

defendants were engaging in unlicensed practices. The defendants are no longer

doing business in Washington, but continue to operate from locations in Oregon

and Idaho.

In the course of investigating and litigating the case, we learned an enormous

amount about the " energy medicine " field. Our research of the device used by

Pacific Health Center uncovered an entire industry devoted to the sale,

distribution and use of various unproven devices. These devices were advertised

widely on the Internet, sold by several manufacturers, and used in clinics

across the country. We found no research that scientifically substantiated their

effectiveness, not even one study that relied on the double-blinded clinical

trials that are the scientific " gold standard " for proving the truth of medical

claims. And yet, they were and are used widely for a variety of purposes

including diagnosing and treating human and animal diseases, determining food

sensitivities and allergies, and finding tooth decay. The amount of money spent

by unwary consumers is enormous, and the risk that these consumers are foregoing

traditional treatment in favor of " snake oil " cures is frighten

ing.

We request that the FDA consider not just the EPFX as the target of your

investigation, but to include all of the unproven and dangerous medical devices

that are currently being sold and used the U.S. market.

In a recent review of Internet websites touting these devices, the Attorney

General's Office was able to find the following numerous examples that are

indistinguishable in their ineffectuality from the EPFX: NES, E-Lybra, LSA

Biofeedback, QXCI/SCIO, Life System, CoRe, Oberon, Mars, Quantec, Metascan,

Etascan, SCENAR, ACUSEN, Interx: VEGA, Prognos, Biomeridian, Rife, Bicom,

BioPuslar, Mitosan Therapy, Bodyscan, Zappers, F-Scan, Q2, Syncrometer,

Magnagraph, Merid, NES, Acusense, Listen, EQ4, Orion, Explorer, Computron,

Elision, Interro, Interactive Query System, MORA, Matrix Physique System,

Propylene, Punts III and Vitel.

This list is not exhaustive, and there are even more devices on the market.

The sale and use of untested medical devices is a national problem. States can

chip away at it through actions under their consumer protection and medical

licensing statutes, but the FDA is the most effective regulator in this area. We

encourage you to ban the manufacture, distribution and use of these dangerous

devices, to step up enforcement against those who are taking consumers' money

and risking their health, and to generalize your approach to include more than

just one device. We pledge to work with you in this endeavor and are happy to

share our thoughts, research and the testimony of the experts we have consulted.

Sincerely,

ROB MCKENNA

Washington State Attorney General

MARY SELECKY

Secretary, Washington State Department of Health