“SEBELIUS: HHS document EXTENDING THE PANDEMIC to 2012 (Federal Register March 5, 2010)

Therefore, pursuant to section 319F-3(b) of the Act, I have determined there is a credible risk that the spread of pandemic  influenza A viruses and those with pandemic potential and resulting disease does or could constitute a public health emergency.     …and extends  through February 28, 2012.

Section 319F-3(a)(4)(A) confers immunity to manufacturers and
distributors of the Covered Countermeasure, regardless of the defined population.    …and amended on September 28, 2009 to provide targeted liability protections for pandemic countermeasures to enhance distribution   100226 Sec HHS Sebelius Pandemic Influenza Vaccines Amendment

[Federal Register: March 5, 2010 (Volume 75, Number 43)]
[Notices]
[Page 10268-10272]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05mr10-76]

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

———————————————————————–

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

Pandemic Influenza Vaccines–Amendment

Authority:  42 U.S.C. 247d-6d.

ACTION: Notice of amendment to the September 28, 2009 Republished

Declaration under the Public Readiness and Emergency Preparedness Act.

———————————————————————–

SUMMARY: Amendment to declaration issued on September 28, 2009 (74 FR

51153) pursuant to section 319F-3 of the Public Health Service Act

(“the Act”)

[[Page 10269]]

(42 U.S.C. 247d-6d) to revise covered countermeasures and extend

effective date and republication of the declaration to reflect the

declaration in its entirety, as amended.

DATES: The amendment of the republished declaration issued on September

28, 2009 is effective as of March 1, 2010.

FOR FURTHER INFORMATION CONTACT: Nicole Lurie, MD, MSPH, Assistant

Secretary for Preparedness and Response, Office of the Secretary,

Department of Health and Human Services, 200 Independence Avenue, SW.,

Washington, DC 20201, Telephone               (202) 205-2882         (202) 205-2882 (this is not a toll-free

number).

HHS Secretary’s Amendment to the September 28, 2009 Republished

Declaration for the Use of the Public Readiness and Emergency

Preparedness Act for H5N1, H2, H6, H7, H9 and 2009-H1N1 Vaccines:

Whereas there are or may be multiple animal influenza A viruses,

circulating in wild birds and/or domestic animals that cause, or have

significant potential to cause, sporadic human infections or have

mutated to cause pandemics in humans;

Whereas, these viruses may evolve into virus strains capable of

causing a pandemic of human influenza because these viruses may cause

infection in and spread among humans and because humans have little or

no immunity to these viruses;

Whereas, one such virus is the 2009 H1N1 Influenza Virus;

Whereas, vaccination may be effective to protect persons from the

threat of pandemic influenza;

Whereas, Secretary Michael O. Leavitt issued a Declaration for the

Use of the Public Readiness and Emergency Preparedness Act dated

January 26, 2007 (“Original Declaration”), as amended on November 30,

2007 and October 17, 2008 with respect to certain avian influenza

viruses;

Whereas, I amended the declaration on June 15, 2009 with respect to

2009 H1N1 influenza virus and on September 28, 2009 to provide targeted

liability protections for pandemic countermeasures to enhance

distribution and to add provisions consistent with other declarations,

and republished the declaration each time in its entirety;

Whereas, the September 28, 2009 declaration extended through

February 28, 2010 for vaccines against influenza virus strains named in

the Declaration other than 2009 H1N1 influenza vaccine;

Whereas, modifications are necessary to revise covered

countermeasures and to extend the effective date of the Declaration;

Whereas, the findings I made in the declaration issued on September

28, 2009 continue to apply;

Whereas, in accordance with section 319F-3(b)(6) of the Act (42

U.S.C. 247d-6d(b)), I have considered the desirability of encouraging

the design, development, clinical testing or investigation,

manufacturing, labeling, distribution, formulation, packaging,

marketing, promotion, sale, purchase, donation, dispensing,

prescribing, administration, licensing, and use of additional covered

countermeasures with respect to the category of disease and population

described in sections II and IV of the September 28, 2009 Republished

Declaration, as hereby amended, and have found it desirable to

encourage such activities for these additional covered countermeasures,

and;

Whereas, to encourage the design, development, clinical testing or

investigation, manufacturing and product formulation, labeling,

distribution, packaging, marketing, promotion, sale, purchase,

donation, dispensing, prescribing, administration, licensing, and use

of medical countermeasures with respect to the category of disease and

population described in sections II and IV of the September 28, 2009

Republished Declaration, as hereby amended, it is advisable, in

accordance with section 319F-3(a) and (b) of the Act, to provide

immunity from liability for covered persons, as that term is defined at

section 319F-3(i)(2) of the Act, and to include as such covered persons

other qualified persons as I have identified in section VI of the

September 28, 2009 Republished Declaration, as amended;

Therefore, pursuant to section 319F-3(b) of the Act, I have

determined that there is a credible risk that the spread of influenza A

viruses with pandemic potential and resulting disease could in the

future constitute a public health emergency and that spread of one of

these viruses (2009 H1N1 Influenza) has caused a disease that

constitutes a public health emergency.

In order to extend the scope of covered countermeasures and to

extend the effective date of the Declaration, the September 28, 2009

Republished Declaration, is hereby amended as follows:

In the title, delete “for H5N1, H2, H6, H7, H9 and 2009 H1N1

Vaccines” and replace with “for Vaccines Against Pandemic Influenza A

Viruses and Those with Pandemic Potential”.

In the recitals, delete the first through the fourth “whereas”

clauses, and insert two new recitals as follows:

Whereas there are or may be multiple animal influenza A viruses

circulating in wild birds and/or domestic animals that cause, or have

significant potential to cause, sporadic human infections or have

mutated to cause pandemics in humans;

Whereas, these viruses may evolve or have evolved into virus

strains capable of causing a pandemic of human influenza because these

viruses may cause infection in, and spread among, humans and because

humans have little or no immunity to these viruses;

In the sixth “whereas” clause, insert “October 1, 2009, and

December 28, 2009” after “July 24, 2009”.

In the “therefore” clause, delete “avian influenza viruses and

resulting disease could in the future constitute a public health

emergency, and that 2009 H1N1 influenza constitutes a public health

emergency” and replace with: “pandemic influenza A viruses and those

with pandemic potential and resulting disease does or could constitute

a public health emergency”.

In section I, first paragraph, delete “the pandemic

countermeasures influenza A H5N1, H2, H6, H7, H9, and 2009 H1N1

vaccines” each time it appears and replace with “vaccines against

pandemic influenza A viruses with pandemic potential”.

In section I, at the end of the second sentence, replace “IX”

with “X”.

In section II, delete “the virus with (1) highly pathogenic avian

influenza A (H5N1, H2, H6, H7, or H9) virus; or (2) 2009 H1N1

influenza” and replace with “animal and/or human influenza A viruses

against which most humans do not have immunity, except those included

in seasonal influenza vaccines and/or covered under the National

Vaccine Injury Compensation Program, that are circulating in wild birds

and/or domestic animals causing or having significant potential to

cause sporadic human infections or have mutated to cause pandemics in

humans”.

In section III, first paragraph, delete in its entirety and replace

with: “The effective period of time of this Declaration commenced as

described in the September 28, 2009 Republished Declaration, and

extends through February 28, 2012.

In section III, second paragraph, delete “; except that with

respect to 2009 H1N1 influenza vaccine, the effective period commences

on June 15, 2009 and extends through March 31, 2013” and replace with

“through February 28, 2012.”

In section III, add to the end of the section as a new paragraph:

“With respect to any covered countermeasure subsequently covered under

the

[[Page 10270]]

National Vaccine Injury Compensation Program, the effective time period

expires immediately upon such coverage.”

In section VIII, insert “and use” after “administration in the

first sentence, delete “the Act’s” from the second sentence and

replace with “this”, and delete “Countermeasure” from the second

sentence and replace with “Countermeasures”.

In section IX, add to the end of the first sentence: “; and

amended on September 28, 2009 to provide targeted liability protections

for pandemic countermeasures to enhance distribution and to add

provisions consistent with other declarations and republished in its

entirety.”

In section X, after the fifth paragraph, insert a new definition as

follows:

Pandemic influenza A viruses and those with pandemic potential:

Animal and/or human influenza A viruses, except those included in

seasonal influenza vaccines and/or covered under the National Vaccine

Injury Compensation Program, that are circulating in wild birds and/or

domestic animals, that cause, or have significant potential to cause,

sporadic or ongoing human infections, or historically have caused

pandemics in humans, or have mutated to cause pandemics in humans, and

for which the majority of the population is immunologically na[iuml]ve.

In Appendix I, title and item 32, add “H7,” after “H6”.

Throughout, insert “National” before “Vaccine Injury

Compensation Fund”.

All other provisions of the June 15, 2009 Republished Declaration

remain in full force.

Republication of HHS Secretary’s September 28, 2009 Republished

Declaration, as Amended, for the Use of the Public Readiness and

Emergency Preparedness Act for Vaccines Against Pandemic Influenza A

Viruses and Those with Pandemic Potential.

To the extent any term of the September 28 Republished Declaration,

as hereby amended, is inconsistent with any provision of this

Republished Declaration, the terms of this Republished Declaration are

controlling.

Whereas there are or may be multiple animal influenza A viruses

circulating in wild birds and/or domestic animals that cause, or have

significant potential to cause, sporadic human infections or have

mutated to cause pandemics in humans;

Whereas, these viruses may evolve or have evolved into virus

strains capable of causing a pandemic of human influenza because these

viruses may cause infection in, and spread among, humans and because

humans have little immunity to these viruses;

Whereas, on April 26, 2009, Acting Secretary Charles E. Johnson

determined under section 319 of the Public Health Service Act, (42

U.S.C. 247d), that a public health emergency exists nationwide

involving the Swine Influenza A virus that affects or has significant

potential to affect the national security (now called “2009-H1N1

influenza”);

Whereas, on July 24, 2009, October 1, 2009, and December 28, 2009 I

renewed the determination by the Acting Secretary that a public health

emergency exists nationwide involving the Swine influenza A virus (now

called “2009-H1N1 influenza virus”);

Whereas, vaccination may be effective to protect persons from the

threat of pandemic influenza;

Whereas, the possibility of governmental program planners obtaining

stockpiles from private sector entities except through voluntary means

such as commercial sale, donation, or deployment would undermine

national preparedness efforts and should be discouraged as provided for

in section 319F-3(b)(2)(E) of the Public Health Service Act (42 U.S.C.

247d-6d(b)) (“the Act”);

Whereas, immunity under section 319F-3(a) of the Act should be

available to governmental program planners for distributions of Covered

Countermeasures obtained voluntarily, such as by (1) donation; (2)

commercial sale; (3) deployment of Covered Countermeasures from Federal

stockpiles; or (4) deployment of donated, purchased, or otherwise

voluntarily obtained Covered Countermeasures from State, local, or

private stockpiles;

Whereas, the extent of immunity under section 319F-3(a) of the Act

afforded to a governmental program planner that obtains Covered

Countermeasures except through voluntary means is not intended to

affect the extent of immunity afforded other covered persons with

respect to such covered countermeasures;

Whereas, to encourage the design, development, clinical testing or

investigation, manufacturing and product formulation, labeling,

distribution, packaging, marketing, promotion, sale, purchase,

donation, dispensing, prescribing, administration, licensing, and use

of medical countermeasures with respect to the category of disease and

population described in section II and IV it is advisable, in

accordance with section 319F-3(a) and (b) of the Act, to provide

immunity from liability for covered persons, as that term is defined at

section 319F-3(i)(2) of the Act, and to include as such covered persons

such other qualified persons as I have identified in section VI;

Whereas, in accordance with section 319F-3(b)(6) of the Public

Health Service Act (42 U.S.C. 247d-6d(b)) (“the Act”), I have

considered the desirability of encouraging the design, development,

clinical testing or investigation, manufacturing and product

formulation, labeling, distribution, packaging, marketing, promotion,

sale, purchase, donation, dispensing, prescribing, administration,

licensing, and use of medical countermeasures with respect to the

category of disease and population described in sections II and IV

below, and have found it desirable to encourage such activities for the

Covered Countermeasures;

Therefore, pursuant to section 319F-3(b) of the Act, I have

determined there is a credible risk that the spread of pandemic

influenza A viruses and those with pandemic potential and resulting

disease does or could constitute a public health emergency.

I. Covered Countermeasures (as Required by Section 319F-3(b)(1) of the

Act)

Covered Countermeasures are defined at section 319F-3(i) of the

Act.

At this time, and in accordance with the provisions contained

herein, I am recommending the manufacture, testing, development,

distribution, dispensing; and, with respect to the category of disease

and population described in sections II and IV, below, the

administration and usage of vaccines against influenza A viruses with

pandemic potential and any associated adjuvants. The immunity specified

in section 319F-3(a) of the Act shall only be in effect with respect

to: (1) Present or future Federal contracts, cooperative agreements,

grants, interagency agreements, or memoranda of understanding for

vaccines against pandemic influenza A viruses with pandemic potential

used and administered in accordance with this declaration, and (2)

activities authorized in accordance with the public health and medical

response of the Authority Having Jurisdiction to prescribe, administer,

deliver, distribute or dispense the pandemic countermeasures following

a declaration of an emergency, as defined in section X below. In

accordance with section 319F-3(b)(2)(E) of the Act, for governmental

program planners, the immunity specified in section 319F-3(a) of the

Act shall be in effect to the extent they obtain Covered

Countermeasures through voluntary

[[Page 10271]]

means of distribution, such as (1) donation; (2) commercial sale; (3)

deployment of Covered Countermeasures from Federal stockpiles; or (4)

deployment of donated, purchased, or otherwise voluntarily obtained

Covered Countermeasures from State, local, or private stockpiles. For

all other covered persons, including other program planners, the

immunity specified in section 319F-3(a) of the Act shall, in accordance

with section 319F-3(b)(2)(E) of the Act, be in effect pursuant to any

means of distribution.

This Declaration shall subsequently refer to the countermeasures

identified above as Covered Countermeasures.

This Declaration shall apply to all Covered Countermeasures

administered or used during the effective time period of the

Declaration.

II. Category of Disease (as Required by Section 319F-3(b)(2)(A) of the

Act)

The category of disease for which I am recommending the

administration or use of the Covered Countermeasures is the threat of

or actual human influenza that results from the infection of humans

following exposure to animal and/or human influenza A viruses, against

which most humans do not have immunity, except those included in

seasonal influenza vaccines and/or covered under the National Vaccine

Injury Compensation Program, that are circulating in wild birds and/or

domestic animals causing or have significant potential to cause

sporadic human infections or have mutated to cause pandemics in humans.

III. Effective Time Period (as Required by Section 319F-3(b)(2)(B) of

the Act)

The effective period of time of this Declaration commenced as

described in the September 28, 2009 Republished Declaration and extends

through February 28, 2012.

With respect to Covered Countermeasures administered and used in

accordance with the public health and medical response of the Authority

Having Jurisdiction, the effective period of time of this Declaration

commences on the date of a declaration of an emergency and lasts

through and includes the final day that the emergency declaration is in

effect including any extensions thereof through February 28, 2012.

With respect to any covered countermeasure subsequently covered

under the National Vaccine Injury Compensation Program, the effective

time period expires immediately upon such coverage.

IV. Population (as Required by Section 319F-3(b)(2)(C) of the Act)

Section 319F-3(a)(4)(A) confers immunity to manufacturers and

distributors of the Covered Countermeasure, regardless of the defined

population.

Section 319F-3(a)(3)(C)(i) confers immunity to covered persons who

could be program planners or qualified persons with respect to the

Covered Countermeasure only if a member of the population specified in

the Declaration administers or uses the Covered Countermeasure and is

in or connected to the geographic location specified in this

Declaration, or the program planner or qualified person reasonably

could have believed that these conditions were met.

The populations specified in this Declaration are the following:

(1) All persons who use a Covered Countermeasure or to whom such a

Covered Countermeasure is administered as an Investigational New Drug

in a human clinical trial conducted directly by the Federal Government,

or pursuant to a contract, grant or cooperative agreement with the

Federal Government; (2) all persons who use a Covered Countermeasure or

to whom such a Countermeasure is administered in a pre-pandemic phase,

as defined below; and/or (3) all persons who use a Covered

Countermeasure, or to whom such a Covered Countermeasure is

administered in a pandemic phase, as defined below.

V. Geographic Area (as Required by Section 319F-3(b)(2)(D) of the Act)

Section 319F-3(a) applies to the administration and use of a

Covered Countermeasure without geographic limitation.

VI. Other Qualified Persons (as Required by Section 319F-3(i)(8)(B) of

the Act)

With regard to the administration or use of a Covered

Countermeasure, Section 319F-3(i)(8)(A) of the Act defines the term

“qualified person” as a licensed individual who is authorized to

prescribe, administer, or dispense the countermeasure under the law of

the State in which such Covered Countermeasure was prescribed,

administered or dispensed. Additional persons who are qualified persons

pursuant to section 319F-3(i)(8)(B) are the following: (1) Any person

authorized in accordance with the public health and medical emergency

response of the Authority Having Jurisdiction to prescribe, administer,

deliver, distribute or dispense Covered Countermeasures, and their

officials, agents, employees, contractors and volunteers, following a

declaration of an emergency, and (2) Any person authorized to

prescribe, administer, or dispense Covered Countermeasures or who is

otherwise authorized under an Emergency Use Authorization.

VII. Additional Time Periods of Coverage After Expiration of

Declaration (as Required by Section 319F-3(b)(3)(B) of the Act)

A. I have determined that, upon expiration of the applicable time

period specified in Section III above, an additional twelve (12) months

is a reasonable period to allow for the manufacturer to arrange for

disposition of the Covered Countermeasure, including the return of such

product to the manufacturer, and for covered persons to take such other

actions as are appropriate to limit the administration or use of the

Covered Countermeasure, and the liability protection of section 319F-

3(a) of the Act shall extend for that period.

B. The Federal Government shall purchase the entire production of

Covered Countermeasures under the contracts specifically listed by

contract number in section I for the stockpile under section 319F-2 of

the Act, and shall be subject to the time-period extension of section

319F-3(b)(3)(C). Production under future contracts for the same vaccine

will also be subject to the time-period extension of section 319F-

3(b)(3)(C).

VIII. Compensation Fund

In addition to conferring immunity to manufacturers, distributors,

and administrators of the Covered Countermeasures, the Act provides

benefits to certain individuals who sustain a covered injury as the

direct result of the administration or use of the Covered

Countermeasure. The Countermeasures Injury Compensation Program (CICP)

within the Health Resources and Services Administration (HRSA)

administers this compensation program. Information about the CICP is

available at               1-888-275-4772         1-888-275-4772 or http://www.hrsa.gov/countermeasurescomp/

default.htm

<http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html\

&log=linklog&to=http://www.hrsa.gov/countermeasurescomp/default.htm> .

IX. Amendments

The Declaration for the Use of the Public Readiness and Emergency

Preparedness Act for H5N1 was published on January 26, 2007; amended on

November 30, 2007 to add H7 and H9 vaccines; amended on October 17,

2008 to add H2 and H6 vaccines; amended on June 15, 2009 to add 2009

H1N1 vaccines and

[[Page 10272]]

republished in its entirety; and amended on September 28, 2009 to

provide targeted liability protections for pandemic countermeasures to

enhance distribution and to add provisions consistent with other

declarations and republished in its entirety. This Declaration

incorporates all amendments prior to the date of its publication in the

Federal Register. Any future amendment to this Declaration will be

published in the Federal Register, pursuant to section 319F-2(b)(4) of

the Act.

X. Definitions

For the purpose of this Declaration, including any claim for loss

brought in accordance with section 319F-3 of the PHS Act against any

covered persons defined in the Act or this Declaration, the following

definitions will be used:

Administration of a Covered Countermeasure: As used in section

319F-3(a)(2)(B) of the Act includes, but is not limited to, public and

private delivery, distribution, and dispensing activities relating to

physical administration of the countermeasures to recipients,

management and operation of delivery systems, and management and

operation of distribution and dispensing locations.

Authority Having Jurisdiction: Means the public agency or its

delegate that has legal responsibility and authority for responding to

an incident, based on political or geographical (e.g., city, county,

Tribal, State, or Federal boundary lines) or functional (e.g., law

enforcement, public health) range or sphere of authority.

Covered Persons: As defined at section 319F-3(i)(2) of the Act,

include the United States, manufacturers, distributors, program

planners, and qualified persons. The terms “manufacturer,”

“distributor,” “program planner,” and “qualified person” are

further defined at sections 319F-3(i)(3), (4), (6), and (8) of the Act.

Declaration of Emergency: A declaration by any authorized local,

regional, State, or Federal official of an emergency specific to events

that indicate an immediate need to administer and use pandemic

countermeasures, with the exception of a Federal declaration in support

of an emergency use authorization under section 564 of the FDCA unless

such declaration specifies otherwise.

Pandemic influenza A viruses and those with pandemic potential:

Animal and/or human influenza A viruses, except those included in

seasonal influenza vaccines and/or covered under the National Vaccine

Injury Compensation Program, that are circulating in wild birds and/or

domestic animals, that cause, or have significant potential to cause,

sporadic or ongoing human infections, or historically have caused

pandemics in humans, or have mutated to cause pandemics in humans, and

for which the majority of the population is immunologically na[iuml]ve.

Pandemic Phase: The following stages, as defined in the National

Strategy for Pandemic Influenza: Implementation Plan (Homeland Security

Council, May 2006): (4) First Human Case in North America; and (5)

Spread Throughout United States.

Pre-pandemic Phase: The following stages, as defined in the

National Strategy for Pandemic Influenza: Implementation Plan (Homeland

Security Council, May 2006): (0) New Domestic Animal Outbreak in At-

Risk Country; (1) Suspected Human Outbreak Overseas; (2) Confirmed

Human Outbreak Overseas; and (3) Widespread Human Outbreaks in Multiple

Locations Overseas.

Dated: February 26, 2010.

Kathleen Sebelius,

Secretary.

APPENDIX

I. List of U.S. Government Contracts–Covered H5N1, H2, H6, H7, H9, and

2009-H1N1 Vaccine Contracts

1. HHSN266200400031C

2. HHSN266200400032C

3. HHSN266200300039C

4. HHSN266200400045C

5. HHSN266200205459C

6. HHSN266200205460C

7. HHSN266200205461C

8. HHSN266200205462C

9. HHSN266200205463C

10. HHSN266200205464C

11. HHSN266200205465C

12. HHSN266199905357C

13. HHSN266200300068C

14. HHSN266200005413C

15. HHSO100200600021C (formerly 200200409981)

16. HHSO100200500004C

17. HHSO100200500005I

18. HHSO100200700026I

19. HHSO100200700027I

20. HHSO100200700028I

21. HHSO100200600010C

22. HHSO100200600011C

23. HHSO100200600012C

24. HHSO100200600013C

25. HHSO100200600014C

26. HHSO100200600022C (formerly 200200511758)

27. HHSO100200600023C (formerly 200200410431)

28. CRADA No. AI-0155 NIAID/MedImmune

29. HHSO100200700029C

30. HHSO100200700030C

31. HHSO100200700031C

32. All present, completed and future Government H5N1, H2, H6, H7,

H9, and 2009-H1N1 vaccine contracts not otherwise listed.

[FR Doc. 2010-4644 Filed 3-4-10; 8:45 am]

BILLING CODE P

SEBELIUS: HHS document EXTENDING THE PANDEMIC to 2012 (Federal Register March 5, 2010)

http://www.theflucase.com/index.php?option=com_content&view=article&id=2944%3Aus-extends-pandemic-emergency-to-2012&catid=1%3Alatest-news&Itemid=64&lang=en

Taylor and his team used two groups of mice, one exposed to BPA as a fetus during pregnancy and another exposed to a placebo. They examined gene expression and the amount of DNA modification in the uterus. They found that the mice exposed to BPA as a fetus had an exaggerated response to estrogens as adults, long after the exposure to BPA. The genes were permanently programmed to respond excessively to estrogen.

“The DNA in the uterus was modified by loss of methyl groups so that it responded abnormally in adulthood,” said Taylor. “The gene expression was permanently epigenetically altered and the uterus became hyper-responsive to estrogens.”

Taylor said that exposure to BPA as a fetus is carried throughout adulthood. “What our mothers were exposed to in pregnancy may influence the rest of our lives. We need to better identify the effect of environmental contaminants on not just crude measures such as birth defects, but also their effect in causing more subtle developmental errors.”

Citation: The FASEB Journal (Journal of the Federation of American Societies for Experimental Biology) Vol. 24, Issue 3 (March 2010)

http://www.medicalnewstoday.com/articles/181667.php

Bu Gu Zhi (botanical name Psoralea corylifolia) is an annual plant in the “Pea family” native to Asia where it often grows as a common weed. It is known as the “Scruffy Pea”. The plant reaches a height of about 2 feet producing yellow clover-like flowers from spring to the summer followed by short black pods containing yellow-black seeds.

Bu Gu Zhi is cultivated in China for its medicinal use. The tiny seeds (with pods) of the plant are used in Chinese medicine as a kidney yang tonic to improve general vitality and treat conditions such as urinary complaints and impotence. The seeds have also been used with very good success to treat alopecia (hair loss).

Modern research has shown that the seed can encourage the production of new skin pigment and that it is of value in the treatment of various skin disorders, including vitiligo and psoriasis. Both internal and external use causes the skin to produce new pigment, especially after exposure to sunlight or ultraviolet light. When applied externally, it can cause some temporary photosensitivity.

It also has antibacterial properties and has been shown to inhibit the growth of the tuberculosis-causing bacteria, Mycobacterium tuberculosis. It is extremely good for the lungs and is quite useful in asthma especially when there is wheezing. It combines well with Schizandrae for this.

In Chinese Bu Gu Zhi means “tonify bone resin”. Because Bu Gu Zhi promotes bone calcification it is useful in treating osteoporosis and other bone diseases. This herb is also used to stop the spread of some forms of cancer as it inhibits the multiplication of osteosarcoma (bone cancer cells) and lung cancer cells. Extracts of the seed have shown amazing antitumour activity. It can significantly inhibit the in-vivo growth of mammary cancer and may induce differentiation in cervical squamous epithelium Hela cells. It also has a relatively strong lethal effect on leukemia white cells. All from this scruffy little pea!

Bu Gu Zhi has a tonic effect on the uterus, causing a contraction of the muscles. It is also quite an effective aphrodisiac and is found in many famous Chinese formulas for libido ( for men and women) including “Love Potion 9 Herbs” and “Blissful Jing”. It is proven to be a very big help with incomplete erections without any dangerous side effects at all. Many consider it even more effective as a sexual stimulant than Yin Yang Hou (Horny Goat Weed). It combines well with this herb but when combined it should be used with a yin tonic such as Go Qi Zhi (Wolfberries). This prevents the drying and over-heating yang energy from causing headaches.

When treating impotence and soreness and weakness of the lower back and knees, the seed combines well with Tu Si Zi (Cuscuta chinensis), Rou Cong Rong (Cistanche deserticola) and Du Zhong (Eucommia ulmoides).

When treating bed wetting and nocturnal emissions due to kidney deficiency, the seed combines well with Bitter Cardamom (Elletaria cardamomum) and Shan Yao (Dioscorea batatas).

Whether used for its powerful tonic effects on the reproductive system, lungs, bones and skin or used as a fighter of acute hot diseases such as tuberculosis, cancer, vitiligo and psoriasis, one thing is for sure: This little pea packs a powerful punch in a broad spectrum of the healing and tonic realm! Remember, this is only one of so very many natural safe medicines the FDA does not want you to know about.

Sources:

Shanghai College Of Traditional Chinese Medicine
U of A Medical Center
Dr. Wen Zi
Author’s own knowledge of TCM

http://www.naturalnews.com/028308_Bu_Gu_Zhi_tonic.html

Marr’s findings come from a comprehensive study that evaluated marathon race results, weather data, and air pollutant concentrations in seven marathons over a period of eight to 28 years. The top three male and female finishing times were compared with the course record and contrasted with air pollutant levels, taking high temperatures that were detrimental to performance into consideration.

Higher levels of particles in the air were associated with slower running times for women, while men were not significantly affected, Marr said. The difference may be due to the smaller size of women’s tracheas, which makes it easier for certain particles to deposit there and possibly to cause irritation

“Although pollution levels in these marathons rarely exceeded national standards for air quality, performance was still affected,” Marr said.

Her work, done in collaboration with Matthew Ely, an exercise physiologist at the U.S. Army Research Institute of Environmental Medicine, appears in the official journal of the American College of Sports Medicine, Medicine and Science in Sports & Exercise.

Her studies were conducted where major U.S. marathons are located, such as New York, Boston, and Los Angeles, where pollution tends to be highest. Although the person might not be significantly impacted by low-yet-still-acceptable air quality, marathoners are atypical because of their breathing patterns, she said.

“Previous research has shown that during a race, marathon runners inhale and exhale about the same volume of air as a sedentary person would over the course of two full days,” Marr said. “Therefore, runners are exposed to much greater amounts of pollutants than under typical breathing conditions.”

Particulate matter appeared to be the only performance-altering factor in air quality, with carbon monoxide, ozone, nitrogen dioxide and sulfur dioxide levels not impacting race times.

Marr is a member of the national Center for Environmental Implications of NanoTechnology, funded by the National Science Foundation. This center is dedicated to determining the relationship between a vast array of nanomaterials and their potential consequences for the environment.

She is also a past recipient of the National Science Foundation (NSF) Faculty Early Career Development Program Award, supporting her work with air pollution, particularly how to measure air pollutant emissions.

Story Source:

Adapted from materials provided by Virginia Tech, via EurekAlert!, a service of AAAS.

Journal Reference:

Marr, Linsey C.; Ely, Matthew R. ”Effect of Air Pollution on Marathon Running Performance” :. Medicine & Science in Sports & Exercise, 2010; 42 (3): 585 DOI: 10.1249/MSS.0b013e3181b84a85

http://www.sott.net/articles/show/204197-Women-More-Affected-Than-Men-by-Air-Pollution-When-Running-Marathons

This study shows that compared to healthy individuals, people who have major depressive disorder have altered functions of the neurotransmitter GABA (gamma-aminobutyric acid). In the study, individuals with the most treatment-resistant forms of illness demonstrated the greatest reductions of GABA levels in the brain.

This points to the possibility that medications which correct a GABA imbalance could advance the treatment of major depressive disorder. Approximately 4% of Canadians experience major depressive disorder each year.

Several current medications for mood disorders correct imbalances in neurotransmitters such as serotonin and dopamine. However, many patients do not benefit from these medications. “Our findings build on the idea that some current medications do not help many patients because those drugs don’t affect the GABA-related brain chemistry,” says study author Dr. Andrea Levinson.

Applying the brakes

The GABA neurotransmitter and its receptors are involved in many different brain functions. Imbalances in GABA also are relevant to bipolar disorder, schizophrenia, and anxiety disorder.

The GABA neurotransmitter and its receptors are critical to how humans think and act, Dr. Levinson adds. “We apply so many conscious and unconscious perceptions and judgments to our actions at every second, without even realizing that we are doing so,” she says. “GABA is part of the brain system that allows us to fine-tune our moods, thoughts, and actions with an incredible level of detail.”

“It’s a little like driving a car. You need the accelerator, but at every stage you need the brakes to work. Some of our neurotransmitters apply the spark and the gas to the engine, and GABA supplies the brakes,” she says. “GABA provides the necessary inhibitory effect that we need in order to block out excessive brain activity that in depression may lead to excessive negative thinking.”

In addition, today’s study points to the reason why electroconvulsive therapy is still the most efficacious therapy for major depressive disorder, Dr. Levinson adds. “Electroconvulsive therapy may act on GABA brain chemicals in a way that can reset the balance,” she says.

Largest study to date

This study of 85 people is the largest such research effort on GABA and major depressive disorder to date. It compared four groups: 25 individuals with treatment-resistant depression, 16 with major depression who were unmedicated, 19 individuals with major depression who were successfully treated with medication and had normal mood, and a control group of 25 healthy individuals.

In all groups, a thumb twitch response to transcranial magnetic (brain) stimulation (TMS) was used to measure how GABA acts physiologically in the brain. GABA receptors were found to be dysfunctional in the three groups with major depressive disorder when compared to healthy subjects. In people who were the least responsive (treatment-resistant) to medications, the physiological effect of GABA in the brain was at its lowest.

Personalized medicine

“We are advancing the goal of a truly personalized medicine,” says study co-author Dr. Daskalakis. “It is intriguing to think that we may soon be able to apply simple brain stimulation to identify which treatments are most likely to help the individual person, eliminating the guesswork. That is, through these findings we may be able to one day determine who is and who is not going to respond to traditional pharmacological approaches to depression.”

The journal published a separate editorial to highlight the potential for an individualized approach to diagnosing depression, one that would include brain stimulation to identify low levels of the GABA neurotransmitters.

Dr. Daskalakis has international expertise in the electrophysiology of psychiatric disorders, particularly related to GABA.

This study was conducted at the Centre for Addiction and Mental Health, with coauthors in Melbourne, Australia. Funders of the study were the Ontario Mental Health Foundation, the Canadian Institutes of Health Research, and NARSAD.

http://www.sciencedaily.com/releases/2010/03/100301102803.htm?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+sciencedaily+%28ScienceDaily%3A+Latest+Science+News%29&utm_content=Google+Reader

Speaking March 1 at the 68th Annual Meeting of the American Academy of Dermatology (Academy), dermatologist Alan Menter, MD, FAAD, chair of the Psoriasis Research Unit at Baylor Research Institute in Dallas, addressed the need for psoriasis to be viewed as a serious disease affecting the whole body with significant quality of life issues.

“In the past, psoriasis was viewed primarily as a cosmetic nuisance that was not thought to extend beyond the obvious plaques apparent on the skin,” said Dr. Menter. “With the discovery of multiple genes related to psoriasis, a better understanding of the immune system responses involved in this disease, and the frequent associations with other serious diseases, we know that psoriasis is a much more complex disease that demands continual monitoring and evaluation by a dermatologist and, if necessary, other medical professionals to address related health issues.”

Link between Psoriasis and Other Serious Medical Conditions

Over the years, multiple studies have found that psoriasis is associated with a number of potentially serious medical conditions, including cardiovascular disease, cancer and lymphoma, obesity and metabolic syndrome (also known as “Syndrome X”), autoimmune diseases (Crohn’s disease and diabetes mellitus I and II, for example), psychiatric diseases (such as depression and sexual dysfunction), psoriatic arthritis, sleep apnea, personal behavior issues, chronic obstructive pulmonary disease (COPD) and even increased mortality. Dr. Menter explained that the majority of these diseases can have a significant impact on a patient’s overall health and affect psoriasis patients in different degrees of severity.

“It is important to note that while we are unsure whether psoriasis causes other diseases or that these other diseases cause psoriasis, the fact that an association exists at all is critically important in treating psoriasis patients,” said Dr. Menter.

One recent observational study of 3,236 patients with psoriasis and 2,500 patients without psoriasis who served as the controls concluded that patients with psoriasis experienced an increased incidence of ischemic heart disease (where the blood vessels are blocked leading to the heart), cerebrovascular disease (where the blood vessels are blocked leading to the brain), and peripheral vascular disease (the obstruction of arteries in the arms and legs), and mortality.1

Another study examining the increased risk of mortality in psoriasis patients suggests that patients with severe psoriasis may have shorter life expectancies by an average of three to five years than individuals who are not affected by psoriasis. 2

In addition, other studies have shown that psoriasis patients are more likely to consume excessive amounts of alcohol and cigarettes, both of which can negatively impact a psoriasis patient’s health. These detrimental behaviors can further aggravate other conditions associated with psoriasis, such as heart disease and COPD.

Impact on Quality of Life from Psoriasis Cannot be Underestimated

Since psoriasis is a chronic lifelong disease that needs to be controlled with a customized treatment regimen, the constant presence of psoriatic lesions or unexpected flare-ups — at times when patients least expect it — can cause a considerable amount of stress and anxiety. In fact, psoriasis has long been known to cause considerable emotional stress for patients, including low self-esteem and feelings of rejection, introspection, weight gain, increased use of alcohol and tobacco, and depression (which in some cases can be severe).

Another study conducted by the National Psoriasis Foundation examining attitudes and beliefs about contagious diseases among the general population of young adults found that approximately one-third (36 percent) of those surveyed were unsure whether psoriasis was contagious. In addition, when asked their attitudes about dating and skin conditions, more than half (62 percent) of the respondents reported that they take the condition of a person’s skin into consideration when first asking someone out on a date.

Dr. Menter added that the findings of this survey lend credence to the belief held by many psoriasis patients that their disease can have a negative impact on their personal lives and affect their interpersonal relationships.

“We cannot underestimate the complexity of psoriasis, particularly the psychological impact the disease can have on young people,” said Dr. Menter. “Even at a young age, psoriasis can affect a person’s relationships at home, work or school, and the disease can contribute to an overall poor body image that can be hard to reverse throughout life.”

Dr. Menter added that studies conducted regarding the effect of newer biologic medications, such as adalimumab, etanercept and infliximab, on psychiatric symptoms have shown that psoriasis patients may experience significant improvement in fatigue and other symptoms of depression. The newest biologic agent recently approved by the Food and Drug Administration (FDA), ustekinumab, also has been shown to improve sexual dysfunction in patients with moderate to severe psoriasis up to 10 fold.

“Although psoriasis is an incurable disease, it is controllable in the majority of cases with proper treatment,” said Dr. Menter. “Over the past several years, there have been a number of newer therapies introduced that are effective in managing psoriasis, and a patient’s dermatologist can determine which therapy would work best to control each patient’s disease.”

Archives of Dermatology: Vol 145 (NO. 6), June 2009, Pages 700-703

Archives of Dermatology: Vol 147 (NO. 12), December 2007, Pages 1,493-1,499.

Story Source:

Adapted from materials provided by American Academy of Dermatology

http://www.sciencedaily.com/releases/2010/03/100306104436.htm

Vaccines given to dogs are making them ill, a pet charity claimed yesterday.

Profit-hungry drug companies and vets are ‘frightening’ dog owners into inoculating their pets more often than necessary, according to Canine Health Concern.

Some puppies have developed conditions including autism and epilepsy after a raft of injections, it warns.

Catherine O’Driscoll, from the charity, said: ‘We are not anti-vaccination. What we are saying is that currently our pets are receiving far too many.

‘The latest scientific research shows that after the first course of injections as a puppy most dogs are immune against these diseases for at least seven years, if not for life.

‘Every year pet vaccination companies hold National Vaccination Month, a national campaign when pet owners whose boosters have lapsed by 18 months or more are terrified into having their pet jabbed.

‘While the vast majority of vets might simply not be aware of the latest scientific research, we are concerned that for a few undoubtedly doing multiple jabs is a way of making more money from worried pet owners.’

Puppies are vaccinated against distemper, hepatitis, parvovirus, leptospirosis and parainfluenza up to three times by the age of four months.

They may also be immunised against coronavirus, rabies, Lyme disease and bordetella or kennel cough. Booster shots are given every year or every three or four years.

But some have suffered dramatic changes in behaviour or been diagnosed with cancer within months of the injections, Canine Health Concern says.

In a letter backed by 17 vets and other pet experts, the charity has called on the Veterinary Medicines Directorate, which monitors animal vaccines, to issue new advice on their use.

Mrs O’Driscoll, who believes cats and rabbits could also be at risk, added that a simple blood test would determine whether an animal needed a booster shot.

Richard Allport, a Hertfordshire vet who has signed the letter to the VMD, said he was ‘constantly’ seeing animals that had developed ‘worrying symptoms’ after vaccination.

But other animal charities said vaccination was vital. The Dogs Trust said all jabs were thoroughly tested for safety and warned that blood tests were not completely reliable. Its veterinary director, Chris Laurence, said a study looking for a connection between jabs and sudden ill-health failed to find a link.

Professor Steve Dean, chief executive of the VMD, said: ‘Many veterinary surgeons can remember the devastating effects these once common-diseases had on our pets, their owners and families, and the huge benefit vaccines have had on improving the health and welfare of the canine population should be recognised.’

A spokesman added that the 80million-plus doses of vaccine since 1985 had generated fewer than 7,000 reports of side effects.

http://www.dailymail.co.uk/news/article-1255863/Vaccines-making-dogs-sick-vets-cash-in.htmlhttp://www.dailymail.co.uk/news/article-1255863/Vaccines-making-dogs-sick-vets-cash-in.html

The product, called hydrolyzed vegetable protein or HVP, is potentially in thousands of food products, including soups, sauces, chilis, stews, hot dogs, gravies, seasoned snack foods, dips and dressings. HVP is manufactured by a Las Vegas company.

No illnesses have been reported, said Dr. Ian Williams, acting chief of outbreak response and prevention branch for the Centers for Disease Control and Prevention.

In coordination with the CDC, the U.S. Department of Agriculture, plus other federal agencies and state health departments, the FDA is closely monitoring and assessing the potential risks of illness from affected products.

“Our investigators were able to identify this problem before any illnesses occurred,” said FDA commissioner Dr. Margaret A. Hamburg. “While the investigation is continuing, the agency is supporting reasonable steps to continue to protect the public health.”

The manufacturer of the affected product is Basic Food Flavors Inc. in Las Vegas. Only HVP manufactured by Basic Food Flavors is involved in this recall. This is the first recall with this ingredient.

Recall will likely grow over days, weeks
“We don’t know precisely how large this recall will get,” said Dr. Jeff Farrar, associate commissioner for food safety, FDA’s Office of Foods. “We expect this to get larger over the next several days to several weeks.”

Many of the products with the flavor enhancer contain a “kill step” designed to destroy salmonella. Those products will not be recalled, said Farrar.

The FDA conducted an investigation at the facility after a customer of Basic Food Flavors reported finding Salmonella Tennessee in one production lot of HVP to the FDA Reportable Food Registry, created in September 2009.

After getting the tip, the FDA collected and analyzed samples at the facility and confirmed the presence of Salmonella Tennessee in the company’s processing equipment. The company is recalling all hydrolyzed vegetable protein in powder and paste form that it has produced since Sept. 17.

The food registry was created after the recall of salmonella-tainted peanuts that sickened several hundred. “When companies receive a product that they believe may be contaminated, they have to let the FDA know,” said Dr. Joshua Sharfstein, principal deputy FDA commissioner. “Within just a few days, we were [investigating].”

The FDA declined to identify the customer who made the report.

At this time, FDA is taking several steps to instruct industry and protect consumers from potential salmonella infection.

“This situation clearly underscores the need for new food safety legislation to equip FDA with the tools we need to prevent contamination,” said Farrar.

FDA is advising industry that the recalled bulk HVP product should be destroyed or reconditioned according to FDA-approved procedures. FDA is also recommending recalls of certain products that might be eaten by consumers without any processing or cooking steps to address the potential risk.

Newsvine poll
Ever been sickened by contaminated food?

“Our investigation is continuing. We are proceeding with special studies to make sure foods containing those products are safe,” Farrar said. “We are working with food manufacturers and distributors to provide guidance on any products that will need to be recalled. We are also creating a Web page to find any recalled products that may be in their pantry.”

For list of recalled products, go to http://www.accessdata.fda.gov/scripts/HVPCP/
Remember to follow cooking instructions for all foods.
Report symptoms of Salmonella or other food-related illness to your local health care professional.

Salmonella bacteria can cause diarrhea, fever and cramps. It can can be a serious and sometimes fatal infection in young children, frail or elderly people and others with weakened immune systems.

http://www.msnbc.msn.com/id/35713702/ns/health-food_safety/

The study, published in the open-access peer-reviewed journal PLoS ONE, builds on earlier studies that have linked gut microflora and obesity.

A breakthrough paper published in Nature in December 2006 reported that microbial populations in the gut are different between obese and lean people.

The results of this new study indicate that type-2 diabetes in humans is associated with compositional changes in intestinal microbiota.

Sources:

Nutra February 12, 2010

PloS One February 5, 2010: 5(2):e9085

Having the right bacteria in your gut has an enormous influence on your health, and yet many people frequently ignore this aspect when they assess their lifestyle.

It’s actually quite likely that one of the main benefits of a healthy diet is that it will nurture proper bacterial growth and balance in your colon.

There is a wealth of evidence demonstrating that the nutritional cause of many diseases is related to an imbalance of bacteria in your gut, a problem easily rectified by eating a diet consisting of high quality, minimally processed, and preferably organic, foods.

In addition, there’s plenty of evidence showing the harm being done by the over-prescribing of antibiotics as they are indiscriminate killers, eradicating all the beneficial bacteria in your gut along with the bad ones.

Consider the fact that if you’re eating conventionally-farmed meats, you’re ingesting antibiotics with every bite, whether you know it, and approve of it, or not.

In fact, 70 percent of all antibiotics produced are used on healthy livestock, and consuming these antibiotic-laden meats may be a significant factor underlying many people’s health problems. This is why I constantly stress the importance of eating grass-fed and organically-raised meats of all kinds.

Gut Flora May Affect Diabetes and Obesity Risk

Previous studies have found links between gut flora and some cases of obesity. And although I don’t believe it’s the explanation for the obesity epidemic, I believe it may be a factor.

The same goes for the connection between your intestinal flora and diabetes.

After all, inside your gut is a living ecosystem, full of both good bacteria (probiotics) and bad bacteria that play a major role in your physical and mental health. So it’s quite conceivable that a fundamental shift in your gut flora might make it easier to gain weight, and/or affect the delicate balance of leptin and insulin in your body.

And if you’ve read my newsletter for any amount of time, you may remember that diabetes and obesity are indeed linked – by disruptions in your leptin regulation.

Gut Bacteria Differs Between Diabetics and Non-Diabetics

Although there appears to be a link between gut flora and both obesity and diabetes, the two problems might be associated with different bacterial populations, according to this study.
“Assuming that diabetes and impaired glucose tolerance are linked to obesity, our results are in agreement with the recent evidence obtained for overweight persons,”

“Furthermore, based on the assumption above, a positive correlation between ratios of Bacteroidetes to Firmicutes and BMI could be expected.”

“However, the reverse tendency was observed, indicating that overweight and diabetes are associated with different groups of the intestinal microbiota.”
The results showed significant differences in intestinal populations of various bacterial groups between diabetics and non-diabetics. In particular, diabetics had fewer Firmicutes and more plentiful amounts of Bacteroidetes and Proteobacteria, compared to non-diabetics.

They also found a positive correlation for the ratios of Bacteroidetes to Firmicutes and reduced glucose tolerance.

What Does this Mean for You?

The bad news is that although the use of probiotics may be used by conventional medicine in the future, your doctor is not likely to make the connection and give you a “prescription” today.

The good news is that positively influencing the bacteria growing in your body is relatively easy and something you can do right now, on your own. The only thing you can’t do is determine exactly which type of beneficial bacteria you might be in need of.

However, there is a solution!

Remember that any time you begin at the ground floor, meaning your diet, you don’t need to focus excessively on individual ingredients, such as one specific probiotic strain, because your body works with your diet to form a symbiotic whole, greater than any of the individual parts.

And in this case, one of the most important steps you can take to improve the bacterial balance in your intestines is to simply stop consuming sugary foods.

Eating a healthy diet low in sugars, grains and processed foods will generally cause the good bacteria in your gut to flourish, and naturally build up a major defense against excessive amounts of bad bacteria that can damage your health. In essence, your body will self-regulate, as long as you don’t confuse or overwhelm it.

This is one of the many reasons I highly recommend reducing, with the plan of eliminating, sugars and most grains from your diet.

Eating foods that are suitable for your nutritional type is an important aspect of shedding excess pounds, as you will then give your body the fuel it needs to run optimally, AND it’s a crucial factor for successfully treating diabetes.

So by making just that one change, you’re automatically addressing three health problems at the same time: being overweight, diabetes (insulin and leptin resistance), and potential imbalances in your gut flora.

In addition to switching to an extremely low-sugar diet, these other factors are also best avoided as they negatively influence your gut bacteria:
Antibiotics

Chlorinated water

Antibacterial soap

Agricultural chemicals

Pollution
All of these things help to kill off your good bacteria. This is why it’s a wise choice to “reseed” your body with good bacteria from time to time by taking a high-quality probiotic supplement or eating properly fermented foods like natto, healthy sauerkraut, or kim chee.

Beware When Buying Probiotic Food Products

Unfortunately, the food industry is now looking to cash in on the health-supporting properties of probiotics, and there’s no shortage of food products claiming to correct your intestinal imbalance.

But you really need to know what you’re looking for when it comes to probiotic supplements.

For example, the pasteurized “probiotic” yogurts you find in every grocery store these days are NOT a good choice because they are pasteurized, and will be associated with all of the problems of pasteurized milk products. They also have added sugars, dyes, and often contain artificial sweeteners, which will worsen your health.

You’re far better off seeking out fermented foods to get your probiotics.

One of my favorites is natto, but it can be a challenge for most people to get down. I season my natto with mustard, onions, and some Himalayan salt, which I think makes it quite palatable.

There are many other food products that are excellent choices for natural probiotics, but you won’t find them in fancy packages at your supermarket. They are traditionally fermented food products – items like sauerkraut (that you make at home in a crock) and other fermented veggies, and kefir, a fermented milk drink made from RAW milk, for example. These are true superfoods that will naturally fortify your gut with plenty of good bacteria.

Guidelines for Probiotic Supplements

Probiotic supplements can be very beneficial as well, especially if you opt not to include any of the fermented foods I just mentioned in your diet. They’re one of only two supplements that are recommended to nearly all new patients at my Natural Health Center.

However, you need to make sure you’re getting a high-quality variety. Here’s what you need to look for in a probiotic supplement:
The bacteria strains in the product must be able to survive your stomach acid and bile, so that they reach your intestines alive in adequate numbers.

The bacteria strains must have health-promoting features.

The probiotic activity must be guaranteed throughout the entire production process, storage period and shelf life of the product.
One thing I’ve found through my years of clinical practice is that no single probiotic supplement works for everyone. However, I have found that more people respond favorably to Lactobacillus sporogenes than any other probiotic, so when in doubt, that’s a great place to start.

http://www.sott.net/articles/show/204023-Diabetes-Alert-Your-Gut-Microflora-May-Be-Out-of-Balance

Months after experts discounted the importance of routine mammograms and Pap smears for many women, the American Cancer Society is warning more explicitly than ever that regular testing for prostate cancer is of questionable value, too, and can do men more harm than good.

The cancer society has not recommended routine screening for most men since the mid-1990s, and that is not changing. But the organization is urging doctors to talk frankly with their patients about the risks and limitations of the PSA blood test when offering it.

The widely used test often spots cancers too slow-growing to be deadly, and treatment can lead to incontinence and impotence. Two big studies last year suggested prostate cancer screening doesn’t necessarily save lives, and any benefits can come at a high price.

Some doctors and advocates are troubled by the new guidelines.

“Prostate cancer is still something to be respected if not feared, and we still need to be vigilant. I hope primary care docs or insurance companies don’t use the ’softening’ of the guidelines as an excuse to not do screening at all,” said Dr. David Roberts, medical director of an Atlanta clinic that caters to businessmen.

Men will need to weigh their fear of having a potentially aggressive cancer versus treatment that can cause ugly side effects. Another option if cancer is found is watchful waiting – that is, doing nothing – but that can mean high anxiety.

The cancer society’s new guidance released Wednesday urges doctors to:
Discuss the pros and cons of testing with patients, offering written information or videos that discuss the likelihood of false test results and the side effects of treatment.

Stop routinely giving the rectal exam because it has not clearly shown a benefit, though it can remain an option.

Use past PSA readings to determine how often follow-up tests are needed and to guide conversations about treatment.
Cancer experts have been having second thoughts in recent years about the value of regular screening to detect certain types of cancer in its early stages. Last year, a government task force said most women don’t need mammograms in their 40s, and a doctors group said most women in their 20s don’t need annual Pap tests.

The new advice on prostate cancer runs counter to what men have been told on TV and other public service campaigns for several years.

Prostate cancer screening became a medical mantra in the 1990s, thanks to the development of the PSA test. Some celebrities became advocates for regular testing, including former New York Mayor Rudy Giuliani, who credited a PSA test during a routine exam with helping him beat prostate cancer a decade ago. Actor Brad Garrett from “Everybody Loves Raymond” had an on-the-air digital rectal exam for a TV special.

For American men, prostate cancer is the second-deadliest cancer after lung cancer. An estimated 192,000 new cases and 27,000 deaths from it occurred last year in the United States. But it is often a slow-growing cancer, and depending on a man’s age, he may be more likely to die of something else.

Another problem with the PSA test is that an elevated or fast-rising PSA reading can indicate the presence of cancer, but can also be caused by something minor, such as an infection or an enlarged prostate. A biopsy is needed to confirm cancer, and that can cause unnecessary pain and fear.

The new recommendations could be “game changers” in two respects, said Dr. John Davis, a urologist who directs prostate cancer screening for the University of Texas M.D. Anderson Cancer Center in Houston.

First, it may mean many doctors will stop routinely giving the PSA test during regular physicals and will discuss it with their patients first, he said. About 41 percent of men 50 and older get annual prostate cancer screenings, he said.

Second, the guidelines could have a chilling effect on community screening clinics in which hundreds of men line up and get free, quick exams, Davis said.

That was the intent, said Dr. Andrew Wolf, a University of Virginia physician who led the group that wrote the new guidelines.

“Yes, the guideline was explicitly crafted to put a damper on those community prostate screening activities that do not offer men the opportunity to make an informed decision whether to screen,” Wolf said.

Last year, the American Urological Association – a longtime proponent of regular prostate screening – backed off its call for annual tests after age 50. The group said men should be offered a baseline test at 40, with follow-ups based on each man’s situation.

The group also has stood by the rectal exam as a standard part of screening, saying it can find cancer that the blood test does not.

The cancer society last issued guidelines in 2001, which said merely that doctors should offer screening and discuss the risks and benefits. The new guidelines back away even more, dropping the sentence that doctors should offer prostate screening.

Instead, the society said that some evidence indicates periodic screening can save lives but that there is uncertainty about the value of finding prostate cancer early. Screening should not take place unless the patient is fully informed of the trade-offs, the society said.

Men at average risk should get detailed information around age 50, the society said. Men at higher risk, including blacks and men with a father or brother who had prostate cancer before age 65, should get the information beginning at 45. Men with more than one close relative with prostate cancer before 65 should get such information at 40.

For men who want to be screened regularly, the new guidelines recommend every other year if the PSA reading is less than 2.5, a measure of prostate specific antigen. Annual tests are recommended for 2.5 or higher, and a 4 suggests consideration of a biopsy.

Early prostate cancer has no symptoms. Advanced disease may interfere with urination or cause blood in the urine. Many men with slow-growing cancers have been successfully treated after symptoms appear.

The society’s new guidelines rankle Skip Lockwood, president and CEO of Zero – The Project to End Prostate Cancer, formerly known as the National Prostate Cancer Coalition.

Lockwood’s group recommends annual PSA tests for men beginning at 45, and conducts mobile prostate cancer screening programs. The group provides information about the risks and benefits of screening, and connects men to follow-up care if needed, he said.

What bothers him most in the new guidance is “the certainty of its tone,” Lockwood said.

“We acknowledge that the PSA test is lacking. I think nobody disagrees on that fact. I think that we all understand that this is not cut and dry – not an all-or-nothing situation,” he said.

http://www.sott.net/articles/show/204020-Cancer-society-casts-more-doubt-on-prostate-tests