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Archive for the ‘rBST bovine somatotropin (Posilac)’ Category

Posilac (rBST or bovine somatotropin) Eli Lilly/Elanco product information

POSILAC bovine somatotropin is widely accepted and used as a management tool to enhance dairy cow productivity. Of the nearly 9 million dairy cows in the United States, approximately one-third are in herds supplemented with POSILAC.

Approximately 8,000 dairy producers are currently taking advantage of the benefits offered by POSILAC. The product is sold in all 50 states. Dairy producers using POSILAC have herds ranging in size from 5 to thousands of cows.

Since introduction in February 1994, POSILAC has become the largest selling dairy animal pharmaceutical product in the United States.

To help meet growing world demand for POSILAC, Elanco has received FDA approval of a new multi-million dollar manufacturing facility in Augusta, Georgia.

The average dairy operator using POSILAC is supplementing more than 50 percent of the herd at any one time. Customer usage rates on their herds vary depending on individual herd management.

Dairy farmers continue to report excellent results with POSILAC — over 99 percent of producers using POSILAC reported increases in milk production.

Satisfied customers across the United States, many with over twelve years experience, attest to the product’s efficacy and safety in dairy herds. Furthermore, the FDA has confirmed and reconfirmed that POSILAC is safe for cows and does not compromise the safety of the milk supply.

POSILAC continues to prove itself to be an effective management tool that helps dairy producers, both large and small, improve their operations, lower their cost for producing high quality milk and achieve higher profitability.

As an added means of supporting dairy producers, Elanco works with the feed and animal health industries to help dairy producers improve animal nutrition and herd management practices.

Elanco is committed to working with producers who experience dairy herd management problems, or who have other concerns, to ensure their experience with POSILAC is successful.

For additional information, click here:
http://www.posilac.com
http://www.make10.net

http://www.elanco.us/products/pdfs/posilac/Recombinant_Bovine_Somatotropin_rbST_-_A_Safety_Assessment.pdf

on Appendix 11. I The final scientific report of the European Committee for Veterinary Medicinal Products it is stated that rbST does not present: “any risk to the health of consumers of meat of milk obtained from treated animals”

Here’s the report. Eli Lilly/Elanco is hoping concerned consumers will just believe everything they say and not review the actual report. The EU report supports a ban on the use of rbST. It’s important to understand why no other western nation legalized rbST.


EU Committee for Veterinary Medicinal Products Report on Animal Welfare Aspects of the Use of Bovine Somatotropin (rBST or Posilac)

The Committee for Veterinary Medicinal Products report for the European Union recommended a ban due to scientific evidence supporting the negative effects on the welfare of dairy cows. The information below was found at the European Union website explaining the scientific evidence used to base the policy ban on Monsanto’s Posilac. Here are their findings and recommendations below and you may also access the full report below.


Animal welfare and the effects on welfare of dairy cows when BST is used.

13. Animal welfare can be assessed in a scientific way and indicators of welfare include those of physiological states, behaviour and health. A proper assessment of the effects of BST on the welfare of dairy cows must be based on the whole range of indicators that are available to measure welfare in these animals. As reviewed in the rest of this report some evidence concerning the welfare of cows treated with BST exists but studies using a wide range of welfare indicators have not been carried out.

14. BST usage increases the risk of clinical mastitis above the risk in non-treated cows. The magnitude of this increase has been variously estimated by meta analyses or large scale studies at 15 to 45%, 23%, 25%, 42% and 79%. Clinical mastitis is often a painful disease. The welfare of cows with mastitis is poor, the extent of poor welfare being dependent on the severity of the condition.

15. The duration of treatment for mastititis in BST treated cows was longer than in non BST treated cows.

16. An increased incidence of foot and leg disorders associated with the long term administration of BST has been described by several authors. In the largest scale study, the number of multiparous cows with foot disorders was increased by a factor of 2.2 and the number of days affected was increased by a factor of 2.1.

17. As a consequence of the nature of the different foot and leg disorders there will be pain and other suffering in these animals. Hence welfare will be seriously and adversely affected as a consequence of the BST treatment.

18. Injection site reactions occur in most cows injected with BST, but not with placebo, and are exacerbated by repeated injections. Studies have shown severe reactions in at least 4% of cows. The pain associated with this problem has not been adequately assessed.

19. There is evidence that BST treatment can adversely affect reproduction. Pregnancy rate dropped from 82 to 73% in multiparous cows and from 90-63% in primiparous cows, 75 gestation length was shortened by 2-4 days and the number of days open increased in primiparous cows. The effects do not carry over after cessation of treatment. The frequency of multiple births which can cause welfare problems, was substantially increased by BST. Failure to conceive is an indicator of poor welfare and multiple births lead to poor welfare.

20. The immuno-stimulatory effects of BST observed experimentally have not been confirmed clinically.

21. Very preliminary results indicate that GH might enhance the production of pathogenic agents that develop intracellularly, such as viruses. However, the importance of this effect for BST treatment and its functional consequences in vivo remain largely unknown.

22. BST treated cows often have a lower then normal body condition at the end of lactation and experience increased “off-feed” periods

23. The incidence of bloat, indigestion and diarrhoea has been shown to increase in BST treated cows.

24. BST lowers the ability to cope with high temperatures which in certain conditions can result in poor welfare.

25. The Post-Approval Monitoring Program study in the USA reported a higher culling rate in multiparous cows treated with BST.

26. BST usage increases the incidence of several disease conditions and hence is likely to increase the usage of veterinary medicines. Increased antimicrobial usage may lead to resistance to antimicrobials with consequences for the health of humans, cattle and other animals. This topic is the subject of a report of another Scientific Committee.

General conclusion

BST is used to increase milk yield, often in already high-producing cows. BST administration causes substantially and very significantly poorer welfare because of increased foot disorders, mastitis, reproductive disorders and other production related diseases. These are problems which would not occur if BST were not used and often results in unnecessary pain, suffering and distress. If milk yields were achieved by other means which resulted in the health disorders and other welfare problems described above, these means would not be acceptable. The injection of BST and its repetition every 14 days also causes localised swellings which are likely to result in discomfort and hence some poor welfare

Recommendation

BST use causes a substantial increase in levels of foot problems and mastitis and leads to injection site reactions in dairy cows. These conditions, especially the first two, are painful and debilitating, leading to significantly poorer welfare in the treated animals. Therefore from the point of view of animal welfare, including health, the Scientific Committee on Animal Health and Animal Welfare is of the opinion that BST should not be used in dairy cows.

There was no recommendation or approval from the Committee for Veterinary Medicinal Products of rBGH to the European Union and no evaluation on the safety of the milk itself.

The report also followed up with the information below from Canada.

6.1.3. The situation in Canada

Over the years there has been a great deal of debate over this item in Canada, including the mastitis issue. Recently, the Canadian authorities made a submission to the Joint FAO/WHO Expert Committee on Food Additives (JECFA) meeting in 1998 which e.g. refers to the risk of antibiotic residues resulting from treatment of mastitis in BST cows and to the expression of the opinion that: “The greatest hazard is the emergence and spread of antibiotic resistant bacteria through the food chain, as an iatrogenic effect of treating mastitis in BST cows” (Canada, 1997).

In 1998 there was a report by scientists from Health Protection Branch, Health Canada which critically reviewed previous reports by Canadian authorities on the public health and human safety evaluations made. This included a conclusion that antibiotic resistance in farm-borne human pathogens associated with the increased risk of mastitis associated with the use of BST was not properly addressed so far, although it has obvious human health implications (Health Canada, 1998).

As recently as January 1999 the Canadian authorities finally decided, that BST should not be approved for use in Canada due to “ a sufficient and unacceptable threat to the safety of dairy cows”.

This was substantiated by a scientific report from a committee of veterinary experts headed by an internationally recognised veterinary epidemiologist, in which increased risks of mastitis, infertility and lameness were found (Health Canada, 1999).

http://ec.europa.eu/food/fs/sc/scah/out21_en.pdf


Full Report EU Committee for Veterinary Medicinal Products

 

Report on Animal Welfare Aspects of the Use of Bovine Somatotrophin


What’s in Your Milk? An Exposé of Industry and Government Cover-Up on the dangers of the Genetically Engineered (rBGH) Milk You’re Drinking by Samuel S. Epstein M.D.

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Report on Animal Welfare Aspects of the Use of Bovine Somatotrophin
EU Committee for Veterinary Medicinal Products Report on Animal Welfare Aspects of the Use of Bovine Somatotropin (rBST or Posilac)

The Committee for Veterinary Medicinal Products report for the European Union recommended a ban due to scientific evidence supporting the negative effects on the welfare of dairy cows. The information below was found at the European Union website explaining the scientific evidence used to base the policy ban on Monsanto’s Posilac. Here are their findings and recommendations below and you may also access the full report below.


Animal welfare and the effects on welfare of dairy cows when BST is used.

13. Animal welfare can be assessed in a scientific way and indicators of welfare include those of physiological states, behaviour and health. A proper assessment of the effects of BST on the welfare of dairy cows must be based on the whole range of indicators that are available to measure welfare in these animals. As reviewed in the rest of this report some evidence concerning the welfare of cows treated with BST exists but studies using a wide range of welfare indicators have not been carried out.

14. BST usage increases the risk of clinical mastitis above the risk in non-treated cows. The magnitude of this increase has been variously estimated by meta analyses or large scale studies at 15 to 45%, 23%, 25%, 42% and 79%. Clinical mastitis is often a painful disease. The welfare of cows with mastitis is poor, the extent of poor welfare being dependent on the severity of the condition.

15. The duration of treatment for mastititis in BST treated cows was longer than in non BST treated cows.

16. An increased incidence of foot and leg disorders associated with the long term administration of BST has been described by several authors. In the largest scale study, the number of multiparous cows with foot disorders was increased by a factor of 2.2 and the number of days affected was increased by a factor of 2.1.

17. As a consequence of the nature of the different foot and leg disorders there will be pain and other suffering in these animals. Hence welfare will be seriously and adversely affected as a consequence of the BST treatment.

18. Injection site reactions occur in most cows injected with BST, but not with placebo, and are exacerbated by repeated injections. Studies have shown severe reactions in at least 4% of cows. The pain associated with this problem has not been adequately assessed.

19. There is evidence that BST treatment can adversely affect reproduction. Pregnancy rate dropped from 82 to 73% in multiparous cows and from 90-63% in primiparous cows, 75 gestation length was shortened by 2-4 days and the number of days open increased in primiparous cows. The effects do not carry over after cessation of treatment. The frequency of multiple births which can cause welfare problems, was substantially increased by BST. Failure to conceive is an indicator of poor welfare and multiple births lead to poor welfare.

20. The immuno-stimulatory effects of BST observed experimentally have not been confirmed clinically.

21. Very preliminary results indicate that GH might enhance the production of pathogenic agents that develop intracellularly, such as viruses. However, the importance of this effect for BST treatment and its functional consequences in vivo remain largely unknown.

22. BST treated cows often have a lower then normal body condition at the end of lactation and experience increased “off-feed” periods

23. The incidence of bloat, indigestion and diarrhoea has been shown to increase in BST treated cows.

24. BST lowers the ability to cope with high temperatures which in certain conditions can result in poor welfare.

25. The Post-Approval Monitoring Program study in the USA reported a higher culling rate in multiparous cows treated with BST.

26. BST usage increases the incidence of several disease conditions and hence is likely to increase the usage of veterinary medicines. Increased antimicrobial usage may lead to resistance to antimicrobials with consequences for the health of humans, cattle and other animals. This topic is the subject of a report of another Scientific Committee.

General conclusion

BST is used to increase milk yield, often in already high-producing cows. BST administration causes substantially and very significantly poorer welfare because of increased foot disorders, mastitis, reproductive disorders and other production related diseases. These are problems which would not occur if BST were not used and often results in unnecessary pain, suffering and distress. If milk yields were achieved by other means which resulted in the health disorders and other welfare problems described above, these means would not be acceptable. The injection of BST and its repetition every 14 days also causes localised swellings which are likely to result in discomfort and hence some poor welfare

Recommendation

BST use causes a substantial increase in levels of foot problems and mastitis and leads to injection site reactions in dairy cows. These conditions, especially the first two, are painful and debilitating, leading to significantly poorer welfare in the treated animals. Therefore from the point of view of animal welfare, including health, the Scientific Committee on Animal Health and Animal Welfare is of the opinion that BST should not be used in dairy cows.

There was no recommendation or approval from the Committee for Veterinary Medicinal Products of rBGH to the European Union and no evaluation on the safety of the milk itself.

The report also followed up with the information below from Canada.

6.1.3. The situation in Canada

Over the years there has been a great deal of debate over this item in Canada, including the mastitis issue. Recently, the Canadian authorities made a submission to the Joint FAO/WHO Expert Committee on Food Additives (JECFA) meeting in 1998 which e.g. refers to the risk of antibiotic residues resulting from treatment of mastitis in BST cows and to the expression of the opinion that: “The greatest hazard is the emergence and spread of antibiotic resistant bacteria through the food chain, as an iatrogenic effect of treating mastitis in BST cows” (Canada, 1997).

In 1998 there was a report by scientists from Health Protection Branch, Health Canada which critically reviewed previous reports by Canadian authorities on the public health and human safety evaluations made. This included a conclusion that antibiotic resistance in farm-borne human pathogens associated with the increased risk of mastitis associated with the use of BST was not properly addressed so far, although it has obvious human health implications (Health Canada, 1998).

As recently as January 1999 the Canadian authorities finally decided, that BST should not be approved for use in Canada due to “ a sufficient and unacceptable threat to the safety of dairy cows”.

This was substantiated by a scientific report from a committee of veterinary experts headed by an internationally recognised veterinary epidemiologist, in which increased risks of mastitis, infertility and lameness were found (Health Canada, 1999).

http://ec.europa.eu/food/fs/sc/scah/out21_en.pdf


Full Report EU Committee for Veterinary Medicinal Products

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Monsanto’s website provides false information July 24, 2007 regarding the European Union Ban on Posilac (rBST)

“Today, POSILAC has been safely used on tens of millions of dairy cows.”

http://www.monsanto.com/monsanto/posilac/safetyInfo.asp
link no longer functional

Why did FDA approve this drug for use in the U.S. when it is banned in Europe?

The European Community placed a ban on the use of rbST on economic and political grounds. This had nothing to do with rbST safety. In January 1993, the Committee for Veterinary Medicinal Products of the European Union reaffirmed that food products from cows treated with rbST are safe for human consumption, and they recommended the approval of two rbST products based upon their review of all aspects of safety and effectiveness.

http://www.monsantodairy.com/faqs/fda_safety.html
The above link is no longer accessible

I decided to check out the Committee for Veterinary Medicinal Products report regarding rBST or Posilac.

Here’s the report

Report on Animal Welfare Aspects of the Use of Bovine Somatotropin

http://ec.europa.eu/food/fs/sc/scah/out21_en.pdf


EU Committee for Veterinary Medicinal Products Report on Animal Welfare Aspects of the Use of Bovine Somatotropin (rBST or Posilac)

The Committee for Veterinary Medicinal Products report for the European Union recommended a ban due to scientific evidence supporting the negative effects on the welfare of dairy cows. The information below was found at the European Union website explaining the scientific evidence used to base the policy ban on Monsanto’s Posilac. Here are their findings and recommendations below and you may also access the full report below.


Animal welfare and the effects on welfare of dairy cows when BST is used.

13. Animal welfare can be assessed in a scientific way and indicators of welfare include those of physiological states, behaviour and health. A proper assessment of the effects of BST on the welfare of dairy cows must be based on the whole range of indicators that are available to measure welfare in these animals. As reviewed in the rest of this report some evidence concerning the welfare of cows treated with BST exists but studies using a wide range of welfare indicators have not been carried out.

14. BST usage increases the risk of clinical mastitis above the risk in non-treated cows. The magnitude of this increase has been variously estimated by meta analyses or large scale studies at 15 to 45%, 23%, 25%, 42% and 79%. Clinical mastitis is often a painful disease. The welfare of cows with mastitis is poor, the extent of poor welfare being dependent on the severity of the condition.

15. The duration of treatment for mastititis in BST treated cows was longer than in non BST treated cows.

16. An increased incidence of foot and leg disorders associated with the long term administration of BST has been described by several authors. In the largest scale study, the number of multiparous cows with foot disorders was increased by a factor of 2.2 and the number of days affected was increased by a factor of 2.1.

17. As a consequence of the nature of the different foot and leg disorders there will be pain and other suffering in these animals. Hence welfare will be seriously and adversely affected as a consequence of the BST treatment.

18. Injection site reactions occur in most cows injected with BST, but not with placebo, and are exacerbated by repeated injections. Studies have shown severe reactions in at least 4% of cows. The pain associated with this problem has not been adequately assessed.

19. There is evidence that BST treatment can adversely affect reproduction. Pregnancy rate dropped from 82 to 73% in multiparous cows and from 90-63% in primiparous cows, 75 gestation length was shortened by 2-4 days and the number of days open increased in primiparous cows. The effects do not carry over after cessation of treatment. The frequency of multiple births which can cause welfare problems, was substantially increased by BST. Failure to conceive is an indicator of poor welfare and multiple births lead to poor welfare.

20. The immuno-stimulatory effects of BST observed experimentally have not been confirmed clinically.

21. Very preliminary results indicate that GH might enhance the production of pathogenic agents that develop intracellularly, such as viruses. However, the importance of this effect for BST treatment and its functional consequences in vivo remain largely unknown.

22. BST treated cows often have a lower then normal body condition at the end of lactation and experience increased “off-feed” periods

23. The incidence of bloat, indigestion and diarrhoea has been shown to increase in BST treated cows.

24. BST lowers the ability to cope with high temperatures which in certain conditions can result in poor welfare.

25. The Post-Approval Monitoring Program study in the USA reported a higher culling rate in multiparous cows treated with BST.

26. BST usage increases the incidence of several disease conditions and hence is likely to increase the usage of veterinary medicines. Increased antimicrobial usage may lead to resistance to antimicrobials with consequences for the health of humans, cattle and other animals. This topic is the subject of a report of another Scientific Committee.

General conclusion

BST is used to increase milk yield, often in already high-producing cows. BST administration causes substantially and very significantly poorer welfare because of increased foot disorders, mastitis, reproductive disorders and other production related diseases. These are problems which would not occur if BST were not used and often results in unnecessary pain, suffering and distress. If milk yields were achieved by other means which resulted in the health disorders and other welfare problems described above, these means would not be acceptable. The injection of BST and its repetition every 14 days also causes localised swellings which are likely to result in discomfort and hence some poor welfare

Recommendation

BST use causes a substantial increase in levels of foot problems and mastitis and leads to injection site reactions in dairy cows. These conditions, especially the first two, are painful and debilitating, leading to significantly poorer welfare in the treated animals. Therefore from the point of view of animal welfare, including health, the Scientific Committee on Animal Health and Animal Welfare is of the opinion that BST should not be used in dairy cows.

There was no recommendation or approval from the Committee for Veterinary Medicinal Products of rBGH to the European Union and no evaluation on the safety of the milk itself.

The report also followed up with the information below from Canada.

6.1.3. The situation in Canada

Over the years there has been a great deal of debate over this item in Canada, including the mastitis issue. Recently, the Canadian authorities made a submission to the Joint FAO/WHO Expert Committee on Food Additives (JECFA) meeting in 1998 which e.g. refers to the risk of antibiotic residues resulting from treatment of mastitis in BST cows and to the expression of the opinion that: “The greatest hazard is the emergence and spread of antibiotic resistant bacteria through the food chain, as an iatrogenic effect of treating mastitis in BST cows” (Canada, 1997).

In 1998 there was a report by scientists from Health Protection Branch, Health Canada which critically reviewed previous reports by Canadian authorities on the public health and human safety evaluations made. This included a conclusion that antibiotic resistance in farm-borne human pathogens associated with the increased risk of mastitis associated with the use of BST was not properly addressed so far, although it has obvious human health implications (Health Canada, 1998).

As recently as January 1999 the Canadian authorities finally decided, that BST should not be approved for use in Canada due to “ a sufficient and unacceptable threat to the safety of dairy cows”.

This was substantiated by a scientific report from a committee of veterinary experts headed by an internationally recognised veterinary epidemiologist, in which increased risks of mastitis, infertility and lameness were found (Health Canada, 1999).

http://ec.europa.eu/food/fs/sc/scah/out21_en.pdfReport on Animal Welfare Aspects of the Use of Bovine Somatotrophin


Full Report EU Committee for Veterinary Medicinal Products

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Eli Lilly to Buy Monsanto’s Dairy Cow Hormone for $300 Million –
August 20, 2008.

MERGERS & ACQUISITIONS – NEW YORK TIMES.

Eli Lilly said Wednesday that it will pay $300 million for the rights to Posilac, Monsanto’s controversial hormone to boost milk production in cows.

Elanco, an Eli Lilly division, will acquire the worldwide rights to Posilac, as well as the brand’s sales team and a manufacturing plant in Augusta, Ga.

Posilac has stood at the center of a sometimes fierce debate over the use of hormones in food since its approval by the Food and Drug Administration in 1994. A recent surge in consumer opinion against its use has led major food chains to say they will no longer use milk from cows treated with Posilac.

In a statement, Elanco president Jeff Simmons emphasized the need to boost milk production at a time of rising food prices.

“Global dairy demand is increasing, outstripping supply, and consumers are seeing rapidly rising prices,” Mr. Simmons. “With the purchase of Posilac, Elanco can enhance its overall product portfolio and work together with the industry to provide dairy farmers more options and give consumers affordable choices. Critically, we remain focused on the health and care of the cow in working with farmers to increase global milk supply.

The deal is expected to close in the fourth quarter, and it isn’t expected to change Eli Lilly’s financial guidance for the rest of the year.


Eli Lilly press release

Elanco Announces Acquisition of Posilac(R) Dairy Business

Deal Provides Strategic Fit with Lilly’s Animal Health Division
GREENFIELD, Ind., Aug 20, 2008 /PRNewswire-FirstCall via COMTEX News Network/ — Elanco, a division of Eli Lilly and Company (NYSE: LLY), today announced that Lilly has signed an agreement to acquire the worldwide rights to the dairy cow supplement, Posilac(R) (sometribove), as well as the product’s supporting operations, from Monsanto Company (NYSE: MON).

“Global dairy demand is increasing, outstripping supply, and consumers are seeing rapidly rising prices,” said Jeff Simmons, president, Elanco. “With the purchase of Posilac, Elanco can enhance its overall product portfolio and work together with the industry to provide dairy farmers more options and give consumers affordable choices. Critically, we remain focused on the health and care of the cow in working with farmers to increase global milk supply.

“With our rich history and experience in the dairy industry, Elanco is the ideal steward of this vital technology,” Simmons said. “Elanco remains committed to using science to address the growing need for safe, affordable food; and to choices for consumers, retailers and producers.”

Elanco has exclusively sold sometribove outside of the United States for a decade. Posilac has been safely used for more than 14 years.

Under the terms of the agreement, Lilly will acquire all rights to the Posilac brand, as well as the product’s U.S. sales force and its manufacturing facility in Augusta, Georgia. In return, Monsanto will receive a $300 million upfront payment, as well as contingent consideration. The Posilac dairy business manufacturing and sales teams will be integrated into the Elanco business. The transaction is expected to close near the beginning of the fourth quarter of 2008, contingent upon clearance under the Hart-Scott-Rodino Anti-Trust Improvements Act and other customary closing conditions. Lilly confirmed that the acquisition will not result in a change to the company’s full-year 2008 financial guidance, as detailed in its second quarter 2008 financial results press release issued July 24, 2008.

About Posilac(R)

Posilac (rbST) is approved by numerous regulatory authorities worldwide to help dairy farmers improve milk productivity. BST (bovine somatotropin) is a natural protein produced in all cattle, helping adult cows produce milk. Milk from cows receiving Posilac is unchanged from milk from cows not receiving this supplement.

Since it received U.S. FDA approval in 1994, Posilac has become a leading dairy animal supplement in the United States and many other countries. Supplementing dairy cows with Posilac enhances milk production and serves as an important tool to help dairy producers improve the efficiency of their operations and produce more milk more sustainably.

About Elanco

Elanco is a global innovation-driven company that develops and markets products to improve animal health and food animal production in more than 100 countries. Elanco employs more than 2,000 people worldwide, with offices in more than 30 countries, and is a division of Eli Lilly and Company, a leading global pharmaceutical corporation. Additional information about Elanco is available at http://www.elanco.com.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information – for some of the world’s most urgent medical needs. C-LLY

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