FDA could require tamper-resistant painkillers; without such action, prescription-drug abuse problem would worsen

UPDATE, Jan. 14 : Laura Ungar of The Courier-Journal reports, "Addicts by the scores used to get a quick and easy high from snorting or shooting up the powerful narcotic OxyContin — until manufacturer Purdue Pharma developed a new version that’s harder to abuse. But with the company’s patent on its original drug set to expire in April, activists, lawmakers and doctors are worried that cheaper, easily crushable generic versions will flood Kentucky and worsen the state’s already-devastating prescription drug abuse problem."

The Food and Drug Administration will force generic manufacturers of powerful pain pills to switch to a tamper-resistant composition if it finds evidence the composition curbs prescription drug abuse and addiction, Alan Rappeport of The Financial Times reports. Public-health advocates worry that if generic versions of opiate pills are not made tamper-resistant, the prescription drug abuse epidemic may worsen.

If the agency finds tamper-resistance significantly deter abuse, it has legal authority to require generic drug makers to switch their opiate formulas. Just as manufacturers of some pain pills began switching formulas to make the pills harder to crush, easily crushable, generic forms of OxyContin and Opana were released. Purdue Pharma and Endo Pharmaceuticals, which make Opana, have hoped to extend patent life of their drugs by pushing the FDA to prevent generic makers from using old versions of their drugs. Generic makers argue this will keep patients from buying cheaper drugs.

The FDA said it will take a "flexible" approach to determining the effectiveness of tamper-resistant drugs because abusers are constantly finding new ways to avoid deterrents. (Read more)

UPDATE, Jan. 14 : Laura Ungar of The Courier-Journal reports, "Addicts by the scores used to get a quick and easy high from snorting or shooting up the powerful narcotic OxyContin — until manufacturer Purdue Pharma developed a new version that’s harder to abuse. But with the company’s patent on its original drug set to expire in April, activists, lawmakers and doctors are worried that cheaper, easily crushable generic versions will flood Kentucky and worsen the state’s already-devastating prescription drug abuse problem."

The Food and Drug Administration will force generic manufacturers of powerful pain pills to switch to a tamper-resistant composition if it finds evidence the composition curbs prescription drug abuse and addiction, Alan Rappeport of The Financial Times reports. Public-health advocates worry that if generic versions of opiate pills are not made tamper-resistant, the prescription drug abuse epidemic may worsen.

If the agency finds tamper-resistance significantly deter abuse, it has legal authority to require generic drug makers to switch their opiate formulas. Just as manufacturers of some pain pills began switching formulas to make the pills harder to crush, easily crushable, generic forms of OxyContin and Opana were released. Purdue Pharma and Endo Pharmaceuticals, which make Opana, have hoped to extend patent life of their drugs by pushing the FDA to prevent generic makers from using old versions of their drugs. Generic makers argue this will keep patients from buying cheaper drugs.

The FDA said it will take a "flexible" approach to determining the effectiveness of tamper-resistant drugs because abusers are constantly finding new ways to avoid deterrents. (Read more)

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Pike court will keep lawsuit county and attorney general filed against Purdue Pharma over damage done by its OxyContin

A state court will hear the Kentucky attorney general's 2007 lawsuit against OxyContin manufacturer Purdue Pharma, against the wishes of the company. The U.S. Court of Appeals for the 2nd Circuit affirmed a lower court's order returning the suit to Kentucky from New York's Southern District, where Purdue wanted the case heard. The suit was filed in Pike Circuit Court, in Kentucky's easternmost county.

"After years of delay tactics, Purdue will now answer to a Kentucky court and a Kentucky jury," Attorney General Jack Conway said. Purdue Pharma spokeswoman Libby Holman said the company is disappointed by the decision, but now it is "fully prepared to vigorously defend this action on its merits, and we expect to prevail."

Then-AG Greg Stumbo and Pike County sued Purdue Pharma in October 2007, alleging that the company's "aggressive and deceptive marketing campaign saddled taxpayers with millions of dollars in social, health care and other costs," Laura Ungar of The Courier-Journal in Louisville reports. The suit also alleges the company misled health-care providers, consumers and the government about the highly addictive nature of OxyContin. The suit is largely based on admissions of guilt made by the company and several top-ranking company officials in a May 2007 Virginia federal court settlement. Purdue Pharma, its president, chief legal counsel and former medical director pleaded guilty to misleading doctors, regulators and patients about OxyContin during that case.

The nation's prescription-drug epidemic apparently began in the region, largely because of the introduction and high rate of prescription of OxyContin. Kentucky has nearly 1,000 overdose deaths a year. Conway's office said the suit against Purdue Pharma seeks reimbursement for drug-abuse programs, law-enforcement actions and prescription payments through Medicaid and the Kentucky Pharmaceutical Alliance Program. (Read more)

A state court will hear the Kentucky attorney general's 2007 lawsuit against OxyContin manufacturer Purdue Pharma, against the wishes of the company. The U.S. Court of Appeals for the 2nd Circuit affirmed a lower court's order returning the suit to Kentucky from New York's Southern District, where Purdue wanted the case heard. The suit was filed in Pike Circuit Court, in Kentucky's easternmost county.

"After years of delay tactics, Purdue will now answer to a Kentucky court and a Kentucky jury," Attorney General Jack Conway said. Purdue Pharma spokeswoman Libby Holman said the company is disappointed by the decision, but now it is "fully prepared to vigorously defend this action on its merits, and we expect to prevail."

Then-AG Greg Stumbo and Pike County sued Purdue Pharma in October 2007, alleging that the company's "aggressive and deceptive marketing campaign saddled taxpayers with millions of dollars in social, health care and other costs," Laura Ungar of The Courier-Journal in Louisville reports. The suit also alleges the company misled health-care providers, consumers and the government about the highly addictive nature of OxyContin. The suit is largely based on admissions of guilt made by the company and several top-ranking company officials in a May 2007 Virginia federal court settlement. Purdue Pharma, its president, chief legal counsel and former medical director pleaded guilty to misleading doctors, regulators and patients about OxyContin during that case.

The nation's prescription-drug epidemic apparently began in the region, largely because of the introduction and high rate of prescription of OxyContin. Kentucky has nearly 1,000 overdose deaths a year. Conway's office said the suit against Purdue Pharma seeks reimbursement for drug-abuse programs, law-enforcement actions and prescription payments through Medicaid and the Kentucky Pharmaceutical Alliance Program. (Read more)

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Rep. Westrom, bolstered by increasing public support, thinks third time may be the charm to pass a statewide smoking ban law

A coalition of health groups say they will give state Rep. Susan Westrom, D-Lexington, the most public support ever for a bill to ban smoking in Kentucky restaurants and workplaces, a bill she's tried to get passed twice, Jacqueline Pitts of CN2 reports. The coalition, which includes Smoke-Free Kentucky and the American Lung Association, revealed plans yesterday for a two-week ad campaign about the benefits of a statewide smoking ban law.

So far, 24 states have approved smoking bans, and more than 30 Kentucky cities and counties have passed similar local bans. Westrom said that Gov. Steve Beshear, who once said bans should be left to localities to decide, is more supportive of a statewide ban now. A 2012 Foundation for a Healthy Kentucky poll shows that 59 percent of Kentucky adults are in favor of a statewide ban. Westrom said she wants to work with new legislators to get their support for the bill. (Read more)

A coalition of health groups say they will give state Rep. Susan Westrom, D-Lexington, the most public support ever for a bill to ban smoking in Kentucky restaurants and workplaces, a bill she's tried to get passed twice, Jacqueline Pitts of CN2 reports. The coalition, which includes Smoke-Free Kentucky and the American Lung Association, revealed plans yesterday for a two-week ad campaign about the benefits of a statewide smoking ban law.

So far, 24 states have approved smoking bans, and more than 30 Kentucky cities and counties have passed similar local bans. Westrom said that Gov. Steve Beshear, who once said bans should be left to localities to decide, is more supportive of a statewide ban now. A 2012 Foundation for a Healthy Kentucky poll shows that 59 percent of Kentucky adults are in favor of a statewide ban. Westrom said she wants to work with new legislators to get their support for the bill. (Read more)

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Evolving insights into FIP virulence

Terada Y, Shiozaki Y, Shimoda H, et al. Feline infectious peritonitis virus with a large deletion in the 5'-terminal region of the spike gene retains its virulence for cats. The Journal of general virology. 2012; 93: 1930-4. 

The acquisition of macrophage tropism appears to be an essential step in the transformation of feline enteric corona virus (FECV) to feline infectious peritonitis virus (FIPV).This is a transformation from a largely non-pathogenic and localized enterocyte pathogen to a highly virulent and systemic monocyte/macrophage pathogen. Therefore, determining the critical genetic mutation(s) leading a change in tropism is required for understanding the pathogenic phenomena of feline coronavirus (FCoV) infections. Although various viral proteins such as 3c and 7b have been considered to be involved in the transformation, the spike (S) protein may also play a role in a switch toward macrophage tropism and enhanced virulence. 

In coronaviruses, the S protein functions in cell entry and is responsible for receptor attachment and membrane fusion. While the receptor-binding site is located in the N-terminal part of the protein, fusion is mediated by its membrane proximal part. Surprisingly, previous studies have suggested virulence mutation(s) in the S protein occur in the membrane-proximal domain of the protein and not in the N-terminal region. 

In the present study, a type I FCoV strain, C3663, was found to have a large deletion of 735 bp within the gene encoding for the S protein, resulting in an estimated 245 amino acid loss in the N-terminal region of the protein. FIP developed in three out of four cats that were infected with strain C3663, suggesting that the 5’-terminal region of the S gene is not essential for pathogenic transformation. If the S protein is indeed involved in the transformation and development of FIP, then this result is consistent with the localization of the determinant for macrophage tropism lying in the domain responsible for membrane fusion suggesting a role for fusion function rather than for receptor binding. [GO]

See also: Rottier PJ, Nakamura K, Schellen P, Volders H and Haijema BJ. Acquisition of macrophage tropism during the pathogenesis of feline infectious peritonitis is determined by mutations in the feline coronavirus spike protein. J Virol. 2005; 79: 14122-30. 

Related blog articles:
Understanding FIP virulence (October 2012)
Development of new therapies for FIP (March 2012)

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Winn Feline Foundation Library
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Terada Y, Shiozaki Y, Shimoda H, et al. Feline infectious peritonitis virus with a large deletion in the 5'-terminal region of the spike gene retains its virulence for cats. The Journal of general virology. 2012; 93: 1930-4. 

The acquisition of macrophage tropism appears to be an essential step in the transformation of feline enteric corona virus (FECV) to feline infectious peritonitis virus (FIPV).This is a transformation from a largely non-pathogenic and localized enterocyte pathogen to a highly virulent and systemic monocyte/macrophage pathogen. Therefore, determining the critical genetic mutation(s) leading a change in tropism is required for understanding the pathogenic phenomena of feline coronavirus (FCoV) infections. Although various viral proteins such as 3c and 7b have been considered to be involved in the transformation, the spike (S) protein may also play a role in a switch toward macrophage tropism and enhanced virulence. 

In coronaviruses, the S protein functions in cell entry and is responsible for receptor attachment and membrane fusion. While the receptor-binding site is located in the N-terminal part of the protein, fusion is mediated by its membrane proximal part. Surprisingly, previous studies have suggested virulence mutation(s) in the S protein occur in the membrane-proximal domain of the protein and not in the N-terminal region. 

In the present study, a type I FCoV strain, C3663, was found to have a large deletion of 735 bp within the gene encoding for the S protein, resulting in an estimated 245 amino acid loss in the N-terminal region of the protein. FIP developed in three out of four cats that were infected with strain C3663, suggesting that the 5’-terminal region of the S gene is not essential for pathogenic transformation. If the S protein is indeed involved in the transformation and development of FIP, then this result is consistent with the localization of the determinant for macrophage tropism lying in the domain responsible for membrane fusion suggesting a role for fusion function rather than for receptor binding. [GO]

See also: Rottier PJ, Nakamura K, Schellen P, Volders H and Haijema BJ. Acquisition of macrophage tropism during the pathogenesis of feline infectious peritonitis is determined by mutations in the feline coronavirus spike protein. J Virol. 2005; 79: 14122-30. 

Related blog articles:
Understanding FIP virulence (October 2012)
Development of new therapies for FIP (March 2012)

More on cat health:
Winn Feline Foundation Library
Find us on Facebook
Follow us on Twitter
Join us on Google+

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Coalition of health groups launches two-week ad campaign to drum up support for a statewide smoking ban

A geographically targeted newspaper and online advertising campaign calling for "a comprehensive, statewide smoke-free law" is hitting Kentucky media outlets this week, as the legislature convenes, and next week. The campaign was launched by Smoke-Free Kentucky Coalition, the Campaign for Tobacco-Free Kids and the Robert Wood Johnson Foundation. The newspaper ad can viewed here.

Twenty-nine percent of Kentucky adults are smokers, giving the state the highest smoking rate in the U.S., and ranks very high in youth smoking, according to the Centers for Disease Control. Kentucky also has the nation's highest lung cancer death rates, 87 percent of which are caused by smoking, according to the National Cancer Institute. The state also "lags behind other states in enacting a comprehensive, statewide smoke-free law that covers all indoor workplaces, including bars and restaurants," a press release about the ad campaign says. Twenty-four states have smoking bans. A fall poll for the Foundation for a Healthy Kentucky showed that 59 percent of Kentucky adults support a smoking ban in workplaces, restaurants and bars. For a story on the poll, click here.

Tobacco-Free Kids communications manager Catherine Butsch said the ad is running in the Lexington Herald-Leader, the Messenger-Inquirer of Owensboro, the Daily Independent of Ashland, the Commonwealth Journal of Somerset, the Kentucky New Era of Hopkinsville, the Glasgow Daily Times, the Paducah Sun, the Paducah-based West Kentucky News, the Sentinel-Echo of London, the Lebanon Enterprise, the Jessamine Journal, the Tompkinsville News, the Carlisle Weekly of Bardwell, the Fulton Leader, the Marshall County Tribune Courier, and the Kentucky Gazette, a government-oriented twice-monthly in Frankfort. The online ad will run on websites of the Herald-Leader, Business Lexington, The Lane Report and CN2, a cable news service. The campaign will cost $93,000, Butsch said.

A geographically targeted newspaper and online advertising campaign calling for "a comprehensive, statewide smoke-free law" is hitting Kentucky media outlets this week, as the legislature convenes, and next week. The campaign was launched by Smoke-Free Kentucky Coalition, the Campaign for Tobacco-Free Kids and the Robert Wood Johnson Foundation. The newspaper ad can viewed here.

Twenty-nine percent of Kentucky adults are smokers, giving the state the highest smoking rate in the U.S., and ranks very high in youth smoking, according to the Centers for Disease Control. Kentucky also has the nation's highest lung cancer death rates, 87 percent of which are caused by smoking, according to the National Cancer Institute. The state also "lags behind other states in enacting a comprehensive, statewide smoke-free law that covers all indoor workplaces, including bars and restaurants," a press release about the ad campaign says. Twenty-four states have smoking bans. A fall poll for the Foundation for a Healthy Kentucky showed that 59 percent of Kentucky adults support a smoking ban in workplaces, restaurants and bars. For a story on the poll, click here.

Tobacco-Free Kids communications manager Catherine Butsch said the ad is running in the Lexington Herald-Leader, the Messenger-Inquirer of Owensboro, the Daily Independent of Ashland, the Commonwealth Journal of Somerset, the Kentucky New Era of Hopkinsville, the Glasgow Daily Times, the Paducah Sun, the Paducah-based West Kentucky News, the Sentinel-Echo of London, the Lebanon Enterprise, the Jessamine Journal, the Tompkinsville News, the Carlisle Weekly of Bardwell, the Fulton Leader, the Marshall County Tribune Courier, and the Kentucky Gazette, a government-oriented twice-monthly in Frankfort. The online ad will run on websites of the Herald-Leader, Business Lexington, The Lane Report and CN2, a cable news service. The campaign will cost $93,000, Butsch said.

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Republicans moving to gain a say over Beshear's decisions about insurance exchange, Medicaid expansion; Democrat dismissive

Kentucky Senate Health and Welfare Committee Chair Julie Denton, R-Louisville, left, said yesterday that she would file legislation that would block Democratic Gov. Steve Beshear from setting up a health-insurance exchange or expanding Medicaid coverage without legislative approval, Joseph Gerth of The Courier-Journal reports. Beshear has already established an exchange under the federal health reform, but hasn't announced whether he will expand Medicaid.

Denton said the exchanges and Medicaid expansion would be too costly for the state and shouldn't be something Beshear can set up unilaterally. But her effort will likely face opposition in the Democrat-controlled House, Gerth writes. Liberal Rep. Tom Burch, D-Louisville, said Denton "should save the ink that it would take to print the bills," and House Democrats would not receive the bill favorably. Burch has been in the legislature longer than any other current member.

State health-insurance exchanges will allow the uninsured to buy insurance from private companies and perhaps get government subsidies to help pay for it. If Medicaid were expanded in Kentucky, hundreds of thousands of more people would be covered, with the fedreal government paying all the extra cost in 2014-16, decreasing to 90 percent by 2020. Gerth reports that Senate Republicans said they will make it a priority "to rein in Beshear on Medicaid," which they fear would be unsustainable if it were expanded. Denton said requiring legislative approval of these parts of "Obamacare" would give Kentucky citizens a greater voice in the process. (Read more)

Kentucky Senate Health and Welfare Committee Chair Julie Denton, R-Louisville, left, said yesterday that she would file legislation that would block Democratic Gov. Steve Beshear from setting up a health-insurance exchange or expanding Medicaid coverage without legislative approval, Joseph Gerth of The Courier-Journal reports. Beshear has already established an exchange under the federal health reform, but hasn't announced whether he will expand Medicaid.

Denton said the exchanges and Medicaid expansion would be too costly for the state and shouldn't be something Beshear can set up unilaterally. But her effort will likely face opposition in the Democrat-controlled House, Gerth writes. Liberal Rep. Tom Burch, D-Louisville, said Denton "should save the ink that it would take to print the bills," and House Democrats would not receive the bill favorably. Burch has been in the legislature longer than any other current member.

State health-insurance exchanges will allow the uninsured to buy insurance from private companies and perhaps get government subsidies to help pay for it. If Medicaid were expanded in Kentucky, hundreds of thousands of more people would be covered, with the fedreal government paying all the extra cost in 2014-16, decreasing to 90 percent by 2020. Gerth reports that Senate Republicans said they will make it a priority "to rein in Beshear on Medicaid," which they fear would be unsustainable if it were expanded. Denton said requiring legislative approval of these parts of "Obamacare" would give Kentucky citizens a greater voice in the process. (Read more)

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Evaluating disinfection methods for viruses and bacteria

Tuladhar E, Hazeleger WC, Koopmans M, Zwietering MH, Beumer RR and Duizer E. Residual viral and bacterial contamination of surfaces after cleaning and disinfection. Applied and environmental microbiology. 2012; 78: 7769-75.
 
Cleaning and disinfection are important facets of animal care and critical for multi-cat settings, such as veterinary clinics, breeding catteries, and shelters. These investigators examined the ability of various methods to disinfect surfaces of a multitude of viruses (e.g., norovirus, rotavirus, and others) and bacteria (e.g., Staphylococcus, Salmonella, and others) that vary in environmental stability. A single wipe with water, liquid soap, or free chlorine solution led to reduction in contamination but not total elimination of the pathogens. A second wipe with chlorine solution led to significantly more reduction in contamination. However, a single wipe with liquid soap followed by a single wipe with chlorine solution reduced contaminant levels significantly for most pathogens tested. [MK]

See also: Murphy CP, Reid-Smith RJ, Weese JS and McEwen SA. Evaluation of specific infection control practices used by companion animal veterinarians in community Veterinary practices in southern Ontario. Zoonoses Public Health. 2010; 57: 429-38.

Related blog articles:
Disease control in animal shelters (May 2011)

More on cat health:
Winn Feline Foundation Library
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Tuladhar E, Hazeleger WC, Koopmans M, Zwietering MH, Beumer RR and Duizer E. Residual viral and bacterial contamination of surfaces after cleaning and disinfection. Applied and environmental microbiology. 2012; 78: 7769-75.
 
Cleaning and disinfection are important facets of animal care and critical for multi-cat settings, such as veterinary clinics, breeding catteries, and shelters. These investigators examined the ability of various methods to disinfect surfaces of a multitude of viruses (e.g., norovirus, rotavirus, and others) and bacteria (e.g., Staphylococcus, Salmonella, and others) that vary in environmental stability. A single wipe with water, liquid soap, or free chlorine solution led to reduction in contamination but not total elimination of the pathogens. A second wipe with chlorine solution led to significantly more reduction in contamination. However, a single wipe with liquid soap followed by a single wipe with chlorine solution reduced contaminant levels significantly for most pathogens tested. [MK]

See also: Murphy CP, Reid-Smith RJ, Weese JS and McEwen SA. Evaluation of specific infection control practices used by companion animal veterinarians in community Veterinary practices in southern Ontario. Zoonoses Public Health. 2010; 57: 429-38.

Related blog articles:
Disease control in animal shelters (May 2011)

More on cat health:
Winn Feline Foundation Library
Find us on Facebook
Follow us on Twitter
Join us on Google+

Read More