05.03.2012 15:00:00
On February 29, a federal district court judge issued an
Order requiring that Cardinal Health, Inc. comply with an Immediate Suspension Order ("ISO" issued by the Drug Enforcement Administration ("DEA" . The court previously granted a temporary restraining order delaying Cardinal's compliance with the ISO, pending a decision on a preliminary injunction requested by Cardinal. However, the Court denied this preliminary injunction in its Order. Cardinal
appealed this decision on the same day as the court's Order.
Partially at issue in this dispute is the question of who is responsible for stopping diversion, a form of illegal sales of controlled drug substances. Diversion is distributing controlled drug substances to an entity without a valid DEA registration. In this case, diversion of the prescription pain killer oxycodone allegedly took place at pharmacies supplied by Cardinal's Lakeland, Florida distribution facility. Cardinal states that it has a system in place to stop diversion and that it is ready and willing to suspend shipments to any pharmacy that the DEA identifies as likely to be engaged in diversion. The DEA, however, states that the Lakeland facility has a continuing, affirmative obligation to police its retail customers to ensure that the controlled drug substances it provides are not being unlawfully diverted--and the Lakeland facility fell short of its legal and contractual obligations.
According to a
Complaint filed by Cardinal, the ISO requires the Lakeland facility to immediately halt shipments of all controlled drug substances to about 2,700 pharmacies, hospitals, and other customers to prevent alleged imminent danger to the public health or safety. Notably, only Cardinal's Lakeland facility is subject to the ISO. The DEA, however, does not allege that Cardinal itself distributed controlled drug substances to any entity not permitted to purchase them. Instead, the ISO was issued because four pharmacies that were supplied by the Lakeland facility have allegedly distributed oxycodone for illegitimate uses.
05.03.2012 12:59:03
Despite a multitude of warnings about the dangers of drinking raw milk (milk that hasn't been pastuerized , why do some people continue to turn a deaf ear to those warnings, even in light of continued food poisoning outbreaks linked to raw milk?
Could it be the "messenger" -- typically federal and state agencies and public health officials?
A clue to that possibility surfaced in
a recent study, "Motivation for Unpasteurized Milk Consumption in Michigan, 2011," by Paul Bartlett and Angela Renee Katafiasz, of Michigan State University, which appeared in a recent issue of "Food Protection Trends."
In an email to Food Safety News, Bartlett said that what surprised him the most about the results of the survey of raw-milk drinkers was that such a small percentage of them trusted public health officials regarding what food is safe to eat.
Only 4 (or 7.1 percent of the 56 raw-milk consumers who responded to the study's questionnaire agreed with a statement that "in general, they trusted recommendations made by state health officials about what foods are safe to eat." Another 10 (or 17.9 percent indicated they didn't agree with the statement, while another 41 (or 73.2 percent said they weren't sure.
"This lack of trust," says the study, "casts doubt on whether or not consumer education by local or state health departments would be effective in preventing milk-borne disease due to raw-milk consumption."
None of this surprises Mark McAfee, the outspoken co-owner of California-based
Organic Pastures, the nation's largest raw-milk producer. In an email to Food Safety News, McAfee said he has always thought that any area where raw milk is sold should have a huge ultra-red pink sign that says something like: "The FDA says raw milk is dangerous because it has not been processed."
"If that were the case," he said, "sales would skyrocket. No one trusts the Food and Drug Administration or its propaganda."
McAfee said the problem is that "state and federal agencies have cried wolf so many times against raw milk that now any cries that might be an honest attempt to warn of the rare incidence of illness is ignored as hatred against all things FDA."
FDA comes into the picture because the agency doesn't allow raw milk sold for human consumption to be transported across state lines.
That same skepticism about what public health officials and agencies have to say about raw milk kept surfacing in the recent Michigan study. When asked if raw milk should be regulated by the government to ensure quality standards, 27 (or 48.2 percent of the respondents disagreed, while only 9 (or 16.1 percent agreed. Another 17 (or 30.4 percent said they weren't sure.
Along those same lines, some of the raw milk consumers in the study said they generally believe that their producers maintain a higher standard of animal care and cleanliness than does the mainstream dairy industry.
The respondents also took issue with some of the survey's other statements, once again revealing sharp differences of opinion with official government views on the potential health hazards of drinking raw milk. For example, when asked if they agreed or disagreed with the statement that "Drinking raw milk increases your risk of getting a foodborne disease," an average of 44 (or 78.6 percent disagreed. Only 6 respondents agreed with the statement, and another 5 (or 8.9 percent of the respondents said they weren't sure. In Februrary, the Centers for Disease Control and Prevention
released a study showing that the rate of disease outbreaks linked to raw milk was 150 times greater than outbreaks linked to pasteurized milk.
In 2010, Michigan had two
Campylobacter foodborne outbreaks associated with raw milk. And last year, 3 probable cases of
Q-fever were reported in people who participated in raw-milk cow-share arrangements, which according to the report, were presumably caused by drinking raw milk. Back in 1947, Michigan became the first state to require that all milk for sale be pasteurized. As such, the sale of raw milk for human consumption is illegal in that state. However cow- and goat-share agreements in which people buy a share of a herd and are therefore considered owners of the milk from the herd are permitted through an informal agreement on the part of the state.
Profile of a raw-milk drinker
The Michigan study starts off by acknowledging that "it is largely unknown why some consumers prefer raw milk over pasteurized milk."
As such, one of the goals of the peer-reviewed study was to come up with a some sort of profile of raw-milk drinkers in Michigan and from there, to summarize their reasons for preferring raw milk to pasteurized milk.
The profile that emerged was a well-educated adult in his/her late 20s who typically lives in a rural area. Overall, the ages of the raw-milk drinkers, which included family members, ranged from less than one year to 75.
The profile, which, co-author Bartlett readily says is limited due to the small number of raw-milk drinkers surveyed, contrasts starkly with a profile of raw-milk drinkers in California that emerged in an earlier report, "
Profile of Raw Milk Consumers."
Authored primarily by scientists then at FDA's Center for Food Safety and Applied Nutrition, the report analyzed responses to questions in the 1994 California Behavioral Risk Factor Surveillance System Survey that asked respondents about whether they drank raw milk, the amount consumed, the reason for drinking raw milk, and where raw milk was most often obtained.
The researchers found that among the 3,999 survey respondents, 128 (about 3.2 percent reported drinking raw milk the previous year. These raw-milk consumers were more likely that those who didn't drink raw milk to be younger than 40, male, Hispanic and to have less than a high school education.
However, these survey results included any responder who had drunk raw milk in the previous year no matter how much or how little.
One of the conclusions of the California report was that additional research is needed to further refine the profile of raw milk drinkers and determine their risk of adverse effects from drinking raw milk.
The report also said that "Although the role of raw milk as a vehicle in disease transmission has been well-documented, information regarding the prevalence of raw-milk consumption in sparse."
Estimates of the percentage of milk drinkers who drink raw milk range from 1 to 3 percent of the U.S. population, although no one knows for sure since it's too difficult to track the information.
Organic Pastures McAfee was happy to share some information about his raw-milk customers, based on informal studies and polls conducted by the dairy. What surfaces is that 50 percent of the dairy's raw-milk customers are well-educated moms between 20 and 45 years old. The rest of the dairy's raw-milk customers are what McAfee describes as "being all over the place" and can be anyone: young, old, fat, skinny, gay, straight, religious, agnostic, healthy, sick, abandoned by doctors, not wanting to go to doctors, Eastern Bloc immigrants, left wingers, right wingers, no wingers, Tea Party members, and homeschoolers.
"It is everyone," he said.
Why raw milk?
Supporting local farms topped the list of the reasons the Michigan raw-milk survey respondents gave for preferring raw milk, with 48 (or 85.7 of them citing that as a reason. Next came taste, with 47 (or 83.9 percent giving that as a reason. "Holistic health benefits" were cited by 43 (or 76.8 percent of the respondents. Thirty-two respondents (or 57.1 percent said they don't feel processed milk is safe. A majority of the study's raw-milk drinkers shared their beliefs that raw milk was beneficial for relieving digestive problems, intestinal diseases and allergies. Some said they believe raw milk is beneficial for heart disease, neurologic disease, acne, and cancer. Others shared anecdotal claims that when they drink pasteurized milk, they experience symptoms of lactose intolerance, which they said doesn't happen when they drink unpasteurized milk. People with lactose intolerance have a hard time digesting lactose, which is a type of natural sugar found in milk and dairy products. The intolerance occurs when the small intestine doesn't make enough of the enzyme, lactase, which is needed to break down or digest lactose. Symptoms include gas, belly pain, and bloating.
However, a
study out of Stanford Medical School (financed by raw milk advocates not only raised questions about how widespread lactose intolerance really is, but found that raw milk did not confer any benefit over pasteurized milk in relieving symptoms of lactose intolerance. Health authorities say that no matter what benefits might be associated anecdotally with raw milk, the risk of contracting a foodborne disease such as E. coli, Salmonella, Campylobacter or Listeria infection outweighs any of the unproven benefits. They point out that if harmful microorganisms from cow excrement contaminates the raw milk, those drinking it can come down with serious digestive problems, kidney failure, or even death.
In California, labels on raw-milk containers must say: "Raw (unpasteurized milk and raw milk dairy products may contain disease-causing micro-organisms. Persons at highest risk of disease from these organisms include newborns and infants; the elderly; pregnant women; those taking corticosteroids, antibiotics or antacids; and those having chronic illnesses or other conditions that weaken their immunity." The Michigan study also revealed that the average number of years the respondents have been drinking raw milk is 6.1 and that 92 percent of the milk the respondents' families drink is raw milk.
A commitment to purchasing raw milk can be seen in the average number of miles a respondent travels out of his or her way to buy raw milk: 24.2 miles. The average number of pickups of raw milk each month was 4.1.
The study
Questionnaires were sent out to raw-milk producers, 20 of whom agreed to participate in the study. The producers, in turn, were sent survey questions, which they forwarded on to their cow- or goat-share members. Of the 160 questionnaires sent out, 56 were returned.
While the study has been criticized for being self-selecting in that it only questioned people who drink raw milk and biased because it started out with the assumption that it's potentially harmful to your health to drink raw milk, co-author Bartlett told Food Safety News that it was done "for the cost of postage" as a project for a 3-credit course. And, yes, he definitely would have liked to have had a higher response rate and a larger study.
He also pointed out that the hypothesized health benefits of raw milk are difficult to study because it would be unethical to randomly assign people to drink raw milk and others to drink pasteurized milk. Besides which, such a study could not be done blindly because the study subjects would certainly know if they were drinking raw or pasteurized milk (although the Stanford study effectively masked the taste differences with an added flavoring.
More information about raw milk can be found
here.
Could it be the "messenger" -- typically federal and state agencies and public health officials?
A clue to that possibility surfaced in
a recent study, "Motivation for Unpasteurized Milk Consumption in Michigan, 2011," by Paul Bartlett and Angela Renee Katafiasz, of Michigan State University, which appeared in a recent issue of "Food Protection Trends."
In an email to Food Safety News, Bartlett said that what surprised him the most about the results of the survey of raw-milk drinkers was that such a small percentage of them trusted public health officials regarding what food is safe to eat.
Only 4 (or 7.1 percent of the 56 raw-milk consumers who responded to the study's questionnaire agreed with a statement that "in general, they trusted recommendations made by state health officials about what foods are safe to eat." Another 10 (or 17.9 percent indicated they didn't agree with the statement, while another 41 (or 73.2 percent said they weren't sure.
"This lack of trust," says the study, "casts doubt on whether or not consumer education by local or state health departments would be effective in preventing milk-borne disease due to raw-milk consumption."
None of this surprises Mark McAfee, the outspoken co-owner of California-based
Organic Pastures, the nation's largest raw-milk producer. In an email to Food Safety News, McAfee said he has always thought that any area where raw milk is sold should have a huge ultra-red pink sign that says something like: "The FDA says raw milk is dangerous because it has not been processed."
"If that were the case," he said, "sales would skyrocket. No one trusts the Food and Drug Administration or its propaganda."
McAfee said the problem is that "state and federal agencies have cried wolf so many times against raw milk that now any cries that might be an honest attempt to warn of the rare incidence of illness is ignored as hatred against all things FDA."
FDA comes into the picture because the agency doesn't allow raw milk sold for human consumption to be transported across state lines.
That same skepticism about what public health officials and agencies have to say about raw milk kept surfacing in the recent Michigan study. When asked if raw milk should be regulated by the government to ensure quality standards, 27 (or 48.2 percent of the respondents disagreed, while only 9 (or 16.1 percent agreed. Another 17 (or 30.4 percent said they weren't sure.
Along those same lines, some of the raw milk consumers in the study said they generally believe that their producers maintain a higher standard of animal care and cleanliness than does the mainstream dairy industry.
The respondents also took issue with some of the survey's other statements, once again revealing sharp differences of opinion with official government views on the potential health hazards of drinking raw milk. For example, when asked if they agreed or disagreed with the statement that "Drinking raw milk increases your risk of getting a foodborne disease," an average of 44 (or 78.6 percent disagreed. Only 6 respondents agreed with the statement, and another 5 (or 8.9 percent of the respondents said they weren't sure. In Februrary, the Centers for Disease Control and Prevention
released a study showing that the rate of disease outbreaks linked to raw milk was 150 times greater than outbreaks linked to pasteurized milk.
In 2010, Michigan had two
Campylobacter foodborne outbreaks associated with raw milk. And last year, 3 probable cases of
Q-fever were reported in people who participated in raw-milk cow-share arrangements, which according to the report, were presumably caused by drinking raw milk. Back in 1947, Michigan became the first state to require that all milk for sale be pasteurized. As such, the sale of raw milk for human consumption is illegal in that state. However cow- and goat-share agreements in which people buy a share of a herd and are therefore considered owners of the milk from the herd are permitted through an informal agreement on the part of the state.
Profile of a raw-milk drinker
The Michigan study starts off by acknowledging that "it is largely unknown why some consumers prefer raw milk over pasteurized milk."
As such, one of the goals of the peer-reviewed study was to come up with a some sort of profile of raw-milk drinkers in Michigan and from there, to summarize their reasons for preferring raw milk to pasteurized milk.
The profile that emerged was a well-educated adult in his/her late 20s who typically lives in a rural area. Overall, the ages of the raw-milk drinkers, which included family members, ranged from less than one year to 75.
The profile, which, co-author Bartlett readily says is limited due to the small number of raw-milk drinkers surveyed, contrasts starkly with a profile of raw-milk drinkers in California that emerged in an earlier report, "
Profile of Raw Milk Consumers."
Authored primarily by scientists then at FDA's Center for Food Safety and Applied Nutrition, the report analyzed responses to questions in the 1994 California Behavioral Risk Factor Surveillance System Survey that asked respondents about whether they drank raw milk, the amount consumed, the reason for drinking raw milk, and where raw milk was most often obtained.
The researchers found that among the 3,999 survey respondents, 128 (about 3.2 percent reported drinking raw milk the previous year. These raw-milk consumers were more likely that those who didn't drink raw milk to be younger than 40, male, Hispanic and to have less than a high school education.
However, these survey results included any responder who had drunk raw milk in the previous year no matter how much or how little.
One of the conclusions of the California report was that additional research is needed to further refine the profile of raw milk drinkers and determine their risk of adverse effects from drinking raw milk.
The report also said that "Although the role of raw milk as a vehicle in disease transmission has been well-documented, information regarding the prevalence of raw-milk consumption in sparse."
Estimates of the percentage of milk drinkers who drink raw milk range from 1 to 3 percent of the U.S. population, although no one knows for sure since it's too difficult to track the information.
Organic Pastures McAfee was happy to share some information about his raw-milk customers, based on informal studies and polls conducted by the dairy. What surfaces is that 50 percent of the dairy's raw-milk customers are well-educated moms between 20 and 45 years old. The rest of the dairy's raw-milk customers are what McAfee describes as "being all over the place" and can be anyone: young, old, fat, skinny, gay, straight, religious, agnostic, healthy, sick, abandoned by doctors, not wanting to go to doctors, Eastern Bloc immigrants, left wingers, right wingers, no wingers, Tea Party members, and homeschoolers.
"It is everyone," he said.
Why raw milk?
Supporting local farms topped the list of the reasons the Michigan raw-milk survey respondents gave for preferring raw milk, with 48 (or 85.7 of them citing that as a reason. Next came taste, with 47 (or 83.9 percent giving that as a reason. "Holistic health benefits" were cited by 43 (or 76.8 percent of the respondents. Thirty-two respondents (or 57.1 percent said they don't feel processed milk is safe. A majority of the study's raw-milk drinkers shared their beliefs that raw milk was beneficial for relieving digestive problems, intestinal diseases and allergies. Some said they believe raw milk is beneficial for heart disease, neurologic disease, acne, and cancer. Others shared anecdotal claims that when they drink pasteurized milk, they experience symptoms of lactose intolerance, which they said doesn't happen when they drink unpasteurized milk. People with lactose intolerance have a hard time digesting lactose, which is a type of natural sugar found in milk and dairy products. The intolerance occurs when the small intestine doesn't make enough of the enzyme, lactase, which is needed to break down or digest lactose. Symptoms include gas, belly pain, and bloating.
However, a
study out of Stanford Medical School (financed by raw milk advocates not only raised questions about how widespread lactose intolerance really is, but found that raw milk did not confer any benefit over pasteurized milk in relieving symptoms of lactose intolerance. Health authorities say that no matter what benefits might be associated anecdotally with raw milk, the risk of contracting a foodborne disease such as E. coli, Salmonella, Campylobacter or Listeria infection outweighs any of the unproven benefits. They point out that if harmful microorganisms from cow excrement contaminates the raw milk, those drinking it can come down with serious digestive problems, kidney failure, or even death.
In California, labels on raw-milk containers must say: "Raw (unpasteurized milk and raw milk dairy products may contain disease-causing micro-organisms. Persons at highest risk of disease from these organisms include newborns and infants; the elderly; pregnant women; those taking corticosteroids, antibiotics or antacids; and those having chronic illnesses or other conditions that weaken their immunity." The Michigan study also revealed that the average number of years the respondents have been drinking raw milk is 6.1 and that 92 percent of the milk the respondents' families drink is raw milk.
A commitment to purchasing raw milk can be seen in the average number of miles a respondent travels out of his or her way to buy raw milk: 24.2 miles. The average number of pickups of raw milk each month was 4.1.
The study
Questionnaires were sent out to raw-milk producers, 20 of whom agreed to participate in the study. The producers, in turn, were sent survey questions, which they forwarded on to their cow- or goat-share members. Of the 160 questionnaires sent out, 56 were returned.
While the study has been criticized for being self-selecting in that it only questioned people who drink raw milk and biased because it started out with the assumption that it's potentially harmful to your health to drink raw milk, co-author Bartlett told Food Safety News that it was done "for the cost of postage" as a project for a 3-credit course. And, yes, he definitely would have liked to have had a higher response rate and a larger study.
He also pointed out that the hypothesized health benefits of raw milk are difficult to study because it would be unethical to randomly assign people to drink raw milk and others to drink pasteurized milk. Besides which, such a study could not be done blindly because the study subjects would certainly know if they were drinking raw or pasteurized milk (although the Stanford study effectively masked the taste differences with an added flavoring.
More information about raw milk can be found
here.
05.03.2012 12:59:03
Antibiotic resistance remains common among meat-borne pathogens, according to the annual National Antimicrobial Resistance Monitoring System report released late last week.
NARMS, which is coordinated between the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention and some state laboratories, is meant to serve as a "reference point identifying and analyzing trends in antimicrobial resistance among these organisms."
From January to December 2010, samples of retail chicken breast, ground turkey, ground beef, and pork chops were collected and tested for Salmonella. Poultry samples were also cultured for Campylobacter. Some labs also pulled samples of meat and poultry to test for E. coli and Enterococcus.
In all, NARMS collected 5,280 samples from California, Colorado, Connecticut, Georgia, Maryland, Minnesota, New Mexico, New York, Oregon, Tennessee, and Pennsylvania.
Salmonella serotypes Typhimurium, Saintpaul, and Heidelberg accounted for 44.5 percent of retail meat isolates. The prevalence of Salmonella Heidelberg -- which was the subject of a
massive ground turkey recall and multistate foodborne illness outbreak over the summer -- among all retail meat continued to decrease, according to the report, from 22.8 to 9 percent from 2002 through 2010.
The report highlighted a number of findings that may reinforce what many public health advocates have been arguing for years: that antibiotic use in agriculture is contributing to drug resistance in bacteria. The NARMS report pointed out that third-generation cephalosporin resistance rose in chicken breasts (10 to 34.5 percent and ground turkey (8.1 to 16.3 percent isolates from 2002 to 2010.
This trend was a key factor in the FDA's recent
decision to limit the off-label uses of cephalosporin in food animals.
"It is likely that the extralabel use of cephalosporins in certain food-producing animal species is contributing to the emergence of cephalosporin-resistant zoonotic foodborne bacteria," reads the FDA rule. "Resistance to certain cephalosporins is of particular public health concern in light of the evidence of cross-resistance among drugs in the cephalosporin class."
NARMS also found that 43.3 percent of chicken breast isolates were resistant to three or more antimicrobial classes in 2010 compared to 33.7 percent in ground turkey. More than 29 percent of chicken breast isolates showed resistance to 5 or more classes in 2010. Salmonella Albert was isolated from ground turkey for the first time since 2002 and was resistant to all 8 classes of antimicrobials tested.
Salmonella isolates susceptible to all antimicrobials decreased in pork chops (50 to 35 percent from 2009 to 2010 and multidrug resistance among Salmonella increased among chicken breasts (29 to 35.7 percent and ground turkey (22.3 to 30.7 percent .
NARMs also noted that E. coli -- which is only harmful in certain cases, but can serve as a marker for the level of contamination -- is common in all retail meat products tested in NARMS.
Of 1,840 retail meats tested in 2010 for E. coli, 64 percent were culture-positive for E. coli, with pork chops having the lowest prevalence (39.8 percent and ground turkey with the highest (80.2 percent .
Gail Hansen, senior officer for the Pew Campaign on Human Health and Industrial Farming, said the report further backed up the importance of limiting antibiotic usage in agriculture, a move that Pew and a wide range of public health groups have been pushing for years.
"It really does reinforce what decades of research has been telling us about antibiotic resistance," said Hansen, a veterinarian. She noted that NARMS data helped FDA's decision to limit cephalasporins: "I was stuck by how much this [resistance] has gone up."
The full NARMS report is available
here.
NARMS, which is coordinated between the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention and some state laboratories, is meant to serve as a "reference point identifying and analyzing trends in antimicrobial resistance among these organisms."
From January to December 2010, samples of retail chicken breast, ground turkey, ground beef, and pork chops were collected and tested for Salmonella. Poultry samples were also cultured for Campylobacter. Some labs also pulled samples of meat and poultry to test for E. coli and Enterococcus.
In all, NARMS collected 5,280 samples from California, Colorado, Connecticut, Georgia, Maryland, Minnesota, New Mexico, New York, Oregon, Tennessee, and Pennsylvania.
Salmonella serotypes Typhimurium, Saintpaul, and Heidelberg accounted for 44.5 percent of retail meat isolates. The prevalence of Salmonella Heidelberg -- which was the subject of a
massive ground turkey recall and multistate foodborne illness outbreak over the summer -- among all retail meat continued to decrease, according to the report, from 22.8 to 9 percent from 2002 through 2010.
The report highlighted a number of findings that may reinforce what many public health advocates have been arguing for years: that antibiotic use in agriculture is contributing to drug resistance in bacteria. The NARMS report pointed out that third-generation cephalosporin resistance rose in chicken breasts (10 to 34.5 percent and ground turkey (8.1 to 16.3 percent isolates from 2002 to 2010.
This trend was a key factor in the FDA's recent
decision to limit the off-label uses of cephalosporin in food animals.
"It is likely that the extralabel use of cephalosporins in certain food-producing animal species is contributing to the emergence of cephalosporin-resistant zoonotic foodborne bacteria," reads the FDA rule. "Resistance to certain cephalosporins is of particular public health concern in light of the evidence of cross-resistance among drugs in the cephalosporin class."
NARMS also found that 43.3 percent of chicken breast isolates were resistant to three or more antimicrobial classes in 2010 compared to 33.7 percent in ground turkey. More than 29 percent of chicken breast isolates showed resistance to 5 or more classes in 2010. Salmonella Albert was isolated from ground turkey for the first time since 2002 and was resistant to all 8 classes of antimicrobials tested.
Salmonella isolates susceptible to all antimicrobials decreased in pork chops (50 to 35 percent from 2009 to 2010 and multidrug resistance among Salmonella increased among chicken breasts (29 to 35.7 percent and ground turkey (22.3 to 30.7 percent .
NARMs also noted that E. coli -- which is only harmful in certain cases, but can serve as a marker for the level of contamination -- is common in all retail meat products tested in NARMS.
Of 1,840 retail meats tested in 2010 for E. coli, 64 percent were culture-positive for E. coli, with pork chops having the lowest prevalence (39.8 percent and ground turkey with the highest (80.2 percent .
Gail Hansen, senior officer for the Pew Campaign on Human Health and Industrial Farming, said the report further backed up the importance of limiting antibiotic usage in agriculture, a move that Pew and a wide range of public health groups have been pushing for years.
"It really does reinforce what decades of research has been telling us about antibiotic resistance," said Hansen, a veterinarian. She noted that NARMS data helped FDA's decision to limit cephalasporins: "I was stuck by how much this [resistance] has gone up."
The full NARMS report is available
here.
05.03.2012 19:07:21
Bayer Healthcare currently faces about 11,300
Yaz lawsuits filed by women who claim that Yaz causes serious injuries. The pharmaceutical giant agreed to settle about 70 of these lawsuits.
In its 2011 Annual Financial Report, the company informed investors it has have settled a number of cases and may continue to settle case by case.
On December 8, 2011, a panel of advisors for the U.S. Food and Drug Administration met to discuss the benefits of birth contraceptives
Yaz and Yasmin®. In a vote of 15 to 11, the agency determined that the benefits of the pills outweighed the risks.
A study conducted by Canada Health officials compared what are considered “new generation” birth control pills, which includes Yaz and Yasmin, to traditional birth control pills. Results of the study revealed that Yaz and Yasmin pose a higher risk for blood clots than traditional pills.
Yaz was introduced by Bayer in 2006. The oral contraceptive generated sales of $781 million for the company in 2009 but those sales have since dropped to $374 million due to emerging safety concerns.
Women who have taken Bayer’s oral contraceptives claim to have suffered adverse side effects such as stroke, pulmonary embolism, deep vein thrombosis, gallbladder disease, and even death.
Yaz, Yasmin, and other new generation birth control pills contain an active ingredient known as drospirenone which is not found in traditional birth control pills. The FDA conducted a study examining more than 800,000 women. The study compared pills containing drospirenone to pills not containing drospirenone. Results revealed that women on pills containing drospirenone face a 74% higher risk for developing blood clots than women taking traditional pills.
Prior to the settlement of
Yaz lawsuits, mediation was ordered between all parties involved. Judge Hendon, who is presiding over all Yaz lawsuits, issued an order which indefinitely continued the start of the first trial. The order mandated both parties to engage in settlement negotiations in good faith.
http://consumer-drug-report.com/content/bayer-settles-yaz-lawsuits#comments
04.03.2012 9:00:00
The Android-based platform developed by two industry veterans processes payments, manages inventory and, perhaps most importantly, displays nutritional information that will soon be required the federal government.
Watch video
View full size
VendScreen co-founder Paresh Patel launched
Twenty years later, with
an 1,800-machine vending operation that stretches from Salem to Vancouver, he's about to launch a device that experts say could transform the industry and potentially become standard on all machines.
VendScreen, developed at his Northeast Portland operations base a half-mile from his alma mater, is an Android-based platform that connects vending machines to 3G technology. The touch-screen device accepts payments, displays ads and manages inventory, connecting manufacturers to consumers at the point of sale and giving operators a direct, cloud-based connection to their machines.
But, perhaps most important, it also displays nutritional information, a pending requirement under the
Affordable Care Act of 2010. The new rules stand to cost operators hundreds of thousands of dollars to update the estimated 7 million vending machines across the United States, and gives VendScreen the perfect cue to enter the market.
"Someone is going to win big doing what they're going to do," said Gerry Langeler, a managing director of venture capital firm
OVP Venture Partners. "The only question is -- is it them?"
Other digital products dot the vending landscape. But industry experts say VendScreen is the first platform that tracks inventory, processes credit cards and discloses nutritional facts, all while fitting on existing machines. And because it's based in the cloud, VendScreen can be updated wirelessly, adding new applications as competitors introduce new options. Eventually, the device will be able to accept payments via smartphone.
In turn, VendScreen plans to charge operators 2.75 percent of all sales that go through the machine. Patel and his business partner Glenn Butler, another industry vet, plan to target such brands as Coca-Cola and Pepsi as the devices are added to more and more machines. The technology already has attracted $12 million in venture capital ahead of its targeted April launch at
an industry trade show.
"To me, that's the best kind of venture deal," Langeler said. "You come in at the end of the meeting, you slap your head, and you say, 'Wow.'"
Patel and Butler handpicked VendScreen's first customers and say they've signed two deals worth $5 million in sales. They're beta-testing 500 devices now to prepare for its launch this spring.
"We want to make sure we're disrupting the marketplace in a way that succeeds," Patel said. "We want to make sure we can deliver."
Technological solutions
The path to VendScreen started three years ago at a Gresham Baskin-Robbins, when Patel looked closely at the menu. There, printed next to the ice cream options, were their calorie counts. "They're going to start making us do that too," he recalled thinking.
His small vending operation had served as an applied learning lab while he worked his way through Portland State University and graduate school at the University of Washington. Then, in 1999, it became his full-time job.
He doubled the business year after year, eventually buying out seven area operators. By 2005, he had built
Courtesy Vending into an 1,800-machine operation. "I've watched Paresh's brand of entrepreneurship for a few years," said Angela Jackson, who co-manages the Portland Seed Fund, a local startup incubator. "He owns that space, going back to high school."
Technology, meanwhile, had always fascinated him. At 16, he launched his first business, a desktop publishing service that created business cards. Years later, as his vending operation grew, he started tracking its inventory, down to the chocolate bar, and managed the massive database electronically. The move increased the company's efficiency and boosted its sales. Drivers knew which machines to prioritize and which to skip. "I didn't invest in technology for technology's sake," he said. "I was ultimately looking to solve our problems."
Calorie counts presented a big problem. Vending machine lineups rotate often as operators swap out less popular options with new ones. The only way to account for all the possible snack combinations, Patel thought after that trip to Baskin-Robbins, was a digital platform.
Meanwhile, Butler, who served as chief technology officer for vending-machine-maker
Crane Merchandising Systems, was working on the same problem in Boston. The pair met last year and decided in June to move forward as a team.
Months later, and just hours before they interviewed for one of eight spots with the
Portland Incubator Experiment, they powered on the prototype. They hoped it would work.
It did. As part of Wieden+Kennedy's startup lab, they built the business from the ground up. They met with investors, refined the prototype and pitched to customers.
"We weren't sitting at the computers," Patel said. "We were making deals."
In January, Patel stood before a packed crowd at the Bagdad Theater in Southeast Portland, where hundreds were waiting to hear presentations from the startup incubator's first class.
After making his pitch, he started to leave the stage, then paused. "I have a very exciting announcement to make as well," he said. "Last Friday (Jan. 13 , I signed a term sheet that will commit an investment into VendScreen for $12 million."
He tried to go on, but had to stop until the cheering subsided.
Patel and Butler have declined to disclose any details about the investors, citing Securities and Exchange Commission regulations as the deal closes, though Patel did say the funding is largely local.
Portland investor Nitin Khanna said he is leading the investment round. His
MergerTech firm helps broker deals in the tech sector.
"I looked at the technology ... I immediately said yes," he said. "It's probably the most disruptive technology that I've seen for any industry. In my mind, the single biggest reason is to display nutrition information."
The cost of compliance
When President Barack Obama signed the Affordable Care Act in March 2010, a small section in the landmark legislation stood to wallop the vending industry. It required access to nutritional information before purchase.
For many vendors, compliance would mean adopting stickers or posters to display calorie counts. The Food and Drug Administration estimated that that task alone could cost vending machine operators 14.1 million hours a year to update such information on millions of U.S. vending machines.
It's a costly proposition for an industry already functioning on thin margins. Operators' pretax profits averaged 2.4 percent in 2010, according to the
National Automatic Merchandising Association.
The recession hurt vendors as their corporate clients downsized, leaving fewer workers to buy from machines. Experts pegged the industry's value at $23.2 billion in 2007. By 2010, it had fallen to $19.3 billion, a 17 percent drop.
Last summer,
comments from frustrated vendors poured into the FDA, the agency tasked with implementing the new regulations. A handful said it would push them out of business. Others urged the agency to require manufacturers to print calorie counts on the front of packages that would be visible through machines' glass windows. Some of the nation's biggest brands also weighed in on the conversation, from Starbucks to Kraft Foods, which both make products sold in vending machines.
The FDA has yet to issue final guidelines on when the changes will take effect. Still, manufacturers already are scrambling to figure out how to comply with the rules.
Mark Stein, whose Mark Vend Co. operates 2,000 machines in the Chicago market, said his company plans to switch to a digital product for convenience and aesthetics.
In comments to the FDA, Stein endorsed a separate nutritional information system known as the
Make Informed Nutritional Decisions (MIND touch screen. Unlike VendScreen, the system isn't connected wirelessly to operators. Instead, every machine is updated with memory cards.
Regardless of the system, a digital solution is the only one that makes sense, said Mike Kasavana, a Michigan State University professor who studies the technologies that drive self-service vending machines. He serves as the endowed professor of the industry's trade group, the National Automatic Merchandisers Association.
"You're not really sure if the item that's in A-1 this month is going to be the same item in A-1 next month," Kasavana said. "It's got to be digital."
The college students Kasavana teaches view vending machines as passive, aging devices, he said. Most expect to make their purchases with a debit card, an option that 96 percent of today's vending machines don't afford.
Devices like VendScreen could change those perceptions, making sales that machines wouldn't have otherwise.
"Once you put digital media on the machine, you've changed the whole interface," Kasavana said.
--
Molly Young;
@PDXSmlBizNews
02.03.2012 1:16:27
Hackers demonstrate new wireless attacks against insulin pumps, GE and Masimo ink a new OEM deal and Cardiac Science and Flight Medical launch Class I recalls.
Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of MassDevice.com's coverage highlights our 3 biggest and most influential stories from the day's news to make sure you're up to date on the headlines that continue to shape the medical device industry.
If you read nothing else today, make sure you're still in the know with MassDevice +3.
News Well,
Diabetes,
Food & Drug Administration (FDA ,
Health Information Technology,
Insulin Management,
Plus 3,
Recalls,
Wall Street Beat
Diabetes,
Food & Drug Administration (FDA ,
Health Information Technology,
Insulin Management,
Plus 3,
Recalls,
Wall Street Beat
http://www.massdevice.com/news/massdevicecom-3-top-3-med-tech-stories-march-1-2012#comments
No comments:
Post a Comment