FROM: U.S. FOOD AND DRUG ADMINISTRATION
FDA’s Survey of Milk Finds Few Drug Residues
March 5, 2015
The U.S. Food and Drug Administration today announced results from its milk sampling survey, involving the testing of nearly 2,000 dairy farms for drug residues in milk. More than 99 percent of the samples are free of drug residues of concern-- underscoring the safety of the US milk supply. These findings provide evidence that the nation’s milk safety system is effective in helping to prevent drug residues of concern in milk, even in those limited instances when medications are needed to maintain the health of dairy cattle.
The agency initiated the study to determine whether dairy farms with previous drug residue violations in tissue derived from dairy cows were more likely to have violative drug residues in milk than other dairy farms. The FDA tested samples from two groups: a “targeted” list of farms with known previous tissue residue violations and a control group of farms. Results show that the occurrence of drug residues in milk is very low, even in the targeted group. However, the limited number of residues detected involved drugs that are not included in routine testing under the current milk safety program.
Despite the finding of a small number of drug residues in samples collected, the FDA intends to take steps to maintain the strongest possible system to ensure milk safety. The FDA will work closely with state regulators to consider modifying testing to include collecting samples as necessary from milk tanks on farms when investigating illegal drug residues in tissues involving culled dairy cows. The agency is also working with its milk regulatory partners to update the existing milk safety program, as necessary, to include testing for a greater diversity of drugs and to educate dairy producers on best practices to avoid drug residues in both tissues and milk.
Showing posts with label DRUGS. Show all posts
Showing posts with label DRUGS. Show all posts
Friday, March 6, 2015
Sunday, June 1, 2014
GENERIC CELEBREX APPROVED BY FDA FOR ARTHRITIS, OSTEOARTHRITIS
FROM: U.S. FOOD AND DRUG ADMINISTRATION
FDA approves first generic versions of celecoxib
May 30, 2014
Release
Teva Pharmaceutical Industries received approval to market celecoxib capsules in 50 milligram, 100 mg, 200 mg, and 400 mg strengths, and has 180-day exclusivity on the 100 mg, 200 mg, and 400 mg strength products. Mylan Pharmaceuticals, Inc. received approval to market 50 mg celecoxib capsules.
“It is important for patients to have access to affordable treatment options for chronic conditions,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Health care professionals and patients can be assured that these FDA-approved generic drugs have met our rigorous approval standards.”
Celecoxib is a Non-Steroidal Anti-Inflammatory Drug (NSAID). All NSAIDs have a Boxed Warning in their prescribing information (label) to alert health care professionals and patients about the risk of heart attack or stroke that can lead to death. This chance increases for people with heart disease or risk factors for it, such as high blood pressure, or taking NSAIDs for long periods of time. The Boxed Warning also highlights the risk of serious, potential life-threatening gastrointestinal (GI) bleeding that has been associated with use of NSAIDs.
In the clinical trials for Celebrex, the most commonly reported adverse reactions in patients taking the drug for arthritis were abdominal pain, diarrhea, indigestion (dyspepsia), flatulence, swelling of the feet or legs (peripheral edema), accidental injury, dizziness, inflammation of the throat (pharyngitis), runny nose (rhinitis), swollen nasal passages, (sinusitis), upper respiratory tract infection, and rash.
Generic prescription drugs approved by the FDA have the same high quality and strength as brand-name drugs. Generic drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.
Information about the availability of generic celecoxib can be obtained from the companies.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Wednesday, April 9, 2014
REMARKS BY WILLIAM BROWNFIELD ON "DRUGS, SECURITY, AND LATIN AMERICA"
FROM: U.S. STATE DEPARTMENT
Drugs, Security, and Latin America: The New Normal?
William R. Brownfield
Assistant Secretary, Bureau of International Narcotics and Law Enforcement Affairs
Assistant Secretary, Bureau of International Narcotics and Law Enforcement Affairs
Lyndon B. Johnson School of Public Affairs, University of Texas
Austin, Texas
March 27, 2014
Ladies and gentlemen, it is indeed a pleasure to be back in Austin. As the Dean has suggested, I spent three years of my life at that fine academic institution, just across the street in that direction, and in fact it was my nearly three years at the law school that brought me into the Foreign Service and the Department of State. Trust me when I tell you that the first year of law school was so decidedly unpleasant that when I saw the advertisement on the bulletin board, which said Foreign Service exam and included the magic word, “free,” I said, “Right. Maybe I want to be a Foreign Service Officer.”
And for those of you who actually are still trying to determine your own profession or career choice for the next 30 or 35 years of your lives, let me assure you: sometimes you just enter a profession, if you will, by the back door, through no more systematic or intellectually driven process than that the entry exam is free. And that, ladies and gents, was 35-plus years ago. And at least for me it worked out just fine.
Ladies and gentlemen, the title of today’s little talk is “Drugs, Security, and Latin America: The New Normal?” I’m actually going to talk about anything that you want me to talk about, because that is the purpose of a dialogue. However, there is some logic to the title. I have spent virtually my entire professional career doing Latin America, so logically I might have at least some observations of value that are related to Latin America. Drugs are part of what I now deal with for a living. I am the Assistant Secretary of State for Drugs and Law Enforcement, and to be clear, I officially oppose the former and support the second. I want there to be no confusion on that particular point, although I have a broader responsibility as the Assistant Secretary for INL.
We started life 40 years ago as the part of the State Department that does international drug programs. Beginning about 20 years ago, we expanded to broader crime issues, realizing perhaps that there is more crime out there of an international nature than just drug trafficking. Within about the last 15 years, we expanded more broadly into law enforcement writ large – police training, exchanges, equipment, support, academics, etc. And within the last 10 years or so, driven, believe it or not, by our experiences in Iraq and Afghanistan, we’ve expanded our portfolio and our writ to cover what we would call all of rule of law, which is not just police, but is also prosecutors, courts, judges, corrections systems. If it is part of the criminal justice system in essence, we will now work with and support it in some way, shape, or form.
And the last two or three words of the title of this talk – The New Normal? – is just a way to tease you into wondering if this is the direction we are heading in the Western Hemisphere in the 21st century.
Let me start with a little bit of history. I’ll offer some observations, and then I will stop and let you all actually guide me in the direction you would prefer to hear from me in terms of your own thoughts and your own interests.
A little bit of history: In the 1970s, the United States of America, or at least its government, discovered the drug issue. Richard Nixon declared a ‘war on drugs,’ a very unfortunate selection of terms, by the way, since in fact it’s not a war. It’s certainly not a war against our own population that in some way, shape, or form is part of the drug issue. And for that reason, ever so wisely, in the year 1993, the then newly-inaugurated president of the United States Bill Clinton said, and I quote, “It’s not a war, and we’re going to stop calling it a war on drugs.” Things move slowly in the federal government and the media, but don’t you all come at me in 15 minutes and start condemning me for the war on drugs, because I have already told you in advance it is not a war on drugs, it has not been a war on drugs for 21 years, and what we are doing goes a bit beyond the classical, typical definition of the term war, combined with the word drugs.
Having, however, declared a war on drugs in 1972, the Nixon Administration then proceeded to attempt to win it. They did it by what I would call single-issue approach to the drug abuse problem. First it was eradication. We will go down to Peru, Bolivia, and Colombia, eradicate it at the source, and the problem will be solved. Now, they had some success in eradicating. At the end of the day, however, for every hectare or acre eradicated, another acre or two or three would come under production and cultivation. Obviously, eradication alone was not the answer or the solution.
Solution number two, we will dismantle. We will go after the criminal organizations and arrest or remove their leadership from operation. Once we have removed the leadership of the criminal organizations, the cartels, the entire structure that drives the drug trafficking industry, will then collapse. Once again, there were the occasional successes. Those of you – and some of you are actually not old enough to remember when this happened – in 1993, in a particularly effective operation, the Colombian National Police took down, literally removed – perforated about 125 times – Mr. Pablo Escobar, who had been for the preceding 10-15 years the head of the largest, most vicious, most violent drug trafficking cartel in the history of the human race, called the Medellin Cartel, a cartel that might quite conceivably have been responsible for up to 10,000 murders in the preceding decade.
Impact? Well, 1994 came along and drugs continued to flow. Taking down or decapitating organizational leadership, in and of itself, obviously was not the solution.
Next proposal, in the 1980s, was interdiction. “Okay,” they said. “We can’t seem to stop it by eradicating at the source, we can’t seem to stop it by eliminating the leadership of the trafficking organizations. Let us build a picket line down below the U.S. southern borders, both on the ground and at sea, stop the ships, the boats, the planes that are bringing this stuff into the United States, andvoila, problem is solved.
Once again, there were some successes. The truth of the matter is the Caribbean in the 1980s was a region that was at risk of losing control. Fourteen different governments were at risk of losing control of their sovereign national territory to multi-billion dollar drug trafficking industries. And in their defense, that generation of the 1980s actually did effectively interdict the flow of drugs through the Caribbean toward the United – the southeastern United States of America.
But did that solve the problem? No. Where are we today? We’re in central Texas. Where do the drugs now flow into the United States? They come up straight through the land corridor, starting in Colombia, working their way through Central America, processing up through Mexico, and entering through the southwest border of the United States of America. In other words, yes, you can plug your finger in one hole of the dam, but in all likelihood – one might almost say with complete certainty – another hole is going to open up. And at the end of the day you have a finite number of fingers to plug with, defined by how much money the United States Congress and the taxpayers that send them to office are prepared to dedicate to this particular exercise.
Finally, and with somewhat greater coherence and success, the government began to develop an approach in the 1990s which I would call sustainable economic development. And that is accepting the reality that campesinos – or if you’re in Afghanistan and dealing with opium poppy, subsistence-level farmers, actually are not inherently criminal; they do not plant coca or opium poppy because they wish to be part of criminal enterprises. They do it because they are trying to provide a basic living to their families, and coca or opium poppy actually gives them better income and more secure income than corn or frijoles or wheat or whatever it might be that is otherwise being grown in that region.
Now this approach actually made some degree of sense, and I would suggest to you that where it is applied, it does produce long-term results. Problem: It is amazingly expensive. It costs a good bit of money to actually manage on a nationwide basis an alternative development program. It’s not just giving them a barrel of corn seed so that they will plant corn rather than coca. It’s also giving the tools and the training. It’s also giving them the infrastructure, the road system that allows them to get their product to market once they have harvested it, because remember: the drug traffickers will come to them, buy their product, and take it away at no cost to the farmer. The farmer who has instead two tons of corn somehow has to get it to market, or within a month or two he has more or less two tons of mulch that is gradually deteriorating and rotting in his back yard.
On top of that, if you want the campesino to remain committed to this, you have to give him or her some stake in the community. That means maybe schools, maybe clinics. That means electricity, running water, sewage, the sort of thing that makes a family say, one, I do have an interest in staying here, and two, I have a future here over and above whether I can grow an acre of coca or an acre of opium poppy.
Okay. Eradication, dismantling, interdiction, economic development – none of them in and of themselves solved the drug problem. So the question is, since the drugs are still an issue, what is the correct response? Are you ready? Bill Brownfield says the correct response is all of the above and then a little bit more as well.
Let us flash-forward to 1999, when the United States Government, jointly with the Government of Colombia, actually did this the right way. But I will prejudge the conclusion by letting you know the right way cost $8.5 billion over roughly a 12-year period of time. But we launched – the Colombian government launched what came to be called Plan Colombia. Plan Colombia was a comprehensive, structured approach designed to address the economic issue, the security issue, and the drugs and law enforcement issue. And when I said economic, I should also have said social, to include health impact, education, as well as job generation and economic activity.
Ladies and gentlemen, I would suggest that that worked for Colombia. The huge cartels that in the 1990s were actually threatening the very existence of the Colombian government have been atomized, admittedly to still annoying criminal activities, but are not anywhere remotely as powerful, as strong, or as threatening as Mr. Pablo Escobar and his Medellin cartel at the start of the 1990s, or the Rodriguez Orejuela brothers and the Cali cartel at that same timeframe.
Cocaine production in Colombia, we estimate, is down 60 percent or so from its heyday, as recently as 10 years ago. The tourism industry in Colombia today is booming. There are probably 20 times as many tourists going to Colombia today as 10 years ago. And if you will, tourists vote with their feet. If tourists are going to Colombia, you assume the security situation obviously has reached a point where people are prepared voluntarily to spend their own money to go visit a country that 10 or 15 years ago they would not have dreamed of doing so without a battalion of the United States Army or Marine Corps joining them and providing them security at every step.
And may I note as well that there is some correlation between the fact that production of cocaine in Colombia has dropped by some 60 percent, and consumption of cocaine in the United States of America has dropped by some estimates between 40 and 50 percent? I’m not giving you the Pollyanna story here. I freely acknowledge other sorts of drug consumption have grown in this same time period. But the two things that have most driven the Latin America to North America drug trafficking crisis – cocaine and methamphetamines – have both gone down dramatically in terms of demand in the United States.
Heroin is moving at a much smaller level – I mean, the simple truth, the quantity of heroin that moves. Marijuana, synthetics, and pharmaceuticals: apparently we’re quite capable of producing our own domestically in the United States of America. What has been driving the crisis of violence, of homicide, of crime in the Central America-Mexico corridor is cocaine and methamphetamines. The extent to which that product and the trafficking in that product is going down is actually good news for those seven Central American and Mexican countries and governments.
That said, I do not mean to suggest to you that by addressing the problem in Colombia the problem was resolved. On the contrary – and I’m not going to walk you through each of these in the same degree of detail, but the balloon theory – they were squeezed, the bad guys were squeezed in Colombia. What did they do? Largely they moved to Mexico, where, as those of you who could remember where we were about seven or eight years ago, Mexico was confronting a crisis of large cartels that actually represented a threat to the sovereignty of the government itself. And we launched what came to be known as the Merida Initiative, a joint effort in which the Mexican Government offered roughly $13 to every $1 offered by the United States to address this problem.
We squeezed them in Mexico, and what happened? Many of them moved to Central America. The crisis of the last five years has been the surge in violence, in homicides, in crime, in gang activities in Central America. Response? CARSI, the Central America Regional Security Initiative. Much smaller than that for Mexico, but the truth of the matter is there’s a finite number of dollars that are available to be applied to this problem. We squeeze them in Central America and what do we see increasingly happening? You will be stunned to learn that the statistics of drug flows through the Caribbean, that same region that was in fact successfully shut down in the 1980s, has been growing from a factor of roughly 4 percent of U.S. drug consumption three years ago to 8 percent two years to 9 or 10 percent over the last year, and now an estimated 14 percent.
If you’re tracking the trend line, even if we don’t know precisely how much is moving, the fact of the matter is what I have described for you is a tripling of drug flow through the Caribbean over the last three years. Watch this space. If in the course of the next two or three years you see the occasional headline saying, “Drug crisis in the Caribbean,” you will be able to say, yeah, Brownfield at least was prescient enough to predict that would be happening.
Each of the initiatives that I have laid out – Plan Colombia, Colombia; Merida Initiative, Mexico; CARSI, Central America; CBSI, Caribbean Basin Security Initiative, for the Caribbean – had, I would suggest – while each was different, each had its own particular characteristics – they had several common principles.
One, there was an attempt and still is an attempt to link together all the elements of the problem: law enforcement, security, rule of law institutions, economic and social development. Second, they are sustainable. Sustainable means the host government – whether it’s Colombian, Mexican, Central American, Caribbean – sees enough of their own interest at stake that they’re prepared to put their own resources into the problem and the solution. Third, they accept as a principle that the host government makes the decision. If we want a particular program and they don’t, at the end of the day, their view is what determines what will be done. Fourth, they try to focus on institutions and institution-building rather than equipment, rather than hard stuff, rather even than operations, the thinking being if you build an institution, you get value for a generation. If you do a successful takedown operation, you get a headline and value that might last you for a day or two.
Fifth, they are regional in nature – by the way, even the bilateral programs, Colombia and Mexico, are regional to the extent that they link into other countries in the region. Today, for example, Colombian police are training more police in Central America than is the United States. And some of it is actually being done with our assistance, which is another way of saying we actually pay for it. But the quality of the training and the ability of the trainers from Colombia is actually greater than what we ourselves can offer, partly because of their experience, partly because, of course, it’s a lot easier for a Spanish-speaking national police officer from Colombia to do training in Central America than it is even for a Spanish-language-trained U.S. law enforcement officer.
And the sixth principle that we have – I think linking all of these together – is the concept of partners. With each initiative, we have drawn in more and more international partners to play into this effort. Why? One reason I suggest to you is that even as consumption of cocaine in the United States has been dropping steadily since 2007, consumption of cocaine in Western Europe or in East Asia has been growing dramatically, without even mentioning the largest country in South America – Brazil – which is today confronting what could almost be called a crack cocaine crisis. And obviously, as their populations and communities are increasingly victims – or participants, depending upon your perspective – in this process, there is obviously greater interest in joining in efforts as partners to address the problem either at its source or in the midpoint, in short, before it arrives on the shores of France or Italy or Spain or the United Kingdom.
Ladies and gentlemen, may I suggest to you that it is a little bit early, perhaps a century or two, perhaps a millennium or so, to declare success on this particular issue? May I suggest to you it is not too early to say the year 2014 and the next five or ten years will offer a different problem set, a different set of realities from what we were dealing with in the 1970s, ‘80s, ‘90s, or even the last decade? First, you have one nation that has emerged, if you will, from the hell of the 1990s, and is now able to export its experience and its talent set. That nation is Colombia. And let us not forget that having a model out there that other nations in the region can look at has an impact. That is different from where we were 10 or 15 years ago.
Second, let us accept that you now have two new – not so new, but two much more major players in this drama in the region. They are named Bolivia and Peru, and their production level is moving in a sharply upward direction. What is also new, however, is that they are not feeding the North American market; they are feeding the Brazilian and Western European market. It’s an east-west problem as much as a north-south problem. I don’t say one is better than the other; I say it is a different problem set, which is going to require a different set of solutions.
Third, as I have mentioned several times, we are dealing with a consumption matter, a consumption issue, that is changing. As the American taste, if you will, shifts from cocaine and methamphetamines to other sorts of drugs, whether it is heroin or opium-based drugs, other synthetics, diverted pharmaceuticals or marijuana, it is a different problem set and presumably requires a different set of solutions.
Fourth – if you wondered if I was going to mention it, and I’m going to mention it right now – nations are experimenting with alternative approaches to drug control. Uruguay, a small nation located in between Brazil and Argentina, has recently, as a matter of national law, legalized the consumption of marijuana throughout the country. Some of you who have been asleep for the last 12 months may be unaware that two states of the union in the United States of America have done exactly the same thing. One of them is wrapping up its third month of this experiment, that’s Colorado, and the other goes online sometime, I think, about the first of July as they work their way through their rules and procedures. And I am not yet in a position to draw any firm conclusions from any of these experiences. I am in a position to say this is a 2014 reality, and let’s take it into account as we figure: How are we going to work this issue over the next five to ten years?
And fifth, and finally – and I do emphasize this point, because I do believe we haven’t – this Administration, the Administration of Barack Obama has not gotten credit or at least as much credit for this as it should – there is a strong realization in this country, your country, the United States of America, that drugs, drug abuse, and the overall total drug issue is far more a matter of public health than it is a matter of criminal justice. It is both unfair to the criminal justice system as well as to many of those who are caught up in the criminal justice system to try to address drug abuse solely in the criminal justice system. It is not just a matter of criminal justice. It is obviously a matter of health, of the medical care and medical profession, and of how you deal with the health and medical aspects of the use of drugs.
Now, I am not saying that the one excludes the other, but I am very definitely saying that trying to address the issue from only one side is pretty much condemned to failure. Those, I submit, are four new elements available as of the 27th of March, 2014, that were different from what we would’ve discussed if we had been sitting here 20 years ago, 10 years ago, quite frankly even as recently as five years ago. We’ve got to figure how to incorporate them into our own thinking.
These are, ladies and gentlemen – those of you who are – it’s about 75 percent of you who I predict are at least below the age of 40 if not below the age of 30 – these are going to be your challenges. Why? Because, I got to tell you, old Brownfield’s going to be checking out of this business in another three or four years, and it’s going to be you and your generation who have to figure out how to deal with these issues. I will offer you only five suggestions as you move proudly into the future on this issue on how to do it.
One, think long term. We didn’t get into this mess overnight, and we’re not going to get out of it overnight. Don’t even think in terms of years, maybe not even decades. Think in terms of generations. Don’t come up with some program that is supposed to solve the problem by 2015. It’s not going to happen.
Second, flexible and adaptable. Tastes change, conduct and behavior changes. The bad guys, the large, transnational criminal organizations who are involved in this, are constantly adapting and adjusting their approach. You had better have your own strategy and policy that can be adjustable and adaptable as well.
Third, be comprehensive. We tried the single-issue approach, ladies and gentlemen. It doesn’t work. We cannot just eradicate ourselves out of this problem. We cannot just interdict our way out of this problem. We also cannot just economic develop our way out of this problem. We have got to address all aspects of the problem. Otherwise we will not succeed.
Fourth principle, build institutions. No one loves a cool operation more than I do. No one loves some snappy new equipment as much as I do. But at the end of the day, your long-term value comes from building better law enforcement capabilities, building more competent prosecutors and investigators, building more effective, efficient, and honest courts and judicial systems, and don’t forget, building a corrections system that actually provides correction as opposed to a graduate course on how to advance from Criminal Activity 101 to the advanced Ph.D. course during three months of incarceration in a detention facility.
And finally, if I might, there is and always will be a criminal justice aspect to this, but principle number five: focus on the big organizations. It’s fine to pump up your numbers, I guess, in terms of how many you can arrest, but if you’re not going after the multibillion dollar organizations who engage not just in drug trafficking, but in trafficking in firearms, trafficking in people, trafficking in general contraband, money laundering that actually corrupts and undercuts and hollows out entire financial institutions, if you’re not focused on them, you’re missing the entire picture.
Okay, back to the title. So what is the new normal? Are you ready? The new normal is constant change. That, ladies and gents, is what we had better wrap our heads around. And we never have for the last 40 years. We’ve always taken the snapshot and said here is what we’re dealing with; now let us develop a strategy that will solve that problem. Wrong-o. That is not what we are going to be dealing with. What we’re looking at today on the 27th of March, I absolutely assure you, is going to be completely different by the time we get into 2015. That’s the new normal. And we had better be ready and able to address that, domestically and internationally, as a criminal justice matter and as a public healthcare matter.
The truth of the matter is we have to have a policy and approach that allows us to move in whatever direction our societies and those who are trying to take advantage of them will be moving in. And ladies and gentlemen, if that’s the new normal, I at least think we’ve got an approach that we can work with in a realistic way and that at least would take us one step beyond where we were 30 or 35 years ago when we started down this road.
And for those of you who actually are still trying to determine your own profession or career choice for the next 30 or 35 years of your lives, let me assure you: sometimes you just enter a profession, if you will, by the back door, through no more systematic or intellectually driven process than that the entry exam is free. And that, ladies and gents, was 35-plus years ago. And at least for me it worked out just fine.
Ladies and gentlemen, the title of today’s little talk is “Drugs, Security, and Latin America: The New Normal?” I’m actually going to talk about anything that you want me to talk about, because that is the purpose of a dialogue. However, there is some logic to the title. I have spent virtually my entire professional career doing Latin America, so logically I might have at least some observations of value that are related to Latin America. Drugs are part of what I now deal with for a living. I am the Assistant Secretary of State for Drugs and Law Enforcement, and to be clear, I officially oppose the former and support the second. I want there to be no confusion on that particular point, although I have a broader responsibility as the Assistant Secretary for INL.
We started life 40 years ago as the part of the State Department that does international drug programs. Beginning about 20 years ago, we expanded to broader crime issues, realizing perhaps that there is more crime out there of an international nature than just drug trafficking. Within about the last 15 years, we expanded more broadly into law enforcement writ large – police training, exchanges, equipment, support, academics, etc. And within the last 10 years or so, driven, believe it or not, by our experiences in Iraq and Afghanistan, we’ve expanded our portfolio and our writ to cover what we would call all of rule of law, which is not just police, but is also prosecutors, courts, judges, corrections systems. If it is part of the criminal justice system in essence, we will now work with and support it in some way, shape, or form.
And the last two or three words of the title of this talk – The New Normal? – is just a way to tease you into wondering if this is the direction we are heading in the Western Hemisphere in the 21st century.
Let me start with a little bit of history. I’ll offer some observations, and then I will stop and let you all actually guide me in the direction you would prefer to hear from me in terms of your own thoughts and your own interests.
A little bit of history: In the 1970s, the United States of America, or at least its government, discovered the drug issue. Richard Nixon declared a ‘war on drugs,’ a very unfortunate selection of terms, by the way, since in fact it’s not a war. It’s certainly not a war against our own population that in some way, shape, or form is part of the drug issue. And for that reason, ever so wisely, in the year 1993, the then newly-inaugurated president of the United States Bill Clinton said, and I quote, “It’s not a war, and we’re going to stop calling it a war on drugs.” Things move slowly in the federal government and the media, but don’t you all come at me in 15 minutes and start condemning me for the war on drugs, because I have already told you in advance it is not a war on drugs, it has not been a war on drugs for 21 years, and what we are doing goes a bit beyond the classical, typical definition of the term war, combined with the word drugs.
Having, however, declared a war on drugs in 1972, the Nixon Administration then proceeded to attempt to win it. They did it by what I would call single-issue approach to the drug abuse problem. First it was eradication. We will go down to Peru, Bolivia, and Colombia, eradicate it at the source, and the problem will be solved. Now, they had some success in eradicating. At the end of the day, however, for every hectare or acre eradicated, another acre or two or three would come under production and cultivation. Obviously, eradication alone was not the answer or the solution.
Solution number two, we will dismantle. We will go after the criminal organizations and arrest or remove their leadership from operation. Once we have removed the leadership of the criminal organizations, the cartels, the entire structure that drives the drug trafficking industry, will then collapse. Once again, there were the occasional successes. Those of you – and some of you are actually not old enough to remember when this happened – in 1993, in a particularly effective operation, the Colombian National Police took down, literally removed – perforated about 125 times – Mr. Pablo Escobar, who had been for the preceding 10-15 years the head of the largest, most vicious, most violent drug trafficking cartel in the history of the human race, called the Medellin Cartel, a cartel that might quite conceivably have been responsible for up to 10,000 murders in the preceding decade.
Impact? Well, 1994 came along and drugs continued to flow. Taking down or decapitating organizational leadership, in and of itself, obviously was not the solution.
Next proposal, in the 1980s, was interdiction. “Okay,” they said. “We can’t seem to stop it by eradicating at the source, we can’t seem to stop it by eliminating the leadership of the trafficking organizations. Let us build a picket line down below the U.S. southern borders, both on the ground and at sea, stop the ships, the boats, the planes that are bringing this stuff into the United States, andvoila, problem is solved.
Once again, there were some successes. The truth of the matter is the Caribbean in the 1980s was a region that was at risk of losing control. Fourteen different governments were at risk of losing control of their sovereign national territory to multi-billion dollar drug trafficking industries. And in their defense, that generation of the 1980s actually did effectively interdict the flow of drugs through the Caribbean toward the United – the southeastern United States of America.
But did that solve the problem? No. Where are we today? We’re in central Texas. Where do the drugs now flow into the United States? They come up straight through the land corridor, starting in Colombia, working their way through Central America, processing up through Mexico, and entering through the southwest border of the United States of America. In other words, yes, you can plug your finger in one hole of the dam, but in all likelihood – one might almost say with complete certainty – another hole is going to open up. And at the end of the day you have a finite number of fingers to plug with, defined by how much money the United States Congress and the taxpayers that send them to office are prepared to dedicate to this particular exercise.
Finally, and with somewhat greater coherence and success, the government began to develop an approach in the 1990s which I would call sustainable economic development. And that is accepting the reality that campesinos – or if you’re in Afghanistan and dealing with opium poppy, subsistence-level farmers, actually are not inherently criminal; they do not plant coca or opium poppy because they wish to be part of criminal enterprises. They do it because they are trying to provide a basic living to their families, and coca or opium poppy actually gives them better income and more secure income than corn or frijoles or wheat or whatever it might be that is otherwise being grown in that region.
Now this approach actually made some degree of sense, and I would suggest to you that where it is applied, it does produce long-term results. Problem: It is amazingly expensive. It costs a good bit of money to actually manage on a nationwide basis an alternative development program. It’s not just giving them a barrel of corn seed so that they will plant corn rather than coca. It’s also giving the tools and the training. It’s also giving them the infrastructure, the road system that allows them to get their product to market once they have harvested it, because remember: the drug traffickers will come to them, buy their product, and take it away at no cost to the farmer. The farmer who has instead two tons of corn somehow has to get it to market, or within a month or two he has more or less two tons of mulch that is gradually deteriorating and rotting in his back yard.
On top of that, if you want the campesino to remain committed to this, you have to give him or her some stake in the community. That means maybe schools, maybe clinics. That means electricity, running water, sewage, the sort of thing that makes a family say, one, I do have an interest in staying here, and two, I have a future here over and above whether I can grow an acre of coca or an acre of opium poppy.
Okay. Eradication, dismantling, interdiction, economic development – none of them in and of themselves solved the drug problem. So the question is, since the drugs are still an issue, what is the correct response? Are you ready? Bill Brownfield says the correct response is all of the above and then a little bit more as well.
Let us flash-forward to 1999, when the United States Government, jointly with the Government of Colombia, actually did this the right way. But I will prejudge the conclusion by letting you know the right way cost $8.5 billion over roughly a 12-year period of time. But we launched – the Colombian government launched what came to be called Plan Colombia. Plan Colombia was a comprehensive, structured approach designed to address the economic issue, the security issue, and the drugs and law enforcement issue. And when I said economic, I should also have said social, to include health impact, education, as well as job generation and economic activity.
Ladies and gentlemen, I would suggest that that worked for Colombia. The huge cartels that in the 1990s were actually threatening the very existence of the Colombian government have been atomized, admittedly to still annoying criminal activities, but are not anywhere remotely as powerful, as strong, or as threatening as Mr. Pablo Escobar and his Medellin cartel at the start of the 1990s, or the Rodriguez Orejuela brothers and the Cali cartel at that same timeframe.
Cocaine production in Colombia, we estimate, is down 60 percent or so from its heyday, as recently as 10 years ago. The tourism industry in Colombia today is booming. There are probably 20 times as many tourists going to Colombia today as 10 years ago. And if you will, tourists vote with their feet. If tourists are going to Colombia, you assume the security situation obviously has reached a point where people are prepared voluntarily to spend their own money to go visit a country that 10 or 15 years ago they would not have dreamed of doing so without a battalion of the United States Army or Marine Corps joining them and providing them security at every step.
And may I note as well that there is some correlation between the fact that production of cocaine in Colombia has dropped by some 60 percent, and consumption of cocaine in the United States of America has dropped by some estimates between 40 and 50 percent? I’m not giving you the Pollyanna story here. I freely acknowledge other sorts of drug consumption have grown in this same time period. But the two things that have most driven the Latin America to North America drug trafficking crisis – cocaine and methamphetamines – have both gone down dramatically in terms of demand in the United States.
Heroin is moving at a much smaller level – I mean, the simple truth, the quantity of heroin that moves. Marijuana, synthetics, and pharmaceuticals: apparently we’re quite capable of producing our own domestically in the United States of America. What has been driving the crisis of violence, of homicide, of crime in the Central America-Mexico corridor is cocaine and methamphetamines. The extent to which that product and the trafficking in that product is going down is actually good news for those seven Central American and Mexican countries and governments.
That said, I do not mean to suggest to you that by addressing the problem in Colombia the problem was resolved. On the contrary – and I’m not going to walk you through each of these in the same degree of detail, but the balloon theory – they were squeezed, the bad guys were squeezed in Colombia. What did they do? Largely they moved to Mexico, where, as those of you who could remember where we were about seven or eight years ago, Mexico was confronting a crisis of large cartels that actually represented a threat to the sovereignty of the government itself. And we launched what came to be known as the Merida Initiative, a joint effort in which the Mexican Government offered roughly $13 to every $1 offered by the United States to address this problem.
We squeezed them in Mexico, and what happened? Many of them moved to Central America. The crisis of the last five years has been the surge in violence, in homicides, in crime, in gang activities in Central America. Response? CARSI, the Central America Regional Security Initiative. Much smaller than that for Mexico, but the truth of the matter is there’s a finite number of dollars that are available to be applied to this problem. We squeeze them in Central America and what do we see increasingly happening? You will be stunned to learn that the statistics of drug flows through the Caribbean, that same region that was in fact successfully shut down in the 1980s, has been growing from a factor of roughly 4 percent of U.S. drug consumption three years ago to 8 percent two years to 9 or 10 percent over the last year, and now an estimated 14 percent.
If you’re tracking the trend line, even if we don’t know precisely how much is moving, the fact of the matter is what I have described for you is a tripling of drug flow through the Caribbean over the last three years. Watch this space. If in the course of the next two or three years you see the occasional headline saying, “Drug crisis in the Caribbean,” you will be able to say, yeah, Brownfield at least was prescient enough to predict that would be happening.
Each of the initiatives that I have laid out – Plan Colombia, Colombia; Merida Initiative, Mexico; CARSI, Central America; CBSI, Caribbean Basin Security Initiative, for the Caribbean – had, I would suggest – while each was different, each had its own particular characteristics – they had several common principles.
One, there was an attempt and still is an attempt to link together all the elements of the problem: law enforcement, security, rule of law institutions, economic and social development. Second, they are sustainable. Sustainable means the host government – whether it’s Colombian, Mexican, Central American, Caribbean – sees enough of their own interest at stake that they’re prepared to put their own resources into the problem and the solution. Third, they accept as a principle that the host government makes the decision. If we want a particular program and they don’t, at the end of the day, their view is what determines what will be done. Fourth, they try to focus on institutions and institution-building rather than equipment, rather than hard stuff, rather even than operations, the thinking being if you build an institution, you get value for a generation. If you do a successful takedown operation, you get a headline and value that might last you for a day or two.
Fifth, they are regional in nature – by the way, even the bilateral programs, Colombia and Mexico, are regional to the extent that they link into other countries in the region. Today, for example, Colombian police are training more police in Central America than is the United States. And some of it is actually being done with our assistance, which is another way of saying we actually pay for it. But the quality of the training and the ability of the trainers from Colombia is actually greater than what we ourselves can offer, partly because of their experience, partly because, of course, it’s a lot easier for a Spanish-speaking national police officer from Colombia to do training in Central America than it is even for a Spanish-language-trained U.S. law enforcement officer.
And the sixth principle that we have – I think linking all of these together – is the concept of partners. With each initiative, we have drawn in more and more international partners to play into this effort. Why? One reason I suggest to you is that even as consumption of cocaine in the United States has been dropping steadily since 2007, consumption of cocaine in Western Europe or in East Asia has been growing dramatically, without even mentioning the largest country in South America – Brazil – which is today confronting what could almost be called a crack cocaine crisis. And obviously, as their populations and communities are increasingly victims – or participants, depending upon your perspective – in this process, there is obviously greater interest in joining in efforts as partners to address the problem either at its source or in the midpoint, in short, before it arrives on the shores of France or Italy or Spain or the United Kingdom.
Ladies and gentlemen, may I suggest to you that it is a little bit early, perhaps a century or two, perhaps a millennium or so, to declare success on this particular issue? May I suggest to you it is not too early to say the year 2014 and the next five or ten years will offer a different problem set, a different set of realities from what we were dealing with in the 1970s, ‘80s, ‘90s, or even the last decade? First, you have one nation that has emerged, if you will, from the hell of the 1990s, and is now able to export its experience and its talent set. That nation is Colombia. And let us not forget that having a model out there that other nations in the region can look at has an impact. That is different from where we were 10 or 15 years ago.
Second, let us accept that you now have two new – not so new, but two much more major players in this drama in the region. They are named Bolivia and Peru, and their production level is moving in a sharply upward direction. What is also new, however, is that they are not feeding the North American market; they are feeding the Brazilian and Western European market. It’s an east-west problem as much as a north-south problem. I don’t say one is better than the other; I say it is a different problem set, which is going to require a different set of solutions.
Third, as I have mentioned several times, we are dealing with a consumption matter, a consumption issue, that is changing. As the American taste, if you will, shifts from cocaine and methamphetamines to other sorts of drugs, whether it is heroin or opium-based drugs, other synthetics, diverted pharmaceuticals or marijuana, it is a different problem set and presumably requires a different set of solutions.
Fourth – if you wondered if I was going to mention it, and I’m going to mention it right now – nations are experimenting with alternative approaches to drug control. Uruguay, a small nation located in between Brazil and Argentina, has recently, as a matter of national law, legalized the consumption of marijuana throughout the country. Some of you who have been asleep for the last 12 months may be unaware that two states of the union in the United States of America have done exactly the same thing. One of them is wrapping up its third month of this experiment, that’s Colorado, and the other goes online sometime, I think, about the first of July as they work their way through their rules and procedures. And I am not yet in a position to draw any firm conclusions from any of these experiences. I am in a position to say this is a 2014 reality, and let’s take it into account as we figure: How are we going to work this issue over the next five to ten years?
And fifth, and finally – and I do emphasize this point, because I do believe we haven’t – this Administration, the Administration of Barack Obama has not gotten credit or at least as much credit for this as it should – there is a strong realization in this country, your country, the United States of America, that drugs, drug abuse, and the overall total drug issue is far more a matter of public health than it is a matter of criminal justice. It is both unfair to the criminal justice system as well as to many of those who are caught up in the criminal justice system to try to address drug abuse solely in the criminal justice system. It is not just a matter of criminal justice. It is obviously a matter of health, of the medical care and medical profession, and of how you deal with the health and medical aspects of the use of drugs.
Now, I am not saying that the one excludes the other, but I am very definitely saying that trying to address the issue from only one side is pretty much condemned to failure. Those, I submit, are four new elements available as of the 27th of March, 2014, that were different from what we would’ve discussed if we had been sitting here 20 years ago, 10 years ago, quite frankly even as recently as five years ago. We’ve got to figure how to incorporate them into our own thinking.
These are, ladies and gentlemen – those of you who are – it’s about 75 percent of you who I predict are at least below the age of 40 if not below the age of 30 – these are going to be your challenges. Why? Because, I got to tell you, old Brownfield’s going to be checking out of this business in another three or four years, and it’s going to be you and your generation who have to figure out how to deal with these issues. I will offer you only five suggestions as you move proudly into the future on this issue on how to do it.
One, think long term. We didn’t get into this mess overnight, and we’re not going to get out of it overnight. Don’t even think in terms of years, maybe not even decades. Think in terms of generations. Don’t come up with some program that is supposed to solve the problem by 2015. It’s not going to happen.
Second, flexible and adaptable. Tastes change, conduct and behavior changes. The bad guys, the large, transnational criminal organizations who are involved in this, are constantly adapting and adjusting their approach. You had better have your own strategy and policy that can be adjustable and adaptable as well.
Third, be comprehensive. We tried the single-issue approach, ladies and gentlemen. It doesn’t work. We cannot just eradicate ourselves out of this problem. We cannot just interdict our way out of this problem. We also cannot just economic develop our way out of this problem. We have got to address all aspects of the problem. Otherwise we will not succeed.
Fourth principle, build institutions. No one loves a cool operation more than I do. No one loves some snappy new equipment as much as I do. But at the end of the day, your long-term value comes from building better law enforcement capabilities, building more competent prosecutors and investigators, building more effective, efficient, and honest courts and judicial systems, and don’t forget, building a corrections system that actually provides correction as opposed to a graduate course on how to advance from Criminal Activity 101 to the advanced Ph.D. course during three months of incarceration in a detention facility.
And finally, if I might, there is and always will be a criminal justice aspect to this, but principle number five: focus on the big organizations. It’s fine to pump up your numbers, I guess, in terms of how many you can arrest, but if you’re not going after the multibillion dollar organizations who engage not just in drug trafficking, but in trafficking in firearms, trafficking in people, trafficking in general contraband, money laundering that actually corrupts and undercuts and hollows out entire financial institutions, if you’re not focused on them, you’re missing the entire picture.
Okay, back to the title. So what is the new normal? Are you ready? The new normal is constant change. That, ladies and gents, is what we had better wrap our heads around. And we never have for the last 40 years. We’ve always taken the snapshot and said here is what we’re dealing with; now let us develop a strategy that will solve that problem. Wrong-o. That is not what we are going to be dealing with. What we’re looking at today on the 27th of March, I absolutely assure you, is going to be completely different by the time we get into 2015. That’s the new normal. And we had better be ready and able to address that, domestically and internationally, as a criminal justice matter and as a public healthcare matter.
The truth of the matter is we have to have a policy and approach that allows us to move in whatever direction our societies and those who are trying to take advantage of them will be moving in. And ladies and gentlemen, if that’s the new normal, I at least think we’ve got an approach that we can work with in a realistic way and that at least would take us one step beyond where we were 30 or 35 years ago when we started down this road.
Tuesday, March 25, 2014
OTEZLA APPROVED BY FDA TO TREAT ADULT ACTIVE PSORIATIC ARTHRITIS
FDA NEWS RELEASE
For Immediate Release: March 21, 2014
Media Inquiries: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
Media Inquiries: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA approves Otezla to treat psoriatic arthritis
The U.S. Food and Drug Administration today approved Otezla (apremilast) to treat adults with active psoriatic arthritis (PsA).
PsA is a form of arthritis that affects some people with psoriasis. Most people develop psoriasis first and are later diagnosed with PsA. Joint pain, stiffness and swelling are the main signs and symptoms of PsA. Currently approved treatments for PsA include corticosteroids, tumor necrosis factor (TNF) blockers, and an interleukin-12/interleukin-23 inhibitor.
“Relief of pain and inflammation and improving physical function are important treatment goals for patients with active psoriatic arthritis,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “Otezla provides a new treatment option for patients suffering from this disease.”
The safety and effectiveness of Otezla, an inhibitor of phosphodieasterase-4 (PDE-4), were evaluated in three clinical trials involving 1,493 patients with active PsA. Patients treated with Otezla showed improvement in signs and symptoms of PsA, including tender and swollen joints and physical function, compared to placebo.
Patients treated with Otezla should have their weight monitored regularly by a healthcare professional. If unexplained or clinically significant weight loss occurs, the weight loss should be evaluated and discontinuation of treatment should be considered. Treatment with Otezla was also associated with an increase in reports of depression compared to placebo.
The FDA is requiring a pregnancy exposure registry as a post-marketing requirement to assess the risks to pregnant women related to Otezla exposure.
In clinical trials, the most common side effects observed in patients treated with Otezla were diarrhea, nausea, and headache.
In clinical trials, the most common side effects observed in patients treated with Otezla were diarrhea, nausea, and headache.
Saturday, January 25, 2014
CDC ON TREATING HEAD LICE
FROM: CENTERS FOR DISEASE CONTROL AND PREVENTION
Head lice. Every parent’s nightmare.
A year-round problem, the number of cases seems to peak when the kids go back to school in the fall and again in January, says Patricia Brown, M.D., a dermatologist at the Food and Drug Administration (FDA).
An estimated 6 to 12 million cases of head lice infestation occur each year in the United States in children 3 to 11 years of age, according to the Centers for Disease Control and Prevention. Head lice are most common among preschool children attending child care, elementary school children, and household members of children who have lice.
Contrary to myth, head lice are not caused by poor hygiene, Brown says. They are spread mainly by direct head-to-head contact with a person who already has head lice. You cannot get head lice from your pets; lice feed only on humans.
Lice don’t fly or jump; they move by crawling. But because children play so closely together and often in large groups, lice can easily travel from child to child, especially when they touch heads during playing or talking.
Blood-Sucking Bugs
Head lice are blood-sucking insects about the size of a sesame seed and tan to grayish-white in color. They attach themselves to the skin on the head and lay eggs (nits) in the hair.
According to Brown, you can check for head lice or nits by parting the hair in several spots. You can use a magnifying glass and a bright light to help spot them. Because head lice can move fast it may be easier to spot the nits. Nits can look like dandruff, but you can identify them by picking up a strand of hair close to the scalp and pulling your fingernail across the area where you suspect a nit. Dandruff will come off easily, but nits will stay firmly attached to the hair, Brown explains.
FDA-approved treatments for head lice include both over-the-counter (OTC) and prescription drugs, such as Nix and Rid, in the form of shampoos, creams and lotions. “Many head lice products are not for use in children under the age of 2, so read the label carefully before using a product to make sure it is safe to use on your child,” Brown says.
Although OTC drugs are available for treatment of head lice, Brown says your health care professional may prescribe drugs recently approved by the FDA, such as Ulesfia (approved in 2009), Natroba (approved in 2011) or Sklice (approved in 2012).
Steps for Safe Use
Follow these steps to use any head lice treatment safely and appropriately:
After rinsing the product from the hair and scalp, use a fine-toothed comb or special “nit comb” to remove dead lice and nits.
Apply the product only to the scalp and the hair attached to the scalp—not to other body hair.
Before treating young children, talk with the child’s doctor or your pharmacist for recommended treatments based on a child’s age and weight.
Use medication exactly as directed on the label and never more often than directed unless advised by your health care professional.
Use treatments on children only under the direct supervision of an adult.
Heading Off Head Lice
Teach children to avoid head-to-head contact during play and other activities at home, school, and elsewhere (sports activities, playgrounds, slumber parties, and camps).
Teach children not to share clothing and supplies, such as hats, scarves, helmets, sports uniforms, towels, combs, brushes, bandanas, hair ties, and headphones.
Disinfest combs and brushes used by a person with head lice by soaking them in hot water (at least 130°F) for 5–10 minutes.
Do not lie on beds, couches, pillows, carpets, or stuffed animals that have recently been in contact with a person with head lice.
Clean items that have been in contact with the head of a person with lice in the 48 hours before treatment. Machine wash and dry clothing, bed linens, and other items using hot water (130°F) and a high heat drying cycle. Clothing and items that are not washable can be dry-cleaned or sealed in a plastic bag and stored for two weeks.
Vacuum the floor and furniture, particularly where the person with lice sat or lay. Head lice survive less than one or two days if they fall off the scalp and cannot feed.
Do not use insecticide sprays or fogs; they are not necessary to control head lice and can be toxic if inhaled or absorbed through the skin.
After finishing treatment with lice medication, check everyone in your family for lice after one week. If live lice are found, contact your health care professional.
Heading Off Head Lice source: Centers for Disease Control and Prevention
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Updated: January 23, 2014
Head lice. Every parent’s nightmare.
A year-round problem, the number of cases seems to peak when the kids go back to school in the fall and again in January, says Patricia Brown, M.D., a dermatologist at the Food and Drug Administration (FDA).
An estimated 6 to 12 million cases of head lice infestation occur each year in the United States in children 3 to 11 years of age, according to the Centers for Disease Control and Prevention. Head lice are most common among preschool children attending child care, elementary school children, and household members of children who have lice.
Contrary to myth, head lice are not caused by poor hygiene, Brown says. They are spread mainly by direct head-to-head contact with a person who already has head lice. You cannot get head lice from your pets; lice feed only on humans.
Lice don’t fly or jump; they move by crawling. But because children play so closely together and often in large groups, lice can easily travel from child to child, especially when they touch heads during playing or talking.
Blood-Sucking Bugs
Head lice are blood-sucking insects about the size of a sesame seed and tan to grayish-white in color. They attach themselves to the skin on the head and lay eggs (nits) in the hair.
According to Brown, you can check for head lice or nits by parting the hair in several spots. You can use a magnifying glass and a bright light to help spot them. Because head lice can move fast it may be easier to spot the nits. Nits can look like dandruff, but you can identify them by picking up a strand of hair close to the scalp and pulling your fingernail across the area where you suspect a nit. Dandruff will come off easily, but nits will stay firmly attached to the hair, Brown explains.
FDA-approved treatments for head lice include both over-the-counter (OTC) and prescription drugs, such as Nix and Rid, in the form of shampoos, creams and lotions. “Many head lice products are not for use in children under the age of 2, so read the label carefully before using a product to make sure it is safe to use on your child,” Brown says.
Although OTC drugs are available for treatment of head lice, Brown says your health care professional may prescribe drugs recently approved by the FDA, such as Ulesfia (approved in 2009), Natroba (approved in 2011) or Sklice (approved in 2012).
Steps for Safe Use
Follow these steps to use any head lice treatment safely and appropriately:
After rinsing the product from the hair and scalp, use a fine-toothed comb or special “nit comb” to remove dead lice and nits.
Apply the product only to the scalp and the hair attached to the scalp—not to other body hair.
Before treating young children, talk with the child’s doctor or your pharmacist for recommended treatments based on a child’s age and weight.
Use medication exactly as directed on the label and never more often than directed unless advised by your health care professional.
Use treatments on children only under the direct supervision of an adult.
Heading Off Head Lice
Teach children to avoid head-to-head contact during play and other activities at home, school, and elsewhere (sports activities, playgrounds, slumber parties, and camps).
Teach children not to share clothing and supplies, such as hats, scarves, helmets, sports uniforms, towels, combs, brushes, bandanas, hair ties, and headphones.
Disinfest combs and brushes used by a person with head lice by soaking them in hot water (at least 130°F) for 5–10 minutes.
Do not lie on beds, couches, pillows, carpets, or stuffed animals that have recently been in contact with a person with head lice.
Clean items that have been in contact with the head of a person with lice in the 48 hours before treatment. Machine wash and dry clothing, bed linens, and other items using hot water (130°F) and a high heat drying cycle. Clothing and items that are not washable can be dry-cleaned or sealed in a plastic bag and stored for two weeks.
Vacuum the floor and furniture, particularly where the person with lice sat or lay. Head lice survive less than one or two days if they fall off the scalp and cannot feed.
Do not use insecticide sprays or fogs; they are not necessary to control head lice and can be toxic if inhaled or absorbed through the skin.
After finishing treatment with lice medication, check everyone in your family for lice after one week. If live lice are found, contact your health care professional.
Heading Off Head Lice source: Centers for Disease Control and Prevention
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Updated: January 23, 2014
Wednesday, May 22, 2013
DIALYSIS COMPANY TO PAY $7.3 MILLION TO RESOLVE ALLEGATIONS IT SUBMITTED FALSE CLAIMS TO MEDICARE
FROM: U.S. DEPARTMENT OF JUSTICE
Tuesday, May 21, 2013
U.S. Renal Care to Pay $7.3 Million to Resolve False Claims Act Allegations
Allegedly Submitted False Medicare Claims for Drug Provided to Dialysis Patients
U.S. Renal Care, headquartered in Plano, Texas, has agreed to pay $7.3 million to resolve allegations that Dialysis Corporation of America (DCA) violated the False Claims Act by submitting false claims to the Medicare program for more Epogen than was actually administered to dialysis patients at DCA facilities, the Justice Department announced today. U.S. Renal Care, which acquired DCA in June 2010, owns and operates more than 100 freestanding outpatient dialysis facilities throughout the United States.
Epogen is an intravenous medication that is used to treat anemia, a common condition afflicting patients with end-stage renal disease. Epogen vials contain a small amount of medication in excess of the labeled amount, known as "overfill," to compensate for medication that may remain in the vial after extraction and in the syringe upon administration. The United States contends that from January 2004 through May 2011, DCA billed for 10-11% overfill whenever it administered Epogen. However, because of the types of syringes DCA used, the United States alleges that DCA was not able to withdraw and administer 10-11% overfill every time it administered Epogen to patients, and thus submitted false claims to Medicare that overstated the amount of Epogen that it was actually providing.
"Today’s settlement shows that the Justice Department will aggressively pursue those health care providers who cut corners at the expense of the American taxpayers, such as by billing for items and services that were not provided," said Stuart F. Delery, Acting Assistant Attorney General for the Justice Department’s Civil Division. "We will continue to protect scarce Medicare dollars."
"Medical care providers who submit false claims for services and products that were not actually delivered threaten the financial viability of the Medicare Trust Fund," said Rod J. Rosenstein, U.S. Attorney for the District of Maryland.
"Health providers billing for phantom services cheat taxpayers, cheat programs straining to pay for vitally needed care, and cheat patients who pay inflated copayments," said Nick DiGiulio, Special Agent in Charge, Office of Inspector General, U.S. Department of Health and Human Services for the region including Maryland. "We will continue to work with the Department of Justice to ensure health professionals get reimbursed only for services they actually provide"
This resolution is part of the government’s emphasis on combating health care fraud and another step for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced by Attorney General Eric Holder and Kathleen Sebelius, Secretary of the Department of Health and Human Services in May 2009. The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation. One of the most powerful tools in that effort is the False Claims Act, which the Justice Department has used to recover $10.2 billion since January 2009 in cases involving fraud against federal health care programs. The Justice Department’s total recoveries in False Claims Act cases since January 2009 are over $14.2 billion.
The allegations settled today arose from a lawsuit filed by Laura Davis against DCA under the qui tam, or whistleblower, provisions of the False Claims Act. The Act allows private citizens with knowledge of fraud to bring civil actions on behalf of the United States and share in any recovery. Ms. Davis will receive $1,314,000 as part of today’s settlement.
This case was handled by the Civil Division of the Department of Justice and the U.S. Attorney’s Office for the District of Maryland with assistance from the Office of Inspector General for the Department of Health and Human Services. The claims settled by this agreement are allegations only, and there has been no determination of liability. The whistleblower suit is captioned United States ex rel. Laura Davis v.
Tuesday, May 21, 2013
U.S. Renal Care to Pay $7.3 Million to Resolve False Claims Act Allegations
Allegedly Submitted False Medicare Claims for Drug Provided to Dialysis Patients
U.S. Renal Care, headquartered in Plano, Texas, has agreed to pay $7.3 million to resolve allegations that Dialysis Corporation of America (DCA) violated the False Claims Act by submitting false claims to the Medicare program for more Epogen than was actually administered to dialysis patients at DCA facilities, the Justice Department announced today. U.S. Renal Care, which acquired DCA in June 2010, owns and operates more than 100 freestanding outpatient dialysis facilities throughout the United States.
Epogen is an intravenous medication that is used to treat anemia, a common condition afflicting patients with end-stage renal disease. Epogen vials contain a small amount of medication in excess of the labeled amount, known as "overfill," to compensate for medication that may remain in the vial after extraction and in the syringe upon administration. The United States contends that from January 2004 through May 2011, DCA billed for 10-11% overfill whenever it administered Epogen. However, because of the types of syringes DCA used, the United States alleges that DCA was not able to withdraw and administer 10-11% overfill every time it administered Epogen to patients, and thus submitted false claims to Medicare that overstated the amount of Epogen that it was actually providing.
"Today’s settlement shows that the Justice Department will aggressively pursue those health care providers who cut corners at the expense of the American taxpayers, such as by billing for items and services that were not provided," said Stuart F. Delery, Acting Assistant Attorney General for the Justice Department’s Civil Division. "We will continue to protect scarce Medicare dollars."
"Medical care providers who submit false claims for services and products that were not actually delivered threaten the financial viability of the Medicare Trust Fund," said Rod J. Rosenstein, U.S. Attorney for the District of Maryland.
"Health providers billing for phantom services cheat taxpayers, cheat programs straining to pay for vitally needed care, and cheat patients who pay inflated copayments," said Nick DiGiulio, Special Agent in Charge, Office of Inspector General, U.S. Department of Health and Human Services for the region including Maryland. "We will continue to work with the Department of Justice to ensure health professionals get reimbursed only for services they actually provide"
This resolution is part of the government’s emphasis on combating health care fraud and another step for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced by Attorney General Eric Holder and Kathleen Sebelius, Secretary of the Department of Health and Human Services in May 2009. The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation. One of the most powerful tools in that effort is the False Claims Act, which the Justice Department has used to recover $10.2 billion since January 2009 in cases involving fraud against federal health care programs. The Justice Department’s total recoveries in False Claims Act cases since January 2009 are over $14.2 billion.
The allegations settled today arose from a lawsuit filed by Laura Davis against DCA under the qui tam, or whistleblower, provisions of the False Claims Act. The Act allows private citizens with knowledge of fraud to bring civil actions on behalf of the United States and share in any recovery. Ms. Davis will receive $1,314,000 as part of today’s settlement.
This case was handled by the Civil Division of the Department of Justice and the U.S. Attorney’s Office for the District of Maryland with assistance from the Office of Inspector General for the Department of Health and Human Services. The claims settled by this agreement are allegations only, and there has been no determination of liability. The whistleblower suit is captioned United States ex rel. Laura Davis v.
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