Currently, it is illegal to introduce counterfeit drugs into interstate commerce, but the penalties are the same as for illegal trafficking other goods, such as electronics or other merchandise. In essence, the penalties for copying a company's logo on a prescription bottle were more severe than for making and selling counterfeit drugs. The Bill targets violators who knowingly manufacture, sell, or traffic counterfeit medicines in the United States.
Senator Leahy was clearly pleased with the result and is urging the House to act quickly on the Senate's lead, stating:
We cannot allow the counterfeiting of life-saving medicine to be just one more low-risk venture from which international organized criminals can profit . . . While we should not expect that enactment of this or any legislation will completely deter the serious problem of counterfeit medication entering the American supply chain, it is an important step in the fight. I urge the House of Representatives to act quickly on this legislation.
Worldwide counterfeit medicines are a multi-billion dollar industry, and growing at an alarming pace, especially over the internet. These medicines pose a serious threat to the health and safety of unsuspecting Americans . . .The House should act as quickly as possible to ensure that counterfeit drug traffickers are punished accordingly for putting people's lives at risk with this serious crime.
WAYNE, N.J., March 14, 2012 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA has approved a new indication for Natazia (estradiol valerate and estradiol valerate/dienogest ...
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Silver Spring, MD 20993 Larry Downey Executive Vice President, US Branded Pharmaceuticals Teva Pharmaceuticals USA c/o Teva Neuroscience, Inc. 901...
Led by Boxer and DeFazio, Bicameral Letter Calls for Reversal of Two Decade-Old Labeling Policy, Supports CFS Legal Petition In Only 6 Months, Already 850,000+ Public Comments To FDA In Support Of Labeling This morning a bicameral letter signed by 55 Members of Congress was sent to U.S. Food and Drug Administration (FDA Commissioner Margaret Hamburg calling on the agency to require the labeling of genetically engineered (GE foods. The bicameral, bipartisan letter led by Senator Barbara Boxer (D-CA and Congressman Peter DeFazio (D-OR was written in support of a legal petition filed by the Center for Food Safety (CFS on behalf of the Just Label It campaign and its nearly 400 partner organizations and businesses; many health, consumer, environmental, and farming organizations, as well as food companies, are also signatories. Since CFS filed the labeling petition in October 2011, the public has submitted over 850,000 comments in support of labeling.
International phase 3 trial is largest study ever of rare endocrine disorder
A new investigational drug significantly reduced urinary cortisol levels and improved symptoms of Cushing's disease in the largest clinical study of this endocrine disorder ever conducted. Results of the clinical trial conducted at centers on four continents appear in the March 8 New England Journal of Medicine and show that treatment with pasireotide cut cortisol secretion an average of 50 percent and returned some patient’s levels to normal.
"Cushing's disease is a rare disorder, with three to five cases per million people. It can affect all ages and both genders but is most common in otherwise healthy young women," says Beverly M.K. Biller, MD, of the Massachusetts General Hospital Neuroendocrine Unit, senior author of the study. "Often misdiagnosed, Cushing's is associated with a broad range of health problems – causing physical changes, metabolic abnormalities and emotional difficulties – and if not controlled, significantly increases patients' risk of dying much younger than expected."
One of several conditions that lead to Cushing's syndrome – chronically elevated secretion of the hormone cortisol – Cushing's disease is caused by a benign pituitary tumor that oversecretes the hormone ACTH, inducing increased cortisol secretion by the adrenal glands. Symptoms of Cushing's syndrome include weight gain, hypertension, mood swings, irregular or absent periods, abnormalities of glucose processing – insulin resistance, glucose intolerance and type 2 diabetes – and cardiovascular disease. Since those symptoms are associated with many health problems, physicians may not consider the rare possibility of Cushing's. The diagnosis can be difficult to make and usually requires the expertise of an endocrinologist. Since cortisol levels normally fluctuate during the day, a single blood test probably would not identify chronic elevation, so the most common diagnostic test measures a patient's 24-hour urinary output.
First-line treatment for Cushing's disease is surgical removal of the ACTH-secreting tumor, which can lead to remission in 65 to 90 percent of patients who are treated by expert pituitary surgeons. But symptoms return in 10 to 30 percent of those patients, requiring repeat surgery, radiation therapy or treatment with drugs that interfere with part of the cortisol control system. Until last month, there was no specific FDA-approved medical treatment for Cushing's syndrome; and while the newly approved drug mifepristone should benefit some patients, it does not affect the pituitary source of the condition or reduce cortisol levels.
The current phase 3 trial of pasireotide – the first drug that blocks ACTH secretion by binding to somatostatin receptors on the pituitary tumor – was sponsored by Novartis Pharma and enrolled 162 patients at 62 sites in 18 countries. Almost 85 percent of participants had either persistent disease that had not responded to surgery or had recurrent disease. The other 15 percent were recently diagnosed but not appropriate candidates for surgery. Participants were randomly assigned to two groups, one starting at two daily 600-microgram injections of pasireotide, the other receiving 900-microgram doses. Three months into the 12-month trial, participants whose urinary cortisol levels remained more than twice the normal range had their dosage levels increased. During the rest of the trial, dosage could be further increased, if necessary, or reduced if side effects occurred.
At the end of the study period, many patients had a significant decrease in their urinary cortisol levels, with 33 achieving levels within normal range at their original dosage by month 6 of the trial. Participants whose baseline levels were less than five times the upper limit of normal were more likely to achieve normal levels than those with higher baseline levels, and the average urinary cortisol decrease across all participants was about 50 percent. Many Cushing's disease symptoms decreased, and it became apparent within the first two months whether or not an individual was going to respond to pasireotide.
Transient gastrointestinal discomfort, known to be associated with medications in the same family as pasireotide, was an expected side effect. But the investigators observed elevated glucose levels in 73 percent of participants, something not seen to the same extent with other medications in this family. That will require close attention, since many Cushing's patients already have trouble metabolizing glucose. Biller explains, "Those patients who already were diabetic had the greatest increases in blood sugar, and those who were pre-diabetic were more likely to become diabetic than those who began with normal blood sugar. However, elevations were even see in those who started at normal glucose levels, so this is real and needs to be monitored carefully."
Additional trials of pasireotide are in the works, and a phase 3 study of a long-acting version of the drug was recently announced. Biller notes that the potential addition of pasireotide to available medical treatments for Cushing's disease would have a number of advantages. "It's very important to have medications that work at different parts of the cortisol control system – which is the case for the currently used medications that work at the adrenal gland level, pasireotide which works at the pituitary gland, and mifepristone which blocks the action of cortisol at receptors in the body. Having more options that work in different ways is valuable because not all patients respond to one medicine and some may be unable to tolerate a specific drug's side effects.
"As we have more drugs available to treat Cushing’s," she adds. "I think in the long run we may start using combinations of drugs, which is the approach we use in some patients with acromegaly, another disorder in which a pituitary tumor causes excess hormone secretion. Ultimately we hope to be able to give lower doses leading to fewer overall side effects, but that remains to be determined by future studies." Biller is a professor of Medicine at Harvard Medical School.
Annamaria Colao, MD, PhD, University of Naples, Italy, is the lead author of the New England Journal report. Additional co-authors are Stephan Petersenn, MD, University of Duisberg-Essen, Germany; John Newell-Price, MD, PhD, University of Sheffield, U.K.; James Findling, MD, Medical College of Wisconsin, Milwaukee; Feng Gu, MD, Peking Union Medical College Hospital, Beijing, China; Mario Maldonado, MD, Ulrike Schoenherr, Dipl-Biol, and David Mills, MSc, Novartis Pharma; and Luiz Roberto Salgado, MD, University of São Paulo Medical School, Brazil.
Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than $750 million and major research centers in AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, regenerative medicine, reproductive biology, systems biology, transplantation biology and photomedicine.
Sanuwave plans to run additional clinical trials of its dermaPace foot ulcer treatment after the FDA deems its initial submission insufficient.
Regenerative medicine firm Sanuwave Health (OTC: SNWV will run another clinical trial of its dermaPace foot ulcer treatment, after the FDA determined that its initial pre-market approval bid failed to meet its primary endpoint.
New trials may take up to 2 years before the company re-submits its device for FDA review, according to a press release.
Del Monte Fresh Produce has withdrawn its threatened lawsuit against the Oregon Public Health Division and its senior epidemiologist, who with other public health officials last year traced a multistate outbreak of Salmonella infection to cantaloupes imported from the company's Asuncion Mita farm in Guatemala.
The news was reported by Lynne Terry of The Oregonian. She wrote that Del Monte Fresh Produce notified the state earlier this month that it would not go forward with legal action against William Keene and his department.
Del Monte Fresh Produce had announced its threat in a news release in August, claiming that "misleading allegations" had been made in naming the Guatemalan cantaloupes as the likely source of Salmonella infection that sickened at least 20 people, and sent three to the hospital. The case patients were from Arizona, California, Colorado, Maryland, Montana, Nebraska, Oregon, Pennsylvania, Utah and Washington.
Twelve of 16 ill people had reported eating cantaloupe in the week before they became ill, according to a Centers for Disease Control and Prevention report on the outbreak investigation. Eleven of those 12 people had purchased cantaloupes from eight different Costco stores and traceback information indicated the melons were from a single farm -- Asuncion Mita in Guatemala.
Del Monte Fresh Produce voluntarily recalled the Guatemalan cantaloupes on March 22, 2011 after it was notified of the epidemiological link between the melons the outbreak of Salmonella Panama infection.
But when the Food and Drug Administration banned further cantaloupe imports from the company's Guatemalan farm, Del Monte Fresh Produce sued the FDA and got it to back down on the import alert. It also claimed it was wrongly blamed for the outbreak.
Food safety experts and consumer activists predicted the case targeting Oregon Public Health -- recognized for its food safety leadership -- would not go far, but said they saw the complaint filed by Del Monte Fresh Produce as an attempt to intimidate public health programs across the country.
Dr. Katrina Hedberg, Oregon state epidemiologist, told The Oregonian that dealing with the tort claim had been time-consuming, so it was a relief when it was withdrawn and they could resume focusing on their job -- protecting the public's health.
The claim was unprecedented, Terry noted:
State epidemiologists investigate dozens of foodborne illness outbreaks every year and name the culprits to prevent more people from getting sick. No other company has ever filed a suit or threatened to sue Oregon over one of those investigations.
"There have been lots of outbreaks," Hedberg said. "Why some companies choose to work with public health and others want to fight it -- I can't answer that."
A Del Monte Fresh Produce spokesman declined to comment, telling Terry the company "does not comment on ongoing or closed investigations."
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American schools will soon be able to stop receiving the ammonia-treated ground beef product known alternately as boneless lean beef trimmings, lean finely textured beef, and--more derisively--"pink slime," the U.S. Agriculture Department ( USDA announced on Thursday. According to Michael Hill of the Associated Press (AP , starting next fall districts will be able to choose to continue receiving 95% lean beef patties that include the filler product, or fattier cuts of ground beef that is free of the ammonia-treated substance. The change in policy cannot go into effect immediately due to existing contracts, an unidentified USDA official told the news organization. "Though the term 'pink slime' has been used pejoratively for at least several years, it wasn't until last week that social media suddenly exploded with worry and an online petition seeking its ouster from schools," Hill wrote. "The petition quickly garnered hundreds of thousands of supporters" "The low-cost ingredient is made from fatty bits of meat left over from other cuts. The bits are heated to about 100 F and spun to remove most of the fat. The lean mix then is compressed into blocks for use in ground meat. The product, made by South Dakota-based Beef Products Inc., also is exposed to 'a puff of ammonium hydroxide gas' to kill bacteria, such as E. coli and salmonella," he added. The USDA told Hill that the agency, which is responsible for purchasing about 20% of the food used in school lunches across the country, "continues to affirm the safety" of the boneless lean beef trimmings. However, they said that they wanted to be "transparent" and recognized that schools wanted to be able to opt out of receiving the ammonia-treated lean finely textured beef. The controversy involves not just the beef itself, but also the use of ammonium hydroxide to treat the meat. The product itself, AFP reporter Robert MacPherson says, is "left-over bits of slaughtered cattle… that is mixed in a centrifuge" -- or as chef Jamie Oliver puts it, according to an article by Amy Hubbard of the Los Angeles Times, "all of the bits that no one wants." Once the beef products are mixed together, they are treated with ammonium hydroxide in a USDA-approved process in order to prevent E. coli and salmonella contamination, Hubbard said. International Food Information Council Director of Media Relations Steven Cohen told her that the substance had been reviewed and deemed safe by the Food & Drug Administration ( FDA in 1974, and that it is an additive used in other products, including cheese and chocolates. However, the Times reporter adds that it is also used as a "sanitizer in many household and industrial cleaners," which has led McDonalds and other restaurant chains to discontinue the use of the so-called "pink slime" beef products. Despite the USDA's announcement Thursday, Hill says that Maine Representative Chellie Pingree has asked Agriculture Secretary Tom Vilsack to immediately and permanently ban its use in schools. "The beef industry sent my office an email the other day describing pink slime as 'wholesome and nutritious' and said the process for manufacturing it is 'similar to separating milk from cream.' I don't think a highly processed slurry of meat scraps mixed with ammonia is what most families would think of as 'wholesome and nutritious,'" the Congresswoman said in a statement.
It's hard to know these days which way the proverbial worm is turning when it comes to shifts in drug policy. Election years tend to do that. Despite an historical turn of events in Central America which saw Presidents of drug trafficking nations come together to call for world wide decriminalization of drugs, in an effort to end the violence and corruption of the drug trade, the US continues to demur, absurdly claiming that the "War on Drugs" has been a success. Even stranger is Canada's recent announcement that they plan to follow the US model of a "tough on crime" approach to drug policy, which threatens to swell their correctional system in the same ways as in the US. Still, good news abounds with recent studies showing that LSD can cure alcoholism, psychedelics can cure PTSD, and cannabis smoking is not nearly as harmful as the prohibition governments claim. ~ CS
To liberalise or prohibit, that is the question. And to answer it the masters of live debate have joined forces with the masters of web technology to create a never-seen-before combination of Oxford debating and Silicon Valley prowess.
Prohibitionists argue that legalising anything increases its consumption. The world has enough of a problem with legal drugs like alcohol and tobacco, so why add to the problem by legalising cannabis, cocaine and heroin?
The liberalisers say prohibition doesn’t work. By declaring certain drugs illegal we haven’t reduced consumption or solved any problem. Instead we’ve created an epidemic of crime, illness, failed states and money laundering.
Julian Assange and Richard Branson; Russell Brand and Misha Glenny; Geoffrey Robertson and Eliot Spitzer. Experts, orators and celebrities who’ve made this their cause – come and see them lock horns in a new Intelligence?/Google+ debate format. Some of our speakers will be on stage in London, others beamed in from Mexico City or Sao Paulo or New Orleans, all thanks to the “Hangout” tool on Google+.
The web will have its say, and so can you at the event in London. Be part of the buzz of the audience, be part of an event beamed across the web to millions. Come and witness the future of the global mind-clash at the first of our Versus debates, live at Kings Place
The message is (or should be deeply disturbing. Shouldn't the USA be ashamed at having the world's largest prison system and highest incarceration rate (754 per 100 000 people ? The richest country in the world has so many of its citizens in prison that it can't afford to house them with even basic minimum medical care (more than half of all prisoners have mental health or drug problems . Prison overcrowding itself has become so terrible in California, that in May, 2011, the US Supreme Court affirmed a lower court order that California release some 46 000 prisoners because of the inhuman conditions under which they were being held. In the Court's words, “A prison that deprives prisoners of basic sustenance, including adequate medical care, is incompatible with the concept of human dignity and has no place in a civilised society.”
More women are ending up behind bars than ever. Between 1980 and 1989, the number of women in U.S. prisons tripled. And the number of women in prison has continued to rise since. In the last 10 years, the number of women under jurisdiction of state or federal authorities increased 21 percent to almost 113,000. During the same time period, the increase in the number of men in prison was 6 percentage points lower, at about 15 percent. The increase in women in the federal population was even larger- over 41 percent from 2000 to 2010.
Most women are incarcerated for nonviolent offenses. Over one-fourth are in prison for a drug offense, while 29.6 percent were convicted of a property crime. Addiction plays a large part in a number of women's property crimes, and a lack of available or appropriate treatment only serves to drive their contact with the justice system.
Stephen Vittoria is that rare commodity in Hollywood today: a filmmaker with a conscience. To be more precise, a filmmaker with a strong political conscience. After making two feature films,>Black and White& Hollywood Boulevard (1996 , as well as three feature documentaries:Save Your Life -- The Life and Holistic Times of Dr. Richard Schulze (1998 ,;Keeper of the Flame (2005 and the award-winning art house hit One Bright Shining Moment: The Forgotten Summer of George McGovern (2005 , a portrait of the South Dakota senator who tried to unseat Richard Nixon from the White House in 1972.
For his latest exploration into America's socio-political landscape, Vittoria joins forces with radio producer Noelle Hanrahan to bring Long Distance Revolutionary, the story of Mumia Abu-Jamal, to the screen. Born Wesley Cook in Philadelphia, Abu-Jamal made his name as a tireless writer and journalist during the racially-charged 1970s that often portrayed the City of Brotherly Love as anything but. With his intense coverage of the MOVE organization, a black empowerment group whose ongoing battle with the police and city hall came to a fiery end in 1985, Abu-Jamal become a constant thorn in the side of the city's powerful establishment. Things came to a sudden head for Abu-Jamal himself on the evening of December 9, 1981 when he was accused of murdering a Philadelphia police officer. He received a death sentence the following year, and has been on Pennsylvania's death row until early this year, when his death sentence was commuted to a life sentence in December, 2011.
Abu-Jamal's case remains one of the most controversial and heatedly debated in American legal history, with participants on both sides either protesting his innocence in the murder of Officer Daniel Faulkner or his absolute guilt with equal passion and more often, great vehemence.
At a recent conference of journalists at John Jay College, I raised an issue I have about language in the media: the frequent use of the word “felon” to describe a person who has been convicted of a crime.
“Felon” is an ugly label that confirms the debased status that accompanies conviction. It identifies a person as belonging to a class outside many protections of the law, someone who can be freely discriminated against, someone who exists at the margins of society.
In short, a “felon” is a legal outlaw and social outcast.
Scientific theories that addiction hijacks the brain have just increased the stigma that they were meant to stop. At least in the moralistic bad old days, addicts were still viewed as having free will. Here's an alternative to both of these no-win approaches.
Mind-altering compounds, such as LSD and psilocybin, stirred controversy in the 1960s. As the counter-culture’s psychedelic drugs of choice, the widespread use - and abuse - of hallucinogens prompted tougher anti-drug laws.
