Monday, March 19, 2012

News and Events - 20 Mar 2012




19.03.2012 15:00:00

by


counterfeitdrugs.jpg
Last week, the U.S. Sentate unanimously passed a bill sponsored by Patrick Leahy (D-VT ,
S. 1886, the Counterfeit Drug Penalty Enhancement Act of 2011. The Bill increases penalties for trafficking counterfeit drugs.

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.

Continue Reading



16.03.2012 2:03:11
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 ...



16.03.2012 17:16:01
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...



19.03.2012 1:00:58
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.



19.03.2012 4:39:25
An FDA panel on Tuesday will review new cancer drugs by Merck and Glaxo.

Saturday, March 17, 2012

News and Events - 18 Mar 2012




16.03.2012 17:42:00

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.

From 
http://www.massgeneral.org/about/pressrelease.aspx?id=1444#.T2I2Ue9AMtQ.facebook

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16.03.2012 14:12:15
Few Americans think twice about whether their medicine bottle really contains what it says on the label.



15.03.2012 23:53:19
Few Americans think twice about whether their medicine bottle really contains what it says on the label.



16.03.2012 22:15:59

Sanuwave plans to run additional clinical trials of its dermaPace foot ulcer treatment after the FDA deems its initial submission insufficient.

Sanuwave logo

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.



read more

http://www.massdevice.com/news/sanuwave-takes-its-dermapace-foot-ulcer-treatment-back-trials#comments



info@foodsafetynews.com (News Desk
16.03.2012 7:00:42
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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2012-03-16 04:45:59
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.



16.03.2012 20:51:27
An FDA panel on Tuesday will review new cancer drugs by Merck and Glaxo.

Thursday, March 15, 2012

News and Events - 16 Mar 2012




15.03.2012 15:53:36

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 

Google+ Presents: 
It's Time To End The War On Drugs

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

Source:
Intelligence 2 from Google +

North America


America's plague of incarceration

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.”

Source:
"
A Plague of Prisons: The Epidemiology of Mass Incarceration in America," 
The Lancet.


International Women's Day:  U.S. Must Address Impact of Mass Incarceration on Women.

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.

Source:
Justice Policy Institute


From Cell to Screen: The Story of Mumia Abu-Jamal -- Part I


 

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.

Source:
Huffington Post


What’s In a Name? A Lot, When the Name is “Felon”

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.  

Source:  
The Crime Report


Addiction: Medical Disease or Moral Defect?

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.

Source:
The Fix


Scientists Explore Hallucinogen Treatments for PTSD, Sex Abuse Victims

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.

That also led to a crackdown on clinical studies of the drugs’ complex psychological effects. However, now the U.S. Food and Drug Administration (FDA has begun to approve limited research into the potential benefits of psychedelic drugs.

No one is more aware of the stigma attached to psychedelics than Rick Doblin, director of the Multi-Disciplinary Association for Psychedelic Studies (MAPS , a drug development firm that funds FDA-approved clinical trials to examine the potential therapeutic uses of psychedelics.

Source: Voice of America

PBS Newshour: "Clearing the Smoke: The Benefits, Limits of Medical Marijuana"

Sixteen states have passed laws that allow patients to use medical marijuana to treat side effects of various illnesses, but now some are moving to either limit or repeal those laws. Anna Rau of Montana PBS reports.

Source: PBS Newshour

Drug users' union in San Francisco part of growing movement

Heroin shooters, speed users, pot smokers and even some men and women who now are drug-free convene regularly in this city's gritty Tenderloin district — not for treatment, but to discuss public health policy and share their experiences free from shame or blame.

Source: LA Times

New Report on Police Use of Force

How do varying policies affect police use of force? A new report, from research funded by the Department of Justice, examined eight police agencies, (Columbus, OH, Charlotte-Mecklenburg, NC, Portland, OR, Albuquerque, NM, Colorado Springs, CO, St. Petersburg, FL, Fort Wayne, IN, and Knoxville, TN and examined how different policies changed law enforcement strategies.

Researchers found that there is no ideal (or flawed policy approach across all outcomes, but the report offers ranking and outcomes for each policy offered allowing police executives to choose the best route for their force.

Access the report  here.

Source: The Crime Report

End 'destructive' war on pot, panel urges Harper

The Global Commission on Drug Policy says it's "very weird" that Canada is taking a tougher line on marijuana when governments across the globe are reconsidering the war on drugs.

In an open letter Wednesday to Prime Minister Stephen Harper, the Brazil-based commission calls on Canada to stop pursuing the "destructive, expensive and ineffective" prohibition of pot.

Louise Arbour, a former Supreme Court of Canada judge, former Brazilian president Fernando Cardoso, former Swiss president Ruth Dreifuss and Virgin Group founder Richard Branson are among the signatories to the letter that warns Canada is repeating "the same grave mistakes as other countries."

"Building more prisons, tried for decades in the United States under its failed war on drugs, only deepens the drug problem and does not reduce cannabis supply or rates of use," says the letter. "Instead, North American youth now report easier access to cannabis than to alcohol or tobacco."

Source: CBC

Marijuana Smokers Breathe Easy Says The University of Alabama

As of January 10, 2012, a new study has been published in the Journal of the American Medical Association exonerating marijuana from the bad reputation of being as harmful to your lungs when smoked as tobacco cigarettes. Researchers at the University of California San Francisco and the University of Alabama at Birmingham completed a twenty-year study between 1986 and 2006 on over 5,000 adults over the age of 21 in four American cities. Study co-author Dr. Stefan Kertesz is a professor of preventive medicine at the University of Alabama at Birmingham. He explained that the studies measured the pulmonary obstruction in individuals with up to seven joint-years of lifetime exposure (one joint per day for seven years or one joint per week for 49 years . "What this study clarifies," Kertesz explains in a released video, "is that the relationship to marijuana and lung function changes depending on how much a person has taken in over the course of a lifetime."

Source: Nugs.com

Marijuana Training Considered In Colorado Senate

DENVER (AP – Colorado senators have delayed action on a proposal to increase training for medical marijuana workers in Colorado. A Senate committee delayed a vote Wednesday on a bill setting up an optional “preferred vendor” classification for dispensaries and other companies that deal with medical marijuana. Under the proposal,the business community could decide to give all their employees additional training in exchange for a chance at softer penalties if they ever run afoul of state marijuana rules.

Source: CBS 4 Denver

Europe

Greek Health Crusader Is Arrested For Ordering Hemp Protein

Athens, Greece — On Wednesday morning July 16th, Anna Korakaki went to her local post office in Athens, Greece to pick up her latest health product order from Navitas Naturals, a health food company based in the USA. Anna had previously received shipments from Navitas which included raw cacao and maca from Peru, goji berries from China, and other high-quality nutritious foods. Moments after accepting her package Anna was immediately intercepted by 4 police officers, thrown on the hood of a police car and brutally handcuffed. Police then ransacked her apartment and after finding nothing suspicious or illegal, took Anna to a police station for further interrogation. Anna was then forced to spend the night in an Athens jail cell. The reason for Anna Korakaki's arrest was that she had received 4.5 kilos of hemp protein (a 'super-food' made from powdered hemp seeds , which she had ordered for the express purpose of making healthy smoothies. The order had a value of 57 Euros (US$89 , and represented but one of hundreds of hemp products available worldwide in health food stores, super-markets and via the Internet.

Source: Hemp Industries Association

LSD 'helps alcoholics to give up drinking"

A study, presented in the Journal of Psychopharmacology, Helmet, Freesans looked at data from six trials and more than 500 patients. It said there was a "significant beneficial effect" on alcohol abuse, which lasted several months after the drug was taken.

An expert said this was "as good as anything we've got".

LSD is a class A drug in the UK and is one of the most powerful hallucinogens ever identified. It appears to work by blocking a chemical in the brain, serotonin, which controls functions including perception, behaviour, hunger and mood.

Source:  BBC

Having trouble with drinking? Maybe you should try a dose of Acid. Researchers claim that a single dose of LSD could be helpful in treating alcoholism. A new paper, published in the  Journal of Psychopharmacology , examines six different trials throughout the '60s and '70s, involving a total of 536 patients being treated for alcohol problems. The researchers, from the Norwegian University of Science and Technology's department of neuroscience, discovered that 59% of subjects given a single dose of LSD showed improvements in their alcohol habits in follow-up assessments months later—compared with just 38% of people who didn't take the drug.

Source: The Fix

Source: The Journal of Psychopharmacology: "Lysergic acid diethylamide (LSD for alcoholism: meta-analysis of randomized controlled trials."

Latin America

Legalization Debate Takes Off in Latin America

Something incredible is happening right now in Latin America.

After decades of being brutalized by the U.S. government's failed prohibitionist drug policies, Latin American leaders, including not just distinguished former presidents but also current presidents, are saying "enough is enough." They're demanding that the range of policy options be expanded to include alternatives that help reduce the crime, violence and corruption in their own countries -- and insisting that decriminalization and legal regulation of currently illicit drug markets be considered.

Source: Ethan Nadelmann, Huffington Post

Is Latin America heading towards drug legalization?

On Saturday February 11, Guatemalan President Otto Perez Molina declared that following discussions with Colombian President Santos, he will present a proposal for the legalization of drugs in Central America at the Summit of the Americas, on April 14-15. Guatemalan Vice-President Roxana Baldetti toured Central America to discuss the proposal with regional leaders and garner support for it, starting with Panama on February 29. Unsurprisingly, the move was greeted by a quick rebuke from the US government who hurriedly dispatched Secretary of Homeland Security Janet Napolitano to the region on February 28, one day ahead of Roxana Baldetti’s own tour. Baldetti still managed to gain the support of Costa Rica and Salvador. The US is now pulling out its heavy artillery, sending to the region VP Biden, a staunch supporter of the War on Drugs.

Source: World War-D

Honduras Invites Colombia and Mexico to Join Drug Legalization Debate

President Porfirio Lobo yesterday invited Colombian President Juan Manuel Santos and Mexican President Felipe Calderon to a meeting of the presidents of Central American Integration System (SICA on March 24 in Guatemala. The gathering will focus on a recent proposal by Guatemalan President Otto Perez Molina to legalize drugs. On Tuesday, presidents met in Honduras with United States Vice-President Joe Biden to discuss the issue of drug legalization as strategy for combating the growing power of organized crime in Central America and Mexico and the associated violence plaguing the region. Despite Vice-President Biden's reiteration that the US government is adamantly opposed to legalizing drugs, there appears to be enough support for the idea among SICA heads of state to continue the debate and expand it to other nations such as Mexico and Colombia, which have also been affected by transnational narcotrafficking.

Source: Honduras Weekly

New Exile Nation Video

JULIE FALCO & DAN LINN

Julie Falco and Dan Linn are two of the leading drug policy reform activists in the State of Illinois. They have spent the better part of the last 10 years attempting to pass a medical cannabis bill, and have found themselves consistently thwarted.

Julie has advanced Multiple Sclerosis and is confined to a wheelchair. When she discovered edible cannabis as a medicinal therapy for MS patients it changed her life, and so she dedicated herself to bringing this medicine to others. But it was only after the death, in police custody, of a quadriplegic named Johnathan Magbie, that she found her strength to speak out.

Dan Linn began his activist work as a college student, and has since grown into a formidable voice for reform, appearing on television and in the news debating with career drug warriors.

Weekly Newsletters & Digests

Drug War Chronicle #725 - March 15, 2012

UK Drug Policy Commission - New Reports Online

Pharma International's US Correspondent
13.03.2012 11:48:07

The government in India has granted the rights to an indigenous pharmaceutical group to manufacture a generic version of the cancer treatment drug Nexavar.

For the first time, an Indian drugs firm has been approved to produce a medication under licence when the original's still patent-covered.

As a result of the agreement, the firm - Natco Pharma - is obliged to forward six per cent in royalties back to Bayer, which presently markets Nexavar alongside Onyx Pharmaceuticals.

Bayer, meanwhile - according to reports - isn't best pleased with the Indian government's move. "We are disappointed about this decision", company representative Sabrina Cusimano stated in comments made to the Associated Press. "We will see if we can further defend our intellectual property rights in India".

Nexavar Cancer Drug

Nexavar is the market name for sorafenib, an orally-taken medication now approved to treat two types of cancer - advanced hepatocellular carcinoma (liver cancer and advanced renal cell carcinoma (kidney cancer .

The kidney cancer approval came first, in 2005, when the US FDA declared its satisfaction with the product. It did the same for the drug as a liver cancer treatment two years later and, with clinical trials now in progress, thyroid cancer could be the next condition added to this approved treatment list.

Controversially, the drug's not available as a UK liver cancer treatment, after being rejected - on grounds of cost - by the National Institute for Health and Clinical Excellence in November 2009.

Natco Generic Nexavar Approval

The Natco generic Nexavar approval decision will see the production of drug copies priced at the equivalent of £112 for a box of 120: less than £1.00 each. This is dramatically cheaper than the original drug, with the same quantity presently priced at over 30 times that cost.

The Indian pharmaceutical firm believes that the drug's availability is key to the treatment of close to 9,000 cancer patients in India.

"This is a victory for Indian patients and for India's generic manufacturers, which are under attack", Natco Pharma's General Manager, Madineedi Adinarayana, stated according to the BBC, adding: "many more such cases will follow."

15.03.2012 16:18:45

The first Pradaxa lawsuit was filed against drug manufacturer Boehringer Ingelheim last week on behalf of Bertha Bivens, who claims her mother died after suffering a gastrointestinal bleed that Pradaxa allegedly caused.  Since the first lawsuit was reported, at least five more have been filed.

Pradaxa (dabigatran is a blood thinning medication first approved in 2008 by the European Commission for treatment of post-knee surgery and atrial fibrillation. Two years later in October, the U.S. Food and Drug Administration approved Pradaxa for treatment of atrial fibrillation, a condition in which a dysfunctional heartbeat leads to blood clot formulation. These blood clots may cause serious and even deadly conditions if left untreated.  For example, a blood clot can cause a stroke if it travels to the brain or a pulmonary embolism if it travels to the lungs.

Shortly after FDA approval, a flood of complaints was  filed linking Pradaxa to a number of adverse side effects including gastrointestinal bleeding, internal bleeding, brain hemorrhaging, heart attack, and death. The FDA has not issued a recall, but it has begun to investigate the reported internal bleeding occurrences.

Some researchers pose the argument that Pradaxa’s side effects may be reversible if it contained a reversing agent present such as the one in Warfarin, a traditional and competing blood thinner. Other researchers believe that the reported adverse side effects are caused by healthcare professionals’ improper dosing.

Pradaxa is included in a class of drugs called direct thrombin inhibitors that work by preventing the functionality of the enzyme that causes blood cells to form clots.

In the case Bivens vs. Ingelheim , Bivens alleges that her mother was prescribed Pradaxa in January of 2011 and died from gastrointestinal bleeding three months later. As of November 2011, more than 260 deaths linked to Pradaxa were reported. The majority of these are associated with intense bleeding events.

 
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http://consumer-drug-report.com/content/pradaxa-lawsuits-intensify-victims-pursue-justice#comments
12.03.2012 10:00:00
MONDAY, March 12 (HealthDay News -- A U.S. Food and Drug Administration advisory panel on Monday will weigh the wisdom of allowing new clinical trials of a class of powerful painkillers for osteoarthritis. The drugs may have worked so well for so...
12.03.2012 9:00:00

A coalition of consumer advocacy groups, health organizations, and food and nutrition groups has officially called on the U.S. Food and Drug Administration (FDA to enact new labeling requirements for foods that contain added sugars. The Environmental Working Group ...
hbottemiller@foodsafetynews.com (Helena Bottemiller
15.03.2012 0:03:20
Tainted fish, spices top list

Foodborne illness outbreaks linked to imported food appeared to rise between 2009 and 2010, according to a new analysis released by the Centers for Disease Control and Prevention Wednesday.

tilapia-350.jpgCDC reported that half of the foods implicated in outbreaks were imported from "areas which previously had not been associated with outbreaks." The research was presented at the International Conference on Emerging Infectious Diseases in Atlanta.
 
"It's too early to say if the recent numbers represent a trend, but CDC officials are analyzing information from 2011 and will continue to monitor for these outbreaks in the future," said Hannah Gould, Ph.D., an epidemiologist in CDC's Division of Foodborne, Waterborne and Environmental Diseases and the lead author of the study.
 
The report looked at outbreaks reported to CDC's Foodborne Disease Outbreak Surveillance System from 2005 to 2010 and then parsed out which implicated foods were imported.

CDC researchers found that in that five-year period, 39 outbreaks and 2,348 illnesses were linked to imported food from 15 countries. Of those outbreaks, 17, or almost half of them  occurred in 2009 and 2010.

The review found that fish was the most common culprit, with 17 outbreaks total. The second most common food group was spices, the report said six outbreaks were tied to spices, including five from fresh or dried peppers.

Where exactly were these imported foods from? CDC reported that nearly 45 percent of the foods tied to outbreaks came from Asia.
 
"As our food supply becomes more global, people are eating foods from all over the world, potentially exposing them to germs from all corners of the world, too," Gould said.

David Acheson, former associate commissioner of foods at the U.S. Food and Drug Administration who now consults for the food industry, said the results of CDC's review were not all that surprising considering the United States is not only importing more food, but more high risk items like seafood, spices and produce.

According to the U.S. Department of Agriculture's Economic Research Service (ERS , food imports grew from $41 billion in 1998 to $78 billion in 2007 and most of that growth was in produce, seafood and processed food products. It's now estimated that as much as 85 percent of the seafood consumed domestically is imported and, depending on the season, as much as 60 percent of fresh produce is imported.

On the whole, ERS estimates that 16 percent of all of the food Americans eat each year is imported.
 
In CDC's release on the review, it noted that the findings "likely underestimate the true number of outbreaks due to imported foods, as the origin of many foods causing outbreaks is either not known or not reported."
 
"We need better - and more - information about what foods are causing outbreaks and where those foods are coming from," said Gould. "Knowing more about what is making people sick, will help focus prevention efforts on those foods that pose a higher risk of causing illness."
 
Food safety experts and public health officials have been working to improve food attribution data so more can be understood about which foods are high risk, where contamination occurs in the supply chain, and how it can be prevented.

Acheson noted that it's not necessarily an issue of whether food is imported or not, but whether producers are focused on prevention.

"Let's not forget that there is also plenty to focus on domestically - such as the recent major Listeria outbreak and not move all the emphasis onto imported foods," he said in an email. "This is part of the reason why [The Food Safety Modernization Act] has focused so much on preventive controls for imported foods and why FDA has changed their model away from relying just on port of entry inspections."