Sunday, March 11, 2012

News and Events - 12 Mar 2012




NHS Choices
09.03.2012 15:42:00

LSD “helps alcoholics to give up drinking”, BBC News has today reported.

This unusual claim is based on a review examining research into the powerful hallucinogenic and its potential to treat alcoholism. The review analysed the results of six medical trials performed between 1966 and 1971, a time when LSD was still used for the treatment of some psychiatric conditions. Although it seems unthinkable now, the drug was prescribed to some patients until evidence began to suggest that it could cause long-term harm, leading it to be withdrawn.

Although the review suggested that LSD could help dependent people to stop drinking, the limitations of the quality, methods and age of the research gathered mean that the researchers cannot support using the drug to treat alcohol misuse or dependency. Since the research was conducted, social and medical perceptions of drug harms have changed considerably, and it is highly unlikely the benefits - if any - would outweigh the risks, particularly as there are now many options for helping people with alcohol problems.

LSD is a class A drug that is illegal to possess or sell. The effects of taking LSD are highly unpredictable, and while some individuals may experience enjoyable hallucinations it carries high risk of considerable personal and psychological harm, both at the time of taking the drug and in the longer-term.

Where did the story come from?

This study was carried out by researchers from the Norwegian University of Science and Technology (NTNU and Harvard Medical School. It was funded by the Research Council of Norway and published in the peer-reviewed Journal of Psychopharmacology.

The Daily Mail gives slightly overinflated coverage of this story, which doesn’t take into account the review’s numerous and significant limitations. BBC News does make it clear that the review looked at trials from the 1960s and 1970s.

What kind of research was this?

LSD (lysergic acid diethylamide was first created in a lab in the 1930s, and in the decades that followed there was great interest in whether the psychedelic chemical could have medical uses. As the drug significantly alters how people think and perceive their surroundings, there was some speculation that it could open patients’ minds to psychotherapy.

This speculation centred on whether the substance could help people with severe mental health problems, although it was also considered as a potential treatment for more minor conditions, such as anxiety and phobias. Given its perceived benefits, LSD was administered to psychiatric patients for several years; but as it became associated with recreational use and negative effects for patients, it was withdrawn from medical use.

According to the authors of this new research, numerous clinical investigators have claimed that treating alcoholics with individual doses of LSD in combination with psychosocial interventions may help prevent further alcohol misuse. They suggested this could work by allowing patients to understand better their behavioural patterns and therefore become motivated to build and maintain a sober lifestyle.

This was a systematic review and meta-analysis, which aimed to combine the results of all relevant trials that have used LSD (lysergic acid diethylamide to treat alcoholism. A systematic review of randomised controlled trials (RCTs is the best way of reviewing the available evidence on the health effects of a particular intervention. Systematic reviews are, however, often inherently limited by the different methods of the individual trials that they combine, including the populations they studied, how the intervention is given (such as frequency, dose and duration and outcomes measured.

What did the research involve?

The researchers searched PubMed and PsycINFO databases to identify any published trials that included key terms relating to LSD, alcohol and dependence. They included any RCTs of LSD treatment for alcoholism. In RCTs, an intervention such as LSD-use is compared with a “control treatment”, such as standard treatment or no specific treatment. The researchers described that the control treatments in eligible trials could involve any type of other treatment, including using “low doses” of LSD (up to 50 micrograms, which was lower than the intervention doses . Two reviewers analysed the studies and extracted data.

Primary outcomes of interest were alcohol misuse, which was defined as “alcohol use or consequences of alcohol use, as systematically measured by interview or self-report at the first reported follow-up”. Secondary outcomes of interest were alcohol misuse in the short-term (approximately three months , medium-term (approximately six months and longer-term (approximately 12 months . They also looked at reports of abstinence and adverse events. Where possible, they pooled the results of individual studies. If any trials had included people with psychiatric conditions such as schizophrenia or psychosis, the researchers excluded these from their analyses.

The researchers identified six eligible trials, all of which were dated between 1966 and 1971. Five trials were conducted in the USA and one in Canada. The trials included 536 individuals (general age range 30s-50s; all male except two females , of whom 61% were randomly assigned to receive “full-dose” LSD and 39% a control treatment or no intervention. The trials all gave a single oral dose of LSD as the intervention, with doses ranging between 210 and 800 micrograms (average 500 . Control conditions included “low-dose” LSD (25 or 50 micrograms , amphetamines, ephedrine sulphate (a stimulant drug or no drug treatment. All participants were said to be seeking treatment for alcoholism and had been admitted to alcohol-focused treatment programmes before being recruited to the trials.

The researchers said that the individual trials varied in their preparation for the LSD treatment session, with most studies providing only brief participant information, with often little or no description of the possible effects of LSD. During treatment, the most common procedure was described to be “simple observation with brief reassurance by clinical staff”. In only three studies did the treatment groups also receive clinical interviews, psychotherapy or active guidance. After the experimental drug session, only one study included multiple review sessions that reviewed the experiences during the drug session. The other five studies provided either only one brief review session or no review session at all.

All of the trials defined their methods for assessing the effects of the drug on alcohol use, but these varied between trials (such as using rating scales on alcohol use, assessing abstinence or using social adjustment rating scales .

What were the basic results?

Five trials gave “categorical” data (for example, whether a patient was improved or unimproved , and in these five trials 59% of those taking LSD (185 of 315 and 38% of controls (73 of 191 had improvements in their alcohol use at first follow-up. The pooled results of all six trials demonstrated increased odds of improvement in alcohol misuse, with LSD treatment compared to control ( odds ratio 1.96, 95% confidence interval 1.36 to 2.84 . This, they calculated, meant six people would need to be treated with LSD for one person to gain benefit at the time of first follow-up.

When the researchers divided the trials up into those assessing short-term (two to three months , medium-term (six months and longer-term effects (12 months , significant improvements were only seen at short- and medium-term follow-up.

Three trials reported on abstinence rates but only found a benefit of LSD at short-term follow-up.

In total the trials reported eight adverse reactions at the time of taking the drug. These included becoming agitated, acting “bizarrely” and having a seizure.

How did the researchers interpret the results?

The researchers concluded that “a single dose of LSD, in the context of various alcoholism treatment programmes, is associated with a decrease in alcohol misuse”.

Conclusion

Fifty years ago, researchers and doctors considered LSD to be a possible treatment for patients with mental health problems, until evidence showed that it could cause long-term psychological problems in some people. This review of six previous trials cannot be considered to provide evidence that LSD could be beneficial for people with alcohol problems. This is in no small part due to the questionable methods of the reviewed trials, the most recent of which was carried out 41 years ago.

Although LSD may have been considered suitable for testing in a trial at a time when its recreational use was quite common, it is highly unlikely that it would be considered now, given how considerably social and medical perceptions of drug harms have changed since then. This is notable by the attitudes displayed in the previous trials, which reportedly gave the participants very little information ahead of their LSD treatment session: most studies provided only brief participant information with often little or no description of the possible effects and risks of taking LSD. This would be considered unethical and unacceptable in trials today.

There was also very little follow-up of patients to see the long-term effects of taking LSD. Only one study included multiple review sessions assessing the individual’s experiences of taking the drug; the other five studies provided either only one brief review session or no review session at all. Therefore, how individuals are affected by taking LSD – regardless of its effects on their subsequent alcohol use - are unknown. At the time of taking the drug, there were eight reports of participants being agitated, acting “bizarrely”, having a seizure or having other “unspecified” adverse reactions.

LSD is a class A drug that is illegal to possess or sell. The effects of taking LSD are highly unpredictable, and while some individuals may experience “pleasant” hallucinations, the individual is putting themselves, and potentially others, at high risk of considerable personal and psychological harm, both at the time of taking the drug and in the long term.

Given the potential danger, it seems unlikely that LSD would be considered for future testing in people with alcohol dependence. It’s particularly important to note that we now have a range of medicines and psychological interventions for treating alcoholism that weren’t available at the time of this previous research.

Links To The Headlines

LSD 'helps alcoholics to give up drinking'. BBC News, March 9 2012

LSD could treat alcoholism because 'trips' make you reassess addiction. The Daily Telegraph, March 9 2012

Can LSD cure alcoholism? Trials show 59 per cent of problem drinkers improve after a single dose of powerful hallucinogen. Daily Mail, March 9 2012

Links To Science

Krebs TS, Johansen PO. Lysergic acid diethylamide (LSD for alcoholism: meta-analysis of randomized controlled trials. Journal of Psychopharmacology. Published online March 8 2012




09.03.2012 23:23:09



As Vice President Joe Biden wraps up a trip to Central America insisting the drug war must continue, a growing number of Latin American leaders are calling for the decriminalization or legalization of drugs.

"This debate now is no longer going to be suppressed," says Ethan Nadelmann, founder and executive director of the Drug Policy Alliance. "Once U.S. officials are obliged to participate in the discussion and to do it in a real way, the smartest among them know there’s no way to defend the current U.S. strategy."

read more

http://www.cannabisculture.com/v2/content/2012/03/09/US-Faces-Challenge-Drug-War-Latin-American-Countries-Mull-Decriminalization-Legal#comments



11.03.2012 1:16:56
As unbelievable as it sounds, current law makes it illegal for food producers to share certain types of scientific information with you. So when Diamond Food relayed health information about the omega-3 fats in walnuts on product packaging and also on their Web site, the U.S. Food and Drug Administration (FDA attacked. Even though the information was entirely true, and backed by peer-reviewed scientific research. If a Food Can Prevent a Disease, it Must be a Drug This is the backward thinking that goes on at the FDA, where regulations currently prohibit manufacturers of dietary supplements or producers of food from referring to any scientific study documenting the potential effect of the substance on a health condition, punishable by large fines and even jail. Disclosure about the benefits of a dietary supplement or food, no matter how credible, places the food in the category of an "unapproved drug." In other words, if a product makes a medical claim, it's automatically classified as a drug. This is how the FDA got away with sending Diamond Food a warning letter[1], stating: "... we have determined that your walnut products are promoted for conditions that cause them to be drugs because these products are intended for use in the prevention, mitigation, and treatment of disease. The following are examples of the claims made on your firm's website under the heading of a web page stating "OMEGA-3s... Every time you munch a few walnuts, you're doing your body a big favor ... " These claims are backed by science[2], but it doesn't matter under FDA rules, which are so counter to rationality and logic that it boggles the mind. The FDA letter goes on to list several health claims made by Diamond Foods regarding omega-3 fats, claims such as: "Studies indicate that the omega-3 fatty acids found in walnuts may help lower cholesterol; protect against heart disease, stroke and some cancers; ease arthritis and other inflammatory diseases; and even fight depression and other mental illnesses." "[O]mega-3 fatty acids inhibit the tumor growth that is promoted by the acids found in other fats... " "[I]n treating major depression, for example, omega-3s seem to work by making it easier for brain cell receptors to process mood-related signals from neighboring neurons." "The omega-3s found in fish oil are thought to be responsible for the significantly lower incidence of breast cancer in Japanese women as compared to women in the United States." Walnuts are "New Drugs" Because Diamond Food dared to let consumers know that natural substances in a natural food may offer some health benefits and protections, the FDA views this as a new drug. In their eyes, only FDA-approved drugs are capable of offering such protections ...



10.03.2012 14:08:00

SALT LAKE CITY — After years of delays, Dr. Daniel Simmons, a longtime professor in the Department of Chemistry and Biochemistry at Brigham Young University, is about to get his day in court.

In October 2006, Simmons and BYU sued drug giant Pfizer, claiming the pharmaceutical company unfairly profited from his discovery and cheated the professor out of professional credit and compensation. The lawsuit involves potentially millions, perhaps even billions of dollars in royalties for BYU and has resulted in more than five years of legal wrangling.

The dispute revolves around the drug Celebrex, a revolutionary drug to treat arthritis and inflammation. The so-called “super-aspirin” blocks the COX-2 enzyme, reducing pain and inflammation without triggering the sometimes deadly gastrointestinal effects of some other non-steroidal anti-inflammatory drugs, including aspirin. COX is scientific shorthand for the enzyme cyclooxygenase.

Back in 1991 and into 1992, Simmons and BYU had a research agreement with Monsanto, later acquired by Pfizer.

According to BYU, Dr. Simmons' research about the COX-2 enzyme was critical in the development of Celebrex, yet Monsanto ended the agreement, without including him or the university in the credit or compensation.

"The agreement was to share his discovery with the company and to share in any reasonable royalties that resulted from their collaboration,” BYU said in a prepared statement. “The company then used Dr. Simmons' work as a road map to develop the blockbuster drug Celebrex."

Pfizer claims the company met all of its obligations under the agreement. In a prepared statement it said, “Many years ago, Monsanto had a research agreement with BYU and Dr. Simmons, and the company met all of its obligations under the agreement. Years later, BYU and Dr. Simmons made unfounded allegations against Pfizer in an effort to capitalize on the company’s commercial success. The lawsuit has no merit.”

Brent Hatch, an attorney for Pfizer, said, "It's a big case and the judge was exceptionally well-prepared. He was very thorough in his questions. We're very much looking forward to receiving his decisions."

Judge
Ted Stewart will rule on pretrial motions submitted Friday in anticipation of a May 29 trial date. Both sides will then take jurors down a road two decades in the making, unveiling documents, detailing science, and relying on expert witnesses and patent law to reach a decision. 

BYU officials previously said it worked for years to reach an agreement before heading to court, but to no avail. Pfizer was penalized in October 2009 for causing unnecessary delays in the case, and was ordered to pay BYU $825,315 for costs that included attorney fees.

The trial is scheduled to last six weeks.

E-mail:
spenrod@ksl.com

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08.03.2012 20:06:38

Once a juicer, always a juicer?

That may indeed be the case as Jose Canseco's attempt to play in the Mexican Baseball League ended on Wednesday after league officials said the former star admitted to taking a banned substance without a prescription.

League president Plinio Escalante
told ESPN Deportes that the banned substance was testosterone and that Canseco refused to take a drug test.

The 47-year-old former slugger had been trying out with the Quintana Roo Tigers, publicly stating that it was his goal
to again play in the major leagues one day. The Mexican League is Triple-A level ball, but teams do not share any affiliation with MLB franchises.

Still, it was better than the independent league ball that Canseco had been playing in.

As has been his custom, Canseco took to his Twitter account and defended himself with a flurry of stream-of-consciousness tweets:

"How can I test positive when I never took any test don't believe everything the media tells you.the truth always comes out I am not using any illegal substanced,"
he wrote from @josecanseco. "All I am on is prescription medication for low testosterone .legal and very important for my health."

Whether it's explaining why
he sent his twin brother to box for him or
professing his love for Lady Gaga, Canseco's uninhibited tweets have always been a particularly sad piece of theater. He has become the ultimate outsider in a sport that he turned upside down with the revelatory publication of "Juiced" back in 2005.

[Rewind:
Jose Canseco demands $2,000 for blog interview
]

That Canseco would be injecting testosterone into his aging body as he continues his delusional "dream" to play big-league baseball would be no surprise if true, of course.

It would also be no surprise if Canseco's claims that years of steroid use have driven his testosterone to low levels that would necessitate these injections.

Either way, it's against baseball's rules to take unauthorized testosterone for any reason if you want to play the game. Canseco made this sad world for himself, but it'll always be impossible for him to acknowledge that.

Spring training has started, so don't miss a beat ...
Follow
@bigleaguestew,
@KevinKaduk and the
BLS Facebook page!

More baseball news from Yahoo! Sports


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2012-03-09 14:00:51
Lawrence LeBlond for RedOrbit.comUPDATE: March 9, 2012 3:00 p.m Eastern. Reports that were originally received from various media outlets stating that Coca-Cola was changing its formula to avoid adding cancer warning labels to its beverages are false. In a
statement posted on its website today, Coca-Cola said that it is in fact not changing its world-famous formula. “The caramel color in all of our products has been, is and always will be safe, and The Coca-Cola Company is not changing the world-famous formula for our Coca-Cola beverages. Over the years, we have updated our manufacturing processes from time to time, but never altered our Secret Formula,” Coca-Cola said on its website. The No. 1 soft drink maker said they have asked its caramel suppliers to modify their production process to reduce the amount of 4-MI in the caramel, but that it will not have any effect on the formula or the flavor of its products. “These modifications will not affect the color or taste of Coca-Cola,” it said. The company added it is committed to the “highest quality and safety” of its products, and it will “continue to rely on sound, evidence-based science to ensure that our products are safe.” --------- A specific caramel coloring found in Pepsi, Coca-Cola, and other popular soft drinks that a consumer watchdog said contain high levels of a chemical linked to cancer in animals has now been deemed safe by US regulators. Despite this, PepsiCo and Coca-Cola both decided to adjust the formula of their caramel coloring across the US so they do not have to label their products with a cancer warning to comply with additional regulations enforced in California. The recipe has already been changed for drinks sold in the Golden State and the companies said the changes will be expanded nationwide to streamline their manufacturing processes. The Center for Science in the Public Interest (CSPI
reported earlier this week that it found the unsafe levels of the chemical 4-methylimidazole (4-MI -- used to make caramel color -- in cans of Coke, Pepsi, Dr. Pepper, and Whole Foods’ 365 Cola. Coca-Cola confirmed that changes were being made at its facilities to keep within the law but argued that the CSPI’s allegations on the dangers the ingredient posed on humans were false. “The company has made the decision to ask its caramel suppliers to make the necessary manufacturing process modification, to meet the specific Californian legislation,” A spokesperson for Coca-Cola told
Daily Mail Online. “Those modifications will not change our product.” California added 4-MI to its list of carcinogens, after studies showed high levels of the chemical led to tumors in lab animals. However, the studies were inconclusive on whether the chemical was dangerous to humans or not. “Caramel is a perfectly safe ingredient and this has been recognized by all European food safety authorities,” the spokesperson added. “The 4-MEI levels in our products pose no health or safety risks. Outside of California, no regulatory agency concerned with protecting the public’s health has stated that 4-MEI is a human carcinogen.” “The caramel color in all of our ingredients has been, is and always will be safe. That is a fact,” the spokesperson said. This had been the CSPI’s second go-around with the Food and Drug Administration (FDA over the dangers of 4-MI in soft drinks. It first petitioned the regulator last year, but the FDA has continually maintained that the claims were exaggerated. “It is important to understand that a consumer would have to consume well over a thousand cans of soda a day to reach the doses administered in the studies that have shown links to cancer in rodents,” said FDA spokesman, Doug Karas to the Daily Mail's Laura Pullman. CSPI maintains that the regulator is allowing soft drink companies to needlessly expose millions of Americans to a chemical that is known to cause cancer. “If companies can make brown food coloring that is carcinogen-free, the industry should use it,” CSPI’s executive director Michael Jacobson told
Reuters. The FDA said it will review the watchdog’s petition, but that the soft drinks in question were still safe. CSPI took cans from stores in the Washington DC area, where they found some had levels of 4-MI near 140 micrograms per 12-ounce can. California has a legal limit of 29 micrograms of 4-MI per 12 ounces, it noted. The FDA’s limit for 4-MI in caramel coloring is 250 parts per million (ppm . Once the caramel is mixed in with the soda it becomes diluted. According to calculations by Reuters, the highest levels of 4-MI found in the soft drinks were about 0.4 ppm, significantly within the safe zone. “This is nothing more than CSPI scare tactics,” the American Beverage Association (ABA told Reuters in a statement. “In fact, findings of regulatory agencies worldwide ... consider caramel coloring safe for use in foods and beverages.” ABA said its member companies will continue to caramel coloring in certain products but that adjustments were being made to meet California requirements. “Consumers will notice no difference in our products and have no reason at all for any health concerns,” the ABA said. Diana Garza-Ciarlante, a representative for Coca-Cola, said its suppliers would modify the manufacturing process used to reduce the levels of 4-MI, which is formed during the cooking process and as a result may be found in trace amounts in many foods. “While we believe that there is no public health risk that justifies any such change, we did ask our caramel suppliers to take this step so that our products would not be subject to the requirement of a scientifically unfounded warning,” she said in an email to
The Telegraph. --- On the Net:



09.03.2012 16:00:00
Headlines for March 09, 2012; U.S. Faces Challenge to "Drug War" as Latin American Countries Mull Decriminalization, Legalization; "Beautiful Souls": Eyal Press on the Whistleblowers Who Risk All to "Heed the Voice of Conscience" ; "El Librotraficante" Tony Diaz Defies Ethnic Studies Book Ban with Caravan to Arizona

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