Posts Tagged ‘FDA’

CANNABIS SAFER THAN ASPIRIN, SAYS OXFORD SCIENTIST

Tuesday, March 9th, 2010

March 9, 2010 – Cannabis is a safer drug than aspirin and can be used long-term without serious side effects, says a book by a leading Oxford scientist.

The Science of Marijuana, by Dr Leslie Iversen of Oxford University’s department of pharmacology, found many “myths” surrounding marijuana use, such as extreme addictiveness, or links with mental illness or infertility are not supported by science.

He also found cannabis is an inherently “safe drug” which does not lead to cancer, infertility, brain damage or mental illness. Legalisation of the drug for medical conditions should be considered, he says.

Dr Iversen’s findings will increase pressure on the Government to reopen the debate about the decriminalisation of marijuana.

The author, a fellow of the prestigious Royal Society, found cannabis was far less toxic than other drugs and had “an impressive record” compared with heroin, cocaine or tobacco and alcohol.

His study showed that the active element of cannabis, tetrahydrocannabinol (THC), which made users high, had a lot of potential as a safe drug to treat Aids patients and people suffering severe pain.

He also found “stoned” drivers were less dangerous and better able to co-ordinate than people who were drunk. “By any standards, THC must be considered a very safe drug both acutely and on long-term exposure,” he writes. “The available animal data are more than adequate to justify its approval as a human medicine, and indeed it has been approved by the FDA [American drug authority] for certain limited therapeutic indications.”

The book says “alarming claims about the harmful effects of long-term exposure to cannabis” should be “put to rest”, and there “is no evidence the drug causes any impairment in fertility or sexual function in men or women”. He says people who stop using cannabis do not suffer long-term side-effects.

“Cannabis does not cause structural damage to the brains of animals as some reports had claimed, nor is there evidence of long-term damage to the human brain or other than slight residual impairments in cognitive function after drug use is stopped.” The author says many adverse effects of cannabis are related to smoking the drug.

But cannabis itself did not appear to cause cancer. Compared with alcohol and cigarettes, which led to more than 100,000 deaths a year (in the U.K.) , cannabis had a far better record.

“Tetrahydrocannabinol is a very safe drug,” he said. “Despite the widespread illicit use of cannabis here are very few if any instances of people dying from an overdose. Even such apparently innocuous medicines as aspirin and related steroidal anti-inflammatory compounds are not safe.

“Thousands of people die every year because of the tendency of these drugs to cause catastrophic gastric bleeding.”

Keith Hellawell, the drug czar, also agrees cannabis use does not lead to heroin addiction. Source.

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Big Pharma Brands Afraid of Social Media due to Loss of Control & Threat of Class-Action Law Suits

Saturday, November 14th, 2009

November 14, 2009 – It’s no surprise that pharma brands have been reluctant to enter the social media sphere. Indeed, it’s been repeated over and over at this week’s Food and Drug Administration hearing on 31655pharma marketing online.

Pharma marketers are intimidated by social media for several reasons: lack of control over brand messages, fear of violating the FDA’s cloudy regulations, and the threat of class-action lawsuits brought as a result of consumers using social tools to report adverse drug effects.

These marketers are struggling to determine how to monitor social media — in part to report adverse effects of their drugs and products as required by the FDA. However, their hesitance to acknowledge social conversations by monitoring them, creating Twitter accounts, or responding to consumer comments in forums, also is hampering their desire to buy online advertising and other online marketing services.

That’s led an array of online media firms, ad agencies, and marketing services firms to Washington, DC, in the past two days to participate in a discussion hosted by the FDA intended to assist the agency in crafting clear rules for this highly-regulated advertiser sector.

“Most pharma and medical device companies are unwilling to advertise” in social media sites alongside user generated content, said Christopher Schroeder, CEO of health site HealthCentral.

According to the Interactive Advertising Bureau and PricewaterhouseCoopers, pharma and healthcare advertisers spent the smallest amount on Web ads in 2007 and 2008 compared to other advertiser verticals, accounting for 4 percent of online ad revenues in both years. In contrast, pharmaceutical marketers represented the second largest ad vertical across all media based on ad expenditures in 2007 and 2008, according to Nielsen. Automotive is the largest.

In addition to simply running ads adjacent to online conversations, pharma marketers also worry about the time and effort it takes to monitor user generated media to watch for mentions of their brand names and reports of negative side effects of their drugs. They also question how often they’ll need to revisit Web sites where they’ve spotted relevant postings.

In 2008, Nielsen’s BuzzMetrics measured 500 randomly selected healthcare messages online. According to hearing speaker Melissa Davies, research director, healthcare, at Nielsen’s Online division, only four messages — less than 1 percent — mentioned an adverse event. Clearly it’s in Nielsen’s best interest to promote its BuzzMetrics social media monitoring service, along with its finding that pharma brands don’t have a lot to worry about if they do start monitoring social media.

Google and Yahoo stopped by the hearing yesterday. Both firms suggested that search ads for pharmaceutical products have become less transparent since the FDA sent warning letters to 14 pharma companies in April accusing them of failure to include drug risk information in online ads. Many advertisers, as a result, have been running sponsored search listings with generic messages that do not mention drug brands by name. Google reported lower click-through rates on pharma ads since the FDA letters were sent.

It’s clear media and marketing services firms are pushing for the FDA to establish clear guidance on how pharma brands should handle online advertising and social media because they expect to benefit from more pharma dollars moving online. Now, as expressed by many hearing speakers, it’s up to the FDA to move quickly to develop regulations that are relevant to the evolving technologies and cultures of the Internet.
Source. By Kate Kaye.

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