November 24, 2009 – Marijuana. It’s a small word that generates a large reaction (for better or for worse). People are polarized on the topic. Yes, there is a definite social stigma surrounding this infamous, leafy plant. Consequently, the potential for cannabis-based drugs has been greatly hindered by legal and political considerations – obstacles that researchers and pharmaceutical companies do not normally find themselves battling. After all, it’s not everyday that research and development teams are looking to create novel drugs from a Schedule I substance – a substance that by definition is not considered to have a legitimate medical use. However, with the recent recommendation by the American Medical Association (AMA) that marijuana’s Schedule I drug classification be reconsidered in order to facilitate research and development of cannabinoid-based medications, could this be the dawn of a new era?

I believe that the AMA’s recommendation is right on the mark. From the limited number of clinical trials conducted on smoked cannabis, the description conferred by a Schedule I classification – namely, that there is no legitimate medical use – no longer appears to apply. According to the executive summary of the Council on Science and Public Health’s (CSAPH) report accompanying the new recommendation, trials have suggested that smoked cannabis can reduce neuropathic pain, improve caloric intake and appetite in patients with reduced muscle mass, and possibly reduce pain and improve spasticity in patients with multiple sclerosis. Thus, it seems plausible that cannabis-based medicines could be developed. The re-classification of marijuana from its current Schedule I status is a necessary step to take if we hope to further explore and take advantage of the ameliorating properties of cannabis.

The question then becomes, should pharmaceutical companies dedicate some of their research and development budgets to cannabis-based drugs? From a scientific perspective, the answer is a resounding yes. Scientists steer their investigations based on preliminary experiments and promising results, and as articulated in the CSAPH report, preliminary trials suggest a variety of medicinal uses for cannabis. Furthermore, assuming that there are legitimate medicinal applications for cannabis, the development of cannabis-based medicines (in the form of pills, for example) would work to neutralize much of the stigma associated with medicinal marijuana (only 13 states even allow the use of marijuana for medicinal purposes). Cannabis-based drugs, a few steps removed from the plant itself, would allow patients access to the therapeutic effects of cannabis, while distancing the treatment from the contentious issue of smoked marijuana. This is, of course, in addition to the obvious advantage that an efficacious cannabis-based pill or other medication medium is much safer than toxic, unrefined smoke.

So what is the greatest obstacle threatening to hinder the development of cannabis-based drugs? Ironically, it is the same thing that I just mentioned above: medicinal marijuana. While the current guidelines regarding medicinal marijuana leave much to be desired – and in fact invite the development of safer, easier-to-regulate cannabis-based treatments – the fact of the matter is, pharmaceutical companies are looking to make a profit. Nobody is going to invest the funds necessary to get a drug on the market unless there is a foreseeable fortune to be made on that product. Drug companies are in the business of “blockbusters,” after all. As long as the raw marijuana plant is legal in some states for medicinal purposes, there really isn’t a market for other cannabis-based treatments. (At least, not the financially-fruitful market for which drug companies are always on the lookout.) A consequence of the legalization of marijuana for medicinal purposes is the creation of numerous, often poorly-regulated marijuana shops and boutiques (just look at the 800+ dispensaries in California). Given the diversity of outlets from which to purchase the plant, as well as the wide variety of plant strains and price range for medicinal marijuana, patients in need could no doubt find a cheaper alternative to expensive pills. Thus, if cannabis-based drugs are ever to be developed, not only does the federal classification of marijuana need to be changed, the availability of the raw plant for medicinal purposes needs to be restricted. It’s a game of supply and demand – and that’s a game that pharmaceutical companies are looking to win. Source.

Advertisements

November 17th, 2009 – A widely prescribed and expensive cholesterol drug is not as effective as niacin, a cheap vitamin, in helping to unclog coronary arteries in people already taking statins, the standard medicines used to lower cholesterol, according to a new study.

The research, which appears Monday in the New England Journal of Medicine, is sending rumbles through the medical community because it is the third recent study to raise questions about the effectiveness of Zetia and its sister drug, Vytorin, highly profitable pharmaceuticals made by Merck & Co.

Introduced in 2002 and 2004 amid heavy direct-to-consumer marketing, Zetia and Vytorin became blockbusters for Merck and Schering-Plough, which had collaborated on their development. The companies recently merged.

Last year, a study released by Merck showed that Zetia did not reduce plaque in arteries compared with patients taking only statins, which are much less expensive and available in generic form. Although released in January, the study had been completed in 2006, prompting a class-action lawsuit alleging that Merck intentionally withheld unfavorable results of a clinical trial. The company paid $41.5 million in August to settle the claims.

Another study published last year showed a potential increase in cancer among patients taking Zetia and Vytorin, compared with those taking only statins.

So what does this have to do with medical marijuana? Everything. Understand that these same profit-making mega-corps of Big Pharma are desperately trying to create cannabinoid-based medicines that can’t be grown in your back yard or closet. While we rejoice that the AMA reversed its position and urged the rescheduling of cannabis, keep your mind focused on why they might have done that. Is it the pure altruism of realizing a mistake and returning to a rational scientific approach to cannabis moderated by compassion for suffering people and the benefit herbal cannabis would provide?

Or is it the realization that the people are crusading for legal marijuana and succeeding, and if herbal cannabis becomes truly legal their friends in the pharmaceutical industry lose all the profits off of cannabinoid pills, sprays, and inhalers to the ultimate “less expensive generic”?

Remember that drug companies only make money if you take drugs. If you’re not sick, you don’t take drugs, so they need to keep finding new drugs to push on you for new ailments you never knew you had. If you go about relieving your unhealthful stress with a joint after a long day, you’re not going to get those stress-related diseases for which you’ll need a lifelong regimen of drugs.

Beware the medicalization of marijuana. I can forsee a ruling where herbal cannabis is placed in Schedule II so research is then allowed to take place. At Schedule II, your doctor could prescribe it to you, but since Schedule II drugs are tightly controlled (no refills, for instance) perhaps he won’t. Meanwhile, Big Pharma identifies and synthesizes the medically-effective compounds in cannabis (taking out the pesky “high”, of course) and these expensive drugs are packaged and mega-hyped on TV. These drugs are placed, like Marinol, at Schedule III or lower. With effective alternatives to herbal cannabis found (and lobbying pressure from Big Pharma looking to protect their investments), states have no reason to begin or continue their herbal cannabis programs.

Next thing you know, the “medical marijuana era” is a relic of the history books, “crude” marijuana is rejected, and those who grow it are busted just like now (remember, possession and manufacture of an unauthorized Schedule II substance can get you in as much trouble as Schedule I.) By: Radical Russ. Source.

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.