Naked Medicine

A Consumer Reports video of the Requip DTC ad (another drug used to treat RLS, manufactured by GlaxoSmithKline) has been published.

Let me first state that I’ve seen the Requip ad in question many times when I watch TV, and each time I have the same negative reaction to the ad. This means I have some negative personal bias against the ad itself and the way the company is marketing this to consumers en masse. That said, I decided not to go to the drug company’s “defense video”, which may predispose me to additional bias, and I present my analysis of the anti-ad video by Consumer Reports.

A young woman is seen in the ad to go through the drug company’s ads line by line. She comments on the statements made by the drug company ad. She doesn’t really “analyze” the statements as much as comment – and there’s a big difference between an unbiased analysis and editorial/opinion/commentary (example, “Ooh! Sounds Serious” and “Sounds like the side effects are worse than the condition!” and lots of sentences beginning with exclamations like “Ahh!”).

Given that she doesn’t suffer from RLS, her commentary is biased and nothing more than an opinion. I’d like to hear from a member of that 3% population who DOES suffer from RLS and hear whether he or she agrees that the side effects are worse than the condition.

She does mention selectively the 2 people whose compulsive gambling caused them to lose over $100K each as a result of the side effect of Requip. $100K is a lot of money, no question about it. But 2 people – that’s a small “sample size” and in the medical community and the lines of “evidence based medicine” would constitute “case reports” – the weakest type of “evidence” and would be considered anecdotal more than actual evidence. Other types of side effects like nausea and headache probably had more reports, but $100K is more sensational. It seems like the Consumer Reports anti-ad video is using some of the techniques that they’re criticizing the drug company for doing – sensationalizing what is actually a very small percentage of occurrence.

Does the Consumer Report ad make valid points? Sure. Is the anti-ad “ad” video a spin? Yes. A gloating male voice comes at the end to say “This ad is sponsored by – NO ONE!” as a vehicle to suggest that everything it claims in the its video must be unbiased and therefore, credible. However, the video itself contains very little evidence, lots of editorial claims, and does not address symptoms of the actual condition of RLS so that consumers can be “better educated” if Consumer Reports does not believe the GSK’s Requip ad is doing a good job.

This reminds me a bit of smear campaigning that politicians use against each other. What I’d like to see is a curbing of anti-anything from activist groups. For once, I’d like to see someone spend the dollars coming up with the better solution to educating consumers credibly and objectively and setting a positive example for others to follow.

Source: John Mack who has been following the restless leg syndrome (RLS) “phenomenon”.

New England Journal of Medicine recently published a paper looking at “A Decade of Direct-to-Consumer Advertising of Prescription Drugs”, where the study authors looked at pharma company spending on DTC advertising and physician promotion in the past 10 years (1996-2006). The authors also looked at the FDA regulation of drug advertising during this time. While drug companies’ promotional spending went from $11.4 billion (1996) to $29.9 billion (2005) where DTC ad expenditures grew by 330%, this made up “only” 14% of the almost $30 billion in drug companies’ promotional spend.

On the other hand, FDA’s warning letters fell from 142 in 1997 to 21 in 2006. The authors speculate this could either be due to drug companies becoming better behaved and playing by the rules, or due to the FDA being too short-staffed to follow up on all violative behaviors. I’m skeptical whether this reduction in FDA warning letters is mostly due to staff shortage at the FDA given how steep this drop was (142 to 21 per year); while I’d like to think that drug companies are finally being “scared straight” by the various scandals and class action lawsuits in the recent years, I’m also not so much of a pollyanna to believe that no violative behaviors are being produced. Still, it looks like DTC is here to stay, as much as many doctors loathe it with a passion of a thousand suns. Read the rest of this entry »

With all the media attention on high cholesterol and heart health, it’s not surprising that some companies are preying on consumers with “natural” treatments like “red yeast rice products” that may contain prescription drugs without obtaining authorization from the US FDA. The FDA is now warning consumers about these products sold on the Internet as dietary supplements for high cholesterol:

Red Yeast Rice and Red Yeast Rice/Policosonal Complex, sold by Swanson Healthcare Products, Inc. and manufactured by Nature’s Value Inc. and Kabco Inc., respectively; and Cholestrix, sold by Sunburst Biorganics.

These products were found to contain lovastatin, an anti-cholesterol drug, yet the manufacturers do not warn consumers about the potentially dangerous side effects of products containing this chemical the way that pharmaceutical companies are required by law to warn consumers. The FDA has sent warning letters to these companies to stop selling these products. Source: FDA

I’ve been tracking the various developments and commentaries on the controversy surrounding diabetes drug Avandia (rosiglitazone, manufactured by GlaxoSmithKline). For those of you interested in background information and commentaries relating to the use of Avandia and increased risk for heart disease, as well as the affordability of chronic medications like diabetes drugs, I’ve compiled a short reading list including abstracts to the original research articles to help you get started. Please read my conflict of interest disclosure at the end of this article. Read the rest of this entry »

… And as the geniuses at Pfizer’s marketing department go with this latest “Viva Viagra” ad, I don’t blame the doctors.

thanks to Vincent for the link.