Naked Medicine

This past week’s Sunday “Post Secrets” had a postcard that said, “I don’t care what you said, I still think RLS IS BULLSHIT” sent on a postcard made from a Mirapex (prescription drug for restless leg syndrome or RLS) ad. This generated a flurry of comments in the Post Secret discussion forum, where people talked about experiencing RLS or witnessing a loved one who suffers from RLS.

Hence is the dilemma for direct to consumer advertising by drug companies.

On the one hand, there is a grain of truth in the ethics of drug companies to mass market to consumers a condition that affects a very small percentage of the population. One wonders why a drug company would choose huge media outlets like magazines and television to talk about a drug for a condition a very small percentage of the population suffers from. Would this create false diagnoses? Foster hypochondrias in those who do not actually suffer from the condition, but have become suggestive to think they do based on what little they know about the condition in a 30 second TV commercial?

On the other hand, those who do suffer from the rare condition can feel a sense of relief that they were not alone or “crazy”, that the condition is indeed a medical one requiring medical intervention, and that there is medical help. Even if drug companies try to educate doctors on a rare condition, doctors may not always have time to do a detailed workup and uncover the condition unless the patient proactively offers this information.

As cynical as I am of DTC advertising by drug companies, I still choose having the information out there than not having the information available at all.

The FDA has just approved changes to product labeling for popular “lifestyle” drugs Viagra, Cialis, and Levitra. These drugs are meant to treat erectile dysfunction or ED, and my calling them “lifestyle” drugs will trigger the ire of pharma companies, but let’s face it, these types of drugs don’t become blockbuster for no reason.

If you didn’t know, Viagra was born of research on a compound originally intended to treat heart disease. Who knew that the interesting side effect of the compound would create such a media sensation? (not to mention all the lame jokes and commercials accompanying these medications)

The FDA began investigating the potential link between Viagra and similar drugs with hearing loss after reading a case report published in April 2007 in the Journal of Laryngology & Otology. The agency found 29 post-marketing reports of sudden hearing loss in one ear for patients taking Viagra and similar compounds. Now, the FDA wants the drug makers to warn consumers taking ED drugs about the risk of sudden hearing loss after “a very small number of patients” reported sudden hearing loss, sometimes with ringing in the ears and dizziness. Patients who experience sudden hearing loss are advised to stop taking the drug immediately and get medical help.

Given the number of prescriptions that have been dispensed for Viagra and family, 29 reports of sudden hearing loss really isn’t a “big” number. However, let’s take this in the context of the current media attention on children’s cough medication calling to be banned because of less than 60 total deaths over the span of more than 35 years (1969-2006). Even if infant deaths due to cough mixture were attributed to inappropriate dosing, 29 drug-related adverse events of anything these days may be too many to be ignored.

My blog buddy Johnny Ancich created this very smart cartoon about cigarettes:

It may not be a bad idea if Steve Jobs gets into the cigarette manufacturing business. Just consider at least these 3 benefits: Read the rest of this entry »

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