Let’s take the trend of “personalized medicine” to start. Yes, gene-based and protein-based medicines sound alluring. We talk about targeted therapies like they’re silver bullets against deadly diseases, when we still don’t know of the long term effects of many small molecule and biologics as medicines.
All that talk about personalized medicine and how wonderful it would be if we were to have drugs tailored for us? We’ve been doing that for years!
Yet pharma has been providing a level of “personalized” medicine for years, which has created its reputation as a greedy industry with “mediocre” innovation as perceived by its critics.
Critics ask why we need yet another statin? Do we really need to have that many antidepressants in the SSRI class? How many more erectile dysfunction product ads can we endure? Should we blackbox all the glitazone drugs?
We can apply the “personalized” medicine argument to these so called “me-too” drugs reviled by academics and consumer watch dogs. We do need that many statins, because a patient may tolerate atorvastatin better than rosuvastatin. Someone’s life may be saved by paroxetine even when their depression symptoms didn’t respond well to sertraline.
But all this comes at a cost, because of the fundamental reality that personalized medicine requires segmentation of patient types to the point where what used to be ‘blockbuster marketing” is becoming “specific patient population/niche marketing”.
Truthfully, pharma marketers don’t like that. The return on investment isn’t as impressive. Investors on wall street are more impressed by blockbuster numbers than special patient populations. Executives don’t get as big of a bonus at the end of the year. Ad agencies don’t get as many multi-million dollar contracts for celebrity ads or computer graphic-generated creatures talking about allergies.
So the first shift requires pharma companies to begin training their marketers and sales teams to view patients as patient groups with specific tolerances and response profiles rather than a faceless generic group from which blockbusters are created.
This shift in marketing thinking, however, is going to take a while.
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”.
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.
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. (more…)
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
First it’s zapping bad memories (see previous article) and now – monthly periods for women. Gents, you may think of this post as “for ladies only” but keep reading: this has general biological implications for either gender.
Gardiner Harris of New York Times wrote about Vermont’s disclosure of the amount of funds that the states doctors received from drug companies. While the focus was on psychiatrists, because they received top total dollars, I was particularly intrigued that endocrinologists as a specialty followed a close second. Those of you familiar with the field (I briefly worked in the field when I was a pharma employee) know that compared to psychiatrists, endocrinologists are a much smaller group as a specialty.
Still, I was concerned that psychiatrists earn so much money from drug companies because in general, doctors can earn money from drug companies mainly through consulting fees (including speaking fees) or from participating in clinical trials. In neuroscience, clinical trials tend to be very large and time-consuming to have any meaning behind the results. This means psychiatrists wouldn’t make much money per year from clinical trial participation alone, and the bulk of their revenues would come from “consulting” agreements. Consulting agreements usually comprise of speaking engagements and other “advisory board” activities. While we have many more drugs within the psychiatric therapeutic area than endocrinology, why wasn’t cardiovascular specialists a close second or even topping the list? The number of psych drugs could rival the number of cardiovascular drugs on the market.
Could it be that there is much more off-label (unapproved) use of psychiatric drugs than there is for cardiovascular drugs? This was implied by the NYT article, when it noted that psychiatrists who earned a lot of money tend to prescribe psych meds to children the most often. (more…)