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No doubt that many of you already know that DTC advertising is an effective way for pharmaceutical companies to “push” their drugs. However, when I saw the amount of money that was spent on DTC in 2007 I was shocked! In 2007 alone, drug companies spent $5,375,117,382 on advertising. Yes, that's $5.375 billion dollars (think of how many research grants could have been funded or how much money could have been spent on universal healthcare!).  The aggregate ROI for 25 pharma companies examined was impressive–totaling about $32 billion or roughly 7-fold!

A table published by Consumer Reports AdWatch highlights 25 of the biggest spenders along with their sales, giving an indication of how much their ad spending has paid off —or not! The drugs that received the biggest bang for the buck are bolded. Despite the conflict of interest and false advertising DTC flap over Lipitor, it still managed to have the third best return among the 25 products analyzed.

¹Consumer Reports Consumer Drug Reference, 2008.
²Data compiled by Nielsen Media research, March 2008.
³Data provided by Drug Topics and Verispan, March 2008.

No wonder why everybody wants to work for a pharmaceutical company–despite the downsizing there is still substantial money to be made!

Until next time….

Good Luck and Good Job Hunting!!!!!!

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The newest culprit in the direct-to-consumer (DTC) television ad cat and mouse game between pharmaceutical manufacturers and US regulators is Cordis, a medical device subsidiary of Johnson & Johnson. The ad in question deals with promotion of the use of a cardiac stent called Cypher that is manufactured by the company. The television ad is the first ever to market a medical device. Nevertheless, according to an article published in this week’s New England Journal of Medicine, the ad overstates the benefits of the stent without mentioning possible adverse effects that can include heart attack and stroke.

The current brouhaha is nothing new in the ongoing battle between drug manufacturer (and now, medical device companies) and regulators over DTC advertising. As some of you may know, the US is one of a few industrialized countries in the world that allows DTC advertising.  Further, DTC ads don’t require FDA review or approval before they are aired or printed–although in some instances, companies do request FDA review. 

Because of growing problems with DTC ads (especially television spots), there is mounting pressure on FDA to limit consumer medical advertising or, at the very least, increase regulatory oversight of it. To that end, on Friday, an FDA advisory panel will convene to discuss whether television ads for prescription medications ought to include a statement encouraging consumers to report any adverse side effects via a toll free number to the agency. At present, this type of disclaimer is only required for DTC print ads.

For those of you who don’t know, FDA has (by law) a post marketing surveillance network in place to allow consumers to report any side effects (big or small) that they may experience after taking prescription or over the counter medications. Further, companies are required by FDA regulations to immediately report any and all side effects associated with their products.

Of interest, in a hearing last week on drug advertising (being conducted by the House Energy and Commerce Committee), several drug company representatives in attendance were asked whether or not they would support a toll free number on television ads to encourage viewers to report adverse side effects. Surprisingly (perhaps not) they could or would not directly answer the question. According to John D. Dingell, chair of the committee and advocate of greater regulatory oversight of DTC advertising, “Some ads appear to be misleading and others appear to be downright deceptive.” Imagine that!

What is particularly disturbing about the DTC controversy is that government officials and legislators are frequently incredulous when they learn about DTC advertising abuses. As I have stated time and time again, there are larges sums of money at stake here. This coupled, with little or no regulation, and mounting pressures to keep company stock price shares high, is a sure recipe for disaster (as we have begun to witness over the past 5 years or more). In my opinion, there is only a single solution to the problem–craft more stringent regulations and greater FDA oversight for DTC advertising. Asking drug and medical devices companies to regulate themselves in any area is tantamount to allowing a fox to live in a hen house—the pickings are easy and only the fox gets fat!

Until next time….

Good Luck and Good Job Hunting!!!!!

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I am old enough to remember when the artificial heart was invented and used to extend the life of Barney Clark, a dentist in Seattle, WA. It was a phenomenal accomplishment back in the day. So, it seemed appropriate to me that Robert Jarvik, the guy who invented the artificial heart, appeared in Pfizer’s Lipitor ads as a spokesperson to promote heart health. However, a Congressional committee examining consumer drug advertising has questioned whether the Lipitor ads may have misrepresented Dr. Jarvik and his credentials to promote the drug.

Although Dr. Jarvik has a medical degree, he is not a cardiologist nor is he licensed to practice medicine! Further, one television ads depicts Dr. Jarvik as an accomplished rower but the ad used a body double for him and, as it turns out, he does not even row! To make matters worse, a former colleague of Jarvik contends that he is not the actual inventor of the artificial heart. He suggested that the distinction belongs to Jarvik’s mentor Willem J. Kolff and his associate Tetsuzo Akutsu at the University of Utah. Go figure! Despite the firestorm, Pfizer continues to air the television ad ( I saw it just a few days ago).

Pfizer has spent more than $258 million advertising Lipitor (a cholesterol-lowering statin) since January 2006, most of it on the Jarvik campaign in an attempt to protect Lipitor from generic competition. Lipitor is the world’s best selling drug and generated $12.7 billion in revenues in 2007. While Lipitor has patent protection until 2010, some patients have already switched to a generic version of a competing cholesterol drug Zocor. According to published reports Pfizer agreed to pay Jarvik about $1.35 million under a two-year contract that expires next month. I think it is safe to assume that Jarvik will not appear in any future Lipitor ads.

As many of you may know, drug companies FDA is not required to review direct-to-consumer ads before they are aired to the American public. While some companies request FDA review of their promotional materials before they are used in advertising campaigns, the vast majority of companies do not. Unfortunately, because of this regulatory loophole, direct-to-consumer advertising has turned into something of a cat and mouse game–there are only consequences and penalties if you get caught misrepresenting or not fully disclosing information about your products.

In my opinion, Pfizer’s misrepresentation of Jarvik’s credentials (and Jarvik’s complicity) is unethical and unconscionable. More importantly, it demonstrates how easily and willing companies are to “bend the truth” to preserve blockbuster drug franchises that generate billions of dollars in annual revenues. I think that what Pfizer did was wrong and shameful. The company should be fined and sanctioned for the Lipitor campaign. That said, it is likely that the size of the fine levied by FDA will pale in comparison to Lipitor revenues generated by the Jarvik campaign. I believe that it is time for Congress and FDA close the loopholes in current direct-to-consumer advertising regulations–the safety and health of the American public depends on it!

Until next time….

Good Luck and Good Job Hunting!!!!!!!

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