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I came across a recent post on Adage.com entitled “Pharma Drops Search Advertising After FDA Warning” that revealed that paid search ads by pharmaceutical companies dropped a 84% between March 26 of this year and the end of June. As you may recall, March 26 was when 14 companies received warning letters from the US Food and Drug Administration (FDA) indicating that they had violated marketing guidelines for search ad advertising. The letters stated that sponsored-link advertisements for specific drugs were misleading due to the exclusion of risk information associated with the use of the drug -- even though the regulatory agency's guidelines are for print and broadcast, not online or social media. Pharma companies that believed they were in compliance with the unwritten "one-click rule"— taking the consumer from the ad to a site that offered fair balance and the risk information by clicking on the ad. What? Did I read that correctly; the words “unwritten and FDA” in the same sentence? This is very surprising since anybody who has worked with the agency is well aware of the “if it isn’t written it didn’t happen” principle. But I digress....

The post went on to say that pharmaceutical companies are “fearful of running afoul” of the agency again. Say what? The words “pharma and fearful” used in the same sentence? The point that I am trying to make is that pharma chose to keep things vague about web-based advertising to see how far they can push the envelope with FDA instead of taking the proverbial “bull by the horns” and directly asking FDA for guidance on web 2.0 technologies and their uses. Wouldn’t it be in everyone’s best interest if companies took a more active role to help craft new rules on the use of new media technologies rather then rely on and wait for FDA to do it for them? While the old “cat and mouse” game worked for old media, it is no longer tenable when it comes to Web 2.0 and related technologies.

The FDA is holding public hearings next month to begin the process of establishing internet advertising guidelines and the use of social media in the life science industry. This offers drug and devices companies an opportunity to show FDA that they no longer want to be part of the problem but part of the solution.  I have always subscribed to the notion that “you don’t get if you don’t ask!”

Until next time...

Good Luck and Good Surfing (on the Internet that is)

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Thanks for reading my blog!

Until next time...

Good Luck and Good Job Hunting sic Advertising???

 

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Today's New York Times reported that the US Food and Drug Administration (FDA) issued warning letters and ordered 14 pharmaceutical and biotechnology companies to stop running what it calls misleading ads on internet search pages displayed by search engines like Google. The agency faulted the companies for failing to identify product names (brand) and not listing potential side effects (only benefits) for the drugs. In other words, the ads lacked “fair balance” something that FDA stresses and that all drug makers are very familiar with. 

Drug makers and other interest groups pay search engines like Google to place ads on search result pages after someone types in a related search word. The sidebar ads typically contain a eye-catching headline about a relevant medical condition or product and links to websites promoting certain products. The companies receiving warning letters included: Bayer, Biogen Idec, Boehringer Ingelheim, Cephalon, Eli Lilly, Forrest Laboratories, Genentech, GlaxoSmithKline, Johnson and Johnson, Merck, Novartis, Pfizer, Roche, and Sanofi-Aventis. Not surprisingly, most of the world’s largest and most profitable were guilty of running misleading Internet search engine ads.

Historically, drug companies and FDA have engaged in a cat and mouse approach when it comes to advertising and marketing drug and medical devices and diagnostics. This is because FDA’s existing regulations that guide marketing and advertising practices are relatively lax and it provides drug makers with the opportunity to see how far they can push the agency before “they get caught.” While this practice may have been acceptable for print and television advertising, it may no longer be appropriate for Internet advertising— which potentially has a much broader and larger reach than traditional media because there are not national borders on the Web. Unfortunately, FDA has been slow (reluctant?) to react to digital media and is even more perplexed about social media and the drug industry. Rather than continue to play cat and mouse, I think it would be in the best interest of consumers if FDA and drug makers would sit down and craft new guidance on regulating Internet advertising and marketing practices. It is becoming increasingly apparent that the old rules are no longer sufficient as digital and social media continue to evolve.

Until next time....

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

 

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How many of you read the printed ingredients and nutrition fact boxes found on packaged foods to help you decide which of two similar products you ought to buy? What if the same concept was applied to direct-to-consumer (DTC) prescription drug ads? Do you think that it would be easier to determine which of two similar medications may be best for you? Well, researchers at Dartmouth Medical School think so! And, they are urging the US Food and Drug administration to adopt a similar concept for all DTC advertising.

Based on results from two randomized, clinical studies, the Dartmouth team proposed that numerical tables that quantify the benefits of a drug (compared with placebo) and also the odds of developing certain side effects should be included on DTC advertisements including television, print and web-based ads. In those studies, patients were shown drug ads that did and did not include a fact box. Participants looked at ads (with and without fact boxes) for two similar prescription heartburn medications and two widely prescribed cardiovascular drugs. The trial using the heartburn medications was designed to evaluate consumer decision-making about drugs that are used to treat symptoms whereas the cardiovascular medications trial was used to evaluate decision-making about the use of preventative medications that reduce the risk of future events, e.g., heartache or stroke.

Overall, the researchers said, the addition of facts boxes to prescription drug ads allowed consumers to make better decisions about the choices of drugs for their symptoms and were better informed about the benefits of drugs that could be used for prevention. For example, when asked which drug they would choose for heartburn 68 percent of those who had seen ads with facts boxes picked what the researchers referred to as "the superior drug," as compared with 31 percent of those who had seen ads without facts boxes. Also, about 80 percent of the facts-box group, as compared with 38 percent from the non-fact-box group, knew that both drugs had similar side effects. After looking at cardiovascular drug ads with or without fact-boxes, 72 percent of those who saw ads with facts boxes correctly described the risk reduction associated with both drugs whereas only 9% of non-fact-box participants were able to do this.

DTC advertising is big business—last year the pharmaceutical industry spent approximately $4.8 billion on television and print ads alone. While DTC advertising is known to influence prescription drug sales, it is also somewhat controversial suggested Dr. David L. Katz, director of the Prevention Research Center at Yale University School of Medicine "Direct-to-consumer drug advertising is controversial in medical circles, largely out of concern that drug companies will talk patients into preferences not in their best interest, "But I often encounter the opposite problem in my patients. After hearing the litany of potential side effects of a drug, they absolutely refuse to take it," Katz said. Nevertheless, he and the Dartmouth researchers agree that better-informed patients make better drug choices.

Drs. Woloshin and Schwartz, leaders of the Dartmouth team, are scheduled to present their findings tomorrow to an FDA advisory panel on “risk communication.” The panel is tasked with examining how best to provide consumers with data about prescription drugs using printed matter. 

Adding fact-boxes to print, television or web-based ads won’t substantially increase the cost of creating and producing them. Also, rather than hurt prescription drug sales—what most pharmaceutical companies are worried about—the new approach may be good for the industry. According to Robert Ehrlich, who heads DTC Perspectives, a company that specializes in pharmaceutical marketing, “If there is high benefit and low risk, doctors will prescribe more of the drugs. If there is low benefit and high risks than the drug should probably not be on the market,” said Ehrlich.

Stay tuned for updates.

Until next time...

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

 

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I previously posted a piece on BioJobBlog about direct-to-consumer advertising that is used by many pharma and biotech companies to induce people who see the ads to ask their physicians about a “ drug that they heard about on TV.” John Heubusch who runs Writing Frontier.com, read the post and pointed me in the direction of a piece that he wrote on the same topic. His slant on the topic is different than mine but we both reach similar conclusions—DTC advertising needs to be better regulated by FDA.

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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