Succeeding in Spite of a Black Box
One of my family members once used Pfizer’s Celebrex to help her cope with her arthritis. I remember her disappointment when she stopped taking it because of the cardiovascular problems associated with CO2 inhibitors first uncovered with Vioxx. Another family member depended on Zelnorm to control stomach problems, and was profoundly disappointed with its withdrawal when a link was made between its use and an increased risk of heart attack, stroke and unstable angina. With time, both of these medications returned to the market, but both now wear the FDA’s strictest warning, the Black Box label.
Because I’m paranoid, if I were in need of either of these medications it would be unlikely that I would risk taking them. However, because this is a label, and not a full withdrawal from the market, there must be a value for both patients who need the drug and the pharmaceutical companies who manufacture it. So how do you market a drug that has been given this serious warning? “Out of the Black Box: Marketing a Product with a Warning Box,” an article in this month’s Pharmaceutical Executive Magazine, explores that very issue and gives some interesting insight into the reasons why the Black Box is not automatically a death sentence for the drug.
Kathy Magnuson argues in her piece that communication is the key to making a drug a success once it has been labeled with a black box. If it’s an entire class of drugs that is in question, such as the warning to pregnant women against taking any ACE inhibitor because of increased fetal risk, she indicates that the challenge to marketing groups is differentiating products from their competitors. For example, ACE inhibitor Altace, distributed by King Pharmaceuticals, reduces the risk of heart attack, a characteristic that isn’t shared by other drugs in the same class. King used this information to partner with the American Heart Association and help disseminate information on the risk of heart attack and, one would presume, boost sales of its own drug.
Warnings on individual drugs can be more complex. Novartis’ Zelnorm was specifically cited by Magunson as an example of a withdrawn drug that returned to the market with a black box warning in spite of increased risk of heart attack, stroke and unstable angina to its patients. In spite of this, benefits of the drug to its patients may have outweighed the risk in many cases, which consequently led the FDA to permit the restricted use of Zelnorm under a treatment investigational new drug (IND) protocol to treat irritable bowel syndrome (IBS) and other symptoms linked to IBS. In order to get the drug now, patients must sign consent forms indicating they have received a comprehensive review of Zelnorm’s potential risks and benefits. It is this level of communication that can effectively negate the concerns raised by a black box warning, giving a drug a better chance at success in a more challenging scenario.
Magnuson offers some sage advice in a three-part approach when mounting an effort to sell your drug that has been hindered by a black box. First, drug companies should be able to disseminate information clearly and effectively to the intended audience for this drug. Crucial to this is full disclosure of clinical trial results, with especially succinct presentation of risks to patients. Brands that downplay or withhold this kind of information will be exposed, and ultimately find it difficult to follow the second step in Magnuson’s plan, which is to develop a genuine trust with customers in order to gain their loyalty. It is through this trust and open dialog that customers, both in the form of patients and regulatory agencies, will feel compelled to support companies’ efforts to keep brands in the market.
Finally, an ongoing review of brand performance will extend an image of responsibility to the public for a brand that will continue to provide some relief or solution to its patients. Both honesty and consistency are imperative in order to achieve long-term success in spite of the short-term stumble of a black box.
When I saw Celebrex stumble with its other CO2 inhibitors, it was during the time that I was consulting at Pfizer. I didn’t want to believe that a company for which I was consulting could possibly keep information from the public that could endanger its patients without their knowledge. Thankfully, this article implies that Celebrex is among those medicines that was able to successfully communicate with its patients and buck the black-box with good information and an undeviating effort towards patient safety. I believe that medicine with risk can, in some cases, be extraordinarily beneficial to the patients that need it, and now have a clearer understanding as to why a black box isn’t the same as a withdrawal from the market.
I believe that Magnuson hones in on important points in how effective patient communication can make or break a drug. The same line of thinking can be applied to many areas in life, and it seems to me that an open line between a company and its customer can nearly assure success. In a few instances in my life, I’ve attempted to avoid confrontation by withholding truth and it’s never ended well. Someone once said to me that I wasn’t actually protecting anybody by following that methodology and likely would end up making matters worse, so I should just suck it up, disclose everything, and deal with the consequences, because it would be better in the long run.
So I swallowed that pill a long time ago, and never looked back. According to Magnuson, there were 45 products between 1975 and 2000 that carried the black box, a sharp contrast to the 91 that were labeled with it between 2004 and 2005. Chances are, drug companies are going to increasingly be challenged with this type of scenario, and those who may not have adopted a model of open communication with their clients will have to swallow the same pill sooner than they think.
(1) See “Out of the Black Box: Marketing a Product with a Warning Box“, Kathy Magnuson, Pharmaceutical Executive Magazine, February 2008.
