Editorial: Learning from VIOXX

By Len Monheit
[email protected]

The buzz on the SupplySide West show floor seemed almost gleeful as Merck & Co. issued a voluntary recall on its Vioxx ( Rofecoxib) COX-2 inhibitor and non-steroidal anti-inflammatory drug. The recall was based on a study which showed an increased risk of cardiovascular events (including heart attack and stroke) in patients on Vioxx compared to placebo, particularly those who had been taking the drug for longer than 18 months, and as the details began to unfold, marketers and industry strategists began gauging their opportunities.

It is not often that such a promising opportunity comes along, and as is usually the case, this one has potential pitfalls. Even with the safety concerns raised last year with hormone replacement therapy, even though several natural product alternatives were presented and gained immediate press, according to recent data, the traction and market penetration of these natural alternatives may not have been significant.

So what is the correct approach and what are the pitfalls?
No one can deny the opportunity that this recall, based on product safety, provides. Mismanagement of the opportunity though, will lead to not only squandering of this chance, but also to an even further loss of credibility. I think its probably obvious that the approach needs to involve both safety and efficacy.

Sheldon Baker of the marketing and communications firm Baker Dillon Group notes, For the industry, " this is an opportunity to step forward and promote its products and science as viable alternatives”. (http://www.npicenter.com/anm/anmviewer.asp?a=10532&z=2 ) He adds, "Major manufacturers should have stepped up to the plate and immediately produced an educational campaign through broadcast and print media to inform consumers about the healthy alternatives for inflammation and overall immune function".

This comment brings up a few critical issues. First of all, it refers to 'alternatives' which implies an entire category, or at least several products. In the past, any industry effort that involves multiple products across a category has been dealt with by trade associations, and perhaps they have some comments and a message in the works on this subject. One of the best examples of category promotion is CRN"s efforts to promote quality, standards and category growth for omega-3 products through its omega-3 working group, and even more recently product testing conducted by Consumerlab.com (http://www.npicenter.com/anm/templates/newsATemp.aspx?articleid=10517&zoneid=2 ) By creating and consolidating a message, consumers are not confused or bombarded with multiple brands, various claims and companies and differing levels and arguments on science. Instead, the simple message conveyed is that product quality is consistently high.

Is there a category message that can be simply and effectively delivered in this case? Is there a group that can get together to construct such a message?

It's relatively easy to identify the key players with products in this category that might stand to benefit, products with a strong science base, especially on the ingredient side, and it will be interesting to see both individual and collective communication in the next few weeks.

Another issue raised in Baker's comments is the specific language of the industry or company response. Governed by DSHEA in the US and permitted Natural Health Product claims in Canada, there are limitations to what can be said for both products and the entire category. And given past marketing exuberance, I would certainly expect to soon observe a frantic rush to press for numerous natural alternatives being positioned as magic bullets for everything from arthritis to fibromylagia and more. Ironically, the quick windfall that companies can get before FDA enforcement steps will likely allow them to reap millions with limited fear of penalty - all the more reason for responsible companies to be quite active when they see abuse of this current market opportunity.

Out of curiosity, I did a 'Google' search for the term 'Vioxx' earlier today and noted with interest the paid ads in the right hand column of the first several pages - particularly those touting natural alternatives. And my expectations were certainly met, with companies pushing the envelope (or stepping right over the line) with product announcements and disease treatment claims. Rakesh Amin, partner at Chicago-based Amin Law observes, " this is a good time to increase promotion of safe and natural inflammatory modulating and joint/cartilage promoting dietary supplements. However, the marketers of such products should be particularly careful with regards to regulatory compliance and the types of claims they make." Amin goes on, "Both industry and the public know that in labeling, we can only make structure-function claims as opposed to disease claims (treat arthritis, reducing inflamation or fibromylagia). We can however use third party literature to cite scientific evidence, providing this information is truthful and non-misleading." Amin concludes, "I would expect FDA to be on the lookout for anti-inflammatory disease claims in labeling."

All said, there is a compelling opportunity for industry to present strong safety and efficacy data about several products. As is always the case, the message must be simple and compelling, and must be reiterated numerous times through numerous vehicles.

Is the Vioxx recall a lesson for the supplements industry?
Merck has received accolades from media and regulators for quickly, proactively and voluntarily initiating the recall. In fact, the editorial of this week's Lancet notes, "For Merck to act so promptly in the face of these most recent safety concerns is commendable and should serve as an example of responsible pharmaceutical industry practice." (I think there's a line in here somewhere we should attempt to borrow as we describe our own industry and practices)

We often commiserate about the unfair treatment given dietary supplements by the medical community, or the lack of benefit awarded in the critical examination of a risk to benefit ratio to determine safety of products. On this subject, the Lancet editorial goes on to say, "drug regulators must now reassess the safety and efficacy thresholds required for the licensing of a new pharmaceutical product. Clearly, this is an immensely complicated equation involving, among other factors, the nature of the condition being treated, the therapeutic strategies already available, and the perceived benefit-to-hazard ratio of the new treatment." (clearly now, more than ever, building the supportable benefit side of the equation is imperative, especially for products with such a history and documented practice of safe use)

Finally, the Lancet notes, "The Vioxx story is one of blindly aggressive marketing ... mixed with repeated episodes of complacency by ... regulators."

Sound familiar?

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