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Out of Order: Watch that last step
March 2012
by Randall C. Willis  |  Email the author

My wife and I cancelled our organic produce service this week, and we're not happy about it. Living in condo canyons, it can be difficult to get good organic produce, so we signed up for a service that delivers it to our door. For more than a year, we enjoyed some of the best-tasting produce available in the city—until this past week.  
For the last couple of months, the delivery person has not brought the produce to our door, but rather has left it with the concierge, where it may wilt for a day or so before we find out it's there. The company assured us that things would change but they haven't, so we've gone back to the grocery store.
Amazing food. Great web interface. Responsive customer service. Good prices. All undone by failure in that last vital customer-facing step.  
Every year, the pharmaceutical and biotech industries spend billions on cutting-edge R&D, clinical trials, sales and marketing and medical education and training, to get just a handful of drugs into the medical community. And yet, every year, another drug is recalled or sees its market significantly curtailed by unfortunate events in that final step—delivery to patients.  
Certainly there are cases where the flaw is inherent to the compound or biologic (e.g., unforeseen racemization in vivo), but I believe that in most cases, the fault lies not with the drug (or its excipients). Instead, a perfectly good drug that could have provided medical value has been demonized and pulled from the market because of a failure at that last vital customer-facing step: delivery to the right patient. A handful of patients react badly to a marketed drug, and that drug can see its market dry up so badly that it becomes unsupportable, regardless of how many patients responded to the drug as planned.  
Where does the fault lie? With clinicians who use the drugs too aggressively in too wide a patient population? Drug companies determined to accelerate the time to market or expand a drug's market and therefore profitability? Clinical trial designers who don't understand their target patient populations or test against a wide- enough sampling? Federal regulators who don't ask enough (or the right) questions when reviewing applications? Or R&D departments that haven't invested enough in companion diagnostics for each of their new products?  
The answer is probably "all of the above," and "none of the above."
In an era of economic downturn and healthcare cost inflation, it is difficult for clinicians to take the time to not only understand their patients, but to also deeply understand the products they prescribe. Too often, the only consideration for incorporating a new treatment into their practices is to simply determine what old drug the new product replaces and how many samples they can get. Before they wonder in what percentage of patients the new drug extended overall survival, they might be better served to ask in what patients the new drug extended overall survival.
Likewise, while I appreciate the demands on companies to maximize profit, we are repeatedly seeing how short-sighted this rush can be. It is only through a thorough understanding of how and when to use a new drug compound—and more importantly, when NOT to use the drug—that a company can begin to ascribe any long- term value to a new product and truly maximize profits.
Further flying in the face of cost-cutting is the need to actually slow and expand the clinical trial process, or at least better understand the limitations and implications of trial results. If a trial only included 40 male bush pilots from Northern Manitoba, do you really feel comfortable in extrapolating the results to any other population? If the company's goal is to identify the broadest possible target market for a new drug, then it is up to the clinical trial specialists to test the broadest possible patient population and then correlate the results with each segment of that population.
And if nobody else is willing to do this, then it is the role of federal regulators to step in and ask the tough questions before approving a new therapy. How much true value is there in an FDA-approved product indication statement that reads: "Indicated for the treatment of metastatic ovarian cancer?" Treat how (accomplishing what)? For whom?
I appreciate that the indication statement is typically followed by 30 to 60 pages of product monograph, but I know of few healthcare specialists who have read a product monograph, let alone understood its contents.
And the R&D folks aren't off the hook, either. Clues for who would most benefit or be most harmed by a new product are littered throughout the basic research, and could form the basis of tools to help healthcare specialists identify the best candidates for treatment. Headway has been made on many fronts (e.g., targeted oncology products), but progress has been slow despite the industry's focus on personalized medicine. The best R&D specialists are so because of their innate abilities to see patterns that are invisible to others. They need to broaden the scope of their search.  
Now, having taken everyone to task, I want to stress that no drug can guarantee 100-percent safety. But there are things we could all be doing better to get us closer and avoid seeing an amazing drug, designed by the best people in the field and applied to help patients lead better lives, being undone by failure in that last vital customer-facing step.  
Formerly the executive editor of ddn, Willis has worked at both ends of the pharmaceutical industry, from basic research to marketing, and has written about biomedical science for almost two decades.



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