Out of Order: Watch that last 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.

Randall C Willis
My wife and I cancelled our organic produce service thisweek, and we're not happy about it. Living in condo canyons, it can bedifficult to get good organic produce, so we signed up for a service thatdelivers it to our door. For more than a year, we enjoyed some of thebest-tasting produce available in the city—until this past week.
For the last couple of months, the delivery person has notbrought 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 companyassured us that things would change but they haven't, so we've gone back to thegrocery store.
Amazing food. Great web interface. Responsive customerservice. Good prices. All undone by failure in that last vital customer-facingstep.
Every year, the pharmaceutical and biotech industries spendbillions on cutting-edge R&D, clinical trials, sales and marketing andmedical education and training, to get just a handful of drugs into the medicalcommunity. And yet, every year, another drug is recalled or sees its marketsignificantly curtailed by unfortunate events in that final step—delivery topatients.
Certainly there are cases where the flaw is inherent to thecompound or biologic (e.g.,unforeseen racemization in vivo), butI believe that in most cases, the fault lies not with the drug (or itsexcipients). Instead, a perfectly good drug that could have provided medicalvalue has been demonized and pulled from the market because of a failure atthat last vital customer-facing step: delivery to the right patient. A handfulof patients react badly to a marketed drug, and that drug can see its marketdry up so badly that it becomes unsupportable, regardless of how many patientsresponded to the drug as planned.
Where does the fault lie? With clinicians who use the drugstoo aggressively in too wide a patient population? Drug companies determined toaccelerate the time to market or expand a drug's market and thereforeprofitability? Clinical trial designers who don't understand their targetpatient populations or test against a wide-enough sampling? Federal regulatorswho don't ask enough (or the right) questions when reviewing applications? OrR&D departments that haven't invested enough in companion diagnostics foreach of their new products?
The answer is probably "all of the above," and "none of theabove."
In an era of economic downturn and healthcare costinflation, it is difficult for clinicians to take the time to not onlyunderstand their patients, but to also deeply understand the products theyprescribe. Too often, the only consideration for incorporating a new treatmentinto their practices is to simply determine what old drug the new productreplaces and how many samples they can get. Before they wonder in whatpercentage of patients the new drug extended overall survival, they might bebetter served to ask in what patients the new drug extended overall survival.
Likewise, while I appreciate the demands on companies tomaximize 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 drugcompound—and more importantly, when NOT to use the drug—that a company canbegin to ascribe any long-term value to a new product and truly maximizeprofits.
Further flying in the face of cost-cutting is the need toactually slow and expand the clinical trial process, or at least betterunderstand the limitations and implications of trial results. If a trial onlyincluded 40 male bush pilots from Northern Manitoba, do you really feelcomfortable in extrapolating the results to any other population? If thecompany's goal is to identify the broadest possible target market for a newdrug, then it is up to the clinical trial specialists to test the broadestpossible patient population and then correlate the results with each segment ofthat population.
And if nobody else is willing to do this, then it is therole of federal regulators to step in and ask the tough questions beforeapproving a new therapy. How much true value is there in an FDA-approvedproduct indication statement that reads: "Indicated for the treatment ofmetastatic ovarian cancer?" Treat how (accomplishing what)? For whom?
Iappreciate that the indication statement is typically followed by 30 to 60pages of product monograph, but I know of few healthcare specialists who haveread a product monograph, let alone understood its contents.
And the R&D folks aren't off the hook, either. Clues forwho would most benefit or be most harmed by a new product are litteredthroughout the basic research, and could form the basis of tools to helphealthcare specialists identify the best candidates for treatment. Headway hasbeen made on many fronts (e.g.,targeted oncology products), but progress has been slow despite the industry'sfocus on personalized medicine. The best R&D specialists are so because oftheir innate abilities to see patterns that are invisible to others. They needto broaden the scope of their search.
Now, having taken everyone to task, I want to stress that nodrug can guarantee 100-percent safety. But there are things we could all bedoing better to get us closer and avoid seeing an amazing drug, designed by thebest people in the field and applied to help patients lead better lives, beingundone by failure in that last vital customer-facing step.
Formerly the executiveeditor of ddn, Willis has worked at both ends of the pharmaceutical industry,from basic research to marketing, and has written about biomedical science foralmost two decades.

Randall C Willis

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