Despite recent post-tsunami generosity, the reputation of the pharmaceutical industry will take a long time to mend. Highly publicized news coverage and discussions regarding pharma’s disclosure of safety information were kindled by SSRI-associated suicide risk and fanned by recently disclosed COX-2 inhibitor-associated cardiovascular risks. The question so far has been “How much did the pharmaceutical companies know about adverse drug experiences or adverse events associated with drugs?” The real question should be “How much have regulatory and corporate bureaucracies botched the reporting of adverse events from the field?”
Systemic reporting issues
How much time during the congressional hearings on Whitehouse Station, NJ-based Merck & Co. Inc.’s Vioxx will be dedicated to the impotence of current adverse event reporting systems? My guess is that administrative bottlenecks and bureaucracies aren’t as exciting as allegations of agency-industry cover-ups and conspiracies. In a recent letter to the Wall Street Journal, cardiologist Dean Kross summarized his experience of reporting adverse events to the Food and Drug Administration as tantamount to harassment by the regulatory agency. Upon first inspection, the one-page MedWatch reporting form (available at [url=http://www.fda.gov/medwatch/getforms.htm)]www.fda.gov/medwatch/getforms.htm)[/url] looks straightforward. However, busy physicians like Kross may not anticipate the barrage of questions they face after submitting an adverse event reporting form. As a result, Kross told me that he has learned to refrain from reporting to the FDA, especially without compensation for time and effort.
Healthcare professionals are not required to report adverse events, but pharmaceutical manufacturers are. Representatives may ask physicians about patient experiences with their products and gain feedback on both positive effects and adverse events associated with the drug. If healthcare professionals’ experience with reporting adverse events is any indication of administrative responsibility, I would venture that sales representatives are not embracing the opportunity to report adverse events to their companies. Most representatives may consider reporting adverse events too much of a hassle to warrant action. Some may harbor a notion that reporting adverse events may make their drugs “look less safe” in comparison with competitor drugs. I wonder how many adverse events were reported from the field for SSRIs and COX-2 inhibitors. Would a robust adverse-event-reporting program have prevented the public relations nightmare of these drug classes?
Hearing a physician’s account of a depressed patient ideating suicide would not prompt surprise unless the representative were trained on what “adverse event” means and whether suicidal ideation is classified as such. Similarly, a representative might assume that particular types of patients would be chronically taking a COX-2 inhibitor, such as those with comorbid conditions like cardiovascular dysfunction, and thus reason that a cardiovascular event could not be related to the medication — unless the representative were trained on the broad definitions of “adverse event.”
Last month, I stated that clinically competent representatives will make up the sales force of the future. Optimizing (not indiscriminately maximizing) product sales is a key responsibility of the pharmaceutical representative. However, selling is but one part of the total responsibility of pharmaceutical sales representatives. Many who enter the industry express a desire to improve patient care, and this desire can only be fulfilled as a long-term objective of partnering with — not selling to — physicians, as well as keeping patient care at the forefront of all professional decisions and actions. Pharmaceutical companies need to reinforce the fact that proactive adverse event reporting is part of risk management for companies, simplify the corporate process for representatives to report adverse events and reward representatives who proactively report adverse events from the field.
For the individual sales representative, feedback from a physician about a side effect may appear to be a fluke, an incident that may not be related to drug therapy at all. For the pharmaceutical organization, a picture can emerge from a collection of individual cases of adverse events reported by sales representatives. The company can then take corrective actions early, help stave off massive litigation and preserve corporate reputation — factors that contribute to a company’s competitive advantage. Adverse event reporting is not just a formal requirement; it has critical business implications for the pharmaceutical organization.
Jane would like to thank representative Lorraine Ley for suggesting this topic.