Viagra and Blindness: Now the FDA is Accusing Pfizer of Covering Up Eye Problems
Just as Pfizer (PFE) appeared to have successfully discredited the notion that Viagra causes vision loss, the FDA has accused the company of covering up eye problems associated with the erectile dysfunction drug. In an audit of Pfizer's drug side-effect reporting systems, the FDA found the company failed to submit reports of vision loss associated with Viagra in a timely fashion or downgraded the seriousness of those reports even though they involved "blindness" and "visual acuity loss/reduction"
The lesson for managers here is, if you're going to go around discrediting your critics, you'd better make sure there aren't any skeletons in your closet while doing so. This skeleton is sizeable: The FDA's warning letter to Pfizer is 12 pages long and covers multiple record-keeping issues on different drugs; normally they're only a couple of pages long and focused on a single product.
The FDA found that Pfizer failed to report 11 cases of vision loss linked to Viagra within the 15-day period required by regulations. The company was late in its reporting because it was "misclassifying and/or downgrading reports to non-serious without reasonable justification," the FDA said. The reports -- from consumers who believed they were injured by the drug -- included "blindness," "blind in right eye" and "lost right eye vision":
The FDA said:
Your [Pfizer's] response indicates that only four of the above reports contained serious and/or expected reports of postmarketing ophthalmologic adverse events requiring a 15-day Alert report. However, the remaining seven adverse events were deemed as non-serious although serious outcomes such as "visual acuity loss/reduction" were noted.Some context: It's only 11 reports from the millions of men who take Viagra, and we don't know the circumstances of each case (some people abuse the drug by taking too much). Still, Pfizer has gone to lengths to show that the evidence that Viagra damages your vision by reducing blood flow to your eyes is weak, and yet here it is downgrading serious adverse event reports and submitting them late to the FDA. There may be no ill intent, but it looks bad.
Pfizer said:
We will continue to work closely with FDA to address these issues to the Agency's full satisfaction and to assure optimal surveillance and reporting of postmarketing adverse events. We are committed to full compliance and timely and accurate submission of individual adverse event reports. Patient safety is of primary importance to Pfizer, and ensuring the safe and effective use of our medicines is central to our purpose.
Pfizer's product safety system is multifaceted, and individual adverse event reporting is one element of this system. Pfizer believes we provide complete and accurate data to determine the benefit and risk profile for all of our medicines, and to enable their safe and appropriate use. The information necessary to support the safe and effective use of our products is fully disclosed in product labeling, and we stand behind the safety and efficacy of all our products used worldwideThe FDA's letter covers record keeping generally at the company, and the federal agency didn't have to look very hard to find lapses. In an audit of 35 pharmaceutical sales reps drug sample stores, the FDA found that 14 of the reps had not had an annual inventory check. Separately, three staffers were associated with drug losses, theft or "variance" in their drug samples.
Related:
- Does Viagra Make You Deaf? Author of Discredited Blindness Study Takes a 2nd Swing at Pfizer's Pill
- Pfizer Savors a Rare Victory in War Over Whether Viagra Causes Blindness
- Pfizer Succumbs to Temptation (Again) on "Viagra for Women"
- Pfizer Seeks Non-Prescription Status for Viagra Despite Health Risk Worries