Drug companies cover up side effects? Say it ain't so! (NOT!)

[Guest guest]

Viagra and Blindness: Now the FDA is Accusing Pfizer of Covering Up Eye Problems | BNET Pharma BlogJust 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.http://industry.bnet.com/pharma/10008587/fda-accuses-of-pfizer-of-downgrading-blindness-linked-to-viagra/

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