Is Public Citizen's Petition On the Up and Up?
Public Citizen (PC) has petitioned to FDA to require black box warnings on erectile dysfunction drugs, including Viagra, Cialis and Levitra. PC also wants pharmaceutical companies to write millions of "Dear Doctor" letters warning that the drugs can cause vision loss from ischemic optic neuropathy (ION). The problem is that PC doesn't have the hard evidence to support their claims.

As Newsweek notes, "between 1998 and 2004, there were 48 reports to the FDA's database of people taking Viagra and developing..." ION. PC claims to found an additional 50 cases "of other visual problems among Viagra patients..." However, "That's out of 89 million prescriptions written during that period."

So, PC wants FDA to require place their most dire warning on medicines because of a less than one in one-million chance of visual problems? That's just nuts. Of course, PC seems quite aware that their flimsy statistics can't satisfy the criteria for changing FDA labeling requirements. Which is why PC tries to inflate their impotent claims by making irrelevant comparisons.

PC states that ION occurs at a far higher rate in people taking Viagra than in people taking a cholesterol lowering medication. Never mind that cholesterol medications are not prescribed for health conditions such as diabetes and hypertension that can lead to both vision problems and erectile dysfunction. The apples-oranges comparison just highlights the likelihood that higher rates of vision problems among patients taking sildenafil and similar drugs is due to pre-existing medical conditions and unrelated to the medication.

Winston doesn't doubt that PC has genuine concern for people taking erectile dysfunction medications. Winston also doesn't doubt that some of PC's financial supporters in the legal community are likely preparing for lawsuits against pharmaceutical manufacturers. Not that Winston would ever accuse trial lawyers of placing profit before science. No, the thought of tens of millions of dollars in legal fees could never cloud the judgement of trial lawyers...or the organizations they support.