Letter to FDA Office of Prescription Drug Promotion
July 28, 2014Claude A. Curran MD
www.SafeTvAds.com
849 Hope Street
Bristol, RI 02809
October 31, 2013
Federal Drug Administration
Office of Prescription Drug Promotion (OPDP)
10903 New Hampshire Ave., Building 51, Room 3200
Silver Spring, MD 20993-0002
Dear OPDP,
I would like to make a complaint to the FDA BADAD office against drug manufacturers, Pfizer and Eli Lilly, based on their advertising of the drugs Viagra and Cialis, used to treat sexual dysfunction in men.
In their television commercials both companies unnecessarily use sexually explicit language in violation of state and federal obscenity, harassment, and child abuse and child neglect statutes. Both drug companies rationalize and justify their use of sexually explicit language on the basis of a misleading and overstated claim regarding the risk of “an erection lasting more than four hours.”
According to information in the PDR (Physician’s Desk Reference) regarding pre-marketing clinical trials, none of the 3,000 participants in those trials experienced priapism or an erection lasting more than 4 hours. Information on other more frequent and more medically serious side effects such as accidental falls and diarrhea are avoided in these commercials. The “erection lasting more than four hours” was reported post-marketing and without clarification as to whether it was considered a side effect of or associated with Viagra use.
Sildenafil was originally developed as a PDE5 inhibitor for the treatment of pulmonary hypertension. The trade name is Revatio. Despite being the same molecule and despite being dosed daily to treat pulmonary hypertension rather than the intermittent dosing pattern of most Viagra use, priapism or an erection lasting more than 4 hours, is not given the same priority in Revatio’s patient information.
It appears that Pfizer and Eli Lilly are overstating their claim of risk of these side effects in order to pique interest in and discussion about their ED products. In an interview with NBC News (http://www.nbcnews.com/health/too-much-good-thing-4-hour-erection-1C9926694) , Dr. Ira D. Sharlip, clinical professor of urology at the University of California at San Francisco and spokesperson for the American Urological Association and a practicing urologist stated:
“It (priapism) does happen even in men who aren’t taking erection drugs – I’ve taken care of the problem at the emergency room at the medical center where I work — but it’s really rare. So rare, that I don’t discuss this as a potential complication with my patients (to whom he prescribes impotence drugs).”
Page 2 Dr. Claude A. Curran MD
So if a practicing urologist feels that the risk of this side effect is so low, its occurrence is so infrequent, and the outcome is so rarely impairing that he doesn’t even warn about it, why do Pfizer and Eli Lilly feel obligated to broadcast this risk so glaringly?
The term “erection” is a sexually explicit term; it conjures specific sexual imagery. Obscenity laws allow the use of sexually explicit matter when used in the context of science, art, and education. Pfizer and Eli Lilly have used this sexually graphic term in the context of patient education. In other settings the use of this term would violate harassment laws (harassment can be defined as two or more unwanted or annoying communications) and child abuse and neglect laws (these laws protect children from exposure to “developmentally inappropriate information”). Of course these companies will wrongfully justify these warnings on the basis of patient education and safety. However in consideration of the safety and welfare of children and the expectation that one should be spared from harassment and embarrassment in their own home, the risk to benefit analysis of these sexual impotence ads is clearly skewed in favor of these drug manufacturers.
Even the nomenclature adopted in recent years to describe this condition is of dubious propriety. Erectile dysfunction is inaccurate in as erectile tissue exists in areas of the body other than the penis. “Impotence” may be somewhat ambiguous but it adequately communicates this condition.
International documents (eg. Convention on the Rights of the Child) and state laws advocate for the safeguard of children’s moral and spiritual development as well as describing the responsibility of the media toward children. These drug companies appear to be unaware of this.
We ask the FDA, in consideration of the safety and welfare of children, and to remind the influential and powerful of their obligation to safeguard the common good, to intervene to remove these disturbing, creepy, inappropriate ads from television.
Please end this electronic bullying.
Thank you for your attention in this distressing matter.
Claude A. Curran M.D.
www.SafeTvAds.com
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