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Viagra Advertising Lawsuit - AIDS Healthcare Foundation Hosts NYC Press Conference Today on Suit Against Pfizer

Posted on: Monday, 22 January 2007, 06:00 CST

NEW YORK, Jan. 22 /PRNewswire-FirstCall/ -- AIDS Healthcare Foundation (AHF), the largest AIDS healthcare, prevention and education provider in the United States which operates free AIDS treatment clinics in the US, Africa, Latin America/Caribbean and Asia, including 14 healthcare and treatment centers in California and Florida, is holding a press conference today in New York to announce its filing of a lawsuit against Pfizer Inc., the world's largest pharmaceutical company and manufacturer of erectile-dysfunction drug Viagra (sildenafil citrate), over its marketing tactics and advertising. The press conference will take place Monday January 22nd at 10:00 a.m. EST at the Helmsley New York Hotel, 212 East 42nd Street, (Turtle Bay Room, 3rd Floor), New York, NY 10017. (NOTE: the press conference is being held directly across from Pfizer's World Headquarters at 235 East 42nd St., and Pfizer will host its 2007 Analyst Meeting later today at 1pm EST).

AIDS Healthcare Foundation is bringing this legal action -- believed to be the first of its kind against any erectile-dysfunction drug manufacturer over direct to consumer drug advertising practices -- which is being filed Monday morning in Superior Court of the State of California, Los Angeles County, for "Unlawful, Unfair and Fraudulent Business Practices" in Violation of California Business and Professions Code Section 17200, et seq., and Section 17500 et seq., against Pfizer Inc. and Does 1 through 10 to challenge, "...the unjust and illegal conduct of drug maker Pfizer Inc., whose unlawful and deceptive marketing of its erectile dysfunction drug Viagra has caused an increase in the spread of sexually transmitted diseases including but not limited to HIV/AIDS. Pfizer has engaged in and continues to engage in this conduct despite clear evidence of its illegality and harmful effects."

"Pfizer's direct to consumer marketing of Viagra as a drug to enhance sexual performance is primarily aimed at men who don't necessarily suffer from a clinical diagnosis of erectile dysfunction, and we believe it is not only irresponsible, but also illegal, especially in light of the drug's known use as part of a 'circuit party cocktail' of drugs that is fueling the spread of STDs and HIV," said Michael Weinstein, President of AIDS Healthcare Foundation. "We are filing this lawsuit today to seek an injunction against Pfizer to force it to stop advertising this prescription medication in the reckless manner it has been doing, and to require Pfizer to undertake an immediate public information/education campaign to both inform members of the general public as to its prior advertising practices, and to educate the public, and in particular, men who have sex with men, about the increased risks of transmission of sexually transmitted diseases associated with using Pfizer's Viagra."

"As a physician and public health professional who has conducted extensive research on sexual risk behavior and the risk for getting or spreading sexually transmitted diseases and HIV in persons who use Viagra, I am deeply troubled by what I consider to be the continued misleading and potentially 'off-label' direct-to-consumer marketing practices of Pfizer for this drug," added Jeffrey D. Klausner, MD, MPH, Director, STD Prevention and Control Services, San Francisco Department of Public Health. "Several of our studies and those I reviewed for my research showed strong independent associations between the use of Viagra and increased sexual risk behavior, including an increased risk for diseases like syphilis, gonorrhea, chlamydia and HIV infection. Pfizer's marketing may go beyond the FDA-approved indications for the drug when they ask, 'Want to improve your sex life?' -- as its current ad campaign does -- and state that the drug is appropriate for, 'mild' erectile dysfunction, and suitable for men with 'all degrees of ED, even if it only happens once in a while.' The promotion of Viagra for what some have called 'recreational use' must be stopped. Why the FDA has not acted on this is unclear to me."

A Brief History and Background of Erectile Dysfunction (ED) Drugs, and Pfizer's Advertising of Viagra

Viagra, the first erectile dysfunction drug on the market, was patented by Pfizer in 1996 and subsequently was approved for use in erectile dysfunction by the Food and Drug Administration (FDA) on March 27, 1998, becoming the first pill approved to treat erectile dysfunction in the United States. It was offered for sale in the United States later that year, and quickly became a blockbuster drug for Pfizer: annual sales of Viagra in the period 1999-2001 exceeded $1 billion. Early advertisements for Viagra included television and print ads featuring septuagenarian and former Senator and Presidential candidate, Bob Dole (R, Kansas), who, as a spokesperson for Viagra, lent significant credibility and gravitas to Pfizer and the drug, particularly as he was widely-known to have suffered from, and undergone surgery for, prostate cancer.

With the introduction of two competing erectile dysfunction drugs in 2003, Eli Lilly & Company's Cialis (tadalafil), and Bayer AG's Levitra (vardenafil), Pfizer's marketing of Viagra changed dramatically. One subsequent campaign for Viagra features an attractive fortysomething year-old man sporting an impish grin and airbrushed devil's horns on his head. The Food & Drug Administration sent Pfizer a warning letter saying its racy consumer ads for the male impotence drug didn't contain enough information about risks and side effects. Pfizer agreed to pull the ads after the FDA's letter was made public.

Earlier last year, AIDS Healthcare Foundation criticized Pfizer for running a holiday-themed print ad campaign that AHF believed promoted unsafe sex by encouraging the recreational use of Viagra on holidays such as New Year's Eve and the Super Bowl. The ads, seen in The Wall Street Journal and The L.A. Daily News, among other publications, depicted a handsome, forty-ish male grinning knowingly at the camera with taglines, such as "What are you doing New Year's Eve?" and "Be this Sunday's MVP." Pfizer continued this irresponsible advertising campaign despite having been forced by the FDA to withdraw its previous ads, which inferred that men could re-capture their youthful vigor and become a devil-horned "wild thing" by taking Viagra.

More recently, AHF felt the urgency to launch its own public awareness and prevention campaign regarding the dangers of increased STD and HIV transmissions among individuals who may combine use of drugs such as Viagra and crystal methamphetamine, a subject that is also addressed in the lawsuit filed today against Pfizer. The AHF ad campaign features a series of print ads with a headline: "Viagra/Meth Alert," and features a tagline: "Viagra + Crystal Meth = Rx for HIV Infection" (Viagra and crystal meth equals a prescription for HIV infection). The ads have run, or are now running, in select magazines and newspapers in New York, Los Angeles, San Francisco, Washington, and in South Florida.

Crystal meth, like many club drugs, is a type of "speed" that keeps the body feeling energetic and hypersexual. Because of the heightened sex drive and feelings of invincibility that crystal meth causes in users, the potential for unprotected sex, and HIV infection, increases dramatically. One of the side effects of crystal meth is that while it increases libido, it also causes impotence, causing many to use erectile dysfunction drugs, like Viagra, to obtain an erection.

Studies Linking Viagra Use with Increased Risk for STDs and HIV Infection

Numerous studies linking the use of Viagra -- both independently and when used in combination with crystal meth -- to an increased risk for STDs and HIV infection, particularly among men who have sex with men, prompted AHF to create the Viagra + Meth = Rx for HIV Infection campaign. A review published in the May 26, 2005 edition of The American Journal of Medicine (Volume 118, No.6) called Sildenafil use, sexual risk behavior, and risk for sexually transmitted diseases, including HIV infection (authored by Sean G. Swearingen, BA, Jeffrey D. Klausner, MD, MPH and funded by the STD Prevention and Control Services, San Francisco Department of Public Health) analyzed data from fourteen studies related to Viagra use (clinical name: sildenafil). The conclusion: "Most studies reported frequent sildenafil use in men who have sex with men, and several showed independent associations between use of the drug and sexual risk behavior, as well as an increased risk for STDs, including HIV infection."

Among the review's findings: the use of Viagra and illegal substances were found in all eleven of the studies that looked at the use of Viagra and other recreational drugs; a study of men who have sex with men in San Francisco showed that 36% of all Viagra users combined its use with other drugs including meth; five studies of men who have sex with men found an increase in unprotected anal sex with a partner of unknown or serodiscordant HIV-status among Viagra users, with users between twice as likely to almost six times as likely to engage in this risk behavior.

AIDS Healthcare Foundation's Lawsuit against Pfizer Over Its Advertising and Marketing for Viagra

The AHF lawsuit against Pfizer (AIDS Healthcare Foundation vs. Pfizer, Inc., and Does 1 through 10) is being filed today in Superior Court of the State of California in the County of Los Angeles (Case # TBA). AHF is filing the action there because that is where it operates a number of HIV medical clinics that stand on the front lines in the battle against the emerging STD epidemic -- an epidemic that has been fueled in large part by Viagra misuse.

"By marketing Viagra to men with 'mild' erectile dysfunction or as a way to 'improve your sex life' -- as many of the ads state -- Pfizer is selling the drug as a way to enhance sexual experience, not as a treatment for an illness," said Tom Myers, General Counsel for AIDS Healthcare Foundation. "Through our lawsuit, we are urging Pfizer to not only end this dangerous marketing tactic, but also to fund a national educational campaign on the dangers of Viagra and crystal meth in order to mitigate the negative impact their advertising has had -- and continues to have."

Among the remedies AIDS Healthcare Foundation is seeking in its 'Prayer for Relief' in its lawsuit against Pfizer are --

* An injunction prohibiting Pfizer from pursuing its allegedly unlawful and deceptive marketing of Viagra; An injunction requiring Pfizer to undertake an immediate public information/education campaign to (a) inform members of the general public as to its prior practices and (b) educate MSMs about the STD risks associated with using Viagra. * An order requiring disgorgement of Pfizer's ill-gotten gains and to pay restitution to AHF of monies it has spent treating people infected with HIV or other STDs as a result of Pfizer's conduct, and monies it has spent on public education campaigns on the risk of Viagra and meth -- in an amount to be proven at trial.

AHF General Counsel Tom Myers and AHF Legal Counsel Laura Boudreau represent AIDS Healthcare Foundation in this action, which is being filed against Pfizer Inc. in Superior Court of California, Los Angeles County this morning (Monday, January 22, 2007).

For more information about AHF's lawsuit against Pfizer and AIDS Healthcare Foundation in general, please visit: http://www.aidshealth.org/

AIDS Healthcare Foundation

CONTACT: Tom Myers, AHF General Counsel, +1-323-860-5259, or GedKenslea, AHF Communications Director, +1-323-860-5225, or mobile, +1-323-791-5526, both of AIDS Healthcare Foundation

Web site: http://www.aidshealth.org/

Source: PRNewswire-FirstCall

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