Company Accused of Misleading Ads About Children's Ear Infection Drug
(SACRAMENTO) – Attorney General Bill Lockyer today announced his office and the Attorneys General of 18 other states have settled a consumer protection investigation into Pfizer's advertising for Zithromax, a product used to treat severe ear infections in young children.
"When a child is sick, parents can panic and may insist on medications that may not be the cure-all for their child's illness," Lockyer said. "This settlement should help encourage consumers to never rely solely on claims made in paid advertisements. Consumers should always consult a physician, who can discuss all possible treatments and determine which drug, if any, is appropriate."
California and eighteen other Attorneys General Offices began the investigation in 2001 into Pfizer's direct advertising to consumers touting Zithromax, as well as promotional material aimed at health care professionals. The consumer ads ads focused on how many doses and how often Zithromax should be administered. But the ads failed to disclose information about antibiotic resistance and other factors that need to be considered by a physician before prescribing antibiotic treatment for otitis media, a severe ear infection suffered by young children.
Under the agreement, Pfizer will pay the 19 states a total of $4 million for costs and attorneys fees. The company also will fund a $2 million public service announcement (PSA) campaign during the next three years to educate parents about medical decisions that are made when describing specific treatments. The campaign will run during the cold and flu seasons, November through March, in 2003-2005.
The agreement also prohibits Pfizer from making any representations in consumer ads about Zithromax regarding dosing convenience, frequency of use or effectiveness unless Pfizer has competent and reliable scientific evidence to support such claims.
Under the agreement, Pfizer will not make representations about Zithromax in consumer ads:
* Regarding the dosing convenience or frequency of use unless the company includes the following disclosure: "Your doctor will consider many factors when choosing an antibiotic. Dosing convenience is one of them."
* Comparing the effectiveness of Zithromax for treatment of otitis media to other antibiotics unless the company includes the following disclosure: "Antibiotic resistance is a consideration that may affect your doctor's choice of treatment for your child's ear infection."
Pfizer also must include the following disclosure in all direct consumer ads promoting Zithromax:
"Remember that antibiotics don't work for viral infections, such as a cold or flu, so don't insist on a prescription for an antibiotics. Only your doctor can decide what type of infection your child has and the best way to treat it."
Additionally, if consumer ads for Zithromax refer to data in a scientific study related to dosing convenience, frequency of use or effectiveness, Pfizer must disclose whether the study was published, reviewed by peers, or funded by Pfizer. The company also must make available to consumers the full study or a summary of the study. In addition, the company must post the study or a summary on its Internet site. To ensure summaries are accurate and complete, an unabridged copy of the study must be made available to any Attorney General on request.
Pfizer also agreed to permanently discontinue the direct consumer ads that were the subjects of the investigation.