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AG sues major drugmaker for false advertising

TUCSON — Pfizer misrepresented the risks associated with one of its products and recruited doctors to promote it in order to reap up to $4 billion in sales, a recent lawsuit claims.

The Arizona Attorney General filed a 15-page court complaint recently that alleges New York-based Pfizer Inc. repeatedly deceived consumers to pump up sales of Bextra, which the FDA approved for treatment of arthritis and menstrual pains.

Specifically, the complaint in Pima County Superior Court claims that Pfizer:

• Withheld studies that showed safety risks,
• Deployed an enormous sales staff to promote Bextra’s “off-label” uses,
• Gave improper gifts to physicians in return for their help marketing the product.

Lawyers for state Attorney General Terry Goddard claim the deceptions began in 2001 after the U.S. Food and Drug Administration declined to approve Bextra for all of the “off-label” uses Pfizer was counting on to make Bextra a financial “blockbuster,” the complaint states. It has since settled with the federal government for almost $900 million.

The state claims Pfizer was trying to push Bextra as a treatment for acute and perioperative pain and as a way to reduce gastrointestinal side effects without the research to prove it or tell both sides of the drug’s story.

The controversy involves a line of drugs called COX-2 inhibitors. These drugs block one of two enzymes that make the feeling of pain and inflammation more pronounced.

Three types of this drug received FDA approval, according to the complaint. Pfizer released Celebrex in early 1999, which was followed several months later by Vioxx from Merck, a Pfizer competitor. Vioxx was withdrawn from the market in 2004; Bextra was withdrawn in 2005; and Celebrex was given a “black box” warning on its label for certain risks associated with COX-2 drugs, the complaint states.

Still, Pfizer allegedly persisted in selling Bextra under its new pain-killing role. The state claims it cast negative studies associated with Bextra as a fluke, bought research from advertising agencies it had under contract and, in one case, got positive studies published in a major medical journal before editors could retract it.

It also disclosed only “favorable” data for Bextra, and ran several ad campaigns that touted Bextra as the ideal pain-killer for the “weekend warrior.”

The company “also sought out and developed physician speakers who were high prescribers of Bextra and supported its off-label use,” the complaint claims. “These health care providers were then paid to give lunch or dinner talks relating to off-label use of Bextra.”

Sales staff often accompanied doctors on their presentations, which were usually held at the best restaurants in town, the complaint claims. The most successful doctors were rewarded with “preceptorships” in which they received up to $500 to allow Bextra sales reps to accompany them on their rounds or in the operating room.

The state Attorney General is seeking a permanent injunction that bars Pfizer from continuing these alleged practices in Arizona, as well as civil penalties and attorney’s fees. The state is represented by assistant Arizona Attorney General Noreen R. Matts in Tucson.

Demand for cervical cancer vaccine soars, docs say

PHOENIX — Doctors say they are seeing a spike in the number of females between the ages of 9 and 26 that are using Gardasil to guard against cervical cancer.

“We seem to be giving more Gardasil vaccines this year,” says Dr. Stefanie Schroeder, of the Arizona State University Campus Health Service in Tempe. “Women have started the series at home and are coming to us for their second or third booster.”

Gardasil is the first vaccine to prevent cancer caused by human papillomavirus virus, or HPV, a sexually transmitted disease. It protects against four types of the virus: 6, 11, 16, and 18, with types 6 and 11 resulting in genital warts and types 16 and 18 resulting in cervical cancer, doctors say.

Dr. Emily Cyr of Central Phoenix Women’s Health says women should seek medical help to detect cervical cancer early because the effects can be horrible if discovered too late.

“Anything that decreases the risk for cervical cancer is a good thing,” Cyr says. “Gardasil can do that.”

But Gardasil is still a new vaccine. Doctors say its protection lasts anywhere from 24 months to 10 years.

So what is the incentive for young females to get it?

Jacqueline Agenbroad, nurse practitioner at Banner Good Samaritan Medical Center in Phoenix, says mothers who have had the HPV virus support the vaccine because they do not want their daughters to contract it.

“Just because nobody is for sure how long Gardasil will last has not changed a woman’s reliability on the product,” Agenbroad says. “Personally, I am seeing an increase in the number of females getting the vaccine.”

Schroeder says another reason people support the vaccine is the decrease in incidence of cervical cancer and in the amount of colposcopies necessary after an abnormal Pap smear.

Gardasil has received a lot of positive publicity, doctors say. However, it has also raised some questions for people. The vaccine is strictly for females between the ages of 9 and 26; but for some, 9 years old seems a little young for an STD-related vaccine.

Some parents oppose having their daughters vaccinated because they think it will lead to promiscuity, doctors say.

“Sex. It has something to do with that three-letter-word,” Agenbroad says. “Parents think girls will use Gardasil as a type of birth control and go out and have sex.”

The age at which females are experiencing their first sexual encounter has been decreasing every year as well, doctors say.

“Coiarche, or the age at first sexual contact, is getting younger,” Schroeder said. “The thought is to protect women as early as possible and to have immunity by the time of their first sexual contact.”

Gardasil’s target age group was chosen based on lab testing, doctors say. It is a recombinant vaccine that takes a small portion of the HPV virus and combines it with other solutions to change its form, Agenbroad says. Nurses administer it as three injections over a course of six months, with minor side effects, doctors say.

“Gardasil will prevent subtypes of HPV to invade the body and thereby prevent the development of cervical cancer,” Schroeder says.

Interior design major, Amy Lundwall, 20, just received the first out of three shots.

“We get shots to prevent other diseases when we are younger,” Lundwall says. “So why not get one to prevent cervical cancer?”

Schroeder says about 10,000 women are diagnosed with cervical cancer every year in the United States, and Gardasil is the only vaccine to effectively prevent this form of cancer.

The number of females getting vaccinated has been increasing, leaving more people aware of the serious outcomes of cervical cancer, and preventing females from getting cervical cancer in the future, doctors say.

“If my daughter was that age, I would have her get it,” Agenbroad says. “If I was that age, I would get it, and I will definitely see that my granddaughters get it.”

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>>Email the editor at aklaw@zoniereport.com.

Farmer shortage stunts growth of farmers markets

PHOENIX — Farmers markets are budding all over Arizona, but there are not enough farmers to meet the needs of all the Arizonans who are hungry for local, organic food.

The craze for organic and local food has brought about 21 farmers markets in the Valley, but Dee Logan, senior coordinator for Arizona Community Farmers Markets, says that the demand for farmers greatly outweighs the actual number of direct-market farmers – those that sell produce directly to buyers.

Logan said that the markets that customers want across the Valley cannot be created until Arizona has more direct market farmers.

“We need to grow farmers, and we need to grow growers before we expand too much more,” Logan says.

Cindy Gentry, executive director of Community Food Connections, says she gets five calls a day from people requesting more farmers markets. However, the work required for direct-market farmers is too great to keep up with the demand for markets.

Several factors prevent the development of more direct market farmers, like the effort required to produce organic food that customers seek, Gentry says. Zoning laws make it difficult for commercial and residential land to be converted back to farm land. Also, market farmers sell directly to the public, and this requires more marketing expertise that conventional farmers may lack.

Gentry says she is very concerned about where the next generation of growers will come from. She believes that changes need to be made in order to keep farmers selling to customers instead of large companies.

“The trend is that everybody wants to be at the market and benefit from its value,” Gentry says. “But we have some work to do, including some public policy work to make it viable and possible for farmers to stay on the land and in business.”

Maya Dailey, a vendor at the Downtown Phoenix Public Market, says that her passion for growing food for customers is what keeps her in the business. Her farm, simply called Maya’s Farm, is an organic and biodynamic farm located at 32nd Street and Southern Avenue in Phoenix.

“I am a very conscious food person, so the only pressure that’s on me is the pressure to grow food in a conscious, healthy, environmentally friendly way,” Dailey says.

However, very few farmers feel the way Dailey does about their produce. In 2006, there were about 10,000 farms in Arizona, but the vast majority of them grew for larger companies, according to the U.S. Department of Agriculture.

In an effort to keep direct-market farmers in business, the Arizona Farm Bureau created a program last year called Fill Your Plate. The program is helping local farmers get the word out about their produce so they can rely on business from farmers markets and visitors to the farm instead of larger companies to market their produce.

“We are trying to take care of our farmers, whether they are a small direct-market farmer or they are a cotton farmer, but we’re attempting to be a brand extension on their behalf,” says Julie Murphree, Arizona Farm Bureau spokeswoman.

There are 107 Arizona farmers involved in Fill Your Plate. The program connects the community with local farmers by including farmer biographies on their website, placing banners in high traffic areas to welcome customers to farms, and creating search engines where customers can find a farm that sells exactly what they are looking for.

Gentry says that although direct-market farming is a hard way to make a living, all the effort is well worth it for farmers and customers.

“I think that the farmers market offers something beyond just buying the food as a commodity that you need for your household,” Gentry says. “It offers a sense of community; people recognize you, people say hi, and they know you by your name.”

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>>Email the editor at aklaw@zoniereport.com.