Tuesday, October 27, 2009

Should pregnant women get H1N1 vaccine?


Dr. Bob Sears has tried to avoid controversy during the swine flu outbreak. But his recommendation that pregnant women not get the H1N1 vaccine departs from the rest of the medical community.

The federal government and most physicians have spoken in unison on the issue, and they advise pregnant women to receive the injected form of the vaccine because of the virulence of the H1N1 strain and the vulnerability of a pregnant woman's immune system. Two Orange County pregnant women are among 28 who have died nationally since the pandemic began in April. But Sears says the vaccine has never been sufficiently tested for safety on this demographic.

"As a doctor, we swear an oath to 'First, do no harm.' So I have a hard time recommending a treatment that doesn't show it causes no harm," he said. "It's not just the H1N1 vaccine that's not been tested. The regular flu vaccine has not been tested in pregnant women, either, to show that it's safe in babies. That kind of boggles my mind, because the regular flu vaccine has been around for years, and there have been plenty of opportunities for the companies to do some safety testing on them so pregnant women can feel more comfortable about them."

Dr. Felice L. Gersh, an OB/GYN at Women's Medical Group of Irvine who has been practicing for 28 years, echoes the assessment of governmental health agencies, who say the vaccine is safe and are mounting a campaign to urge pregnant women to get the H1N1 and seasonal-flu vaccines. Gersh said Sears and other doctors skeptical of the H1N1 vaccine are "going against the weight of scientific evidence."

"Sometimes in medicine, as in life, you have to go with your best guess using available data," she said. "Everything can't be signed, sealed and guaranteed. This is a judgment call. And all the data is in favor of getting the vaccine."

Christina Chambers, an epidemiologist and associate professor in the Department of Pediatrics at UC San Diego, said Sears' views "don't hold water." She added that history has shown that pregnant women are at greater risk of hospitalization and death during flu pandemics.

"One day you could be feeling fatigued and achy, the next day you could be in a coma," she said.

Because he's part of a nationally trusted brand, Sears' opinions carry great influence. His pediatrician father, Bill, and registered-nurse mother, Ruth, wrote a series of books ("The Birth Book," "The Baby Book") that have become indispensible references for expectant and new parents. Sears, his parents and his brother Jim operate out of their seaside practice in Capistrano Beach.

"Dr. Bob," as patients and staffers call him, published his first solo book, "The Vaccine Book: Making the Right Decision for Your Child," in 2007. His inclusion of an "alternate vaccination schedule" brought him criticism from some fellow doctors who see his views as anti-vaccine, an accusation he hotly denies. But in recent postings about H1N1 on the family Web site, AskDrSears.com, his neutrality might have brought more questions than reassurance.

On July 30, he was undecided about the upcoming mass-vaccination effort. But he told readers that "what you can fret about is whether or not the government will make the vaccine mandatory." The first commenter wrote: "Way to fan the hysteria fire there Dr. Bob."

The Centers for Disease Control and Prevention has stated that the H1N1 vaccine is made the same way as the seasonal-flu vaccine, which "millions of Americans have received" over the years. Sears says that's a "completely unscientific statement." He points out, correctly, that no widespread clinical trial of either vaccine has been conducted on pregnant women. The 19-page product insert issued by Sanofi Pasteur, the largest of the five companies that supply the U.S. with H1N1 vaccines, acknowledges that it's "not known whether these vaccines can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity." It adds that the vaccine "should be given to a pregnant woman only if clearly needed."

Chambers, who runs a support center out of UCSD to answer questions about H1N1 (in California, 1-800-532-3749), is gathering information for a future vaccine study. She said symptoms of H1N1 include fever, fatigue, muscle aches, headaches, runny nose, cough and sometimes vomiting and diarrhea. She urges women to get vaccinated, and if they feel symptoms to seek medical attention. Antiviral medications like Tamiflu can be prescribed within 48 hours of the symptoms arising.

"We don't know of any risk from the vaccine, but we do know the risks from getting the virus," Chambers said.

Contact the writer: lhall@ocregister.com

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