http://www.nytimes.com/2009/09/28/health/policy/28vaccine.html?_r=1

Don’t Blame Flu Shots for All Ills, Officials Say

As soon as swine flu vaccinations start next month, some people getting them will drop dead of heart attacks or strokes, some children will have seizures and some pregnant women will miscarry.



The first day of vaccination in New York in 1976. Forty-five million Americans got the medicine.

But those events will not necessarily have anything to do with the vaccine. That poses a public relations challenge for federal officials, who remember how sensational reports of deaths and illnesses derailed the large-scale flu vaccine drive of 1976.

This time they are making plans to respond rapidly to such events and to try to reassure a nervous public — and headline-hunting journalists — that the vaccine is not responsible.

Every year, there are 1.1 million heart attacks in the United States, 795,000 strokes and 876,000 miscarriages, and 200,000 Americans have their first seizure. Inevitably, officials say, some of these will happen within hours or days of a flu shot.

The government “is right to expect coincident deaths, since people are dying every day, with or without flu shots,” said Dr. Harvey V. Fineberg, president of the Institute of Medicine and co-author of “The Epidemic That Never Was,” a history of the 1976 swine flu vaccination campaign.

Officials are particularly worried about spontaneous miscarriages, because they are urging pregnant women to be among the first to be vaccinated. Pregnant women are usually advised to get flu shots, because they and their fetuses are at high risk of flu complications, but this year the pressure is greater. Expectant mothers are normally advised to avoid drugs, alcohol and anything else that might affect a fetus.

“There are about 2,400 miscarriages a day in the U.S.,” said Dr. Jay C. Butler, chief of the swine flu vaccine task force at the federal Centers for Disease Control and Prevention. “You’ll see things that would have happened anyway. But the vaccine doesn’t cause miscarriages. It also doesn’t cause auto accidents, but they happen.”

In the opening days of the 1976 vaccination campaign, which eventually vaccinated 45 million Americans, three elderly Pittsburgh residents died soon after receiving their shots at the same clinic. Though scientists believe it was just a freakish coincidence, some news reports suggested the vaccine had killed them.

“Press frenzy was so intense it drew a televised rebuke from Walter Cronkite for sensationalizing coincidental happenings,” Dr. David J. Sencer, who was then the director of the C.D.C., wrote in 2006 reflections on the vaccination campaign.

Two months later, reports emerged of vaccine recipients suffering from Guillain-Barré syndrome, in which the body’s immune system attacks the nerves, leading to temporary or permanent paralysis and, in a few cases, death. That effectively ended the campaign, as officials suspended it to investigate. Experts still disagree over whether the vaccine caused cases to increase that year, and the C.D.C. will be on high alert for reports of it this year.

Guillain-Barré’s cause is unknown, though different studies have suggested it more often affects people who have had a flu shot, the flu itself, some bacterial infections — or even, according to Dr. Sencer’s paper, people who have been struck by lightning.

In any case, after the suspension, there was no reason to restart because the predicted swine flu epidemic never emerged.

That, experts emphasize, is the great difference between 1976 and 2009. The earlier virus apparently burned out the previous winter inside Fort Dix, N.J., before any vaccine was even made, while this pandemic H1N1 virus has already infected millions and, unchecked, will probably reach over two billion, according to the World Health Organization.

In 1976, getting flu shots into 45 million Americans was unprecedented. Now about 100 million get annual shots, and the government has ordered twice that many doses of swine flu vaccine.

Other changes since 1976 worry officials. The 24-hour cycle of news on television and the Internet did not then exist; public health officials now must be ready to respond to rumors instantly. In 1976, the C.D.C. did not hold news conferences, and it took it five days to respond to the Pittsburgh deaths, Dr. Fineberg said.

“Back then, it was a neat thing to have a fax machine and get out four pages a minute,” said Joe Quimby, a press officer for the disease centers. “Now, communications have to be multimodal. Turning on the three broadcast news outlets is not going to reach everybody any more.”

The agency now has a “war room” in its Atlanta headquarters and, since the pandemic began in April, has held news conferences, sometimes even daily, at which reporters from around the world ask questions by phone. They can be seen live on the agency’s Web site, and it has another Web site, flu.gov, devoted to the pandemic, as well as a constantly updated Facebook page and Twitter feed.

Complicating the challenge for officials, some experts argue, is that health news coverage has suffered since 1976.

“I’ve seen the rise and fall of experienced medical reporters,” said Dr. Michael T. Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota. “I can’t tell you how many reporters have come to me since last spring who don’t really know what flu is.”

Also, antivaccine activists are far more powerful now. Thirty-three years ago, vaccines were enthusiastically welcomed; many parents or grandparents still remembered children dead of smallpox, measles or polio. The minority opposing them were often followers of natural healing or traditional chiropractic beliefs.

In 1976, autism was not on the public’s mind, and the problem was still attributed to indifferent mothering. Vietnam veterans with chronic illnesses usually blamed Agent Orange, a defoliant.

Today, many parents blame vaccines for their children’s autism and some ill Gulf War veterans blame their anthrax shots.

Some antivaccine groups are raising fears of thimerosal, a preservative used in some brands of flu vaccine. Others issue dire warnings about squalene, an immune booster used in military vaccines and in some European flu vaccines but not in any American ones.

And, in the rancor over health insurance reform, unfounded rumors are spreading that the Obama administration will make swine flu shots mandatory. Administration officials have emphatically denied that. But a recent decision by New York State to make them mandatory for all hospital employees has reinvigorated those rumors on the Internet.

To defend itself, Dr. Butler said, the C.D.C, has compiled data on how many problems like heart attacks, strokes, miscarriages, seizures and sudden infant deaths normally occur. And it has broken those figures down for various high-priority vaccine groups, like pregnant women or children with asthma. When vaccinations begin, it plans to gather reports from vaccine providers, hospitals and doctors, looking for signs of adverse events, so it can detect problems before rumors grow.

“Then we’ll try to verify the signal, see if it’s real,” Dr. Butler said. “Then we’ll try to see if it’s associated with the vaccine. If it is, we’ll say so. The process will be as transparent as we can make it.”