Tuesday, November 10, 2009

Health

USN Current Issue

On the Bookshelf: A shot against vaccine critics

By Josh Fischman
Posted 10/11/05

Fifty years and several months ago, America's greatest medical catastrophe hit with shock waves that still affect us today. The Salk polio vaccine, just approved, was being rushed to waiting children by Cutter Laboratories in California. But the lab accidentally mixed live polio virus in with its vaccine doses. Some 40,000 people developed polio symptoms, and 10 died. The lawsuits and distrust that resulted, says vaccine specialist Paul Offit, set precedents that today have crippled our ability to produce vaccines, leaving Americans vulnerable to preventable diseases like pneumonia, the measles, and the flu. In The Cutter Incident (Yale University Press), Offit, chief of the division of infectious diseases at Children's Hospital of Philadelphia, argues that the situation is going from bad to worse, and public attitudes—not vaccine makers—are to blame.

What went wrong at Cutter?

They were trying to roll out the vaccine too fast, and the safety tests at that time were not sensitive enough to detect problems. When I started writing this book, I assumed that Cutter was a bad actor and did things wrong. But after looking in Salk's archives and looking at the results of the government investigation, I've changed my mind. They tested the doses in monkeys, and the monkeys were fine. They did the tests they were supposed to do. But you don't really know there's going to be a problem in humans until you put a vaccine in humans.

Does that mean that vaccines now can be just as dangerous?

No. Because of Cutter, vaccines go through thousands of tests to make sure they contain exactly what they are supposed to contain. They are tested in thousands of people before they are licensed, and they're watched carefully afterwards to make sure they don't cause any rare side effects.

So things are good with vaccines?

Also no. Cutter spawned a lawsuit that eventually brought the vaccine industry to its knees, which is where it is today.

To its knees?

In the 1950s there were more than 20 companies making five vaccines. Today there are four making 12. So we routinely have shortages, and children die because they don't get vaccines. Last year we had rationing of flu vaccine. A few years ago we had rationing of pneumonococcus vaccine. The vaccines routinely recommended for young children only have one manufacturer each, and if there's a problem with the manufacturing, there's a problem getting the vaccine. Plus companies don't want to develop new vaccines. And that's because of the lawsuit that happened after Cutter.

Shouldn't people who were harmed by Cutter have sued? And won? They got polio, after all.

I'm not saying they shouldn't sue. But the jury found that Cutter was liable even though they were not negligent. That meant vaccine makers could be sued for any harm. And juries who don't understand science, and who don't understand the difference between causality and coincidence, award giant sums of money. That scares companies away from making vaccines. Group B strep infections—the leading bacterial killer of newborns—could be prevented with a vaccine for pregnant women. We have the technology to do it. But nobody is willing to risk lawsuits from women with babies born with unrelated birth defects.

In your view, this risks child health more than side effects from vaccines?

Of course it does. Look at what happened with whooping-cough vaccine. In the 1970s, a British researcher claimed it caused brain damage. At the time, 80 percent of children got the vaccine. But the claim got publicized, and the vaccination rate dropped to 30 percent. Within two years, more than 100,000 children in England were hospitalized with whooping cough. In the U.S. more than 800 lawsuits adding up to more than $20 million dollars were filed against the vaccine makers. Yet the scientific community did further studies, and the evidence is conclusive that there's no link between the vaccine and brain damage.

People today think they have some inalienable right to compensation if things go wrong. That's new. It wasn't my parents' attitude. And it's not how medicine works. You learn things the hard way in medicine, when things do go wrong. And medicine evolves, and you fix them. But people no longer accept that.

But don't you yourself have a financial stake in vaccines? You hold a patent on a rotavirus vaccine.

I do. But I don't make any money from it. I'm a basic scientist, and I'm funded by grant money. The vaccine is made by Merck, and I don't get any money from Merck.

Seems like a conflict of interest, though.

When people say that, they presume to know what's in my heart, and that really gets me angry. I'll tell you what's in my heart. I'm a pediatrician. I have kids myself. If a rotavirus vaccine ever gets approved, it can save 2,000 lives a year. That's why I do this.

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