Pandemic Flu, the Cutter Incident and Vaccine Liability - Op-ed

Op-ed by Dr. Offit Originally Published in the Parents Pack Newsletter, Nov. 2005

Published on in Parents PACK

In response to the growing threat of bird flu in Southeast Asia, President Bush released his "National Strategy for Pandemic Influenza" on November 2, 2005.

One component of the plan surprised and angered some lawmakers: "The Administration is seeking to remove one of the greatest obstacles to domestic vaccine production — the growing burden of litigation...Congress must pass liability protection for the makers of life-saving vaccines."

Many suspected the President was simply offering a gift to pharmaceutical companies, thanking them for supporting his campaign. They worried that the President's plan would enable companies to cut corners and make even larger profits, free from the supervision of the courts if their vaccines caused harm. "We don't need to throw out important consumer protections to address problems in our vaccine supply," said a spokesperson for Henry Reid (D, Nevada).

But was Bush merely rewarding his friends? Or did vaccine makers really need protection from litigation? The answer can be found in the history of vaccine litigation.

During the past 100 years, pharmaceutical companies have made vaccines against pertussis (whooping cough), polio, measles, rubella (German measles), and Haemophilus influenzae type B (Hib), among others. As a consequence, the number of children in the United States killed by pertussis decreased from 8,000 each year to less than 20; the number paralyzed by polio from 15,000 to 0; the number killed by measles from 3,000 to 0; the number with severe birth defects caused by rubella from 20,000 to 0; and the number with meningitis and bloodstream infections caused by Hib from 25,000 to less than 50.

Vaccine makers have been the single most powerful force in determining how long we live; during the twentieth century, the lifespan of Americans increased by 30 years — mostly because of vaccines. But the landscape of vaccines is also littered with tragedy.

In the late 1800s, starting with Louis Pasteur, scientists made rabies vaccines using cells from nervous tissue (such as animal brains and spinal cords); the vaccine prevented a uniformly fatal infection. But the rabies vaccine also caused seizures, paralysis, and coma in as many as 1 of every 230 people that used it.

In 1942, the military injected hundreds of thousands of American servicemen with a yellow fever vaccine. To stabilize the vaccine virus, scientists added human serum. Unfortunately, some of the serum came from people unknowingly infected with a hepatitis virus. As a consequence, 330,000 soldiers were infected, 50,000 developed severe hepatitis, and 62 died.

In 1955, five companies stepped forward to make Jonas Salk's new formaldehyde-inactivated polio vaccine. One company - Cutter Laboratories of Berkeley, California - made it badly. Because of Cutter's failure to completely inactivate the virus in their vaccine, 120,000 children were inadvertently injected with live, dangerous poliovirus; 40,000 developed mild polio, 200 were permanently paralyzed, and 10 were killed. It was one of the worst biological disasters in American history.

Given all of these problems, what role did personal-injury lawyers play in pushing vaccine makers to make better, safer products? The answer is — none. That's because the tragedies caused by vaccines weren't the result of foul play, cost cutting, deceit, misrepresentation, or dark figures lurking in the shadows. Every problem was caused by the inevitable, painful, but requisite process of knowledge gained with time that is required for advances in science and medicine.

Scientists eventually found a way to grow rabies virus in safer cells. The Cutter tragedy — later found to be caused by a problem filtering the virus and shared by all five companies making polio vaccines — was quickly identified and corrected. And, when researchers later discovered hepatitis B virus — the virus that had in retrospect contaminated the yellow fever vaccine — they made a vaccine to prevent it.

Like it or not, we learn as we go. And no amount of suing is ever going to change that. In addition to contributing nothing to making vaccines safer, personal-injury lawyers have made vaccines more expensive and less available. That's because most lawsuits have been directed at problems that were not, in fact, caused by vaccines. For example, in the late 1970s and early 1980s, personal-injury lawyers sued vaccine makers claiming that the pertussis vaccine caused sudden infant death syndrome (SIDS), paralysis, mental retardation, epilepsy, and unexplained coma.

Despite a series of epidemiologic studies showing these claims to be groundless, many lawsuits were successful. As a consequence, the price of the pertussis vaccine increased from $0.17 per dose to $11.00, the number of companies making vaccines decreased from 26 to 4, and the number of U.S.-based companies making influenza vaccine decreased from 6 to 0.

And they're still at it. Today, personal-injury lawyers are claiming that thimerosal, a mercury-containing preservative in vaccines, caused autism — despite abundant scientific evidence to the contrary.

So, how can we protect pharmaceutical companies from frivolous litigation and still compensate people for those rare times when they really are harmed by vaccines? The answer lies in the government's response to the pertussis-vaccine litigation, when vaccines became the first medical product almost eliminated by lawsuits.

To save vaccines, Congress passed the National Childhood Vaccine Injury Act in 1986 — an act which included the Vaccine Injury Compensation Program. Now, when people claim to be harmed by vaccines, they take their case to "vaccine court" where scientists, epidemiologists and clinicians review data and decide whether the claim is valid. The system brings reason and fairness to decisions about vaccine safety.

"Vaccine court" could also protect against the unlikely possibility of harm caused by a pandemic-influenza vaccine. Because, if companies are left exposed to the vagaries of juries (as is likely with the current thimerosal litigation), vaccine makers won't make a pandemic-influenza vaccine. And young Americans will be able to experience first-hand just what an influenza pandemic looks like — something that all of the lawsuits in the world won't be able to stop.

Materials in this section are updated as new information and vaccines become available. The Vaccine Education Center staff regularly reviews materials for accuracy.

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