June 14, 2007

David Kirby: What if The Parents Win?

I had honestly not thought that far ahead. I am so used to having all our points ignored, I think I just assumed that no matter how good the Cedillo's case was, that of course the court would not want to set the prescient.

If Parents Win in Vaccine Court, What Do We Tell the World?
David Kirby

Will parents win their case against the government in Vaccine Court by convincing three federal judges that there's enough evidence to support a link between the MMR vaccine, thimerosal and autism spectrum disorders?

I, for one, am not placing any bets. But several thimerosal defenders are now dispatching dire warnings about the looming decline of the nation's public health -- and the pharmaceutical industry's corporate health -- should any of the 4,800 families win their vaccine/autism case in federal court.

"Massive litigation could force companies to leave the vaccine business, threatening the future of one of medicine's greatest achievements," Dr. Paul Offit, chief of infectious diseases at the Children's Hospital of Philadelphia, wrote in the Boston Globe on June 3rd.

If the claims are successful, Dr. Offit wrote, they "could exhaust the pool of money currently set aside to compensate children who have been hurt by vaccines," and would open the floodgates for private litigation directly against the drug companies, threatening their financial viability and compelling them to abandon the vaccine business.

(It should be noted, at this point, that Vaccine Court claims are awarded in just one third of the cases, and payouts average about $800,000 -- which might cover the proper care, treatment, and special education of an autistic child for maybe a decade. Victory in this particular court does not get you a condo in Maui, just a little temporary financial relief from endless costs).

Critics of the autism claims also contend that a victory in court by any of the families would drive panicked parents away from immunizing their children at all, resulting in new epidemics of infectious disease and lots of sick and dying youngsters

Maybe that's why Dr. Offit -- who incidentally stands to make some money from the recently approved rotavirus vaccine he co-developed with Merck -- referred to the court as a "circus" in his Boston Globe Op-Ed.

While this gives us insight into one pediatrician's contempt for the American legal system, it is somewhat puzzling, given that the first "test case" has proceeded with nothing but respect, decorum and a sobering sense of the Herculean task at hand.

It's entirely possible that all 4,800 cases will go down in flames. But what if some of the parents and their attorneys can beat the tough odds, and make a good enough case to convince the judges?

Irrespective of one's views on the merits of these cases, I think everyone needs to stop and think about dealing with the ramifications -- on a worldwide scale -- of any family victory in Vaccine Court.

Yes, some drug companies would likely face some big lawsuits in civil court. But in the age of Vioxx and Avandia, that almost seems to be a routine cost of doing business.

And let's face it; neither the American government, nor its people, would stand for the wholesale collapse of the pharmaceutical industry -- which does, after all, keep millions of people alive each year. No, I am reasonably sure that Big Pharma, somehow, would muddle through and survive (possibly with a major assist from you, the taxpayer, so think about that one as you stand in the pharmacy prescription line).

But what about vaccination rates? Wouldn't they tumble?

Not if we start to educate parents now about the thorny issues that could arise with a decision in favor of the plaintiffs.

First of all, it's important to remember that thimerosal has been in the news since 2005, when Don Imus began to not shut up about it. Later that year, I appeared on "Meet the Press" to discuss the controversy, and the subject has been raised in innumerable media outlets ever since.

And what happened? Immunization rates rose to new record levels.

We need to show a little more faith and confidence in young parents. If causation from thimerosal is found, new parents might actually breathe a sigh of relief, knowing that childhood shots now contain only residual amounts of mercury (with the glaring exception of 90% of the flu shot, so they might want to put in their order soon for mercury-free influenza vaccine for the 2007-2008 season).

If the MMR triple-live-virus vaccine, which never contained thimerosal, is implicated, then we as a society might want to consider having those shots administered separately. Even though that would mean two more jabs for the baby, it might also calm a lot of jittery parental nerves, and keep immunization rates robust.

Meanwhile, none of the other vaccines that children receive today are on trial here, and parents will almost universally understand that.

I am sure that critics will deride this scenario as being far too rosy, and I hope they are wrong. Nobody wants to see measles, or mumps, or polio sweep the country. But I don't think that will happen.

But I do wonder about the ramifications overseas.

The US has largely removed thimerosal from the routine shots we give our own kids (out of an "abundance of precaution," we are told), but children in the developing world are afforded no such consideration.

Today, millions of children in Latin America, Asia and Africa are receiving American-export vaccines that still contain the full battery of ethylmercury -- in amounts that put children dozens of times over the US EPA maximum daily limit on vaccination days.

Immunization rates are rising in many developing countries, but so are the reported rates of autism. In Mexico, for instance, vaccine rates are now about 92%, UN figures show, while reported cases of autism are also moving upward (proof of nothing, but interesting and disturbing nonetheless).

Several well-placed sources have told me that the CDC and FDA will never agree to an outright ban on thimerosal in vaccines, due to pressure from the World Health Organization, and because the message this would send to developing nations would be untenable: "Yes, thimerosal might cause harm, but we are going to give it to you anyway, for your own good. Trust us. We're Americans. We know what we're doing."

Talk about driving people away from vaccines in droves. The result could be catastrophic, with rising rates of infectious diseases and child mortality to follow.

In other words, we can probably convince American parents to keep on vaccinating, because the mercury here has largely been removed. But what do we tell parents in South Korea, or Brazil, or Nigeria?

Thimerosal is not a necessary ingredient in vaccines. We can still ship multi-dose vials -- which require a preservative but are cheaper to buy and administer -- to poor countries, a noble goal indeed. But the preservative does not need to be based on a deadly neurotoxin.

The MMR shot itself is preserved not with thimerosal (which would kill the live viruses) but with a type of phenol. Why can't we find a non-mercury based preservative for all vaccines? I have never been able to get a satisfactory answer to that question.

But even if we could switch to alternative preservatives tomorrow, and boost global confidence in vaccines, we might still inherit another, more sinister problem to deal with.

On the very last page of my book, Evidence of Harm, I close with these words:

"If thimerosal is one day proven to be a contributing factor to autism, and if U.S.-made vaccines containing the preservative are now being supplied to infants the world over, the scope of this potential tragedy becomes almost unthinkable. The United States, at the dawn of the 21st century, is not exactly the most beloved nation on earth. What if the profitable export of our much vaunted medical technology has led to the poisoning of tens of millions of children? What then?"

We need to prepare for at least the possibility of a parental victory in vaccine court. We need to prepare our own parental population, and we need to think about what we are going to tell the rest of the world.

Vietnam just suspended a certain US-made MMR vaccine after some patients died from it. This could be the tip of the iceberg in terms of social, economic, and physical retribution against the United States.

What do we tell the Chinese and their hundreds of millions of vaccine consumers? What will we say to people in booming India, or next door in Mexico? Will our immigration policy bar parents of autistic kids from coming to America, even if American shots might have made their kids sick?

And then there is the Middle East.

Osama, for one, has a very extended family. We are exporting thimerosal containing vaccines to many Muslim nations. Some vaccines contain not only mercury, but products derived from pigs.

I don't need to tell you where I am going with this train of thought. You already know.

I do not think these court cases should be decided on the larger ramifications. That is just not the way our legal system works. Still, a victory for the families -- justified or not -- will produce endless headaches for the pharmaceutical industry, the US public health establishment, and the WHO.

If just one family wins their case in that Washington courtroom, then we, as a nation, have a lot of explaining to do.

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