Why you should trust the coronavirus vaccine

Let me start by making one thing clear: at the time of this writing, we don't have a scientifically validated vaccine for COVID-19. But more than 150 vaccines are being developed around the world, and many of them are already in advanced stages of testing.

So we'll have a vaccine soon, likely in a matter of months. And everyone should take it. I know I will.

Today I’m going to try to de-mystify vaccines a bit, in the hope that this might help people feel more comfortable with them.

Before explaining what a vaccine actually is, let me point out that vaccines are probably the single greatest medical advance in the history of human civilization. Vaccines have saved hundreds of millions of lives: prior to vaccines, people lived in fear of diseases like smallpox, which killed 300 million people in the 20th century alone. Thanks to the vaccine, we eradicated smallpox from the entire world in 1980. Polio is another dreaded disease that killed or permanently injured millions, until the 1950s, when Hilary Koprowski, Jonas Salk, and Alfred Sabin invented vaccines that protected against it. Today, no one in the U.S. or Europe worries about polio, and it too has nearly been eradicated worldwide.

What exactly is a vaccine? It’s a pretty simple concept. Our immune system has the remarkable ability to “remember” pathogens that we’ve been exposed to. So once you’ve been infected with some viruses or bacteria, you acquire immunity to those diseases that may last the rest of your life. A vaccine is basically a way to teach the immune system to recognize a pathogen without actually making you sick.

The simplest way to do this (conceptually) is to take a batch of viruses or bacteria, kill them so they’re harmless, and then just inject them into a person. The immune system then “sees” the proteins in the dead pathogens (because the proteins are still floating around), and it learns all it needs to know from these. Later on, if a live virus infects that person, her immune system will say “aha, I know you!” and will quickly surround and destroy the invaders.

Simple as it sounds, there are many complications with this process. One is that it’s often very hard to isolate and grow enough of the virus (or bacteria) for large-scale production. The viruses then need to be isolated, killed, and purified, which can be complicated and costly. For COVID-19, though, any cost is worth it.

Another, much newer way to make vaccines uses modern molecular technology to make RNA. There’s no need to isolate or grow the virus at all! This is how Moderna’s new mRNA vaccine works (see their whitepaper here).

The mRNA vaccine relies on the fact that we already know which protein in the SARS-CoV-2 virus is the most important one. It’s called the spike protein, so I’ll just call it Spike. Spike is what attaches to human cells and lets the virus infect them. We also know the sequence of the Spike gene: the sequence of the entire SARS-CoV-2 virus was released in early January, and we’ve now sequenced thousands of these viruses.

An mRNA vaccine simply uses the RNA itself, rather than dead viruses. Today we can synthesize RNA in large quantities, so if you take some of this RNA and inject it into a person, what happens? Well, our own cells will translate this RNA to produce the Spike protein. All by itself, the protein cannot possibly cause an infection. It’s analogous to having a motor without a car: you can’t go anywhere without the whole package.

But here’s the good part: our immune system will recognize Spike anyway, even without the virus, and it will remember this invader. So the RNA vaccine is, in theory at least, even safer than traditional vaccines, because live pathogens are never used in the production process. (Before the anti-vaxxers jump on me here, let me emphasize that traditional vaccines are incredibly safe.)

This is just one example: there are 23 vaccines already in human trials, and over 150 in development, using mRNA, proteins, and other approaches.

There are other ingredients in vaccines too: preservatives and adjuvants. Anti-vaxxers like to read vaccine ingredients and then claim that all sorts of harmful stuff is in there, but their claims are mostly just gross ignorance. Preservatives are there to prevent the growth of things like bacteria, so they make vaccines safer. And adjuvants like aluminum salts (the most common adjuvant) are ingredients that enhance the effectiveness of vaccines, meaning you can use a lower dose. Aluminum salts have a very long safety record.

So why don’t people trust vaccines? Largely because the anti-vaccine movement has spent years spreading misinformation and fear, and it is already pronouncing strong opposition to any coronavirus vaccine, regardless of the evidence. The New York Times reported this week that mistrust of future coronavirus vaccines could imperil public health, especially in the United States. Polls have shown that large proportions of Americans say they won't take a vaccine even when it's available, which is, frankly, kind of crazy. (It didn’t help when tennis player Novak Djokovic expressed doubts about whether he’d be willing to take any future coronavirus vaccine.) Last month, NIH’s Anthony Fauci said that the “general anti-science, anti-authority, anti-vaccine feeling” in the U.S. may seriously undermine the effectiveness of any future vaccine. Of course, this could change once we really do have a vaccine, and we should all hope it does. But the anti-vaxxers never let up.

It also doesn't help build trust when the Trump administration calls their vaccine program "Operation Warp Speed." This might have sounded exciting to some sci-fi fans in the White House, but to many people it sounds more like a devil-may-care approach that emphasizes speed over safety. 

So how do we establish trust in the new vaccines, which are probably coming just a few months from now? One way to reassure people is to publish all the numbers from the vaccine trials. A just-published study in NEJM on the Moderna vaccine (the RNA vaccine) provides exactly these numbers, and they look very good in terms of both safety and effectiveness. 

In that study, all 45 participants had a robust antibody response–a stronger response, in fact, than in many people who’d been infected with the virus itself. There were some side effects, including fever and chills, but all were graded as mild or moderate. The scientists looked at 3 different dosage levels, and the side effects were greatest in the highest dose–but the antibody response was perfectly adequate in the lower dosage levels. So the next phase of testing, already under way, is using the lower dosages.

This was a phase 1 study, but it's very encouraging. If these results hold up in a large group–a question that is being tested now, in a phase 3 study–we'll have a working vaccine. 

And if you want to know more about this trial, you can read about it at the public NIH site, ClinicalTrials.gov.

Many if not all of the vaccines being developed in Europe and the U.S. are going through the same kind of scrutiny, and we’ll be able to see the results of those tests too. This is how we generate trust in the results: share them openly. I’m very re-assured by what I’ve seen so far.

The bottom line: vaccines work, and our methods for testing them are rigorous and thorough. With a little luck, the world will have multiple COVID-19 vaccines by the end of 2020. Once we have enough people vaccinated, our long nightmare with the coronavirus pandemic will come to an end.

Would you trust your kids with this man? No? I didn't think so.

Today I want to shine a bit of light on the conspiracy theorist behind the film "Vaxxed" and its recent sequel, "Vaxxed II." I'm not going to provide any links to the movie, or to describe it, except to say that it's a slickly-produced conspiracy theory masquerading as a documentary. Don't watch it.

Anti-vax activists often use conspiracy theory tactics, which work like this: they simply make up a claim, out of thin air, that a secret cabal of doctors (or government scientists, or pharma companies) is out to harm patients by giving them vaccines, and is hiding the "truth" about the risks of vaccination. Never mind how irrational this is, and never mind that there's not a shred of evidence behind it: if you try to argue with the anti-vaxxer, you're part of the conspiracy.

So rather than try to disprove something that was never proven in the first place, let's look instead at the source of the anti-vax propaganda film, "Vaxxed." The source is one man: Andrew Wakefield. Who is this guy, and why is he so obsessed with vaccines?

Wakefield was once a doctor, before he had his license revoked a decade ago. In his former life, he was a gastroenterologist, with no special training in vaccines or infectious diseases. He first gained fame–a lot of fame–for a 1998 paper in a medical journal, The Lancet, in which he claimed to have discovered a link between the MMR vaccine (that's the one that covers measles, mumps, and rubella) and autism.

Here are some things you need to know about Wakefield before watching his movie:

1. Wakefield's 1998 paper, it eventually turned out, was "an elaborate fraud." Wakefield defrauded the public, his patients, and even his own co-authors on the paper, most of whom were unaware of his elaborate conflicts of interests.
2. Before he published his 1998 study, Wakefield was hired by a lawyer, Richard Barr, who was trying to build a lawsuit against vaccine makers. Barr paid Wakefield £435,000 (equal to $750,000 US dollars at the time) to help him build his case. Wakefield's co-authors were unaware of this contract.
3. The study claimed that 8 out of 12 children had been diagnosed with autism soon after getting the MMR vaccine. It described these children as "a consecutive series" of admissions to the hospital where Wakefield worked. That was a lie. It turned out, as investigative journalist Brian Deer revealed, that all 12 children and their parents were referred to Wakefield by Barr–the lawyer who was paying Wakefield to conduct the study, and who was trying to sue vaccine makers.
4. Wakefield also falsified data on all 12 of the children in his original study.
5. Wakefield conducted "invasive and distressing procedures" on the children without approval from his hospital's ethics board.
6. After learning some of the back story, 10 of his 12 co-authors tried to retract the paper in 2004. Wakefield refused to join them, so they published a partial retraction, signed by the 10 co-authors. The Lancet itself later fully retracted the paper (over Wakefield's objections), but it took until 2010 for them to act. By then, the anti-vax movement had spread widely.
7. Prior to publishing his paper, Wakefield filed a patent claim for a "safer" vaccine for measles, one that would have profited him greatly once he discredited the (perfectly safe) MMR vaccine.
8. After losing his license in the UK, Wakefield moved to Austin, Texas where he ran an organization called Thoughtful House, through which he paid himself a salary of $280,000. (Perhaps coincidentally, Austin is now a hotbed of anti-vaccination activism.)

For more than 20 years, Andrew Wakefield has made money off false claims that vaccines cause autism, first put forth in his discredited 1998 paper. He gives talks, writes books, conducts seminars, and now makes movies, of which make him money. Since the publication of his paper, dozens of studies involving literally millions of children have shown, time and again, that vaccines do not cause autism. Wakefield has denied every one of those studies, and continues to push his bogus claims.

(Why, you might ask, have scientists conducted studies looking for a link between autism and vaccines, if there was never any evidence for such a link? The answer is simple: anti-vaxxers have been so successful at scaring people about a nonexistent threat that scientists and public health experts felt it necessary to conduct those studies, in order to reassure people. Literally millions of dollars have been spent to prove something we already knew.)

Meanwhile, measles outbreaks have appeared with increasing frequency in the U.S., the UK, other European countries, and around the world, including the deadly outbreak in Samoa late last year, which caused 5,700 infections and 83 deaths in a population of just 200,000. Wakefield's new movie was released in the middle of that outbreak.

So to anyone who watched the movie Vaxxed and is now having doubts about vaccines, I ask: would you trust your children with this man? I wouldn't.

Germany takes action to stem measles outbreak. Anti-vaxxers to blame–again.

Measles is on the rise in Europe, driven by "vaccine gaps" which in turn are due to misinformation about the benefits of vaccines. Vaccines are possibly the single greatest contribution to human health in the past century. Literally millions of people are alive today who would not be, thanks to vaccines.

And yet: vaccine rates have dropped in recent years in multiple countries. In March, the BBC reported that measles had become endemic (meaning that it is self-sustaining, continuing to spread within the country) in France, Germany, Italy, Poland, Romania, Switzerland and Ukraine. The worst measles outbreak is in Romania, which reported over 3,400 cases and 17 deaths in just the first 3 months of this year.

Now measles is spreading in Germany, which is scrambling to contain it. Germany had 504 cases through mid-April, versus just 33 cases for the same period last year. At least one person, a young mother of three children, has died. The primary reason for the spread of the disease, as reported by the German news outlet RT, is unvaccinated individuals, and the reason their numbers are growing is simple: the anti-vaccine movement.

In the U.S., the anti-vaccine movement caused the worst measles outbreak in 20 years in 2015. The outbreak in Germany appears even worse, despite the fact that parents can be fined as much as €2500 ($2800) for failing to vaccinate their children. In a remarkable effort to try to get this outbreak under control, the German parliament has decided to require kindergartens to report parents who don't vaccinate their kids. Let's hope this works.

Vaccination is safe and remarkably effective, but the anti-vax movement is furiously trying to convince parents not to vaccinate. Their latest gambit is "Vaxxed," a conspiracy-mongering anti-vaccine screen produced by Andrew Wakefield, the notorious ex-doctor who published a fraudulent (and later retracted) study claiming that MMR vaccines caused autism. Nearly 20 years later, despite Wakefield losing his medical license because of his "elaborate fraud," he continues to push his debunked claims.

Fortunately, many people are now pushing back. Just last week, noted New Zealand physician Dr. Lance O'Sullivan jumped up on stage at a screening of "Vaxxed" to warn people in the audience that they were being defrauded. O'Sullivan was named New Zealander of the Year in 2014 for his efforts to bring health care to disadvantaged people in rural areas. I will close with his words from a Radio New Zealand story describing the dangers of vaccine refusal:

"We are trying to save a child's life, we put it on a helicopter, it flies to Starship Hospital. The kidneys are failing, its heart's failing, its lungs are failing. All because we didn't put a bloody $7.50 meningococcal vaccine into that child's thigh."

Government scientists go rogue. What a great idea!

Government scientists are very worried, apparently with good reason, that their new boss wants to muzzle them. They've just come up with a brilliant strategy to circumvent this attempt at censorship.

Donald Trump and his minions have already made moves to suppress science within the government, with word going out that government employees cannot say anything to the public without the prior approval of political appointees. This has the marks of Stalinist (or should I say Putinist?) repression of free speech, not the sort of thing any of us ever expected to see in the United States. However, after running a campaign marked by outrageous anti-science claims on climate change and vaccine safety, Trump appears on track to use the enormous power of the federal government to suppress basic scientific facts.

Vladimir Putin has done the same thing. Most Russians think that Malaysia Airlines Flight 17, which was shot down in Ukraine in 2014, killing all 298 passengers, was shot down by Ukraine–despite the overwhelming evidence that the plane was shot down by a Russian missile provided to Russian-backed separatists by Russia. Putin had a record of suppressing, threatening, and even murdering those who speak out against him. Yet Donald Trump seems to find him the most admirable of all world leaders. And one of his closest advisors, Newt Gingrich, has said that he wants to fire all federal workers who didn't vote for Trump.

In just the past few days, though, government scientists have come up with a devilishly clever–and entirely legal–strategy to oppose the Trump administration's efforts to suppress their speech. Using Twitter, the same vehicle that Trump himself used so effectively throughout his campaign, they have created a set of "rogue" and "alt" accounts that have already started tweeting the real news about science, medicine, and the environment.

All of these accounts are run by non-government employees with no government sponsorship, but government scientists, in their off-hours time, can't be prevented from sending them information. In just a few days, these accounts have over 3.3 million followers, a number that is rising fast. Here's are some of the account with their total followers as of January 29:

• @NotAltWorld 1.3 million followers
• @RogueNASA  734K followers
• @altUSEPA  226K followers
• @ActualEPAFacts (a second alt-EPA) 176K followers
• @BadHombreNPS (National Park Service) 158K followers
• @alt_fda 144K followers
• @altusda 145K followers
• @altHHS 121K followers
• @alt_CDC 106K followers
• @alt_NIH 104K followers
• @AlternativeNWS 93K followers (deactivated on 29 Jan - no idea why)
• @ungaggedEPA 79K followers
• @altNOAA 69K followers
• @NatParkUndrgrnd 52K followers

Here are just a few of the tweets from these accounts so far:

As one tweet already pointed out, quoting the ACLU, "the First Amendment still protects workers' ability to speak in their own private capacities, on their own time, about matters that concern the public."

We might not be able to trust any official statements from the government for the next few years, but perhaps we'll still be able to find accurate science through the alt-gov Twitter accounts. So when you hear the Secretary of Health and Human Services (far right Congressman Tom Price, if he's confirmed) making claims about health care, check out @AltHHS to find out the real story. And when you hear Secretary of Big Oil Energy Rick Perry claim that global warming is a hoax, go to @NotAltWorld or @RogueNasa to find out the real story.

A surprising triumph in the fight against polio

Source: polioeradication.org

The last case of polio in India occurred exactly one year ago, on January 13, 2011.  In the decades-long battle against this devastating disease, this is one of the best pieces of news in a long time.  Just two years ago, health officials counted 741 polio infections in India, and it seemed that the battle was far from over.  It may yet be, but in 2010 the cases dropped dramatically, to just 42, and last year there was only one, on January 13.


As recently as the 1950s, polio was a dreaded, incurable disease that killed or paralyzed millions of children each year.  The U.S. alone had 58,000 cases in 1952. Then came the invention of a vaccine by Jonas Salk, one of the great medical breakthroughs of the 20th century.  By the 1960s, widespread vaccination campaigns had virtually eliminated polio from Europe and the U.S.  Polio lingered in the U.S., mainly in the Amish population who refused to accept vaccinations, but it finally disappeared in 1979.

The worldwide campaign to eliminate polio started in 1988, when 350,000 infections were recorded.  Polio is extremely difficult to control, because a large majority of infected people show no symptoms, but they can still spread the virus.  Vaccination campaigns need to treat everyone who comes in contact with an infected individual in order to break the cycle of transmission.  This is especially hard to do in remote areas of poor countries, especially when the populace is suspicious and uncooperative.

The greatest challenge in India came in the desperately poor, crowded regions of the north, where health care, hygiene, and education are all very poor.  The vaccination efforts were made even more difficult by conspiracy theories among the Muslim population.  As Simon Denyer wrote in the Washington Post this week:

"Rumors spread among the region's numerous Muslims that the polio vaccination campaign was an American conspiracy to wipe them out, by making their sons impotent and their daughters infertile.... Vaccinators were stoned as they approached Muslim neighborhoods. 'The general mind-set was that the immunization campaign was aimed at ending our lineage,' said Anwar Ahmad, the head of a madrassa in a Muslim neighborhood in the city of Meerut."

The campaign turned around after UNICEF and Rotary international launched a major education effort that first convinced Muslim leaders, and then everyone else, that the vaccine would benefit their communities.  With this success in India, polio is now endemic in only three countries in the world: Afghanistan, Pakistan, and Nigeria.  The same rumors and conspiracy theories that plagued India have spread within Muslim populations in these countries as well, but India shows that the misinformation - and polio - can be defeated.

Unfortunately, even here in the U.S. we have our own conspiracy theorists: the anti-vaccination zealots over at Age of Autism, where Dan Olmsted and Mark Blaxill recently posted a series of articles claiming that polio is "a harmless intestinal bug" that only causes disease when triggered by pesticides or by arsenic.  Never mind that there is no evidence to back this truly wacky assertion; these two anti-vaxxers seem happy to invent facts to support their single-minded campaign against all vaccines, even when the vaccines are demonstrably saving tens of thousands of lives.

Polio is still with us, and it could return.  Besides the 3 countries with endemic polio, 9 other countries continue to suffer polio cases that were imported from endemic countries.  Without widespread vaccination in those countries, polio could re-establish itself in any of them.

If polio stays out of India, we can thank the thousands of health care workers who traveled to remote villages, in extremely difficult conditions, to dispense lifesaving vaccines.  Their heroic efforts have paid off for everyone.  We should also thank the combined efforts of the WHO, UNICEF, Rotary International, the Gates Foundation, and the CDC, all of whom are backing the worldwide effort to eradicate polio.  Let's root for humanity to win this one.

The anthrax vaccine boondoggle

The anthrax vaccine is a truly bad idea. The U.S. has wasted billions of dollars on it, and it just seems to go from bad to worse. Now a government panel has recommended that we test the vaccine on children, which raises a whole new array of ethical questions.

Don't get me wrong: vaccines are the greatest boon to public health of the last 200 years. We eradicated smallpox, we're close to eradicating polio, and childhood deaths from infectious diseases are far, far lower thanks to the vaccines we give our children. These are truly wondrous advances.

But the anthrax vaccine is different, from start to finish.

For starters, anthrax is not infectious. This might come as a surprise to those who've only heard about this through the media. An anthrax "outbreak" is impossible, because the B. anthracis bacterium cannot spread from person to person. Vaccines against diseases such as measles, mumps, and influenza protect millions of people each year, because these are common infectious diseases that spread easily between people.

Anthrax was never a public health threat, and it isn't one now. We don't need an anthrax vaccine. And by developing and then promoting one, the government is abusing the good will that the public has towards vaccines, possibly endangering the public health further by playing into the hands of the anti-vaccine movement.

The Centers for Disease Control (CDC) does not recommend that children be vaccinated against anthrax. In fact, it doesn't recommend that anyone get routine vaccinations against anthrax:

"Vaccination is recommended only for those at high risk, such as workers in research laboratories that handle anthrax bacteria routinely."

The CDC recommendation makes sense. Therefore I was stunned to learn this week that the National Biodefense Science Board (NBSB) recommended that we launch an anthrax vaccine testing program in children (see page 37 of their report).

The NBSB report admits that

"Currently, U.S. children are not at immediate risk from anthrax and would not benefit directly from pre-event AVA [anthrax vaccine] administration."

It also states that

"There is no known benefit to vaccinating children in the absence of an imminent threat from exposure to B. anthracis other than potential future benefit."

Case closed, right? We can't conduct vaccine trials in children if there's no benefit.

Somehow, though, even after these statements in their own report, the NBSB managed to recommend testing the vaccine in children. As justification, they present this claim:

"Preparation for a national and potentially global threat from the use of B. anthracis spores by terrorists is a major priority for U.S. national security."

This is a massive overstatement. A national and global threat? Anthrax is not infectious, as the NBSB knows. The only people affected in an attack would be those directly exposed to the bacterium, likely only a handful of people. We don't vaccinate millions of people just to protect a hypothetical few: this is an abuse of the public trust in vaccines.

So why are we wasting billions of dollars to develop, test, and administer a vaccine against something that hardly infects anyone? The anthrax vaccine development project was on its way to being cancelled by the U.S. before the 2001 anthrax attacks. In an ironic twist, the likely perpetrator of the attacks, Bruce Ivins, was allegedly motivated by his interest in reviving the anthrax vaccine program. If so, then he succeeded in a big way: in 2004, the government announced Project Bioshield, which dedicated $5.6 billion to biodefense, much of that going to anthrax vaccine research.

I'm not surprised that if the government dedicates billions of dollars to biodefense, and distributes it to companies and universities who then become dependent on these funds, then advisory panels such as the NBSB will recommend an ever-increasing number of security measures. After all, some of the members of that committee are funded by biodefense dollars, and if we cut the funding, their own livelihoods might suffer.

Speaking to the Washington Post, panel member Ruth Berkelman said:

“We need to know more about the safety and immunogenicity of the vaccine as we develop plans to use the vaccine on a large number of children in the event of a bioterrorist’s attack.”

No, we don't. We don't need to know about the safety of the vaccine in children because it would be unethical to test it on them. And if there is an attack, we shouldn't respond by vaccinating "a large number of children," because anthrax doesn't spread from person to person. This is one vaccine we can do without.

[Note: I was a member of the research group that sequenced the DNA of the B. anthracis used in the 2001 attacks. We published our findings in two papers, one in 2002 and the second, after the investigation concluded, in 2011.]

Measles invades U.S.: anti-vaccine movement scores again

How can we keep unvaccinated people from bringing infectious diseases into the U.S.? These diseases are a real threat to public health, and while we're spending billions on national security, almost all that money goes towards "security theater," such as full-body scanning equipment at airports, which does almost nothing to protect the public. We'd be much better off spending those scarce funds on detecting infections at the border.

In the most recent invasion, the measles virus has snuck in thanks to a single unvaccinated student from Utah, who picked up the disease in Poland. The junior high student traveled to Poland with his family to pick up his sister, who was there as a Mormon missionary. As reported by the Associated Press, up to 1000 people have already been exposed, and the circle could easily spread beyond that.

Measles is a dangerous and incredibly infectious virus, transmitting easily between people. According to the CDC:

"About one out of 10 children with measles also gets an ear infection, and up to one out of 20 gets pneumonia. For every 1,000 children who get measles, one or two will die."

This is not a disease to take lightly. Fortunately, the vaccine is highly effective, which means the real challenge is getting people to take it.

Utah requires measles vaccinations for public schools, but (as in many other states) parents can refuse vaccines for personal or religious reasons. California now has about 2% of parents refusing vaccines for their children for personal beliefs. This gaping hole in our public health system needs to be closed: if parents refuse to vaccinate their children, they are putting the rest of us at risk, and these children need to be kept out of public schools.

Most of the parents refusing vaccines for the children are doing so out of fear that vaccines cause harm. Despite countless studies showing that vaccines are safe (and in particular, that vaccines do not cause autism), these rumors persist, amplified greatly by the anti-vaccine movement, which seems impervious to evidence or reason.

Meanwhile, anti-vaccine groups such as Age of Autism are fighting to keep or even expand these exemptions. Other sites such as ThinkTwice.com http://www.thinktwice.com/laws.htm and Internet quacks Joseph Mercola and Sherri Tenpenny advise parents to refuse vaccination and use whatever loopholes they can to enroll their kids in school. Parents who follow this advice rely on the immunization of others to protect their own children, but they appear unconcerned about the risk they forcing on the rest of us. They also neglect to consider that vaccines are never 100% effective, so even those of us who vaccinate our kids are still bearing a greater risk by allowing the unvaccinated to attend school.

Europe has its own problems with vaccine coverage, and measles is spreading rapidly this year, having hit 24 countries so far. France had 3749 cases and one death in the first two months of this year. Many of the victims are children too young to be vaccinated, but the disease is often spread by people who simply refuse to get the vaccine.

The latest measles outbreak in Utah could have been avoided if the student involved had simply been vaccinated. Realistically, though, we will always have citizens traveling abroad and bringing infectious diseases back. If the U.S. really wants to use its security dollars wisely, we should implement greater screening at the border to keep these disesases out. We could start by telling people to get vaccinated before they leave the country. If they refuse, we could require them to be tested for infections when they return. We could implement this using funds we'd save when we stop telling everyone to take off their shoes at the airport.

Supreme Court saves the vaccine system

Unbeknownst to most people, the Supreme Court heard a case last week that, had they ruled differently, might have destroyed the vaccine system in the United States. On February 22, the court ruled 6-2 to keep the special Vaccine Court system intact. In particular, they ruled against Russell and Robalee Bruesewitz, who were suing for damages on behalf of their daughter Hannah. But even though the system is saved for now, the two judges who voted in the minority demonstrated a frightening disregard for possible consequences, and encouraged those who would like to take us all back to an era when millions of children died each year from diseases like measles, polio, and whooping cough.

Hannah Bruesewitz's case is heartbreaking: she suffered a seizure in April 1992, within a day of receiving the vaccine for diphtheria, pertussis, and tetanus (DPT), and she had many more seizures in the following months. She was eventually diagnosed with with “residual seizure disorder” and “developmental delay" which she still has today. Her parents blamed the vaccine, and in 1995 they sued in Vaccine Court. They lost, although the Special Master of that court awarded them $126,800 for lawyer's fees and other costs. The Bruesewitzes rejected the award and sued in a state court in Pennsylvania.

The case last week wasn't about whether Hannah's disability was caused by the DTP vaccine. It was only about whether her parents could sue in state court after losing their case in vaccine court. The Supreme Court said no. Had they allowed the case, state courts across the country would have been flooded with thousands of vaccine lawsuits, and it is entirely likely that vaccine makers would simply stop selling vaccines in the United States. The ensuing loss of vaccines would be a public health disaster of enormous magnitude, leading to tens of thousands of deaths from diseases that we now have largely defeated in this county.

This sounds awfully dire. Why do I claim it could happen? Because it almost did, some 25 years ago.

Back in the 1980s, largely due to one incredibly irresponsible, inaccurate television documentary called DPT: Vaccine Roulette "started a firestorm" of panic, as Paul Offit explains in his latest book (1). It also caused an avalanche of lawsuits, and juries were soon making multi-million dollar awards. As Dr. Offit documents, jury awards in vaccine cases increased from $25 million in 1981 to $3.2 billion in 1985. Two of the three companies making the DPT vaccine stopped distributing it, leaving only one company, Lederle (now owned by Wyeth) supplying it.

It wasn't just DPT. Companies making measles and polio vaccines also dropped out of the U.S. market, leaving just one company for each. We were very close to a situation where we simply wouldn't have childhood vaccines in this country.

Then, remarkably, the federal government passed the National Childhood Vaccine Injury Act of 1986. This set up a special fund to compensate anyone damaged by vaccines, covered by a tax on all vaccines. It also created a special Vaccine Court to hear cases, and required that vaccine cases go through this court. The standard of evidence for the court was lower than regular courts: for some conditions, the parents merely have to show that their child suffered the condition soon after getting a vaccine, regardless of whether the vaccine was the cause.

The law also took juries and state courts out of the equation. Vaccine makers were protected, and the childhood vaccination system was saved. The Vaccine Court functions remarkably well, using Special Masters who become far more educated about vaccines and possible side effects than any regular judges can be. There is a very small but real risk of harm from vaccines, and the Vaccine Court has made thousands of awards to compensate victims. Meanwhile, millions of severe illnesses and countless thousands of deaths have been prevented by vaccines.

So I was very dismayed that two justices, Sandra Sotomayor and Ruth Bader Ginsburg, voted against the majority. I usually agree with these two, but their reasoning in this case was wildly off. Sotomayor's dissent shows her to be misinformed, confused, or just plain naive:

"Trial courts, moreover, have considerable experience in efficiently handling and disposing of meritless products liability claims, and decades of tort litigation (including for design defect) in the prescription-drug context have not led to shortages in prescription drugs. Despite the doomsday predictions of respondent and the various amici cited by the concurrence ... the possibility of a torrent of meritless lawsuits bankrupting manufacturers and causing vaccine shortages seems remote at best."

Apparently Sotomayor is unaware of the actual "torrent of meritless lawsuits" from the 1980s that forced Congress to create the Vaccine Court in the first place, although I cannot understand how she could fail to know this history. I am also disappointed by her naive faith in trial courts to quickly dispose of "meritless product liability claims." Perhaps in an ideal world, yes. But a smart lawyer, a sympathetic victim, and a complex medical case can easily confuse both judge and jury, leading to enormous jury awards regardless of what the scientific evidence shows.

Apparently Sotomayor can't bear to limit the ability of plaintiffs to sue wherever they choose. The Vaccine Court, although imperfect, is a much better model for handling complex medical claims than the roulette of a jury trial. We should all breathe a sigh of relief that the Supreme Court kept this system intact.

Of course, the anti-vaccination movement has been quick to attack the decision. Age of Autism, one of the biggest anti-vax sites, posted an article titled "Supreme Court Ruling Abandons Vaccine-Injured Children, Threatens Vaccine Safety" in which they call the decision "a crushing blow to the rights of every U.S. citizen." A coalition of anti-vax organizations including Generation Rescue issued a press release calling the decision "misguided" and making a number of incorrect claims about vaccine safety. But scientists and doctors, notably the American Academy of Pediatrics, applauded the decision.

Reference

1. Paul A. Offit, M.D. Deadly Choices: How the Anti-Vaccine Movement Threatens Us All. Basic Books (2011). See especially pages 2-12.