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.]

Don't take your vitamins

We've known for a long time that vitamins are good for you. Perhaps the best example is vitamin C, which completely cures scurvy, a disease that has plagued mankind for millenia. (It was described by Hippocrates some 2400 years ago.) Scottish doctor James Lind described how to cure scurvy with citrus fruit back in 1753, but it wasn't until 1932 that scientists Albert Szent-Gyorgyi and Charles Glen King identified vitamin C as the essential nutrient behind the cure for scurvy. (Szent-Gyorgi gave vitamin C the name ascorbic acid because of its anti-scurvy properties.)

Many other vitamins and micronutrients are required for good health, such as vitamins B and D, iron, folic acid, calcium, and potassium. Deficiencies in these vitamins cause all sorts of diseases, some of them very serious.

So it seems intuitively obvious that if a little bit of these nutrients is good for you, then a lot should be even better. Right? This intuition is the basis for the a huge and powerful nutritional supplements industry, which makes billions of dollars each year selling multi-vitamins and high-dose supplements in a bewildering variety.

The problem is, our intuition is wrong. Two separate studies published this past week, involving tens of thousands of subjects, showed that high doses of vitamins and supplements, rather than being helpful, can sometimes kill you.

In the first study, Jaakko Mursu and colleagues have been following 38,772 older women since 1986. The women in the study, whose average age was 62 back in 1986, have reported their use of multivitamins and supplements for the past 25 years. The news was not good: the risk of death INCREASED with long term use of multivitamins, vitamin B6, folic acid, iron, magnesium, zinc, and copper. The risk of death only decreased with the use of calcium. They also noted that in other studies, calcium had the opposite effect.

The authors concluded that there's

"little justification for the general and widespread use of dietary supplements,"

and the story was widely reported as showing that supplements are risky (Wall St. Journal) and unnecessary (New Zealand Herald).

In the second study, Eric Klein and colleagues studied 35,533 men over the past 10 years, looking at whether vitamin E or selenium would decrease the risk of prostate cancer. Both supplements have been claimed to have benefits, so the researchers randomly divided the subjects into four groups, giving them daily doses of (1) vitamin E only, (2) selenium only, (3) vitamin E and selenium, and (4) nothing (in the form of placebo pills).

The result: the risk of cancer INCREASED for the men taking vitamin E, selenium, or both. Although the increased risk is small, it is abundantly clear that neither of these supplements is helpful against prostate cancer.

Not surprisingly, the supplements industry hasn't taken this news lying down. The Council for Responsible Nutrition is an industry lobbying group representing the supplements industry (don't be fooled by the name). They released a statement by their vice president, Duffy MacKay (a naturopath, which is a form of quackery I'll have to treat separately in the future), grasping at the fact that, in the study, the increased risk of cancer from vitamin E plus selenium wasn't quite as big as the increase from vitamin E alone.

"This reinforces the theory that vitamins work synergistically," said MacKay.

Aha! So if I take even more supplements, perhaps my risk of cancer will go up only an eensy-teensy bit?

The Council released a second statement about the study on multivitamins, saying

"CRN maintains that nutrients may be robbed of their beneficial effects when viewed as if they were pharmaceutical agents, with scientists looking to isolate those effects, good or bad."

I see... so the benefits of supplements will disappear if we treat them as drugs: wouldn't that include taking vitamins and supplements as pills?

The supplements industry (Big Supp?), which is largely unregulated, has a darker side too: countless hucksters, many operating primarily through the Internet, who are making a fortune selling overpriced supplements (and advice on how to use them) that they claim will cure cancer, diabetes, and a host of other diseases. These include internet quack Mike Adams, who posted a response to this week's studies on his Nature News website, claiming:

"Recent attack on vitamins a fabricated scare campaign."

In Adams' response, he starts by arguing that the American Medical Association"has a long and sordid history of openly attacking vitamins and nutrition," a bizarre claim that has nothing to do with the study results even if it were true (it's not). He goes on to claim that the

"study data were ALTERED!"

(the all-caps is his) and

"voodoo statistics [were] used to alter the outcome."

I looked at the numbers he extracted from the paper to support these claims, and he failed - badly - to understand the data. Apparently for Mike Adams, statistics that he doesn't understand are just "voodoo."

So I'm afraid the news boils down to this: eat lots of fruit and vegetables, and a balanced diet, and you'll get all the micronutrients and vitamins you need. Supplements are only needed if you have a demonstrable deficiency. For most people, multivitamins and other supplements are a waste of money, and they might even be harmful. But hey, apples are in season right now, and spinach can be kind of tasty if you prepare it properly.

Is the government hiding something about the next flu pandemic?

Remember the flu pandemic? The one that swept the world just two years ago? You might be forgiven if this has slipped your mind - after all, it doesn't seem like such a big deal now. That's because we got lucky: despite many dire warnings about the danger of another 1918 "Spanish flu", when the 2009 pandemic arrived, it was far milder than previous pandemics. Hundreds of millions of people got the flu in 2009, but for most of them, it wasn't so bad. In fact, the new flu is less severe the old flu - the strain that was circulating before the new pandemic hit.

Now we have two flus circulating: the "old" H3N2, and the 2009 pandemic flu, called H1N1. (And the vaccine protects against both of them, so get your flu shot! Your friends, neighbors, and co-workers will all benefit.)

We really dodged a bullet in 2009. Despite our best efforts, it took 7 months (April to November) before a new vaccine was ready. Before we realized how mild it was, people were desperately snapping up stores of Tamiflu, an anti-viral medicine that only barely helps to treat the flu. If it had been like 1918, Tamiflu wouldn't have helped much, and tens of millions would have died.

The 2009 pandemic originated in pig farms in Mexico. We don't know precisely where it made the first leap into humans, but it appears that two different strains joined together in a pig somewhere to create the new H1N1. The flu has a nasty habit of jumping the species barrier, hopping to humans from both pigs and chickens.

So now that we know all this, next time will be different, right? The world's influenza scientists are monitoring pigs and chickens closely now, keeping a close eye on any new flu strains. Right? RIGHT???

Er, no. Not exactly. For one thing, surveillance in pigs appears to be nonexistent. I checked to see how many flu sequences from pigs in Mexican have been desposited in the public archive at GenBank since 2009 (using this terrific database). The result? One, in 2009. Nothing from 2010 or 2011. Hello, is anyone awake at the CDC and the WHO?

This despite the fact that scientists have serious concerns that the deadly H5N1 avian flu (the "bird flu") could combine its genes with H1N1 and create a really nasty new flu strain. And scientists have long had concerns that pigs could be the mixing vessels for new flu outbreaks - exactly what happened in 2009.

But wait… maybe they are monitoring the flu, but they're just not telling us. That would feed into all the fringe government conspiracy groups that claimed the 2009 pandemic was an intentionally engineered government-funded enterprise (see this BMJ article for more). I don't believe any of those conspiracy theories - most of them are just nuts - but read on.

Sharing data about flu viruses has been a touchy subject with the WHO and the CDC for years. As reported by the University of Minnesota's CIDRAP,

"In late 2006, virus sharing became an international flash point when Indonesia broke a long tradition of free international sharing of flu virus specimens by withholding its H5N1 virus samples as a protest against the high cost of commercial vaccines derived from such samples. The controversy has drawn attention to the problem of equitably distributing vaccines in the event of a pandemic."

A few months ago, the WHO finally agreed on a new set of principles on data sharing, which states that

"The WHO GISRS laboratories [which includes the CDC] will submit genetic sequences data to GISAID and Genbank or similar databases in a timely manner."

Excellent! If they do it.

As every biomedical scientist knows, GenBank is a free, public database of genetic sequence data that contains millions of sequences, from humans, bacteria, viruses, you name it. But GISAID is another database, in Switzerland - one that I initially supported - just for flu data. The original mission of GISAID was that data deposited there would go to GenBank as well, with little or no delay. But in a classic bait-and-switch move, the GISAID board changed that policy after the database was up and running, and now they can sit on data as long as they want.

OK, you say, but it's a private database, so they can do what they want. True enough. But here's the surprising bit: the CDC deposits most of its flu sequences ONLY in GISAID, where they can milk them for scientific results for years without sharing them with others. As one of GISAID's original supporters, I have an account there, and here's what I found.

So far, the CDC has deposited sequences from 6,801 flu isolates in GISAID, of which only a tiny handful are in GenBank. 3201 of these originated in the U.S., so there can't be any foreign government insisting that they be kept secret. These provide critical data that could help scientists predict what is coming in the next flu season. But you can't get these sequences without a GISAID account. And even if you have a GISAID account, as I do, you have to agree not to release the data as a condition of getting a look.

So why does the CDC deposit sequences in GISAID? I think it's precisely because of the restrictions. CDC's scientists don't want others to look at "their" data, because they're afraid someone else might discover something important and publish it before them.

The CDC, of course, is part of the U.S. government, and all its work is funded by the public. But it seems that the CDC flu scientists have forgotten their public health mission - or at least, they appear to be more concerned about their own careers (and the papers they might publish) than about making sure the world is ready for the next pandemic.

And by the way, even these sequences don't seem to include anything from pigs in Mexico. Hello, CDC? You are looking at swine flu now, aren't you?

Perhaps I'm being a bit harsh. I love the CDC: they do a terrific job most of the time, providing vital services to protect the public from infectious diseases. But their internal scientists sometimes seem to operate within a cocoon, and I'm afraid that's happening here. This culture of secrecy has got to stop, and I suspect that will only happen under pressure from the outside. The CDC Director, Thomas Frieden, needs to tell his flu people to start sharing what they know with the rest of the world. And they can start by putting their data in GenBank.