"Recontrolling pertussis": a phrase we shouldn't have to hear

The word is going out that a lot of people need to get a pertussis booster shot Pertussis, more commonly known as whooping cough, is a bacterial infection that is very dangerous and sometimes fatal in young infants, whose immune systems are too immature to protect them. The only way to protect the very young is to make sure those around them -- parents, siblings, other relatives, and day care providers -- are vaccinated. Many adults were vaccinated as children, but the vaccine's protection wanes after about ten years, so they still need a booster shot if they are caring for children.

What's new here? First, there's a new report from an expert advisory panel to the Centers for Disease Control. The CDC panel is urging doctors to vaccinate everyone who might be in contact with young children, even if they can't remember when or if they had the pertussis vaccine. A report in the Journal of the American Medical Association this past week quotes pertussis expert Michael Brady, M.D., who chairs the American Academy of Pediatrics committee on infectious diseases, who says the new recommendations are needed as part of our efforts at "recontrolling pertussis."

What does Dr. Brady mean when he says "recontrolling"? Well, whooping cough is not under control right now. In California, a serious epidemic continues. (See my previous post about it here.) The CDC reports over 7,800 cases of pertussis throughout California, including the deaths of 10 infants. These infants were too young to be vaccinated, and their deaths are a tragedy that could have been prevented. The last time we saw this many cases of whooping cough in California was 63 years ago, in 1947.

Meanwhile, Michigan continues to have its own pertussis outbreak, with 1,092 cases this year, and 902 cases last year. And the pertussis epidemic has spread to Ohio, where two counties collectively report 910 cases this year, the largest number in 25 years.

In infants and very young children, pertussis causes violent, spasmodic coughing that repeats over and over. The cough is so strong that babies cannot breath properly, and after multiple coughs they will breathe in sharply with a classic "whooping" sound, which gives the disease its name. Pertussis is far more dangerous in infants than in adults: from 2000-2004, 92% of the pertussis deaths in the U.S. were in children less than one year old.

Whooping cough used to be under control. The number of nationwide cases was dropping for years, and although the disease didn't disappear, we were getting to the point where most people didn't know anyone who'd had it. The question is, why did we lose control? Is a new strain of pertussis to blame? Or is it our own behavior?

Unfortunately, the answer seems to be that these outbreaks are spreading as a result of falling vaccine rates, for which we can thank the anti-vaccine movement, which has been very effective at getting their message out through mainsteam media, including the Larry King show, Oprah, and The Huffington Post. One of the main groups in this movement is the mis-named National Vaccine Information Center, which really should be called the Vaccine Misinformation Center. Their pertussis web page contains a section titled "Can pertussis vaccine cause brain damage and death?" The mere act of asking this question is part of their anti-vaccine strategy. And rather than answering "no," the website goes on for several paragraphs, selectively quoting from studies that looked at vaccine risks - which are very small, but not zero - while ignoring the much greater risks of the disease itself. NVIC's website concludes by claiming (without citation) that

"Most pediatric neurologists acknowledge that vaccination, including use of vaccines for smallpox, rabies, influenza, mumps, measles, tetanus, polio and pertussis, can and does occasionally cause neurological complications that can lead to permanent brain dysfunction."

Scare tactics indeed. Not only is NVIC trying to scare parents away from the pertussis vaccine, but they take the opportunity to warn against many other vaccines. NVIC claims on its website that it "does not promote the use of vaccines and does not advise against the use of vaccines," but that, to put it bluntly, is a lie. Their primary mission is anti-vaccine advocacy, as illustrated by their current advertising campaign that claims we are "over-vaccinating" children and injecting them with harmful toxins.

So we can thank NVIC and other anti-vaccine groups, such as Generation Rescue (which claims, among many other mistaken notions, that the pertussis vaccine causes autism), for the re-emergence of whooping cough.

In contrast, here's what the CDC says about the pertussis vaccine:

"Results from clinical trials showed that these vaccines are very safe for infants and children....The most common adverse events reported have been tenderness and redness where the shot was given, headache, diarrhea, and fussiness."

Unlike NVIC, the CDC gives details and citations to the scientific literature. The CDC also maintains a separate page listing all possible side effects from a long list of vaccines.

The current vaccine against whooping cough is called DTaP or TDaP (short for " tetanus toxoid, reduced diphtheria toxoid and acellular pertussis", and the evidence shows that it is very safe. The vaccine does not contain any whole cell, not even killed bacteria, meaning that it is impossible for the vaccine to cause even a mild case of any of the diseases that it protects against.

The CDC advisory on the pertussis vaccine is not part of a conspiracy to "over-vaccinate" the public, or to pad the profits of Big Pharma. (By the way, to pre-empt some of the commenters: I am not paid a single penny by any pharmaceutical company, nor am I paid by Forbes.) The advisory is a necessary step to "recontrol" whooping cough, a disease that we should not have let back into our communities. I fear that if we keep listening to the anti-vaccine activists, pertussis will be just the first in a series of diseases that will return to plague us, causing needless suffering and anguish.

Short and sweet: the strawberry genome

Happy holidays to everyone, and here's a very short seasonal post: the strawberry genome is here! Kevin Folta from the University of Florida led the effort to put the paper together for the journal Nature Genetics, and he has a nice behind-the-scenes summary on his blog here. One tasty tidbit is that the initial proposal for funding failed because the peach and apple genomes had stronger support - but strawberry beat them both (neither of those genomes is yet complete). It's the first plant to be assembled entirely from next-generation sequences, thanks in large part to the efforts of assembly guru Art Delcher.

And the genome really is "short and sweet", weighing in at just 240 million bases of DNA. (See the paper here.) That's pretty small, for a plant. The apple tree genome is over ten times larger, and the pine tree is 100 times larger. But strawberries are sweeter.

Non-GMO foods: nonsense

I was at a local organic food market recently buying lunch, and I noticed that my avocado-and-hummus sandwich proclaimed that it contained "non-GMO" ingredients (GMO = "genetically modified organism).

Now, I happen to like organic groceries. The ones near me tend to have better produce and fish, two of the main ingredients in my diet. But organic markets are a hotbed of bogus, even laughable health claims, and I often have to suppress my urge to complain to the store's management. (I once wrote to Whole Foods, but they never responded.)

Here in the U.S., most of our food supply is filled with so-called GMO foods, but in Europe the situation is dramatically different. For some reasons, our otherwise well-educated European friends are terrified of GMO foods. They don't seem to realize that we've been modifying the genes in our foods for centuries, and it's generally been a good thing. The latest biotechnology merely allows us to modify plants (and animals too, though none are yet on the market) much more quickly, and more intelligently. Today we can alter just a few genes to produce a more-desirable plant, rather than doing it by trial-and-error over many generations.

In fact, the "GMO" foods of the past likely had hundreds of unknown gene modifications.Farmers selected plants for seed because they looked and tasted good, without having any idea of what was really different about them.

Let's take a look at corn. The corn we eat today, organic or not, looks nothing like the "real" corn (or maize) from centuries ago. The earliest corn cobs discovered by archaeologists were tiny, with only a few kernels. This picture shows a primitive form of corn, called teosinte, compared to modern corn:

The history of corn is a history of genetic modifications made by earlier humans who didn't even know what a gene was. Today's GMO food is simply a continuation of that history.

That hasn't stopped opponents of GMO foods from sounding the alarm. Even the World Health Organization makes some errors on its website, where it discusses three main "issues of concern for human health":

1. Allergenicity. Not a problem. The WHO says "No allergic effects have been found relative to GM foods currently on the market."
2. Gene transfer. The WHO gets this one wrong. They write that "gene transfer from GM foods to cells of the body or to bacteria in the gastrointestinal tract would cause concern if the transferred genetic material adversely affects human health." Gene transfer is a topic that I've studied in some detail, and published papers on. The WHO says that the likelihood of a gene transfer event is "low," but in fact it is vanishingly small - so small, in fact, that not a single gene transfer event has ever happened. In the history of our species, and of all mammals, going back tens of millions of years, not a single gene from something we've eaten has been transferred into the human genome or, as far as we can tell, into bacteria within our guts.
3. Outcrossing. This is "the movement of genes from GM plants into conventional crops," and this really can happen - they're the same species, so they can interbreed. But it's only a concern if GM plants are harmful, which they're not.

The bottom line is, you're far more likely to be harmed by being hit on the head by a corn cob than by some kind of deviant GMO corn gene.

The WHO concludes that GM foods "are not likely to present risks for human health." Of course, not all GMO foods are good. I'm not a fan of engineering crops to be more tolerant of pesticides, for example: this type of GMO food benefits big agricultural firms rather than the consumer. And it is theoretically possible to insert harmful genes into plants, but agricultural firms wouldn't have any reason to do that.

So the next time you see the non-GMO claim in your grocery, ask yourself whether the ingredients could really be completely unmodified from their "natural" state. I doubt it.

My sandwich was really good, by the way.

At the movies: popcorn and anti-vaccine fearmongering

The anti-vaccinationists have launched a new campaign this holiday season to spread cheer – oops, I mean fear – to moviegoers everywhere. Yes, the folks at SafeMinds and Age of Autism have produced an advertisement that they are trying to place in AMC theaters across the country. In fact, they almost succeeded, but quick action by skeptical science bloggers at SkepChick, Respectful Insolence, and their readerships convinced AMC to cancel the ad – for now.

The ad that SafeMinds is trying to run is intended to scare people away from getting their flu vaccine, just as flu season is beginning. The vaccine this year will protect you against both the new “swine” flu, called H1N1, and the previous flu strain, H3N2. Early data from the CDC makes it clear that both strains are still around, with H3N2 showing up somewhat more frequently so far this fall. The vaccine not only protects you, but also your family, your colleagues, and the many other people you might come into contact with each day while at work, shopping, or elsewhere.

Why try to scare people? Well, the people behind SafeMinds and Age of Autism believe that the preservative thimerosal, which is used in some but not all flu vaccines, causes autism. This theory has been thoroughly investigated over the past 10 years, and just as thoroughly discredited. In fact, it never had any positive evidence to support it in the first place, but it has been promoted aggressively by a journalist, David Kirby, who made his fortune off a book based on the thimerosal-autism hypothesis. (I’m not providing a link – Kirby has already made far too much money off this bogus claim, and I don’t want to give him the web traffic.)

Thimerosal was introduced into vaccines in the 1930s, and it is a very effective means to prevent the growth of bacteria without affecting the potency of the vaccine itself. In over 60 years and hundreds of millions of doses, it has proven to be quite benign. Nonetheless, it contains a form of mercury called ethylmercury, which anti-vaccinationists claim causes autism and other neurological disorders.

The claim that thimerosal causes autism was the central question of a large, multi-year Autism Omnibus trial, which ruled definitively last year that thimerosal does not cause autism. I wrote about that ruling at some length back in March, and I won’t repeat it here, except to quote again from the Special Master’s decision:

“The numerous medical studies concerning the issue of whether thimerosal causes autism, performed by medical scientists worldwide, have come down strongly against the petitioners’ contentions. Considering all of the evidence, I find that the petitioners have failed to demonstrate that thimerosal-containing vaccines can contribute to the causation of autism.”

The anti-vax crowd will not give up, unfortunately. Rather than spending their time and effort trying to find the true causes of autism, they continue to repeat claims that have already been shown false. For example, the SafeMinds website lists 5 “key points” that are just flat-out wrong. Here are the first two:

1. “The autism epidemic that began in the late 1980’s is likely due primarily to toxins adversely affecting fetus and infants during development.” Wrong, in at least two ways. First, there is no autism “epidemic.” The best evidence today indicates that the rising rates of autism are due to a combination of factors, primarily (a) rising rates of diagnosis due to increased awareness among physicians and patients and (b) a dramatically broader medical definition of autism that was introduced in the early 1990s.
2. “Mercury is likely a major contributor to this toxin-induced autism, whether the source of the mercury is from vaccines or environmental mercury exposure.” Wrong again. This is the claim that was so thoroughly refuted in the lengthy Autism Omnibus trial, with hundreds of pages of testimony from dozens of experts, and epidemiological data from literally hundreds of thousands of people.

But data doesn’t seem to have any effect on the anti-vax zealots at Age of Autism and SafeMinds.

Because AMC refused to run their ad, Age of Autism is telling its readers to stay away from AMC theaters this holiday season. I hope they do! Why? Because these unvaccinated individuals are a genuine threat to public health. Movie theaters, and the malls in which they are located, are an ideal place for infectious diseases to spread. Without vaccines, countless thousands of people would fall ill every holiday season after mingling with other shoppers, and some would likely die. My message to the unvaccinated crowd at SafeMinds is: stay away from the rest of us.

And I encourage everyone else to get your flu shot, get your kids vaccinated, and then go see a movie at an AMC theater. Meanwhile, you can also tell them at this link that you appreciate their taking a stand against misinformation and for the benefit of public health.

Oscillo – what? Homeopathic flu “cures” and dead ducks

Oscillococcinum sounds like medicine. And if you saw this package in a store next to all the other cold and flu remedies, you might be tempted to give it a try. It looks just like a box of anthistamines or other real medicines. With flu season coming soon, you might want to look at this box more closely before you buy it.

You can buy oscillococinum at Walgreen’s, Target, Amazon.com, and many other places. At Walgreen’s, one of the largest pharmacy chains in the U.S., it’s listed under “Cough and Cold” where it sells for $9.99 (a savings of $4.50!) for 6 doses.

It sounds like medicine, but it’s not. The front of the box says (in small print) that it’s “homeopathic medicine,” which isn’t medicine at all. In fact, it’s nothing more than a sugar pill, which is why the product can advertise that it has “no side effects” and “no drug interactions.”

But in much larger print, the package says “Flu-like Symptoms”, followed by a list of symptoms: “Feeling run-down, hadaches, body aches, chills, fever.” Anyone might be fooled into thinking this product is supposed to treat these conditions. If you go to the manufacturer’s (Boiron) website, they make the explicit claim that it “Temporarily relieves flu-like symptoms such as feeling run down, headache, body aches, chills and fever.” The Walgreen’s website says the same thing.

What’s in Oscillococcinum, and how can its producer get away with these claims?

Oscillo contains “Anas barbariae hepatis et cordis extractum 200CK.” Don’t be fooled by the Latin – it just means extract from the heart and liver of a duck. Yes, they kill ducks to make this stuff. The manufacturer then dilutes it to 200C, which in homeopath-speak means that 1 gram of extract is diluted to one part in 10⁴⁰⁰. Yes, that’s 10 raised to the power 400. Wow! The entire known universe has far fewer than 10⁴⁰⁰ molecules. If you filled the entire solar system with water, and mixed in one molecule of duck liver, it would be much more concentrated than this stuff. Oscillo is so diluted that there is essentially zero chance that even a single molecule of the original extract is in the product. The package does say that sugar is added to the pills, and that’s all they are: sugar pills.

The idea that infinitely diluted substances can cure disease is a type of magical thinking, and it’s at the heart of homeopathy, whose proponents believe that the more dilute something is, the more powerful its effects. This bit of nonsense goes against basic principles of chemistry and physics, but no matter: homeopaths continue to insist on it.

And I shouldn’t forget to mention that there’s not a whit of evidence that extracts made from the heart and liver of a duck can cure the flu. Nope, not a chance.

The French-based manufacturer, Boiron, and the U.S. stores selling Oscillo can get away with this because it’s not a drug at all – it’s a supplement. Supplements are basically unregulated in the U.S., thanks to laws passed decades ago, some of them specifically designed to protect homeopaths. As long as you don’t claim that your product can treat a specific illness, you can sell it.

The box itself doesn’t say that Oscillococcinum cures the flu, but the product’s manufacturers have been making this claim on their website. Some of them have stepped over the line: the FDA sent a warning letter to one homeopathic marketer this past summer telling them that Oscillo “has not been approved or otherwise authorized by FDA for use in the diagnosis, mitigation, prevention, treatment , or cure of the H1N1 Flu Virus” and requesting that they “immediately cease marketing unapproved or unauthorized products for the diagnosis, mitigation, prevention, treatment, or cure of the H1N1 Flu Virus.”

Unfortunately, the FDA only steps in when the claims get particularly outrageous, or when (as here) they involve a high-profile disease such as avian flu. The purveyors of Oscillo can simply modify their packaging (and websites) slightly and go right ahead misleading the public.

So if you want to waste $10 on 6 sugar pills, go ahead. But at least try find a product that doesn’t require dead ducks.

Further reading: see Orac’s recent post on this same topic here.

U.S. comes down against gene patents

In a surprising move, the U.S. Justice Department filed a brief last Friday that declared, for the first time, that the U.S. government does not support the patenting of naturally occurring human genes. This new position is contained in a document filed as part of the ongoing legal challenge to the gene patents on the human breast cancer genes, BRCA1 and BRCA2.

As background: a company called Myriad Genetics has held the patents on these two genes since the late 1990s. They sell diagnostic tests that cost nearly $4,000, and if a woman wants to test her own DNA for any mutations in the BRCA genes, they are required to pay for this very expensive test. The gene patents prevent any competitors from offering the same test without paying Myriad a license fee. Earlier this year, the ACLU challenged these patents in federal court, and the initial court ruling, which came as a surprise to many, invalidated the patents. Myriad appealed, and it seems likely this will end up in the Supreme Court before it is finally settled.

I have a scientific interest in this case, having just published a paper that directly challenges gene patents by providing free software that allows anyone to test their own DNA for mutations in the BRCA genes. Our software requires that you first have your genome sequenced, which (of course) is not feasible for most people today, but which I think will be routine in the not-too-distant future.

It seems absurd that, having your own DNA in hand (on a flash drive, perhaps), you wouldn’t be allowed to check your own genes for mutations without first paying a license fee to a company. Actually, under current law you might have to pay hundreds of license fees, because thousands of human genes have already been patented.

The same government that issued these patents has finally woken up to this absurdity. In their amicus brief, the Justice Department wrote:

“the unique chain of chemical base pairs that induces a human cell to express a BRCA protein is not a ‘human-made invention.’ Nor is the fact that particular natural mutations in that unique chain increase a woman’s chance of contracting breast or ovarian cancer. Indeed, the relationship between a naturally occurring nucleotide sequence and the molecule it expresses in a human cell – that is, the relationship between genotype and phenotype – is simply a law of nature. The chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is ‘isolated’ from its natural environment than are cotton fibers that have been separated from cotton seeds.”

Rarely have I seen such sensible scientific reasoning from lawyers, and I must say it is very refreshing. Just in case the text quoted above is isn’t clear enough, the brief goes on to point out that “the patent laws do not, however, embrace the products and processes of nature itself.” The reason for the bit about “isolated” DNA is that Myriad’s patents cover DNA that has been “isolated” from the cell, and the Justice Department wanted to make it clear that this distinction should not somehow make the DNA patentable.

The legal implications of my own challenge to the BRCA gene patents were discussed at length at Genomics Law Report, and by Forbes blogger Robert Langreth. It will be interesting to see how this latest filing by the Justice Department changes the picture. The implications go far beyond the BRCA gene patents: if the initial court ruling and the Justice Department’s position hold up, then virtually all gene patents, on human genes and on many other species’ genes, will become invalid.

It’s about time. New genes have been the basis of many exciting discoveries, but they are not inventions. No one should have exclusive rights to a gene that occurs naturally in a human, another animal, a plant, or any other living species.

Osteopathic medicine redux

Some of you may have noticed that I removed my blog post on osteopathic medicine. Over at Forbes there is a fierce debate in the comments section, and I've put up a new post there, at this link, correcting what may have been a too-harsh commentary, if anyone wants to follow this discussion further.

Whooping cough in California: deaths caused by the anti-vaccination movement

California is suffering the worst epidemic of pertussis, or whooping cough, in 60 years, with over 5,200 cases already, the most since 1950. Nine babies have died, all of them too young to receive the vaccine. Michigan is also reporting a serious outbreak, with over 600 cases so far this year. The deaths of the infants in California are tragic, and what’s more tragic is that some of them almost certainly could have been prevented if more people had been vaccinated.

The pertussis vaccine, called DTaP (diphtheria, tetanus, and pertussis) has been responsible for a dramatic drop in whooping cough in recent decades. It isn't 100% effective, but its effectiveness relies in part on “herd immunity”: if enough people are immune to the bacteria, then even if someone gets sick, the disease cannot easily spread through the community. This is especially true for very young infants, who are too young to be vaccinated and whose immune systems are not yet strong enough to defeat the bacteria on their own.

Unfortunately, it’s not a coincidence that California is the center of the new pertussis epidemic. Vaccination rates among adults in California have been dropping in recent years, largely due to the influence of anti-vaccination zealots such as Jenny McCarthy and groups such as Age of Autism. Anti-vaccination sentiments seem to strike a chord with relatively well-educated segments of the population – the same people who favor organic food and want to use “natural” products as much as possible. Anti-vaxers appeal to this group by arguing that vaccines are unnatural, and that the body’s own immune system can be “boosted” by various natural treatments. Appealing though this may sound, it has no basis in science. California makes it easy for parents to claim exemptions from the required vaccinations for their children, and exemptions have more than doubled since 1997, according to the L.A. Times.

Among the anti-vaccinationists who deserve blame for the current pertussis outbreak is “Dr. Bob” Sears, a kindler, gentler anti-vaxer who claims (like many of them) to be in favor of vaccines, but only under his own, unscientific terms. He stated flatly in the Huffington Post (a hotbed of medical misinformation) recently that pregnant women should not get the DTaP vaccine. But as Dr. Paul Offit tells us in a tragic story, refusing the vaccine can lead directly to the death of an infant. Dr. Bob is just wrong. I should add that Sears has written two books on vaccines and autism, promoting his misguided “alternative” vaccine schedule (see this article in Pediatrics about that) and his rather naive theories about the rise in autism diagnoses.

Everyone should have their children vaccinated. On top of that, in order to maintain herd immunity, most of us should get the pertussis booster shot if we haven’t had one in the last ten years. That’s what vaccine expert Paul Offit recommends, and I’m planning to follow his advice myself. It won’t take long, and it might save a life.

For-profit universities: the Yugos of higher education

For-profit universities (FPUs) have been spreading like wildfire the past few years, thanks to the growth in Internet access, aggressive marketing, and, as we’ve learned recently, government-subsidized student loans. Some of these “universities” are enormous, such as the University of Phoenix, with over 400,000 students. The U.S. government has recently figured out that students at these universities are failing to repay their government-subsidized loans at alarming rates, and it’s planning to impose stricter rules on these loans. This has spurred a frantic lobbying campaign from the FPUs. Today’s Washington Post, for example, has a column by former Secretary of Education Margaret Spellings, now a consultant for the FPU industry, in which she claims the government is trying to “restrict access to a full range of education providers,” cleverly avoiding any mention of what she really wants: continued access to the cheap government loans that prop up these out-of-control institutions.

As a college professor, I’ve been following the growth of these companies, and here’s this professor’s blunt conclusion: they offer low-quality, almost worthless degrees. They have virtually no academic standards. They will accept anyone who can pay, and they seem to care primarily about the bottom line. They also haven’t addressed (and virtually never mention) the elephant in the room: many online students are probably cheating to pass their courses, which aren’t very demanding in the first place. As a result, degrees from FPUs are not highly regarded by employers, who are right to view them with suspicion.

Like it or not, an important part of any college diploma is the reputation of the school that awards it. The Yugo was indeed a car, but would you really want to buy one?

Stem cell heroes and villains

Stem cell research in the U.S. has been on a roller coaster ride the past few weeks. First, federal judge Royce Lamberth surprised everyone on August 23 by calling a halt to all federally-funded work on embryonic stem cells (ESCs). Hundreds of NIH-funded scientists learned overnight that their funding was about to be cut off, halting work on cures for a wide range of incurable diseases and conditions, including Parkinson’s disease, spinal cord damage, Lou Gehrig’s disease, heart disease, diabetes, arthritis, and others.

Then, this past Thursday, a federal appeals court announced a temporary stay on Judge Lamberth’s ruling, which allows the funding to continue. However, the court gave both sides only until September 20th to make new arguments, and the research could again be called to a halt before the month is out. Many scientists, including this one, hope the appeals court will throw out the case and let the research proceed.*

Stem cell research is one of the most promising opportunities for truly revolutionary breakthroughs in human health that we’ve seen in decades. Unfortunately, its progress has been slowed dramatically in the U.S. due to objections from the religious right, which mistakenly confuses stem cell research with abortion. Many of these opponents don’t seem to know that thousands of fertilized human eggs are discarded every year, perfectly legally, by fertility clinics, and their opposition to embryonic stem cell research only serves to hamper progress on life-saving cures.

So who is the villain in this latest battle? Much of the media attention has focused on Judge Lamberth, whose interpretation of the Dickey-Wicker amendment has been disputed by many legal and medical experts (for example, here and here). I don’t want to re-hash those arguments here. Instead, let’s take a look at the so-called scientists who filed the case, and examine their claims.

Virginia's war on science and academic freedom

The attorney general of Virginia, Ken Cuccinelli, is waging a war on science. Earlier this week, a federal judge dismissed Cuccinelli's lawsuit against the University of Virginia, but Cuccinelli has already announced that he will appeal the decision. This battle threatens not just climate researchers, but any scientist working in the state of Virginia.

Cuccinelli is a disturbingly right-wing politician whose primary actions since taking office have all been designed, seemingly, for his own political gain. He doesn't seem to mind wasting the tax dollars of Virginia's citizens as long as he can get his own name in the headlines.

His current battle is against global warming. Back in May, he announced with great fanfare that he was suing the University of Virginia over the work of climate scientist Michael Mann, a professor at Pennsylvania State University. It appears that Mr. Cucinelli disagrees with Prof. Mann over his findings about global warming. Prof. Mann is one of the world's leading experts on global warming, and he co-authored the study that produced the "hockey stick graph" showing a dramatic increase in temperature in recent decades:

Source: 2001 IPCC Third Assessment Report

The conclusions that the Earth is warming up, and that humans are one of the main causes, are no longer controversial within the scientific community, especially after the UN's Intergovernmental Panel on Climate Change (the IPCC) issued its report a few years ago. Nonetheless, many global warming denialists, including Mr. Cucinelli, continue to dispute them.

But Cucinelli isn't just a global warming denialist. He's also the attorney general of Virginia, which gives him quite a bit of power within that state. He's not a scientist, but that didn't stop him from suing the University of Virginia. His legal "trick" - what allowed him to use his power to go after Prof. Mann - hinges on the fact that Prof. Mann formerly was a professor at UVA, and while working there, he received a small grant from the state to support his work. (Never mind that the vast majority of his funding came from the federal government.) This was enough for Cucinelli to sue UVA, claiming that Prof. Mann had committed fraud by misusing state funds.

Cucinelli demanded that the University release all documents related to Prof. Mann's work, including all emails, laboratory notes, and any other correspondence since 1999. (This was a classic "fishing expedition: he didn't say what he was looking for.) To its credit, UVA refused, citing academic freedom, and challenged Cucinelli in court. The judge who dismissed the case pointed out that Cucinelli's suit was so vague that it didn't even specify how it was that Prof. Mann committed fraud. Apparently Cucinelli was unable to come up with a single concrete example of fraud.

Academic freedom is often cited in defense of questionable behaviors, but this case goes to the very heart of what academic freedom is all about. University professors - scientists, economists, historians, all of us - should be free to pursue the evidence wherever it takes us, and to write about our findings without fear of retribution. Even if his lawsuit fails on appeal, Cucinelli's lawsuit threatens to cast a chill over research in Virginia. Will scientists at UVA or other state universities, perhaps concerned about lawsuits, word their findings more carefully in the future? Will they simply avoid research on controversial topics, even if those topics are important to society?

The Virginia attorney general's groundless lawsuit, based on his purely political views and ambitions, is clearly intended to intimidate academic scientists at Virginia universities. Prof. Mann himself called the case "criminal harrassment." This kind of political threat is reminiscent of the oppressive regimes of the Soviet Union, whose scientists only published findings that met with the approval of their political masters. Political threats are a recipe for bad science.

UVA is a great university, but I'm glad I don't work there right now. If I did, I'd probably be looking to move.

Acupuncture infiltrates the University of Maryland and NEJM

This is embarrassing. In a recent article in the New England Journal of Medicine, Brian Berman from the University of Maryland argues why acupuncture should be recommended for patients with lower back pain. In the very same article he and his colleagues explain that the evidence shows that there is no difference between real acupuncture and sham acupuncture. That’s right: it doesn’t matter where you place the needles, or even if you puncture the skin. Even toothpicks will give the same effect. Any good scientist would conclude, obviously, that acupuncture doesn’t work.

But not Dr. Berman. Or (to give proper credit) his co-authors, Drs. Langevin, Witt, and Dubner.

Without a hint of irony, Berman and colleagues describe how

“Internal disharmony is believed to cause blockage of the body’s vital energy, known as qi, which flows along 12 primary and 8 secondary meridians. Blockage of qi is thought to be manifested as tenderness on palpation. The insertion of acupuncture needles at specific points along the meridians is supposed to restore the proper flow of qi.”

Note the careful wording: they write “is believed to cause” and “is supposed to restore.” Perhaps they don’t believe it themselves? Maybe they’ll explain later that this pre-scientific magical thinking has no place in modern medicine, and no basis in biology, physiology, physics, or any other science.

Nope! Instead, they say

“Efforts have been made to characterize the effects of acupuncture in terms of the established principles of medical physiology on which Western medicine is based. These efforts remain inconclusive, for several reasons.”

How about this reason: there’s no effect, therefore nothing to explain. Perhaps Berman missed that first-year course in logic.

Let’s be clear: acupuncture is pseudoscience. It’s based on magical thinking about a non-existent “life force” that has never had one whit of evidence to support it. The only benefits are placebo effects, as the sham acupuncture experiments demonstrate. The notion of “meridians” that can be somehow fixed by sticking needles into the skin is laughable. (A 2000 review article concluded that meridians and acupuncture points simply don’t exist.) Berman’s article attempts to give acupuncture credibility by pointing to studies that show, for example,

“Acupuncture has been shown to induce the release of endogenous opioids in brain-stem, subcortical, and limbic structures.”

Without getting into the details (most of these studies are poorly done), it’s no surprise that sticking needles into the skin causes a physiological effect. Duh!

Berman has gone to great lengths to try to show that acupuncture works. One of the studies he cites is his own NIH-funded study of “electroacupuncture”, a treatment that involves sticking in needles and then applying an electrical current. (One wonders how the “ancient” Chinese acupuncturists managed to plug in their needles.) To demonstrate that electroacupuncture releases hormones, they tortured some rats – nearly electrocuted them, in fact. To quote from the study:

“EA [electroacupuncture] intensity was adjusted slowly over the period of approximately 2 min to the designated level of 3 mA, which is the maximum EA current intensity that a conscious animal can tolerate. Mild muscle twitching was observed.”

But hey, what’s wrong with a bit of rat torture in the name of pseudoscience?

Why do I say this is embarrassing? Well, I’m a professor at the University of Maryland. I’m not at the the School of Medicine (where Berman is), which is an independent campus in Baltimore, quite distinct from the much larger main campus in College Park, where I work. But when the headline says “University of Maryland”, it reflects on all of us. And while I can’t prevent Dr. Berman from promoting pseudoscience, at least I can make it clear that he’s not speaking for me.

Dr. Berman is the recipient of millions of dollars in grants from NIH’s National Center for Complementary and Alternative Medicine (NCCAM) (here's one). It’s no surprise, then, that Berman concludes his NEJM article by calling for more research into acupuncture:

“It may also be important to try to identify the optimal candidate for acupuncture on the basis of individual beliefs, expectations, and psychological profile.”

In other words, let’s see if particularly gullible people might be more willing to tell us that acupuncture works. He recommends other studies too, presumably to be funded by NCCAM. Berman’s work is an example of why I have repeatedly called on Congress and the President to eliminate NCCAM. NCCAM’s annual budget of $129 million is an appalling waste, and after >15 years and >$2 billion in funding, it has yet to prove the efficacy of a single “alternative” treatment.

After reviewing the research and acknowledging out that sham acupuncture is just as effective as “real” acupuncture, Berman and colleagues recommend how to treat a hypothetical patient with chronic lower back pain:

“We would suggest a course of 10 to 12 treatments over a period of 8 weeks from a licensed acupuncturist or a physician trained in medical acupuncture.”

This is astonishing: they just finished explaining that acupuncture doesn’t work any better than sham treatment. So why go to a “licensed” acupuncturist, since you can use toothpicks that don’t puncture the skin and get the same effect? Toothpick acupuncture won’t cost $125 per session (that’s $1000 for Berman’s recommended treatment), and it doesn’t carry the very real risk of infection. Based on the evidence reviewed in their own article, Berman et al. are recommending a treatment that seems to border on malpractice.

I hasten to add that the University of Maryland at Baltimore (not my campus!) has many outstanding scientists and excellent research programs. But UMB seems happy to support this rotten apple in its midst (as does NEJM, I should add). It issued a press release about Berman’s article in which Albert Reece, Dean of the medical school, says

“Dr. Berman and his team at the University of Maryland Center for Integrative Medicine are international leaders in the field of integrative medicine; they are among the many innovative, world-class researchers at the University of Maryland School of Medicine.”

I’m afraid I’ll have to disagree with the Dean on that. Berman's Center for Integrative Medicine is an embarrassment to the University, and its presence undermines the efforts of other scientist to understand and treat disease.

But hey, maybe I’m missing something. Perhaps I just have a blockage in my qi.

(For further reading, I highly recommend the excellent blog posts on the Berman et al. study by Mark Crislip, David Gorski, and Steven Novella, all at Science-Based Medicine.)

Scientists build a better salmon

Salmon may soon be the first genetically modified animal to hit our dinner plates. We've been eating GMO foods for years, mostly without noticing it, but until now all the genetically modified organisms have been plants.

The new salmon was developed by AquaBounty Technologies, a company in Massachusetts, and here╒s how it works: start with Atlantic salmon, add a growth gene from the Pacific Chinook salmon, and add another gene from the ocean pout (Trisopterus luscus). In combination, these two genes make the Atlantic salmon grow to maturity in just 18 months, instead of the normal 3 years. The new salmon have the potential to make salmon farming much more efficient. The Washington Post reported this week that the FDA is close to approving the fish for human consumption.

This is cool science. So why are all the reports, both in the mainstream media and the blogosphere, making it sound like a frightening development?

Let's get one thing straight: we have to learn how to farm our fish. The human race is rapidly depleting the stocks of almost every wild fish that we like to eat, and many traditional fisheries are already wiped out. Others have been depleted so badly that severe fishing limitations have been imposed in a desperate attempt to allow stocks to recover. This can't go on.

Think about it: we farm all the other animals that we eat. Imagine that we only ate wild cows, or chicken, or pigs. The human race can't be fed by wild animals alone - we're too numerous and too hungry. Sooner or later, we will drive wild fish to extinction, unless we make the switch to farmed fish.

And as I wrote recently, oily fish like salmon contain omega-3 fatty acids, which appear to carry health benefits, especially when compared to the fats contained in other meats. We should all eat more salmon.

Okay, but what about the downsides of GMO salmon? The anti-GMO forces have issued statements warning of dire consequences if these "Frankenfish" are allowed on the market. Wenonah Hauter, the director of Food and Water Watch, a nonprofit whose goals I generally support, issued a statement that is full of misinformation. For example, she claims that the salmon are "toxic", which sounds pretty scary. As evidence, she says "a recent study commissioned by the European Union revealed that fish that have been modified to grow faster also have a higher tolerance to the toxins in their environment."

I looked up the EU study, by by Fredrik Sundström at the University of Gothenburg, to learn what it actually said. Although the university's press release says that "transgenic fish can be more resistant to environmental toxins," the study itself didn't provide any evidence for this claim. In fact, it didn't even study toxins. Instead, Prof. Sundström looked at what might happen if GMO fish escaped into the wild, and he concluded that they might survive better than wild fish. He didn't conclude anything about toxins.

Hauter of Food and Water Watch isn't the only one to get this wrong. Reporter Paulina Reso at the New York Daily News got it just as wrong, reporting that "A study commissioned by the E.U. found that these engineered fish have a higher tolerance to toxins, putting consumers at risk." She cites the same press release from the University of Gothenburg.

Not only is the claim about toxins unfounded, but it ignores the very real (and widely documented) danger of mercury accumulating in wild fish, including salmon. If you're truly concerned about toxins in fish, you would support fish farming, not oppose it.

The Center for Food Safety's George Kimbrell, quoted in The Post article and elsewhere, threatened to sue the FDA if they approve the new transgenic salmon. He says they are concerned about "catastrophic consequences like the gulf oil spill." Wow, that sounds awful! Transgenic salmon will be as bad as the largest oil spill in U.S. history? Is he kidding? Rather than spend time on breathless hyperbole, Kimbrell should be worried about the very real possibility of driving wild salmon to extinction. He doesn't explain what his concern is based on, and it seems that his group simply opposes any genetically modified organisms on principal. Their opposition is not based on science, nor on any well-thought-out concern about nature or the environment.

And yes, I know that fish farming itself can be harmful to the local environment. But our response can't be to abandon fish farming and continue overfishing until all wild fish are extinct. As the saying goes, don't let the perfect be the enemy of the good. We should work on ways to improve fish farming techniques and make them more sustainable.

Transgenic technology is cool. Of course it can be used in ways that don't benefit consumers - but so can traditional genetic techniques (which don't require any FDA approval, by the way). Take tomatoes: I can't remember the last time I found a tasty store-bought tomato in the U.S. They look great but taste like cardboard, all thanks to selective breeding that makes them easier to pack and transport. If someone creates a transgenic tomato that tastes good, I'll be the first in line to buy it. Meanwhile, I'm looking forward to the day when I can taste the new transgenic salmon.

Fish oil salesmen

Well, they’re not quite the modern-day equivalent of snake-oil salesmen, but the parallels are irresistible. In the 19th century, snake oil was promoted as a cure for joint pain and other ills, and the figure of the snake-oil salesman was widely ridiculed. (Ironically, snake oil is still used as a treatment in China today, despite the lack of any evidence for its efficacy.)

Today we have a new figure: the fish oil salesman. This modern figure, though, is no joke: he is a polished, sophisticated figure with the full weight of the FDA behind him. Should we buy his product?

Last week, while watching a major sports event, I was treated to a new commercial for a product called Lovaza, which I learned “helps to lower very high triglycerides in adult patients.” It’s a beautiful commercial, with an actor in a lab coat (am I supposed to think he’s a scientist?), carrying a clipboard and walking through a lab surrounded by blue aquariums. (Apparently the lab is under water.) You can see the ad here.

Deceptive marketing of dietary supplements

Without any fanfare, Congress held a hearing recently on how supplements are marketed to the elderly. The Government Accountability Office (GAO) conducted a study of 40 different herbal supplements, looking at what the supplements actually contained as well as how they were being sold, both in stores and online. Not surprisingly, the GAO found that companies have been making deceptive, inaccurate claims about many of the most popular supplements sold in the U.S. (I’m shocked, shocked!)

As reported in last week’s Journal of the American Medical Association, the report was requested by Senator Herb Kohl. The report states that some of the companies involved have been referred to the FDA and FTC for appropriate action. But for some mysterious reason, it fails to provide any specific information about who these snake-oil purveyors are. That’s right: not a single company or website is named. Why not?

Well, thanks to the Internet, I can name a few of them - keep reading.

Another hero of the anti-vaccine movement bites the dust

I often wonder what motivates anti-vaccinationists. Are they in it because they truly believe they are offering valid treatments and advice? (Some of them do, I think.) Or are they just in it for baser reasons, such as money and fame?

Boyd Haley is a retired professor of chemistry from the University of Kentucky. His name has appeared several times in the Comments sections of this blog (for example, here and here), when commenters have presented him as a scientific expert supporting the claim that thimerosal in vaccines causes autism.

In his own words, Haley has said

“I have been a strong proponent of investigating thimerosal as the casual agent for autism spectrum disorders based on the biological science that shows thimerosal to be incredibly toxic, especially to infants.”

Haley also wrote

“If, indeed, the complete removal of thimerosal from vaccines was not followed in an appropriate time by a decrease in autism then this would be solid proof that thimerosal was not causal for autism.”

Thimerosal was removed from childhood vaccines in the U.S. by 2002, and the rate of autism diagnoses continued to increase, but Haley simply changed his tune and continued to claim that thimerosal causes autism. The overwhelming (and still growing) evidence against the thimerosal-autism link has apparently done nothing to change his mind.

Is Haley simply a confused chemist who fails to understand epidemiological evidence? Or does he have another agenda?

Well, he does: money.

As Los Angeles Times reporter Trine Tsouderos wrote in a two-part story this past week, Haley and his company have been marketing a chelating agent – a powerful, highly toxic chemical that removes mercury from the bloodstream – as a treatment for autism. They also claim that this chemical, called OSR#1, is a harmless dietary supplement. Haley’s company, CTI Science, is selling OSR#1 as "a toxicity free, lipid soluble antioxidant dietary supplement." The LA Times ordered 30 100-milligram capsules of OSR#1 for $60 through an online pharmacy.

The FDA has sent Haley and his company a formal warning letter telling them to stop marketing this unapproved drug as a supplement. Haley’s claim that OSR#1 is a supplement is a flimsy attempt to try to avoid regulation of this dangerous chemical as a drug, though it clearly is a drug. (Dietary supplements are unregulated in the U.S. - a topic for another day.) The FDA letter is unambiguous, stating:

“this product is a new drug, as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling.”

Just to be sure, I checked the CTI website today, and the main headline is “CTI Science Introduces OSR#1.” Haley is President and CEO of the company and his former University of Kentucky holds a patent on it. There are no clinical trials or other data showing that OSR#1 is safe or effective; on the contrary, the FDA letter explains that it has several serious side effects, including diarrhea, abnormalities of the pancreas, and lymphoid hyperplasia.

This hasn’t stopped Boyd Haley and his company from marketing their drug as a treatment for autism. The anti-vaccination site Age of Autism has promoted it; indeed, the LA Times reported that

[AoA’s] managing editor, Kim Stagliano wrote of sprinkling the white powder on her three daughters' breakfast sandwiches and orange juice. "We've seen some nice 'Wows!' from OSR," she wrote.

Boyd Haley may be misguided, but he has a deep financial reason for pushing the link between thimerosal and autism: without it, his company can’t sell its product.

Will the anti-vaccinationists start to doubt Dr. Haley? Will his obvious conflict of interest, and his violation of FDA regulations, make them wonder why he’s selling them a powerful, possibly harmful chelating agent to treat their children? I hope so.

For further reading, I recommend the recent articles by Dr. Steven Novella at Neurologica and Orac’s detailed discussion at Respectful Insolence.

Save NIH $$$: eliminate “alternative” medicine

This past week, President Obama called on all federal agencies to voluntarily propose budget cuts of 5%. What, cut the science budget? Well, Mr. President, you might be surprised to learn that there's a way for you that cut the NIH budget without hurting biomedical research. In fact, it will help.

Here's my proposal: save over $240 million per year in the NIH budget by cutting all funding for NCCAM and OCCAM, the two centers that fund alternative medicine. NCCAM is the National Center for Complementary and Alternative Medicine, and OCCAM is the Office of Cancer Complementary and Alternative Medicine, and both of them exist primarily to promote pseudoscience. For the current year, NCCAM’s budget is $128.8 million, an amount that has rapidly grown from $2 million in 1992, despite the fact that not a single “alternative” therapy supported by NCCAM has proven beneficial to health. OCCAM’s budget was $121 million in 2008 (the latest I could find) and presumably higher in 2010. That’s over $240M, not counting money these programs got from the stimulus package (and yes, they did get some stimulus funding).

These two organizations use our tax dollars – and take money away from real biomedical research – to support some of the most laughably pseudoscientific claims that you can find. To take just one example, NCCAM has spent $3.1 million supporting studies of Reiki, an “energy healing” method. Energy healing is based on the unsupported claim that the human body is surrounded by an energy field, and that Reiki practitioners can manipulate this field to improve someone's health. Not surprisingly, the $3.1 million has so far failed to produce any evidence that Reiki works. But because there was never any evidence in the first place, we should never have spent precious research dollars looking into it.

A breakthrough cure for Ebola

Ebola is one of the nastiest, most frightening viruses known to man. Its victims suffer fevers, muscle weakness, and other symptoms that progress to severe bleeding, both internal and external, that eventually causes them to bleed to death. All known strains of Ebola virus have very high mortality rates, ranging from 25% to 90%, and there is no cure. Ebola virus was the subject of a dramatic and frightening 1995 disaster movie, Outbreak, starring Dustin Hoffman, Rene Russo, and Morgan Freeman.

Last week, in what may be the biggest medical breakthrough of its kind in years, a group of scientists published results in The Lancet describing a completely new type of anti-viral treatment that appears to cure Ebola. They report a 100% success rate, although admittedly the test group was very small, just 4 rhesus monkeys.

This is a breakthrough not only because it may give us a cure for an uncurable, incredibly nasty virus, but also because the same method might work for other viruses, and because we have woefully few effective antiviral treatments. We can treat bacterial infections with antibiotics, but for most viruses, we have either a vaccine or nothing. And a vaccine, wonderful as it is, doesn’t help you after you’re already infected.

The scientists, led by Thomas Geisbert at Boston University, used a relatively new genomics technique called RNA interference to defeat the virus. Here’s how it works. First, a little background: the Ebola virus is made of RNA, just like the influenza virus. And just like influenza, Ebola has very few genes - only 8. One of its genes, called L protein, is responsible for copying the virus itself. Two others, called VP24 and VP35, interfere with the human immune response, making it difficult for our immune system to defeat the virus.

Geisbert and his colleagues (including scientists from Tekmira Pharmaceuticals and USAMRIID) designed and synthesized RNA sequences that would stick to these 3 genes like glue. How did they do that? We know the Ebola genome’s sequence – it was sequenced way back in 1993. And we know that RNA sticks to itself using the same rules that DNA uses. This knowledge allowed Geisbert and colleagues to design a total of 10 pieces of RNA (called “small interfering RNA” or siRNA) that they knew would stick to the 3 Ebola genes. They also took care to make sure that their sticky RNA would not stick to any human genes, which might be harmful. They packaged these RNAs for delivery by inserting them into nanoparticles that were only 81-85 nanometers across.

In the key experiment, the scientists infected rhesus monkeys with a dose of Ebola that was 30,000 times greater than the normal fatal dose. They injected the siRNA treatments 30 minutes later, and again each day for 6 days. All the monkeys survived with no long-term effects.

When I read this story in The Lancet, my first reaction was: wow. A brand-new antiviral treatment, and against Ebola? In a commentary in The Lancet, Heinz Feldmann wrote that we are “in desperate need of approved countermeasures against Ebola-virus infections,” and called the new study a “milestone.” That’s putting it mildly.

Somehow, except for the UK Daily Mail, the major media outlets seem to have entirely missed this story, which I think is by far the biggest medical story of the week, if not the year. Ebola virus doesn’t get much attention (notwithstanding the 1995 movie about it), primarily because it occurs in central Africa. But air travel has made our world much smaller, and even a relatively isolated virus could easily get out of control.

There’s still a much work needed to turn the new Ebola treatment into an approved drug, but the prospect of a cure is suddenly very real, and the techniques used to create it are truly remarkable.