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.