The worst quackery of 2011: battlefield acupuncture

Pseudoscience continued to thrive in 2011, making my choice for the worst quackery of the year a difficult one.  So much nonsense!  Promoters of both new age and old-time hocus pocus continued to sell their unscientific therapies, as they have for decades (or centuries), including homeopathy, Ayurveda, acupuncture, qigong, reiki, magnet therapy, and a cornucopia of special "super foods", all guaranteed to cure whatever ails you.  These various alternatives to medicine are just as ridiculous today as when they were invented, decades or centuries ago.

How can anyone choose the worst practice among so many false claims?  Well, those that cause real harm to patients are worse than those that are merely useless.  I also decided to give extra weight to newer forms of mumbo jumbo.  But I could have chosen differently, and I encourage readers to nominate their own favorites in the Comments section.

And the 2011 winner of the worst quackery award is: battlefield acupuncture.  This particular bizarre medical practice offers a trifecta of ills:

1. It offers no medical benefit and carries a real risk of harm for some patients.
2. The U.S. government is wasting tens of millions of dollars per year on it, and plans to increase its spending next year.
3. The patients are wounded combat veterans who have no choice about where to get treatment.

Battlefield acupuncture has a growing number of supporters in the U.S. Defense Department (especially Richard Niemtzow, its proud inventor), who are determined to see it delivered to as many troops as possible.  I've written about this before, but it's in the news again this month, in Wired magazine.  In battlefield acupuncture, the "doctor" (no competent doctor would do this) sticks needles into the patient's ear to relieve pain.  Yes, that's right: needles in the ear.

Battlefield acupuncture was invented out of whole cloth by military doctor Richard Niemtzow, who runs an acupuncture clinic out of Andrews Air Force Base in Maryland.  Niemtzow appears to be the leading advocate for the use of acupuncture on wounded soldiers, and he has been disturbingly effective.  The military publication Stars and Stripes reported in August that the Air Force has

"launched a program to train more than 30 military doctors to use acupuncture in the war zone and at their base clinics. The program will be expanded next year with the Air Force, Army and Navy combining funds for two courses to certify 60 active-duty physicians as medical acupuncturists."

Multiple scientific studies have shown clearly that acupuncture doesn't work. The benefit is the same no matter where you place the needles, or even if you use toothpicks that don't pierce the skin.  (See a summary here, with multiple references.)  Acupuncture points and "meridians" - the pathways that acupuncturists claim to manipulate with their needles - don't even exist.

Acupuncture carries a real risk of harm, too, primarily from infection.  Acupuncturists don't practice sterile procedure, as I've pointed out before.  They claim that they do, because they think that using sterilized needles is sufficient.  Wrong again.  Sterile procedure requires that every site of needle insertion be properly sterilized, because most infections are caused by bacteria already present on the skin.  As reported last year in BMJ:

"Although most patients recovered, 5-10% died of the infections and at least another 10% had serious consequences such as joint destruction, paraplegia, necrotising fasciitis, and multiorgan failure."  

Pretty serious harm from a procedure with no real benefit.

The evidence for "auricular acupuncture" - sticking needles in the ear - is less than zero.  This shouldn't be surprising, since Neimtzow just pulled this wacky theory out of thin air - but he and his converts have repeatedly asserted that it works, although they offer nothing more than anecdotes.  Niemtzow has even claimed that 18th-century pirates pierced their ears to improve their night vision.  Yes, really.  Now he's piercing the ears of wounded soldiers.

A big part of the Wired story is how the billionaire founders of the Samueli Institute, an institute dedicated to pseudoscience, have used their political muscle to obtain millions of dollars in Defense Department earmarks to support acupuncture research.  ($7.6 million in 2010, for example.)  Make no mistake, there's plenty of money in acupuncture, as in the rest of the alt-med industry.

But the real harm is in treating wounded soldiers by sticking needles in their ears, instead of offering real treatments.  To their credit, some soldiers are not fooled by Niemtzow's claims.  As a veteran over at Military.com said,

"In civilian medicine, this [battlefield acupuncture] would be called malpractice. This smacks of using military personnel in the field as guinea pigs. That's a dangerous game. If the pain of severe trauma isn't treated effectively in a timely manner, shock and even death can follow."

That discussion appeared in 2008, but three years later, Andrews Air Force Base has a full-time acupuncture clinic, and the military is training more doctors in this dangerous, ineffective, and highly unethical practice.  For this, battlefield acupuncture gets my award for the worst quackery of 2011.

(For further reading, see David Gorski's excellent takedown of battlefield acupuncture from 2008.)

The Skeptical Optimist

Some readers of this blog may be surprised to learn that I'm very optimistic about the future of science and medicine.  Over the past few years, I've criticized many different frauds, fakes, bad scientists, bogus claims, quack medical practices, and scam artists.  I will continue to do so.

But deep down, I'm an optimist.  Science has transformed our lives over the past century, thanks to a list of discoveries far too long to write down, including cures and vaccines for many childhood diseases, better ways to heat and light our homes, and faster ways to travel and communicate. I'm confident science will continue to make progress on all sorts of problems affecting our species. One reason I focus my criticism on pseudoscience is that every minute spent on bad science is a minute that could have been spent on real science, moving us closer to genuine treatments or real scientific discoveries.

I also write on occasion about true breakthroughs, such as the recent success using stem cells to treat damaged hearts, or last year's development of a vaccine against the Ebola virus.  It's good to remind ourselves that good stuff is happening despite all the nonsense being pushed by quacks out there.

But I'm a skeptical optimist.  All real scientists must be skeptics: we know that initially exciting results often turn out to be statistical flukes, experimental errors, or just plain randomness.  We have to check and double-check our results before publishing, and even then we sometimes make mistakes.  Our training makes us skeptical whenever we hear about some amazing new breakthrough, even when we are hopeful that the results are true.

But we can't let pseudoscience take precious resources away from real work.  So it's back to the front lines in the ongoing battle against the anti-science forces: watch this space tomorrow for my choice for the worst quackery of 2011.

Kill the tigers

Here's a choice: save the last remaining tigers on the planet, or kill them, chop them into pieces, and eat them in the mistaken belief that tiger parts can be used as medicine.

Sounds like an easy choice, no? Unfortunately, humans have already decided to kill the tigers rather than saving them. Fewer than 4,000 wild tigers survive on the planet. As journalist Caroline Alexander wrote in a compelling article in the December issue of National Geographic, "tigers in the wild face the black abyss of annihilation." And their greatest threat, she writes, is "the brutal Chinese black market for tiger parts."

Traditional Chinese Medicine (TCM) practitioners claim that tiger parts can be used to treat a wide variety of ailments, including malaria, bacterial infections, bad skin, ulcers, leprosy, and impotence. There is not a whit of scientific evidence to support any of these claims; they are nothing more than folk medicine, based on primitive beliefs dating from a pre-scientific era, when it was believed you could acquire the properties of an animal by eating it. Unfortunately, these beliefs have driven the mightiest of the big cats to the brink of extinction.

The World Federation of Chinese Medicine Societies asked its members to stop using tiger bones last year, but their action is far too little, too late. The New York Times reported around the same time that tiger-based "medicines" are widely available in China.

Proponents of Traditional Chinese Medicine claim that it is beneficial, but they have no science to back them up. NIH's National Center for Complementary and Alternative Medicine (NCCAM), an apologist for all sorts of quack medical practices, explains that

"In the TCM view, a vital energy or life force called qi circulates in the body through a system of pathways called meridians. Health is an ongoing process of maintaining balance and harmony in the circulation of qi."

This is little more than fantasy. Too bad NCCAM's leaders seem to have forgotten whatever they knew about human physiology. They might just as well explain that midi-chlorians circulating in the blood are the source of the Force. (Actually, there are midichlorians in nature now, in a species of tick.  Really.)

Some forms of "alternative medicine" are ineffective but mostly harmless (think homeopathy, which is just water and sugar pills), while others can be harmful to the patients who use them (think acupuncture, with its risk of infection, or ayurveda, which uses toxic chemicals). TCM is doubly harmful: it doesn't benefit patients, and it is the single greatest threat to the world's tigers. I hope people come to their senses before the last tiger is gone.

Stem cell hopes for damaged hearts

As the holiday season begins, I decided to discuss some good news about real science.

The promise of stem cell research just got a lot brighter.

There was some very good news from the world of medicine just a couple of weeks ago. For the first time, stem cells were injected into the hearts of humans who had suffered serious heart damage, and patients improved dramatically. It appears that, as everyone hoped, the stem cells grew into new heart cells to replaced the damaged tissue. This is the promise of all stem cell research: to repair or replace damaged organs that otherwise would never recover. In principle, we can someday use the same technique to replace damaged livers, kidneys, spinal cords, cartilege, and virtually all other tissues in the human body.

In the new study, just published in The Lancet, a group of researchers led by Robert Bolli grew stem cells from patients' own hearts, after the patients had suffered serious heart attacks, leaving their hearts permanently damaged. Bolli explained to CNN reporter Caleb Hellerman:

"Once you reach this stage of heart disease, you don't get better. You can go down slowly, or go down quickly, but you're going to go down."

In an effort to repair the patients' hearts, Bolli and colleagues collected a small amount of tissue from each patient's own heart, and purified stem cells from that tissue. By using the patient's own cells, there is no danger of rejection as there would be with cells from an unrelated donor.

They measured the patients' heart function by how much blood was being pumpled through the left ventricle. The patients had an average Left Ventricular Ejection Fraction (LVEF) of 30.3% at the beginning of the study, an indication of very severe heart disease. Four months later, the 16 patients who received the stem cells had an average LVEF of 38.5%, while patients in the control group (who didn't get the stem cells) showed no change. Even more dramatically, after one year the patients LVEF had improved further, to 42.5%.

Thus, remarkably, the cardiac stem cells seem to have "taken" in these patients, growing back into healthy cardiac cells in these severely ill patients. The researchers used MRI to measure the damaged heart tissue in 7 of their patients, and found that it had actually decreased by 30% after one year. In a companion trial at Cedars-Sinai Heart Institute in Los Angeles, Dr. Eduardo Marbán reported similarly positive results. Marbán told CNN that the patients grew approximately 600 million new heart cells after the procedure, comparable to the number of cells that die in a serious heart attack.

One reason these findings are especially dramatic is that they show convincingly that the human heart contains stem cells that can re-grow into new heart cells. It is entirely possible that heart damage that has always been thought to be irreversible can be completely repaired - someday.

The results are very preliminary, and only a few patients have been treated so far, but this is a major triumph for stem cell research. The research in question used adult stem cells, but embryonic stem cells may prove even more effective, and may be easier to obtain because they don't have to come directly from someone's heart.* Heart disease is the leading cause of death in the U.S., and we need to pursue every possibility for new treatments. Those who oppose stem cell research - including embryonic stem cell research - should wake up and take notice: many lives are at stake.

*Disclaimer: Until June 2011, I was a member of the Maryland Stem Cell Research Commission, a state commission established by the legislature and the governor to promote human stem cell research through state-funded grants. The views expressed here, as always, are my own, and do not represent the Commission.

Football has corrupted America's universities

(In which I take on the football-industrial complex again.)

Big-time college football is no longer a sport. It's a very expensive entertainment industry with commercial sponsors, big-money television contracts, and highly paid executives. Its proponents have corrupted the mission of almost every university with a large football program, especially those in the NCAA's top division. It's time to acknowledge that this large, expensive entertainment business should be expelled from campus.

No, I'm not talking about Penn State. (Not this week, that is. I wrote about Penn State's scandal in a New York Times forum last week.) This week we have another scandal, which illustrates all too well how football will crush any forces that might try to rein it in, including university presidents. Here's the scenario:

1. Pay $2 million to buy out the old coach and hire a more exciting one, even though the team is having its best season in years.
2. Hire that new coach for another $2 million, who has now produced a losing season (2 wins, 10 losses), leaving games with even lower attendance than last year.
3. Because football is still losing money, get rid of 8 other varsity sports.

This is a bad joke, right? No! This is exactly what the University of Maryland just did. Last week, U. Maryland (where I was a professor until this past summer) announced it was eliminating 8 varsity sports teams to make up for the fact that football was losing too much money. I kid you not. Here's what they are cutting: men’s cross-country, indoor track, outdoor track, men’s swimming and diving, men’s tennis, women’s acrobatics and tumbling, women’s swimming and diving, and women’s water polo.

The president of U. Maryland, Wallace Loh, issued a report that he sent to all students and faculty, describing the tortured reasoning that led to this sorry state of affairs. In it, he illustrates how he and his administration have completely lost sight of their real mission. Poor Dr. Loh: he came into the job only a year ago, with good qualifications to run a major educational institution, but no qualifications to run a football program. After all, why should he?

It's not because football is good for the university, despite the claims of some fans. Just to check, I compared the rankings of the top 25 football teams to the academic rankings of their universities. This graph shows the result.

As you can see, there is no correlation at all - the football team's ranking gives you no indication of the overall academic quality of a school.

So why cut eight other teams when football is failing? Dr. Loh explains:

"In a time of constrained resources, we have to choose: should we have fewer programs so that they can be better supported and, hence, more likely to be successful at the highest level? Or, should we keep the large number of programs that are undersupported compared to their conference peers?"

There you have it. We can't keep all these programs around if they're not winning! "Successful at the highest level" - such broken logic, such nonsense from the president of a major university, is almost enough to make me cry. Obviously, Dr. Loh thinks that "successful" means we beat the other schools' teams. But his own report says that a university's core mission is "education, research, and the arts." Did he evaluate these sports teams based on how well the students are educated? No: what matters is whether a team wins.

And of course there's money: if the football team wins, then the university can make money from oh-so-lucrative television contracts! Dr. Loh acknowledges this:

"If we believe—as I do—that intercollegiate athletics is an integral part of the college educational experience and not only commercialized mass entertainment, then we must come together to reform this financial model …. We have to reset the balance between academics and big-time athletics."

I'll say. But despite these nice-sounding phrases, Dr. Loh's "reform" consists of eliminating eight other varsity teams. Nothing about reigning in football's costs, and certainly nothing about making sure the players themselves get a good education and have a future after college. This is the essence of how big-time football has corrupted America's universities. We pay the players nothing, we give them a lousy education (many of them don't even graduate), and then the university spits them out and moves on.

I've heard the cries of protest from football supporters: football makes money! It subsidizes all the other sports! Oddly, even Dr. Loh makes this claim in his report, despite admitting that football at Maryland is losing millions of dollars per year. To this I have two responses:

1. Fine, let's suppose that football makes money. Then it will do just fine as an independent business. Get it out of the universities, and let each team pay fees use of the university's name, the stadium, practice fields, and parking on game days. Then the football club can pay its coaches whatever it wants, and it can pay the athletes, who are disgracefully paid nothing right now. And the university will still have its team, but without the corrupting influence of money.
2. So what if football does make money? Since when did universities run an entertainment business? Should they open casinos next?

So get football off our campuses. If athletes want to train for the NFL, let the NFL pay for a minor league, the way baseball does. Universities can have a team if they must, but make it independent, and let's stop the farce of having university presidents try to manage large, commercial sports programs. Let them get back to focusing on research and education, topics on which they actually have some expertise.

As for the athletes: let them play. They can play football if their studies leave them enough time. If they just want the exercise, they can go out for other sports that provide great physical training and far lower risks of injuries. They can try the track team, or maybe the swim team. Oh, wait….

[Note: for those who will criticize me as a football-hating weenie, I'll have to disappoint you. I grew up watching and loving college ball, before it become so commercialized. My father played varsity football all through college, and he taught me the game in our backyard.]

Chronic fatigue syndrome researcher arrested

A brief update today: I've written twice before about the mistaken hypothesis that chronic fatigue syndrome (CFS) is caused by a virus known as XMRV. After many followup studies failed to replicate the original findings, other scientists finally determined conclusively that XMRV was a contaminant in the original cells used in the experiments. Lead researcher Judy Mikovits continued to claim she was right and that everyone else was wrong, despite the evidence, but in a surprising move less than two months ago, all the authors (including Mikovits) retracted the paper. (Actually it was a "partial retraction", but they did admit that XMRV was a contaminant which pretty much blows up the whole claim.) Science is now investigating whether some of the data in the paper was falsified, as Trine Tsouderos reported in the Chicago Tribune last month.

In a bizarre twist in this saga, Mikovitz was arrested and thrown in jail on Friday in California. Science magazine's Jon Cohen reported that her former employers, the Whittemore-Peterson Institute, which fired Mikovitz on September 29, filed felony charges against her in Nevada for stealing their laboratory data. It appears that WPI claims Mikovitz kept data about her experiments on her personal computer and has refused to give it back to WPI. Mikovitz' lawyer denied the charges.

I suspect this isn't the last we'll hear of this story. But the science is done: XMRV isn't the cause of CFS, and the search for a cause continues.

Chiropractic adjustments can heal your DNA?

The headline above should be good for a laugh, but believe it or not, chiropractors around the world are claiming that they can help your body repair its DNA. All of them cite the same 2005 article as evidence, so I read the article to find out what it was all about.

The article is titled "Surrogate Indication of DNA Repair in Serum After Long Term Chiropractic Intervention – A Retrospective Study," written by Clayton Campbell, Christopher Kent, Arthur Banne, Amir Amiri, and Ronald W. Pero. They published it in 2005 in a chiropractic journal called the Journal of Vertebral Subluxation Research. This journal has many of the trappings of a scientific journal, but it's really all make-believe: it does not appear to be properly peer-reviewed, it is not indexed by standard biomedical databases, and (most damning of all) it is based on a concept, "subluxation," that does not exist. That's right, even the UK's General Chiropractic Council admitted in 2010 that subluxation was a mirage, saying:

"The chiropractic vertebral subluxation complex is an historical concept but it remains a theoretical model. It is not supported by any clinical research evidence that would allow claims to be made that it is the cause of disease or health concerns."

So about that journal article. The claim that chiropractic treatments could somehow improve your body's ability to heal its own DNA seems wildly implausible, but that's what Campbell and colleagues claim. Their press release, which was reproduced verbatim on many chiropractor's websites, said:

"In a landmark study published in the Journal of Vertebral Subluxation Research, chiropractors collaborating with researchers at the University of Lund found that chiropractic care could influence basic physiological processes affecting oxidative stress and DNA repair."

(I can't help remarking that authors don't usually boast that their own work is a "landmark study," but let's move on.)

Unfortunately for Campbell and colleagues, their study has fundamental flaws that completely undermine their claims, as we'll see below. Nonetheless, many chiropractors' websites are touting this amazing "benefit" today, including sites that were updated as recently as a few weeks ago, such as: this one (updated Oct 31 2011), this one, this one, this one in Australia (updated Oct 2011), this one in Australia, and many more.

So what did Campbell et al. actually study? First, they didn't measure DNA repair at all. They measured serum thiol levels, which at best are a very indirect indicator of DNA repair. And they ran a very small study, with just 76 patients, all who came to chiropractic clinics with back pain, whom they divided into 3 groups. The three groups were:

1. No chiropractic treatment, 30 patients
2. 2-12 months of chiropractic, 21 patients
3. 1-6 years of chiropractic, 25 patients

It was not placebo-controlled, blinded, or randomized, which presents major methodological problems regardless of what happened. Before I tell you the results, which group do you think the chiropractors would want to do the best? Bingo! The group that saw chiropractors for many years did the best, as measured by plasma thiols. At least that's what Campbell reported.

But the results were very odd: first, they saw a drop in plasma thiol levels (a drop is a bad outcome, for this study) in patients treated for 2-12 months, from 124 down to 105. But hang on: in the long-term chiropractic treatment group, the average level was 146. So are we supposed to believe that chiropractic is bad for you in the first year, but good for you after that? The problem gets worse, though, when you look at their claim that "there were statistically significant differences in the serum thiol levels of the three groups." None of the serum thiol levels were significantly different: their claim is simply wrong.

[Note: skip the next paragraph if you don't care about the statistics. But the statistics matter.]

Yes, that's right - Campbell et al. got their statistics wrong. Oops! They reported that the 2-12 month group had signficantly lower serum thiol levels, and the 1-6 year group was significantly higher levels, with a p-value of 0.001. From the numbers in their own tables, I was able to compute the true significance values, to determine if their reported value of 146 (plus or minus 60) was significantly higher than the control group's average of 124 (plus or minus 48). It turns out that this difference isn't significant at any level, and certainly not at a p-value of 0.001. A decent journal would never have published this painfully bad analysis.

There are other problems, but this huge error in their central result is devastating. And not surprisingly, no one has replicated these non-results since.

This hasn't deterred Chad Mathey, a chiropractor in Colorado, from posting this comment on his blog just a few weeks ago:

"This [the Campbell et al. study] is an incredible article! This talks about one of the many reasons people do and should stay under regular Chiropractic care. It’s not just for pain and people are starting to finally understand this."

Incredible indeed. As in "not believable" and "not even close to true."

This is another illustration of how pseudoscientists use the trappings of science to do make-believe science, and then advertise their "findings" to the world, just as Dr. Oz did in his recent apple juice and arsenic experiment. Dr. Oz didn't even publish his findings - he just announced them on his show. Campbell and colleagues used a pseudoscience journal. After all, who's gonna know?

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.

Dr. Oz tries to do science

TV doc Mehmet Oz, who hosts a very popular daily television show, tried to conduct a scientific experiment this week. He wanted to test whether apple juice from some of the most popular juice makers in the U.S. contained toxic levels of arsenic. For some reason - perhaps he was feeling guilty about all the unscientific claims he has been pushing on his show - he decided he would try to prove this scientifically.

With all the resources of his TV network behind him, he was able to put on a pretty good show. But Dr. Oz is no scientist, as he made very clear when he presented his "discoveries." His pretend-science act - and that's what it was - was a disaster. I'd have to give him an "F" for his experiment, where he claimed that he had found dangerous levels of arsenic in five popular brands of apple juice: Minute Maid, Apple & Eve, Motts, Gerbers, and Juicy Juice.

His website proudly displays these results, claiming that the arsenic is from pesticides used in China. After his "extensive national investigation" he concluded:

"American apple juice is made from apple concentrate, 60% of which is imported from China. Other countries may use pesticides that contain arsenic, a heavy metal known to cause cancer. After testing dozens of samples from three different cities in America, Dr. Oz discovered that some of the nation's best known brands of apple juice contain arsenic."

There are many problems with this study, but the biggest one is that its conclusions are false. The reasons include:

1. Oz asked a lab to test for total arsenic, but there are two forms of arsenic, commonly known as organic and inorganic. Organic arsenic is everywhere, and it's mostly harmless. As the FDA explained in its first warning letter to Oz:

"As we have previously advised you, the results from total arsenic tests CANNOT be used to determine whether a food is unsafe because of its arsenic content. We have explained to you that arsenic occurs naturally in many foods in both inorganic and organic forms and that only the inorganic forms of arsenic are toxic, depending on the amount. We have advised you that the test for total arsenic DOES NOT distinguish inorganic arsenic from organic arsenic."

2. Oz didn't try to replicate his own results, and didn't even think to question the numbers he got from the lab he hired. Here's a hint, Dr. Oz: if you come up with a surprising result, then you must try to replicate it yourself to see if you get the same answer. And you should be your own greatest skeptic. Not Dr. Oz: he had all his samples tested at a single lab, which the FDA warned him was giving erroneously high results. The FDA re-tested samples from the same lot for one of the juice makers (Gerber), and sent Oz another letter on Sept 13, telling him the results, as follows:

FDA Sample Total Arsenic Result (Average)
Sample 659595 Lot #1157515791 2.0 ppb
Sample 659596 Lot #1125515762 4.0 ppb
Sample 659597 Lot #1125515761 6.0 ppb
Sample 710623 Lot #1059515761 5.0 ppb
Sample 710624 Lot #1059515762 5.0 ppb
Sample 710625 Lot #1157515761 2.0 ppb
Sample 710626 Lot #1157515762 3.0 ppb

The lab that Oz hired had reported far higher total arsenic levels: 36 ppb. The highest result that the FDA found was six times lower. This would be very, very worrisome to any good scientist. The FDA also warned in this letter that

"it would be irresponsible and misleading for the Dr. Oz Show to suggest that apple juice is unsafe based on tests for total arsenic."

But of course Oz wasn't going to go back and check his results. That would be too scientific! Instead, he aired a show in which he wildly overstated the results and the possible risks. He didn't express even the slightest uncertainty about his findings. He interviewed audience members who dramatically confessed that they hadn't realized they were poisoning their own children. The horror!

To their credit, the mainstream media didn't buy this one. ABC in particular, featured an interview on Good Morning America with both Oz and Dr. Richard Besser, ABC's medical editor, who called Oz's show "extremely irresponsible" to his face. Oz danced around the accusations but never once admitted he might have made a mistake. Besser really lays it on the line in this smackdown (click to watch the video):

Among other things, Besser said that Oz's hyperbolic, poorly-supported claims are like " yelling fire in a movie theater". Bravo for Dr. Besser.

I'm not sure if Mehmet Oz was always the way he is now, but he seems to use his show to sell products (and to sell himself!) rather than to inform the public about medical issues, as one of my fellow Forbes bloggers, Alice Walton, has noted. Dr. Oz has embraced complete quacks, too, notably Joseph Mercola, whom he has had on the show more than once.

Maybe Oz was trying to show his science-y side by doing what he thought was a real study, actually measuring arsenic levels in samples of apple juice. But he botched it so badly that he just demonstrated his own lack of serious science cred.

Dr. Oz ought retract his erroneous claims about arsenic and apologize for his scaremongering and his sloppy science. But he's showing no signs of that: on his website he is sticking by his claims, and he challenges the FDA and the food companies to come on his show. He's also claiming that the source of the arsenic is pesticide sprayed on apples imported from China, although he presents no evidence at all for that. This is not how science is done, Dr. Oz. You made a claim, and others pointed out major problems with it. It's incumbent on you to come up with better evidence. But somehow I suspect that will be too much trouble for you. Real science can be such a pain that way.

The black death is dead

Evolution tells us a lot about death. Of course it's about life too, but it's really about survival, which involves both life and death.

As most people know, the Black Death was a horrible plague that swept through Europe, Asia, and Africa in the 1300's, killing tens of millions of people at a time when there weren't so many people to begin with. The world's population prior to the plague, about 450 million, dropped to 350 million. About one-third of the entire population of Europe, and half the population of China, may have died. Centuries earlier, the Plague of Justinian in 541-542 C.E. may have killed even more, up to half of Europe and untold millions elsewhere around the world. In ancient and medieval times, people thought the plague was caused by rats, but the true cause wasn't discovered until 1894, when Alexandre Yersin of France and Kitasato Shibasaburo of Japan finally traced it to a bacterium now called Yersinia pestis, which is transmitted by fleas, which in turn are carried around by rats.

The plague kills all of its hosts, even the fleas:

"The bacteria multiply inside the flea, sticking together to form a plug that blocks its stomach and causes it to starve. The flea then bites a host and continues to feed, even though it cannot quell its hunger, and consequently the flea vomits blood tainted with the bacteria back into the bite wound. The bubonic plague bacterium then infects a new victim, and the flea eventually dies from starvation. " Source: Wikipedia

Gross, I know. But the original plague, the Black Death, has never returned. Why not? A study last year and another one published just this week provide the answer.

Last year, Barbara Bramanti and colleagues collected DNA from mass graves dating to the Black Death, and showed conclusively that the victims were infected with Yersinia pestis. Until this study, some scientists were uncertain about whether Yersinia pestis was the true cause, but Bramanti's research should settle that question once and for all. They also showed that at least two distinct strains of plague bacteria infected Europe, each arriving via a different route.

Further evidence appears in a remarkable new study published this week by Hendrik Poinar and colleagues. They exhumed over 100 skeletal remains from victims of the Black Death, collected from a ancient London cemetery, East Smithfield, which has been conclusively dated to the plague years, 1348-1350. Using the latest DNA sequencing methods, they identified Yersinia pestis DNA in 20 of the 109 victims.

Both studies collected enough DNA to show that the strain of Yersinia pestis from 1350 C.E. is unlike any modern strain. In other words, the original plague died out, probably long ago. The likely explanation is just this: the Black Death was simply too deadly to persist. Evolutionary theory tells us that a pathogen that kills all its victims will eventually run out of victims, leading to its own extinction. The plague bacteria needed to evolve into something less virulent, and that seems to be what happened. A bug that doesn't kill its host is far more successful evolutionarily. (Just look at the common cold, which we can't seem to get rid of.)

The same thing happened to the "Spanish" flu virus, the one that cause the terrible 1918 flu pandemic. It too evolved into a milder pathogen, and it is still with us today - the 2009 influenza pandemic was caused by a direct descendant of the 1918 virus.

The Black Death was so widespread that it even affected human evolution. In 1998, Stephen O'Brien and colleagues showed that a mutation that confers resistance to HIV first appeared in the human population in the 1300's. They concluded that this mutation can best be explained by "a widespread fatal epidemic"; in other words, the Black Death. I should be careful to explain that the plague didn't actually cause the mutation: the mutation occurred naturally. The Black Death selectively killed more people without the mutation, leaving us with a population of humans that tended to have the mutation.

In light of these new results about evolution, I can't help pointing out that, finally, that evolution has been in the news recently for another reason. Several U.S. politicians, some campaigning for President, have been attacking evolution, saying that it has "got some gaps in it" and even supporting the teaching of creationism. Scientific facts aren't affected by political statements, of course, but the future of the U.S. is. Politicians who attack evolution, whether from ignorance or from some political or religious agenda, only hurt our future potential as a technology leader. I can only hope that the public won't support these anti-science positions.

The $350,000 questionnaire from NIH

Let's see: if you could get $350,000 from the government to develop a questionnaire, does that seem like a good deal? What if the questionnaire was designed mostly to ask people if their "qi" was balanced, or their "prana" was improving? Apparently, we don't have enough surveys of patients asking them these vital questions, but never fear: NIH's National Center for Complementary and Alternative Medicine (NCCAM) has money to burn.

To be specific, NCCAM has given $354,341 to Cheryl Ritenbaugh at the University of Arizona (grant number R01-AT003314) to develop a questionnaire designed specifically to address "CAM" outcomes, "especially those therapies that have an energetic or spiritual component" which includes homeopathy, energy healing, and acupuncture. According to the grant's abstract, CAM therapies

"focus on vital force, qi, prana, or similar concepts. This contrasts with biomedicine, where the focus is on specific diseases, organs, symptoms, or mechanisms."

Let's see if I understand this statement. Biomedicine tries to understand and cure diseases. CAM, according to Dr. Ritenbaugh, focuses on magical fairy dust - oops, I mean vital force and qi. And alas, laments Ritenbaugh,

"CAM researchers have not had tools to measure outcomes that are based on CAM clients experiencing whole person outcomes or transformative experiences."

Clearly, we need a questionnaire designed to ask people about their qi.

To be fair, Ritenbaugh isn't merely going to develop a questionnaire. She also proposes

"to rigorously evaluate this tool in appropriate populations chosen for ethnic diversity and CAM experiences."

Phew, that's a relief. We have to be sure the questionnaire works.

NIH's website lists the published results reported for all of its grants, and so far this one has nothing to report, despite being in its third year. In another NIH institute, this would be an embarrassing failure. But in any other institute, a proposal asking for $350,000 to create a questionnaire about imaginary life forces would have no chance of being funded in the first place.

But wait, it gets better! Last year, NCCAM awarded Dr. Ritenbaugh an additional $120,000 for this project, part of the federal government's stimulus funding. So it's really a $470,000 questionnaire.

As a long-time reviewer on NIH review panels, I can only imagine what the NCCAM reviewers discuss. They must inhabit an alternate reality, where magical forces flow through and around the body, and magical, pseudoscientific treatments like acupuncture, healing touch, magnet therapy, and homeopathy somehow really work. The mind boggles.

I tried unsuccessfully to find Ritenbaugh's $470,000 questionnaire, even a piece of it. Perhaps when she finishes the project, she'll publish it. I think she owes it to the public - after all, we paid for it.

(An aside: the University of Arizona is one of NCCAM's biggest recipients of grant funds. UA's Iris Bell has received multiple NCCAM grants over the years, which I've written about before, including a ridiculous proposal to study how often you need to shake a homeopathic remedy while you're diluting it to nothing. Ritenbaugh is currently sharing a grant with Bell on a large training grant from NCCAM to Arizona, which will train "junior investigators preparing for a career in whole systems of CAM research." Good thing they're training more pseudoscientists; must keep the work going.)

Does NIH recommend acupuncture?

"NIH recommends acupuncture" - that's the headline on a recent web article on an acupuncturists' website. Now, I know that NIH has granted millions of dollars to acupuncture researchers who have tried their best to prove it works, but I didn't think NIH officially endorsed it. For one thing, despite these wasted millions, the best evidence shows that acupuncture doesn't work, not even a little bit.

What the article was referring to illustrates the dangers of NIH's far-too-gentle treatment of acupuncture and other "alternative" practices. It also shows how promoters of questionable or downright bogus practices can distort the facts to suit their own ends.

What the acupuncturists found was an NIH news site that ran an article called "Understanding acupuncture: time to try it?" (Note the question mark.) The article was written by Harrison Wein, a science writer at NIH who interviewed a handful of researchers, most of them promoters of acupuncture themselves who are funded by NCCAM.

(I've written about NCCAM before, so here I'll just remind readers that it was created by Congress as a way to earmark funds for bad science that can't pass muster in normal peer review. NCCAM grants over $200 million per year to its stable of mediocre scientists.)

Wein did a very poor job of describing the complete implausibility of acupuncture, but he did at least point out that sham acupuncture works just as well as "real", and it doesn't even matter if you use toothpicks that don't pierce the skin. So does his article endorse acupuncture? In a sidebar titled "If you want to try acupuncture," it says:

• "Don’t use acupuncture as a replacement for conventional care"
• "Don’t rely on a diagnosis of disease by an acupuncturist who doesn’t have conventional medical training"

and a few similar things, none of them recommendations for acupuncture. The article concludes by asking the question again:

"Should you try acupuncture? Studies have found it to be very safe, with few side effects. If you’re thinking about it, talk to your doctor."

So no, not an endorsement. Just a much-too-gentle recommendation to talk to your doctor first. The writer (Wein) regurgitates the claims of acupuncture promoters hook, line, and sinker - and he doesn't cite any evidence for his statement that it is "very safe." In fact, acupuncture often causes infections, sometimes serious ones. And as I wrote last month in The Atlantic: in 1995, a 40-year-old Norwegian woman visited an acupuncturist for relief from fibromyalgia. As described in The Lancet, she died two hours later, and an autopsy revealed that the needle had punctured her left ventricle.

Think that's just one unfortunate anecdote? Well, in the journal BMJ last year, researchers reported that acupuncture infections are a significant problem worldwide, and that they have been under-reported for years. Infections caused by acupuncturists have led to "joint destruction, multi-organ failure, flesh-eating disease and paralysis" as well as hepatitis B and C and mycobacteriosis.

So I don't agree that acupuncture is "very safe." After I gave an interview on Minnesota Public Radio last month, I was attacked by acupuncturists claiming that they don't use "dirty needles" (which I never claimed) - but in saying this, the attackers reveal their own ignorance. Needles aren't the problem: it's that every site on the skin as well as the acupuncturists hands that need to be sterilized. You see a photo on the website of the American College of Acupuncture and Oriental Medicine of a bare-handed person inserting needles into someone's skin. In case they remove it after reading this article, here it is:

All this should be beside the point, though, because acupuncture simply doesn't work. One of the acupuncture researchers (funded by NCCAM) interviewed in the NIH news story, Karen Sherman, had this response to the data showing that toothpicks work as well as needles:

"For example, when researchers have compared inserting needles with just pressing a toothpick onto acupuncture points, they’ve often found both treatments to be successful. But Sherman questions whether these are really controls. Many traditional acupuncturists would consider them true treatments, too. The important thing, in their view, is to hit the right spot, not necessarily how deep you go."

So when the evidence doesn't show what she likes, Dr. Sherman changes the definition of placebo. This is called "moving the goalpost," and it's a classic sign of bad science (and a bad scientist). Actually, she goes even further, saying "I don’t really think you can come up with a great placebo needling." In other words, in Dr. Sherman's world, acupuncture can't really be tested. I guess it's just magic.

Even though the NIH article doesn't recommend acupuncture, it uncritically repeats some ridiculous claims, such as:

"… the body contains a delicate balance of 2 opposing and inseparable forces: yin and yang. Yin represents the cold, slow or passive principle. Yang represents the hot, excited or active principle. Health is achieved through balancing the 2. Disease comes from an imbalance that leads to a blockage in the flow of qi—the vital energy or life force thought to regulate your spiritual, emotional, mental and physical health. Acupuncture is intended to remove blockages in the flow of qi and restore and maintain health."

I want to laugh at this, but it appears on an honest-to-goodness NIH website. As my colleagues at Science-Based Medicine put it, "acupuncture is a pre-scientific superstition." It does not deserve our respect, nor should we take it seriously.

There's no scientific evidence whatsoever that "the flow of qi" has any physiological basis. The passage above should have been followed with a bit of real information, such as: "Scientifically, there is no more evidence for qi than there is for the tooth fairy or Santa Claus. However, some researchers argue that Santa Claus is quite a bit more plausible." But that would perhaps be hoping for too much backbone from NIH. Note to NIH: don't give pseudoscientists the imprimatur of legitimacy by repeating their claims. And pay better attention to what you allow on your website.

Federal judges decide that private companies own your DNA

Many scientists cheered last year when a federal judge ruled that human genes couldn't be patented. The case involved Myriad Genetics, which holds the patent rights on two genes, BRCA1 and BRCA2, that are associated with increased risks for breast and ovarian cancer. Thanks to these patents, you can't look these genes in your own body without paying a fee to Myriad. Sounds ridiculous, right? Well, that was the state of gene patents until last May, when judge Robert Sweet ruled that the Myriad's patents were invalid.

But now the courts have reversed themselves again. In a 105-page decision, two federal judges decided that the whole matter comes down to the meaning of the word "isolated." I kid you not.

Judge Sweet's ruling last year was based on the obvious scientific fact that genes are a product of nature, not an invention, and therefore they could not be patented. Patent lawyers were very upset over Sweet's ruling. Why was this controversial? Well, because the U.S. Patent and Trade Office has been granting gene patents for decades. Basically, once the USPTO decided to allow one gene patent, they never looked back, and they've now given out patents for over 4,000 human genes.

But this past week, an appeals court reversed last year's ruling and said yes, Myriad Genetics does indeed own the rights to the BRCA genes. The decision by Judge Alan Lourie reveals an astounding lack of understanding of DNA, genes, and genomes. I guess I shouldn't be surprised, but I had been hopeful that after the earlier ruling throwing out these patents, science and logic would prevail. I guess I should never underestimate the scientific ignorance of judges, though I should add that one of the three judges voted against his colleagues.

What was their contorted reasoning? They decided that "isolated DNA" is not the same as the natural DNA in your body, and that this distinction allows companies to patent it. (The word "isolated" occurs 219 times in the decision.) The judges wrote:

"According to Myriad, isolated DNA does not exist in nature, and isolated DNAs, unlike native DNAs, can be used as primers and probes for diagnosing cancer."

The mind boggles. Following this nugget, Judges Lourie and Moore give us a little mini-lesson in molecular biology:

"Native DNA exists in the body as one of forty-six large, contiguous DNA molecules…. Isolated DNA, in contrast, is a free-standing portion of a native DNA molecule, frequently a single gene…. Accordingly, BRCA1 and BRCA2 in their isolated state are not the same molecules as DNA as it exists in the body."

This is scientific nonsense, but the court bought it. (Over at TechDirt.com, Mike Masnick made the colorful analogy that this is like "arguing that because a severed finger is not attached to a hand, the finger is not naturally occurring, and, thus, is patentable.") Wrote the judges:

"we conclude that the challenged claims are drawn to patentable subject matter because the claims cover molecules that are markedly different—have a distinctive chemical identity and nature—from molecules that exist in nature."

Among other problems, Judges Lourie and Moore don't understand a basic fact of genetics: that genes are "isolated" by our body's own genetic machinery when they are copied into RNA and then translated into proteins. Or perhaps they do understand, but they don't care because they just want an excuse to keep gene patents around. This is what can happen when lawyers (judges) make scientific decisions: they go on for pages and pages about the semantics of a word ("isolated"), and produce a result that is scientifically meaningless.

Judge Bryson makes much more sense in his dissent, writing:

"the question in this case is whether an individual can obtain patent rights to a human gene. From a common-sense point of view, most observers would answer, `Of course not. Patents are for inventions. A human gene is not an invention.' The essence of Myriad’s argument in this case is to say that it has not patented a human gene, but something quite different—an isolated human gene."

So that's two judges (Sweet and Bryson) against human gene patents, and two in favor. This case isn't over yet; last week's ruling by the 3-judge panel will likely be appealed to the full appeals court next. It's hard to predict what they will say. Meanwhile, Myriad charges $4000 to run tests on BRCA1 and BRCA2, as I wrote last year. This means that if a woman wants to test her own DNA for any mutations in the BRCA genes - including mutations that weren't even known when Myriad got the patent - she must pay Myriad merely to look at her own genes.


I'm not a lawyer, but I already see one way around Myriad's patents in this flawed decision. The judge's (and Myriad's) reliance on "isolated BRCA genes" refers to the process of isolating and copying the genes using a laboratory method called RT-PCR, and then sequencing just the isolated bits. Today, though, we can sequence a person's entire genome, without "isolating" any particular genes, for under $5000, and then we can test for mutations in the BRCA genes without ever "isolating" them. In fact, a colleague and I published a paper just last year describing how to do this, and we released a free software package that allows anyone to test their BRCA genes at home on a desktop computer. Genomics Law Report has a detailed legal analysis of what our software means for the Myriad case.

Scientifically, it shouldn't matter how the judges define "isolated" DNA. And as two federal judges have now ruled, genes are not inventions, full stop. What's more, gene patents slow down science by throwing legal barriers in the path of anyone who wants to work on those genes. Finally, I'm amazed at the hubris of companies like Myriad - or anyone else - who claim they "own" a gene. Let's hope the full appeals court will reverse the tortured reasoning of Judges Lourie and Moore, and get the patent lawyers out of the laboratory.

The Baltimore Sun dives into the anti-vaccination pool

In recent weeks, the Baltimore Sun, once an excellent newspaper, has dived headfirst into the pool of anti-vaccination pseudoscience. With two prominent opinion pieces, the Sun has given a platform to the anti-vaccine movement that they probably didn't expect, and that they certainly didn't deserve. The puzzle is, why? Who on the Sun's editorial board decided to offer their pages to the voices of fear and unreason?

First, on June 16, the Sun printed an Opinion article by Mark Geier, where he argued that his unfounded theories about the causes of autism make it okay for him to chemically castrate young boys. (I know this sounds shocking, but it's all too true.) I wrote about Geier two years ago: he and his son David administer what they called the "Lupron protocol" to autistic boys. They charge $5000-$6000 per month for their treatment, which is based on their belief that autism is caused by an excess of testosterone. Lupron, the drug they give to children, is a testosterone-suppressing drug that is the chemical equivalent of castration. It is a harsh treatment used to treat advanced prostate cancer. There is no evidence that it helps autistic boys. When the Chicago Tribune interviewed Simon Baron-Cohen, a professor and director of the Autism Research Center at Cambridge University, here was his reaction:

"The idea of using it [Lupron] with vulnerable children with autism, who do not have a life-threatening disease and pose no danger to anyone, without a careful trial to determine the unwanted side effects or indeed any benefits, fills me with horror."

Finally, after Geier had spent many years of selling his quack treatment to vulnerable families, the state of Maryland suspected his medical license suspected in April. Now, for reasons I cannot fathom, the Baltimore Sun has given him a huge billboard to ask for his license back so he can resume his discredited Lupron protocol.

(Geier also claims that mercury in vaccines causes the rise in testosterone levels that he claims to treat. He ignores the overwhelming evidence, re-affirmed again last year, that there is no link between mercury-containing vaccines and autism.)

This wasn't enough bad science for the Sun, which just a few weeks later published another Opinion piece, this one by anti-vaccine activist Margaret Dunkle. In her article, Dunkle claims that the vaccine schedule includes too many doses, and she further claims that these are harmful to children. This "too many, too soon" argumen is a constant refrain of the anti-vax movement (particularly Jenny McCarthy), despite the lack of science to support it. The evidence on her side: a new study published by Gayle Delong, claiming that autism rates and vaccination rates are linked. Who is Gayle Delong? It turns out she is an economist, not a scientist, and she's a board member of SafeMinds, a well-known anti-vaccination group. Delong's study has already been thoroughly debunked by Neuroskeptic, Sullivan, Liz Ditz, and others, who pointed out its deeply flawed statistics and other problems. Dunkle, though, was happy to jump on this junk science and ignore the real science.

The real science tells just the opposite tale. For example, a thorough review published in Pediatrics in 2002 showed that infants today are exposed to fewer antigens than they were 40 years ago, due to better vaccine formulations. It also found that vaccines "prevent the weakening of the immune system." Countless other articles have shown the efficacy of vaccines; the Immunize for Good site is a good source for a realistic picture of the risks versus the benefits.

Is the Baltimore Sun responsible for the anti-vaccination stories appearing on its Opinion pages? I can imagine their response: "we're just presenting both sides," they might argue. Debates are just fine when political opinions are concerned, but you don't get to argue about facts. Scientific facts are not debated from "both sides" - for example, we don't waste time arguing that diseases are caused by "miasmas" as was once believed. And when the subject is vaccines, presenting the anti-science, anti-vaccine argument has real, and harmful, consequences.

The science is clear: vaccines have been the single greatest boon to public health in the history of mankind. Vaccines have saved millions of lives, and allowed parents to live without the fear that their children will sicken and die. Here are some facts: pre-vaccination, whooping cough caused 9000 deaths per year in the U.S. Post-vaccine, this has dropped to 20 deaths per year. Pre-vaccination, there were 350,000 polio cases worldwide in 1988. In 2009, there were just 1,604, and there's a chance we can eliminate polio entirely. Back in 1921, diptheria caused 206,000 cases in the U.S. alone. In 2001, there were just 2 cases.

If we stop vaccinating, these diseases will return. And make no mistake about it: if measles, whooping cough, polio, and other vaccine-preventable diseases return, children will die. I'm sure that the editors of the Baltimore Sun don't want this to happen. But through their ignorance of the science around vaccines, they have allowed their newspaper to become a voice for a dangerously misinformed group of activists whose main goal is to stop vaccines.

How to correct the damage? Well, the Sun could publish multiple articles on their Opinion pages explaining how many lives vaccines have saved. They could help to re-educate parents about how valuable these medicines are, so they will demand them for their children, rather than refusing them as some parents now do. I have only a faint hope that the Sun's editors will take such action, but I'm calling for it anyway. They owe it to the public.