NIH halts chelation study after patients die

Yet more proof emerged today that "alternative" medicine is not only useless - it can kill. The U.S. government had funded a study to test chelation therapy on heart attack survivors. At least two patients have died already, and the National Institute of Health has now halted the study and launched an investigation. The patients weren't properly informed of the risks - namely, that the treatment could kill you - and there were other serious problems as well.

Kimball Atwood and colleagues published an article in May 2008 (freely available in PubMed) that looked at this study, called TACT (Trial to Assess Chelation Therapy), and wrote:

"We conclude that the TACT is unethical, dangerous, pointless, and wasteful. It should be abandoned."

Wow. It doesn't get much more blunt than this. Nonetheless, the study had already gone on for years, and it was another 4 months (until now) before NIH pulled the plug.

Chelation therapy involves injections of a powerful drug, disodium EDTA, into patients. Proponents claim - with little or no evidence - that disodium EDTA will bind to arterial plaques and help flush them away. Chelation therapy has also been proposed - and used - on autistic children, despite evidence that it carries great risks and despite no evidence that it works.

The just-halted study involves some 1500 patients. The US government approved the study, according to AP reports, because some heart patients were trying chelation therapy anyway, and the study would provide evidence of whether it worked or not. (Note that this is the same argument that NIH recently used when it announced it would study chelation therapy for autistic children.) The argument is bogus. It is a classic example of a logical fallacy, which could be re-stated in this case as "lots of people believe this, so it must be true."

There are (were) multiple problems with this study. The Atwood article states them very bluntly:

We present evidence that chelationists and their organization, the American College for Advancement in Medicine, used political connections to pressure the NIH to fund the TACT. The TACT protocols justified the trial by misrepresenting case series and by ignoring evidence of risks. The trial employs nearly 100 unfit co-investigators. It conflates disodium EDTA and another, somewhat safer drug. It lacks precautions necessary to minimize risks.

Astonishing. And yet, unbelievably, the group of chelation doctors (who should more accurately be called quacks and scam artists), known by the deceptive name American College for Advancement in Medicine (ACAM), are insisting that the allegations of impropriety are "political" and that the trial should resume as soon as these allegations can be dismissed. On ACAM's own website, their president, Jeanne Drisko, says "We call for a swift end to the moratorium and a resumption of the trial."

These chelation practitioners (I can't call them doctors) are deceiving their patients and making money off them by offering harmful therapies. This is, frankly, despicable.

Finally, I have to shine the spotlight of shame on the study's Principal Investigator, Gervasio Lamas of Mt. Sinai Medical Center in Miami Beach. If you know anyone in Miami who needs a cardiologist, stay away from this doctor! Back in 2001, he said of chelation therapy, "It's pretty different - it's cool." I want a doctor who chooses therapies because they work, not because he thinks they're cool.

And finally, which part of NIH funded this study? NCCAM, of course. See my earlier posts on that. This is yet another example of why NCCAM should be shut down.

Knee surgery is a poor choice for arthritis

A report appears today in the New England Journal of Medicine, one of the foremost medical journals, that has a surprising result:

"Arthroscopic surgery for osteoarthritis of the knee provides no additional benefit to optimized physical and medical therapy."

I write "surprising" because this will indeed be surprising to many surgeons, and to their patients who have undergone unnecessary knee surgery. This study is interesting - and important - because it is a negative result, something which is difficult to obtain scientifically. It is also a classic case of a medical treatment that was initiated based on intuition rather than science: orthopaedic surgeons have been telling patients for years that their arthritis could be alleviated by "debridement" of the inside of your knee.

The new study by Kirkley et al. shows that the control group, which received physical therapy and "medical therapy" - ibuprofen, in other words - did just as well as the surgical group. Both groups improved, although neither group improved much. The conclusion: don't get the surgery! There is a huge downside to surgery - not only does it require weeks or months of followup therapy, but there is also the possibility of infection, not to mention the cost.

A friend of mine recently had exactly this surgery - he has arthritis in both knees, and his doctor told him that arthroscopy would smooth out the rough spots, which were causing him pain. This sounded reasonable, so my friend agreed. After months of follow-up therapy, his knee was only slightly improved.

Arthroscopic knee surgery was developed to treat torn cartilege and ligaments, and it works beautifully for these acute injuries. I have personal experience of this - some years ago I tore my cartilege in my left knee, and I couldn't even straighten my leg for a while. I had arthroscopic surgery which removed the torn cartilege and fixed the acute problem - though it left me with much less cartilege. However, treating an acute injury is far different from treating arthritis, which is a chronic, degenerative condition that affects huge numbers of people as they age.

Unfortunately, orthopaedic surgeons are not likely to give up this lucrative procedure so easily. An editorial appears in the same issue of NEJM, written by Robert Marx, a surgeon. He argues - with no scientific evidence to back him up - that some patients have both arthritis and torn cartilege, and that in such cases "it can be difficult to determine which of the two is the major cause" of knee pain. I can hear him already explaining to his patients that he recommends surgery.

Brian Feagan, a co-author of the new study, was clearly disappointed that NEJM printed this editorial, which he said (in today's Washington Post) would result in continued overuse of arthroscopic surgery. The Post points out that a second study in the same issue of NEJM, involving nearly 1000 patients, found that many arthritis patients have small cartilege tears, but that their pain is caused by arthritis, not the tears. "I'm very disappointed by the editorial. I'm not sure who he [Marx] is advocating we should treat," said Feagan.

Arthroscopic knee surgery is performed on hundreds of thousands of patients in the U.S. alone each year, costing about $5000 per operation. This new study shows that many of these operations - perhaps most of them - are unnecessary. I hope that surgeons will pay attention, but Marx's editorial makes it clear that some of them won't. For their patients, only a healthy skepticism - and perhaps a 2nd or 3rd opinion - will save them the pain and expense of unnecessary surgery.

Evolution and the candidates

Well, the election line-up is set. We know all four major-party candidates for president and vice president. And for those of us who believe it is important to teach good science to our children, the choice is pretty clear: the Republican candidates favor the teaching of creationist dogma in the science classroom. The Democrats support the teaching of evolution. On this issue, there is a clear different between the candidates in this election.

Let’s look at a few specifics. On evolution, John McCain has waffled. In 2005, he supported the teaching of creationism in the classroom, in this newspaper interview:

Arizona Daily Star: Should intelligent design be taught in schools?
McCain: I think that there has to be all points of view presented. But they’ve got to be thoroughly presented. So to say that you can only teach one line of thinking I don’t think is - or one belief on how people and the world was created - I think there’s nothing wrong with teaching different schools of thought.
Daily Star: Does it belong in science?
McCain: There’s enough scientists that believe it does. I’m not a scientist. This is something that I think all points of view should be presented.

(By the way, I’m not falling for the ploy by the Discovery Institute and other creationists that “intelligent design” is different from creationism. It’s not, so I will call it what it is.) The following year, in 2006, McCain reversed himself, saying: “I think Americans should be exposed to every point of view. I happen to believe in evolution… I respect those who think the world was created in seven days. Should it be taught as a science class? Probably not.“ And again in 2007, McCain stated explicitly to CNN: “I believe in evolution.”

However, McCain’s VP choice, Sarah Palin, is a firm believer in creationism. She is a fundamentalist Christian who has stated explicitly, when asked if creationism or evolution should be taught in science class:

Palin: Teach both. You know, don’t be afraid of information. Healthy debate is so important and it’s so valuable in our schools. I am a proponent of teaching both. And, you know, I say this, too, as the daughter of a science teacher.

This is the standard “teach the controversy” argument made by creationists. But it’s a bogus argument: within the scientific community, there is no controversy. Evolution has been widely accepted for over one hundred years, and virtually all of modern biology is built upon it. This argument is used merely as a ploy to get creationism into the classroom. It doesn't belong there.

How about the Democrats? Obama has made it clear he supports the teaching of evolution:

Obama: But I also believe our schools are there to teach worldly knowledge and science. I believe in evolution, and I believe there’s a difference between science and faith. That doesn’t make faith any less important than science. It just means they’re two different things. And I think it’s a mistake to try to cloud the teaching of science with theories that frankly don’t hold up to scientific inquiry.“ (from the York, PA Daily Record)

That’s a refreshingly clear statement for a political candidate. And Joe Biden too has said that he strongly opposes teaching creationism alongside evolution.

McCain, as you can see above, has been wishy-washy about this topic, clearly trying to placate the Christian right, who would like to see their religious views on creationism taught in science classes (not to mention all their other views). And by picking an outspoken supporter of creationism who is anti-science in other ways too (Palin doesn’t agree with the scientific consensus on global warming, for example), McCain has placed himself solidly in the pro-Creationism camp, despite his attempts to avoid being pinned down.

This is serious business. Sometimes I feel like politicians treat all these topics as a game, and maybe it is – to them - but it shouldn’t be. If science education is going to be taken over by religious fundamentalists, then we are in big trouble as a country. Our science education is already well behind many other countries, and we are pathetically behind on educating students about evolution. We can’t elect leaders who would put us further behind, but that’s exactly what Sarah Palin would do.

I realize there are many other issues separating the candidates, some of them perhaps more important. But for our long-term future, we need to restore respect for science, not only in our classrooms, but at all levels of government. On this topic, Sarah Palin would be a huge step backwards.

Other blog posts on this topic (a selection among many):
Brian Switek on scienceblogs
Matt Nisbett on scienceblogs
Brandon Keim at Wired
Jonathan Eisen at phylogenomics

T. rex peptides now available to public

I'm pleased to follow-up my August 22 post with a note that John Asara has responded to the calls for him and his colleagues to release the spectra from their study that reported the identification of Tyrannosaurus rex collagen protein isolated from a 68-million-year-old fossil. Pavel Pevzner, Tom Kaye, Mike Buckley, and others have all called this data into question, arguing in 3 separate papers that the protein fragments represent modern contaminents or statistical artifacts, rather than original T. rex proteins.

Pevzner argued forcefully that the only way to validate the claim was to have independent scientists look at all the spectra generated in the original experiment. Asara has now agreed, and has released all the spectra at the PRIDE database. I encourage those with expertise in the analysis of mass spec data to take a look. It will likely take some time for this analysis, but I will follow the developments and report them here.

I should add that although I remain skeptical that original T. rex proteins - even fragments - survived for 68 million years, I find it very plausible that such proteins would indeed be similar to those from modern birds. But the issue of whether proteins could survive for so long is a separate question from their evolutionary relatedness to modern species.