$3.7 million to study quack medicine at a leading cancer center

Sometimes I'm not sure whether the best response to pseudoscience is to ignore it, or to patiently try to explain why it's wrong, or to get mad.

This week I'm mad.

My anger and frustration was triggered by a tweet from Memorial Sloan-Kettering's Integrative Medicine account, shown here:

For those who don't know, Memorial Sloan-Kettering Cancer Center is one of the world's leading cancer centers, both for treatment and research. If you are diagnosed with cancer, MSK is one of the best places to go.

But not everything at MSK is world class. Unfortunately, they have an "integrative medicine" center that offers a mixture of therapies ranging from helpful to benign to useless. One of their biggest activities is acupuncture, which they claim offers a wide range of benefits to cancer patients.

The MSK tweet shown here was boasting about a new, $3.7 million study funded by NIH to study the effect of acupuncture on pain that cancer patients experience from chemotherapy and bone-marrow transplants.

Here's why I'm mad: cancer patients are extremely vulnerable, often suffering the most frightening and difficult experience of their lives. They are completely dependent on medical experts to help them. When a place like MSK suggests a treatment, patients take it very seriously–as they should. But they really have no choice: a cancer patient cannot easily look for a second opinion, or switch hospitals or doctors. Even if they have the money (and cancer treatment is extremely expensive), switching hospitals might involve a long interruption with no treatment, during which they could die, and it might also involve traveling far from their home.

Offering these patients ineffective treatments based on pseudoscience–and make no mistake, that's what acupuncture is–is immoral. Now, I strongly suspect that the MSK's "integrative medicine" doctors sincerely believe that acupuncture works. Their director, Jun Mao, is clearly a true believer, as explained in this profile of him on the MSK website. But that doesn't make it okay.

I've written about acupuncture many times before (here, here, here, and here, for example), but let me explain afresh why it is nonsense.

Acupuncture is based on a pre-scientific notion, invented long before humans understood physiology, chemistry, neurology, or even basic physics, which posits that a mysterious life force, called "qi," flows through the body on energy lines called meridians. As explained in this article by MSK's Jun Mao:

"According to traditional Chinese medicine ... interruption or obstruction of qi was believed to make one vulnerable to illness. The insertion of needles at specific meridian acupoints was thought to regulate the flow of qi, thus producing therapeutic benefit."

Today we know that none of this exists. There is no qi, and there are no meridians. In that same article, Jun Mao continued by admitting that

"the ideas of qi and meridians are inconsistent with the modern understanding of human anatomy and physiology."

And yet this is what they offer to patients at MSK.

Just to be certain, I read one of the latest studies from MSK, published early this year, which claims to show that acupuncture relieves nausea, drowsiness, and lack of appetite in multiple myeloma patients who were going through stem cell transplants.

It's a mess: totally unconvincing, and a textbook case of p-hacking (or data dredging). The paper describes a very small study, with just 60 patients total, in which they measured literally dozens of possible outcomes: overall symptom score at 3 different time points, a different score at 3 time points, each of 13 symptoms individually, and more. I counted 24 different p-values, most of them not even close to significant, but they fixated on the 3 that reached statistical significance. The two groups of 30 patients weren't properly balanced: the sham acupuncture group started out with more severe symptoms according to their own scoring metric, and Figure 2 in the paper makes it pretty clear that there was no genuine difference in the effects of real versus sham acupuncture.

But they got it published (in a mediocre journal), so now they point to it as "proof" that acupuncture works for cancer patients. This study, bad as it is, appears to be the basis of the $3.7 million NIH grant that they're now going to use, they say, in "a larger study in 300 patients to confirm these previous findings."

And there you go: the goal of the new study, according to the scientists themselves, is not to see if the treatment works, but to confirm their pre-existing belief that acupuncture works. Or, as one scientist remarked on Twitter, "they already have a result in mind, the whole wording of this suggests that they EXPECT a positive outcome. How did this get funded exactly?"

Good question.

So I'm mad. I'm mad that NIH is spending millions of dollars on yet another study of a quack treatment (acupuncture) that should have been abandoned decades ago, but that persists because people make money off it. (And, as others have explained in detail, acupuncture is actually a huge scam that former Chinese dictator Mao Zedong foisted on his own people, because he couldn't afford to offer them real medicine. For a good exposé of Chairman Mao's scam, see this 2013 Slate piece.)

But I'm even more upset that doctors at one of the world's leading cancer centers are telling desperately ill patients, who trust them with their lives, that sticking needles into their bodies at bogus "acupuncture points" will relieve the pain and nausea of chemotherapy, or help them with other symptoms of cancer. I'm willing to bet that most MSK doctors don't believe any of this, but they don't want to invest the time or energy to try to stop it.

(I am somewhat reassured by the fact that MSK's Twitter account has nearly 75,000 followers, while it's integrative medicine Twitter account has just 110.)

Or perhaps they are "shruggies": doctors who don't believe in nonsense, but figure it's probably harmless so they don't really object. To them I suggest this: read Dr. Val Jones's account of how she too was a shruggie, until she realized that pseudoscience causes real harm.

And finally, let me point to this study in JAMA Oncology from last year, by doctors from Yale, which looked at the use of so-called complementary therapies among cancer patients. They found that

"Patients who received complementary medicine were more likely to refuse other conventional cancer treatment, and had a higher risk of death than no complementary medicine."

And also see this 2017 study from the Journal of the National Cancer Institute, which found that patients who used alternative medicine were 2.5 times more likely to die than patients who stuck to modern medical treatments.

That's right, Memorial Sloan-Kettering: patients who use non-traditional therapies are twice as likely to die. That's why I'm mad. This is not okay.

NIH will spend $37 million to study discredited treatment that may harm patients

What do you do when you've spent $30 million to study a highly controversial, possibly harmful treatment, only to learn that it doesn't work?

If you're NIH's alternative medicine center, you double down. More than double, actually: NIH's NCCIH* just announced they will spend another $37 million to study chelation as a treatment for heart disease. Or to be more specific, Mount Sinai of Florida and Duke University issued a press release this past week proudly announcing that they'd won a $37 million grant to launch TACT2, the second Trial to Assess Chelation Therapy. TACT2 will be a followup study from TACT, which ended in 2012 after largely failing, as I'll explain below.

Chelation is a harsh chemical treatment, using a chemical called disodium EDTA, that is sometimes used to treat lead poisoning, because it can help to remove heavy metals from the blood. Some people think that this can somehow remove plaques from arteries, a sort of Roto-Rooter for your circulation, which in turn might improve cardiovascular health. This turns out to be wrong.

(Chelation is also promoted, tragically, as a treatment for autism. Anti-vax doctors who think that mercury causes autism have been pushing this for years. In 2014, the FDA issued a warning for parents to beware of this dangerous and ineffective therapy.)

Let's briefly review what TACT was, and some of its problems. There are far too many to list here, but I'll refer readers to a lengthy article published in 2008 by Dr. Kimball Atwood and colleagues for details. That article, which called for a halt to TACT, explained that:

• a series of randomized trials in the 1990s found no evidence that chelation worked for coronary artery disease
• most of the early advocates of chelation (in the 1960s) were also outspoken advocates for Laetrile and other ineffective therapies
• at least 30 deaths have been report associated with EDTA, but the doctors pushing its continued usage deny that any deaths have occurred.
• the scientific literature has shown that the underlying "heavy metals" hypothesis is implausible
• the TACT study includes "nearly 100 co-investigators who, in our opinion, are unsuitable to care for human subjects or to report trial data ... several have been disciplined, for substandard practices, by state medical boards; several have been involved in insurance fraud; at least 3 are convicted felons."
• "The researchers failed to inform the subjects that one risk of the treatment was death." (from The Chicago Tribune.)

Atwood and colleagues called for a halt to the TACT study, saying it was "pointless, dangerous, unethical, and wasteful."

The TACT study was indeed halted in 2008 for these and other ethical concerns, but it was quietly resumed about a year later. Then in 2012, the final results were reported. Although the results were almost entirely negative, the lead investigator, Gervasio Lamas, claimed that there was a benefit for a sliver of patients: people with diabetes who had a prior heart attack. That's the group he plans to focus on in the new TACT2 trial.

As Forbes writer Matt Herper explained in 2012, most doctors were highly skeptical of these results. Cardiologist Steve Nissen of the Cleveland Clinic said "It would be tragic if the result of this was a widespread use of chelation." Science blogger (and cancer doctor) Orac provided a detailed analysis of the results at the time, explaining why the study essentially failed to prove any benefit for chelation. Most of the results were not statistically significant, and the best the study could claim was very marginal significance for a small benefit, a result that could easily be explained by bias, which was rampant in this study.

TACT2 is being run by the same doctor, Gervasio Lamas, who recruited questionable practitioners into the first trial. There's no reason to think the second trial will be run any better. The new trial will subject 1,200 diabetic heart attack survivors to chelation therapy in an effort to prove that chelation helps prevent a second heart attack. Not only is this extremely unlikely to provide any benefit, it also exposes the patients to serious risks that Lamas and his colleagues don't seem to acknowledge, and probably won't tell the patients about.

NIH should pull the plug on this enormous ($37 million) and dangerous trial before it begins. If potential patients are informed correctly that there is a serious risk of harm with virtually no chance of benefit, then hopefully they will simply refuse to enroll. That would be the best outcome for everyone.

*In case you're wondering what NCCIH is, it's the new acronym for the former National Center for Complementary and Alternative Medicine, NCCAM. Last year it was renamed. The new name is the National Center for Crackpot and Implausible Hypotheses, Or maybe it's the National Center for Complementary and Integrative Medicine, you decide.

Alternative medicine quacks show their greedy side

Congress is on holiday this month, but the lobbyists are baiting their hooks, planning their strategies for how to get more money for themselves.

A growing lobby is Complementary and Alternative Medicine (CAM) providers, who have discovered a new opportunity to extract even more money from patients than they do already. They want the government to force insurance providers to pay for quack treatments, regardless of whether or not the treatments work. Any attempt to require evidence, they argue, amounts to discrimination.

Discrimination? Yes! We must not allow the government to exclude health care providers just because those providers don't cure anything.  The CAMmers argument boils down to this: we have patients who want our services.  The patients like us. In some cases, thanks to lobbying at the state level, we even have state-approved licenses. Therefore insurance companies must pay for our services.

Neat.

To be specific, the CAMmers are lobbying furiously to try to protect a special clause in the Affordable Care Act (Obamacare) that promises them a fertile new ground for making money from vulnerable patients.

The strategy is simple: require the government to fund any treatment that a patient wants, and dress this up as "patient choice."  Then if insurance companies resist paying for ineffective treatments, accuse them of discriminating against the poor, hapless "integrative medicine" providers.

Thus through a diabolical twist of illogic, if Obamacare doesn't cover homeopathy, or naturopathy, or acupuncture, or magnetic energy healing, or any other so-called alternative therapy, it's discrimination.

The mind boggles.

Why is this an issue now?  Because, unbeknownst to most people outside the Washington beltway, two pro-CAM lobbying groups slipped a clause into the ACA, section 2706, that attempts to force insurance providers to cover a wide range of quack practices.  This section requires that insurers

"shall not discriminate with respect to participation under the plan or coverage against any health care provider who is acting within the scope of that provider's license or certification under applicable state law."

Sounds harmless, right?  Well, no.  This language was added to the ACA by Senator Tom Harkin, after heavy lobbying by the American Chiropractic Association and the Integrative Healthcare Policy Consortium.  In fact, it is virtually certain that lobbyists wrote the section, and Harkin simply inserted it into the law. The IHPC is a lobbying group dedicated to obtaining more government money for homeopathy, naturopathy, chiropractic, acupuncture, and a raft of other ineffective medical practices.

Section 2706 opens the door to anyone who provides what they claim is health care - no matter how ridiculous the claim - to file a lawsuit claiming discrimination if an insurance company won't pay for their services.  You could start offering dried bird poop for arthritis, call it "avian nature therapy," and if an insurer won't pay for it, you can sue.

Some in Congress have realized how truly bad an idea this is, and just a few weeks ago, a new bill was introduced to get rid of it, HR 2817.  The American Medical Association supports the new bill. This has some CAM proponents alarmed.

Over at the Huffington Post, John Weeks, an outspoken apologist for questionable medical practices, offers the predictable, whining claim that this is all about "discrimination" by legitimate health care providers (the big, bad AMA) against poor, defenseless integrative medicine providers.

Make no mistake: this is all about greed.  The CAM industry sees Obamacare as a chance to reap huge profits, by forcing insurance companies to pay for ineffective treatments, including many that are wildly implausible.

Homeopaths, naturopaths, acupuncturists, reiki practitioners, energy healers, and other CAM practitioners don't want to subject their methods to rigorous tests of effectiveness.  They know that their methods have failed scientific scrutiny, time and time again.  So now they want to force health care providers to pay for anything the patient wants. "Our patients believe us," they argue, "so pay us."

Forcing health care providers to pay for anything a patient wants, even if it doesn't work, is guaranteed to drive up costs, without any benefit to patients.  Let's ditch this bogus "discrimination" clause in the ACA, and insist that all medical care be held to the same high, scientifically rigorous standards.

Bad medicine at the University of Maryland

Pseudoscience is insinuating itself into our medical schools across the nation, going by the name "Integrative Medicine." Integrative medicine is just the latest buzzword for a collection of superstitions, myths, and pseudoscience that has gone by various names over the years. First it was Holistic medicine, and once that fell out of favor, it became Alternative medicine, followed soon after by Complementary and Alternative medicine (CAM), and lately Integrative medicine. These names can't disguise the fact that many of the practices lumped together are bad medicine. What disturbs me particularly, as a professor, is that CAM is moving into the medical curriculum at respectable medical schools, including the University of Maryland.

Perhaps the best way to reverse this trend is to call attention to it. Academic freedom allows professors to proclaim all sorts of wild ideas, including nonsensical ones, but we don't have to allow them to teach courses with no basis in reality. That same academic freedom, incidentally, allows me to criticize bad science wherever I find it, including my own university.

So what's going on at Maryland's medical school? UMM is home to one of the nation's premier "integrative medicine" programs, which promotes a wide range of questionable practices. Its clinical services include:

• Acupuncture
• Homeopathy
• Reflexology
• Reiki
• Qi Gong

Although each of these has a different history, all of them are, well, nonsense. Let's take a closer look homeopathy, which is perhaps the most ridiculous pseudoscience on the list. Homeopathy is based on two ideas: that "like cures like", and that vanishingly small quantities of medicine are stronger than larger quantities. Both ideas were invented by Samuel Hahnemann in the late 1700s, back when most medicine was pretty bad for you. Unfortunately for Hahnemann, his ideas were no better.

The idea that "like cures like" is used to justify treating (for example) itchiness with extract of poison ivy. I'm not making this up: this is a standard homeopathic preparation, promoted on many homeopathic sites, even (sorry, cycling fans) on Lance Armstrong's Livestrong website.

The second idea is that you dilute these substances so much that instead of causing the symptom, they cure it. Alas, Hahnemann was unaware that when you dilute a substance to the degree that he recommended, you end up with nothing left. Typical dilutions used today go by the abbreviations 10C, 20C, or 30C. One "C" is a dilution of 1 in 100, and 20C means that you dilute the active ingredient 100-fold, and then repeat the process 20 times over. This is a dilution of 100 to the 20th power, a ridiculously large number. If you had a single molecule immersed on a sphere of water the size of the entire planet, it would still not be dilute enough.

That's right: homeopathic treatments are just water. Or rather, water dropped onto a sugar pill, and sold at stores such as Whole Foods, which has a section devoted to homeopathic remedies. And offered up as medicine by the University of Maryland's Center for Integrative Medicine through their clinical services. (Why isn't this malpractice? I haven't figured that out yet.)

The other treatments offered by the UMM Center are no better. Their Qi Gong brochure explains that

"sickness, pain or physical disorders are the result of qi blockage, or unbalanced qi in the body. Qigong practice helps to balance the qi system in the body and break the qi blockage(s) to recover health."

There's no scientific basis for qi - it is simply magical thinking. The brochure, though, claims that Qigong will give you "an increased resistance to illness through a stronger immune system." None of these claims have any good science to back them up.

But it gets worse. The Center for Integrative Medicine is offering lectures and courses in all four years of the medical school curriculum, and it boasts that the "integrative medicine elective has become a top choice for fourth year medical students." How unfortunate that this pseudoscience has infiltrated its way into the medical curriculum, and that the UMM Center is, in essence, mis-training medical students at one of the nation's oldest medical schools.

By providing a respectable home for these pseudoscientific practices, UM Medicine is undermining its own scientific and educational missions. But when the money is coming in, the administration seems quite happy to support it. Last August, the Dean of Medicine issued a glowing press release about the Center, after its Director published a very poor study (see my earlier blog about that one) arguing for the use of acupuncture. I don't know if the Dean believed that press release, but someone ought to tell him that Integrative Medicine has no place in a 21st century medical curriculum. I guess I just told him.

Note: why do I pick on U. Maryland? Primarily because it's my own institution (although I noted previously that UM Medicine is a separate campus from the main campus at College Park where I work). There are plenty of other Integrative Medicine programs at reputable medical schools, most of them just as deserving of criticism.