Pseudoscience and Dishonesty, continued: “Reliable Information”?

In the previous post, we examined misrepresentations by the late National Center for Complementary and Alternative Medicine (NCCAM) Director Stephen Straus and Margaret Chesney, written in 2006 as a rebuttal to a critical article by Donald Marcus and Arthur Grollman in Science magazine. Here, we continue. According to Straus and Chesney:

Before the establishment of NCCAM, there was no central source of CAM information. NCCAM brings evidence-based information on CAM to the public, practitioners, and researchers. NCCAM disseminates research findings and provides reliable information about commonly used CAM practices through numerous channels, including…its award-winning Web site… NCCAM’s communications program deals with a field that is controversial, that has many critics, and that reaches a public that wants reliable information.

Before the establishment of the NCCAM, there was an excellent source of reliable information about “CAM”: Quackwatch. It continues to be the most comprehensive source of such information.

The NCCAM itself does not provide “reliable information about commonly used ‘CAM’ practices.” Rather, it bends over backward—in some instances making categorically false statements—to portray absurd, dangerous, implausible, or disproved practices as safer and more promising than they are.

Examples follow, but first please consider an implicit yet abundant and compelling piece of evidence that has left several of us (1, 2, 3) scratching our heads since the NCCAM began: each year the Center bestows numerous grants for the purpose of teaching “CAM” (not “CAM research”) to health professionals or for “integrating CAM” into various programs, or for establishing “integrative medicine” centers. For examples, look here. Isn’t this putting the cart before the horse? How can this be viewed as anything other than promoting “CAM”? Consider that Straus and Chesney also wrote:

In the early years of NCCAM, there was a sense of urgency to scientifically assess a range of CAM therapies that had been in long use by the public in the absence of proof of safety or efficacy.

In the subsequent 8 years, there has not been a burgeoning list of “CAM therapies” that have been proven safe and effective. The number of treatments that would qualify for that list, or for a comparable list before the creation of the NCCAM is, if you’ll excuse the rudeness of reliable information,…zero. In other words, the NCCAM admits that the treatments that characterize its “CAM integration” projects have not been shown safe and effective.

But back to a few explicit examples of unreliable information.

According to the Award-Winning NCCAM Website…

Learn More About Chelation Therapy and the Study

Chelation with EDTA has been used to treat heavy metal poisoning such as lead. For this use, there is a low occurrence of side effects.

No: Intravenous Na2EDTA, the form used in the chelation trial, has never been approved to treat heavy metal poisoning such as lead, nor has it been studied in formal trials for that purpose. The form of EDTA that is so used, CaNa2EDTA, is considerably safer: it is usually given by the safer intramuscular route and in a safer location (a hospital), and it does not carry the risk of acute hypocalcemia. Hypocalcemia due to Na2EDTA has killed several people, including 5-year old Abukar Tariq Nadama. The award-winning NCCAM Web site does not distinguish between the two drugs or mention death as a risk of the study drug, nor does the consent form for the trial itself. For a detailed critique of that consent form, a form that provides additional, highly unreliable information to those who would be subjects in the trial, look here under Comments on the TACT Consent Form. The risks of “chelation therapy,” known at the trial’s inception but not acknowledged by TACT investigators, are discussed in the same article under The Risks for Na2EDTA Chelation and Supplements.

As stated in the first part of this series, the Trial to Assess Chelation Therapy provides an overwhelming refutation to Straus and Chesney’s essay. Continuing in the category of Unreliable Information are categorically false statements, made by the trial’s Principal Investigator and accepted by the NCCAM, about previous studies and case reports of chelation for atherosclerosis. In the absence of those statements it would have been clear to any rational observer that there was no scientific basis for the TACT. For a comprehensive discussion, look here under III. State of the Evidence.

In the categories of Conflicts of Interests and corrupt Scientific Review Committees was the presence, on the NIH Special Emphasis Panel that reviewed the original TACT application, of L. Terry Chappell: a chelationist who had been instrumental in convincing Rep. Dan Burton to bully the NIH into initiating a chelation trial, and who was nominated, by the very application that the NIH had asked him to judge, to be one of the “prominent experts” on the “TACT Liaison Committee to the ACAM.” Chappell would also become a TACT Investigator. For a thorough discussion of these points, look here under II. Genesis of the TACT.

Another conflict of interest in the TACT is the apparent (i.e., reported by himself) presence of Robert Nash, another conspicuous chelation proponent, on the Data Safety and Monitoring Committee. Nash has claimed, regarding chelation, that “established detoxification techniques…have been proven safe and effective over time…” He is hardly an unbiased or prudent choice for the Safety committee. For more discussion of this and related points, look here under Risks Ignored in the TACT Protocols.

Also unreliable is the presumption that TACT investigators are competent to be investigators or to provide medical care for experimental subjects. Many (probably most) are not, as shown here, under Chelationists as Co-Investigators and Will Subjects Receive Indicated Medical and Surgical Therapies?; and here: The TACT is at least as Bad as We Predicted.

The “Gonzalez Regimen” for Cancer of the Pancreas

Nicholas Gonzalez, who administered his regimen to subjects in the other NCCAM-sponsored trial that Drs. Marcus and Grollman selected for criticism (only to be ignored by Straus and Chesney), was also not competent to provide medical care for experimental subjects. Gonzalez’s incompetence, like that of the ACAM members who represent the majority of TACT investigators, was known well before the trial began, as demonstrated here.

The Gonzalez trial exemplifies another sort of unreliable information. As mentioned in the previous post, Straus and other operatives at the NCCAM must have known, since the fall of 2005, that the Columbia Data and Safety Monitoring Committee had “recommended that the study be terminated due to predetermined stopping criteria” after only 62 of the planned 90 subjects had been enrolled, and that the study had been so terminated. As discussed here, this must have meant that the outcomes had been so bad that it would have unethical to continue the trial. The NCCAM website has offered no clarification. It states:

On the basis of promising pilot study data, the National Center for Complementary and Alternative Medicine (NCCAM) and the National Cancer Institute (NCI) funded a clinical trial comparing gemcitabine-containing chemotherapy to an alternative cancer treatment consisting of proteolytic enzyme therapy with nutritional support (known as the Gonzalez regimen) to treat patients with advanced pancreatic cancer. The study is being conducted at the Herbert Irving Comprehensive Cancer Center at Columbia University and affiliated sites in New York City.

In October 2005, Columbia University closed the study to new enrollment after the Data and Safety Monitoring Board unanimously agreed that sufficient numbers of subjects had been enrolled to permit the study to achieve the predetermined research endpoints. Patients already enrolled on the trial will continue to be followed until the study is complete.

Once the data from all the patients in the study are complete, the investigators will analyze and report their findings. Final results are expected 2 years after that.

Until now I had not been aware that the NCCAM website had admitted even that much about the cessation of the Gonzalez trial. Nevertheless, the statement provides barely a hint of the reason for the trial’s early cessation or that it was highly unusual. Nor does it mention that the whole, sordid mess of the “Gonzalez trial” illustrates what’s wrong with the current “CAM” social experiment and with the NCCAM in particular.

I suspect that between the phrase “closed to new enrollment” and the sentence “Patients already enrolled on the trial will continue to be followed…,” the statement is additionally misleading. Readers might presume that subjects already enrolled in the trial were to continue to receive the “Gonzalez regimen.” I suspect, however, a very different implication: that the trial investigators merely intended to gather data from those subjects until they died, i.e., “until the study [was] complete.” We also read, again, the misleading claim of “promising pilot study data,” previously refuted here and here. Finally, we must wonder what has happened to those “final results.” Surely enough time has passed for them to be reported.

The National Cancer Institute (NCI), by the way, gives no indication that the Gonzalez trial was stopped before its planned enrollment was complete; it merely reports the trial’s “status” as “closed,” but continues to report the “expected enrollment” as “90.” Similarly, reports that “This study is ongoing, but not recruiting participants,” and “Estimated enrollment: 90.”

More Unreliable Information

All of the information about homeopathy on the NCCAM website is misleading. Much of it is plainly wrong. This can be demonstrated by comparing it to the series on homeopathy with which I began my tenure as a blogger on SBM.

Naturopathic physicians are educated and trained in a 4-year, graduate-level program at one of the four U.S. naturopathic medical schools accredited by the Council on Naturopathic Medical Education. Admission requirements include a bachelor’s degree and standard premedical courses. The study program includes basic sciences, naturopathic therapies and techniques, diagnostic techniques and tests, specialty courses, clinical sciences, and clinical training…Some therapies used in naturopathy have the potential to be harmful if not used properly or under the direction of a trained practitioner…Naturopathic physicians are trained to know that herbs and some dietary supplements can potentially interact with drugs, and to avoid those combinations.

Again, no: “naturopathic physicians” are neither ethically nor scientifically competent to prescribe herbs and “dietary supplements,” as shown here. Nor are they competent to practice primary care medicine, which is their claim, as shown in the rest of that series and in its numerous references, including here and here. Nevertheless, the NCCAM regularly includes several “naturopathic physicians” on its advisory council, and regularly grants funds for naturopathic “research” boondoggles, including purported demonstrations of the paranormal fantasies of psychokinesis and remote viewing, as documented here .

A landmark study has shown that acupuncture provides pain relief and improves function for people with osteoarthritis of the knee and serves as an effective complement to standard care. The study, the largest Phase III clinical trial of acupuncture for knee osteoarthritis, was funded by NCCAM and the National Institute of Arthritis and Musculoskeletal and Skin Diseases…

In reality, the “landmark study,” published in 2004, suggested trivial differences between “true acupuncture” and “sham acupuncture.” The differences were most prudently explained by expectation, as demonstrated in the report itself: subjects’ believing that they were in the “true acupuncture” group was more predictive of a favorable outcome than was their actual group assignment. The trial was subsequently disconfirmed by another, much larger trial, reported in 2006 in the same journal. As previously mentioned by Steve Novella, a 2007 meta-analysis of acupuncture for osteoarthritis of the knee, which included the “landmark study” among the nine that it analyzed, and was co-authored by the first author of that study, concluded:

Sham-controlled trials show clinically irrelevant short-term benefits of acupuncture for treating knee osteoarthritis. Waiting list–controlled trials suggest clinically relevant benefits, some of which may be due to placebo or expectation effects.

The accompanying Editors’ Notes concluded:

The use of different types of comparisons (sham acupuncture vs. interventions in which the participant knew whether they [sic] were receiving acupuncture) explains the variability in the conclusions of published trials about the effectiveness of acupuncture for treating knee osteo-arthritis. Placebo or expectation effects probably account for the observed benefits.

In other words, acupuncture for osteoarthritis of the knee does exactly as prior probability predicts: it comforts people who believe in it. If people want to use it, let them, but let’s stop wasting taxpayers’ money on frivolous trials. None of the relevant literature, other than the “landmark study,” is mentioned on the NCCAM website. Could the reason be that subsequent findings have rendered the 2004 study no longer “landmark”?

The first author of the “landmark study” was Brian Berman, the Director of the University of Maryland Center for Integrative Medicine and a member of the Cochrane CAM Field (previously discussed here). Remember that name, because he will be discussed in the next part of this series.

two NCCAM-funded studies did not find a benefit from echinacea, either as Echinacea purpurea fresh-pressed juice for treating colds in children, or as an unrefined mixture of Echinacea angustifolia root and Echinacea purpurea root and herb in adults.

In [the adult] study, the researchers found that none of the three preparations of E. angustifolia at the 900 mg per day dose had significant effects on whether volunteers became infected with the cold virus or on the severity or duration of symptoms among those who developed colds. However, critics of this study believe the dose of E. angustifolia used was too low.

[In the pediatric study], the researchers found that between those receiving echinacea and those receiving placebo at the onset of symptoms there was:

  • No difference in the duration of upper respiratory infection symptoms
  • No difference in the overall severity of symptoms
  • No difference in the number of days of fever
  • No difference in parents’ assessment of severity of infection
  • No overall difference in side effects (adverse events); however, children taking echinacea were more likely to develop rashes than those taking placebo.

The researchers concluded that the “results do not support the use of echinacea for treatment of upper respiratory infections in children 2 to 11 years old.” In addition, the researchers recommend more studies to look at other echinacea preparations or different doses or dosing schedules to determine if there is any possible role for echinacea in treating colds in children. They also suggest further research to determine whether echinacea has any role in preventing colds.

NCCAM will continue to support research on Echinacea. A number of preclinical, Phase I, and Phase II studies of Echinacea products are currently under way. This research is being done both because of the public health burden of the common cold and the public’s widespread use of this natural product. A recent survey of complementary and alternative medicine use by adults in the United States found that, among those who reported using natural products, Echinacea was the most commonly used.

In the case of echinacea, the NCCAM’s bluff has been called: the Center sponsored two trials of this popular “herbal remedy,” each of which was, predictably, negative. Yet our NIH-based source of reliable information on implausible medical claims can’t seem to take “no” for an answer. It should be obvious that there are enough “other echinacea preparations or different doses or dosing schedules” to keep grant recipients busy for a long, long time. In the meantime, has there been any diminution in echinacea hype by either sellers or “integrative medicine” experts since the two trials were reported? It doesn’t seem so.

Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT)

  • a primary, or original, study that investigated whether glucosamine and/or chondroitin could treat the pain of knee osteoarthritis.
  • an ancillary, or additional, study that investigated whether the dietary supplements could diminish the structural damage of knee osteoarthritis.

The results…showed that the popular dietary supplement combination of glucosamine plus chondroitin sulfate did not provide significant relief from osteoarthritis pain among all participants. However, a smaller [too small to be interpretable–KA] subgroup of study participants with moderate-to-severe pain showed significant relief with the combined supplements.

The ancillary study results…showed that glucosamine and chondroitin sulfate, together or alone, appeared to fare no better than placebo in slowing loss of cartilage in knee osteoarthritis.

This $12.5 million, 4-year study, involving more than 1500 subjects, was the best trial that the NCCAM has funded. It showed, beyond any reasonable doubt, that glucosamine and chondroitin sulfate are ineffective for treating osteoarthritis of the knee. You might expect that the NCCAM, in the spirit of providing reliable information to the public that paid for the trial, would happily inform its benefactors that the matter has finally been put to rest, and that they no longer need waste their money on glucosamine/chondroitin pills. You’d be wrong:

“While these results are of interest, we cannot draw definitive conclusions about the utility of glucosamine or chondroitin in reducing joint space width loss, in part because the placebo group fared better than anticipated based on prior research results,” said Josephine P. Briggs, M.D., director of the National Center for Complementary and Alternative Medicine, at the National Institutes of Health (NIH), one of the study’s funders. “The results of the study provide interesting insights for future research.”

Consumer Information and Next Steps

Should people with osteoarthritis use glucosamine and chondroitin sulfate?

People with osteoarthritis should work with their health care provider to develop a comprehensive plan for managing their arthritis pain: eat right, exercise, lose excess weight, and use proven pain medications. If people have moderate-to-severe pain, they should talk with their health care provider about whether glucosamine plus chondroitin sulfate is an appropriate treatment option.

Can U.S. consumers get the glucosamine and chondroitin sulfate products used in GAIT?

Identical products may not be commercially available…

Another bluff called. Why is the NCCAM so reluctant to tell it like it is?

More from Straus and Chesney:

We fully support the Institute of Medicine’s recommendation that the same principles and standards of evidence apply to all treatments, whether labeled as conventional medicine or CAM. We believe that we have succeeded in establishing a research enterprise that will achieve this standard. While challenges remain, we are confident that knowledge gained from NCCAM-supported studies will continue to inform the public, health-care providers, and policy-makers about how and when evidence-based CAM therapies should be used and effectively integrated into conventional medical care.

Yes: the 3 trials just discussed ought to inform the public, health-care providers, and policy-makers. It ought to inform them that there is no justification for integrating acupuncture or glucosamine/chondroitin sulfate for osteoarthritis of the knee, or echinacea for colds, into conventional medical care—exactly as prior probability had predicted. The NCCAM’s sympathetic language regarding these claims, even in the wake of its own, disconfirming trials, is characteristic of all such expositions presented by “CAM” proponents, including those associated with “CAM” or “integrative medicine” programs in medical schools. Maybe there are considerations involved other than scientific evidence. Ya think?

Posted by Kimball Atwood