A few days ago, while gathering information for last week’s post about intravenous hydrogen peroxide, I noticed this:
ACAM Supports NIH Decision to Suspend TACT Trial
September 3, 2008, Laguna Hills, Calif. — The American College for Advancement in Medicine, ACAM today announced its support for the National Institute for Health’s (NIH) decision to suspend patient accrual of the Trial to Assess Chelation Therapy (TACT) Trial until allegations of impropriety can be proven false. ACAM believes that the TACT trial represents a important milestone in assessing the role of chelation therapy in modern healthcare and respects the decision of the NIH.
ACAM continue to work with Dr Tony Lamas to answer the unfounded allegations of impropriety.
“We believe that the Office of Human Research Protection (OHRP) will find that the allegations are of a political nature. To serve the best interests of participants enrolled in the TACT trial and all patients and their physicians who seek answers about chelation therapy, we call for a swift end to the moratorium and resumption of the trial,” said Jeanne Drisko, MD, President of ACAM.
I alerted a few others, including Stephen Barrett of Quackwatch, who queried the news room of the National Heart, Lung and Blood Institute (NHLBI: the joint sponsor, along with the NCCAM, of the trial) and got this reply:
The investigators and institutions performing the Trial to Assess Chelation Therapy (TACT), in conjunction with their Institutional Review Boards, have temporarily and voluntarily suspended enrollment of new participants in the study. NIH has not issued any announcement or press release about this action. To contact the Office for Human Research Protections’ (OHRP) press office, call Pat El-Hinnawy, (202) 253-0458.
Anecdotal evidence. An oxymoron? Or a valid approach to understanding data?
The problem is there are different kinds of anecdotes, used for different purposes, but the purpose of anecdotes is rarely if ever defined explicitly. Anecdotes are used for one purpose by one speaker/writer but interpreted in a different context by the listener/reader. People love anecdotes, especially if the anecdotes are about them or their beliefs. Anecdotes are how patients transmit the particulars of their disease to their health care providers. The medical history, as taken from the patient, is an extended anecdote, from which the particulars of the disease have to be extracted. Anecdotes are how physicians explain disease and treatments. Anecdotes are a tool with which teachers instruct their students. Anecdotes are how CAM proponents validate their particular system, and how skeptics invalidate them.
Anecdotes are useful tools for presenting yourself and your ideas. The convention season is over and is was striking how the candidates attempted to win over voters with anecdotes about their lives rather than the particulars of their policies. Using variations of ‘anecdote’ as a pubmed search term yields little of substance. The predominant theme on medline is to contrast anecdotes with evidence, always to the detriment of anecdotes. Anecdotes have power to influence far greater than evidence.
On The Skeptics Guide to the Universe #165 there was an interview with Ben Goldacre, who noted that there was the popular misbelief that the MMR vaccine was a cause of autism. The belief waned not when the voluminous data on the safety and lack of association with autism and the MMR was released, but when it was discovered that the primary proponent of the MMR/autism link received large sums of money to testify about that MMR/autism link. It was the anecdote about his conflict of interest that invalidated the idea, not the science.
In yet another round of science by press release, a particularly unimpressive acupuncture study is making the rounds of the major news outlets proclaiming that acupuncture works. I guess that is a sort-of answer to my title question – why are so many scientifically worthless acupuncture studies being done?
Let’s take a look at this particular study to see why it is so weak. All I have to go on is the press release, since the study is not published. It was presented at a scientific meeting – which is legitimate, I just don’t have access to it. (The bar for publication in a peer-reviewed journal is much higher than presentation at a meeting, and there may, in fact, be changes to the text prior to publication.) But we can still say a great deal about this study from the information provided.
Note: The reason that I am posting today rather than my usual Monday slot is because the article I discuss here was embargoed until last night. Consequently, I asked Harriet if she would trade days with me this week, and she was kind enough to do so.
One thing that science relies on almost absolutely is transparency. Because one of the most important aspects of science is the testing of new results by other investigators to see if they hold up, the diligent recording of scientific results is critical, but even more important is the publication of results. Indeed, the most important peer review is not the peer review that occurs before publication. After all, that peer review usually consists of an editor and anywhere from one to four peer reviewers on average. Most articles that I have published were reviewed by two or three reviewers. No, the most important peer review is what occurs after a scientist’s results are published. Then, all interested scientists in the field who read the article can look for any weakness in methodology, data analysis, or interpretations. They can also attempt to replicate it, usually as a prelude to trying to build on it.
Arguably nowhere is this transparency quite as critical as in the world of clinical trials. The reason is that medications are approved on the basis of these trials; physicians choose treatments; and different medications become accepted as the standard of care. Physicians rely on these trials, as do regulatory bodies. Moreover, there is also the issue of publication bias. It is known that “positive” trials, trials in which the study medication or treatment is found to be either efficacious compared to a placebo or more efficacious than the older drug or treatment it is to replace, are more likely to be published. That is why, more and more, steps are being taken to assure that all clinical trial results are made publicly available. For example, federal law requires that all federally-funded clinical trials be registered at ClinicalTrials.gov at their inception, and peer-reviewed journals will not publish the results of a clinical trial if it hasn’t been registered there. Also, beginning September 27, 2008, the US Food and Drug Administration Amendments Act of 2007 (FDAAA) will require that clinical trials results be made publicly available on the Internet through an expanded “registry and results data bank,” described thusly. Under FDAAA, enrollment and outcomes data from trials of drugs, biologics, and devices (excluding phase I trials) must appear in an open repository associated with the trial’s registration, generally within a year of the trial’s completion, whether or not these results have been published. Although there are some practical issues over this law, for example determining how much information can be disseminated this way without constituting prior publication, which is normally a reason to disqualify a manuscript from publication.
I’m frequently asked, “Is what that ad says really true?” Three recent inquiries have been about products advertised in Scientific American. An ad may acquire a certain cachet by appearing in a prestigious science magazine, but that doesn’t mean much. Scientific American’s editorial standards apparently don’t extend to its advertising department. I remain skeptical about the claims for all three of these: Juvenon, the StressEraser, and the ROM exercise machine. I discussed the ROM machine last week.
This product is advertised as “The Supplement That Can Slow Down the Clock on Aging Cells.” Andrew Weil also sells this on his website. It supposedly helps keep your mitochondria from decaying, promotes brain cell function, sustains energy levels, and is a powerful antioxidant.
The first time I noticed an ad for Juvenon in Scientific American I wrote the following letter to the editor: (more…)
I had intended today’s posting to be a summary of a real case faced by a state medical board. It is a case of licensed physicians treating patients with a substandard, dangerous, and unequivocally illegal method. My intent was to use it as an illustration of how difficult it can be for medical boards to discipline such practitioners, even when the treatment involved is obviously, blatantly bad. Only yesterday, I was informed by the pertinent board that because this case has yet to be resolved, I may not discuss it. So be it: I’ll save the specifics for another time. Instead I’ll offer a general example of a dubious treatment as a prelude to Part 2 of this series,† which will attempt to discover some of the reasons that medical boards might, under such circumstances, be ineffectual.
Intravenous Hydrogen Peroxide
Hydrogen peroxide (H2O2) is a highly reactive compound that is caustic to living tissues. It spontaneously decomposes to water and oxygen, a reaction that is greatly accelerated in the presence of peroxidases (mainly catalase), which are ubiquitous in human blood and tissues. It has been used as a disinfectant for superficial skin wounds and in the mouth, and also for fabric and medical equipment. It has been used as a bleaching agent for teeth and hair. When used as an irrigant in surgical fields, in other large wounds, or consumed in any form (including intravenously), however, it has resulted in predictable, catastrophic complications: arterial and venous gas emboli, emphysema, respiratory arrest, strokes, multiple cerebral infarcts, seizures, colonic ulcers, intestinal gangrene, acute hemolytic crises, shock, cardiac arrest, and death.[1-7]
Anyone attempting a systematic review of the medical literature on sectarian medical systems (“CAM”) starts with a serious disability; the literature itself. The National Library of Medicine still lists abstracts for over 30 “alternative medicine” journals, but more concerning, is my estimate that half or more of the articles on sectarian systems published in standard medical journals range from the erroneous to the fraudulent. If one is conscientious, honest, and wants to produce a realistic review of sectarian systems that reflects reality, one cannot do it.
The problem spills over and beyond boundaries of medical research and practice. Often neglected is a massive literature of the allied professions – nursing, psychology, social work, and others. There are data bases for these professions as well (CINAL, EMBASE, CISCOM, Psychlit.) So not only do physicians and patients deal with a disabled medical literature, other professions also face the same problem in theirs. Little wonder that the “CAM” – “Integrative” movement has been tolerated instead of rejected in the community of health and allied health.
The editor of Research on Social Work Practice sent me a copy of a review of intercessory prayer published in his journal (Hodge DR, A Systematic Review of the Empirical Literature on Intercessory Prayer. Res Soc Work Pract 2007;17(2):174-186.) Intercessory prayer is the prayer offered by others for an ill person, usually not in the person‘s presence. Prayer is usually performed on a regular daily schedule by groups of prayers of one or more religious denominations.
Yesterday was a good day.It was a good day because it was one of the days that shows that, sometimes, science and ethics do win out after all:
CHICAGO (AP) — A government agency has dropped plans for a study of a controversial treatment for autism that critics had called an unethical experiment on children.
The National Institute of Mental Health said in a statement Wednesday that the study of the treatment — called chelation — has been abandoned. The agency decided the money would be better used testing other potential therapies for autism and related disorders, the statement said.
The study had been on hold because of safety concerns after another study published last year linked a drug used in the treatment to lasting brain problems in rats.Chelation (kee-LAY’-shun) removes heavy metals from the body and is used to treat lead poisoning. Its use as an autism treatment is based on the fringe theory that mercury in vaccines triggers autism — a theory never proved and rejected by mainstream science. Mercury hasn’t been in childhood vaccines since 2001, except for certain flu shots.
But many parents of autistic children are believers in the treatment, and NIMH agreed to test it.The researchers had proposed recruiting 120 autistic children ages 4 to 10 and giving half a chelation drug and the other half a dummy pill. The 12-week test would measure before-and-after blood mercury levels and autism symptoms.The study outline said that failing to find a difference between the two groups would counteract “anecdotal reports and widespread belief” that chelation works.
Except that it wouldn’t have.
Bisphenol A (BPA) is a chemical used in the manufacture of hard plastics which can be found in a wide range of products, including baby bottles, plastic utensiles, and plastic food containers. It has been the focus of some controversy over its safety, and the resulting debate reveals much about how the current system deals with such issues.
The concern is that BPA can leech from plastic containers into the food or liquid it contains, and when consumed can have negative health effects. The debate is over how to interpret existing evidence about BPA safety, which gives conflicting results. Essentially it is a debate about how to weight different kinds of evidence, and where safety thresholds should be.
The Science of Toxins
Toxicity is always a function of dose. Anything is toxic at high enough dose, and safe at a low enough dose. Regulatory agencies concerned with protecting the public health, therefore, typically use scientific evidence to establish doses that are likely to cause toxicity in humans and then set safe levels of exposure significantly below that level to create a buffer of safety. But what kind of evidence is used?
I know I should exercise regularly, but I’m congenitally lazy and am ingenious at coming up with excuses. There’s an exercise machine that sounds like the end of all excuses, a dream come true. You’ve probably seen the ads in various magazines. The ROM Machine: “Exercise in Exactly 4 Minutes per Day.” It claims that you can get the same benefit, at home, from 4 minutes a day on the ROM as you can from 20 to 45 minutes aerobic exercise plus 45 minutes weight training plus 20 minutes stretching at the gym. It allegedly balances blood sugar and repairs bad backs. It is for everyone from age 10 to over 100.
Does this sound too good to be true? That’s usually a clue that it is too good to be true. I was skeptical and I sent in for the company’s free DVD. There were more clues in the DVD. They had testimonials from 2 chiropractors, several trainers, and lots of satisfied users, but they didn’t have recommendations from a single medical doctor or scientist. In fact, they mentioned a couple of doctors who disputed their claims, including one cardiologist who told his patient that kind of strenuous exercise could kill him. To prove you could get a good workout from the machine, they put people on it, got them to huff and puff and sweat a lot, and then got them to say, “That was a real workout!” (more…)