A new study which randomized 638 adults to either standard acupuncture, individualized acupuncture, placebo acupuncture using tooth picks that did not penetrate the skin, and standard therapy found exactly what previous evidence has also suggested – it does not seem to matter where you stick the needles or even if you stick the needles through the skin. The only reasonable scientific conclusion to draw from this is that acupuncture does not work.
But let me back up a minute. Imagine if we were evaluating the efficacy of a new pain drug. This drug, when tested in open trials (no blinding or control) has an effect on reducing pain – it is superior to no treatment. When compared to a placebo, however, the drug is no more effective than the placebo, although both are more effective than no treatment.
Now imagine that the pharmaceutical company who manufactures this drug sends out a press release declaring that their drug is effective for pain, but that their research shows that a placebo of their drug is also effective (FDA applications are pending). Therefore more research is needed to determine how their drug works. Would you buy it?
That is the exact situation we are facing with acupuncture research.
There is no question that patients on insulin benefit from home monitoring. They need to adjust their insulin dose based on their blood glucose readings to avoid ketoacidosis or insulin shock. But what about patients with non-insulin dependent diabetes, those who are being treated with diet and lifestyle changes or oral medication? Do they benefit from home monitoring? Does it improve their blood glucose levels? Does it make them feel more in control of their disease?
This has been an area of considerable controversy. Various studies have given conflicting results. Those studies have been criticized for various flaws: some were retrospective, non-randomized, not designed to rule out confounding factors, high drop-out rate, subjects already had well-controlled diabetes, etc. A systematic review showed no benefit from monitoring. So a new prospective, randomized, controlled, community based study was designed to help resolve the conflict. (more…)
My first post on this blog addressed the problem of what I have called “fake diseases” (a problem which needs a more neutral moniker). As I wrote at the time, people suffering from vague ailments are often twice victimized: the medical establishment cannot satisfy them, and quacks prey on them. There’s a certain sense of satisfaction and validation to having your symptoms clearly labeled. While it isn’t a good thing to have heart disease, no one tells you you’re not sick. Not so with people with more vague and protean symptoms. It’s human nature to want answers, to try to understand patterns, and when we, as physicians, cannot help someone understand their symptoms, they’re going to reach out to others for answers.
The Lyme disease community is like that. The internet has helped them to form communities and to share information. This whole idea of “chronic Lyme disease” (CLD) has become a way for people who don’t feel they have a medical home to come together. I understand that impulse. Any human being should be able to understand it.
But the other side of me, the analytic side, has a problem with it. No, not a problem with people supporting each other, but if you read these websites, message boards, etc., you can see a certain commonality—people aren’t getting any better. They are still suffering. Much of that suffering is blamed on a heartless medical community, and when they find a “Lyme literate” doctor, there is a huge sense of relief. But the symptoms often continue.
The very idea of CLD is not implausible (as opposed to Morgellons and other such fake diseases). Other spirochetes give us models for diseases with extended, multi-system effects, syphilis being the most studied. One of the key concepts in science-based medicine is plausibility, because, as Dr. Harriet Hall puts it, no matter how much you study the characteristics of the tooth fairly, you still haven’t proven her existence. But CLD certainly has a plausibility to it, and if an idea is plausible, then it is certainly worth studying and gathering evidence.
During the past academic year, I have written about CAM on campus for my student newspaper and fancy myself now somewhat notorious among the students who care about the issue. My article in the fall issue was a review of a homeopathy lecture that I described in detail for my first SBM post. In the winter issue I discussed two dueling WSJ opinions and the silliness of the “4 in 10 Americans use CAM” argument, channeling Drs. Gorsky and Crislip. I had a piece planned to wrap up the series, but sadly the spring issue has been canceled because the rest of the editorial staff is studying for USMLE Step 1. This is life at medical school, probably not just mine but universally: huge stresses and time obligations often crowd out extracurricular activities.
I began imagining this essay, an open letter to the campus CAM advocates about how I would direct their programming, just before my run-in with a pair of students unhappy about an SBM post. Before the accusations of unprofessionalism began flying around, I was thinking about how we could find common ground. Are there aspects of CAM that even a self-described skeptic can support? Clearly everyone on campus cares firstly about providing the best possible care for patients. Could the CAM advocates and I be collaborative rather than antagonistic? Some disagreement is inevitable given that I have classmates who have taken coursework in homeopathy and integrative nutrition, but I wondered if I could offer constructive advice on improving the CAM club rather than simply dismissing it as having no place on campus. (more…)
Perhaps you have discovered for yourself that I am always the last to write a post on a ‘hot’ topic. I am definitely the slowest writer (and thinker?) on this blog, starting each post at least a week before it is up. So the faster writers weigh in first and I am left with clean up.
As I finish writing on Thursday, there have been 892 cases of H1N1 aka Swine flu and 2 deaths in the US. Looks like the world has avoided a disastrous pandemic like the 1919 flu that killed off 2 to 5% of the world. For now. Maybe. I hope.
However, the flood of nonsense about the flu far exceeds the infection rates from H1N1. This entry will be the limited by necessity. The quantity of quackery (9) far exceeds my ability to type. I thought that influenza virus replicated and spread fast. It pales next to the flu woo.
My inaugural post was about vaccines, and I promised that I wouldn’t write exclusively on this topic. But something rotten is brewing in the state of Georgia and this story is just too important to ignore.
The first successful challenge to the National Childhood Vaccine Injury Compensation Act (NCVICA) has taken place in Georgia, and we all should be just a little bit worried. In Ferrari v. American Home Products Corp., the plaintiffs, Marcello and Carolyn Ferrari of Atlanta, have sued American Home Products Corp. (otherwise known as Wyeth) and the co-defendant GlaxoSmithKline, claiming that the vaccine preservative thimerosal led to their son’s autism. The consequences of this ruling could effect the health of the entire nation. To understand why, we need to delve a bit into what the NCVICA is exactly, and why it was created in the first place.
I recently had a pleasant, brief email exchange with Kris Newby, the producer of the latest medical advocacy pic, Under Our Skin. There’s been a number of similar movies lately, mostly about quacky cancer therapies. This one is apparently much better made, and follows the controversy regarding “chronic” Lyme disease.
I’d heard an interview about the movie on Diane Rehm, and was rather unnerved by it. It sounded like a typical I-drank-the-Kool-Aid-now-I’m-gonna-make-a-movie kind of thing. Still, I haven’t written about it, because I haven’t seen the movie. That’s going to change. Kris is being kind enough to send me a copy, despite my warning that I’m very likely to pan it.
Anyway, in our conversation, she recommended that I check out a particular piece in the Journal of Medical Ethics. Before I go into the significance of this paper, let me give you a little background. Stick with me here, I’ll make it brief. (more…)
Loose Ends: Dr. Koh and More
After Dr. Federman’s letter and my reply, posted in Part V of this series,† there seemed little point in pursuing the matter further. Although Dr. Federman never answered my reply, he did send, at my request, a copy of Commissioner of Public Health Howard Koh‘s written “construction of the events in the Massachusetts Special Commission.” As you may recall, those events had occurred at meetings that Dr. Koh never attended:
July 29, 2002
Dear Dr. Federman:
I have had an opportunity to review Dr. Kimball Atwood’s characterizations of the role Dr. David Eisenberg played as an advisor and designee of the Department of Public Health (DPH) and I am writing to clarify several misrepresentations of that role. As you may know, I personally selected Dr. Eisenberg as my designee for the Massachusetts Special Commission on Complementary and Alternative Medical Practitioners based on his high level of scientific and clinical expertise in the field, as well as his international reputation for evidence-based research. I felt at that time, as I do now, that he was the appropriate choice to represent the Department and I am extremely grateful for his advice and his integrity during this most contentious process.
During the course of the Commission, Dr. Eisenberg brought to my attention some of the conflicts that had arisen among the members, despite his attempts to diffuse the hostility and to engage the members in collegial debate. In an effort to overcome these difficulties and deflect unwarranted criticism, Nancy Ridley, Assistant Commissioner for Health Quality Management, attended the meetings over the last six months as the DPH voting designee, with Dr. Eisenberg as an advisor. She also organized a DPH workgroup of the Commission in an attempt to bring consensus and closure to what had become a very polarized and highly personalized process.
I need to state emphatically that the approval of the final Commission report is my responsibility, and is largely a product of the DPH workgroup that Assistant Commissioner Ridley chaired. Dr. Eisenberg had actually not been supportive of either the “majority” or “minority” reports that were originally presented, and neither was Ms. Ridley. She attempted to address as many of Dr. Eisenberg’s concerns as possible but knew he still had issues with the final document. She feels very strongly that there needs to be regulatory oversight of non-physician practitioners of complementary and alternative naturopathic practice. Assistant Commissioner Ridley, on behalf of the Department and with my consent, signed the report that included a significant number of revisions which narrowed the scope of practice, ensured collaborative relationships between physician and non-physician practitioners, and broadened the scope of any proposed regulatory oversight required. Dr. Eisenberg’s advice to DPH was delivered in a fair and balanced manner based his outstanding experience as a clinician and scientist.
I believe that one of the contributing factors for the polarization within the Commission had little to do with Dr. Eisenberg’s participation rather than that of his staffperson, Michael Cohen, who attended Commission meetings in his absence. Mr. Cohen was repeatedly characterized as the alternate DPH designee, which he was not.
In summary, Dr. Eisenberg’s expertise and professionalism throughout this difficult process have been greatly appreciated by the Department. DPH was truly fortunate to be represented and advised by a person of Dr. Eisenberg’s stature and character. I would be more that pleased to speak to you or Dean Martin on his behalf. Please feel free to contact me at xxx.xxx.xxxx if you need any additional information.
Howard K. Koh, MD, MPH
The range of self-serving misrepresentations in that letter is wide, and is worrisome in someone who will be “responsible for the major health agencies, including the CDC, FDA and NIH, and [will be] the leading health advisor to the Secretary of HHS.” I have already discussed some of the facts here and here, and will add more now.
This is the second installment analysis of a three (and now 4) part series of articles on effects of homeopathy on childhood diarrhea. This second installment elaborates on our findings on data from the second clinical trial in Nicaragua. (1)
I should first explain the title. In order for homeopathy to operate as a base or operating system for medicine “for the 21st century,” the entire system of measurement and of course all physical laws would have to be changed. In analogous political terms, it would be similar to – but more massive a change than – changing a nation from a democracy to a completely different system such as a theocracy with completely different laws and behavior expectations. So…well, it was the best I could think up at the time.
Last time I recounted how the Jacobs ll trial setup was incoherent and unable to produce results that could prove efficacy – unless the differences between treatment and controls were quite large, greater than just barely significant. Most patients were treated differently from others, with multiple preparations (that were in reality the same: pill filler) at differing times during the illness, with each preparation selected according to symptoms that likely varied by the hour, and influenced by memory, well known to be faulty in medical studies.
In fact, given the lack of homogeneity in the trial diagnoses and treatments, outcomes should not have made sense at all. Now I must admit that the thought did not occur to us at the time we undertook the review, nor during the review. If it had, our job would have been easier and the paper shorter.
It is unfortunately a common human reaction to respond to criticism by attacking those leveling the criticism, rather than addressing the points being made. This is especially true if the criticism is legitimate and one cannot reasonably counter it.
Substantive criticism is also a central part of the scientific endeavor, and so the culture of science has developed a tolerance for harsh criticism and a general understanding that the only proper response is with logic and evidence. Examples of exceptions are legion, human frailty being what it is, but you cannot live in the world of science for long without learning the rules of the game. Peers are expected to pull no punches when criticizing the errors or countering the arguments of their colleagues. Everyone is expected to be their own harshest critic (criticize your own data before someone has a chance to). And when criticized yourself, acknowledge what is legitimate and make appropriate corrections, but feel free to defend yourself against weak criticisms by pointing out additional data, interpretations, or errors in the arguments of your critics.
This meat grinder approach to scientific discourse works. Slowly, bad ideas and claims are beaten down, and only good ideas have the stamina to persist.
But here at science-based medicine we engage not only with the scientific community, but also with the public, and with those on the fringes of science. This means we often engage with those who do not play by the rules of science. A recent example is that of J.B. Handley from Age of Autism. David Gorski and I (and later Mark Crislip) wrote blog entries criticizing their 14 studies website with a detailed analysis. Handley responded with a full frontal personal assault sprinkled with irrelevant accusations. He ignored the vast majority of our actual criticisms, and those few he took on he completely botched.