Whether it’s acupuncture, homeopathy or the latest supplement, placebo effects can be difficult to distinguish from real effects. Today’s post sets aside the challenge of identifying placebo effects and look at how placebos are used in routine medical practice. I’ve been a pharmacist for almost 20 years, and have never seen a placebo in practice, where the patient was actively deceived by the physician and the pharmacist. So I was quite surprised to see some placebo usage figures cited by Tom Blackwell, writing in the National Post last week:
The practice is discouraged by major medical groups, considered unethical by many doctors and with uncertain benefit, but one in five Canadian physicians prescribes or hands out some kind of placebo to their often-unknowing patients, a new study suggests.
The article references a paper in the Canadian Journal of Psychiatry which, sadly, does not have much of a web presence. The article continues:
Late last week, the anti-vaccine underground was all atwitter. The reason was the announcement of an impending press conference, scheduled for yesterday at noon in Washington, DC that proclaimed:
Investigators and Families of Vaccine-Injured Children to Unveil Report Detailing Clear Vaccine-Autism Link Based on Government’s Own Data
Report Demands Immediate Congressional Action
Directors of the Elizabeth Birt Center for Autism Law and Advocacy (EBCALA), parents and vaccine-injured children will hold a press conference on the steps of the U.S. Court of Federal Claims (717 Madison Place, NW in Washington, DC) on Tuesday, May 10 at 12:00 PM to unveil an investigation linking vaccine injury to autism. For over 20 years, the federal government has publicly denied a vaccine-autism link, while at the same time its Vaccine Injury Compensation Program (VICP) has been awarding damages for vaccine injury to children with brain damage, seizures and autism. This investigation, based on public, verifiable government data, breaks new ground in the controversial vaccine-autism debate.
The investigation found that a substantial number of children compensated for vaccine injury also have autism. The government has asserted that it “does not track” autism among the vaccine-injured. Based on this preliminary investigation, the evidence suggests that autism is at least three times more prevalent among vaccine-injured children than among children in the general population.
I could hardly wait.
Crossposted from NeuroLogica Blog
Over the last 20 years the prevalence of autism (now part of autism spectrum disorder, ASD) has been increasing. The medical community is largely agreed that this increase is mostly due to expanding the diagnostic category and greater efforts at surveillance. There remains some controversy over whether or not these factors explain all of the measured increase, or if there is a small real increase hidden in there as well. But largely – we are finding more children with ASD because we are casting a wider net with smaller holes.
If this is true, then we do not yet know what the true prevalence of ASD is. There must be a pool of undiagnosed children out there. Eventually the measured prevalence will hit the ceiling of the true prevalence (unless, of course, we expand the definition further) – but where is the ceiling?
That is the question researchers recently set out to answer, and they did so with a comprehensive 5 year study conducted in South Korea. The results surprised even them:
In my recent review of Peter Palmieri’s book Suffer the Children I said I would later try to cover some of the many other important issues he brings up. One of the themes in the book is the process of critical thinking and the various cognitive traps doctors fall into. I will address some of them here. This is not meant to be systematic or comprehensive, but rather a miscellany of things to think about. Some of these overlap.
Everything is attributed to a pet diagnosis. Palmieri gives the example of a colleague of his who thinks everything from septic shock to behavior disorders are due to low levels of HDL, which he treats with high doses of niacin. There is a tendency to widen the criteria so that any collection of symptoms can be seen as evidence of the condition. If the hole is big enough, pegs of any shape will fit through. Some doctors attribute everything to food allergies, depression, environmental sensitivities, hormone imbalances, and other favorite diagnoses. CAM is notorious for claiming to have found the one true cause of all disease (subluxations, an imbalance of qi, etc.).
One of the most persistent myths is one that’s been particularly and doggedly resistant to evidence, science, clinical trials, epidemiology, and reason. It’s also a myth that I’ve been writing about a long time. Specifically, I’m referring to the now scientifically discredited myth that the mercury-containing thimerosal preservative that used to be in quite a few childhood vaccines causes autism. The myth began in the late 1990s and was later fed by the publication of David Kirby’s book Evidence of Harm, which was basically a paean to various brave maverick doctors who promoted the claim that mercury in vaccines cause autism. Among the “scientists” promoted by David Kirby were the father-son team of Mark and David Geier. Mark Geier is a physician who also has a PhD and represents himself as a medical geneticist; his son David has no medical degree, leading to my wondering from the very beginning how it was that he got away with helping his father evaluate and treat autistic children, in essence practicing medicine without a license.
The Geiers are most infamous for their “Lupron protocol,” which I first learned about back in 2006. As I wrote about it in 2009, when the mainstream media finally noticed the Geiers’ dubious medicine and how they were franchising it to different states, it was chemical castration for autism. The short version is that, somehow some way, Mark Geier got the idea in his head that testosterone contributes to autism. That in and of itself isn’t woo, given that scientists have from time to time hypothesized that very thing. What made the Geiers’ conclusions pseudoscience is their explanation. Basically, Geier claimed that testosterone binds mercury from vaccines, making it more “toxic” to the brain and also making it harder to get rid of the mercury using chelation therapy. Never mind that the only paper showing testosterone binding to mercury did it in benzene (hint: your blood is not benzene) under extreme conditions. What was worse, however, was the Geiers’ “solution” to this problem, which was to add to the autism quackery known as chelation therapy another potentially harmful form of quackery, namely chemical castration using Lupron, a drug that shuts down the production of sex hormones, including testosterone. It’s a drug that’s used to treat metastatic prostate cancer, a treatment that replaced the old treatment for metastatic prostate cancer, namely surgical castration. (Not coincidentally, it’s also used to chemically castrate sex offenders.) Even worse still, the Geiers somehow got away with a highly unethical clinical trial in which they packed the Institutional Review Board overseeing it with their cronies, going merrily on their way offering an unethical “clinical trial” untouched and seemingly untouchable.
The anti-vaccine movement is a frequent topic on the Science-Based Medicine blog. There are a number of reasons for this, not the least of which being that the anti-vaccine movement is one of the most dangerous forms of pseudoscience, a form of quackery that, unlike most forms of quackery, endangers those who do not partake of it by breaking down herd immunity and paving the way for the resurgence of previously vanquished diseases. However, anti-vaccine beliefs share many other aspects with other forms of quackery, including the reliance on testimonials rather than data. Even so, although the intelligentsia (and I do use the term loosely) of the anti-vaccine movement realizes and exploits the power of anecdotes and testimonials and how human beings tend to value such stories over dry scientific data, leaders of the anti-vaccine movement realize that science is overwhelmingly against them and that testimonials alone are not adequate to counter that science in the realm of public policy and relations.
That’s why, over the years, various anti-vaccine “scientists” (and I use that term very loosely as well) have produced poor quality, sometimes even fraudulent studies, which are then touted as evidence that vaccines cause autism or at least as evidence that there is actually still a scientific controversy when in fact from a scientific standpoint the vaccine-autism hypothesis is pining for the fjords. Examples abound, including the work of Mark and David Geier, whose studies led the to use chemical castration to treat autistic children; Andrew Wakefield, whose small case series almost certainly included fraudulent data; a truly incompetent “phone survey” commissioned by Generation Rescue designed to compare “vaxed versus unvaxed” children; and an even more incompetent “study” in which Generation Rescue used a cherry picked group of nations to try to argue that nations that require more vaccines have higher rates of infant mortality. These efforts continue. For example, last year Generation Rescue requested $809,721 from the Airborne settlement to set up a “vaxed versus unvaxed” study, despite the known difficulties with such a study and the low likelihood of finding anything without huge numbers of children.
Last week, they were at it again.
I saw a patient recently for parasites.
I get a sinking feeling when I see that diagnosis on the schedule, as it rarely means a real parasite. The great Pacific NW is mostly parasite free, so either it is a traveler or someone with delusions of parasitism.
The latter comes in two forms: the classic form and Morgellons. Neither are likely to lead to a meaningful patient-doctor interaction, since it usually means conflict between my assessment of the problem and the patients assessment of the problem. There is rarely a middle ground upon which to meet. The most memorable case of delusions of parasitism I have seen was a patient who I saw in clinic who, while we talked, ate a raw garlic clove about every minute.
“Why the garlic?” I asked.
“To keep the parasites at bay,” he told me.
I asked him to describe the parasite. He told me they floated in the air, fell on his skin, and then burrowed in. Then he later plucked them out of his nose.
At this point he took out a large bottle that rattled as he shook it.
“I keep them in here,” he said as he screwed off the lid and dumped about 3 cups with of dried boogers on the exam table.
To my credit I neither screamed nor vomited, although for a year I could not eat garlic. It was during this time I was attacked by a vampire, and joined the ranks of the undead. (more…)
In the comments to my previous article I had said I would tackle the topic of how Pharmaceutical Products are marketed and how the FDA is involved in that process. Then I managed to get a new job with a different company, and have been busy getting up to speed. I still do the same thing, but with a different company and more responsibility. All of that aside, I am now up to speed, and had the good fortune to be browsing the FDA’s website when I came across, the following article: “FDA issues warnings to marketers of unapproved ‘chelation’ products”. This seemed to me a good lead in to discuss the situation down at the FDA and why it is beneficial to have an outside party look at your marketing materials before you present them to the public.
In general, the promotional review process at the FDA works as follows. A Pharmaceutical, or CAM Company decides upon an advertisement they wish to have for their product. They review it internally to ensure compliance with the regulations as they understand them, then they send it to the FDA either as an informational piece or requesting a formal review. Which one they choose is dependent on how much of a risk they feel they are willing to take, which can also come down to the risk/benefit profile of the product in question. There is a group in each Center for the FDA which handles this. For the two Centers I have primarily dealt with on these issues, it is DDMAC (Division of Drug Marketing, Advertising and Communications) in CDER (Center for Drug Evaluation and Research) and APLB (Advertising and Promotional Labeling Branch, also pronounced “Apple-Bee”) in CBER (Center for Biologics Evaluation and Research). Now this is where the path between legitimate Pharmaceuticals and CAM takes a massive divergent twist.
Regulations have just gone into effect in the EU regarding the sale of herbal products. The regulations seem reasonable, but they have sparked near hysteria on the part of herbal sellers and advocates of “natural” medicine. They are calling the regulation a “ban” on herbal products, which much of the media has parroted, but it is not a true ban, just a requirement for registration.
The law was sparked by cases of toxicity from over-the-counter herbal products. For example, aristolochia is a toxic plant species that is either used deliberately or can be accidentally or carelessly substituted for other plant species. It is known to cause kidney damage – even leading to kidney failure is some cases. Another herb, kava, has been linked to liver damage.
The new EU law, which went into effect May 1, 2011, will require herbal products to be licensed, or prescribed by a licensed herbal practitioner. In order to be licensed evidence for safety of the product must be presented. It is estimated that it will cost between 80,000 and 120,000 British pounds to get an individual herbal product licensed.
A friend asked me to look at the evidence for hash oil as a treatment for glioma. His teenage daughter was recently diagnosed with brain cancer: a grade 3 anaplastic ependymoma. It recurred very rapidly after surgery and radiotherapy and the latest tissue diagnosis shows an aggressive grade IV glioma. Her prognosis is not good. No further attempts at curative therapy are indicated; the oncologist prescribed only palliative therapy with temozolomide. Her father, who had recently lost his wife to cancer (breast cancer metastatic to lungs and brain), was understandably devastated. As he puts it, he remains “focused on the belief that just maybe a cure can be found.” He stumbled on what he calls “earth-shattering news” regarding hash oil. He and his friends established a private wiki website which they are constantly updating with information about THC (tetrahydrocannabinol, the active ingredient in marijuana and hash) and other possible cancer cures: everything from curcumin to diet. He asked me to look at the information he has accumulated. He said
I hope to convince you in the same way I have done with my daughter’s GPs and her neuro-oncologist at BC Children’s Hospital.
The oncologist was not exactly convinced. He didn’t say he thought hash oil was likely to work; he only said it would be reasonable to try it as a complementary therapy. He said
the data published so far appears very preliminary, most of its potential effectiveness in vivo so far appears in colonic disease, having said that there doesn’t appear to be any obvious down side as a complementary therapy and may have synergistic effect, so may be reasonable as add on to temodal if she tolerates it
I wasn’t convinced either.
I will discuss two issues here:
- What does the evidence say about gliomas and hash oil?
- When is it reasonable to try an unproven treatment as a last resort?