by Igor I. Bussel & Andrey A. Pavlov Jr.
Jann Bellamy has recently authored an excellent piece on the limitations of the FDA and how the DSHEA actually protects the profits of supplement manufacturers rather than the health and well-being of consumers. Bellamy used the very poignant and currently “controversial” example of DMAA (methylhexanamine or 1,3-dimethylamylamine) to illustrate her point regarding the loopholes and lack of enforcement power of the FDA. The authors of this piece had been considering writing about DMAA and felt this would be an excellent time to further expound on Bellamy’s work. The goal of this article will be twofold: 1) to discuss the known history and pharmacology of DMAA, especially in regards to the basic methodology for evaluating novel substances or novel uses of substances in the context of lacking RCT level evidence (i.e. the concept of science vs. evidence based medicine) and 2) how the DMAA story clearly and unequivocally demonstrates how the DSHEA allows for unscrupulous profiteers to game the system with little, if any, consequence and nothing but profit until the cost in lives forces the issue.
DMAA was originally developed by Eli-Lilly in 1948 and then later trademarked as Forthane to be used as a nasal decongestant (there are varying accounts but it seems that Eli Lilly patented the molecule in the early 1940’s and then trademarked and marketed it as Forthane in 1971 for allergic rhinitis and then voluntarily withdrew it in 1983). The mechanism of action was vasoconstriction – the blood vessels in the nose would constrict so that less blood flow would lead to less nasal discharge. This is a mechanism used by common OTC nasal sprays like oxymetazoline (Afrin) and is indeed quite effective. However, Forthane was later withdrawn from the market because of significant side effects including headaches, tremors, and increased blood pressure. These effects likely occur because DMAA is structurally similar to amphetamine and as a result, the compound is not only a vasoconstricting agent but is also a central nervous system (CNS) stimulant.
Lest anyone think I am a heartless bastard, I would like it to be known that I do not like to see any creature suffer or die. I am the kind of person who, when finding a spider in the house, is likely to catch it and toss it outside. I always think, “I can’t squish the end result of 6 billion years of evolution”. Except mosquitoes. Those I squish with glee. Infection vectors can die die die die.
I like animals and hate to see them suffer unnecessarily. Like sticking them with needles. Frontal lobes are nice to have. They can let you know that pain is coming and provide preparation and compensation. Once I had a steel bar smack me on the head, opening up a six-inch cut to the bone. No, my brain was not affected, thank you very much. Everything predates the head trauma. When the ER doc numbed the scalp for sutures, he missed the last half-inch and I felt the needle. Knowing what was going on I steeled myself and let him do the last two sutures with no lidocaine, since the needle hurt only a little worse than the lidocaine injection. I have had many other unpleasant medical procedures in my 56 years but knowing what was coming and understanding why makes it easier to tolerate a needle popping into the knee joint or an abdominal drain being pulled.
Animals, and young humans, lack the ability to comprehend the what and why of pain inflicted as part of medicine. Adults can make a conscious decision to be endure pain and fool themselves into thinking it is of benefit. No pain, no gain. Animals can make no such choice.
For example consider sea turtles, who, apparently, are subjected to all sorts of nonsense at the New England Aquarium including acupuncture and laser therapy. As is obvious, I am no veterinarian, the only animal of which I have any understanding of anatomy and physiology is a human, but even with that background it is remarkable what is reported from New England. I used to say the ‘B’ students went into journalism; given the credulous reporting perhaps the standards have been lowered. They certainly have for marine biologists and veterinarians, who are evidently shortchanged in their education. (more…)
The Star Trek universe is a fairly optimistic vision of the future. It’s what we would like it to be – an adventure fueled by advanced technology. In the world of Star Trek technology makes life better and causes few problems.
One of the most iconic examples of Star Trek technology is the medical tricorder. What doctor has not fantasized about walking up to a sick patient, waving a handheld device over them, and then having access to all the medical information you could possibly want. No needle sticks for blood tests, no invasive tests, scary MRI machines, and no wait. The information is available instantly.
It’s clear that we are heading in that direction as technology progresses, but how close are we?
The Smartphone in Medicine
Many people in developed nations today are walking around with supercomputers in their pocket – their smartphone. Technological advances are often strange – the ones we anticipate seem to never come, but then life-changing technology creeps up on us.
Has one physician uncovered the secret to Olympic Gold medals? And is that secret as simple as undiagnosed low thyroid function? That’s the question posed in a recent Wall Street Journal column entitled U.S. Track’s Unconventional Physician. Like the story that Steven Novella described yesterday, this narrative describes the medical practice of Dr. Jeffrey S. Brown, who sees thyroid illness where others see normal thyroid function. He has his critics, but his high-profile athlete patients have won a collective 15 Olympic gold medals. Case closed & Q.E.D.? Not quite. The WSJ actually does a pretty good job questioning the validity of Brown’s claims, which are far removed from the current medical consensus:
In athletic circles, Brown is a medical hero. He’s a paid medical consultant to Nike. The most renowned running coach at Nike, Alberto Salazar, calls Brown the best sports endocrinologist in the world. And athletes in growing numbers are coming to share Brown’s belief that heavy training can suppress the body’s production of the thyroid hormone, leaving them too exhausted to perform at peak. On the wall of the medical office of Jeffrey S. Brown is a photograph of Carl Lewis, the nine-time Olympic gold medalist. Lewis is one of several former or current patients of Brown’s who have climbed the Olympic podium, including Galen Rupp, who won a silver medal in the 10,000 meters at the London Olympics. “The patients I’ve treated have won 15 Olympic gold medals,” said Brown. Among endocrinologists, Brown stands almost alone in believing that endurance athletics can induce early onset of a hormonal imbalance called hypothyroidism, the condition with which he diagnosed Lewis and Rupp. Brown said he knows of no other endocrinologists treating athletes for hypothyroidism, a fatigue-causing condition that typically strikes women middle-aged or older. Several endocrinology leaders had never heard of hypothyroidism striking young athletes.
Now when I read “unconventional” and “stands alone” my skeptical alarm starts ringing. There is no shortage of debate about thyroid disease, ranging from the utter nonsense offered by “alternative health” practitioners to valid scientific discussions about the thresholds where normal function is considered abnormal and subject to treatment. Brown is an endocrinologist, however, and he’s treating elite athletes who are pushing their physical conditioning far beyond that seen by most medical doctors and almost all endocrinologists. So what’s the basis of the concern? The WSJ story goes on to discuss two different issues: What the proper threshold is for thyroid disease, and whether thyroid replacement is performance enhancing. Let’s take each of these in turn. I’ve covered thyroid diseases and its related pseudoscience before, and a summary of the standard approach is necessary before we look at the some of the broader questions that have emerged from the story. All I know about these patients is what the WSJ is describing, so for the sake of brevity I’m going to focus on the types of cases that Dr. Brown appears to be identifying and ignore other causes of thyroid disease, which would require different treatment approaches.
Animal-assisted therapy is a huge topic: almost 1500 hits using those terms alone. There is no way I am going to cover all of them and do them justice. Instead I am going to cherry pick, er, I mean, select references of interest to illustrate issues surrounding animals in the hospital. Sometimes I get the impression that readers of the blog expect encyclopedic knowledge and understanding of a topic whenever we put pixel to screen. That is only true of the other contributors to the blog, not me.
I would like to mention that I do, in fact, like animals, even dogs. I loathe most dog owners, as confirmation bias suggests there is no such thing as a considerate dog owner. But I never have contact with the dogs that don’t bark, that don’t crap on my yard, that don’t run up to me to nip at my legs. I only see the dogs that their owners allow to behave in ways I would never allow a human to behave.
It is no surprise that my kids have grown up mostly animal free. My eldest did wear me down and I bought him a hamster. It promptly bit me, drawing blood. Great, I thought, LCM. Just what I need. Then in the dead of winter it escaped, fell down a heating duct (we were putting in new floor) and electrocuted itself on the heating coils so every time the heat turned on we smelled rotting, roasting hamster. It cost $500 to take the furnace apart and clean it. Good thing it wasn’t a beagle. That was enough pets in the house for me. (more…)
If the “Health Freedom” movement has its way, everyone in the United States will be able to practice medicine. It may be quack medicine but that doesn’t seem to bother them. Short of that, chiropractors, naturopaths and acupuncturists are aiming to reinvent themselves primary care providers and even physicians. As David Gorski pointed out, this will reduce medical doctors to just another iteration of physician, the “allopathic” type, equal in stature to the chiropractic, naturopathic and acupuncture types. These “physicians” already call themselves “doctor” (e.g., “Doctor of Oriental Medicine”) and claim to graduate from four-year “doctoral” programs. This despite the fact that their schools operate outside the mainstream American university system and avoid some of the basics of typical graduate programs, such as entrance exams, as well as the extensive clinical training required for medical doctors.
Consumers are confused by all of this, and who wouldn’t be? In 2008 and 2010, surveys done for the American Medical Association by outside firms revealed that many patients did not know the qualifications of their healthcare provider. The comparisons were between allied health professions (e.g., audiologists and nurse practitioners) and medical doctors, but chiropractors were included. In 2008, 38 per cent of those surveyed (n=850) thought chiropractors were medical doctors, although that dropped to 31 per cent in 2010. Still, we are talking about roughly one-third of the survey participants.
The surveys also asked about the use of the term “physician” and confusion in advertising materials.
A concept that has been well-recognized in pediatric medicine, at least since it was first described in 1964, is that of vulnerable child syndrome (VCS). Classically VCS occurs when a currently healthy child is felt to be at increased risk for behavioral, developmental, or medical problems by a primary caregiver, usually a parent, and typically follows a serious illness. It can lead to some pretty serious behavioral complications in the parent, and subsequently the child, and severely impact entire families.
In the past, I have mistakenly thought of this entity more as “sick child syndrome” but that is problematic. It implies that it only occurs in the aftermath of true illness or injury. As I will explain in detail, there is much more to the development of VCS and it is the concern of VCS in children without true medical problems that led me to amend my understanding and make the connection with alternative medicine.
Is VCS Really a Problem?
Every parent (well, most parents – I’ve seen some things), worries about the well-being of their children. The desire to protect our personal genetic repositories is hardwired. And as with many behaviors, there is a point where parental worry becomes pathologic and interferes with normal functioning. In the case of VCS, the relationship between the parent and child can be severely impacted and the consequences can be disastrous.
Infectious diseases (ID), as those who read my not-so-secret other blog know, is without a doubt the most interesting speciality of medicine. Every interesting disease is infectious in etiology. What is cool about ID is that it has connections into almost every facet of human culture and history.
I note that at some point I have gone from being the young whippersnapper to the Grandpa Simpson at my hospitals and am one of the few who has been around long enough to be a repository of institutional memory. I remember what it was like 20 plus years ago, when no one consistently washed their hands, when all S. aureus (S. aureui?) were sensitive to beta-lactams and we wore an onion on our belt, as was the style of the day. Oh the changes I have seen.
Besides remembering the not so good old days of my professional career, ID keeps me reminded of how the world used to be in the past. Medicine used to be about the epidemics that would routinely sweep across the world. Polio, measles, mumps, scarlet fever, rheumatic fever, tuberculosis and on and on. I occasionally see TB but thanks to modern medicine many of these scourges have mostly faded from medical practice in the US. Not a one, I might add, has faded due to the efforts of alt med practitioners.
Influenza still gives me pause. It is, as infections go, quite the tricky virus and it remains a difficult beast to treat and prevent. Which is a drag as it remains one of the more consistent causes of infectious morbidity and mortality. (more…)
The integrity of the scientific basis of medicine is under attack from numerous fronts. It is not only the intrusion of pseudoscience and mysticism into mainstream institutions of medicine, but also attempts to distort or game the scientific process for ideological and financial reasons.
Ideological groups such as the anti-vaccine movement, or grassroots organizations promoting pseudodiseases such as chronic Lyme, electromagnetic sensitivity, or Morgellon’s often misrepresent the scientific evidence while they lobby for special privilege to avoid the science-based standard of care within medicine.
Pharmaceutical companies, with billions on the line, have been very creative in figuring out ways to optimize their chances of getting FDA approval for their drugs, and then promoting their drugs to the medical community. Ghost-writing white papers, hiding negative trials, and designing trials to maximize positive outcomes have all been documented.
Vacation then taxes have consumed my focus the last two weeks, and I have had little time to devote to issues of infectious diseases, much less SBM, so I will instead meander around a more philosophical terrain. I feel guilty when I do not have a substantive, data driven post evaluating a paper or essay in detail, but some weeks there just is not the time.
Being involved with SBM has been, like all intellectual endeavors, a process rather than result. I keep experimenting with conceptual frameworks with which I can understand the differences between a SBM approach and a SCAM (supplements, complementary and alternative medicine) approach. Nothing clarifies thoughts quite like writing them down. Or maybe not.
The motto of the blog is “exploring the relationships between science and medicine” but it is often more about non-overlapping boundaries* than relationships. We are often separated more by Berlin walls than Venn diagrams.
There are perhaps four boundaries that separate science-based medicine from those who prefer SCAMs. More if you are a splitter; I am a lumper by nature. At work I am an Occam kind of guy. (more…)