Back in January, the Connecticut Board of Chiropractic Examiners held a four-day hearing to decide whether chiropractors must, as a part of the informed consent process, (1)warn patients about the risk of cervical artery dissection and stroke following neck manipulation and (2) give patients a discharge summary listing the symptoms of stroke.1 On June 10th, the Board of issued a written opinion that stroke or cervical artery dissection is not a risk of cervical spine manipulation, so no warning is necessary. Presumably, although it is not specifically mentioned in the decision, no discharge summary is required because, if there is no risk of a stroke after neck manipulation, what would be the point?
Janet Levy and Britt Harwe are two Connecticut women who suffered strokes resulting from neck manipulation by chiropractors. That’s not just their lay opinion, it’s the opinion of their respective treating physicians, right there in the medical records.
Each decided that some good should come of their unfortunate situations, so each formed a non-profit and began warning patients of the risk of stroke following manipulation. Victims of Chiropractic Abuse, Levy’s organization, put giant ads on the sides of busses in Bridgeport, CT., much to the chagrin of the folks at the University of Bridgeport. Within the hallowed halls of the University (Go Purple Knights!) is a College of Chiropractic, a College of Naturopathic Medicine, and the Acupuncture Institute. The chiropractors demanded that the ads be taken down, which got exactly nowhere.
Some chiropractors also began harassing Levy and Harwe, calling them Nazis and KKK members, for example, and threatening their personal safety and that of their families.(What is it with the pseudoscience crowd and calling people Nazis? Perhaps, having used up their entire supply of imagination creating their nostrums, they are reduced to these tired tropes.) The FBI recommended Levy and Harwe have one of the harassers arrested, which they did, and that calmed things down for a while. (more…)
Some chiropractors also practice homeopathy. According to Frank King, D.C., many more should be doing just that:
Homeopathy is an energetic form of natural medicine that corrects nerve interferences, absent nerve reflexes, and pathological nerve response patterns that the chiropractic adjustment alone does not correct. The appropriate homeopathic remedies will eliminate aberrant nerve reflexes and pathological nerve responses which cause recurrent subluxation complexes.
Not only does homeopathy correct nerve interferences, it empowers the doctor of chiropractic to reach the entire nervous system. What this means is that we can now better affect the whole person, and all of the maladies that affect us. Homeopathy’s energetic approach reaches deep within the nervous system, correcting nerve interferences where the hands of chiropractic alone cannot reach. Homeopathy is the missing link that enables the chiropractor to truly affect the whole nervous system!
But that’s not all:
How the Food and Drug Administration came to be is a story that is filled with death, intrigue and dubious characters. It also, like most stories, has its share of heroes and vindications. The list of those who have died to bring us the agency we know today is long, but even today, the death-toll continues. Now this is not the horrible thing it may at first seem. People are all born with a terminal disease known as life, and they will die. The goal of Medicine is to forestall that death as long as possible and to give people good, long, healthy and safe lives. This is where the Food and Drug Administration comes into play. They help guide the pharmaceutical world in the safest manner possible.
The legal quagmire that is the Food and Drug Administration (FDA) is a result of a series of laws which it behooves the Science-Based Medical community, to understand. Many of these laws were a result of deaths, which were themselves the result of either poor safeguards, or, as we will see in one case, lack of information on the part of a company. It began with the Division of Chemistry inside the U.S. Department of Agriculture. The original concern of this group was the misbranding and adulteration of both food and drugs. The first of the laws which came into effect, to give the Bureau of Chemistry as it became known, was the Biologics Control Act of 1902. As is so often the case with FDA regulations, this was a result of deaths in the populous.
The International Society for Stem Cell Research (ISSCR) is a professional organization of stem cell researchers. I am happy to see that they see it as their responsibility to respond to the growth of dubious stem cell clinics offering unproven treatments to desperate patients.
In a recently published handbook for patients, they write:
The International Society for Stem Cell Research (ISSCR) is very concerned that stem cell therapies are being sold around the world before they have been proven safe and effective.
Stem cell therapies are nearly all new and experimental. In these early stages, they may not work, and there may be downsides. Make sure you understand what to look out for before considering a stem cell therapy.
Remember, most medical discoveries are based on years of research performed at universities and companies. There is a long process that shows first in laboratory studies and then in clinical research that something is safe and will work. Like a new drug, stem cell therapies must be assessed and meet certain standards before receiving approval from national regulatory bodies to be used to treat people.
This is good advice for any new treatment.
On March 30th, President Obama signed the final piece of healthcare reform legislation concluding an epic battle that ultimately lead to the passage of the Patient Protection and Affordable Care Act (PPACA). The bill enforces the largest change to US healthcare for decades and has provided an opportunity for Complementary and Alternative Medicine (CAM) advocates to be federally endorsed in our future healthcare system. This entry is an attempt to present excerpts from the PPACA itself that could lay the groundwork for incorporating CAM into the future healthcare system.
CAM proponents tout a few sections in the PPACA as a victory for their cause. One of these sections is 3502, entitled Establishing Community Health Teams To Support The Patient-Centered Medical Home, which endorses government grants “to establish community health teams,” which are defined as “community-based interdisciplinary, interprofessional teams.” It goes on to say that such a ‘team’ may include, “doctors of chiropractic, [and] licensed complementary and alternative medicine practitioners.”1
The requirements of such a health team are listed and one of them reads, “to provide support necessary for local primary care providers… [and] to provide coordination of the appropriate use of complementary and alternative (CAM) services to those who request such services.” What this entails, is that there will be an influx of federal spending into CAM services with the enactment of the new bill.
When Daniel David Palmer, the inventor of chiropractic, and his acolytes first took up the practice of chiropractic, around the turn of the last century, they were jailed for the unlicensed practice of medicine. If history had left them there, we might not be fighting a continuing battle with the pseudoscience that is “alternative” medicine today.
Unfortunately, the Kansas legislature intervened on the chiropractors’ behalf and passed the first chiropractic practice act in 1913. Over the years, state by state, the notions that subluxations interfere with nerve flow, causing ill health, and that only chiropractors could “correct” these subluxations, thereby restoring health, were incorporated into state law. As well, chiropractors were given a broad scope of practice and allowed to call themselves “doctor.” In 1974, Louisiana’s passage of a chiropractic practice act made chiropractic legal in all 50 states.
Acupuncturists and naturopaths copied this successful formula by convincing state legislatures to incorporate their pseudoscientific ideas directly into practice acts, thereby managing to become licensed health care providers. Legislative fiat triumphed over scientific facts time after time.
Laws allowing the practice of “alternative” medicine did not totally eliminate resistance to pseudoscientific practices from some quarters. Insurance companies, for example, refused to pay for treatments they considered experimental. Medicare did not cover chiropractic. Labs and x-ray facilities wouldn’t allow use of their services. But for each roadblock science tried to put in the way, state and federal legislators were there to remove it, paving the way toward “acceptance.”
What evidence standard should exist for health products sold in pharmacies? That’s today’s bleg, and I’m seeking your input.
In most countries, pharmacy is a registered, self-regulated health profession, with a responsibility to optimize the use of drugs. Pharmacist education consists of several years of university-level education and practical training in real-world health care settings. Pharmacists with advanced degrees and post-graduate residencies are common. Not all pharmacists work in community (retail) pharmacies, but that’s where many pharmacists end up, and it’s the public face of the profession.
In most countries, pharmacies are private businesses, either owned by a pharmacist or by a corporation. They are granted a privileged and exclusive right in the provision of health care: certain health products (both prescription and non-prescription) are only available in pharmacies, because pharmacist consultation and availability has been deemed necessary to maximize the safe use of these products. While it’s a setting for health care (and often the first point of contact into the system), retail pharmacy is a business. Pharmacies count on the retail sale of products for revenue and traffic. And in general, pharmacies have the legal right to stock and sell whatever products they want. Tobacco is one exception, where it is no longer sold in most Canadian pharmacies, but remains prevalent in American pharmacies. And as I discussed in a prior post, when we look internationally there can be considerable differences between which drugs are prescription, and these that can be sold over-the counter.
How Much Evidence?
The evidence standard for products sold in pharmacies is facing increasing scrutiny. Concerns have been raised in several countries that pharmacies may be taking advantage of their privileged status as provers of prescription drugs, and are selling products that aren’t supported by good scientific evidence. Some recent examples:
In the world of the anti-vaccine underground, there is one time of the year that looms large. Over the last few years, this time has generally come right around the end of May, usually coinciding with the Memorial Day weekend and the unofficial beginning of the summer vacation season here in the U.S. I’m referring, of course, to Autism One, which blights one of my favorite cities in the world, Chicago, every year about this time. True, of late Autism One has been metastasizing, most recently to blight the city of Toronto and the very grounds of the University of Toronto itself. As you may recall, last fall, when Autism One descended upon Toronto, I described it as “a conference of believers in two things: (1) that vaccines cause autism and (2) that ‘biomedical’ and CAM/IM therapies can treat and even reverse autism,” and it’s true, but Autism One is more than that. It’s a combination of a networking meeting for the anti-vaccine set, a revival meeting for the cult of anti-vaccinationism and autism “biomedical” therapy, and a trade show for “biomed” treatments for autism, all dressed up to appear to be a legitimate scientific conference.
Of all the fake scientific conferences out there, Autism One in Chicago, which begins today, far eclipses all the others, including even Barbara Loe Fisher’s National Vaccine Information Center (NVIC) conference. Closely aligned with the anti-vaccine propaganda group Generation Rescue and its outlet in the blogosphere Age of Autism (both of which, not surprisingly, have been promoting the conference incessantly), Autism One is the granddaddy of fake academic autism conferences, where anyone who’s anyone in the anti-vaccine “autism biomed” underground goes to see and be seen. It even has a keynote address by anti-vaccine celebrity spokesmodel Jenny McCarthy herself this year, just like the previous two years. This year, however, Autism One has expanded from three or four days to a full week, and it has taken on a note of political activism that was generally lacking in previous conferences. In previous years, Autism One pretty much stayed localized to a hotel near O’Hare, far from the center of the city. This time around it’s still at a hotel near O’Hare, but its organizers plan an anti-vaccine protest rally right smack dab in the middle of Grant Park on Wednesday afternoon. All of this leads me to conclud that this year Autism One’s organizers appear to be cementing the relationship between the autism “biomed” movement, the anti-vaccine movement, and the “health freedom” movement.
Imagine you’re an FDA reviewer looking at a new drug application. Drug A relieves a symptom, but doesn’t cure any disease. It doesn’t conflict with other medications. It’s considered safe in pregnant and breastfeeding women. At normal doses, there are virtually no side effects. There’s one unfortunate problem: If you take ten times the dose, liver damage is very likely and may be fatal. In other countries, Drug A is the number one cause of acute liver failure.
Should Drug A be available without a prescription?
Now consider another drug. Drug B also treats a symptom, but can also be used to treat a number of acute and chronic conditions, some of which require monitoring by specialist physicians. Drug B should generally be avoided in children, as it is associated with a rare but fatal toxicity. Even at normal doses, it can cause an array of side effects, and severe digestive system toxicity, resulting in hospital admission, is not uncommon. It interacts with other prescription drugs, and can be fatal in overdose situations.
Should Drug B be available without a prescription?
Mark Crislip is always a hard act to follow, particularly when he’s firing on all cylinders, as he was last Friday. Although I can sometimes match him (and, on rare occasions, even surpass him) for amusing snark, this time around I’m going to remain mostly serious because that’s what the subject matter requires. I’ve said it before and I’ll say it again: I’m a bit of an odd bird in the world of cancer in that I’m both a surgeon and I run a lab. Sadly, there just aren’t very many surgeons doing basic and translational research these days, thanks to declining NIH funding, increasing clinical burden necessitated by declining reimbursements, and the increasing complexity of laboratory-based research. That’s not to say that there aren’t some surgeons out there doing excellent laboratory research, but sometimes I feel as though I’m part of an endangered species, particularly years like this when grants are running out and I need to renew my funding or secure new funding, the consequence of failure being the dissolution of my laboratory. It’s a tough world out there in biomedical research.
As tough as biomedical research is in cancer, to my mind far tougher is research trying to tease out the relationship between environmental exposures and cancer risk. If you want complicated, that’s complicated. For one thing, obtaining epidemiological data is incredibly labor- and cost-intensive, and rarely are the data clear cut. There’s always ambiguity, not to mention numerous confounding factors that conspire to exaggerate on the one hand or hide on the other hand correlations between environmental exposures and cancer. As a result, studies are often conflicting, and making sense of the morass of often contradictory studies can tax even the most skillful scientists and epidemiologists. Communicating the science and epidemiology linking environment and cancer to the public is even harder. What the lay person often sees is that one day a study is in the news telling him that X causes cancer and then a month later another study says that X doesn’t cause cancer. Is it any wonder that people are often confused over what is and is not dangerous? Add to this a distinct inability on the part of most people, even highly educated people, to weigh small risks against one another (an inability that has led to phenomena such as the anti-vaccine movement), and the task of trying to decide what is dangerous, what is not, how policy is formulated based on this science, and how to communicate the science and the policy derived from it to the public is truly Herculean.