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.
A few years ago a friend asked me to comment on advice given to her adult daughter by a psychiatrist whom she’d consulted for depression. The psychiatrist had recommended testing samples of saliva and urine for hormone and neurotransmitter levels, the results of which would likely indicate a need for supplements to correct deficiencies or imbalances. According to the psychiatrist, who had an academic appointment at a medical school in New York City, “I have been using these supplements with a great deal of success.” My friend is not medically or scientifically sophisticated, but this made her a little uncomfortable. In that, she was entirely justified.
During our recent panel discussion at the NECSS, a member of the audience identified himself as a clinical pathologist at a major medical center, and wondered what he might do to become involved in the good fight against encroaching pseudoscience in medical schools. Clinical pathology is the medical specialty that concerns itself, in summary, with laboratory tests—their development, their validity, their interpretation, their usefulness and, by implication, their misuse. A topic that we haven’t much featured on SBM (we touched upon it here, here and here, and probably elsewhere) is that of bogus laboratory or other diagnostic tests.
Early in my own education in modern quackery, I found it particularly distasteful not merely that quacks misuse laboratory tests, but that several commercial laboratories market misleading tests. To the untrained eye these laboratories appear to be legitimate, even to the point of their being approved by apparently legitimate certifying bodies. We’ll discuss that below, but first let’s look more closely at the psychiatrist’s recommendations to my friend’s daughter and at other examples of bogus tests.
Over the past two plus years of the existence of Science-Based Medicine (SBM) we have been highly critical of the National Center for Complementary and Alternative Medicine (NCCAM) – going so far as to call for it to be abolished. We are collectively concerned that the NCCAM primarily serves as a means for promoting unscientific medicine, and any useful research it funds can be handled by other centers at the NIH.
So we were a bit surprised when the current director of the NCCAM, Josephine Briggs, contacted us directly and asked for a face-to-face meeting to discuss our concerns.
That meeting took place this past Friday, April 2nd. David Gorski, Kimball Atwood and I met with Dr. Briggs, Deputy Director Dr. John Killen, Karin Lohman PhD (Director, Office of Policy, Planning, and Evaluation) and Christy Thomsen (Director, Office of Communications and Public Liaison).
Dr. Briggs very graciously began the meeting by telling us that she and her staff have been reading SBM and they find our arguments to be cogent and serious. She shares many of our concerns, and feels that we are an important voice and are having an impact. She then essentially turned it over to us to discuss our primary concerns regarding the NCCAM.
We were prepared for this.
For a number of reasons, well-argued many times here on SBM, it would be beneficial to American citizens if the National Center for Complementary and Alternative Medicine (NCCAM) were abolished. This does not seem to be in the cards anytime soon. Here, then, are my suggestions for making the Center less dangerous and less of a marketing tool for pseudomedicine than it has been since its inception. Some suggestions might even make the Center somewhat useful. They are listed in order of priority. The Center should:
1. Abandon all unethical trials, beginning with the Trial to Assess Chelation Therapy (TACT, which is under the joint auspices of the NHLBI). This should be done in a very public manner. The reasons for abandoning the TACT, in summary, are as follows.