If science-based medicine reflects the application of the best evidence, then we should expect practices to change when new data emerges. In the long run that’s generally true, and the progressive gains we’ve seen in the management of disease reflect this. But in the short run, change can be maddeningly slow, and there are many areas of medicine where we could be doing a better job of applying what we already know to improve outcomes and reduce harms. One area where this is obvious is drug treatments, which can provide remarkable benefits but are also sources of significant harms.
Somewhat problematically, the real world is often the setting where the full extent of harms from treatments are identified. Bringing new drugs to market means tradeoffs: Do you demand larger and longer clinical trials to get as much information as possible about a drug before it’s sold? Or do you approve based on more preliminary, potentially weaker evidence, to meet (potentially) important patient need? There is no set formula or right answer to this questions – it’s ultimately a value judgement exercised by regulators like the FDA, who decide which drugs are allowed for sale (the benefits are assumed, overall, to exceed the harms) or removed for sale (when the opposite is felt to be the case).
Via the magic of legislative alchemy, chiropractors are already licensed health care providers in all 50 states. Thus their legislative efforts tend to focus on expanding their scope of practice and forcing public and private insurers to cover their services, in some cases at the same rate as medical doctors. Those efforts continue in 2013 with 65 bills impacting chiropractors introduced so far. Of those including substantive provisions (as opposed to, say, simply raising fees), only one is not to their advantage.
New Mexico chiropractors are once again attempting expansion of their scope of practice. In 2008 and 2009, the New Mexico legislature created a new iteration of chiropractor, called “the certified advanced practice chiropractic physician.” A certain faction of the chiropractic industry is attempting to rebrand chiropractors nationwide as primary care physicians and this was a signature event in those efforts. With 90 hours of additional education, these advanced practice chiropractors can administer a bevy of dubious remedies, such as bioidentical hormones.
The new law also permitted prescription of dangerous drugs and controlled substances and administration of drugs by injection, but only if on a formulary approved by the state pharmacy and medical boards. The chiropractic board didn’t like having to get approval from pharmacists and medical doctors, so they went ahead and added what they wanted to the formulary, ignoring the other boards despite their own attorney’s advice that they couldn’t do this. This got them into a couple of court battles with the pharmacy and medical boards. The International Association of Chiropractors (ICA), the traditional, subluxation-only chiropractic faction, jumped into the fray to oppose this power grab. The ICA believes chiropractic should remain drug and surgery free.
A fresh season of state legislative sessions is upon us and with it comes the ubiquitous attempts by purveyors of so called “complementary and alternative medicine” (or “CAM”) to join the health care provider fraternity. Via the magic of legislative alchemy, state legislatures transform pseudoscientific diagnoses (e.g., “chronic yeast overgrowth”) and treatments (e.g., homeopathy) into faux, but legal, health care. Once the imprimatur of legitimacy is bestowed by the state in the form of a health care practice act tailored to their special brand of quackery, these newly licensed health care providers are free to foist their practices onto an unsuspecting public and charge them for the privilege. All of this is done under the false assumption that such legislation is necessary to protect the public health, safety and welfare.
We might well want to consider how far this whole thing is going. Will practitioners of CAM split into an ever-expanding number of CAM provider guilds, all with their own practice acts? First, chiropractors were the only CAM practitioners who managed to get themselves licensed in all 50 states. Then along came acupuncturists, who are now licensed to practice in over 40 states. A few states license homeopaths. Some states licensed naturopaths early on. Now the naturopaths, licensed in 16 states, are in a full court press to catch up and legitimize themselves with licenses to practice “naturopathic medicine.”
Why? Because, according to Lorilee Schoenback, ND, a Vermont practitioner and American Association of Naturopathic Physicians (AANP) Board member:
If the law [the Affordable Care Act, or ACA] is implemented as intended NDs in 16 states will immediately be covered by insurance.
Now that the XMRV myth has been put to rest, patients with Chronic Fatigue Syndrome (CFS) are no longer jumping the gun to demand anti-retroviral treatments. But they are jumping the gun in new ways, based on very preliminary data coming out of Norway.
A correspondent in Norway wrote to tell me patients from Norway with myalgic encephalitis/chronic fatigue syndrome (ME/CFS) are travelling to the US to have Dr. Andreas Kogelnik in San Francisco treat them with IV infusions of rituximab, apparently to no avail. A course of treatment costs over $6000, not to speak of travel and other expenses. (more…)
A few weeks ago I reviewed Ben Goldacre’s new book, Bad Pharma, an examination of the pharmaceutical industry, and more broadly, of the way new drugs are discovered, developed and brought to market. As I have noted before, despite the very different health systems that exist around the world, we all rely on private, for-profit, pharmaceutical companies to supply drug products and also to bring newer, better therapies to market. It’s great when there are lots of new drugs appearing, and they’re affordable for consumers and health systems. But that doesn’t seem to be the case. Pipelines seem to be drying up, and the cost of new drugs is climbing. Manufacturers refer to the costs of drug development when explaining high drug prices: New drugs are expensive, we’re told, because developing drugs is a risky, costly, time consuming endeavor. The high prices for new treatments are the price of innovative new treatments, both now and in the future. Research and development (R&D) costs are used to argue against strategies that could reduce company profitability (and presumably, future R&D), be it hospitals refusing to pay high drug costs, or changing patent laws that will determine when a generic drug will be marketed.
The overall costs of R&D are not the focus in Goldacre’s book, receiving only a short mention in the afterword, where he refers to the estimate of £500 million to bring a drug to market as “mythical and overstated.” He’s not alone in his skepticism. There’s a fair number of papers and analyses that have attempted to come up with a “true” estimate, and some authors argue the industry does not describe the true costs accurately or transparently enough to allow for objective evaluations. Some develop models independently, based on publicly available data. All models, however, must incorporate a range of assumptions that can influence the output. Over a year ago I reviewed at a study by Light and Warburton, entitled Demythologizing the high costs of pharmaceutical research, which estimated R&D costs at a tiny $43.4 million per drug – not £500 million, or the $1 billion you may see quoted. Their estimates, however, were based on a sequence of highly implausible assumptions, meaning the “average” drug development costs are almost certainly higher in the real world. But how much higher isn’t clear. There have been at least eleven different studies published that estimate costs. Methods used range from direct data collection to aggregate industry estimates. Given the higher costs of new drugs, having an understanding of the drivers of development costs can help us understand just how efficiently this industry is performing. There are good reasons to be critical of the pharmaceutical industry. Are R&D costs one of them?
On my recent trip to Nashville for CSICon, I took advantage of the long hours on the plane to read Breakthrough: Elizabeth Hughes, the Discovery of Insulin, and the Making of a Medical Miracle, by Thea Cooper and Arthur Ainsberg. One of our commenters recommended it. I’m not sure who (was it Chris?), but I want to thank you.
It’s the history of insulin told from the perspective of the scientists and of a typical patient, and it touches on a number of issues that we have addressed on SBM. It shows how science works to save lives, in stark contrast to the empty promises of CAM. (more…)
Plenty of new drugs, but few that are truly innovative. Growing costs from their use. Physicians deemed “Dupes of Big Pharma” for their interactions with the pharmaceutical industry. A call to produce better information on which drugs work best. Finally, shoddy drug manufacturing is injuring and even killing patients. These stories could be lifted from today’s headlines — but they’re actually from 1962. Problems with the behavior of the pharmaceutical manufacturing industry, and our relationship with it, are not new. Nor are they restricted to one country. Every developed country’s health-care system is different, but one feature is near-universal: none have a public pharmaceutical industry. Ever nation relies on for-profit, private companies to supply its population with drug products.
Blog posts here can get pretty wonkish about health policy, as many of the substantial challenges to science-based medicine have their roots in regulation — whether it’s DSHEA which implemented a regulatory double-standard for supplements, or the state-by-state legislative alchemy that Jann Bellamy has documented, which transforms magical thinking and pseudoscientific practices into registered and regulated health practitioners. Federal food and drug regulations have also come under some scrutiny (and praise). The FDA’s under fire again; this time over its responsibility to oversee pharmaceutical manufacturing. But in this case, it’s not Big Pharma that’s the villan — it’s pharmacies. (more…)
There’s an oft-quoted saying that’s become a bit of a cliché among skeptics that goes something like this: There are two kinds of medicine: medicine that’s been proven scientifically to work, and medicine that hasn’t. This is then often followed up with a rhetorical question and its answer: What do call “alternative medicine” that’s been proven to work? Medicine. Of course, being the kind of guy that I am, I have to make it a bit more complicated than that while driving home in essence the same message. In my hands, the way this argument goes is that the whole concept of “alternative” medicine is a false dichotomy. There is no such thing. In reality, there are three kinds of medicine: Medicine that has been shown to efficacious and safe (i.e., shown to work); medicine that has not yet been shown to work (i.e., that is unproven); and medicine that has been shown not to work (i.e., that is disproven). So-called “complementary and alternative medicine” (CAM or, its newer, shinier name, “integrative medicine”) consists almost completely of the latter two categories.
Part of the reason why this saying and its variants have become so commonplace among those of us who support science-based medicine is that they strike at a common truth about medicine, both science-based and “alternative.” That common truth is what we here at SBM have been arguing since the very inception of this blog, namely that there must be one science-based standard of evidence for all treatments, be they “alternative” or the latest creation of big pharma. That point informs everything I write here and everything my blogging parters in crime write about too. What that means is a single, clear set of standards for evaluating medical evidence, in which clinical evidence is coupled to basic science and scientific plausibility. Indeed, one of our main complaints against CAM and its supporters has been how they invoke a double standard, in which they expect their therapies to be accepted as “working” on the basis of a much lower standard of evidence. Indeed, when they see high quality clinical trials demonstrating that, for example, acupuncture doesn’t work, they will frequently advocate the use of “pragmatic” trials, lower quality trials of “real world effectiveness” that do not adequately control for placebo effects. It’s putting the cart before the horse.
I contribute biweekly to Science-Based Medicine and could easily devote every post to writing about weight loss supplements, and never run out of topics. As soon as one quick fix falls out of favour, another inevitably replaces it. Some wax and wane in popularity. And pharmacies don’t help the situation. I cringe every time I walk down the aisle where weight loss products and kits are located. Detox? Hoodia? The “fat blaster”? Here are pharmacists, well educated and perfectly positioned to provide good advice to consumers, but standing behind a wall of boxes with ridiculous weight loss promises. Yet pharmacists tell me that these products are not only sought out by customers, but they actually sell well. It’s a lost opportunity to provide good advice, and consumers pay the price.
Perhaps because consumers associate these products with pharmacies, I get regular questions about weight loss programs. I end up developing some degree of familiarity with many of them, if only to be able to credibly redirect away from some of the more harmful plans and approaches. It’s that philosophy that I used recently when I was asked about how to best to manage a “plateau” on the HCG diet. I’d never dispensed human chorionic gonadotropin (HCG) before, but knew of its use for the treatment of infertility, where it promotes egg release. But weight loss? I couldn’t think of a mechanism for how HCG could promote weight loss. So I did some digging, and found a long, rich vein of pseudoscience that dates back decades. (more…)