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…)
Disclaimer: I am a paid Medscape blogger and writer, and since they are in part supported by advertisements from the Pharmaceutical companies, indirectly I am in the thrall of Big Pharma.
I found Harriet’s post on the Medscape Connect topic of How do you feel about Evidence-Based Medicine? interesting.
I wondered about the breakdown of the comments by both specialty and opinions about SBM. So I read the 226 comments and classified them by field and response. I classified each response as disapprove, approve or nuanced. It is not, obviously, a legitimate survey and there was more than a little subjective interpretation in deciding how to classify the responses. I have no doubt that others would get different results; it is not methodologically sound analysis. The discussion was in the Family Medicine & Primary Care section, so it is unlikely to be representative of any population, including that of Family Practitioners and Primary Care Physicians. I would bet, as in alternative medicine and most topics, Shruggies predominate and are the silent majority.
Even though I belong to what a commentator referred to as the not so silent “militant wing” of SBM, I was surprised at my results: (more…)
Is the best medicine no medicine at all? Sometimes. My past posts have emphasized that the appropriateness of any drug depends on an evaluation of benefits and risks. There are no completely safe interventions, and no drug is free of any side effects. Our choice is ideally informed by high-quality data like randomized controlled trials, with lots of real-world experience so we understand a drug’s true toxicity. But when it comes down to a single patient, treatment decisions are personalized: we must consider individual patient characteristics to understand the expected benefits and potential harms. And in a world with perfect prescribing and drug use, harms wouldn’t be eliminated, but they would be minimized. Unfortunately, we’re not there yet. There is ample evidence to show that the way in which prescription drugs are currently used causes avoidable harms to patients.
The art and science of medicine is a series of interventions to improve health. In making these treatment decisions, we strive to minimize iatrogenic harm — that is, harms caused by the intervention itself. High up on the list of of avoidable harms are adverse events related to drug treatments. Audits of adverse events are astonishing and shameful. Studies suggest 28% of events are avoidable in the community setting, and 42% are avoidable in long-term care settings. That’s a tremendous amount of possible harm resulting from treatments that were prescribed to help. And the group that is harmed the most? The elderly. (more…)
Is the health care spending tide turning? Unnecessary medical investigations and overtreatment seems to have entered the public consciousness to an extent I can’t recall in the past. More and more, the merits of medical investigations such as mammograms and just this week, PSA tests are being being widely questioned. It’s about time. Previous attempts to critically appraise overall benefits and consequences of of medical technologies seem to have died out amidst cries of “rationing!” But this time, the focus has changed – this isn’t strictly a cost issue, but a quality of care issue. It’s being championed by the American Board of Internal Medicine Foundation (ABIM) under the banner Choosing Wisely with the support of several medical organizations. The initiative is designed to promote a candid discussion between patient and physician: “Is this test or procedure necessary?”. Nine organizations are already participating, represent nearly 375,000 physicians. Each group developed its own list based on the following topic: Five Things Physicians and Patients Should Question. Here are the lists published to date:
ABIM has partnered with Consumer Reports to prepare consumer-focused material as well, so patients can initiate these discussions with their physicians. How did this all come to be? A candid editorial from Howard Brody in the New England Journal of Medicine in 2010:
In my view, organized medicine must reverse its current approach to the political negotiations over health care reform. I would propose that each specialty society commit itself immediately to appointing a blue-ribbon study panel to report, as soon as possible, that specialty’s “Top Five” list. The panels should include members with special expertise in clinical epidemiology, biostatistics, health policy, and evidence-based appraisal. The Top Five list would consist of five diagnostic tests or treatments that are very commonly ordered by members of that specialty, that are among the most expensive services provided, and that have been shown by the currently available evidence not to provide any meaningful benefit to at least some major categories of patients for whom they are commonly ordered. In short, the Top Five list would be a prescription for how, within that specialty, the most money could be saved most quickly without depriving any patient of meaningful medical benefit.
Health care professionals are, in general, self-regulating professions. That is, governments entrust them to set the standards for their profession and regulate members, in the public interest. Consequently, attempts by payors of services (i.e., government and insurers) to guide medical practice are usually met with substantial resistance. No-one wants insurers interfering in the patient-physician relationship. That’s why it’s exciting to see this initiative in place -it’s being driven by the medical profession itself.
As a pharmacist I’m also a member of a self-regulating profession, one in which the public places a considerable degree of trust in. In order to maintain the public’s confidence, it is essential that the pharmacy profession maintain the highest professional and ethical standards, and do its part to reduce unnecessary testing and investigations. With this in mind, I’ve taken up Brody’s challenge and developed my own list of Five things Pharmacists and Patients Should Question. While eliminating them may not provide the most savings to patients, they are pharmacy-based, widely offered, and offer little to no benefit to consumers. Here are my top five candidates: (more…)