When I wrote a week ago about the sham that is “right-to-try”, one criticism (among many) that I made of these misguided, profoundly patient-unfriendly laws was that I have as yet been unable to find a single example of a patient who has managed to obtain access to an experimental therapeutic through such a law, much less been helped by it. So-called “right-to-try” laws, of course, claim to provide a mechanism by which patients with terminal illnesses can obtain access to experimental therapeutics not yet approved by the FDA but still in clinical trials. They are, as I’ve pointed out, a cruel sham, placebo legislation that makes lawmakers feel as though they’ve done something good but do nothing of substance for patients while providing them with false hope. The federal government through the FDA controls drug approval, which means that states can’t compel a drug company to provide a drug to a patient, and most drug companies would not want to risk jeopardizing approval of their drug, which is what could happen if they grant access to an investigational drug under right-to-try and the patient suffers an adverse event. After all, the success rate for drugs that have passed phase 1 (which is all that right-to-try requires) in phase 3 trials is only on the order of 9-12%, meaning that that’s the most optimistic probability that such drugs would benefit a patient. In reality, it’s almost certainly much, much lower.
If science-based medicine is unaffordable, then your care won’t be science-based. Prescription drug costs are one of the biggest concerns in health care today. There seems to be no upper limit on prices, with some new treatments costing over $1,000 per day. The arrival of new drugs to treat (and cure) hepatitis C has created a perfect pharmaceutical storm: highly effective treatments, a large population of potential patients, and huge per-patient costs. It’s renewing the debate about whether important medical treatments are being priced out of the reach of the patients that need them. It’s not just hepatitis. Cancer drug costs are rising as well, driven by more patients and new drugs that in some cases are transforming our expectations about what cancer drugs can do. And while many of us rely on some form of drug insurance to protect us from high drug costs, insurers are struggling with balancing coverage and premiums: A report by Express Scripts paints a grim picture:
An estimated 576,000 Americans spent more than the median household income on prescription medications in 2014. This population of patients grew an astounding 63% from 2013. Further, the population of patients with costs of $100,000 or more nearly tripled during the same time period, to nearly 140,000 people. The total cost impact to payers from both patient populations is an unsustainable $52 billion a year.
This isn’t just an issue in the United States. Prescription drug costs are climbing around the world, because we’re effectively all in this together: We all rely on private companies to bring new drugs to market, and we’re largely buying the same drugs from the same small group of companies. Because ready access to safe and effective prescription drugs is so important to the practice of medicine and the delivery of health care, the pharmaceutical industry is heavily regulated – not just by the FDA, but by regulators worldwide. Yet despite the dual requirements of regulatory disclosure and the financial obligation to be transparent (as many pharmaceutical companies are publicly-held), little is known about how much it costs to bring drugs to market, and how manufacturers arrive at their selling prices. Pharmaceutical manufacturers claim that high drug costs reflect the high costs of research and development (R&D), and provide the incentives for companies to invest heavily and take risks, when many drugs may never make it to market. Are they correct? (more…)
A cycling enthusiast asked me about helmets. It seems compellingly obvious to me that a head impacting the pavement without a helmet is likely to sustain more damage than a head protected by a helmet. He challenged that, citing a BMJ article by Ben Goldacre that questioned whether the evidence showed that helmets do any good. He said I was making a non-evidence-based assumption and challenged me to actually look at the evidence, so I did.
Goldacre says there is a:
complex contradictory mess of evidence on the impact of bicycle helmets. Like most places where there’s controversy and disagreement, this is a great opportunity to walk through the benefits and shortcomings of different epidemiological techniques, from case control studies to modeling.
He proceeds to give a lesson in epidemiology. He points out that there are a lot of emotion involved, and that epidemiologic studies, because of their inherent imperfections, are probably not capable of resolving the debate.
There are basically two questions:
- What is the effect of wearing a helmet for the individual?
- What is the effect of a public policy that promotes or requires helmet use?
Last year, I did several posts on what I consider to be a profoundly misguided and potentially harmful type of law known as “right-to-try.” Beginning about a year and a half ago, promoted by the libertarian think tank known as the Goldwater Institute, right-to-try laws began popping up in state legislatures, which I likened to Dallas Buyers Club laws. Both Jann Bellamy and I wrote about how these laws are far more likely to do harm than good, and that is a position that I maintain today. The idea behind these laws is to give terminally ill patients access to experimental drugs—in some cases drugs that have only passed phase I testing—that might help them. It’s an understandable, albeit flawed argument. After all, it’s perfectly understandable why terminally ill patients would fight for drugs that give them hope, and it’s just as understandable why politicians and the public would see such a goal as a good thing. In practice, as I will explain again in the context of this update, such laws are far more likely to harm patients than help them. Indeed, as you will see, in the year since the first wave of right-to-try laws have passed, not a single patient that I can find has obtained access to experimental drugs under a right-to-try law, much less been helped by them.
Unfortunately, given how effectively “right to try” has been sold on grounds of providing terminally ill patients hope and as a matter of personal freedom, it’s clear that this wave is not going to abate. Since Colorado passed the very first right-to-try law almost exactly a year ago today, a total of 17 more states now have passed passed similar legislation, the most recent being Tennessee, and 22 others have introduced legislation. It’s a good bet that right-to-try will pass in all of those states, because, as I’ve explained many times before and in many interviews, if you don’t understand clinical trial ethics and science, opposing the concept of right-to-try comes across like opposing Mom, apple pie, and the American flag. It also leaves opponents open to false—but seemingly convincing—charges of callousness towards the terminally ill on the order of taking pleasure from drop kicking yipping puppies through flaming goalposts. (I exaggerate, but only slightly, I assure you.)
The Lyme tick
As the saying goes, when you do not have the facts, argue the law. This tried and (?) true approach was successful in New York where a law was passed protecting those who are, shall we say, creative in treating patients with Lyme and ‘chronic’ Lyme.
The bill protects those from investigation of misconduct:
based solely on treatment that is not universally accepted by the medical profession.
The major bone of contention has been extended courses of IV antibiotics for ‘chronic’ Lyme, but there are a wide variety of treatments that may be used by so called “Lyme literate” doctors.
The number of therapies divorced from reality that are offered to Lyme patients is remarkable. I do not know if chronic Lyme patients have greater use of pseudo-medical therapies than other pseudo-diagnoses, but I am impressed by the offerings in a recent review:
Results. More than 30 alternative treatments were identified, which fell into several broad categories: these included oxygen and reactive oxygen therapy; energy and radiation-based therapies; nutritional therapy; chelation and heavy metal therapy; and biological and pharmacological therapies ranging from certain medications without recognized therapeutic effects on Borrelia burgdorgeri to stem cell transplantation. Review of the medical literature did not substantiate efficacy or, in most cases, any rationale for the advertised treatments.
Conclusions. Providers of alternative therapies commonly target patients who believe they have Lyme disease. The efficacy of these unconventional treatments for Lyme disease is not supported by scientific evidence, and in many cases they are potentially harmful.
In February, 2015, the American Chiropractic Association House of Delegates ratified “Six Key Elements of A Modern Chiropractic Practice Act.” For what it’s worth, this means that the “Six Elements” are part of the official “Public Policy” of the ACA.
1. “Chiropractic Physician” and “Chiropractic Medicine” as the Regulatory Terms of Licensure.
2. Scope of Practice Determined by Doctoral and Post-Doctoral Education, Training and Experience Obtained Through Appropriately Accredited Institutions.
3. Full Management, Referral and Prescription Authority commensurate with contemporary chiropractic education for Patient Examination, Diagnosis, Differential Diagnosis and Health Assessment.
4. Full Management, Referral and Prescription Authority commensurate with contemporary chiropractic education for the Care and Treatment of Neuromusculoskeletal and Other Health Conditions or Issues.
5. Full Authority for the Delivery of Information, Advice, Recommendations and Counseling Regarding General Health Matters, Wellness and Health Optimization.
6. Full Authority and Adaptable Requirements for the Management and Training of Health Care Teams and the Participation in Collaborative or Integrative Health Care Groups.
Naturopathic genetics: a new specialty?
Naturopathy is chock-full of quackery. No doubt about it. Here at SBM and elsewhere, the seemingly limitless nonsense that can be incorporated into naturopathic practice has been documented time and again: detoxification, food “sensitivities,” anti-vaccination ideology, fake diseases (chronic yeast overgrowth, adrenal fatigue, chronic Lyme disease), bogus tests (also here), homeopathy, chelation therapy, assorted other odd-ball treatments, lack of ethical standards, and just general wackiness.
So, let’s give naturopaths licenses to practice primary care! What a good idea.
This affinity for nonsense is perfectly understandable, given their pseudoscience-filled education and foundation in vitalism. Once the scientific method is chucked in favor of “philosophy,” what’s to stop them from simply making things up? As far as I can tell, nothing. But why inflict this on the public under the guise of promoting health, safety and welfare?
To be fair, naturopaths aren’t the only ones who incorporate quackery into their practices. There are chiropractors, acupuncturists, reiki masters, doctors of Oriental Medicine, and “integrative medicine” practitioners. But what sets naturopaths apart, in my mind, is the sheer range of pseudoscience they will accommodate without the slightest hint of doubt in its efficacy or safety and their unwavering belief in their ability to diagnose and treat patients with the expertise and skill of medical doctors. “Delusional” is not too strong a word to describe their utter lack of awareness of their ignorance or the danger to patients they may pose. (more…)
Opioids are widely available as prescription drugs for pain: hydrocodone (e.g., Vicodin), oxycodone (e.g., OxyContin, Percocet), morphine (e.g., Kadian, Avinza), and codeine. Heroin, which has no medically approved use, is also an opioid. Unfortunately, opioids are also widely abused.
How enticing it is to imagine a magic bullet for opioid drug addiction. Addiction causes huge social problems. Yet it is hard to treat and suffers from a stigma that does not attach to other chronic diseases, like diabetes. Drugs like naltrexone, methadone and buprenorphine, as well as behavioral therapies, are common opioid addiction treatments, although the relapse rate for addiction treatment is high.
One of the barriers to treatment is the addict’s fear of the side effects of withdrawal, which can be extremely uncomfortable, including nausea, cramping and vomiting. It is no wonder, then, that the opioid addict and his family would be drawn to a detoxification procedure advertised as both rapid, to speed up the initiation of relapse-prevention therapy, and relatively painless: anesthesia-assisted rapid opioid detox (AAROD), sometimes called ultra-rapid detox, or even just plain rapid detox, although the latter also refers to detox under lighter sedation. (more…)
Bold moves from the New York State attorney general’s (AG) office are shaking up the supplement industry. In February, the AG accused four retailers (GNC, Target, Walmart, and Walgreens) of selling supplements that failed to contain their labelled ingredients. Using a testing method called “DNA barcoding“, the AG’s office concluded that few of the products it tested actually contained the labelled ingredient, and some contained undisclosed ingredients. It demanded that they stop the sale of those products. All four retailers complied.
When the recall occurred, I noted that the AG may not have had an airtight case: manufacturers and other critics challenged the AG’s methodology, claiming that DNA barcoding was unvalidated, inappropriate, and insufficient. They also stated that the DNA may not survive processing, so the absence of DNA didn’t imply a lack of the original product. Some claimed that the “contaminants” that AG found could have been acceptable fillers. The Attorney General refused to release further information about the testing methods it used, raising further questions about its validity. (more…)
Wikipedia’s front page
Wikipedia, an online open-source encyclopedia, can boast 470 million visitors each month, making it one of the most popular websites on the internet. It is an incredibly useful resource – I think it’s fair to say it is the online reference of record. For that reason people care how topics important to them are represented in Wikipedia.
Wikipedia, in fact, has become no less than a battleground over certain controversial topics. In essence people generally want Wikipedia to reflect their opinions on controversial topics, and if it doesn’t then there must be something wrong with Wikipedia (rather than there being something wrong with their opinions). I don’t mean to imply that Wikipedia always gets it right – it is a crowdsourced reference and the content is only as good as the editors. But at least they make honest efforts to be neutral and to have standards.
Those standards are the real conflict here, and it is part of a broader conflict over standards. In medicine there is a standard of care, which in turn is based on an underlying system of professional and scientific standards. Medical education is standardized, students have to pass standardized exams, post-graduate clinical training is standardized, there are standardized exams for specialty certification, there are ethical standards enforced by institutions, hospitals, professional organizations, and the state boards of health, and peer-reviewed journals have standards.
This is all meant to ensure that individual patients receive the highest quality of care.