Under the Medicare Choices Empowerment and Protection Act (S. 2240), which was introduced this month, the Department of Health & Human Services will pay Medicare beneficiaries $75 to register their advance directives.
As I have reviewed bef…
Blog.
Four Mayo Clinic physicians have just published a high level overview of medical, ethical, legal, financial, and policy issues relating to medical futility. Here are the 10 questions. Read the article for the answers.
What is the definitio…
Images powerfully impact how we think and how we live. Metaphors, those images we use to describe the indescribable, to portray the unfamiliar and mysterious, are particularly so because of the identity relationships they create. In my last post, I commented on an article in the NYT entitled, “A Tumor: the Embryo’s Evil Twin,” which described the similarities between embryogenesis and the cellular behavior of… // Read More »
04/18/2014
“Breakthrough Cures”? Reasons for Skepticism
Earlier this week I posted about the current issue of the New England Journal, and mentioned in passing the appearance of antiviral drugs for hepatitis C that are being touted as new miracle cures. My focus in that post—
http://brodyhooked.blogspot.com/2014/04/summarizing-market-failure-special.html
–was how our so-called free market fails to protect the public interest, so I looked only at the outrageous cost of the hepatitis C drugs and gave a free pass, more or less, to the “cure” claims.
In doing so I overlooked an older and a more recent blog post by our good pal Dr. Roy Poses at Health Care Renewal:
http://hcrenewal.blogspot.com/2014/04/knee-deep-in-hoopla-triumph-of-medical.html
http://hcrenewal.blogspot.com/2014/03/too-good-to-be-true-sovaldi-kerfuffle.html
Dr. Poses takes care to show the extraordinarily flimsy evidence on which these new drugs are being ballyhooed. He says a number of things about study design and so on, all of which seem pertinent. But if we try to get a sense of the big picture, all I think we need to know is the natural history of hepatitis C. As Dr. Poses reviews for us, hepatitis C can be a very bad disease leading to liver failure and death. But the total number of folks with the virus who end up with this extreme version of the disease is not that large. A goodly number of people who carry the hepatitis C virus never develop any obvious disease at all. Another good chuck of them develop some liver inflammation, but it never develops into the extreme life-threatening forms.
So before one can get all that excited about a new treatment for hepatitis C, insofar as actual patient-centered outcomes are concerned, we’d need a large-scale follow-up study that showed that people getting the new drugs actually had improved health over the long haul. That would in turn depend on showing that the apparently decent (but hardly perfect) side effect profile of the new drugs is maintained long-term, else the chance of having a bad side effect might be as great as the chance one would have had the bad kind of rapidly-advancing hepatitis C infection with liver damage.
According to Dr. Poses who’s checked out the literature much more carefully than I have, what we know so far is that the new drugs do a pretty good job of clearing the hepatitis C virus from the bloodstreams of patients when followed for a period of up to 24 weeks.
It may well be that a drug that does this good a job of clearing the virus in the short term does an equally good job of saving the patient from long-term, serious consequences of having the virus. Or that may not be the case—we’ve seen many, many instances of initially promising treatments that ultimately fail to pass that test. (This may also be a good time here to remind ourselves of Dr. John Ioannidis’s warning:
http://brodyhooked.blogspot.com/2011/03/how-honest-reports-of-research-can.html
–about how it’s a mathematical near-certainty that the first reports about any new drug will give an unduly rosy picture of its effectiveness.)
Now, let’s be fair to the advocates for the new drug. It will take years, to say nothing of tons of money, to do the studies needed to show the real effectiveness of these new hepatitis C drugs. So in the meantime, the data we have so far is probably what’s to be expected at this stage. And so far, the drug is performing more or less as one would expect if indeed it is going to turn out to be a breakthrough drug.
OK, I’ll buy all that. So how about some recognition of the actual limitations of what we know, when this drug is being talked about? Why should supposedly scientifically-aware advocates for the drug feel a need to talk like used car salesmen? (Unless, in fact, their ultimate goal is to sell us a clunker?)
So mea culpa for my earlier post, if I inadvertently added to the hype around these new drugs, instead of joining Dr. Poses in raising the appropriate skeptical concerns. One can hope that the drugs turn out to be what they are hoped to be; and one can also hope that somehow, if that’s the case, people who need them will be able to afford them.
[New York Times] Doctors are prescribing opioid painkillers to pregnant women in astonishing numbers, new research shows, even though risks to the developing fetus are largely unknown.Of 1.1 million pregnant women enrolled in Medicaid nationally, nearly 23 percent filled an opioid prescription in 2007, up from 18.5 percent in 2000, according to a study published last […]
04/18/2014
Life before Anesthesia
This is how Fanny Burney described the mastectomy she received in 1811, a long time before effective anesthesia was available: I mounted, therefore, unbidden, the bed stead. When the dreadful steel was plunged into the breast – cutting through … Continue reading →
Maya Sabatello
“Why is it called Good Friday?” my ten-year-old son asks. “What’s good about it?” What, indeed. The day we remember a death — and not what people usually mean by a “good” death. When people speak of a good death, they usually mean either that the one dying didn’t die too young or with too much suffering, or that it was as “least-bad” as possible… // Read More »
One theme in HOOKED is the need to see today’s relationship between the medical profession and the pharmaceutical industry in proper historical context. When HOOKED was written, I had to struggle, as a non-historian, to try to put together an adequate historical background picture. Since then, useful books have appeared that make that task easier.
Prof. Dominique Tobbell of the University of Minnesota has contributed Pills, Power, and Policy: The Struggle for Drug Reform in Cold War America and Its Consequences. She makes two basic points about our struggle today to reform drug policy, in a direction that brings pharmaceutical manufacture, research, and marketing better into line with public health and public interest. The first point is that this struggle is not new; basically the same issues have recurred ever since the end of World War II. The second point is that the pharmaceutical industry has never waged this battle against what it considers burdensome government regulation on its own; it has always had allies among medical organizations and academic physicians who had a strong interest in defending the status quo.
Prof. Tobbell points out that by the mid-1960s, the drug industry had achieved an impressive enough record in fighting off government regulation that the tobacco industry turned to Pharma for advice and help. During all those years, medical practitioners were primed by the AMA to fear the bogeyman of socialized medicine, and academic physicians worried about excessive federal influence over research policies. It was easy to get these fellow travelers on board when Pharma wrapped itself in the mantle of “free enterprise” and presented a less-regulated industry to Congress and to the American public as a bulwark against communism.
In the heady postwar days, when everyone was thrilled with the tremendous advances in antibiotic, hormonal, and psychiatric therapy, the climate of ethical thought was quite different from what reigns today. For example, Prof. Tobbell describes the efforts at the University of Pennsylvania to create a training program in clinical pharmacology in 1955: “Norman Topping, the university’s vice-president in charge of medical affairs, sought to create an institutional structure that would ensure the program could be responsive to the industry’s needs. Indeed, Topping believed the new program should function, essentially, as a service unit for the drug industry.”While today such a stance would at least raise some eyebrows, apparently no one gave it a second glance in the 1950s.
Similarly, when the National Academy of Sciences formed the Drug Research Board in 1963, to help conduct the massive amount of research required to implement the new FDA amendments Congress had just passed to require that drugs be shown to be effective as well as safe, some in Congress looked askance at the inclusion of scientists with strong industry ties. The Board basically pooh-poohed any such concerns, insisting that it was a great advantage to have these scientists as part of the effort because of their inside knowledge and policy smarts. Conflict of interest—who, us?
One theme that I have addressed at some length in earlier posts—most recently:
http://brodyhooked.blogspot.com/2014/03/a-bit-of-history-louis-lasagna-and.html
–is the impact of the ideology that I prefer to call economism and others call neoliberalism on today’s Pharma policy. Prof. Tobbell was kind enough to respond to an e-mail query, since I noted that the word “neoliberalism” is virtually absent from her volume. Consistent with her thesis, she states that the anti-government-regulation, pro-free-market stance that the drug industry has adopted was present all through the 1950s and 1960s. When neoliberalism/economism entered the US political discourse in a big way in the middle to late 1970s, Pharma was happy to hitch its wagon to that rising star, just as it was happy to jump on the anticommunist bandwagon in earlier decades; but one cannot say that neoliberalism played a major formative role in Pharma’s policy or strategic thinking.
Dominique A. Tobbell, Pills, Power, and Policy: The Struggle for Drug Reform in Cold War America and Its Consequences. Berkeley, CA: University of California Press/Milbank Books on Health and the Public, 2012.
04/17/2014
Pediatric Euthanasia Redux
Today brings the online publication in JAMA (free access) of an essay, “Pediatric Euthanasia in Belgium: Disturbing Developments,” by Andrew Siegel (U. Penn), Dominic Sisti (U. Penn) and Arthur Caplan (now at NYU). In specific view is Belgium’s February 2014 amendment to its 2002 law legalizing euthanasia. The amendment, which is now fully enacted in Belguim, extends lawful euthanasia to children with “constant and unbearable… // Read More »
AJOB
Target Articles:
Transferring Morality to Human–Nonhuman Chimeras
Ethical Review of Health Systems Research in Low- and Middle-Income Countries: A Conceptual Exploration
Correspondence:
Changing the Discourse on Health Systems Research: Response to Open Peer Commentaries on “Ethical Review of Health Systems Research in Low- and Middle-Income Countries: A Conceptual Exploration”