The wheels of French bureaucratic justice are grinding slowly by surely, and this time, it is a regulatory agency that is on the receiving end of the guillotine…
I previously reported on the very unusual story that broke out a year ago about the French pharmaceutical regulator being potentially the subject of criminal investigation for allowing the continuing sales of the anorectic drug Mediator despite the publication of data suggesting it could be harmful.
I commented that the scientific data with which the agency is getting indicted is incredibly meager, but the criminal aspect of the conduct may not be so much that AFFSAPS allowed a harmful drug to be sold on the market, but that it allowed it on the market longer than the other EC countries.
With bureaucratic principles and legal doctrine becoming more similar among Western nations subjecting themselves to the oversight of supranational organizations, I suspect US trial lawyers will be watching this development with great interest.
The release of the latest report from the Joint National Committee on Hypertension (JNC-8) has been delayed for several years. It’s already been a decade since the prior report was issued.
Until recently the reason for the delay was obscure, but in the March issue of Cardiology News inside information is provided by cardiologist Sidney Smith. The UNC professor of medicine, who has made a career out of writing practice guidelines for the American Heart Association, is a senior writer on the JNC-8 panel and this is what he had to say:
The delay has been due in large part to an unprecedented degree of prerelease review by numerous government agencies at a multitude of levels. This extensive and time-consuming advance scrutiny was instituted mainly because many health officials felt blindsided by the publication of the U.S. Preventive Health Services Task Force controversial mammography guidelines, which kicked up a hornet’s nest of criticism in the breast cancer and public health communities. Government officials don’t ever want to be caught by surprise like that again, explained Dr. Smith, professor of medicine at the University of North Carolina, Chapel Hill.
That’s right. There is nothing more frustrating for a government official than to be caught by surprise by a body of medical experts sifting through scientific data for the benefit of practitioners. The report must first be approved by the authorities!
Thanks to John Mandrola for reporting on the buzz being created by Dr. James O’Keefe from the Mid-America Heart Institute. Besides the recent WSJ article that cites a yet to be published paper by O’Keefe, this recently posted 18-minute TED-x talk by Dr. O’Keefe informs us of the gist of his claims:
SOCRATES: Well, Geoffrey, let’s get into the meat of your population approach.
ROSE: It’s about time!
SOCRATES: I’ll skip the short Chapter 5 for now, although we’ll get back to it in due time. Let’s look at Chapter 6 where you are most specific about what the population approach entails. You first make the point that changing the population mean of a given characteristic will be accompanied by a change in the prevalence of clinical cases or of “deviants,” as you put it.
Los Angeles, CA – The Action for Health Diabetes (Look AHEAD) study, a trial comparing an intensive lifestyle-intervention program aimed at achieving and maintaining weight loss and fitness in patients with type 2 diabetes, has been stopped for futility. Continue reading →
ROSE: I’m fine, but I sure would like to pick up the pace and quit getting bogged down into ridiculous minutiae.
SOCRATES: I have a feeling this will happen. You are now going to share with me your perspective on what you call the “high-risk” strategy of prevention. If I understand correctly, this prevention essentially aims at “lopping off the tail” of the distribution curve, sort of like this:
SOCRATES: So Geoff, let’s recap the main aspects of your theory that we have covered so far. If I may, I would summarize them as:
1) From a population-based perspective, there is no dividing line between normal and pathological processes. A frequency distribution function for a disease can be envisioned as a smooth, continuous curve, provided all the transition steps that lead up to clinical manifestations are included—and not just the obviously symptomatic cases. These are just the visible tip of the iceberg, which can neither be understood nor properly controlled if it is thought to constitute the entire problem (1). Continue reading →
Parenteral sympathomimetic agents, usually dobutamine, and phosphodiesterase inhibitors, usually milrinone, are used for the management of exacerbations of chronic systolic heart failure. Although hemodynamics, and occasionally clinical status, improve, such therapy is associated with increased mortality and can potentially hasten a patient’s demise.
As we undergo another round of monetary stimulus, experience unprecedented deficits, and contemplate de jure or de facto tax increases, any reason why treatment for economic failure shouldn’t be modeled after treatment for heart failure?
SOCRATES: Geoffrey, that’s an interesting graph you showed me. Let’s talk about it some more.
ROSE: I’m glad it piqued your interest, Socrates
SOCRATES: So, it’s on the basis of a chart such as this one that you have developed your theory, isn’t it?
ROSE: Yes, Socrates. If you take each setting individually and ask “why do some people have a higher blood pressure than others?” you may reasonably answer that a variability in a large number of predominantly genetic factors among individuals account for this gradual, continuous curve. Pickering’s position, as you recall, was that hypertension simply identified the individuals at the higher tail end of the distribution.
But if you juxtapose the 2 curves on the same graph, as I did here, and ask the question “why is hypertension common in Britain but absent in Kenya?” you can see that the answer has nothing to do with the characteristics of individuals but everything to do with the determinants of the population mean. Continue reading →