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:
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 →
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?
As predicted, central line infections will be reduced one way or another…
A recent survey reveals wide variation in the perceived value of catheter-drawn cultures among infectious disease specialists. But to be caught between a reporting mandate and punitive sanctions may quickly establish a consensus…
There’s been a bit of a buzz following the release of the latest edition of the ACP’s Ethics Manual. For the first time, it seems, the manual includes a section on “stewardship of resources” with directives summarized in Box 4.
In the wake of a recent breast implant scandal, French drug regulator AFSSAPS is now the target of a criminal investigation for keeping on the market the anorectic benfluorex (Mediator) which allegedly caused the premature deaths of hundreds if not thousands of French citizens from valvulopathies. Some AFSSAPS executives have even had their homes searched. The head of the agency resigned.
The story was reported by Reuters and by the heart.org. The investigation is taking place after a couple of papers were published claiming that over the course of the last 33 years, Mediator has been responsible for over 1300 deaths from valve disease. The most recent one is available from Wiley free online, at least for now.
The heart.org has the following news report about a Maryland doctor accused of overstenting:
Baltimore, MD – A malpractice lawyer is accusing Dr John Chung-Yee Wang (Union Memorial Hospital, Baltimore, MD), a member of the committee tasked with stopping improper stenting in Maryland, of improper stenting in his own practice .
The Baltimore Sun reports that medical malpractice attorney Jay Miller has filed complaints with the state health claims arbitration office against Wang. Miller alleges that Wang, Dr Mark Midei, and Dr Kourosh Mastali wrongfully stented patient John Bowers in 2005 and 2006, when the three interventionalists were partners in MidAtlantic Cardiovascular Associates, a practice that has since disbanded. Miller also charges that Wang overstated the extent of coronary disease in patient Lorie Skillman to justify implanting a stent (…)
Wang is part of the Technical Advisory Group on Oversight of Percutaneous Coronary Intervention Services, a group of experts tasked by the Maryland Health Care Commission (MHCC) to develop recommendations for legislative changes that would improve oversight of coronary intervention labs in the state. The committee is set to report its findings at a public meeting of the health commission today. “The allegations could cast a shadow over the work of the advisory committee,” the Sun reports. Wang was nominated for the committee by the Maryland chapter of the American College of Cardiology (ACC).
We may recall another period of time when committees played a prominent role in regulating safety and security. Continue reading →