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A new study in the Journal of Public Health shows that German physicians have "a feeling" when evidence-based medicie is being used as a cost containment tool rather than a clinical tool to improve patient outcomes. The study also indicates that for certain disease states (i.e., diabetes) EBM may play a greater role than in others (i.e., CNS ).
Here’s the abstract:
The MHRA started investigating Mr Essadki in January 2006 after receiving information from Pfizer that customers had complained about two websites advertising Viagra and Cialis for sale. On March 2006 MHRA enforcement officers, accompanied by representatives from Pfizer and Eli Lilly together with the Metropolitan Police, went to Mr Essadki’s home address and found a quantity of Viagra and Cialis tablets. These were seized along with computers, mobile phones and a laptop.
Mick Deats, Group Manager of Enforcement at the MHRA said, “The MHRA will not hesitate to take action against those who undermine public health. There is considerable risk to the public from obtaining medicines through unregulated websites. A medicine bought in this way has no guarantee of safety, quality or effectiveness. It could be counterfeit. It may not contain the right amount of medicine. At worst it may cause a severe side effect."
First – the operation began in March 2006 – over two years ago.
According to the Wall Street Journal, “Powerful members of Congress want to remake the Food and Drug Administration by giving it broad powers to levy fines, order drug recalls and restrict drug-industry advertising. Leading the drive are Rep. John Dingell (D., Mich.) and his longtime friend in Congress, Sen. Chuck Grassley (R., Iowa).”
“The lawmakers say an FDA restructuring should build a much taller wall between the agency and the industry it regulates. The FDA would gain authority to recall drugs, which it can't do today, and to impose significant fines on drug companies for safety violations. The lawmakers also want the FDA to inspect generic-drug makers before approving a new product. Perhaps most importantly, they want the next president to appoint a tough FDA commissioner completely independent from the industry.”
Can anyone out there think of even one drug that the FDA wanted recalled that was not “voluntarily” recalled?
No – I didn’t think so.
(Also, isn't the FDA already an entirely independent government agency?)FDA officials "are too cozy with the companies they regulate," Mr. Grassley said, adding that new leadership must "fix the culture."
What does “too cozy” mean? Really, what does it mean?
Senator Grassley believes the FDA Office of New Drugs, which he said has been compromised by its relations with industry lobbyists, among them former top FDA officials.”
And what does that mean? Any evidence to back up such blowhard accusations?
Too boot, here’s some really shoddy reporting by the Journal’s Alicia Mundy,
“Some current and former FDA safety reviewers have opened a whistleblower Web site to air their concerns that FDA leaders are pushing them to approve some drugs”
She is referring to www.thoreau-fda.com/index.php.
Oops.
But who needs facts when you have red-hot rhetoric and a gullible reporter who's willing to take a leak anywhere?
Consider the Federal Register notice announcing the August 14/15 meeting of the FDA's Risk Communications advisory committee:
"The committee will meet for presentations and discussion of the scientific basis for translating principles of risk communication into practice in situations of emerging and uncertain risk."
And this is the committee that's mandated to create clear ways to discuss risk communications (or as it's cool to say in DC "Plain English").
I think it was Albert Einstein who said something along the lines of, "If you can't explain a complicated topic in a simple way -- then you don't really understand it."
What happens is the meeting of the Patient-Centric Health Leadership Forum.
This new report shares the cutting edge thinking of the folks mentioned above along with other similarly talented leaders. And the key phrase is patient-centric.
The report can be found at the top of this page or here, the first item under "reports."
A worthwhile and important read.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
