Digital Dharma

The Middle Path, One Day At A Time

Medical News:


Waxman Says FDA Plans to Ease Restrictions on Off-Label Marketing – Allow Drug Companies to Make End Run Around Rules

If approved, the FDA proposal “would allow drug and device companies to short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns,” he said.

Cholesterol Tied to Death Risk from Ischemic Heart Disease but Not Stroke

For every 1 mmol/L decrease in cholesterol, ischemic heart disease mortality dropped by half among patients ages 40 to 49, by a third among those 50 to 69, and by a sixth among those 70 to 89, according to a review of observational studies in the Dec. 1 issue of The Lancet.

Author: Bill

Stumbling down the Middle Path, one day at a time.

2 thoughts on “Medical News:

  1. Uh oh, I’m misunderstood.

    To clarify, I have no trust in the FDA or any other governmental agency, bureacracy or other organized institution. And I completely agree with your assessment of the strangebedfellows relationship between pharmaceutical companies and the FDA, to name one of many other similiar liaisons.

    All I’m sayin’ is, talking and sharing information not ususally funneled through “acceptable” standards is appreciated. Many drugs are used in ways drug companies can’t discuss but docs et al benefit from the wisdom of other colleague experience…aka “off label” use.

    Th-th-that’s all, folks.

    Hope all’s well with you, Bill.
    Funeral, huh?

    Ah, so…Given the way unskilled docs hand out psych drugs, it seemed like an odd position for a shrink. šŸ˜‰

    It was an elderly aunt. She had a good life, and went easy.

  2. As usual, I regret having a life when popping in here. There are simply not enough hours in my day to pursue the wonderful assortment of goodies you put forth for consideration.

    That said, I took a minute to scan the FDA article and have these thoughts: anecdotal sharing of off-label drug use is precious in my world. At every pharmaceutical dinner I orchestrate and/or attend, I make sure I ask attendees about their personal prescribing practices regarding a particular drug. PDR print outs and black box warnings pale in comparison to real life use in the trenches and I am a trench warrior, big time.

    All I’m saying is the sharing of information is necessary to greater functioning of the whole. There is no need to “shock jock” the public that such action equates with an FDA loss of control. “N” word, puh-leez.

    /stepping off soapbox, returning to clearing the dinner dishes.

    You may have a vested interest in trusting the FDA. I don’t. I don’t care to argue the point, but there is too much “anecdotal” evidence to the effect that the department is in the pocket of the drug companies to suit me.

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