Trump quietly signs FDA reauthorization bill, officially funding a new digital health unit

[Weird Tolkienish Figure]

President Donald Trump signed a bill reauthorizing the Food and Drug Administration’s user fee agreements for drugs and devices that will fund a new digital health unit and allow the agency to tap into new data sources.

http://www.fiercehealthcare.com/regulatory/trump-quietly-signs-fda-reauthorization-bill-officially-funding-a-new-digital-health

[Smokin Joe]

More taxes, and more Big Brother. Yippie!

[To-Whose-Benefit?]

Oh Joy.

The FDA.

http://ahrp.org/former-fda-commissioner-charged-in-federal-racketeering-lawsuit/

Anyone know what happened to this one?

[To-Whose-Benefit?]

Drats!

The Deep State strikes again.

We are Way overdue for a Judiciary housecleaning.

https://www.lexislegalnews.com/articles/16128/levaquin-rico-lawsuit-dismissed-by-judge-in-district-of-columbia

[Oceander]

So how come the Trump worshippers aren't all over this one?

[Smokin Joe]

Lots of worms in that apple.

I am one of those people who read the package inserts.  I have known Cipro and Levaquin both have risk for tendon bursts and other possible life-changing problems, and when messing in the medicine chest would not use either unless some other, more 'ordinary' antibiotic would not do the trick. So far, those ordinary ones have worked.
I have counseled family members to ask their doctors for some other antibiotic rather than take them.
 
That people would approve a drug, fully knowing those risks were extant, and without allowing the appropriate warnings to accompany the medication, for profit, is just a measure of the evil in this world.
 Regardless of the actions of the court, may The Almighty reward those in collusion as they so richly deserve--only He knows their hearts, regardless of what I may conjecture.

(I got my first PDR in college from a somewhat shady character who knew I had been an EMT, who would call me from time to time and ask about overdose symptoms and whether they could 'walk it off' or should seek medical attention for some slob who had been partying too hard. If any doubt existed, I recommended taking them to the ER.)

[Suppressed]

That people would approve a drug, fully knowing those risks were extant, and without allowing the appropriate warnings to accompany the medication, for profit, is just a measure of the evil in this world.
 Regardless of the actions of the court, may The Almighty reward those in collusion as they so richly deserve--only He knows their hearts, regardless of what I may conjecture.

The warning is in there... for example, Cipro's package insert states:

Tendon Effects: Ruptures of the shoulder, hand, Achilles tendon or other tendons that required
surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones,
including ciprofloxacin. Post-marketing surveillance reports indicate that this risk may be increased in
patients receiving concomitant corticosteroids, especially the elderly. Ciprofloxacin should be
discontinued if the patient experiences pain, inflammation, or rupture of a tendon. Patients should rest
and refrain from exercise until the diagnosis of tendinitis or tendon rupture has been excluded.
Tendon rupture can occur during or after therapy with quinolones, including ciprofloxacin.

I have no problem with them approving a drug that might have rare problems for some people.  The benefit to many is there, and it allows the consumer and physician to judge whether they think the risk is worth it.  To most people, it is, and the government shouldn't be in the business of denying people the right to make that choice.

Far more often, FDA prevents people from getting needed medication because of being overly cautious.  It might very well cost me my life, as there's a medication that is unavailable because "substitutes are available".  However, for some poor sods like me, they don't work or have serious side effects.

And it's not just by an outright ban that FDA can cause these problems.  They can issue statements that make anyone making the drug subject to lawsuits.   Look at how that rotten study on PPA from Duke led to warnings from FDA that meant PPA was dropped from the market.

Sickening.  (No pun intended.)

[Smokin Joe]

The warning is in there... for example, Cipro's package insert states:

I have no problem with them approving a drug that might have rare problems for some people.  The benefit to many is there, and it allows the consumer and physician to judge whether they think the risk is worth it.  To most people, it is, and the government shouldn't be in the business of denying people the right to make that choice.

Far more often, FDA prevents people from getting needed medication because of being overly cautious.  It might very well cost me my life, as there's a medication that is unavailable because "substitutes are available".  However, for some poor sods like me, they don't work or have serious side effects.

And it's not just by an outright ban that FDA can cause these problems.  They can issue statements that make anyone making the drug subject to lawsuits.   Look at how that rotten study on PPA from Duke led to warnings from FDA that meant PPA was dropped from the market.

Sickening.  (No pun intended.)

My point, though, that while you and I may read package inserts, many do not, nor will they understand them. Over the time I have been aware pf problems that may arise with Cipro and related antibiotics, the trend in the Pharmaceutical industry has been for pharmacists to issue pages with a summary of possible problems, interactions, and things to watch for. Package inserts were a bit too technical for a lot of people. The situation is improving, in terms of warning people of risk.

That said, to approve a product for compensation, despite risks, is a violation of public trust.
Those are decisions best made in the absence of undue and possibly corrupting influences.

[To-Whose-Benefit?]

Here, poke around a bit.

Does this shed any light on WHY the FDA is a bought and Paid for, Lethal Cluster Fail?

https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm152775.htm

A 3rd of their operating budget comes directly from the Industry they're in charge of policing in the form of 'User Fees'.

Drug makers Tank/File Drawer the trials they don't like, bundle the remaining 5% - which were designed from the word go to reach their predetermined outcome - (the patient Didn't die) - write off those who Did die as "statistically insignificant outliers", staple a 7 figure check to it, and Presto!

Their drug is FDA approved.

$2.5 Billion of FDA inducement to look the other way for their best clients.

Pre designed trials:

The bar for efficacy is ridiculous, when you consider the Trial Control groups are usually on a placebo: IE: a sugar pill, a nothing.

The drug has to show it's more efficacious than Nothing: not whatever other drug it's supposed to be as good as or better than.

If you ever get into reading the actual Clinical Trial summaries themselves you can invariably figure out what they're going to conclude by simply starting with Who funded the Trial itself.