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More than half of the FDA entire budget now comes from Big Pharma, not the govt. – Sept 2018

Drug Companies Pay FDA and NIH Pays Universities to Fast Track and Market Vaccines Mercola Sept 2018

  • “In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA) to accelerate FDA licensing approvals of new drugs and vaccines. More than half of the FDA’s budget is now funded by the pharmaceutical industry through PDUFA fees” Reference
  • “This raises serious questions about the integrity of the FDA licensing process when Congress has allowed drug companies to, in effect, bribe the FDA to lower licensing standards in order to grease the skids for certain drugs and vaccines to be fast-tracked to licensure”

50 references on the Mercola webpage


The Biopharmaceutical Industry Provides 75% Of The FDA's Drug Review Budget. Is This A Problem? Forbes June 2018


FDA Repays Industry by Rushing Risky Drugs to Market ProPublica June 2018

  • "Faster reviews mean that the FDA often approves drugs despite limited information. It channels more and more experimental treatments, including Nuplazid, into expedited reviews that require only one clinical trial to show a benefit to patients, instead of the traditional two."

Note: Even after clinical trials showed that Vitamin D treated or prevented 80+ health problems, the FDA still will not permit a single health claim for Vitamin D 


Additional references for a single trial being enough - which started in 1998

  1. CLINICAL TRIAL EVIDENCE SUPPORTING FDA APPROVAL OF NOVEL THERAPEUTICS, 2005–2012 - 2014
     Download the PDF from VitaminDWiki__
    Image
  2. Substantial Evidence: When Is a Single Trial Sufficient for Approval and Promotion? 2011
     Download the PDF from VitaminDWiki
    Since 1998 a single trial is enough in various cases (details in PDF)
    Case 1: substantial evidence proven via extrapolation from existing studies or from new comparative PK bioavailability trial. No new AWCT required
    Case 2: a single AWCT with independent substantiation from related clinical data
    Case 3: reliance on a single multicenter study, without supporting information. Single AWCT
  3. Guidance for Industry FDA - 1998
     Download the PDF from VitaminDWiki
  4. FDA Expedited Approval Process Raises Concerns About Risks July 2018
    "In addition, over half of the approvals were based on the results of a single trial."
    "It is not known whether the effect observed in the single small trial will be observed in a larger population or replicated in another trial, or whether the effect observed over the short term will persist over the longer term"
    "many new cancer drugs approved on the basis of surrogate endpoints retain their approval status and remain available to prescribing physicians even though postmarketing studies show no survival or quality-of-life (QoL) benefit compared with placebo or observation groups."
    "Of 36 drugs that were approved between 2008 and 2012,
    • 18 did not significantly prolong overall survival in postmarket studies.
    • QoL information was available for 7 drugs, and
  • Compared with placebo or observation groups,
    • 2 drugs demonstrated worse effects on QoL,
    • 4 drugs showed no statistical difference, and
    • 1 drug had mixed results. In addition,
    • 1 drug reduced overall survival and
    • 6 offered no survival benefit compared with placebo or observation groups."

Note: Vitamin D trials have found scores of health problems with excellent real-world efficacy including improved Quality of life

Note:

  1. It is unlikely that any group has the $2.4 million to pay the FDA to consider Vitamin D for anything
  2. It is unlikely that the FDA would approve it anyway, as doing so could significantly decrease their income
    "It is difficult to get a man to understand something when his salary is dependent upon his not understanding it”  Upton Sinclair

Not a single trial is needed for FDA approval in some cases

  1. FDA’s Historical Use of “Real World Evidence” - 2017?
  • "In June 2017, FDA approved a new indication for a medical device without requiring any new clinical trials."
Created by admin. Last Modification: Saturday May 18, 2019 15:50:05 GMT-0000 by admin. (Version 18)

Attached files

ID Name Comment Uploaded Size Downloads
10603 Guidance for Industry FDA 1998.pdf admin 28 Sep, 2018 14:49 129.17 Kb 73
10602 Substantial_Evidence_When_Is_a_Single_Trial_Suffic.pdf admin 28 Sep, 2018 14:36 543.82 Kb 64
10601 Clinical trials.jpg admin 28 Sep, 2018 14:22 55.64 Kb 100
10600 CLINICAL TRIAL EVIDENCE.pdf admin 28 Sep, 2018 14:22 382.89 Kb 63
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