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21st Century Cures Act Will Hasten Drug Approval


Rockingchaircat
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The 21st Century Cures Act has passed the House and Senate. It’s now headed to President Obama, who has pledged to sign it. The bill is a behemoth, packed with provisions and funding to address the opioid epidemic, mental health research, genetic medicine, and electronic health records. It includes Vice President Joe Biden’s signature “cancer moonshot,” aimed at new therapies and cancer vaccines. And it promises nearly $5 billion in funding over the next 10 years for the National Institutes of Health, the nation’s flagship biomedical research arm.


The act also gives the FDA more discretion on which drugs and devices to approve, by loosening regulatory standards and allowing “real-world evidence” and anecdotal data to stand in for the gold standard of medical tests, the randomized controlled trial. Patient advocates say the move will get life-saving new drugs to patients faster. But critics contend that looser regulations will only increase the number of unsafe and ineffective drugs that make it to consumers, which they say could be a costly—and dangerous—mistake.


http://www.sciencefriday.com/segments/21st-century-cures-act-will-hasten-drug-approval/


Meaning- that we will be seeing many of us- being the Guinea Pigs.  Antidepressants included.


Your thoughts?


 


1)Zoloft- 6/99 to 8/04 2)Escitalopram- 8/04 to 8/10 3)Citalopram 8/10 to 4/14 (C/T), 4)Paxil a week or so, 5)Wellbutrin a week or so, 6)Reinstated Citalopram- 9/14 to 7/15

Before Taper- Celexa/20 mg....Taper Start- 04/21/15- 15mg....05/26/15- 10 mg...06/22/15- 5 mg...07/18/15- 0mg. http://tinyurl.com/qjfoqe9 Ativan/Lorazepam use/taper 10/14 to 2/15- http://tinyurl.com/ljebp84

Baclofen- Intermittent use of from 2008 till 2014. Some use of Promethazine. Some use of Zofran. Clobetasol Propionate- for Lichen Planus. Some Flexeril use. 

Ativan- GABA,A receptor Agonist., Baclofen- GABA,B receptor Agonist., Celexa/Lexapro- Serotonin 5-HT1A Receptor Agonist., Zofran- Serotonin 5-HT3 Receptor Agonist..Promethazine- Histamine H1-Receptor Antagonist. Flexeril- Serotonin 5HT2a Antagonist.

 

My self imposed Amino Acid Therapy: Tyrosine 500mg 1xday, Theanine 200 mg 1xday, & Taurine 500 mg 2x day. (All neurotransitter pre-cursors)- seems to have helped me immensely. And of course- eating healthy, including Black Beans for the oligosaccharides for gut health.

 

The attempt to develop a sense of humor and to see things in a humorous light is some kind of trick learned while mastering the Art of Living. - Viktor Frankl, Man's Search for Meaning.

 

 

 

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Even if the evil Murphy mental health bill wasn't a part of it, it is a horrible bill and unsafe patient wise.

 

http://www.healthnewsreview.org/2016/12/with-media-watchdogs-sidelined-pharma-funded-advocacy-groups-pushed-cures-act-to-the-finish-line/#.WEde_HY-sD8.facebook

 

Unfortunately, as passage proves, both political parties are beholden to big pharma who will gain considerably from this bill.

Drug cocktail 1995 - 2010
Started taper of Adderall, Wellbutrin XL, Remeron, and Doxepin in 2006
Finished taper on June 10, 2010

Temazepam on a PRN basis approximately twice a month - 2014 to 2016

Beginning in 2017 - Consumption increased to about two times per week

April 2017 - Increased to taking it full time for insomnia

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