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Title: Big Pharma & An Army of Lobbyists Just Sidestepped the FDA
Published: 2016-12-14
Source: https://www.youtube.com/watch?v=J5m19khJd2Y
Title: Big Pharma & An Army of Lobbyists Just Sidestepped the FDA
Published: 2016-12-14
Source: https://www.youtube.com/watch?v=J5m19khJd2Y
1/23
she does the Senate work for big pharma that hires lobbyists and people who make giant campaign contributions or does the Senate work for the American people who actually sat it's here I everyone I'm Spiro for news but dot com in that was senator Elizabeth Warren speaking on the Senate floor on November twenty eight she's talking about house resolution thirty four known as the twenty first century2/23
cures at there's a bill in Congress that could help unlock a cure for Alzheimer's and cancer as we know it and help people seeking treatment for opioid addiction finally get the help they need it's called the twenty first century cures act it's an opportunity to save lives and opportunity we just can't miss well I have to admit the twenty first century cures acts sounds very nice3/23
in the same kind of way that the patriot act of the affordable health Care Act sounded giving everyone that warm and fuzzy feeling I know that we all want cures for Alzheimer's and cancer so the twenty first century cures act disposed to accelerate the pace of cures in America by streamlining the drug and device development process because according to their own website the federal drug and4/23
device approval apparatus is in many ways a relic of another era in other words it's outdated takes too long and they're looking to speed up this whole process so the twenty first century cures act was originally introduced and passed by the house in July twenty fifteen as resolution six at that point time well after passing the house the bill stalled but over this most recent thanksgiving5/23
holiday the bill was revised and many of the provisions in the bill were reassembled and repackaged into house resolution thirty four which was originally named the tsunami warning education and research act which has nothing to do with what it's become today and it's no secret that the pharmaceutical industry and the government have enjoyed the perks of the revolving door that exists between them the current acting6/23
FDA commissioner Robert caliph was appointed by Obama earlier this year but before heading to the FDA caliphal is the chancellor of clinical and translational research at Duke University and he received money from twenty three drug companies including giants like Johnson and Johnson lily Merck GSK and all of this is according to a disclosure statement on the website of do clinical research institute now on the FDA7/23
website they state that the food and drug administration is responsible for protecting the public health by ensuring safety efficacy and security of human and veterinary drugs biological products and other medical devices so one of the names being floated right now for the FDA is Jim o'neal on this would be under the trumpet ministration well back in twenty fourteen o'neill had this to say about the FDA8/23
process of drug approval another great %HESITATION the public even better idea as on my quest idea yesterday if you were in this panel of progressive approval we should reform FDA so there's approving drugs after their sponsors have demonstrated safety and let people start using them at their own risk but not not much risk of safety but let let's prove efficacy after they've been legalized at your9/23
own risk well Neil hasn't been officially named the FDA commissioner by trump the but the language in the cure's act is very similar to o'neal's view on how the FDA should handle the new drug approval process and this is relying on the drug companies who stand to benefit financially to demonstrate the safety and effectiveness of their new drugs not the regulatory agencies like the FDA although10/23
some may argue that the FDA is already a puppet for the pharmaceutical and biotech industries it looks as though the drug companies are trying to sidestep the FDA altogether and this could give a whole new meaning to the term FDA approved because this funding is political cover for huge giveaways to giant drug companies there are more examples than I can count in this bill but I'm11/23
gonna talk about three first give away legalize fraud you know it is against the law for drug companies to market drugs for uses not approved by the FDA now so from drug companies find this rule would knowing after all they could make a lot more money selling %HESITATION headache pill is a cure for everything from hair loss to cancer but pushing treatments without scientific evidence that12/23
they work is fraud fraud that can hurt people it also undercuts the development of real curious and that is why some of the largest law enforcement actions against big drug companies over the past fifteen years have involved off label marketing drug companies have paid billions of dollars in penalties yeah one solution would be for those companies to follow the law but they prefer plan be cozy13/23
up to enough people in Congress to pass this curious bill that would shoot holes in the unity fraud law in other words make it easier for drug companies to get away with fraud in section thirty thirty seven of the bill that allows pharmaceutical companies to promote off label uses to insurance providers allowing them to expand their markets while of fading requirements of the FDA approval now14/23
this bill also promises to speed up approval of new drugs and medical devices by loosening the requirements for the drug makers opponents of the bill say that the trade offs that lie within it strip the FDA of the regulatory power so I think it away cover up bribery right now the law requires drug companies to disclose the buckets of money that they shower on doctors and15/23
hospitals to encourage them to prescribe certain drugs it is by the way all published on a government website you can go look up your doctor in your hospital right now online if you want to do that now the drug companies could have responded by ending kickbacks to doctors but instead they've chosen plan B. again cozy up to enough people in Congress to pass this curious bill16/23
that would let drug companies keep secret any splashy junkets sort deists associated with so called medical education and make it harder for enforcement agencies to be able to trace those bribes over fourteen hundred lobbyists acting on behalf of more than four hundred companies and other organizations lobbied on behalf of the cure's act this is according to the center for responsive politics third giveaway handout dangerous special17/23
deals to Republican campaign contributors according to news reports a major Republican donor stands to benefit financially from selling cellular in regenerative medical therapies if this guy had his way he'd be able to sell them to desperate people without a final FDA determination that those therapies were either safe or effective of course that would be against the law right now so this mega donor has poured millions18/23
of dollars into Mitch McConnell's personal campaign coffers and into his Republican super PAC and now he wants his reward curious act offers to sell government favors it delivers a special deal so that people can sell these treatments without meeting the FDA goal standards for protecting patient safety and making sure that these drugs actually do some good in the newest revision of the cure's act you will19/23
see a provision that was not in the previous version in section thirty thirty three of the cure's act you'll find the accelerated approval for a genitive advanced therapies it creates an expedited review pathway for regenerative medicine that allows use of surrogate endpoints and post approval studies Edgar size is a wealthy businessman in a regenerative medicine investor and he runs a stem cell firm called per size20/23
life sciences number size donated two million dollars to Senate Majority Leader Mitch McConnell super pacs since October of twenty fifteen %HESITATION size stance directly benefit from this added provision in addition to benefiting the drug companies financially and expediting the approval process for new drugs and vaccines while sidestepping the FDA guidelines ensuring that the drugs are safe and effective cures act also upholds the legal cover for21/23
the manufacturers of vaccines preventing injured persons from vaccines from taking the drug companies to court in section thirty ninety three titled courage in vaccine innovation vaccines recommended for use in pregnant women the build the first potential victims to the vaccine injury compensation fund which the government not the corporations have paid out over three billion dollars since the program's inception in the nineteen eighties while everyone was22/23
still consumed with the results of the presidential election and eating leftovers from thanksgiving the house and the Senate both passed the twenty first century cures act now the bill sits on president Obama's desk waiting to be signed into law also cited as soon as it reaches my desk if you found this video useful sharing but for these are only made why are you subscribe to news