Dangerous Legislation From Ted Cruz, 21st Century Cures Act and the FDA
By Wayne Rohde
Presidential campaign politics generally brings a lot of surprises and some WTF moments, all courtesy of candidates and their political parties. And mixed into this year’s campaign rhetoric of false promises and fear mongering are two pieces of legislation that needs to be examined very closely.
First, in May of 2015, the US House passed the 21st Century Cures Act or HR.6. Autism Speaks and other disability advocate organizations praised the House of its passage. I wrote about how problematic the legislation will be if the Senate passes the bill in its current form and the President signs it into law.
Currently stalled in the US Senate, the bill is waiting on hearings and hopefully a lot of close scrutiny. Sen Lamar Alexander, Chair of the HELP committee, wants to act upon the legislation in 2016 and also wants to pare it down. What that means remains to be seen. Presidential candidates, Sen Rand Paul and Sen Bernie Sanders are members of the HELP committee.
The bill would dramatically increase funding of the NHI and ask the FDA to accelerate the approval rate of medical interventions, drugs and devices. And that is where the heartburn for most of us begins.
The mechanisms to accomplish this goal are suspect by encouraging the FDA to approve shorter or smaller clinical trials or in some cases, drugs that are not tested in controlled clinical trials.
The most egregious and damning part of this legislation is the expeditious and dangerous circumvention of vaccine clinical trials.
Pharma and the medical device industry were hoping for a big Christmas present before the end of the year. And we would be left with a lump of coal. A new detail regarding the very close relationship between FDA and industry was disclosed earlier this week. News reports now state that FDA Acting Commissioner Stephen Ostroff, and other agency officials, met with representatives from the Advanced Medical Technology Association (AdvaMed) to discuss the Cures legislation.
Second, during the crazy season of presidential campaigns were candidates start introducing legislation in Congress as a way to keep their name on the front page, Senator Ted Cruz of Texas, introduces what only can be seen as a complete circumvention of the FDA and an end-around of any and all safety regulations.
On Dec 10th, 2015, Sen. Cruz introduced S. 2388 “Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act” or RESULT Act. This legislation is very dangerous for those who are advocates for safer and transparent research of all medical interventions including vaccinations.
The Act would allow “for the reciprocal approval of drugs, devices, and biologics from foreign sponsors in EU member countries, Israel, Australia, Canada, and Japan.” Basically, a drug or medical device manufacturer by obtaining approval from another country with lower safety and clinical trial standards and enter the US market without having to deal with the FDA.
Whether or not this segment of the legislation holds up to committee scrutiny is anyone’s guess, but for a presidential candidate to introduce this type of legislation does create some doubt about the sincerity of that candidate towards those who have suffered injuries and those who are advocating to prevent future injury or death.
I am not writing this article as a means to create a hit piece against his candidacy. I like his fight, his debating skills and his willingness to go his own way, sometimes the path less traveled. I am very concerned that he does not understand the full ramification of his legislation.
Sen. Cruz, not a fan of most government agencies, wants to remove or eliminate the FDA in their oversight of medical interventions including devices and drugs. This includes vaccines. Now many of us have big issues and complaints with our government regarding the very close relationships between the FDA, the CDC, HHS, and Pharma. We need to keep pushing our elected officials to examine this very intimate relationship. Reforming these agencies is a must. Elimination of them and allow Pharma to self-regulate, not a chance.
The FDA has made major blunders in the past and in my opinion continues to make blunders. We all remember Vioxx was initially approved by the FDA and then later removed from the marketplace due to the extreme number of deaths and severe injuries caused by this medication.
But they have also done some good.
Some of you might remember it was the FDA or actually Dr. Frances Oldham Kelsey, a young pharmacologist working for the FDA that would not allow Thalidomide into the US market. This drug was approved for European markets in the early 1950’s but because of Dr. Kelsey; the drug was not approved in the US for use with pregnant women.
Also included in Sen Cruz’s legislation is a provision to allow Congress to override FDA denials of certain applications for life-saving drugs with a majority vote via a joint resolution. Why should we allow 434 members of the House and 100 members of the Senate to make more scientific and medical decisions than the FDA? I am no fan of the FDA and CDC because of certain players within the agency and the revolving door to Pharma. But this is not the reason to scrap the agencies and give 535 yahoos the ability to make sound, rational decisions. It is the very reason why we have a separate government agency established, to take the emotion out of the decision process.
It was because of Dr. Kelsey’s actions and perseverance, that the US and the FDA has the most strict approval standards of all nations.
We need to be very vigilant and begin conversations with representatives of the candidates to inform them of our concerns regarding the RESULT Act and 21st Century Cures Act.
Wayne Rohde, author of The Vaccine Court – Dark Truth of America’s Vaccine Injury Compensation Program
Wayne: So this bill offers a list of countries (the EU and a few other nations) and states that if a drug or vaccine is approved in these countries, it is automatically approved for the US, bypassing the FDA, correct? Does that mean the product only has to be approved by any one of these thirty-odd countries, and then we wave it on through? What if it is approved by (say) Lithuania but banned by all the others on the list?
Posted by: Jonathan Rose | December 22, 2015 at 10:32 AM
This is a very important article. Thank you, Wayne.
What crazy thinking. Cruz wants to make the FDA completely powerless. He wants to let (Pharma's) Congress approve drugs that the FDA's scientists have said no too. Truly frightening that he could have become a senator, let alone run for president.
They want to do away with scientific research, put drugs on the market without knowing what they'll do (which is pretty much what they do with vaccines now, but they don't admit it), pick and choose from the drugs sold in other countries without having to think about it, and then we've got Paul Offit running around claiming that infants can tolerate 100,000 vaccines at one time, with absolutely not a shred of evidence to back that statement up. But he doesn't need evidence. They're doing away with evidence. Maybe they'll redefine the word evidence in the dictionary while no one is looking, so that they can still claim to practice "evidence-based medicine".
Posted by: Linda1 | December 22, 2015 at 12:40 AM
Sun Rose
It was not approved for the United States - but it was in the UK and Canada - and I think Europe.
Posted by: Benedetta | December 21, 2015 at 11:08 PM
Wayne, yes thalidomide in the 1950's, but it seems to me, perhaps because I may be unaware, that it has been a drought ever since when the FDA did right. Even when problems emerge, they [the FDA] first try to silence those blowing the whistle. The operating rules for drug approval is that they only have to marginally better than a placebo or existing drug and we know how easy it is arrange a trial,or a study to get some statistical betterment by hook or by crook, not report any negative studies and the FDA says OK sale away.
Could it be worse, we are getting there anyway.
Posted by: michael | December 21, 2015 at 09:39 PM
If thalidomide wasn't approved, how did it cause so much damage?
Posted by: Sun~Rose | December 21, 2015 at 09:13 PM
I don't suppose Cruz's bill works the reciprocal way when something is banned or considered unsafe in one of the other countries.
Posted by: Greyone | December 21, 2015 at 09:13 PM
Sure, no problem, Wayne, though it would be nice to have the name corrected in the article itself so it is clear that
Dr. Kelsey was a woman. I find it remarkable that she was able to withstand the considerable pressure on her to approve this drug, especially given her age and gender.
Posted by: Cait from Canada | December 21, 2015 at 04:59 PM
TO Ciat from Canada. Spell check will always be a thorn in my side. Thanks for the correction.
For those who want to research Dr. Kelsey, she was a fascinating scientist.
Posted by: Wayne Rohde | December 21, 2015 at 01:15 PM
Wayne
Thank you as ever. We are engulfed in monumental human catastrophe and in very large part it is to do with lazy, corrupt and neglectful politicians engaged in magical thinking. If you don't look you won't see, and "they" spend all their time not looking. The thought has sometimes been articulated on this site that one day the cost to human society would become so great that something would have to be done. Actually, human society can collapse in total ruin and the politicians could still be looking around and pretending it wasn't anything they did, or that there was anything to do. The message with this legislation is that if you thought things were already bad you ain't seen nothing yet.
Posted by: John Stone | December 21, 2015 at 12:25 PM
Do these people even really read or research what in the heck it is that they are promoting??? Our children are ill enough!! Think politicians. Or is that asking too much?
Posted by: Cruz' Cures act is going to cause harm | December 21, 2015 at 12:16 PM
Correction: The pharmacologist responsible for keeping thalidomide out of the U.S. was Dr. Frances, not Francis, Kelsey. Apparently thalidomide was the first file she dealt with at the FDA.
Unfortunately Canada, Kelsey's country of origin, did approve the use of thalidomide, with disastrous results.
Posted by: Cait from Canada | December 21, 2015 at 11:21 AM
Front runners - you also wonder where the money is "really" coming from.
Trump; I sure hope he is watching his back, has hired good people to watch his back, watch what he eats, breaths, no vaccines at his time - no antibiotic shots at this time.
Then of course even if you are on the side of big pharma will still do you end.
After all we had the first President Bush come down with Graves - the same time his wife came down with Graves, and their little dog too.
Seeing the vet often is just as dangerous for a dog as having your own medical doctor.
Posted by: Benedetta | December 21, 2015 at 09:03 AM