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