Christmas in July. What the 21st Century Cures Act is Really About.
By Wayne Rohde
Recently, the U.S. House of Representatives voted 344-77 to approve H.R. 6, better known as the 21st Century Cures Act. I received a promotional email solicitation from Autism Speaks a few weeks ago to ask me to contact my representative and ask them to vote in favor of this legislation.
That is when my curiosity bugged me to actually investigate the 21st Century Cures Act. And boy did the red flags pop up after reading the table of contents of the proposed bill.
The bill seeks to increase funding for the National Institutes of Health (NIH), nearly 9 billion, and asks the Food and Drug Administration (FDA) to accelerate the rate of medical innovations. Who can say no to this? Maybe a few very stout fiscal hawks that voted against any new federal spending. And there were a few that actually did.
In a July 10th press release, Autism Speaks stated the following “We applaud the bipartisan efforts of Chairman Fred Upton and ranking member Congressman Diana DeGette for their leadership on H.R. 6, or the 21st Century Cares Act, to accelerate the discovery, development and delivery of the new treatments for all, including many families with autism,” said Liz Feld, president of Autism Speaks. “Our advocates will continue the work of educating Senators on the importance of this legislation to our community and we are hopeful that H.R. 6 will move quickly through the Senate to bring us closer to new breakthroughs in medicine.”[i]
This bill really sounds very promising for all of us, those families dealing with autism, those individuals having to live with life altering disabilities, and those who live in pain daily dealing with chronic disease, those patients in need of a life-saving medical device. So I ask you, who would vote against this? The bill passed out of the House Energy Committee 51-0 and the complete House voted 344-77.
But as the old saying goes, the devil is in the details. So let’s look behind the curtain, place a spotlight on the language of this fast moving bill and see where the cockroaches scatter.
We know that the pharmaceutical industry and medical device companies are responsible for drafting the language and promoting it to Congress.[ii]
I contacted several congressional offices seeking comment on the vote. Most declined but a couple of unnamed staffers stated that the large increase in new federal spending without the promise of results led to decision to vote against the bill. One staff member mentioned that the Congressman was not happy with the track record of NIH and credible research. We have we heard that before?
One has to wonder about the speed of this bill being introduced in May of this year, receiving a fast committee vote and over whelming support for the full House. I want to ask you to focus your attention to page 162-168 of this entire 360+ page bill. Just seven pages. It is like the infamous 16 words stuck in the middle of a 5,400 word document spoken by President Bush in the 2003 State of the Union speech. Those 16 words dealt with the yellowcake uranium claim that Iraq was seeking to acquire from a nation in Africa. And we all know where that claim led us.
But if you read the 7 pages hidden in H.R. 6, you will find language that basically circumvents the existing committee approval structure for public comment and thorough medical discussion regarding vaccine development and recommendations for the vaccine schedule. The fast tracking process is very problematic. Not just for all of us that advocate for safer vaccines and more independent research but also from other medical advocates. Enter Dr. Jerry Avorn, Harvard Medical School professor.
In the June 25th article of the New England Journal of Medicine, Dr. Avorn, made the following arguments against the passage of the 21st Century Cares Act.
- The existing approval process for new drugs by the FDA is currently approving new applications every 6 to 10 months. The legislation encourages the FDA to approve by using nontraditional methods. This will rush through approvals even faster. “The law encourages the FDA to approve devices that were tested in shorter or smaller clinical trials and drugs that weren’t even tested in controlled clinical trials.”
- The legislation also encourages the FDA to rely more on surrogate measures rather than actual clinical end points to assess submitted drugs and devices.
- The proposed legislation would make immediate changes with the respect to new antibiotics and antifungals by enabling the FDA to approve them without clinical trials if the agency decides that these untested compounds can treat serious or life-threatening infections in patients where no existing medications are available. “In place of proof”, Dr. Avorn wrote, “the legislation would empower the FDA to accept nontraditional efficacy measures drawn from small studies or other sources.”
- Another questionable provision of the 21st Century Cures Act seeks to get drugs approved expeditiously without placebo-controlled trials, to use surrogate markers instead of actual outcome studies and to incentivize hospitals to use untested antibiotics and compromise patient’s informed consent rights. This strikes at the heart of those who have been fighting for parental choice and informed consent for all medical procedures.
- And there is language to repeal a small section of the Affordable Care Act. In the ACA, there is language requiring Pharmaceutical companies and device manufacturers to report all payments and gifts they make to doctors. This bill, H.R. 6, would remove that language, thus bribery and the world of hidden speaking and consulting fees would reign over the drug industry. As reported in the Wall Street Journal from data received from the Center for Responsive Politics shows that the members of the House committee that approved H.R. 6 by a vote of 51-0, received on average $ 70,000.00 during the last 2 years. The Chair received $ 302,700.00 and the ranking Democrat received just under $ 175,000.00. No wonder why the bill sailed through the House committee. Just wonder what the House leadership received for their positive vote?
The Wall Street Journal reported on July 9th that the new NIH funding will go to projects such as President Obama’s “precision medicine” initiative, which focuses on using a person’s genetic profile to tailor to treatment. It also includes a project to amass genomic information on more than one million U.S. volunteers, assembling a database designed to home in on genetic mutations responsible for disease.[iii]
So why is this bill needed? It appears to be an early Christmas present for the Pharmaceutical Industry. And a bag of coal for the rest of us. It removes all existing high standards for research and approval of new medicines and medical devices. It allows the expedited process of approving medicines including vaccines without the standard placebo based clinical trials.
With the emphasis in the states to remove any and all exemptions for compulsory vaccination for children and soon for adults, the combination of those efforts along with the introduction and passage of the 21st Century Cares Act, we have now reached a crossroads in America where the state has control over the family regarding mandatory vaccines, perhaps other medical procedures in the near future, and our government allowing industry to determine their own approval process.
And the number of vaccine injured persons continues to increase, the prevalence of autism continues to increase, the control and manipulation by our government over its citizens continues to increase, so why is Autism Speaks promoting this legislation and directing parents to contact their legislators to support this bill?
Pharma has been promising that we can “manage” autism by a small yellow pill. That we should be more concerned about funding research than discovering what is causing autism. So we all need to band together, contact our elected officials and ask them to support the 21st Century Cares Act. So what if we have to remove or eliminate informed consent and ignore the high standard for clinical research and studies.
Maybe the 21st Century Cares Act is more about returning our country back to the 19th century medical standards.
This is so tragic.
Posted by: Katie Wright | July 27, 2015 at 12:31 AM
Hi Grace,
Steve Jones, who is a geneticist, will know that the growth of genetic research came from tobacco industry funding trying to prove that lung cancer was due to "genetic defects" in susceptible individuals:
http://www.truth-out.org/news/item/17916-science-as-social-control-political-paralysis-and-the-genetics-agenda
And bear in mind Jones is a piece of work too:
http://www.ageofautism.com/2011/07/scientific-totalitarianism-at-the-bbc.html
Posted by: John Stone | July 26, 2015 at 12:26 PM
Laurie, that argument about genetic makeup can be easily answered by the comment by British geneticist Professor Steve Jones: " If everyone smoked smoking would be called a genetic disease." The fact that not everyone who smokes gets lung cancer is similarly an argument against the epidemiological studies which are claimed to prove vaccines don't cause autism.
Posted by: Grace Green | July 26, 2015 at 10:22 AM
The real scandal: autism and cancer
Although most of us on this site are aware of the role of Big Pharma in autism, I suspect that the real scandal of the damage done by the corruption of the medical system by big pharma is related to the explosion of cancer in 20th century.
The establishments response to exponential rise in Autism and Cancer are identical - "oh it was always there, it's just being diagnosed more now". Make no mistake, this is the Big Lie.
It is now increasingly being understood that cancer can only take hold because of immune system disruption.
Antibiotics and vaccines are common denominators to autism and cancer, and possibly a plethora of other auto-immune diseases.
1) The role of antibiotics in destroying the microbiome and 2) the role of vaccines in damaging the nervous system and brain, has not been studied, and is not being studied, probably intentionally.
Given the millions of cancer victims, and the $100 billion spent on the "cure for cancer" (and much more resources in form of countless runs/walks/charity events), over the last 40 years, with ZERO, absolutely nothing to show for it, the biggest scandal of the last hundred years is the role of Big Pharma in causing cancer and keeping quiet about it.
Posted by: Ed | July 25, 2015 at 11:14 AM
As a homeopath, I should be happy about this bill. It will make Western Medicine even less safe than it is. Unfortunately, people don't care. And they won't know. It is up to us to educate them. It is bad enough that most drugs are only slightly more effective than placebo. But hey, if they can say it works without research, so can I.
Posted by: Kathryn Berg | July 24, 2015 at 06:13 PM
There is some language in the bill that is confusing regarding the employment status of NIH directors. I did not include it in my article until I could confirm how the employment system works.
But on first reading, it appears that some directors of NIH will now be placed on 5 year contracts for employment. This is very concerning since the renewal of the contract will now be politicized by the administration and the perceived direction of policy.
This bill really sucks, it really does. And I do not know if there are any Senators that will go against Pharma on this, especially those who sit on the HELP cmte.
Posted by: Wayne Rohde | July 24, 2015 at 05:11 PM
Linda1, that would be Chris Hickie.
Posted by: Researcher | July 24, 2015 at 04:23 PM
California Governor Gerry Brown recently launched a statewide 'precision medicine initiative' too [just as Obama is doing]. I already knew it would be really about gathering genetic information and more database statistics that track us. Sure enough, the NIH funding states this. It's all very apparent that the vaccine exemption removal has everything to do with further control and tracking in the future, even more so than short term pharmaceutical profits.
The more information they have about human genetics, the more biotech/DNA modification they can do. Oh yea, and the more they can 'blame' genetics for failed vaccines or any kind of 'side effects' from increasingly toxic pharmaceuticals that are prescribed in increasing numbers [including vaccines]. 'Oops, rare 'mitochondrial disorder'. 'Oh, sorry, turns out YOUR body is defective; you have a genetic disorder so our medical technology just didn't work for you'.
It's another way to displace blame, detract from the real issues and allow people to further internalize any questioning of the medical industrial complex, as surely they will be met with people continually telling them that 'it's individual; you just never know what one person's genetics will do.' Oh, and it will be a convenient way to co-opt holistic medicine's 'individualized' approach, too. Precision medicine: It's advanced and individualized for each person!
21st Century Cures Act is as dark as the Dark Act and TPP. Honestly cannot believe they are really pulling this on the public. It's surreal. https://www.ucsf.edu/news/2015/04/125111/california-launches-initiative-advance-precision-medicine
Posted by: Laurie | July 24, 2015 at 01:52 PM
A few years back across the nation, there were a number of "Access to Cures" state constitutional amendments / which passed in many states and provided millions for research for who knows what.
A decade later, no one knows what they have found, what the cures are, and where to get access to them.... or how much money they have been provided.
Posted by: go Rand | July 24, 2015 at 01:41 PM
Thanks for the heads up. With nearly 300 new vaccines in the works, speeding up the approval process for "biologics" might be one of the major aims of the bill.
Posted by: Jeannette Bishop | July 24, 2015 at 01:20 PM
Let me add Sidney Wolfe of Public Citizen, the self proclaimed domestic medical practice and ethics watchdog, who should be screaming, who should have been screaming before, during and after SB277 and all the other federal and state level coups. Where the hell is Public Citizen?
Posted by: Linda1 | July 24, 2015 at 01:07 PM
LMAO, " Arizona based foul mouthed attack dog Pediatrician."
If Donald Trump speaks about vaccine safety I have a few pointers for him:
-use the term 3 in 1's or "combination vaccines" rather than refer to them as big shots.
-talk about how the CDC has inappropriate COI - in charge of both uptake and surveillance (the fox is guarding the henhouse.
-most of the studies are biased and the parents and public are realizing this. Pukes like Anderson Cooper pretend not to know this and are heralded but honest reporters like Sharyl Attkison and Katie Couric are destroyed for speaking the truth or even questioning.
Posted by: for Linda1 and Donald Trump | July 24, 2015 at 12:47 PM
Yes John. The present day equivalents of Nazis, Stalinists and Maoists governing the US are not the elected. They are the puppeteers pulling strings from the shadows and oftentimes right out in the open. The elected are empty shells, mindless puppets who move their mouths according to the puppeteer's script - like Elizabeth Warren in her performance "questioning" the CDC's sadistic matron in military uniform. How they really got that way is a good question. Could it really be simply the corrupting influence of power and money and the need to go along to get along, to preserve one's own skin at all costs? They are all so mentally and morally deficient that they are not even there. Then, where is the rest of the country? Where in hell are this nation's physicians as the ground is being moved out from under them and replaced with quicksand? Where is the voice of Cochrane? John's Hopkins? Duke? All the leading hospitals and research universities? Where the hell is everyone? Have they all lost their minds?
Posted by: Linda1 | July 24, 2015 at 12:20 PM
Linda was remarking on another thread about the extremism and deceit of modern government. One might remark how unlike the extreme totalitarian regimes of the twentieth century it all happens quite surreptitioulsy in legislation which barely even gets reported in mainstream sources. This is a big document but it would not take much to fathom its extreme wickedness, but the attention of everyone is so overloaded with junk - including the congressmen who voted for this inanity - that the world and its inhabitants are aloud to drift away on a cloud of wishful thinking. The culpable US politicians who are doing this are nothing like Nazis, Stalinists or Maoists: they are just weak and their minds are blown.
Posted by: John Stone | July 24, 2015 at 11:33 AM
So, no clinical trials and using clinical experience to determine efficacy in approving new drugs and devices is ok as long as it isn't a Dr. Gonzalez or a Dr. Bradstreet who is proposing the novel treatment?
Now let's watch as Gorski and his ugly team of trolls, always proclaiming the superiority of their brand of "evidence" based medicine, try to spin this sham into their sick framework. Emily? Dorit? What's his name - the Arizona based foul mouthed attack dog pediatrician?
Posted by: Linda1 | July 24, 2015 at 11:24 AM
9 billion dollars? 9 billion dollars To a federal agency that already has a budget that dwarfs our military A federal agency that has been doing such a bang up job with the health of the United States --Ya' all know they have been with soaring diabeties, thyroid type autoimmunity - let alone Shootings every week by a mental ill person -- but heck mental illness is really just a sign of a weak character - and those autoimmune diseases -- they just need to stop eating donuts -- All the population is just a bunch of Homer Simpsons - and besides mental health is not really a process of a disease just that Homer Simpson type of citizens. We will not even talk about mental illness -- let us talk about old flags and them darn red neck guns.
With 9 billion dollars they own us.
Oh, that is why the armed forces are going to have to reduce the troops by -- what was it ? 40,000?
How do turn this behemoth ship around?
Posted by: Benedetta | July 24, 2015 at 10:58 AM
It's crazy stuff- how can they?
Posted by: John Stone | July 24, 2015 at 10:34 AM
Not surprising the "usual suspects" .. pharmaceutical companies, federal regulatory agencies and elected representatives .. to name just three of many more self-serving bureaucracies (AS) .. all in favor of any measure that would "fast track" medical/drug/vaccines products and devices .. in order to prioritize the "vested interests" of the powerful .. over the people .. who will surely suffer the "unintended consequences" that are certain whenever the ancient proverb ... "act in haste .. repent at leisure" is violated.
Instead of HR 6 being labeled "The 21st Century Cares Act" .. it should be re-named "The 21st Century E-Z PASS ACT" .. in honor of all those vested interests mentioned above .. who will profit from having their products and devices brought to market as quickly as if "driving a car past the takeout window of McDonald's"
Posted by: Bob Moffitt | July 24, 2015 at 10:13 AM