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.