Stop 21st Century Cures Act
Special thanks to our allies at A Voice for Choice for sharing this call to action and for organizing citizen activists to be heard on this issue. The folks at A Voice for Choice share our goal of ensuring everyone has access to the truthful, non-misleading information so important for deciding how to maintain one’s health and wellness.
ACTION NEEDED: We need your help to stop the 21st Century Cures Act (HR34 – was HR6), by calling both of your Senators NOW and urging them to vote NO on this bill AND NO on the Cloture (details and reasons below). To do this take 5-10 minutes now and:
- Go to www.senate.gov, find out who your Senators are.
- Call their offices in Washington, D.C. and communicate that you want them to vote NO on HR 34 the 21st Century Cures Act. Let them know that Senators need to recognize that they need to do what is morally, ethically and humanly right and Vote No on the 21st Century Care Act. They should not be blinded by the language written in this Bill that it will save lives and find cures.
- Call their local district offices and communicate that same message again.
- Forward this email to everyone you know – it affects everyone.
Legislative Details: Last week, the House of Representatives passed the 21st Century Cures Act nearly unanimously (392-Yea; 26 Nay) (https://www.govtrack.us/congress/votes/114-2016/h592). This bill (HR 34) heads to the Senate this week. Senator McConnell has called for a cloture vote which will take place on Monday at 5:00 pm. If 60 members approve (he said they likely would), it means they will then debate the bill for up to 30 hours and take a final vote likely on Tuesday or Wednesday, this week. We do not want the Cloture as it will allow a filibuster to get it through. Therefore we have less than 72 hours to make a change. The 21st Century Cures Act legislation was originally passed in the house last year on July 10, 2015 as HR 6. After passing the house in 2015, the legislation stalled. Many of the provisions of HR 6 were broken up into several smaller bills, but over the Thanksgiving holiday, the legislation was quickly reassembled into a new version including some sections from HR 6 and adding some new sections, amending them all onto bill HR 34. HR 34 was originally a bill that only addressed “Tsunami Warning, Education, and Research”, but was passed by the US House of Representatives on November 30th.
A few legislators have spoken out against it. They include:
Bill Details: Although this is coveted as a wonderful bill that is needed in the US so that drugs and medical devices can be fast tracked, if you read the nearly 1000 pages it is clear this is dangerous bill that is has the best interests of the Pharmaceutical industry at heart, NOT its consumers. Over 1400 lobbyists were involved in the creation of this bill. “The 21st Century Cures Act is a drug company stockholder’s dream and a consumer’s worst nightmare,” said Barbara Loe Fisher, NVIC Co-founder and President. “Making experimental drugs quickly available for the sick and dying, who voluntarily choose to use them, is one thing but Congress should not be greasing the skids to license experimental vaccines that government will recommend and legally require healthy children and adults to use. It is a prescription for disaster.”
HERE ARE SOME OF THE ISSUES WITH THIS BILL:
Informed Consent (or lack thereof) in HR34: The 21st Century Cures Act would no longer require the informed consent of the subjects for medical devices or drugs. All patients receiving treatment by any medical doctor may be, WITHOUT THEIR KNOWLEDGE, enrolled in a clinical trial for drugs and devices as long as there is “minimal risk” to the patient and the practitioner, and as long as there are “safeguards”. This means that the person being given the drug or having the medical device used on them does NOT have to be informed that they are entered into the clinical trial or of the adverse side effects or risks. This provision makes no sense logically, or scientifically, and is dangerous. We use clinical trials not only to study the efficacy of drugs and devices, but also to determine their safety profiles. Under the 21st Century Act, no clinical trial can proceed unless the safety profiles are known. The effect of this act is to leave “safety” to guesswork and rationalization, and to allow the medical establishment to assess harm in drugs and devices in a manner in which (1) the patients are not informed that they are in a clinical trial, and (2) they have no right to say “No” to being part of an experiment. If they are harmed during the trial, they cannot know that they should sue because any ill effect of the experimental drug or device cannot be traced to the experiment. This allows the medical establishment to experiment on the population with impunity. The act does not specify “minimal risk”. (This is probably one of the ones that resonates most with staffers)
Vaccines in HR34: The 21st Century Cures Act would fast track the approval of all vaccines, and shields drug companies and vaccine administrators from liability for fetal injuries and deaths caused by vaccines marketed for and given to pregnant woman. It also allows the approval of drugs by the FDA vaccines “with the least BURDENSOME means.” Drugs should require the MOST rigorous testing, not the least burdensome means.
Health Information Privacy (or lack thereof) in HR34: The 21st Century Cures Act would allow the government to access and use your private health information and records without your authorization.
Disability in HR34: The 21st Century Cures Act would create big brother mechanisms in (IHSS) In Home Supportive Services for home care providers with the creation of the electronic visit verification system.
Electric shock “therapy” in HR34: The 21st Century Cures Act would fast track Electric shock “therapy” as a cure for maladaptive behaviors and seizures.
Reduced Funding of NIH and FDA in HR34: The 21st Century Cures Act would trade temporary additional funding for the National Institutes of Health and the FDA for permanent weakening of the FDA’s approval process.
HR34: 21st Century Cures Act in the media and related articles
“David Hilzenrath at the Project on Government Oversight (POGO) reports that at least 39 of 42 patient advocacy groups who participated in discussions with the FDA over agency review processes for prescription drugs received funding from pharmaceutical companies. And at least 15 have representatives of drug or biotechnology companies on their governing boards.
“Kaiser Health News reviewed the lobbying records filed by the Pharmaceutical Researchers and Manufacturers of America, the trade group representing drug makers, and found the industry group spend up to $24.7 million lobbying on the bill. (On some of the lobbyists’ disclosure forms, multiple healthcare laws are listed, and it was not clear how the industry’s lobbyists divided their time.) The mega-drug maker AbbVie — which manufacturers Humira, one of the most lucrative pharmaceuticals marketed for multiple uses — spent up to $7.7 million. The U.S. Chamber of Commerce spent up to $136.5 million.
The bill also had support from the US. Oil and Gas Association — which spent $293,000 on lobbying — since some of the new funding for research would come from selling oil crude from the Strategic Petroleum Reserve.”
Don’t let Pharma get the better of us.
More bill specific info from the NVIC Advocacy Page:
To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes
|Title:||To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes|
|Action Required:||Contact your US Senators and US Congressman and tell them to oppose HR6|
|Status:||Reworked and amended, scheduled for a vote in US House 11/30/16|
|UPDATE: 11/30/2016 – The 21st Century Cures Act debate can be watched here – http://houselive.gov/MediaPlayer.php?view_id=23&event_id=92|