Contact the President to let him know you OPPOSE the “21st Century Cures Act” also known as HR34: PHONE number (202) 456-1414. Ask him to VETO it! AAN writes, "The US Senate voted yesterday to pass HR34, the 21st Century Cures Act on a 94 to 5 vote. President Obama has said he will sign the bill. Senators who voted "No" are Elizabeth Warren of Massachusetts, Ron Wyden and Jeff Merkly of Oregon, Bernie Sanders of Vermont and Mike Lee of Utah. Please click on the Take Action link to send a message to President Obama asking him to reconsider signing the bill. And please call the White House and politely ask that the President not sign the bill, 202-456-1414 The Los Angeles Times said this about the bill, "The 21st Century Cures Act is a huge deregulatory giveaway to the pharmaceutical and medical device industry, papered over by new funding for those research initiatives. The punchline is that the regulatory rollback is real, but the funding may not be — it’s subject over the next decade to annual appropriations by Congress that might never come." Michael Carome, director of the Health Research Group at the advocacy organization Public Citizen said, “This continues a trend of eroding standards at the Food and Drug Administration since the 1990s.” The bill would allow: Experimental drugs and vaccines to be used on people without informed consent, The licensing of medical devices and drugs that have not gone through rigorous safety and efficacy trials, "Expedited" safety and efficacy testing for drugs, vaccines and medical devices, It eliminates current law that requires physicians to report gifts and other forms of compensation from drug, vaccine and medical devices firms. Currently, a child injured in utero by a vaccine has a legal right to sue the doctor and vaccine manufacturer. HR 34 takes away those basic rights and would force the child to apply in the dead-end National Vaccine Injury Compensation Program. Please share this message with friends and family, and post to social networks." ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ Talking points from The Weston A. Price Foundation: "1) While the 21st Century Cures Act may sound good because the package is touted to bring relief to suffering patients faster and increase funding for mental health care and the opioid epidemic, the nearly 1,000 page measure includes a number of provisions that have many patient advocacy groups and physicians deeply concerned for the safety of their patients. Within these pages are provisions that will compromise patient safety. https://www.congress.gov/bill/114th-congress/house-bill/6 2) This bill tampers with currently; crucial regulations that are meant to prevent unsafe drugs and medical devices from reaching patients. The 21st Century Cures Act would change that by speeding up the approval process, allowing use of anecdotal evidence and observational data to license new drugs. 3) A major concern is that the bill includes language that would allow drugmakers to use “real-world evidence” to support the approval of new uses of an existing drug or for new drugs that are approved through an accelerated regulatory pathway. This bill allows FDA approval without rigorous clinical trials. Instead companies can submit safety monitoring data or observational studies as proof that a drug works. 4) You STRONGLY OPPOSE the 21st Century Cures Act because it legalizes fraud. As Massachusetts Democrat, Elizabeth Warren states, “Pushing treatments without scientific evidence that they work is fraud.” In the past 5 years, drug makers have paid the US Government 19.2 billion in criminal and civil FRAUD penalties. Skepticism of the pharmaceutical industry is well deserved. http://www.fiercepharma.com/regulatory/pharma-shelled-out-3-75b-fraud-penalties-record-setting-year-feds-say 5) The drug and device industries intensely lobbied House members to pass this legislation. The Senates lobbying database lists more than 1,100 lobbyists that pushed for the passing of the 21st Century Cures Act for over the last several years. You believe the bill is too heavily influenced by the pharmaceutical industry. 6) Simply put, we cannot allow the already corrupt FDA to use relaxed regulations to evaluate new drugs and devices that encourage companies to bring substandard or ineffective devices to market. 7) The 21st Century Cures Act is a way to RUSH experimental vaccines to licensure that the government will likely legally require healthy children and some adults to buy and use. http://www.nvic.org/nvic-vaccine-news/july-2015/21st-century-cures-act-eliminates-good-science.aspx 8) Although the word “vaccines” has not been publically uttered by anyone sponsoring the Cures Act, the Biotechnology Industry Organization (BIO), which represents more than 1,500 pharmaceutical and other health product organizations, influenced Capitol Hill politicians to incorporate the “Vaccine Access, Certainty and Innovation Act of 2015” into the 21st Century Cures Act. https://www.congress.gov/bill/114th-congress/house-bill/786 9) If the Senate approves (which they now have) and the President signs the revised Cures Act, imagine what will happen with the hundreds of experimental vaccines in development. They will potentially be “fast-tracked” to licensure and mandated. There are currently several thousand vaccine clinical trials being conducted, including for infectious and non-infectious diseases such as gonorrhea, syphilis, chlamydia, HIV/AIDS, genital herpes, RSV, avian flu, asthma, strep B, cytomegalovirus, hepatitis C, tuberculosis, e-coli, salmonella, asthma, diabetes, obesity, anti-cocaine and heroin use. 10) Children today already receive 69 doses of vaccines for 16 different viral and bacterial illnesses which more than doubles the government childhood schedule of 34 doses of 11 different vaccines in the year 2000. 11) Vaccine makers and the healthcare providers who administer them bear zero liability for vaccine injuries and deaths. Vaccine makers have no incentive to make vaccines safe. 12) You OPPOSE the 21st Century Cures Act because one of its provisions seems to put structures in place for amending the current vaccine schedule and including more vaccinations for pregnant mothers. S. 2742 (the “Promoting Biomedical Research and Public Health for Patients Act”) contains the following language: "Notwithstanding any other provision of law, for purposes of this subtitle, both a woman who received a covered vaccine while pregnant and any child who was in utero at the time such woman received the vaccine shall be considered persons to whom the covered vaccine was administered and persons who received the covered vaccine. The Centers for Disease Control and Prevention (CDC) already recommend that pregnant mothers get whooping cough, flu, and hepatitis B vaccines. Flu vaccines contain mercury. https://www.congress.gov/bill/114th-congress/senate-bill/2742 13) Currently we have one of the fastest regulatory systems in the world and we already have in place several expedited pathways for new drugs, called “fast-tracking, “breakthrough,” “priority review,” and “accelerated approval.” We do NOT need to further speed up the process at the FDA, by relaxing its current (often questionable) safety and effectiveness standards. http://www.vox.com/2016/11/30/13792732/21st-century-cures-act-warren-sanders 14) History shows medicine is replete with examples of drugs and devices that caused more harm than good, several of which were approved without proper research or rushed to market – such as Vioxx for arthritis, metal-on-metal hip implants, power morcellators (a surgical device used to cut tissue) and Avastin for breast cancer. 15) This bill exempts physicians from disclosing speaking engagements and other relationships with medical companies. This could greatly influence doctors prescribing habits, thus reversing current transparency requirements. "