Your Phone Calls and Faxes Needed 

to US Senate H.E.L.P. Committee Against the 21st Century Cures Act, H.R.6 http://www.congress.gov/bill/114th-congress/house-bill/6

Dear Health and Mental Health Care Safety Reform Supporter,

Your help is urgently needed in countering the 21st Century Cures Act. The act has been touted as a way to speed up the drug approval process and improve access to life saving treatments. In truth it is a huge gift to drug and device makers at taxpayer expense. This bill has already passed the US House of Representatives.

This bill is a direct threat to patient safety, erodes vital protections for human research subjects, threatens your medical privacy, and provides for rapid approval of medical devices like shock machines and deep brain stimulation devices without rigorous clinical trials.

This bill codifies fraudulent drug marketing schemes, that have already cost our country billions of dollars, into law.

Here are some talking points:

• The 21st Century Cures Act threatens our safety by rushing drugs to market without adequate scientific testing. Patients have already been harmed by drugs that were rushed to market in such fashion. (google Vioxx if you need to.)

• This bill erodes parental rights. Informed consent for human research could be bypassed if researchers decide the research involves no more than “minimal risk.” Minimal and risk are very subjective terms. Parents, patients, and not drug company funded researchers need to make the choice of whether or not a risk is acceptable. In this bill, pediatric research is one of the areas given priority.

• In some cases allows medical devices, including shock treatment machines, deep brain stimulation devices, and others to be approved based not on clinical trials but on journal articles and case histories.

• Codifies questionable and sometimes fraudulent off-label marketing practices into law. Such schemes have already cost state Medicaid programs billions.

• Decreases transparency by hiding drug company payments to doctors for “continuing education” lectures.

• This bill contains a “medical software” section that specifically mentions possible use of such software for monitoring adherence to medications.

We need phone calls to the members of the Senate Health, Education, Labor, and Pensions Committee. These are needed rapidly. The following Senators are on the committee.

Lamar Alexander (TN), Chair- (202) 224-4944

Patty Murray (WA), Ranking Member- (202) 224-2621

Michael B. Enzi (WY)- (202) 224-3424

Barbara Mikulski (MD)- (202) 224-4654

Richard Burr (NC)- (202) 224-3154

Bernie Sanders (VT)- (202) 224-5141

Johnny Isakson (GA)- (202) 224-3643

Robert P. Casey, Jr (PA)- (202) 224-6324

Rand Paul (KY)- (202) 224-4343

Al Franken (MN)- (202) 224-5641

Susan Collins (ME)- (202) 224-2523

Michael F. Bennet (CO)- (202) 224-5852

Lisa Murkowski (AK)- (202) 224-6665

Sheldon Whitehouse (RI)- (202) 224-2921

Mark Kirk (IL)- (202)224-2854  

Tammy Baldwin (WI)- (202) 224-5653

Tim Scott (SC)- (202) 224-6121

Christopher S. Murphy (CT)- (202) 224-4041

Orrin Hatch (UT)- (202) 224-5251

Elizabeth Warren (MA)- (202) 224-4543

Pat Roberts (KS)- (202) 224-4774

Bill Cassidy, M.D. (LA)- (202) 224-5824

Tell them you oppose this bill, briefly why you do, and that they should oppose it too. The name of the bill is the 21st Century Cures Act.  Let them know that while you understand the concept of allowing people with terminal conditions the right to access experimental drugs, this bill opens this up to psychiatric conditions and other conditions that are absolutely not life and death.  The bill calls for putting these drugs on the market and then monitoring “patient experience.”   In essence, Americans becomes the world’s test subjects. Let them know you oppose this bill and any other bill like it that may be written.

Thanks very much Kevin Hall for providing us with this information.

Take back your health America!

Peace,

Wendy Love Edge