The 21st Century Cures Act Reduces Patient Safety

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The 21st Century Cures Act passed through the U.S. House of Representatives last week, and it is anticipated that the Senate will vote on it this week–possibly as early as today. Please, please, please contact your Senators and ask them to reject this bill because it sacrifices patient safety and loosens regulations on pharmaceutical companies when they should be tightened.

Here are two posts I wrote about problems with The 21st Century Cures Act that you can forward or tweet to your Senators:

1. Collective Evolution: “THE 21ST CENTURY CURES ACT” IS ON ITS WAY – HERE’S WHY YOU HAVEN’T HEARD ABOUT IT
2. Hormones Matter: The 21st Century Cures Act Is Passing, No Matter How Many Patients Are Hurt

Additionally, here are some excellent articles about the dangers of The 21st Century Cures Act:

1. New England Journal of Medicine: The 21st Century Cures Act — Will It Take Us Back in Time?
2. STAT: 21st Century Cures Act will distort the meaning of ‘FDA approved’

I am sending the following to my Senators. Please feel free to send the same letter to your Senators:

Dear Senator ____,

I am writing to encourage you to reject The 21st Century Cures Act as it stands. The 21st Century Cures Act gives too much power to the pharmaceutical industry, and diminishes patient safety requirements at a time when they need to be strengthened. My reasons for opposing The 21st Century Cures Act include the following:

1. With passage of The 21st Century Cures Act, approval of new pharmaceutical drugs and medical devices will be based on surrogate measures rather than actual improvement in health outcomes. This means that drugs and medical devices will be put into the market that have not been proven to save lives or successfully treat diseases.
2. Lowering the standards by which the FDA approves drugs will diminish the meaning behind FDA approval. Neither patients nor physicians will be able to trust that FDA approval means that a drug or medical device is safe or efficacious if testing that shows safety and efficacy is not required.
3. Too many people are currently being killed and sickened by pharmaceutical drug “adverse reactions.” Patient safety standards need to be strengthened, not reduced.
4. The 21st Century Cures Act diminishes transparency and encourages bribery of doctors by pharmaceutical companies.
5. Once a drug is approved, it is very difficult to get it removed from the market. The “fast track” provisions in The 21st Century Cures Act will allow dangerous drugs onto the market, and once they’re available, the FDA is reticent to remove them.
6. The 21st Century Cures Act removes informed consent requirements for medical device, drug, and vaccine safety trials. It is imperative that we maintain informed consent.
7. The 21st Century Cures Act fails to address concerns about drug safety and adverse drug reactions.
8. The 21st Century Cures Act doesn’t focus it’s attention on disease prevention, and it will even exacerbate the problem of pharmaceutical-caused chronic illness.
9. There are more than 1400 lobbyists with pharmaceutical companies fighting for this legislation, more lobbyists than any other bill, including the Affordable Care Act. This is a lobbyist-led bill, not a patient/consumer/constituent led bill. Yet patients/consumers/constituents will be affected by lower drug safety standards.
10. The 21st Century Cures Act makes devastating cuts to Medicaid, with no plans to replenish the funds that are cut.

Thank you very much for your time and consideration! Please reject this bill as it stands, and revise it until patient protections are strengthened.

Thank you,

Lisa Bloomquist Palmer

___

This speech from Senator Elizabeth Warren goes over some of the problems with The 21st Century Cures Act: