21st Century Cures Act

21st Century Cures Act

H.R.6, the 21st Century Cures Act, is rushing through Congress now. This bill amends the Public Health Service Act to reauthorize the National Institutes of Health (NIH) budget, and to make some major changes in the NIH, the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), Medicare, the Controlled Substances Import and Export Act, and the Department of Health and Human Services.

We are pretty sure that not all of these changes are going to be benign. We invite you to read the Act and read the rebuttal, decide for yourself, and contact your Congressmen now with your personal opinions.

Warning: the text of the Act is difficult to read in the context of the laws it is proposing to change, since it does not print the revisions in line of the original law, as in proposed Missouri legislation for example, but instead just prints the text being removed and the text being inserted.

Here are some salient quotes from the rebuttal:

“The Act is a give-away to the pharmaceutical industry, removing many of the safety mechanisms in place that are supposed to keep the public protected from unsafe drugs and medical devices.”

“The 21st Century Cures Act will diminish another bedrock of modern medicine – informed consent.”

“But if pharmaceuticals are no longer required to have evidence that they improve health outcomes, how are they any better than snake oils? One only needs to look as far as the recent history of psychiatry to see that the line between snake oils and ‘evidence based medicine’ is already woefully thin.”

“The 21st Century Cures Act diminishes the rocks on which modern medicine are based – informed consent, individual body autonomy, the Hippocratic Oath, and basing medicine on scientific evidence.”

Obviously we are not diagnosing or recommending treatments here. We want to alert you to this Congressional action, and make sure you are informed so that you can exercise your own judgment. While sections of this proposed legislation are likely useful, there are other sections that may be damaging in the long term and may be passed into law in haste.

Here is an example of a section called out in the rebuttal (“With the passage of the 21st Century Cures Act, drugs will be rushed to market with little testing required.”):

“SEC. 2022. Accelerated approval development plan. In the case of a drug that the Secretary determines may be eligible for accelerated approval in accordance with subsection (c), the sponsor of such drug may request, at any time after the submission of an application for the investigation of the drug under section 505(i) of this Act or section 351(a)(3) of the Public Health Service Act, that the Secretary agree to an accelerated approval development plan described in paragraph (2).”

This refers to paragraph (2) which describes the use of a “surrogate endpoint” in an accelerated approval development plan. The term “surrogate endpoint” means a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure, that is not itself a direct measurement of clinical benefit. So a result of this could be that clinical trials no longer measure the clinical benefit of a new drug on the fast track to approval, just unspecified changes in various measurements that may, or may not, be beneficial to the patient. This is the kind of change that causes us to question the haste and wisdom of this proposed Act.

Let us know when you contact your Congressmen about this, and any response you may receive.

And read what we have to say about Informed Consent.

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