By Carolyn Johnson, The Washington Post
July 8, 2015
The bill slated to land on the House floor on Thursday seems unassailable on its face – the 21st Century Cures legislation promises to modernize medicine and speed the development of lifesaving treatments.
But a vocal chorus of physicians and pharmaceutical industry watchdogs warn that the bill is full of stealth provisions that could actually put sick people in harm’s way, by speeding the development of treatments that are neither safe nor effective.
It’s not exactly easy to oppose a widely-supported bipartisan bill that is often referred to as just “Cures.” But opponents say the proposed law is full of flaws, starting with its name and its key premise: that bottlenecks in the regulatory process are a big reason we haven’t cured cancer, Alzheimer’s, and a panoply of rare diseases.
To drug companies and patient advocates, expedited access to drugs and devices might seem like a huge boon. But critics are worried that the law will relax America’s standards for evaluating new drugs and devices, which are approved based on careful review of evidence — including rigorously designed clinical trials. The bill offers up a slew of new ways to evaluate drugs: for example, allowing antibiotics to be approved based on what would today be considered preliminary evidence — animal and test tube studies and very small trials in people. New medical devices could be approved based on “case histories” — potentially of just a handful of patients.
“The irony is calling this 21st Century Cures, when they’re talking about standards that were left behind in the 20th century, because they were found to not be good,” said Diana Zuckerman, president of the National Center for Health Research, a nonprofit, non-partisan think tank that does not accept money from drug or medical device companies.
Here are a few of the provisions that have sparked debate:
-The bill would allow antibiotics to be approved based on laboratory and animal tests and small, early clinical trials.
-The bill allows companies to seek expedited drug approval based on so-called “surrogate endpoints” — early indicators that a drug is working, such as whether a tumor has stopped growing in cancer.
A study published last month in the journal JAMA Internal Medicine found that efforts to expedite cancer drug approval by using such criteria has resulted in the approval of many cancer drugs that do not extend life, but do have side effects.
-The bill also threatens disclosure requirements that are intended to limit pharmaceutical companies’ influence on physicians. The bill would allow physicians to receive speaking fees and gifts from companies without disclosing them, as long as they were for medical education.
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