At Breast Cancer Action, we have been calling for more effective, less toxic treatments since our founding. Why then are we opposed to an optimistically-named bill currently before Congress that claims to help patients?
Supporters of the 21st Century Cures Act (HR 6) say it will help bring new medical technologies and treatments to the marketplace. But the truth is that this industry-friendly bill is a give-away to Pharma and Biotech that would reduce standards of safety and efficacy necessary to protect patients.
Quick Food and Drug Administration (FDA) approvals don’t help patients if the treatment or technology doesn’t work in the first place—or worse, if it is harmful! Members of the House of Representatives are voting on the bill this FRIDAY.
Supporters of the 21st Century Cures would lower the bar for evidence on medical devices and drugs in ways that may harm patients by:
- Weakening clinical trial design. Shorter clinical trials are cheaper for industry but often rely on surrogate endpoints that can be unreliable predictors of ultimate outcome and patient benefit. Adequate data is needed to determine whether benefits outweigh the risks of treatment.
- Allowing “clinical experience” in place of clinical trials. Clinical experience—which includes observational studies, patient registries, and insurance claims—should inform and guide research questions, but it cannot replace rigorously-collected research data through well-designed, randomized controlled clinical trials.
Rather than focusing on the real challenge of driving innovative research to create more effective, less toxic treatments, 21st Century Cures focuses on streamlining regulatory review – making it more lucrative for companies to sell treatments that don’t necessarily work. Innovative breakthroughs and dramatic advances in breast cancer treatments and technologies are unfortunately too few and far between. Lowering standards for safety and efficacy will not speed up innovation but rather threaten to lower the quality of treatments that come to market.
At Breast Cancer Action, we refuse to allow safety and efficacy standards to be undermined in the name of patients. Please join us by asking your Representative to vote “No on HR 6.”