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BIG PHARMA INFLUENCES GOVERNMENT AND COULD HARM AMERICANS – The 21st CENTURY CURES ACT
Lawrenceville, NJ (Dr Simone) – The 21st Century Cures Act was introduced by the pharmaceutical, biotechnology, and device industries to the US House of Representatives to speed the approval of and promote the development of new drugs and devices. It was approved in committee unanimously 51 to 0. If it becomes law it would increase the annual budget of the National Institutes of Health greatly and consequently generate many new findings upon which so many new drugs and devices are based. That’s the good news.
Now the darkside for Americans. Currently, one third of trials for new drugs require 760 patients and two thirds of new drugs are approved from studies lasting only six months or less that will not reveal adverse long term consequences for those patients requiring the medication for a lifetime.
But 21st Century Cures Act would get drugs and devices approved with fewer patients, shorter times, and require the FDA to use nontraditional study designs to speed the approvals even faster by relying on evidence from clinical experience including observational studies, registries, therapeutic use, small studies, preclinical, pharmacologic, or pathophysiologic evidence instead of randomized, controlled trials for approval. This decreases the ability to assess the safety and efficacy of the drug or device.
And worse is that the bill requires the FDA to rely on biomarkers like tumor markers, and other measures, rather than actual clinical end points to assess efficacy. Many biomarkers are simply not accurate in predicting disease risk or the subsequent clinical status of the patient. Most clinical organizations do not recommend obtaining these biomarkers at all because they don’t change the lifespan of the patient. Some drugs do not change outcomes: Avastin delayed cancer progression in breast cancer patients but did not increase lifespan; Avandia improved the blood parameters for diabetics but caused heart attacks; another drug lowered the tuberculosis bacterial count but increased the death rate from tuberculosis by 400%.
The bill will give hospitals a financial bonus for administering costly new but unproven antibiotics.
The bill also gives one person, the Secretary of Health and Human Services, the unilateral authority to expand nontraditional approval pathway “if the public health would benefit from expansion.”
The darkside continues for the American people with regard to medical devices. The new bill requires the FDA to approve a medical device by using single case studies or registries or an article in the medical literature rather than rigorous clinical trials. And the bill allows a medical device maker to pay a third-party to assess its own product.
And finally, informed consent is dramatically changed as well. The new drug could be administered to anybody if there is “minimal risk.” Who gets to decide if there is minimal risk for an individual patient?
The best part of the 21st Century Cures Act if enacted into law would be for an increased NIH funding. But the rest could lead to approval of drugs and devices that are not safe and not effective.
July 10, 2015 – In a rare act of bipartisanship, House members voted 344-77 on Friday in favor of the 21st Century Cures Act, the fast-moving bill that will cost $106 billion to implement.
(c) 2017 Charles B. Simone, M.MS., M.D.