After three years of debate, countless hearings, and pleas from patient advocates, lawmakers on Tuesday approved legislation to speed new medicines to market and to authorize an additional $4.8 billion in spending for medical research.
The House of Representatives passed the 21st Century Cures Act by a 392 to 26 vote, showing a bipartisan spirit that has been rare in recent years. The Cures Act now heads to the Senate, for a vote early next week.
The Cures Act includes numerous provisions that set the stage for the faster approval of prescription drugs and medical devices. Although proponents claim these new measures will not lower safety standards, numerous critics, including some former Food and Drug Administration officials and national consumer groups, disagree. They have argued that FDA already moves faster than similar agencies in other countries.
www.vox.com/2016/12/2/13809984/what-is-21st-cures-act
So...from the various news reports, this new legislation is a potential disaster.But health researchers have been calling the Cures Act "lipstick on a pig" and the "19th Century Fraud Act" — for good reason. The bill’s research spending is offset by cutting public health spending elsewhere. And researchers worry the bill could seriously damage the regulatory authority of the Food and Drug Administration, and compromise patient safety.
Now,lawmakers on both sides are tempted to vote for the act, because it promises cures and puts support toward Obama BRAIN initative, Precision medicine and Biden Cancer moonshot.
The problem is, it assumes a non existent problem in need of a cure and robs Peter to pay Paul.
1. The monies promised is not confirmed but requires Congressional appropriations in future budgets.
2. It is partially funded by selling oil and defunding parts of preventive campaigns under the ACA, targeted towards preventive care such as smoking cessation AND immunisation.
This is weakening known, protective interventions in favour of uncertain, certainly costly cures.
Worse of all, the weakening of the FDA power is absurd. Vioxx was a wakeup call to strengthen the FDA process. Yet, this act now stipulates that the raw data of the trial needs not be submitted, meaning that the secondary, post market analysis done by the FDA invested researchers on Vioxx cant be done without the company permission.
To make it worse, we have mutiple examples of Vioxx, celebrex and etc. In reverse, we have only one miracle cure. Gleevec which the trial was terminated early so as to get it out on the market earlier.
Other wonder drugs like herceptin and intaminib, the later being another lifechanging drug had risks and side effects, requiring lengthy trials to get a good risk benefit analysis.
On the contrary, the wonder drug Avastin certainly should be an issue. Using easier to measure indicators such as shrinking tumours and progress free state or disease free state, we now know from trials that Avastin is singularly useless for breast cancer.
To put it simply... How many cures are delayed by lengthy trials? Velcade? Gleevec? Immantinib? How many problems were avoided? Uncountable drugs.
The idea that new tools from precision and genomics will overcome the issues of the past isnt that comforting.
I not a real scientist so correct me if i wrong but this gotta be more dangerous than it promises to be
