The name “21st Century Cures” sounds reasonable, and even as if it could be a good thing. The idea behind this legislation, now before Congress, is to speed up the approval process for certain prescription drugs and medical devices – ostensibly, so they can get to patients faster and help to save lives. The reasoning here is that the “urgent need” for new cures and treatments is more important than the risks associated with new, untried treatments.
When this bill becomes law, as seems certain as of this writing, it will expedite the approval process by lowering standards, as happened almost 20 years ago with the “FDA Modernization Act of 1997.” It will enable pharmaceutical companies to submit data, such as case histories, in lieu of results from scientifically-controlled clinical trials, and allow third parties other than the FDA to do reviews of new health care products – which could very well be based on anecdotes rather than hard scientific evidence.
Therein lies the reason for concern. “21st Century Cures” essentially hamstrings and bypasses the FDA, which already has questionable relationships with pharmaceutical companies and medical device manufacturers. The legislation, which has already passed in the House of Representatives by a wide margin, was written in large part by lobbyists. The bill received significant input from corporate representatives from Johnson & Johnson (already targeted in lawsuits over several defective products), as well as medical device suppliers St. Jude medical and CVRx, Inc.
If you are a regular reader of Drug Safety News and have been paying any attention at all to the alarming rise in medical-related lawsuits, the danger of this new law should be patently obvious.
According to Senator Elizabeth Warren (D-MA), 21st Century Cures is little more than yet another giveaway to a corrupt industry that consistently puts profits over human life. It weakens protections, allowing drug companies to market their products for “off-label” use with little regulation or accountability, and reduced transparency, gutting disclosure rules that currently force companies to make public all information about “perks” (such as free vacations, gifts and rebates – or “kickbacks”) given to doctors and health care providers to encourage them to prescribe their products to patients.
It will allow the industry to sell unproven and potentially hazardous treatments to patients who are desperate for relief. On top of that, it will delay the availability of low-cost generic prescriptions, insuring that the cost to patients for life-saving drugs will remain at obscenely high levels.
Senator Warren says, “In the final days of this Congress, the 21st Century Cures bill has been hijacked by Big Pharma and big Republican donors… 21st Century Cures doesn’t reduce crushing drug prices. It doesn’t really expand the invention of new cures. And it doesn’t increase access to lifesaving therapies.”
It is small wonder that Americans’ faith in their government has dropped to the lowest levels in history – and their faith in a health care “system” that profits off of disease and suffering is even lower than that.
And so it should be.