Remember the tale about the frog that got cooked when it didn’t jump out of the pot? A lot of Americans could turn into frogs if the 21st Century Cures Act becomes law. Yet few people know about it. So they have no way of objecting before they wind up “cooked.”
Prominent doctors are saying there are devils in the details of the proposed law that could cost a lot of American their lives. Even so, the 21st Century Cures Act is close to passing in Congress. The U.S. Senate is considering it now. The House of Representatives has already approved it. It passed the House with no opposition.
Benefits of the proposed law
The 21st Century Cures is designed to speed up the U.S. Food and Drug Administration’s approval of new drugs and medical devices and it will give the National Institutes of Health more money to fund medical research, according to the New England Journal of Medicine.
No need for more speed
But doctors writing for the NEJM, one of the most prestigious medical publications in the world, are questioning the need to speed up the approval process for new drugs as well as crucial aspects of the proposed law that they say would turn Americans into guinea pigs.
Currently, the FDA only takes 6 to 10 months to evaluate new drugs. Getting a drug approved, the doctors write in their NEJM article, is based on “a single pivotal trial.” The median size of such trials is “just 760 patients.” Two-thirds of the drugs that are approved by the FDA now are based on trials that only last “six months or less.” That, the doctors say, is already a “potential problem” for people who must take the drugs all their lives.
Scientific tests not necessary
The “21st Century Cures Act” will also instruct the FDA to use non-traditional studies instead of “randomized, controlled trials for approving new uses for existing drugs.” According to an Op-Ed in the New York Times, the proposed law will also make it possible for “high risk medical devices” to be approved based on “anecdotal evidence” rather than scientific studies. The doctors who wrote the Op-Ed say that these changes will turn patients into test animals.
Both doctors are prominent cardiologists. The conclusion they draw about the proposed law is both blunt and stunning. They write that it “would subject millions of Americans to unsafe or untested medical devices.” There is a crucial difference, they say, between prescription drugs and medical devices: If a drug is found to be dangerous, it can be immediately discontinued. If a medical device turns out to be dangerous, it is hard to remove because they are permanently implanted in the body.
Bad drugs and medical devices galore
The FDA’s own data base is a catalogue of suffering caused by devices and drugs released under its present approval methods. “…close to 29,000 deaths or injuries from cardiac defibrillators have been reported since 2009, according to Consumer Reports. An investigation by the Milwaukee Sentinel Journal and its partner MedPage Today revealed that “…more than 3,000 deaths and an estimated 20,000 hospitalizations have been linked to diabetes drugs over the last decade, including such widely promoted drugs as Januvia, Byetta, and Victoza.” The failing defibrillators and dangerous diabetes drugs are just two of many examples that could be cited for injuring and even killing unsuspecting Americans over the last 10 years.
Anyone who suspects that they or a loved one, have been injured by a failing medical device or dangerous prescription drug should contact Wayne Wright for a free evaluation. No one should have to suffer because of our country’s already lax approval system. Too many American have been injured as it is. They deserve compensation for their suffering.