By Dr. Mercola
In December 2016, the 21st Century Cures Act was passed by Congress and signed into law by President Obama.
After easily passing through the House of Representatives during the summer of 2015, the bill (H.R. 34) stalled in the Senate until the end of November 2016, when it was put on a fast track and pushed through the Senate with a 94-5 vote.
The nearly 1,000-page Act touts some impressive-sounding rhetoric, like a $1.8-billion investment in cancer research and another $1 billion pledged to fight the abuse of opioids, heroin and other addictive drugs.
Over the next decade, the 21st Century Cures Act pledges $6.3 billion in spending and will "streamline" drug and medical device approvals by the U.S. Food and Drug Administration (FDA).1
Unfortunately, drug, vaccine and medical device manufacturers and lobbyists are the big beneficiaries of the Act, as the International Business Times (IBT) reported:2
"Originally conceived as a bill to boost research, the law has been revised and tweaked countless times to build bipartisan support.
At the same time, pro-industry groups have used the bill as a vehicle to achieve their long standing legislative agenda: to reduce the regulatory burden of bringing products to market."
The 21st Century Cures Act Relaxes FDA Standards
Dr. Michael Carome, director of the consumer advocacy group Public Citizen's Health Research Group, told IBT that "all sorts of goodies" were added to the Act, courtesy of medical device and pharmaceutical companies.3
In a nutshell, the Act makes it easier for these industries to bring their products to market by loosening testing requirements.
The relaxed FDA standards will no longer require drug companies to conduct large, randomized and controlled human clinical trials, considered to be the gold standard for proving pharmaceutical product safety, including approval to sell a drug to treat more than one condition.
Instead, observational data could be regarded as sufficient to "prove" safety and approve the drug for multiple uses.
Also concerning, the Act grants "breakthrough" medical devices expedited regulatory approval and, in some cases, allows industry to submit only summaries of data to the FDA when seeking approval. Drug companies will also be allowed to team up with insurance companies to promote off-label uses for their drugs.4
Experimental Drugs and Vaccines Fast-Tracked to the Market at the Expense of Public Health
While the Act is disguised as a consumer-friendly piece of legislation, it will make it easier for experimental vaccines to be fast-tracked to licensure by the FDA.
Almost all new vaccines licensed by the FDA and recommended by the Centers for Disease Control and Prevention (CDC) for use by children are subsequently added to state vaccine mandates for children to attend school.
Some are also added to mandates for adults to work in the health care and daycare professions.
The Act also weakens informed consent protections for people taking part in experimental vaccine clinical trials, as well as allows the use of surrogate endpoints to evaluate vaccine effectiveness.
For instance, many cancer drug studies use surrogate endpoints, which means the study may not reveal whether the drug improves survival or quality of life, but instead may evaluate a different outcome, such as tumor shrinkage.
The problem is that it's often unknown whether the surrogate endpoint, such as tumor shrinkage, leads to better health outcomes. The end result is that FDA-approved drugs and vaccines may appear to be more effective and beneficial than they really are.
Further, the Act will enable the FDA to accept "novel statistical analyses and clinical experience related to a new vaccine's reactivity, instead of requiring drug companies to conduct large randomized clinical trials to demonstrate safety," the National Vaccine Information Center (NVIC) reported.5
"It [also] prevents vaccine manufacturers from being sued in civil court if an FDA licensed vaccine given to a pregnant woman causes the injury or death of her unborn child in the womb," NVIC noted.6
Presidential Veto Urged to Protect Public Health
NVIC co-founder and president Barbara Loe Fisher referred to the 21st Century Cures Act as "a wolf in sheep's clothing," and NVIC called for a presidential veto of the legislation passed by Congress in order to protect public health.
"Instead of building a firewall between industry and government to protect the public health and safety, Congress has allowed the pharmaceutical industry to further co-opt the federal vaccine licensing and policymaking process," she said, continuing:7
"There is a difference between prescription drugs and medical devices designed to help sick people get well, which are subject to product liability in civil court, and vaccines given to healthy people that are not.
Congress has handed the liability-free vaccine industry another free pass to make unlimited profits by exploiting Americans legally required to purchase and use inadequately tested vaccines."
Fisher is far from the bill's only critic. Harvard historian Daniel Carpenter, Ph.D., warned that the relaxed FDA standards found in what he dubbed the "19th Century Fraud Act" could take us back more than a century.
Dr. Reshma Ramachandran, co-chair of the National Physicians Alliance (NPA), IBT reported, also harshly criticized the bill, stating it could seriously distort the meaning of "FDA-approved."8
Senators Openly Opposed to the Legislation
While the Act easily passed through the Senate, not all members were fans. Vermont Sen. Bernie Sanders was among those who called the Act "a bad bill," with others reporting that lobbyists were so pleased with the heavily padded bill that they referred to it as a "grab bag" and a "Christmas tree."9 Sanders openly criticized the bill and its drug company "handouts:"10
"At a time when Americans pay, by far, the highest prices in the world for prescription drugs, this bill provides absolutely no relief for soaring drug prices … The greed of the pharmaceutical industry has no limit, and this bill includes numerous corporate giveaways that will make drug companies even richer …
It's time for Congress to stand up to the world's biggest pharmaceutical companies, not give them more handouts."
Among Sanders' objections was a provision in the Act that would allow antibiotics to be approved even if they'd only been tested in small clinical trials on a limited number of patients.
The drugs could have risks that are not detected during the small studies, and approval could lead to their inappropriate use in a large number of people.11
Considering the fact we're facing a proverbial avalanche of antibiotic-resistant disease, issuing ineffective antibiotics is foolhardy in the extreme. It may simply add fuel to the fire of drug resistance, while simultaneously failing to help patients.
Sens. Dick Durbin of Illinois, Jeff Merkley of Oregon and Elizabeth Warren of Massachusetts also criticized the bill and its "giveaways to the pharmaceutical and tobacco industries."12
"Does the Senate work for Big Pharma that hires the lobbyists and makes the campaign contributions, or does the Senate work for American people who actually sent us here?" Warren asked.13
A Slick PR Campaign
The 21st Century Cures Act was written largely by the pharmaceutical and health care industries, according to emails obtained through the Freedom of Information Act by InsideHealthPolicy. Its name makes the promise of cures for currently incurable diseases plaguing the nation.
The U.S. House Energy and Commerce Committee even went so far as to use cases of dying children and their families to promote the bill, "suggesting that a new law is somehow going to inspire researchers to suddenly cure their diseases," Motherboard reported.14
Sadly, with the bill's passing, drug companies and device makers will enjoy increased profits from putting their products on the market with less oversight. Patients will inevitably be harmed when some of these products turn out to do more harm than good, and the children whose lives were promised to be saved will continue their fight to stay alive.
Instead of furthering the ability to prevent and cure diseases, the 21st Century Cures Act threatens to undermine public safety. The legislation actually contradicts other recent laws calling for more stringent research into drug effects based on age and sex differences, for instance.
Three years ago, a law was passed directing the FDA to make sure all age groups and both sexes are included in testing to ascertain safety and efficacy. Just last year, the General Accountability Office also concluded the National Institutes of Health (NIH) needs to make analysis of sex differences a priority.15
Meanwhile, the PR campaign and intense lobbying efforts used to get this bill passed played unfairly on people's heartstrings, using sick children as mere pawns to further their corporate greed.
If you have a debilitating and lethal disease, you may be willing to take risks you'd never take under normal circumstances. This bill will make medicine increasingly risky for everyone, including in the case of fast-tracked vaccines (and there are literally hundreds of experimental vaccines in the pipeline) that could become state-mandated for use in healthy children and adults.
"The 21st Century Cures Act is being sold as a way for the FDA to quickly license experimental pharmaceutical products for people suffering with rare or life threatening diseases, whether or not those products have been adequately tested.
However, greasing the FDA's licensure skids to make experimental drugs available for the sick and dying who voluntarily choose to use them is one thing, while greasing the skids to bum rush experimental vaccines to licensure that government will legally require healthy children and adults to buy and use is quite another," Fisher said.
How Many New Drugs and Devices Will Come to Market in 2017?
As regulators continue to grant the FDA "regulatory flexibility" to usher more drugs and vaccines to market, public trust in the Agency is at a historic low. One study in JAMA Internal Medicine revealed that 37 percent of respondents in an online poll agreed the FDA is "intentionally suppressing natural cures for cancer because of drug company pressure."16
Some have even suggested the 21st Century Cures Act is the beginning of the end for the FDA and that the agency will eventually be eliminated altogether.17 There is perhaps no better evidence of where the FDA's loyalty lies than in the sheer number of new drug approvals granted in 2015 — 45 in all, which is the most new drug approvals granted in one year since 1996.18
About 60 percent of the new drug approvals were granted some type of expedited review process, allowing them to come to market faster. With the 21st Century Cures Act in place, only time will tell how many new drug approvals will be granted in 2017 and how public health will be altered as a result.
As it stands, Carome told IBT, the final version of the bill is "a bad deal for patients," making it easier for drugs, vaccines and medical devices to get approved without demonstrating consumer safety,19 and that just isn't right.