By Dr. Mercola
Last year, a shocking piece of legislation was introduced in the U.S. Congress called the 21st Century Cures Act.1
Proponents of the bill claimed it would deliver faster, easier drug and medical product approvals from the U.S. Food and Drug Administration (FDA), which would translate into improved medical care and access to valuable treatments for sick and dying Americans.
Industry and political backers of the bill didn't talk publicly about the fact that the sweeping legislation also covered "biological products," which means vaccines that are government licensed, recommended and mandated for all Americans to use.
Fifty-eight percent of Americans oppose changing safety and effectiveness standards to allow for fast-tracking of drugs; half of respondents object to regulatory changes to accelerate approvals of new medical devices.
Yet despite a lot of criticism from concerned citizens, the bill sailed through the House of Representatives last summer.
In July 2015, the bill was referred to the Senate's Health, Education, Labor and Pensions Committee, where it stalled amid arguments about funding and after consumer groups, including the National Vaccine Information Center, voiced strong opposition to the gutting of already low FDA licensing standards.4,5
This year, Senators supporting passage of the 21st Century Cures Act cut the legislation up into seven smaller bills with hopes it will be easier to quietly move those smaller bills through Congress without publicity and accomplish the original goals of the 21st Century Cures Act:
- S. 2030 The Advancing Targeted Therapies for Rare Diseases Act
- S. 1622 The FDA Device Accountability Act
- S. 2014 Next Generation Researchers Act
- S. 800 The Enhancing the Stature and Visibility of Medical Rehabilitation Research at NIH Act
- S. 849 Advancing Research for Neurological Diseases Act
- S. 2503 Preventing Superbugs and Protecting Patients Act
- S. 2511 Improving Health Information Technology Act
Summary of the 21st Century Cures Act
The entire 21st Century Cures House bill came in at a hefty 400 pages, but if you want to get an overview of the long term goals of pharmaceutical and medical trade lobbyists partnering with federal health agencies, you can read through a 102-page Congressional Research Service summary of it.6,7
Once you're done, you'll probably agree that the only real beneficiaries here are the drug companies and federal health agencies, as this legislation intends to fast-track drug and vaccine approvals, cut corners on pre-licensure testing, severely restrict informed consent protections in scientific research on humans, and give billions of dollars to the National Institutes of Health (NIH) to develop more drugs and vaccines in partnership with pharmaceutical companies.
In short, the legislation would continue to push the one-size-fits-all type of medical care focused on expensive (and now poorly tested) drugs and vaccines that has contributed to the U.S.' abysmal health ratings.
It will give large amounts of money to NIH to fund experimental drug and vaccine research, while simultaneously relaxing FDA oversight — a move that will hardly result in safer medicine. It's also a clear danger to natural health, and as noted by Barbara Loe Fisher last year, the bill poses a particular threat to vaccine safety.8
As passed by the House last July, this federal legislation9 intends to establish a new fund within the U.S. Treasury in the amount of $1.86 billion per year through 2020, for a total of $9.3 billion. The monies will go to the NIH to develop new drugs and vaccines.
This is in addition to funding from the Department of Health and Human Services (HHS). Of the $1.86 billion per annum, $1.75 billion would go to NIH Biomedical Research and $110 million for Cures Development.
Focus areas are: precision medicine (treatments based on genetic makeup of the patient and/or disease), infectious diseases, antibiotics and biomarkers (markers that gauge the biological response to a drug, supposedly eliminating the need to wait for the results from a full-fledged patient trial). No mention is made of research relating to natural health or prevention.
Patient Safety Seemingly Abandoned Altogether
Harm to patients is at an all-time high in our country, with preventable medical errors and drug side effects being the third leading cause of death in the U.S.
Yet, the legislative goals of the 21st Century Cures Act that Senators this year cut up into smaller bills apparently for the purpose of sliding them through Congress before the public knows what has happened, contains numerous provisions that can only worsen the situation.
As noted by Fisher, "there are so many breathtaking ways the 21st Century Cures Act will endanger the public health that it is hard to know where to begin." For starters, the bill increases "regulatory flexibility" by the FDA in reviewing and approving drugs, biologics and medical devices. Specifically, it:
• Increases the ability of pharmaceutical companies and device makers to have a greater voice in the regulatory process and to streamline ways for FDA to approve their products.
• Lowers FDA licensing standards for drugs, medical devices and biological products, the latter of which includes vaccines, which means companies will be able to forgo large case-controlled clinical trials to evaluate safety and effectiveness.
In lieu of large-scale clinical trials, drug companies would be allowed to use biomarkers and other endpoint measures to prove the vaccine's effectiveness. But what about safety?
Public Trust in FDA at Historic Low
It's interesting to note that all of this is happening at a time when public trust in the FDA is already at a historic low. According to a 2014 paper10 in JAMA Internal Medicine, 37 percent of respondents in an online poll agreed the FDA is "intentionally suppressing natural cures for cancer because of drug company pressure."
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. As noted by ProPublica:11
"The legislation has its roots in a longstanding push by conservative groups to liberate drug and device development from red tape. 'Now, I don't want to get your hopes up, but Phase Three, maybe we'll take out FDA,' said Newt Gingrich during the Republican Revolution of 1994, when he also called the agency the nation's 'leading job killer.'
More recently, the deregulatory crusade against the FDA has been led by conservative think tanks such as the Goldwater Institute and Manhattan Institute, which launched its 'Project FDA' to reform the agency so that it provides a 'more predictable, transparent, and efficient pathway' for new medications and devices."
Enter 'Good Enough Science'
When assessing the safety and effectiveness of a drug or vaccine, the FDA would even be allowed to accept such flimsy evidence as Bayesian statistical analyses — a novel data analysis method based on probabilities and "best guesses" — and clinical experience, including anecdotal evidence!12
"It's interesting that clinical experience and anecdotal evidence will constitute 'good science' for the purpose of demonstrating a vaccine is safe before its licensed, while clinical experience and anecdotal evidence have never been enough to demonstrate that a vaccine is unsafe after its licensed," Fisher says.
Political scientist Daniel Carpenter, Ph.D. who specializes in the FDA, calls the legislation "the 19th Century Fraud Act," saying, "This is a part of the bill that threatens to take us back more than a century."13 Even the FDA commissioner Dr. Robert Califf has stated that unless the legislation is "carefully crafted, [it] could pose significant risks for FDA and American patients. Innovative therapies are not helpful to patients if they don't work, or worse, cause harm."14
Disturbingly, the legislation would also allow clinical testing of experimental drugs on people without first obtaining their informed consent, provided "the proposed clinical testing poses no more than minimal risk." It's unclear what constitutes "minimal risk," and who would have the right to make such a determination. This seems like a monumental step backwards, considering the legal protections put in place across the world to prevent covert medical experimentation on humans.
The legislation also outlines provisions related to the delivery of health care, including interoperability of electronic health information technology, and includes a number of proposed Medicare and Medicaid changes to offset costs. Oddly, it also calls for a drawdown in the nation's strategic petroleum reserve, presumably to help pay for it all.
Lowering Licensing Standards Is a Really Bad Idea
The 21st Century Cures Act legislation now embodied in seven separate Senate bills seeks to bring more medicines to people with rare disorders for which few treatments are available. But by tying together funds for increased research and loosened regulatory controls across the board, the risks will be carried by ALL people.
If you have a debilitating and lethal disease, you may be willing to take risks you'd never take under normal circumstances. If this law takes effect, medicine will be increasingly risky for everyone. As noted by STAT:
"There is no question that more research funding is necessary and that finding legitimate ways to get medicines to patients faster is crucial. But Congress ought to separate the debate over research funding from the rest of the legislation. Loosening regulatory standards would only create problems for which real cures will be needed."
This is particularly true for vaccines, which are given to healthy infants, young children and adults. Moreover, once a vaccine is licensed by the FDA and recommended for all children by the CDC, it often is mandated by state health officials for school attendance, and that's true whether the vaccine is fast-tracked or not.
The risks to public health, however, are FAR greater with a fast-tracked vaccine and there are literally hundreds of experimental vaccines in the pipeline, including vaccines for HIV/AIDS, hepatitis C, genital herpes, syphilis, norovirus and tuberculosis, just to name a few.
"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 says.
Ignoring the Basics Can Have Serious Consequences
While precision medicine with its focus on genetic makeup is a goal worthy of research, the Cures Act legislation completely ignores far more basic differences between individuals, such as age and sex. As noted by The Washington Post:15
"Throughout the 20th century, most medical research was conducted on relatively young, healthy men. In recent years, researchers have realized that treatments often affect women and older patients differently than men or younger patients.
These differences can affect safety and effectiveness ... [T]he 21st Century Cures Act is based on the assumption that there will be more cures if drugs and devices are studied more quickly by testing them on fewer patients — in some cases, on just a handful.
Unfortunately, such studies would be too small to allow safety and effectiveness findings to be broken down for subgroups such as men, women, young adults and seniors. This embrace of smaller, more preliminary studies could drastically lower scientific standards. When fewer people are studied, it is more likely that a drug will seem safe and effective even if it has dangerous side effects for many patients — who may not have been included in those small studies.
Worse, the bill specifies that after studying only small groups of patients, drug manufacturers could sell a new treatment to anyone, even if the patient was not among the types studied. In fact, hospitals would be paid extra to make it financially feasible to prescribe more expensive new drugs to Medicare patients, even if the drugs were never studied on patients older than 65 ..."
The 21st Century Cures Act legislation actually undermines other recent laws calling for more stringent research into drug effects based on age and sex differences. 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 NIH needs to make analysis of sex differences a priority.16
Fast-tracking, which requires only minimal testing, has other pitfalls as well. Like vaccines, the bill would allow antibiotics to be fast-tracked based on limited data from test tubes and animal studies.17 This makes no sense at all, as research shows these kinds of tests don't always translate into safety and effectiveness in humans.
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.
Members of Congress Spend Most of Their Time Raising Funds for Reelection
Americans have not only lost trust in the FDA. A mere 14 percent of Americans think Congress is doing a good job. CBS' 60 Minutes recently aired a segment discussing the inordinate amount of time Congress spends raising money for their own elections and the party — about 30 hours a week! — and Florida Republican David Jolly's call to quit "dialing for dollars" and get down to real business. According to 60 Minutes:
"Nearly every day, they spend hours on the phone asking supporters and even total strangers for campaign donations — hours spent away from the jobs they were elected to do. The pressure on candidates to raise money has ratcheted up since the Supreme Court's Citizens United decision in 2010. That allowed unlimited spending by corporations, unions and individuals in elections.
So our attention was caught by a proposal from a Republican congressman that would stop members of Congress from dialing for dollars ... Rep. David Jolly: 'You have six months until the election. Break that down to having to raise $2 million in the next six months. And your job, new member of Congress, is to raise $18,000 a day. Your first responsibility is to make sure you hit $18,000 a day.'"
Jolly has quit making fundraising calls — a move that might cost him his position, but it's a risk he's willing to take. He's also introduced a bill called the "Stop Act," which would ban all federal elected officials from soliciting donations directly. It's a good start, but truly, we need comprehensive reform.
Corporate donations play a huge role in the kinds of legislation brought forth, and it's hard to look at the 21st Century Cures Act legislation as anything but another gift to the big political spenders — the pharmaceutical industry that has developed a public-private business partnership with federal health agencies — at the direction of Congress!
And it was Congress that bailed out the vaccine manufacturers in 1986 by shielding them from product liability for injuries and deaths caused by government licensed, recommended and mandated vaccines.18 Congressman Rick Nolan (D-Minnesota), who is co-sponsoring the Stop Act, agrees that the influx of corporate money has had a dramatically negative influence on Congress.
Anonymous Congressman Writes Tell-All Book
The 86 percent of Americans who have lost faith in Congress will likely not be shocked by "The Confessions of Congressman X," a brand new tell-all book written by an anonymous Democrat. He too reveals that his main job as Congressman is to raise money for reelection, leaving no time to actually read any of the bills he votes on. (Apparently, it also leaves precious little time to write, as the book is a mere 84 pages.) According to The Daily Mail:19
"The anonymous spleen-venter has had a lot to say about his constituents, however. Robert Atkinson, a former chief of staff and press secretary for two congressional Democrats, took notes on a series of informal talks with him — whoever he is — and is now publishing them with his permission.
'Voters claim they want substance and detailed position papers, but what they really crave are cutesy cat videos, celebrity gossip, top 10 lists, reality TV shows, tabloid tripe, and the next f***ing Twitter message,' the congressman gripes in the book ...
'Fundraising is so time-consuming I seldom read any bills I vote on,' the anonymous legislator admits. 'I don't even know how they'll be implemented or what they'll cost. My staff gives me a last-minute briefing before I go to the floor and tells me whether to vote yea or nay. How bad is that?'
And on controversial bills, he says, 'I sometimes vote 'yes' on a motion and 'no' on an amendment so I can claim I'm on either side of an issue. It's the old shell game: if you can't convince 'em, confuse 'em' ... 'Our party used to be a strong advocate for the working class,' he says. 'We still pretend to be, but we aren't. Large corporations and public unions grease the palms of those who have the power to determine legislative winners and losers' ...
'Most of my colleagues are dishonest career politicians who revel in the power and special-interest money that's lavished upon them,' Atkinson recorded his mystery collaborator saying. 'My main job is to keep my job, to get reelected. It takes precedence over everything.'"
Long-Term Public Health Sacrificed for Short-Term Goals
Our political process is in shambles, and the fact that corporations are running the show has become increasingly self-evident. The 21st Century Cures Act legislation is just one of the latest clues. For an excellent summary of the many shortfalls of this bill, see this previous Health Affairs' article.20
If made into law, it will make newly approved drugs and medical devices LESS safe and likely LESS effective, while further increasing costs in a country that already has the highest medical expenditures on the planet while lagging far behind other industrialized nations when it comes to health statistics.
Modern medicine is the third leading killer of Americans, and we need increased patient safety, not more fast-tracked drugs and vaccines with limited safety and effectiveness testing. Recent research shows many of the drugs approved by the FDA are already tainted by massive corruption, allowing worthless and/or dangerous drugs on the market.
We need stronger drug licensing requirements, not more lax ones. As noted by Health Affairs, "many of the provisions appear to be favorable to the pharmaceutical, biotechnology and medical device industries, while not providing benefits to patients." This just isn't right.
If you agree, I urge you to contact your senators and share your views on this bill. You can also find your senators' contact information by calling the Capitol Switchboard at 202-224-3121.