The 21st Century
Cures Act is going through the U.S. Congress right now, and it will
likely pass into law unless some opposition materializes (it passed
through the House of Representatives Energy and Commerce Committee with a vote of 51 to 0).
The Act is a give-away to the pharmaceutical industry, removing many of
the safety mechanisms in place that are supposed to keep the public
protected from unsafe drugs and medical devices.
The 21st Century Cures Act
allows drugs to be rushed to the market, removes phase 3 testing as a
requirement for drug approval, bases drug approval on biomarkers rather
than actual health outcomes, and encourages the production of new
antibiotics at a time when microbiome destruction is increasingly being
linked to chronic diseases.
Rushing Drugs to Market
With the passage of the 21st Century Cures Act, drugs will be rushed to market with little testing required. A New York Times piece, “Don’t Weaken the F.D.A.’s Drug Approval Process” notes that the 21st
Century Cures Act “could substantially lower the standards for approval
of many medical products, potentially placing patients at unnecessary
risk of injury or death.” The Act weakens an already weak regulatory
process that is currently doing a poor job of protecting the public from
adverse reactions to drugs and medical devices. (In the currently weak
system, preventable medical errors in hospitals are the third leading
cause of death in the United States, and, “between 210,000 and 440,000
patients each year who go to the hospital for care suffer some type of
preventable harm that contributes to their death.” source)
The End of Evidence Based Medicine
Modern medicine is supposed to be
“evidence based medicine” backed up by replicable, placebo controlled
scientific experiments that show that a drug or medical device
effectively treats the disease or symptom that it is purported to treat.
This standard of evidence will no longer exist if the 21st
Century Cures Act passes into law. The Act will allow drug approval to
be based on biomarkers and surrogate measures rather than health
outcomes. This has been disastrous in the past and it will be even more
disastrous in the future. For example, we’re now seeing that statins do
well at reducing cholesterol, but despite improving that biomarker, they
don’t improve health outcomes for large portions of the population (notably, the female portion of the population).
A New England Journal of Medicine (NEJM) article, “The 21st Century Cures Act — Will It Take Us Back in Time?” notes that:
But though a
drug’s effect on a biomarker can make approval quicker and less costly,
especially if the comparator is placebo, it may not always predict the
drug’s capacity to improve patient outcomes. Bevacizumab (Avastin)
delayed tumor progression in advanced breast cancer but was shown not to
benefit patients. Similarly, rosiglitazone (Avandia) lowered glycated
hemoglobin levels in patients with diabetes even as it increased their
risk of myocardial infarction. In 2013, patients began to receive a new
drug for tuberculosis approved on the basis of a randomized trial
relying on a surrogate measure of bacterial counts in the sputum — even
though patients given the drug in that trial had a death rate four times
that in the comparison group, mostly from tuberculosis.
Representative Diana DeGette (D-CO), one of the co-sponsors of the 21st Century Cures Act, bragged on Twitter that,
“In 120yrs we have gone from #snakeoil to mapping the #humangenome.
W/your help #Cures2015 is ready to take us further.” But if
pharmaceuticals are no longer required to have evidence that they
improve health outcomes, how are they any better than snake oils? One
only needs to look as far as the recent history of psychiatry
to see that the line between snake oils and “evidence based medicine”
is already woefully thin. Removing regulatory and procedural
requirements from the drug approval process, via the 21st
Century Cures Act, will just encourage the production of more dangerous
pharmaceuticals that are no better or safer than snake oil.
Diminishing requirements for evidence of
efficacy is bad for the medical system too. Basing medicine on
scientific inquiry and actual evidence of efficacy is a bedrock of
medicine, and without it the medical system will lose credibility.
The Loss of Informed Consent
The 21st Century Cures Act will diminish another bedrock of modern medicine – informed consent. The NEJM article notes that:
“Informed
consent by patients in drug trials has traditionally been sacrosanct,
with exceptions made only when consent is impossible to obtain or
contrary to a patient’s best interests. But another clause in the
proposed law adds a new kind of exception: studies in which ‘the
proposed clinical testing poses no more than minimal risk’ — a major
departure from current human subject protections. It is not clear who
gets to determine whether a given trial of a new drug poses ‘minimal
risk.’”
Informed consent is crucial not only for the credibility of modern medicine, it is crucial for liberty.
Dangerous New Antibiotics
One of the least controversial, but in reality most dangerous, parts of the 21st
Century Cures Act is its encouragement of new antibiotics. Before I go
into why this part of the Act is dangerous, let me acknowledge that
bacterial resistance to antibiotics is a huge problem, and antibiotic
resistant infections are causing many deaths.
Without being able to keep pathogenic bacteria in check, many medical
procedures will be impossible, and many lives will be lost. But we got
into the predicament of bacteria being resistant to antibiotics by
over-using antibiotics in both agriculture and medicine, and to
encourage increased use of antibiotics will only perpetuate the problem.
The solution to antibiotic resistance is prudent use of available
antibiotics and finding sustainable ways to reduce harm caused by
pathogenic bacteria (perhaps by using healthy bacteria to keep the
unhealthy bacteria in check), not doubling down on the “kill all
bacteria” tactic that led us to the problem of antibiotic resistant
bacterial infections in the first place. Bacteria will continue to adapt
in us and around us, and increasing the intensity of the war between us
and bacteria is beyond foolish. We will lose any war that we wage
against bacteria because we need bacteria – they are not separate from
us – and they play a larger role in human health than we can currently
imagine.
A healthy and balanced microbiome (“the ecological community of commensal, symbiotic and pathogenic microorganisms that literally share our body space”) is crucial for all areas of health, and a disturbed microbiome has been linked to all of the diseases of modernity, including mental health disorders, neurodegenerative diseases like Parkinson’s and Alzheimer’s, autoimmune diseases, inflammatory bowel disease and Crohn’s disease, mysterious diseases like fibromyalgia, autism,
etc. And while there is acknowledgement of the role that a healthy
microbiome plays in these diseases, researchers and journalists alike
have been loath to acknowledge the role antibiotics have played in
contributing to these diseases of modernity. No one wants to be
anti-antibiotic. Everyone knows that antibiotics have saved millions of
lives, but that doesn’t mean they are without consequences. And the good
that penicillin has done doesn’t mean that all antibiotics are equally
safe or effective. I can make a pretty thorough argument that
fluoroquinolone antibiotics, like Cipro/ciprofloxacin and
Levaquin/levofloxacin, drugs that work by “inhibition of the enzymes
topoisomerase II (DNA gyrase) and topoisomerase IV (both Type II
topoisomerases), which are required for bacterial DNA replication,
transcription, repair, and recombination,” are at least partially
responsible for many of the diseases of modernity (more information can
be found HERE, HERE and HERE).
Fluoroquinolone antibiotics do not have the same safety profile as
amoxicillin, and to assume that they do because both are categorized as
antibiotics, is foolish on multiple levels.
The 21st Century Cures Act will encourage the production of new antibiotics, regardless of their safety profile or mechanism of action. Doctors Avorn and Kesselhem note in the NEJM that:
The proposed
legislation would make immediate changes with respect to new antibiotics
and antifungals by enabling their approval without conventional
clinical trials, if needed to treat a “serious or life-threatening
infection” in patients with an “unmet medical need.” In place of proof
that the antimicrobial actually decreases morbidity or mortality, the
FDA would be empowered to accept nontraditional efficacy measures drawn
from small studies as well as “preclinical, pharmacologic, or
pathophysiologic evidence; nonclinical susceptibility and
pharmacokinetic data, data from phase 2 clinical trials; and such other
confirmatory evidence as the secretary [of health and human services]
determines appropriate to approve the drug.” Antimicrobials approved in
this manner would carry disclaimers on their labeling, but there is no
evidence that such a precaution would restrict prescribing to only the
most appropriate patients. If passed in its current form, the bill would
also provide hospitals with a financial bonus for administering costly
new but unproven antibiotics, which could encourage their more
widespread use. The bill gives the secretary of health and human
services the authority to expand this nontraditional approval pathway to
other drug categories as well, if “the public health would benefit from
expansion.”
Fluoroquinolone antibiotics like Cipro and Levaquin, some of the most popular antibiotics on the market,
cause a chronic illness known as fluoroquinolone toxicity syndrome or,
colloquially, “floxing,” that includes damage to connective tissue
(tendons, ligaments, cartilage, fascia, etc.) throughout the body,
damage to the nervous systems (central, peripheral, and autonomic), and
more. Rather than putting mechanisms in place that help victims of
iatrogenic antibiotic poisoning, or to prevent their pain and suffering
in the first place, the 21st Century Cures Act opens the door for more damaging antibiotics to flood the market.
The Ever-Increasing Power of the Pharmaceutical Industry
The current medical system lacks the mechanisms required to protect consumers from the dangers of pharmaceuticals. The FDA is failing to protect people from dangerous drugs, the justice system is failing
to compensate people for harm done by dangerous drugs, doctors,
pharmacists and even research scientists are so indoctrinated in the
“there’s a pill for that” culture that they fail to question it, and the
drug-consuming public ends up poisoned and sick because no one is
keeping the pharmaceutical companies in check. All powerful entities
need checks and balances, the pharmaceutical industry is no exception.
The 21st Century Cures Act gives the too-powerful pharmaceutical industry even more power, power that will undoubtedly be abused.
Pros and Cons
There are a couple good elements to the 21st
Century Cures Act. It increases the NIH budget, which some can argue is
an improvement. It also focuses on finding pharmaceutical solutions to
rare diseases, which many people with rare diseases will find to be
cause for hope.
I fear though, that people with rare
diseases will be turned into guinea pigs because the pharmaceutical
companies seeking cures for their rare diseases will have no limits put
on what they can do to the people suffering from them. I also find it
objectionable that there is no mention in the Act of investigating the causes of “rare” diseases or “rare” adverse drug reactions.
The potential harm that can be brought on by the 21st Century Cures Act far outweighs its potential benefits, and I encourage all Americans reading this to contact your Congressional Representatives to voice your concerns about this bill.
Human Health is Too Important to Leave to Congress
The human body is amazingly, beautifully, mind-bogglingly complex and intricate. New discoveries about our biology are being made every day. For example, it was recently discovered that the brain has a lymphatic system, a discovery that may have huge implications for human health. Additionally, the burgeoning fields of epigenetics and microbiome research
have far more questions than answers within them, and exciting
discoveries are being made within those fields every day. Though there
are undoubtedly brilliant scientists working in the biological sciences,
even they are far from knowing “enough” about unforeseen consequences
of messing with a biological system (through use of a drug) that
connects to all other biological systems. Any doctor or scientist who
is worth his/her title realizes how little anyone knows about the
complex workings of the human body, is aware that medicine is constantly
changing as new discoveries are made, and has humility about the
consequences of what he/she doesn’t yet know.
If scientists can’t possibly know
“enough” about human biology to produce pharmaceuticals that are exact
and without side-effects (aka collateral damage), the shills and
corporate-whores in Congress certainly don’t know “enough” about human
health to legislate major changes that affect how medicine is
implemented. They have that power though, and the 21st
Century Cures Act is a consequential piece of legislation that is going
to have major effects on the entire medical system if it is signed into
law. Most of those effects are negative.
The 21st Century Cures Act
diminishes the rocks on which modern medicine are based – informed
consent, individual body autonomy, the Hippocratic Oath, and basing
medicine on scientific evidence. The people of America, and the world,
need to fight to keep those bedrocks in place. If all medical decisions,
and all medical legislation, were made with informed consent,
individual body autonomy, the Hippocratic Oath, and scientific evidence
in mind, the world would be a much better place. Don’t assume for a
second that current medical and legislative decisions are being made
with those basic principles in mind. They are constantly being eroded.
Diligently protect them to the best of your ability – and call your Representatives.
Resources:- New York Times, “Don’t Weaken the F.D.A.’s Drug Approval Process”
- The New England Journal of Medicine, “The 21st Century Cures Act — Will It Take Us Back in Time?”
- Medscape Medical News, “Bill Aims to Expand Drug Indications Minus Randomized Trials”
- Modern Healthcare, “Beware a 21st Century Quackery Act”
- Public Citizen, “Cures for the 21st Century: Five Simple Ideas Congress Has Ignored”
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