Curtailing Cures?

For more than 25 years, the U.S. Food & Drug Administration (FDA) has relied on established clear and enforceable standards for the manufacture and sale of homeopathic medicines in the U.S.

Now the FDA wants to withdraw this standard and replace it with a vague enforcement policy. Without clear guidance on what is legal, regulatory enforcement quickly becomes arbitrary and capricious.

Why is the FDA taking this step? We’re not sure. All the FDA says is that there has been a significant increase in products labeled as homeopathic.

Homeopathic medicines are used by millions of Americans and their kids. These remedies gently stimulate the body to heal itself, and are safe, natural and without side effects.

In an era where the U.S. healthcare system ranks dead last among industrialized nations, based on things like quality of care, access to doctors and equity throughout the country, consumer choice is more important than ever.

Could the FDA be trying to limit access to homeopathic medicines in favor of protecting the $446-billion pharmaceutical industry?

TAKE ACTION: Don’t Let FDA Needlessly Restrict Your Access to Homeopathic Remedies!

h/t: The Organic Consumers Association

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All Homeopathic Products Now Illegal?

Story at-a-glance

• In a draft guidance document released by the U.S. Food and Drug Administration (FDA), the agency takes aim at homeopathic remedies


• In a reversal of a long-standing decision to treat homeopathic remedies differently from other drugs, the FDA has now labeled virtually all of these products as “new drugs” that are “subject to FDA enforcement action at any time”


• Homeopathic products are now a close to $3 billion industry and such remedies have been shown effective for a variety of ailments, from the flu and allergies to vitiligo

About 5 million U.S. adults and 1 million U.S. children use homeopathy every year, and the remedies are known to be “generally safe and unlikely to cause severe adverse reactions,” according to the U.S. National Institutes of Health’s National Center for Complementary and Integrative Health.¹ Yet, if the U.S. Food and Drug Administration (FDA) continues on its latest crusade, this natural health modality may soon be much harder to come by.

In a draft guidance document released in December 2017, the FDA takes aim at homeopathic remedies, or as they put it, “drug products labeled as homeopathic.”^2,3 In a reversal of a long-standing decision to treat homeopathic remedies differently from other drugs, the FDA has now labeled virtually all of these products as “new drugs” that are “subject to FDA enforcement action at any time.”

FDA Declares Homeopathic Drugs Illegal, Plans to Ramp Up Enforcement Actions

While deaths from drugs like opioids are now a public health crisis, homeopathy has maintained a much lower, and presumably safer, profile. Yet, the FDA is using its limited resources to target the latter, citing a need to “protect consumers who choose to use homeopathic products.” Why now? The FDA also cited a “large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions,” to the extent that homeopathic products are now a close to $3 billion industry.⁴

Perhaps that’s $3 billion too much for Big Pharma, FDA’s cozy partner in crime. “[I]n one fell swoop, the FDA has declared that virtually every single homeopathic drug on the market is being sold illegally,” the Alliance for Natural Health USA (ANH USA) wrote⁵ — and it’s not an exaggeration. In essence, the FDA’s guidance reads:⁶

1. Any homeopathic drug that has not been considered “generally recognized as safe and effective” (GRAS/E) is considered a new drug


2. FDA has not determined that any homeopathic drugs are GRAS/E


3. A new drug cannot be marketed unless it goes through the FDA’s approval process


4. No homeopathic drugs have gone through FDA approval nor can any producer afford to take them through the approval process

The FDA then states that it’s proposing a “new, risk-based enforcement approach” and first plans to target the “unapproved drug products labeled as homeopathic that have the greatest potential to cause risk to patients.” This includes:⁷

Products with reported safety concerns	Products that contain or claim to contain ingredients associated with potentially significant safety concerns
Products for routes of administration other than oral and topical	Products intended to be used for the prevention or treatment of serious and/or life-threatening diseases and conditions
Products for vulnerable populations	Products that do not meet standards of quality, strength or purity as required under the law

FDA Does About-Face, ‘Penalizes an Entire Industry’

The draft guidance is a complete turnaround from the FDA’s prior stance on homeopathic remedies, which stated, under the 1988 Compliance Policy Guide (CPG) 400.400, Conditions Under Which Homeopathic Drugs May be Marketed, they did not need to get FDA approval prior to coming on the market. Instead, the ingredients in homeopathic remedies were to be verified by the Homeopathic Pharmacopoeia of the United States (HPUS). As noted by law firm Venable:⁸

“Essentially, the HPUS creates a monograph for homeopathic drugs to follow, not dissimilar to the OTC drug monographs that FDA has developed for allopathic drugs. Accordingly, by virtue of an ingredient’s inclusion in the HPUS, the ingredient has already been closely examined and determined to be safe and effective by the HPCUS [Homeopathic Pharmacopoeia Convention of the United States].

Compliance with the HPUS functions as a premarket review of safety and effectiveness in the homeopathic context. By classifying homeopathic drugs as unapproved new drugs, the FDA is requiring a second showing of safety and effectiveness, a step that is unnecessary, not to mention impractical, given that the Agency intends to hold homeopathic products to an allopathic standard that is inappropriate, given the nature of homeopathic products.”

Further, it was by the FDA’s own deliberate decision that homeopathic drugs were excluded from former drug approval processes and intended to be a separate category. Venable continued:⁹

“The FDA deliberately excluded homeopathic drugs from both the Drug Efficacy Study Implementation (DESI) review (the process by which all drugs approved between 1938 and 1962 were retrospectively evaluated by the FDA for effectiveness) and the OTC Drug Review in 1972 (the process used to develop OTC drug monographs for allopathic drugs), deciding instead in the latter case to regulate homeopathic products separately because of their uniqueness.

By withdrawing the CPG and classifying all homeopathic drugs as unapproved drugs subject to FDA drug approval, the FDA is now requiring higher regulatory thresholds for OTC homeopathic drugs than are applicable to allopathic OTC drugs, many of which are permitted to be sold pursuant to the FDA monograph system. This move in effect penalizes an entire industry for the Agency’s 1972 decision.”

FTC Targeted Homeopathy in 2016

The FDA isn’t the first government agency to target this centuries’ old natural medicine system. In a notice filed in November 2016, the FTC stated that in order for homeopathic remedies to claim they are effective, their makers must provide proof. If no proof is provided, the remedies must state there is “no scientific evidence that the product works.”

In order to not mislead consumers, the FTC further stated that homeopathic remedies lacking sufficient proof must communicate to consumers that “the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.”¹⁰ Dana Ullman, MPH, CCH, one of the leading advocates for homeopathy in the U.S., said at the time:¹¹

“Considering the longtime safety history of homeopathic medicines, it is surprising and even shocking that the FTC would consider proposing new regulations now.

One cannot help but wonder who or what is pulling their strings … policies … commonly result from powerful economic forces at play … it is clear that this governmental agency is ignoring important scientific evidence, and one must wonder if they are protecting Big Pharma from competition more than protecting the consumer.”

Does Homeopathy Work?

Based on the theory that “like cures like,” or the Law of Similars, homeopathy was founded by German physician Dr. Samuel Hahnemann. The idea is that health conditions can be healed by treating a person with minute doses of a substance that would produce similar symptoms to their health condition if given in larger doses.

Homeopathy’s other guiding principle is that of the minimum dose, which is based on the premise that the more a substance is diluted, the more potent homeopathic remedy it becomes, known as the “law of infinitesimals.” Homeopathic remedies may be made from plants, minerals or other substances and are commonly administered in pellet form, dissolved under the tongue. A number of intriguing studies suggest homeopathy is effective and safe for a variety of ailments, including flu. According to Ullman:

“The use of a homeopathic medicine called Oscillococcinum is an example of a remedy that can be effective for many people with the flu, though clinical experience suggests that it is most effective when used within 48 hours of getting flu symptoms. Although most homeopathic medicines are made from the plant or mineral kingdom, Oscillococcinum is unusual in that it is made from the heart and liver of a duck.”

In one study, nearly twice as many patients who were given Oscillococcinum recovered from the flu within 48 hours as those given a placebo.¹² Further, Ullman noted:

“A different group of researchers conducted a randomized, double-blind study involving 372 patients (188 treated with Oscillococcinum and 187 with placebo) of both sexes, ranging in age from 12 to 60, who presented rectal temperature ≥ 100.4 F, muscle pains, headache, or at least one of the following symptoms: shivering, chest pain, spine pain, coughing, irritation of nasal mucosa or feeling of malaise.¹³

Patients received three tubes of Oscillococcinum or placebo each day (morning, noon and night) for three days. The results of this trial show a highly statistically significant difference between the two groups, for what concerns disappearance of symptoms after 48 hours (19.2 percent in the Oscillococcinum group versus 17.1 percent in the placebo group) and improvement in symptoms (43.7 percent versus 38.6 percent for placebo).”

Additional research shows homeopathy’s promising role in the following conditions:

In patients with allergies, those using homeopathy reported improvements in nasal airflow compared with a placebo group. With homeopathic treatment, the researchers described a “clear, significant and clinically relevant improvement in nasal inspiratory peak flow, similar to that found with topical steroids.”14	Homeopathy significantly reduced the severity and duration of chemotherapy-induced stomatitis (swelling and sores in the mouth) in children.15
Homeopathic medicine was effective in treating acute childhood diarrhea, decreasing both the duration of the diarrhea and the number of stools per day.16,17	Homeopathy has positive effects in children with attention deficit hyperactivity disorder (ADHD), particularly in the areas of behavioral and cognitive functions.18
Homeopathy lessened tender point pain and improved quality of life in people with fibromyalgia.19	Homeopathic was effective in treating the early stages of vitiligo in a report of 14 cases20

FDA Continues to Crack Down on Natural Substances, Protect Big Pharma

The FDA’s new push to regulate homeopathic products is eerily reminiscent of their recent crackdown on the plant kratom. Leaves from the kratom tree have been used for pain relief for hundreds of years, but scientists now know they contain compounds that target the brain similarly to opioids, helping to relieve pain. It appears the plant may be safer than opioids for pain relief and could even act as a tool to help those suffering from opioid withdrawal.

In November 2017, however, rather than targeting the prescription opioids that are the root of the opioid epidemic, the FDA issued a public health advisory regarding risks associated with kratom use, suggesting that its usage could “expand the opioid epidemic.” What this comes down to, for some, is the right to choose what form of “medicine” to put in your body. As Dr. Lee Hieb, an orthopedic surgeon and past president of the Association of American Physicians and Surgeons, wrote in WND:²¹

“I’m not here to tout any particular over-the-counter remedy, but who gave the FDA total ability to limit what we can take into our bodies, while virtually forcing us to be given what they prescribe? It’s none of their business whether a ‘homeopathic remedy’ is worthless.

That’s an issue of commerce and truth in advertising. I, for one, want the freedom to research and decide for myself what supplements to take, even if my supplements ultimately do me no good. (Many do a great deal of good as Big Pharma knows only too well.)”

People have the right to choose their treatment, and doctors (many of whom admit to prescribing placebos to their patients) also retain the right to offer treatments they deem useful, whether it be homeopathy or another remedy.

As for the FDA’s new draft guidance on homeopathic drugs, it’s attempting to discredit such remedies’ proven healing powers before their mechanisms of action have even been fully understood. If you want to express your opinion on the matter, the FDA is accepting comments from the public until March 30, 2018.

– Sources and References 

• ¹ National Center for Complementary and Integrative Health, Homeopathy


• ^2, 4 U.S. FDA December 18, 2017


• ^3, 7 U.S. FDA Draft Guidance December 2017


• ^5, 6 Alliance for Natural Health USA January 11, 2018


• ^8, 9 Venable December 22, 2017


• ¹⁰ U.S. Federal Trade Commission


• ¹¹ The Huffington Post November 27, 2016


• ¹² Br J Clin Pharmacol. 1989 Mar;27(3):329-35.


• ¹³ British Homoeopathic journal 87(2):69-76


• ¹⁴ BMJ. 2000 Aug 19; 321(7259): 471–476.


• ¹⁵ Cancer August 1, 2001


• ¹⁶ Pediatrics. 1994 May;93(5):719-25.


• ¹⁷ Pediatr Infect Dis J. 2003 Mar;22(3):229-34.


• ¹⁸ Eur J Pediatr. 2005 Dec;164(12):758-67.


• ¹⁹ Rheumatology (Oxford). 2004 May;43(5):577-82.


• ²⁰ Am J Case Rep. 2017 Dec 2;18:1276-1283.


• ²¹ WND December 22, 2017

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‘90% Accuracy Rate’: New Artificial Intelligence Can Predict Your Death

(ANTIMEDIA) — New deep learning algorithms, commonly referred to as artificial intelligence, are increasingly finding a home in the medical industry, where health care professionals are often overwhelmed. In palliative care centers, which include nursing and end of life care, an aging population has stretched medical and personnel resources to the limit, which just may mean this is the perfect time for AI to step in and help with both monitoring patients’ vital signs and making potentially life-saving prognoses.

The Food and Drug Administration (FDA) just approved the first algorithm that can monitor a patient in critical care and anticipate a life-threatening change in condition by up to 6 hours. The algorithm, called Wave Clinical Platform and developed by medical technology company ExcelMedical, is able to keep a 24/7 vigil over a patient, which is simply not possible for already overworked human care workers triaging in busy hospitals. The AI can also monitor patterns in vitals so as to determine whether, say, a sudden and simultaneous drop in oxygen saturation and a spike in blood pressure could be lethal.

Meanwhile, a research team at Stanford University is using an AI algorithm to predict patient mortality. A notoriously difficult task, predicting when a patient will die involves assessing a variety of factors from age and patient history to drug response and the illness itself. But it’s important to be as accurate as possible. Admitting a patient into end-of-life care too soon consumes valuable resources; admitting them too late risks leaving the patient cut off from their family.

Stanford’s AI has a 90% accuracy rate, which, according to some, is surprisingly and unsettlingly good. Created by feeding electronic health records (EHR) into a deep learning neural network, the AI is able to “sense” patient mortality within the next three to twelve months.

Jeremy Hsu of IEEE Spectrum described the model used as “an 18-layer Deep Neural Network that inputs the EHR data of a patient, and outputs the probability of death in the next 3-12 months.”

However, researchers admit they do not understand how the algorithm comes to its conclusion, a conundrum known as the “black box” problem. The Stanford team’s work is described in full detail in their paper, “Improving Palliative Care with Deep Learning.”

Ken Jung, a Stanford Medicine research scientist, and Anand Avati, whose team created the AI, hope the use of AI technology in medical environments could help with a number of problems, including palliative care and triage. Currently, while 80 percent of people say they want to die at home, only about 35 percent are able to. Employing new deep learning technology could enable better end of life care preparation and more personalized, consistent care once the patient is hospitalized.

That is, of course, if people can get past the stigma of having an advanced computer algorithm monitoring them when they’re ill.

Creative Commons / Anti-Media / Report a typo

FDA Approves New Digital Sensor To Ensure "Patients With Mental Health Issues" Take Their Meds

Authored by Mac Slavo via SHTFplan.com,

The Food and Drug Administration has just approved a new pill with a digital sensor in it.

It will “ensure” that patients who suffer from mental health issues take their medicine when they are told. But privacy concerns have not gone unnoticed.

Regulators in the United States have approved the first pill that can be digitally tracked as it makes its way through the human body.  The Abilify MyCite aripiprazole tablets used for treating schizophrenia and manic episodes have an ingestible sensor embedded inside them that records that the medication has been taken. A patch worn by the patient transmits this information to their smartphone.

But many are raising the red flag that this could simply be another form of medical “big brother.” You may no longer have the right to refuse medications in the very near future.

The Abilify MyCite features a sensor the size of a grain of sand made of silicon, copper, and magnesium. An electrical signal is activated when the sensor comes into contact with stomach acid - the sensor then passes through the body naturally.

 

A patch the patient wears on their left rib cage receives the signal several minutes after the pill is ingested. The patch then sends data like the time the pill was taken and the dosage to a smartphone app over Bluetooth.

 

The patch also records activity levels, sleeping patterns, steps taken, activity, and heart rate, and must be replaced every seven days. The patient’s doctor and up to four other people chosen by the patient, including family members, can access the information. The patient can revoke access at any time.

– The Verge

Is it really hard to understand why people are raising concerns about privacy over this new pill? The pill is one way to address the prevalent problem of patients not taking their medication correctly. According to the IMS Institute’s estimates, the improper and unnecessary use of medicine cost the US healthcare sector over $200 billion in 2012.

But, the approval also opens the door for pills that are used for other conditions beyond mental health to be digitized and monitored, and could eventually lead to tracking devices for humans being slipped into medication. What is the government’s obsession with keeping the people doped up? Complacency, perhaps?

Others are worried that tracking pills will be a step towards punishing patients who don’t comply with either medical or government demands to take drugs.

Ameet Sarpatwari, an instructor in medicine at Harvard Medical School told The New York Times the digital pill “has the potential to improve public health. [But] if used improperly, it could foster more mistrust instead of trust.”

FDA Approves New Digital Sensor To Ensure ‘Patients With Mental Health Issues’ Take Their Meds

The Food and Drug Administration has just approved a new pill with a digital sensor in it. It will “ensure” that patients who suffer from mental health issues take their medicine when they are told. But privacy concerns have not gone unnoticed.

Regulators in the United States have approved the first bill that can be digitally tracked as it makes its way through the human body.  The Abilify MyCite aripiprazole tablets used for treating schizophrenia and manic episodes have an ingestible sensor embedded inside them that records that the medication has been taken. A patch worn by the patient transmits this information to their smartphone.

But many are raising the red flag that this could simply be another form of medical “big brother.” You may no longer have the right to refuse medications in the very near future.

The Abilify MyCite features a sensor the size of a grain of sand made of silicon, copper, and magnesium. An electrical signal is activated when the sensor comes into contact with stomach acid — the sensor then passes through the body naturally. A patch the patient wears on their left rib cage receives the signal several minutes after the pill is ingested. The patch then sends data like the time the pill was taken and the dosage to a smartphone app over Bluetooth. The patch also records activity levels, sleeping patterns, steps taken, activity, and heart rate, and must be replaced every seven days. The patient’s doctor and up to four other people chosen by the patient, including family members, can access the information. The patient can revoke access at any time. – The Verge

Is it really hard to understand why people are raising concerns about privacy over this new pill? The pill is one way to address the prevalent problem of patients not taking their medication correctly. According to the IMS Institute’s estimates, the improper and unnecessary use of medicine cost the US healthcare sector over $200 billion in 2012.

But, the approval also opens the door for pills that are used for other conditions beyond mental health to be digitized and monitored, and could eventually lead to tracking devices for humans being slipped into medication. What is the government’s obsession with keeping the people doped up? Complacency, perhaps?

Others are worried that tracking pills will be a step towards punishing patients who don’t comply with either medical or government demands to take drugs. Ameet Sarpatwari, an instructor in medicine at Harvard Medical School told The New York Times the digital pill “has the potential to improve public health. [But] if used improperly, it could foster more mistrust instead of trust.”

The Government Has Created Every Step In The Development Of The Opiod Crisis

Authored by Mark Thornton via The Mises Institute,

The Washington Post and “60 Minutes” have just peeled back another sordid layer in the War on Drugs by exposing Big Pharma’s role in expanding the Opiod Crisis that has resulted in more than 30,000 deaths per year.

All the disgusting details can be found here, but it is really a straight forward case of legal bribery and corruption in the market for legal opiates — the driving force in this crisis as doctors continue to turn untold thousands of innocent people into opiate addicts.

Opiate medicines have been a Godsend to humanity, but it comes also with scourge of addiction, dependence, and overdose deaths. The Harrison Narcotics Act of 1914 made the situation worse thanks to the meddling of federal bureaucrats who turned regulation and oversight into prohibition.

One of the most demaging side effects of federal meddling in drug markets, however, has been the Opiod Crisis. I have detailed here and here the primary cause as Big Pharma bribing the board responsible for setting pain maintenance guidelines and the resulting explosion of prescriptions for Opiod drugs by doctors.

The newest wrinkle uncovered shows that pharmaceutical drug distributors have paid off select members of Congress to rewrite the enforcement guidelines for the Drug Enforcement Agency (DEA). A good case in point is Representative Tom Marino who withdrew his name from consideration as President Trump’s Drug Czar.

The new guidelines and their enforcement have effectively neutered any restraint on pharmaceutical producers and distributors. They can sell untold millions of these pills to pharmacies and pain clinics without any constraints. The additional cost of producing these heroin-like pills is virtually zero.

Is Bribery and Corruption a Good Thing?

Normally, bribery and corruption of public officials is a good thing because it allows more producers and more consumers to obtain gains from trade from each other. Such is not the case with prescription opiates in this environment.

The problem here is that there is not a functioning marketplace at all when it comes to distribution of prescription opiates. It is a government-granted monopoly in every respect. The products we are examining have not passed the market test and the producers are effectively protected by the government against torts, liability, and claims of misrepresentation.

In addition, pharmaceutical drugs have been approved by the Food and Drug Administration (FDA) and, essentially, the FDA grants monopolies to drug companies for their patented drugs and gives them an FDA seal of approval that the drugs are safe and effective.

Then another government-created monopoly, the American Medical Association (AMA) and its doctor-members have the monopoly on writing the necessary prescriptions to obtain drugs from yet another monopoly the pharmacists.

A doctor’s prescription is essentially another AMA seal of approval that the vast majority of people do not even question or even concern themselves with what they are taking. All of these monopolies are usually protected when consumers die as long as it happened when all the monopoly rules are followed.

Thus, with these products, like Oxycontin and Vicodin, there is no attempt to pass the "market test" by seeking to primarily please consumers. Instead, consumers end up being an afterthought after producers of the drug have catered to the needs and desires of countless regulatory agencies.  In real free market competition, an entrepreneur of dangerous products has to assure consumers that the products are safe and effective enough to use compared to the alternatives.

Opiates in Unhampered Markets

In other words, pain medications do not have to be perfectly safe and perfectly effective to be the best alternative choice for people who suffer with pain. However, they have to be reasonably safe and effective. The high potential for addiction, harm to health, and even death would be a “competitive disadvantage” in a real free market.

Just the opposite is the case here.

The government has created and overseen the creation of every step in the development of this crisis. The fact that crony capitalists have taken advantage of the situation should not be a surprise, especially when it is the only way to legally participate in the pharmaceuticals "market." 

 

"Worse Than Big Tobacco": How Big Pharma Fuels The Opioid Epidemic

“I used to think that there was nothing more reprehensible than what the tobacco industry did in suppressing what it knew about the adverse effects of an addictive and dangerous product,” says Berger.

“But I was wrong. The drug makers are worse than Big Tobacco.”

The U.S. prescription drug industry has opened a new frontier in public havoc, manipulating markets and deceptively marketing opioid drugs that are known to addict and even kill. It’s a national emergency that claims 90 lives per day. Berger lays much of the blame at the feet of companies that have played every dirty trick imaginable to convince doctors to overprescribe medication that can transform fresh-faced teens and mild-mannered adults into zombified junkies.

So how have they gotten away with it?

A Market for Lies

The prescription drug industry is a strange beast, born of perverse thinking about markets and economics, explains Berger. In a normal market, you shop around to find the best price and quality on something you want or need - a toaster, a new car. Businesses then compete to supply what you’re looking for. You’ve got choices: If the price is too high, you refuse to buy, or you wait until the market offers something better. It’s the supposed beauty of supply and demand.

But the prescription drug “market” operates nothing like that. Drug makers game the patent and regulatory systems to create monopolies over every single one of their products. Berger explains that when drug makers get patent approval for brand-name pharmaceuticals, the patents create market exclusivity for those products—protecting them from competition from both generics and brand-name drugs that treat the same condition. The manufacturers can now exploit their monopoly positions, created by the patents, by marketing their drugs for conditions for which they never got regulatory approval. This dramatically increases sales. They can also charge very high prices because if you’re in pain or dying, you’ll pay virtually anything.

Using all these tricks, opioid manufacturers have been able to exploit the public and have created a whole new generation of desperate addicts. They monopolize their products and then, as Berger puts it, “market the hell out of them for unapproved and dangerous uses.”

Opioids are a drug class that includes opium derivatives like heroin (introduced by German drug maker Bayer in 1898), synthetics like fentanyl, and prescription painkillers like oxycodone (brand name: OxyContin). A number of factors are aggravating the addiction crisis: There has been a movement in medicine to treat pain more aggressively, while at the same time wide-ranging economic distress has generated a desire to escape a dismal reality. But a key driving force is doctors—who have been wooed by pharmaceutical marketing reps—overprescribing for chronic pain.

“For the first time since the years after heroin was invented,” writes investigative journalist Sam Quinones in Dreamland: The True Tale of America’s Opiate Epidemic, “the root of the scourge was not some street gang or drug mafia but doctors and drug companies.”

Doctors were once reluctant to write prescriptions for opioids. The U.S. drug regulator, the Food and Drug Administration (FDA), would only approve such drugs for severe cases like cancer patients in chronic agony or certain people in short-term pain after, say, an operation. But representatives of Connecticut-based drug maker Purdue, which released OxyContin in 1996, along with other companies, began to flood doctors’ offices with reports asserting that using the drug for off-label purposes was harmless. Often the targets were primary care physicians with little training in addiction. Have a chronic arthritis case? Give your patient OxyContin. Tell folks take it every day, for weeks, even years, to treat just about any kind of chronic pain. The upshot was addiction —typically not because people were getting high for fun, but because they used a legal drug in precisely the way the doctor ordered.

Purdue and others whisked doctors to stylish retreats to push them to prescribe drugs for uses not approved by U.S. regulators—a marketing strategy banned by federal law. They even created fake grassroots organizations to make it seem as though patients were demanding more prescriptions. Pharmaceutical companies like to dodge responsibility for the opioid crisis by blaming dishonest distributors and pointing out that they’re not the ones prescribing or handing out drugs to patients. True enough: They don’t need to, because they’ve done their work hooking you long before the drug is in your hands.

“The marketing is not only fraudulent; it’s incredibly elaborate,” says Berger.

“Fake scientific studies promote the lie that opioids are better than other medications for pain. They’ve gone to just about any length. Bribery, you name it. It’s outrageous.”

OxyContin is so addictive that it can create physical dependency in a matter of weeks. As drug makers and doctors who began to dole out pills by the handful in pain clinics learned, addicts do not behave like ordinary consumers. They don’t “choose” to buy or to wait until next week. They need their drug right away and will do anything to get it because if they don’t, they will suffer excruciating symptoms.

A Los Angeles Times report shows that among the lies Purdue spread about OxyContin was that one pill subdued pain for twelve hours. Except that for many patients it wears off much sooner, exposing them to horrific pain and withdrawal. Purdue knew this, but feared lower sales if it admitted the truth. So sales reps advised doctors to just give stronger doses, which increased the addiction risk.

As the money from hooked patients piled up, so did the bodies. So many bodies that earlier this year the Ohio Coroner’s Office found nowhere to store them. 

In 2007, Purdue pleaded guilty in federal court in Virginia to misleading doctors and patients about OxyContin’s safety and paid a $600 million fine. But that sum was hardly an annoyance. From 1995 to 2015, Purdue made $35 billion from OxyContin sales alone. The Sacklers, who own the company, are now one of the richest families in America, as revealed by this triumphant Forbes spread. They know that lax regulation keeps the heat off, and that even litigation and criminal prosecutions can do little to stop them. Berger says that until such legal programs are massive in scale and scope, companies will go on with business as usual.

“We have to have injunctive relief [a court order to stop a behavior] that bans the marketing to doctors of opioids completely for unapproved uses, as well as an expansion of the FDA and DEA [Drug Enforcement Agency] to specifically target the drugs,” says Berger. His law firm, Berger & Montague, is involved in the effort to seek relief for the city of Philadelphia, which has seen above-average opioid prescribing and suffered the highest rates of fatal drug overdoses in the state last year.

Even though prescriptions have been slightly reduced across the country since 2012, Philadelphia is finding out what happens to many people hooked on opioids when they can’t get a prescription or find the price too high: They turn to smack. Fatal overdoses of heroin, oxycodone’s close cousin, have been skyrocketing since 2007 across the country.

“Landscapes of Despair”

The opium poppy has been part of human history since at least 3,400 B.C. when it was cultivated in Mesopotamia as the “joy plant.” Derivates, such as laudanum and morphine, offered more convenient and, people wrongly believed, safer ways to get the plant’s benefits. Bayer originally touted heroin as a non-addictive substitute for morphine, even for children, until it was outlawed in the U.S. in 1925. Rendering it illegal did not stop it from destroying the lives of many of America’s most celebrated artists, from Billie Holiday to Philip Seymour Hoffman.

Drug overdoses now kill more people than gun homicides and car crashes combined. In 2015, nearly two-thirds of all overdoses had one thing in common: opioids. As more and more names appear in the obituaries linked to opioid overdoses, most recently Buddhist teacher Michael Stone, Americans begin to wonder who is next.

Syracuse University’s Shannon Monnat, a sociologist focused on rural issues and an INET grantee, has been studying the epidemic and how it impacts various populations. Her research reveals that the rise in drug-induced deaths has been especially sharp among middle-aged people (45-55), with prescription opioid overdoses increasingly impacting both middle-aged and older populations. Heroin, whose sedating and euphoric effects are very similar to prescription opioids, looks to be the culprit in more young adult overdoses.

Monnat considers how the opioid crisis points to bigger societal problems impacting the economy, educational institutions, the health care system, political systems, and communities. Her work centers on investigating the characteristics of what she calls “landscapes of despair”—places where people are hurting economically and socially, like Appalachia, the Industrial Midwest, and parts of New England. She points out that persistent disadvantage and long-term poverty are clearly connected to the opioid crisis, noting that many of the areas most impacted were once robust centers of manufacturing before jobs moved to other countries.

Opioid addiction seems to thrive in downwardly mobile small cities in rural areas—but not all of them.

“What’s fascinating is that some of these areas have very high mortality rates from drug overdose, like Appalachia,” say Monnat.

“But others, like the Southern “Black Belt” [a region which stretches across Alabama and Mississippi], have not seen such rises.”

Originally named for its rich, dark, soil - which attracted cotton planters in the 19th century - the Black Belt has a large African American population. The area has a history of unremitting poverty, low incomes, high unemployment, and high mortality. Yet despite many hardships, which are linked the legacy of slavery, Monnat says that the region is also distinct for its “very tight-knit communities, strong kinship networks, and other networks where people can find emotional support.” It seems that when people have somewhere to turn in hard times, they may build up immunity to an epidemic like the opioid scourge.

Ironically, another factor that may have protected these communities is prejudice, as Quinones discusses in Dreamland. The low-profile heroin dealers originating from a small municipality on Mexico’s west coast who are associated with the current opioid scourge have tended to fear black Americans, preferring to target white communities. They also avoid big cities where large cartels are already established. So small, predominately white towns are their sweet spot.

Appalachia is known for kinship networks, but it also has a legacy of isolation and an outlaw tradition associated with the history of moonshining and bootlegging which can feed into today’s underground selling and distribution of opioid drugs. In this region, much of the struggling white working class has experienced economic distress with little hope of relief from America’s political system. Democrats often openly disdain “rednecks” and “hillbillies” while concentrating on identity politics rather than economic hardship. Republicans promote policies of free trade and deregulation that cast the region further into destitution.

Monnat has found that counties with large numbers of people employed in physical labor—especially occupations with higher rates of disability—have higher rates of drug fatalities. These are places where coal miners work in backbreaking positions and military veterans suffer the pain of injuries. She observes that drug companies have besieged these areas with aggressive marketing of pain pills. “In Appalachia, you’d see mining companies with physicians on staff prescribing opioids to keep people in pain working,” she says. “That was happening before OxyContin, but companies like Purdue targeted these communities to push OxyContin as a safer alternative to other pain medications.”

The National Institutes of Health (NIH) report that the opioid epidemic, which started as a regional crisis, is now a national crisis. It casts a pall over far more than individual lives; it is now decimating communities and even helping to reshape the American political landscape. Monnat finds a relationship between the landscapes of despair and the 2016 presidential election. Voting patterns show that areas in which President Trump did better than expected, like Pennsylvania and Ohio, were also places where opioid overdoses and deaths from alcohol and suicide occurred at high rates over the past decade.

During his campaign, Trump expressed concern for people in regions like Appalachia and flung stinging barbs at the politicians who had failed them. These voters supported him in high numbers, and yet sadly, his policies will likely give more power to the pharmaceutical companies that have turned their suffering into stock windfalls.

Profit Trumps People

Trump the campaigner shook his fist at Big Pharma for “getting away with murder” - one of those statements that occasionally drops from his lips with atomic accuracy. But Trump the President has done an about-face. As journalist David Dayen has pointed out, a draft of an executive order on drug prices (which never materialized) called for deregulation of the FDA and favors to industry. It was written by none other than a pharmaceutical lobbyist.

In March, President Trump issued an executive order creating a commission to study drug addiction and the opioid epidemic. The commission, headed by New Jersey Governor Chris Christie, has so far released recommendations which locate the overprescribing problem “in doctor’s offices and hospitals in every state in our nation,” while making nary a mention of pharmaceutical marketing departments.  The panel suggests insufficient remedies like new treatment facilities and educating schoolchildren on the dangers of opioids, along with ineffective ones like more funds to Homeland Security. Regulation of Big Pharma? Nope.

The federal government did announce that it would team up with drug makers to research and generate non-opioid pain medications and additional medication-assisted treatment options. Among the participants? Purdue.

Economist William Lazonick of the University of Massachusetts Lowell and an INET grantee, agrees with Berger that the way the pharmaceutical industry operates amounts to a catastrophe for the public.

“It’s crazy that each and every drug is not treated like a regulated monopoly,” he says. “Taxpayers fund much of the research that goes into creating these drugs through the NIH and other public research facilities. Moreover, the companies are gifted with a monopoly through patents which last two decades.”

Lazonick notes that Big Pharma claims that it needs high profits to keep inventing new drugs, but it spends more of its profits buying back its own stock than increasing investment in R&D on new drugs. Executives running drug companies are incentivized to make profits any way they can because they are rewarded by high stock prices. Lazonick explains that they stoke those stock prices by gouging patients or lying about the safety of products—whatever it takes.

He observes that for the past several decades America has undergone a devastating experiment based on the philosophy of economist Milton Friedman, who claimed that the only social responsibility of a company is to make a profit. Untimely deaths from tobacco-related illnesses, auto safety failures, and now, harmful opioid drugs, prove that the experiment is a tragic failure.

Lazonick sees the need for nothing less than a new structure of corporate governance that ensures the ethical responsibly of drug makers to do what they are supposed to do: create high-quality, low-cost products that are safe. The current structure, based on the misguided idea that companies should be run for the sole purpose of enriching shareholders, is particularly perverse when it comes to products that are potentially fatal. The problem with this model is that when shareholders are the only people who matter, the rest of us suffer.

Since taxpayers support pharmaceutical companies by funding public research and many other things they require to do business, Lazonick says it is only fair and logical that someone representing the public sit on their boards. Berger adds that companies should be required to make drugs widely available at affordable prices in return for their use of publicly-funded, basic research at no cost whatsoever.

America, for the time being, stands out among nations in letting pharmaceutical companies run amok to inflate drug prices, advertise and market drugs without proper regulation, and use taxpayer resources while exposing them to egregious harm.

“The only thing America’s drug companies are competitive about,” says Lazonick, “is getting people addicted."

"Colossal Fraud": Lawsuit Accuses Poland Spring Of Selling Groundwater

Ever wonder if that bottled mineral water you just spent several dollars on is really mineral water? According to a bombshell new lawsuit filed this week, at least in the case of one company it isn"t.

A group of bottled water drinkers has brought a class action lawsuit against Nestle, the company which owns Poland Spring, alleging that the Maine business has long deceived consumers by mislabeling common groundwater. The lawsuit was filed on Tuesday in a Connecticut federal court and accuses Nestle Waters North America Inc. of a “colossal fraud perpetrated against American consumers” the Bangor Daily News reports.

The plaintiffs claim that falsely labeling its "groundwater" product as pure spring water allowed Nestle to sell Poland Spring water at a premium; as a result the consumers who brought the legal action are seeking at least $5 million in monetary damages for a national class and several state subclasses. They requested a jury trial. The civil suit was brought by 11 people from the Northeast who collectively spent thousands of dollars on Poland Spring brand water in recent years. It seeks millions of dollars in damages for a nationwide class and hinges on whether the sources of Poland Spring water meet the Food and Drug Administration’s definition of a spring.

The 325-page lawsuit, which was filed by lawyers from four firms, claims that none of the company’s Maine water sources meets the federal definition for spring water and that the company has “politically compromised” state regulators. Rather than spring water, Nestle Waters is actually purifying and bottling groundwater, some of which comes from sites near waste and garbage dumps, the suit claims. The legal challenge comes as Nestle is looking to expand its operations in Maine.

For instance, the suit claims that the company’s wells in Poland, Maine, have never been scientifically proven to be connected to a spring and draw in surface water, which cannot legally be called spring water. It further alleges that the company has put water from some of these wells through a purification process that disqualifies it as spring water under federal regulations.

The suit makes similar claims about Poland Spring water sources in Hollis, Fryeburg, Denmark, Dallas Plantation, Pierce Pond Township and Kingfield.

Poland Spring has gotten away with this deception for years, the suit claims, by co-opting state regulators and interweaving its interests with those of state government. Since 1998 the company has generated millions of dollars for Maine through licensing agreements, and since 2003 it has had an executive on the governor-appointed body that oversees the state drinking-water regulation enforcement agency, the suit states.

The court complaint further says that the Maine Drinking Water Program scientist who approved many of the company’s spring water permits spent a decade working with this executive at a private engineering firm and that the agency failed to get independent proof of the springs’ existence.

In response to the lawsuit, a Nestle Waters spokesperson said that its water meets all relevant federal and state regulations on the classification and collection of spring water and that the suit is “an obvious attempt to manipulate the legal system for personal gain.”

“The claims made in the lawsuit are without merit. Poland Spring is 100 [percent] spring water.”

This is not the first time that Nestle Waters has faced such allegations. In 2003, it settled a class action lawsuit alleging that Poland Spring water doesn’t come from a spring. In that case, the company did not admit the allegation but agreed to pay about $10 million in discounts to consumers and charity contributions. In other words, pulling a page from Wall Street, it neither admitted, nor denied guilt.

The full lawsuit is below

Panel: The FDA Desperately Needs to Review its Approach to Opioids

In a report, the National Academy of Sciences, Engineering, and Medicine (NASEM) is calling on the U.S. Food and Drug Administration (FDA) to review the safety and effectiveness of opioid painkillers. The panel of experts says monumental changes are needed to the way in which physicians treat pain, their patients cope with pain, and government and private insurers support individuals’ treatment for chronic pain. [1]

However, the panel says in no uncertain terms that efforts to prevent future opioid addicts will unfortunately drive some current painkiller abusers to seek harder street drugs, including heroin and fentanyl.

The panel wrote that:

“It is therefore ethically imperative to couple a strategy for reducing lawful access to opioids with an investment in treatment for the millions of individuals [already addicted to opioids].

The FDA commissioned the panel in 2016 to shape advice for how the agency should tackle the nation’s opioid epidemic. Many experts, including those on the panel, say the answer to the problem lies in regulating drug companies, as well as prescribers.

As we speak, lawmakers in Washington are debating a healthcare bill that would reduce access to addiction treatment – the polar opposite of what the panel calls for in its comprehensive report. What is needed, panel members say, is for states and the federal government to provide “universal treatment to addiction in hospitals, community-based programs, jails, and prisons.

The topic is a bone of contention for many people who don’t believe taxpayers should have to foot the bill for such treatment. But according to the panel, it is the only way to bring an eventual end to the opioid crisis sweeping America. Make no mistake about it – it is going to take years to gain control over the situation.

Source: U.S. Centers for Disease Control

A member of the report committee, Dr. Aaron Kesselheim of Harvard Medical School said:

“Our recommendation is for a much more systematic approach, integrating public health decision-making into all aspects of opioid review and approval. It would be an ambitious undertaking.” [2]

While the panel stopped short of acknowledging that the war on drugs has not worked, it urged states to reject the current trend of cracking down hard on illicit drug use. This, it said, will reduce harm to opioid users who have turned to the streets to supply their habit.

Instead, the panel said that states should adopt needle exchanges, safe havens for those who inject drugs, and wider access to naloxone – a drug that reverses overdoses from opioids, including heroin. [1]

In deciding how to regulate opioids, the FDA should study how the drug will affect patients’ families, society at-large, and the black market for drugs, the panel continued.

Kesselheim said:

“This is in distinction to the traditional approach that the FDA takes when it evaluates products. But the particular characteristics of opioids, we believe, requires a certain amount of what we term ‘opioid exceptionalism’ from the regulator.

… Overzealous promotional and financial relationships between the pharmaceutical manufacturers of opioids and physicians through the ’80s, ’90s, and 2000s, I think, at this point, has been shown to be a contributor to overprescribing in this area.” [3]

Other recommendations by the panel include:

• Requiring drug companies to follow stricter rules for marketing opioids than they would for other drugs.

• Developing campaigns to inform doctors and patients about other was of managing chronic pain. These campaigns should not be run by drug companies, however, even though many drug companies sponsor ongoing pain-management education programs for physicians.

Source: U.S. Centers for Disease Control

In 2016, the CDC released fresh guidelines intended to limit the prescribing of opioids, though there is no legal mandate for physicians to follow them. The agency recommended, among other things, that:

• Doctors don’t immediately prescribe opioids to treat pain. Instead, physicians should prescribe non-drug interventions first, such as exercise therapy and weight loss.

• When a doctor does prescribe an opioid, he or she should start the patient on the lowest dose possible, and prescribe immediate-release opioids for short periods of time, rather than for weeks or months at a time.

• Doctors should urine-test patients to make sure they are following the prescription’s directions.

Read: The DEA Will Slash Opioid Production 25% by 2017

Also in 2016, the FDA published draft guidelines outlining testing standards for harder-to-abuse generic opioids. Under those guidelines, the FDA can only approve a generic painkiller if the maker can prove it is the bioequivalent of a brand-name medication. Prior to that, generic drugs were not individually scrutinized for safety and efficacy the way that brand-name drugs were.

Additionally, the FDA required black-box warnings – the FDA’s most serious drug warning – on all fast-acting opioids concerning the risks for addiction, misuse, overdose, and death.

Sources:

[1] Los Angeles Times

[2] The Street

[3] Pacific Standard

U.S. Centers for Disease Control

U.S. Centers for Disease Control

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About Julie Fidler:
	Julie Fidler is a freelance writer, legal blogger, and the author of Adventures in Holy Matrimony: For Better or the Absolute Worst. She lives in Pennsylvania with her husband and two ridiculously spoiled cats. She occasionally pontificates on her blog.

Selective enforcement of Federal Law, the tragic cases of Sam Girod and Donald Trump.

"All animals are equal, but some animals are more equal than others."
-George Orwell, Animal Farm"

In two days, the FDA and a federal judge are going to put a Kentucky farmer and grandfather, Samuel Girod, in jail for up to 68 YEARS with up to $3M in fines for charges related to selling a homemade herbal salve.

From: http://www.kyfreepress.com/2017/03/updated-sam-girod-v-fda/

Samuel Girod [G as in Gee: gi-ROD] and his family have been making and selling three all-natural herbal products for nearly 20 years.

No one has ever been harmed by the products; the Girods have pages of testimonials and scores of repeat customers.

Similar products are currently made and sold online worldwide (including on Amazon) by other people using the same or similar basic ingredients. The recipes are online as well, you can make them in your kitchen.

In 2001, an FDA agent informed Sam that his product labels were making medical claims regarding healing certain conditions. At the time, Sam’s label said, ““[g]ood for all skin disorders. Skin cancer, cuts, burns, draws, and poison ivy.”

Sam had to change his label, removing the skin cancer claim specifically, or do very expensive testing proving the claims. Sam changed the label, removing any reference to skin cancer.

Sam did not receive any further communication from the FDA until 2012 when someone called the FDA and reported that a store in MO was selling Sam’s products and that medical claims were being made.

The “medical claims” were in fact customer testimonials contained in a brochure about Sam’s products! These testimonials are no different than Amazon reviews.

Then the FDA claimed to have found a MO customer who had been harmed by Sam’s bloodroot salve.

In early 2013, during the investigation on that claim, FDA agents went to Sam’s home and demanded a warrantless search. Wanting to be cooperative, Sam said OK on one condition: that no photographs were taken (the Amish are religiously opposed to photography). The agents said no problem, no photos.

Then they got on the property, whipped out their cameras and took photos of everything.

Several months later, the Girods discover that, not only has this customer never been identified or produced, the bloodroot salve this customer used was not even Sam’s!!!

Yet that judge put an injunction on Sam’s products with three stipulations:

• none could be sold until all medical claims were removed (referring to the brochures);


• Sam’s bloodroot salve could never be sold again EVER (1); and


• Sam had to allow inspection of his property where the products were made FOR FIVE YEARS.


• Sam complied with 1 and 2: he stopped selling the bloodroot salve and stopped using the brochures. He was not so compliant with the searches.

In late 2013, after the injunction, FDA agents came to do a second search. Sam informed them that nothing had changed since the first search 7 months earlier, and that, since they had lied and taken photos during the first search, they were not welcome to do a second.

The FDA agents had a Bath County Sheriff’s deputy along with them (as they are required since they are federal agents rather than state). This sheriff witnessed the entire event and eventually told the agents to leave the property. Which they did.

These three product sales are how Sam’s family made their living. They had been denied this right via an arbitrary regulation made up by a federal agency with no true jurisdiction in the states — and with NO VICTIM.

So the Girods started selling their products again. Then, in 2014, Sam started a legal private membership club and sold his products to members via that framework. Perfectly legal.

Meanwhile, the FDA started criminal proceedings against Sam for disobeying the injunction (selling his products and refusing the search) plus two other very serious charges:

1. The FDA agents claimed that, when they came for the 2nd search, Sam and his family threatened them with physical violence. That is ludicrous enough on the face of it. Plus, the Sheriff’s deputy testified under oath that absolutely no threats were made, that, essentially, the FDA agents lied under oath.

2. The FDA also charged Sam with witness tampering. The witness who was supposedly tampered with? Read the eyewitness account of Mary Miller’s testimony, link below. (2)

The Trial 2.27.17

The Amish do not use lawyers as a rule and Sam did not. This is a decision made by the community, not just the accused. Apparently the Amish don’t trust lawyers. Imagine that.

Because he barely presented a defense against federal prosecutors for whom money and conscience are not problems, Sam was convicted on all counts. (3)

The judge ordered Sam to remain in jail until sentencing on 6/16/17. [apparently rescheduled to 6/30/17] He’s been in jail since 2/27/17.

Had Sam had a good attorney, he would certainly have been acquitted on the most egregious counts (threatening federal agents and witness tampering). These charges were clearly manufactured solely to make Sam into a “real” criminal, with the FDA being the only victim.

The only other charges — selling “drugs” across state lines — were manufactured out of whole cloth as well. The FDA’s own tests proved that the products were not drugs, that they were made from all-natural ingredients!!! These charges should have been dismissed from the start.

Sam’s sentencing is 6/30 and he is looking at up to 68 years in prison and up to $3M in fines. This is essentially a life sentence for charges stemming from an innocent labeling infraction!

Now, compare and contrast the prosecution of Girod"s case, above, with the complete lack of enforcement of the War Powers Resolution, in regards to the deployment of United States military forces in Syria and elsewhere.

http://www.zerohedge.com/news/2017-03-11/assad-calls-us-forces-syria-inv...

In Syria, the US is currently working with an alliance of Kurdish and Arab militias and its biggest focus at this moment is to encircle and ultimately capture the ISIS capital of Raqqa. This week, the U.S.-led coalition announced that around 400 additional U.S. forces had deployed to Syria to help with the Raqqa campaign and to prevent any clash between Turkey and Washington-allied Syrian militias that Ankara sees as a threat. Around 500 U.S. forces are already in Syria in support of the campaign against Islamic State, which this week added several hundred, marines who were recently caught on video as they prepare for the Raqqa offensive.

 

Asked about a deployment of U.S. forces near the northern city of Manbij, Assad said: "Any foreign troops coming to Syria without our invitation ... are invaders."

Unlike the Amish grandfather"s herbal salve, President Trump"s illegal invasion of Syria has actually harmed others.

http://www.cbsnews.com/news/syria-civilians-killed-us-coalition-airstrik...

Dozens more civilians allegedly killed in U.S.-led strikes

...various activists groups reported different casualty tolls, saying the U.S.-led coalition, which is waging war on ISIS, was likely behind the attacks.

The Britain-based Syrian Observatory for Human Rights (SOHR) monitoring group said the strike hit the village of Akayrshi on Sunday night and that 12 women were killed. The activist-run, Raqqa Raqqa is Being Slaughtered Silently, said the strike hit a convoy of farm workers and that 22 died.

Below is what The Library of Congress has to say about the War Powers Resolution.  Apparently, however, our congress is too busy funding the FDA to prosecute Amish grandfathers and receiving unlimited campaign contributions from pharmaceutical and weapons companies and AIPAC to bother to read, understand, and do the job they were supposedly elected by the American people to do.

http://www.loc.gov/law/help/war-powers.php

The War Powers Resolution, Public Law 93-148, 87 Stat. 555, passed over President Nixon"s veto on November 7, 1973. The War Powers Resolution is sometimes referred to as the War Powers Act, its title in the version passed by the Senate. This Joint Resolution is codified in the United States Code ("USC") in Title 50, Chapter 33, Sections 1541-48.  

The term "Resolution" can be misleading; this law originated as a Joint Resolution and was passed by both Houses of Congress pursuant to the Legislative Process, and has the same legal effect as a Bill which has passed and become a law. For more information on Bills and Joint Resolutions see this explanation of Congressional Forms of Action.

The Constitution of the United States divides the war powers of the federal government between the Executive and Legislative branches: the President is the Commander in Chief of the armed forces (Article II, section 2), while Congress has the power to make declarations of war, and to raise and support the armed forces (Article I, section 8). Over time, questions arose as to the extent of the President"s authority to deploy U.S. armed forces into hostile situations abroad without a declaration of war or some other form of Congressional approval. Congress passed the War Powers Resolution in the aftermath of the Vietnam War to address these concerns and provide a set of procedures for both the President and Congress to follow in situations where the introduction of U.S. forces abroad could lead to their involvement in armed conflict.

Conceptually, the War Powers Resolution can be broken down into several distinct parts. The first part states the policy behind the law, namely to "insure that the collective judgment of both the Congress and the President will apply to the introduction of United States Armed Forces into hostilities," and that the President"s powers as Commander in Chief are exercised only pursuant to a declaration of war, specific statutory authorization from Congress, or a national emergency created by an attack upon the United States (50 USC Sec. 1541).

The second part requires the President to consult with Congress before introducing U.S. armed forces into hostilities or situations where hostilities are imminent, and to continue such consultations as long as U.S. armed forces remain in such situations (50 USC Sec. 1542). The third part sets forth reporting requirements that the President must comply with any time he introduces U.S. armed forces into existing or imminent hostilities (50 USC Sec. 1543); section 1543(a)(1) is particularly significant because it can trigger a 60 day time limit on the use of U.S. forces under section 1544(b).

The fourth part of the law concerns Congressional actions and procedures. Of particular interest is Section 1544(b), which requires that U.S. forces be withdrawn from hostilities within 60 days of the time a report is submitted or is required to be submitted under Section 1543(a)(1), unless Congress acts to approve continued military action, or is physically unable to meet as a result of an armed attack upon the United States. Section 1544(c) requires the President to remove U.S. armed forces that are engaged in hostilities "without a declaration of war or specific statutory authorization" at any time if Congress so directs by a Concurrent Resolution (50 USC 1544 (external link)). Concurrent Resolutions are not laws and are not presented to the President for signature or veto; as a result the procedure contemplated under Section 1544(c) is known as a "legislative veto" and is constitutionally questionable in light of the decision of the United States Supreme Court in INS v. Chadha, 462 U.S. 919 (1983). Further sections set forth expedited Congressional procedures for considering proposed legislation to authorize the use of U.S. armed forces, as well as similar procedures regarding proposed legislation to withdraw U.S. forces under Section 1544(c) (50 U.S. 1545-46a).

The fifth part of the law sets forth certain definitions and rules to be used when interpreting the War Powers Resolution (50 USC 1547 (external link)). Finally, the sixth part is a "separability provision" and states that if any part of the law is held (by a court) to be invalid, on its face or as applied to a particular situation, the rest of the law shall not be considered invalid, nor shall its applicability to other situations be affected (50 USC 1548 (external link)).

U.S. Presidents have consistently taken the position that the War Powers Resolution is an unconstitutional infringement upon the power of the executive branch. As a result, the Resolution has been the subject of controversy since its enactment, and is a recurring issue due to the ongoing worldwide commitment of U.S. armed forces. Presidents have submitted a total of over 120 reports to Congress pursuant to the Resolution.

If we are not a nation of laws, then what are we?

h_h