Epi-Pen Prices Soar as FDA Makes Life Tough for Its Competitors

Last October, Sanofi withdrew Epi-Pen’s last true competitor, Auvi-Q,  from the market after some suspected device malfunctions.  Without competition, Mylan, which acquired the Epi-Pen in 2007, when it was selling for around $57, raised their prices to $600 for a 2-pack.  I was actually quoted $800 at my pharmacy.

Teva had submitted an application for a generic version of the Epi-Pen to the FDA.  However, the agency felt “certain major deficiencies” needed to be addressed. Marketing of Epi-Pen’s new competitor will be delayed until at least 2017.

Adamis wants to market a syringe prefilled with epinephrine, the active drug in the Epi-Pen. Some diabetics must inject themselves with insulin, so use of a syringe, rather than an Epi-Pen-like device, is not unprecedented.  The FDA wouldn’t approve it without more studies on patient usability and product stress testing. Mylan is protected from still another competitor by regulatory delays.

Competition keeps corporate greed in check

 

In theory at least, your compounding pharmacist might be able to prepare epinephrine-filled syringes for you.  However, your doctor will have to prescribe them; once the Adamis syringe is approved, compounding pharmacists will be forbidden by FDA regulations from preparing them anymore. The syringe might be a bit more difficult to use, especially for children trying to cope in an emergency, so this option isn’t for everyone.

In the meantime, consumers are usually unaware that there is still another, less expensive alternative.  Adrenaclick is similar to, but not identical with, the Epi-Pen and is available for a fraction of the price. If you decide to try it, be sure and become familiar with it: it has two caps that need to be removed instead of Epi-Pen’s one.

However, the FDA won’t let your pharmacist substitute Adrenaclick unless your doctor re-writes your prescription.  The FDA isn’t sure that you’ll get the exact same blood levels of epinephrine, even though the dose is the same.  Your doctor will have to specify Adrenaclick on your prescription or your pharmacist can’t fill it.

Competition is the greatest price regulator of all.  Without it, Mylan has a virtual monopoly on a life-saving device; about 40% of its profits come from the Epi-Pen. The $1.2 billion in 2015 sales from this product should have encouraged other companies to rush to market with an imitator; epinephrine is cheap and off patent, even though the Epi-Pen itself is patent-protected.

However, the average generic drug takes about 3 years or so to wend its way through the FDA approval process.  Devices generally take even longer.  In the meantime, Mylan can pretty much charge what they want.

Critics of the pharmaceutical companies will use the Epi-Pen price hike as another example of corporate greed—and so it is. However, the real culprit here is the FDA, which has delayed or killed Mylan’s competition. The recent price hike only happened after Auvi-Q was withdrawn and Sanofi decided not to dump it.  Competition keeps corporate greed in check better than any form of legislative price control, which has deadly side effects of its own.

The big casualty of price-fixing by government is less innovation.   Countries that try to keep drug prices down through regulation end up delaying or denying their citizenry access to new, life-saving drugs.  People in other countries might not pay as much money for the drugs they get, but their loss of access can cost them their very lives.

Surprisingly, the marketplace punished Mylan for its price gouging on the life-saving Epi-Pen, even though that strategy would have increased profits to investors.  Their stock price fell about 9% last week for a loss of $3 billion. Mylan tried to stop the stock from dropping further by giving $300 coupons to out-of-pocket buyers, but the stock has not recovered. Even though corporate greed is a real phenomenon, social conscience is too.

Sadly, we can expect to see the cost of other generic drugs and devices soar in the future. In 2000, the FDA intensified its Good Manufacturing Practices (GMP) demands. Companies had to upgrade their equipment, even if was working perfectly, and were fined for any violations in record keeping.  The FDA didn’t find any product problems during these inspections, just failure to check its multitude of regulatory boxes.

When faced with new FDA manufacturing demands, some companies chose to abandon products that were older and brought in low revenue instead of making expensive upgrades. As the number of competitors dwindles, expect to see more generic drugs become unaffordable—courtesy of the FDA.

 

 

 

Join Me in Austin March 11 (Date Change)!

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Liberty International, formerly the International Society for Individual Liberty, is hosting a one day event in Austin, Texas, to update you on the health care crisis brought on by our government.  More importantly, you’ll learn about changes in recent legislation and scientific knowledge that can help you not only survive, but thrive.

I’ll be speaking about the FDA, how it’s thwarting scientific progress, and what needs to be done to stop it.

Starlee Coleman from the Goldwater Institute will be sharing the exciting new Right to Try legislation sweeping the nation state by state. Right to Try allows the terminally ill to bypass the FDA for access to cutting edge therapies.

Sally Pipes from the Pacific Research Institute will be updating us on the the negative impact of Obamacare on all Americans and the ongoing legal challenges that will hopefully derail it.

John Mackey, founder of Whole Foods and Conscious Capitalism, will share his ideas on nutrition, supplements, and other aspects of healthy living.

We are expecting other speakers to join us as well, so please save the date March 11.  The event will be held in Austin, Texas, exact time and place to be announced.  Sign up for updates  here.

Join us if you can!

Privatize the Police for Public Safety!

In the mid-1980s, I went into classrooms several times a year to talk about the libertarian philosophy.  I discussed how some cities had saved money using private police instead of public ones.  Invariably, students expressed concern that private police might become an outlaw gang, robbing those they were supposed to be protecting and shooting them if they didn’t cooperate.

By now, these students are adults.  On the nightly news, they are hearing more and more about police shooting unarmed individuals, even those on their backs with their hands up! The public perception is that police who shoot or tase innocent people are rarely held accountable.

What is less publicized, but in fact much more common, is the theft of private property by police using asset forfeiture.  If property (car, house, cash, bank account) rather than a person is suspected of being linked to drugs, for example, it can be seized without any real proof of wrongdoing.  The police have strong incentive in most states to confiscate property on mere suspicion, since the department usually gets a share of the proceeds.

Chapter 16 police

What looks suspicious to the police can actually be quite innocent.  Are you carrying more than $500 in cash? It must be from a drug deal, so the police confiscate it.  Do you make deposits to your bank account in amounts between $5,000 and $10,000?  You must be “structuring” to avoid having to fill out the paperwork associated with deposits of $10,000 or more, so your account is forfeit.  Do you run a motel and report drug users to the police?  Your motel is guilty of criminal activity and is seized even though you’ve done nothing wrong!  Luckily, the libertarian Institute for Justice is fighting back on behalf of these innocent victims; the Republicans and Democrats don’t have a problem with the seizures and so do nothing.

If you are victimized by the police, you may try to do things the American way and sue.  That won’t be much help.  Even if you prevail, which is unlikely since the courts tend to support the police, you may be charged “storage fees” for the time that those who confiscated had to care for it. The attorney bills to recover what’s rightfully yours are likely to make even a full recovery a pretty big loss.  It’s horrifying that your life savings or home can be taken from you without due process.

However, for the police, the profit is incentive to simply confiscate more. “It’s kind of like pennies from heaven,” explains Kenneth M. Burton, Columbia, Mo., police chief, discussing the money generated from asset forfeiture. “It gets you a toy or something that you need is the way that we typically look at it, to be perfectly honest.”

If a private police force did such things, individuals would cancel their subscriptions to it.  Enraged citizens would make sure that city managers would consider the policing contract null and void.  Of course, in real life, the private police service would have great incentive to fire rogue officers in order to maintain their contract. The service would be self-policing.  If it wasn’t successful in keeping bad cops in line, the company would be replaced with one that truly was there to “serve and protect.”

Instead, we are stuck with a government monopoly on defensive force.  When the police become predators, it’s tough to dislodge them.  The city managers, police chief, the courts, and the entire police force are all  government employees who tend to protect each other, instead of the citizens who employ them.  Without the power to withhold our subscriptions, or our taxes that pay police salaries, we have little recourse.

Private police actually save us money.  Communities that utilize them not only pay them less, but get the bonus of crime prevention.  Policing companies make more money if they can prevent crime rather than chase after criminals, so that’s what they do.  It’s not just safer for the citizens; it’s safer for the police too.

Let’s face it: policing is a tough, stressful job.  You can get killed doing it.  Our police put their lives on the line every day when they don the uniform and strap on their firearm.  When cops shoot unarmed citizens or steal property they are sworn to protect, all of our guys and gals in blue are tainted by it.  Privatizing our police may be the only way to clean up the corruption.

I wonder how those students that I talked to back in the 1980s are feeling about public police now.

Should Women Be Drafted?

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My short answer is that no one should be drafted. After all, our Constitution prohibits involuntary servitude, which is exactly what the draft is. Our young men—and possibly women—will be forced—at gunpoint, if necessary—to take up arms and kill other people.

Except for a few psychopaths, taking up arms with the intention to kill others day after day is difficult, even when our nation is truly threatened. It’s a rare individual who remains unscathed by killing others and being a target, which is why so many return home with post-traumatic stress disorder or serious mental illnesses. Going to war should always be the last resort, since the cost in lives, money, and disabilities is so high. In recent times, however, sending troops overseas seems to be a knee-jerk response to any provocation.

When our young people perceive that a war is not just or not warranted, they become unwilling to risk their lives or kill for it. In Vietnam, a war I remember well, this is exactly what happened. Although young men enlisted early in the war, they soon concluded that Vietnam was not a threat to the United States, and resisted the draft overtly or covertly.

Today, not enough of our young men are enlisting to sustain the conflicts in the Middle East. Our troops look forward to going home after their tours are up, only to be forcibly reenlisted under the stop-loss fine print in their contracts. We claim to have a volunteer army, but in fact those who enlist can be drafted for another deployment. This discourages further enlistment, as new recruits start to understand that they are actually signing an open-ended contract.

Clearly, the government believes it will need a draft in the not-so-distant future to maintain its chosen  military action. We are told that without a draft, our young people will not step forward when our country is threatened. This is patently false. After 9/11, volunteers flooded to sign up for the anticipated military action. Now they no longer do, as they perceive their government is embarked on never-ending wars.

If our nation is truly threatened, our young people step forward willingly; if it isn’t truly threatened, why should they risk life and limb? We can’t keep killing people overseas because maybe, someday, they might try to harm us.  There are simply too many people who “might” try to hurt us.  A better strategy is to make sure our domestic security is strong enough that those who would do us harm will be thwarted in their attempt.

If we engage in overseas wars that are not truly defensive ones, and may even be primarily in the service of special interests, our young people should refuse to go.  These young adults become the canaries in the coal mine, warning us that the war we wish to fight might not be so right.

Killing is difficult enough when it is perceived as a necessary evil, but it’s even more difficult without the motivation to protect our homes and loved ones. The draft isn’t only involuntary servitude; its slavery of the worst kind as it asks the draftees to do things they find morally repugnant. How are we to spread freedom abroad by taking it away from our young people at home?

Women have a major role to play in discussions about the draft. They should indeed talk about equal rights—for both men and women. Self-determination, the decision whether or not we are willing to go out and kill others, is a right that belongs to both sexes. Instead of insisting that their own rights should be violated, as the rights of men are today, women should be lobbying for an end of the draft. Our great, great-grandmothers fought to end the slavery of black people; today, we honor their memories by fighting to end the slavery of the draft.

 

Gun-Free Zones Are Anything But!

Would you post a sign on your front yard saying “This house is a gun-free zone?” No matter how much you hate guns, your gut reaction is likely “Certainly not!”  Intuitively, we know that such a sign makes our home a target for criminals, who don’t obey gun bans any more than they obey the laws against rape, theft, and murder.  Advertising that you and yours are defenseless is never a good idea.

Gun Free Zone 2

Similarly, when bars, schools, and other public venues are posted as “gun-free zones,” we should be wary.  After all, over 98% of the mass public shootings in the United States occur in places where guns, even those carried by law-abiding citizens with permits, are banned (1).

Much of the tragedy that happened at Pulse, a gay bar in Orlando, in the wee hours of June 12 could have—and should have—been prevented.  Had any of the patrons been carrying a firearm, the perpetrator might have been quickly stopped. Instead, at least 50 people lost their lives and a similar number were injured.

Mass shooters do consider where they can find helpless victims (2,3,4). After all, most of these killing sprees are pre-meditated, so the ability to execute their victims without minimal interference is a significant part of their planning.

Instead of doing away with gun-free zones, where killers enjoy open season on those who can’t fight back, many politicians are calling for more victim disarmament.  These same politicians, who want to deny private citizens the ability to defend themselves, often have armed body guards for themselves—sometimes paid for with our tax dollars (5,6,7).

If our politicians can use guns to protect themselves, why shouldn’t we be able to?

Healing Our World Is Inevitable (from the “Cliff Notes” Version of “Healing Our World”)

GoodNeighborMR Chapter 17

 

Past posts have talked about the harmony and abundance that the Good Neighbor Policy brings, especially to the disadvantaged among us. Honoring our neighbor’s choice and righting our wrongs brings us more than material benefits, however. Our inner peace, which helps to heal both body and spirit, is greatly augmented by embracing the non-aggression principle.

 When we choose aggression as our means, we become suspicious of other people. For example, we  fear that drug manufacturers might sell us a dangerous, untested drug just to make a few dollars. The people who benefit from pharmaceutical regulation encourage our hostility by focusing our attention on a few unscrupulous individuals. We forget about the many dedicated researchers trying to discover cures for our diseases and begin to view pharmaceutical manufacturers as enemies. When the aggressive regulations that we enact destroy competition and cause the price of drugs to skyrocket, we blame drug makers for “exploiting” us. We become cynical as our own original suspicions are validated by “proof” that we ourselves unwittingly create. Our self-destructive spiral continues as we demand more aggression-through-government.

Suspiciousness, hostility, cynicism, and blame, which “justify” our aggression-through-government, constitute the toxic core of Type A behavior. Negative judgments about others, rather than the fast pace associated with Type A attitudes, alters the body’s biochemistry in a way that accelerates cardiovascular disease even in individuals not genetically predisposed the heart problems.

As we’ve seen in previous chapters, the poor are hurt most by our well-meaning aggression. The lower rungs on the Ladder of Affluence are destroyed, preventing the disadvantaged from beginning their climb. Unable to legally create wealth, some steal it instead. Others simply give up in sheer frustration, succumbing to the seeming helplessness of their situation. Caught in the poverty trap, they resign themselves to their fate. The disenfranchised put up only a token struggle, believing that they “can’t fight city hall.” Consequently, their helplessness becomes a self-fulfilling prophecy.

These attitudes of frustration, helplessness, suppressed anger, giving up, and resignation are Type C traits that suppress our body’s immune system, making us more susceptible to cancer and other diseases. Aggression-through-government encourages Type C thinking in its victims.

 Unlike Type A and C thinking, Type S (self-actualized) thinking focuses on how we can change our situation by changing ourselves. For example, if we want to be paid more, we can work harder or get training in a more lucrative field. When we stop looking toward others to fulfill our dreams, we automatically turn to strategies that make us less dependent upon them. We have greater control over our own lives when we stop trying to control others. As we practice Type S thinking, we become more disease resistant and live longer. People who get counseling to change their Type A or Type C beliefs to Type S beliefs can cut their chance of heart disease or cancer in half.

In dealing with others, Type A thinkers generally attack; Type C people generally submit; people with Type S attitudes generally do neither. Because of their fear-based strategies, people with Type A or Type C attitudes often feel isolated from others, while Type S personalities are most likely to feel connected.

 The importance of feeling connected was revealed to me by a man involved in convincing the American public to accept aggression-through-government. I asked him what he wanted out of life, and he quickly replied, “Power and money.” He already had both, so I next asked what he thought would make him happy. Despite his apparent success, he felt disconnected and apart from the rest of humanity. Happiness, he believed, required this connection.

Years later, I finally recognized how profound this gentleman’s insight had been. With his “propaganda” campaigns, he regularly manipulated public opinion. Before we can deceive people, steal from them, or assault them, we must first separate ourselves from them internally. We feel justified in bending them to our will because we consider ourselves wiser, nobler, or stronger. In other words, we feel that we are somehow better than they are; we are different, separate, apart. Aggression is the physical manifestation of our judgment of others and our internal separation from them. In using aggression as his means, this power broker destroyed the connectedness (goodwill toward all) that appears to be a necessary precondition for happiness.  In using aggression as his means, he sabotaged his ends.

Now we see that the thoughts used to justify aggression also keep us from health and happiness. Even those who have succeeded in acquiring power and money suffer until they learn this lesson. Their own quest for happiness will drive them to become Good Neighbors.

But won’t many aggressors die before they learn that nonaggression serves them? Certainly! However, as the importance of abandoning aggressive thoughts becomes more prevalent in our culture, the benefits of becoming Good Neighbors will become more obvious. More people will learn; fewer will aggress. Finally, aggression will become a cultural aberration, rather than being accepted as a necessary evil.

Indeed, a great deal of progress has already been made in the last few centuries. Slavery, at least in its most blatant forms, is no longer acceptable in “civilized” society. Women are no longer considered the property of their husbands in developed nations; most people there also consider torture barbaric.

The desire to end our own suffering and experience better health and more happiness drives each of us to become Good Neighbors. Truly, it can be—and will be—a win-win world!

Last Day: YOUR Vote Is Needed to Make “Healing Our World” #1!

Healing Our World: The Compassion of Libertarianism, is in a contest for a prestigious Readers’ Choice award—but Friday is the last day!!!!

If Healing gets enough votes, Foreword Reviews will promote it to bookstores, libraries, and other book buyers in the next few months. Imagine voters, frustrated with the presidential candidates of the two mainstream parties, searching for an alternative. We can help them discover how liberty can enrich the poor, protect the environment, deter crime, defuse terrorism, and much, much more!

 Facebook

 

You don’t have to buy anything to make this happen, pledge money, or even invest a lot of time.  All you need to do is go to this link, scroll to the bottom of the page, and put #INDIEFABFAV in the comment section.  You can add why you are voting for the book, and even post it to your Facebook page by checking the box right below the comment section. That way, you can encourage all your Facebook fans to vote with you!  Foreword Reviews uses your Facebook sign in to validate your vote.

Won’t you please take a moment right now and cast your vote?  And thank you, for all that YOU do, to make the world a better place!

 

Please VOTE to give “Healing Our World” a prestigious “Readers’ Choice” Award!

We have a chance to get a popular libertarian primer in front of librarians, book stores, and readers who might not otherwise pick it up—right before the elections!  My book, Healing Our World: The Compassion of Libertarianism, is a finalist in two separate categories for the prestigious Foreword Reviews “Book of the Year Award.”

More importantly, because it is a finalist, YOU have a chance to vote for it as a “Readers’ Choice.”  If Healing gets enough votes, Foreword Reviews will promote it to bookstores, libraries, and other book buyers in the next few months. Imagine voters, frustrated with the presidential candidates of the two mainstream parties, searching for an alternative. We can help them discover how liberty can enrich the poor, protect the environment, deter crime, defuse terrorism, and much, much more!

Facebook

You don’t have to buy anything to make this happen, pledge money, or even invest a lot of time.  All you need to do is go to this link, scroll to the bottom of the page, and put #INDIEFABFAV in the comment section.  You can add why you are voting for the book, and even post it to your Facebook page by checking the box right below the comment section. That way, you can encourage all your Facebook fans to vote with you!  ForewordReviews uses your Facebook sign in to validate your vote.

If you don’t have a Facebook account, you can create one at Facebook.com or you can create an account at ForewordReviews.com, sign in, and then navigate to the link above. Yes, it’s a bit of extra work, but having a libertarian book promoted to the American voters just before the election is a big payoff for us.

Won’t you please take a moment right now and cast your vote?  And thank you, for all that YOU do, to make the world a better place!

 

Policing Aggression (from the Cliff Notes Version of “Healing Our World”

In the 1980s, whenever I would go into the classroom to explain libertarian principles, students were very concerned about the idea of private police. They feared that private police would turn into gangs that would steal from, and maybe even kill, the people they were supposed to protect with impunity. My answer was that this was more likely to happen with public police, who could not be fired simply by refusing to continue to pay their fees. My comments were met with a great deal of skepticism, because private policing was rare back in those days.

Fast forward to the present: our public police are on YouTube tasering ladies who don’t get out of their vehicles fast enough during a traffic stop. SWAT teams often kill or seriously injure innocent people when they go to the wrong house. How often does this happen? When Manhattan city officials started a hotline for the victims of such mistakes, it received over 100 calls the first week!

Prosecutors rarely go after law enforcement when they raid the wrong house. Instead, they try, convict and imprison, victims who have defended themselves, believing they were being attacked by a gang instead of police. Defending yourself against police officers is a crime, even when those officers are at the wrong house! Instead of getting an apology and restitution from the local government, these innocent victims are treated like criminals!

Seizure meme

In 2009, federal officers seized over $1 billion of property in civil forfeiture action. Forfeiture means that the government takes your property (cash, house, auto, etc.) without due process. They claim that the property is guilty and it has no rights under the law.  You don’t even need to be charged with a crime for the government to take everything you own on a mere suspicion of wrong-doing.

The feds share this money with state and local enforcement agencies, giving them incentive to support such seizures. Not to be outdone, the locals operate their own “policing for profit.” In Chicago suburbs, automobiles are confiscated on the spot for blaring radios. The city of Detroit seized 3000 cars in 1995 because they were allegedly used to solicit prostitutes. Even if a victim is lucky enough to sue successfully for repossession of their property, they are often assessed outrageous “storage fees” which must be paid before the property is returned.

One of the unexpected consequences of our numerous overseas wars is an abundance of obsolete military equipment. Local police departments are encouraged to buy tanks, body armor, and military weaponry for pennies on the dollar. Gearing up as if they were going to war subtly suggests that the public is their enemy rather than their employer. Local police forces often recruit officers from the pool of military veterans, some of whom still feel that they are in a war zone. Many of our police are no longer “peace officers,” dedicated to protecting the public.

Unfortunately, officers who truly want to protect and serve find it increasingly difficult to avoid actions which harm the very people they are pledge to protect. The bad apples drive the good ones out.

While our public police have, to some, turned on the very people they are supposed to protect, private police are growing in numbers. Since it is more cost effective to prevent crime rather than to chase and apprehend aggressors, private police usually implement procedures that will greatly reduce crime. Consequently, a 10% increase in private security in a U.S. county decreases violent crime there by the same percentage, while investing in public police has little impact. Private police are not only less expensive to hire, they are usually more effective. Unlike the public police, private law officers can be personally liable if they harm someone without just cause.  Consequently, abuse by private law enforcement is rare, even though there are three times as many private officers in the U.S. as public ones.

One of the most cost effective ways to decrease crime is to make it easy for peaceful citizens to carry concealed weapons. Exhaustive studies demonstrate that violent crime, including robberies, assaults, rapes, and murders, decrease steadily in the decade after right to carry laws are passed. Criminals don’t know whether or not they will be confronted by an armed victim. This uncertainty appears to be enough to deter at least some of them. Attacks against women and minorities decrease the most, probably because these groups were most vulnerable before they had an opportunity for concealed carry.

In contrast, some countries have instituted nationwide gun bans. Ten years after Britain did so, gun related killings and injuries were up 440%! Ireland and Jamaica, which banned handguns in 1972 and 1974 respectively, have seen murder rates quadruple as well. Russia, which bands gun ownership, had four times the rate of homicides and suicides as in the U.S. where homicides have been dropping steadily since 1990. Clearly, people who are willing to steal, rape, and kill disobey the gun laws—and are thrilled that law-abiding citizens have been rendered virtually defenseless.

Sometimes we forget that we’ve created a great deal of the crime that plagues us when we outlaw drug use by peaceful people. Our police spend half of their time going after drug users instead of murderers, thieves and rapists. If we stop our police from going after people whose biggest crime is trying to feel good and focus their efforts on those who would actually harm us, it’s likely that crime wouldn’t pay.  That, in itself, would be a strong deterrent.

These posts are part of a “Cliff Notes” version of my award-winning international best-selling libertarian primer, Healing Our World. The next post in this series will be Chapter 17, “By Their Fruits You Shall Know Them.” If you’d like to learn more about policing aggression before the next post, check out Chapter 16 of the 1993 edition of Healing Our World, in my Free Library at www.ruwart.com

Join Me in San Antonio This Weekend!

This weekend, I’ll be at the TX LP State Convention, where I hope you can join me.  Saturday morning, I’ll be discussing what it means to be a libertarian with those who have questions. On Sunday, I’ll be on the Ladies of Liberty Leadership Panel with Kristen Tynan (Fully Informed Jury Association), Noelle Mandell (Texas Millennial Institute), and Tatiana Moroz (Crypto Media Hub). 
Find out more here.

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Join me if you can!