What’s Next After “Right to Try”?

 

The Right to Try bill, which gives terminally ill patients quicker access to new medicines, passed Congress earlier this year.  The Goldwater Institute initially promoted the passage of this bill state-by-state. Over 40 states passed Right to Try before it before it was signed into federal law by President Trump, who championed the bill himself.

Right to Try got its start after cancer patients sued the FDA for the right to try drugs that were not yet FDA approved.  Te court initially ruled in their favor until the FDA asked them to reconsider.  In 2007, the federal court reversed its initial ruling and told cancer patients that they had no constitutional right to save their lives with drugs that had not been FDA-approved.  Right to Try was fashioned after  the requests made by the cancer patients, which would have allowed the terminally ill to negotiate directly with the manufacturer once a drug had gone through Phase 1 safety testing, but before its effectiveness had been demonstrated.

In many cases, patients will continue to be disappointed. Most pharmaceutical companies aren’t able to ramp up manufacturing until after FDA approval, so the supply of drug might not be enough to give or even sell to patients while continuing the FDA-mandated testing. Without such testing, the drug might never become available to all of the patients who need it; in addition, drugs have to continue in their development in order to qualify for Right to Try.

No one still employed or involved in the industry is likely to admit publicly their concern that the FDA will punish them if they negotiate directly with patients and go around the agency.  The FDA has a history of  dragging its feet at crucial decision points in the regulatory process, saddling companies it dislikes with additional studies, or refusing an approval altogether.

Right to Try has brought national attention to the 10-14 years that it now takes for a drug to go from the lab bench to the pharmacy.  From the late 1940s to 1962, it took about 4 years, but the Amendments to the Food & Drug Act incentivized the FDA to increase the number and complexity of studies. Even so, safety hasn’t increased: the pre-Amendment withdrawal rate was about 2.5%; post-Amendment withdrawals have held steady at 3.3% and properly prescribed prescriptions are now the fifth leading cause of death in the United States. Meanwhile, about 15 million people—10 times as many who have died in all wars since our countries founding—have died waiting for drugs that might have saved them.

Perhaps this is why a new initiative from the Heartland Institute called “Free to Choose Medicine” is in the works. Unlike Right to Try drugs, those entering the Free to Choose Medicine tract don’t need to continue in the FDA approval program. Consequently, drug companies won’t have fewer disincentives o entering the program.

Free to Choose Medicine does require a more comprehensive data sharing program, which could concern drug companies (learn more at FreetoChooseMedicine.com). However, the ability to leave the FDA regulatory requirements after the requisite first Phase 2 study might be enough to offset this concern.  Having a two track development system, FDA approval vs. Free to Choose Medicine, will tell us if the current lengthy regulatory requirements can be safely scraped. Given that these requirements haven’t improved safety discernibly, it’s highly likely.

What about effectiveness?  After all, most of the late phase studies are highly focused on efficacy.  Once again, the data suggests that the extra regulatory studies put into place after 1962 have saved the consumer—at most—about 10% from ineffective drugs.  On the other hand, post-Amendment studies probably increased development costs—and drug prices—20-40 fold.  Being able to remove even part of these costs would not only lower the prices we pay at the pharmacy, but would stimulate innovation.  Innovation is vital, since none of us can buy cures that have not yet been discovered. Taking medicine, even medicine as expensive as it is today, is almost always less costly than surgery or hospitalization.

Free to Choose Medicine may give us better drugs, faster, and at lower cost. Because of its data sharing, we will learn how these benefits compare to the regulatory system we have today.  Shouldn’t the FDA’s requirements be tested to be sure that they are as safe and effective as the new drugs they regulate?

Rising Development Costs Are Causing Drug Companies to Abandon Antibiotic Research

This week, Novartis announced that it would be ending its research program designed to discover new antibiotics. The announcement was greeted with great concern, as “superbugs” resistant to our current arsenal of antibiotics, are a growing threat.

In the early 1900s, infection was the primary cause of death. After improvements in sanitation, nutrition, and the introduction of antibiotics, fatalities plummeted. Cardiovascular disease, cancer, and stroke became the top three killers and remain so today. Without new antibiotics in the pipeline, “superbugs” may become difficult to stop and infection may become as deadly as it once was.

What is driving companies to abandon research in these much needed drugs? The answer is simple: as the FDA demands more involved regulatory studies, pharmaceuticals meant to treat disease for a short period of time can’t recover their out-of-pocket development costs, as shown in the Figure below. If a company can’t recover its development costs, and continues to lose money by developing a certain class of drugs, it will go out of business.  Antibiotics are especially vulnerable because new ones are used sparingly and usually only in desperate cases in order to prevent further resistance in the “superbugs.”

The data points shown in the Figure above come from several studies by Tufts University. They indicate that increased complexity of clinical trials designed to show effectiveness, as well as the number of patients needed to complete them, are at fault. If these increased costs gave us safer and more effective drugs, we might be willing to pay these extra costs, but studies show no improvements in either of these measures. For example, about 3.3% of FDA-approved drugs are withdrawn after serious side effects are seen; this rate of withdrawal has been constant since the 1970s. The best way to stimulate research in antibiotics and other life-saving drugs is to lower the development costs by getting rid of the excess regulation that drives up development cost without compensating benefits.

Figure and statistics taken from my new book, Death by Regulation: How We Were Robbed of a Golden Age of Health and How We Can Reclaim It.

Mr. President, You Can Slash Drug Prices Virtually Overnight Without Destroying Life-Saving Innovation

On July 9, President Trump lashed out at Pfizer for increasing prices of 41 drugs and lowering prices for 5. According to a Trump tweet, “Pfizer and others should be ashamed that they have raised drugs prices for no reason. They are merely taking advantage of the poor… We will respond!”

Just a day later, Pfizer agreed to defer these prices hikes that went into effect last week after meeting with Trump, who had talked to Pfizer chief executive Ian Read and Alex Azar, Secretary of Health and Human Services, after a discussion of how to deal with rising drug prices.

Ian Read could have told the president that there is a very good reason for ever-increasing prices. He could have told Trump that the soaring regulatory demands of the FDA makes these price hikes inevitable, but probably didn’t dare. Drug companies are well aware that the FDA can “punish” those who speak out against the agency by dragging their feet on upcoming approvals or any steps along the way. Consequently, you’ll rarely hear a complaint about the FDA from drug company executives. The FDA has kept life-saving drugs off the U.S. market to teach companies that criticize it a devastating lesson.

Lowering drug prices by fiat will destroy pharmaceutical innovation by decreasing the amount of money available for research and development. No matter how much money someone has, they can’t buy a cure that hasn’t been invented. People who might have been saved by that cure will die without knowing that their premature death was totally avoidable. However, there is a way to slash drug prices, virtually overnight, by removing the waste from the regulatory red tape.

As you can see from the following figure, prescription drug prices rise as the cost of regulatory-driven research and development do. According to studies done by Tufts University, the increasing costs are due to the FDA’s demands for more elaborate clinical studies. Without these studies, the agency will not approve new drugs for marketing in the United States.
We might be willing to pay the higher costs of regulation and the soaring pharmaceutical prices that they engender if drugs were safer and more effective. By any measure that we use, however, this doesn’t appear to be the case.

 

The rate at which newly approved drugs are withdrawn from the market when side effects occur hasn’t changed much in the last several decades, but is steady at about 3.3%. Indeed, the biggest drug disaster in U.S. history was FDA-approved Vioxx. By the agency’s own estimates, Vioxx was responsible for at least 140,000 heart attacks and 60,000 deaths. Properly prescribed drugs are now the 5th leading cause of death in the United States.

In many ways, the finding that all of these extra studies don’t improve drug safety is not surprising. Most “bad” drugs get to market because our science isn’t good enough to detect side effects that affect a subset of the population.

Effectiveness hasn’t gotten better either. Most drugs only work in some, but not all, patients. If we aren’t improving safety and effectiveness with regulations that increase every year, we could slash pharmaceutical prices virtually overnight by getting rid of this waste. The data suggests that drug prices would be about 5-10% of what they are now if we rolled back regulations that don’t give us more safety and effectiveness. Innovation would soar!

Don’t expect drug companies to tell President Trump how to slash drug prices, while stimulating innovation, though. They can’t afford to anger the FDA. Maybe someone should educate our president and Alex Azar before they destroy life-saving pharmaceutical innovation in a vain attempt to control drug prices.

Figure and statistics taken from my new book, Death by Regulation: How We Were Robbed of a Golden Age of Health and How We Can Reclaim It.

Dr. Norman Horn Reviews “Death by Regulation”

Longtime Libertarian writer and activist Dr Mary Ruwart has a must-read book: Death by Regulation: How We Were Robbed of a Golden Age of Health and How We Can Reclaim It.

This book draws on her years as a medical researcher for Upjohn Pharmaceuticals, her knowledge of libertarian philosophy, and her passion for liberty to explain how the 1962 Amendments to the Food and Drug Act, which gave the FDA the power to keep a drug off the market if it didn’t meet the FDA’s idea of effectiveness and safety. It not only stripped individuals of the ability to make their own health care decisions, but enriched big pharmaceutical companies. The FDA has literally killed people.

For example, the FDA prevented Americans from learning of how aspirin can help those with heart problems for a couple decades. This knowledge could have saved about 1.7 million lives. The FDA continues to delay and deny Americans from reviving life-saving cures and knowledge about how minor adjustments to their diets can help avoid certain illnesses.

Campaign for Liberty Chairman Ron Paul, who wrote the foreword for the book says, “While I was serving in Congress, Dr. Ruwart was working at Upjohn, a drug company known for its ground-breaking research. Step-by-step, she shows how the Amendments, even today, are re-shaping the FDA, the drug industry, and the field of medical practice, while shifting us away from a prevention paradigm to a treatment-based one.” You’ll want to read this book carefully: your life may depend on it.

It’s time we were all learned the truth!

Corruption, Power and Dirty Politics

Power corrupts. When we give someone authority over us, it will likely become abuse. For example, when we gave the government power of eminent domain to construct roads, it began using it to condemn private homes so that corporate developers could build malls. When we gave the government the power of civil forfeiture (taking property and money without trial) from known criminals, it began to take cash from innocent people.

When we gave the government the power to regulate industries, presumably for consumer protection, it drove the mom-and-pop shops out of business and became a way for Big Business to destroy its smaller competitors Thankfully, the libertarian Institute for Justice is fighting against these abuses pro bono. Ultimately, however, only lessening the authority of government can stop the abuse.

Remember: less authority to abuse means less abuse of authority.

We usually think that making a law makes it so, but just the opposite is usually true. When we try to legislate virtue, we end up harming the very people we intended to help. That’s why prohibition, whether of drugs or alcohol, does more harm than good. That’s why outlawing prostitution or gambling only drives it underground. That’s why regulations intended to protect the consumer usually harm them instead. Using government to force peaceful people to act as we think that they should backfires. Bad means result in bad ends, not good ones.

Most people feel politics is dirty, even if they can’t tell you why. The “why” is that government is allowed to do things that the rest of us would be thrown in jail for. Politicians and regulators often enjoy sovereign immunity for actions that would land us in prison for decades. Government officials have become a privileged class, just like the monarchs of old. Isn’t it time that they have to obey the same laws that we do?

We defer to these authority figures because they are supposed to know more than we do. If a mistake is made, it’s easy to lay the blame at their feet. Ultimately, however, we are responsible for choosing the authority figure we defer to.

Power, as in political power, is used to bend others to our will. No one who seeks to take away the liberty of others can legitimately claim to love their neighbors. Liberty, on the other hand, is consistent both with self-love and love of others, since we must be willing to grant liberty to others to have it for ourselves.

Discover the ONLY way to fix Big Pharma—it’s NOT what you think!

Ever-increasing prices, serious side effects, unscrupulous practices—and more—are hallmarks of today’s drugs and their manufacturers. Pharmaceutical industry critics blame corporate greed, but that can’t be the whole story because ALL company managers must cater to the bottom line.

In my new book, Death by Regulation, I show that the 1962 Amendments to the Food & Drug Act have reshaped the drug industry, creating almost all of the practices that its critics rail against. Unfortunately, the critics are mostly unaware of these regulations and propose “solutions” that will just make matters worse.

Click here to order now and receive up to $60 in FREE gifts immediately! On April 10, we’ll place your order with Amazon to put Death by Regulation on the best-seller list!

Find out from someone who used to work in the industry what’s really behind the problems with Big Pharma—and how to fix them for good!

Death by Regulation demonstrates tht bad law can be just as deadly as bad drugs—and tells us what we need to know to reclaim our Golden Age of Health. Foreword by Ron Paul, MD; preface by Jonathan Wright, MD; afterword by Foster Gamble.

Order Death by Regulation by clicking here!

The $60 in FREE gifts won’t be available after April 10. Order today: the life you save may be your own!

Get up to $60 in FREE bonuses when you pre-order my new book, Death by Regulation!

 

 

Death by Regulation: How We Were Robbed of a Golden Age of Health and How We Can Reclaim It 

(Click here to buy!)

In 1962, Congress passed possibly the deadliest regulations of all time: the 1962 Amendments to the Food & Drug Act. This “living law” continues to metastasize to this day, reshaping the pharmaceutical cartel, the supplement industry, the practice of medicine and transforming our health care paradigm from prevention to treatment.  Research shows at least half of Americans who have died since 1962 lost about 10 years of their lives to the Amendments; in all likelihood, each of us has been affected.

What exactly did the Amendments do to destroy what would have been a Golden Age of Health for us? The Amendments added about 10 years to the time it takes for new drugs to get from the lab bench to the marketplace. They destroyed over 50% of our innovations and censored the dissemination of life-saving information.

Not only have the Amendments cost us our lives, we paid for the “privilege” of dying prematurely. The Amendments have increased the cost of new drug development each year. What we pay for new drugs at the pharmacy is directly related to what manufacturers pay to jump through the Amendments’ regulatory hoops.

So why did Congress pass the Amendments in the first place?  The idea was to make drugs safer and more effective, but that didn’t happen. Indeed, drugs may actually be less safe and no more effective than they were before Amendment passage.

Death by Regulation demonstrates the bad law can be just as deadly as bad drugs—and tells us what we need to know to reclaim our Golden Age of Health.  Foreword by Ron Paul, MD; preface by Jonathan Wright, MD; afterword by Foster Gamble.

Check it out today and help put Death by Regulation on the Amazon best-seller list by ordering books for yourself, family, friends and colleagues.  You’ll receive up to $60 in FREE bonuses just for pre-ordering my new book. This offer won’t be available after April 10, so order today. The life you save may be your own!

Get a FREE Digital Copy of “Healing Our World” When You Help Its Romanian Translator

When the Berlin Wall fell in late 1989, and the Soviet Union crumbled, books about liberty in Eastern European languages were non-existent. A few passionate liberty-lovers rectified this by spending their free time translating pivotal freedom-oriented books into their native languages.

Valentina Nicolaie was one of those intrepid individuals. She translated Healing Our World and several other important books into her native language (Anthem, by Ayn Rand; The Adventures of Jonathan Gullible by Ken Schoolland; La liberte – deux ou trois choses que je connais d elle by Christian Michel, and Defending the Undefendable, by Walter Block). Finally, Romanians could learn about freedom’s benefits in their own language! Valentina received little or no compensation for this monumental work.

Now Valentina needs our help. She has metastatic breast cancer and wasn’t able to withstand the recommended chemotherapy. Valentina has turned instead to alternative methods, such as high dose Vitamin C infusions, but, as in the U.S., she’ll need to pay out of her own pocket.

Liberty International, formerly International Society for Individual Liberty, is raising funds to help Valentina. She was awarded the Bruce Evoy Memorial Award in 2001 for her dedicated service to liberty under trying conditions in her country. Your contribution towards her medical fund is tax-deductible.

Best of all, EVERY contributor will receive a PDF of Valentina’s Romanian translation of the 1992 edition of Healing Our World to share with any Romanians that you might know. Donors who contribute $25 or more will also get a Kindle, ePub, and PDF of the 2015 English edition of Healing, which sells on www.ruwart.com for $9.99.  Please note: You will receive the complimentary copies via e-mail August 20.

Please contribute now and help Valentina live to translate another day!

Please help impoverished Indians secure title to their lands!

Liberty International is raising funds to help impoverished Indian farmers and villagers gain clear title to the lands that they have homesteaded. Without secure title, their government can drive them off their land for the benefit of the elite. Securing their land rights not only prevents government-sanctioned land grabs, but greatly enriches the poor. Clear title makes them land owners instead of squatters. Click here to help them!

 

Hundreds of thousands of desperately poor, subsistence farmers in India now urgently need help to protect their land and their lives. Thousands of small farms and forest villages, where native Indians have lived sustainably for centuries, are being stolen by corrupt corporations and government officials, using increasingly brutal tactics.

It’s a land grab of epic scale and epic inhumanity.

In the last six months, the situation has become critical: Without our help, thousands will soon be homeless and destitute, or worse. Everything these poor people have is at risk, including their lives and way of life. Once their land is taken, it’s gone forever.

Liberty International is rushing to their aid. Our goal of $400,000 will enable us to protect land and lives in 200 native villages. Over 100,000 native Indians in over 250 villages have already been helped by Liberty Institute and ARCH teams we are working with in India. (ARCH: the Action Research in Community Health & Development, India). But for every Indian villager who has been saved, dozens more remain in danger.

Thousands of native lives saved

Over the last few decades, India’s land rights movement has dramatically transformed the lives of hundreds of thousands of poor, native Indians – protecting their land, their homes, and their lives.

Trupti Mehta of ARCH (India) explains that before the land rights movement:

“The people lived in squalor. They hovered around the fire in bitter cold winter for lack of clothing, blankets, and shelter. They scrounged for roots to eat. Their huts were straw and demolished at the whim of Forestry officials.”  They “were constantly beaten by officials and the local police. Forestry officials would fine them, force them to do labor for the government, wreck their homes and fields, seize their livestock.”

To stop these outrages, Liberty International is working with Liberty Institute and ARCH land rights teams in India using hand-held GPS units to register their land, and legal teams to defend their rights.

With secure land titles, villagers are protected from forced labor and the confiscation of their produce, homes and livestock. For poor Indian farmers, secure land rights have made the difference between extreme poverty and economic security . . . starvation and plentiful food . . . and even life and death.

You can help make the difference between desperate poverty and prosperity for thousands! Your support for Liberty International’s India Land Rights Initiative will help secure land rights and end poverty for thousands of poor villagers and farmers.

Technical, legal and other costs average $2,000 a village to train villagers, use GPS to register property, teach them to non-violently stand up for their land rights, and legally protect their land.

Please contribute whatever you can to Liberty International’s Emergency India Land Rights Intervention. Every dollar counts. A small donation now can literally help change the course of a nation.

For U.S. contributors, donations are 100% tax deductible. Liberty International is a 501(c )(3) nonprofit organization. Help us save thousands of desperately poor Indians and change the course of a nation. Click here to donate whatever you can.

Libertarian Lee Wrights Dead at 58

Liberty lost a great champion today when Lee Wrights passed away just a few months shy of his 59th birthday.  Lee, a veteran of the U.S. Air Force, spent decades as a libertarian activist and journalist.

After college degrees in history and journalism, Lee became a contributing editor for the Eagle News, a monthly political news and commentary newspaper in Forsyth County. Wrights founded Liberty for All with J. Michael Bragg in 2000, a free speech publication with the motto “Let Your Voice Be Heard” which claimed “no one is turned away and no one is censored.”

In 2001, Wrights became an editor of Free Market Daily, an e-mail newsletter. A year later, he helped to found the Rational Review News Digest, a daily web and email-based news and commentary roundup. From 2005 to 2008, Wrights worked as editor of the Choice Channel for the International Society for Individual Liberty, now Liberty International.

Wrights has been active in local, state and national Libertarian Party organizations since 2000 and is a lifetime member of the Libertarian Party (LP). He has served as secretary and chair of the Libertarian Party of Forsyth County, N.C. and was vice chair of the Libertarian Party of North Carolina (LPNC) for seven years. He also served as the LPNC ballot access director for two years.

Wrights served twice as the Vice Chair of Libertarian National Committee (LNC), and an at-large member.  He was a member of the LNC’s platform committee and judicial committee as well.  Lee chaired the Burnet County LP of Texas and was the Senate District 24 representative to the Texas LP State Executive Committee. In 2008, Wrights was my campaign manager when I ran for the 2008 presidential nomination for the LP; in 2010, he managed my campaign for Texas State Comptroller.

Wrights was also the president of the Foundation for a Free Society, a non-profit educational organization dedicated to promoting the principles of liberty, personal sovereignty, private property, and free markets.

Lee ran for the 2012 presidential nomination of the Libertarian Party with the goal of stopping all war, referring not only to war with foreign nations, but also to war on the American people and their civil liberties waged by the U.S. government. Wrights was defeated by former New Mexico Governor, Gary Johnson.

For the past few years, Lee has handled several libertarian Facebook pages, including my own.  He has inspired friends and fans with his trademark “Reddpaw” memes.

Lee leaves behind supporters from all over the world, as well as his two daughters, parents, brothers and sisters, and other family.  He will be sorely missed by his close friends who love him dearly, myself included.