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Is it Corporate Greed That Led to Turing Pharmaceuticals’ “Price Gouging” on Daraprim?

in Ask Dr. Ruwart, Liberator Online by Mary Ruwart Comments are off

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Question: Is it corporate greed that led to Turing Pharmaceuticals’ “price gouging” on Daraprim?

Turing PharmaceuticalsOver the last couple of days, the media has been aghast as Turing Pharmaceuticals CEO, Martin Shkreli announced his plan to increase the price of Daraprim from $13.50 to $750 a pill. Daraprim was patented in the 1950s, and is used for treating parasitic infections in fewer than 13,000 people a year in the U.S.  Turing bought exclusive rights to distribute the drug in the U.S. from Impax for $55 million; drug sales are less than $10 million/year.  Impax itself bought daraprim several years earlier. It upped the price from $1 to $13.50/pill, causing the number of prescriptions to drop about 30%.

Shkreli’s assertion that the profits would be used to develop a better drug for treating toxoplasmosis was met with skepticism.  Shkreli is a former hedge fund manager, not a pharma veteran, and might not be aware that the new drug will have to be tested against daraprim itself. Testing against placebo would be unethical, given that daraprim is part of the treatment standard.  Showing superiority, in terms of effectiveness or side effects, is much more difficult against another drug than placebo. Indeed, given the small number of patients who need the drug, it might be impossible to show the “statistical significance” required by the FDA, since large numbers of patients can’t be tested.

Why, you might ask, can Shkreli price his drug so high and not fear that a generic competitor will undercut him? After all, the daraprim no longer has patent protection.

The answer: Turing Pharmaceuticals has a de facto monopoly, courtesy of the ever-increasing costs of gaining FDA approval, both for new drugs (over $1 billion and 11 years) and generics. Any generic company could make daraprim; its patent expired decades ago.

However, the FDA would require that the company demonstrate that its pill released the drug into the blood stream at the same rate as the original daraprim.  Coupled with the cost of setting up FDA-approved manufacturing facilities for the new drug, a turn-around time of a couple years or so due to regulatory red-tape, and the expensive clinical trials, a generic company would need to commit to spending many millions, perhaps tens of millions, even with the special exemptions that the FDA gives drugs that have small or “orphan” patient populations.  After jumping through all of these costly hoops, the competitor might be unable to take a substantial part of the market from Turing should it choose to lower its prices for the sole reason of preventing the competitor from getting a foothold.

The $750 pill might be considered an example of “corporate greed.”  However, Turing probably wouldn’t have even attempted such a price hike without high cost of FDA-mandated drug development, both new and generic, which virtually eliminated his competition.


Outsourcing is TERRIBLE!

in Communicating Liberty, From Me To You, Liberator Online, Walk the Walk by Brett Bittner Comments are off

This article was featured in our weekly newsletter, the Liberator Online. To receive it in your inbox, sign up here.

Jobs shipped overseas!

Sweatshops exploiting the poor!

Workers laid off!

Camden NJ

We’ve all seen a politician or two try to score political points by talking about outsourcing and how outsourcing destroys the fabric of America… Or it takes jobs from Americans… Or it is bad for the economy…

What if I told you that none of those politicians sees that they serve as the mechanism by which EVERY American outsources the worst thing we possibly could.

We outsource responsibility.

Within (and hopefully outside) the libertarian movement, we discuss individual liberty and all that flourishes with that liberty, while recognizing that the price of individual liberty is responsibility, both personal and social.

Today, Americans outsource responsibility to government.

Rather than seeking knowledge about what is in the food we eat and how safe it is, we outsource that responsibility to the FDA and USDA. They do such a great job of preventing outbreaks of foodborne illness and ensuring that we have nutritious meals every time we eat, don’t they?

Rather than caring for others through mutual aid societies and private charity, we outsource that responsibility to the alphabet soup that is SNAP, AFDC, and TANF. Those programs keep people from going hungry and from living on the street so well, don’t they?

Rather than choosing the type and quality of education our children receive, we outsource that responsibility to a school system that chooses for our children the type and quality based on our ZIP code. Government schools continue to provide the highest-quality, individualized education that each of our children will need to succeed in the world they will face as adults, don’t they?

What if we chose to take back the responsibility of all that we’ve outsourced to government and focus on how we can flourish with the liberty that comes along with it?

Will you be more responsible with me and end this outsourcing?

New House Bill Will Protect Your Freedom to Vape

in Drugs, Liberator Online, News You Can Use, Personal Liberty by Jackson Jones Comments are off

The Food and Drug Administration (FDA) is planning to expand its vast regulatory reach to e-cigarettes and vape products, but new language in an agriculture bill currently in the U.S. House of Representatives could throw a wrench into the machine.

vapeThe FDA plans to use a “deeming rule” to move forward on regulations that would treat e-cigarettes and vape products like tobacco. Though these products can contain nicotine, which is entirely up to the user, they don’t have tobacco. In fact, there is, according to the American Vaping Association, “no fire, no ash, [and] no smoke.”

Many people who use e-cigarettes or vape products do so to quit smoking, using high-nicotine e-juices and gradually lowering the dosage until they’ve kicked the habit. The FDA and public health advocacy groups claim that e-cigarette and vape products are dangerous and target minors through different flavors available on the market. Despite the concerns, studies have shown these products don’t emit significant amounts of toxins, especially when compared to real cigarettes.

“Does this mean e-cigarette vapor is about as safe as air? Not quite, since we don’t know the long-term respiratory effects of inhaling the glycerin or propylene glycol that delivers nicotine into vapers’ lungs,” Jacob Sullum wrote at Reason. “But whatever those effects are, it is safe to say they will not compare to the effects of smoking.”

Rep. Robert Aderholt, R-Ala., has introduced language to the agriculture appropriations bill currently working its way through committee that would reduce the impact of the awaited FDA regulations. The bill would prevent the FDA from reviewing products already available on the market, which, opponents say, could virtually put the industry out of business.

“Without action by Congress, the FDA’s proposed regulations threaten to ban 99 percent-plus of vape products currently available on the market,” said Gregory Conley, President of the American Vaping Association, of the bill’s introduction in the House. “This would be a disaster not only for thousands of small businesses, but also public health.”

“This proposal does not remove the FDA’s ability to regulate vape products. The FDA will retain the authority to immediately move forward with science-based product standards, disclosure requirements, and many other measures. Anyone who claims that this bill would somehow render the FDA toothless is either not familiar with the law or not being forthright,” he added.

While a ban on the sale of e-cigarette and vape products to minors may be appropriate – though most sellers already refuse to sell to anyone under the age of 18 – promulgating regulations that would subject this industry to extensive regulation is a bridge too far.

Interestingly, “Big Tobacco” is encouraging the FDA to implement the regulations. Some traditional cigarette makers are in the e-cigarette business. Reynolds American, for example, the maker of Newport and Camel cigarettes, owns Blu e-cigs. Conley believes Reynolds and other cigarette makers, which are already subject to the regulation and can easily absorb the cost, are trying to snuff out refillable vapor producers, which are typically small businesses.

The FDA regulations are due to be announced in the coming weeks, if not sooner. In the meantime, puff ‘em while you have ‘em, because your freedom to vape may not be around much longer.

FDA Bureaucrats Kill 150,000 Americans

in Liberator Online by James W. Harris Comments are off

(From the Intellectual Ammunition section in Volume 19, No. 19 of the Liberator Online. Subscribe here!)

Never mind Ebola, terrorists and school shootings. Abolish the FDA

What Americans should fear is… the FDA (U.S. Food and Drug Administration).

The FDA’s failure to approve life-saving drugs in a timely fashion is killing thousands, even tens of thousands, of Americans every year, critics charge.

Take just one example. An estimated 150,000 Americans have died or will die from idiopathic pulmonary fibrosis — a disease in which tissue deep in the lungs becomes thick and stiff, or scarred, making breathing difficult — because of the FDA’s four-year delay in the approval of the drug pirfenidone — a drug already approved and marketed in Europe (since 2011), Japan (2008), Canada (2012) and China.

That estimate comes from Dr. Henry I. Miller, a medical researcher, founding director of the FDA’s Office of Biotechnology, and 15-year member of the FDA.

That’s more Americans than were killed in any American war except the Civil War and World War II.

And pirfenidone is just one example among many others. The FDA’s slow approval of beta-blocking drugs in the 1970s may have led to the unnecessary deaths of up to 100,000 people, according to Sam Kazman, J.D., of the Competitive Enterprise Institute.

For many years the FDA prohibited aspirin makers from advertising the widely-accepted argument that aspirin could significantly reduce the risk of heart attack for some patients. According to economist Paul H. Rubin, “The FDA surely killed tens, and quite possibly hundreds, of thousands of Americans by this restriction alone.”

Indeed, says Reason magazine’s science correspondent Ronald Bailey, “the FDA’s increased obsession with safety may be killing more people than it saves. …After all, if it takes the FDA ten years to approve a drug that saves 20,000 lives per year that means that 200,000 people died in the meantime.”

The FDA’s approval process can take up to… 18 years. For people desperately fighting fatal illnesses, such long waits are death sentences.

Making things worse, the FDA’s review process is so expensive that,according to Yevgeniy Feyman of the Manhattan Institute: “The typical drug approval costs between $1.2 and $1.3 billion.”

According to Reason magazine’s Bailey, many drugs that could save lives are never introduced because of this cost.

In 2000, economist Daniel B. Klein of the Independent Institute wrote: “Because the FDA process is so expensive, so protracted, and so uncertain, thousands of untold drugs are never discovered or developed. It is impossible to estimate the suffering and death caused, but surely it greatly exceeds 50,000 premature deaths annually.”

Why is the FDA so agonizingly (literally) slow and expensive? Prior to 1962, the average time for FDA approval was just seven months. However, in 1962 Congress passed the Kefauver Harris Amendment, which added a new requirement of proof of effectiveness, in addition to the old standard of proof of safety, for approval of new drugs. Effectiveness is a far more difficult, and expensive, standard to meet.

Perhaps worst of all, the FDA typically doesn’t give even gravely ill patients the opportunity to choose promising treatments it has not approved. As journalist Kate Jenkins asks: “If you had a fatal disease and were told you only had one year to live, wouldn’t you prefer to be allowed to make your own choice?”

This article by Ronald Bailey gives a further look at this mess, and offers libertarian alternatives.

The Independent Institute offers an overview of the situtation and proposals for replacing the FDA.

And for a great movie that dramatizes this life-and-death struggle, see The Dallas Buyers Club starring Matthew McConaughey.

What 10 Federal Laws, Agencies or Rulings Would You Abolish?

in Liberator Online, Libertarian Answers on Issues, Libertarian Stances on Issues, Libertarianism by Mary Ruwart Comments are off

(From the Ask Dr. Ruwart section in Volume 19, No. 14 of the Liberator Online. Subscribe here!)

QUESTION: If you could repeal 10 federal laws, reverse 10 Supreme Court rulings or dismantle 10 federal agencies, which laws, rulings or agencies would you do away with? I guess what I’m looking for is the libertarian “hit list.”

TargetMY SHORT ANSWER: Each libertarian might answer this differently, so I can only give you my personal favorites. If I could magically change our government ten ways, I would end all taxation (1), confiscation (2), and eminent domain (3), effectively cutting off the government’s revenue. The borrowing powers of the government would be rescinded to prevent it from deficit spending in retaliation (4). Any outstanding obligations would be retired (5), as much as possible, from sales of government property (including about 42% of our country’s land mass).

Without the means to compel payment for government services, all government agencies would have to operate like any business by voluntary exchange with its customers. Agencies that failed to provide satisfactory service would have to shut their doors. Since some people would undoubtedly be willing to support a government that regulated in their favor, any initiation of force, by government or individuals, would be outlawed (6).

Sovereign immunity would be eliminated (7), making government officials subject to direct prosecution by their victims. For example, bureaucrats in the FDA, if they managed to survive the above reforms, could be held liable for deaths that they caused by denying the American consumer access to drugs of their choice or information about them.

Gold and silver would likely become legal tender, by simply ending the Federal Reserve’s monopoly on currency issue (8). I’d make a declaration of war by Congress necessary for sending troops overseas (9), taking away the president’s power to wage war by naming it something else.

Finally, I’d save my last “wish”‘ for something critical that I may have missed!

Read the next article from this issue here.

Go back to the full issue here.

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Short Answers to Tough QuestionsGot questions?  Dr. Ruwart has answers! If you’d like answers to YOUR tough questions on libertarian issues, email Dr. Ruwart

Due to volume, Dr. Ruwart can’t personally acknowledge all emails. But we’ll run the best questions and answers in upcoming issues.

Dr. Ruwart’s previous Liberator Online answers are archived in searchable form.

Dr. Ruwart’s latest book Short Answers to the Tough Questions, Expanded Edition is available from the Advocates, as is her acclaimed classic Healing Our World.

Who’s to Blame for Dangerous Prescription Drugs: The FDA or Big Pharma?

in Healthcare, Liberator Online, Libertarian Answers on Issues, Libertarian Stances on Issues by Mary Ruwart Comments are off

(From the Ask Dr. Ruwart section in Volume 19, No. 10 of the Liberator Online. Subscribe here!)

QUESTION: The pharmaceutical company is sometimes caught pressuring the FDA to approve drugs with dangerous prescription drugsside effects and the FDA does so. Who is the prime mover of aggression here, the FDA or the pharmaceutical cartel?

MY SHORT ANSWER: It’s the karmic circle. The American public allowed the FDA to regulate the pharmaceutical companies under the largely erroneous assumption that they were nefarious. In the beginning, the primary loss to the American public was fewer life-saving drugs, since more money had to be spent on development instead of discovering new drugs.

The regulations reshaped the industry in a way that encouraged graft, as the regulations got more onerous. The industry “fought back” with the Prescription Drug User Fee Act which lets companies pay about $1 million for a faster review. This co-opted the regulators, since about half of their budget now comes from such fees.

In addition to losing many life-saving drugs, the drugs that we get now are less safe. The biggest safety problem with drugs on the market today is that they are meant for long-term use, which amplifies side effects. That’s because only drugs for long-term use can recover the high cost of development that regulations have produced. Even with the high prices of drugs, only 3/10 recover their costs.

This is a lose-lose situation for the American public, the industry itself (which has become close to unsustainable), and even the regulators, who will one day die or watch their loved ones die from diseases that might have been cured without regulations.

LEARN MORE: Suggested additional reading on this topic from Liberator Online editor James W. Harris:

* “Abolishing the FDA: FDA Policies Keep People Sick and Create a False Sense of Security“ by Larry Van Heerden The Freeman, March 1, 2007.

Excerpt: “The Food and Drug Administration (FDA) started out as a bulwark against snake-oil peddling. It has since swung back and forth between hostility and subservience to the drug industry. The FDA seems indifferent to the many deaths its own intransigence has caused and imperious when forced to defend its actions in court, resulting in a system that withholds life-saving drugs from the market, approves dangerous drugs, and denies everyone freedom of choice. The time has come to seriously consider abolishing the FDA.”

The FDA Vs. the Health and Safety of Americans

in Communicating Liberty, Healthcare, Liberator Online by Mary Ruwart Comments are off

QUESTION: Which problem is the greatest: the FDA’s approving unsafe drugs, or the FDA’s delaying the approval of life-saving ones?

MY SHORT ANSWER: In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA), allowing drug companies to voluntarily pay about $100,000 to get a speedier review. The money went to hire new reviewers.

The fee has grown steadily; it’s now over one million dollars per drug. The part of the FDA that reviews drug applications now receives about 50% of its funding from drug companies. FDA employees (e.g., Dr. David Graham, the whistleblower on Vioxx) have reported being told by supervisors that the drug companies — not the American public — are the FDA’s clients. This should be expected, as he who pays the bills makes the rules.

Does this mean that the FDA now approves unsafe drugs? It depends on how you look at it. Withdrawal rates (the percent of approved drugs removed from the market) from 1962-1992 and 1993-2013 are virtually identical at about 3%. As time goes on, however, more drugs approved during 1993-2013 are likely to be withdrawn. The differences may be small, though, as most withdrawals occur quickly. On the other hand, Vioxx, approved post-PDUFA, was by far the biggest drug disaster in history.

Does the FDA still delay approval of life-saving drugs? Yes! It does so by demanding that companies perform studies taking an average of 13-plus years. Prior to 1962, the average time was about 4 years. I suspect that these delays are still more costly, in terms of lives lost, than approvals of unsafe drugs.

* * * * * * * * * *
Buy It Now!Got questions?  Dr. Ruwart has answers! If you’d like answers to YOUR tough questions on libertarian issues, email Dr. Ruwart

Due to volume, Dr. Ruwart can’t personally acknowledge all emails. But we’ll run the best questions and answers in upcoming issues.

Dr. Ruwart’s previous Liberator Online answers are archived in searchable form.

Dr. Ruwart’s latest book Short Answers to the Tough Questions, Expanded Edition is available from the Advocates, as is her acclaimed classic Healing Our World.