Browsed by
Tag: Food and Drug Administration

One Bill Could Massively Improve Access to Lifesaving Drugs – Article by Alex Tabarrok

One Bill Could Massively Improve Access to Lifesaving Drugs – Article by Alex Tabarrok

The New Renaissance HatAlex Tabarrok
******************************

Reciprocity is an effective and common-sense idea

Senators Ted Cruz (R-Texas) and Mike Lee (R-Utah) have just introduced a bill that would implement an idea that I have long championed: making drugs, devices, and biologics that are approved in other developed countries also approved for sale in the United States.

Highlights of the “Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act (S. 2388), or the RESULT Act,” include:

  • Amending the Food, Drug and Cosmetic Act to allow for reciprocal approval of drugs, devices and biologics from foreign sponsors in certain trusted, developed countries including EU member countries, Israel, Australia, Canada and Japan.
  • Encouraging the FDA to expeditiously review life-saving drug and device applications, this legislation would provide the FDA with a 30-day window to approve or deny a sponsor’s application….
  • The HHS Secretary is instructed to approve a drug, device or biologic if the FDA confirms the product is:
    • Lawfully approved for sale in one of the listed countries;
    • Not a banned device by current FDA standards;
    • There is a public health or unmet medical need for the product.
  • If a promising application for a life-saving drug is declined Congress is granted the authority to disapprove of a denied application and override an FDA decision with a majority vote via a joint resolution.

In explaining why he introduced the bill, Senator Cruz argued:

We continue to lose far too many of our loved ones to the “invisible graveyard,” as economist Alex Tabarrok has described: lives that could have been saved but for a bureaucratic barrier that rejects medical cures and innovation…

The bill I am introducing takes the first step to reverse this trend. It provides for reciprocal drug approval, so that cures and medical devices that are already approved in other countries can more expeditiously come to the U.S.

This post first appeared at Marginal Revolution.

Alex Tabarrok is a professor of economics at George Mason University. He blogs at Marginal Revolution with Tyler Cowen.

Fast-Tracking Safe Drugs without Sacrificing Scientific Rigor – Article by Alex Tabarrok

Fast-Tracking Safe Drugs without Sacrificing Scientific Rigor – Article by Alex Tabarrok

The New Renaissance HatAlex Tabarrok
******************************

Here’s how to do it

In a post earlier this year, I noted that Japan has significantly liberalized its approval process for regenerative medicine. Writing in Forbes, Bart Madden and Nobelist Vernon Smith outline a similar proposal for the United States.

Recently, Japanese legislation has implemented the core Free To Choose Medicine (FTCM) principles of allowing not-yet-approved drugs to be sold after safety and early efficacy has been demonstrated; in addition, observational data gathered for up to seven years from initial launch will be used to determine if formal drug approval is granted. …

FTCM legislation in the U.S. would create a dual track system (see figure below) that preserves the existing FDA clinical trial process while offering patients an alternative. Patients, advised by their doctors, would be able to contract with a drug developer to use not-yet-approved drugs after Phase I safety trials are successfully completed and one or more Phase II trials have demonstrated continued safety and initial efficacy.

The resulting early access could make FTCM drugs available up to seven years before conventional FDA approval, which entails Phase III randomized control trials and a lengthy FDA review before the FDA makes an approval decision. …

bartgraph

The heart of the dual track system is the Tradeoff Evaluation Drug Database (TEDD) which would be available to the public through a government-supervised web portal. TEDD would contain all treatment results of FTCM drugs including patients’ health characteristics and relevant biomarkers, but no personal identification.

This open access database would be a treasure-trove of information to aid drug developers in making better R&D decisions consistent with fast-paced learning and innovation. …

Today’s world of accelerating medical advancements is ushering in an age of personalized medicine in which patients’ unique genetic makeup and biomarkers will increasingly lead to customized therapies in which samples are inherently small. This calls for a fast-learning, adaptable FTCM environment for generating new data.

In sharp contrast, the status quo FDA environment provides a yes/no approval decision based on statistical tests for an average patient, i.e., a one-size-fits-all drug approval process.

I hold the Bartley J. Madden Chair in Economics at the Mercatus Center, so I am biased, but this is an important proposal. Japan is leading the way and similar ideas are being discussed in Great Britain, but as the most important pharmaceutical market in the world, the United States has an outsize influence on world drug development. We need to lower costs and speed new drugs to market.

This post first appeared at Marginal Revolution.

Alex Tabarrok is a professor of economics at George Mason University. He blogs at Marginal Revolution with Tyler Cowen.

Is the FDA Too Conservative or Too Aggressive? – Article by Alex Tabarrok

Is the FDA Too Conservative or Too Aggressive? – Article by Alex Tabarrok

The New Renaissance HatAlex Tabarrok
September 21, 2015
******************************

I have long argued that the FDA has an incentive to delay the introduction of new drugs because approving a bad drug (Type I error) has more severe consequences for the FDA than does failing to approve a good drug (Type II error). In the former case at least some victims are identifiable and the New York Times writes stories about them and how they died because the FDA failed. In the latter case, when the FDA fails to approve a good drug, people die but the bodies are buried in an invisible graveyard.

In an excellent new paper (SSRN also here) Vahid Montazerhodjat and Andrew Lo use a Bayesian analysis to model the optimal tradeoff in clinical trials between sample size, Type I and Type II error. Failing to approve a good drug is more costly, for example, the more severe the disease. Thus, for a very serious disease, we might be willing to accept a greater Type I error in return for a lower Type II error. The number of people with the disease also matters. Holding severity constant, for example, the more people with the disease the more you want to increase sample size to reduce Type I error. All of these variables interact.

In an innovation the authors use the U.S. Burden of Disease Study to find the number of deaths and the disability severity caused by each major disease. Using this data they estimate the costs of failing to approve a good drug. Similarly, using data on the costs of adverse medical treatment they estimate the cost of approving a bad drug.

Putting all this together the authors find that the FDA is often dramatically too conservative:

…we show that the current standards of drug-approval are weighted more on avoiding a Type I error (approving ineffective therapies) rather than a Type II error (rejecting effective therapies). For example, the standard Type I error of 2.5% is too conservative for clinical trials of therapies for pancreatic cancer—a disease with a 5-year survival rate of 1% for stage IV patients (American Cancer Society estimate, last updated 3 February 2013). The BDA-optimal size for these clinical trials is 27.9%, reflecting the fact that, for these desperate patients, the cost of trying an ineffective drug is considerably less than the cost of not trying an effective one.

(The authors also find that the FDA is occasionally a little too aggressive but these errors are much smaller, for example, the authors find that for prostate cancer therapies the optimal significance level is 1.2% compared to a standard rule of 2.5%.)

The result is important especially because in a number of respects, Montazerhodjat and Lo underestimate the costs of FDA conservatism. Most importantly, the authors are optimizing at the clinical trial stage assuming that the supply of drugs available to be tested is fixed. Larger trials, however, are more expensive and the greater the expense of FDA trials the fewer new drugs will be developed. Thus, a conservative FDA reduces the flow of new drugs to be tested. In a sense, failing to approve a good drug has two costs, the opportunity cost of lives that could have been saved and the cost of reducing the incentive to invest in R&D. In contrast, approving a bad drug while still an error at least has the advantage of helping to incentivize R&D (similarly, a subsidy to R&D incentivizes R&D in a sense mostly by covering the costs of failed ventures).

The Montazerhodjat and Lo framework is also static, there is one test and then the story ends. In reality, drug approval has an interesting asymmetric dynamic. When a drug is approved for sale, testing doesn’t stop but moves into another stage, a combination of observational testing and sometimes more RCTs–this, after all, is how adverse events are discovered. Thus, Type I errors are corrected. On the other hand, for a drug that isn’t approved the story does end. With rare exceptions, Type II errors are never corrected. The Montazerhodjat and Lo framework could be interpreted as the reduced form of this dynamic process but it’s better to think about the dynamism explicitly because it suggests that approval can come in a range–for example, approval with a black label warning, approval with evidence grading and so forth. As these procedures tend to reduce the costs of Type I error they tend to increase the costs of FDA conservatism.

Montazerhodjat and Lo also don’t examine the implications of heterogeneity of preferences or of disease morbidity and mortality. Some people, for example, are severely disabled by diseases that on average aren’t very severe–the optimal tradeoff for these patients will be different than for the average patient. One size doesn’t fit all. In the standard framework it’s tough luck for these patients. But if the non-FDA reviewing apparatus (patients/physicians/hospitals/HMOs/USP/Consumer Reports and so forth) works relatively well, and this is debatable but my work on off-label prescribing suggests that it does, this weighs heavily in favor of relatively large samples but low thresholds for approval. What the FDA is really providing is information and we don’t need product bans to convey information. Thus, heterogeneity plus a reasonable effective post-testing choice process, mediates in favor of a Consumer Reports model for the FDA.

The bottom line, however, is that even without taking into account these further points, Montazerhodjat and Lo find that the FDA is far too conservative especially for severe diseases. FDA regulations may appear to be creating safe and effective drugs but they are also creating a deadly caution.

Hat tip: David Balan.

This post first appeared at Marginal Revolution.

Alex Tabarrok is a professor of economics at George Mason University. He blogs at Marginal Revolution with Tyler Cowen. 
Japan Liberalizes Gene Therapy and Regenerative Medicine – Article by Alex Tabarrok

Japan Liberalizes Gene Therapy and Regenerative Medicine – Article by Alex Tabarrok

The New Renaissance HatAlex Tabarrok
September 17, 2015
******************************

Japan is liberalizing its approval process for regenerative medicine:

Regenerative medicines in Japan can now get conditional marketing approval based on results from mid-stage, or Phase II, human trials that demonstrate safety and probable efficacy.

Once lagging behind the United States and the European Union on approval times, there is now an approximately three-year trajectory for approvals, according to Frost’s Kumar. That compares with seven to 10 years before. …

Around the world, companies have also faced setbacks while pushing such treatments. In the U.S., Geron Corp., which started the first nation-approved trial of human embryonic stem cells, ended the program in 2011, citing research costs and regulatory complexities. …

While scientists globally have worked for years in this field, treatments have been slow to come to market. But there is hope in Japan that without the political red tape, promising therapies will emerge faster and there will be speedier rewards.

Japan is liberalizing because with their aging population treatments for diseases like Alzheimer’s and Parkinson’s disease are in high demand.

Under the new system, a firm with a gene or regenerative therapy (e.g. stem cells) can get conditional approval with a small trial. Conditional approval means that the firm will be able to sell its procedure while continuing to gather data on efficacy for a period of up to seven years. At the end of the seven-year period, the firm must either apply for final marketing approval or withdraw the product.

The system is thus similar to what Bart Madden proposed for pharmaceuticals in Free to Choose Medicine.*

Due to its size and lack of price controls, the US pharmaceutical market is the most lucrative pharmaceutical market in the world.

Unfortunately, this also means that the US FDA has an outsize influence on total world investment. The Japanese market is large enough, however, that a liberalized approval process if combined with a liberalized payment model could increase total world R&D.

Breakthroughs made in Japan will be available for the entire world so we should all applaud this important liberalization.

This post first appeared at Marginal Revolution.

* Editor’s note from the Foundation for Economic Education: There may well by a direct connection here. According to Madden, an early version of his proposal in Free to Choose Medicine was published in a booklet by the Heartland Institute, which was then translated and distributed in Japan by a Japanese free-market think tank.

For more on free markets in medicine, see Bart Madden’s article “The Pathway to Faster Cures” in the autumn print edition of the Freeman and on The Rational Argumentator.

Alex Tabarrok is a professor of economics at George Mason University. He blogs at Marginal Revolution with Tyler Cowen. 

Mr. Stolyarov Cited in The Heartland Institute’s Articles on E-Cigarettes, Medicaid Estate Recovery, and Doctors Withholding Treatment

Mr. Stolyarov Cited in The Heartland Institute’s Articles on E-Cigarettes, Medicaid Estate Recovery, and Doctors Withholding Treatment

The New Renaissance Hat
G. Stolyarov II
May 17, 2015
******************************

My remarks have been cited in three new articles from The Heartland Institute regarding health policy issues.

* FDA Moves to Regulate E-Cigarettes – Article by Matthew Glans

As a nonsmoker, I do not have any attraction to e-cigarettes, but I am opposed, on both moral and practical grounds, to any attempts to restrict them. This article by Matthew Glans cites my remarks with regard to recent FDA attempts to limit the availability of e-cigarettes to young people.

***

Excerpt:

FDA’s push to regulate e-cigarettes may invite unintended health consequences, says Gennady Stolyarov, editor-in-chief of The Rational Argumentator. Although many nonsmokers have absolutely no attraction to e-cigs or tobacco products of any sort, for some individuals, e-cigs may work as a substitute for traditional tobacco products or as a part of a transitional approach toward the cessation of smoking.

E-cigs lack the high levels of more than 40 carcinogenic byproducts found in traditional tobacco smoke, and they also minimize the harm caused by secondhand smoke, says Stolyarov. If somebody wishes to smoke, it is better for that person’s health and the health of others if the person smokes an e-cigarette.

***

* California Seizes Estates of Deceased Medicaid Patients – Article by Kenneth Artz

This article by Kenneth Artz cites my remarks in opposition to the Medi-Cal “estate recovery” program, whereby California Medicaid recipients’ homes can be expropriated from them upon their deaths.

***
Excerpt:

Stolyarov says the estate recovery program is an example of an extremely hardhearted government program that forces people to suffer because of family members’ prior debts or health care needs.

“A person should not lose the family home because one of his or her deceased parents had little or no income and took recourse to Medicaid to pay for treatments for terminal cancer or another terrible disease,” Stolyarov said. “This is especially true given the fact most Medicaid recipients have no easy way of knowing their estates are put in jeopardy when they sign up for the program.”

This situation also sends a cautionary message about socialized health care arrangements purporting to provide “free” medical care, Stolyarov says.

“There is always a cost, and there are always strings attached when any aspect of health care is centrally planned,” said Stolyarov.

***

* Dutch Doctors Withholding and Withdrawing Treatment from the Elderly – Article by Kenneth Artz

It is essential to treat all medical patients as human beings with decision-making autonomy, whose lives are worth living. In particular, a decision to shorten life by forgoing medical treatment should never be made by anyone except the patient him/herself. This article by Kenneth Artz cites my remarks regarding a recent study in the Journal of Medical Ethics is that withholding treatment from certain patients (particularly the elderly) appears to be becoming a default decision by doctors in the Netherlands in many cases – rather than a decision deliberately opted into by patients.

While people ought to have a right to voluntarily refuse medical treatment, it is also the case that they should have the right to insist on any and every measure that could possibly prolong their lives, even if their chances are remote. If a patient wishes to try a treatment that has a remote chance of succeeding, but where the alternative is a certain death, that patient’s desires should not be overridden by a central authority or even a medical expert.

***

Excerpt:

It is extremely important to respect the liberty of patients to make choices regarding their medical care and the aggressiveness with which they want to fight for their lives, says Gennady Stolyarov, editor-in-chief of The Rational Argumentator.

“What is disturbing about the findings of this study is that withholding treatment from certain patients—particularly the elderly—appears to be becoming a default decision by doctors in many cases, rather than a decision deliberately opted into by patients,” Stolyarov said. “The culture of medicine should always be guided by the premise that taking action to save life is the default, and only the patient should be able to make a different decision.”

***

23andMe and the FDA’s Travesty of Justice – Video by G. Stolyarov II

23andMe and the FDA’s Travesty of Justice – Video by G. Stolyarov II

Mr. Stolyarov explains that the US Food and Drug Administration has hit a new low in warning the genetic testing service 23andMe to halt sales of its $99 testing kits. The kits are not a drug or medical treatment; they merely provide information and violate no one’s rights. The irrationality of some people is used as an excuse to deny everyone else potentially life-saving information while establishing artificial barriers that would prevent declines in the cost of medical care.

References
– “FDA warns Google-backed 23andMe to halt sales of genetic tests” – Toni Clarke – Reuters – November 25, 2013
23andMe Website
Petition to “overrule the FDA’s decision to bar 23andMe from selling their potentially life-saving diagnostic kits”

The FDA: A Pain From the Neck to the Big Toe – Article by Mark Thornton

The FDA: A Pain From the Neck to the Big Toe – Article by Mark Thornton

The New Renaissance Hat
Mark Thornton
October 25, 2013
******************************

I recently experienced severe pain in my feet, particularly in the big toes. In my imagination it felt like my feet had been run over by a truck and that several of my toes had been broken. But I knew that was not the case, and that the pain came on slowly at first, and then spread to other parts of my feet until I could barely walk.

My first approach was to take some ibuprofen to relieve the pain and swelling. When this did not resolve the matter, I thought perhaps a new pair of soft shoes might work. That idea also failed, and with a little internet research I realized I had a classic case of the gout. I was soon off to see my doctor to determine what the problem was and to get it solved with the powers of modern medicine.

The doctor confirmed that I had the gout. I was not pleased to find out, that in my case, the gout was probably brought on by another drug that I had been taking daily, against my better judgment. However, I was pleased to learn that I would no longer have to take it, that as part of my treatment I was being prescribed an ancient and natural drug, and that I would only have to take this drug “as needed.”

I was off to get my prescription filled at the pharmacy when a thought came to mind: if this drug was as natural and ancient as advised by my doctor, why did I need a prescription in the first place? Upon inspection the prescription was for Colcrys, the brand name of the drug colchicine. Furthermore, when I picked up my prescription the price was much higher than I anticipated given that it was a natural drug. When questioned, the pharmacy technician replied that the actual price was much higher and that my insurance paid for more than three-quarters of the bill. The cash price (without insurance) was $198.99 which is $6.63 per pill if taken daily, or nearly $20 per dose if used to treat flare-ups.

An extremely high price for an ancient natural drug? I knew I had a new case to solve and that the solution was probably the same old answer.

After conducting some research on Wikipedia, I learned the following: Colchicine can be used to treat gout, Behcet’s disease, pericarditis, and the Mediterranean fever. It has been in use as a medicine for over 3,000 years. After serving as ambassador to France, Benjamin Franklin brought colchicum plants back to America in order to treat his own gout. Modern science has further refined the drug for better medicinal use.

Colcrys has been used to treat gout for a very long time, although the Food and Drug Administration (FDA) had not approved Colcrys specifically for the treatment of gout prior to 2009. Alternative drugs, such as Allopurinal, are also used to treat gout and related ailments. Until recently, you could treat your own gout using one of these medicines for pennies a day.

In the summer of 2009, the Food and Drug Administration approved Colcrys as a treatment for gout flare-ups and the Mediterranean fever. The FDA gave pharmaceutical company URL Pharma an exclusive marketing agreement for selling Colcrys in exchange for completing studies on Colcrys and paying the FDA a $45 million application fee.

This deal effectively created a patented drug with no generic alternative. Therefore it gave the company a monopoly for the duration of the agreement. URL Pharma immediately raised the price from less than a dime to nearly $5 dollars per pill. Comprehensive medical insurance does substantially reduce the price to consumers, but it does not reduce the cost. Insurance only spreads the cost-burden across policy holders.

At the same time, doctors are encouraged by pharmaceutical companies to employ more expensive and profitable treatments. As a result the overall cost burden increases. Evidence suggests that doctors are prescribing Colcrys in large volumes to treat gout flare-ups and as a long-term preventative measure.

Once again the federal government has taken something that was both cheap and beneficial and turned it into a monopoly that hurts the general public and drives up the cost of medical care to the benefit of Big Pharma.

Note: Just because it is natural and produced in a pharmaceutical environment, does not mean that Colcrys is harmless. It can be considered toxic in large amounts, has a long list of possible side effects, and is not recommended for people with certain conditions.

Mark Thornton is a senior resident fellow at the Ludwig von Mises Institute in Auburn, Alabama, and is the book review editor for the Quarterly Journal of Austrian Economics. He is the author of The Economics of Prohibition, coauthor of Tariffs, Blockades, and Inflation: The Economics of the Civil War, and the editor of The Quotable Mises, The Bastiat Collection, and An Essay on Economic Theory. Send him mail. See Mark Thornton’s article archives.

You can subscribe to future articles by Mark Thornton via this RSS feed.

This article was published on Mises.org and may be freely distributed, subject to a Creative Commons Attribution United States License, which requires that credit be given to the author.

Libertarian Life-Extension Reforms – Video Series by G. Stolyarov II

Libertarian Life-Extension Reforms – Video Series by G. Stolyarov II

The New Renaissance Hat
G. Stolyarov II
December 10, 2012
******************************

This video series is derived from Mr. Stolyarov’s essay, “Political Priorities for Achieving Indefinite Life Extension: A Libertarian Approach“. The series highlights each of the proposed areas of pro-liberty life-extension reforms in an effort to spread these ideas and achieve their broader public consideration.

#1 – Repeal FDA Approval Requirements

Mr. Stolyarov discusses the greatest threat to research on indefinite human life extension: the  current requirement in the United States (and analogous requirements elsewhere in the Western world) that drugs or treatments may not be used, even on willing patients, unless approval for such drugs or treatments is received from the Food and Drug Administration (or an analogous national regulatory organization in other countries).

Such prohibitions on the quick development and marketing of potentially life-saving drugs are not only costly and time-consuming to overcome; they are morally unconscionable in terms of the cost in human lives.

#2 – Abolishing Medical Licensing Protectionism

There are too few doctors in the West today – not enough to deliver affordable, life-saving treatments, and certainly not enough to ensure that, when life-extending discoveries are made, they will rapidly become available to all.

Mr. Stolyarov advocates for the elimination of compulsory licensing requirements for medical professionals, and the replacement of such a system by a competing market of private certifications for various “tiers” of medical care.

#3-4 – Abolishing Medical and Software Patent Monopolies

Patents – legal grants of monopoly privilege – artificially raise the cost and the scarcity of new drugs and new software. Mr. Stolyarov recommends allowing free, open competition to apply to these products as well.

#5 – Reestablishing the Doctor-Patient Relationship

The most reliable and effective medical care occurs when both patients and doctors have full sovereignty over medical treatment and payment. A libertarian system is most likely to prolong individual lives and lead to the rapid discovery of unprecedented life-extending treatments.

Mr. Stolyarov presents the case for political reforms that maximize patient choice and free-market experimentation with various methods of payment for and provision of medical services.

#6 – Medical Research Instead of Military Spending

Mr. Stolyarov concludes his series on libertarian life-extension reforms by offering a way to reduce aggregate government spending while also increasing funding for medical research. If government funds are spent on saving and extending lives rather than destroying them, this would surely be an improvement. Thus, while Mr. Stolyarov does not support increasing aggregate government spending to fund indefinite life extension (or medical research generally), he would advocate a spending-reduction plan where vast amounts of military spending are eliminated and some fraction of such spending is replaced with spending on medical research.

Political Priorities for Achieving Indefinite Life Extension: A Libertarian Approach – Article by G. Stolyarov II

Political Priorities for Achieving Indefinite Life Extension: A Libertarian Approach – Article by G. Stolyarov II

The New Renaissance Hat
G. Stolyarov II
November 22, 2012
******************************

While the achievement of radical human life extension is primarily a scientific and technical challenge, the political environment in which research takes place is extremely influential as to the rate of progress, as well as whether the research could even occur in the first place, and whether consumers could benefit from the fruits of such research in a sufficiently short timeframe. I, as a libertarian, do not see massive government funding of indefinite life extension as the solution – because of the numerous strings attached and the possibility of such funding distorting and even stalling the course of life-extension research by rendering it subject to pressures by anti-longevity special-interest constituencies. (I can allow an exception for increased government medical spending if it comes at the cost of major reductions in military spending; see my item 6 below for more details.) Rather, my proposed solutions focus on liberating the market, competition, and consumer choice to achieve an unprecedented rapidity of progress in life-extension treatments. This is the fastest and most reliable way to ensure that people living today will benefit from these treatments and will not be among the last generations to perish. Here, I describe six major types of libertarian reforms that could greatly accelerate progress toward indefinite human life extension.

1. Repeal of the requirement for drugs and medical treatments to obtain FDA approval before being used on willing patients. The greatest threat to research on indefinite life extension – and the availability of life-extending treatments to patients – is the current requirement in the United States (and analogous requirements elsewhere in the Western world) that drugs or treatments may not be used, even on willing patients, unless approval for such drugs or treatments is received from the Food and Drug Administration (or an analogous national regulatory organization in other countries). This is a profound violation of patient sovereignty; a person who is terminally ill is unable to choose to take a risk on an unapproved drug or treatment unless this person is fortunate enough to participate in a clinical trial. Even then, once the clinical trial ends, the treatment must be discontinued, even if it was actually successful at prolonging the person’s life. This is not only profoundly tragic, but morally unconscionable as well.

As a libertarian, I would prefer to see the FDA abolished altogether and for competing private certification agencies to take its place. But even this transformation does not need to occur in order for the worst current effects of the FDA to be greatly alleviated. The most critical reform needed is to allow unapproved drugs and treatments to be marketed and consumed. If the FDA wishes to strongly differentiate between approved and unapproved treatments, then a strongly worded warning label could be required for unapproved treatments, and patients could even be required to sign a consent form stating that they have been informed of the risks of an unapproved treatment. While this is not a perfect libertarian solution, it is a vast incremental improvement over the status quo, in that hundreds of thousands of people who would die otherwise would at least be able to take several more chances at extending their lives – and some of these attempts will succeed, even if they are pure gambles from the patient’s point of view. Thus, this reform to directly extend many lives and to redress a moral travesty should be the top political priority of advocates of indefinite life extension. Over the coming decades, its effect will be to allow cutting-edge treatments to reach a market sooner and thus to enable data about those treatments’ effects to be gathered more quickly and reliably. Because many treatments take 10-15 years to receive FDA approval, this reform could by itself speed up the real-world advent of indefinite life extension by over a decade.

2. Abolishing medical licensing protectionism. The current system for licensing doctors is highly monopolistic and protectionist – the result of efforts by the American Medical Association in the early 20th century to limit entry into the profession in order to artificially boost incomes for its members. The medical system suffers today from too few doctors and thus vastly inflated patient costs and unacceptable waiting times for appointments. Instead of prohibiting the practice of medicine by all except a select few who have completed an extremely rigorous and cost-prohibitive formal medical schooling, governments in the Western world should allow the market to determine different tiers of medical care for which competing private certifications would emerge. For the most specialized and intricate tasks, high standards of certification would continue to exist, and a practitioner’s credentials and reputation would remain absolutely essential to convincing consumers to put their lives in that practitioner’s hands. But, with regard to routine medical care (e.g., annual check-ups, vaccinations, basic wound treatment), it is not necessary to receive attention from a person with a full-fledged medical degree. Furthermore, competition among certification providers would increase quality of training and lower its price, as well as accelerate the time needed to complete the training. Such a system would allow many more young medical professionals to practice without undertaking enormous debt or serving for years (if not decades) in roles that offer very little remuneration while entailing a great deal of subservience to the hierarchy of some established institution or another. Ultimately, without sufficient doctors to affordably deliver life-extending treatments when they become available, it would not be feasible to extend these treatments to the majority of people. Would there be medical quacks under such a system of privatized certification? There are always quacks, including in the West today – and no regulatory system can prevent those quacks from exploiting willing dupes. But full consumer choice, combined with the strong reputational signals sent by the market, would ensure that the quacks would have a niche audience only and would never predominate over scientifically minded practitioners.

3. Abolishing medical patent monopolies. Medical patents – in essence, legal grants of monopoly for limited periods of time – greatly inflate the cost of drugs and other treatments. Especially in today’s world of rapidly advancing biotechnology, a patent term of 20 years essentially means that no party other than the patent holder (or someone paying royalties to the patent holder) may innovate upon the patented medicine for a generation, all while the technological potential for such innovation becomes glaringly obvious. As much innovation consists of incremental improvements on what already exists, the lack of an ability to create derivative drugs and treatments that tweak current approaches implies that the entire medical field is, for some time, stuck at the first stages of a treatment’s evolution – with all of the expense and unreliability this entails. More appallingly, many pharmaceutical companies today attempt to re-patent drugs that have already entered the public domain, simply because the drugs have been discovered to have effects on a disease different from the one for which they were originally patented. The result of this is that the price of the re-patented drug often spikes by orders of magnitude compared to the price level during the period the drug was subject to competition. Only a vibrant and competitive market, where numerous medical providers can experiment with how to improve particular treatments or create new ones, can allow for the rate of progress needed for the people alive today to benefit from radical life extension. Some may challenge this recommendation with the argument that the monopoly revenues from medical patents are necessary to recoup the sometimes enormous costs that pharmaceutical companies incur in researching and testing the drug and obtaining approval from regulatory agencies such as the FDA. But if the absolute requirement of FDA approval is removed as I recommend, then these costs will plummet dramatically, and drug developers will be able to realize revenues much more quickly than in the status quo. Furthermore, the original developer of an innovation will still always benefit from a first-mover advantage, as it takes time for competitors to catch on. If the original developer can maintain high-quality service and demonstrate the ability to sell a safe product, then the brand-name advantage alone can secure a consistent revenue stream without the need for a patent monopoly.

4. Abolishing software patent monopolies. With the rapid growth of computing power and the Internet, much more medical research is becoming dependent on computation. In some fields such as genome sequencing, the price per computation is declining at a rate even far exceeding that of Moore’s Law. At the same time, ordinary individuals have an unprecedented opportunity to participate in medical research by donating their computer time to distributed computing projects. Software, however, remains artificially scarce because of patent monopolies that have increasingly been utilized by established companies to crush innovation (witness the massively expensive and wasteful patent wars over smartphone and tablet technology). Because most software is not cost-prohibitive even today, the most pernicious effect of software patents is not on price, but on the existence of innovation per se. Because there exist tens of thousands of software patents (many held defensively and not actually utilized to market anything), any inventor of a program that assists in medical, biotechnological, or nanotechnological computations must proceed with extreme caution, lest he run afoul of some obscure patent that is held for the specific purpose of suing people like him out of existence once his product is made known. The predatory nature of the patent litigation system serves to deter many potential innovators from even trying, resulting in numerous foregone discoveries that could further accelerate the rate at which computation could facilitate medical progress. Ideally, all software patents (and all patents generally) should be abolished, and free-market competition should be allowed to reign. But even under a patent system, massive incremental improvements could be made. First, non-commercial uses of a patent should be rendered immune to liability. This would open up a lot of ground for non-profit medical research using distributed computing. Second, for commercial use of patents, a system of legislatively fixed maximum royalties could emerge – where the patent holder would be obligated to allow a competitor to use a particular patented product, provided that a certain price is paid to the patent holder – and litigation would be permanently barred. This approach would continue to give a revenue stream to patent holders while ensuring that the existence of a patent does not prevent a product from coming to market or result in highly uncertain and variable litigation costs.

5. Reestablishing the two-party doctor-patient relationship. The most reliable and effective medical care occurs when the person receiving it has full discretion over the level of treatment to be pursued, while the person delivering it has full discretion over the execution (subject to the wishes of the consumer). When a third party – whether private or governmental – pays the bills, it also assumes the position of being able to dictate the treatment and limit patient choice. Third-party payment systems do not preclude medical progress altogether, but they do limit and distort it in significant ways. They also result in the “rationing” of medical care based on the third party’s resources, rather than those of the patient. Perversely enough, third-party payment systems also discourage charity on the part of doctors. For instance, Medicare in the United States prohibits doctors who accept its reimbursements from treating patients free of charge. Mandates to utilize private health insurance in the United States and governmental health “insurance” elsewhere in the Western world have had the effect of forcing patients to be restricted by powerful third parties in this way. While private third-party payment systems should not be prohibited, all political incentives for third-party medical payment systems should be repealed. In the United States, the pernicious health-insurance mandate of the Affordable Care Act (a.k.a. Obamacare) should be abolished, as should all requirements and political incentives for employers to provide health insurance. Health insurance should become a product whose purchase is purely discretionary on a free market. This reform would have many beneficial effects. First, by decoupling insurance from employment, it would ensure that those who do rely on third-party payments for medical care will not have those payments discontinued simply because they lose their jobs. Second, insurance companies would be encouraged to become more consumer-friendly, since they will need to deal with consumers directly, rather than enticing employers – whose interests in an insurance product may be different from those of their employees. Third, insurance companies would be entirely subject to market forces – including the most powerful consumer protection imaginable: the right of a consumer to exit from a market entirely. Fourth and most importantly, the cost of medical care would decline dramatically, since it would become subject to direct negotiation between doctors and patients, while doctors would be subject to far less of the costly administrative bureaucracy associated with managing third-party payments.

In countries where government is the third-party payer, the most important reform is to render participation in the government system voluntary. The worst systems of government healthcare are those where private alternatives are prohibited, and such private competition should be permitted immediately, with no strings attached. Better yet, patients should be permitted to opt out of the government systems altogether by being allowed to save on their taxes if they renounce the benefits from such systems and opt for a competing private system instead. Over time, the government systems would shrink to basic “safety nets” for the poorest and least able, while standards of living and medical care would rise to the level that ever fewer people would find themselves in need of such “safety nets”. Eventually, with a sufficiently high level of prosperity and technological advancement, the government healthcare systems could be phased out altogether without adverse health consequences to anyone.

6. Replacement of military spending with medical research. While, as a libertarian, I do not consider medical research to be the proper province of government, there are many worse ways for a government to spend its money – for instance, by actively killing people in wasteful, expensive, and immoral wars. If government funds are spent on saving and extending lives rather than destroying them, this would surely be an improvement. Thus, while I do not support increasing aggregate government spending to fund indefinite life extension (or medical research generally), I would advocate a spending-reduction plan where vast amounts of military spending are eliminated and some fraction of such spending is replaced with spending on medical research. Ideally, this research should be as free from “strings attached” as possible and could be funded through outright unconditional grants to organizations working on indefinite life extension. However, in practice it is virtually impossible to avoid elements of politicization and conditionality in government medical funding. Therefore, this plan should be implemented with the utmost caution. Its effectiveness could be improved by the passage of legislation to expressly prohibit the government from dictating the methods, outcomes, or applications of the research it funds, as well as to prohibit non-researchers from acting as lobbyists for medical research. An alternative to this plan could be to simply lower taxes across the board by the amount of reduction in military spending. This would have the effect of returning wealth to the general public, some of which would be spent on medical research, while another portion of these returned funds would increase consumers’ bargaining power in the medical system, resulting in improved treatments and more patient sovereignty.