As Insulin Prices Rise, Diabetics Turn to Black Markets

A 2015 report released by the Centers for Disease Control found that nearly thirty million people in the United States had diabetes (about ten percent of the total population). The same report also found an additional seventy million people are at risk to develop diabetes in the next five years. These alarming figures are only expected to increase in the near future.

Managing diabetes usually entails a restrictive diet, regular physical activity, and regularly taken medication. Approximately 30 percent of diabetics require regular insulin injections to manage their condition. Those with type 1 diabetes are unable to produce insulin and typically require multiple daily injections to prolong their lives.

Tragically, although insulin is indispensable for many people with diabetes, it is also quickly becoming unaffordable. From 2012 to 2016, the price of insulin doubled. In 2016, the average person with type 1 diabetes spent nearly $6,000 on insulin per year. The American Diabetic Association found people with diabetes spent over $15 billion on insulin 2017.

When a life-saving medication becomes unaffordable, patients become desperate. Skyrocketing insulin prices have led many diabetics to limit (or ration) the amount of insulin they use to make financial ends meet. The trade-off is deadly. Not using enough insulin increases the risk of long-term complications or falling into a diabetic coma.  Survey results published in the Journal of the American Medical Association Internal Medicine finds nearly 30 percent of diabetics ration their insulin use.

To avoid financial hardship and medical complications, many diabetics have turned to black markets.

Some turn to the internet, where second-hand markets are providing solutions. For example, numerous kinds of insulin are available with 24-hour shipping from websites such as Millions of U.S. citizens engage in such transactions.  Domestically, Facebook, Craigslist, E-bay, and other websites also provide ways for those needing insulin and those willing to sell it to make an exchange.

However, buying insulin online, reselling insulin, and even giving it away is illegal in the United States. These barriers work to complicate how willing buyers and (re)sellers can exchange. For example, some insulins must remain at room temperature, or they expire prematurely. Operating on the black market makes this and other safety standards a secondary matter, increasing the risk of buying and using expired insulin, which can be harmful.

Others cross country borders to take advantage of cheaper foreign prices. A recently published article in the Washington Post reports that Minnesotan Lija Greensied, the mother of a diabetic child, went with five other people to Canada and “paid about $1,200 for drugs that would have cost them $12,000 in the United States.” Elated, Lija noted, “It had been years since I had 10 vials [about a year’s supply of insulin] in my hands.” Others have had similar success traveling to Mexico to buy insulin.

But bringing prescription drugs across the U.S. border is also illegal. Those who attempt to bring foreign drugs into the U.S. risk having their medication confiscated or facing criminal charges. Although the Food and Drug Administration makes some allowances, they are best selectively enforced. Purchasing drugs in foreign countries also poses the risk of receiving counterfeit medications.

The rise in black markets for insulin provides both a deeply concerning picture of the harmful effects of regulation and the incredible ability of international competition to curb pressing healthcare concerns. Although drug importation policy between countries with different quality standards and pricing strategies is complex, the efforts of millions of U.S. patients to obtain cheaper foreign drugs indicate solutions are possible.

With President Trump considering reforming drug importation policy to lower prescription drug costs, let’s hope the struggles of many diabetics to navigate black markets and prolong their lives provides enough motive to liberalize foreign drug access. Managing diabetes is challenging. Managing diabetes and poorly designed policy only makes already difficult situations more taxing.

San Francisco’s Vaping Ban Is Doomed To Go Up in Smoke

Since last September, the Food and Drug Administration has engaged in a “historic crackdown” of the vaping industry to curb an alleged “epidemic” of underage vaping. A short list of its heavy-handed crackdowns included demanding that five e-cigarette companies provide it with comprehensive plans on how they will prevent teen vaping and raiding e-cigarette company headquarters and confiscating their documents. The agency also fined over 1,300 retailers for allegedly selling to minors.

But the FDA planned to intervene further. Then FDA Commissioner Scott Gottlieb also proposed banning flavored e-juices, banning convenience stores from selling e-cigarettes, and imposing age-verification mechanisms for online sales. Although never enacted, vaping industry leaders were preparing for these and other changes to take effect. However, Gottlieb resigned from his position this April. With his departure, the agency’s involvement in regulating the vaping industry has stalled.

But where Gottlieb and the FDA have stopped, the city of San Francisco has continued and doubled-down.

San Francisco recently became the first U.S. city to outright ban e-cigarette sales. The ban also includes flavored tobacco products and online purchases shipped to a San Francisco address. The ordinance does allow certain restrictions to be lifted once a vaping product has undergone a premarket review by the FDA. However, no vaping product has undergone a premarket review to date.

Preventing minors from vaping and becoming addicted to nicotine is the ban’s primary motive. As Mayor of San Francisco London Breed expressed, “We need to take action to protect the health of San Francisco’s youth and prevent the next generation of San Franciscans from becoming addicted to these products.” City Attorney Dennis Herrera, who authored the ordinance, similarly believes, “This is a decisive step to help prevent another generation of San Francisco children from becoming addicted to nicotine.”

Will it work? Unfortunately, governmental efforts to reduce or eliminate vices are often spectacular failures.

The Drug Awareness and Resistance Education Program (often shortened to DARE) was designed to educate children about the dangers of illicit drug use in hopes they would reframe from using them later in life. Despite receiving considerable funding from government sources and having a presence in 75 percent of the nation’s school districts, research finds the program resulted in more drug experimentation. Similarly unsuccessful, anti-obesity campaigns launched by government agencies have resulted in comparatively higher obesity rates.

The same shortcomings occurred previously in the e-cigarette market. Before the FDA began regulating the e-cigarette market, such matters were left to the states. By 2014, forty states had banned e-cigarette sales to minors. The FDA first passed regulation banning e-cigarette sales to minors in 2016. However, teen vaping rates have increased since the agency became involved.

But it could be worse.

Government efforts to regulate away vices can also motivate more dangerous or unhealthy behaviors. Regulations limiting physicians ability to prescribe opioids frequently motivate patients to seek out illicit alternatives (such as heroin) to cope with their addiction. Taxing soda entices more consumption of acholic beverages or switching to sugary fruit drinks. Research published in the Journal of Health Economics finds taxing fast-food meals encourages over-consumption of fatty foods at home, amounting to less healthy eating.

San Francisco may be the first U.S. city to ban e-cigarette sales, but it will certainly not be the first city to cause considerable harm from enacting overzealous vice policies. Let’s hope San Francisco learns from the past before it serves as another example of a well-intended but disastrously harmful policy.

Right-to-Try Legislation Helps Patient Battling Bone Cancer

Millennial Natalie Harp has battled stage two bone cancer for most of her life. To make matters worse,  a medical error made in 2015 while receiving treatment left her wheelchair-bound and in constant pain. There was no known cure for her condition, and her quality of life was in quick decline.

Natalie was quickly running out of treatment options. Two rounds of chemotherapy failed to eradicate her cancer. Opioids, medical marijuana, and barbiturates were unable to relieve her pain. She was denied entry into numerous clinical trials. As her condition worsened, Natalie was also advised to consider voluntarily stopping all eating and drinking (a method commonly shorted to VSED).

Courageously, she refused, insisting, “No, I just want to get better.” Miraculously, she did.

After receiving access to experimental treatments through right-to-try legislation, Natalie’s condition improved substantially. In her own words, “I’m walking. I am healthy. I am living the quality of life that I always wanted.” She continued, “I’m not dying from cancer any more thanks to President Trump, I’m living with cancer.”

In May 2018, President Trump signed national right-to-try legislation in law. The law provides patients with terminal illnesses access to potentially lifesaving treatment options before the Food and Drug Administration fully approves them. By requiring permission from only the patient, their physician, and the drug provider to administer treatment, right-to-try laws cut the FDA out of the picture. As a consequence, patients are granted more options to prolong their lives with less regulatory barriers.

Natalie is grateful for the opportunities that right-to-try laws have provided. Before right-to-try became national law, she endured four years of being denied treatment options she hoped would help her condition. As she expressed, “it took President Trump going to Washington to be able to get that [more treatment options] for me.”

An unfortunate consequence of government involvement in healthcare is that medicine becomes more political. Despite the testimonies of patients electing to utilize right-to-try laws and being grateful for them, the laws continue to suffer from defamatory comments from political figures. Among the most common attacks are those calling the legislation “false hope” and declaring it hasn’t helped. Natalie’s inspiring conviction to keep fighting for her life, and her remarkable recovery, provide overwhelming evidence otherwise.

As long as the government remains involved in healthcare, the rights of terminally ill patients to try experimental medication to prolong their lives are at risk. Let’s hope stories like Natalie’s work to secure them. With 42 million US citizens suffering from a terminal illness or knowing someone with one, it’s a fight that affects us all.

FDA Approves $2 Million Drug. Blame the Price on Excessive Regulation.

Colored pills with money. Health costs a lot. medicine

Last year, drug producer Brainstorm Cell Therapeutics received significant criticism for attempting to offer patients access to an experimental treatment procedure for amyotrophic lateral sclerosis (often called ALS or Lou Gherig’s disease) for $300,000. A drug recently approved by the Food and Drug Administration dwarfs this price.

A new gene therapy drug named Zoglensma became the most expensive drug in the world, costing patients over $2.1 million for one-time use. Zoglensma joins a small (and outlandishly expensive) group of treatments called gene therapy drugs. Gene therapy uses actual genes to treat or prevent diseases.

Before Zoglensma’s approval, its predecessor treatment, named Spinraza, cost patients $750,000 for the first year’s treatment and an additional $375,000 for each additional year. Other FDA approved gene therapy treatments cost between $375,000 and $875,000.

FDA To Stop Regulating the Amount of Cherries in Frozen Cherry Pie

Slice of Homemade Cherry pie with almond on a red plate. Next is an old fork and towel. Toned photo.

When he first took office, President Trump pledged to eliminate 75 to 80 percent of all Food and Drug Administration regulations. A recent deregulatory effort is a small step in this direction. It also serves as a comical (and a little concerning) example of how far the agency’s regulatory authority extends.

The FDA recently committed to deregulating the frozen cherry pie market. Specifically, the agency is re-examining current regulations dictating that frozen cherry pies are required to be at least 25 percent cherries by weight and that no more than 15 percent of these cherries may be blemished.

The FDA has dedicated considerable effort to publicize its efforts. As (recently resigned) FDA Commissioner Scott Gottlieb tweeted, the agency considers deregulating cherry pie to be “among other high priorities.” He later referred to the initiative as “a down payment on a comprehensive effort to modernize food standards to reduce regulatory burden and remove old-fashioned barriers to innovation.”

Some thought Gottlieb was joking. But those who believe the FDA involving itself in determining how many cherries should be in cherry pie might not know how wacky frozen pie regulations have become.

The agency has been regulating frozen pies since 1977. In that time, it has developed numerous additional regulations specifying what makes cherries blemished, what counts as frozen, and how much crust is needed to cover the pie. Frozen cherry pies are also the only fruit pies which must meet these standards.

Even bakers seeking political favors (yes, they exist) are eager to see such outlandish regulations eliminated. As one New York Post article reports, Lee Sanders of the American Bakers Association is “hopeful the cherry pie standard will finally be revoked, but that it would not make a big difference for the industry.” It’s not every day you find a regulation so poorly executed that not even special interest groups support them.

Regardless of how the regulation passed, and how long overdue removing it is, we should be happy it will soon be gone. Maybe next the FDA will loosen its requirements on the size of the holes in Swiss cheese.

Political Rhetoric Against Right-to-Try Laws Continues, Undermining Support for Medical Treatments of Last Resort

Imagine someone who has late-stage amyotrophic lateral sclerosis (often called ALS or Lou Gehrig’s Disease). After battling the disease for years, the patient is largely paralyzed and their quality of life is drastically diminished. With no known cure, any attempts to prolong the patient’s life will be risky.

Who should decide whether the risk is worth taking? Should it be policymakers and bureaucrats? Or should the patients, their physicians, and willing drug providers be allowed to weigh the pros and cons themselves?

Right-to-try laws argue for the latter.

Right-to-try legislation provides hope for those with terminal illnesses by providing them access to potentially lifesaving medication before it is fully approved by the Food and Drug Administration. From 2014 to 2018, forty-one states passed right-to-try laws. In May 2018, right-to-try became national law. In 2016, California became the thirty-second state to enact right-to-try legislation. However, if one state-senate candidate has her way, California will the first state to repeal its right-to-try laws.

In a recent opinion piece published in the Desert Sun, state Senate hopeful Joy Silver writes that right-to-try “seems good, but provides false hope and can endanger us all.” Silver continued:

There are two main problems with this legislation and its premise: 1. Because these drugs haven’t been rigorously tested, there’s every chance that they’ll actually increase a patient’s suffering, while providing no help. 2. Chipping away at the regulations required of pharmaceutical companies doesn’t serve the best interests of the patients, but only serves to increase corporate profits while opening the door to cutting more regulations later.

Ms. Silver is right to be concerned about healthcare policy for the terminally ill. Across the United States and California in particular, chronic illness rates are skyrocketing. An effective healthcare system must be able to serve this growing and vulnerable demographic. That said, Ms. Silver’s criticisms of right-to-try laws are ill-conceived.

First, simply because any treatment hasn’t been “rigorously tested,” it does not mean that “they’ll [the treatments] increase a patient’s suffering while providing no help.” A lack of testing means that any benefits, harm, or ineffectiveness remain unknown. It is misleading to only emphasize harm or ineffectiveness and minimize potential benefits.

Consider the incredible story of Ted Harada. In 2012, Harada stunned the medical community when his ALS symptoms reversed after he received an experimental treatment. The treatment was in the early stages of the FDA approval process. Even Harada’s physicians told him the procedure would not help him. Despite anticipating little benefit, Harada became the first and only person to beat ALS. Harada’s story, although unprecedented, can be replicated if terminally ill patients can gain access to experimental treatments.

Second, Ms. Silver fails to recognize that right-to-try laws allow experimental medications only to terminally ill patients who have exhausted all other treatment options. It is difficult to see how denying other treatment methods, albeit risky ones, harms patients who are already fighting to prolong their lives with no other alternatives available.

It is even less clear how right-to-try laws increase corporate profits or have instigated further deregulation. After writing about right-to-try laws for over two years, I have yet to find an example of a drug provider that has handsomely profited from these laws. Right-to-try legislation at the state and national level began as a grassroots effort to eradicate cruel and unjust laws harming those with terminal illnesses. Little of this movement advanced through corporate interests.

On the contrary, many large drug producers spend millions of dollars lobbying governments to increase the amount of regulation in the industry to protect them from the competition. As one New York Times piece notes, when national right-to-try legislation reached the Senate, drug-industry lobbyists and other healthcare interest groups failed to take a position.

Silver’s misgivings continue. Silver would prefer the terminally ill to rely on the status quo prior to the political victories of the right-to-try movement:

Following the FDA’s regulatory process results in safer, more effective treatments. And, the FDA’s “Compassionate Drug Use” rules already allow for the use of a new, unapproved drug to treat a seriously ill patient when no other treatments are available, but through a regulated, safe process.

The FDA’s Compassionate Use Program has been an excellent program for terminally ill patients. However, even with recent efforts to expand the program, only 9,000 patients gained access to experimental treatments over the last five years. With nearly 25,000 patients dying annually while waiting for the FDA to approve potentially life-saving medication, the program clearly comes up short. Unfortunately, similar FDA programs have been coming up short since the 1970s. It hardly seems this time will be different.

Lastly, Silver writes:

Although the law allows companies to provide unapproved drugs, it doesn’t require them to do so, and it doesn’t appear any of them have.

Ms. Silver is mistaken. Earlier this year, the University of California, Irvine, and the Epitopoietic Research Corporation worked together to provide experimental treatment for a patient suffering from a malignant form of brain cancer through right-to-try legislation. About a year ago, drug producer Brainstem Therapeutics attempted to offer its experimental treatment for ALS through national right-to-try legislation. Unfortunately, the company was unable to provide treatment due to financial issues.

I do not fault Ms. Silver for her misunderstandings. I am fearful, however, that she and other misinformed political figures will sway health policy to limit access to experimental treatments for terminally ill patients. I can think of no greater “false hope” than putting life-saving decisions in the hands of politicians. Unfortunately, rhetoric against right-to-try laws pushes public opinion further in that direction. Let this be my attempt to set the record straight (again).

FDA Approves Ketamine-Based Drug to Treat Difficult Cases of Depression

Ketamine, often referred to as “Special K”, is a powerful hallucinogenic drug which, when abused, can help users detach from reality. Long-term ketamine use can have harmful psychiatric effects such as memory loss, decreased sociability, and even permanent psychosis. However, Ketamine is also classified by the Drug Enforcement Agency (DEA) as a Schedule III substance, one with beneficial medicinal properties in addition to its risk of being abused.

Despite its reputation as a party drug, Ketamine is now hailed as a “game-changing” treatment for types of depression that do not respond to typical treatment methods.

Last year, a special panel assembled by the Food and Drug Administration overwhelmingly endorsed a ketamine-based drug named esketamine for treatment of depression. A few weeks later, the FDA approved the drug under the name Spravato (a nasal spray version of esketamine).

Spravato provides a rare treatment option for anti-depressant resistant forms of depression. Unlike anti-depressant treatments, which can take months before patients feel the effects, Spravato can offer relief in days. Consequently, the drug is currently being tested in patients whose depression places them at higher risks to commit suicide.

Spravato joins a quickly growing list of FDA-approved treatments which are also banned or strictly controlled by the DEA. Ecstasy is expected to be approved by the FDA to treat post-traumatic stress disorder (PTSD) in 2021. Last year, the FDA approved Epidiolex, which is made from marijuana. Well before Epidiolex, 33 states enacted legislation granting patients access to marijuana access for numerous medical purposes. Paradoxically, ecstasy and marijuana are classified as Schedule I substances, deemed to have no medicinal properties, while simultaneously approved, or nearly approved, by the FDA to treat serious conditions.

Despite the inconsistency, such situations are common. Medicine is rife with examples of treatments containing both the power to harm and the power to heal. When physicians are not entrusted to exercise judgment in balancing the costs and benefits of some treatments, regulators use their power to limit patient access. These regulators, and the FDA in particular, have little incentive to grant patients access to risky treatments. However, recent developments defy what historic drug-policy trends seem to dictate.

Although much work remains to reverse the DEA’s overzealous scheduling system, Ketamine-based treatment for mental illness is another step in the right direction. Indeed, the FDA’s decision provides a reason to be optimistic for future pharmaceutical policy and for the market to treat mental illnesses. The agency should be praised, and I don’t say that often.

Generic Insulin Now Available After Nearly One Hundred Years of Regulatory Protection From Competition

Diabetes is arguably the biggest epidemic of the twenty-first century. According to the federal Centers for Disease Control, more than 100 million Americans are diabetic or prediabetic. If left unmanaged, diabetes is fatal and can result in serious health complications, including nerve damage, heart disease, stroke, blindness, kidney disease, and damage to extremities requiring amputation.

For an increasing number of people with diabetes, regular insulin injections are indispensable for managing their condition. Tragically, insulin in the United States is alarmingly expensive, taking a financial toll on many who need it to prolong their lives. A recent CBS News article reports finding “horror stories every day” of diabetics reducing and rationing their insulin doses, risking long-term complications or falling into a diabetic coma.

Fortunately, these stories may now be a thing of the past.

Drug producer Eli Lilly and Company recently released Lispro, the first ever generic insulin to enter the U.S. market. Lispro is available in pen or vial form and lists for $137.35 per vial (or $265.20 for a pack of five pens), half the price of Humalog, its brand-name alternative. Generic insulin provides much-needed financial relief. As Eli Lilly and Company CEO and Chairman Dave Ricks noted in a statement, “We don’t want anyone to ration or skip doses of insulin due to affordability. And no one should pay the full Humalog retail price.”

But many are still upset that a generic alternative is still expensive and is coming so late. Ben Wakana, executive director of the nonprofit advocacy group Patients For Affordable Drugs, echoes the frustrations of many when he expressed, “Charging nearly $140 for a vial of insulin—a drug that was invented almost a century ago—is still too high.”

He has a point. Insulin has been available to treat diabetes since 1922. The first generic insulin was approved just a few weeks ago. Why?

Unlike pharmaceuticals, which enjoy 20 years of patent protection from competition, insulin is classified as a biological compound. Under the FDA’s regulatory system, producers can extend patents for biological compounds by slightly modifying their product components. This possibility creates an incentive for insulin producers to alter their products rather than releasing generic drugs and competing by offering patients lower prices.

As my coauthors and I note in an article published in the Journal of Entrepreneurship and Public Policy, insulin has been adapted to enter the bloodstream quicker, to last longer by using different preservatives, and has also been extracted from different animals since first becoming available to patients. Many of these changes offered little medicinal benefits but protected producers from generic competitors. The result is that three insulin producers encompassed 99 percent of the market for nearly one hundred years.

Offering a generic alternative for insulin is a much-welcomed addition to the diabetic care market. I expect this change to prolong and save many lives, which is certainly worth celebrating. However, the development of insulin in the United States also provides a cautionary tale of how devastating the misaligned incentives created by poorly designed regulations can be for patients.

It’s been a costly and long-lasting mistake. Let’s hope we learn from it.

FDA Wants More Sunscreen Regulations, but Would Consumers Get Burned?

Although many consumers and dermatologists are satisfied with the quality and safety of current sunscreens, sweeping changes may soon be coming.

The Food and Drug Administration recently proposed a variety of new heavy-handed regulations for over-the-counter sunscreen. The regulations getting the most media attention involve sixteen ingredients common in sunscreen products. According to the new guidelines, many of these ingredients have “insufficient data to decide on safety,” requiring manufacturers to undertake additional tests and submit their products for FDA approval. The proposal is currently under discussion and taking comments from the public.

By requiring sunscreen to undergo additional tests and earn FDA approval, the agency hopes to incorporate current scientific knowledge into supposedly outdated standards. As FDA Commissioner Scott Gottlieb stated in a news release, the agency’s proposal “is an important step in the FDA’s ongoing efforts to take into account modern science to ensure the safety and effectiveness of sunscreens.”

He continued:

The proposal we’ve put forward would improve quality, safety and efficacy of the sunscreens Americans use every day. We will continue to work with industry, consumers and public health stakeholders to ensure that we’re striking the right balance.

But in its attempt to find “the right balance,” the FDA is more likely to throw the sunscreen market wildly out of balance.

The costs of undergoing safety testing and obtaining FDA approval would raise the cost of over-the-counter sunscreen, making it less affordable for consumers needing stronger protection from ultra-violet rays. The proposed regulations are estimated to cost sunscreen producers over $3.5 billion, most of which would be passed on to consumers. With melanoma and other skin cancer rates steadily increasing since 1999, policies making sunscreen less accessible may cause considerable harm.

As a secondary consequence, other products using these ingredients would also face FDA scrutiny. For example, para-aminobenzoic acid (PABA) and trolamine salicylate, both ingredients in question, are found in numerous skin creams, towelettes,  body washes, and shampoos. If the proposed regulations are approved, these products will also require FDA approval.

Perhaps most troubling frustrating about the FDA’s proposal is that calling these ingredients into question is hardly “incorporating current scientific knowledge.” Many of them are already approved by regulators in Europe. Several ingredients have been under investigation by the FDA for over ten years. And with previous regulations implemented by the FDA in 2011, 2014, and 2016 aimed to reform sunscreen regulation, there is little reason to suspect that current efforts will provide noticeable benefits.

Let’s hope the FDA learns from its previous failures and retracts its proposal. If not, we’ll be the ones who get burned.

FDA Panel Backs Ketamine-Based Treatment for Depression

New hope for depression patients may be on the horizon.

A recent WebMD article reports that a special panel of experts assembled by the U.S. Food and Drug Administration strongly endorsed a new drug to help patients with treatment-resistant depression (a form of depression resilient to many anti-depressants). This new drug, named esketamine, also provides an unprecedented ability to take effect within days whereas others require months.

With nearly 30 percent of Americans experiencing depression at some point in their lives, and with the sporadic success of currently available treatment options, esketamine has tremendous potential to help millions manage their depression. As UCLA assistant professor of psychiatry Walter Dunn, who served on the panel, expressed, “I think esketamine has the potential to be a game-changer in the treatment of depression.”

Despite its exciting potential, esketamine is receiving significantly more attention for being similar to the street drug ketamine (if you couldn’t tell by its name). Ketamine, sometimes referred to as “Special K” or “K,” is a street drug taken for its hallucinogenic effects. The Drug Enforcement Agency currently lists ketamine as a Schedule III substance, containing both potential to cause psychological harm but also provide medical benefits. Regardless, it remains a controlled substance and largely reaches the public only through illicit means.

But ketamine’s reputation as a dangerous street drug runs counter to its reputation in medical literature. Indeed, knowledge of ketamine’s therapeutic abilities to combat depression dates back much further than recent developments. A 2014 paper published in Current Neuropharmacology reviews twenty-four previous academic publications (some dating back twenty years) and finds “ketamine may be considered a valid and intriguing antidepressant option for the treatment of TRD (treatment-resistant depression).”

Unfortunately, government restrictions that hinder the adoption of pioneering medical science are commonplace. As I’ve noted in a previous Beacon post, ecstasy is currently classified as a Schedule I substance by the DEA, deemed to have no medicinal benefits. However, ecstasy is also expected to be approved by the FDA to treat Post-Traumatic Stress Disorder (PTSD) by 2021. Marijuana is also a Schedule I substance, but 33 states have passed legislation granting patient access for medicinal purposes. Further, the FDA has approved marijuana-based medication to treat epilepsy.

The FDA will likely decide in early March whether it will allow esketamine to advance in its drug approval process. Despite widespread support of the panel (which voted 14-2 in favor), the agency may not heed its advice.

Considering the seriousness and pervasiveness of depression, as well as the history of medical professionals to find appropriate uses of drugs (even potentially dangerous ones), I hope the FDA allows esketamine to advance. Despite ketamine’s reputation, trusting scientists rather than government regulation is the safer bet.