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.

Let Competition, Not Politicians, Bring Insulin Prices Down

After turning 26, Alec Smith could no longer be covered by his mother’s health insurance policy. He was also ineligible for coverage from his employer. This was a problem—for Smith was a type 1 diabetic.

Dependent on insulin to prolong his life, Smith faced out-of-pocket expenses of nearly $1,300 a month. To manage this cost, he began rationing his insulin doses, a deadly tradeoff between keeping up financially and maintaining his long-term health. Tragically, this caused him to go into a diabetic coma and die.

Many other diabetics are in similar financial situations. CBS News recently reported finding “horror stories every day” of diabetics reducing their insulin doses to cope with the astronomical prices. With over 100 million Americans living with diabetes or prediabetes and increasingly more needing insulin to manage their conditions, high prices can mean the difference between life and death for a considerable portion of the population.

Outraged and deeply concerned, many have called on the government to make insulin more affordable. Officials have answered the call. Recently, the Senate Finance Committee held its first of several planned meetings addressing the cost of insulin. As Sen. Charles Grassley (R-IA) stated in his opening remarks, “This is unacceptable and I intend to specifically get to the bottom of the insulin price problem.”

But how much success can we expect from politicians? The government’s many recent failures to lower drug prices provide little room for optimism.

In the past year the Trump administration issued an executive order to lengthen short-term healthcare plans, developed an international pricing index to keep foreign drug producers from overcharging, targeted drug rebates to prevent producers from strategically raising prices, signed legislation to allow health-care plans more power to negotiate with drug producers, proposed legislation to require producers to disclose product prices in TV advertisements,  and even threatened drug providers–via Twitter–if they increased prices.

These tactics don’t seem to be working.

The government’s failure to implement policies to lower drug prices extends back much farther. The Clinton administration and everyone since then have employed numerous tactics to lower drug prices with little success. The failure is bipartisan.

Perhaps most frustrating is that insulin has become so expensive because of government policy. Although insulin treatment was developed nearly 100 years ago, no generic versions are available in the United States. Because insulin is classified as a biological compound, its producers are able to extend their patents by slightly modifying recombinant DNA techniques. This process stifles competition, allowing three insulin producers to extend their patent protections for over 90 years and encompass 99 percent of the market.

That is the insulin price problem. The solution is competition.

In other countries, insulin producers do not enjoy similar protections from competitors. Consequently, they charge lower prices.  According to the Access to Insulin and Supplies Survey, almost anywhere that producers face less government protection from competition, insulin prices are lower for rapid-acting, short-acting, long-acting, and mixed forms of insulin. Although the global insulin market, like the U.S. market, is dominated by a few firms, competition requires them to lower their prices to stay in business.

Diabetes is a complex and taxing condition that requires discipline and access to medication. High insulin prices are an obstacle for millions trying to manage their diabetes, but things could be different.

Evidence suggests that competition, not politicians, would provide the best chance to help diabetics obtain their life-prolonging medication. With millions of lives at stake, we can no longer afford to eschew competition in favor of government policy.

Right-to-try Laws Help Patient with Terminal Brain Cancer

Earlier this month, a patient with terminal brain cancer gained access to a potentially life-saving experimental treatment. Suffering from glioblastoma, considered to be “the most aggressive and malignant type of brain cancer,” the patient faces little hope of survival with conventional treatment methods.

Fortunately, the patient was able to access a new and promising treatment option named Gliovac. Gliovac helps patients fight cancer by providing a vaccine-like treatment which helps their immune system attack, and even eliminate, tumors or cancerous cells.

However, Gilovac is currently unapproved by the Food and Drug Administration. The patient’s family persevered, contacting Gilovac’s drug provider Enhanced Recovery Company who, with the assistance of the University of California, Irvine, was able to administer treatment through national right-to-try legislation.

Signed into law in May, national right-to-try legislation allows patients with terminal illnesses to access experimental treatments with only the permission of their physicians and the drug provider. The law cuts the Food and Drug Administration out of the process. In doing so, right-to-try provides patients access to potentially life-saving treatment with less regulatory obstacles. A statement released to Cancer Updates, Research, and Education, by the University of California, Irvine notes, “It was believed that (Right to Try) offered a more expedited path to treatment, which UCI (University of California, Irvine) began after meeting regulatory and compliance requirements of state and federal Right to Try laws.”

Remarkably, this is the first time national right-to-try laws have been used to access experimental treatments. Yet it is difficult to imagine a better representation of what right-to-try represents.

The patient is being given a chance to prolong their life when other options to try experimental medication failed. Before utilizing right-to-try laws, the patient was unable to enlist in an ongoing clinical study due to their health.

Clinical trials often will not include terminally ill patients to avoid skewing statistical results. As Daniela Bota, medical director of the UCI Health Comprehensive Brain Tumor Program, explains, “The Right to Try laws may be the only alternative for many patients who may not qualify for clinical trials based on a variety of factors, including progression of disease, comorbidities, existing medications, physical limitations, and others.”

Perhaps more importantly, the patient was not the victim of the sluggish FDA approval process. Gilovac is currently in the second phase of the FDA’s approval, yet to enter the more time-consuming later phases. With more than 23,000 adults developing cancerous tumors in the brain or spinal cord each year, right-to-try provides hope for many in dire situations.

When treatments are unavailable, and prognoses are fatal, the best chance to prolong life is to consider all remaining options. National right-to-try laws recognize this and provide more options for terminally ill patients.

Now that one patient has used the process, more are likely to follow. Let’s hope for the best.

FDA Approves Record Number of Generic Drugs in 2018

In the 2018 fiscal year, the Food and Drug Administration set a record by approving and tentatively approving 971 generic drugs, including a record-breaking month with 110 generic drug approvals in October. This eclipses the previous record set in 2017 of 937 approvals.

Generics drugs play an important role in the U.S. pharmaceutical market by providing patients with an alternative, and often much cheaper, treatment options. With U.S. drug prices among the highest in the world, generics provide significant financial relief for millions using prescription drugs. As FDA Commissioner Scott Gottlieb recently announced, “Through our efforts, generic drugs entering the market from January 2017 through July 2018 saved consumers $26 billion through the lower prices they enabled.”

Much of these record-breaking totals can be attributed to earlier policy changes. In 2012, Congress passed the Food and Drug Administration Safety and Innovation Act, which allows drug companies to utilize the FDA’s Accelerated Approval Process to receive an expedited FDA review by paying a fee. This process has cut nearly one year off the average time it takes for generic drug approval and has greatly expanded the generic drug market. Before the act passed in 2012, the FDA faced a backlog of about 2,800 generic drugs seeking approval. As of January 2018, the backlog was in the low 100s.

Fortunately, President Trump signed the FDA Reauthorization Act of 2017, allowing the FDA to continue offering user fee programs for expedited approval. The reauthorization also provides an opportunity to “revise and extend the user-fee programs” to include a variety of other applications. And more drug providers are utilizing the process.

But much work remains to be done. While generic drug approvals are at record-breaking highs, new drug approvals languish behind with only 59 approvals in 2018 (the FDA approved 100 new drugs in 2017). Further, as an article from the Washington Examiner notes, only 12 percent of the FDA’s 2018 generic approvals were for complex drugs, which have comparatively less generic competitors (and often higher prices).

Perhaps most importantly, including quicker approval times for a fee only adds to an already extremely expensive approval process. The FDA’s efforts to “deregulate by regulating,” such as by charging more for a less burdensome approval process, are an improvement. Unfortunately, it is still a poor substitute for genuine deregulation. But with national right-to-try regulation enacted and other proposed regulatory changes gaining traction, changes to the FDA’s approval process could be coming.

The FDA should be praised for this accomplishment. I hope its New Year’s resolution is to break the record again in 2019.