The American Heart Association finds that over 1 million heart attacks occur in the United States every year. Fourteen percent of all heart attacks are fatal. Many heart attacks and other cardiovascular issues result from heart disease, which is even more common (and often more deadly).
When a heart attack happens, victims need immediate medical attention. In some cases, emergency heart surgery may be necessary. When it is, physicians often turn to a drug named Heparin.
President Trump has nominated (and fired) numerous individuals to governmental positions while in office. Arguably, his most popular nominee was Food and Drug Administration Commissioner Scott Gottlieb. As a Modern Healthcare article notes, “Dr. Scott Gottlieb accomplished a rare feat during his two-year tenure as head of the Food and Drug Administration—he earned praise from Republicans and Democrats alike.”
Although popular, Gottlieb considerably expanded the power and regulatory oversight of the FDA. For example, he took unprecedented steps in regulating tobacco markets and began a “historic crackdown” of the vaping industry. He also established the agency’s first board to regulate homeopathic drugs, an expanding component of the healthcare field.
Young male doctor in telehealth concept[/caption]Imagine you suddenly became injured and needed medical help quickly. How long would it take you to see a physician? For an increasing number of Americans, the answer may be concerning.
According to a recent survey of 15 major metropolitan areas, wait times to see a physician for new patients increased by about 30 percent from 2014 to 2017. Some of the more eye-opening estimates include a two-month wait period to get a physical exam in Boston and a one-month wait for a heart evaluation in Washington state. Wait times in some areas have become so excessive that patients change their physician entirely.
After many successful years as a corporate manager, Roger retired in his late sixties to spend more time with family. Three years into retirement, his once energetic and outgoing demeanor deteriorated, and he no longer found interest in things he once enjoyed. Concerned, his physician referred him to a psychiatrist.
During his evaluation, Roger could not recall what day or month it was. He struggled to solve basic subtraction problems and performed poorly on a basic memory exercise. Unfortunately, Roger was diagnosed with Alzheimer’s Disease.
Alzheimer’s is a neurodegenerative condition that slowly robs victims of their memory, speech, and other cognitive abilities. Nearly ten percent of the U.S. population over the age of sixty-five suffers from Alzheimer’s. This concerning figure is expected to increase. By 2050, the number of Americans with Alzheimer’s is expected to more than double, notwithstanding a medical breakthrough.
Fortunately, such a breakthrough may be here.
Recently, drug producer Biogen announced exciting news regarding its experimental drug named aducanumab. After conducting an analysis using an expanded dataset, aducanumab demonstrated the ability to curtail the devastating effects of Alzheimer’s including curbing memory loss and preserving the ability to perform other cognitive functions. These benefits may allow patients to preserve their precious independence and dignity.
Biogen’s pioneering discovery comes during a period when scientists were unable to develop a new drug to treat Alzheimer’s in the previous ten years. The news leaves many hopefully. As Hilary Evans from Alzheimer’s Research UK notes, “People affected by Alzheimer’s have waited a long time for a life-changing new treatment, and this exciting announcement offers new hope that one could be in sight.”
Remarkably, Biogen abandoned trying to get aducanumab approved by the U.S. Food and Drug Administration earlier this year. The project was first abandoned after aducanumab failed the agency’s phase 3 futility analysis. Phase 3 of the FDA’s approval process requires the most time and financial resources in addition to requiring larger sample sizes and more demanding evidence to complete.
However, the expanded dataset, using much larger sample sizes, revealed that patients taking larger doses of aducanumab benefited tremendously. As a consequence, Biogen is resubmitting aducanumab for FDA approval. Allowing the provider to resume the approval process would be highly unusual. Typically drugs require numerous positive trails to advance through phase 3. Currently, aducanumab has one.
However, the agency has approved drugs which did not meet historical standards in the past based on medical need and availability of treatment options. Meetings between the FDA and Biogen also suggest the agency is receptive to resuming testing.
If the FDA allows Biogen to resubmit, it could provide an avenue for future drugs to receive approval without meeting current standards. Consequently, the agency’s approval process could face scrutiny. It would not be the first time. Peer-reviewed research and many case studies highlight weaknesses in the FDAs drug approval approach.
From a policy standpoint, shortcomings in the approval process can make U.S. patients significantly worse off by delaying or failing to approve drugs based on the fragility of statistical findings. In her book Death by Regulation, author Mary Ruwart notes that although eighty-two percent of new drugs begin testing in the United States, only twenty-five percent are first introduced there. Instead, many of these drugs became available to patients in the United Kingdom years before they are fully approved in America. With over 850,000 British citizens who have Alzheimer’s and Biogen also seeking approval in the U.K., history may soon repeat itself.
Biogen plans to submit a license application to the FDA in early 2020. From there, it is up to the FDA whether to allow Biogen’s pioneering drug to resume its path to approval or seek approval elsewhere. I sincerely hope exceptions are made. The quality of life for millions hang in the balance.
In 2001, twenty-one-year-old Abigail Burroughs was dying of cancer. After all conventional treatment methods failed to improve her condition, Abigail’s oncologist pleaded with the Food and Drug Administration to allow her to try Erbitux. At the time, Erbitux had not fully passed the FDA’s drug approval process. Abigail was denied access and lost her battle to cancer shortly after. The FDA eventually approved Erbitux in 2004 to treat the same cancer which cost Abigail her life.
Heartbreaking stories like Abigail’s (and thousands of others) provoked a country-wide movement to allow terminally ill patients the right to try experimental treatments to prolong their lives. This movement became the impetus for right-to-try legislation. Right-to-try legislation grants patients with terminal illnesses access to potentially lifesaving drugs before the FDA fully approves them. By side-stepping the FDA’s formal approval process, decisions to try unproven, although potentially beneficial, treatments are left to patients, physicians, and drug producers.
Josh Wilkerson had type 1 diabetes and depended on regular insulin injections to manage his blood glucose levels. Without them, he risked long-term complications from his condition or slipping into a diabetic coma. When he turned 27, he was no longer covered under his stepfather’s insurance. His employer-provided health insurance did not cover insulin treatments. Without coverage, Josh found himself paying nearly $1,200 a month for insulin, a burdensome expense for someone earning $16.50 an hour.
To make financial ends meet, Josh switched to another insulin named ReliOn. ReliOn is available without a prescription at many pharmacies and some national retailers such as Walmart and CVS. More importantly, it is often considerably cheaper than most prescription insulins. A vial of ReliOn (about a month’s supply) costs about $25. A vial of Humalog, a comparable kind of insulin, typically costs $275.
But ReliOn’s lower price is not without its tradeoffs. Older insulins, such as ReliOn, have more variable rates of absorption compared to more recently developed ones. This leaves patients more susceptible to blood glucose fluctuations. Unfortunately, Josh struggled to keep his blood sugars under control once he switched. After his fiancé found him unconscious, he was taken to the emergency room. Tragically, he passed away five days later.
Josh’s heartbreaking story has received widespread attention and is provoking many to call for action. Popular press headlines demanding action be taken to include “Walmart insulins are not the answer,” “Drug prices are killing diabetics,” and “A man who switched to affordable insulin died.” Others raise questions such as “Is over the counter, cheap insulin safe?”
Frustration over skyrocketing insulin prices and the challenges they pose to many diabetics is undoubtedly justified. Unfortunately, many have erroneously declared retailers like Walmart have failed and task government to step in and make insulin cheaper. As a piece in the Washington Post states:
Much to the relief of insulin affordability advocates, who have been raising awareness about costs and pushing for policy changes, the public is increasingly aware of this crisis. But instead of working with advocates to rectify the situation, too many people are simply promoting older, cheaper insulin…Such gestures come from a good place, but they put insulin-dependent people at greater risk and threaten to exacerbate the larger problem.
Such claims are fallacious at best.
Is true that ReliOn and other “older cheaper, insulins” are not a solution? Yes. However, no insulin is a solution. Diabetes management requires strict dieting, healthy lifestyle choices, regular physician visits, consistent sleep schedules, and a personal commitment to regularly testing blood glucose levels. Although modern insulins have their advantages, they hardly constitute a “solution” for a demanding and taxing life-long condition.
Further, medical studies indicate personal choices are far more likely to lead to premature death and diabetic-related complications than the kind of insulin used. A 2008 study published in the peer-reviewed journal Diabetes Care found that consequences of mismanaged diabetes in Demark (where insulin is significantly cheaper) were due to dietary and lifestyle choices. These findings, coupled with medical testimony that ReliOn is safe and effective, undermine claims that such insulins “threaten to exacerbate the larger problem.”
Most importantly, we should hesitate to call on further policies to make insulin affordable. As I have argued before, the primary reason insulin is so expensive in the United States is because of poorly designed policies that allow insulin producers to charge high prices. Under the FDA’s regulatory system, insulin is considered a biological compound rather than a pharmaceutical. Biological compounds can have their patents extended as long as their chemical composition is modified. This regulatory policy has allowed three insulin producers to encompass 99 percent of the insulin market for nearly one-hundred years, stifling competition and keeping their prices high. In that time, advocacy groups and government panels have failed to find any solution to the insulin problem.
In contrast, retailers like Walmart have done what policymakers, advocacy groups, and government panels could not: make life-saving medication widely available and affordable. In doing so, they have undoubtedly saved lives and provided financial relieve for numerous patients in dire situations.
We should be extremely hesitant to chastise retailers for making cheaper insulins available. Their critics’ talk, unlike their solutions, is cheap.
Luka Kinard started vaping when he entered high school and quickly became addicted. By his sophomore year, his grades were slipping, and he was no longer interested in activities he once enjoyed. At one point, Luka spent nearly $150 a week on vaping products.
After experiencing a seizure, Luka sought substance abuse treatment. Fortunately, he was able to kick his habit. However, recently collected reports by the Food and Drug Administration indicate other teens may find themselves in similar situations.
In April, the FDA launched an investigation of vaping after receiving nearly three dozen reports of young vapers experiencing seizures. Recently, the agency announced it had collected 127 reports of people experiencing seizures after vaping. Although rare, the Centers for Disease Control lists seizures as a potential symptom of nicotine poisoning.
Alarmed by the rapid influx of reports, acting FDA Commissioner Ned Sharpless called for “the public to submit new or follow-up reports with as much detail as possible.” He continued, “Additional reports or more detailed information about these incidents are vital to help inform our analysis and may help us identify common risk factors and determine whether any specific e-cigarette product attributes, such as nicotine content or formulation, may be more likely to contribute to seizures.”
Although the FDA acknowledges it has yet to find a causal relationship between vaping and seizures and will be unlikely to do so in the future, it may continue and strengthen its “historic crackdown” of the vaping industry. As former FDA Commissioner Scott Gottlieb noted, “the FDA is so concerned about the dangerous effects of e-cigarettes on American youth that the products may have to be pulled from stores.” Although the agency has yet to enact such measures, two Californian cities (San Francisco and Livermore) have already banned e-cigarette sales.
But continuing to regulate the vaping industry because its products allegedly cause seizures would be a considerable mistake.
First, only 92 (about 72 percent) of these reports occurred since this April. The rest happened over the previous ten years. However, vaping rates for minors have increased significantly over the same period, casting doubts that e-cigarettes are the culprit.
Further, seizures occurring from nicotine poisoning are rarely detrimental. Many last only a few seconds and do not cause permanent damage. All seizures are a cause for concern and might indicate potential neurological issues. But enacting heavy-handed regulations to prevent relatively rare and mild side-effects seems to be overkill.
Perhaps most importantly, as I have argued elsewhere, banning or sharply restricting access to e-cigarettes will likely considerably harm minors by motivating them to seek other nicotine products. The most likely candidate is cigarettes. Unlike the speculative relationship between vaping and seizures, medical research finds that smoking cigarettes strongly increases the likelihood for seizures. Cigarettes also contain tobacco, which includes other serious side-effects for younger users.
The FDA’s reports are concerning, but also highly speculative. Before we accept additional oversight, we should consider the harmfulness of vaping in conjunction with the harm caused by regulating it further. It may be the case that the FDA’s investigation is all smoke and no fire.
[This piece was co-authored by Vincent Geloso and originally published at the American Institute for Economic Research.]
Ramming an icepick through someone’s eyelid to remove a part of their brain sounds like a horrifying method of torture. However, this procedure, named the lobotomy, was a common method to treat mental illness in the United States for nearly 40 years. From 1936 until 1972, nearly 60,000 people were lobotomized. Most lobotomies were performed without the patient’s or their legal caretaker’s consent.
Unsurprisingly, the procedure was a spectacular failure. After surgery, patients often found themselves paranoid, emotionally volatile, incontinent, and with severely impaired intelligence. Surgical complications often left patients unable to function independently, requiring constant supervision and caretaking. When a patient was released from the asylum after being lobotomized, they typically found themselves returning within a few months. Upon their return, they often underwent a second (or, in one case, fourth) lobotomy.
The lobotomy has been described as “one of the most spectacular failures in the history of medicine.” But unlike many historic medical practices which seem barbaric and detrimental only in hindsight, the lobotomy was scorned and dismissed by medical professionals when it became most popular. By 1941, the American Medical Association denounced the lobotomy as ineffective. Shortly after, a world-wide consensus developed along the same lines. However, the procedure continued to grow in popularity, eventually reaching a “lobotomy boom” in the mid-1940s and early-1950s.
But why did the lobotomy become popular, and why was it used for so long after the medical community came out against it? In our paper forthcoming at Research Policy we argue the answer comes down to incentives.
In the early 1900s, a large public health movement led by politically-connected physicians called on the federal government to increase funding for public mental asylums. The movement was successful. Through the 1940s, public asylums and psychiatric hospitals gained additional federal funding based on the number of committed patients they housed. At the state level, physicians lobbied for less stringent commitment laws, reducing the legal requirements to have citizens involuntarily committed to asylums. Accordingly, commitment rates skyrocketed and those managing asylums, often called superintendents, received considerably more funding.
However, the staff-to-patient ratios within asylums did not keep up. By 1949, the National Bureau of Mental Hygiene estimated there was one asylum employee per 21 patients. Medical historians estimate committed patients often received only 30 minutes of contact with a physician per month.
Consequently, those managing asylums sought low-cost treatment options. The lobotomy provided such an opportunity. Unlike the therapeutic or hydro and shock treatments available (all of which are still used today), the lobotomy was comparatively cheaper and did not take years to complete. It also frequently made difficult patients more docile and easier to manage.
Because superintendents received federal funding based on the number of committed patients rather than offering effective medical care, treating patients was a secondary matter. State agencies funding public asylums also faced little reason to care for the patient’s wellbeing. As we note in our article, many asylums would document the number of lobotomies performed to secure additional funding.
In contrast, private asylums, which also faced overpopulation issues and treated the same patient demographics as public asylums, were funded by philanthropic donors and the patients’ legal caretakers. When patients failed to improve, were mistreated, or not offered sufficient quality of care, an asylum risked its profitability. Accordingly, using erroneous or excessively harmful treatment methods like the lobotomy would be detrimental to their bottom line.
Predictably, private asylums and private practicing psychiatrists were significantly less likely to lobotomize their patients. In 1950, during the peak of the lobotomy’s popularity, only six percent of lobotomies were performed in private practices or asylums. The literature on mental asylums also notes most lobotomies in public asylums occurred within a few months after a patient was committed. Lobotomies performed in private asylums or private practice occurred after years (or decades) of failed treatment and typically at the patient’s request.
The use of the lobotomy in US medical history is a shocking and concerning event which continues to leave many asking how such a thing could happen. By examining the incentives stemming from well-intended but ultimately harmful public health policy, we can provide answers. Furthermore, while the lobotomy continues to offer a cautionary tale of medicine gone astray, we argue it should also provide a cautionary tale of the harmful consequences of state-assisted health policies. The lobotomy is an extreme example, but the reasons it became popular and endured are eerily familiar.
A recent study conducted by the Pacific Legal Foundation examined 2,952 regulations issued from 2001 until 2017 by the Department of Health and Human Services. The study found that 2,094 of these regulations (about 75 percent) were unconstitutional. Many of these rules negatively impacted small businesses and individuals’ well-being.
The HHS’s unconstitutional, excessive, and harmful rulemaking were nearly entirely driven by its largest agency, the Food and Drug Administration. Over the same period, 98 percent of the regulations enacted by the FDA (totaling 1,860) were found unconditional. Twenty-five of these rules had an economic impact of at least $100 million.
Perhaps even more worrisome is what makes these regulations unconstitutional (and illegal). The Constitution requires that regulations enacted by federal agencies such as the FDA or their umbrella departments such as the HHS come from principal officers. Typically, these officers are appointed by the President after Senate confirmation.
However, the vast majority of these regulations were passed by “low-level officials and employees with no authority to issue rules.” Legally, these regulations cannot be backed by the rule of law. As Thomas Berry, one of the study’s co-authors, notes, “Only properly appointed officers in the executive branch may issue regulations that are binding on the public. This preserves democratic accountability for significant executive branch actions.”
But the frequency of FDA’s issuance of fines and product-recall mandates strongly suggests the Constitution has little authority to restrict the agency’s “evolving regulatory powers.” Unfortunately, these powers have been evolving since at least the 1930s. Regularly allowing those with no legal authority to issue regulations is one of many examples.
So what can be done to hold these regulators accountable? Although difficult, the answer is to reduce their power. Luckily, pressure from the Trump administration to deregulate has shown some success in reducing the FDA’s enforcement actions. Right-to-try legislation reduces the agency’s authority to restrict access to potentially life-saving but unapproved treatments for patients with terminal illnesses. Other efforts to deregulate are also underway.
The findings in the Pacific Legal Foundation’s study are alarming but predictable. Government power, including its influence over the healthcare field, increases rapidly when it is left unchecked. The FDA’s rapid and illegal regulatory expansion is just one example. Let’s hope studies like these and others motivate the public to push back and discipline the FDA. It’s certainly overdue.
Industry-leading pharmaceutical companies, often referred to collectively as “Big Pharma,” remain one of the public’s least trusted entities. A major reason for this lack of trust is drug producer’s perceived influence over powerful legislative and regulatory bodies.
David Mitch, president and founder of the campaign group Patients for Affordable Drugs, echoed this sentiment when he wrote, “I sort of view Big Pharma, as an industry, as an octopus with many tentacles, and at the end of every tentacle is a wad of cash… It reaches into academic medical centers, professional organizations, patient organizations, state houses, campaigns, Congress – they’re everywhere.”
A recent career change from one of the most powerful men in the industry isn’t helping this image.
After serving as Commissioner for the Food and Drug Administration for just under two years, Scott Gottlieb unexpectedly resigned in April to spend more time with his family. He left behind a legacy of unprecedented expansion of the FDA’s regulatory powers, a persistent commitment approving generic drugs, and an unclear path for the future of the agency.
Eighty-three days later, Gottlieb announced he was joining Pfizer’s advisory board. He will also serve on the company’s science and technology committee as well as its regulatory and compliance committee.
Pfizer, one of the largest drug providers in the United States, is thrilled to have him. As Pfizer’s executive chairman of the board Ian Read stated, “Scott’s expertise in health care, public policy and the industry will be an asset to our company and enable our shareholders to continue to benefit from a board representing a balance of experience, competencies, and perspectives.”
Although Gottlieb provides a wealth of experience and expertise, many are upset that his previous role at the FDA provides Pfizer with a too-close-for-comfort relationship with the agency. One STAT article liked the transition to “walk[ing] through the revolving door” between the FDA and the pharmaceutical industry. Outraged, Senator Elizabeth Warren called for Gottlieb’s immediate resignation from the Pfizer board.
While there is cause for concern whenever regulators and the private sector form a partnership, we should first ask why this partnership exists. As with many issues in the U.S. pharmaceutical market, the issue stems from the FDA’s regulatory power.
In 1962, the Kefauver Harris Amendments granted the FDA authority to determine whether drugs were effective and safe. Granting the agency the power to decide which drugs were safe or unsafe gave it more ability to discriminate between pharmaceutical firms competing to have their products approved first. To compete for FDA attention, drug makers now needed a way to navigate new safety hurdles to have their products approved.
That way was for the drug industry to hire FDA employees. As Dr. Mary Ruwart notes in her book Death by Regulation, only ten percent of FDA officials left the agency for the pharmaceutical industry between 1959 and 1963. After the amendments took effect, the percentage increased to seventy-six percent. Such figures continue today as the FDA continues to develop “evolving regulatory powers.”
It is no surprise that Pfizer was eager to hire the former FDA Commissioner. Gottlieb knows perhaps better than anyone which drugs the FDA is most likely to approve and how best navigate their approval process. Other former FDA employees share similar insights, placing them in high demand.
Until these insights become less critical for drug providers than satisfying patient needs, the problems posed by “Big Pharma” will continue. Without reducing the FDA’s regulatory power, the agency will continue to be Big Pharma’s enabler.