Donald Trump’s FDA and the ‘United States of Oxy’

How will the pharmaceutical industry be impacted under the Trump administration? Who’s the new FDA Commissioner? How will e-cigarettes be effected? How will the opioid crisis be impacted?

Trump’s FDA and “the United States of Oxy”

By Lucas Richert

The US Food and Drug Administration (FDA) may be headed for a major overhaul under the Trump presidency and the agency’s new head, Scott Gottlieb. At a recent meeting with pharmaceutical industry leaders, President Trump asserted that “we’re going to be cutting regulations at a level that nobody’s ever seen before.” His most recent statements, made at a White House confab, echoed loudly throughout the medical and pharmaceutical industries.

Just talk? It’s tough to say, yet supporters of pharmaceutical deregulation have long wanted to reduce bureaucracy and lessen oversight of drugs and devices. Critics, by contrast, contend the drugs market could be destabilized and public health undermined. The tricky task will be to strike the proper balance of speed and safety, as well product innovation and consumer protections.

An American drugstore, circa 1963. Courtesy of Library of Congress.

Scott Gottlieb, a physician and regulator recently approved to lead the agency by the US Senate in a 57-42 vote, pledged he would lower prices, reduce approval times, and fight the widespread abuse of opioid painkillers. This kind of addiction, said Gottlieb, was “a public health crisis of staggering human and economic proportion.”

This rhetoric and attempted reforms at FDA are not new, but the devastating painkiller crisis certainly is.

Opioids

Gottlieb’s critics noted that he was too closely tied with the pharmaceutical industry to tackle the opioid epidemic. “We are suffering this public health epidemic because big pharma pushed pills they knew were dangerous and addictive, the FDA approved them, Senator Ed Markey (D-Mass) told reporters. The United States had been turned into the “United States of Oxy,” Markey added.

The FDA approved OxyContin, a powerful opioid to treat severe pain, such as in the case of patients with terminal cancer. With mild pain, though, the FDA deemed the dangers of addiction too great, and has not allowed the marketing of Oxy for such pain.

Not able to solve the opioid alone, the FDA nonetheless will play an important role. He has made this case quite forcefully. However, Gottlieb’s critics (mainly Democrats) have pointed to his past views on the regulation of opioids. In particular, he has suggested that policies restricting pharmacies and drug distributors might burden innocent patients.

This will be one of the defining issues of his career.

E-cigs

The Food and Drug Administration’s move in May, 2016 to crack down on e-cigarettes brought regulation in line with existing rules for cigarettes, smokeless tobacco and roll-your-own tobacco. This had been highly anticipated after the FDA issued a proposed rule over two years ago.

“Millions of kids are being introduced to nicotine every year, a new generation hooked on a highly addictive chemical,” U.S. Secretary of Health and Human Services Sylvia Burwell stated during the announcement of the new rules. She asserted, too, that health officials still didn’t have the scientific evidence showing e-cigarettes can help smokers quit, as the industry asserts, and avoid the known ills of tobacco.

The Trump administration recently approved a delay in the FDA’s e-cigs guidelines. It was a decision that divided officials in the public health establishment. And it’s undoubtedly true that several Trump administration officials, including FDA chief Gottlieb, have connections to the e-cig and tobacco industry.

From March 2015 to May 2016, according to Bloomberg, Gottlieb was a director of Kure Corp., a Charlotte, North Carolina-based firm that distributes e-juices and vaping pens in coffeehouse-style lounges known as vaporiums. Of course, he had a financial interest in the company as of March, according to financial and ethics disclosures, and promised to sell his stake if confirmed as head of the FDA.

“How to regulate e-cigarettes is one of the most critical questions on tobacco regulation that the FDA is going to be facing in the coming years,’’ said Vince Willmore, a spokesman for Washington-based Campaign for Tobacco-Free Kids.

Vaping will also be a significant issue for Gottlieb and the FDA. Getting the regulation right matters – not just in the U.S., but places like Glasgow and Vancouver.

FOR MORE ON E-CIGARETTES:

Why aren’t we regulating e-cigarettes?

Do We Regulate E-Cigs, Ban Them, or What?

Red Tape

The writer Matthew Herper suggested recently how “talk of speeding up [drug] approvals for serious diseases first gained traction in the early 2000s.” Actually, the trend extends much further back. Debate about quickening drug approvals has a complex and compelling history.

The FDA under President Ronald Reagan, for instance, offers a useful tool to evaluate the Trump administration’s approach to the FDA and the drug industry.

In mid-January, as Mr. Trump awaited his inauguration and the transition team worked furiously to establish his cabinet and select suitable agency nominees, the FDA generated serious debate. Trump met with Jim O’Neill, a venture capitalist, and a close friend of PayPal’s Peter Thiel. He met with Balaji Srinivasan, a cofounder of genetics testing firm Counsyl.

Both men subscribed to the idea – now conservative doctrine, according to Forbes – that the FDA prevented a flood of new drugs from hitting the market. Neither held an M.D., which has been for years a prerequisite for the FDA’s top job. Yet, by 20 January the frontrunner for the Commissioner’s job was Gottlieb, who had made it known publicly he believed the FDA should trim bureaucratic red tape and approve drugs in a speedier fashion.

Trump ultimately settled on Gottlieb, whose selection was welcomed by the pharmaceuticals sector. His ties to industry were questioned by Democrats, but the vote wasn’t close.

The Gipper’s FDA

Ronald Reagan, whether as a candidate or later President of the United States, did not desire the dismantling of the FDA, but neither did he trust it. In his optimistic view, its authority, like that of many other regulatory agencies, simply needed curtailing.

In 1975, he told an audience at the American Enterprise Institute, a conservative think tank, that the FDA was hurting Americans, yet also made clear he did not wish to totally “eliminate the responsibility of the FDA…”

The problem, as Reagan saw it, rested in the restriction of freedom of choice for American consumers, since the agency had established itself “as the doctor and decided that they will tell us what medicines are effective.”  He felt that a degree of regulation was necessary to protect Americans from each other, but the FDA had overreached and, as bureaucracies do, went beyond “protecting us from poisonous or harmful substances…”

In 1980, the Republican presidential ticket of Ronald Reagan and George Bush promised to change Washington. President Jimmy Carter represented failure, Republicans argued, be it botched rescue attempts and helicopter crashes in the desert, the loss of the Panama Canal, or an impotent economy. The jaunty and upbeat Reagan succeeded in shifting the policy discourse about the size and scope of federal government programs; harkening back to halcyon days, he moved the conversation about which government program to launch (or expand) to how much of a program’s or agency’s budget ought to be cut.

In 1981, the debate about drug regulation continued to polarize people; finding a middle ground was often difficult, and as the new administration took power, the outgoing FDA Commissioner Goyan articulated a consensus-oriented, centrist approach to drug regulation. Think tanks such as the Heritage Foundation and American Enterprise Institute promulgated changes to the FDA’s mission as a means of unleashing the once-mighty American pharmaceutical industry. This would fuel the U.S. industry and the greater economy.

For some, the FDA transcended presidential politics and ideology.  It protected all Americans – conservative and liberal – as it carried out its duties. “My view,” said the bearded, grey, and somewhat feisty Jere Goyan, “is that government regulation needs to strike a balance between preserving the maximum freedom for individuals while at the same time establishing the rules that are needed for us to live together, to survive as a society.”

Jere Goyan and President Jimmy Carter. Courtesy of Library of Congress.

By voting for Reagan, Americans indicated they wanted “modifications” to the current models – reform rather than removal. “It would be a mistake,” Goyan argued, “a tragic one, to interpret the election results to mean that the public wants a lessening of the standards that provide the foundation for the food and drug industries in this country, standards that make our food and drug supply the best in the world.”

Often, his approach went unheeded, overwhelmed by disputes about individualism and consumer choice and bureaucratic incompetence. One the one hand, many Americans regarded FDA staff members “as a bunch of demented bureaucrats running amok,” even though the agency’s “balanced” regulation of drugs was both “socially valid and moral.”

On the other hand, the president of the Pharmaceutical Manufacturers Association illustrated an alternative. Lewis Engman felt that taking medicines, like smoking cigarettes, was a matter of personal choice. “Any time you interfere with the basic market system,” he said in 1981, “you’re in trouble…the consumer is his own best guardian.”

Impossible as it was to know how the new president would transform the FDA in early 1981, political pundits, economic analysts and pharmaceutical industry insiders suggested that Reagan meant less regulation, which meant industry growth. The President of the National Association of Retail Druggists (NARD), Jesse M. Pike, sent a congratulatory letter to Reagan. It emphasized how delighted NARD was to see him in the White House and just how his regulatory reform beliefs would be good for business. In Pharmaceutical TechnologyJames Dickinson wrote, “everyone expects life to be easier for industry under the new Reagan Administration.”

Apparently, the Washington cocktail circuit was rife with speculation about the new administration repealing the Kefauver-Harris 1962 drug efficacy requirements – a move that would further enhance prospects for industry growth. This was nonsense, according to knowledgeable policymakers and reporters. Still, the fact that the notion was even bandied about, however fancifully, represented a substantial change in the debate about drug regulation.

Reagan promoting Chesterfield, circa 1952

The press envisaged a pharmaceutical industry boom in the near future. Newspapers reported how “The Drug Business Sees a Golden Era Ahead” and that pharmaceutical associations were positively giddy. Rep. James Scheuer (D-NY) publicly denounced the agency’s over-cautiousness and emphasized the need for immediate reform. It was risk averse, to the detriment of sick Americans. Moxalactum, he argued, was an American-made antibiotic for pneumonia used by Marshal Tito in Yugoslavia – yet it was not available in the United States. The narrative Scheuer framed was that the FDA was protecting Americans to death – and this before the onset of the HIV/AIDS crisis.

Mounting enthusiasm about pharmaceutical growth in the wake of the Reagan election was palpable. Reports indicated that the pharmaceutical industry and investors were confident about the future – a golden era – in this new regulatory climate. There was bullishness about drug stocks in general, and many predictions that pharmaceutical companies would start to generate more and more earning in 1981 and 1982. Overall, these stories proved to be accurate.

Ronald Reagan, however, had pledged in 1980, with trademark sincerity, not to gut the FDA. Rather, he made oblique references to the agency’s storied history and resorted to prosaic comments about the danger of hidebound power-hungry bureaucracies. “There’s a certain amount of regulation that is always necessary to protect us from each other,” he told CBS’s Walter Cronkite. “And that I recognize. We don’t want to, for example, eliminate the responsibility of the FDA…”

Much can be gleaned from Reagan’s public statements about the Food and Drug Administration, but they fail to reveal the entire picture. On May 20, 1986, Reagan described a meeting between Paul Laxalt, Jack Dreyfus, and himself. Dreyfus, who had “spent $50 mil. of his own money” was attempting to have the epilepsy drug Dilantin approved and found a roadblock in the form of the FDA. According to Reagan’s personal diary: “The villain in the case is the Fed. Drug Admin & they are a villain.”

 Red Herrings and Empowered Patients

Under the Trump administration, will the FDA play the villain role? President Trump will build on earlier Republican efforts to streamline the agency, whether these took place during Reagan or Bush presidencies. He has promised to remove barriers for overseas drugs and support ‘Right to Try’ laws, which will attempt to provide access to unapproved drugs. Indeed, some of these measures may help patients. And the Trump administration will be the right track if it can safely accelerate drug approvals, promote production and use of generics, and lower drug prices through increased competition.

Gottlieb and others have suggested they would radically restructure the drug approval process –  even if that remains something of a red herring argument. QuintilesIMS Institute, among various other organizations, have determined that the total time between patent and approval has dropped 31% since 2008. Yale researchers hold that the FDA is already considerably faster than Europe and Canada when it comes to approving drugs.

Another area of regulation that ought to be monitored closely is advertising. Every other nation besides the US and New Zealand has concluded that advertising powerful drugs for treating complex illnesses makes no sense when your target market lacks the qualifications to fully grasp the risks. How will powerful painkillers be regulated in the years ahead.

The drug industry wants to empower patients, to invest them in the writing of prescriptions. Looking ahead, it will be important to watch the administration’s and FDA’s role in faciliating this.

FOR MORE ON PATIENT ACTIVISM

Quarrelsome cannabis in the UK

Trimming Down: The Debate over Weight Loss Drugs and the Push for a Leaner FDA, 1979-2001

“The [industry] idea is that consumers are central players in their health management and therefore have a right to be informed of different drugs,” Lewis Grossman, a specialist in food and drug law, told the Los Angeles Times.

Yet, the practice of medicine should not be placed in the hands of amateurs and junk scientists. In the post-truth era, however, when an opioid epidemic soars and drug prices are hitting Americans in the pocketbooks, these “facts” could be lost in the noise.

**

 

Thanks for reading. For more, please follow the blog.

Lucas Richert is a Lecturer in History at the University of Strathclyde (Glasgow, UK). He is the author of Conservatism, Consumer Choice, and the Food and Drug Administration during the Reagan Era. He’s currently at work on a second book, tentatively called Strange Medicines: Drugs, Science, and Big Pharma in Culture.

Radicalism, Trump and the Past

In  the era of Trump and Hillary, we may occasionally forget about strange and seemingly ‘radical’ political moments.  But there have always been times of flux, of discrete moments of radicalism. I’ve tried my best to engage with some of these moments and some of the literature that surrounds these moments.

“The term political radicalism (or simply, in political science, radicalism) denotes political principles focused on altering social structures through revolutionary means and changing value systems in fundamental ways.”

Below are a few examples of specific radical’ moments.

EARLY 19th CENTURY RADICALISM

For example, Peter Adams’s The Bowery Boys: Street Corner Radicals and the Politics of Rebellion (Praeger, 2005). A fly-under-the-radar expose of 19th century radicalism, the book has a lot of resonance now.

bowery boys

At the heart of The Bowery Boys – and of street corner radicalism – is Mike Walsh. His was a New York of ethnic and class division. In his 2005 book, Adams contends that the Industrial Revolution had fostered division by modifying the nature of the urban workplace. People felt disenchanted. Empty. The body was a vessel to be exploited.

He also holds that, by 1820, economic and political power had come to be controlled by a group of commercial and merchant elites (26). Walsh was an anti-intellectual rabble-rouser, who recognized and inveighed against this growing inequality. He voiced the frustrations of New York’s poverty-stricken immigrants and nativeborn alike with his incendiary newspaper Subterranean.

In short, Mike Walsh was radical in a radical time and place, a point
hammered home with vigor in this book. Adams cites Walt Whitman, one
of Walsh’s on-again, off -again supporters as writing, “At this moment New York is the most radical city in America” (63). Adams himself characterizes New York as “a center of radical thinking,” a safe haven rife with bohemians, trade-unionists, and utopian socialists (63). Walsh, a product of this environment, touted the Subterranean as “the most radical paper on earth” (xxi). And Walsh’s Bowery Boys, according to Adams, represented “a radical insurgency that threatened the public order and existing class relations” (xxii)

This sounds very familiar…

The Bowery Boys is also an instructive book for those readers interested in the history of Tammany Hall, the Democratic Party’s internecine squabbling, and as popularized by Martin Scorsese in 2002, the radical ruffians and scrappers that participated in certain Gangs of New York.

 

POST-WAR 60s RADICALISM

I’ve also been very interested in the women and activists of the 1960s & 1970s. Hence, my close reading of Anne Valk’s Radical Sisters: Second-Wave Feminism and Black Liberation in Washington, D.C. (Illinois Press, 2010)

Valk investigates numerous grass-roots movements and organizations, such as the D.C. Women’s Liberation Movement, D.C. Area Feminist Alliance, and Gay Liberation Front. She offers absorbing portraits of movement figures like Mary Treadwell and Etta Horn, but the core strength of Radical Sisters is the delineation of the synergy, cross-fertilization, and antagonism between strains of feminism in Washington, D.C. This monograph, Valk’s first, is thus instructive for those readers with a broad interest in social movement interactions and feminism in the United States.

The book capably captures the points of both convergence and departure that characterized ‘radical’ women’s groups in Washington, D.C. On the one hand, Valk skillfully articulates how dogmatism stunted collaboration and consequently the longevity of certain organizations (the Metropolitan Abortion Alliance). Liberal feminists, she suggests, wanted legal and statutory reform and displayed a “fundamental faith in the soundness of America’s economic and political institutions,” whereas radical feminists, often far more bellicose, wanted to free women “within both personal and public realms” (4).

radical sisters
Read a full review here: https://muse.jhu.edu/article/465454

Radical feminists, in some instances, advocated the toppling of America’s capitalistic economy to terminate patriarchy, racism, and imperialism, thereby creating conditions in which an inclusive democracy would blossom.

In some cases, pugnacious radical women established shelters for battered women, children’s programs, rape crisis centers, and feminist publications such as Aegis andQuest. They were taking control of their bodies.

On the other hand, Valk correctly contends that the scholarly distinctions between radical and liberal are misleading and somewhat overplayed. She illustrates how “the line separating liberals and radicals often blurred” (8) and takes care to clarify how flexibility and adaptation also characterized interactions between movements like the Washington Area Women’s Center and National Black Feminist Organization. In explicating these tensions and negotiations, Radical Sisters paints a picture of a dynamic and protean feminism in the 1960s and 1970s.

Valk’s narrative begins with an overview of antipoverty and civil rights activism in the early 1960s, describing how branches of the Congress of Racial Equality (CORE) and Student Nonviolent Coordinating Committee (SNCC) supported women participants in these initial efforts. Together, these groups campaigned to influence welfare policies, reproductive rights, and the socioeconomic status of women. Meanwhile, Valk traces the concurrent rise of radical feminists, who not only took cues from liberal feminism but also served to spark a fiery exchange of ideas about ethnic and class division in Washington, D.C., social movements. She then addresses this evolving dialogue as she unpacks and highlights the Black Power era. “Most Black Power advocates reacted negatively to organized feminism,” she explains, “and black women sought to advance gender equality through racial oppression” (11).

Black-Power-Gossip

Finally, the narrative turns to lesbian feminism, another vital element of the fractionalized feminist landscape. According to Valk, the Furies, as the gay feminist collective was called, distinguished themselves by attacking homophobia in extant feminist organizations, igniting discussion around feminist philosophy, and ultimately alienating others in the broader Washington, D.C., feminist movement.

RECENT ‘BUSH’ RADICALISM

But then I got even more ambitious and modern with Radical in the White House?, which explored a number of books on George W. Bush and radicalism. These books included:

Fred Barnes. Rebel-in-Chief: Inside the Bold and Controversial Presidency of George W. Bush. New York: Crown Forum, 2006. ISBN 030-7336492

Bruce Bartlett. Imposter: How George W. Bush Bankrupted America and Betrayed the Reagan Legacy. New York: Doubleday Books, 2006. ISBN 978-0385518277

Sidney Blumenthal. How Bush Rules: Chronicles of a Radical Regime. Princeton, N.J.: Princeton University Press, 2006. ISBN 978-0691128887

Sean Wilentz. The Age of Reagan: A History, 1974-2008. New York: HarperCollins, 2008. ISBN 978-0060744809

I felt that clashes over George W. Bush’s legacy – his radical legacy – had begun in earnest.

Authors of all political colorations had begun crafting books and articles about the appalling mishandling of the U.S. economy, the tepid response to broken levees in New Orleans, and the early failed strategy in Iraq, among a host of other topics. Conservatives, for their part, were especially introspective about and critical of their agent in the White House. Michael Tanner, a writer at the Cato Institute in Washington, pilloried the Bush administration’s disloyalty to principles held by those on the Right, whereas others in the conservative establishment – for instance, Daniel Casse – strived to rebrand Bush as a pro-government conservative.

gwb

A significant element of this debate centered on Bush’s putative domestic and foreign policy radicalism. In fact, the topic was broached as early as January 2003. According to Bill Kellar, Bush, the ideological torch-bearer of Reaganism, had a high-quality “chance of advancing a radical agenda that Reagan himself could only carry so far.” Not only were political and economic conditions apposite for the continued promotion of a radicalized version of Reaganite doctrines, but the Bush administration in early 2003 proved adept in pivoting off scandal. In foreign affairs, moreover, Bush’s Middle East policy was considered a “radically new approach” to the region. According to Daniel Pipes, it was time for Americans to buckle up. Succeeding years were going to be a “wild ride.” By 2008, a number of authors – including Barnes, Bartlett, Blumenthal, and Wilentz – began to address the thrills and perils of that ride.

It appears Bush was a radical of various shades. He audaciously and radically bucked the approval of the conservative establishment because he believed in the veracity of his own ideas: on prescription drug entitlements, education policy, and Supreme Court nominee Harriet Miers, just to name three examples. Yet Bush also oversaw the enactment of hefty tax cuts, first in 2001 and then again in 2003, and these measures – historic in size and scope – symbolized to moderates and liberals a radicalized adaptation of President Reagan’s economic conservatism. Moreover, after his “bullhorn moment” at Ground Zero in 2001, Bush embarked on a radical foreign policy that not only expanded the wartime powers of the presidential office but also included the sanctification of torture and domestic spying.

bush bullhorn

This stimulating and provocative selection of George W. Bush books asks us to acknowledge wildly disparate views of Bush and his administration. The first, a macabre vision, holds Bush as an obdurate radical ideologue who oversaw the precipitous economic and moral decline of the nation.

The second, by contrast, casts Bush as a transgressive conservative, a man driven not by dogma, but rather by a desire for results, for positive conservative outcomes in American society – and by whatever means necessary, including government intervention. His radicalism thus lay in his willingness to defy the shrill cries of his own base. The third view, Bartlett’s forceful argument, holds that Bush was a disloyal scoundrel – in effect, a liberal – and it condemns the president for his very lack of radicalism.

Bush was pretty serene about the whole thing. As he told Bob Woodward: “History. We don’t know. We’ll all be dead.”

The debate continues.

Now, however. Now.

The era of Trump. And Clinton. And Sanders. In 2016, we have a different version of radicalism. According to National Review, “Sanders and Trump Have Risen from the Wreckage of a Broken Culture” and suggests pop culture can “normalize” radicalism with “astonishing speed.” Trump, for his part, has called for a Radical Islam Commission.  He’s also been recast as a Marvel super-villain.

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Let the good times roll.

A blast from the past…