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.

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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.

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Beyond Vape Fear

Richard Roope, of the RCGP, has recently released a report on e-cigarettes.

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Essentially, the Royal College of General Practitioners, the official channel for General Practice of Medicine in the UK, has given their informed recommendations to health professionals regarding smoking cessation and the use of e-cigarette.

The recommendations:

1. GPs provide advice on the relative risks of smoking and e-cigarette use, and provide effective referral routes into stop smoking services.

2. GPs engage actively with smokers who want to quit with the help of e-cigarettes.

3. Where a patient wants to quit smoking, and has not succeeded with other options, GPs should recommend and support the use of ENDS.

BEGIN DIGRESSION.

[GENEVA – Electronic nicotine delivery systems (ENDS), of which electronic cigarettes are the most common prototype, are devices that do not burn or use tobacco leaves but instead vaporise a solution the user then inhales. The main constituents of the solution, in addition to nicotine when nicotine is present, are propylene glycol, with or without glycerol and flavouring agents. ENDS solutions and emissions contain other chemicals, some of them considered to be toxicants.The World Health Organization (WHO) submitted a report on Electronic nicotine delivery systems to the sixth session of Conference of the Parties to the WHO Framework Convention on Tobacco Control (COP 6), which occured in Moscow, Russian Federation, from 13 to 18 October 2014.]

END DIGRESSION.

4. GPs recognise ENDS offer a wide reaching, low-cost intervention to reduce smoking (especially deprived groups in society and those with poor mental health, both having elevated rates of smoking).

5. All GPs encourage smokers who want to use e-cigarettes as an aid to quit smoking to seek the support of local stop smoking services.

Harm-reduction has come out on top. Vape Fear has lost this one.

****

I have written my fair share about e-cigarettes in Canada, the United States, and Great Britain.

For example:

* ‘Why Aren’t we Regulating E-Cigarettes?,’ Regina Leader-Post [May 16, 2016]

* ‘Let’s Get Proactive with E-cigarettes,’ Saskatoon Star Phoenix [April 24, 2015].

* ‘Lot of Smoke and Mirrors with Vape Policy,’ Saskatoon Star Phoenix [November 28, 2014]

Often, I have suggested a measured response. My sense is, a little bit of regulation can go a long way. Minor rules can make a major difference. Don’t go overboard, but the waters are rough. Vaping should play by the rules, basically.

With my last op-ed back in May, people in Canada weren’t impressed with my approach. Folks were not interested in a middle-ground perspective. Here’s a list of the harshest responses to my articles on vaping. I’m basically the Red Skull mixed with Lex Luthor for suggesting some thoughtful rules might be in order.

1. “Please take the check that you earned from writing this trash and take an ethics course. Or a journalism degree.”

(Uh, I didn’t get paid. Woulda been nice.)

2. “It’s pretty obvious you don’t quite understand how the system works here in Canada…”

(Does anybody. There are no regulations? Ha.)

3. “You help tobacco companies profit from murder.”

(Jeez, really?! C’mon it’s my birthday.)

4. “…governments are making decisions based on MONEY, NOT PUBLIC HEALTH.”

(No comment.)

5. “What tobacco lobbyist wrote this trash?”

(I’m no tobacco lobbyist, but I sure do think they’re funny in the movies. Aaron Eckhart, anyone?)

Anyway, read the piece and decide for yourself. And share. http://leaderpost.com/opinion/columnists/why-arent-we-regulating-e-cigs

Crackdown? Regulating E-Cigarettes

In the Regina Leader-Post today I write about Canadian e-cigarette rules. Both the U.S. and E.U. have moved ahead with new rules. Should Canada?

*

Why Aren’t We Regulating E-Cigarettes?

Recently, the regulation and use of e-cigarettes in Canada, the U.S. and European Union has raised serious challenges for consumers, politicians, and health officials. Now, the U.S. and the EU have moved forward with new policies and Canada is being left in the dust.

In the U.K., an estimated 2.6 million people use e-cigs, prompting more calls for regulation. And this week, new regulations go into effect.

These include rules that limit the size of refill containers and the potency. All packaging must be “child proof.” Manufacturers will be asked to submit to government scrutiny. Finally, if three EU member states express a willingness to ban e-cigs, it will be possible to start a process banning them across the whole of the union.

Last week, the U.S. government also took broad steps to crack down for the first time on e-cigarettes, which have been growing in popularity among teens and are projected to be a $4-billion industry this year.

The Food and Drug Administration’s move brought regulation of e-cigarettes in line with existing rules for cigarettes, smokeless tobacco and roll-your-own tobacco. This action had been anticipated after the FDA issued a proposed rule two years ago on how to supervise the e-cigarette industry.

“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 said. She suggested that health officials still don’t have scientific evidence showing e-cigarettes can help smokers quit, as the industry asserts, and thus avoid the known ills of tobacco.

In Canada, considering that both the Harper Conservatives and Trudeau Liberals have dithered on crafting any meaningful policy, perhaps it would be easiest simply to follow the lead of the EU or U.S.

First, e-cigarettes have not been proven as a legitimate and conclusive aid in quitting smoking. Anecdotally, many believe they are a useful harm-reduction tool. Many former smokers praise the devices, while many physicians and public health experts also support their use. Yet, there is anything but scientific or medical consensus on the e-cig.

Second, the flavoured liquid that substitutes for nicotine lacks proper regulatory standards, so the safety is problematic. Business owners either can craft the liquid themselves or purchase it from anywhere they wish. This raises questions of security. It’s basically a “wild west” market. Without appropriate controls over the liquid mixing process or the supply and distribution chain, consumer protection is weakened. It is unthinkable that a pharmacy down the block could operate in an unregulated, unstandardized environment.

Also, a recent report in the U.S. found that e-cigs have “sickened rising numbers of young children,” and in most cases this involved swallowing liquid nicotine. In Lethbridge, an e-cig exploded in the face of young Ty Greer. It “lit his face on fire,” knocked out teeth and seared the back of his throat. The young man will bear the scars of this accident forever.

Do such examples mean we ought to crack down hard and regulate this market out of existence? No. Does this mean we should think proactively? Yes.

Alberta, Saskatchewan and Newfoundland and Labrador are the only provinces that have not banned sale of electronic cigarettes to minors, according to the Non-Smokers Rights Association.

Les Hagen of the group Action on Smoking and Health said what happened in Lethbridge is another reason why e-cigarettes must be regulated federally and provincially. By contrast, Jesse Kline of the National Post has told us, “Don’t believe the fear campaign — e-cigarettes can save millions of lives.”

It is time for federal leadership. We need rules that meet the needs of consumer protection and business owners, and balance health concerns for children with harm reduction for adults. According to federal Health Minister Jane Philpott, “Health Canada is actively reviewing health and safety data and scientific studies on vaping products, including e-cigarettes.” She noted a report will be issued reasonably soon.

It will be a tricky task, especially with the marijuana file looming large.

Lucas Richert teaches the history of pharmaceutical and recreational drugs at the University of Saskatchewan.

SMOKE AND MIRRORS – MORE ON VAPING

Last year I had opinion-editorials published in the Saskatoon Star Phoenix and elsewhere. Both focused on “vaping,” Oxford English Dictionary’s word of 2014.

My take was this: we need to think more clearly about e-cigarettes in Saskatoon – as well as the wider world. The government needs to get proactive. We, as consumers, should also think about them more critically. Essentially, we need to cut through all the smoke and mirrors.

300px-Humphrey_Bogart_by_Karsh_(Library_and_Archives_Canada) imagesarticle-1316595870295-0E038E5700000578-348441_466x436

Now, Saskatoon’s city council is voting (that is, tonight folks) on “a vaping ban” in the city.

As reported by the local paper, “If city council approves a proposed change to the local smoking bylaw, use of electronic cigarettes — also known as vaping — will be banned anywhere in Saskatoon that regular cigarettes are. The change, which will be considered at Monday’s council meeting, would expand the city’s Smoking Control Bylaw to include vaping as of Jan. 1, 2016. It would make vaping prohibited in public buildings, bus shelters, schools, businesses and other places cigarettes are currently not allowed.”

So, big changes are afoot here. And these changes could influence the smoking of traditional cigarettes at the local and provincial level. Indeed, many supporters of e-cigs make the case that the new technology deters relapses.

The Star Phoenix also quotes a local “vaping” business owner, Jim Wollf, who said he understands the argument that vaping puts unnatural chemicals into a person’s body, but argued it should be looked at as a harm-reduction strategy.

This is exactly the problem that my opinion-editorials have tackled. Here’s a taster:

“In September 2014, federal Health Minister Rona Ambrose called for more research on e-cigarettes from the Commons standing committee on health. Last month, the committee released its initial report, which called for an end to the legal grey zone that surrounds the technology in Canada and the implementation of a new set of rules that balances the benefits and risks of “vaping.”

Premier Brad Wall and the Saskatchewan government would be wise to take the committee’s advice and do the same. In their brief history, e-cigarettes have proven to be divisive products. They have raised serious challenges for consumers, politicians and health officials. It is time, however, to cut through the fog and for the provincial government to get proactive.”