How FDA Failures Contributed to the Opioid Crisis

Andrew Kolodny, MD

AMA J Ethics. 2020;22(8):E743-750. 

doi: 10.1001/amajethics.2020.743.

Abstract

Over the past 25 years, pharmaceutical companies deceptively promoted opioid use in ways that were often neither safe nor effective, contributing to unprecedented increases in prescribing, opioid use disorder, and deaths by overdose. This article explores regulatory mistakes made by the US Food and Drug Administration (FDA) in approving and labeling new analgesics. By understanding and correcting these mistakes, future public health crises caused by improper pharmaceutical marketing might be prevented.

Introduction

In the United States, opioid use disorder (OUD) and opioid overdose were once rare. But over the past 25 years, the number of Americans suffering from OUD increased exponentially and in parallel with an unprecedented increase in opioid prescribing. Today, OUD is common, especially in patients with chronic pain treated with opioid analgesics, and opioid overdose is the leading cause of accidental death.

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Oversight Recommendations

While fewer clinicians are initiating long-term opioids, overprescribing is still a problem. According to a recently published report, more than 2.9 million people initiated opioid use in December 2017. The FDA’s continued approval of new opioids exacerbates this problem. Each time a branded opioid hits the market, the company, eager for return on its investment, is given an incentive and, in essence, a license to promote aggressive prescribing. The FDA’s continued approval of new opioids pits the financial interests of drug companies against city, state, and federal efforts to discourage initiation of long-term opioids.

To finally end the opioid crisis, the FDA must enforce the Food, Drug, and Cosmetic Act, and it must act on recommendations from the NAS for an overhaul of its opioid approval and removal policies. The broad indication on opioid labels must be narrowed, and an explicit warning against long-term use and high-dose prescribing should be added. The label should reinforce, rather than contradict, guidance from the CDC, the Department of Veterans Affairs, the Agency for Healthcare Research and Quality, and other public health agencies that are calling for more cautious prescribing.

The information is here.

Samsung faces ethics charges in France over deceptive advertising

French Press Agency
Originally published March 7, 2019

The French subsidiary of Samsung Electronics is facing charges of deceptive marketing over its corporate ethics pledges after local activists complained that the smartphone giant's practices in its factories, including the use of underage labor, violated human rights, two NGOs said Wednesday.

The preliminary charges were lodged in April against the South Korean firm by a Paris investigating magistrate following a complaint by two French activist groups: Sherpa and ActionAid France - Peuples Solidaires.

The complaint directly to the investigating magistrate circumvents prosecutors, who declined to pursue similar complaints by activists.

"This is the first time in France that it was recognized that corporate ethics pledges may be considered marketing practices that are binding on a firm," the activist groups said in a statement.

In their complaint filed in June 2018, a copy of which was viewed by AFP, the groups accused Samsung of not respecting the ethics pledges it makes on its website.

The info is here.

We need to talk marketing ethics: What to consider as a content writer

Natasha Lane
thenextweb.com
Originally posted June 30, 2019

Here is an excerpt:

Are content marketing ethics journalism ethics?

Content marketing and blogging aren’t journalism. Journalism is primarily impartial, and when content is created as part of a business’ marketing strategy, it’s understood that it can’t be entirely impartial.

However, well-written content (whether it’s blog posts, case studies, how-to guides, white papers, etc.) will have journalistic value. The bottom line is that a brand should seek to provide value through all their marketing efforts, so rather than trying to sell, content created with the intention to inform and teach its audience will be a legitimate resource to its readers.

And to make something a trustworthy resource, you’ll need to stick to the same ethical principles of traditional journalism. It’s about being honest and outright with the reader – honest in your intention to inform truthfully and honest about your biases. Providing appropriate disclosures to acknowledge potential conflicts of interest and making it clear in the byline for which company the author works are the most basic starting points.

Whose responsibility is it? 

In an era when audience trust is increasingly difficult to gain, businesses are best advised to follow white-hat practices across all their marketing strategies. But we have to face the facts – that won’t always be the case.

As freelance writers, we come across all sorts of offers. I know I did. It might be a request to write a review for a product you’ve never tried or to plug in some shady statistics.

The info is here.

Psychiatry’s Incurable Hubris

Gary Greenberg
The Atlantic
April 2019 issue

Here is an excerpt:

The need to dispel widespread public doubt haunts another debacle that Harrington chronicles: the rise of the “chemical imbalance” theory of mental illness, especially depression. The idea was first advanced in the early 1950s, after scientists demonstrated the principles of chemical neurotransmission; it was supported by the discovery that consciousness-altering drugs such as LSD targeted serotonin and other neurotransmitters. The idea exploded into public view in the 1990s with the advent of direct-to-consumer advertising of prescription drugs, antidepressants in particular. Harrington documents ad campaigns for Prozac and Zoloft that assured wary customers the new medications were not simply treating patients’ symptoms by altering their consciousness, as recreational drugs might. Instead, the medications were billed as repairing an underlying biological problem.

The strategy worked brilliantly in the marketplace. But there was a catch. “Ironically, just as the public was embracing the ‘serotonin imbalance’ theory of depression,” Harrington writes, “researchers were forming a new consensus” about the idea behind that theory: It was “deeply flawed and probably outright wrong.” Stymied, drug companies have for now abandoned attempts to find new treatments for mental illness, continuing to peddle the old ones with the same claims. And the news has yet to reach, or at any rate affect, consumers. At last count, more than 12 percent of Americans ages 12 and older were taking antidepressants. The chemical-imbalance theory, like the revamped DSM, may fail as science, but as rhetoric it has turned out to be a wild success.

The info is here.

Study Links Drug Maker Gifts for Doctors to More Overdose Deaths

Abby Goodnough
The New York Times
Originally posted January 18, 2019

A new study offers some of the strongest evidence yet of the connection between the marketing of opioids to doctors and the nation’s addiction epidemic.

It found that counties where opioid manufacturers offered a large number of gifts and payments to doctors had more overdose deaths involving the drugs than counties where direct-to-physician marketing was less aggressive.

The study, published Friday in JAMA Network Open, said the industry spent about $40 million promoting opioid medications to nearly 68,000 doctors from 2013 through 2015, including by paying for meals, trips and consulting fees. And it found that for every three additional payments that companies made to doctors per 100,000 people in a county, overdose deaths involving prescription opioids there a year later were 18 percent higher.

Even as the opioid epidemic was killing more and more Americans, such marketing practices remained widespread. From 2013 through 2015, roughly 1 in 12 doctors received opioid-related marketing, according to the study, including 1 in 5 family practice doctors.

The info is here.

James Gunn's Firing Is What Happens When We Outsource Morality to Capitalism

Anhar Karim
Forbes.com
Originally posted September 16, 2018

Here is an excerpt:

A study last year from Cone Communications found that 87% of consumers said they’d purchase a company’s product if said company showed that they cared about issues consumers cared about. On the flip side of that, 75% of consumers said they would not buy from a company which showed they did not care. If business executives and CEOs are following along, as they surely are, the lesson is this: If a company wants to stay on top in the modern age, and if they want to maximize their profits, then they need to beat their competitors not only with superior products but also with demonstrated, superior moral behavior.

This, on its face, does not appear horrible. Indeed, this new development has led to a lot of undeniable good. It’s this idea that gave the #MeToo movement its bite and toppled industry giants such as Harvey Weinstein, Kevin Spacey and Les Moonves. It’s this strategy that’s led Warner Brothers to mandate an inclusion rider, Sony to diversify their comic titles, and Marvel to get their heroes to visit children in hospitals.

So how could any of this be negative?

Well, consider the other side of these attempts at corporate responsibility, the efforts that look good but help no one. What am I talking about? Consider that we recently had a major movie with a song celebrating difference and being true to yourself. That sounds good. However, the plot of the film is actually about exploiting minorities for profit. So it falls flat. Or consider that we had a woman cast in a Marvel franchise playing a role normally reserved for a man. Sounds progressive, right? Until we realize that that is also an example of a white actor trying her best to look Asian and thus limiting diversity. Also, consider that Sony decided to try and help fight back against bullying. Noble intent, but the way they went about it? They helped put up posters oddly suggesting that bullying could be stopped with sending positive emojis. Again, all of these sound sort of good on paper, but in practice, they help no one.

The info is here.

Nike picks a side in America’s culture wars

Andrew Edgecliffe-Johnson
Financial Times
Originally posted September 7, 2018

Here is an excerpt:

This is Nike’s second reason to be confident: drill down into this week’s polls and they show that support for Nike and Kaepernick is strongest among millennial or Gen-Z, African-American, liberal urbanites — the group Nike targets. The company’s biggest risk is becoming “mainstream, the usual, everywhere, tamed”, Prof Lee says. Courting controversy forces its most dedicated fans to defend it and catches the eye of more neutral consumers.

Finally, Nike will have been encouraged by studies showing that consumers reward brands for speaking up on divisive social issues. But it is doing something more novel and calculated than other multinationals that have weighed in on immigration, gun control or race: it did not stumble into this controversy; it sought it.

A polarised populace is a fact of life for brands, in the US and beyond. That leaves them with a choice: try to carry on catering to a vanishing mass-market middle ground, or stake out a position that will infuriate one side but excite the other. The latter strategy has worked for politicians such as Mr Trump. Unlike elected officials, a brand can win with far less than 50.1 per cent of the population behind it. (Nike chief executive Mark Parker told investors last year that it was looking to just 12 global cities to drive 80 per cent of its growth.)

The info is here.

Nike, Kaepernick and the morality of capitalism

Steve Chapman

The Chicago Tribune
Originally posted September 5, 2018

Here is an excerpt:

The Republican Party has a large complement of corporate titans in its camp. But conservatives are reminded every day that some of the most successful and innovative companies are led and staffed by people whose worldview is deeply at odds with conservative ideology.

There is Amazon, whose founder and CEO, Jeff Bezos, owns The Washington Post, a frequent target of Trump’s animosity. There is Apple, where CEO Tim Cook has been a vocal critic of racial injustice and anti-gay discrimination. Facebook executive Sheryl Sandberg has written, “A truly equal world would be one where women ran half our countries and companies and men ran half our homes.”

Starbucks responded to Trump’s travel ban by pledging to hire 10,000 refugees. After the Parkland school massacre, Dick’s Sporting Goods stopped selling military-style firearms. Google, under pressure from employees opposed to creating “warfare technology,” withdrew from a Pentagon project on artificial intelligence.

But at the moment, the most visible face of corporate liberalism is Nike, whose new ad campaign features Kaepernick, a former San Francisco 49ers quarterback known for kneeling during the pregame national anthem to protest police abuses and racism. The campaign decision provoked a tweet from the president, who asserted, “Nike is getting absolutely killed with anger and boycotts.”

The info is here.

Doctors In Maine Say Halt In OxyContin Marketing Comes '20 Years Late'

Patty Wight
npr.org
Originally posted February 13, 2018

The maker of OxyContin, one of the most prescribed and aggressively marketed opioid painkillers, will no longer tout the drug or any other opioids to doctors.

The announcement, made Saturday, came as drugmaker Purdue Pharma faces lawsuits for deceptive marketing brought by cities and counties across the U.S., including several in Maine. The company said it's cutting its U.S. sales force by more than half.

Just how important are these steps against the backdrop of a raging opioid epidemic that took the lives of more than 300 Maine residents in 2016, and accounted for more than 42,000 deaths nationwide?

"They're 20 years late to the game," says Dr. Noah Nesin, a family physician and vice president of medical affairs at Penobscot Community Health Care.

Nesin says even after Purdue Pharma paid $600 million in fines about a decade ago for misleading doctors and regulators about the risks opioids posed for addiction and abuse, it continued marketing them.

The article is here.

Don't Blame PPC, Blame Poor Ethics

Kyle Infante
Forbes.com
Originally posted on February 2, 2018

Here is an excerpt:

To sum up the entire debacle in a nutshell: Marketing entities would create referral ads and websites to bid on highly sought after addiction keywords, drive traffic to their call centers and send people to facilities-based purely on profit. There was no clinical or medical prescreening being conducted, no thought put into placing that individual with the appropriate level of care. Suffering addicts and alcoholics were being misled by strategic digital marketing tactics and pushed to the highest bidder. Often, these high bidders had a slew of ethical issues. This drove the cost per click for each ad through the roof, and soon enough only the Goliaths could compete on PPC (pay per click). Unless you had the money to hire an advertising agency or had an in-house marketer with extensive digital experience, there was no way to survive.

Recently, Google stepped in and placed restrictions on these ads to curb the gross abuse of the market. In September 2017, Google began to limit the kinds of ads facilities could create and just this year placed a temporary ban on all recovery ads to audit the entire industry.

The article is here.

Freezing Eggs and Creating Patients: Moral Risks of Commercialized Fertility

Elizabeth Reis and Samuel Reis-Dennis
The Hastings Center Report
First published: 24 November 2017

Abstract

There's no doubt that reproductive technologies can transform lives for the better. Infertile couples and single, lesbian, gay, intersex, and transgender people have the potential to form families in ways that would have been inconceivable years ago. Yet we are concerned about the widespread commercialization of certain egg-freezing programs, the messages they propagate about motherhood, the way they blur the line between care and experimentation, and the manipulative and exaggerated marketing that stretches the truth and inspires false hope in women of various ages. We argue that although reproductive technology, and egg freezing in particular, promise to improve women's care by offering more choices to achieve pregnancy and childbearing, they actually have the potential to be disempowering. First, commercial motives in the fertility industry distort women's medical deliberations, thereby restricting their autonomy; second, having the option to freeze their eggs can change the meaning of women's reproductive choices in a way that is limiting rather than liberating.

The information is here.

Masked Marketing: Pharmaceutical Company Funding of ADHD Patient Advocacy Groups

Marnie Klein
Hastings Center
Originally posted June 29, 2017

In 1971, the United Nations passed a resolution prohibiting its member nations from advertising psychotropic drugs to the general public. More than 40 years later, this resolution has done little to halt pharmaceutical companies from marketing stimulants as treatments for attention deficit-hyperactivity disorder. The means by which, and the ethical dilemmas involved when, pharmaceutical companies market their products was discussed earlier this month at the annual PharmedOut conference, which investigated how industry influences medical discourse.

Alan Schwarz, the author of ADHD Nation, exposed how drug companies have, often covertly, sponsored educational resources and patient advocacy groups. These groups face a difficult conflict of interest: by accepting drug company funding, they can increase their reach to those looking for resources; however, their neutrality is compromised, particularly when they fail to disclose the funding source. The New England Journal of Medicine reports that pharmaceutical industry-sponsored advocacy groups may be likely to support drugs, as well as policy proposals, that cater to their sponsors’ financial interests.

One such pharmaceutical company is Shire. One of the British company’s highest-grossing products is Adderall, a stimulant used in treating ADHD that has earned the company billions in sales to date. Shire sponsors ADHD patient-advocacy groups, like Children and Adults with ADHD (CHADD).

The article is here.

How Gullible Are We? A Review of the Evidence From Psychology and Social Science.

Hugo Mercier
Review of General Psychology, May 18 , 2017

Abstract

A long tradition of scholarship, from ancient Greece to Marxism or some contemporary social psychology, portrays humans as strongly gullible—wont to accept harmful messages by being unduly deferent. However, if humans are reasonably well adapted, they should not be strongly gullible: they should be vigilant toward communicated information. Evidence from experimental psychology reveals that humans are equipped with well-functioning mechanisms of epistemic vigilance. They check the plausibility of messages against their background beliefs, calibrate their trust as a function of the source’s competence and benevolence, and critically evaluate arguments offered to them. Even if humans are equipped with well-functioning mechanisms of epistemic vigilance, an adaptive lag might render them gullible in the face of new challenges, from clever marketing to omnipresent propaganda. I review evidence from different cultural domains often taken as proof of strong gullibility: religion, demagoguery, propaganda, political campaigns, advertising, erroneous medical beliefs, and rumors. Converging evidence reveals that communication is much less influential than often believed—that religious proselytizing, propaganda, advertising, and so forth are generally not very effective at changing people’s minds. Beliefs that lead to costly behavior are even less likely to be accepted. Finally, it is also argued that most cases of acceptance of misguided communicated information do not stem from undue deference, but from a fit between the communicated information and the audience’s preexisting beliefs.

The article is here.

Gifts and influence: Conflict of interest policies and prescribing of psychotropic medications in the United States

Marissa King and Peter S. Bearman
Social Science & Medicine
Volume 172, January 2017, Pages 153–162

Abstract

The pharmaceutical industry spends roughly 15 billion dollars annually on detailing – providing gifts, information, samples, trips, honoraria and other inducements – to physicians in order to encourage them to prescribe their drugs. In response, several states in the United States adopted policies that restrict detailing. Some states banned gifts from pharmaceutical companies to doctors, other states simply required physicians to disclose the gifts they receive, while most states allowed unrestricted detailing. We exploit this geographic variation to examine the relationship between gift regulation and the diffusion of four newly marketed medications. Using a dataset that captures 189 million psychotropic prescriptions written between 2005 and 2009, we find that uptake of new costly medications was significantly lower in states with marketing regulation than in areas that allowed unrestricted pharmaceutical marketing. In states with gift bans, we observed reductions in market shares ranging from 39% to 83%. Policies banning or restricting gifts were associated with the largest reductions in uptake. Disclosure policies were associated with a significantly smaller reduction in prescribing than gift bans and gift restrictions. In states that ban gift-giving, peer influence substituted for pharmaceutical detailing when a relatively beneficial drug came to market and provided a less biased channel for physicians to learn about new medications. Our work suggests that policies banning or limiting gifts from pharmaceutical representatives to doctors are likely to be more effective than disclosure policies alone.

The article is here.

Doctors often overestimate promise of newly approved drugs

By Dennis Thompson
HealthDay News
Originally posted April 12, 2016

Here is an excerpt:

The U.S. Congress in 2012 gave FDA the power to designate a drug as a "breakthrough therapy" if preliminary clinical evidence suggests an advantage over existing medications.

But a survey of nearly 700 doctors revealed that many tended to misinterpret "breakthrough." Doctors often believed the drugs were supported by stronger evidence than the law requires to achieve that designation, said lead author Dr. Aaron Kesselheim. He is a faculty member at Brigham and Women's Hospital in Boston.

"When people hear 'breakthrough,' it gives them an inappropriately elevated sense of what the drug might do," Kesselheim said. "It may give physicians false reassurance about the outcomes they might expect to receive when they prescribe it."

The article is here.

Off-label Promotions: Pharma Wants More Freedom to Pitch Durgs

By Ed Silverman
Stat News
Originally published February 29, 2016

Drug makers have long argued that the Food and Drug Administration is squelching their free speech rights by barring off-label promotion of their medicines. A new proposal may give them a voice.

This month, a think tank at Duke University called for a new independent entity to review claims and recommend exactly what off-label information drug and device makers should be allowed to share with doctors.

Companies say current regulations prevent them from distributing important data to physicians about unapproved, off-label uses of their medicines. The FDA worries public health can be compromised if marketing claims aren’t backed up by solid evidence. A neutral third party, the authors of the white paper say, could provide much-needed arbitration.

The article is here.

Generation XXX

The Economist
Originally published September 26, 2015

Here is an excerpt:

Whenever pornography becomes more available, it sparks a moral panic. After the advent of girlie magazines in the 1950s, and X-rated rental films in the 1980s, campaigners claimed that porn would dent women’s status, stoke sexual violence and lead men to abandon the search for a mate in favour of private pleasures. Disquiet about the effects of online pornography is once more rising (see article). Most of it is now free. As commercial producers fight over scarce revenue, their wares are becoming more extreme. Because of smartphones, tablets and laptops, hardcore material can be accessed privately by anyone. The result is that many teenagers today have seen a greater number and variety of sex acts than the most debauched Mughal emperor managed in a lifetime.

The entire article is here.

The way to fix outrageous drug pricing in the US is simply to do what all other rich countries do

Written by Annalisa Merelli
The Quartz
Originally published September 25, 2015

Here is an excerpt:

The US is an outlier among industrialized nation: it’s the only rich country that does not offer a publicly funded health system, relying instead largely on private insurance. This affects the pricing of drugs in several ways that are independent from the actual regulations imposed on pharmaceutical companies.

First, and perhaps most importantly, the power in setting the price for drugs is skewed toward drug manufacturers. Unlike countries where universal health coverage is in place, the negotiating is left to individual care providers rather than being in the hand of a large, publicly funded buyer that’s able to negotiate since it purchases most (if not all) of the drugs.
For those with health insurance, high drug prices result in higher premiums, but it’s hard to notice the price increases directly. This means consumers lack awareness of the actual medication prices, and consequently, any pressure to keep them under control.

Plus, the costs of bringing a drug into the US market are higher, partially because of marketing expenses. The US is one of only two countries (the other being New Zealand) that allows direct-to-consumer advertisement of prescription drugs, while elsewhere promotion is limited to medical professionals. This raises the already steep marketing bill of drugs manufacturers. As Robert Yates, former World Health Organization senior health economist told Quartz, “the amount [pharmaceutical companies] spend on marketing is massively more than they do on research and development.”

The entire article is here.

Doctors got $84M from drug companies

By Lauryn Schroeder
The San Diego Union Tribune
Originally published July 29, 2015

Doctors in San Diego County received $84 million in payouts from drug and medical device companies last year, according to federal data.

Health professionals received payments for services such as consulting, promotional speaking and research, as well as gifts in the form of meals and entertainment, according to a review of federal data by The San Diego Union-Tribune. More than 107,000 transactions were documented.

The information is being gathered and disclosed as part of a federal effort to bring more transparency to relationships that could lead to conflicts of interest, if doctors take money or gifts and then prescribe certain drugs.

The San Diego data was dominated by some larger transactions, such as a doctor collecting royalties on an invention, or a La Jolla couple who recently sold their medical device maker to one of the large drug companies.

The entire article is here.

Lies, fraud, conflicts of interest, and bogus science: The real Dr. Oz effect

By Scott Gavura
Science-Based Medicine
Originally published January 29, 2015

I thought I’d written my final post on the Dr. Oz-fueled green coffee bean extract (GCBE) diet supplement fad. But now there’s another appalling chapter, one that documents just how much contempt The Dr. Oz Show seems to show for its audience, and how little Dr. Oz seems to care about providing advice based on good science. This week it was revealed that the “naturopath” that Dr. Oz originally featured in his GCBE segment, Lindsey Duncan, didn’t disclose a direct conflict of interest when he spoke. After inaccurately describing the supplement’s effectiveness, he directed consumers, using keywords, to web sites that he owned or operated. The infamous “Dr. Oz Effect” worked, with Duncan selling $50 million in GCBE supplements in the following months and years. This week it was announced that Duncan and his companies have been fined $9 million by the Federal Trade Commission. The documentation released by the FTC [PDF] gives remarkable insight into how a scam to make millions was launched, and how the Dr. Oz Show is a platform for the routine promotion of dubious “experts” and worthless supplements.

The entire article is here.