Unsettled Ethical Standards for Drug Use Impact the Workplace 17:18, August 25, 2016

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Unsettled Ethical Standards for Drug Use Impact the Workplace

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A blockbuster wakefulness drug’s use and abuse by big pharma, doctors, and amped-up workers illustrates the ways unsettled ethical standards in medicine impact the workplace.

Deceptive Dealings Drove Drug Prices Higher

Teva Pharmaceutical Industries must pay $125 million to settle a lawsuit against its predecessor company, Cephalon, for illegal and deceptive delay tactics to keep generic versions of the company’s drugs off the market, including antitrust violations and fake patent applications. As we recently noted, due diligence requires companies to own up to the wrongful practices of companies they purchase.

Prior to Teva’s takeover of Cephalon, 48 states had sued that drug-maker for anti-competitive practices intended to keep generic versions of Provigil (brand-name for modafinil), a wakefulness drug, off the market. According to the Georgia Attorney General’s (AG) press release, Cephalon quashed competition for more than six years by 1.) filing fraudulent patent applications 2.) suing potential competitors for “patent infringement,” then 3.) paying competitors to delay selling generic versions as a condition of settling the frivolous lawsuits.

The AG claims Cephalon’s deceptive practices go back more than ten years; 2005 and 2006 settlements with generic drug-makers required those companies to accept payment to delay the sale of generic versions until at least April of 2012. However, a court later deemed the patents that were the subjects of Cephalon’s lawsuits invalid and unenforceable. “Because of that delayed entry,” wrote the AG, “consumers, states, and others paid hundreds of millions more for Provigil than they would have had generic versions of the drug launched by early 2006, as expected.”

$35 million of the settlement will go to consumers who bought Provigil. Just over $500,000 will pay for Georgia’s share of costs, and the rest will go to state entities and individuals who made Provigil-related payments or purchases.

The 48 states were able to fund their successful efforts with partial proceeds of a $1.2 billion 2012 settlement between Teva and the Federal Trade Commission (FTC), which resolved the FTC’s related 2008 lawsuit against Cephalon for anti-competitive practices based on the illegal patent settlements of 2005 and 2006.

Super Soldiers & A Secret Society

It turns out that the blockbuster wakefulness drug in question is not without controversy. Modafinil is approved for narcolepsy, sleep apnea, and shift-work sleep disorder. But the US military has reportedly tinkered with using the drug to try to make “super soldiers” with artificially enhanced brains, according to ABC News. The report credits biomedical ethics professor Jonathan D. Moreno with the chilling statement that  “the human being is the weakest instrument of warfare . . . The first state to build superior fighters will make an enormous leap in the arms race.”

ABC also notes an alarming trend among  a “secret society” of healthy individuals (think lobbyists, programmers, and globe-trotting executives) to treat modafinil as a work-productivity drug, leading “ethicists [to] wonder why performance-enhancing drugs should be so readily available when they have been banned for Olympic athletes.” Medical ethicists also worry about the unstudied long-term effects of the drug, including sleep deprivation. In fact, The Atlantic points to studies showing that while “work doping” may be safe in low doses, high doses of such stimulants can lead to increased trips to the ER and even, rarely, psychosis.

Smarter Workers or Just Overworked?

The Harvard Business Review explores these ethical questions in a recent article:

(*) Assuming for the sake of argument that low doses of modafinil were legal and safe to use to reboot worker productivity, wouldn’t that be “cheating”?

(*) Would work use tend to perpetuate our plugged-in, 24/7 work-cycle that leads to early burn out?

(*) Would work use help employees clear their inboxes more quickly, go home earlier, enjoy a higher quality of life, and stay productive long-term?

(*) Would a drug-enhanced workplace culture lead to a neurological arms race?

(*) Would wide-spread work use be ethically acceptable?

(*) Would employers be justified in encouraging or even requiring work use?

Hypotheticals aside, there is a simpler way for employees to safely and legally increase their energy, productivity, and quality of life: get enough sleep and exercise, eat nutritious foods, and maintain a healthy work-life balance. Employers can encourage long-term employee retention and job-satisfaction by allowing (or requiring) their employees to unplug after-hours and by fostering a culture of purpose.

Doctors, Patients & Pharma-Monopolies

Some uses of modafinil (for example, street use as a “smart drug“) may raise legal issues; others may raise ethical questions. “Off-label” prescriptions, which doctors provide for purposes that the US Food and Drug Administration (FDA) has not approved, point to a murky area of medical ethics. A post in Harvard Law’s Bill of Health notes that pharmaceutical firms may not legally advertise off-label uses of FDA-approved drugs, whereas doctors may prescribe these drugs for non-approved purposes. But manufacturers may – and often do, when their financial interests dictate it – encourage doctors to prescribe drugs for off-label purposes. But ethical standards for how doctors should respond to such encouragement remain unclear.

For example, because the AMA Journal of Ethics recognizes the benefits of off-label uses (such as aspirin to prevent strokes before that use was FDA-approved), the Journal advocates transparency, and raises the possibility that doctors should seek informed consent of the patient before prescribing drugs for off-label purposes. By contrast, the author of the Bill of Health post seems to have little patience for these perceived benefits, instead arguing that off-label usage is anti-competitive: “[t]he FDA grants market exclusivity for new drugs—with resulting monopoly profits—only for approved uses. Allowing firms to earn monopoly profits from off-label prescribing undermines the whole point of FDA regulation.”

The Bottom Line

As these controversies surrounding the marketing and use of modafinil illustrate, many ethical issues elude simple resolution. Medicine often grabs the headlines because the ethical choice can be easily framed as “money vs. healthcare.” However, while some of the issues discussed in this article clearly do pit money against health, others are more nuanced. Conflicts of interest and institutional inertia are not limited the field of medicine; any organization with unsettled ethical standards for how to handle hard cases is likely to flounder in the face of uncertainty.

Concern for the bottom line need not be a barrier to building or enforcing strong ethical standards in any field. On the contrary, the evidence suggests that ethics lead to better business decision-making to the benefit of the bottom line.

Compliance training is one way employers can reinforce strong ethical standards among their workforce. If you’re unsure about how to do it, this case study on Namely, an HR-compliance startup that combined growth and culture with training, provides an inside look.

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Steve Treagus
Stephen Treagus, JD's, previous practice as an attorney specializing in employment litigation exposed him to the rough-and-tumble world of employment relationships gone awry. Today, this experience informs his articles and courses, helping employers avoid costly litigation and get employment law right. Stephen earned his JD from John F. Kennedy University School of Law and his BA from Sonoma State University.

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