(Originally published 1/19/11)
Legal developments show that drug companies may have already abdicated their fundamental responsibility.
Research published today in the New England Journal of Medicine indicates that two of the primary drugs used to treat opioid addiction are “highly likely” to be contributing to the opioid epidemic. By manipulating the active ingredient in “generic” versions of acetaminophen (sold as Tylenol) and oxycodone (sold as OxyContin), the addictive effects of these drugs could be significantly reduced.
Prescription opioids, in particular, have evolved a reputation for causing a wide range of health problems, including cancer-related pain and death, as well as constipation, nausea, and digestive disorders. While many of these side effects occur due to the inherent risk of prescription opioids, many people choose to take them because they appear to be less harmful than over-the-counter pain relievers.
Any therapeutic advantage of opioids presents a profound ethical and legal dilemma: just how does a pharmaceutical company properly weigh the risk/benefit of these drugs when it’s determining whether to market them to prescribers?
The consensus is that the prescription opioid industry must primarily protect the public interest in acquiring safe and effective drugs. In recent years, the dilemma has been exacerbated by increased black-market sales of prescription opioids, which are often cheaper and easier to obtain than traditional, safer, FDA-approved drugs.
The decline in such traditional treatments as cancer surgery and prolonged hospital stays to treat chronic pain also exposes patients to opioid abuse, addiction, and death. Many patients are given addictive pain medications without their informed consent.
Acetaminophen and oxycodone are generic versions of older drugs that were withdrawn from the market. Just because these drugs are effective and reasonably priced, however, does not mean they should be marketed to over-the-counter uses.
On Nov. 18, 2017, opioid company Mylan’s monopoly on large amounts of heroin base (sold as suboxone) to treat heroin addiction ended. Because patients have become so dependent on the drug, they are more than likely to die from abusing it, leading to less demand. Over the last decade, Mylan claimed it produced the highest amount of heroin base on the market—materially greater than its competitors, OxyContin and Suboxone—representing two-thirds of the market.
U.S. District Judge Dan Polster of the Southern District of Indiana has ordered Mylan to pay $1 billion to the states, Puerto Rico, and American Samoa for misleading the public about OxyContin’s addictiveness. This decision arises from a lawsuit filed by states in 2011, after the FDA required two new warnings about the risks of addiction for the oxycodone painkiller. Mylan responded by removing its deceptive advertising claim that its product was the “toughest pill to get addicted to” from its website. It defended itself in court by claiming that the warning labels were not forceful enough, that the company’s prior advertising did not indicate that prescription opioids were addictive, and that OxyContin’s extremely high doses were underrepresented in its marketing, even if some users were getting addicted.
Judge Polster’s decision is not good news for the millions of Americans suffering from opioid abuse. However, he also allowed Mylan to pay only $166 million, as the U.S. government claimed, with the rest going to victims. Thus, the jury found Mylan liable for negligence, not fraud. In this way, the drug manufacturer might be able to claim a “moral victory” in some cases. If the litigation proceeds as it appears to be, we may see a rapid return to generic versions of the prescription opioids that many doctors have insisted on using.
Whatever our opinions on the issue, the fundamental responsibility of the drug industry should be to protect the public interest in obtaining effective and safe drugs. This seems to be a reasonable ask. Rather than trying to establish otherwise, however, the industry should be ensuring that its products do not pose a risk to public health and safety.
Robert F. Garry is associate professor of Health Law and Policy at the Medill School of Journalism, Northwestern University. The views expressed in this article represent his own and are not necessarily those of the university. Please see http://medill.northwestern.edu/content/advocacy/legal-professor-expertise for more information about his work in the field of health law.