The United States is still suffering from the opioid crisis that claims many lives. Although there are always risks such as addiction and respiratory depression, this class of powerful drugs may be helpful for patients in acute health conditions to relieve severe pain. Nevertheless, the investigation conducted by Frontline, in partnership with the Financial Times, reaffirmed the growing issue of the opioid epidemic and highlighted how pharmaceutical companies contributed to it. The crisis, which began in 1999, has already taken more than 750 000 lives due to drug overdose (Kuchler et al.) The majority of opioids are approved by the US Food and Drug Administration (FDA) only for a specific diagnosis. However, the article published by Joe Kita warns that so-called off-label drug prescription practice can be exploited as an evidence-practice loophole contributing to opioid overprescribing. Joe Eaton, in his article, also analyzes the Insys Therapeutics case to argue that profit-seeking drug manufacturers play an important role in fuelling the epidemic. Despite the FDA’s regulations, pharmaceutical companies utilize off-label prescription and speaker programs as loopholes to push even highly addictive painkillers.
One of the main reasons for opioid overprescribing is the FDA’s inability to regulate and control the usage of opioid drugs adequately. Insys’s fentanyl-based painkiller called Subsys underwent specific testing and then was approved by the FDA. According to Eaton, it was allowed to be used “only for a very specific purpose: treating the severe pain of cancer patients for whom other opioids had failed.” The approval process is complicated and demanding for firms that strive to offer new medication on the market, especially when it comes to painkillers containing narcotic substances. The CEO of Insys, Kapoor, allegedly was not happy with that profile because it limited the sales of the product that was perceived as the company’s most important one. Nevertheless, even when the drug is recommended and tested for a specific application, “it may be prescribed for different diseases or ailments, in different dosages, to other age groups, as a doctor sees fit” (Kita). It means that the FDA, as a regulatory authority, carries the policy of non-interference to the process of prescribing.
Moreover, such organizations as the American Psychiatric Association and the American Medical Association support this policy asserting that professionals can deal with it better by themselves. David Cavilla criticizes this approach by claiming that the FDA’s position on this issue is “an offense to the principle of evidence-based medicine” (Kita). He explains it by admitting the existence of a gap between strict manufacturing standards and the absence of prescription regulation. The author also insists that this kind of freedom that doctors enjoy deciding over opioid drugs contributes to overprescribing. Instead, the FDA used to issue a penalty or corporate settlement agreements in response to such kinds of violations. This retrospective approach, of course, could not avoid “more than 8,100” deaths since 2012 when Subsys entered the market (Eaton). Thus, the FDA provided companies with gaps in drug regulations.
The cases involving pharmaceutical firms like Cephalon and Insys showed the off-label prescribing weaknesses that evolve from the already mentioned FDA’s position. This common pharmaceutical industry practice was recognized as a loophole because “If a doctor saw a need, he or she could prescribe the drug for virtually any unapproved purpose” (Eaton). Currently, more than “21 percent of prescriptions written by office-based doctors” were for the use not initially mentioned by the FDA (Kita). Kita also stresses that executives of Insys considered it and designed their criminal conspiracy to increase sales and profits. If healthcare professionals are not obliged to recommend their patients only approved drugs for a specific indication, they can prescribe everything they think would have a positive effect. The same applies to opioids, which can be used even to treat fibromyalgia and car accidents injuries (Eaton). Medicines designed to help patients with terminal cancer dealing with abnormal pain would not be sold at high numbers because of their limited application. Thus, in order to maximize profits, manufacturers are able and usually interested to influence the decision-making process of physicians and doctors.
The speaker programs constitute another weakness of the system that can be exploited by ill-minded executives of particular firms. It is a common and legal healthcare practice that is about financing doctors to make them promote specific drugs among their peers by telling them about their benefits. Nevertheless, the already mentioned CEO, Kapoor, and his chief salesman Burlakoff exploited it by paying them “simply to write masses of Subsys prescriptions for all kinds of ailments” (Eaton). This practice successfully masked the illegal bribery practice that made the creators of Subsys extremely rich. Eaton reveals that Burlakoff was the head of a new speaker program aimed to find more doctors who are ready to accept a bribe. Insys salespeople were paid a high bonus if they convinced some professionals to prescribe their opioid drug. Moreover, doctors were encouraged to prescribe Subsys at the highest rates possible, increasing doses. The medicines approved by the FDA “sell for the same prices whether it is prescribed on-label or off-label”; thus, more prescriptions mean more money for drug manufacturers (Kita). Drug sellers are interested in additional uses that yield bonus profit.
In general, doctors received their knowledge and experience regarding off-label uses by communicating with colleagues, reading professional literature, and attending medical conferences. However, doctors in the Insys’ case were encouraged by the company’s representatives who used monetary and other unlawful incentives. For instance, sales managers even took them to strip clubs, restaurants, and sometimes offered an office job to win their loyalty. Eaton highlights that Insys made a deal only in case when profit from prescriptions was expected to be two times higher than the bribe itself. Former CEO Michael Babich explained that “we knew that if we got a patient on the drug, over time, they would become a greater revenue stream” (Eaton). Doctors played an essential role in this business model as they recruited people that almost inevitably became drug addicts. Although “$11 billion paid in penalties by pharmaceutical companies for unlawful promotion” during the 2004 -2017 period, pharmaceutical representatives try to find fresh ways to win the business (Kita). Such methods include funding of research and studies, free meals, and the company’s information dissemination, which are legal ones.
To conclude, doctors are free to prescribe what they think will help their patients following medical experience and good practice. There is no specific prescription regulation of the FDA that strictly controls the manufacturing and drug approval process. Healthcare professionals are allowed to write medicine recommendations off-label, not taking into consideration the FDA’s indications. Pharmaceutical companies that sell dangerous opioids still abuse such practice loopholes as off-label prescription and speaker programs. Hence, the industry should be better monitored and regulated.
Eaton, Joe. “How a Drugmaker Bribed Doctors and Helped Fuel the Opioid Epidemic.” AARP, 2020, Web.
Kita, Joe. “What you Need to Know About Off-Label Drugs.” AARP, 2019, Web.
Kuchler, Hanna, et al. “Opioids, Bribery and Wall Street: The Inside Story of a Disgraced Drugmaker.” Frontline, 2020, Web.