They are some of the strongest painkillers available and were developed for use in only the most extreme of circumstances, yet opioids are prescribed at an alarming rate in the United States. Their use – and misuse – represents a major and growing safety concern and has led many medical professionals to refer to the situation surrounding opioids as an “epidemic” of abuse. The use of such a strong term is certainly warranted. Statistics show that nearly 20,000 people die annually from opioid prescription overdoses.
Sarah Fuller may be one such victim. Her family is suing Insys Therapeutics, the maker of Subsys, a drug to which Fuller became addicted before her premature death. Subsys is a brand name version of fentanyl and is a fast acting opioid that is 50 times stronger than heroin. It was prescribed to her for chronic pain as the result of two car accidents, yet the drug was only approved by the FDA for severe pain brought on by cancer.
New versions of Subsys come with a black box warning, which is the strongest warning the FDA places on any product. Subsys comes in spray form and is applied to the underside of the tongue. It is absorbed into the bloodstream instantly through mucous membranes and can begin to ease pain within five minutes.
Fuller would take Subsys every four hours – six times daily. When it was prescribed to her, her father recalls a sales rep being present in addition to his daughter’s doctor, Vivienne Morton, whose license has since been suspended. He says the salesperson did most of the talking and never mentioned “anything about risk” or what the drug was actually approved for.
Having a sales representative present in a doctor’s office during an appointment with a patient is not the only unusual or controversial tactic Insys Therapeutics has employed to push the use of Subsys. Fuller’s suit claims that the company “infiltrated the medical community with lies, misinformation, kickbacks, and financial rewards.” Specifically, USA Today reports that two pharmaceutical sales representatives have been arrested for paying New York-area doctors $259,000 for writing more than $6 million in Subsys prescriptions.
Additional allegations made against Insys include paying doctors to promote its drug, fraudulently imitating staffers from physicians’ offices to claim patients had cancer, and creating a nationwide conspiracy to bribe doctors. These alleged actions prompted a Senate investigation which yielded evidence suggesting that the pharmaceutical industry was one “apparently focused not on preventing abuse but on fostering addiction as a central component of its business model.” The Senate investigation also found that one Insys sales representative’s approach to patients was to “start them high and hope they don’t die.”
The opioid industry outspends the gun lobby by more than eight times to influence the government and regulations. If allegations over an industry-wide desire to get as many people as possible addicted to their medications prove true, then the power of that lobby would dictate that there is a problem in the United States far more severe than any “epidemic.” It would mean that there is a faction within the US government that is actively selling out those they were sent to represent and protect in the name of campaign contributions. In the meantime, families from America’s cities to its heartland endure the anguish of addiction and loss; all brought on by a few scribbles on a federally-controlled pad of paper.