Sept. 13U.S. Sen. Claire McCaskill (D., Mo.) took aim during a hearing Tuesday at marketing practices by the pharmaceutical industry generally and the behavior of one company in particular: Insys Therapeutics Inc., which made the powerful opioid believed to have played a role in the death of 32-year-old Sarah Fuller in Camden County last year.
Her mother, Deborah, described listening to an audio recording in which a drug company representative falsely said she was from Sarah's doctor's office and misled a pharmacy benefits manager into believing that Sarah had breakthrough cancer pain. That's the only condition that Insys' fast-acting fentanyl brand, Subsys, was approved to treat.
"Every day of my life, I must live with the realization that Sarah is gone because of Insys' greed," Fuller said. "I believe that Sarah's death certificate should be changed to indicate her death was a homicide and the cause of death should be changed to 'corporate greed.'"
Also testifying at the hearing was a pain patient named Jeffrey Buchalter, a veteran of four tours in Iraq, who now lives in Maryland. Insys allegedly paid his physician $34,000 as part of a "speakers program" about Subsys, after which his doctor prescribed inappropriate amounts of the drug, making him into what he called a "full-blown addict."
The pharmaceutical companies for decades have spun a web of influence throughout the medical profession and the public, said Adriane Fugh-Berman, an associate professor at Georgetown University Medical Center, in her testimony. They made payments to doctors that led the doctors to write more opioid prescriptions, published educational articles that touted their products' nonaddictive nature, and funded patient advocacy groups that unwittingly carried out the industry mission of raising the profile of pain so that drugs could be prescribed to treat it, said Fugh-Berman, who directs PharmedOut, a Georgetown project that is described on its website as advancing evidence-based prescribing and educating the health-care community about pharmaceutical marketing.
The whole area of prescription advertising looks like "we've lost our minds," said McCaskill, who pointed to a drug designed specifically to treat constipation brought on by opioids.
McCaskill, a ranking member of the Senate Homeland Security and Governmental Affairs Committee, announced in the spring that she was investigating the roles that five pharmaceutical companies, including Chandler, Ariz.-based Insys and Stamford, Conn.'s Purdue Pharma, the maker of OxyContin, played in fueling an epidemic that has killed more than 180,000 Americans since 1999. Over the summer, she added four more including Teva Pharmaceuticals, with North American headquarters in North Wales, and Malvern-based Endo International along with the three biggest distributors of prescription medications, among them AmerisourceBergen Corp. of Chesterbrook.
The committee last week released a report titled "Fueling an Epidemic: Insys Therapeutics and the Systemic Manipulation of Prior Authorization." The report discussed various state and federal investigations involving the marketing of Subsys, the company's only approved drug. FBI agents arrested a former CEO and five other executives last year on charges that they bribed physicians to prescribe it.
Much of McCaskill's 31-page report, which was accompanied by a video summary, focused on the Fuller case, especially the audio recording after the prescription was submitted. On the audio, the Insys rep identified herself falsely as a member of the doctor's staff and then, by careful placement of words, suggested that Fuller was suffering from the necessary "breakthrough" ... "cancer pain" when she never had cancer.
A different company rep attended and did most of the speaking at Fuller's office visit with her Cherry Hill doctor, whose license has been suspended, when the prescription was written a short time before, according to the patient's father, who also attended.
The 8-minute, 46-second audio was obtained by Richard Hollawell, an attorney in Marlton who filed a civil suit against Insys on behalf of Fuller's estate. He turned the tape over to the committee.
In a statement released after the hearing, Insys said that it "takes responsibility for the actions of its employees, including former employees, and has invested significant resources over the past several years to establish an effective compliance program."
The company has "fundamentally altered our business practices in connection with the prior authorization process that was discussed in Sen. McCaskill's report. Insys employees no longer interact with insurance companies on behalf of patients; these interactions have been outsourced to a Fortune 500 company with the relevant expertise and to specialty pharmacies with specific and professional responsibilities to patients," the statement said. It added: "By many estimates, the opioid crisis that is driving so many inquiries, including Sen. McCaskill's investigation, began more than a decade and a half ago."
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