Thursday, 2 August 2018

F.D.A. Did Not Intervene to Curb Risky

F.D.A. Did Not Intervene to Curb Risky

F.D.A. didn't Intervene to Curb Risky Fentanyl Prescriptions

WASHINGTON — A fast-acting class of fentanyl drugs approved just for cancer patients with high opioid tolerance has been prescribed frequently to patients with back pain and migraines, putting them at high risk of accidental overdose and death, consistent with documents collected by the Food and Drug Administration.

The F.D.A. established a distribution oversight program in 2011 to curb inappropriate use of the damaging medications, but entrusted enforcement to a gaggle of pharmaceutical companies that make and sell the drugs.

Some of the businesses are sued for illegally promoting other uses for the medications and in one case even bribing doctors to prescribe higher doses.

About 5,000 pages of documents, obtained by researchers at the Johns Hopkins Bloomberg
School of Public Health through the liberty of data Act and provided to The NY Times, show that the F.D.A. had data showing that so-called off-label prescribing was widespread. But officials did little to intervene.

“If any opioids were getting to be tightly regulated, it might be there,” said Dr. Andrew Kolodny, an opioid policy researcher at Brandeis University, who wasn't involved in the investigation.

“They had the fox guarding the henhouse, people were getting hurt — and therefore the F.D.A. sat by and watched this happen.”

Officials at the F.D.A. said that they had reviewed evidence indicating that a lot of patients without cancer got the drugs.

But they said that piecemeal data from various stakeholders — prescriber surveys, insurance claims, and industry reports — made it difficult for the agency to live potential harm to patients.

“The information we've isn’t excellent, but it seems to point people that aren’t cancer patients are becoming this and other people who aren’t opioid-tolerant are becoming this,” Dr. Janet Woodcock, the director of the middle for Drug Evaluation and Research at the F.D.A. said in an interview.

“There has been an incredible back-and-forth with companies on the way to recover information.”

The class of medicine — quick-79 pages, 4.56 MB absorbing fentanyl sprays, tablets, and lozenges called T.I.R.F.s (for transmucosal immediate-release fentanyl) — contain a narcotic up to 50 times stronger than heroin and up to 100 times stronger than morphine.

Examples include Actiq and Fentora, made by Cephalon, and Subsys, made by Insys Therapeutics.

The F.D.A. began approving the drugs outside of the hospital settings in 1998 to treat cancer patients with “breakthrough” pain — sudden, sharp rushes of pain that overwhelm even around-the-clock regimen of other opioids.

But for people taking the drugs, maintaining a the round-the-clock regimen is vital: Without it, patients’ tolerance to them decreases, and that they are in danger of accidental overdose, respiratory depression, and death.

To restrict the damaging drugs only to “opioid-tolerant” cancer patients, the F.D.A. in December 2011 established a security program, called a risk evaluation and mitigation strategy, for a consortium of T.I.R.F. manufacturers.

The program required doctors to undergo training for prescribing T.I.R.F.s and to sign a form saying they understood that prescribing to other patients is often dangerous.

To administer the program, the consortium hired McKesson, the outsized national distributor that supplies drugs, including T.I.R.F.s, to pharmaceutical retailers.

In a statement, McKesson said it had been doing its job as a third-party administrator of the program and noted that its requirements were “developed jointly by the manufacturers and therefore the F.D.A. with ultimate approval resting with the F.D.A. McKesson administers the program consistently with these F.D.A. requirements.”

The safety program is going to be discussed during a meeting of an F.D.A. advisory committee on Friday, and therefore the Johns Hopkins researchers have submitted written testimony.

In a statement, Insys Therapeutics said it looked forward to the session and to “continuing to figure with the F.D.A. to strengthen the program to make sure that only opioid-tolerant adult cancer patients with breakthrough cancer pain who are indicated for this special and highly regulated class of medicines receives them.”

T.I.R.F. sales are lucrative: One prescription for a month’s worth can cost quite $30,000.

Dr. Woodcock said a stricter oversight program would be “extremely onerous” which the harm caused by the drugs is difficult to live, since “all drugs have risks and cause harm.”

With chronic back pain from two car accidents and a fibromyalgia diagnosis, Sarah Fuller, 31, needed pain medication.

She scheduled her medical appointment for a Monday in January 2015, each day her father took faraway from his job as a baker to accompany her.

They met with a doctor — and, unexpectedly, a sales a representative from Insys, maker of Subsys, an under-the-tongue narcotic spray.

“At no time were we told this drug was for terminally ill cancer patients,” said her mother, Deborah Fuller. “She had complete trust in doctors.

I don’t skills they put their heads on their pillows in the dark .”

Ms. Fuller said her daughter had hoped that the medication would enable her to volunteer in nursing homes together with her dog, Roxy.

But 14 months later, Sarah’s fiancé found her dead in her bedroom.

The fentanyl in her blood was between 15 and 20 times the acceptable level, consistent with a toxicology report.

The F.D.A. documents obtained by researchers included the survey by the industry group in 2013 during which nearly 40 percent of T.I.R.F. prescribers said that they had used the drug to treat chronic pain in patients who didn't have cancer, like Ms. Fuller?

In the survey, 42 percent of pharmacists stated that the drugs were appropriate for those ailments.

In another survey three years later, in February 2017, almost one in five T.I.R.F. prescribers (18 percent) and almost one in two patients (48 percent) said they believed, wrongly, that the medications were formally approved by the F.D.A. to treat illnesses aside from cancer.

Just over half of patients prescribed the drugs weren't already taking around-the-clock opioid regimen and thus were vulnerable to an accidental overdose, consistent with an analysis of economic health plan claims for quite 25,000 patients by the industry group in 2016. A follow-up analysis had an identical result.

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