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‘Clean-up or cover-up?’ Philly-area drugmaker plays one-man army against FDA in opioid crisis

Edwin Thompson's company used to make Opana ER, an opioid, for Endo International. He's also waging a crusade against the FDA, saying that the federal agency's poor oversight has helped cause the opioid epidemic.

The webpage of Pharmaceutical Manufacturing Research Services (PMRS, Inc.), based in Horsham, PA .
The webpage of Pharmaceutical Manufacturing Research Services (PMRS, Inc.), based in Horsham, PA .Read moreInternet

Edwin Thompson, the president of a pharmaceutical firm in Horsham, Pa., didn’t hold back when he showed up at an FDA advisory committee meeting last June to talk about opioids.

“The root cause of the opioid epidemic is the illegal FDA approval of opioids for the treatment of chronic pain,” Thompson said, urging a “no” vote on a drug under consideration that summer afternoon, in a hotel ballroom just outside Washington, D.C.

“Your individual vote and committee recommendation,” he added, “will tell us if you’re the clean-up committee or the cover-up committee.”

Thompson was no typical critic. His company manufactured opioids. And as the opioid epidemic claims tens of thousands of lives every year – more than 47,000 in 2017 – Thompson has waged a crusade on the agency that approves the powerful painkillers.

In a slew of petitions to the FDA, his company has attacked the regulator’s methodology as scientifically “flawed,” to the point of being unlawful. He has named the FDA in several lawsuits, and even proposed his own new opioid to the agency – one, he argued, that “embodies a novel approach” to reducing the possibility of abuse. The FDA rejected it.

In December, his company, Pharmaceutical Manufacturing Research Services, filed suit against the FDA yet again, this time for denying its new drug application.

Thompson declined requests to sit for an interview for this story. But he sent the Inquirer a link to a preview of a 60 Minutes segment, set to air Sunday night, critical of the approval and marketing of opioids for long-term use. Former FDA commissioner David Kessler told the program: “The rigorous kind of scientific evidence that the agency should be relying on is not there.”

A spokesperson for 60 Minutes confirmed that Thompson will also appear in the piece.

One of Thompson’s main arguments is that the FDA doesn’t have clinical evidence that’s good enough, as required by law, to label an opioid as safe for chronic use – an approval carried by drugs such as Purdue Pharma’s OxyContin. (Purdue on Friday defended the clinical trials for OxyContin as the “gold standard” in the 1990s.) Nor, he says, does the agency have the evidence for “abuse-deterrent" labeling, meaning that a drug is harder to crush, dissolve, snort, or inject.

During the advisory meeting last June, Sharon Hertz, the FDA’s director of the division overseeing painkillers, insisted that opioids work for chronic pain. "This whole debate about absence of evidence ... has really gone entirely too far, and patients are currently being harmed as a result of a complete breakdown in scientific thinking,” she said, according to a transcript.

Thompson is not alone in challenging certain FDA-approved claims for opioids.

“Abuse-deterrent is really a marketing term,” said Diana Zuckerman, president of the National Center for Health Research, which has advocated, instead, for more specific phrasing, like crush-resistant. “The FDA has fallen into the trap of using terms that are really promotional in nature.”

The National Academies of Sciences, Engineering, and Medicine produced an extensive opioid-abuse report in 2017. The study, sponsored by the FDA under former commissioner Robert Califf, determined that “available evidence does not support the long-term use of opioids for management of chronic non-cancer pain.”

Instead, the report found, evidence indicates that taking opioids over the long-term puts patients at “increased risk” of developing opioid-use disorder, and overdosing.

Along the way, Thompson has won support from another figure who has often disagreed with the FDA: Raeford Brown, chair of the FDA’s advisory committee on analgesic and anesthetic drug products. Brown submitted a letter to the court in one of Thompson’s lawsuits, saying when it came to “abuse-deterrent” opioids, the agency “pressed the committee to review and make decisions based on data that was incomplete.” There are currently eight abuse-deterrent opioids on the market.

As for using opioids for chronic pain, Brown, a pediatric anesthesiologist, wrote there was “never any substantial evidence” for such a claim. The agency’s insistence on that labeling, he said in the letter, “is directly related to inappropriate prescribing of opioids to patients.”

“They don’t always want all the information,” Brown said of the FDA. “And some of the information they don’t want to hear about,” he told the Inquirer, “is the information Mr. Thompson presents to them in these repeated petitions.”

Thompson has worked in the pharmaceutical industry for more than 40 years. Pharma companies outsource various aspects of researching and making drugs, and that’s where the company Thompson founded comes into play. PMRS provides manufacturing services for four FDA-approved drugs and “numerous developmental and investigational drugs,” according to court filings.

Since at least April 2016, and as recently as November, Thompson has attended FDA advisory committee meetings on opioids, where he’s joined the ranks of members of the public, who are each allowed a few minutes to speak. Sometimes he has talked in the jargon of studies, clinical trial results, and approval histories, and at other times, in the blunt language of death counts.

In March 2017, committee members were talking about safety concerns related to Endo Pharmaceuticals’ opioid Opana ER. It had been linked to IV abuse and the spread of HIV and another illness. When it was Thompson’s time to present, he said his company manufactured Opana ER, and had “extensive experience” testing abuse-deterrent formulations.

Then he told the committee that “an unskilled person can easily extract Opana ER to high purity level ... using commonly available solvents and tools." He knocked one study of the drug’s abuse-deterrent properties as “clearly invalid.”

Asked after the meeting if he risked upsetting Endo or other drug companies, Thompson told the trade outlet Pink Sheet: “I was focused on having good science and good practices in place. I wasn’t focused on the other issues.” But Thompson also wouldn’t confirm to the publication whether he was working with other firms on abuse-deterrent medications. (Three months later, the FDA requested that Endo take Opana ER off the market, and the company, which has its U.S. headquarters in Malvern, agreed.)

Thompson’s strategy can appear puzzling. If his goal is to get his new drug application approved, he has gone about asking for the FDA’s blessing while also blasting the agency’s process as “hypothetical” and lacking scientific merit.

Also, if Thompson’s goal is to make a larger case about the system for approving opioids -- or to change that system entirely -- he has chosen an expensive approach. It costs about $2 million to file such an application without a waiver, not to mention the costs of the lawsuits he has filed. And courts tend to defer to the agency on questions of science, says Sara Koblitz, an attorney on FDA issues.

“It’s a bizarre tactic to take, which just highlights that he’s trying to make a point," said Koblitz, who has blogged about Thompson’s litigation. "All of this shows he’s trying to get attention from FDA ,and maybe the public.”

Compared to what’s on the market, Thompson argued that his product’s claims would be “more limited” and instead follow guidelines on opioid prescribing published by the Centers for Disease Control and Prevention. He wants his label to say it’s for acute pain, not chronic. And he wants the label to state “abuse-deterrent properties have not been proven," documents state.

His business “refuses to be part of the problem,” a company filing to the FDA stated, even if that means pursuing a drug application that is “most decidedly not a popular position to take with FDA nor industry.”

The agency has countered Thompson at nearly every move. In October, the FDA denied PMRS’s new drug application – saying the company submitted insufficient, or no data, on abuse-deterrence, and that it was proposing a “false and misleading” drug label.

The FDA also denied the company’s request for a hearing on the matter, saying PMRS’s “legal and policy objections” to the FDA’s approach to opioids didn’t justify a hearing. “The agency continues to take a variety of steps to address the public health crisis created by opioid abuse and the resulting addiction and death,” the order stated.