McCaskill investigation: Industry advocacy groups tied to opioid makers

An investigation into the opioid manufacturing industry launched by Sen. Claire McCaskill in March 2017 has led her to conclude opioid makers have funded efforts to minimize the knowledge about risks of opioid addiction and promote the drugs’ use, possibly setting the stage for an epidemic.

In 2016, in Missouri, about 60 percent of 1,300 drug overdose deaths involved opioids, and opioids cost the state $12.6 billion, according to the Missouri Hospital Association. The Centers for Disease Control and Prevention (CDC) revealed in July 2017, Howell County ranked highest in the state in prescription opioid saturation and 30th in the nation.

McCaskill, top-ranking Democrat on the U.S. Senate Homeland Security and Governmental Affairs Committee, announced this week the release of an eye-opening report, “Fueling an Epidemic: Exposing the Financial Ties Between Opioid Manufacturers and Third Party Advocacy Groups.” The report is the second product of the investigation, and the first Congressional report on the subject.

“The pharmaceutical industry spent a generation downplaying the risks of opioid addiction and trying to expand their customer base for these incredibly dangerous medications and this report makes clear they made investments in third-party organizations that could further those goals,” McCaskill said. “These financial relationships were insidious, lacked transparency, and are one of many factors that have resulted in arguably the most deadly drug epidemic in American history.”

The 25-page document describes significant financial investments by the top five opioid makers into third party groups engaged in pro-opioid advocacy over a long period of time, including minimizing the risks of opioid addiction and the endorsement of opioids for long-term treatment of chronic pain.

‘HIDDEN FROM PUBLIC VIEW’

Describing the report, McCaskill explained the investigation concerns sales and marketing practices of the opioid manufacturers and distributors with regard to addiction. The distribution side of the equation is still under investigation, she said, and a detailed report concerning those companies is forthcoming.

The latest release focuses on payments made to third-party advocacy groups by the five largest opioid manufacturing companies: Purdue Pharma, Mylan, Depomed, Insys Therapeutics and Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson.

“It is basically an attempt to look at something that is hidden from public view,” said McCaskill during a press conference call. “At a minimum, it is something that should be disclosed to the public.”

She said some of the companies may be doing worthwhile work, which is all the more reason why the information should be public record.

The report notes many of the groups have some form of IRS tax-exemption status allowing them to choose how much information to divulge regarding donors, if any at all; not one of the organizations receiving funds from the five major manufacturers has any kind of online list linking to donors, their specific donations and the projects benefiting from those funds. Some outright state they do not disclose such information to the public at all.

As a result, it’s difficult for doctors, patients or health care industry professionals to make informed decisions about the information they’re provided with regard to opioid medication, or the motivation behind any recommendations, said McCaskill.

As a result of the committee’s latest discovery, McCaskill said she is working with colleagues on both sides of the aisle to draft a bill, in progress now, tailored to address the lack of public disclosure regarding funding.

KEY FINDINGS

“Organizations receiving substantial funding from manufacturers have, in fact, amplified and reinforced messages favoring increased opioid use,” reads the report’s conclusion. “By aligning medical culture with industry goals in this way, many of the groups described above may have played a significant role in creating the necessary conditions for the U.S. opioids epidemic.”

Key findings from the investigative report show the five leading opioid manufacturers contributed nearly $9 million to 14 third-party advocacy organizations over five years, and additional payments of $1.6 million to group-affiliated doctors between 2013 and the present, bringing total contributions to more than $10 million.

According to the report, several of the groups received the majority of their outside contributions and grants for certain years within the specified time frame from opioid manufacturers.

Purdue Pharma, which makes five opioid analgesic medications, made the largest combined payout and the most diverse, giving more than $4 million total to 12 groups over five years, according to the report. The company reportedly gave more than $1 million to the Academy of Integrative Pain Management, formerly the American Academy of Pain Management, which ranked second in payments received overall, including those made to individuals affiliated with the company.

In a statement made Friday, a few days prior to the release of McCaskill’s report, Purdue Pharma announced it would be changing its approach.

“We have restructured and significantly reduced our commercial operation and our sales representatives will no longer promote opioids to prescribers,” said company officials, adding the corporation will now direct inquires about opioid products to health care professionals in its Medical Affairs department.

SPENDING PATTERNS

A change in Purdue’s reported spending habits appeared to take place in 2016. Prior to that year, estimated annual payments ranged from $812,000 to $973,000; in 2016, those payments dropped to about $558,000, and then in 2017, declined even more sharply to $50,000.

However, at about the same time Purdue was paying out less, Insys Therapeutics, the maker of Subsys, a highly addictive oral fentanyl spray, was paying out more, the report shows. That company went from paying out $14,000 to advocacy groups in 2012 to $2.5 million in 2017.

Insys is the same company that, last fall, came under legal fire when McCaskill released audio of a sales representative for the company allegedly portrayed herself as a doctor’s employee to promote the drug’s use, even for off-label purposes, ultimately resulting in a patient’s death.

According to the manufacturer’s website, Subsys is intended only for cancer patients who are already on round-the-clock opioid pain management.

A month following the audio release, Insys Therapeutics former CEO John Kapoor was arrested on multiple federal charges.

Since then, the Associated Press (AP) has reported a doctor in Rhode Island has come under legal fire for aggressive promotion of the drug. Citing grand jury testimony filed by prosecutors, AP reports the doctor is accused of jeopardizing patients’ health and causing one to lose 40 pounds and repeatedly vomit for years. Court documents show two patients required treatment with Narcan, an opioid overdose antidote, for “opioid intoxication.”

The case is one of several across the country brought against people associated with Insys Therapeutics and Subsys prescriptions.

FUNDS SUPPORTED PRO-OPIOID EFFORTS

The investigative team noted the groups under scrutiny in the report often pushed initiatives to echo and amply messages favorable to increased opioid use – and the financial interests of opioid makers.

According to the report, those advocacy groups issued guidelines to health practitioners that minimize the risk of opioid addiction or encourage long-term usage of opioids for chronic pain. A complaint from the city of Chicago cited in the report charged that two large advocacy groups said in 1997 the risk of patients becoming addicted to the medication was low.

One of those two organizations, the American Academy of Pain Medicine, is attributed by McCaskill’s office as saying in a 2009 patient guide that “opioids are rarely addictive when used properly for the management of chronic pain.”

That group received almost $1.2 million in contributions from four of the five manufacturers. Outlier company Mylan, manufacturer of several generic opioid medications, submitted a statement to investigators that it has a “very limited role” in the opioid-containing marketplace.” That particular company only made $20,250 in payments to one group, the American Pain Society.

“The report lays it out in black and white that this is not a problem that Mylan has,” said McCaskill.

The report also finds some advocacy groups have lobbied extensively to stop legislation restricting opioid prescribing or promote laws encouraging treatment, citing action from two such groups to protect a 2001 Tennessee law making it difficult to discipline doctors for overprescribing.

For her part, McCaskill has said in the past she believes legislating prescription practices, as a solution to the crisis, is less effective than would be top-down improvements in industry-led standards issued by such entities as the American Medical Association. She still believes that to be the case, she said, and hopes the investigation can inform those standards.

“I think that it’s important that we shine a bright light on this sector,” said McCaskill. “There is a blurring of the lines for doctors that makes getting this information difficult.”

Advocacy groups are also called into question by investigators for efforts to criticize or undermine CDC guidelines regarding opioid prescribing practices and limit accountability for medical providers prescribing opioids.

Despite its thorough look at industry practices, the report does not capture the full extent of the financial links between manufacturers and third parties, investigators note, as many of these relationships existed prior to 2012, and that data was not included.

To learn more about McCaskill’s investigation, visit www.mccaskill.senate.gov/opioid-investigation.