The hundreds of pending opioid abuse lawsuits likely have just received a jolt from a report from the Senate Committee on Homeland Security and Governmental Affairs linking opioid manufacturers and patient advocacy groups.
Released Monday, Feb. 12, the report notes more than $10 million in payments to patient advocacy groups and affiliated physicians from 2012 to 2017 and illustrates how a group of five drugmakers used the donations to shape public opinion and raise the profile of their drugs. The companies in statements Tuesday, however, cast the payments as standard or charged the report with serving a political agenda.
Sen. Claire McCaskill, D-Mo., led the effort to explore the relationship between the groups and Purdue Pharma LP, Janssen Pharmaceuticals Inc., Insys Therapeutics Inc. (INSY) , Depomed Inc. (DEPO) and Mylan NV (MYL) . Those companies were the largest sellers of opioids on an international basis in 2015, according to the report from McCaskill, the top-ranked Democrat on the committee. The inquiry began in March 2017 when the committee requested documents from the drugmakers regarding payments from the companies to 15 different groups.
The data show Purdue sent a total of $4.1 million to the groups, while Insys contributed $3.1 million, Johnson & Johnson Inc. (JNJ) affiliate Janssen paid $465,152, Depomed chipped in with $1 million, and Mylan paid $20,250. The companies made an additional $1.6 million in payments to physicians affiliated with the groups from 2013 to the present.
The report pointed out that payments from drug companies to patient groups is not unusual. According to PharmedOut, a project of Georgetown University Medical Center, almost all of the 7,865 groups across the country take money from drug companies. But the $10 million flowing from opioid makers presents a particular danger given the current abuse crisis and the lack of transparency involving the funding.
Another factor mentioned in the report is that while the money came without any outward strings, in some cases the groups that received money took positions supporting the companies' products or lobbied supporting their interests.
"Several groups have also lobbied to change laws directed at curbing opioid use, strongly criticized landmark [Centers for Disease Control and Prevention] guidelines on opioid prescribing and challenged efforts to hold physicians and industry executives responsible for overprescription and misbranding."
The drugs named in the report include OxyContin, Fentanyl and Vicodin.
The 23-page report, "Fueling an Epidemic: Exposing the Financial Ties Between Opioid Manufacturers and Third-Party Advocacy Groups," included not only which patient groups received money and from whom; it also detailed how drug manufacturers changed payment patterns based on factors that included market conditions and public opinion.
For instance, Purdue has come in for criticism over the past year over the opioid crisis, and the company's donations dropped from $558,068 in 2016 to just $50,135 a year later.
While Purdue scaled its donations back, Insys demonstrated its generosity by giving $2.5 million in 2017, the largest total for any manufacturer in any year in the report. The company in a statement characterized the payments as "patient focused," noting it "strived to comply with all such laws and regulations in making such contributions."
Insys made headlines last year when former CEO John Kapoor and six other company officials were arrested on racketeering, fraud and conspiracy charges tied to allegedly bribing doctors to prescribe paid medication Subsys outside normal boundaries.
The company pointed out in its statement that new management believes in emphasizing research and development, one reason for a 77% drop in donations in the second half of 2017.
Two of the companies in the report, Janssen and Depomed, engaged in a transaction in 2015 that is reflected in the report's data. In January, Janssen sold opioid-based brand Nucynta to Depomed for $1 billion. Up to that point, Janssen had paid $465,152 to patient groups, but with Nucynta off its books, it stopped making donations altogether.
But Depomed, with Nucynta now in its portfolio, picked up the pace in 2015 and 2016, paying out $668,357 in total, or more than triple the average of the three previous years. A subsequent deal led its patient group payments to decline to $80,879 in 2017: Depomed licensed Nucynta to Collegium Pharmaceutical Inc. (COLL) last year for just $10 million up front and a minimum of $135 million a year for four years.
In a statement, Depomed spokesman Christopher Keenen said: "These contributions covered corporate advertising, conference booth fees, sponsoring training certifications and membership fees. Depomed believes that it has acted responsibly with respect to the marketing and advertising of the Lazanda and Nucynta franchises."
A Janssen representative noted the company stopped developing opioid products in 2015 after the Nucynta sale, adding, "We recognize that opioid abuse and addiction are serious public health issues, and finding solutions will require collaboration among many stakeholders."
Mylan took issue with its grouping with the other drugmakers, as its payments totaled only $20,250 from 2015 through 2017.
"This executive summary is yet another example of Washington putting politics over people," the company said. "In fact, lumping Mylan in with this group of companies is not only highly irresponsible but also highlights more of a political agenda rather than finding real solution to the opioids crisis. Conspicuously, Sen. McCaskill omits the largest supplier of opioids in the U.S. that happens to be located in her home state. [Mylan did not name the company, but Mallinckrodt plc (MNK) has its U.S headquarters in St. Louis and makes oxycodone.] To address this national epidemic and find a solution, we believe the entire opioids supply chain needs to be examined instead of a targeted campaign against a select few."Purdue spokesman John Puskar said: "We have supported third-party organizations, including with annual dues and unrestricted grants, that are interested in helping patients receive appropriate care and share our commitment toward addressing the opioid crisis. We agree that the CDC's guideline [on opioid prescribing] is an important public health tool and have been directing prescribers to the guideline and its recommendations since it issued in March 2016."