Bioethics Forum Essay
Fentanyl at Your Door: Who are Pain Groups Advocating For?
In February, Senator Claire McCaskill (D-Missouri) published a report that revealed the unsettling relationship between opioid manufacturers and pain advocacy groups. Focusing on five opioid manufacturers, Purdue, Janssen, Depomed, Insys, and Mylan, the report found that manufacturers contributed $9 million to 14 pain advocacy groups within five years.
The U.S. Pain Foundation received the most money — a total of $2.9 million. The day after the report was released, the U.S. Pain Foundation website went down; a day later, the site reappeared with a prominent letter of explanation displayed on the homepage.
The letter states that: “$2.5 of the $2.9 million the report notes we have received over the last five years goes toward a large copay assistance program for cancer patients dealing with pain.” The program referred to appears to be the Gain Against Pain program, to which Insys Therapeutics, Inc. donated $2.5 million, according to the McCaskill report.
Most insurance companies have a tiered system in which patients pay little or nothing for generic drugs and higher copays for drugs deemed unnecessary or unnecessarily expensive (for example, a brand name version of a generic drug). Pharmaceutical companies often provide vouchers or coupons to cover copay costs for expensive drugs, because patients are willing to choose a higher-priced drug if using a copay coupon or voucher means they don’t have to pay the difference. The insurer, however, is stuck with what may be a usurious bill. A pharmaceutical company that pays a patient’s $50 copay with one hand while billing an insurer $1,000 for the same drug with the other hand is making an excellent investment.
The U.S. Pain Foundation letter states that the copay assistance program is “for cancer patients dealing with pain” and “helps to cover the high costs of treatment; assistance is not limited to any specific type or brand of pain medication.” However, when we asked for more information, we learned from a representative of NeedyMeds, the program’s administrator, that the only drugs covered are “analgesic medications that are prescribed for breakthrough cancer pain.” Breakthrough pain is a spike in pain that some cancer patients experience in between doses of long-acting opioids.
NeedyMeds has another copay assistance program, the Subsys Patient Assistance Program, which covers only Subsys, a highly addictive sublingual form of fentanyl approved to treat breakthrough cancer pain. In email correspondence, the same NeedyMeds representative stated that the program “is administered by NeedyMeds for Insys Therapeutics, Inc.” The representative also wrote that qualifying patients are provided Subsys “directly to the patient via FedEx shipping to their doctor’s office, home or hospice” free of charge.
In other words, neither the U.S. Pain’s copay assistance program nor the NeedyMed’s Patient Assistance Program cover standard pain medications; both copay programs cover only rapid-acting fentanyl products. One program covers only Subsys, and the other covers Subsys as well as other rapid-acting fentanyl drugs.
Subsys, the market leader among the fentanyl drugs used to treat breakthrough cancer pain, is manufactured by Insys, the sole copay assistance program sponsor listed by the U.S. Pain Foundation. “The funder of the program has no influence on the specific medications covered,” the NeedyMeds representative wrote. “The program reimburses participants for their copayments for any analgesic medications that are prescribed for breakthrough cancer pain.”
Although these copay charities cover multiple medications, they will still primarily benefit Insys. There are at least six so-called transmucosal immediate-release fentanyl (TIRF) products (including Subsys, Fentora, Actiq, Abstral, Lazanda, Onsolis, and generics). Subsys leads the TIRF market, with 42% of market share, based on number of prescriptions. In 2016, TIRF products generated $710 million in annual U.S. product sales.
Although Subsys is approved only for breakthrough cancer pain, it has been widely and inappropriately promoted and prescribed for other types of pain. Relatively few physicians prescribe Subsys; about 90% of sales were written by only 1,600 physicians, or about 0.18% of the total number of physicians in the U.S. Five physicians are charged with prescribing unnecessary Subsys; one was sentenced to four years in prison.
Senator McCaskill’s previous report, released in September 2017, describes how Insys manipulated insurance companies to approve payments for Subsys for off-label uses.
Another way to manipulate insurance companies – and Medicare – is through copay assistance programs. About 42 million of the 59 million people covered by Medicare are enrolled in Medicare Part D plans, which subsidize most of the expense of outpatient prescription drugs; the beneficiary often only pays a copay. Medicare forbids the use of coupons and copay vouchers on the quite reasonable basis that they are kickbacks.
Copay assistance programs (also called copay charities) were created to get around this restriction. Medicare allows copay charities to cover Medicare copays, so pharmaceutical companies funnel money through these groups to cover copay costs for Medicare patients while bilking Medicare, which bears the full cost of unnecessarily expensive (and often unnecessary, period) drugs.
Pharmaceutical companies sometimes give away products for free to patients who can’t afford them, but copay charities allow companies to appear altruistic while raking in millions. As the head of a copay charity wrote, “We provide a way for pharmaceutical companies to turn their ‘free product’ programs into revenue by finding long-term reimbursement solutions.” Copay charities may look like corporate altruism, but they are not. In fact, they enable pharmaceutical companies to make huge profits under the guise of charitable donations and to take advantage of payers.
Billion-dollar contributions from pharmaceutical companies resulted in copay charities accounting for 10 of the top 20 largest charities in the U.S. in 2014. For every million-dollar donation, pharmaceutical companies can generate up to $21 million in sales. The contributions of pharmaceutical companies to copay charities have come under scrutiny. Copay charities have been shown to make drugs from sponsoring pharmaceutical companies easily available while making competing drugs less available—for example, putting patients on waitlists they might never get off of. Former employees of the Caring Voice Coalition Inc., a copay charity that gave $129 million in 2016 to assist in copay payments of Medicare Part D beneficiaries, admitted to favoring drugs from Jazz Pharmaceuticals and other donors over nondonor companies.
More than 15 pharmaceutical companies, including Jazz Pharmaceuticals, Celgene Corp., United Therapeutics Corp., Gilead Science, and Johnson & Johnson, have received subpoenas from the U.S. Department of Justice since 2015 because of their relationship with copay assistance charities. Perhaps the Department of Justice should take a look at Insys, as well. Medicare has paid substantial amounts for Subsys — more than $97 million for 12,163 prescriptions of Subsys in 2015. This comes out to nearly $8,000 per prescription, compared to an average of about $300 per prescription for a generic fentanyl TIRF.
The U.S. Pain Foundation insists that pharmaceutical funding, “like any funding we receive, does not influence our values.” But when their activities increase sales of the products of their sponsors, their independence must be called into question. The U.S. Pain Foundation has “participated in more than 30 state and national advocacy coalitions, alliances, and task forces” and is “actively engaged in 70 legislative bills in 20 states with the support of 250 advocates engaged in outreach to policymakers.” How much has the money provided by opioid manufacturers influenced their efforts to protect overuse of opioids?
The U.S. Pain Foundation’s cozy relationship with its funders may be the rule rather than the exception. The Academy of Integrative Pain Management, the American Academy of Pain Medicine, and the American Pain Society together received over $3.4 million over five years from opioid manufacturers. Industry-funded pain groups have testified before Congress and state legislatures on policies that affect opioid manufacturers. What should strike the public as egregious is not only the impact that such groups have on the health of the public and political discourse, but the implications for the taxpayers who fund Medicare. The nonprofit status of such advocacy groups means that they do not pay taxes into the very federal system that funds Medicare, which pays the lion’s share of drug costs for all beneficiaries who use copay charities.
Senator McCaskill is introducing legislation to expand the Physician Sunshine Payment Act that would require pharmaceutical companies to disclose payments to nonprofit organizations. Awareness of financial ties is necessary to determine the extent to which a nonprofit’s agenda is bought. We can search pharmaceutical companies’ gifts to physicians in teaching hospitals. We can look up contributions to politicians’ campaigns. Why do we not demand that nonprofit advocacy groups be subjected to the same standards of transparency?
[This post has been updated with a correction. The U.S. Pain Foundation has the Gain Against Pain copay assistance program, but it is not associated with the Subsys patient assistance program.]
Breon Wise, Stephanie Obiorah, and Jane Kim are MS in physiology candidates at Georgetown University Medical Center and have completed this article as part of a research project for which they are receiving academic credit. Joy Eckert is the project manager for the DC Center for Rational Prescribing, a DC Department of Health-funded project based at the George Washington University Milken Institute School of Public Health that provides industry-free continuing education to physicians, nurses, and pharmacists. Sophie Krensky is the project manager of PharmedOut, a Georgetown University Medical Center project that promotes rational prescribing. Adriane Fugh-Berman directs PharmedOut. Adriane Fugh-Berman is a paid expert witness at the request of plaintiffs in litigation regarding pharmaceutical marketing practices. No other authors have conflicts of interest.
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