Big Pharma settlements in kick-back cases fuel doubts on patient groups, too

actelion-300x110Patients now have more than half a billion reasons to wonder whether advocacy groups that purport to speak up for the special needs of folks with diseases and conditions like theirs really do so. Or has Big Pharma corrupted these organizations with cash?

The New York Times reported Actelion Pharmaceuticals, now owned by Johnson & Johnson, agreed to pay a $360 million settlement in an investigation by federal prosecutors of the firm’s allegedly funneling kickbacks through a charity that claimed to assist patients with the cost of drug co-payments. This case involved financial exchanges connected with pricey medications to treat a rare lung disease.

But the newspaper said it was just the latest of several such matters involving Big Pharma and patient advocacy and charity groups in which prosecutors sought to ferret out “contributions” designed to help makers plump up prices for already expensive products:

In 2017, United Therapeutics paid $210 million to settle similar allegations, and Pfizer paid nearly $24 million to do so in May. Several other drug makers have disclosed that they are also under investigation for their use of patient-assistance charities, including Biogen, Celgene and others. ‘Pharmaceutical companies cannot have it both ways — they cannot continue to increase drug prices while engaging in conduct designed to defeat the mechanisms that Congress designed to check such prices and then expect Medicare to pay for the ballooning costs,’ Joseph H. Hunt, an assistant attorney general for the Justice Department, said in a news release.

The newspaper explained how prosecutors viewed Big Pharma actions as problematic:

Drug companies often help patients pay their out-of-pocket costs through coupons or other financial assistance. These payments are not just about benevolence — they also help blunt the outrage over rising drug prices by limiting how much patients have to pay. Insurers then cover most of the cost. But federal anti-kickback laws prohibit companies from giving such financial assistance to Medicare and Medicaid beneficiaries because doing so is considered an inducement to buy their drugs. For years, drug makers have skirted those laws by instead donating to nonprofit charities, which then give the money to Medicare patients. Such arrangements are legal as long as there is no direct coordination between the pharmaceutical company and the nonprofit organization.

Acetelion, the New York Times said, exceeded acceptable bounds with its aggressive data collection and its use, and by other means, of steering patients to its payment programs offered by charitable and advocacy groups. They told the firm to stop. It did not, and, instead, bolstered its competitive position with its “charitable” donations.

As they have grown in ambition, size, activity, and influence, groups that advocate for patients, including those that provide them charitable support, have struggled to keep and build their own finances — and to ensure that their goals and missions don’t get corrupted by money.

The independent, nonpartisan Kaiser Health News Service has created a telling database that shows how slightly more than a dozen Big Pharma firms gave more than $100 million to influential, outspoken patient advocacy groups, raising questions as to whose interests such organizations most robustly represent. Concerns about outside funding apparently grew severe enough so that Otis Brawley, executive vice president and chief medical officer of the American Cancer Society, quit that organization after just under a dozen years.

In my practice, I see not just the harms that patients suffer while seeking medical services, but also their struggles to afford and access safe, efficient, and excellent care. This gotten even more difficult, as patients must make tough decisions about costly and invasive tests and treatments, and what benefits they might see from prescription medications that not only come with sky-high prices but also may turn out to be damaging and dangerous to them.

Major illness and injury can leave patients and their loved ones feeling frightened and alone. It can be invaluable for them to share in camaraderie and support from others who have shared their challenges. At the same time, however, this bonding and trust — forged in dire times in patients lives — should not be exploited and commercialized by patient advocacy and charitable groups. Prosecutors deserve credit for busting up cozy and wrong financial relationships between Big Pharma and these organizations.

But the groups themselves, as well as the ethical doctors, hospitals, and other care-givers who work with them, must lead the charge to clean up and avoid dubious dealing that undercuts their credibility and crucial relationships with communities that already know too much about pain and suffering.

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