In the Summer of 2021 I wrote about a controversial new drug for Alzheimer’s Disease. The drug, Aduhelm, did not have a lot of evidence showing it worked. It did have plenty of data showing it came with an extensive list of nasty side effects, including brain swelling and brain bleeds. The U.S. Food and Drug Administration (FDA) approved it despite the agency’s advisory panel of experts recommending against it. The decision was controversial, and several members of the advisory panel resigned in protest. One of the reasons for approval included that it was the first new drug application for an Alzheimer’s disease therapy in years, a disease with no effective treatment. Another reason was a patient advocacy group for Alzheimer’s patients lobbied for its approval. Patient advocates for other dread diseases also applauded the controversial approval.
Did these patient advocacy organizations know something the experts did not know? Well, maybe. Big Pharma showers patient advocacy organizations with millions of dollars in financial support. In other words, they (to some degree) are being paid for their support, which is another lobbying tool in Big Pharma’s tool chest. According to Kaiser Health News:
Pharma money is all over the place — in universities, companies doing continuing medical education for doctors and in prominent patient advocacy organizations that are household names across America.
Public Citizen, a consumer advocacy nonprofit, reports today that between 2010 and 2022, the drug industry’s main lobbying group and member companies provided at least $6 billion in grants to more than 20,000 organizations. The analysis, provided exclusively to KFF Health News in advance of its release, focused on the Pharmaceutical Research and Manufacturers of America (PhRMA) and 31 drug companies that were members of the trade group as of March.
The money dwarfs industry spending over that time on federal lobbying and campaign contributions to lawmakers.
Drug companies seeking drug approvals could spend millions on additional clinical trials. Or drug companies could donate to Members of Congress. Or they could pay lobbyists to lobby Members of Congress and officials at the FDA. Drug makers could even pay for advertising to encourage citizens to write their Member of Congress. Or they could do all the above. A multifaceted strategy works well but it is hard to beat the appeal of disease advocacy. More from Kaiser Health News:
“There’s a risk that those entanglements influence the work of those organizations,” said Matthew McCoy, an assistant professor of medical ethics and health policy at the University of Pennsylvania who has studied patient advocacy groups’ influence and transparency.
A couple examples you’ll recognize: The American Heart Association received $64.1 million over the 12-year period. The American Cancer Society and its advocacy affiliate, the American Cancer Society Cancer Action Network, together received $23.1 million.
It is safe to assume that drug makers are not showering patient advocates with money out of the goodness of their hearts. They presumably expect something in return. If a well-known patient advocacy organization is in favor of approving a particular drug, it makes it harder to reject a new drug application. An advocacy organization also has the ear of constituents and their families, who could complain to their Congressional representatives.
A natural priority of disease advocacies is affordable medications for their constituents. At the same time, a policy priority for drug makers is to prevent Medicare from establishing price negotiations for Part D plans and to encourage Congress to do nothing tangible to lowering high drug prices. Donating funds to advocacy groups is a way to bribe them to not rock the boat. Even though a disease advocacy may prefer lower drug prices they also want to be able to pay the bills and meet payroll for the organization. Kaiser Health News had this to say:
[T]he American Cancer Society Cancer Action Network, said in an emailed statement that the organization didn’t take a formal position on Medicare drug negotiation because “the policy’s impact on patient access to and affordability of cancer treatments was unclear.” In contrast, the Part D out-of-pocket cap “has evidence-based patient benefit.”
The American Heart Association similarly has touted its support of the three-year extension of enhanced Obamacare tax credits in the IRA, but was silent on drug price negotiation. “We have strict standards in place to monitor relationships with industry and protect against conflicts of interest,” Steve Weiss, a spokesperson for the group, said in an emailed statement. “These funds in no way influence our advocacy, programs or science.”
Many groups receiving grants do criticize high drug prices generally or highlight patients’ difficulties in affording care. But, “specifically calling out pharma companies doesn’t seem to be a huge priority for them,” Tanglis said.
It makes sense from a public relations perspective. If your organization can do little to actually lower drug prices for your constituents, at least take the money and do not rock the boat. But of course, donations influence policy positions.